Infected Blood Inquiry: The Report

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Volume 4

Presented to Parliament pursuant to section 26 of the Inquiries Act 2005.

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Contents

4.1 Role of Government: Response to Risk

This chapter examines whether government discharged its fundamental responsibility to ensure that treatment given through the National Health Service was safe. It looks at how government responded to the risk of viral infections in blood and blood products and considers whether actions could have been taken earlier and more effectively.


Key Dates

May 1975 despite Hepatitis B risk, “Dr Doctor” letter allows blood collections from prisons.

15 September 1980 Dr Walford describes the risks from non-A non-B Hepatitis in a DHSS minute: “can be rapidly fatal … or can lead to progressive liver damage

16 July 1982 Dr Gunson warns civil servants in DHSS of the possibility of AIDS being transmitted through blood.

May 1983no conclusive proof ” first used in line to take drafted for the Prime Minister.

9 May 1983 Dr Galbraith writes to DHSS recommending the temporary withdrawal of US blood products. His paper is not brought to the attention of ministers or the CMO.

June 1983 Council of Europe’s Committee of Ministers recommends taking “all necessary steps and measures” to help avoid AIDS.

1 September 1983 First AIDS donor leaflet is distributed to RTCs to be reviewed after three months.

29 January 1985 Expert Advisory Group on AIDS meets for the first time.

February 1985 Second AIDS donor leaflet.


People

Sir Donald Acheson Chief Medical Officer (1983 - 1991)

Professor Arthur Bloom chairman, UKHCDO

Kenneth Clarke Minister of State for Health (March 1982 - September 1985)

Dr John Craske virologist and chairman, UKHCDO’s Hepatitis Working Party (from 1977)

Norman Fowler Secretary of State for Health and Social Services

Dr Spence Galbraith director, Communicable Disease Surveillance Centre

Lord Simon Glenarthur (Lords) Parliamentary Under-Secretary of State for Health (June 1983 - March 1985)

Dr Harold Gunson consultant adviser to the Chief Medical Officer

Dr Archibald McIntyre principal medical officer, SHHD

John Patten (Commons) Parliamentary Under-Secretary of State for Health (June 1983 - September 1985)

Dr Diana Walford principal medical officer, DHSS

Sir Henry Yellowlees Chief Medical Officer (1973 - 1983)


Abbreviations

ACVSB Advisory Committee on the Virological Safety of Blood

EAGA Expert Advisory Group on AIDS

MRC Medical Research Council

SHHD Scottish Home and Health Department

RTC Regional Transfusion Centre


Introduction

As a matter of principle, a first duty of the state is to look after the safety of its population. That duty must extend to the safety of patients receiving blood or blood products.[1]

Put another way, and with specific reference to the role of the Secretary of State for Health (in the words of one who held that office between 2009 and 2010), “The job as I see it is to get the best possible health care – the safest, highest quality health care – for the people of England. And to protect them from risks. I guess that’s it really.[2] That applies, of course, with equal force to the people of Scotland, Wales, and Northern Ireland.

It was the responsibility of the Department of Health and Social Security (“DHSS”),[3] and of the Secretary of State for Health, and of those in positions of equivalent responsibility in Scotland, Wales and Northern Ireland, to ensure, as much as possible, that treatment given through the National Health Service was safe.[4] Norman Fowler, now Lord Fowler, who was the Secretary of State for Health and Social Services for nearly six years during the 1980s, described the DHSS’s role as being to keep up the review of public health, and take any action necessary to try to preserve it. Public health was, he said, “one of the most important things that we had to do … an absolutely vital issue.[5]

Ensuring the safety of the public from risks to their health is not just a question of taking steps to protect them. Kenneth Clarke, now Lord Clarke, who was Minister of State for Health between March 1982 and September 1985, accepted in evidence that an emerging potential threat to public health needs to be dealt with speedily.[6] The right steps should not only be taken – but taken without any unreasonable delay.

This chapter examines whether government discharged this fundamental responsibility.

Some specific and significant aspects of government activity (or inactivity) are addressed in other chapters of this Report: the failure to achieve self-sufficiency; failures in relation to the licensing of blood products, including the decision in July 1983 not to ban the importation of factor concentrates; whether there was delay in the introduction of HIV screening of blood donations; whether there was delay in the introduction of Hepatitis C screening of blood donations; the failures of decision-making in relation to surrogate testing for both HIV and Hepatitis C; government responsibilities in matters relating to the organisation and activities of the blood services and guidance on transfusion practice; all these are addressed separately elsewhere in the Report.

This chapter explores the following issues in particular: departmental policy on the collection of blood from prisons; the government’s response to the emergence of AIDS as a threat to the safety of blood and blood products; the response – or lack of it – to the letter and paper from Dr Spence Galbraith in May 1983; the response – or lack of it – to the Council of Europe’s Committee of Ministers’ June 1983 recommendations; the adoption of the “no conclusive proof” line; the production of the first and second AIDS donor leaflets; the role of ministers and of the Chief Medical Officer (“CMO”) during this period; the use of committees and working groups; the actions of the Scottish Home and Health Department (“SHHD”) at this time; and decision-making with regard to Wales and Northern Ireland.

It does not examine the governments’ responses to claims, made later, that governments had failed in their basic duty to keep the public safe and in doing so to act with all due speed. The chapters in volumes 6 and 7 of this Report explore those responses.

Knowledge of risk of infection from blood and blood products

It was well known to government in the early 1970s (and indeed much earlier[7]) that treatment with blood and blood products carried a risk of transmission of viral hepatitis. The seriousness of Hepatitis B was also well understood. Not only did the DHSS and SHHD have their own in-house medical expertise[8] to enable them to understand the risks of viral transmission but they had access to a range of external expertise through the multiplicity of committees and working groups that existed at various stages in the 1970s and 1980s.

Dr Diana Walford confirmed that throughout the period of time she was a principal medical officer in Med SEB[9] (ie from the end of 1979 to the end of 1983) she knew both that the transmission of non-A non-B Hepatitis (“NANBH”) through blood products and blood was a significant problem, and that it had the potential to have serious consequences in terms of chronic liver disease.[10] There was a general understanding too, which she shared, that the larger the pool size the greater the risk. She had a sense that not everyone within the DHSS was conscious of the fact that NANBH could potentially give rise to severe chronic disease; this was one of the reasons why she spoke about it “really quite forcibly” in her minute of 15 September 1980, where she wrote that “This form of hepatitis can be rapidly fatal (particularly when acquired by patients with pre-existing liver disease) or can lead to progressive liver damage. It can also result in a chronic carrier state, thus increasing the pool of these viruses in the community.[11] Dr Walford deliberately copied her minute “pretty widely”: it was addressed to John Harley in HS1A[12] and copied not only to her boss (Dr Ronald Oliver) but to Peter Wormald (John Harley’s boss), Stanley Godfrey (principal grade civil servant in HS1), Mr Hart (head of supply division) and others within the DHSS.[13]

No one receiving this minute could have been under any illusion from this point onwards about the seriousness of NANBH. No steps, however, were taken by the DHSS to ensure that the serious nature of this condition was also properly understood by doctors, patient cohorts or representative bodies (such as the Haemophilia Society) or the public.[14]

AIDS would soon emerge, in 1982, as a further threat to the safety of the blood supply and the safety of blood products. As detailed later in this chapter, the DHSS was well aware from mid 1982 of the possibility of transmission of AIDS through blood.

The organisation of the DHSS in the 1970s and early 1980s

The ministerial structure within the DHSS, as with other Westminster government departments at the time, involved three tiers of ministers: the Secretary of State, the Minister of State, and the Parliamentary Under-Secretary of State.

The role of Secretary of State for Health and Social Services had been filled by Barbara Castle (1974-1976) and David Ennals (1976-1979). Following the Conservative election victory in May 1979 Patrick Jenkin became Secretary of State. Norman Fowler took over in September 1981 (succeeding Patrick Jenkin) and remained in post until June 1987.[15]

David Owen was Minister of State for Health between 1974 and 1976, followed by Roland Moyle (1976-1979); their role is considered further in the chapter on Self-Sufficiency. Gerard Vaughan became Minister of State for Health in 1979 and was succeeded by Kenneth Clarke in March 1982; Kenneth Clarke remained in that position until September 1985.[16]

There were two Parliamentary Under-Secretaries of State with responsibility for health: one in the House of Commons and one in the House of Lords.[17] Geoffrey Finsberg was the Parliamentary Under-Secretary of State in the House of Commons from September 1981 to June 1983, replacing George Young, and was succeeded by John Patten (later Lord Patten) in June 1983 who remained in post until September 1985. Lord David Trefgarne was the Parliamentary Under-Secretary of State in the House of Lords from April 1982 to June 1983; he was succeeded by Lord Simon Glenarthur from June 1983 to March 1985.

Lord Fowler told the Inquiry that rapid ministerial change was very common and too rapid.[18]

Ministers below the level of Secretary of State had particular areas of responsibility allocated to them. Blood and blood products fell under the responsibility of Geoffrey Finsberg during his time in post; they then became the responsibility of Lord Glenarthur in June 1983. For a short period of time in 1983 – from 9 May 1983, when a general election was called, to 9 June 1983 when the election took place – there was a period of “purdah”[19] during which, to Lord Trefgarne’s recollection, he was responsible for the day-to-day control of the DHSS, although it was made clear to him by the Permanent Secretary (Sir Kenneth Stowe) that he should not make any substantive new policy decisions during that period.[20]

The Chief Medical Officer[21] (“CMO”) was Sir Henry Yellowlees, who had held that role since 1973, and then Dr (later Sir) Donald Acheson, who took over in late 1983 (with a three month period of overlap). Sir Henry was described by Lord Fowler as a somewhat distant character with whom he did not have regular meetings and as someone who “wasn’t really in the public health, general public health, area”.[22] Lord Clarke was less flattering still.[23]

There were two parallel civil service hierarchies within the DHSS at this time: a medical (and scientific) hierarchy, which ultimately reported to the CMO, and an administrative hierarchy which would take the lead on policy development, financial matters and support for ministers and which would report through the conventional civil service structure and ultimately to the Permanent Secretary.[24]

HS1 (divided into HS1A and HS1B) was a division in the administrative hierarchy which had responsibility for, amongst other health services, the blood transfusion services, blood supply and blood safety.[25] As at 1983 HS1A took the lead on AIDS-related problems within the DHSS.[26] There were two medical branches of particular relevance: Med SEB (whose responsibility encompassed blood and blood products) and Med IMCD (with responsibility for the surveillance of infectious/communicable diseases). It was Med IMCD which would receive data gathered through the Public Health Laboratory Service (“PHLS”) and sent to the Communicable Disease Surveillance Centre (“CDSC”).

The senior medical officer with particular responsibility for blood and blood products generally attended the annual meetings of the UK haemophilia centre directors, and thus the DHSS would have a good insight into trends and patterns of treatment for bleeding disorders. Thus, for example, the medical officer attending the United Kingdom Haemophilia Centre Directors’ Organisation (“UKHCDO”) meeting on 30 September 1980 – by this time Dr Walford – would know about the substantial usage of commercial concentrates (because Dr Charles Rizza gave a presentation on his report on the 1979 annual returns); would hear the expression of concern from Professor James Stewart as to the increasing usage of commercial Factor 8; would hear the discussion of Dr John Craske’s report of the findings of the Hepatitis Working Party and reference to the results of liver biopsy studies; would glean that first-time exposure to large pooled Factor 8 concentrates resulted in many cases of hepatitis; and would learn that there was an increasing number of people with haemophilia on prophylactic therapy.[27] Dr Walford indicated that the UKHCDO represented, for the DHSS, “the group” with relevant expertise, and that on questions of treatment and risks and benefits the DHSS would very much be guided by and defer to the UKHCDO’s views.[28]

It is important to record that not all material generated within the DHSS would be seen by ministers. Civil servants had to decide whether or not documents or information should be sent to ministers. If they exercised their judgement to do so, the material would be sent to the minister’s private office. There would then be a judgement by the private office as to whether the material actually needed to be seen by the minister. Where there was a change of minister, the incoming minister would not necessarily be briefed about developments that had occurred earlier and on decisions which had been made by one of their predecessors.

The collection of blood from prisons[29]

In 1971-1972, the United Kingdom introduced screening for Hepatitis B among blood donors.[30] Around this time, evidence emerged suggesting a higher prevalence of Hepatitis B in the UK’s prison populations compared to the general population, mirroring findings observed in the US.

The following year, in 1971, the World Health Organization (“WHO”) published A Guide to the Formation and Operation of a Transfusion Service[31]which identified prisons as optimal locations for blood collection.[32]

At a National Blood Transfusion Service (“NBTS”) regional transfusion directors’ (“RTDs”) meeting on 6 October 1971, chaired by Dr William d’A Maycock and attended by officials from the DHSS, it was confirmed that all regional transfusion centres (“RTCs”) in the UK were involved in collecting donations from prisons, borstals, or equivalent institutions. It was noted at the meeting that the American Red Cross had stopped collecting blood from donors in “correctional institutions” due to the incidence of Hepatitis B; two RTDs reported a greater incidence of Hepatitis B positive donations among prisoners than among other donors; and it was recognised that there was great difficulty in following up prisoners or keeping records of prison donors. The meeting agreed that prison governors should be asked to prevent known drug users from volunteering as donors but that before deciding whether to stop collecting blood from such institutions, more information should be obtained about the association with cases of serum hepatitis.[33]

Despite this indication that prison donation might not be safe, throughout the 1970s and early 1980s blood collection from prisons was a common practice in the UK. The Annual Reports on the Work of the Prison Department noted the practice of blood donation sessions in prisons throughout this period.[34] Similarly, in Scotland this practice was briefly noted in the SHHD’s annual prison reports presented to Parliament for the years 1978,[35] 1979,[36] and 1980,[37] indicating its ongoing nature and the significance attached to prisons as sources for blood donations during this period.

At a meeting of RTDs on 26 September 1973, again chaired by Dr Maycock and attended by representatives from the DHSS and from the SHHD, the primary focus was the prevalence of the Australian antigen (HBsAg) in blood donors. A key concern raised was the higher incidence of “antigenaemia”[38] in prisoners compared to the general public. The minutes recorded that the RTDs debated whether to continue blood collection in prisons, with half of them arguing against continuing to bleed prisoners and half advocating for continuing blood collection in prisons at least until the statistical significance of the figures was thoroughly examined. No decision was reached although it was resolved that any decision to discontinue bleeding prisoners would necessitate the DHSS first informing the Home Office, who supported the practice.[39] A report prepared for the meeting observed that “It seems clear that the incidence of antigenaemia among donors who are inmates of prisons, borstals etc. is higher than among other donors.[40]

Shortly thereafter, on 4 October 1973, there was a meeting of the Scottish National Blood Transfusion Service (“SNBTS”) directors, chaired by Dr Albert Bell of the SHHD, during which it was reported that Dr Maycock had presented data on the incidence of Au-positive blood[41] among prisoner donors and that “English directors were considering withdrawal of prison sessions.[42]

Subsequently, on 24 April 1974, the RTDs met again, with Dr Bell representing the SHHD and six representatives attending from the DHSS. They discussed an article from The Sunday Times regarding the North London Blood Transfusion Centre’s decision to suspend the use of blood from donors from tropical areas, who were considered a high risk group due to a higher incidence of Hepatitis B antigen. The RTDs agreed to form an ad hoc committee to determine which donor groups required special consideration and whether any groups should be excluded entirely from blood donation.[43] This might have afforded the opportunity for all concerned to agree to the exclusion of prisoners as donors, but this did not happen and the collection from prisoners continued in most RTCs.

In July 1974 a document prepared for RTDs in England and Wales reported the frequency of Hepatitis B in various donor groups, including new general public and factory donors, Armed Forces personnel, and inmates from prisons and borstals.[44] The incidence of Hepatitis B antigen in donations from new general public and factory donors in 1973 was relatively low,[45] whereas in prisons and similar institutions, it was approximately five times higher.[46]

In February 1975, the Advisory Group on Testing for the Presence of Hepatitis B Surface Antigen (the Maycock Group), established in 1970, produced a draft of their second report. This included findings from a sub-group formed in May 1974, which specifically considered populations with a high incidence of HBsAg. The appendix to the draft report addressed blood collection in prisons, acknowledging the “relatively high risk” of hepatitis transmission but suggesting that it was comparable to risks in other groups, such as drug addicts, who were less easy to identify in advance than prisoners. The sub-group recommended not discontinuing blood collection in prisons, provided that all donations underwent one of the more sensitive tests, such as RPH or RIA.[47] Two civil servants from the DHSS (one of whom was Dr Sheila Waiter, a medical officer) were secretaries to the Maycock Group and Dr Maycock, chair of both the overall group and the sub-group, was, of course, the consultant adviser on blood transfusion to the CMO.

This appendix was not included in the final version of the report published in September 1975.[48] Instead, in May 1975 the conclusions reached by the sub-group were communicated by means of a “Dear Doctor” letter from Dr Yellowlees, the CMO for England, to all regional medical officers in England. This letter repeated the sub-group’s advice that, despite the higher risk of Hepatitis B in prison donations, collections could continue if all donations were subjected to more sensitive Hepatitis B tests.[49] The deeply flawed logic in this letter (and also in the advice on which it drew) – namely, its reliance on the fact that there were other high risk groups such as drug users as a reason for continuing to collect from prisons – is discussed in the chapter on Response to Risk by the Blood Services.

SHHD and SNBTS received[50] the CMO’s letter but, in subsequent discussions, focused their attention more on donors from high-risk geographical areas than on prison donations. Dr Graham Scott, Deputy CMO at the SHHD, noted in a memorandum on 8 May 1975 that the Maycock Group had established a small working group to consider “geographical and racial factors” in blood donation which had produced recommendations in an appendix for an early draft of their report. However, Dr Scott revealed that, upon further deliberation by the Advisory Group, it was believed that including such an appendix could be inflammatory, which led to its omission from the final report.[51] In response to Dr Yellowlees’ letter, Dr Scott intended to ask his colleague Dr Archibald McIntyre[52] to discuss the recommendations with Major-General Hugh Jeffrey,[53] and to assess the practices in Scotland at that time, especially concerning the more sensitive methods of antigen screening.[54] Subsequently, on 16 May 1975, Dr McIntyre wrote to Major-General Jeffrey; the focus of his letter was the question of donations from high-risk malarial and hepatitis areas.[55] There was no mention of blood donations from prisoners. The SNBTS directors reviewed the CMO’s letter during their meeting on 11 June 1975, but the discussions were, again, centred on blood donors from endemic malarial areas, without any recorded deliberation on the continuation of blood collections from prisoners.[56]

Unsurprisingly, given the contents of the Dear Doctor letter from the CMO, blood donations from prisoners continued to be collected in most RTCs in the UK, as described further in the chapter on Blood Services and Addressing Risk: Regional Transfusion Centres.

In February 1980, the DHSS produced a note regarding the establishment of an Advisory Group on Hepatitis, in which it recognised that certain groups, including drug addicts and the prison population, exhibited significantly higher rates of infection.[57] However, no action was taken by the Advisory Group, which began to meet in October 1980, in relation to this issue.

In 1982 the Medicines Inspectorate of the DHSS began to examine the practice of collecting blood from prisons and borstals during their visits to transfusion centres and other facilities in Scotland. Their scrutiny included an inspection of the Dundee RTC on 25 March 1982. The inspectors’ report raised significant concerns about the practice of collection from prisons and borstals, noting the absence of prison medical officers in assessing the suitability of donors, the increased risk of infection within the prison population, and the potential unreliability of answers to pre-donation questionnaires from such donors, whose motivations were questionable.[58] Similarly, during their visits to the Edinburgh and Southeast Scotland BTS, the inspectors questioned the appropriateness and necessity of collecting blood from donors in prisons and borstals.[59]

The issue of prison donations continued to be a point of discussion in Scotland in 1982, with Dr John Cash writing to John Watt that they needed “to consider, formally, in the not too distant future, the question of Sessions in Prisons” and whether “we should abandon this practice”.[60] It was discussed at a meeting of the SNBTS directors on 29 March 1983, attended by representatives of SHHD: blood collection sessions were being held in penal institutions across all regions, though some planned to review this practice in their respective regions.[61] Despite these discussions, the directors did not agree on a unified future policy.

On 12 April 1983, Dr Cash wrote to David Haythornthwaite of the DHSS Medicines Division conveying the lack of consensus among the SNBTS directors on the question of donor sessions at prisons and borstals.[62] On 6 May 1983 John Davies, Assistant Secretary in the SHHD, sent a minute to the Parliamentary Under-Secretary of State for Scotland, John Mackay (later Lord), concerning the emerging issue of AIDS, in which he indicated that the RTDs in Scotland were very aware of the problem of AIDS and that among their considerations was the avoidance of blood collection “in high risk locations, such as prisons” or areas with a high proportion of homosexuals or drug abusers.[63] The minister merely expressed gratitude for the note: he did not request or require any action to be taken.[64]

In July 1983, the matter was raised within the DHSS: J B Brown (Medicines Division) wrote to John Parker in HS1, referring to the concerns of the Medicines Division’s Inspection Action Group about the collection and use of blood from prisons and borstal institutions. The Group deemed the practice “highly questionable” due to the prevalence of homosexual activity in prisons, coupled with the growing unease about the incidence of AIDS among homosexuals. The note sought advice on the departmental policy regarding this practice.[65]

On 16 August 1983, a handwritten SHHD note recorded a conversation with Paul Winstanley of the DHSS concerning the Medicines Inspectorate’s inquiry about departmental policy on donor sessions in prisons and borstals. Paul Winstanley appeared to be of the view that the RTDs in England and Wales had tended to avoid such collections partly due to hepatitis concerns[66] and inquired about Scottish practices. He emphasised that if a policy of withdrawal was to be considered, it would likely necessitate consultation with the Home Office, given the “importance placed on the social responsibility aspect of such sessions.[67]

On 23 August 1983, Paul Winstanley responded to J B Brown (copying his response to SHHD) indicating that it was “difficult to advise any particular Departmental policy on the collection of blood from borstals and prisons at the moment.” It was, he said, for individual RTDs to determine how, and from where, donations were sought in the light of the targets they needed to achieve and the numbers of donors on their panels. However, RTDs had been aware of the dangers of relying too heavily on prisons as a source of donations for some time prior to the advent of AIDS, because of the risk of hepatitis in prisons (also connected to the higher incidence of homosexuality) which could be spread through blood transfusion. Although most regions might not need to use prisons, there was at least one which had to view them as a major source of donations in order to meet targets. He continued: “AIDS has of course now called the wisdom of continuing to view prisons as a source of blood even further into question”. The RTDs were due to discuss it at their next meeting in September. Paul Winstanley concluded: “We shall obviously need to liaise closely with Home Office also since they have in the past been very much in favour of blood donation by prisoners.[68]

In a letter dated 23 August 1983 to Dr Cash, Dr Ewa Brookes, the director of the Dundee RTC, reporting on a recent meeting of the Working Party on the Selection of Donors/Notes for Transfusion, informed Dr Cash that in England and Wales, the practice of hosting donor sessions at prisons and borstals had already been discontinued.[69] This left the decision to the Scottish regions to determine whether they would follow suit. However, at their meeting on 13 September, SNBTS directors could not reach agreement on a blanket decision to cease visiting prisons.[70]

The collection of blood finally stopped from closed prisons and borstals in England and Wales at the end of 1984 and from the last open prison in 1986.[71] By December 1983, Dr Brookes told the SNBTS directors’ meeting that “the only Scottish region to continue holding sessions” was now Glasgow,[72] which held its final session on 25 March 1984.[73] In Northern Ireland, the last prison session occurred in Belfast on 26 October 1983.[74]

Commentary

It was plainly known to both the DHSS and the SHHD from the early 1970s that the collection of blood from prisons and similar institutions gave rise to an increased risk of transmission of Hepatitis B.[75] Despite this no action was taken, as it should have been, to bring an end to this practice: on the contrary, the CMO’s misguided letter in May 1975 effectively endorsed and encouraged its continuance.

The increased awareness of the extent and potential seriousness of NANBH during the second half of the 1970s, as well as continuing knowledge that Hepatitis B screening was still imperfect, should have refocused attention on the practice of prison collection, but did not. NANBH was highly likely to be more prevalent in prisons, just as Hepatitis B was known to be. Both seemed to share similar modes of transmission.

The emergence of AIDS finally brought the issue back into focus, but should have led to the immediate cessation of all prison collections by the beginning of 1983: instead it continued in some regions into 1983 and 1984.

The hands off approach of the DHSS and the SHHD – leaving the matter entirely to the judgement of local RTDs – was wholly unacceptable. This was a matter of blood safety: it should have been taken seriously by government and was not. There should have been a “departmental policy” and there was not. This was wrong.

The failure to bring the question of prison donation to the attention of ministers was also wrong. It was not raised with a Scottish minister until May 1983; it was not raised with ministers within the DHSS at all. Whether that would have made any difference is debatable – the Parliamentary Under-Secretary of State for Scotland took no action when the matter was finally drawn to his attention; the Minister of State, Kenneth Clarke, appeared somewhat blasé about the collection of prison blood as late as 1983 in his oral evidence to the Inquiry: he did not think he knew that prison blood was collected but did not seem to think that ministers needed to know about it.[76] However a minister properly addressing their mind to the risks ought to have taken decisive action if the matter was brought to their attention. It is disappointing also that no minister appears to have thought proactively to inquire as to whether blood was collected from prisoners in the UK.[77]

The emergence of AIDS and the response of the Government 1982-1984

The next part of this chapter looks at the Government’s response to the emergence of AIDS as a threat to those receiving treatment with blood or blood products. Two important aspects which overlap with the chronology of events described below are, however, considered elsewhere: the role of the Licensing Authority in responding to the threat of AIDS (and in particular the decisions of the Committee on Safety of Medicines (“CSM”) and Sub-Committee on Biological Products (“CSM(B)”) in July 1983, and decision-making regarding concentrates manufactured from plasma collected pre March 1983) is addressed in the chapter entitled Regulation of Commercial Factor Concentrates and the question of screening for HIV is examined in the chapters on HIV Surrogate Screening and HIV Screening.

The context

The emergence of AIDS as a threat to people who received blood or blood products was a part of a much larger picture. What became a world-wide epidemic first came to notice in the western world on 5 June 1981. Five cases of immune failure amongst young gay men in Los Angeles were reported.[78] By July there were 10 cases and by August 70 more.[79] By December, 160 were being investigated.[80] The mortality rate was very high – 40%.[81] On 10 December 1981 the New England Journal of Medicine carried an editorial, and three separate articles about the disease – including one speaking of an outbreak of “community acquired” pneumocystis carinii pneumonia.[82] It was in January 1982 that the first case of AIDS in a person with haemophilia was identified by the CDC.[83] If the same exponential growth in the numbers infected were to happen amongst people with haemophilia as was happening overall, it would then have been obvious that their lives would be put significantly at risk.

The point arising from this last paragraph is that unless the wider context was considered, a single case of AIDS in a person with haemophilia was unlikely to suggest a significant risk to others with haemophilia. Where that context was one of exponential growth of an infection which was likely to be fatal for almost half of those infected amongst a variety of people (not all of whom were homosexual), a single case was no longer something which could be dismissed so easily. It would more likely be the tip of the iceberg.

That very phrase – “tip of the iceberg” – was one the New England Journal of Medicine used in January 1982 when it returned to the theme of AIDS again. This time the article had the added weight that it was penned by a CDC task force; and, chillingly, the phrase was used to describe not just one case but all the cases so far known in the population.[84] In short, AIDS was epidemic. It was spreading. One infection presaged others. There was already a large number of cases, increasing monthly. And many more were coming, even if (to use the iceberg analogy) they were below the water line and not visible. Yet.

The DHSS July 1982 - April 1983

On 16 July 1982 – the same date as the Morbidity and Mortality Weekly Report (“MMWR”) carried a report of pneumocystis pneumonia in three haemophilia patients in the US[85] – the possibility of AIDS being transmitted through blood was explicitly drawn to the attention of civil servants within the DHSS by Dr Harold Gunson, in his capacity as the consultant adviser in blood transfusion. Dr Gunson warned that there “may be considerable publicity in the next couple of weeks concerning the safety of American Factor VIII.[86] Stanley Godfrey[87] wrote to Dr John Holgate[88] in the following terms:

“From the DHSS point of view, we can defend the National Blood Transfusion Service’s own record.[89] Someone taking drugs (gay or not) would not be bled provided that the injection marks showed. In any case with our voluntary unpaid donor system we do not have the same problem as in the States where drug addicts are tempted to give blood simply for the money. However, about half of the Factor VIII bought from commercial companies is imported from the USA. Your Division … may have to consider revoking licences of certain manufacturers. Of course it may turn out that none of the Factor VIII involved is supplied to this country.”[90]

Dr Holgate responded four days later, confirming his awareness of the “potentially adverse publicity concerning the safety of Factor VIII in the USA (and certain other blood products, in my opinion)”. Although he did not think Stanley Godfrey had got some of the technicalities right, “that makes no difference to the eventual outcome.” Dr John Griffin[91] was said to be aware of this, as was Dr Leslie Fowler[92]who will have to take any action that proves necessary.” Referring to the risks from homosexual activities, Dr Holgate added that “our own blood production system may not be exempt.[93] It may be inferred from Dr Holgate’s response, given his knowledge that Drs Griffin and Fowler were already aware of the position, that some discussion had already taken place regarding AIDS within the DHSS, and that Dr Holgate had a sufficient understanding of the issue to doubt the particular thesis posited by Stanley Godfrey.

Beyond this, however, there is no evidence of there being, over the next few months, within the DHSS, any documented discussions or planning or any consideration of what steps might need to be taken with regard to the safety of blood or blood products in light of this grave new threat. Indeed, except for the discussion regarding Stanley Godfrey’s note, there is no record of discussions about AIDS and blood within the DHSS between 16 July 1982 and the end of 1982.

Although there was little or no action within or by the DHSS, some steps began to be taken by the PHLS and CDSC. In August 1982, the CDSC set up a surveillance scheme to monitor opportunistic infections and cases of Kaposi’s sarcoma, based on death certificates identified by the Office of Population, Censuses, and Surveys,[94] information on opportunistic infections on laboratory report forms,[95] and information from venereologists and dermatologists.[96] Dr Galbraith wrote to venereologists and dermatologists in England and Wales in September 1982 seeking their “cooperation” in a trial clinical reporting system of Kaposi’s sarcoma due to the “inadequacies of existing surveillance systems.[97]

There was a passing discussion of AIDS at the UKHCDO annual meeting on 13 September 1982, where Dr Trevor Barrowcliffe, Anthony Curtis and Geoffrey Kemball-Cook of the National Institute for Biological Standards and Control, Dr Craske of PHLS and Dr Richard Lane of BPL, were all listed as in attendance, although there were no officials present from the DHSS.[98]

In early November 1982 Dr Craske produced a paper on AIDS for the Medical Research Council (“MRC”) Hepatitis Vaccine Working Group which met on 12 November 1982.[99] Present at that meeting was a representative from the DHSS: Dr Mary Sibellas of Med IMCD. Whilst the particular focus of the discussion at the Working Group’s meeting was the potential for contamination of batches of the source plasma for Hepatitis B vaccines, it would have been clear to those attending, including Dr Sibellas, that Dr Craske considered an infectious agent to be the most likely cause of AIDS.[100]

On 3 December 1982 the newly established Central Blood Laboratories Authority (“CBLA”) held its first meeting; members included Dr Edmund Harris (one of the Deputy CMOs), and attendees included John Parker,[101] Stanley Godfrey and Dr Walford of the DHSS.[102] Surprisingly there was no discussion about AIDS.

Dr Walford told the Inquiry that by or at the beginning of 1983 her sense was that it was likely that AIDS was transmissible through blood and blood products. She thought that the view developed incrementally, but that the San Francisco baby case was “a sort of watershed” and “rang all sorts of alarm bells.[103] She thought that gradually the feeling within the wider DHSS too was that it was “looking more and more likely that blood and blood products are certainly capable of transmitting this agent” and was not aware of anyone voicing any markedly different views (other than, perhaps, Dr Fowler, whose later report for the Committee on Safety of Medicines is considered in the chapter on Regulation of Commercial Factor Concentrates).[104]

On 10 January 1983 Dr Craske wrote to Dr Walford, informing her of arrangements for the investigation of “factor VIII related” AIDS: any patient detected in the UK who had received commercial concentrate would be reported directly to CDC and to CDSC.[105]

On the same date the Advisory Committee on the National Blood Transfusion Service met at the DHSS, under the chairmanship of Dr Harris, and with Dr Walford, Stanley Godfrey and Steven Green of the DHSS in attendance as the secretariat.[106] There was, again surprisingly, no discussion about AIDS.

On 16 January 1983 The Observer carried an article under the heading “Mystery disease threat” which suggested that imported Factor 8 concentrates “may pose a grave threat to the health of haemophiliacs who inject it.[107] It reported that the deaths of at least ten people with haemophilia in the US were known to have been caused by AIDS, and referred to an imminent meeting of directors of British haemophilia centres to discuss the problem. This prompted someone in the DHSS to send the article to Dr Walford, suggesting that it would be useful to know the outcome of that meeting and adding “Perhaps we can discuss at an opportune moment.[108] On 19 January Dr Walford wrote to Professor Arthur Bloom noting that recent publicity about AIDS cases in people with haemophilia in the US had “generated quite a bit of interest in the Department.[109] In the meantime, an internal DHSS minute of 18 January reported Dr Walford as having confirmed that the value to people with severe haemophilia of Factor 8 and 9 concentrates “far outweigh the possible, and as yet unproven hazards of the transmission of acquired immune deficiency syndrome.[110] Dr Walford described her thinking at the time that the hazards of transmission were unproven and that it was known that people with severe haemophilia desperately needed factor concentrates.[111] From all the evidence available to the Inquiry it appears that was likely to have been the thinking of the Department as a whole at the time. But it was wrong – and not just with hindsight. The hazards of AIDS may have been “unproven”, and the extent of the risk at that stage unclear, but that there was a risk, and that the consequences of infection were grave, was clear and should have weighed more heavily in the balance. As for the “desperate” need for concentrates, the DHSS had insufficient appreciation of the availability of alternative treatment strategies and over-inflated the risks to people with bleeding disorders.

The CBLA, now under the chairmanship of David Smart, but with the Deputy CMO as a member and Stanley Godfrey in attendance, met for the second time on 26 January 1983. Any response to AIDS was still not considered.[112]

On 17 February 1983 Dr Gunson wrote to Dr Walford, drawing her attention to statements from the American Association of Blood Banks (“AABB”) as well as a recent article on AIDS. He stated that the most important recommendation coming from the US was the increased usage of cryoprecipitate, commenting that “if this philosophy takes off in the U.K. it will have considerable implications for the Regional Centres and for the plasma supply situation.[113]

Other than exchanges such as those set out above, and despite continuing reports in medical and other journals, a number of which concluded that transmission through blood was likely,[114] there is no evidence of the DHSS taking any particular steps at all in response to the risk of AIDS in relation to blood or blood products in the period up to April 1983.[115] There was a brief discussion of AIDS at the CBLA’s fourth meeting on 23 March 1983:[116] Professor Bloom suggested that the CBLA should discuss AIDS at a future meeting and Dr Gunson told the meeting that it would be discussed at a forthcoming Council of Europe meeting in May.[117]

April itself saw little activity. Dr Craske sent Dr Walford a copy of his March 1983 paper (itself an update of his November 1982 paper).[118] Civil servants attended the fifth meeting of the CBLA on 27 April 1983 as observers.[119] The minutes record a brief discussion of AIDS, with Dr Gunson reporting that at the next meeting of RTDs it would be recommended that no further measures be taken, apart from those already being carried out, and Professor Bloom reporting his impression, following a talk on AIDS to the Haemophilia Society’s AGM, that “haemophiliacs were not greatly concerned about AIDS”.[120] Reference was made to Paul Winstanley trying to ascertain the number of calls made following a TV programme which had recently been aired.[121]

There is no evidence, during this period, of any issues relating to AIDS and blood being brought to the attention of the Secretary of State or other ministers.[122]

May 1983 onwards

It was not until May 1983 that there was within the DHSS any real focus on how best to respond to the risks of AIDS from blood or blood products and that was as a response to press reporting.[123] On 1 May 1983 reports appeared in the Sunday newspapers: The Mail On Sunday carried Susan Douglas’ article under the headline Hospitals using killer blood[124] and the Observer carried two articles: one headed Killer disease alert over gay blood donors and the other headed The epidemic spreads.[125] This triggered a response within the DHSS: a minute dated 3 May 1983 records that officials were asked to provide a briefing for Prime Minister’s Questions on the stories which appeared over the weekend about AIDS. A background note and suggested “lines to take” were sent to Number 10 and to Geoffrey Finsberg, the Parliamentary Under-Secretary of State at the DHSS with responsibility for blood policy, and copied to the Private Office of the Secretary of State.[126]

The “line to take” for the Prime Minister – although not actually used by her – read as follows:

“I was very concerned to read this weekend’s Press reports and can well understand the anxiety which some sensational reports may have caused. It is important to put this in perspective: there is as yet no conclusive proof that AIDS has been transmitted from American blood products. The risk that these products may transmit the disease must be balanced against the obvious risks to haemophiliacs of withdrawing a major source of supplies. Already, in this country, there is a special surveillance system, established by the Communicable Disease Surveillance Centre, to monitor the occurrence of AIDS, in collaboration with the Centres for Disease Control in the USA. Every opportunity is being taken for this country to learn from the experience of this disease in the USA.”[127]

The briefing note which accompanied the “line to take” noted that people with haemophilia requiring treatment with Factor 8 concentrates had been identified as being at increased risk. It explained that the cause of AIDS was unknown and that “although medical opinion is tending to favour a virus as the agent responsible, there is no proof that this is the case.” The mortality rate was described as high, with at least 40% dying. In response to the question “Is it transmitted in blood or blood products?” the note read “As yet there is no conclusive proof that AIDS is transmitted by blood as well as by homosexual contact but the evidence is suggestive that this is likely to be the case. Reference was made to 11 people with haemophilia in the US and three in Spain in whom the most likely explanation for the development of AIDS was their exposure to US Factor 8 concentrates, and to evidence that AIDS had been transmitted to babies in blood transfusions. There were said to be “no proven cases” of AIDS in people with haemophilia in the UK, although there was a “suspect case” in Cardiff.[128] Noting that this patient had received a great deal of British concentrate since 1980 (having last received US concentrate in 1980), the note recorded that it was not possible to know whether British concentrate might contain the AIDS agent. In response to the question “Should a ban be placed on imports of US Factor VIII concentrate?” the note responded that at present haemophilia experts in the UK “take the view that to ban the imports of US FVIII would be to place haemophiliacs at greater risk from bleeding than they would be from acquiring AIDS.[129] The note then explained the action that was being taken. This was threefold: blood transfusion directors would avoid wherever possible bleeding donors known to be homosexual (it being considered “impossible to ask donors if they are homosexual”); all haemophilia centre directors had received instructions to report any suspect case of AIDS to Oxford and to the CDSC; and the CBLA’s Blood Transfusion Research Committee would be considering “the problems posed by AIDS to the Blood Transfusion Service.[130]

Lord Fowler rightly described the information in this paper as something that “should have been ringing alarm bells more widely”.[131]

On 6 May 1983 Dr Galbraith of CDSC telephoned Dr Sibellas at the DHSS to report that the Cardiff patient had the right symptoms and signs for a diagnosis of AIDS, and to flag up the three cases in Spain. He asked that the DHSS “consider the matter as a priority – and asks that any top level meeting should include CDSC”.[132] Three days later, on 9 May 1983, Dr Galbraith wrote to Dr Ian Field at the DHSS. Having referred to known, or likely, cases of AIDS in people with haemophilia in Spain and the US, and to the Cardiff patient, he said this:

“I have reviewed the literature and come to the conclusion that all blood products made from blood donated in the USA after 1978 should be withdrawn from use until the risk of AIDS transmission by those products has been clarified … Perhaps the subject could be discussed at an early meeting with haematologists, virologists and others concerned so that a decision may be made as soon as possible.”[133]

Appended to the letter was a paper in which Dr Galbraith set out his reasons for the temporary withdrawal of such blood products. His reasons can be summarised as follows:

  1. The AIDS epidemic in the US was probably due to a transmissible agent.
  2. The agent was probably transmitted by blood and blood products.[134]
  3. Although the number of cases was very small in relation to the number receiving the products, this did not indicate that the risk was small (not least because the incubation period was long).
  4. Pooled products had a high risk of contamination because homosexuals and drug abusers were known to be frequent blood donors.
  5. There was no known means of ensuring that blood or blood products were free of the AIDS agent.
  6. The mortality rate exceeded 60% one year after diagnosis and was expected to reach 70%.[135]

Dr Galbraith’s reasoning was impeccable and his views deserved to be given great weight and to be circulated widely. Unfortunately, and as described further below, that did not happen.

On 12 May 1983 Dr Sibellas sent Dr Field a minute setting out her understanding that Dr Galbraith had written to him suggesting that there should be a Working Party on AIDS.[136] Dr Sibellas suggested that papers could be sought from Dr Walford, Dr Gunson, Dr Craske, Dr Galbraith and Dr Catterall.[137] Handwritten across the minute are the words “this idea has now been abandoned. Drs will now have ad hoc discussions.[138]

Dr Galbraith’s letter to Dr Field, and his paper, was the subject of internal comment by Dr Walford following her attendance at the reference centre directors’ special meeting on 13 May 1983,[139] but does not otherwise appear to have been acted on or shared more widely (either within the DHSS or externally) and was not provided to the reference centre directors at or for their meeting.[140] Dr Walford’s view was that the suggestion was “premature” and “unbalanced” because it did “not take into account the risks to haemophiliacs of withdrawing a major source of their FVIII supplies.” She suggested that the situation was “best put in perspective” by a statement in the reference centre directors’ minutes, then in draft.[141] This statement (which was not for publication, as the final wording might not be precisely the same) read as follows:

“Many Directors have until now restricted their use of FVIII in young children (under the age of 4 years) and in mild haemophiliacs to NHS materials and we consider that it would be circumspect to continue with that policy.

There is not sufficient evidence to restrict the use of imported FVIII concentrates in other patients in view of the benefits of the treatment but the situation will be kept continuously under review by means of a surveillance system which has been instituted and by means of regular meetings of the Reference Centre Directors…

The Directors welcome the fact that the Regional Transfusion Directors would be meeting to consider steps which could be taken to avoid bleeding donors who might be in a category thought capable of transmitting AIDS.” [142]

Dr Walford suggested, with regard to the Working Party on AIDS proposed by Dr Galbraith, that Professor Bloom be invited to represent haemophilia centre directors.[143]

It appears that Dr Field responded to Dr Walford in a minute of 19 May which has not been found. Her subsequent response was to “agree entirely with your suggestion for handling this issue” and she said that she “certainly would not wish to press for a formal Working Party at this stage.[144]

The DHSS’s response to Dr Galbraith’s letter and paper was wholly inadequate. It was not placed before the CSM(B) or the CSM, as it should have been.[145] It was not brought to the attention of ministers,[146] or to the CMO, as it should have been. Lord Patten told the Inquiry “unequivocally” that ministers should have been informed about it – and that if he had seen it “I think I probably would have pressed the panic button.[147] It was not circulated to haemophilia centre directors or to RTDs, so as to allow a fully informed and comprehensive debate and discussion, as it should have been. The only internal DHSS consideration of which the Inquiry has any evidence is Dr Walford’s response.

In dismissing, or at least ignoring, Dr Galbraith’s position, the whole issue of concentrate use seems to have been seen as a binary choice, an all or nothing scenario of continuing unabated with the status quo or providing people with haemophilia with no treatment at all. That was the wrong way to look at it. There were, moreover, other ways in which the risks to people with haemophilia could be addressed at least on a temporary basis, which were not considered, adequately or at all, by the DHSS.[148]

Not only were ministers not told of Dr Galbraith’s paper, they were not told about the CSM’s decision-making. This failure to tell ministers of the CSM’s decision meant that they could not then explore whether there were less radical steps that could nonetheless be taken to minimise the risks.[149] It was Lord Fowler’s expectation that Lord Glenarthur and the CMO would be fully briefed about the results of the meeting; but without being aware of it, a minister could not consider whether they agreed or whether there needed to be challenge to it.[150]

In Lord Glenarthur’s statement to the Inquiry he talked about people with haemophilia being “in peril” from the unavailability of Factor 8 if imports were stopped, and agreed with not stopping importation because “There seemed no practical alternative, other than to suddenly imperil the lives of haemophiliac patients.[151] He believed that the risk to people with haemophilia of not having treatment was very grave.[152] His understanding, therefore, was that the only choice was a stark all or nothing one and that there was no alternative to the continuation of use of imported concentrates.[153] In fact there were a whole range of strategies that could have been considered: the increased use of cryoprecipitate, the postponement of elective surgery, a more conservative approach to treatment, the temporary cessation of home and prophylactic treatment, reserving concentrates for life threatening or essential surgery only, a system of batch dedication, greater use of DDAVP. Moreover, if concentrate were thought essential for treatment in individual cases, NHS concentrates were likely to be much safer than imported commercial products. There is no evidence to suggest any of this was considered, explored or assessed by the DHSS, and Dr Walford acknowledged that it was “fair” to say no one applied their minds to a more nuanced strategy than Dr Galbraith proposed.[154]

On 3 June 1983 an internal DHSS meeting took place to consider AIDS. An agenda identified 8 issues for consideration:

  1. whether there was any further action NBTS or haemophilia reference centres could take, and whether any further assistance or complementary action by the DHSS was appropriate;
  2. what action could be taken by Medicines Division and Supply Division to minimise risks in light of the new Food and Drug Administration requirements;
  3. what action was appropriate with regard to the implications of the introduction of heat treated Factor 8 concentrates;
  4. what should be done further to encourage research into AIDS;
  5. to consider the implications for NBTS of the line taken by the Council of Europe;
  6. to consider the implications for the CBLA and the plans for the redevelopment of BPL;
  7. to consider what action was needed by the DHSS in respect of homosexual rights groups; and
  8. what further action should be taken with the Haemophilia Society.[155]

A number of papers were prepared for the meeting, including a background paper which included the “no conclusive proof” line.[156] The second paper referred to the recommendations of the reference centre directors at their meeting on 13 May 1983 and their agreement that no restriction should be placed on the use of imported Factor 8 concentrate “other than to continue with the present policy of using only NHS material for children under the age of 4 years and for mild haemophiliacs”.[157] The sixth paper dealt with the implications of AIDS for BPL and suggested, amongst other matters, that there would be major operational and financial problems for RTCs if there were to be a significantly increased demand for cryoprecipitate. This assertion appears to have been based on Dr Gunson’s views alone.[158]

The meeting on 3 June was attended by a range of policy and medical civil servants from different divisions within the department. Ministers were not involved. It was opened by John Parker explaining that the meeting had been arranged to consider the implications “for the Department” of “recent media reports on AIDS” and to consider possible courses of action.[159] This language is telling of the DHSS’s stance and priorities.

The actions that were agreed as a result of the meeting were limited: Dr Walford would approach the chair of the RTDs to ascertain their views on questioning donors about the presence of symptoms such as night sweats; the Medicines and Supply Divisions would instigate informal discussions with pharmaceutical companies regarding concentrate manufactured from plasma donated pre 23 March;[160] HS1A should keep a close watch on developments in relation to heat-treated Factor 8; John Parker would write again to regional administrators rehearsing the benefits of self-sufficiency and pressing for urgent action;[161] there would be liaison with the Medical Research Council (“MRC”) group on AIDS regarding research; Dr Harris should be asked to seek the CBLA’s comments on greater use of single donor or small pool products and the introduction of heat-treated concentrate; and a recommendation would be made for an early meeting between ministers and the Haemophilia Society.[162]

The meeting also considered Dr Gunson’s report on the proposed Council of Europe resolution. It is of note that rather than considering each element of the resolution and determining what steps would need to be taken to comply, the meeting instead agreed that “when the opportunity to comment arose” the potential problems to the UK created by small pool production and the ban of imports “should be brought to the Council’s attention.[163]

There was no discussion whatsoever of Dr Galbraith’s letter and paper. Nor was there any discussion about any different approaches to the treatment of bleeding disorders: should different policies be adopted for different classifications (mild/moderate/severe)? Should treatment be minimised? Should home and prophylactic treatment be temporarily suspended? Should there be a reversion to cryoprecipitate? Should non-elective surgery be deferred? Dr Walford suggested that this reflected the departmental position that, having regard to the principle of clinical freedom, it was not the role of the DHSS to provide guidance or advice to clinicians.[164] She was no doubt right when she said this was the departmental position, but it was a short-sighted position for the DHSS to adopt and a dereliction of its responsibility to patients. There was no discussion either of patients being informed – again reflecting the departmental position that this was the responsibility of haemophilia centre directors. On an individual patient-doctor basis it is obviously correct that it is the primary duty of the doctor to provide such information to their patients, but that does not, and did not at the time, absolve the Department of all responsibility for ensuring that there was sufficient information available for patients regarding this new and deadly risk.

The CSM(B) and CSM meetings took place in July 1983 and their decision-making is considered separately in the chapter on Regulation of Commercial Factor Concentrates. However, as set out in that chapter, the decision taken in July 1983 does not appear to have been kept under any kind of active review as it should have been. Whilst that is a matter for which the CSM(B)/CSM/Medicines Division bears primary responsibility, it is also right to note that the non-licensing divisions within the DHSS, in particular HS1A as the “lead”, did not take any steps to bring the matter back before the CSM(B)/CSM or to tell ministers, as they should have done.

The Council of Europe recommendation

The need to take steps to protect people with bleeding disorders from AIDS was not a question solely for the UK. Other countries in Europe were affected too. The Council of Europe’s Committee of Ministers met to consider what could and should be done.

The DHSS had advance notice of the Council of Europe’s Committee of Experts’ intended recommendations from Dr Gunson in May 1983.[165] Dr Gunson wrote to Dr Walford on 16 May 1983 telling her that:

“You can see that what they are leading to is the greater use of cryoprecipitate, and we saw two years ago that this tends to be the standard product in many European countries. Although I put forward the UK view of this product the consensus was against us. Like you, I do not think BPL could change to freeze-dried cryo rapidly and the logistic problems would be considerable … Fortunately everyone here was in agreement that it was vital to present a balanced view of this problem and to avoid emotive over-reaction”.[166]

The DHSS’s International Relations Division asked for comments on the draft recommendations,[167] which were provided by Dr Walford on 13 June. The DHSS’s main difficulty was, Dr Walford said, with the first part of the recommendation: avoiding the use of large pool concentrates. This was said to be “theoretically desirable” but that in practice there was “no option but to treat the majority of our haemophiliacs with large-pool products”, and the risks of non-treatment were greater than the risks of treatment. The DHSS would prefer the recommendation to be reworded by the insertion of the phrase “wherever possible” or “wherever practicable”.[168]

The Council of Europe’s Committee of Ministers’ resolution was adopted on 23 June 1983. Its recommendations were addressed to the governments of member states. The overarching recommendation was “to take all necessary steps and measures with respect to” AIDS and there were then three specific recommendations “in particular”.

The first was “to avoid wherever possible[169] the use of coagulation factor products prepared from large plasma pools; this is especially important for those countries where self-sufficiency in the production of such products has not yet been achieved”.[170] The Government took no steps in response to this recommendation. It took the view that the continuing use of imported concentrates was unavoidable[171] and because self-sufficiency had not been achieved there was nothing that could be done. That missed the point of the second part of this recommendation – the particular importance of taking steps where self-sufficiency had not been achieved (because the risks would be greater). To decide that there was nothing to be done because the UK was not self-sufficient was to misunderstand the whole point of the recommendation.

The second was “to inform attending physicians and selected recipients, such as haemophiliacs, of potential health hazards of haemotherapy and the possibilities of minimising these risks”.[172] This was a recommendation to tell two different cohorts – clinicians and patients – about two matters: the risks of treatment with blood/blood products and the possibilities of minimising the risks. The UK Government took no steps in response to this recommendation, either to provide information to clinicians or to provide information to patients, it being the DHSS’s position that providing such information was not its role.[173] Nor did the DHSS contact relevant professional bodies, medical royal colleges or the like to see what information was being provided either to clinicians or to people with bleeding disorders.[174] It did not take any steps to ascertain what haemophilia clinicians were in general telling their patients. Dr Walford pointed in her evidence to the Inquiry to a report from Dr Gunson dated 13 June 1983, prepared for the CBLA,[175] in which he asserted that “Physicians and patients, especially haemophiliacs are being informed of the risks of AIDS.” It is unclear what Dr Gunson meant by the statement that physicians were being informed of the risks of AIDS; as for patients, it is difficult to understand how Dr Gunson, who was not involved in the care and treatment of people with haemophilia, could give any kind of reliable assurance that patients were being informed, and his CBLA report contained no further information or detail in that regard. It was almost certainly no more than an assumption on his part that haemophilia clinicians would be telling patients of the risks, because that was, of course, the right thing to do.[176] The evidence that the Inquiry has heard establishes beyond doubt that patients were as a general rule not being informed of the risks.

Dr Walford did not accept that it was a failure on the part of the DHSS not to take some steps in accordance with the Council of Europe’s recommendation to ensure that people with haemophilia had the requisite information to enable them to make an informed decision about balance of risks. She said this:

“It would only have been a failure if it had been the normal process, the normal procedure, for the Department to intervene in this sort of way, with -- after all, there was a plethora of conditions, in each case, important findings, important developments taking place. The Department could not -- and did not -- provide relevant information to clinicians about clinical matters of that kind. It was simply not set up to do and it did not do it … it wasn’t a failure because it’s not what we normally did.”[177]

Though I acknowledge that what Dr Walford was being asked to consider would be a departure from its habitual practice, I find it difficult to accept this. Whether or not it was something that the DHSS normally did, in respect of other conditions, is not the point. This was not one of the plethora of conditions in which there might be multiple side effects of varying degrees of severity. This was a situation in which there was a very real risk that the very treatment being provided by the NHS – and for which the DHSS bore ultimate responsibility – would directly transmit to patients a fatal, untreatable and new viral disease. It was a situation in which there was a specific Council of Europe recommendation, to which the Government had effectively signed up, that the Government take all practical steps to inform patients both of the risks and of the possibilities of minimising that risk. Whatever the normal approach of the DHSS might be, this was a different situation, and one in which there was a culpable failure by the Government to act.

The third specific recommendation was “to provide all blood donors with information on the Acquired Immune Deficiency Syndrome so that those in risk groups will refrain from donating”.[178] The Government did take steps to comply with this – as detailed below under the heading The AIDS leaflet – but it was not until early 1985 that all donors were being provided with information.

In July 1983 Mr A Cumming of the International Relations branch sent to ministers a minute regarding the Council of Europe’s Recommendation R(83)8; a copy of the recommendation was provided and the covering minute explained that it was normal practice during the preparation of such documents “to ensure that the UK is not committed to policies which would not otherwise be followed, so that there is, correspondingly, no action to be taken if and when they are adopted.” It was noted, however, that such recommendations “are often of interest to pressure groups” and it was thought ministers might wish to be aware of it. The minute stated that “the recommendation aims to ensure that appropriate precautions are taken in the preparation of certain blood products, and that specific groups of recipients such as haemophiliacs are accordingly reassured.” The recommendation did not, ministers were told, prevent the UK from continuing to import concentrates from the US.[179] No reference was made in the text of the minute to the second recommendation regarding the provision of information to clinicians and patients. The minute – wrongly – did not explain that there were areas in which the UK was failing to meet the recommendation and ministers were not asked to take any particular decisions. They should have been.

Lord Glenarthur responded on 22 July, expressing the view that “we should accept the Recommendation” and querying whether there was a publication date for the AIDS leaflet.[180] In his written statement to the Inquiry he was certain that any recommendations on avoiding products from large plasma pools would have been “fully considered by officials including medical advisors”, likewise the provision of information to practitioners and patients.[181] The evidence available to the Inquiry demonstrates that was not the case. He said that officials did not come forward with any particular direction which they encouraged ministers to take – which is correct.[182] He did, however, accept that he would at least expect the DHSS to have made some steps to satisfy itself as to what information clinicians had about the risks of treatment and ways of minimising risks, agreeing that this was a rapidly developing field and that “unless you ask, you don’t know.[183] He agreed also that it was incumbent upon the DHSS to seek to ascertain what information was generally being given to patients, and to have considered the adequacy of it and whether further information needed to be provided to comply with the recommendation.[184] He could think of no practical or principled reason why an equivalent process to the production of the AIDS donor leaflet could not have been undertaken, to provide to the cohort of people with haemophilia.[185]

Lord Clarke thought he would have read the recommendation.[186] That should have led him to ask what was being done to comply with it, but he did not. Lord Clarke, when giving evidence, took the view that so far as the second recommendation was concerned it was really a matter for haemophilia clinicians to tell their patients of the risks: although the recommendation said in terms that haemophilia patients should be told, as well as clinicians, and should also be told anything relevant about minimising risk.[187] As a simple matter of reading what the recommendation says, it cannot be interpreted in that way. He spoke, too, of doctors taking the decisions on what treatment a patient should have in terms which suggested this was matter solely for the doctor. Though I accept (as he says) that attitudes were different in the 1980s from those that operate today, it was already well established that as part of the central ethical principle of patient autonomy the patient should ultimately determine their own treatment, though the clinician has a role as an expert in giving the information which should help the patient to do so. The result was that the DHSS did not honour the second recommendation, although the Government had signed up to it, and ministers did not ensure that they did so.

There is little doubt that patients, as was generally reflected in their evidence to this Inquiry,[188] were not told adequately or at all of the risks they ran; nor were they advised of what might be done to minimise those risks in their own case, or that of their child. These are serious failures, which resulted in exposure to infection which may never have occurred if they had been told, and advised. These failures resulted, too, in a sense in many of betrayal by doctors they had relied on to give them such information and advice; and in a loss of trust in the Department of Health. There can be little doubt that the Government’s failure to honour a recommendation, despite having accepted it, played a part in this.

Reversion to cryoprecipitate, alternative approaches to treatment and guidance to doctors and patients

As already described, no consideration was given by the DHSS to alternatives to treatment with imported concentrates. In particular there was no consideration of a policy encouraging a reversion to cryoprecipitate use, at least as a temporary measure. The DHSS’s belief appears to have been that there was not enough cryoprecipitate and that it could not have been made quickly.[189] But no assessment was undertaken by the DHSS of the ability of RTCs to produce cryoprecipitate in much larger quantities in at least the short/medium term. The issue was simply not explored with regional transfusion directors. Dr Walford pointed to the position of Dr Gunson,[190] who said it was not feasible, and Dr Lane who said that he could not produce small pool freeze-dried cryoprecipitate.[191] She acknowledged, however, that she was not aware of anyone asking each RTC questions such as “What’s your capacity to produce cryoprecipitate? How much do you produce? Could you produce more? If so, over what period of time? Would you need new equipment or have you got the right equipment?”.[192]

This was not solely a matter for the RTCs and prescribing clinicians to consider. In circumstances where there was a significant public health risk giving rise to the possibility of children and adults being infected through their NHS treatment with a disease known to have an extremely high mortality rate and for which there was no treatment, it was not good enough for the DHSS to say that it was a matter for others. The Secretary of State was ultimately responsible for the NHS and for the safety of patients, and it was incumbent upon him to act.

The DHSS neither issued nor even considered issuing any kind of advice or guidance or steer to clinicians advising, or even simply encouraging them to consider alternative approaches to treatment. This was because the DHSS did not regard it as its role to do so.[193]

It both could have done, and should have done.

Thus when Lord Glenarthur was asked in Parliament on 14 July 1983 by Baroness Rachel Gardner the question “Will the Minister issue instructions to practitioners, or ask his department to look into the need to do so?” he answered yes.[194] On 19 July 1983 Christopher Joyce from his Private Office wrote to Margaret Edwards in the DHSS asking for a draft “which tells Lady Gardner what the Department is doing to promote practitioners’ awareness and diagnosis of AIDS.”[195] An answer then appears to have been provided in a letter of 30 August to Baroness Susan Masham (rather than by way of a separate letter to Baroness Gardner) in the following terms: “We have been looking very carefully at our position on this matter and our medical advisers consider that the publications which have already appeared in the medical press provide sufficient and adequate guidance and information about this disease for practitioners, given the present state of knowledge.” Reference was made to the communicable disease reports issued by CDSC and to a British Medical Journal article published on 6 August, before the letter concluded that “We shall, however, be keeping the matter under close review to see whether any further Departmental action might be appropriate in due course”.[196]Neither the CDSC reports nor the British Medical Journal article addressed the question of risk reduction measures and alternative approaches to treatment, and there is no evidence of the matter being kept under any kind of review, let alone a close one.

It is in truth no answer at all to say that the DHSS (or CMO – as to which see further below) did not provide advice to doctors. It actually did – though not in 1983. Such advice was indeed provided from time to time. In August 1985 a summary of action taken in response to AIDS was provided to John Patten. This showed that all sorts of advice had by this stage been provided to health professionals from a variety of different sources (including the CMO); that further advice was planned; that information had been provided to health and local authorities; and that information had been provided to at risk groups and the public, with reference being made to a Health Education Council leaflet and the NBTS leaflet.[197]

That ministers could provide information to the public, or sectors of the public, in the interests of their health is both obvious as a matter of principle and demonstrated by a further example. In September 1982 the Secretary of State for Health, Norman Fowler, issued a statement regarding whooping cough. That statement gave information about the numbers of cases; the importance of immunisation; the state of knowledge about the risks of the disease and the benefits of vaccination in reducing that risk.[198] This was a campaign initiated by the Secretary of State himself – a “specific campaign in response to a perceived public health risk ... the purpose of which [was] to enable people to be better informed and take better informed decisions.” It was, moreover, a campaign which the DHSS believed saved lives.[199]

It was a failing on the part of the DHSS not to take measures to ensure that both clinicians and people with haemophilia were made aware of the risks of concentrate therapy and of possible alternative approaches to treatment. There was no impediment to it doing so.

September 1983

In September 1983 Lord Glenarthur asked for a meeting with fellow ministers to discuss what he described as “the balance of risk”: the risk to people with haemophilia if they did not get Factor 8 and the risk of AIDS if they did. That meeting took place on 15 September 1983 with Kenneth Clarke and John Patten (Norman Fowler being unavailable).[200] Lord Glenarthur wanted to ensure that what the DHSS was doing was “correct and justifiable and defensible in every single sense.” There is no record of what was discussed at this meeting but it was a missed opportunity for a reset: for the DHSS finally to take some proactive steps. By this time, of course, the DHSS was aware of a second haemophiliac with AIDS, who had died.[201]

Dr Walford attended the reference centre directors’ meeting on 19 September “to hear the latest on AIDS”. She sent a summary of the“salient points” to Paul Winstanley. These included the fact that some of the commercial Factor 8 concentrate from the batches administered to the patient in Bristol, who had died, had found their way to hospitals which were not haemophilia centres. This was described as “undesirable, both from the point of view of patient care, but also because these patients and the treatment they receive do not get included in the national statistics on the use of FVIII which provide so much valuable information”.[202] This fact should have – but did not (or, if it did, no action was taken) – alerted the DHSS to the fact that, given that some people with haemophilia were treated elsewhere than at haemophilia centres, those treating them might have a limited understanding of the risks of treatment. Neither the CMO nor the DHSS could have made any assumptions about the state of knowledge of those hospitals.[203] Two cases described by Dr Mark Winter in his oral evidence to the Inquiry vividly demonstrated the consequences of treatment in such circumstances.[204] That people with bleeding disorders could find themselves being treated in hospitals that were not haemophilia centres and that transfusion might be needed by a member of the public at any time were two scenarios where Dr Walford agreed there might have been particular reasons for a Dear Doctor communication.[205] This risk should have been an impetus to the dissemination of information, whether by the CMO or the DHSS directly, but did not lead to any action.

No conclusive proof

The first use of “no conclusive proof” appears in the “line to take” drafted for the Prime Minister in early May 1983: “It is important to put this in perspective: there is as yet no conclusive proof that AIDS has been transmitted from American blood products.[206]The briefing note accompanying this line to take included the sentence: “As yet there is no conclusive proof that AIDS is transmitted by blood as well as by homosexual contact but the evidence is suggestive that this is likely to be the case.[207]

On 31 May 1983 a letter from Lord Trefgarne to Nicholas Baker MP stated: “I can well appreciate the anxiety, particularly amongst haemophiliacs and their families, which recent press reports on AIDS may have caused and would first of all like to put matters into perspective: the cause of AIDS is as yet unknown and there is no conclusive proof that the disease has been transmitted by American blood products.[208] This letter was drafted by officials for Lord Trefgarne and, it being the purdah period before a general election, he “would have assumed that any letters put before me for signature would have been drafted by officials based on well-established policy.[209] Lord Trefgarne did not know why the caveat in the briefing note (“but the evidence is suggestive that this is likely to be the case”) had been omitted from the letter he signed.[210]

On 22 June a paper on AIDS produced by Dr Walford was provided to Lord Glenarthur.[211] This paper did not use the language of “no conclusive proof ”. It explained, amongst other things, that there was thought to be considerable under-reporting of cases of AIDS to the CDC (some 1,450 cases having been reported to date); that there was a “so-called four ‘H’ list of those particularly susceptible to the disease;[212]that a handful of cases had developed in recipients of ordinary blood transfusions which had provided valuable evidence to indicate that the incubation period might vary from several months to up to four years; and that people with haemophilia “seem at greatest risk of acquiring AIDS” through the secondary method of spread (transfusion). In respect of the one case of AIDS in a person with haemophilia reported to CDSC, the paper said that there was “still some uncertainty over the diagnosis.[213] The cause of AIDS was unknown “but the evidence is suggestive that it may be a virus.” The paper went on to discuss the “steps which are being taken to prevent the spread of AIDS in the UK”. The first was case reporting (to CDSC and CDC); the second was in relation to blood donors – a leaflet had been prepared and would be published by the DHSS – and the regional transfusion directors were currently considering whether to introduce additional questioning for donors as regards their general health or the presence of key symptoms;[214] the third was in relation to people with haemophilia – the DHSS’s Medicines and Supply Divisions were “endeavouring to ensure that there will be no ‘dumping’ of high-risk plasma products on the UK market and are seeking various assurances from the manufacturers in relation to the quality of their product”; and the fourth involved research into male homosexual patients attending the Department of Genito-Urinary Medicine at the Middlesex Hospital.[215]

On 1 July 1983 a further paper (together with the draft AIDS donor leaflet) was sent to Lord Glenarthur. This paper referred to “increasing evidence that AIDS may be transmitted by the transfusion of blood … Blood products … may also transmit AIDS and haemophiliacs are at particular risk ... It is believed that there may be under-reporting of cases … Although there is no conclusive evidence, it seems very likely that AIDS is caused by an as yet unidentified virus.[216]

On 14 July 1983 the “no conclusive proof” line to take was used in Parliament: Lord Glenarthur, answering a question about AIDS, stated that “Although there is no conclusive evidence that AIDS is transmitted by blood or blood products, the department is considering the publication of a leaflet indicating the circumstances in which blood donations should be avoided.” In the course of the debate, Baroness Masham posed a question to which Lord Glenarthur did not know the answer; he said that he would “find out and let her know.[217]

On 19 July Christopher Joyce, of Lord Glenarthur’s Private Office, wrote to John Parker, referring to the fact that Lord Glenarthur undertook to write to Baroness Masham about possible transmission through Factor 8: “I do not know that there is much more we can say than to refer to the balance of risk to haemophiliacs and the development of production at the new Elstree lab, but Lord Glenarthur is concerned to allay Lady Masham’s anxieties so far as possible. She is an energetic lobbyist.[218]

On 20 July Dr Walford produced some wording for a reply by Lord Glenarthur to the question from Baroness Masham, which included the following: “There is no conclusive proof that AIDS can be transmitted by blood, cryoprecipitate or Factor VIII concentrates but the assumption is that such transmission may be possible.[219] By the time John Parker of HS1 sent Lord Glenarthur’s Private Office a fuller text for the suggested letter to Baroness Masham on 26 July 1983, the wording had become “I should emphasise that there is no conclusive proof that AIDS can be transmitted by blood, cryoprecipitate or Factor VIII concentrates.[220]

The letter as sent to Baroness Masham on 30 August 1983 stated that “There is, in fact, no conclusive proof that AIDS can be transmitted by blood, cryoprecipitate or Factor VIII concentrates.[221] Thus, it can be seen that not only did “no conclusive proof” become part of the line to take, but the qualifying phrase in Dr Walford’s original draft (“but the assumption is that such transmission may be possible”) was dropped.[222] Lord Glenarthur did not know why that qualification had been omitted from the version sent to his office, and duly sent by him to Baroness Masham: “Mr Winstanley, or somebody else in the Department, took it upon themselves to remove that, I don’t know why they never referred it back to Dr Walford to say no -- so that she could say, ‘No, I really think it ought to go in, and if necessary, ministers have got to be consulted about whether it should go in.’” In retrospect, this troubled him.[223]

On 25 August 1983 Lord Glenarthur wrote to Nicholas Baker, providing information about the monitoring of AIDS cases by CDSC; his letter ended “Finally, I would like to stress that there is as yet no proof that AIDS is transmitted by blood or blood products.[224]

On 26 August 1983 Lord Glenarthur wrote to Clive Jenkins, the general secretary of the Association of Scientific Technical and Managerial Staffs. His letter read: “I think that I should emphasise, firstly, that there is no conclusive evidence that AIDS is transmitted through blood products.” It continued “Nevertheless we are taking all practicable measures to reduce any possible risks to recipients of blood and blood products.[225]

On 1 September 1983 the publication of the AIDS donor leaflet was announced with a press release in which Kenneth Clarke said “It has been suggested that AIDS may be transmitted in blood or blood products. There is no conclusive proof that this is so.” He went on to say that nevertheless he could “well appreciate the concern that this suggestion may cause”.[226] A draft of the press release and a Q&A brief were sent to Kenneth Clarke for approval in advance.[227] The Q&A brief suggested that in response to the question “What is being done to protect haemophiliacs?” the answer should be “I must emphasise that there is no conclusive evidence that AIDS has been transmitted by American blood products”. In response to the question “What is the Government doing to stop imports of Factor VIII from America?” the suggested answer was “Factor VIII is essential to the treatment of many haemophiliacs and the possible risk of infection from AIDS must be balanced against the obvious risks of not having enough Factor VIII”.[228] In response to the question “Why issue a leaflet at all?”the suggested answer was: “While there is no conclusive evidence that AIDS is transmitted through blood or blood products we believe that it is right that blood donors should be fully informed about AIDS”.[229]

The purpose of Kenneth Clarke making a ministerial statement that would be incorporated into a press release had been discussed earlier in August 1983. The arguments for so doing were twofold: political and media interest, and “the need for the Government to be seen to be taking a positive step in an area where, because of the lack of knowledge of the cause of the disease and its treatment, there is limited scope for action.[230] It was, therefore, a deliberate decision to make the statement by way of press release on 1 September, in part to portray the Government as acting proactively, and it was made in the expectation that it would excite political and media interest.

The ministerial statement was indeed reported in the press on 2 September: The Daily Telegraph carried a story which included the paragraph that “Mr Kenneth Clarke, Health Minister, said there was no conclusive proof that AIDS was transmitted in blood or blood products”; and The Times likewise reported that “Announcing publication of the leaflet, Mr Kenneth Clarke, Minister for Health, said: ‘It has been suggested that Aids may be transmitted in blood and blood products. There is no conclusive proof that this is so.’[231] The British Medical Journal on 17 September 1983 reported in “Medical News” the publication of the leaflet and repeated that “The Minister of Health said that although it has been suggested that AIDS may be transmitted in blood or blood products there is no conclusive proof that that is so.[232]

At the 17 October 1983 meeting of the Advisory Committee on the NBTS the minutes record a contribution from Dr Walford that “Although there was as yet no conclusive proof of a link between AIDS and blood products the Department had, in conjunction with RTDs produced a leaflet aimed at reducing the risk of transmission of AIDS by blood donation.[233]

On 1 November 1983 The Guardian carried an article about the death (in the summer) from AIDS of a British person with haemophilia from Bristol, quoting from Dr Helena Daly and Dr Geoffrey Scott (director of the Bristol Haemophilia Centre) that “It seems highly probable that the development of Aids was related to this treatment. This case provides further evidence for a link between blood products and Aids.” This report prompted Steven Green to ask Dr Walford on 23 November “is it Ok for me to continue to say there is no conclusive proof that the disease has been transmitted by American blood products’”, to which Dr Walford replied “Yes it is ok”.[234]

On 14 November 1983 Kenneth Clarke told Parliament that “There is no conclusive evidence that acquired immune deficiency syndrome (AIDS) is transmitted by blood products.” That same statement asserted that professional advice had been made available to all haemophilia centres in relation to the possible risks of AIDS from Factor 8 concentrates.[235]

On 16 November 1983 Lord Glenarthur wrote to Jerry Wiggin, in response to a letter from the latter to Kenneth Clarke and an enclosed letter from a constituent whose 14 year old son had haemophilia. The letter read “I can well appreciate the anxiety, particularly amongst haemophiliacs and their families which recent press reports on AIDS may have caused and would first of all like to put matters into perspective: the cause of AIDS is as yet unknown and there is no conclusive proof that the disease has been transmitted by American blood products.” Forwarding the letter to his constituent, Jerry Wiggin expressed the hope that “Lord Glenarthur’s reply will reassure you on the Government’s stand on this issue.[236]

On 16 December 1983 Lord Glenarthur wrote to John Maples MP, in response to a letter to Kenneth Clarke, in which he stated “I can well appreciate the anxiety, particularly amongst haemophiliacs and their families which recent press reports on AIDS may have caused and would first of all like to put matters into perspective: the cause of AIDS is as yet unknown and there is no conclusive proof that the disease has been transmitted by American blood products.[237] This letter was, as Lord Glenarthur acknowledged, designed to provide a degree of reassurance, and there was nothing within it that recognised the strong circumstantial evidence.[238]

Clive Jenkins rightly took issue with the statement that there was no conclusive evidence that AIDS was transmitted through blood products. In a letter of 27 October 1983, he argued that the evidence was very strong; he set out his understanding that the number of people with haemophilia with AIDS in the US was likely an underestimate because of the long incubation period; he stated that people with haemophilia in Europe were contracting AIDS; and he pointed to a paper submitted to a recent meeting of the Advisory Committee on Dangerous Pathogens (“ACDP”) which recorded that there “is now strong circumstantial evidence that AIDS may be transmitted by blood and blood products.[239] Clive Jenkins then posed a pertinent question: “I am tempted to ask you what you would consider to be conclusive evidence, particularly in the circumstances where the agent or agents for AIDS are as yet unidentified?”.[240] Lord Glenarthur did not think he would have seen this letter until he was sent a suggested reply in January 1984; he did not recall being made aware of the situation in Europe or of the paper for the ACDP. He would, he said, have expected officials to examine what was in Clive Jenkins’ letter and advise him if there was evidence of a real cause for concern or conflict with what the Government was saying.[241] Lord Glenarthur told the Inquiry that had he seen that paper it would have given him pause for thought as to whether it was right to emphasise the absence of conclusive proof, and that he would have asked questions about it.[242]

The reply that Lord Glenarthur sent reiterated that there was no conclusive evidence, acknowledged that the circumstantial evidence was strong and suggested that the two statements in no way contradicted each other.[243]

On 25 March 1984 The Sunday Times carried an article titled “New Aids alarm over blood link” which suggested that doctors “now have conclusive proof that the mysterious and generally fatal ailment known as Aids has been passed to a hospital patient through a blood transfusion.[244] In a handwritten note from Steven Green of the DHSS dated 26 March 1984 it was confirmed that “We dropped ‘there is no conclusive proof that AIDS is transmitted through blood or blood products’ from our standard line some time ago.[245] Lord Glenarthur had no recollection of the dropping of the line to take coming to him for consideration or approval.[246]

In 1987-88 the “no conclusive proof” line to take was looked at by the DHSS. Dr Roger Moore’s assessment was that: “Throughout 1983 the Government’s public line in Private Office cases and Parliamentary replies was that there was no conclusive evidence that AIDS was transmitted by blood products. This statement was strictly true and in view of the very small number of UK cases was intended to reduce public anxiety.[247] Dr Moore thought that it was clear from the files that:

“the Department adopted a precautionary stance and assumed in its policy decisions that AIDS was transmitted by an infective agent … Not until April 1984 when the AIDS virus was isolated could it be said that conclusive evidence was available.[248] However by then public interest had waned and not until December 1984 did a Departmental Press Release need to refer to the AIDS virus in Factor VIII thereby acknowledging the fact for the first time.”[249]

Dr Hilary Pickles, writing to the CMO on 19 April 1988, and referring to Kenneth Clarke’s parliamentary response of 14 November 1983, said that the reply was “strictly true at the time. Although with the benefit of hindsight, in November 1983 there were strong indications that AIDS could be transmitted by blood products conclusive proof was not available.[250]

Commentary on the “line to take”

By the summer of 1983 (indeed, as Dr Walford confirmed, from at least the beginning of 1983), the DHSS rightly understood that, as a matter of probability, AIDS could be transmitted by blood. In a briefing for the then minister, Geoffrey Finsberg, on 20 May 1983, Dr Walford wrote that “The general view is that the transmission of AIDS seems to follow the pattern seen with the hepatitis B virus, that is, it may be transmitted … by contact with blood[251] Dr Gunson’s report on 19 May 1983 of the proceedings of the Council of Europe’s Committee of Experts stated that “Absolute proof that AIDS is caused by a transmissible infectious agent is not yet available, but the consensus in the Committee was that it should be regarded as such”.[252] Dr Richard Tedder’s letter of 20 May 1983 to Dr Walford explained that “This condition is likely to be caused by an infectious agent or agents.[253] The donor leaflet that was going through the process of approval by the DHSS posed the very question “Can AIDS be transmitted by transfusion of blood and blood products?” and answered it in these terms: “Almost certainly yes”.[254]

The line “no conclusive proof”, whilst technically correct, was indefensible. It did not spell out the real risk. It gave false reassurance. It lacked candour and, by not telling the whole truth, it was misleading. There was no good reason for the decision to adopt and maintain this line. It represented a deliberate choice by the DHSS to emphasise the absence of conclusive proof rather than the presence of a likely risk. Its motives for so doing are likely to have been a combination of reassuring people who might need a transfusion and encouraging people with bleeding disorders to continue to accept treatment with concentrates[255] and because it might mitigate the fact that the DHSS was not taking more radical or proactive steps.[256] It is noteworthy that at a meeting on 6 July 1983 Kenneth Clarke said, in relation to the oral Parliamentary Question that Lord Glenarthur would be answering on 14 July, that the latter should, if asked about the transfusion service, “emphasise that the risk to haemophiliacs was very small.[257] This too was part of the DHSS’s wish to downplay the risks to people with bleeding disorders.

The line to take was not an accurate reflection of the DHSS’s actual understanding and belief, which was that it was likely that AIDS was transmitted through blood and blood products. It did not, therefore, set out the true internal understanding within government. As one submission to the Inquiry points out, to explain that use of the phrase was to avoid alarming the public, showed a disrespect for the right of citizens to know the truth, and was a mismanagement of the response to a risk to public health.[258]

No minister challenged the “no conclusive proof” line. They could have. If they had, it is likely that the qualification – “but that it is very likely that it does” – would have been given to them, and then to the public.

As Dr Walford pointed out in relation to the language used in the AIDS donor leaflet, donors needed something that was clear and unambiguous. But it was equally, if not more, important, that those who might be exposed to the risk should have that risk clearly spelt out to them.

The line to take was used in Parliament, in press releases, in communications with members of Parliament who were raising matters on behalf of constituents and would no doubt report back to them. It was designed to influence public opinion and may well have done so.[259] It is of course right that there was some scientific uncertainty about a number of matters. But that reinforced the importance of clarity and transparency. Both the public and the particular cohorts of patients most likely to be directly affected were entitled to be told what was known for sure, what was thought to be likely, and what was recognised as a possibility. Far from seeking to reassure those taking blood or blood products that doing so came without significant risk, the authorities ought to have been emphasising that there were indeed risks.[260]

The AIDS leaflet

Until such time as a screening test was available, the only means of reducing the risk of AIDS transmission within the domestic blood supply was to ensure, as far as possible, that those donors most likely to transmit the virus did not donate. The risk was pressing.[261] A leaflet for potential donors was, therefore, a key measure. Unhappily, however, and as set out below, this took far too long.

The production of the first leaflet

On 16 May 1983 Dr Gunson wrote to Dr Walford to inform her of discussions at the Council of Europe meeting which he was attending. Amongst the measures which were expected to be in the Committee of Ministers’ resolution was the provision of information “to all donors so that those at risk will abstain from donating.[262] Dr Walford attended the meeting of regional transfusion directors two days later;[263] it was her recollection that she asked to be invited and that her purpose was to urge the regional transfusion directors to produce a leaflet for donors discouraging high risk groups from donating.[264] It was, she said, the DHSS’s view by this time that blood donors in the risk groups (men who had sex with men and injecting drug abusers) should as far as possible be excluded from donating, and she requested at the meeting that a leaflet be prepared, which she envisaged could be used in conjunction with questioning by the transfusion doctor to elicit possible risk factors. The proposal was not, she recalled, well received, but Dr Gunson had also written to the regional transfusion directors with options,[265] and although there was reluctance to proceed with a leaflet the RTDs agreed one should be prepared. The RTDs were adamant, however, that there should be no questioning of donors about their sexual habits or injecting drug use.[266]

When Dr Walford received the original draft leaflet, she did not think it was sufficiently clear and asked Dr Gunson to redraft it. The redraft was sent to Paul Winstanley, for onward transmission to the DHSS’s Information Division, on 17 June 1983.[267] Paul Winstanley had, in an earlier minute to the Information Division, already set out concerns about the lack of speed:

“The object of this exercise is to take, and to be seen to be taking, urgent action to reduce the risk of AIDS being spread through blood transfusions by seeking to exclude those donors thought most likely to be carriers of AIDS. Any delay obviously reduces its effectiveness. It is not beyond the realms of possibility that a minor epidemic of AIDS could break out in the near future … I should have thought we are not likely to earn the gratitude of Ministers for delaying a measure designed to reassure blood donors and reduce the risk of AIDS when they are being asked awkward questions about what the Department is doing and why action was not taken before. It is worth remembering that this leaflet is a low-key measure compared to the examination and questioning of donors which the FDA in the USA has instituted.”

Paul Winstanley added that “it was essential to act without delay” and that “As it is, the time for printing and distribution seems painfully slow.[268]

Despite Paul Winstanley’s concerns, matters did not proceed particularly swiftly thereafter. On 1 July a paper and the revised leaflet were sent to Lord Glenarthur[269] by John Parker (HS1) with the observation that the issue of the leaflet “would be seen as a positive step to minimise the risk of the transmission of the disease through blood donation in this country.[270] The paper suggested that ministers’ agreement was being sought to the funding (£5,000) and publication of the leaflet in view of“the sensitivity of the issue as it relates to homosexuals”.[271] The recommendation was that, despite the potential sensitivity, “early publication of the information leaflet is in the best interests of the public health.[272]

Lord Glenarthur responded promptly on 4 July: he was content with the proposed leaflet and cost.[273] John Patten expressed the view that “public concern on this issue is mounting, and rightly” and that the “earliest possible publication seems desirable.[274]The Minister of State, however, Kenneth Clarke, appears to have been less convinced and a meeting took place on 6 July 1983 between Kenneth Clarke, Lord Glenarthur and officials to discuss the issue.[275]

The note of the meeting records that Kenneth Clarke had two main concerns: to establish the necessity of a leaflet and to agree how the inevitable publicity surrounding it should be handled. Officials having explained the main objective of the leaflet (to discourage those who were most at risk from AIDS from giving blood), Kenneth Clarke accepted the argument, but wanted it to “emphasise unequivocally that donors would not be questioned about sexual matters” and that a press notice should “repeat that there was no question of donors being quizzed about their sexual habits.” The main objective, he said, “was to minimise any damage to the transfusion service.[276]

A letter from Dr Gunson to Dr Ronald Oliver (who was present at the meeting on 6 July and had subsequently spoken about it to Dr Gunson) gives a sense of Kenneth Clarke’s concern: “that the issuing of the leaflet may be regarded as a panic measure by the Government and lead to resentment amongst donors and alarm amongst patients.[277]“[Against] the background of the need for a low-key approach to the publication of the leaflet and the need to ensure that we do not spread unnecessary alarm and despondency amongst donors”, the Minister of State did not want the leaflet to be distributed with call-up cards.[278] Dr Oliver, by contrast, held the strong view that the leaflet should be sent out with the call-up cards:

“I am quite sure that the best way is to send out the leaflet with the call-up cards so that the contents can be studied by individuals in private. I do not think donors would take exception to receiving a leaflet in this way, couched in the way it is as general information on a subject of public interest. I personally would have thought this would entirely satisfy the low key approach that Ministers and all of us want.

The only alternative is to make the leaflet available at donor sessions or positively hand it out at donor sessions. In either event it could place a donor in an impossibly embarrassing situation or defeat the objective of the leaflet. For example, if having read the leaflet before donation the donor feels he should decline to give blood it is embarrassing to walk out as everyone will suspect the reason for his doing so. If he reads the leaflet or considers it while actually donating blood, again he can hardly say anything without embarrassment, and if he is in the high risk group of donors possibly infected blood will get into the system.” [279]

John Bolitho, of the Information Division, thought that Kenneth Clarke would be “very irritated if we are not able to control distribution the way he wants it. He reacted very unfavourably when this was suggested at the meeting.” He expressed the concern that if it was distributed with call-up cards “it will soon be in the news media and we could have a similar furore to the Gillick case with family planning.[280]

Whilst John Parker acknowledged the need to “bow to Ministers’ wishes on the matter of handling the distribution”, he was not convinced that ministers “have fully understood the pros and cons”, and they needed to weigh the possible disadvantage of letting “risky” blood “slip through the net” against the advantage of minimising adverse publicity. He was convinced that sending the leaflet out with the call-up cards was “the only sensible thing to do”.[281]

On 29 July 1983 a submission was sent to ministers seeking their agreement to the printing, distribution arrangements and publicity for the proposed AIDS leaflet.[282] The submission stated that opinion amongst regional transfusion directors as to the best means of distribution was divided. Two methods were described: issuing the leaflet with the donor call-up cards and making the leaflet available at donor sessions. The pros and cons of each were set out.[283] It is obvious from the articulation of those pros and cons in the ministerial submission that the issue of the leaflet with the donor call-up cards was more likely to meet the public health objective of the exercise. Yet the submission surprisingly continued by stating that it was “not immediately obvious which method is to be preferred” and recommended that regional transfusion directors should be given the discretion to decide, for a six month trial period, the most effective means of distribution in their own regions.

Lord Glenarthur, responding (again promptly) on 3 August, approved the text of the leaflet. He favoured using both methods of distribution and felt that “the risk of embarrassment to potential donors is outweighed by the need to achieve wide distribution”, adding that “We may be at the tip of an iceberg with AIDS and find ourselves in trouble in 18 months’ time unless we are really positive in our approach.[284] John Patten expressed very similar views: the arrangements should go ahead “as soon as possible” and, like Lord Glenarthur, he asked whether there was any reason why regional transfusion directors could not follow both methods of distribution for the trial period.[285]

Kenneth Clarke, by contrast, in a minute of 2 August, thought the arguments in terms of the methods of distribution were “finely balanced” and was “prepared to allow directors discretion on how to distribute for six months”.[286] Kenneth Clarke’s preference was for the leaflet not to go out with call-up cards: his reasoning was the reaction of recipients – some people would say “What are you calling me gay for? I’m not gay” and others would say “Good grief, what have they got against gays? The Department of Health is getting homophobic.[287]

Somewhat bizarrely, just over three weeks later, on 26 August, Kenneth Clarke commented that the range of views from regional transfusion directors was alarming, queried whether there had been agreement from the Department on one method of using the leaflet, and asked what authority he had to insist on one national method.[288] On 31 August, however, he clarified that he had “forgotten” that he had earlier agreed to regional transfusion directors having discretion on a six month trial period. At the same time his Private Office asked that Lord Glenarthur’s comments on the six month trial proposal be obtained as soon as possible.[289]

On 1 September Lord Glenarthur suggested that the trial period should last three months rather than six, a proposal with which Kenneth Clarke agreed.[290] It had seemed to Lord Glenarthur that “a six-month trial was unnecessarily long … was excessive in my view. I was used to dealing with stuff much more rapidly than that and it seemed an unconscionably, whatever the word is, long period of time.[291]

The leaflet went into distribution with effect from 1 September 1983. In a press release of the same date, Kenneth Clarke stated that:

“It has been suggested that AIDS may be transmitted in blood or blood products. There is no conclusive proof that this is so. Nevertheless I can well appreciate the concern that this suggestion may cause. We must continue to minimise any possible risk of transmission of the disease by blood donation but it is not possible to test a person’s blood for the presence of AIDS. The best measure which can be taken at the present time is to ask people who think they may have AIDS or be at risk from it, to refrain from giving blood. This is what this leaflet sets out to do.”

The press release emphasised that there was “no question” of donors being asked about their sex lives at blood donation sessions or at any other time.[292]

Commentary on the production of the first leaflet

Given that the risk of transmission of AIDS through blood or blood products was something the DHSS knew about since mid 1982,[293] it took far too long until the production of a leaflet was first discussed in May 1983.

Though rightly described as urgent internally within the DHSS,[294] it then took too long for the leaflet to be finalised and made available to RTCs at the beginning of September 1983.

When the matter finally did come to the attention of Lord Glenarthur, he was in no doubt that the leaflet was required and needed to be done quickly: “I felt that there was a degree of urgency … and we ought to get it out as soon as possible.[295]He told the Inquiry that it all took “too long”.[296]

Lord Clarke was less troubled by the delay (which was contributed to by the belief that ministerial approval was necessary and by the time then taken for that ministerial approval to be obtained). He identified two concerns: he “didn’t want it to be done in such a way that we stopped people volunteering to donate blood”and he “really was very worried that we didn’t want people put off from blood transfusions.[297]He intervened “because I just wanted to make sure that we didn’t start setting off some sort of mayhem that damaged the Transfusion Service.[298] He wanted there to be emphasis in the leaflet on how few cases of AIDS there had been, describing this as “trying to minimise panic before we knew more about it.[299] His reason for not supporting the sending out of the leaflet with the donor call-up cards was that it would result in the DHSS being regarded as homophobic;[300] he also thought that the donor receiving the leaflet with the call-up card “would get the impression that when you went to the blood donation you were going to be quizzed about your sex life.[301] In terms of the time taken to produce the first leaflet, he asserted first in his oral evidence that “any delay in issuing the first leaflet had had no effect on anybody’s health at all” – which he was not in any position to know – and then said “I will concede that in the five weeks between the first leaflet being proposed and it going off to the printers, it is conceivably faintly possible that such a case[302] had occurred.[303]

A concern that the DHSS might be seen as homophobic should not have slowed the process down, nor should it have influenced the method of distribution of the leaflet as it did; as for the concern to avoid panic or mayhem, this was never a realistic scenario.

It is unclear why the submission to ministers in July 1983 suggested that it was not immediately obvious which method of distribution of leaflets was to be preferred: it ought to have been obvious (as it plainly was to both Dr Oliver and John Parker) that sending the leaflet out with the call-up invitation was the method most likely to achieve the objective of preventing donation by high risk donors. It is conceivable that the submission was framed in the way that it was because civil servants knew that Kenneth Clarke preferred that the leaflets not be distributed with call up. In any event, the decision to leave the method of distribution to regional transfusion directors rather than ensure from the outset that the leaflets reached donors to the greatest possible extent was wrong.

The production of the second leaflet

The three month trial period for distribution of the first leaflet should have led to a review at the end of November or the beginning of December. It did not. Instead, there was substantial delay in evaluating whether the content of the first leaflet was sufficient to achieve its purpose and whether there should be a changed approach to distribution of the leaflets.

There was some limited communication between officials and ministers on the subject of the AIDS leaflet in late November 1983, but this appears to have been limited to the question of distributing the leaflet to sexually transmitted disease (“STD”) clinics.[304]

At a meeting of the CBLA’s Working Group on AIDS on 14 October 1983, there was a discussion about the AIDS leaflet, with Dr Gunson commenting that it was at present “the only practical step being taken by the Transfusion Service.[305] The minutes record that approximately half of the RTCs were distributing the leaflet with call-up cards with the others either having the leaflet available at sessions or being handed out to donors. The Working Group’s view was that a uniform system of distribution[306] would be advantageous. The minutes also noted that RTCs had been asked by the DHSS to report on the distribution at the end of November 1983.[307] Other steps were discussed (including distribution to special clinics, approaches to health education councils and gay societies and highlighting the importance of the message not to give blood if in a high risk group) and it was agreed that these would be raised with the DHSS on 17 October when the Advisory Committee on the NBTS was next to meet.

It is unclear whether these matters were in fact raised with the DHSS as proposed: the minutes of the Advisory Committee’s meeting on 17 October 1983 merely refer to the existence of the leaflet.[308]

The three month period came and passed with little further action. Such as there was consisted of Paul Winstanley making enquiries of regional transfusion directors by phone at around the end of the three month trial period;[309] and Dr Wagstaff (director of Sheffield RTC) also seeking information from regional transfusion directors regarding their use of the leaflet in around late November 1983,[310] which he then tabulated for Paul Winstanley at the start of the next year.[311]

Action seems to have been prompted by a request on behalf of the Medical Society for the Study of Venereal Diseases for copies of the AIDS leaflet to be provided to STD consultants. On 8 February 1984 this request[312] was passed to Dr Smithies by Dr Sibellas under cover of a minute which suggested that RTCs would soon be needing more leaflets, adding “? Preferably the amended version when the others have run out.”[313] Handwritten notes on the minute asked “what is the amended version?”.[314]

The DHSS belatedly realised it needed to take some action. On 14 February 1984 Dr Smithies, who was relatively new in post, wrote to Alun Williams,[315] raising the concern that “our current advice to donors could seem too lax” and that it “may also be necessary to take up with the Transfusion Directors the need for more positive distribution rather than the negative approach that some of the Centres have used.”[316] On 6 March she wrote to Dr Sibellas, referring to the intention to revise the pamphlet (a handwritten note added that this proposal was likely to need ministerial agreement, adding “did we not promise Ministers a progress report on the usefulness of the pamphlet?”);[317] and on 12 March 1984 Steven Green wrote to all transfusion directors, explaining that the leaflet was “due for review[318] and asking for information about usage, the method of distribution and impact on donor attendance.[319] Regional transfusion directors were also invited to comment on the content of the leaflet.[320]

By now, what ministers had agreed should be a three month trial had begun more than six months earlier.

At the 10 April 1984 meeting of the Advisory Committee on the NBTS, Dr Smithies reported that “The 6 month trial period of the leaflet ‘AIDS and how it concerns blood donors’ was now complete and the survey of RTDs showed little adverse comment. DHSS now proposed to prepare, in consultation with RTDs, a revised version of the leaflet for submission to Ministers.[321] The Advisory Committee recommended that, in contrast to the trial period when the method of distribution had been left to the discretion of regional transfusion directors, ministers should now consider the issue of the revised leaflet with donor call-up cards in all regions. It is unclear why Dr Smithies referred to a six month trial period: those present from the DHSS (Dr Harris, the Deputy CMO; Dr Smithies, Alun Williams and Steven Green) ought all to have known that ministers had decided upon a three month trial period, not six months.

On 17 April 1984 a submission was sent to ministers, covering a range of matters relating to AIDS.[322] In relation to the AIDS donor leaflet, the submission repeated the (inaccurate) reference to a six month trial, which was described as successful,[323] and explained that both leaflet and method of distribution were “under review”.[324] Lord Glenarthur, in response, sought a fuller note on the NBTS leaflet trial.[325]

It took nearly four months for that note to be provided – an astonishing delay, all the more remarkable when added to the mistake about the length of the trial period, and the relaxed approach to reviewing the results of it.

What happened in the intervening period was to-ing and fro-ing, with no real sense of urgency, regarding amendments to the leaflet. Thus, Dr Smithies sent Dr Sibellas (and others within the Department) a draft amended leaflet on 9 May 1984;[326] comments were received from the Information Division on 16 May[327] and from others within the Department on 23 May;[328] on 6 and 7 June Dr Smithies sent regional transfusion directors the redrafted leaflet for comment, requesting any suggested amendments or comments by 6 July;[329] at the regional transfusion directors’ meeting on 11 July it was recorded that amendments had been sent to Dr Smithies;[330] on 18 July Dr Smithies sent Alun Williams a revised draft of the leaflet and the outline of a draft submission to ministers;[331] on 23 July Dr Smithies wrote to Dr Sibellas and others asking for comments on the redraft before it was sent to ministers;[332] and on 31 July Dr Smithies wrote to Alun Williams saying that the redrafted leaflet had been cleared with Med IMCD and the Information Divisions and was ready for printing “provided Ministers agree.[333]

A submission was finally sent to Lord Glenarthur on 10 August 1984, almost a year after the first leaflet had been introduced. There was no good reason for it to take so long, and no evidence that any minister chased for it. The submission explained that the current AIDS leaflet was now out of date and that there was a need to strengthen its warning to high risk groups not to donate. Ministers were told that there had been, “as anticipated”, a wide variation in the manner in which the leaflet had been distributed by RTCs and that there should be a “more uniform and consistent distribution system to be adopted by Regional Transfusion Centres in England and Wales.” All regional transfusion directors that did not send out the leaflet individually to registered donors should now be asked to do so;[334] donor teams should also make certain that new or unregistered donors had an opportunity to read the leaflet before they were committed to donation. Ministers were asked to agree to this action and to the revision of the leaflet.[335]

Lord Glenarthur agreed, his approval being communicated by a minute dated 21 August 1984. A handwritten note on the minute suggests that the submission was sent to the Minister of State for Health (Kenneth Clarke) on 14 September, asking if he had any comments or was content for the leaflet to be revised as suggested.[336] On 16 October a minute on behalf of Kenneth Clarke, to Alun Williams, reported that the Minister had now seen the August submission and was “content for the leaflet to be revised and distributed in the way in which you suggest”, adding “I am sorry this has taken so long to clear.[337]

Despite the clearance of the contents of the revised leaflet and its method of distribution from the minister responsible for blood (Lord Glenarthur) on 21 August, and its (already belated) approval by the Minister of State for Health (Kenneth Clarke) on 16 October, it was another three and a half months before the revised leaflet was put into circulation. Events during that period (described below) would strike an almost farcical note, if the underlying subject matter were not so serious.

On 19 November 1984 Dr Smithies provided a note summarising the current situation on AIDS which had been requested by the Secretary of State for Health (Norman Fowler).[338] Insofar as the leaflet was concerned, the note stated that the revised version was now being printed and would be given to every donor. However on 22 November Janet Hewlett-Davies, in the Information Division, wrote attaching “a revised version of the leaflet drafted by my Publicity Branch.” This endorsed a view which had apparently been expressed by John Cashman[339] that the revised draft circulated previously by Alun Williams had to be looked at again “in the light of recent developments[340] and ministerial statements[341] and that the need was for “a much more strongly worded leaflet and for urgent approval, production and distribution.[342] This intervention had the unfortunate effect of slowing down the process even further.

On 22 November 1984 a briefing session with Kenneth Clarke, in preparation for an ITV interview, revealed that, in addition to having strong views on spending money on the blood test for HTLV-3, he was “content to hold up the donor leaflet until after the Working Group meeting”, but was “obviously satisfied with it as it is at present.[343] His mention of a meeting was to the first meeting (on 27 November) of the new Working Group on AIDS of the Advisory Committee on the NBTS. When it met, it generally endorsed the latest donor leaflet (with “a few small but important changes suggested”) although the closer questioning of donors was not supported.[344]

The importance of the leaflet as a central plank of DHSS policy was apparent from Kenneth Clarke’s statement in Parliament on 28 November, the day after the meeting: “After consulting the Advisory Committee on the National Blood Transfusion Service we have decided to ask all regional blood transfusion centres to issue, on an individual basis to all blood donors, a revised leaflet ‘AIDS and how it concerns blood donors’. This leaflet reinforces our previous advice that persons at high risk of transmitting the AIDS virus should not donate blood.[345] The statement to Parliament made no reference to the delay in reaching that stage, or to the fact that the wording for the revised leaflet had not yet been agreed.

On 30 November John Patten, having seen Janet Hewlett-Davies’ minute and redrafted leaflet, indicated that he was “Content with this line if MS(H)/PS(L) are.[346]

On 3 December a revised version with the Working Group’s suggestions was sent to Kenneth Clarke for approval; the covering minute from Dr Michael Abrams set out the Working Group’s view that it was not necessary to adopt the stronger line proposed by the Information Division.[347]

On 4 December Lord Glenarthur indicated that he was content with the revised wording – but he was referring to the Information Division’s rewrite and not the Working Group’s.[348] A handwritten note from Dr Smithies to Alun Williams on 5 December then posed the question “Are we sure that Dr Abrams leaflet is the accepted version now?[349]

On 14 December – John Patten and Lord Glenarthur having both confirmed approval of the Information Division’s rewrite of the leaflet – Mr Harris of HS1 sent a chasing minute to Kenneth Clarke’s Private Office, referring to the version approved by the Working Group and stressing that it was “highly desirable that action on this is taken forward in the near future.[350] Kenneth Clarke was chased again on 20 December by Alun Williams: his “urgent” clearance of the revised text of the AIDS leaflet (the Working Group version) was sought, it being pointed out that NBTS could not be asked to effect a more positive distribution of the leaflets until ministers had approved the text.[351] By this time there had been media reports of transmission of HIV by blood transfusion in the UK.[352]

The Minister responded promptly on 20 December, setting out his preference for the Information Division leaflet and asking that officials “co-operate with Information Division in producing a third (and hopefully final) version of the leaflet based upon the ID text to take account of any recent significant developments, and amended as necessary to ensure medical accuracy.[353] A revised version was sent to the Minister the following day.[354] The Minister responded on 31 December by asking whether it was still true to say that there was only a remote chance of anyone getting AIDS from an ordinary blood transfusion[355] and by requesting the omission of a paragraph describing what else was being done because he remained “wary of offering to promise blood screening tests and heat treatments.[356]

Attention then moved to the need for a health circular to accompany the publication of the leaflet, which required “to be issued fast.[357] On 3 January 1985 ministers were sent a draft circular and asked to agree to its issue.[358] Lord Glenarthur and John Patten confirmed their agreement on 15 January 1985.[359]

The health circular was sent to regional health authorities and regional transfusion directors on 23 January 1985 with the leaflets being – finally – available to RTCs by or on 1 February 1985.[360] The circular explained that ministers had decided that it was essential that the revised leaflet be brought to the attention of each donor“on an individual basis”, continuing:

“This would normally be achieved by sending each donor a copy of the leaflet with his next call-up notification. It is realised that this may not be practicable for industrial sessions (or for new donors presenting at sessions) – in these cases alternative arrangements should be made to ensure that each donor is individually given the leaflet before any blood is taken. Displays of leaflets, whilst continuing to be useful, will not meet these new distribution requirements. Because the advice has changed significantly, the revised leaflet should be sent even to those who received the 1983 version.”[361]

The DHSS met the costs of printing the revised leaflet, but any resource implications in distribution, postage etc for RTCs would “have to be found from within existing RHA funding.[362]

Commentary on the production of the second leaflet

The trial period for the initial leaflet finished at the end of November 1983. It had been delayed in coming, despite it being the only available line of defence against the possibility of infection through blood and domestically made blood products. The need to take whatever steps could reasonably be taken was urgent. Yet the response was delayed.

These delays are almost as nothing when compared to the delay before a revised leaflet was available in England – one should have been decided on by the end of December 1983, if not earlier. It was not until February 1985 that one emerged. The debate had not been about whether or not the original version needed to be strengthened – that was agreed on all fronts – but on the precise wording to be used to provide for this strengthened message. Yet all the time that that message was not “out there” the risks posed to others by donors in high-risk groups were inadequately addressed. Though it cannot be said in the case of any individual that they might have been spared infection with all that followed, it is highly likely that some infections followed which need not have ensued, and should not have done. Moreover, blood was being taken from people who came forward out of a desire to help other people as best they could. They would have been mortified if they learned that there was a real risk that they might have been doing more harm than good, unintentionally, though others had known for some time that they might be, but just hadn’t yet found the right words to tell them this. Such donors were entitled to regard this as a betrayal of their good will.

Lord Glenarthur described the fact that he did not receive a substantive update on the leaflets until nearly a year after their production as “certainly disappointing”.[363] He described the process for producing an amended leaflet as “a protracted and rather bureaucratic process to get it approved and out where it should be, but that seemed to be the system at the time.[364]

It was more than disappointing. It was, as Lord Glenarthur acknowledged in his evidence to the Inquiry, “an absurdly long period of time … for such an important public health measure”. The “continual toing and froing within the Department and between ministers’ offices, tweaking the leaflet and the statements that go with it, were frustrating … But on the other hand, you know, Mr Clarke had strong views on these things, he was dealing with lots of other things, and it may have been that he didn’t quite perceive the same degree of urgency when he looked at it as those of us who were more immediately involved.[365] Lord Patten, giving evidence to the Inquiry, could not understand why it had taken so long or why there was no sense of urgency.[366] Even Lord Clarke accepted that the second leaflet “took far too long”,[367] although in terms of his own delay he admitted that it was “unfortunate” only with “the wisdom of hindsight”.[368]

There was no good reason for the failure to review the leaflet and its method of distribution at the end of the agreed three month period; no good reason for the civil servants to be under the illusion that the trial period was six months; no good reason for the failure of civil servants to send a submission to ministers before August 1984; no good reason for the failure of ministers to have raised the matter themselves at an earlier stage, at or towards the end of the three month review period; and no good reason for the delay that then elapsed between August 1984 and January 1985 when the revised leaflet was finally approved.

The result of these multiple failures was that for a year – from January 1984 to January 1985 – a leaflet that was known to be “too lax” in its wording, and which was not being distributed in a way that maximised the prospect of deterring high-risk donors, continued to be used.

The wording of the leaflets

As set out in the chapter on Blood Services and Addressing Risk: Response,the first step towards the production of information to discourage high-risk donors was in fact taken in Scotland. The Edinburgh and South East Scotland RTC prepared a draft leaflet in May 1983 which asked various groups to refrain from donating blood.[369] However, by the time the leaflet began to be used in the South East Scotland region in June 1983, the list of “at risk” groups had been amended.[370] Amongst other changes, “Homosexual men” became “Men who have multiple partners of the same sex[371] and “Anyone who abuses drugs” became “Intravenous drug abusers”. The June 1983 leaflet also included “Haemophiliacs[372] and recipients of blood transfusion. At an SNBTS meeting on 14 June 1983 Dr Brian McClelland explained that the leaflet was amended following discussion with representatives of the Scottish Homosexual Rights Group.[373]

The first AIDS leaflet that was available across the UK from September 1983 described AIDS as a “new, serious, but rare disease”. It identified three groups as appearing to be “particularly susceptible”: “Homosexual men who have many different partners”,“Drug addicts, male and female, using injections” and “Sexual contacts of people suffering from AIDS”.[374]

In response to the question “How can the risks be reduced?” the leaflet explained that “At present, there is no screening test the Transfusion Service can use to detect people with AIDS. So, until there is and until more is known about this disease, donors are asked not to give blood if they think they may either have the disease or be at risk from it.” The most emphatic part of the leaflet was the response to the question “Will donors be questioned on sexual matters when they attend to give blood?” The answer, in bold and enlarged print, was “Definitely not.[375]

The wording of this first leaflet was problematic in at least the following five respects. First, those in the risk groups were merely requested not to give blood, rather than being instructed that they should not or must not give blood. Second, the request was contingent upon the donor thinking “they may either have the disease or be at risk from it”, but the leaflet twice described the disease as rare, and in terms of the numbers of cases in the UK indicated that “about a dozen cases have been reported, by the middle of 1983.[376] Donors might, not unreasonably, have thought it unlikely that they themselves would be at risk of such a rare disease and thus thought that they did not need to self-exclude. Third, the risk group in relation to homosexual men was limited to those “who have many different partners”: this was problematic both in terms of the present tense (“have”) and in terms of the reference to “many different partners” – those who had only one partner or more than one (but not “many” – whatever that meant) would not think to self-exclude; nor would they have thought themselves excluded if they had had only one partner, but that partner had had several others before him.[377] Fourth, the risk group in relation to IV drug use was limited to “Drug addicts”: those who had previously engaged in IV drug use but no longer did so, or who had used drugs but did not consider themselves to be “addicts”, would not necessarily think to self-exclude. Fifth, the risk group in relation to sexual contacts was limited to the sexual contacts of those suffering from AIDS, rather than sexual contacts of people at risk of AIDS.

By February 1984 the DHSS had acknowledged the need to amend the advice within the leaflet, but it should have been evident from the outset that the first leaflet was, as Dr Smithies put it, “too lax.[378] It was too tentative in merely asking donors not to donate if they thought they had, or might be at risk of, AIDS. Something stronger, making plain in emphatic terms that donors must not give blood if they fell within the at-risk groups, was required from the beginning. It was too narrow in its delineation of the at-risk groups.[379] There was, amongst both ministers (primarily Kenneth Clarke) and regional transfusion directors, a misplaced concern not to offend – whether the concern was one of offending those in the gay community, or offending other donors by raising (even if just in a leaflet) matters of sexual behaviour, or both. Such concerns should not have been allowed either to slow down the process of producing the leaflet, or to water down its content.

The press release which accompanied the publication of the second AIDS leaflet on 1 February 1985 reported the Minister, Kenneth Clarke, as saying “The new leaflet is more explicit than the previous version. It lists those at risk from AIDS – practising homosexual and bisexual men; drug abusers, both men and women, who inject drugs; and the sexual contacts of people in these groups – and stresses that donors in the risk groups must not give blood as they may unknowingly be carriers of the AIDS virus.[380] The second leaflet had thus been introduced in recognition of the limitations of the first. It was an improvement, not least because of the emphatic “IMPORTANT NEW ADVICE FOR BLOOD DONORS” on the front of the leaflet, and because it stated that “Donors in the risk groups must not give blood”.[381] However, two of the risk groups were still ambiguously and confusingly described.[382] The first was described as “Practising homosexual and bisexual men”. Whilst there was no longer the reference to “many different partners”, the word “practising” was ambiguous[383] and would exclude those who (perhaps because of fear of transmission of AIDS) might have stopped having sexual relations with men. Drug “addicts” had been replaced by “Drug abusers”, but this was qualified by the phrase “who inject drugs”: the present tense thus did not encompass those who had previously injected drugs but no longer did.

By the time the second leaflet was issued, it had already been recognised that it needed further redrafting. At the very first meeting of the Expert Advisory Group on AIDS (“EAGA”) on 29 January 1985 it was recorded that:

“The blood-donor leaflet was not considered sufficiently forceful. It needed some redrafting particularly with regard to its objective of persuading homosexuals not to donate blood. Consideration should be given to the introduction of some means by which the ‘closetted’ homosexual – possibly faced at a visit to a NBTS Centre with advice not to give blood – could unobtrusively withdraw from the system.”[384]

A third AIDS leaflet, produced in September 1985, redefined and simplified the first at-risk group by removing the word “practising”. Thus “homosexual and bisexual men” were now told not to give blood: “People in the high risk groups MUST NOT GIVE BLOOD. They should not attend donor sessions. The test may not pick up early cases of infection.[385] It is unclear why this amendment was not made until September 1985: it may have been because the third leaflet also explained to donors that donations would now include a test for antibody to the AIDS virus and that its introduction was thus timed to coincide with the introduction of HIV screening in October 1985.[386]

The advice to potential donors became even clearer in September 1986 with the addition of dates: “Men who have had sex with another man at any time since 1978. Drug users, both men and women, who have injected drugs at any time since 1978”, thus making it clear for the first time that a single sexual encounter or use of injected drugs would be sufficient to prevent a person from giving blood.[387] Such wording should have been adopted from the outset.

Commentary

As set out above, the AIDS leaflet was one of the few, key, measures that could be taken to try to ensure that those donors most likely to transmit the virus did not donate. The delay in producing the first leaflet, the failure to stipulate the most effective method of distribution, the delay in producing a revised second leaflet, and the terms in which both leaflets (particularly the first) were expressed increased the risk that donors from high risk groups might continue to give blood and that the recipients of transfusions (or of blood products made domestically) might be infected. The safety of the blood supply, not a preoccupation with adverse publicity, should have been the central focus.

The potential consequences of the failure to act earlier, more speedily and more decisively in relation to the production and dissemination of the AIDS leaflet are plain. They are starkly illustrated in the case of the Wessex donor: a donor diagnosed with AIDS at Bournemouth Hospital in autumn 1984, who had previously donated blood, including in late March 1984. Transfusions had been given to three recipients all of whom were infected with HIV in consequence.[388] The donor’s plasma was also part of the source material for one batch of Factor 8 concentrate (HL3186) which was used in the treatment of 38 people with bleeding disorders in Wessex and South Wales and which transmitted HIV to a number of recipients.[389]

Role of and reliance upon Professor Arthur Bloom

Professor Bloom appears to have played a central part in shaping the thinking of the DHSS and others. Fuller details of his activities are described elsewhere in this Report. However, he was the principal haemophilia clinician from whom Dr Walford sought advice.[390] He was the only haemophilia expert who participated in the meeting of the CSM(B) on 13 July 1983, having been invited by Dr Joseph Smith. He shaped the views of the Haemophilia Society, who in turn made representations to the DHSS about the correct response to AIDS. He was, amongst other roles, a member of the CBLA and its Committee on Research and Development in Blood Transfusion, the MRC Working Party on AIDS, the Expert Advisory Group on AIDS and the Working Group on AIDS of the Advisory Committee to the NBTS. His was the dominant voice in relation to haemophilia treatment and it is likely that his views influenced the way in which the DHSS viewed the emergence of AIDS and the threat posed to people with bleeding disorders.

Lord Fowler rightly recorded that it would concern him if the DHSS was largely taking its advice about haemophilia care from one clinician – it would not, he said, be good practice.[391] Yet this was undoubtedly the position. There was an over-reliance on Professor Bloom’s input that may have, amongst other matters, influenced the response of the CSM and the approach of the DHSS to the assessment of relative risks. There was an uncritical acceptance of his line of thinking and a failure to challenge or at least probe the advice being provided.

Failure to establish EAGA or its equivalent earlier

Allied with the over-reliance on a single haemophilia clinician was the failure to establish a body such as the Expert Advisory Group on AIDS until late 1984. As set out earlier in this chapter, the idea of a working group on AIDS was mooted but rejected by the DHSS in May 1983. Dr Walford thought it would have been wonderful to have had an expert group reporting to the CMO with multidisciplinary doctors and scientists to give the best view and that in retrospect it was “a terrible shame that we didn’t”.[392] Sir Donald Acheson, in his later biography, described the decision to establish EAGA in the following terms:

“As far as HIV/Aids was concerned, a few cases of what was already seen as a fatal virus infection associated with infected blood and sexual intercourse had already occurred prior to my appointment. I decided that the implications of the infection were so serious and our knowledge so limited that I should seek expert advice as soon as possible. The expert advisory group on Aids (EAGA) was set up and having met seven times in 1985 and regularly thereafter, it made a series of recommendations which led to more effective control of HIV/Aids within the UK, than in any other country that had links with the African continent.” [393]

However, the dates do not support Sir Donald’s claim to have acted “as soon as possible”: he began work as CMO (overlapping with his predecessor) in around October 1983; EAGA met for the first time in January 1985.[394]

It is not clear why the initiative to establish EAGA was not seized earlier, in 1983: had the DHSS done so, it would have provided a multidisciplinary forum for the proactive discussion of the issues that have been explored earlier in this chapter and might have led to more decisive and earlier action.

Lack of involvement of the Chief Medical Officer

The role of CMO is a particularly important one, not least because the vast majority of ministers appointed to positions within the DHSS had no prior health knowledge, experience or expertise,[395] and because of frequent ministerial churn.

The role of the CMO, as described by Lord Michael Forsyth (referring to the CMO for Scotland but equally applicable to other CMOs), was to inform “Ministers and the public of risks to Public Health and advising on policy measures to minimise these risks. He was also responsible for giving guidance to clinicians, health boards and patients where he thought it appropriate.[396]

However, the CMO was conspicuous by his absence from discussions and decision-making relating to AIDS in the period from mid 1982 to late 1984.

Lord Glenarthur recalled only very occasional dealings with the CMO.[397] Lord Patten never met Sir Henry Yellowlees, as far as he could remember, but did have interactions with Dr Acheson although there was no system of regular meetings with the CMO.[398] Lord Fowler described Sir Henry as a remote figure whom he saw “hardly at all.[399] Whilst on 9 June 1983 Dr Gunson wrote directly to Sir Henry Yellowlees, raising concerns about AIDS,[400] there is no record of any reply, although the CMO did around this time ask for a briefing on AIDS to be provided to Lord Glenarthur.[401]

It took Dr Acheson some time – too long – to appreciate, and respond to, the gravity of the situation: there is no evidence of any active engagement in late 1983 or for most of 1984. He did write to Dr Gunson early in his appointment to ask for “a brief account of the advances in your specialty that have occurred in the past five years and the problems and opportunities which you can anticipate in the next five years.[402] However, it was not until late 1984 that there began to be any real involvement by the CMO, and by the Secretary of State, in the response to AIDS. In October 1984 the CMO requested information about “the problems of AIDS and blood donations”, which was provided by Dr Smithies on 19 October 1984.[403] In November 1984 the Secretary of State asked for a note summarising the current situation, which was provided by Dr Smithies on 19 November 1984,[404] and a paper setting out the current position with regard to AIDS was requested by the CMO in December 1984, with a draft being circulated by Dr Smithies for comment on 31 December.[405] Lord Fowler’s recollection, giving evidence to the Inquiry, was that from 1984, going into 1985, “there was a feeling of impending crisis”, and that it was “probably during the early part of 1985 that we became thoroughly engaged in it.[406]

There is ample evidence of the CMO’s active involvement from this time onwards. By July 1985 the CMO was wanting to be able to give an assurance to the Secretary of State that no people with haemophilia would be infected in the UK from then on.[407] Lord Fowler wanted by this time to become involved with the AIDS issue because it was quite clear that unless a Cabinet minister took charge “we weren’t going to make much progress.[408] By the end of July the CMO was arranging for a letter to go to all haemophilia centre directors to draw their attention to the availability of heat-treated Factor 8 and the need to avoid using any commercial unheated product that might remain from 1984.[409] What is unclear is why there was no such active engagement at an earlier stage, at least from mid 1982 onwards.[410]

It is apparent that one reason for the absence of guidance or information or advice to doctors from the CMO at an earlier stage was the concept of “clinical freedom”. In 1990 the CMO wrote that “Ministers accord great importance to the principle of clinical freedom.[411] Dr Roger Moore told the Inquiry that this was a “major … tenet” which “put a limitation on what the Department could do with clinicians … across all policy areas, clinical freedom was a mantra.[412] Dr Walford described a policy of non-interference with matters of clinical practice; if patients were being treated in a way which exposed them to potentially avoidable risks, she thought that the Department would convene an expert group.[413]

Yet the CMO role had (at least) threefold responsibilities: providing advice to ministers, providing leadership to the medical officers working at the DHSS and, critically, providing public health information to the medical profession and the wider public. Colloquially the role was often described as being “the Nation’s Doctor”. Lord Fowler described the CMO role as including “providing independent advice on public health issues and recommending policy changes to improve public health outcomes. I also considered the CMO to have some responsibility for keeping the public informed on health issues of public concern and explaining the Government’s response.[414] The CMO, in contrast to most other civil servants, “had the option of making public statements in his own right.[415] Dr James McKenna recalled that he “was responsible for advising the public on matters of public health … advised Ministers on all health issues and provided the basis for health policy decisions … was frequently in the position of providing health advice to the public at large.”[416]

Furthermore, announcements weremade, when the CMO so chose, by way of “Dear Doctor” letters circulated to the medical profession via local medical officers and GPs. Thus, for example, a Dear Doctor letter was issued on 31 December 1981, relaying advice on Hepatitis B Surface Antigen Carriers among NHS staff.[417] In October 1982, a Dear Doctor letter provided guidance on use of the Hepatitis B vaccine.[418] In May 1985, the first Dear Doctor letter regarding AIDS was issued, providing general information for doctors[419] and advising doctors to bear the diagnosis in mind;[420] possible clinical presentations and precautionary measures were described. In the accompanying press release the CMO said: “This latest initiative is part of a series of public health measures aimed at health professionals and people at risk. I hope it will provide doctors with information which they will find helpful in the diagnosis and treatment of the disease and in counselling those who have worries about it.[421]

The extent to which the CMO could direct clinicians without infringing on their decision-making autonomy was commented on by various witnesses but misses the point. Lord Clarke’s evidence was that: “it would not have been appropriate for the CMO to provide ‘instruction’ to clinicians about the treatment of their patients. The Department did not then and does not now supervise how patients are treated and clinical freedom was and remains an important and respected principle.[422] Lord Fowler’s evidence was that: “The CMO’s role – as I understood it – did not extend to giving prescriptive guidance to clinicians of that kind. Clinical decision making was for the practising professionals themselves and that freedom was seen by them as important and was generally respected.”[423] The fact that the CMO might understandably be reticent about directing or instructing clinicians was not, however, a good reason for not providing information, advice or guidance – both for the benefit of clinicians and the benefit of patients.

One function of the CMO role (since the 1859 Public Health Act) was to report annually on the state of the nation’s health.[424] These reports provide an insight into the knowledge and priorities of the CMO and the medical personnel at DHSS. There is little reference to hepatitis in the reports in the first half of the 1980s.[425] The first mention of AIDS appeared in the 1982 annual report with reference to the CDSC surveillance.[426] The 1983 annual report included more detailed information regarding AIDS.[427] The 1985 annual report[428] addressed AIDS but with no section on hepatitis, perhaps reflecting the CMO’s new focus on the AIDS crisis. In the 1986 annual report, Sir Donald Acheson addressed AIDS as the first topic in his introduction, noting that cases of and deaths from AIDS showed exponential growth.[429] Again, there was no section on hepatitis. The 1987 annual report again addressed AIDS in the introduction, but less prominently, with a focus on international cooperation;[430] once more, there was no section on hepatitis. The same was true for the 1988 annual report.[431]

The role of Ministers

Ministers were very dependent on the civil service advice which they received – “enormous reliance”, in Lord Glenarthur’s words, particularly in scientific and clinical fields.[432] There were no regular meetings with the CMO or with the consultant advisers to the CMO, and the principal sources of information for ministers lay within the DHSS: ministers did not, for example, have any direct dealings with committees or working parties.[433]

As set out earlier in this chapter, ministers did not see everything that was produced by or within the DHSS. A decision would be made by civil servants as to whether to provide information to the minister’s private office, and a second decision would be made by the civil servants within the private office as to whether the information should be seen by the minister.[434]

There was no particular yardstick or criterion for when something had to be brought to a minister’s attention and when it did not. Dr Walford described it as a “rather arcane art”.[435] Lord Glenarthur thought that ministers were very concerned to ensure that any public statements on issues were properly handled and that substantial changes of policy would be brought to the minister’s attention.[436] Lord Patten told the Inquiry that ministerial submissions would be required for a change of policy or significant new spending commitments; he acknowledged also that a concern about media interest or adverse press comment might also lead to a matter being brought to the attention of ministers.[437] Peter Wormald, who was the Under-Secretary in the DHSS from late 1978 to late 1981, said that all senior civil servants “must have continuously in mind the need to keep Ministers sufficiently informed and to seek Ministerial decisions when appropriate.[438]

There was no training or induction process for ministers – there would be written briefings on some issues, oral briefings on others, “The rest, frankly, was learning on the job as issues arose … You were pitched in, frankly, and got on with it but you could always call for help if necessary.[439]Ministers had little contact with patients or patient groups and only occasional contact with clinicians.[440] It was and remains the convention not to share with ministers the details of decisions taken by ministers in previous administrations or the official advice on which those decisions were based or grant access to papers of previous administrations (at least those of a different political party).[441] The result in the case of policy on blood and blood products was that ministers would not always be briefed in depth on how policy had been derived or on the history of how a policy had come to be adopted, including how it affected patient safety.

Lord Fowler told the Inquiry that one of the most important qualities of a minister is that they must challenge what is being put in front of them.[442]

According to Lord Clarke “blood products was something that hardly ever came across my desk”.[443] He suggested that the CMO “really, was the person in charge of all the medical things”.[444] It was “complete nonsense” to suggest that the minister would have anything to do with the doctor-patient relationship.[445] There would be “constant interaction” between the medical and other clinical professions and the DHSS and that included public health messages.[446]

The evidence available to the Inquiry demonstrates that many matters which should have come to the attention of ministers did not. There was no particular logic or consistency in what went to ministers and what did not. They were not told of the CSM/CSM(B) decision-making. They were not told of Dr Galbraith’s recommendations. As far as Lord Glenarthur was aware, he was not told in late 1984 that it had been learnt that a number of individuals in Scotland had been infected with HIV through NHS Factor 8 produced at the Protein Fractionation Centre (“PFC”).[447] Yet three ministers became involved – in Kenneth Clarke’s case, particularly closely involved – with the detail of what should appear in the AIDS donor leaflet and how it should be distributed.

It is, of course, not the fault of ministers if civil servants do not bring matters to their attention. It is, however, the responsibility of ministers to demonstrate a degree of proactivity and to challenge, as Lord Fowler and Lord Clarke both acknowledged. The DHSS was a very large department. Its ministers had a wide range of topics and responsibilities with which to deal. They faced considerable pressures. Notwithstanding that, there is little evidence, except to some extent in the case of Lord Clarke, of challenge. Although both Lord Glenarthur and Lord Patten responded promptly to most of the communications they received, demonstrating an appreciation that dealing with AIDS required a swift response, and although there are examples of proactivity on the part of the ministers (such as Lord Glenarthur asking for a briefing from the CMO in June 1983[448] and Lord Patten engaging with the AIDS leaflet, and giving impetus to the evaluation process in respect of HIV screening when it became sluggish) when viewed overall ministers appear to have lacked much curiosity in the early period of the developing public health crisis. No minister, for example, asked officials to investigate what other steps could be taken to protect people with bleeding disorders short of the more radical step of stopping the importation of concentrates.

Ministerial evidence

It did not help that all three ministers most closely concerned with the threat of AIDS in blood and blood products were relatively recent in post. Lord Glenarthur served in the House of Lords as Parliamentary Under-Secretary of State at the DHSS from 14 June 1983 until 26 March 1985; and John Patten in the House of Commons as Parliamentary Under-Secretary of State for Health in the DHSS from 14 June 1983 to 2 September 1985. Neither was thus able to draw on the experience of the other in respect of threats which were already emerging by the time they took office. Kenneth Clarke was in post for a little longer – from 5 March 1982 until September 1985 – and his tenure thus covered the main period of rapid adjustment to the threat of AIDS.

There was evidence or material which they did not see, but should have seen. This did not help.[449]

Both Lord Glenarthur and Lord Patten genuinely endeavoured to assist the Inquiry. By contrast, Lord Clarke was combative: he described his natural style as seeking to challenge, and that extended to his questioning why he should have been asked to give any evidence at all to the Inquiry.[450] He claimed that unless someone pointed out to him that something was going on, he had nothing to do with blood transfusion or products and that “The campaigners attributed everything to me because I later became a well-known figure.[451] He was at pains to point out his lack of involvement and lack of responsibility. He seemed to argue that any failure on the part of government did not have any effect on anybody’s health, even though he was obviously not in a position to know whether that was the case (indeed he did not even appear to be aware that people were infected with AIDS from the British blood supply, as well as that which was imported, and wondered whether Factor 8 was a pill to be taken at home).[452] He thought it was “daft” that he be asked detailed questions “about events 40 years ago in a busy Government Department where this was a tiny, tiny proportion of my activity.[453]

He was firmly of the view that if you stopped giving Factor 8 “you were killing some haemophiliacs” and postulated that had the decision to stop imports been taken, whilst lives would have been saved, “we” (the Government) would “have continued to this day to be reviled for condemning haemophiliacs to going back to the kind of life they’d enjoyed before this wonder treatment was devised.[454] He did not think that there was anything the DHSS did wrong and asserted that if the Inquiry came to the conclusion that the introduction of HIV screening took too long “I would reject the conclusion.[455]

This chapter is concerned with the response of government to the risks of infection as and when they arose. As has already been made clear, the Terms of Reference cover not just what happened (to cause infections, disease and death from treatment) but the government response to what had happened – its approach to complaints by those infected and affected about what had happened, its reluctance for many years either to contemplate compensation or to hold a public inquiry, and the possibility that it may have been concerned to cover up the true facts. Since the evidence of Lord Clarke relates (so far as facts are concerned) to his involvement in the events of 1983 to 1985, his views now as to the Government’s response to what had happened, after much of it had happened – when it emerged that the worst treatment disaster in the history of the NHS may have occurred – may not fit naturally within the scope of this chapter. However, it is unlikely that anyone who heard him give evidence orally will easily forget it, nor forget the argumentative style in which it was given. It is thus appropriate to deal now with some of what he said about this second aspect, namely his views as to whether there should have been a public inquiry at all, and the motives of those who campaigned for it.

He complained that the Inquiry was engaged in “historical researchwith the elderly survivors ... of those who are in the Department at the time” years after the events in question.[456] However, to the extent that this is true, I should state here – first – that much of the value of history lies in learning from the past what mistakes may have been made, so as to help to avoid similar errors in future. Second, the survivors (and many of those who were involved in their treatment) would not have been “elderly” if successive governments, of some of which he was a member, had established an inquiry earlier rather than rejecting calls for one.[457] I agree that this Inquiry has been held far too late – but this is not down to the Inquiry, but successive governments which failed to hold one earlier.

As to the motives of those who complained about their treatment, he referred to what he “had to put up with”because he remained “the best-known person of all those people involved”, claiming that campaigners were “always trying to steer [inquiries] to try to find some celebrity whose fault it was.[458] I do not accept that this is a fair characterisation of the motives of campaigners. Nor do I accept that the allegations of fault which have been made since infections occurred as they did are centred on him. What he said was unfairly dismissive of, and disparaging towards, many who have suffered physically, mentally, socially and financially from what occurred – in which he played some part, but in which (as this Report shows) many others did too. This will have aggravated the distress and upset of many.

Lord Clarke may hold the view that nothing wrong was done, that a public inquiry serves no purpose, and that therefore those who called for one were wrong to do so. It is regrettable that he could not moderate his natural combative style in expressing these views. It detracts from a dispassionate evaluation of what he had to say about the facts, which it was important to hear. It is right nonetheless to acknowledge that he balanced what he had said at the end of his testimony – in a way which perhaps highlighted that his normal style is to challenge – by saying that:

“it is one of those terrible incidents of my lifetime … despite, you know, my strong feelings, it was a terrible tragedy … this is probably the worst tragedy that’s ever occurred, and … everybody … is acutely aware of the human suffering that was being caused whilst this HIV and then these infections being spreading [sic] to haemophiliacs carried on … And I genuinely feel very great sympathies, to say the least.”[459]

Several other ministers, whether serving in a junior or senior role, may have taken positions or expressed views with which others participating in the Inquiry might disagree. The Inquiry is fortunate that they have done so in a measured, less personalised way, than Lord Clarke did: indeed, adopting the helpful, responsive or responsible approach to the provision of evidence to a public inquiry into the infection and deaths of thousands of people which the public has the right to expect from former government ministers.

Committees and working groups

There were in the 1970s and 1980s a range of committees/working groups/expert groups which advised the DHSS (and often more widely the whole of the UK) on matters which included hepatitis and HIV. Leaving aside the Committee on Safety of Medicines, which had a specific statutory remit, these committees and groups, some of which are considered below, had varying functions.[460]

Navigating these committees, appreciating the extent to which their remit differed from or overlapped with others, and forming a perspective upon the extent to which any contributed significantly to clinical, regional or central governmental policies is not easy. There may seem at first to be a somewhat confusing list of names.

The list is set out below. However, what is important to recognise at the start of charting a territory through what may seem like an overcrowded landscape is that there was, until 1989, no overarching advisory committee on blood safety. This omission was rectified with the establishment of the Advisory Committee on the Virological Safety of Blood (“ACVSB”) in 1989. It is also important to recognise that each committee or sub-committee or working group had advisory powers only.

The bodies were:

  1. the Advisory Group on Testing for the Presence of Hepatitis B Surface Antigen and its Antibody (the Maycock Group)
  2. the Advisory Group on Hepatitis
  3. the MRC’s Blood Transfusion Research Committee and its Post-Transfusion Hepatitis Working Party
  4. the Advisory Committee on Dangerous Pathogens (“ACDP”)
  5. the UK Working Party on Transfusion-Associated Hepatitis
  6. the MRC’s Working Party on AIDS
  7. the CBLA’s Working Group on AIDS in relation to Blood Transfusion
  8. the Advisory Committee on the Virological Safety of Blood
  9. the Advisory Committee on Transfusion Transmitted Infections (“ACTTI”)

Advisory Group on Testing for the Presence of Hepatitis B Surface Antigen and its Antibody (the Maycock Group)[461]

The Maycock Group was appointed as an advisory group in September 1970. It was a joint appointment between the DHSS, the SHHD and the Welsh Office, and its terms of reference were to advise on the organisation of and responsibility for testing blood donations for Hepatitis B Surface Antigen (“HBsAg”) and its antibody and on related matters.[462] In its first report, published in May 1972, its principal recommendation was the introduction of testing of all blood donations for HBsAg and its antibody.[463] The Group reconvened in December 1973[464] and met on five occasions, resulting in the publication of a second report in September 1975. The recommendations in the second report included a change in the method of testing for HBsAg.[465] In November 1979 the group reconvened to consider whether any alterations in the methods used for testing donations was desirable.[466]

At the Group’s meeting in March 1980, members “agreed that the hazard from non-A, non-B hepatitis should now be recognised and brought to the attention of the appropriate Departmental bodies responsible for control of hepatitis.[467] It is not clear what, if anything, was done in response to that proposal.

In a third report, published in 1981, the Group reviewed the current position regarding HBsAg screening and made various recommendations. It also considered, briefly, non-A non-B Hepatitis (“NANBH”), recommending that research be undertaken in the UK to determine the extent and severity of post-transfusion hepatitis due to NANBH; that regional transfusion directors should encourage hospital haematologists to report all cases of post-transfusion jaundice; and that where such jaundice could be due to NANBH, the facts should be reported to the DHSS or SHHD.[468] A separate recommendation was made for the establishment of a committee of experts to assess the value of any new tests for hepatitis markers which could be used in testing blood donations and preparations of large pool blood products.[469]

Advisory Group on Hepatitis

At the March 1980 meeting of the Maycock Group, Dr Walford and Dr Sibellas had explained that a new committee was being set up to deal with all aspects of communicable hepatitis and that it was the intention that the Maycock Group should become one of its sub-committees. Members expressed concern at the meeting about the incidence of NANBH.[470] Dr Walford observed that the reason the Deputy CMO had proposed to the CMO that there should be an overarching hepatitis advisory group was “because there was a realisation that this was becoming an issue and that the Department -- there shouldn’t be a whole lot of disparate committees or groups looking at things in isolation”.[471]

At the next meeting of the Maycock Group in September 1980, Dr Sibellas referred to numerous requests the DHSS had received for advice on diverse problems regarding viral hepatitis, with “non-A non-B being particularly problematic” and that it had been decided that it was essential to set up an advisory group to consider and advise on these matters. This group (the Advisory Group on Hepatitis) would meet for the first time in October and its terms of reference were “To provide medical advice to the Chief Medical Officers of the Health Departments of the United Kingdom on all aspects of communicable hepatitis.[472]

The idea for a new Advisory Group on Hepatitis had been raised over a year earlier. Dr Terry Geffen[473] wrote to Dr John Evans[474] in early July 1979, to the effect that it had been in his mind “for several months” to get together “an outside group of experts to act as an Advisory Group on Hepatitis”.[475] Dr Geffen’s note observed that “This may not be the time to ask about a new advisory group, particularly if we are proposing to be extremely restricted in the amount of advice which we give to the field, but if there is an infectious disease for which such a group is needed, this is it.[476] Dr Evans responded, “after discussion with CMO and the DCMOs”, that the DHSS should go ahead to take “professional advice on the serious and pressing problems relating to hepatitis particularly those relating to so called carriers of Australia antigen.[477]

After a meeting on 17 July,[478] Dr Sibellas followed this up on 18 July 1979 with a suggestion that it should be a free-standing committee which would only meet occasionally but would be available to give advice if required; she noted that since the Rosenheim Report had been written in 1972, there was “now at least one new type of viral hepatitis” which had not been discovered at that time (ie non-A non-B Hepatitis), and identified among “the many problems currently facing us” the “hepatitis risks involved in blood transfusion.[479]

On 24 July 1979 Dr Geffen produced a paper, to go to the CMO, setting out the reasons why an advisory group on viral hepatitis should be established; he noted that “At present hepatitis B presents the majority of problems and is responsible for the majority of enquiries but non-A/non-B hepatitis may well also become a major source of concern”. Current problems in the field included “the possible hazards of the use of blood and blood products”: “Hepatitis B was originally referred to as serum hepatitis and is still often regarded as being in the main associated with the use of contaminated blood and blood products. While other forms of transmission are now known to be important, the risks involved in blood transfusion are still considerable and the subject of many enquiries.[480]

By November 1979 little progress had been made: according to a further minute from Dr Geffen to Dr Evans on 6 November, other than preliminary discussions with SHHD, the DHSS had “taken no definitive action on this since August”. Reference was made to the “need not to establish new advisory or other bodies without very good reason”. Attaching the new group to the existing Maycock Group would “present real difficulties” because of that Group’s “limited function”, which “in no way touches on the problems with which we are likely to be mainly concerned, and on which we would need advice, in the next few years”. Dr Geffen therefore recommended a new body be established.[481]

In February 1980 Dr Evans and Dr Harris (both Deputy CMOs) discussed the matter with the CMO and it was agreed that the numerous problems arising in relation to hepatitis needed to be brought together into one Advisory Group on Hepatitis “rather than be dealt with in scattered fashion by various ad hoc groups”, and that its terms of reference should be wide enough to encompass “the specialist advice needed by blood transfusion experts.[482]

The creation of a new advisory group or committee being a matter that required ministerial sign-off, the CMO wrote to the Minister of State for Health, Dr Gerald Vaughan, on 13 June 1980, emphasising that there was “an urgent need to pull together our various sources of advice on hepatitis into one proper professional advisory group capable of giving authoritative and coherent medical advice about these diseases.[483] The ministerial submission did not refer to non-A non-B Hepatitis by that name, but did record that “Infections resembling those due to hepatitis B are known to be caused by one or more other agents which have not been fully identified.[484]

By late June 1980 ministerial approval had been forthcoming “with the strict proviso that there should be no other Committees concerned with Hepatitis in operation.[485] At the request of health departments in Scotland, Wales and Northern Ireland, the Group would advise all the departments in the UK, each of which would have an officer present at meetings.[486]

Thus, despite the need for the expert group having been identified in July 1979, it was not established until the autumn of 1980.

The first meeting of this new Advisory Group on Hepatitis was on 3 October 1980: there was no discussion about non-A non-B Hepatitis (“NANBH”).[487] The second meeting was on 5 December 1980: again no discussion about NANBH.[488] The third was on 11 May 1981: still no discussion of NANBH.[489] The fourth meeting was in October 1981: again nothing on NANBH.[490] A year then elapsed before the fifth meeting in October 1982: Hepatitis A and Hepatitis B were both considered, but not NANBH.[491] The next meeting took place a year later, in October 1983: on this occasion AIDS was discussed as well as Hepatitis B, but not NANBH.[492] Nor was NANBH considered at either of the Advisory Group’s 1984 meetings,[493] nor at its October 1985 meeting,[494] nor its July 1987 meeting.[495]

The February 1989 meeting merely noted that there was a paper on “NANB virus in blood for transfusion” but there was no discussion about the issue.[496] By this time, of course, the ACVSB was being set up.[497] The December 1990 meeting of the Advisory Group on Hepatitis again contained no consideration of NANBH/Hepatitis C, other than recording that the blood transfusion service would be testing donations from 1991.[498]

This Advisory Group took too long to establish, the need for it having been identified by mid 1979. Dr Walford described the Department as “quite monolith”, with “an element of bureaucracy involved” and acknowledged that “one of the issues that should have been of considerable concern, which was non-A, non-B, was not perhaps getting the attention that it should have got.[499] She was absolutely right.

Furthermore, once established, and despite the fact that it was envisaged at the time of its establishment that the Advisory Group on Hepatitis would provide expert advice on the prevention and management of NANBH, it failed to consider and advise on this question at all. This was symptomatic of a wider problem within government in the 1980s, namely the lack of attention paid to NANBH and its transmission through blood and blood products.

MRC’s Blood Transfusion Working Party

The origins of the MRC’s Blood Transfusion Research Committee dated back to the 1940s, with the Committee being reconstituted from time to time and specific working parties being set up under its auspices.[500] Its terms of reference were to advise the MRC on research within the field of blood transfusion.

The Committee set up a number of working parties. One was a Working Party on Post-Transfusion Hepatitis. Its terms of reference were “To consider the feasibility of carrying out a survey on the incidence of post-transfusion hepatitis and to arrange for any such survey.[501] It met a number of times between 1967 and 1970. The extent of its meetings in the 1970s is however unclear: a paper from 1978 reported that at that time it had not met for two or three years, but Professor Zuckerman was pressing for it to be reconvened on the basis that “there are no data from the UK or Europe on the importance of so-called non-A, non-B viruses … When a test becomes available, it will be difficult to decide on policy in the UK unless the size of the problem is known.[502]

The main Committee was reconstituted in 1979, having not met since 1976, and at its first meeting in December 1979 discussed, amongst other matters, the encouragement of the use of red cell concentrates. It noted that the transmission of NANBH “was still a problem with factor VIII concentrates”. Other than agreeing to establish a working party to study the use of red cell concentrates and albumin preparations, and to take proposals for an appropriate clinical trial, no specific decisions or actions were agreed.[503] The Committee did not meet again for 18 months: at its second meeting in June 1981 Dr Gunson, chair of the Committee’s Working Party on Post-Transfusion Hepatitis, reported on its main concern: NANBH. The minutes record his observation that “large-pool blood products were especially likely to cause liver damage in haemophiliacs”. In discussion the Committee noted that:

“MRC, DHSS and the Directors of Transfusion Centres were all interested in the field of post transfusion hepatitis. It was agreed that there was at present no need to screen potential blood donors for non-A non-B hepatitis but the production of a vaccine would be waited with interest, mean-time it would be valuable to follow-up those patients previously found to have a raised serum level of alanine transaminase after blood transfusion to find out their present state.”[504]

This was a somewhat curious statement. The reference to screening potential blood donors was presumably a reference to surrogate testing, but no reasoning was provided for the suggestion that there was no “need” for this; a vaccine was unlikely to be on the horizon given that the virus had not yet been identified; and once it was so identified the first step to take would be screening rather than vaccination. As for the follow-up of patients, no specific action or decision appears to have been taken by the Committee in this regard: the minutes simply record that the exercise would be “valuable”.

The reconvened Committee met for a third (and final) time in March 1982. It was decided to disband the Post-Transfusion Hepatitis Working Party, because it was “in a field in which many other groups, both inside and outside the MRC, were active” and that matters in the field of post-transfusion hepatitis arising in the future should be passed to “an appropriate advisory body.[505] There was then a discussion about the future of the Committee itself: Dr Gunson thought it needed to “justify its existence”, whilst the DHSS favoured its continuance.[506]

The Committee was disbanded in July 1982, the MRC board having concluded that its work was being duplicated elsewhere.[507]

Advisory Committee on Dangerous Pathogens

The ACDP was established in 1981.[508] It provided advice to the health ministers of the UK, the agriculture ministers, the Health and Safety Commission and the Health and Safety Executive (“HSE”).[509] Its meetings were (as was commonplace at the time) private and individual members were required not to disclose its decisions. It would normally be for those whom it advised to determine whether any public statement should be made.[510] Unusually, its inaugural meeting in June 1981 was attended by the Minister of State for Health, Dr Gerard Vaughan.[511] The ACDP’s work related to a wide range of pathogens and viruses, and many of its early meetings focused on questions of categorisation, but of note are its observations in 1983 on NANBH and on AIDS. In relation to NANBH, its September 1983 meeting discussed the categorisation of NANBH viruses, with the Chair explaining that “as these viruses had a more serious effect than Hepatitis A, in fact nearly as serious as Hepatitis B, it was decided to use the same category as for the latter”.[512]

At the same meeting, Dr Walford raised the topic of AIDS, explaining that both the DHSS and the HSE were receiving enquiries on the handling of AIDS cases: “Both Departments would like some guidance from ACDP and hopefully a Working Group set up to look into, and report on this problem.”The ACDP agreed recommendations for the safety of health-care workers, noting that “It appears that blood and secretions may well carry the infection”; it was also agreed that a small working group should be formed to “look into this matter more deeply.[513] In advance of the meeting, Dr Walford, in a minute to Dr Oliver and John Parker, expressed the view that “we have now reached the stage with AIDS where we are obliged to seek expert advice.” The ACDP was, she said, “by no means the best possible source of advice on AIDS but, because it exists and because of the status it has been accorded, it is currently the most appropriate source of such advice.[514]

UK Working Party on Transfusion-Associated Hepatitis

The inaugural meeting of the UK Working Party on Transfusion-Associated Hepatitis took place on 27 September 1982. This Working Party was not established by the DHSS, although it was agreed that a request would be made for a member of the DHSS’s Advisory Group on Hepatitis to nominate a member to attend meetings.[515] Its terms of reference were to promote the investigation of the epidemiology of transfusion-associated hepatitis, to promote research into methods of prevention, and to make recommendations to transfusion directors regarding procedures and screening tests necessary for its prevention. The first meeting decided that the Working Party should collate data which determined the importance of NANBH in the UK and should consider the implications of surrogate markers.[516] The Working Party met on three occasions in 1983[517] and then again in November 1986, having been inactive for some time:[518] its discussions about the undertaking of research relevant to surrogate testing are considered elsewhere in this Report.

MRC’s Working Party on AIDS

The Medical Research Council’s Working Party on AIDS met for the first time in October 1983. Its terms of reference were relatively narrow: to review scientific knowledge and research on AIDS in the UK and abroad; to encourage contact and co-operation between research workers in this field; and to advise the MRC on the current state of knowledge in the field and on topics for research.[519] The minutes of its first meeting include the somewhat opaque sentence “The repercussions of AIDS in respect of blood products received particular comment”.[520] The second meeting in December 1983 included a lengthy discussion with the aim of “identifying important problems which could be usefully tackled in the UK” in terms of research.[521] Following this discussion, a report was prepared setting out possibilities for research: this identified the potential for research involving people with haemophilia.[522] The third meeting in April 1984 discussed contact tracing: “The particular issue of contact tracing of blood donations from AIDS patients was also discussed”.[523] The fourth meeting, on 25 October 1984, revealed knowledge of the seroconversion of patients in Scotland: “there was already evidence from haemophiliacs who had seroconverted that some Scottish factor VIII had been contaminated with HTLV-3.[524] The source of that information, which was not yet widely known (and, importantly, not yet known by those who had been so infected), is unclear: Dr Richard Tedder was a member of the Working Party and would have been aware of the position, having conducted the tests. There was also a discussion about whether it was unethical to inform patients who were HTLV-3 positive “since no treatment could be offered if AIDS developed subsequently. However haemophiliacs may wish to know so that they can use barrier methods of contraception”.[525]

The CMO’s Annual Report for 1983 referred to the establishment of the MRC’s Working Party on AIDS in October 1983, stating, “The MRC Working Party is the Department’s main source of information concerning European and World Health Organization AIDS research initiatives.[526]

CBLA’s Working Group on AIDS in relation to blood transfusion

The CBLA established a Central Committee for Research and Development in Blood Transfusion which met on 21 June 1983. Its membership included Dr Gunson, Professor Bloom, Dr Rizza, Dr Lane and Dr Tedder. It was attended by representatives of the DHSS and SHHD and the MRC. Its role was to advise the CBLA on research and development in blood transfusion and related fields. Discussing AIDS, Dr Gunson, as chair, having “outlined the problems caused by AIDS”, suggested that since AIDS appeared to be transmitted through blood and blood products “then it should be considered by the Committee.” It was agreed that an ad hoc group would be formed to consider the question of the Blood Transfusion Service initiating research and report back at the next meeting.[527]

The first meeting of the Working Group on AIDS in relation to Blood Transfusion took place on 14 October 1983.[528] The Group was described as an ad hoc one set up to consider “the problem of AIDS in relation to the transfusion of blood and blood products.[529] It was decided at the first meeting that Professor Bloom should be invited to the next meeting, to provide a link with the MRC’s Working Party on AIDS. There was a discussion about the AIDS donor leaflet and agreement that Dr Brian McClelland would submit outline proposals for a prospective study to enable consideration of anti-HBc screening as a form of surrogate testing.[530] The second meeting took place on 27 January 1984, at which the topics under discussion included surrogate testing and the use of small donor pool material. No further meeting date was fixed and it is unclear whether the Group met again.[531]

Establishment of the Advisory Committee on the Virological Safety of Blood (“ACVSB”)

The ACVSB first met in April 1989.[532] Its terms of reference were “to advise the Health Departments of the UK on measures to ensure the virological safety of blood, whilst maintaining adequate supplies of appropriate quality for both immediate use and for plasma processing”.[533] The expectation was that it would be concerned with “major policy”, rather than detailed implementation, and that other groups with “interests in this field” would bring to the ACVSB any proposals which impacted on the others.[534]

The proposal to establish it followed from an EAGA meeting in June 1988,[535] with Dr Pickles preparing a note for the CMO on 11 July 1988,[536] and Dr Harris, the Deputy CMO, writing to the CMO on 14 July with the proposal for a new advisory group under his chairmanship.[537]

On 2 September 1988 Dr Moore wrote to John Cashman as follows:

“There is growing public awareness, stimulated by the AIDS virus, that many viruses can possibly be transmitted by blood and blood products … From an HS[538] viewpoint the new committee will be invaluable as a source of expert opinion. Over the last 2 years we have had several flaps when ‘new’ viruses have surfaced and policy regarding their testing has needed to be developed on the spot. The new committee should help considerably.”[539]

Meetings took place with the CMO on 6 September and 19 October;[540] there was consultation with Wales, Northern Ireland and Scotland, with the “general agreement of officials in the territorials” having been obtained by 30 September;[541] and a submission then went to ministers on 6 December 1988.[542] The submission – rightly – observed that historically the blood transfusion services had adopted new screening procedures “in an ad-hoc fashion in response to advances in clinical knowledge”, and that concern to maintain the safety of the blood supply had been “heightened by greater public and clinical awareness of the potential for viral contamination and the new developments in product liability legislation.[543]The approval for a new committee from all UK health ministers had been received by 21 February 1989.[544]

It is surprising, and disappointing, that – the need for such a committee having been identified in June 1988 (a need that should in any event have been identified long before)[545] – it took until April 1989 for it to be in a position to meet. The delay was particularly concerning because the purpose of the group was to provide advice so that the Department of Health could “enable quick reactions to be made to new developments in screening techniques and new epidemiological information.[546]

Commentary

Dr Walford rightly said that it would “indubitably” and “obviously” have been a “good thing” to have one overarching body with responsibility for blood safety earlier than there was; she could not recall this being discussed within the DHSS during the time she was involved with blood and blood products (ie from 1976 up to the end of 1983).[547]

Problems were caused by the splintered nature of the structures set up to advise the government (directly, or more usually indirectly) in respect of non-A non-B Hepatitis. Non-A non-B Hepatitis was too often passed over. It was extraordinary that the Advisory Group on Hepatitis was set up in October 1980, less than a month after Dr Walford of the DHSS had described non-A non-B Hepatitis as a form of hepatitis which could “be rapidly fatal … or can lead to progressive liver damage” and could result in a chronic carrier state increasing the pool of non-A non-B Hepatitis in the community,[548] but that the Advisory Group just did not consider non-A non-B Hepatitis at all in any of its meetings, except to mention a paper in 1989 and to mention the date for screening Hepatitis C donations in 1991.

Very little was done before 1991 to address the problems caused by the transmission of non-A non-B Hepatitis.[549] No advice from the main Advisory Group. No decision to undertake surrogate screening except that there should be a study conducted first; and then no funding for a study.[550] No support until the shadow of AIDS began to loom for active research into whether non-A non-B Hepatitis might be inactivated in blood products.[551] No advice to patients as to the risks of non-A non-B Hepatitis.[552] When it came to taking decisions about AIDS, there was a failure to realise that the source which (probably) gave rise to a risk of transmitting AIDS was also a source which (more certainly) gave rise to risks of transmitting non-A non-B Hepatitis. The fact that factor concentrates potentially transmitted both infections at the same time (and thereby not only exposed recipients to all the risks of those infections as separate infections) does not seem to have featured in discussions or advice. There was a real risk arising from this, which was that the combination of non-A non-B Hepatitis and HIV might be all the worse because of the co-infection. This risk actually materialised.[553] The approach taken to non-A non-B Hepatitis thus both weakened the efforts which might otherwise have been made to restrict the use of US-made factor concentrates, and called for research into the effects of co-infection so that patients (and their treating clinicians) might be fully aware of the extent of the risks to which patients with bleeding disorders were being subjected.

Advice in relation to decisions about AIDS from disparate sources was overtaken by the establishment of the EAGA which met for the first time in January 1985. EAGA was formed at the instigation of the CMO, chaired by Dr Abrams (Deputy CMO), and its meetings were attended by representatives of SHHD, the DHSS Northern Ireland, and the Welsh Office.[554] Its purpose was to give advice on all measures required to control the spread of AIDS. As discussed elsewhere in this chapter, it should have been established in 1983. Had it been set up earlier, it is possible that some of the delays and inadequacies in decision-making described in this and other chapters with regards to AIDS would have been avoided. It represented the nearest the UK came to having a single point of reference for expert advice on AIDS as it related to the blood supply until the ACVSB was set up.

Professor Ian Hann (who since his clinical work in Scotland has been concerned with the organisation of blood transfusion services in Ireland), when giving evidence to the Penrose Inquiry, noted that this was a period when they could have done with “a bit less democracy and a bit more guidance”, and that there were many views and many committees but not necessarily many decisions being taken. What was needed, he thought, was “an expert body that comes to the best possible conclusions at the time”: “having a dozen committees doesn’t solve the problem.” In his view, this could only have been co-ordinated by government. The lack of a central government advisory body in 1983 and 1984 indicated that there was a key failure over this important period to recognise the risks. The need was for government, uniquely placed as it was, to rise above the clamour, take informed decisions in the public interest, and take a proactive lead.[555] Professor Hann’s observations have considerable force. Those in government were not well placed to act without the best, reliable, advice, but they were in a position to make sure they had it and did not do so until very late.

There was no single overarching body with responsibility for making recommendations in relation to the virological safety of blood until the establishment of the ACVSB. Had that been established earlier, it is possible that there would have been a central mechanism for decision-making regarding the introduction of surrogate testing and some, at least, of the problems described in the chapter on Surrogate Testing for Hepatitis C would have been avoided.

However, ACVSB did not put an end to the overlapping committees since it was shadowed by a body which advised NBTS, and thus overlapped with much of the discussion being held at ACVSB (though it might be difficult to know, given the secrecy with which ACVSB chose to deliberate): the ACTTI.

This web of committees and groups led to a fragmented and sometimes incoherent system for decision-making, with multiple and to some extent overlapping bodies involved in assessing different aspects and making recommendations on different aspects of risk and risk mitigation. Decision-making on something so fundamental to the health of the nation as blood safety should not have been so “ad hoc”.

The repetition of advice from more than one committee covering the same subject may be reassuring to those who are looking for a reliable star to steer by. However, one of the principal concerns of having so many different bodies, all reporting directly or – more usually – indirectly to government is that both haemophilia care, the blood products fractionation plants, and the blood transfusion service had only a relatively small cohort of leading experts. Some names – for instance that of Professor Bloom – tended to appear on the membership of different bodies. Thus the same voice was being echoed in different sources. Instead of cultivating assurance about the course to steer, this made it difficult to realise that it was essentially the same, one, voice (so far as blood products were concerned), and to look (especially if a minister) to see what if any other views there were which should also be listened to.

Northern Ireland

The Northern Ireland Department of Health and Social Services (“DHSSNI”) played a very limited role in decision-making regarding blood safety in the 1970s and 1980s. This was in part due to the fact that direct rule from Westminster was introduced in March 1972 following the suspension of devolved government. Thereafter, and until 1998, the mechanism of this governance was by way of a Secretary of State for Northern Ireland, the Northern Ireland Office and a number of junior ministers.[556] The actual delivery of health and social services was, from 1973, by four health boards: the Eastern, Northern, Southern and Western boards.[557]

The role of Secretary of State for Northern Ireland was filled by Merlyn Rees from 1974 to 1976, Roy Mason from 1976 to 1979, Humphrey Atkins from 1979 to 1981, Jim Prior from September 1981 to September 1984, Douglas Hurd from September 1984 to September 1985, and Tom King from September 1985 to July 1989. Junior ministers within the Northern Ireland Office included John Patten from January 1981 to June 1983 and Chris Patten from June 1983 to September 1985. Northern Ireland had its own Chief Medical Officer: Dr Thomas Terence Baird (1973 to 1978); Dr Robert Weir (1978 to 1988); and Dr James McKenna (1988 to 1995).[558]

Although few of those involved at the time in government in Northern Ireland who survive have any direct recollection of decision-making regarding blood and blood products, and there is comparatively little contemporaneous documentation available, it is clear that overall the DHSSNI followed the policy decisions made by the DHSS in London and that the DHSSNI had little observable influence on those decisions. Two particular factors contributed to that state of affairs. The first was that in reality security and political aspects “took up a significant amount of ministerial time”.[559] The second was that the responsibilities of the relatively small number of medical and administrative civil servants in Northern Ireland covered a broad range of matters, with less expertise and (in reality) less time devoted to matters of blood and blood products.[560]

Thus, Lord David Owen’s evidence (in relation to his time as Minister for Health at the DHSS between 1974 and 1976) was that “the Secretary of State for Northern Ireland would take decisions but be hugely influenced by -- they would tend never to go against the grain of decisions that were taken in England.[561] When he was Parliamentary Under-Secretary of State in the Northern Ireland Office, Lord John Patten’s recollection was: “the liaison with DHSS on health issues was done by officials rather than at Ministerial level.” Indeed he could not recall any meetings with junior health ministers in the DHSS or in the Scottish and Welsh Offices.[562] Likewise when he moved to the DHSS, he could recall little contact with junior ministers in Northern Ireland (or Scotland or Wales).[563] Lord Fowler, as Secretary of State for Health and Social Services between 1981 and 1987, recalled that Northern Ireland closely followed the DHSS.[564]

Dr Morris McClelland, who was the director of the Northern Ireland Blood Transfusion Centre, described the relationship between the DHSSNI and the DHSS as one where: “policies adopted by DHSSNI typically followed those of DoH (London) since NI was under direct rule from London.”[565]

Civil servants from Northern Ireland would be invited to attend some, at least, of the committees and working parties which reported to the DHSS, although the recollection of Dr Pickles (a principal medical officer in the DHSS from 1986 to 1991) was that this could sometimes be as a “regretful late thought”.[566]

Dr Robert McQuiston, the Assistant Secretary in the Health Services Division of the DHSSNI from 1984 to 1998, thought that “On health policy generally, DHSS had an overall coordinating role on issues impacting on the whole of the UK while DHSS (NI) would tailor its approach to take account of particular considerations relevant to Northern Ireland. On other matters, such as prevention of coronary heart disease, DHSS (NI) took its own initiatives, reflecting a higher local priority.[567]

Examples of the (limited extent of) involvement of Northern Ireland officials include: a December 1980 meeting between the DHSS, SHHD, DHSSNI and Welsh Office to discuss UK self-sufficiency in blood and blood products, attended by Dr J D Acton on behalf of DHSSNI and with express consideration of Northern Ireland’s needs for domestically produced concentrate, following which Dr Acton agreed to discuss with his Department the logistics of sending plasma to Edinburgh;[568] the DHSSNI’s acceptance of the recommendations of the first and second reports of the Maycock Group, followed by the issuing of circulars to the relevant health boards in Northern Ireland in 1973 and 1977;[569]the invitation to Dr Logan of the DHSSNI to attend (as observer rather than member, along with departmental officers from the DHSS and other departments) the meetings of the Advisory Group on Hepatitis in 1980;[570] and attendance of DHSSNI officials as observers at the meetings of the ACVSB.[571]

There appears to have been little or no involvement from Northern Ireland in decision-making on AIDS in the first half of the 1980s. By way of example, the 3 May 1983 letter on the Government’s “line to take” over AIDS had a relatively wide distribution list, including the SHHD and Welsh Office but not Northern Ireland.[572] On the issue of screening of blood for HIV, the DHSSNI followed the approach decided in Westminster.[573] Richard Needham, Parliamentary Private Secretary[574] to Jim Prior, the Secretary of State for Northern Ireland, from 1983 to 1984 (and thus at a key time in relation to AIDS), had a recollection of some discussion on how to handle the treatment of AIDS sufferers and the need to make those vulnerable to risk aware of the dangers of contracting AIDS,[575] but had no recollection of any policy matters relating to blood or blood products ever being raised with him at the time. He suspected that officials in Northern Ireland “would have had little influence when such matters on blood or blood products did arise.[576] Northern Ireland “essentially mirrored health policy from Great Britain”and he was “certain that most health policies of the Department would have been followed in Northern Ireland, making the relationship one of mirrored subservience. However, the presentation of the policy may have been tailored appropriately to meet the social or cultural norms of the local communities in Northern Ireland.[577]

Wales

The role played by the Welsh Office was, on occasions, a little more active than the Northern Ireland Office, but with Wales still following the lead of the DHSS on matters of health policy regarding blood and blood products.

The role of Secretary of State for Wales was filled by John Morris from 1974 to 1979, Nicholas Edwards from 1979 to 1987, Peter Walker from 1987 to 1990 and David Hunt from 1990 to 1993. Barry Jones was Parliamentary Under-Secretary of State from 1974 to 1979. The first CMO for Wales was Dr Richard Bevan from 1969 to 1977; the post was then held by Dr (later Professor) Gareth Crompton from 1978 to 1989, and Dame Deirdre Hine from 1990 to 1997.

Lord Fowler’s recollection was that the responsibility for healthcare in Wales rested with the Secretary of State for Wales (and that responsibility for Northern Ireland and Scotland rested similarly with the respective “Secretaries of State of the ‘Territorial Departments’.”)However, he pointed out that the three Secretaries of State were Cabinet members in their own right, that they were all ministers in the same Government and as such, had the usual collective responsibility for all government policies. He recalled in practice that “on health issues generally … Scotland tended to be the most independent, whereas Wales and Northern Ireland more closely followed the DHSS.[578]Lord Fowler remembered interacting with Nicholas Edwards, who would talk to him fairly frequently on health issues.[579]

Barry Jones (now Lord Jones) recalled meetings with the Welsh CMO and his understanding was that it was part of the CMO’s responsibility to issue guidance and advice to clinicians, patients and the public.[580]

As with the DHSSNI, the Welsh Office was significantly smaller than the DHSS and the medical officers responsible for health would have had a much wider role than in the DHSS, which had someone with specific responsibility for blood and blood products.[581]

As with Northern Ireland, civil servants would be invited to attend some, at least, of the committees and working parties which reported to the DHSS.[582] A Welsh Office representative, for example, was invited to attend the meetings of the Advisory Group on Hepatitis, the Working Group on AIDS of the Advisory Committee on the NBTS[583] and the ACVSB (whose establishment the Welsh Office was asked to, and did, agree to).

A letter sent in January 1990 during the HIV haemophilia litigation indicates that there was no independent Welsh Office action concerning the risk of hepatitis from blood and blood products, although it was recognised as a hazard.[584]

Within correspondence that related to the HIV litigation, the Welsh Office described relying on the DHSS to “take the principal lead in determining national policy on matters relating to HIV/AIDS prevention”but that it“contributes to the formulation of policy through membership of Inter-Departmental bodies and their sub-groups … and reserves the right to adapt policies to the local circumstances in Wales.[585] The Welsh Office also gave advice and information by issuing circulars within Wales “corresponding to those issued by the Department of Health in England.” Examples included the AIDS donor leaflets in September 1983/February 1985 and a CMO letter regarding AIDS in 1986. However, the Welsh Office also issued advice and took action “on its own account”, such as issuing PSM (84)4 in November 1984 asking doctors to inform CDSC of cases of AIDS or Kaposi’s sarcoma;[586] forming an AIDS steering group in September 1985; and issuing a recommendation in December 1985 to all Welsh district health authorities to set up AIDS co-ordinating teams.[587]

There were some discussions within the Welsh Office regarding AIDS, independent of the decision-making being undertaken by the DHSS in the period 1983 to 1984 regarding AIDS. On 3 May 1983, for example, at the same time as Number 10 was being given what was probably its first briefing on AIDS by the DHSS,[588] Dr David Ferguson-Lewis, senior medical officer at the Welsh Office, wrote to the Parliamentary Under-Secretary of State following press reports implicating US blood products in cases of AIDS; those reports included, of course, a report of a person with haemophilia being treated at the University Hospital of Wales. The minute noted that Dr Tony Napier, director of the transfusion centre in Cardiff, had made a statement that had been published in the Western Mail,[589]where it was said that Dr Napier had stressed that “no link between AIDS and blood transfusions have been established … the mechanism of transmission of disease is not yet understood and all present evidence is circumstantial.”Dr Ferguson-Lewis continued by informing the minister “that the Medical Services Health Professional Group are further investigating the local situation and are in contact with DHSS colleagues nationally.”[590]

The following day, 4 May 1983, a meeting was convened by the Welsh Office to discuss the Cardiff patient. It was attended by Dr Crompton, the CMO, along with a number of medical officers, Dr Napier, Professor Bloom, Dr Michael McEvoy (CDSC) and Dr John Skone, chief administrative medical officer of South Glamorgan Health Authority.[591] Kevin Slater’s medical history and clinical condition was discussed in some detail and the assessment was that he presented “a clinical picture which fits within the case definition as set by the CDSC”.There was a discussion of the statement Professor Bloom had made to the Haemophilia Society on 23 April, when he said there was no definite case of AIDS amongst people with haemophilia in the UK. It was asserted that he had spoken from “a typed manuscript”, but that in the discussion that followed he “admitted that a case had been treated in Cardiff which showed some of the features of a mild possible AIDS.” Two journalists – Susan Douglas and a reporter from the South Wales Argus – had made contact with Professor Bloom but he made no comment; the meeting minutes record that he had “provided all relevant information as a precautionary measure to the Medical Protection Society.[592]

The meeting then considered the impact of publicity on the blood transfusion service in Wales, noting that “it was important to keep the problem in perspective” and that “Given that the reported incidence of AIDS in the UK is very low we might be confident that we are not collecting potentially contaminated blood.” The fact that the current reported incidence (which the meeting recognised probably reflected an underestimate of the problem) was very low was not, of course, a reliable guide.

Consideration was then given to a ban on Factor 8 from the US: this would, it was said, necessitate a reduction in patients treated and the modification of the facility for home treatment.[593] The conclusion (a foreshadow of the decision that would be reached in July 1983 by the CSM(B) – perhaps unsurprisingly given Professor Bloom’s participation in both meetings) was that “There is no justification on the basis of facts so far established to ban the importation of factor 8 though it was thought preferable in the case of children to restrict treatment to the BPL concentrate produced in Britain.[594]

On the same day Dr Ferguson-Lewis wrote to the Parliamentary Under-Secretary of State notifying him that the patient at the Cardiff Haemophilia Centre did meet the CDSC definition of AIDS but there was “no cause for precipitate action.[595]

There were further meetings within the Welsh Office in late 1984. On 19 November a meeting was called by the CMO, Dr Crompton, in light of the “considerable media coverage” given to the death of three babies in Australia following transfusion, and to the report of the death of a Newcastle patient with haemophilia from AIDS. The CMO’s intention in calling the meeting was “to establish the known facts as they affected the UK in general and Wales in the particular.[596] Reference was made to the donor whose donations had been used for whole blood transfusion and for the production of concentrate, some of which had “found its way to Wales”.[597] Consideration was given to the question of donor awareness: although the existing leaflet was said to be liberally distributed at every donor session “it was still thought unsafe to rely upon this as the sole means of weeding out the homosexual population from amongst potential blood donors” and “the matter of a more detailed questionnaire could usefully be pursued.[598]

On the same date a briefing was provided to the Parliamentary Under-Secretary of State, copied to the Secretary of State and CMO,[599] to bring ministers up to date with the position in South Wales, which was that there had been three cases of AIDS in South Wales to date: two were dead; the third was a person with haemophilia. The briefing stated that there were at present “a very few haemophiliac patients in South Wales,” but that it was “likely that some may have received treatment with Factor 8 which might have been contaminated.[600]The number at risk was estimated in single figures. Risks to patients from the use of whole blood were said to be negligible, with “no evidence” that any patient has contracted the disease in the UK from this source.[601] There was said to be little the Welsh Office could do to immediately affect the present situation. On 20 November Dr Galbraith of CDSC wrote to Dr Crompton with an update about two important events: the first related to the Wessex donor, the other to a nurse who had seroconverted to HTLV-3 following a needlestick injury.[602] It is of note that none of these communications referred to events in Scotland, and to the fact that it was by now known that a number of patients treated at the Edinburgh Haemophilia Centre had tested positive for HIV.

Scotland

Responsibility for decision-making

Scotland had a large degree of independence in matters of health policy and administration at all times relevant to the Inquiry. Over the whole of the period with which the Inquiry is concerned, Scotland had its own, separate health and transfusion services. Health was a matter which was either part of the administrative devolution arrangements (and was hence within the exclusive competence of the Scottish Office) or part of the more formal devolution settlement after the Scotland Act 1998. Responsibility for decision-making and policy in Scotland was vested in a number of entities which were distinctly Scottish, reflecting these facts. Scotland had its own legislation governing health matters.

The fact that Scotland had its own independent National Health Service and own blood transfusion service (SNBTS) meant that it also had its own transfusion directors and haemophilia directors who met as separate groups or together, often along with representatives of government in Scotland to develop blood collection, screening, transfusion and associated treatment policies. It also had its own fractionation facility at the PFC at Liberton, with products made there also used in Northern Ireland and (in times of excess supply) in other parts of the UK.[603]

At government level, the Scottish Home and Health Department (“SHHD”) within the Scottish Office and then, post-1999, the devolved Scottish Executive, had responsibility for health policy and administration.

However, it must be borne in mind that these arrangements and responsibilities for the administration of matters relating to health in Scotland also occurred within a UK context. The apparent freedom and autonomy of the administrative arrangements relating to health thus have to be seen within that context. Several UK bodies had considerable influence over Scottish policy, though they considered matters on a UK-wide basis rather than specifically with Scottish patients in mind. These included the UKHCDO, the DHSS and the MRC as well as advisory bodies and working groups which had a UK-wide bearing.

The constitutional arrangements in place in the 1970s and 1980s were such that “vast swathes of matter relating to Scotland were handled by the Scottish Office as part of ‘administrative devolution’”, with responsibility for all of them being thinly spread amongst a small handful of ministers. The result was that there was little time for ministerial engagement in matters such as the safety of blood or blood products, which had rather to be handled by civil servants, who rested too much on the assumption that blood supply was safe because of the voluntary donor system.[604]

The structure of the SHHD in the 1970s and 1980s

The Scottish Office was headed by the Secretary of State for Scotland (a member of the UK Cabinet). This was a role filled by Willie Ross from 1974 to 1976, Bruce Millan from 1976 to 1979, George Younger from 1979 to 1986, and Malcolm Rifkind from 1986 to 1990. Junior ministers with responsibilities for health in the 1980s included John Mackay from 1982 to 1986, Lord Glenarthur from 1986 to 1987 and Michael Forsyth (now Lord Forsyth) from 1987 to 1990.[605]

The Chief Medical Officer was Sir John Reid from 1977 to 1985, Dr Iain Macdonald from 1985 to 1988 and Professor Kenneth Calman from 1989 to 1991.

Lord Fowler’s recollection was that whilst the DHSS was so big that anything it did tended to be followed in Wales and Northern Ireland, Scotland remained “determinedly independent” on some things.[606] Lord Forsyth, however, described the SHHD’s resources as limited compared to the DHSS’s.[607]

The Scottish Office was made up of a number of constituent departments, including the SHHD which was responsible for home affairs and the health service. It was subdivided into a number of groups, of which Group IV was responsible for the management of the health service,[608] and like the DHSS the civil service comprised an administrative and medical hierarchy. Medical officers involved in decision-making regarding blood and blood products included Dr Iain Macdonald and Dr Graham Scott, both serving as DCMOs, Dr Archibald McIntyre, who was a principal medical officer from 1977 to 1993, overseeing the Scottish National Blood Transfusion Service, and Dr Albert Bell who was the senior medical officer responsible for blood services until 1985, having been in the position since at least 1973.

Advisory committees tended to be administered by the DHSS in Westminster, with Scottish interests being represented by relevant Scottish experts and Scottish civil servants including medical advisers who attended as observers and reported back to SHHD.[609]

SHHD medical officers regularly attended SNBTS meetings and sought the advice of its consultant adviser, Dr John Cash. The SHHD’s involvement in various meetings and direct correspondence with the DHSS included SHHD officials observing meetings of regional transfusion directors in England and Wales[610] and participating in meetings of groups such as the Central Blood Laboratories Authority.

Duncan Macniven, who was Assistant Secretary in the SHHD between 1986 and 1990, explained that most decisions within the SHHD were taken by officials without always consulting the (limited number of) ministers. Only difficult or politically contentious issues were typically brought before ministers.[611] The criteria for referring matters to ministers were not fixed but relied on the judgement of the responsible officials, typically at or above the level of Assistant Secretary, and if necessary, in consultation with more senior officials.[612] Lord Forsyth described the role of officials as administering agreed policies and ensuring that ministers were alerted to any concerning issues. He expected significant matters that required ministerial decision-making to be “drawn to their attention.[613]

Dr Scott, in evidence to the Penrose Inquiry, described regular liaison with the DHSS at various levels, including attending policy meetings of the DHSS’s Chief Medical Officer and maintaining ongoing communication.[614] However, he recognised that the SHHD did not automatically adopt DHSS policies and, as an example, confirmed that it would have been possible for Scotland to introduce HIV screening ahead of England, with the agreement of Scottish ministers. Duncan Macniven emphasised that health services in Scotland were entirely devolved to the Secretary of State and the SHHD, without any oversight role from the DHSS.[615] He noted that while significant disputes between the departments were rare, any that arose would be resolved through senior-level discussions or ministerial contact. Duncan Macniven spoke of “a great deal of executive devolution to the Scottish Office”prior to the creation of the Scottish Parliament.[616] In an October 1981 minute, Dr Bell emphasised that neither the SHHD nor SNBTS could be committed by policies adopted by the DHSS, suggesting a readiness to follow a uniform UK policy but acknowledging the unpredictability and controversy in the field of blood transfusion.[617]

The SHHD’s response to the risk of AIDS

Though it is reasonable to suppose that similar sources of knowledge about AIDS to those available to the DHSS in London were also available to the SHHD in Scotland, and that those closely involved in policy relating to blood supply and blood products would in general terms be aware of reports in the media about AIDS in America and its possible causes before the end of 1982, there is no documentation which specifically confirms this. The first recorded discussion concerning AIDS which included officials from the SHHD occurred at a meeting held between SNBTS and Scottish haemophilia centre directors on 21 January 1983 chaired by Dr Bell.[618] Before the meeting Dr Cash circulated a briefing paper relating to AIDS.[619] In the meeting he additionally drew attention to recent articles in The Observer[620]and The Lancet[621] and circulated an extract from the December edition of the Morbidity and Mortality Weekly Report (“MMWR”) with his paper.[622] Dr Christopher Ludlam informed members that the UK haemophilia directors had been sent a letter and questionnaire regarding the reporting of possible cases of AIDS.[623] Despite the material provided to the meeting, the minutes do not record that any action to minimise the risks in Scotland of AIDS was to be taken by SHHD (or anyone else).

On 1 May 1983, the Mail on Sunday carried its“Hospitals using Killer Blood” headline to draw attention to the risk of blood transmitting the cause of AIDS. This led to a response from John Parker of the DHSS in London to the private office of the minister (then Geoffrey Finsberg), enclosing a “line to take” and background briefing on AIDS, which had been prepared for the Prime Minister.[624] The response was copied to John Davies, Assistant Secretary at the SHHD.[625]

At this time, the SHHD was also receiving information from international sources. On 5 May 1983, Dr Archibald Prentice forwarded a telex from the WHO to Dr Scott and Dr McIntyre.[626] The telex recorded that a meeting on AIDS would be held in Denmark in November and that as of 1 May 1983 over 120 cases of AIDS had been reported by European countries that were part of the voluntary notification scheme.[627]

In receipt of this information, Dr McIntyre wrote to John Davies on 6 May 1983. He commented on the background briefing provided by the DHSS which he stated “reflects the situation in England and Wales” and that, while some Scottish transfusion directors had been in touch with Dr Gunson, there had not been any formal discussions with regional transfusion directors in England and Wales, contrary to the suggestion in the DHSS’s note. Dr McIntyre recorded that no “proven case” had been notified to date in Scotland and that Dr Prentice was “in close contact with the Communicable Disease (Scotland) Unit at Ruchill to which any case of AIDS arising in Scotland would be notified.”He commented that the signs and symptoms of AIDS were “somewhat vague” and that, as no “specific diagnostic test is available”, it was important that the same diagnostic criteria was being applied. He reminded John Davies that nearly all blood products including Factor 8 used in Scotland were produced at the PFC from blood voluntarily donated within Scotland, although there were a few patients currently being treated with imported Factor 8. He added that the SNBTS directors were very aware of the problem “and have it under constant consideration”, with current thought being given both to the production of a leaflet about AIDS for donors and to avoiding collection in high risk locations such as prisons or where there was known to be a high proportion of homosexuals or drug abusers in the population.[628] In fact, as discussed earlier in this chapter, collection from prisons continued.

Dr McIntyre’s observation was that the situation “does not warrant action until the risks have been more fully evaluated.[629]

John Davies prepared a ministerial submission for John Mackay on the same date, echoing, and confirming officials’ agreement with the general line in the DHSS’s briefing but incorporating specific Scottish points. These points highlighted Scotland’s near self-sufficiency in Factor 8 and the limited use of imported concentrates. John Davies also outlined the absence of confirmed AIDS cases in Scotland and detailed the matters to which SNBTS was currently giving consideration, as set out in Dr McIntyre’s note.[630]

No specific steps to be taken by the SHHD were identified, nor was the Minister asked to make any decision or take any action.

Commentary

There is no reason to suppose that decision-makers in Scotland did not know of the risk of AIDS at broadly the same time as did the DHSS in Westminster. The national and mainstream scientific press had speculated that the cause of AIDS might be blood-borne since November 1982.[631] From 21 January 1983 however there is no doubt about their knowledge of a real risk, and ample material to suggest that though cases of manifest infection had not yet been reported in the UK, it was known how quickly it was spreading in the US.[632] It was thus unlikely to be long before blood donors in Scotland, and thus transfused patients, and people with bleeding disorders would become victim to it, unless effective precautions were taken. Despite this, thought was being taken[633] about when they were required. It may have been understandable that Dr McIntyre should think that the situation did “not warrant action until the risks have been more fully evaluated.[634] He was not alone in needing to know much more than he did about AIDS and its causes. However, the pursuit of full knowledge about a new infection will almost never be completely satisfied, while that infection is in the process of taking hold. Certainty is desirable – but a primary rule in public health is that where there is sufficient information to show that there is a real risk, protective measures must be taken on the basis of the best information then available. It is an understandable, but crucial, mistake to wait for better or further information. It may never come. If the nearby volcano is rumbling in a way it has not done before, it is a mistake to wait until the threatened eruption is underway, and the lava is flowing too fast to escape it. If it turns out, on receipt of further information, to have been a false alarm then no life will have been lost, and comfort may be taken in knowing that the right measures have been taken, and will be taken again when and if necessary.

Dr McIntyre’s attitude thus led to inaction here. Just as in the case of the DHSS in London, the reaction of the SHHD was to do too little, and to do it too late.

Blood donor leaflets: the Edinburgh and South East leaflet

As described above, Dr Brian McClelland from the South East Scotland Regional Transfusion Centre initiated work on an AIDS donor leaflet without SHHD involvement (Dr Brian McClelland told Dr Bell that he was going to produce a leaflet, without seeking approval or permission).[635] On 24 May 1983, at a meeting of the SNBTS Co-ordinating Group, which the SHHD did not attend, Dr Brian McClelland presented a draft AIDS leaflet. The South East Scotland RTC subsequently issued this leaflet in June 1983. It highlighted the potential infectious nature of AIDS, suggesting that the disease, thought to be caused by a virus, could be transmitted through blood products like Factor 8, as observed in a few cases in the US.[636]

The topic of AIDS and donor selection leaflets was further discussed at a SNBTS directors’ meeting on 14 June 1983. Attendees included Dr Bell and John Wastle from the SHHD, as well as Dr Gunson and Dr Wagstaff from England. The meeting involved discussions about the approaches taken in England and Wales and the policies of the American Red Cross and the Council of Europe regarding AIDS. The directors further noted that “the DHSS were closely involved in England and Wales and recommended that the SHHD should have a similar involvement in Scotland. There would also be a need for a Government Press Officer to handle enquiries.[637]

The following day, Dr Bell summarised these discussions and developments in a communication to Dr McIntyre and John Wastle. Dr Bell highlighted the complexity of addressing AIDS in donor centres, including deciding whether the leaflet should be for pick-up or hand-out, and the possibility of needing different leaflets for the general public and specifically for the homosexual community. He commented that there was “no doubt about the desire in the transfusion services to collaborate fully north and south of the Border”, noting that “Dr Gunson has promised to let SNBTS have his latest version ... He will also try to ensure that DHSS consult SHHD in good time before there is ministerial involvement in going public on this subject.” He also noted the increasing public and ministerial attention on AIDS.[638]

In June 1983, the SHHD became aware that the Edinburgh and South East Scotland’s leaflet had started to be circulated with Dr Bell commenting that it “looks as though, de facto, we are about to reach a situation in which there will be two slightly different leaflets.[639]

Although comfort had initially been drawn from what was seen as an absence of AIDS cases in Scotland, by mid 1983 the press in Scotland began reporting AIDS cases. An article in the July/August 1983 edition of Gay Scotland mentioned two suspected cases in Edinburgh and Tayside, reported a consultant at the Edinburgh Royal Infirmary confirming that “It is only a matter of time before more AIDS cases are confirmed in Edinburgh and Glasgow”, and referred to the leaflet in use by the South East Scotland Blood Transfusion Service.[640]

On 30 June 1983, Dr Anne Smith (the donor consultant at the Edinburgh and South East Scotland Centre) issued internal guidelines for the handling of blood and blood products. This document contained information for, and instructions to, staff on the handling of donors. The note stated that people in high risk groups were asked to refrain from volunteering to give blood but that no blood donor was to be turned away merely on suspicion of being in a high risk group. A policy and procedures for handling those who nevertheless presented was set out.[641]

The UK AIDS leaflet

SHHD officials liaised with their DHSS counterparts over the development of an AIDS donor leaflet in late June and early July 1983. In a handwritten file note, an SHHD official recorded a conversation with Paul Winstanley of the DHSS on 20 June 1983. Paul Winstanley was said to have “confirmed that a revised leaflet – based on Dr McClelland’s – was being prepared. He agreed to let me have copies of the final draft and to keep me in touch with developments, especially on the timing of submission to Ministers.” Dr Bell was said to have had a similar conversation with Dr Walford.[642] In a further note, the official recorded a second conversation with Paul Winstanley on 28 June 1983. His note recorded that Paul Winstanley has said“that progress on preparing a draft leaflet and a draft submission to Ministers was slow, but [he] was well aware of the need to consult SHHD on the leaflet and give adequate warning on the timing of an approval to Ministers.[643]

On 1 July 1983 a DHSS submission on the publication of an AIDS leaflet was submitted to ministers, with a copy being sent to John Wastle at the SHHD.[644] The submission, prepared by Dr Walford, stated that “Although there is no conclusive evidence, it seems very likely that AIDS is caused by an as yet unidentified virus.[645] A draft leaflet, dated 24 June 1983, stated that AIDS could “Almost certainly”be transmitted through blood and blood products.[646] Further DHSS internal correspondence was copied to the SHHD, including a 4 July 1983 minute from John Parker confirming that Lord Glenarthur was content with the proposed leaflet.[647]

A 6 July 1983 handwritten note to Dr Bell described a conversation with Steve Green of the DHSS. This recorded that the DHSS “Ministers had mixed reactions and it required a meeting attended by Mr Parker this morning to secure agreement from Ministers who nevertheless wish the terms of the leaflet to be toned down.” DHSS ministers had also asked for a statement to be used when publishing the leaflet to “put the matter in perspective” and to “allay any impression of over-reaction”.[648]

Dr Bell provided Dr Scott with a copy of the DHSS ministerial submission. Dr Bell explained that the submission and proposed leaflet were in line with what had been “tentatively agreed by the English and Scottish RTDs”, although the section requesting high-risk donors not to give blood differed from Dr Gunson’s version, which was based on Dr Brian McClelland’s. The SHHD had been “informed that Mr Fowler’s first reaction” was that “the terms of this leaflet are strong, and that DHSS may therefore be making further amendments.” Dr Cash, however, was in favour of a single UK leaflet, a view shared by Dr Bell.[649]

On 11 July 1983 John Davies briefed the Minister, John Mackay, on the UK AIDS leaflet. He attached the draft leaflet, noting that DHSS ministers had expressed reservations over it and that DHSS officials were “toning down the text somewhat, largely to make clear that, even in the US, only a small number of cases has been reported.[650] John Davies explained that publication and distribution of a donor leaflet would conform with a draft resolution prepared by the Council of Europe’s Committee of Experts on Blood Transfusion. John Mackay was informed that the SHHD considered that the leaflet should be issued on a UK-wide basis, and that officials were arranging for the text to be adjusted accordingly. John Davies advised that “No separate Scottish announcement would be called for, but an important point for any press inquiries is that Scotland is virtually self sufficient in Factor VIII.[651]

Alongside the SHHD’s consideration of these issues, it received updates from SNBTS. In a 19 July 1983 letter to Dr Brian McClelland, copied to Dr Bell, Dr Cash enclosed a draft leaflet he had received (presumably from NBTS). He proposed that the SNBTS Co-ordinating Group meeting on 30 August 1983 be updated on the position with regard to a UK leaflet and agree on a method of distribution to donors.[652]

Further updates from the DHSS included a submission dated 29 July 1983, seeking ministers’ approval for the printing and distribution of the proposed AIDS leaflet, a copy of which was sent to John Davies.[653] John Wastle recorded a conversation with Paul Winstanley, confirming the minister’s agreement on the leaflet’s content and the intention to proceed with printing. Paul Winstanley committed to providing 200,000 leaflets for Scotland and updating John Wastle on the timing of the ministerial statement and press release. However, when the DHSS papers arrived on 3 August 1983, it was noted that amendments agreed between John Davies and John Parker had been overlooked. Nonetheless Paul Winstanley was “not inclined to withdraw the leaflet for amendment.[654]

Dr Cash, in a letter to Dr Brian McClelland on 19 August 1983, mentioned the upcoming statement on AIDS by the English minister and the decision to leave the distribution of leaflets to the discretion of individual RTDs. The Scottish minister was to follow the same approach, with the Scottish Office Information Division issuing a press release based on the English minister’s statement.[655]

Finally, on September 1, 1983, the SHHD issued a press release on the UK AIDS donor leaflet. It stated that there were no confirmed cases of AIDS in Scotland and that “The Scottish Home and Health Department emphasised today that there is no conclusive proof that the disease can be transmitted in blood or in blood products.”The press release highlighted Scotland’s self-sufficiency in whole blood and blood products, with most Factor 8 used for haemophilia treatment being produced from plasma donated to SNBTS by Scottish donors.[656]

Commentary

The SHHD appears to have been content to sit back and let the DHSS take the lead in respect of decision-making on the AIDS leaflet. Dr Brian McClelland in SNBTS stands out above this. He took the initiative, and was not prepared to wait for Westminster. However, whilst Dr Brian McClelland’s leaflet was circulating in the Edinburgh and South East Transfusion Centre, leaflets were not in universal use in Scotland. The SHHD (in contrast to Dr Brian McClelland) neither sought to urge more decisive and speedier action, nor, when it became apparent that there was delay with the DHSS process, to ensure the issue of its own leaflet, nor to argue for the safest method of distribution (namely the direct provision of the leaflet to all donors).

The decision of the SHHD to adopt and use the “no conclusive proof” line to take was wrong, for the very reasons discussed above in relation to the DHSS. Dr Brian McClelland told the Inquiry that the wording in the press release was quite inconsistent with his own view of the risks and that he thought the wording was “misleading and falsely reassuring”: “by this time, you know, frankly, there was really little shadow of doubt that this was a disease transmissible by blood or in blood products. It is just misleading.[657] He was right.

Late 1983: monitoring developments

In late 1983 and early 1984, officials from the SHHD primarily focused on monitoring developments related to AIDS and blood products. Thus, for example, in his note from the 17 October 1983 meeting of the Advisory Committee on the NBTS, Dr Bell reported a suggestion about concentrating on “small pools of donors”, meaning more intensive plasmapheresis of donors whose health status could be closely monitored.[658] The minutes of this meeting also included an update from Dr Walford on AIDS, highlighting that out of the 24 reported AIDS cases in the UK, two were people with haemophilia, with one deceased.[659] At a meeting on 18 October 1983 of the Advisory Group on Hepatitis, which included Dr Prentice representing the SHHD, Dr Craske reported a doubling of AIDS cases every six months in the US, but emphasised the still very low risk of contracting the disease.[660] An article in The Scotsman on 31 October 1983 noted a 50% increase in British AIDS cases in September, from 16 to 24. This report, which was placed in an SHHD file for John Davies, Dr McIntyre, and Dr Bell, mentioned the death of a patient with haemophilia due to a contaminated blood-clotting agent from an AIDS-infected American donor. A manuscript note beside this report suggested that the SHHD was already aware of this.[661]

Dr Bell participated in the 14 November 1983 meeting of the (Scottish) Haemophilia and Blood Transfusion Working Group, where trials of heat-treated PFC Factor 8 were discussed. The meeting also sought feedback on the effectiveness of the leaflet prepared by SNBTS and the DHSS. The general consensus was that the leaflet had not been particularly useful, despite its wide distribution at donor sessions and other locations, including sexual health clinics.[662]

At the 7 November 1983 meeting of the CBLA Central Committee for Research and Development, Dr Bell mentioned discussions about the AIDS leaflet, with some doubts about its effectiveness and plans by Dr Gunson and Dr Walford to consider revisions. Dr Bell expressed confidence in Scottish interests being represented in these discussions, with Dr Brian McClelland on the AIDS Working Group. Additionally, the meeting discussed surrogate screening for AIDS, centring on anti-HBc testing, and “small pool apheresis” was suggested as a potential strategy within transfusion practice to combat AIDS.[663]

Changes to the Scottish AIDS leaflet

At a meeting of the SNBTS directors on 8 December 1983, attended by Dr Bell and Mr Murray, it was decided to adopt a more proactive approach to the distribution of AIDS leaflets, which had been available at donor sessions for some time. The attendees agreed that each blood donor should receive a copy of the leaflet and that the health questionnaire for donors should include a question about their understanding of the leaflet. Dr Brian McClelland was tasked with producing a revised version of the leaflet.[664] The 2 February 1984 meeting of SNBTS and haemophilia directors, chaired by Dr Bell and attended by Dr McIntyre, again discussed the risk of AIDS transmission through blood and the effectiveness of the current leaflet, with a consensus that modifications might be necessary.[665]

The need to strengthen the message, and the realisation that the effectiveness of the leaflet could be of critical importance, was underlined by the first death of an AIDS patient in Scotland which was reported in the Daily Record on 17 February 1984.[666] The risk was plain that donations might be infected in Scotland despite being provided by volunteers.

The AIDS donor leaflet was again a topic of discussion at a SNBTS directors meeting on 13 March 1984, attended by Dr Bell and Mr Murray. A draft revised leaflet by Dr Brian McClelland was circulated, with directors asked to comment within two weeks. It was reported that Dr Alison Smithies of the DHSS would undertake a similar revision for England and Wales. The Scottish directors believed their approach of making the leaflet available at donor sessions and STD clinics should be strengthened by mailing it to all blood donors.[667]

In March 1984, a local leaflet appealing for blood donors in Edinburgh contained a paragraph on AIDS, which was marked in a manuscript note by John Davies as being more assertive than previously seen.[668]

The trial of the DHSS version of a donor leaflet had been agreed by ministers to run until December 1983. As explained above in relation to the DHSS, some mistakenly thought it was to last for three months longer. At the 10 April 1984 meeting of the Advisory Committee on the NBTS, which Dr Bell attended, the committee discussed amending the DHSS/UK leaflet. Dr Smithies presented an update on the AIDS cases and deaths reported to the CDSC and said that the “6 month trial[669] of the AIDS leaflet had concluded.[670] In response, the DHSS planned to prepare a revised version for ministerial submission. The committee debated whether a more assertive approach was necessary to discourage high-risk donors and ultimately recommended that the DHSS ministers consider issuing the revised leaflet with donor call-up cards in all regions. Dr Bell noted in his record of the meeting that Dr Smithies had set out the arrangements for revising the leaflet, incorporating suggestions from SNBTS.[671]

Subsequent to these discussions, a revised leaflet was agreed upon at the 12 June 1984 meeting of SNBTS directors, which Dr Bell also attended. The SNBTS secretary was tasked with making the necessary arrangements to provide leaflets for each transfusion centre, tailored to local methods of preparing call-up letters.[672]

The SHHD was not included in the distribution list for the 10 August 1984 DHSS ministerial submission on a revised AIDS leaflet.[673]

Possible research

Following an SNBTS Co-ordinating Group meeting on 15 February 1984, Professor Cash wrote to Dr Bell suggesting the formation of a single UK group responsible for coordinating AIDS research related to donors, tests and other measures to increase safety of blood and blood products. He proposed a group which included representatives from existing smaller groups, including haematologists, haemophilia centre directors, and SNBTS directors.[674]

At a CBLA Central Committee for Research and Development in Blood Transfusion meeting on 28 February 1984, Dr Bell discussed a proposed study to identify high-risk donors for AIDS through HBc screening. Despite a lack of enthusiasm for the study, the committee felt that some action was needed to identify potential transmitters of AIDS.[675]

The Edinburgh cohort: discovery and response

In October 1984, the SHHD became aware that a cohort of patients from Edinburgh, treated with PFC Factor 8, had developed antibodies to HTLV-3. The exact date when SHHD officials first learned of this development is unclear,[676] but by 20 November 1984, Hugh Morison, the SHHD Under-Secretary, informed John Mackay of the situation in a minute also copied to the Secretary of State and others. In his communication, Hugh Morison said that 16 Scottish people with haemophilia had been identified with antibodies indicating exposure to the virus, though this did not necessarily mean they would develop AIDS. He explained that a batch of Factor 8 produced at PFC in Liberton was implicated. It was likely to have been contaminated by a Scottish donor. The SHHD was taking steps to identify the source of infection and withdraw the contaminated batch.[677]

Hugh Morison forwarded this information, along with briefing notes, to the Scottish Information Office, Dr Scott, Dr Bell, and Mr Macpherson on the same day.[678] He said that a revised SNBTS leaflet had been prepared that August, and had been sent to all donors receiving mailed reminders, apart from those in the West of Scotland, and that steps were now being urgently taken to issue the leaflet to donors in the West of Scotland and to those throughout Scotland who did not receive mailed reminders. It was said that issuing a statement was not appropriate at this stage, but that “suitable defensive briefing” had been given to the Scottish Information Office. The briefing, mainly in a Q&A format, addressed the discovery of HTLV-3 antibodies in Scottish people with haemophilia, the contamination of Scottish plasma, and the steps being taken by SNBTS, including the withdrawal of the implicated batch of Factor 8 and efforts to trace the donor.[679]

John Mackay, responding, emphasised the need for openness to avoid accusations of a cover-up and inquired about the readiness of the heat-treatment process.[680]

In response to a Parliamentary Question on 28 November 1984, John Mackay addressed the issue of AIDS and the actions taken by SNBTS, including the issuance of a revised AIDS leaflet to blood donors in Scotland. He emphasised that individuals at high risk of contracting AIDS should not donate blood, a stance that was covered in a newspaper article the following day.[681] The response did not make any reference to the fact that it was by now known (by ministers and officials – not by the patients themselves) that there had been infection of recipients of Scottish Factor 8.

On 29 November 1984, a meeting took place involving the SHHD, SNBTS, and haemophilia centre directors to discuss the situation of the Edinburgh patients and other haemophilia patients in Scotland who had tested positive for HTLV-3 antibodies.[682] Dr Charles Forbes presented findings from Glasgow, and Dr Brenda Gibson expressed concerns of parents of children with haemophilia treated in Glasgow, where imported Factor 8 had been used until recently, leading to five out of ten patients testing positive for HTLV-3 antibodies. At this stage, none of those infected had been informed what had happened: as recorded in the chapter on Haemophilia Centres: Policies and Practice, the news was broken to some of them at a group meeting held in Edinburgh on 20 December 1984, though not to all in a way that they understood related to them. As to that, the meeting on 29 November 1984 wrestled with whether, and what, they should be told:

“Views were exchanged on the very difficult ethical problems which had arisen. These included whether patients and patients’ relatives should be informed and perhaps subjected to needless worry – whether publicity additional to that already provided should be given, and how directors should respond to direct enquiries or requests for advice. The chairman advised members that ministers had been informed and that SIO[683] had been briefed. While a press statement wouId not be issued by the Department at present any enquiries would be answered. It was agreed that every effort should be made for patients to have the situation explained to them before the impending publicity.”[684]

On 5 December 1984, John Davies updated John Mackay (and the Secretary of State) on the Edinburgh patients and other individuals who had antibodies having received imported Factor 8.[685] Ministers were advised that “no statement can be made at the moment until the haemophilia directors resolve the very difficult ethical problem of what action to take with regard to their patients about the matter.” This was despite the agreement minuted at the meeting on 29 November 1984.[686] Yet again clinical freedom was being asserted.

Commentary

This chapter started with a statement which should be uncontroversial – that a first duty of the state is to look after the safety of its population. That duty must extend to the safety of patients receiving blood or blood products.[687] It is one thing to state a duty: it may be another to recognise the principle not just in rhetoric but in action. The opening words thus described how this chapter would examine whether the government discharged that fundamental responsibility.

This chapter has examined key aspects of the government reaction to the threat of blood-borne disease in the late 1970s and early to mid 1980s. Other chapters deal with further matters which involve the government: but what this chapter has shown is that in each of the areas it has examined the government’s response was lacking. Government did not respond appropriately, urgently and proactively to the risks of transmission of Hepatitis C and HIV through blood and blood products.

For ease of reference, the principal failures discussed in this chapter are summarised below.

Despite full knowledge of the practice of blood being collected from prisoners in almost all transfusion centres in the UK, and it being established from at least the beginning of 1975 that there is a much higher incidence of hepatitis amongst prisoners than amongst the rest of the donor population, no action was taken to stop donations from prisons. Nor even to try to discourage this.[688] This inaction increased the risk of transmission of both Hepatitis B and non-A non-B Hepatitis and, in due course, AIDS. The failure lies principally at the door of the DHSS and the SHHD, but action could and should also have been taken by the DHSSNI and the Welsh Office to put a stop to or discourage the practice in Northern Ireland and Wales respectively.

The response, between 1982 and 1984, to the risks posed to the safety of blood and blood products by the emergence of AIDS was inadequate. In particular:

  1. Having been alerted in July 1982 to the risks to people with haemophilia (and hence indicating that the disease was transmissible by blood, with all the implications that then had for those receiving transfusions), the DHSS (and the SHHD, DHSSNI and Welsh Office, (referred to collectively for these purposes as “the health departments”) did nothing of substance between July 1982 and the end of 1982 to discuss, plan or consider measures that could be taken with regard to the safety of blood or blood products in light of what was a terrible threat of a new and deadly disease.[689]
  2. In the first four months of 1983 there continued to be little consideration of AIDS by any of the health departments, apart from the occasional brief reference at meetings.
  3. Remarkably, no information or advice regarding AIDS and blood was provided to ministers (in any of the health departments) during this period.
  4. Despite a growth in concern in scientific and popular circles, and the exponential growth of the number of AIDS cases in the US, there is no evidence of a minister showing any interest in the issue of their own initiative during this period. They were undoubtedly busy. They had not been briefed. But this is still inexplicable.[690]
  5. It was not until May 1983 – some ten months after the MMWR report of pneumocystis pneumonia in three haemophilia patients in the US, and at least that since the DHSS had been made aware of infections in people with haemophilia in the US – that the DHSS began to consider the position to any meaningful extent,[691] and initially only in response to media reports.
  6. The 9 May 1983 letter to the DHSS from one of the country’s pre-eminent public health doctors, Dr Galbraith, ought to have galvanised the Government into action. It did not.[692] There was no response to Dr Galbraith,[693] and his views were not communicated to ministers, or the CMO, or shared with haemophilia centre directors, or with regional transfusion directors, or with the SHHD, DHSSNI and Welsh Office. Each minister was asked about this and thought ministers should have been told.[694]
  7. Neither the DHSS nor any of the other health departments gave any consideration to reverting to cryoprecipitate, which was an obviously safer treatment.[695] Nor was any consideration given to other treatment strategies that could have been implemented and would have significantly reduced the risks of transmission. Although at the time the treatment by clinicians of their individual patients was regarded as a matter for them,[696] this did not prevent general advice being given, in particular by the CMO who held office in each of the health departments; and such advice both could and should have encompassed advice as to which treatment strategies it was thought might be safer.
  8. The UK Government signed up to the June 1983 recommendations of the Council of Europe’s Committee of Ministers yet failed to do anything at all in response to its first recommendation (being a recommendation to avoid wherever possible the use of large pool factor concentrates, especially if self-sufficiency had not been achieved).[697]
  9. The UK Government also failed to do anything at all in response to the second recommendation (being a recommendation to inform clinicians and to inform patients both of the dangers of treatment and of the possibility of minimising those dangers).[698]
  10. The failure of the DHSS (or any of the other health departments) to provide any advice, information, guidance or direction to clinicians or to patients was a serious one, in the face of a risk of transmission of a fatal, untreatable, new disease to patients by means of the treatment which was being provided to them by the NHS. Given that the treatment was provided by the state’s own public medical system, of which the Government was ultimately the custodian, this failure to engage in this way was inexcusable.
  11. The DHSS adopted and repeated (as did the SHHD in September 1983) a line to take (“no conclusive proof” or “no conclusive evidence”, unqualified by any suggestion of likelihood) which was falsely reassuring, lacking in candour and misleading.
  12. There was one concrete measure introduced by the DHSS during this period – the AIDS donor leaflet. In the absence of identification of the causative virus until 1984,[699] and thus the absence of a definitive test, the taking of greater care to select appropriate donors was one of the few steps that might reduce the chances of infection. It was the first of the risk-reduction measures to which the Expert Committee on Hepatitis of the WHO had referred in 1952, albeit then in respect of hepatitis.[700]

However, despite high-risk groups[701] being known:

The inadequacy of this response was contributed to by the following six factors:

First, the DHSS erroneously formed the view, in early 1983, that the risks of AIDS transmission were far outweighed by the benefits of treatment with factor concentrates: this both understated the risks of AIDS and overstated the advantages of factor concentrates. It was based upon a binary approach – that it was factor concentrates (which would include commercial concentrates) or nothing that could be used to stop serious bleeds. It lacked a proper appreciation of the potential alternatives. Unfortunately, it remained the bedrock of DHSS thinking throughout 1983 and 1984. A contributing factor to that view – or the adherence to it over the next two years – was in all likelihood an uncritical, or insufficiently critical, acceptance of Professor Bloom’s views.

Second, and as described in the course of this chapter, neither civil servants nor ministers discharged their roles as they should have done. Civil servants failed to bring issues to the attention of ministers when they should have done; there is no evidence of a minister taking any interest before the summer of 1983.

Third, there was no proactive involvement or direction from the CMO, and the CMO failed to play the part which he should have done, until the autumn of 1984. The same is essentially true for the CMOs in Scotland, Wales and Northern Ireland.[703]

Fourth, there was no single, overarching multidisciplinary advisory body such as EAGA until late 1984.

Fifth, non-A non-B Hepatitis, and its transmission through blood and blood products, did not receive the attention which it should have done throughout the 1980s. There was no overarching body with responsibility for advice on blood safety until the establishment of the ACVSB in 1989, and the Advisory Group on Hepatitis set up early in the 1980s, despite its name, failed even to address non-A non-B Hepatitis.

Sixth, instead of trusting its citizens with the fullest information it could give, government repeated the “line” that there was no conclusive proof that blood or blood products transmitted the cause of AIDS. As has been pointed out this was misleading – not because it was untrue, because technically it was correct. But it was not “the whole truth”. There may be a natural human desire to reassure others; the phrase “I’m sure it’ll be alright” is an example, often used although the speaker has no idea how true it is. However, government[704] should not expect people to be mature enough to understand the pros and cons of political debate in order to cast a vote, but then act as though they need to be shielded from the whole truth when it comes to threats to their health. If – as here, for a while it was – many of the facts were uncertain, government should not be afraid to admit it. If it is unsure, the truth government should offer is that it does not yet know: it should not be embarrassed by being unable to give exact advice. Government should, instead, be embarrassed by stating less than the whole truth to people who can then take decisions about their lives even with such limited knowledge as government can offer.

Primary responsibility for these several failings rests with the DHSS: on matters of health policy, and in particular public health, those within the SHHD, Welsh Office and DHSSNI at the time usually followed the lead of the DHSS. Nonetheless, the SHHD, Welsh Office and DHSSNI must bear their own share of responsibility as well. Although their resources (particularly in the latter two jurisdictions) were significantly smaller than the DHSS’s, they too should have made it their priority to ensure, as far as possible, the safety of the supply of blood and blood products. They did not do so.

Some of the submissions which the Inquiry received from its core participants submitted that the government failed to act when it should have done on a precautionary basis. The “precautionary principle” as it is now known was not a common currency in much of the discussion about how to deal with risk in the late 1970s and early 1980s.

The essential principles underpinning a response to risk were however well understood. It was easy to understand – then as now – that all begins, as this chapter began, with the recognition that the overriding principle is to seek to ensure safety. If safety is recognised as primary, then where there is a real risk to safety, steps must be taken to reduce that risk. To ask for more details about the risk, or to seek certainty about it, is to let the risk continue unaddressed while greater knowledge is sought. Instead, the risk must be addressed at once – as best it can be – no doubt whilst further studies, or information, or details are being sought, but without waiting for those steps to happen before taking action.

Take an analogy. If a hurricane is approaching, it may well miss landfall. It may be uncertain what its precise course may be. But to wait until the first trees are being shaken violently on the nearby coastline before trying to batten down the hatches and evacuate the region is to wait too long. Further information may show that the risk has been overplayed – but there is no doubt that action should be taken, and if it is to be effective it cannot wait. Here, unfortunately, and wrongly, government waited.

The actions and inactions described in this chapter go beyond what would today be recognised as a failure to act on a precautionary basis, however that is defined.

Sufficient was known about the risks of transmission of both AIDS and non-A non-B Hepatitis during this period to require the Government to act quickly, decisively and proactively, and with the primary objective of reducing the risks of viral transmission. When the failures in this chapter and the preceding ones on Regulation of Commercial Factor Concentrates, Self-Sufficiency, Viral Inactivation, Pool Sizes and the Organisation of the Blood Services are considered, government could not have prevented every infection, but the probability is that timely action would have saved many.

That the government did not act as it should means that the question asked at the start of this chapter has to be answered by saying, clearly, that it failed to discharge its fundamental duty to ensure the safety of the public.

4.2 Haemophilia Centres: Policies and Practice

This chapter examines UK haemophilia centres’ transition from treating with cryoprecipitate to treating with factor concentrates during the 1970s and 1980s. It analyses clinicians’ reluctance to adapt treatment despite the emerging hepatitis and HIV risks and considers ethical failings with regard to consent, communication and research.


Key Dates

1 October 1968 First formal meeting of haemophilia centre directors.

November 1974 Dr Craske reports to UKHCDO hepatitis outbreak in Bournemouth linked to commercial Factor 8.

September 1980 Glasgow symposium considers liver disease in haemophilia.

16 July 1982 US Centers for Disease Control reports three confirmed cases of people with haemophilia who had developed AIDS.

13 September 1982 UKHCDO meeting refers to “remote possibility” that commercial blood products were the cause of AIDS in people with haemophilia in the US.

5 November 1982 Dr Craske’s paper on AIDS makes clear that an infectious agent is the most likely cause.

11 January 1983 Letter from Professor Bloom and Dr Rizza regarding administration of factor concentrates to PUPs. (Letter is misdated 1982.)

13 January 1983 The New England Journal of Medicine warns of risks of AIDS to people with haemophilia and advocates a revised approach to treatment.

24 January 1983 Discussion of AIDS at Heathrow hotel meeting of haemophilia centre directors.

26 April 1983 Professor Bloom reports to CDSC a “probable” case of AIDS in one of his patients.

13 May 1983 Special meeting of reference centre directors discusses AIDS.

24 June 1983 Letter from Professor Bloom and Dr Rizza setting out the general recommendations for treatment agreed at the 13 May 1983 special meeting.

17 October 1983 Professor Bloom tells UKHCDO meeting that there was “no proof that commercial concentrates were the cause of AIDS”; meeting agrees that patients “should not be encouraged to go over to cryoprecipitate for home therapy”.

14 December 1984 UKHCDO prepares AIDS Advisory Document.


Key People

Dr Rosemary Biggs director, Oxford Haemophilia Centre (until 1977)

Professor Arthur Bloom chairman, UKHCDO and director, Cardiff Haemophilia Centre

Dr John Craske virologist & chairman, UKHCDO’s Hepatitis Working Party (from 1977)

Dr Charles Rizza secretary, UKHCDO and director, Oxford Haemophilia Centre


Abbreviations

CDC Centers for Disease Control

CDSC Communicable Disease Surveillance Centre

DDAVP Desmopressin

PUPs previously untreated patients

UKHCDO UK Haemophilia Centre Directors’ Organisation


Introduction

This chapter looks at the policies and practices of haemophilia centres in the 1970s and 1980s. Because there were so many centres, and so many patients treated in them, it is not practicable to consider the position of each and every centre. However, the evidence relating to each centre, much of which has been set out in a series of written presentations prepared by the Inquiry and published on the Inquiry’s website, has been carefully considered and shapes the findings and conclusions that are set out later in the chapter.

The chapter starts by considering the overall organisation of haemophilia care, and then pays close attention to the role of the UK Haemophilia Centre Directors’ Organisation (“UKHCDO”)[705] before turning to consider individual centres.

The organisation of haemophilia centres

Haemophilia centres were first formally designated in the 1950s following discussions involving the Ministry of Health and the establishment by the Medical Research Council (“MRC”) of its Haemophilia Committee. The MRC’s Haemophilia Committee proposed that a number of haemophilia centres should be designated as reference centres with the object of ensuring uniformity of diagnostic standards and co-ordinating the exchange of information.[706]

In 1964 the responsibility for overseeing the organisation of haemophilia care passed to the Ministry of Health and in 1966 the MRC’s Haemophilia Committee was disbanded. In 1968 the Ministry of Health issued a memorandum HM 68(8) “Arrangements for the Care of Persons Suffering from Haemophilia and Related Diseases” with a list of 36 centres that would take responsibility for the care of those with haemophilia and related bleeding disorders.[707] Three centres (Oxford, Manchester, Sheffield) were designated as special treatment centres to undertake major surgical treatment, and it was recommended that close relationships should be developed with the appropriate regional transfusion centre (“RTC”) from which fresh frozen plasma (at that stage just ceasing to be the mainstay of treatment, to be succeeded by cryoprecipitate) would have to be obtained.

Over the next few years there were further discussions about the organisation of haemophilia centres,[708] resulting in the publication of HC 76(4), a memorandum setting out revised arrangements for the care of haemophilia and related bleeding disorders.[709] Centres which had been designated in 1968 but which no longer met fully the new criteria would now be known as “associate centres” and would be linked with a convenient larger haemophilia centre. Thus was introduced a three-tier system: reference centres, designated haemophilia centres and associate centres. Seventy-four centres were listed in the appendix to HC 76(4), of which seven were reference centres: Oxford, Royal Free, St Thomas’, Manchester, Newcastle, Cardiff and Sheffield.[710] In 1980 and 1981 Edinburgh, Glasgow and Belfast were formally recognised as reference centres. The functions of the reference centres included:

  1. to provide a 24-hour telephone advisory service to Haemophilia Centres and Associate Haemophilia Centres ...
  1. to advise on and organise when called upon home therapy and prophylactic therapy for haemophilia patients ...
  1. to ensure close co-operation between the Haemophilia Centres, Associate Haemophilia Centres and the Regional Centres of the Blood Transfusion Service ...
  1. to co-ordinate statistics collected by Haemophilia Centres and Associate Haemophilia Centres
  1. to co-ordinate meetings and research programmes.” [711]

The first meeting, in Oxford, of what became the UKHCDO took place on 1 October 1968. It was attended by directors from centres across the UK, as well as representatives from RTCs. It was at that meeting that Dr Rosemary Biggs suggested that the organisation of haemophilia centres in the UK made it possible to carry out collaborative research not easily done elsewhere.[712]

From 1971 UKHCDO meetings took place annually, under the chairmanship of Professor Edward (“Eddie”) Blackburn. All haemophilia centre directors were invited. The majority of UKHCDO meetings in the 1970s and 1980s were attended by a representative of the Department of Health and Social Security (“DHSS”) and (usually) by representatives from the Blood Products Laboratory (“BPL”).[713] Haemophilia Society representatives also often attended. Dr John Craske, a virologist from the Public Health Laboratory Service (“PHLS”), was a regular attendee from 1974. Minutes from the annual meetings were circulated to all directors, as were the reports from working parties which were prepared for the annual meetings.[714]

Professor Christopher Ludlam (the director from 1980 of the reference centre at the Edinburgh Royal Infirmary) described the annual meetings in these terms: “There was always opportunity to ask questions, to raise topics, but there was a quite a full agenda to get through ... they weren’t meetings where there could be a detailed discussion of issues because of the large number of people in the room.[715] Professor Liakat Parapia (the director from 1982 of the Bradford Haemophilia Centre) offered a slightly different perspective: it was, he said, “very difficult to debate anything”, due to the numbers in attendance, and it would have been “intimidating to try and speak out” for someone relatively junior like himself.[716]

According to Dr Charles Rizza (the director of the Oxford Reference Centre), writing in 1975:

“This conference of haemophilia centre directors has proved useful not only because it provides an opportunity to exchange views on specific problems, but also because within the framework of such meetings it is possible to collect information, not otherwise easily obtained, concerning many aspects of haemophilia and its management. By pooling such information it then becomes possible to make recommendations and plans for the management of haemophilia on a national scale. The haemophilia centre directors of the United Kingdom are now involved in a very active programme of research, including a review of the incidence of hepatitis and factor VIII antibodies in haemophiliacs, a trial of prophylactic treatment, and a survey of home therapy.”[717]

From 1978 it was decided that the annual meeting would be in two parts: a business meeting followed by a scientific session. Professor Arthur Bloom was the chair designate from the autumn of 1978, succeeding Professor Blackburn, and took the chair from the autumn of 1979.[718]

Regular meetings of the reference centre directors began in February 1976.[719] These were not usually attended by a DHSS representative. The minutes of their meetings were circulated only to the reference centre directors themselves.[720] Professor Edward Tuddenham (co-director of the Royal Free Reference Centre) described the reference centre directors as “a group of colleagues who were gathered together under the common objective of organising and improving the management of haemophilia ... to optimise the monitoring of standard of care, gathering data, making representation to the Department of Health for ways to improve.” It was not, he said, hierarchical, but a group of colleagues who respected each other. It was, to some extent, a talking shop and unless a very, very firm line was taken to pursue a particular policy they did not intend to impose views on the rest of their colleagues because they did not have the executive power to do so.[721]

At a January 1977 meeting of the reference centre directors the decision was taken to set up working parties to study problems of particular interest to haemophilia centre directors and patients.[722] There were initially five working parties: the treatment of patients with Factor 8 antibodies; home therapy and prophylaxis; the incidence of hepatitis in patients with haemophilia; the standardisation of assay methods for Factor 8; and methods for the detection of carriers of haemophilia. Over the following years other working parties were set up.

The system for submitting annual returns to Oxford was in operation at least from 1976; from 1977 these returns were to include details of home treatment and treatment of patients with antibodies. Although extensive reference will be made to the annual returns in this chapter – they are, for many centres, the best (and sometimes the only) available guide to treatment practices – it is right to note that they were far from perfect as a record of product usage. Some returns were not fully or legibly completed; there was not a consistent approach to the calculation of the number of international units, in particular in relation to cryoprecipitate; nor was there a consistent approach to the inclusion of desmopressin (“DDAVP”) on the return. Some were simply not returned.

As at 1980 there were, in addition to the reference centres, over 40 other designated haemophilia centres and about 50 associate centres.[723]

The role of reference centres, as described in the Haemophilia Centre Handbook in 1980 included “assisting other Haemophilia Centres to provide a high standard of care for their patients. This is done by giving advice, organising adequate supplies of therapeutic material, and occasionally by taking over the treatment of a difficult patient for a time.[724] Associate centres were small haemophilia centres “which do not always have the medical or laboratory facilities for comprehensive, full-time care of haemophiliacs ... but which do provide treatment for most of their local patients, most of the time.[725]

At a meeting of Scottish National Blood Transfusion Service (“SNBTS”) regional transfusion directors and Scottish haemophilia centre directors in January 1981 (which considered the proposed recognition of Edinburgh and Glasgow as official reference centres) the role of the designated reference centres in England and Wales was explained in these terms: “the designated reference centres were charged with a responsibility for co-ordinating the functioning of the haemophilia service. Many centres in England and Wales are relatively small and look to the larger reference centres for guidance and advice.[726]

Professor Geoffrey Savidge, in written evidence to the Archer Inquiry, described UKHCDO in the 1970s and 1980s in somewhat sceptical terms. It had:

“no formal affiliation with the NHS through the DOH, any Royal College or learned society (eg: BSH[727]) and functioned as an isolated and autonomous advisory body with its own self appointed working parties, essentially to its own members ... Views and opinions involving observations of important health issues in haemophilia patients from members of the executive committee[728] were relayed by informal delegation through the Chairman (or occasionally vice-Chairman) usually to those committees (eg DOH, CSM, CBLA, National Blood Transfusion Organisations, etc) where actual decisions on haemophilia management, blood product production and funding etc would be taken and implemented. Little if any information was reported back on what the chairman actually discussed at these numerous committees although in several matters eg: blood product projected usage, no heed was taken of the UKHCDO data, and deliberations of these committees involving information from the UKHCDO and their decisions were not fed back in a cogent form either to the executive or to the full body of members of the UKHCDO.”[729]

It should be noted that since the 1990s UKHCDO has undergone a number of structural changes. The descriptions above, and the observations within this chapter about the role of UKHCDO in the 1970s and 1980s, are not directed at UKHCDO in its current form.

Treatment policies and practices in the 1970s: UKHCDO meetings

As set out earlier in this Report,[730] the 1970s saw a gradual shift from the almost exclusive use of cryoprecipitate, largely in hospitals, to the extensive use of factor concentrates for the treatment of Haemophilia A, both in hospitals and in home treatment.[731] The next part of this chapter examines this development, firstly by reference to the discussions which took place within UKHCDO and secondly by consideration of the treatment policies and practices of the reference centres and some of the larger haemophilia centres.

Home treatment and prophylaxis

Home treatment was discussed by the haemophilia centre directors at their meeting on 27 October 1972.[732] It was still at a very early stage, but had been commenced in some centres: Oxford was using concentrate for this purpose, whilst the Royal Free used cryoprecipitate.

Over the following years home treatment programmes became more widespread. There appears still to have been some ambivalence and uncertainty about home treatment by the time of the first meeting of reference centre directors in February 1976, the minutes of which recorded that Professor Ilsley Ingram:

“said that he had taken advice from the Medical Defence Union about home therapy and the ruling was that if a policy taken by a doctor (e.g. to institute home therapy) were one which he honestly thought to be best for his patient then the Medical Defence Union would defend him. Another organisation thought that the patient introduced to home therapy should have the risks and advantages of home therapy carefully explained to him.”[733]

Home treatment continued to be the subject of discussion from time to time amongst the haemophilia centre directors and reference centre directors. A joint meeting of haemophilia centre directors and blood transfusion directors in January 1974 “stressed that home therapy was becoming more accepted and widespread and was improving patients’ lives.” The minutes record that some directors were buying commercial concentrates for use in home therapy.[734]

At the September 1975 annual meeting of haemophilia centre directors, it was reported that a study of home therapy in patients with haemophilia was being organised at St Thomas’ and the Oxford Centre, and that, of those centres represented at the meeting, 25 centres were using home therapy, 20 centres were using commercial concentrate for some part of the home therapy programme, and at 2 centres NHS concentrate was used. 12 centres reported using some cryoprecipitate for this purpose.[735]

1977 saw the establishment of UKHCDO’s Home Treatment Working Party, which identified four projects to be undertaken: a study of minimum dosage required for the control of haemorrhage, a study of prophylaxis, a study of employment, and a study of the long-term side-effects of replacement therapy. Replies from a questionnaire that had been sent to haemophilia centres during 1976 showed that there were at that stage some 729 patients on home treatment.[736]

At the reference centre directors’ January 1978 meeting, Dr Katharine Dormandy (director of the Royal Free) explained that she had patients on home treatment with cryoprecipitate and wished to know if the reference centre directors thought such patients should now be treated with commercial concentrate. The minutes record that it “was unanimously agreed that freeze dried concentrates were the material of choice for home treatment and the Reference Centre Directors recommend that all patients on home treatment should have freeze dried concentrates.[737] No discussion about the relative safety of cryoprecipitate versus concentrate, or of the increased risk of viral transmission in consequence of such a change, is apparent in the minutes.

It does not appear that the Royal Free immediately ceased using cryoprecipitate for home treatment. The Haemophilia Centre Handbook, produced by the Royal Free and published (by Immuno) sometime after May 1978, contained an explanation of the arrangements for the collection of supplies of cryoprecipitate for home treatment.[738] The same handbook recorded that “All Haemophilia Centres now teach most of their severely affected patients to treat themselves at home.[739]

A more mixed picture emerges in relation to the provision of treatment on a prophylactic basis.

At the haemophilia centre directors’ first meeting in October 1968 the mood of the meeting was that “at present the treatment of patients with bleeding episodes should have precedence over prophylaxis.” “Experiments in the prophylactic treatment of haemophilic patients” were, however, anticipated.[740] There had been some use of prophylaxis by the time of the April 1971 meeting of haemophilia centre directors, at least in relation to the treatment of Haemophilia B: the conclusion of the meeting was that regular administration of Factor 9 to severely affected Haemophilia B patients was beneficial, regimes of weekly, fortnightly and monthly administration having been tried with success. Prophylactic treatment for Haemophilia A was regarded as more difficult, in part because of the inadequacy of supplies. Some centres were said to be treating a limited number of patients in this way. The minutes recorded that it was felt that a controlled trial of regular weekly treatment for six months and on demand treatment for six months could be useful; Dr Biggs agreed to prepare a draft protocol to test the feasibility of such a trial.[741]

At the October 1972 meeting there was further discussion about a trial: Dr Biggs had had a great deal of trouble preparing a protocol. She concluded that it would be very difficult to organise a prophylactic trial from a haemophilia centre and that Treloar’s might be the only place where it could be done. Dr Biggs had sent her draft protocol to Drs Peter Arblaster, Anthony Aronstam and Seymour Rainsford, and they were planning to organise a trial along the lines of the protocol. Dr Biggs thought it “very important” for a trial to be undertaken, because they really needed to know whether patients were better having prophylactic therapy or just receiving treatment on demand.[742]

The trials that were undertaken are described in the Treloar’s chapter of this Report. In January 1977 Dr Peter Kirk reported to the haemophilia centre directors on the third trial of prophylactic treatment of patients at Treloar’s.[743] Professor James Stewart’s view was that prophylactic treatment should not be entered into until there was sufficient evidence that it was beneficial to patients.[744]

Home therapy figures for 1978 showed that 719 Haemophilia A patients and 87 Haemophilia B patients were on home therapy, and that approximately 77% of those with clinically severe classical haemophilia were now on home treatment in the UK. Cryoprecipitate was still being used but this use was waning. 65 Haemophilia A patients reported receiving prophylaxis in 1978; this was said to be about double the number in 1977.[745]

Supply issues and the growth of concentrate use

Discussions about the availability of Factor 8 concentrates, and concerns about there being insufficient supplies of NHS Factor 8, were a feature of the meetings of the haemophilia centre directors throughout the 1970s.[746] The October 1972 meeting recorded that many directors were pressing for permission to purchase the “good commercial products” manufactured overseas.[747] At a joint meeting of directors of haemophilia centres and blood transfusion directors in January 1974 there was “a wide ranging discussion about the relative merits of cryoprecipitate and freeze dried concentrates with regard to ease of manufacture, recovery from the original plasma, ease of administration and recovery of activity in the patients”. Notably, the discussion did not include relative safety. The minutes recorded the general feeling that “larger supplies of concentrated preparations were required now and urgently” and that none of those present would prefer cryoprecipitate if freeze-dried concentrates were freely available.[748]

The first meeting of reference centre directors in February 1976 discussed difficulties concerning the supply of Factor 8.[749]

Hepatitis

Hepatitis was a constant feature of discussion at UKHCDO meetings in the 1970s. A report tabled for the meeting of haemophilia centre directors in 1971 described transfusion hepatitis as one of the “most alarming complications of treatment of patients with coagulation defects” (the other being inhibitors) and acknowledged that the danger of infection was related to the number of donors used, which “will increase with the use of dried concentrates made from large pools of donors”. The conclusion of the report was, however, “that the increased risk of clinical illness is not so great as to overbalance the advantages of the use of concentrates”.[750] The greater reliability, ease of administration, and economy of manufacture were said to be in favour of concentrated materials.[751]

This was the mindset that prevailed amongst the majority of haemophilia centre directors throughout the 1970s. The increasing awareness of the risks of hepatitis, in particular of non-A non-B Hepatitis (“NANBH”), did not influence the approach to treatment, as it should have done.

As has been described elsewhere in this Report,[752] November 1974 saw Dr Craske of the Public Health Laboratory reporting to the haemophilia centre directors meeting that there had been an “epidemic” of Hepatitis A and Hepatitis B in patients with haemophilia in Bournemouth who had received one particular batch of commercial Factor 8.[753] Dr Rizza reported to the same meeting 11 episodes of hepatitis in Oxford patients since January 1974. Dr Biggs’ recorded contribution to the discussion that ensued included the statement that “it was not yet proved[754] that commercial factor VIII was much more dangerous from the point of view of causing hepatitis than other preparations”; she expressed the hope that commercial concentrate “would not get an unnecessarily bad name” as it was clinically invaluable while the NHS supply was so limited. Dr Craske agreed but felt that a wholly NHS concentrate was likely to be safer when available. He undertook to draw up a plan to study the incidence of various types of hepatitis at different centres and the relationship of infection to the various types of material used.[755]

At the haemophilia centre directors’ meeting the following year, in September 1975, there was, according to the minutes, a “full discussion about the incidence of hepatitis and the problem of anicteric cases.” The significance of pool sizes was recognised, with Professor Ingram observing that “NHS factor VIII was derived from pools of 500-750 donations whereas the commercial factor VIII was often derived from pools of 2,000 to 6,000 litres of plasma and that the probability of including an infected donation was greater with commercial factor VIII.” This meeting was significant also for its recognition that screening would not exclude all infected batches, both because the tests would not pick up all cases of Hepatitis B and because some hepatitis was caused “by viruses not detected by the test”.[756]

Also in September 1975 a symposium took place in Glasgow at which Dr Craske gave a talk entitled Virus hepatitis complicating replacement therapy. Professor Gordon Lowe recalled Dr Craske discussing at the symposium one of the first outbreaks following the early use of concentrate; it was, he thought, the first time he heard about NANBH.[757]

As has been discussed elsewhere in this Report, 8 and 15 December 1975 saw the screening of the World In Action documentary Blood Money.[758] The reference centre directors held their first formal meeting some two months later. Surprisingly the minutes contain no express reference to the documentary or even to hepatitis, and no discussion of the issues and concerns to which that documentary should inevitably have given rise – and so far as many of their more regular patients were concerned, would have done. Instead there was a discussion about taking part in TV programmes which could “distort the facts and present biased views which were embarrassing to doctors and could be alarming to patients”.[759] The subject of participation in such programmes was to be discussed at the meeting of all directors in autumn 1976.[760]

1977 saw the establishment of UKHCDO’s Hepatitis Working Party, under the chairmanship of Dr Craske. Dr Craske prepared a report for its first meeting entitled Hepatitis Associated Commercial Factor VIII 1976, which was a continuation of a study of Hemofil begun in 1974: the 1976 study looked at the incidence of hepatitis after transfusions of Kryobulin in 1976 and compared it with hepatitis caused by Hemofil. The report proposed that such studies continue in order to consider the number of types and incidence of NANBH and the incidence of sequelae after acute hepatitis.[761] Dr Craske recommended in the report that there be a collection of sera, so that retrospective studies could be undertaken should tests for NANBH become available. A discussion took place at the haemophilia centre directors’ meeting in October 1977 about the advisability of liver biopsy in people with haemophilia, with the consensus being that “each case must be considered individually”.[762]

The very establishment of a working party to study “knowledge of transfusion hepatitis in British haemophiliacs and its sequelae[763] (and, indeed, the contemplation of biopsy) reinforces the conclusion that it was, rightly, understood that hepatitis (including NANBH) was something serious, requiring further investigation, rather than, as some clinicians have claimed, something believed at the time to be benign and mild. At the very least it shows that clinicians did not truly know what the consequences were, and that if they thought despite that lack of knowledge that the disease was benign, it was in the words of Dr Brian Colvin “wishful thinking”.[764]

The first meeting of the Hepatitis Working Party took place in December 1977 and opened with discussion of the results of the prospective survey on hepatitis carried out at Edinburgh and Treloar’s. The latter’s results showed a higher proportion of patients treated with concentrates with consistently abnormal liver enzyme tests than in boys treated with cryoprecipitate.[765] Further investigations were planned in Oxford and Edinburgh.[766]

The issue of keeping patients on one type of concentrate for as long as possible was raised by Dr Rizza at the reference centre directors’ meeting in September 1978. Dr Rizza referred to patients being kept on a type of concentrate “which they were used to handling and had found satisfactory” rather than as a risk reduction measure.[767] Analysis of data from the 1977 annual returns was reported as showing “a further increase in the average amount of factor VIII required to treat haemophilic patients”. There was no discussion as to the implications of this in terms of risk. The Hepatitis Working Party wanted to look into the incidence of chronic hepatitis in people with haemophilia “as they felt that the problem might be more widely encountered than was at present realised.” Dr Craske requested haemophilia centre directors to send in details of cases of chronic hepatitis on a new form which the Working Party would draw up and distribute to centres.[768]

The 1978 report of the Hepatitis Working Party explained that the DHSS was providing financial support for the surveillance programme for hepatitis at the Oxford Haemophilia Centre and for a project investigating the incidence of chronic liver disease in patients treated with Hemofil in 1974-75; Dr Susanta Ghosh, a research fellow, had been appointed to run the clinical side of the project. As part of the hepatitis surveillance study there had been, since the original work on hepatitis associated with Hemofil and Kryobulin, a review of cases of hepatitis reported as part of the study since 1974. The report noted that “Apart from the increase in the cases associated with the introduction of commercial concentrates, the incidence of jaundice has remained fairly constant since 1974.[769] Dr Craske’s view at that time was that there was evidence in favour of two types of non-B Hepatitis: “A crucial question yet to be answered is the relative role of each of these agents as a cause of chronic liver disease in haemophiliacs.” In the last few months the Working Party had received reports of patients in several haemophilia centres who were thought to have evidence of chronic liver disease and the Working Party regarded it as important to collect as much information as possible about them. Liver biopsy was a matter for each director to make up their own mind. Dr Craske’s report continued:

“I have recently visited the Department of Medicine at the University of North Carolina at Chapel Hill during a visit to the U.S.A., and had the opportunity to discuss the problem with Dr Roberts and his colleagues. They have carried out almost 100 liver biopsies on patients with chronically elevated serum transaminases in a collaborative survey, and nearly 50% of these have histological changes compatible with cirrhosis, chronic active or chronic persistent hepatitis. These patients have had up to ten years of treatment with freeze dried factor VIII concentrates of different brands. There is controversy as to whether these changes are the sequel to acute viral hepatitis, or are due to some other cause, but Dr Roberts and many other physicians are of the opinion the viral hepatitis is the main factor.”[770]

Dr Craske’s conclusion was that “there remains much work to be done to devise methods to prevent the threat of chronic liver disease clouding the undoubted benefits that large pool concentrates have brought.[771]

When the haemophilia centre directors met again in November 1978, it was reported that the 1976 and 1977 annual returns from haemophilia centres demonstrated that an increasingly large amount of commercial Factor 8 concentrate was being used by centres. In response to a query from Dr Rizza as to whether the DHSS had any views and whether the DHSS was making any progress towards self-sufficiency, Dr Mary Collins on behalf of the DHSS “said that there was no limit on the amount of commercial material which Haemophilia Centres could receive.[772]

Dr Craske’s Hepatitis Working Party report was presented at the scientific session of the directors’ meeting but the minutes do not describe any discussion about its significance.

The fifth meeting of the Hepatitis Working Party in August 1979 considered the results of the studies on “the Oxford Haemophiliacs”. 70 out of 174 patients for whom detailed records of liver function tests were available had persistently abnormal liver function tests, of whom 20 had clinical features of significant chronic liver disease. It was agreed to continue the study and to obtain additional evidence of the relationship of transaminitis and overt chronic liver disease to the mortality in these patients and other factors.[773]

There was little discussion of issues relating to hepatitis at the reference centre directors’ meeting on 15 October 1979. Dr Craske presented a pre-circulated report from the Hepatitis Working Party but the only minuted discussion related to the collection of patient data and the kind of information that should be submitted to the Working Party.[774] When the haemophilia centre directors met the following month, the minutes recorded that “There was much discussion regarding the incidence of chronic hepatitis in haemophilic patients, the possible value of liver biopsies and the type of information which Directors would be willing to give to the Working Party.[775]

The 1979 report of the Hepatitis Working Party explained that the first year of the surveillance programme financed by the DHSS was complete and that the investigation for evidence of chronic liver disease in people with haemophilia undergoing long-term Factor 8 therapy was ongoing at Oxford. There had been an increase in the proportion of NANBH in people with mild haemophilia. “Only 20 ... so far” of the 70 patients with persistent transaminitis had clinical evidence suggestive of chronic liver disease.[776]

At the Hepatitis Working Party’s sixth meeting in February 1980 Dr (later Professor) Howard Thomas and Dr Peter Kernoff (both of the Royal Free) described a prospective study they had carried out on patients receiving concentrate for the first time. Eleven patients were followed for up to four years. All had evidence of chronic hepatitis as judged by persistently abnormal serum transaminases unrelated to Hepatitis B. Most Royal Free patients had received commercial concentrate. Dr Ghosh said similar results at Oxford had been seen in patients receiving mostly NHS concentrate for the first time. It was agreed that more information was needed on the risk to patients of developing chronic NANBH, by prospectively following patients first exposed to concentrate or other products, such as people with mild haemophilia undergoing non-emergency surgery.[777]

The suggestion of an autumn symposium on hepatitis with experts in liver disease emerged from the reference centre directors’ meeting in February 1980. The significance of this symposium is discussed later in this chapter.

Commentary

The evidence is clear that haemophilia clinicians in the 1970s regarded hepatitis as being of huge significance, and knew that it might well have serious long-term consequences, that there was much yet to be learned about it, and that it was a real threat: hence the Working Party, the ongoing studies, and the contemplation of biopsies. At the start of the decade it was seen as one of the most alarming consequences of treatment. By the middle, in 1975, it was recognised that anicteric cases were a real problem, known that there had been an epidemic in Bournemouth, and that the pool sizes from which commercial concentrates were made meant that they were more likely to cause infection. Indeed, the study (of Hemofil on the one hand and Kryobulin on the other) was aimed at seeing which was worse when it came to infectivity.

What is concerning is that while the problem of hepatitis was very real for those patients who became infected with it, no sense of what was happening to them, or the impact the disease was having on them, or might in the future have, is apparent from the minutes. The problem was rather one to be studied, to be kept under surveillance, but not such as to cause any modification of the treatments being given, or even hesitation about pressing on with more of them. Instead, the minutes show the centres marching on inexorably with the ever-increasing use of concentrates, including developing home treatment, which inevitably increased the volume of concentrate used, and to some extent prophylaxis, which used more again.

There is no point at which the minutes suggest that as a group the haemophilia centre directors stopped, reflected, said such as “Perhaps we should not be continuing with ever more product from even larger donor pools of uncertain origin; should we not stop and think about what we might be doing to patients, and offer them alternatives?”

Safety was not the paramount consideration that it should have been.

Treatment policies and practices in the 1970s: the reference centres

In the next part of this chapter, the focus is on the approach to treatment of the reference centres and some of the larger non-reference centres in the 1970s. Associate centres, and the smaller designated haemophilia centres, tended to treat rather fewer patients, who would in any event be registered with a reference centre, and it was usually to the reference centres that the associate centres looked for advice.[778] For that reason product usage in the associate centres is not separately addressed here; however, the position at each and every centre has been considered in the course of formulating the conclusions that appear towards the end of this chapter.[779]

Newcastle

The Newcastle Haemophilia Centre was one of the original centres set up by the MRC in the 1950s. In the early 1970s Dr Peter Jones became its director, succeeding Dr Tom Boon;[780] he was joined in 1978 as co-director by Dr Peter Hamilton.[781] Newcastle was the central reference centre for the Northern Regional Haemophilia Service and Dr Jones considered that “the major part of my responsibility was a regional commitment to the care of children and adults with haemophilia”.[782] Dr Jones’ “Guidelines for the Organisation of a Haemophilia Centre” recorded that “within our geographical region, which has a population of 3.3 million, the home therapy programme is run from the Newcastle Centre and all patients are followed up there by the core team.[783]

Newcastle was an early proponent of home treatment and commercial concentrates were an established part of its treatment practices by or soon after 1973.[784] Dr Jones’ written statement to the Inquiry suggested that cryoprecipitate was the treatment of choice until 1973 “when sufficient factor VIII concentrate became available”.[785] According to a 1974 paper co-authored by Dr Jones and entitled “Optimum Use of Factor VIII Preparations at Present Available in the United Kingdom”, cryoprecipitate was not considered to be suitable for home therapy at Newcastle and Hemofil was used instead for that purpose. Cryoprecipitate would be used for most other purposes: for patients with bleeds, patients undergoing surgery or dental extraction, and patients receiving physiotherapy and mobilisation following bleeds; whilst Hemofil would be used (in addition to home treatment) for the management of severe bleeds when insufficient cryoprecipitate was available, and for patients with antibodies or who had experienced severe reactions to cryoprecipitate or fresh frozen plasma.[786]

Dr Jones’ policy from the 1970s was to treat children under six[787] with “locally produced” cryoprecipitate rather than factor concentrates but from the age of six, depending on their veins and parental expertise, home therapy could be commenced, and this involved factor concentrates.[788] Thus at Newcastle and from the early 1970s onwards children from six upwards were routinely treated with concentrates, including substantial amounts of commercial concentrates. Prophylaxis was also a feature of treatment policy at Newcastle, with, by 1979, “an effect on the average number of factor VIII units per patient per year”,[789] and the Centre’s policy was to encourage both home treatment and prophylaxis.[790]

According to a 1988 letter to the regional medical officer at the Northern Regional Health Authority, which set out statistics on the use of blood products in the region,[791] in 1969, 270,000 units of cryoprecipitate were used and just 280 units of NHS concentrate; in 1973, commercial concentrate was used for the first time (133,000 units compared to 100,000 units of plasma and 917,000 units of cryoprecipitate); by 1975, the use of commercial concentrate had rapidly increased to 972,000 units; and by 1976, a great deal more commercial concentrate (1,649,240 units) was used than cryoprecipitate (676,050 units) and NHS concentrate (82,800 units) put together.[792] The annual returns from 1976 to 1979 show substantial use of a range of different commercial concentrates (as well as the use of NHS concentrate) and the diminishing use of cryoprecipitate over that period.[793]

In his written statements to the Inquiry Dr Jones asserted that clinicians were only reliant on commercial concentrates because there was insufficient NHS product.[794] Whilst the insufficiency of NHS product no doubt played a part in shaping treatment practices at Newcastle, it is clear that commercial concentrates were considered to be preferable for home therapy for reasons including “size of bottle, volume of fluid required for reconstitution, time of reconstitution, viscosity”.[795] It was apparent to Dr Anne Collins, the regional transfusion director at the Newcastle RTC, that there was “a preference at the Haemophilia Centre for commercially produced Factor VIII blood product, for the following reasons: (a) commercial Factor VIII was more easily soluble. (b) Some patients tended to have allergic reactions to NHS produced Factor VIII ... (c) The presentation of commercial Factor VIII was more attractive to the Haemophilia Centre.[796] These factors of convenience were not, however, balanced against the risks of infection as they should have been.

The risks of hepatitis from the use of concentrates (and in particular commercial concentrates) were well known to Dr Jones.[797] For example:

  1. In a June 1975 confidential memorandum entitled The Factor VIII Concentrates and Hepatitis, apparently produced for circulation in the Northern Region, Dr Jones wrote that an association between commercial concentrates and hepatitis had been proven. In Newcastle there had been 16 cases of jaundice over the past 18 months, of whom 15 had received commercial concentrate and 10 had been on home therapy. All had severe haemophilia and had been multi-transfused. The disease had been mild, with only one boy requiring admission to hospital for a week. Dr Jones noted that although Hemofil specifically had been associated with a recent Bournemouth outbreak, all commercial concentrate carried this risk. Following a conference organised by Travenol the previous week, the following recommendations had been made: Factor 8 concentrates to be used only for people with severe haemophilia; and young children and people with mild haemophilia should always receive cryoprecipitate unless there was an overriding clinical reason for concentrate. Dr Jones asked that everyone who used commercial concentrate record full batch details whenever it was used in the region and that he be notified of cases of jaundice.[798]
  2. In October 1977, Dr Jones wrote a paper Development and Problems in the Management of Hemophilia in which he noted that following the introduction of commercial Factor 8 concentrates into the UK there had been “at least three separate outbreaks of hepatitis among hemophilic recipients, both hepatitis B and non-B varieties being implicated. The outbreaks were associated with batches derived from paid donor plasma pools of up to 6000 liters”. He noted that the incidence of hepatitis had declined, “probably” because of increased sensitivity of testing and “the development of an increased resistance to infection in the hemophiliac population.” He went on to state that “While we disagree with the suggestion of Craske et al that commercial concentrates be reserved for the treatment of life-threatening bleeds and to cover major surgery ... it is our practice to restrict young children and mildly affected haemophiliacs to cryoprecipitate therapy.” In addition, he noted that “More worrying than these visible outbreaks of infection, which were expected because of the large donor pools needed for source material, are the possible long-term effects of frequent transfusion therapy with lyophilised concentrates. Several viruses may be involved in posttransfusion hepatitis among them cytomegalovirus and probably other as yet unidentified hepatitis viruses.[799]
  3. The publication Haemophilia Management in 1979 authored by Dr Jones noted when addressing therapeutic agents that “all concentrates prepared from large donor pools carry a greater risk of serum hepatitis and possibly other disease transmission than cryoprecipitate. They should therefore be reserved for the treatment of severe haemophilia A in older children and adults.[800]

Yet some of the information which Dr Jones produced for dissemination to people with haemophilia contained more reassuring messages. Following the World in Action documentary screened in December 1975, Dr Jones wrote in the spring 1976 newsletter of the Haemophilia Society Northumbrian Branch that:

“the programmes screened presented a dramatised account of the danger of hepatitis which, by being taken out of context, was both biased and frightening. As you know the interview filmed in Newcastle was totally cut presumably because in it we tried to present the true picture without condemning a lot of hard working and conscientious people who, through both the National Blood Transfusion Service and the commercial companies, are responsible for allowing us to implement the advances in haemophilia care of which you are all aware.”[801]

Dr Jones went on to set out “the facts”, including an explanation of the “theoretical risk of virus transmission”increasing from 3 to 1 in fresh frozen plasma to between 500 to 1 and 3000 to 1 for AHG concentrate, and to state that “Of course the actual risk will be much lower than these figures suggest as only a very small proportion of donors may carry the virus.[802] A further article in the autumn 1980 Haemophilia Society Northern Branch newsletter stated:

“As everybody who receives blood products for treatment knows one of the possible side effects is yellow jaundice (hepatitis) ... As a result [of screening] we hardly ever see hepatitis B now. However, there is no way of measuring non A non B hepatitis and the risk of infection, which is almost always a very mild one, is therefore still present ... These [liver biopsy] tests [at other centres] have shown abnormalities but we do not think that these are as serious as was at first believed and there has been no reported increase in severe liver disorders in patients treated with far higher doses of blood product than we use.”[803]

This might be thought to contrast with, in the same newsletter, the inclusion of the introduction to Dr Jones’ talk at the twelfth Congress of the World Federation of Haemophilia:

“Thanks to his colleagues engaged in research and in blood collection and fractionation the clinician has powerful tools with which to manage a chronic and painful disorder. But at what price? Is quality being bought at the expense of longevity? Is chronic hepatic damage really one of the expected side effects of intensive, multi-donor transfusion, or do we play with fears based on serological and histological findings with little relevance to clinical fact? If we are harming our patients, at what stage and by what means should we recognise this harm, and most important of all, can we treat (if we cannot prevent) liver damage in haemophiliacs? ... It is evident, that although the safeguards imposed since the outbreaks of hepatitis B six years ago were welcome, the dangers of viral disease transmission inherent in intensive transfusion are far from over, and that these dangers are compounded by the use of large plasma pools from commercial sources.”[804]

Dr Jones’ anonymous editorial in The Lancet on 14 July 1979 stated “The substantial improvements in the quality of life ... may be bought at the expense of shorter survival.[805] Writing at a later date, Dr Jones reported that “by the end of the decade [ie the 1970s] we were in no doubt that haemophiliacs exposed to multi donor concentrates were inevitably infected with non A non B hepatitis, and that a substantial proportion of them could go on to develop chronic liver disease.[806] In Newcastle, as in so many other centres, that knowledge of almost inevitable infection with NANBH and risk of chronic liver disease was not shared with patients as it should have been.[807]

Cardiff

The haemophilia centre at Cardiff moved in 1971 from Cardiff Royal Infirmary to University Hospital Wales.[808] Professor Arthur Bloom was the director of the centre from 1966. He played a very significant part in many of the events with which this Report is concerned.[809]

There is limited contemporary information available about Professor Bloom’s approach to treatment in the early 1970s. In a letter to Dr William d’A Maycock in late 1972 he described the local supply of cryoprecipitate as “quite good” but in anticipation of BPL producing a higher potency concentrate, he explained to Dr Maycock that he would “optimally like to use freeze-dried concentrate if available.[810] At a meeting of haemophilia centre directors and regional transfusion directors in October 1976 he was recorded as stating that Cardiff used cryoprecipitate for ordinary bleeds, such as into joints, but that they needed freeze-dried material for the treatment of inhibitors and home treatment.[811]

A 31 August 1978 file note by David Williams of Speywood Laboratories Ltd, which described a recent meeting with Professor Bloom, recorded that, until recently, Factor 8 purchases at Cardiff had been split three ways between Hemofil, Factorate and “Elstree”.[812] Professor Bloom had stopped using Armour product “following the hepatitis problem”and no longer bought Immuno because of its high price. David Williams was reasonably confident of getting Cardiff’s business, noting that “Bloom always likes to keep two suppliers, but is reluctant to make frequent changes.[813]

The annual return for 1976 shows, for the treatment of Haemophilia A, the use of substantial quantities of cryoprecipitate, but a very modest amount of NHS concentrate. Significant amounts of Kryobulin and Hemofil were also in use, together with comparatively small amounts of Factorate, Profilate and Koate.[814] A home treatment programme had been established by this time. The 1977 return shows cryoprecipitate still being extensively used; over double the amount of commercial concentrate (primarily Hemofil) than NHS concentrate was used.[815] Individual patient records provided with the return show no consistent attempt to keep patients on one type of concentrate only. 1978 saw continued substantial use of cryoprecipitate but again over double the amount of commercial concentrates were used than NHS, with Factorate being the largest in volume, although substantial quantities of Koate and Hemofil were also used. The individual records again show some patients receiving multiple concentrates.[816] The annual returns for 1979 continue to show significant quantities of cryoprecipitate in use but over a million units of commercial concentrate compared with 328,538 units of NHS concentrate.[817]

On 10 February 1975 Professor Bloom wrote to another clinician regarding a patient with haemophilia who had “been selected for home treatment” with Factor 8 concentrate, stating that the “risks from the use of this preparation, especially allergic reactions and hepatitis have been explained.” He expanded upon the hepatitis risks as follows: “A small percentage of these freeze dried preparations contain, unavoidably, the virus of serum hepatitis and therefore potentially dangerous to the patient, his relatives etc.[818]

Professor Ludlam, who worked as a senior registrar in Cardiff from 1975 to 1979, recalled Professor Bloom talking to him on a number of occasions about the “very important event” that was the Bournemouth hepatitis outbreak of 1974 and suggested that the Cardiff director was “cautious” about US concentrates.[819] Dr Saad Al-Ismail, who worked at Cardiff before taking up a consultant haematologist post in Swansea, recalled Professor Bloom’s advice on NANBH as being that for “the vast majority of patients” it was “probably not going to be a big issue.[820]

In the course of the HIV Haemophilia Litigation Professor Bloom prepared a report for some of the defendants. The report does not detail his own approach to treatment at Cardiff but insofar as hepatitis was concerned, he wrote that it “has always been appreciated by doctors who cared for patients” that most patients with haemophilia were infected with both Hepatitis B and NANBH, but that “patients did not, in the main, seem to suffer from clinical liver disease and mortality from this cause during the 1970’s was low.[821] By 1980 “most haemophilia specialists recognised the risk of hepatitis in haemophiliacs after treatment with concentrates and the fact that biopsy changes could occur.” The impact of this recognition on treatment practice was, however, marginal: “The general recommendation however was that bleeding was still the main cause of morbidity and mortality and that treatment with concentrates should continue except perhaps that treatment with cryoprecipitate may have been more circumspect in general in young children and that DDAVP should be used, within its constraints, in mildly affected patients with haemophilia A”.[822]

Given the terms in which Professor Bloom expressed himself in this report, it is reasonable to assume that in treating patients at Cardiff in the 1970s he was content to use concentrates (including large amounts of different commercial concentrates) notwithstanding the risk of transmission of hepatitis. That assumption is reinforced by comments on an individual statement of claim in the HIV Haemophilia Litigation made by Professor Bloom in September 1991:

“The existence of the viruses causing serum hepatitis was well known to doctors caring for haemophiliacs during the 1960’s, 1970’s and later. It was appreciated in the early 1970’s that concentrates made from pooled plasma carried a greater risk of hepatitis than blood products made from single donors. It was also thought that products made from commercial paid donors could present a greater risk of hepatitis than products made from UK domestic voluntary donors although this assumption later proved to be incorrect. However, tests for screening for hepatitis B improved and commercial firms improved their rules of donor selection in the mid 1970’s. Close monitoring of jaundice and deaths from hepatitis carried out by the UK Haemophilia Centre Directors ... indicated a low incidence of jaundice in haemophilia and few, if any, deaths from hepatitis. Even when the occurrence of chronic non A non B hepatitis was recognised in haemophilia in the late 1970’s and early 1980’s there was published evidence from reputable physicians that it was considered to be a benign non-progressive disorder. It was not until the mid 1980’s that the potentially serious nature of chronic hepatitis in haemophilia was fully recognised”.[823]

Manchester

The reference centre at the Manchester Royal Infirmary was part of a regional haemophilia service in North West England, which included Manchester Children’s Hospital and the Lancaster Haemophilia Centre.[824] Dr Irvine Delamore was its director throughout the 1970s and was joined by Dr Richard Wensley in 1974. Somewhat unusually Dr Wensley worked in both haemophilia care and transfusion, being a joint appointment between the regional transfusion centre in Manchester and the Manchester Royal Infirmary. One of the aims of the appointment was a better understanding with the RTC and “a greater availability of cryoprecipitate and better treatment for all haemophiliacs.[825]

A January 1970 article from the Manchester Evening News described what were said to be recent improvements in the lives of those with haemophilia and in particular Manchester Royal Infirmary’s role: “today with modern methods of treatment and patient assessment, much of which has been pioneered over the past 20 years at the Manchester Royal Infirmary, haemophiliacs are for the most part able to lead a near-normal, albeit hazardous, life. Their great salvation comes in small plastic bags containing what is known as the cryoprecipitate.[826]

As at December 1972, Dr Delamore, completing a questionnaire for Dr Maycock on treatment preferences, and treating around 200 patients regularly, preferred to administer cryoprecipitate but observed that if freeze-dried concentrate could be altered to be dissolved more easily and in smaller volume, “we would probably choose that preparation in preference to cryoprecipitate.” He also noted that concentrates were “much more suitable for home treatment, which the Centre hoped to institute in selected cases.[827]

Manchester was slower than some other large centres to institute home treatment and appears to have used cryoprecipitate for home treatment at least until 1978.[828] Dr Douglas Lee, who was the director of the Lancaster Haemophilia Centre from 1977 to 1989, recalled that Dr Wensley was a “powerful advocate of cryoprecipitate”whose “thoughts were that yields of cryoprecipitate over those of concentrate are roughly 70% compared to 20%, and the risks of transfused virus are certainly less.” Dr Wensley “would advise this constantly at haemophilia directors’ meetings, and I remember that he was very much alone on this point at one time.[829]

The annual return for 1976 shows substantial use of cryoprecipitate, NHS concentrate and Kryobulin, with some use of Hemofil. Both FEIBA and porcine Factor 8 were also used.[830] 1977 saw an increase in the volume of NHS concentrate used, but a greater volume of commercial as well. Cryoprecipitate was still in substantial use but the volume had decreased since the previous year.[831] In 1978, NHS concentrate was used in greatest measure, but significant quantities of commercial concentrates and cryoprecipitate were also used.[832] A similar pattern appeared in 1979, with NHS concentrate used in greatest measure, but with large quantities of commercial concentrates and cryoprecipitate all used as well.[833]

A note of a November 1978 meeting between David Williams of Speywood and Dr Wensley records the latter suggesting that the NHS concentrate now compared well with commercial and that he was gradually changing his home treatment patients from commercial to NHS concentrate, with the plan that commercial concentrate would then be used only in operations.[834]

Writing in 1986 Dr Harold Gunson explained that Dr Wensley’s job when appointed in 1974 was “to treat patients with haemophilia at the Manchester Royal Infirmary and to be responsible for the production of cryoprecipitate which was at that time the product of choice for the treatment of these patients.” Dr Gunson said that Dr Wensley “worked very hard and devised a semi-automated method for producing high quality cryoprecipitate from which the patients in the region derived considerable benefit.” However, since 1980 there had been a decline in the use of cryoprecipitate in favour of Factor 8 concentrate.[835]

It would appear that certainly by 1978 the transmission of hepatitis was a matter of concern to Dr Delamore. Having been asked to identify three topics he considered most worthy of study by UKHCDO working parties, he identified the incidence of hepatitis in haemophilia as being the highest priority in a March 1977 letter to Dr Rizza,[836] and at the November 1978 “Haemophilia Today”seminar, held at Manchester Royal Infirmary, Dr Delamore was recorded as noting that: “a very high percentage of patients being treated for haemophilia and Christmas disease are proving after all to be infected by one type of hepatitis or another. A great deal more work in assessing the severity of hepatitis needs to be undertaken, possibly to develop an immunisation against hepatitis or in developing ways of making blood products safer.[837]

Conversely, however, Dr Delamore and Dr Wensley were both contributors to the 1983 article “Liver disease in haemophiliacs: an overstated problem?” 12 multi-transfused patients with haemophilia were biopsied and described in that paper, which reported that “only” 1 showed evidence of progression to active cirrhosis, although a further 4 patients showed some evidence of mild chronic active hepatitis. The study was acknowledged to be small but said to represent “a much lower incidence of severe histological liver damage than many previous reports.[838]

St Thomas’ Hospital

The haemophilia centre at St Thomas’ Hospital was under the directorship of Professor Ingram until 1979, when he was succeeded by Dr (later Professor) Geoffrey Savidge.[839] Professor Ingram was an early advocate of home treatment, writing to Dr Maycock in 1972 that he was “pressing on with training as many severe haemophiliacs as possible to give themselves their own treatment.[840] In 1974 he wrote a letter to the editor of The Lancet in support of Dr Biggs’ request for a realistic supply in terms which suggested that St Thomas’ was using commercial concentrates: “We know that treatment material is being provided within the Health Service in increasing amounts, but it is still far short of what we need. Until the N.H.S. provision is adequate, it is cruel not to make good the shortfall from the large supplies of good commercial material which, as Dr Biggs says, are now available.[841] By 1976 St Thomas’ was “well in our stride with the Home Treatment Study, and have taken in as many patients as the supplies of factor VIII concentrate allow.[842]

On 9 February 1978 Professor Ingram, in correspondence to Dr Maycock, set out the shortfalls that the region (for which St Thomas’ was the reference centre) was continuing to experience:

“Since we already distribute nearly all our monthly allocation from the BPL, it looks as though more and more commercial material will have to be bought to satisfy our demands for home treatment alone, let alone our needs for surgery and patients with antibodies. In fact, our own monthly allocation is only sufficient for 75% of our Home Treatment needs at this Centre as it is. We are of course also using considerable quantities of commercial material for surgical cover ... Can anything further be done to increase NHS production?”[843]

At the reference centre directors’ meeting in September 1980, Dr (later Professor) Geoffrey Savidge asked what the policy of the haemophilia reference centre directors was regarding the use of cryoprecipitate, both for treatment generally and for home therapy. Professor Bloom, responding, said that it was “a matter for the individual Directors to decide”, but then referred to the 1978 reference centre directors’ meeting at which they had agreed that Factor 8 concentrates were preferred for home therapy.[844]

In his oral evidence to the Archer Inquiry, Professor Savidge, when asked about the timescales about knowledge of NANBH, described two schools of thought:

“One school of thought was: this causes problems, and it was backed up by a lot of tissue work biopsies, liver biopsies, which showed progressive liver disease, and then you had another group of individuals, who are quite happy to say that, you know: we just measure it with blood tests and the blood tests stay the same, so we just think it is a little bit of inflammation of blood tests from the liver. So-­called transaminitis, which has no clinical connotation and which is merely a figment of a few people’s imagination. So, by the time the histology data started coming through and by the time children started developing cirrhosis of the liver, perhaps it was a little bit more than inflammation of blood tests.

So I think the majority of responsible physicians and people treating these patients knew by the end of the 70s -- in fact pretty closely about 78 I think tipped it -- that large donor pool concentrates, whether it be for Factor 8 or Factor 9 were the cause of non-A/non-B hepatitis. Nobody knew what the agent was but they assumed it was an infective disorder; it came from an infection. And as time moved on, it became proven that was the case.” [845]

In his written statement to the Archer Inquiry, Professor Savidge gave his perspective on the broad nature of haemophilia treatment in the 1970s and 1980s:

“extra money when found was spent on the purchase of commercial imported factor VIII concentrate, usually from the US, in preference to the safer cryoprecipitate that was the recommend [sic] treatment of children and mild haemophilia patients (assuming failure with DDAVP) generally available (in some regions in excess). The US commercial concentrate was considered to be more user friendly, it could be stored at room temperature and was eminently more suitable for patients on home care programmes.”[846]

There is no reason to think that this description did not encompass treatment practice at St Thomas’. Whilst the annual returns for 1976 and 1977 show NHS Factor 8 concentrate and cryoprecipitate as the most used products,[847] a different picture emerges from both the 1978[848] and the 1979 return:[849] commercial concentrates were then the products most in use.

The Royal Free Hospital

The Haemophilia Centre at the Royal Free Hospital was the largest in London. Its director from 1968 to 1978 was Dr Dormandy. Dr Kernoff and Dr (later Professor) Tuddenham were co-directors between 1978 and 1986.[850]

The Royal Free began to use commercial concentrates in 1973.[851] Its annual return for 1976 indicates that at that stage Haemophilia A patients were treated primarily with cryoprecipitate, followed by commercial concentrate and then NHS.[852] The pattern was similar in 1977.[853]

In January 1978 Dr Dormandy described in a letter to Dr Richard Lane the Royal Free’s treatment policy in relation to NHS concentrate: “It is our policy to use NHS-concentrate for patients on home treatment and for those who are allergic to cryoprecipitate. This material is used for the treatment of patients who attend hospital with uncomplicated bleeds and for minor operations, and commercial factor VIII for major operations, some inhibitor patients and a backlog of patients on home treatment.[854]

In May 1978 Dr Dormandy died. She had been known as an early and keen advocate of cryoprecipitate for home treatment.[855]

The annual return for 1978 shows that over the course of that year, for the first time, more units of commercial concentrates were used than cryoprecipitate.[856] In 1979 the volume of commercial concentrates was almost double that of NHS Factor 8 and cryoprecipitate.[857] As described in Professor Christine Lee’s evidence to the Lindsay Tribunal, Drs Kernoff and Tuddenham “came in in 1978 and very rapidly changed everybody to concentrate.[858]

This was a conscious decision; as recorded at a meeting on 1 September 1978 “it was the intention to switch home treatment patients from cryoprecipitate to concentrate. Half the home treatment patients at the Royal Free were still using cryoprecipitate and this was felt to be an unacceptable state of affairs. If NHS concentrate was not available then commercial concentrate would have to be bought.[859] Professor Tuddenham, in his evidence to the Inquiry, explained that concentrates had practical advantages and that they were more reliable in elevating the factor level in cases of head injury or life-threatening bleeding; he acknowledged in hindsight that the relative risks were not sufficiently appreciated.[860] The switch to concentrates encompassed those with moderate haemophilia, and patients with mild haemophilia may well have been given concentrates as well.[861] Children were prioritised for NHS concentrate.[862]

This was at a time when Dr Kernoff was well aware of the risks from commercial concentrates. Writing in April 1979 in his capacity as chairman of the Haemophilia Working Party of the North East Thames Region Association of Haematologists, he recorded the “growing awareness of the probability that commercial concentrates have a higher risk of transmitting non-A non-B hepatitis than NHS material”, NANBH being a “serious disease with long-term consequences” and therefore there were“both clinical and moral reasons for preferring the NHS material”. He suggested that cryoprecipitate, although relatively cheap to produce, had “serious clinical disadvantages”and that the shortfall in NHS concentrates “has to be met by buying commercial concentrate.[863]

The NANBH risks associated with Factor 8 concentrates were the subject of discussion at the Haemophilia Working Party’s meeting on 4 April 1979, at which Dr Kernoff reported “the increased recognition of Non A/Non B Hepatitis as a risk of Factor VIII concentrates”. There was no discussion about any change of approach to treatment, nor about the provision of information to patients. Instead what was agreed was regular testing for Hepatitis B and liver function tests, and the storage of sera for a retrospective study for NANBH.[864]

At an August 1979 meeting of the Haemophilia Working Party, Dr Kernoff reported on his and Dr Colvin’s “recent experience of post-treatment hepatitis”. It was agreed that all registered haemophiliacs on regular treatment should be fully screened for hepatitis at their regular three-month visits to the major haemophilia centres.[865] That Dr Kernoff was not a fan of cryoprecipitate was clear: he was recorded as stating in relation to the Royal Free that “25% of all Factor VIII used was in the form of cryoprecipitate which was far from satisfactory.[866]

DDAVP was not in use at the Royal Free until some time after 1980.[867] However, between 1981 and 1985 usage increased substantially.[868]

Professor Lee, who did not at this time work at the Royal Free, expressed the firm view that the Royal Free’s haemophilia centre directors could not be criticised for the complete change from cryoprecipitate to concentrate.[869] I disagree. Though she deferred to Professor Tuddenham on the reasons for the change, I consider she was right nonetheless to identify them as “probably the convenience and the efficiency.[870] These reasons persuaded them to change despite the fact, as Professor Lee understood it, that the previous director, Dr Dormandy, had been particularly keen on the use of cryoprecipitate because of a study she had done with US counterparts who had treated exclusively with the new concentrates. It had shown her that they suffered raised transaminases more commonly than her own patients who were treated with cryoprecipitate.[871] The change was despite the fact that Dr Kernoff knew that NANBH was a serious disease with significant long-term consequences, and had made a point of this to other clinicians.[872] It was despite the fact that at the time he believed (as had Dr Dormandy) that factor concentrates exposed recipients to a greater risk of infection because of the large sizes of the pools from which they were made.[873] Professor Tuddenham recognised in his evidence that it was known there was risk, but volunteered that “the extent to which that was a risk in numerical terms wasn’t sufficiently appreciated, in hindsight.[874] I agree with this, save for the reference to hindsight, since the risks were there to be, and were, seen at the time, and patient safety should have required a more cautious approach. After all, Dr Craske had finished his recent report on the hepatitis outbreak in Bournemouth by suggesting that “Commercial factor VIII concentrates should be reserved for the treatment of life-threatening bleeds in all haemophiliacs and for covering major operations.[875]

Oxford

The Oxford Reference Centre became the largest haemophilia centre in the country, treating both adults and children. A large proportion of patients came from outside the area for treatment. The Centre built on earlier work conducted at the Blood Coagulation Research Unit at the Churchill Hospital under the leadership of Dr Gwyn Macfarlane. Dr Biggs served as director until 1977 when she was succeeded by Dr Rizza.[876]

Due in part to its co-location with the Plasma Fractionation Laboratory (“PFL”), the Centre made the switch from cryoprecipitate to factor concentrates relatively early. In a 1977 article, Dr Biggs wrote that:

“It will be seen that at Centres other than Oxford the amount of cryoprecipitate used has increased steadily over the years ... This increase has been due to the efforts made by Regional Transfusion Centres. In 1974 cryoprecipitate still accounted for nearly 80% of all material used (at Centres other than Oxford). By contrast, at the Oxford Centre cryoprecipitate has never constituted more than 43% of material used and since 1971 the proportion of cryoprecipitate has fallen steadily ... In Oxford, plasma previously used to make cryoprecipitate is now fractionated to make NHS concentrate. The amount of NHS concentrate used in Oxford reflects close proximity and the good co-operation between the Oxford Regional Transfusion Service and the Plasma Fractionation Laboratory which has enabled plasma to be fractionated to make all valuable components rather than used for cryoprecipitate and red cells alone.”[877]

During the period 1969 to 1974, the use of cryoprecipitate at the Centre dropped from 21.99% to 3.86% of total Factor 8 material used, while the use of NHS concentrate rose from 45.93% to 60.89% of the total. Commercial Factor 8 was introduced in 1973, when it made up 17.74% of product used, rising to 35.25% the following year.[878]

By 1976, 42.6% of the material used at the Centre was NHS Factor 8 concentrate, just 1.54% was cryoprecipitate, and the rest was commercial concentrate produced by Hyland Laboratories and Immuno Ltd.[879]

In July 1977 Dr Rizza wrote that there had been since April 1977 a greatly increased supply of plasma to the PFL and the Centre was now beginning to receive nearly twice as much locally made NHS Factor 8 compared to the previous year. As a consequence the Centre was able to transfer several patients from commercial to NHS concentrate. This was described as a “bright light on the horizon”.[880]

Dr James Matthews, who worked alongside Dr Rizza, recollected at a later (1998) Wellcome Institute seminar that home treatment was not introduced for some time.[881] However, it appears that home treatment had commenced in 1971 for a very small number of patients. By 1975 there were 54 patients on home therapy (representing about 25% of Haemophilia A patients).[882]

The use of commercial concentrates was well established at the Centre, with Dr Rizza giving a colleague at another hospital an order of preference for Hemofil, followed by Factorate, and then Kryobulin. The Centre had also used Profilate and Koate: Dr Rizza said “we find them all equally effective clinically ... we tend to use Hemofil”.[883]

The 1977 annual return recorded no use of cryoprecipitate at all and greater use of commercial concentrates than NHS.[884] The overall figures for 1978 are unclear.[885] The 1979 return recorded figures for home therapy: no cryoprecipitate; a small amount of Elstree Factor 8; 1,078,110 units of Oxford Factor 8; and 906,830 units of commercial (Factorate, Koate, Hemofil).[886] NHS Factor 8 was (according to Dr Rizza writing in 1984) always in very short supply and reserved “as far as possible” for young children and adolescents: “Ultimately most severely affected patients are changed from NHS to commercial factor VIII especially those who use larger amounts of factor VIII.[887]

Like Professor Bloom, Dr Rizza produced a report for the HIV Haemophilia Litigation. This suggested that during the first half of the 1970s “hepatitis was probably not perceived as a long term problem in haemophiliacs” but that more detailed follow-up of people with haemophilia during the late 1970s showed that a significant number who were clinically well had persistently abnormal tests of liver function and that liver biopsy studies revealed a significant number with abnormal liver histology consistent with chronic liver disease.[888]

Edinburgh

Belfast, Edinburgh and Glasgow were not formally recognised as reference centres in the 1970s but were large and important centres.

The haemophilia centre in Edinburgh Royal Infirmary served a large geographical area, encompassing patients in the south of Fife, Kirkcaldy, Dunfermline and most of the Borders.[889] It received NHS concentrates directly from the Protein Fractionation Centre (“PFC”) in Liberton via the hospital blood bank. Cryoprecipitate was received from the blood transfusion centre in Edinburgh. In the course of the 1970s cryoprecipitate was the preferred treatment of Dr Howard Davies, the then director, with no commercial concentrates being used.[890]

Dr Davies’ preference for locally sourced materials centred on the risks associated with hepatitis viruses as well as a reluctance to introduce novel viruses to the local population.[891]

The annual returns from 1976 to 1979 confirm no use of commercial concentrates. In each of the years 1976, 1977, 1978 and 1979 the principal product used was cryoprecipitate.[892] No commercial concentrates were recorded, even for the treatment of inhibitors. As discussed later in this chapter, the position changed in 1980, following Dr (later Professor) Ludlam’s arrival in place of Dr Davies, when the volume of NHS concentrates used exceeded the volume of cryoprecipitate for the first time, and a (relatively) small amount of commercial concentrate (Factorate) was purchased, which was used for both inhibitor and non-inhibitor patients.[893] Perhaps the most striking feature of the 1980 return is the overall volume of products used in comparison with previous years, for a broadly similar number of patients.

Glasgow Royal Infirmary

In the 1970s the directors of the haemophilia centre in Glasgow Royal Infirmary were Dr (later Professor) Charles Forbes and Dr Colin Prentice. It served effectively as the reference centre for the whole of the West of Scotland (although was not formally designated as a reference centre until 1980/1981). Although it was an adult centre, with children treated at the Royal Hospital for Sick Children in Glasgow, children might transfer from the latter at around the age of 12 or 13 but it was, according to Professor Gordon Lowe (who succeeded Dr Forbes as director in 1988, with Dr George McDonald as his co-director), very much up to the director at the children’s hospital to decide.[894]

Commercial concentrates were in use in Glasgow in 1974 and 1975, although cryoprecipitate was the predominant product in both years.[895] In 1976, according to the annual return, the use of concentrates (more NHS than commercial, although Profilate, Factorate, Koate and Hemofil were all used) exceeded the use of cryoprecipitate;[896] the picture was similar in 1977[897] and 1978.[898] 1979 saw a reduction in the use of cryoprecipitate and an increase in the use of concentrates, both NHS and (in particular) commercial.[899]

According to Professor Forbes’ evidence to the Penrose Inquiry, he did not see the World In Action programme in December 1975 but “It was the talk of the haemophilia part of the hospital. Very much so.” He described a “gasp of disbelief when they showed the types of donors that were being used to give plasma in commercial centres, adding that he thought “that was the dominant thing in the discussions at that time.[900] However, he later suggested that “at the end of the day the risk of dying of bleeding was always much greater and that was what drove all of us to use these products despite the possible downside.[901] Asked about Dr John Cash’s 24 January 1976 letter to The British Medical Journal (in which he observed that “the import into the United Kingdom of Factor VIII concentrates derived from external sources, however well screened for hepatitis viruses, represents an unequivocal pathway by which the level of a potentially lethal virus into the whole community is being deliberately increased”), Dr Forbes indicated that he would not agree with the words “deliberately increased”, but did agree that undoubtedly the importation of concentrates was “bringing with it a potentially lethal virus into the whole community.[902] Discussing home treatment, of which he was a strong advocate, and the increased numbers on home treatment by around 1978, Dr Forbes described this as “the golden age, in which we actually seemed to be doing something valuable for these patients”, and “before all the horrendous complications came on stream.[903] By 1979, the issue of chronic hepatitis “dominated everyone’s lives.[904]

Belfast

The Belfast Haemophilia Centre was established in 1958 but until 1981 it was included in the Oxford supra-region.[905] In 1980/1981 the Centre, which was based at the Royal Victoria Hospital (“RVI”), was designated as a reference centre.[906] It was the only centre in Northern Ireland and served patients drawn from all over the region. Dr Elizabeth Mayne became a consultant haematologist at the RVI in 1972 and director of the Centre from 1978.[907]

In 1988, Dr Mayne, referring to the history of haemophilia care in Northern Ireland, described patients as being “ecstatic”with the advent of cryoprecipitate which was “revolutionary”.[908] However, in a report prepared for the HIV Haemophilia Litigation in May 1991, she described difficulties in the use of cryoprecipitate: “A major disadvantage was the unpredictability of infused dosage ... A further disadvantage was the necessity of storage of the product within a deep freeze unit. Advantages were efficacy, low donor exposure and simplicity of manufacture.” Dr Mayne suggested that the development of factor concentrates “had an estimated dose content. They enabled accurate calculated doses of Factor VIII to be given in small volume, associated with a decreased chance of clinical side effects. They represented manifest advantages over cryoprecipitate.[909]

Dr Mayne recalled the first use of concentrate in Belfast as being in 1971.[910] Thereafter Hemofil was the commercial concentrate used for the next three years.[911]

In January 1974 Dr Mayne reported to a joint meeting of haemophilia centre directors and regional transfusion directors that Belfast was using material prepared from approximately 10,000 donors.[912]

In the mid 1970s Dr Mayne instituted a home treatment programme using commercial concentrate. Her policy was that all home treatment patients would be treated with Kryobulin and all hospital treatment would be with Hemofil. Children would continue to be treated with cryoprecipitate.[913] She chose Kryobulin because the company was straightforward and their packaging ideal; Hemofil because she had been familiar with it since 1971.[914]

Following a meeting with Dr Mayne in October 1978, David Williams of Speywood wrote that:

“Dr Mayne is not prepared to change her present policy concerning human factor VIII. She uses Hemofil for operations and Immuno for home treatment (22 patients). She realises this is an expensive policy, but feels that treatment changes are something best avoided with Haemophiliacs. She is very concerned about liver enzyme changes, but at least she knows what to expect with products which have been used for some years. There is also loyalty to Hemofil, because Baxter obviously gave her considerable financial help in the early days.”[915]

In early 1979 Dr Mayne placed an order for Koate with David Williams. The home treatment programme was likely to expand and it was likely that “our needs for commercial Factor VIII may expand further due to increasing orthopaedic operations, etc. being carried out on the site.[916]

The 1976 annual return records the use of cryoprecipitate (376,190 units) and commercial concentrates (423,656) (Hemofil and Kryobulin). No NHS concentrate was used.[917] A similar picture emerged in 1977[918] and 1978.[919] The returns do not suggest any formal system of batch dedication existed.

In 1979 the vast bulk of treatment was with commercial concentrates (Hemofil: 557,655 units, Kryobulin: 440,051).[920]

Throughout the 1970s liver function tests were performed on patients at Belfast “because of my apprehension about the adverse effect of prolonged IV treatment”;[921] the tests showed persistent abnormal liver function.[922] Dr Mayne’s various descriptions of her evolving knowledge of NANBH are not entirely consistent. In her sixth statement to the Inquiry she said that between “the late-1970s and the mid-1980s, there was increasing evidence that NANB hepatitis was not as benign as had been thought but could progress from chronic persistent hepatitis to cirrhosis.[923] However, in her 1991 HIV Litigation report it was claimed that the “possible significance of asymptomatic hepatitis became apparent by 1978 ... when structural abnormalities of the liver were described in patients”(citing the paper by Spero et al in the New England Journal of Medicine).[924] In another litigation report she suggested that “the risk that non-A non-B hepatitis could progress to chronic hepatitis was known in 1977 but the full significance of its effects was not appreciated, elaborated and investigated until the mid- to late-1980s .[925]

Sheffield (Royal Hallamshire)

The haemophilia centre at Sheffield was first based at the Royal Infirmary before moving to Royal Hallamshire Hospital. It was a reference centre but not one of the larger reference centres.[926] Its first director was Professor Eddie Blackburn.[927] He was succeeded in 1981 by Dr (later Professor) Eric Preston.

At Sheffield there was a particular focus upon hepatitis and liver disease. Significant research into hepatitis was undertaken there and Dr Preston was part of the UKHCDO’s Hepatitis Working Party for many years. Unusually for a haemophilia centre at that time Dr Preston worked closely with a hepatologist, Dr David Triger, as well as a consultant histopathologist with a special interest in liver disease, Dr James Underwood.[928] The importance of the study reported in The Lancet in 1978 has been discussed elsewhere in this Report[929] but Dr Preston told the Lindsay Tribunal that the broad spectrum of chronic liver disease which it revealed “surprised us and concerned us.[930] The results of a collaborative survey between Sheffield and the Royal Free were presented to the Hepatitis Working Party in December 1980 and showed that approximately one third of the patients studied had the appearance of chronic active (aggressive) hepatitis.[931] A letter to The Lancet in 1982 reported that “we have previously shown that there is a high incidence of chronic liver disease among patients receiving blood product concentrates even in the absence of any symptoms” and described a further case in which significant progression of liver disease was shown over two and a half years in the absence of any symptoms.[932]

The annual return for 1976 showed the centre treating its patients with cryoprecipitate, NHS Factor 8 and commercial concentrates.[933] 1977 saw increased use of concentrates (both NHS and commercial) but a substantially reduced use of cryoprecipitate.[934] In 1979 the centre’s return recorded no cryoprecipitate use at all for people with Haemophilia A.[935] In 1980 a small amount of cryoprecipitate was used, but the mainstay of treatment was commercial concentrate (with some NHS concentrate).[936]

The limited use that was made of cryoprecipitate may reflect Professor Preston’s view (as expressed in his statement to the Inquiry) that cryoprecipitate was “not an option for the treatment of sever [sic] haemophiliacs.[937] Professor Preston also indicated that whilst the hepatitis risk from commercial products was substantially greater than from NHS products, “there were insufficient NHS products for the treatment of Royal Hallamshire Hospital patients.[938] His policy was to treat people with mild haemophilia with DDAVP as soon as it became available.[939]

Two aspects of Professor Preston’s approach were: to purchase a number of different commercial concentrates (this was described as “not putting all the eggs in one basket in case something happened with the supply chain and so a number of different products would be used rather than just one product”) but to “keep individual patients on the same concentrate, and the same ‘batch’ for as long as possible to minimise exposure to different blood donations.[940] According to Professor Preston’s evidence both to the Lindsay Tribunal and to this Inquiry, the amount of Factor 8 (and Factor 9) given to patients was very much less than the majority of other reference centres, although he did not think this reflected a deliberate decision to take a conservative approach.[941]

Non-reference centres

Birmingham

Birmingham was not a reference centre but it was one of the largest centres in the country. Haemophilia care was split between the Children’s Hospital and the Queen Elizabeth Hospital (“QEH”) and they were jointly designated as a haemophilia centre in the 1970s.[942] In 1976 Dr (later Professor) Frank Hill succeeded Dr Jillian Mann as director at the Children’s Hospital; Dr (later Professor) John Stuart was director at QEH until 1983 when he was succeeded by Dr (later Professor) Ian Franklin.[943]

By 1974 a home treatment programme had begun.

The West Midlands Regional Health Authority Working Party on the Treatment of Haemophiliacs met regularly throughout the 1970s to discuss issues relating to supply.[944] At a meeting of the Working Party in December 1975 difficulties in producing sufficient plasma were recorded and it was agreed that commercial Factor 8 (Kryobulin) would need to be purchased at an annual cost to the region of £350,000.[945] A meeting of the Working Party in May 1977 noted that the demand for cryoprecipitate was going down and that NHS concentrates were not being used at the rate that had been predicted.[946]

The 1976 return for QEH showed cryoprecipitate, NHS concentrate, Factorate and Kryobulin all being used in substantial quantities.[947] At a Working Party meeting in November 1977 Dr Stuart stated that during 1976 QEH had used 500,000 units of commercial Factor 8 for home treatment, with all the NHS product having been used for treatment in hospital and for dental cases. He stated that his preference was to have all his Factor 8 from the same source (ie either NHS or commercial), and that he was minded to discontinue cryoprecipitate as a home treatment and use NHS product instead.[948] During 1977 QEH used significant amounts of commercial Factor 8 (almost double the amount from the previous year) as well as NHS Factor 8 (at a similar level to the previous year).[949]

During 1978 little cryoprecipitate was used and the NHS and commercial Factor 8 levels broadly remained similar to the year before.[950] In 1979 almost no cryoprecipitate was used and the amount of commercial concentrate (Factorate and Hemofil) was well over double the amount of NHS concentrate.[951]

Whilst Professor Hill told the Inquiry that he believed in the late 1970s that non-A non-B Hepatitis was a minor self limiting condition with no serious long-term consequences[952] (an assessment which, if actually held, was wrong for the reasons described elsewhere in this Report), it appears from the minutes of the November 1976 Working Party meeting that both Dr Hill and Dr Stuart were concerned about the risks of hepatitis: referring to “the hepatitis risk in respect of freeze dried Factor VIII concentrate obtained from commercial sources”, Dr Hill asked whether it might be advantageous to reserve the NHS Factor 8 for children, “leaving the concentrate obtained from commercial sources, largely of foreign origin, for adults”. Dr Stuart agreed with Dr Hill as to the hepatitis risk, and said that “in case of doubt”he would prefer to use cryoprecipitate for children.[953] Following Dr Hill’s attendance at the UKHCDO annual meeting in November 1979, where Dr Craske gave a presentation on the work of the Hepatitis Working Party,[954] he reported back to the December 1979 meeting of the West Midlands Working Party that: “the Hepatitis Working Party had reported that Commercial Factor VIII carried the risk of hepatitis, and he was concerned that some children at the Childrens Hospital had become hepatitis carriers.[955]

Royal London

Dr Brian Colvin was the director of the haemophilia centre at The London (later Royal London) Hospital from 1977. By 1975 he “was aware that there was at least a possibility of chronic liver disease in haemophilia.[956] In relation to NANBH “there was the hope that this wouldn’t be a big problem, and that hope clearly was misplaced ... there was an unjustified but justifiable, if you like, feeling that it would be all right.[957] Dr Craske’s August 1975 paper was very important: “a watershed moment, after which it was known that there was quite a significant problem for the future, at least in terms of numbers ... We didn’t know what was going to happen next but I think we knew that it was going to happen to a lot of people.[958]

Dr Colvin remembered reading the 1978 Sheffield/Preston paper and accepted that this would suggest clinicians could no longer work on the assumption that the absence of overt or acute signs was a reliable indicator that a person would not develop NANBH.[959] Dr Kernoff’s April 1979 letter in which he described NANBH as a “serious disease with long-term consequences” represented Dr Colvin’s understanding by that time.[960]

Dr Colvin attended (as did Dr Kernoff) meetings of the North East Thames Region (“NETR”) Association of Haematologists’ Haemophilia Working Party – a group of consultants from different hospitals who met regularly and discussed a range of issues. In May 1979 Drs Colvin and Kernoff authored guidelines on “the screening and investigation of hepatic disease in patient [sic] with congenital coagulation disorders”, advocating “closer monitoring of patients than has hitherto been the case.[961] The guidelines advised regular liver function tests and Hepatitis B surface antigen (“HBsAg”) checks and outlined proposals for research. The Haemophilia Working Party met in December 1979 and discussed the preliminary findings from the Regional Study of Hepatitis. Up to 70% of patients with severe haemophilia had abnormal liver function tests, with a wide spectrum of histological abnormalities. All types of concentrate were said to constitute a risk with “as yet, no evidence that imported Concentrates are more dangerous.[962] Notwithstanding the recognition of risk, the minutes of the meeting recorded no consideration of how that risk might be reduced, or whether different treatment policies should be adopted.

The home treatment programme at The Royal London started with cryoprecipitate but changed to Factor 8 concentrates – NHS if available but otherwise commercial. Dr Colvin would try to keep very small children on cryoprecipitate but otherwise children would be treated with concentrates.[963]

Dr Colvin accepted that by 1979 the view within the NETR was that cryoprecipitate was the past, concentrates the present and future: “we did give up on cryoprecipitate.[964] No analysis of the relative risks of cryoprecipitate and factor concentrates was undertaken and they did not expressly consider the possibility of returning to cryoprecipitate use in a big way. Cryoprecipitate was “old hat”. Other than through the continuation of the policy of using mostly cryoprecipitate for young children, the approach to treating patients did not change at all in the period 1977-1983 to reflect the risk of hepatitis.[965]

Leeds

The haemophilia centre at Leeds was based at St James’s University Hospital. The director from around 1970 was Dr Layinka Swinburne; she was joined by Dr Bernard McVerry in 1985.[966] Leeds was a relatively large centre and by 1977 was using a substantial volume of commercial concentrates.[967] By 1978 little cryoprecipitate was in use[968] and the 1979 return recorded the use of no cryoprecipitate at all.[969] There does not appear to have been any system of batch dedication, nor any other evidence of a risk reduction or minimisation strategy.[970] Dr Swinburne was a regular attender of UKHCDO meetings, including the 1971 and 1972 meetings at which Dr Biggs’ work on jaundice was discussed,[971] the 1974 meeting at which Dr Craske reported on the hepatitis outbreak in Bournemouth,[972] the 1975 meeting at which there was a discussion about hepatitis, liver function tests and pool sizes,[973] the 1977 meeting at which Dr Craske reported on his study of hepatitis in patients receiving Hemofil,[974] and the 1979 meeting at which Dr Craske presented the report of the Hepatitis Working Party.[975]

Commentary

Six features emerge from examination of the treatment policies and practices towards patients with Haemophilia A in the 1970s. The first is the increasing use of concentrates (particularly commercial). The second is the insufficiency of NHS concentrates outside Scotland: many clinicians complained of a “shortfall” in what was available from BPL.[976] The third is the decreasing use of cryoprecipitate. The fourth is the fact that there was no or little express consideration given to safety. Rather the approach was treatment with the latest, most convenient product, with no self-reflection as to whether that was the right course. The fifth is the growth in using greater quantities of Factor 8 therapies, especially for home treatment, associated in particular with commercial concentrates, but also for some prophylaxis. The sixth is the limited deployment of risk mitigation or reduction measures: for example, DDAVP should have been widely used from 1978 but was not; some centres attempted batch dedication policies, but others did not. There is no record of doctors choosing one concentrate over another because the pool size from which it was manufactured was said to be smaller. Underpinning it all was an assumption that hepatitis was “an inconvenience, but essentially harmless”: an assumption “of the kind that doctors should not make.[977] This was despite the considerable evidence, arising in respect of serum hepatitis from the end of the Second World War, that it could not only be dangerous in its acute phase[978] but in a number of cases could become chronic and lead to cirrhosis, liver failure, and liver cancer. Though Hepatitis B had been identified by the start of the 1970s, clinicians knew it continued to be transmitted through concentrates; once it became clear that a large part of serum hepatitis was NANBH, treating clinicians should not have assumed NANBH to be a harmless part. They knew that was not the case with Hepatitis B; they also had a number of warnings from leading experts that the long-term consequences of NANBH could not be assumed to be benign. Yet that was the assumption most made.

An elementary principle is that if a certain process or procedure carries risks with it then reasonable steps should be taken to eliminate those risks or, if they cannot be eliminated, to reduce them. Scant regard is paid to this principle if no attempt is made to take any such step.

The Glasgow symposium in the autumn of 1980

In September 1980 a symposium entitled Unresolved Problems in Haemophilia was held at the Royal College of Physicians and Surgeons in Glasgow.[979] The symposium immediately followed the annual meeting of haemophilia centre directors on 30 September 1980 and it is reasonable to assume that most directors attending the annual meeting would also have attended the symposium.

At the reference centre directors’ meeting a week or so before, on 22 September, hepatitis had, yet again, been a subject for discussion. Dr Craske had reported a poor response from directors to his request for information about patients thought to have developed chronic hepatitis and he proposed to ask directors at the annual meeting in Glasgow to send in as soon as possible information about all patients who had shown abnormal liver function test results for six months or more. Dr Craske explained that he was awaiting the results of biopsy studies being undertaken in Sheffield and at the Royal Free, and it was recorded that there were other studies underway or anticipated in Oxford and Manchester.[980] There was also a discussion on freeze-dried cryoprecipitate, which led to a query from Dr Savidge as to what the policy was for the use of cryoprecipitate for home therapy: Professor Bloom said that it was a matter for individual directors to decide whilst also referring to the minutes of a meeting in January 1978 where the reference centre directors had agreed that Factor 8 concentrates were preferred for home therapy.[981]

The haemophilia centre directors’ annual meeting on 30 September 1980 included a discussion about “the increasingly inadequate supplies of NHS factor VIII concentrate[982] and included an update from Dr Craske on behalf of the Hepatitis Working Party. The minutes include the following discussion:

“Large pool concentrates appeared to give a higher risk of hepatitis than small pooled concentrates and Dr Craske felt that increased usage of small pooled concentrates would help to reduce the incidence of hepatitis in the haemophilic population. First-time exposure to large pooled factor VIII concentrate resulted in many cases of hepatitis, especially in von Willebrand’s disease patients. Professor Bloom wondered whether cryoprecipitate would be a better product to use for mild haemophiliacs and von Willebrand’s disease but pointed out that there was a problem over the amount of factor VIII in these materials. Dr Creaske [sic] agreed and he said that the NHS product was certainly better than the Commercial products because of the screening of the blood donors and the regular donor panels which were used in the UK. The screening procedure used for donors of plasma used to make Commercial factor VIII is radioimmunoassay but because of the unstable population and the poor social background, it is more likely that there will be a higher incidence of carriers of the hepatitis virus than in the U.K. volunteer blood donors.”[983]

The one and a half day symposium organised by Dr Forbes and the Royal College of Physicians and Surgeons of Glasgow and sponsored by Travenol followed.[984] The first part of the symposium was devoted to the subject of Liver Disease in Haemophilia and in their foreword to the subsequent publication of the proceedings Drs Forbes and Lowe observed that “a major section of these proceedings is devoted to the investigation of liver disease in haemophilia – an area which offers unique opportunities for both basic, applied and clinical research.[985]

The opening remarks, from Professor Roddy MacSween,[986] included the following:

“It was anticipated that the screening of blood donors for HBsAg would substantially reduce the incidence of post-transfusion hepatitis. However, this was not the course of events and, while some reduction did occur, post-transfusion hepatitis remained and remains a significant clinical hazard. It is now established that there are other transmissible agents capable of causing post-transfusion hepatitis, and there is good evidence that more than one virus is involved in what has become defined as non-A, non-B hepatitis ... Of particular interest has been the discovery that non-A, non-B hepatitis is a hazard in haemophilia patients and, as you will hear this afternoon, has been particularly associated with the use of the various concentrates with which these patients are now managed. Thus, while the use of these concentrates has represented a major advance in the therapy of haemophilia, it is unfortunate for the patients that this may be accompanied by an increased risk of acute and, possibly, chronic liver disease.”[987]

Dr Craske gave the first presentation, on The epidemiology of Factor VIII and IX associated hepatitis in the UK, in which he noted that despite the introduction of radioimmunoassay (“RIA”) screening in 1975, a significant amount of both symptomatic and symptomless Hepatitis B “still occurs associated with commercial and NHS Factor VIII transfusions”. Whilst stating that most cases of non-A non-B Hepatitis were mild illnesses, Dr Craske also observed that:

“About 25%-40% of haemophiliacs on regular Factor VIII therapy have persistently elevated serum aminotransferase levels for periods of at least one year. Most of these patients are symptomless. However, a few have clinical features suggestive of chronic liver disease, but the ethical problems associated with the indications for liver biopsy have meant that few patients have so far undergone this procedure. About 40 patients have undergone biopsy in the UK and approximately 50% of these have histological evidence of chronic persistent hepatitis ... Other patients showed evidence of chronic liver disease or cirrhosis ... Most of the patients in this group are children or young adults, though the age range at Oxford is 6-70 years. It seems likely that some patients will develop severe chronic liver disease over the next 10 years.”

Dr Craske’s presentation ended:“There is, therefore, a high risk from the use of Factor VIII or IX concentrate that the patient will contract non-A, non-B hepatitis, and a 20-30% chance of resultant chronic hepatitis, together with a smaller risk of hepatitis B.[988]

A further presentation on Clinical, immunological and histological aspects of non-A, non-B hepatitis in haemophiliacs by Dr Thomas, Dr May Bamber and Dr Kernoff[989] summarised data from a study undertaken at the Royal Free Hospital:

“The data from our prospective study suggests that patients receiving Factor VIII concentrates (commercial and NHS) for the first time run a high risk of developing acute NANB hepatitis. The incidence of chronicity in our study was higher than that observed by others. Six of our patients had persistently elevated transaminases at 6 months ... The high attack rate with a high incidence of chronicity suggests that the majority of the haemophiliac population exposed to Factor VIII concentrates will develop chronic hepatitis, at least as regards the definition of transaminase abnormalities persisting for longer than 6 months ... In a larger series of biopsies in this patient group we found 5 of 17 patients (42%) biopsied during the chronic phase to have chronic active hepatitis. Although the prognosis of this lesion following NANB hepatitis is unknown, it should be noted that a similar lesion associated with chronic hepatitis B virus infection is progressive and, in a proportion of patients, ultimately results in the development of cirrhosis and its attendant complications.”

In the discussion which followed Dr Thomas explained that none of their patients had cirrhosis:

“but then, if we are to believe that this illness at the most has been going on since 1974 when the commercial concentrates were first introduced, then this period is short in the course of the disease. There are some indications that these patients may have lesions which will turn to fibrosis or cirrhosis ... It is really now a question of how long it takes. Just because we have not seen it in this six-year period, it does not mean that it will not happen. I think the thinking is that it takes ten or twenty years, or even thirty years for these lesions to progress. I think we have to realise that these are young patients, with many years ahead, when we are considering the significance of these lesions.”[990]

Professor Peter Scheuer[991] provided the symposium with a short account of biopsies that had been undertaken: two showed acute hepatitis; a third showed an excessive portal and periportal inflammatory reaction suggesting possible transition to chronicity; two more showed chronic active hepatitis; and the last showed chronic persistent hepatitis.

A talk by Dr Preston, Dr Triger and Dr Underwood[992] explained that they had now examined liver biopsies from 19 patients with haemophilia, including 5 children whose ages ranged from two to ten years, and 1 patient with von Willebrand disorder. “The biopsy findings ranged from chronic persistent hepatitis, present in the majority of our cases, to severe chronic active (aggressive) hepatitis with evolving or established cirrhosis.[993] Dr Thomas, responding to a question from Professor Bloom about treatments for hepatitis, observed that “One can predict that there will be problems in the future” and added later, by reference to patients with haemophilia, that “The prediction is that it will be a more significant progressive illness, and I think they will develop fibrosis. Indeed, Dr Triger’s studies have shown that a significant proportion have cirrhosis.” Dr Jones (presumably Dr Peter Jones) asked the speakers to “try to put this into perspective”, stating that“Patients in the UK have now been chronically transfused with commercial concentrate for over 7 years, and in the US and Germany for considerably longer at considerably higher doses. What we do not seem to have seen is chronic morbidity or increasing mortality from liver disease.” In responding, Dr Triger emphasised that “We are dealing with chronic liver disease, in which 5 to 7 years is a very short time – as we all know. 10 to 20 years may be a long time, but we have been looking at liver biopsies of children under the age of 10 years, and what we are concerned with is what is likely to happen to them when they should be fit, healthy 25 year olds ... I think we are just building up trouble.” Dr Thomas agreed: “it is in 10 years time that we shall see the problems. Bearing in mind the proportion of the patients that are infected, or have persistent abnormal liver function tests, anything from 60 to 80 per cent, it will be an enormous problem when it happens.[994]

Sadly, Dr Triger and Dr Thomas were absolutely right.

Professor Thomas in his oral evidence to the Inquiry agreed with this description of his message to the symposium: that the expectation was that “there would be problems with chronic active hepatitis, fibrosis and cirrhosis in the future for this cohort of patients ... the presence of chronic active hepatitis was a bad prognostic sign ... as with hepatitis B, this develops over decades rather than months or years or small numbers of years.[995]

Dr Mark Winter, in his oral evidence to the Inquiry, rightly described the 1978 Sheffield study as showing NANBH to be a “really serious evolving clinical problem.[996] There had been, as he suggested, “a sort of unwillingness to think it might be a problem because this new treatment had brought such spectacular benefits and because the patients were so enthusiastic about it ... people were reluctant ... to say this is a serious problem.[997] The Preston paper was indeed an “absolutely key moment, where any haemophilia doctor should have switched from a viewpoint [from] ‘they have probably got a mild form of the virus’ to ‘I’m very concerned’”;[998] it was “one of the great sea change moments.[999] But for any haemophilia clinician working in that capacity in 1980 who had not picked up on the significance of the Sheffield study, the Glasgow symposium in September 1980 was another “absolutely key moment” and should have driven home the message that NANBH could not be dismissed as “benign” or “mild” or as a risk that did not need to be taken seriously.

Yet treatment with factor concentrates continued unabated throughout the early 1980s. The Hepatitis Working Party continued to meet and discuss its various studies;[1000] the reference centre directors turned their attention to concerns about the new concentrates said to be hepatitis-free or hepatitis-reduced[1001] and noted that the annual returns for 1980 showed that the amount of Factor 8 concentrates used had again increased, especially commercial materials;[1002] the haemophilia centre directors met again in the autumn of 1981 and received Dr Craske’s report on behalf of the Hepatitis Working Party for 1980-81 with its recommendations that the surveillance should continue, as should further studies.[1003] But for most centres little or nothing changed.

The tables below show, from the annual returns for 1980-1982, the use of concentrates and cryoprecipitate in the reference centres and in some of the other sizeable centres.[1004] The figures shown relate to treatment for Haemophilia A.

Newcastle[1005]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 4,138,918 616,785 3,522,133 3,629
1981 4,653,526 1,422,075 3,231,451 136,820
1982 4,582,052 977,610 3,604,442 0
Royal Free[1006]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 3,996,453 602,430 3,394,023 247,900
1981 3,973,175 1,358,905 2,614,270 177,525
1982 5,897,835 1,374,996 4,522,839 142,240
Cardiff [1007]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 1,278,571 245,271 1,033,300 399,210
1981 1,632,468 500,201 1,132,267 330,870
1982 1,919,645 602,930 1,316,715 178,640
Belfast [1008]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 1,396,451 120,672 1,275,779 71,370
1981 2,278,476 122,049 2,156,427 160,100
1982 2,190,252 12,960 2,177,292 77,122
Glasgow Royal Infirmary[1009]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 1,602,158 1,490,449 111,709 108,550
1981 1,396,324 1,246,155 150,169 20,300
1982 2,002,544 1,977,048 25,496 17,350
Edinburgh[1010]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 1,808,730 1,644,730 164,000 1,190,000
1981 1,282,148 840,130 442,018 680,470
1982 1,581,300 1,574,000 7,300 528,000
Sheffield (Royal Hallamshire Hospital)[1011]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 942,627 141,775 800,852 4,690
1981 850,076 419,213 430,863 219 bags
1982 964,010 413,220 550,790 5,250
St Thomas’ Hospital[1012]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 2,033,137 204,982 1,828,155 17,200
1981 2,653,655 335,712 2,317,943 1,800
1982 3,107,716 181,875 2,925,841 2,300
Manchester Royal Infirmary[1013]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 1,510,834 644,356 866,478 725,040
1981 2,558,945 1,368,345 1,190,600 407,760
1982 2,922,861 850,475 2,072,386 479,762
Oxford[1014]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 4,979,538 1,652,045 3,327,493 0
1981 4,920,216 1,616,573 3,303,643 0
1982 6,188,662 1,591,620 4,597,042 0
Birmingham (Queen Elizabeth Hospital)[1015]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 1,503,969 334,669 1,169,300 14,640
1981 2,317,441 1,184,305 1,133,136 44,720
1982 2,338,715 868,910 1,469,805 100,560
Bristol[1016]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 723,873 293,200 430,673 250,400
1981 997,387 473,020 524,367 261,800
1982 992,535 650,750 341,785 239,000
Leeds[1017]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 2,203,590 356,635 1,846,955 0
1981 2,437,273 644,820 1,792,453 0
1982 2,762,230 404,955 2,357,275 0
Liverpool[1018]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 1,790,691 80,605 1,710,086 1,010,000
1981 2,579,240 368,820 2,210,420 331,100
1982 3,860,474 1,156,340 2,704,134 29,260
Royal London[1019]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 1,000,683 366,177 634,506 375,000
1981 1,407,370 731,382 675,988 1,774 packs
1982 1,298,545 776,947 521,598 84,350
Lewisham[1020]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 914,356 193,553 720,803 13,435 bags
1981 884,854 320,966 563,888 925,330
1982 1,003,198 263,608 739,590 570,290
Cambridge[1021]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 374,928 175,937 198,991 1,332 bags
1981 414,227 273,846 140,381 990 packs
1982 356,730 319,540 37,190 36,050
Coventry[1022]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 548,145 292,790 255,355 0
1981 604,603 463,450 141,153 630
1982 946,921 424,000 522,921 0
Kent [1023]
Year Total NHS and Commercial F8 NHS F8 Commercial F8 Cryoprecipitate
1980 165,033 63,305 101,728 0
1981 243,004 109,900 133,104 0
1982 177,700 60,100 117,600 0

The charts below show the use of cryoprecipitate, NHS Factor 8 and commercial Factor 8 as proportions of total treatment in 1980, 1981 and 1982 for the centres in the tables.

The graph shows the product used at 19 centres in 1980. 11 centres use more than 50% commercial product. Only Edinburgh and Glasgow use less than 10%.

Figure 1. Use of Factor 8 products 1980

The graph shows the product used at 19 centres in 1981. 9 centres use more than 50% commercial product. No centre uses less than 10%.

Figure 2. Use of Factor 8 products 1981

The graph shows the product used at 19 centres in 1982. 13 centres use more than 50% commercial product and three use less than 10%.

Figure 3. Use of Factor 8 products 1982

The Glasgow symposium, and what ought on any view to have been understood to be the risks of transmission of NANBH and the potentially serious nature of NANBH, did not lead to any noticeable difference of approach to treatment, or even of any consideration of whether a changed approach was warranted. Nor was there any consideration or discussion about the position of patients and the information that should be provided to them about the risks of treatment.

The emergence of AIDS and the response of UKHCDO

In October 1986 Dr Colvin wrote to David Watters at the Haemophilia Society in the following terms:

in 1976 it was widely believed that commercial factor VIII concentrate was more unsafe with respect to hepatitis than British concentrate although later studies showed this was not necessarily the case ... It was also realised that while importation of factor VIII concentrate continued the potential for the introduction of even more serious infections in the UK haemophilia population existed and that a disaster might occur. That fear was eventually realised when Human Immunodeficiency Virus (HIV) infection, which is the cause of AIDS, was transmitted to patients with haemophilia.” [1024]

A similar idea was expressed by Dr Mark Winter in his oral evidence:

“A central mantra for all the time that I was working was, it wasn’t the virus you knew about; it was the virus that you didn’t know about. If you looked at the history of blood products, every few years ... there would be a new virus apparent and, most importantly, it would then become apparent ... that it had been there for some time ... all blood and blood products are risky because, you know, how do you know what we’re about to discover in three years?”[1025]

It might be thought, therefore, that haemophilia clinicians would and should be in a position to recognise and react promptly to the threat of a new virus. That was not to be the case.

1982-1983

The first mention of AIDS in the meetings of haemophilia centre directors came in early autumn 1982 when it was raised, almost as an afterthought, by Professor Bloom at the reference centre directors’ meeting on 6 September.[1026] Following discussion of the 1981 annual returns[1027] and estimated requirements for Factor 8,[1028] the meeting turned to consider hepatitis, with Dr Craske updating those present about the study being conducted in collaboration with the Oxford Haemophilia Centre on the use of commercial and NHS concentrate for first time or seldom treated patients (9 out of 28 patients who had been entered into the study had developed NANBH). Dr Wensley felt it important to point out that Hepatitis B had not disappeared (there had been two new cases in Manchester that year), and the Hepatitis Working Party was invited to give priority for the drawing up of guidelines for the use of “hepatitis-free” concentrates. Following discussion about the Hepatitis B vaccine, Professor Bloom wondered what value the giving of the vaccine was “when Non-A, Non-B hepatitis seemed to be the larger problem for the haemophilic patients.[1029]

The minutes then record that: “Professor Bloom asked Dr Craske if he had any information about the acquired immune-deficiency syndrome following reports in the United States and the possible relationship with this syndrome of blood products and hepatitis. Dr Craske said that he would find out more about this and agreed to try to have some information available to the Haemophilia Centre Directors at the Manchester meeting.[1030]

A week later, at the annual meeting of haemophilia centre directors on 13 September 1982, the minutes record that the reference centre directors had asked Dr Craske to look into the report from the US “mainly in homosexuals but including three haemophiliacs. It appeared that there was a remote possibility that commercial blood products had been involved.” Dr Craske asked directors to let him know if they had any cases of the syndrome and the Hepatitis Working Party was said to be considering the implications of the reports from the US.[1031]

The next meeting of the Hepatitis Working Party took place that same day. It was dominated by discussions about research projects.[1032] However, towards the end of their meeting the Working Party agreed that, as AIDS had similarities in its epidemiology to Hepatitis B, enquiries would be made by members of the Working Party to ascertain the likelihood of transmission of the disease by blood or blood products and a further meeting would be held when more information became available.[1033]

As set out elsewhere in this Report,[1034] possibly by March 1982, and certainly from July 1982 onward, it was known in the UK to both some clinicians and some within government that there was a real risk that blood, and blood products in particular, would transmit the cause of AIDS. That the reference centre directors and UKHCDO were, as at September 1982, only at the beginning of enquiries into this risk – enquiries that were effectively being delegated to Dr Craske – and that the minutes of the 13 September 1982 meeting could characterise the nature of the risk as being “a remote possibility” amounts to an inadequate response. No sense of urgency arose, as it should have done and on any reasonable view at that stage the risk of commercial blood products was more than a “remote possibility”.

No doubt as part of the process of enquiry that had been delegated to him, Dr Craske wrote to the Centers for Disease Control and Prevention (“CDC”) on 4 October 1982; he seems also to have received information from Dr Kernoff.[1035] On 8 October Dr Rizza wrote to Dr Craske explaining that he had spoken to a physician in the US: “Apparently the whole problem has caused quite a stir in the haemophilia world in the States so much so that one very senior physician has withdrawn his factor VIII concentrates from the accident room and insists on vetting the patients himself before any dose is given.” Dr Rizza felt that “the whole thing should be looked at urgently if only to clear the air and dispel some of the apprehension that has been stirred up.[1036]

On 5 November 1982 Dr Craske prepared a paper about AIDS which described how between June 1981 and January 1982 the CDC had become aware of an increase in the occurrence of Kaposi’s sarcoma, pneumocystis pneumonia and other opportunistic infections. He reported that a considerable delay was noted between the occurrence of initial symptoms and diagnosis, that the signs and symptoms were in most cases insidious and non-specific in nature, and that the overall mortality rate was high. Recently seven cases had been reported in people with haemophilia, three of whom had no association with drugs or sexual promiscuity. Dr Craske described three theories that had been advanced. The first – the effect of drugs such as amyl nitrate – was swiftly discounted by him “as the disease has been described in patients who do not use the drug”. The second – the immunosuppressive effect of cytomegalovirus infection – was also said by Dr Craske to seem unlikely. The third theory was that “The association with sexual promiscuity, intravenous drug abuse and possibly the transfusion of commercial blood concentrates, together with evidence of clustering and a prodromal phase suggest an infectious agent with a similar epidemiology to that of hepatitis B, possibly specific for human T. cell populations.” It is abundantly clear that this was regarded as the most likely cause by Dr Craske.[1037]

Whilst the paper itself had been prepared for a meeting of the MRC Hepatitis Vaccine Working Group, Dr Craske sent a copy of it on 11 November 1982 to Dr Rizza and to Dr Ludlam, both members of the Hepatitis Working Party.[1038] Dr Craske’s letter to Drs Rizza and Ludlam explained that he had spoken to the CDC the previous week. The latest information was that five people with haemophilia had been identified with this syndrome, two of whom recently died. All the cases were without any of the factors that had been found in other patients (drug addiction, homosexual practices, treatment with immunosuppressive drugs). The hypothesis was said to be that one or two patients in the incubation period of the disease had donated plasma which had since been used to prepare concentrates. “The likelihood is, therefore, that other cases will be identified amongst severe haemophiliacs, though probably at a low prevalence.” The basis for the assertion that there would be a low prevalence of other cases is unclear. Dr Craske thought it necessary to have a meeting of the Hepatitis Working Party “to decide what further investigations need to be undertaken in the British haemophiliac population.[1039]

On 22 November 1982 Dr Craske received further information by way of a letter from Dr Dale Lawrence of the CDC, which explained that “We are increasingly concerned that involvement of US Hemophilia - A patients with AIDS is based on (infected) plasma donorship by certain US residents who may have been experiencing subclinical or prodomal states of AIDS illness, but unaware of this state. However, we have no evidence as yet to indicate association among the 8 US hemophilia AIDS cases through common exposure to a Brand or lot.[1040]

On 15 December 1982 a meeting took place at BPL, attended by, amongst others, Professor Bloom, Dr Rizza, Dr Gunson, Dr Craske, Dr Cash and Dr Lane. The purpose of the meeting was to discuss the implications for the haemophilia and blood transfusion services of the commercial introduction of “hepatitis-safe” factor concentrates. AIDS does not appear to have been discussed.[1041]

By 22 December 1982 the “latest information” from CDC, according to Dr Craske and communicated to Dr Lane, was that eight cases had occurred in Haemophilia A patients, all of whom had severe coagulation defects requiring regular treatment with Factor 8, and that two cases had occurred in people without haemophilia which might be related to whole blood transfusions between a year and eighteen months prior to the onset of the syndrome.[1042]

In December 1982, the Royal Free Hospital began to measure the ratio of T4 to T8 cells in patients with haemophilia. This was plainly a reaction to a perceived threat of AIDS taking hold, and implies a belief that whatever the cause of AIDS was it might be transmissible by blood or blood products.[1043]

On 7 January 1983 Alpha Pharmaceuticals issued a press release which said “The evidence suggests, although it does not absolutely prove, that a virus or other disease agent was transmitted to them [patients with haemophilia who had contracted AIDS] in the Factor VIII concentrate ... Surveys now being conducted by NHF [the National Hemophilia Foundation in the US] are producing other disquieting findings: AIDS has jumped from the seventh to the second most common cause of death in hemophiliacs within a year”.[1044]

The Hepatitis Working Party duly met on 19 January 1983. The focus of discussions was, again, the proposed prospective study of Factors 8 and 9 associated hepatitis. It was recorded that Professor Savidge was contemplating taking part in a trial of Travenol’s “hepatitis-reduced” Factor 8. However, Dr Craske also reviewed “developments in the field” relating to AIDS. So far ten cases of AIDS had occurred in Haemophilia A patients, of whom five had died. It “seemed possible that factor VIII or other blood products administered to these patients might be implicated”.[1045] The CDC’s AIDS Task Force was working on the hypothesis that there was an infective agent, which was supported by reports of three cases associated with whole blood or platelet transfusions. According to Dr Craske, US clinicians were keen for UK clinicians to collaborate in the reporting of cases of AIDS possibly associated with transfusions of US Factor 8. No cases so far had been found in Haemophilia B patients. Dr Craske suggested a retrospective survey where haemophilia centre directors would be asked to report patients with clinical features of AIDS-like disease. He agreed to draw up a form for the reporting of AIDS cases and to consider what further information would be needed in a retrospective study.[1046]

There was no suggestion in the Working Party’s meeting of any change of approach in relation to treatment, or any action to ensure the provision of information and advice to patients: rather the emphasis was, as had been trailed in Dr Craske’s 11 November letters to Drs Rizza and Ludlam, on “what further investigations need to be undertaken in the British haemophiliac population.[1047] The unspoken assumption was that treatment would continue unchanged and unchecked. That the role of blood products was still described as something that “seemed possible[1048] rather than being, by this stage, acknowledged as probable, may explain – but does not justify – this approach.

Three further events of significance took place in January 1983.[1049] The first, on 13 January, was the editorial in The New England Journal of Medicine, a publication that was widely read amongst clinicians in the UK, which stated that “The fact that haemophiliacs are at risk from AIDS is becoming clear”and advocated a revised approach to treatment.[1050] The second was the meeting at a Heathrow hotel on 24 January 1983, attended by a number of leading haemophilia centre directors,[1051] at which no one questioned that AIDS was likely to result from the transmission of an infectious agent and at which Dr Craske informed those present that the disease was intractable, had a high mortality rate and appeared to have a lengthy incubation period. Attention was expressly drawn to the recent New England Journal of Medicine, as well as to cases involving platelet transfusion including the San Francisco baby case.[1052] No one present at that meeting could have been left in any doubt as to the seriousness of the position.

The third significant event was the issue, on 11 January 1983,[1053] of a letter from Professor Bloom and Dr Rizza to all haemophilia centre directors which discussed the attempts that had been made by commercial companies to reduce the risk of hepatitis transmission through heat treatment. It emphasised the importance of finding out “by studies in human beings to what extent the infectivity of the various concentrates has been reduced”. Professor Bloom and Dr Rizza suggested that“The most clear cut way of doing this is by administering those concentrates to patients requiring treatment who have not been previously exposed to large pool concentrates,” and encouraged directors to avoid the use of such concentrates on a named patient basis, because this “might seriously hinder controlled studies in the future”.[1054] The importance of this letter is three-fold. First, what is remarkable about this letter is the complete absence of any reference to AIDS. There was no update, even though more was now known, or at least suspected, than had been shared at the last haemophilia centre directors’ meeting four months previously. Second, the letter illustrates that UKHCDO – through its chair and secretary – could give advice and information to haemophilia centre directors where it thought that was warranted. Third, this letter contemplated the administration of large pool concentrates to patients who had not previously received them at the very time when the emergence of AIDS should have led to the avoidance of treatment with concentrates for those who were previously untreated.

The reference centre directors met again on 14 February 1983.[1055] The minutes record a discussion about “The AIDS syndrome” in the following terms:

“Professor Bloom said that the Syndrome would be discussed at the Stockholm meeting of the World Federation of Haemophilia. Reports from the United States indicated that the incidence of AIDS was higher than at first thought and there was some concern that the haemophilic population of the U.K. who had received American concentrates might be at risk. Dr. Craske summarised the latest information from the United States and said that approximately 10 cases of AIDS were thought to have occurred in non-haemophiliacs in London, one in Glasgow and one in Manchester. Dr. Craske had drawn up a draft form for reporting of the cases. There was a lengthy discussion regarding the report form and which of the various documents which Dr. Craske had obtained with the United States should be circulated to the Haemophilia Centre Directors. It was agreed that Dr. Craske should draw up a new form for the reporting of cases and to arrange for this to be circulated to all Haemophilia Centre Directors with appropriate notes regarding the criteria on which the diagnosis should be based. It was suggested that Dr. Craske should invite an Immunologist to join the Hepatitis Working Party in view of the Working Party’s involvement with the AIDS Syndrome.”[1056]

There may have been a “lengthy discussion” about the form which would be circulated to haemophilia centre directors for the reporting of cases, but there was a complete absence of discussion about whether there should now be a different approach to treatment, or about what information should be provided to patients. This showed an unacceptably casual and blasé approach to the risk which treatment with blood products posed to patients.[1057]

Early March saw a meeting of the Haemostasis Club, a gathering at which clinicians were invited to present on topics of interest.[1058] On 8 March it was Professor Jeanne Luscher who talked about AIDS.[1059] She explained that the CDC postulated that AIDS was caused by a transmissible agent and that it shared some common properties with Hepatitis B (a long incubation period). She drew attention to the possibility of altered T4/T8 cell ratios. Recommendations from the US were set out: use cryoprecipitate or fresh frozen plasma for children under four, DDAVP wherever possible, avoid elective surgery, no longer obtain concentrate donations from high-risk areas and attempt to screen out high-risk groups, for example by the use of questionnaires. Dr John Lilleyman (Sheffield Children’s Hospital) was said to be looking at T4 and T8 cell ratios in children.[1060]

On 22 March 1983 Dr Craske wrote to all haemophilia centre directors inviting them to report possible cases of AIDS.[1061] A revised and updated version of his 5 November 1982 report was enclosed with the letter. An infectious agent being the most likely cause, the report still used the language of possibility rather than probability, suggesting that “it is possible that such an agent might be present in the plasma pools used to prepare commercial factor VIII and IX concentrate manufactured from donor plasma collected in the U.S.A.[1062] Directors were provided with guidance in identifying possible cases of AIDS[1063] and a form for the reporting of such cases,[1064] but no advice or guidance about the approach to treatment or the provision of information to patients.

The reference centre directors did not meet again until 13 May 1983, when there was a “special meeting” to discuss AIDS.[1065] But in the meantime, whilst treatment continued as normal, a young man with haemophilia in Wales developed symptoms of AIDS.

Kevin Slater was 20 years old when his AIDS symptoms were first identified and just 22 years old when he died in 1985.[1066] He was suspected of suffering from AIDS in March 1983, following a visit to University Hospital Wales. Professor Bloom was aware of his case and told the audience at a 22 April 1983 Haemophilia Society meeting that one of his patients “may have a mild form”of the syndrome.[1067] The factual basis for Professor Bloom’s conclusion that Kevin had a “mild form” of AIDS is unclear.

Kevin returned to the hospital on 25 April 1983, when he was admitted as an in-patient. The following day, Professor Bloom completed a UKHCDO AIDS surveillance form in relation to Kevin.[1068] Having identified which diagnostic criteria were met and when symptoms first emerged, he wrote that Kevin’s was a “probable”case of AIDS.[1069]

Around 6 May 1983, the Communicable Disease Surveillance Centre (“CDSC”) published a weekly report identifying Kevin’s case (without naming him) and observing that “This is the first report of AIDS in a patient with haemophilia in the United Kingdom known to CDSC.[1070] Dr Spence Galbraith, director of the CDSC, notified the DHSS by telephone of this development on 6 May.[1071]

A week later the reference centre directors held their special meeting. Unusually, Dr Diana Walford of the DHSS was invited to attend: ordinarily she only attended the annual meetings. It was chaired by Professor Bloom and attended by Dr Craske, Dr Hamilton, Dr Kernoff, Dr Ludlam, Dr Savidge, Dr Preston, Dr Delamore and Dr Rizza.

The minutes are short and worth setting out in full:

“Professor Bloom briefly outlined the background to the meeting and its purpose. The recent publicity in the press, radio and television about the problem of acquired immuno deficiency syndrome (AIDS) had caused considerable anxiety to haemophiliacs and their medical attendants as well as to the Department of Health. There was clearly a need for Haemophilia Centre Directors to discuss what should be done with regard to the surveillance and reporting of suspected cases and management of patients. To date in the United Kingdom one haemophiliac is suspected of suffering from AIDS. In London there are reported to be 10 cases of confirmed AIDS in homosexual males. Concern was expressed about the definition of AIDS. It was felt that there might be many individuals with evidence of impaired cell-mediated immunity but only a very small number of these might progress to a full blown picture of the condition. It is important that such individuals are not classified as suffering from AIDS. It was accepted that because of our lack of knowledge of the nature of AIDS, decisions about diagnosis and reporting of suspected cases would prove difficult. Nevertheless the criteria laid down by the Centres for Disease Control, Atlanta, Georgia, and in the form prepared by Dr. J. Craske for use at U.K. Haemophilia Centres, should be followed for diagnostic purposes. The importance of opportunistic infection as a diagnostic criterion was stressed. It was agreed that any patient who was suspected of suffering from AIDS should be reported immediately on the form provided and thereafter the clinical course of the patient would be followed and a definitive diagnosis attached if the patient developed intractable disease.

The steps to be taken should a patient develop the features of the full-blown condition were then discussed. It was agreed that there was insufficient information available from the U.S. experience to warrant changing the type of concentrate used in any particular patient. Moreover once the condition is fully developed it seems to be irreversible so that there would seem to be no clinical benefit to be gained by changing to another type of factor VIII.

With regard to general policy to be followed in the use of factor VIII concentrates, it was noted that many directors have up until now reserved a supply of National Health Service concentrates for children and mildly affected haemophiliacs[1072] and it was considered that it would be circumspect to continue with that policy. It was also agreed that there was, as yet, insufficient evidence to warrant restriction of the use of imported concentrates in other patients in view of the immense benefits of therapy. The situation shall be kept under constant review.” [1073]

The meeting concluded by noting that blood transfusion centre directors were due to meet to discuss the problem of donor screening in relation to AIDS.

There are a number of points to be made about the decisions taken – and not taken – at this meeting.

First, what was set out represented no change at all to existing treatment practices. There was no discussion about any measures such as: reverting to cryoprecipitate (even if only on a temporary basis); batch dedication; more conservative treatment; a cessation of or reduction in home treatment; a cessation of prophylactic treatment for those centres whose approach to treatment included an element of prophylaxis; or cancelling or postponing elective surgery.

Second, the evidence was said to be insufficient in view of the immense benefits of therapy. Underpinning that conclusion was an all-or-nothing assumption: the sense that a restriction on imports would lead to a complete (and long-term) cessation of therapy. That was by no means the only outcome.

Third, the decisions in the meeting were taken in ignorance of the paper which Dr Galbraith had sent to the DHSS on 9 May 1983.[1074] That paper should have been provided by the DHSS to the reference centre directors, whether in advance of the meeting or as soon as practicable thereafter.[1075] It was not. Nor did Professor Bloom tell the meeting that he had sought information about the present situation in the US from Dr Bruce Evatt of the CDC, who described to him how “The evolution of the epidemic is occurring with a frightening pace” and that there were now 13 confirmed cases in people with haemophilia in the US, 1 of whom had Haemophilia B, with 5 more highly suspect cases under investigation, and all of whom had received factor concentrates.[1076]

Fourth, there was no discussion at all about advising patients of the risks.

Finally, the minutes firmly state that the situation “shall be kept under constant review.” Yet there is no evidence of there being any such review, let alone constant review: as set out below, there was little if any reconsideration by the reference centre directors until December 1984.

The meeting was followed, six weeks later, by a letter of 24 June 1983 to all haemophilia centre directors from Professor Bloom and Dr Rizza.[1077] That it took six weeks for such a letter to be produced is redolent of the lack of urgency with which UKHCDO/the reference centre directors acted up until December 1984. The letter contained a material inaccuracy in its opening paragraph: it stated that “So far one possible case has been reported to our organisation.” That could only be a reference to Kevin Slater and Professor Bloom certainly knew by this time that it was not a possible case but a probable one: he himself had reported it in those terms to Dr Craske.

The letter continued:

“At the above mentioned meeting on May 13th the following general recommendations were agreed.

  1. For mildly affected patients with haemophilia A or von Willebrand’s disease and minor lesions, treatment with DDAVP should be considered. Because of the increased risk of transmitting hepatitis by means of large pool concentrates in such patients, this is in any case the usual practice of many Directors.
  2. For treatment of children and mildly affected patients or patients unexposed to imported concentrates many Directors already reserve supplies of NHS concentrates (cryoprecipitate or freeze-dried) and it would be circumspect to continue this policy.

It was agreed that there is as yet insufficient evidence to warrant restriction of the use of imported concentrates in other patients in view of the immense benefits of therapy but the situation will be constantly reviewed.” [1078]

The letter then stated that following the meeting on 13 May, “the Licensing Authority was asked to consider any implications for us of the revised recommendations of the American Food and Drug Administration which were made on March 24th, 1983 to American plasma collecting agencies”.[1079] It is not entirely clear what this refers to, but it is likely to be a reference to the reference centre directors raising misgivings at their meeting about the potential “dumping” of US product in the UK after the Food and Drug Administration (“FDA”) in the US had recommended that products made from plasma from “high-risk” groups should no longer be produced. Professor Bloom is likely to have assumed that Dr Walford was taking the issue forward with the Medicines Division[1080] (as indeed this Report concludes she did, even though, in the result, nothing was done to stop “dumping” happening). The letter did not, however, refer to the prospect of “dumping” in any clearer way, but as Dr Colvin pointed out in his oral evidence to the Inquiry the letter “also implies ... that if patients on home treatment were on imported concentrates, they should remain on imported concentrates[1081] and does not suggest that some of these may create a greater risk than others because of the date of manufacture or the practices of the manufacturer.

The letter continued by referring to two additional points drawn to the authors’ attention since the 13 May meeting. The first related to treatment for Haemophilia B, where it was said that the evidence to incriminate Factor 9 concentrates “is even less than with factor VIII and it seems logical to continue to use our normal supplies of NHS concentrate.[1082] The phrase “even less than with factor VIII” can only be designed to cast doubt on the view that AIDS could be transmitted through use of Factor 8 – yet by mid 1983 no one could reasonably have been under any illusion. The second point concerned proposed trials of “hepatitis-reduced” Factor 8 concentrate: it was, the letter said, still important that the effectiveness of these concentrates vis-à-vis hepatitis “is subjected to formal clinical trials in mild haemophiliacs notwithstanding our general recommendations above”. Directors were urged not to use these concentrates “randomly on a ‘named patient’ basis”. Thus, the reference centre directors were simultaneously suggesting that it was circumspect to treat people with mild haemophilia with DDAVP or NHS concentrate, whilst happily contemplating the enrolment of such patients in clinical trials in which they would be exposed to imported concentrates. Furthermore, whilst recommendations 1 and 2 were plainly drafted with “clinical freedom” in mind, with everything being left to the discretion and judgement of directors, the reference centre directors at the same time urged directors not to use the “hepatitis-reduced” concentrates. Ironically the reference centre directors were willing to urge directors not to use products that might well be safer (at least in relation to hepatitis),[1083] but were unwilling to urge directors not to use products that were very likely if not certain to be unsafe.

The 24 June letter was, remarkably, the only advice issued by the reference centre directors/UKHCDO until December 1984. It was poor advice. It was also too little too late.[1084]

Viewed broadly, it suggested that treatment should continue as before, despite the risks of AIDS on top of those of hepatitis. The complacency which this suggests, and the absence of any practical advice to reduce the risk of these diseases being transmitted by the choice of therapy, represent a failure of leadership and a missed opportunity.

June 1983 was also the month in which the Council of Europe issued its recommendation to member states, recommendations which included avoiding, wherever possible, the use of coagulation factor concentrates prepared from large plasma pools and informing people with haemophilia of the potential health hazards of haemotherapy and the possibilities of minimising these risks.[1085] Professor Ludlam was unaware of the existence of this recommendation, and it appears that it did not come to the attention of the reference centre directors.[1086] As with Dr Galbraith’s letter, those who were aware of the Council of Europe recommendations – which would include the DHSS and Dr Gunson – ought to have ensured that they were shared with UKHCDO/the reference centre directors.

The Hepatitis Working Party’s next meeting was 14 September 1983,[1087] followed by a meeting of the reference centre directors on 19 September, with Dr Walford in attendance again “in view of the Department’s interest in AIDS.” It was now known that a patient with haemophilia had died from AIDS. A paper was presented by Dr Craske, updating the situation regarding AIDS. It was agreed that the patients who had received the same batches of NHS or commercial Factor 8 as the patient who died in Bristol should be followed up. Professor Bloom reported that Dr Galbraith, director of CDSC, had not heard about the Bristol case until after the patient’s death, and it was agreed that reporting to CDSC should be through Dr Craske after discussion with the director involved in patient management.[1088] There were, as Professor Tuddenham (who was one of the reference centre directors at the meeting) accepted, no substantive recommendations at all made about changes in policy or different ways of treating patients or providing information to patients.[1089]

The annual meeting of haemophilia centre directors took place on 17 October 1983. Dr Chisholm, the director of the haemophilia centre at Southampton, raised the problem of patients refusing to take up commercial Factor 8 concentrate because of the AIDS scare. She wondered in view of patients’ worry whether directors could revert to using cryoprecipitate for home therapy. Professor Bloom replied that “he felt that there was no need for patients to stop using the commercial concentrates because at present there was no proof that the commercial concentrates were the cause of AIDS”. Dr Chisholm pointed out a further problem in her region in getting large amounts of commercial concentrates whereas she could get unlimited amounts of cryoprecipitate, and other directors reported the same problem. After discussion it was “agreed that patients should not be encouraged to go over to cryoprecipitate for home therapy but should continue to receive the NHS or commercial concentrates in their usual way”.[1090]

Dr Craske presented the paper which had been pre-circulated to directors.[1091] He outlined his proposals for investigating UK cases of AIDS in people with haemophilia and proposed follow-up for three years of patients who had received “suspect batches of factor VIII”. There was some discussion of the two cases of AIDS in people with haemophilia in the UK and Dr Geoffrey Scott, director of the Bristol Centre, gave details about the case of the patient who had died. Dr Craske urged directors not to put the word AIDS on pathology request forms and said he could supply directors with a copy of the US recommendations about the handling of samples. It was agreed that he would send out details of his proposals as soon as possible.[1092]

It might be thought that the death of a patient from AIDS would have focused minds on the need for a change of approach to treatment, but it is apparent from the minutes that was not the case. It is astonishing that as at October 1983 Professor Bloom felt able to say in response to Dr Chisholm that there was “no proof[1093] that commercial concentrates were the cause of AIDS,[1094] and astonishing that the directors as a whole agreed that patients should not be encouraged to switch to a treatment which was on any view substantially safer. Dr Colvin, in his oral evidence to the Inquiry, described Professor Bloom’s statement as “more wishful thinking”.[1095] It was that and more. It was an unsustainable and misleading position to promulgate in the autumn of 1983. It was tantamount to telling clinicians that they did not need to do anything. It is highly surprising that Professor Bloom was not challenged on this by his peers at the meeting.

The position as at the end of 1983: Commentary

Thus the position as at the end of 1983 was that far too little had been done by UKHCDO or the reference centre directors in response to the emergence of AIDS. The focus was on surveillance and research rather than on taking urgent steps to reduce the risk of transmission. The only guidance that had been provided – the 24 June letter – was woefully inadequate. The reference centre directors were apparently unaware of key pieces of information – Dr Galbraith’s paper and the Council of Europe recommendations – and thus their advice (such as it was) was issued in ignorance of them. The risks were assessed on the basis of the number of cases which had emerged, when the focus should have been on what might be already on the way. And the risks to people with bleeding disorders were consistently, and unjustifiably, downplayed.

1984

1984 saw little by way of positive action by the reference centre directors or UKHCDO. Reference centre directors held their first meeting of the year on 13 February 1984. Dr Craske informed the meeting that there had been 21 cases of AIDS in patients with haemophilia, including 2 with Haemophilia B, and there was discussion about methods for reporting on possible AIDS cases and about Dr Craske’s draft protocol for a study. Professor Bloom reported to the meeting about a survey he had undertaken regarding the possible incidence of AIDS cases in Europe. He had sent out a questionnaire and received 132 replies from all over Europe; 11 cases of AIDS had been reported.[1096]

Despite the increase in the number of cases of AIDS, both in patients with haemophilia and generally,[1097] and despite being told that “One-third of the Centres [ie in Europe] had changed their treatment regimes for patients following the onset of the AIDS problem”,[1098] regrettably the reference centre directors gave no further thought to treatment policy or any risk reduction measures or to the issue of any further advice. If they did not consider it their role to do so, they should have asked the DHSS or the Chief Medical Officer to act.

Likewise, at their next meeting on 10 September 1984 the reference centre directors listened to a presentation from Dr Craske regarding the current situation: he referred to the article in The Lancet on 1 September and stated that a further 20 patients with AIDS-related symptoms had been notified to him.[1099] There was still no consideration of any need for a change to treatment.

The haemophilia centre directors’ annual meeting took place on 27 September 1984. Notably, a substantial part of the meeting focused on discussions about the designation of haemophilia centres (a subject on which the reference centre directors had apparently held several meetings specifically for the purpose of discussing the criteria for designation). A note of self-congratulation may be thought to appear in the minuted assertion that “The UK was recognised throughout the World as having the best organisation for the treatment of haemophilic patients.[1100] AIDS, by contrast, appears to have merited a short discussion in which Dr Craske referred directors to his report on the current AIDS situation and invited them to give special attention to the work on HTLV-3, testing for which had been available since August.[1101] Yet again there was no recorded consideration or discussion of any change to treatment or practice. Yet by now it was generally accepted that Dr Robert Gallo had identified a virus causative of AIDS, which therefore made it as good as certain that blood products could transmit it.

It was not until 10 December 1984 – some two or more years after the risks of transmission of AIDS should have been apparent to all haemophilia clinicians – that the reference centre directors and others finally addressed the implications of, and for, treatment choices. A meeting took place at Elstree on that date, chaired by Professor Bloom and attended by the majority of reference centre directors, representatives from BPL (including Dr Lane, Dr Terence Snape and Dr James Smith), Dr Gunson, Dr Cash, Dr Craske, Dr Philip Mortimer (PHLS), Dr Richard Tedder and Dr Alison Smithies from the DHSS.[1102] The meeting was said by Professor Bloom to have been “precipitated” by “the resulting publicity surrounding the events in Newcastle and Australia, and the continuing work on HTLV III”.[1103]

Following discussions on the arrangements for testing patients and whether patients should be told of their test results,[1104] the meeting considered the use of heat-treated Factor 8 versus non-heat-treated product.[1105] A particular concern was cost, with Dr Cash urging that “the financial considerations be looked at seriously. The implications for the cost of treatment to Haemophilia were enormous for the small number of patients involved”, and Dr Lane adding that “the cost considerations spread to the NBTS, which was not just concerned with Haemophilia management”.[1106] Following discussion of the progress with heat treatment of NHS Factor 8, there was a debate about the best options for treatment, with the chair advising that he would issue guidelines following the meeting: “In summary, the first choice would be HT material followed by the judgement of the individual clinician.” Professor Bloom also suggested that “peripheral treatment centres”should return all unheated commercial material to the reference centres “for transfer back to the Company involved”, most companies having undertaken (according to the note) in writing to accept such material back.[1107]

Following the conclusion of the discussion, it was suggested by Dr Lane that the haemophilia directors present “be allowed to have a private meeting with only themselves present.[1108] No record of this “private” meeting exists.

The “AIDS Advisory Document” dated 14 December 1984 which was prepared in light of the meeting noted that there were in the US over 6,000 cases of AIDS including 52 people with haemophilia and 102 cases in the UK with 3 reported in people with haemophilia, and recorded that“No doubt other cases are developing in the haemophiliac population.[1109] The document gave options in “probable decreasing order of safety from AIDS for Haemophilia A”:

  1. heated UK concentrate
  2. single-donor cryoprecipitate or fresh frozen plasma
  3. heated imported concentrate
  4. unheated UK concentrate
  5. unheated imported concentrate, described as “almost certain to be contaminated.[1110]

The recommendations were:

  1. concentrate is still needed: bleeding is the commonest cause of disability and death;
  2. use DDAVP for mild Haemophilia A and von Willebrand disorder if possible;
  3. for Haemophilia A patients needing blood products:
    1. use cryoprecipitate or heated NHS Factor 8 (if available) for “virgin” patients not previously exposed to concentrate and for children
    2. for people with severe and moderate haemophilia previously treated with Factor 8, use heat-treated NHS Factor 8 if available or heat-treated US commercial
  4. for Haemophilia B patients:
    1. fresh frozen plasma (or otherwise NHS Factor 9) should be used for mild Haemophilia B
    2. the same for “virgin” patients and those not previously exposed to concentrate
    3. for severe and moderate patients previously treated with concentrate continue to use NHS Factor 9.[1111]

The Advisory Document suggested that in individual patients “there may need to be a choice. In general heated concentrate appears to be the recommendation of virologists consulted but individual Directors may wish to make up their own minds.” From 30 January 1985 a limited supply of BPL heated product was expected to be available, with preference being given to previously untreated patients and children and possibly to those willing to participate in clinical trials.[1112]

This was the first guidance issued by UKHCDO since the 24 June 1983 letter (which, as observed earlier, in reality contained little by way of actual guidance); as Dr Rizza acknowledged in his report for the HIV litigation, up to December 1984 “the recommendations set out in the letter of 24th June, 1983 were still being promoted”.[1113] The failure to hold such a meeting earlier, and to provide advice to haemophilia clinicians earlier, was both inexcusable and inexplicable.

It is not clear precisely when the AIDS Advisory Document was sent to haemophilia centre directors, but the minutes of the first meeting of the UKHCDO’s AIDS Group on 11 January 1985 recorded that it had been sent to all centres.[1114]

Professor Savidge, in his written evidence to the Archer Inquiry, suggested that in the period 1983 to 1985 UKHCDO received “little if any information concerning haemophilia treatment from the representative Professor Bloom regarding information from other more influential committees”.[1115] Professor Bloom’s role on other committees, and his relationship with the DHSS, is discussed elsewhere in the Report,[1116] but the criticism is a well-founded one. Professor Savidge was also – and rightly – critical of the lack of timeliness of the December 1984 advice.

One does not have to look far to see the dreadful consequences of this delayed advice. Dr Janet Shirley was the consultant haematologist at Frimley Park Hospital, an associate haemophilia centre with a small number of patients. She had been appointed to her post in February 1980, at which point her experience of bleeding disorders was two years as a senior registrar at St Thomas’.[1117] Dr Shirley was one of a number of haemophilia centre directors to be appointed as such with relatively little experience of treatment for bleeding disorders. Moreover, Frimley Park was an associate haemophilia centre (it was designated as such between 1980 and 1981), with a small number of patients,[1118] and much of Dr Shirley’s time was taken up with other haematology services, unrelated to treatment for haemophilia or von Willebrand disorder. These two factors – a relative lack of experience in treating haemophilia and other bleeding disorders and a small number of patients seen annually – were not uncommon and should have reinforced the importance of there being clear and up-to-date guidance from UKHCDO to all doctors who might be treating patients with bleeding disorders.[1119] Dr Shirley acknowledged the need to keep up-to-date with developments relating to bleeding disorders and their treatment, but emphasised that “you need to understand that we had to keep up-to-date with an awful lot of other haematological diseases. So our ability to be really up-to-date would not be as great as the clinicians at the main centres.[1120]

Dr Shirley thought it unlikely that she would have seen the AIDS Advisory Document before Christmas 1984 and that the likelihood was that she would have read it in January 1985.[1121] She was not aware, as far as she could recall, of the Edinburgh infections which were reported in the press on 20 December.[1122] The fact that a cohort of patients in Scotland had been infected apparently as a result of treatment with the Scottish NHS product – which had been known at least since late October 1984 – should have been immediately notified to all directors but was not.

There was one patient infected with HIV in likelihood as a result of treatment administered at Frimley Park on 17 December 1984.[1123] He had mild haemophilia.[1124] He was treated with unheated NHS concentrates on several occasions; available records suggest that he received a Scottish product as well as BPL. Dr Shirley did not tell the patient of the possible risk of AIDS from concentrates and in hindsight accepted that she should have done.[1125] If she had been in receipt of the AIDS Advisory Document (ie of advice from UKHCDO) at the time of his treatment, the treatment would probably have been different: she would have attempted to obtain heated concentrate. Dr Shirley agreed that the reference centre directors should have done more to ensure that directors such as herself were better informed:

“I think, as far as I can remember, that December 1984 document was the first time that we were given any guidance on what product we should use in what type of patient, and I think if we had had that sort of guidance issued through the 1980s, it would have been – it would have been easier for consultants to know that they were giving the right treatment, and also, I think, it would have enabled consultants like myself to put pressure on the regional Blood Transfusion Services to give us certain types of product.”[1126]

Other clinicians spoke also of the lack of guidance.

“We were desperate for guidance ... for leadership, which I don’t think we ever got properly, either from the Government or UKHCDO or whatever”.[1127]

It is difficult to understand why UKHCDO and the reference centre directors were so painfully and dangerously slow to recognise and react to the risks of AIDS being transmitted to their patients. The reflection of Dr David Bevan,[1128] referring to the generation of clinicians who had experienced periods when treatment for haemophilia was of limited availability and effectiveness, was that “Their attitude and reactions were dominated by determination never to withhold treatment and never to run short – let alone out – of treatment.” He added that “The UKHCDO also took a position in many ways typical of British public health governance: Not to risk over-reaction, not to act prematurely, not to alarm the public, ‘the evidence is not yet conclusive’, ‘we don’t yet have proof.’” Taking all these things into account he thought that UKHCDO continued to hold a line well into 1983 that the evidence of an infectious cause of AIDS was inconclusive and that action would be premature “long after that position became obviously untenable.[1129] It was “a kind of denial of the reality.[1130]

It was wrong.

Treatment practices and policies 1982-1984

Haemophilia centre directors knew, or should have known, no later than the end of 1982 (and probably earlier), of the risks of transmission of AIDS by blood and blood products.[1131]

Those who gave oral evidence to the Inquiry largely accepted that.

Dr Stanley Dempsey, consultant haematologist at the Royal Belfast Hospital for Sick Children, told the Inquiry that from late 1982 he had “no major doubt” or “no real doubt” that AIDS was transmissible by blood or blood products “because any alternative theory didn’t really seem to hold water[1132] but haemophilia clinicians “were not prepared to commit themselves totally and utterly to AIDS being – the idea of AIDS being related to transmission by blood products.” He described UKHCDO as not having come round fully to the idea that commercial concentrates were responsible for the emerging AIDS problem – there was “resistance among the haemophilia treaters about the significance of concentrate and the emerging AIDS problem”, some of which he absorbed.[1133]

Professor Ian Franklin, consultant haematologist at the Queen Elizabeth Hospital in Birmingham from September 1982, said that certainly by the time the San Francisco baby case was reported, it was “pretty clear” that AIDS was probably transmitted by blood and blood products.[1134]

Dr Colvin, consultant haematologist at the London Hospital since 1977, said that he would have read the Dr Jane Desforges editorial in The New England Journal of Medicine and attended the January meeting at the Heathrow hotel, and would therefore have by January 1983 been aware that there was a risk to people with haemophilia of AIDS and that the most likely route of transmission for them was blood products.[1135]

Dr Winter, a lecturer and honorary senior registrar at Guy’s Hospital until he took up a consultant and director post in Margate in December 1983, would have seen the Morbidity and Mortality Weekly Reports (“MMWR”) including that of 16 July 1982.[1136] All doctors would, he said, have been aware of the 1981 reports of gay patients with a new disease but initially it was not suggested that it was to do with blood or anything transmissible.[1137] Then came the reports of three patients with haemophilia with pneumocystis, followed by the report of the San Francisco baby who had a platelet transfusion from a donor who subsequently developed AIDS. “So in this period of six months, say, from July ‘82 to December ‘82, by the end of that period, as a haemophilia doctor, you would have to look at that data and say ... This is something which is in the blood. This must be a virus or something like that”.[1138] As Dr Winter stated to the Penrose Inquiry, by December other theories are no longer tenable and “Any clinician looking at this data would have to believe that AIDS was a transmissible disorder and that it could be transmitted by blood and by blood products. It was the only clinical interpretation of the data that was available.[1139] Importantly, Dr Winter’s evidence recognised that by this point in time “there are two major problems with concentrate therapy”: non-A non-B Hepatitis (“the liver disease is much more significant than we thought”) and AIDS: “set against the extraordinary benefits of concentrate therapy, it’s really stressing the dangers of concentrate therapy.[1140]

Put more colloquially by Dr Winter, “however many alarm bells a human being has, they should all have been ringing at this stage.[1141] Yet as set out below it is clear that those alarm bells were not ringing for many, indeed most, haemophilia clinicians – or if they were, they did not lead to any substantial changes in treatment policies and practices.

They rang in June 1982 for Professor Ian Hann, haemophilia centre director of Yorkhill Children’s Hospital in Glasgow between January 1983 and August 1987. As, then, a junior doctor he attended an international symposium On Infections in the Immunocompromised Host held in Stirling. A paper presented to the conference spoke of “an alarming epidemic of an acquired immunodeficiency syndrome, AIDS, in certain cities in the US ... Nationwide, half of the patients have died ... Blood or body secretions would appear to be potential vehicles of infection.[1142] To him, this was a bombshell, and he thought it might be relevant to people with haemophilia. He called it “part of the burgeoning knowledge that began to explode at that time”.[1143]

It is a pity it did not ring as clearly for more.

Some examples will serve to illustrate this but the picture is a broader one.

Newcastle

It is unclear when Dr Jones first gave active consideration to the risks to his patients at the Newcastle Haemophilia Centre. In a document which he produced in around 1990 he suggested that AIDS in haemophilia patients “was brought to our attention by Professor Bloom at a meeting of the Haemophilia Reference Centre Directors in September 1982 when Dr. John Craske was to look at the question of British haemophiliacs being involved.[1144] It is unclear whether he undertook any further enquiries himself or passively awaited the outcome of Dr Craske’s investigations.[1145] Newcastle was represented at the Heathrow hotel meeting in January 1983 by Dr Hamilton, Dr Jones’ co-director, who no doubt shared what was discussed with Dr Jones.[1146] However, two documents suggest that Dr Jones did not take the risk of AIDS as seriously as he should have done at this stage.[1147] First, in his letter of complaint to the Press Council in early May 1983, criticising The Mail on Sunday’s coverage of the AIDS crisis under the headline “Hospitals using killer blood”, Dr Jones said that“there is no proof that a virus even exists as a cause of the acquired immune deficiency syndrome” and no proof that any transmissible agent had been imported from the US.[1148] Secondly, in late May 1983, Dr Jones sent a circular letter to doctors in the Northern Region regarding “AIDS and Haemophilia” which substantially downplayed the risks.[1149]

In an editorial in The Lancet in April 1983 Dr Jones rejected the need for a change in treatment policy partly because the emergence of HIV/AIDS “in a few haemophiliacs does not necessarily reflect the tip of an iceberg”.[1150] There is nothing to suggest that his position subsequently changed. He did not make any switch to cryoprecipitate (even on a temporary basis or for children older than four or six who had graduated to factor products).[1151] Dr Jones was perceived by his peers to be committed to continuing to use factor concentrates at this time.[1152] In a memo written by Dr Frank Boulton to Dr Brian McClelland on 30 May 1983, Dr Boulton described a recent conversation with Dr Jones in which the latter “claimed that there is a lot of doubt about the diagnosis of all the AIDS cases in the UK, and in particular the haemophiliacs”; Dr Boulton felt that Dr Jones was “still being somewhat less than cautious” with regard to his attitude towards the risk of AIDS.[1153] Dr Collins, at the regional transfusion centre, had to write to Dr Jones in August 1983 to remind him that there was a large supply of BPL concentrate awaiting use at the regional transfusion centre.[1154] Commercial concentrates continued to be the mainstay of treatment in 1983 and 1984.[1155]

In short, there were no significant changes in approach to treatment at the Newcastle Centre in response to the risk of AIDS until the introduction of heat-treated concentrates in December 1984.[1156]

Dr Jones formed the view in the course of November 1984 that there should be a change to heat-treated Factor 8 (in other words in advance of the meeting at BPL on 10 December 1984) and took steps to secure the regional health authority’s agreement to that change.[1157] However, he did not take steps to recall existing unheated product from patients: instead they were told to use up their present stocks and that the switch would be made when they came back for new supplies for their home therapy.[1158] This was despite the fact that he had checked with representatives of the three companies supplying concentrates to the Centre who had all agreed to take back present stocks of non-heat-treated material without any financial consequences to the Health Authority.[1159]

The number of patients of the Newcastle Centre infected with HIV was high. Terence McStay, the second person with haemophilia to die of AIDS in the UK, was a patient at the Newcastle Centre, although he returned to his home in Glasgow shortly after he was diagnosed, and died on 3 November 1984.[1160] A paper published in The British Medical Journal in 1985 stated that out of 99 Newcastle patients with severe Haemophilia A, 76 were HIV positive.[1161] All except one of them had received commercial Factor 8 products at some time. Of the 76 infected patients, 30 were suffering from AIDS-related complex or lymphadenopathy. Three had died from AIDS. Three partners of seropositive patients also tested positive.[1162]

Birmingham

There were no changes in approach to treatment at the QEH[1163] in response to the risk of AIDS prior to December 1984.[1164] Having regard to the May 1983 Haemophilia Society publication[1165] and the October 1983 UKHCDO meeting,[1166] the advice was essentially to “carry on” and that was what Professor Franklin was guided by.[1167]

In March 1984 Professor Franklin wrote to Dr Fereydoun Ala at the regional transfusion centre outlining prescribing policy at the time. The Inquiry does not have that letter, but has a description of it in a later letter from April 1991:

“there had been a meeting of the Haemophilia Centre Directors in which it was considered advisable that patients remain on the Factor VIII product that they had been regularly using. Therefore it did not appear unreasonable at that time to propose that patients who had been using Armour for several years should continue to do so. There was never at any time sufficient NHS Factor VIII available to treat all patients and the decision of Dr Hill and myself was that patients should receive a regular supply of one or other product and not a mixture of both.”[1168]

At a meeting on 27 June 1983 of the West Midlands Working Party the regional transfusion centre advised the meeting through a letter from Dr Ala that cryoprecipitate was “probably a safer product than Factor VIII concentrate in respect of transmission of”AIDS.[1169] No action appears to have been taken in response to this. Professor Franklin’s evidence was that “I think ... in Birmingham the feeling was to carry on, but probably to carry on in the hope that we would eventually get more NHS material”; to switch from factor concentrate to cryoprecipitate“would have really needed some sort of national push to say that’s what needs to be done”.[1170]

A further Working Party meeting in December 1983 did not result in any change of
approach.[1171]

The QEH return for 1983 showed some treatment with cryoprecipitate in hospital but predominantly treatment with NHS concentrate and Factorate in both hospital and home settings.[1172] A similar picture emerged from the 1984 return.[1173]

A further meeting of the Working Party in May 1984 noted that there was a shortfall of 3.5 million units of Factor 8 which it was agreed should be made up by commercial Factor 8.[1174] On 24 May 1984 Dr Franklin wrote to Dr Lane registering his concern about the shortfall, which meant that the Centre might have to treat patients with commercial product who had never been exposed to it in the past.[1175]

Professor Franklin suggested that it would have been beneficial to have something more forthright from UKHCDO as to what to do: he expressed himself as feeling “a bit sad on behalf of the patients of the Queen Elizabeth Hospital that we didn’t get enough advice. You know, there was more to be had, I think ... Mark Winter mentioned the CMO – pretty silent in all this. I don’t think it necessarily had to be the CMO but something definitive as to what we should do.[1176]

It was only after the Elstree meeting on 10 December 1984 that measures were taken. The West Midlands Working Party held an extraordinary meeting on 17 December to discuss the implications of the use of Factor 8 concentrates in light of the death of two people with haemophilia from AIDS and a treatment policy was agreed: DDAVP or cryoprecipitate for mildly affected patients and von Willebrand disorder; newly diagnosed people with severe haemophilia to be managed wholly on cryoprecipitate; NHS Factor 8 for patients with no previous exposure to commercial concentrate; patients with previous exposure to be treated with NHS Factor 8 if available and heat-treated commercial concentrate if not.[1177]

Royal Free

Professor Tuddenham became aware of the reports of an association between haemophilia, factor concentrates and AIDS as soon as it was reported by the CDC in July 1982.[1178] Dr Kernoff attended the Heathrow airport hotel meeting in January 1983. Professor Tuddenham delivered a talk at the World Federation of Hemophilia meeting in Stockholm in late June 1983, describing the “deplorable situation the results of which are being discussed in the seminars on hepatitis and AIDS.[1179] He was using “colourful language to emphasise the inherent risks of pooling blood from thousands of donors.[1180] There was, however, no change in the Royal Free’s treatment policies until heat-treated products became available at the end of 1984, as both Professor Tuddenham and Professor Lee accepted.[1181] December 1984 was the first time that the Royal Free effectively responded to the risks of AIDS by changing its approach to treatment, which it sought to do in two ways: introducing heat-treated products and delaying elective surgery.[1182]

The Royal Free’s annual return for 1983 showed that commercial concentrates remained the principal treatment for Haemophilia A.[1183] The same was the case in 1984 although the volume of NHS concentrates increased.[1184]

Following the decision to use heat-treated products in December 1984, in January 1985 Dr Kernoff wrote to patients explaining that it would not be possible to change everybody to heat-treated products immediately. The overall objective of the Royal Free’s policy was said to be to give the safest possible treatment to an individual. There are two remarkable features about this letter. The first is that the letter makes no reference to AIDS whatsoever: the change is said to be to “reduce the risk of virus transmission” but does not explain which viruses had triggered this change of approach. The second is that home treatment patients (who would be receiving commercial concentrates) were told to continue to use their current stocks until they were almost finished and then call in personally to collect new supplies.[1185]

Edinburgh

When Dr Ludlam became director in 1980, his approach to treatment had three principal features. First, he moved from a system based on cryoprecipitate as the main treatment for Haemophilia A to a system of predominantly PFC Factor 8 concentrates. Secondly, he substantially increased the number of patients on home treatment: when he arrived in Edinburgh there were 6 patients on home therapy; by 1983 there were about 40 or 45. And thirdly, he increased usage of factor concentrates as a whole substantially.[1186]

One effect of Dr Ludlam’s reversal of his predecessor’s policy (which had been based on cryoprecipitate) was that the local blood transfusion service redirected donor blood plasma from cryoprecipitate production to concentrate manufacture.[1187] By May 1982 Dr Boulton, the deputy director of the South East Scotland Blood Transfusion Centre, was writing to Dr Ludlam stating that “your home therapy programme alone has accounted for about 80 per cent of our allocation from PFC” and warning that “we are now very definitely at the limits of our production for home therapy and therefore you may consider the necessity for buying some commercial product.[1188] Dr Boulton wrote again with similar concerns in August 1982.[1189] Minutes of a meeting in August 1982 recorded agreement that Dr Ludlam would “make additional efforts to keep within the monthly allocation from PFC” and a warning from Dr Boulton that there would almost certainly be a need to buy more commercial Factor 8 if the current usage pattern continued.[1190] Similar concerns continued to be expressed at the end of 1982.[1191]

The figures in the annual return for 1981 are not legible.[1192] However, the 1982 return records an increased use of NHS concentrate over cryoprecipitate and the use of small amounts of Factorate and Koate; the use of DDAVP was also recorded.[1193] 1983 showed a further reduction in the use of cryoprecipitate and increase in the use of NHS concentrate, with both Factorate and Koate being used in larger quantities than previously.[1194] 1984 saw a repetition of that pattern, with a further reduction in cryoprecipitate use and increase in NHS concentrate; some commercial concentrate (Factorate) was also used.[1195]

Children with severe Haemophilia A would be treated initially with cryoprecipitate, but might move to concentrate at a youngish age. By 1983 there were around four to six children on home treatment.[1196]

A form of batch dedication was introduced in late 1984. Professor Ludlam was not clear why this was not introduced earlier.[1197]

Professor Ludlam described his perception of non-A non-B Hepatitis as being that it was seen as a “mild non-progressive condition, the first serious study on liver biopsy having been undertaken in 1985.[1198] During questioning by Counsel to the Inquiry he suggested that this was the perception in the mid-1980s.[1199] He said he had been well aware of the Sheffield study of 1978, and of later papers questioning whether it was progressive, but it was “clear” by the mid 1980s. When he came into post in 1980 he said his view “and I think a widely held view was that we were very uncertain about its seriousness ... I think it was more a lack of evidence about its progressiveness that led us to believe that it’s possible it might not be progressive and it became clear that there was a wide range of ways in which it – rates at which it did progress between different people.” He went on to describe the view of Dr Colvin and Dr Kernoff in 1979 that it was a “serious disease with long-term consequences” as being a reasonable view to have held at the time.[1200]

As a comment, where a doctor is uncertain about whether an infection leads to serious long-term consequences, but recognises that there is significant evidence to show that it may do so, and it is reasonable to think that it might, he should not be drawing comfort from a lack of evidence that it does. He should not be looking for and placing importance on it becoming “clear” until he considers taking action: for there is at the very least a real risk from the start that it might do so. To draw comfort from there appearing to be few cases is to confuse incidence with risk, especially where it is believed that the consequences of being infected may emerge only later. The sense of Professor Ludlam’s evidence was that he chose to be reassured by the absence of many cases of serious liver disease (where there was no reliable evidence that he should have been, and it might have been expected that such disease would inevitably take some time to emerge) rather than choosing to take active steps to reduce the potential for the risk to become reality. Professor Ludlam was not alone in this: the criticism in this paragraph applies to most, including his mentor Professor Bloom. However, it is a real pity that he, of all people, someone who came across as painstaking, adopting something of an academic approach to research in haematology, and plainly given to detail, should adopt it, especially since his appointment as director of the Edinburgh Centre led to it largely abandoning cryoprecipitate in favour of concentrate. Though he was justified in placing faith in the voluntary donor system, and local sourcing of blood and plasma in Scotland as protective against the much larger risks from imported commercially sourced products, it was not a complete panacea as events would show.

Professor Ludlam thought that he first became aware of cases of AIDS in people with haemophilia in August to October 1982.[1201] He was, however, in his oral evidence to the Inquiry, at pains to emphasise – and over-emphasise – “the uncertainty that there was at the time about the cause of AIDS.[1202] He was dismissive about the value of the Desforges article in The New England Journal of Medicine, suggesting that she was “a staff writer” for the journal (she was in fact a haematologist with over three decades of clinical experience by 1983 and had been appointed a professor of medicine in 1972; that she was also an associate editor of The New England Journal of Medicine did not undermine that). He accepted that he was by 19 January 1983 (when the Hepatitis Working Party, of which he was a member, received an update from Dr Craske)[1203] aware of the San Francisco baby case, but suggested that this was “circumstantial evidence. It didn’t, in any way, begin to fulfil Koch’s postulates for demonstrating that an agent causes a disease.[1204]

Dr Ludlam attended a meeting on 21 January 1983 of SNBTS directors and haemophilia directors which recorded that purchases of commercial material in Edinburgh had increased; he told the meeting that the reasons were partially clinical and partially a policy of conserving a “cushion” of NHS Factor 8 against an anticipated shortage when production at the PFC would be suspended to carry out alterations required by the Medicines Inspectorate. There was surprisingly little discussion of AIDS; the minutes merely record Dr Cash drawing attention to recent articles and Dr Ludlam informing members that in the UK a letter and questionnaire had been sent out to haemophilia directors. There was no discussion about any change of approach to treatment or any other expression of concern by those present.[1205] Dr Ludlam was also present at the Heathrow hotel meeting on 24 January 1983.[1206] He had no recollection of the contents of the meeting. When asked by Counsel to the Inquiry if he agreed that there was no suggestion in the notes of the meeting that the cause of AIDS in either patients with haemophilia or patients who had had transfusions was anything other than the receipt of blood products or blood, he said “I agree that is as set out by Dr Craske, but of course, Dr Craske is a virologist and would see things from a virological perspective.[1207]

In his testimony there was the following exchange:

“Q. what you are describing is 1983, early 1983, you realised that factor concentrates not only gave rise to a potential risk of non-A, non-B infection and a real risk of HIV infection, but there was a third problem, which was neither hepatitis or HIV, but that was the problem that it might, in any event, separately, give rise to a deterioration in the immune system which, in general, would not be a good thing. Have I understood correctly?

A. Absolutely correctly, yes.

Q. So there were now three reasons why factor concentrates were potentially undesirable if there were any proper alternative?

A. Yes.” [1208]

It would follow if this were well-founded that although PFC-produced concentrate was less likely than commercially produced concentrate to have contributions from donors with a virus which might lead to AIDS,[1209] all factor concentrates – whether domestic or commercial – were as likely as each other to cause people with haemophilia who had been heavily treated with them in the past to have deteriorating immune systems and be more vulnerable to AIDS.

There was no significant change of approach to treatment in 1983 and 1984 at Edinburgh in response to the risk of AIDS, or the threefold risk identified in this exchange, because Professor Ludlam thought the PFC concentrates were reasonably safe and made the assumption that the likelihood of there being a transmissible agent was low in Scotland: “we felt it reasonable to go on with using cryoprecipitate in decreasing amounts and using local concentrate for treating the patients.[1210]

In February 1984, a meeting of SNBTS directors and haemophilia directors recorded Dr Ludlam as saying that “cryoprecipitate was preferred in the treatment of children at present, because of the new danger of AIDS.” Dr Hann was recorded as concurring. The minutes continued “A policy seemed to be emerging however to use less cryo for haemophilia A patients.[1211] Dr Ludlam’s practice in Edinburgh was not, however, now to use cryoprecipitate for the treatment of children. It was unclear from his oral evidence why that was the case and he found it difficult to explain what, in February 1984, his views were as to the relative risks of cryoprecipitate and NHS concentrate.[1212]

In the autumn of 1984, Dr Ludlam sent a number of stored samples to Dr Tedder for testing. He did so without the knowledge or agreement of the patients involved.[1213] It is unclear what prompted that action. Dr Tedder’s evidence, to the Lindsay Tribunal, was that Dr Ludlam “already had a clinical suspicion that something had occurred.[1214] Dr Ludlam told this Inquiry that he had “no prior inkling that any of our patients had been infected” and that he was “pretty confident that they would be negative.” His reasoning was that he sent them because, having read the paper in The Lancet in September describing the testing of different groups, “I thought, well, I should at least find out whether the patients who got commercial concentrate were antibody positive or not and, along the way, why not send some people who had only received Scottish Factor VIII, as I say, expecting them to be negative.[1215]

By 26 October 1984, when Dr Ludlam telephoned Dr McClelland, he had learned that six patients with haemophilia had developed antibody to HTLV-3. By 2 November Dr Ludlam had received further test results relating to sixteen patients.[1216] On 7 November 1984, a meeting was held regarding the “Laboratory and clinical management of patients with evidence of HTLV-3 infection and from groups known to be at risk” following which, on 16 November, Dr Ludlam wrote to a colleague at the Royal Infirmary that “It has recently become apparent to me that some of our patients with haemophilia have antibody to HTLVIII virus.[1217] And on 29 November, a meeting was convened to discuss the implications of the recent findings, at which Dr Ludlam explained the circumstances in which it had been discovered that 16 patients treated exclusively with SNBTS Factor 8 had been infected. Dr Forbes described findings relating to seroconversion in a comparative study of patients in Glasgow and Denmark and Dr Brenda Gibson reported that five out of ten patients tested at the Royal Hospital for Sick Children (Yorkhill) were HIV positive.[1218] The meeting continued:

“Views were exchanged on the very difficult ethical problems which had arisen. These included whether patients and patients’ relatives should be informed and perhaps subjected to needless worry; whether publicity additional to that already provided should be given, and how directors should respond to direct enquiries or requests for advice. The chairman advised members that ministers had been informed and that SIO had been briefed. While a press statement would not be issued by the Department at present any enquiries would be answered. It was agreed that every effort should be made for patients to have the situation explained to them before the impending publicity.”[1219]

Thus by 29 November, over a month after the first results had been communicated to Dr Ludlam, a number of organisations and individuals, including ministers, were aware of what had happened, but patients were still in the dark. Some were known to be infected with HIV but through their own lack of knowledge of that fact were not aware of the importance of taking precautions to avoid infecting others; others continued to treat themselves with concentrates in the erroneous belief that PFC concentrates were entirely safe. As detailed later in this chapter, it was not until 19 December 1984 (by which time Dr Ludlam had known the results for 16 patients, as well as a larger number of negative results, for nearly two months but had not told a single patient) that a group meeting took place to alert patients to what had happened. It was not until 1985 that the process of informing individual patients of their test results commenced.[1220]

According to information provided by Professor Ludlam both to the Penrose Inquiry and to this Inquiry, 23 patients (all with severe Haemophilia A) were infected with HIV as a result of treatment in Edinburgh (2 of them children); 18 of those 23 had received treatment with material from a single batch of SNBTS product; 5 had received treatment with other SNBTS and commercial products.[1221]

Glasgow Royal Infirmary

In 1982, the usage of cryoprecipitate diminished markedly: only 17,350 units in contrast with nearly 2 million units of NHS concentrates (and modest amounts of commercial: 25,496).[1222] 1983 saw an increase in the use of commercial concentrates (200,000 units of Factorate for home treatment), although NHS concentrates remained the mainstay of treatment.[1223] The use of commercial concentrates dropped again in 1984.[1224]

Professor Forbes told the Penrose Inquiry that by March 1983 “already we were starting to look rather differently at our patients to see if they had any of the features that might be an early warning of AIDS.[1225] He also acknowledged that in 1983 there was a potential for contamination of blood products “even from local, home-grown sources ... that was always the concern, that HIV would come into the donor population of the UK.[1226] Whilst accepting that this was a “concern”, there is no indication of any alteration in practice in Glasgow, save that a batch dedication system may have started in around 1983/1984.[1227] The reference to “starting to look rather differently at our patients” may be a reference to the work initiated by Dr Forbes in around late 1982 or early 1983 – a study of immune abnormalities in patients with severe haemophilia, which resulted in the publication in The British Medical Journal on 15 October 1983 of a paper entitled Immunological abnormalities in haemophilia: are they caused by American factor VIII concentrate? The conclusion of the study was that Scottish patients had immunological abnormalities similar to those in their US counterparts.[1228]

In December 1984, a second article emanating from Glasgow was published, this time in The Lancet. This revealed that 77 Scottish people with haemophilia and 22 Danish people with haemophilia were tested for antibodies to HTLV-3. 15.6% of the Scottish people with haemophilia (11 with Haemophilia A, 1 with Haemophilia B) were positive. All but 2 were known to have received commercial factor concentrates in the period 1979-1984. By contrast, 59.1% of the Danish cohort were positive: all but 2 of the cohort had received commercially produced concentrates. The study showed that infection was directly correlated with taking commercial concentrates.[1229]

Blood had been taken from the 77 patients between December 1983 and July 1984. They were not told that their blood was being tested for HIV.[1230]

Belfast

Dr Mayne’s recollection of when she first became aware of AIDS was that it was raised during an informal lunchtime conversation with Professor Bloom, Dr Kernoff and Dr Craske, in which the latter described a recently published paper referring to an immune condition in homosexual males in San Francisco. Dr Mayne could not recall when this discussion took place, but the paper referred to may be the article published in The Lancet on 12 December 1981.[1231] She attended the reference centre directors’ meeting in September 1982 referred to earlier in this chapter, as well as the January 1983 meeting at the Heathrow hotel. She was not in attendance at the 13 May 1983 special meeting of reference centre directors.[1232]

Some years later, in 1993, following the prosecution of Professor Jean-Pierre Allain in France, Dr Mayne wrote to the editor of The Lancet stating that “The evolvement of the HIV problem within the haemophilia population has caused immeasurable distress to patients and to all physicians treating them. The Doctors concerned were guilty of one fault, namely that of ignorance.[1233] That is an inaccurate characterisation of the position. Sufficient evidence and information were available to clinicians, especially in the second half of 1982, to put them on notice that action was required in order to minimise the risk of AIDS being transmitted to their patients. Unfortunately, no such action was taken in Belfast.

In 1982, 1983 and 1984 patients with Haemophilia A continued to be extensively treated with commercial concentrates.[1234] In 1985 Dr Mayne listed the following volumes of product usage:

Dr Mayne suggested that “It is clear from these figures that the increased use of N.H.S. material should have produced an economy in the purchase of commercial material but, due to extensive orthopaedic surgery being necessary following a series of road traffic accidents and bone fractures, the increase in N.H.S. material was inadequate for needs.[1236]

In a report which Dr Mayne prepared for defendants in the HIV Haemophilia Litigation, she commented on measures which might have reduced the risks of hepatitis and AIDS, suggesting that some of them would have denied “the goal of haemophilia treatment, namely to minimise pain and disability and to prolong life.” She objected to restriction of:

“the choice of treatment available to the physicians in charge of the patient: the person in possession of all the information regarding the patient’s needs. The alternative treatments; cryoprecipitate, Desmopressin and animal concentrates have already been discussed and found wanting for the universal treatment of severe haemophilia ... The risk/benefit ratio of non treatment versus treatment could not be upheld in the light of the plight of haemophiliacs in the era before infusion treatment became available.”[1237]

There are four obvious problems with this perspective. The first lies in the characterisation of the physician as being “in charge of” the patient, the physician being the person “in possession of all the information regarding the patient’s needs.” This is paternalism writ large. The person in charge of the patient is the patient. The person in possession of all the information regarding the patient’s needs is, in the broad sense, the patient. The second problem is the sense that only a universal answer would have been satisfactory, whereas in reality what could and should have been implemented was not a single “universal treatment” in place of factor concentrates, but a range of different and time-limited measures: a suspension of home treatment for some, the replacement of concentrates with cryoprecipitate for others, bed rest for those who did not want to run the risks of any treatment. That this was her approach at the time is apparent from her written evidence to the Inquiry, in which she stated that “In reality, the choice was stark – stop treatment with concentrates with all the risks and disruption that would entail for patients or continue with treatment in light of the information then available.[1238] The third problem is her characterisation of the “plight” of people with haemophilia in the pre-concentrate era, which overlooks the role of cryoprecipitate. And the fourth, linked to the first, is the unspoken assumption that it was for the physician to determine the risk/benefit ratio, when that should have been a choice left to the patient.

Dr Mayne’s evidence, and data provided to the Inquiry by UKHCDO, suggests that 16 people were infected with HIV following treatment at the Belfast Centre.[1239]

Cardiff

Professor Bloom was, as the chair of UKHCDO, privy to the information regarding AIDS that is discussed earlier in this chapter. He was aware as at September 1982 that three patients with haemophilia in the US were reported to have AIDS. By, or in, January 1983 he was sent, probably by Dr Cash, the December 1982 MMWR. This reported that all three of the patients identified in the July MMWR had died and more cases had been identified, including two patients aged ten or under, leading to the observation that “children with hemophilia must now be considered at risk for the disease.[1240] He attended the Hepatitis Working Party meeting on 19 January 1983 at which Dr Craske provided a detailed update about the cases in the US, including the San Francisco baby case and the papers in The New England Journal of Medicine.[1241] He attended the Heathrow hotel meeting on 24 January 1983.[1242] Yet, as discussed elsewhere in this Report, he materially downplayed the risks of transmission at this critical time. His stance throughout this time is exemplified by the letter he sent to David Watters on 20 January 1983, in which he wrote:

“Clearly at the present time the cause is quite unknown and neither has it been proven that it is transmitted through contaminated blood products. The incidence of the condition in America is not known but seems to be about one per thousand of the severely affected treated patients. On this basis if the disease exists in the U.K. we could reasonably expect two or three cases amongst British haemophiliacs. So far none have been reported ... As the full blown condition has not yet been reported amongst British haemophiliacs it is not possible to state if the coagulation concentrates produced in this country are safer in this respect than the concentrates produced in the U.S.A. Indeed there is no evidence yet in fact to implicate the latter ... In the meanwhile there is certainly no need for the haemophilic community to be unduly concerned about this ‘new’ syndrome. They can rest assured that every effort is being made to monitor the situation in this country and to collaborate with the Centre for Disease Control in the U.S.A. ... coagulation factor therapy is so essential for the safety and well being of patients that there is no doubt whatsoever that their advantages outweigh this disadvantage which at the moment seems to be potential rather than real in the U.K. at any rate.”[1243]

In early March 1983, Professor Bloom received a letter from Dr Evatt from the CDC who informed him that AIDS was having a major impact on the treatment of people with haemophilia in the US: “The evolution of the epidemic is occurring with a frightening pace ... The incidence rate has been increasing in hemophiliacs and the epidemic curve paralays that of the total epidemic curve.[1244] He was also at around the same time sent Alpha’s press release which reported that the evidence suggested (although did not absolutely prove) that a virus or other disease agent was transmitted through Factor 8 concentrates to those people with haemophilia who had developed AIDS.[1245]

There can be no doubt, therefore, that in early 1983 Professor Bloom had not only all the information about the risks of transmission of AIDS available to him that other haemophilia clinicians had, but he also had additional sources of information that ought on any view to have led him to appreciate that transmission to people with haemophilia in the UK was inevitable unless steps were taken. By April he also had the knowledge that one of his own patients had AIDS. Yet he continued to minimise the risk, as seen by the advice which he provided to the Haemophilia Society, discussed elsewhere in this Report.[1246]

There is, however, evidence to suggest that following the special meeting of reference centre directors on 13 May 1983, Cardiff may have produced written guidelines for haemophilia treatment. These guidelines, dated 18 May 1983, suggested that: for people with mild haemophilia and von Willebrand disorder DDAVP should be used for minor lesions, or cryoprecipitate or NHS concentrate for other lesions; for children with severe haemophilia cryoprecipitate or NHS concentrate should be used; for adults with severe haemophilia cryoprecipitate should be used for in-patient treatment where feasible; those who had never received imported concentrates should where possible only receive NHS concentrate, and other patients should continue to receive imported concentrate; and patients with Haemophilia B should continue to receive NHS Factor 9. There were also some “General Points”, which included:

  1. “Try to maintain patients on same material and same batch if possible to reduce donor exposure.
  2. Remember that even NHS factor VIII will transmit Non A Non B hepatitis. Use DDAVP or cryo. where possible for mild hepatitis susceptible individuals.
  3. Try to avoid introducing a dose of commercial concentrate during a treatment episode which has already commenced on NHS material unless there is a good reason for changing.
  4. Think in terms of material to be used as well as units of factor VIII, especially when instructing resident junior staff.” [1247]

There are four observations to make regarding these guidelines.

The first is that their production in May 1983 suggests that no steps were taken prior to that date in response to the risk of AIDS.

The second is that the picture revealed by the annual returns is not entirely consistent with the implementation of these guidelines. 1983 saw a reduction in the use of cryoprecipitate for the treatment of patients with Haemophilia A, with the main treatment product being NHS concentrates (809,972 units) and commercial concentrates (1,051,422 units).[1248] Whilst Profilate was the main commercial product used (both for home and hospital treatment), Factorate, Koate, Hemofil and Kryobulin were all used in varying degrees. The individual patient data filed with the return shows some people being treated with multiple products during the year. The 1984 return showed a modest increase in the use of cryoprecipitate, a greater increase in the amount of NHS concentrates used (1,704,313 units), and a reduction in the amount of commercial concentrates (861,677 units), although, as the figures show, treatment with commercial concentrates was still a substantial part of the approach at Cardiff. The principal commercial concentrate in use in 1984 was Koate.[1249] DDAVP featured on the return for the first time: there is no record of its use to any significant extent in 1983.[1250]

The third is that the guidelines drew little distinction between the use of NHS concentrate and the use of cryoprecipitate (and indeed Professor Bloom wrote to Dr Boulton on 23 May stating that “at the moment we are not rigidly differentiating between cryoprecipitate and N.H.S. concentrate as far as severely affected patients are concerned at any rate[1251]), yet NHS concentrates were made from large donor pools and on any view carried a substantially greater risk of transmitting both NANBH and the agent causing AIDS than cryoprecipitate. This absence of any clear distinction between cryoprecipitate and NHS concentrate is apparent from the inconsistent treatment of children at the Centre in 1984. The individual patient data filed with the 1984 return shows:

The fourth point is that the Cardiff guidelines may relate only to treatment in hospital. In relation to home treatment, Professor Bloom’s view, as expressed by him at the UKHCDO meeting in October 1983, was that there was no need for patients to stop using commercial concentrates and that patients should not be encouraged to go over to cryoprecipitate for home therapy but should “continue to receive the NHS or commercial concentrates in their usual way.[1254] It is, moreover, clear from both the returns and the statements which the Inquiry has received from those treated in Cardiff, that home treatment continued unabated.

The data provided by UKHCDO to the Inquiry indicates that 45 people treated at the Cardiff Haemophilia Centre were infected with HIV.[1255]

Oxford

In common with Professor Bloom, Dr Rizza, director of the Oxford Haemophilia Centre, and secretary to UKHCDO, knew at least as at September 1982 that three US patients with haemophilia were reported to have AIDS. On 8 October 1982 he wrote to Dr Craske referring to information he had received from the US: “Apparently the whole problem has caused quite a stir in the haemophilia world in the States so much so that one very senior physician has withdrawn his factor VIII concentrates from the accident room and insists on vetting the patients himself before any dose is given.[1256] In November 1983, Dr Rizza was provided with a copy of Dr Craske’s paper on AIDS. He attended the Hepatitis Working Party meeting on 19 January and the Heathrow hotel meeting on 24 January 1983.

In May 1983, Dr Rizza wrote to the Oxford Regional Health Authority’s regional medical officer in support of plans to set up an AIDS screening programme. The terms in which he wrote are instructive:

“I think it is important that we act quickly to set up screening tests to detect the patients who might be at risk of developing the full blown condition.

Apart from their value in helping us manage our patients better, I think it is particularly important to set up tests in Oxford for the following reason. The Oxford Haemophilia Centre is the largest in the country and in addition to using American factor VIII concentrates which are said to carry a risk of transmitting AIDS, we also use large amounts of NHS factor VIII. Our system of treatment is such that many patients have received only NHS factor VIII and others only U.S. concentrates. It should therefore be possible to find out if patients on NHS concentrates are immuno-suppressed to the same degree as those on U.S. concentrates ... The matter is one of great urgency.” [1257]

The letter indicates a clear awareness that people treated at Oxford were and would continue to be at risk. There is, however, no evidence of any change of direction in terms of treatment. The 1983 annual return shows that there was almost no cryoprecipitate used for the treatment of Haemophilia A. 1,636,580 units of NHS Factor 8 were used; over 4.5 million units of commercial concentrates were used.[1258] The return made no mention of DDAVP. The individual patient data filed with the return shows patients being treated with more than one type of concentrate (sometimes treatment with NHS concentrate and with two types of commercial concentrate), suggesting that there was no batch dedication system in place.[1259] The picture in 1984 is similar (save that DDAVP was mentioned for the first time): almost no cryoprecipitate; 1,919,162 units of NHS Factor 8; and 3,907,595 units of commercial concentrates.[1260] The individual patient data shows people being treated with NHS and commercial concentrate and with more than one type of commercial concentrate.[1261]

It was not until December 1984, when the Centre placed its first order for heat-treated concentrates, that there was any significant change of approach.[1262]

Data from UKHCDO records that 128 patients tested positive for HIV at Oxford.[1263]

Bradford

In Bradford, where Dr Parapia took up an appointment as a consultant in 1981 and then became director in 1982,[1264] cryoprecipitate had been used almost exclusively.[1265] The 1982 annual return showed a move away from cryoprecipitate to factor concentrates and the introduction of home treatment,[1266] with a similar pattern in 1983.[1267] It appeared from Professor Parapia’s evidence that this reflected a perceived need to “keep up with the times” and not appear “inferior”. Professor Robert Turner had been “quite old fashioned and he believed cryoprecipitate was okay.” The commercial home treatment packs were “far better” than the NHS packs, being “all ready in a nice little box with the needle and everything” and were more soluble.[1268] In relation to the relative safety of commercial products, Professor Parapia would ask questions of commercial companies about where they were getting their donations from, would be told that they conformed to the appropriate US standards, and had to accept their answers “because [the products] were licensed.[1269] He said “we were desperate for guidance ... for leadership, which I don’t think we ever got properly, either from the Government or UKHCDO or whatever.[1270]

Professor Parapia read The New England Journal of Medicine but following the January 1983 editorial[1271] he did not recall having discussions within the region about what to do: “We were waiting, again, for instruction or guidance.[1272] A reversion to cryoprecipitate for patients with haemophilia was not considered.[1273]

No changes to treatment practice took place in Bradford before December 1984. A meeting of local haemophilia centre directors and transfusion directors took place on 4 December 1984. The note of the meeting recorded agreement that “on theoretical grounds heat-treated material was likely to be safer than non-treated material”: Dr Parapia and Dr Michael McEvoy felt that NHS material was preferable, whilst Dr Swinburne and Dr David Barnard were in favour of heat-treated material (whether NHS or from the US).[1274] In February 1985, Dr Swinburne wrote to Dr Derrick Tovey at the RTC explaining that local directors, having discussed the Elstree protocols (a reference to the AIDS Advisory Document produced following the 10 December meeting at BPL), were not interested in the offer of an interim heat-treated product likely to be available for only two or three months and preferred to wait until April when “a better product is promised”; in the interim they would use untreated BPL Factor 8.[1275] Professor Parapia expressed surprise at the decision (which he could not recall) to turn down the interim heat-treated product and use an unheated product.[1276]

UKHCDO data suggests that 18 patients were infected with HIV at Bradford.[1277] To put that figure in context, 22 patients with Haemophilia A were treated during 1982 and in 1983.

St George’s Hospital

St George’s Hospital had around 25 severely affected patients, including about 8 children, in the late 1970s and early 1980s. Like many haemophilia centres, it had shifted away from cryoprecipitate and towards concentrate, predominantly commercial.[1278] As described by Dr Bevan (who joined St George’s in 1977 as a registrar, then as lecturer and honorary senior registrar, before his appointment as the consultant haematologist in 1984), “this was the pattern all across the haemophilia world.[1279] He recalled the growing use of home treatment, mostly on demand but with some prophylaxis, mostly in children and young people.[1280] Professor Peter Flute, who was until 1985 the director of the Centre, preferred to give NHS concentrate to children and younger adults with severe Haemophilia A because of the risk of transmission of NANBH, but adults were usually given commercial concentrate. So too were younger adults, despite the preference of Professor Flute for NHS product, because there were insufficient supplies of NHS concentrate. It was probably inevitable that children too ended up receiving commercial (Armour) concentrate.

There was no change of treatment policy at St George’s in response to the risk of AIDS until a switch to heat-treated products in early 1985.[1281] Dr Bevan recalled a meeting with Professor Flute at which the issue of AIDS was raised and the risk to people with haemophilia. Professor Flute “in his usual way, kind of gruffly, jovially said he didn’t regard this as in any way a proven infection.[1282] Professor Flute explained that in no way would he take any action in terms of changing infusion practice in haemophilia, unless there was official firm guidance from UKHCDO to do so.[1283] There was, of course, no such guidance until the December 1984 AIDS Advisory Document.[1284]

Dr Bevan’s recollection was that there were between 15 and 18 patients infected with HIV, of whom one had moderate Haemophilia A, one had Haemophilia B and the remainder were people with severe haemophilia (of whom three or four were children).[1285]

Guy’s Hospital and Margate

Guy’s Hospital, in London, was a relatively small haemophilia centre, with about 30-40 registered patients, of whom about 10-15 were severely affected. The director was Dr Percy Barkham, whose interest lay outside haemophilia, and in practice the haemophilia patients were managed by senior registrars. Dr Winter, who worked at Guy’s between 1979 and 1983 as one of the senior registrars, explained that there was “never enough” NHS concentrate.[1286] The RTC at Tooting had to cover both the South East and the South West Thames regional health authority areas and was as a result under a great deal of pressure.[1287] Shortfalls were covered by the use of commercial concentrate, and cryoprecipitate was in limited use only: for mild haemophilia or von Willebrand disorder, or occasionally for a child or rarely treated adult.[1288] Some people with moderate haemophilia would have received commercial concentrate because of the shortfall.[1289] It was possible that a patient with mild haemophilia might also have received commercial concentrates, if DDAVP was not going to work.[1290] Children were prioritised for the NHS product: Dr Winter could not recall giving a child commercial concentrate but could not be absolutely sure that he had not.[1291] There was prophylactic treatment for children.[1292]

Dr Winter could not recall what (if any) changes were made to the treatment practices at Guy’s in response to the risks of AIDS: children would have continued to be prioritised for the BPL product; it was possible (but he could not recall) that prophylaxis programmes might have been suspended; but the key message for him and his colleagues was “do not give concentrate unless the patient absolutely needs it.[1293] There was no reversion to cryoprecipitate; Dr Winter thought that Tooting would not have been able to provide sufficient supplies, but accepted that no one from Guy’s, to his knowledge, approached Tooting to explore the possibility of more cryoprecipitate being supplied.[1294]

In December 1983, Dr Winter moved to take up the post of director at the Haemophilia Centre in Margate.[1295] This Centre had not been operating in the same way as centres elsewhere: patients on home treatment got Factor 8 on prescription from their GP and then collected it from their local pharmacy.[1296] This system appeared to have resulted from a serious lack of local funding in previous years. The result was that there were no records as to what patients had received or as to the type or amount of Factor 8 they had been using for home treatment. Neither the GP nor the pharmacist would have been likely to know anything about Factor 8 or alternative treatments, and patients would have been receiving exclusively commercial concentrates because the pharmacist would not have access to the supply of NHS concentrate from the RTC.[1297]

Following discussions with Dr Savidge, Dr Winter decided to start using heat-treated concentrates (from Alpha) on a named patient basis; this was, he said, a very difficult decision.[1298] Dr Winter recalled Professor Bloom saying to them “You are mad to switch. There will never be HIV in BPL Factor VIII.[1299]

The heat-treated concentrates began to be available in May 1984 and from June 1984 the only concentrates being used were heat-treated Factor 8 and 9 both for hospital treatment and home treatment and prophylactically for children.[1300] Dr Winter’s initiative was, however, too late. When he sent sera to Dr Tedder for testing in October 1984, all but one was positive for HIV, a consequence of the system that had prevailed under his predecessor. About half of those were children and some would have been people with moderate haemophilia.[1301]

Dr Winter was, rightly, critical of the lack of “what you might call powerful, influential, centralised advice ... there was no central body that had published very clear, firm guidance or protocol, or call it what you will, to haemophilia doctors saying, this is what we think you should do in this situation.” When HIV broke, “we were blood specialists, haemophilia doctors, not virologists dealing [on a] day-to-day basis with the problems caused by a virus of which we were not specialists ... We very much lacked firm, central guidance from whatever body ... a body set up for national virological advice, or the Chief Medical Officer or whatever.[1302]

Dr Winter told the Inquiry of two patients who were treated at William Harvey Hospital in Ashford, Kent, a general hospital which did not have a haemophilia centre. A four-year-old boy with mild haemophilia was given commercial Factor 8 in April 1984, was infected with HIV, and subsequently died. A man with mild haemophilia who cut his arm and was taken to the same hospital in June 1984 was given commercial Factor 8, was infected with HIV, and subsequently died.[1303] These starkly illustrate the consequences of the lack of clear central advice and guidance.

The London Hospital

Dr Colvin, the director of the haemophilia centre at The London Hospital, attended, like many of his colleagues, the 24 January 1983 meeting at the Heathrow hotel.[1304] He would have read the Desforges article in The New England Journal of Medicine.[1305] He acknowledged that by January 1983 he would have been aware that there was a risk to people with haemophilia of AIDS and that the most likely route of transmission for them was blood or blood products.[1306] He accepted also that AIDS was known to have a very high mortality rate and that there might be a significant lapse of time before symptoms presented, such that the fact that there were only a few cases so far identified would not be a reliable guide to the true extent of the risk.[1307] Yet when the Haemophilia Working Party of the North East Thames Region Association of Haematologists met on 9 February 1983, there was no discussion whatsoever about AIDS and the risks it posed.[1308] There was no significant change of approach to treatment instituted at The London, although Dr Colvin thought that they would have tried “to minimise the risk where it was sensible and possible to do so.[1309]

It is striking that when in August 1983 Dr Colvin and Dr Kernoff co-authored a paper on haemophilia services in the NETR there was only passing reference to the risks of AIDS: a description of the complications of treatment as including “Plasma product-transmitted disease, particularly hepatitis and (possibly) the acquired immune deficiency syndrome (AIDS)” and a sentence that read “Clinical problems related to impaired immunity seem to be rare at present, but conceivably could become a major clinical problem.” No measures or steps to address or attempt to reduce or minimise those problems were considered in the paper.[1310]

Writing to David Watters of the Haemophilia Society in February 1984, Dr Colvin suggested that “we know little about AIDS at present. In my opinion there is no reason to spurn commercial concentrate and we have to keep an open mind on the risk associated with NHS material.[1311] When the NETR Haemophilia Working Party met again in May 1984, the minutes record a suggestion that “until a positive test for AIDS and/or a vaccine is developed it should be policy to avoid use of blood products except for essential treatments and to use cryoprecipitate or plasma instead of FVIII Concentrate whenever possible.[1312] That suggestion did not lead to any change of policy at The London.[1313] It was not until 13 December 1984 (ie following the meeting at Elstree on 10 December) that the NETR Haemophilia Working Party agreed a change of approach, namely to use heat-treated material whenever possible and to treat all new patients and those with mild haemophilia with heat-treated NHS concentrate or small pool Factor 8 concentrate if treatment with cryoprecipitate or DDAVP was not possible.[1314]

Dr Colvin’s evidence was that there were 41 patients infected with HIV, of whom 31 had severe Haemophilia A, 9 had moderate/mild Haemophilia A and 1 had Haemophilia B. He could recall three children who were infected with HIV from their treatment and one partner of a patient who was infected.[1315]

Of particular interest were Dr Colvin’s views that:

  1. there is a sense with haemophilia care, you get a lot for your first few units. You don’t get much better from your last few units.[1316]
  2. it was fair to say that an analysis of risk did not really come into the picture: “because of the lack of engagement on the non-A, non-B risk of factor concentrate, the potential advantage of cryoprecipitate for relatively infrequently treated patients with haemophilia might not have been addressed properly.[1317]

Also of interest are his reflections on how the service could have managed if importation of commercial concentrates had been suspended in July 1983.[1318]

Leeds

The haemophilia centre at Leeds continued to use substantial amounts of commercial concentrate and no cryoprecipitate for the treatment of Haemophilia A patients between 1982 and 1984. Thus in 1982 the annual return shows somewhere between four and five times as much commercial concentrate being used as NHS.[1319] Although the volume of NHS concentrate increased in 1983, a very substantial amount of Factorate continued to be used.[1320] 1985 showed the use of a tiny amount of cryoprecipitate, with NHS concentrate and commercial concentrates being used in substantial amounts.[1321] There is no evidence from the returns or any other material of any risk reduction or minimisation strategy being pursued. The data received from UKHCDO suggests that 53 patients were infected with HIV.

Liverpool

Liverpool was another large non-reference centre. Dr Bernard McVerry was (in practice) the director between 1980 and 1985. A meeting of regional haematologists at the Mersey RTC in November 1983, attended by Dr McVerry and Professor Alastair Bellingham, was notable for the absence of any discussion at all about the issue of AIDS.[1322] From 1981 commercial concentrates predominated,[1323] with a marked decline in the use of cryoprecipitate from 1982,[1324] although the use of NHS concentrate increased in 1983 and 1984.[1325] The individual patient data filed with returns showed patients being treated with more than one type of concentrate.

Dr McVerry recalled consulting Dr Jones, the director of the Newcastle Haemophilia Centre, before choosing what products to prescribe: “Based on Dr Jones’s experience I was encouraged to switch to commercial F8 for two reasons, the first related [to] availability and reliability of supply, and second there was a mood at that time to continue using a particular product in an individual patient as this may reduce the prevalence of factor antibodies arising (although this later proved not to be the case).[1326] Dr McVerry could not recall giving cryoprecipitate to a patient in Liverpool.[1327]

A document prepared by Dr Charles Hay (who became the director at Liverpool in 1987) for the HIV Haemophilia Litigation set out his understanding that “All patients were treated with whichever material was available. No cohorts were treated with any specific product ... Patients were treated with whatever was available and were not reserved particular products or batches (as was the practice in some centres). There was no pattern of use, and this did not change. All factor VIII used prior to mid 1985 was untreated and after that all was heat treated.” His view was that “insufficient use of cryo was made in this centre. Children and mild haemophiliacs should have been treated preferentially with cryo and possibly domestic concentrate.” He also confirmed that DDAVP was used less in Liverpool than in other centres.[1328] Other documentation arising in the context of litigation suggests that “no specific priority was given to mild haemophiliacs for treatment with NHS product at the time.[1329]

Dr McVerry’s statement indicates that he had no awareness of AIDS until the September 1982 UKHCDO meeting. He referred to Professor Bloom saying even up to mid 1984 that there was no proven association with blood products, although he said it was reasonably clear there was a real risk at the end of 1983 or beginning of 1984. He would have read the Desforges article (having worked with her in Boston) and did not recall any reversion to cryoprecipitate in Liverpool (as is borne out by the annual returns).[1330]

Sheffield

1981 saw substantially increased use of NHS concentrate, although commercial concentrates remained the most used product (however, the usage for commercial concentrates was significantly less than the previous year); a relatively small amount of cryoprecipitate was used.[1331] In 1982, the picture was broadly similar to 1981.[1332] 1983 showed no particular change of approach. The Centre treated its patients with a mix of NHS concentrates and commercial.[1333] 1984, however, saw a rather greater use of NHS concentrates than commercial, although a substantial amount of the latter (and a small amount of cryoprecipitate) was still used.[1334] It is likely that some of the commercial concentrates would have been heat-treated, although that is not apparent from the return itself.[1335] In 1985, the vast majority of treatment was with commercial concentrates, with very little NHS concentrate used: this is likely to reflect the use of heat-treated concentrates.[1336]

Dr Preston was present at the January 1983 Heathrow hotel meeting and as a reference centre director was party to the special meeting on 13 May 1983. He could not remember the detail of the meeting, although his general recollection was that nobody amongst the reference centre directors disagreed “with the concept of continuing with treatment, with the concentrates.[1337] Treatment with concentrates “had to continue” because otherwise patients “would be severely incapacitated or even die.[1338] The advent of AIDS did not lead to any reversion to cryoprecipitate for the Royal Hallamshire: it appears to have remained Dr Preston’s view that it was not particularly easy to use, there was no guarantee of the amount of Factor 8 in each bag, and it was not a particularly useful therapeutic option for major surgery or major bleeds.[1339]

The numbers of patients infected with HIV in consequence of treatment at the Royal Hallamshire Hospital is not entirely clear. Data from UKHCDO suggests 24 patients[1340] and Professor Preston’s recollection when he gave evidence to the Lindsay Tribunal was that the percentage of patients infected with HIV in Sheffield was lower than many other centres.[1341]

Leicester

It will be clear from the above narrative that little was done by haemophilia centres in response to the risks of AIDS. Few centres implemented, or even contemplated, a reversion to cryoprecipitate. But cryoprecipitate could successfully be used for the treatment of both adults and children.

Dr Vivian Mitchell became the director at Leicester Haemophilia Centre in November 1979. When he arrived home treatment was established, with patients mostly using commercial concentrates. There was not a great deal of NHS Factor 8 being used. Dr Mitchell had worked as a senior registrar in Sheffield, under Professor Blackburn and Dr Preston. He understood from the 1978 Sheffield study that at least in some patients liver disease was significant and progressive.[1342] Dr Mitchell decided to adopt an approach to treatment that was explicitly based on the reduction of risk, restricting the use of large donor pool concentrates whenever possible. He was “convinced by the Sheffield work and the Sheffield report that there was a connection between the use of multi-donor factor concentrates and the development of liver disease” which could be progressive.[1343] Dr Mitchell described professional isolation. There was no national or regional guidance and he was some 70 miles from the reference centre in Sheffield. He therefore devised his own policy. For mild and moderate haemophilia and for von Willebrand disorder, he used DDAVP and tranexamic acid wherever possible and largely successfully, although it was not always sufficient for moderate patients.[1344] If he could not use DDAVP/tranexamic acid, he would use cryoprecipitate where feasible. For children with severe haemophilia, they would be treated with cryoprecipitate until they went onto home treatment (probably around the age of ten).[1345] Dr Mitchell did not experience difficulties in obtaining sufficient quantities of cryoprecipitate or with adverse reactions to cryoprecipitate.[1346] For adults with severe Haemophilia A, the approach was to treat them with NHS concentrates as much as possible,[1347] although there were insufficient supplies so commercial concentrates were used. He would have used more NHS product if it had been available.[1348] When he arrived, the majority of patients on home treatment were receiving commercial concentrate and he did not have the ability to switch them all over to NHS concentrates given the amount received.[1349] The second element of Dr Mitchell’s policy in relation to adults with severe Haemophilia A was to adhere to one batch of one concentrate as much as possible. He would buy as much as he could of a batch from a single commercial supplier. It took a year or so to implement this approach.[1350]

Dr Mitchell wrote to The British Medical Journal in July 1985 in response to Professor Bloom’s letter suggesting that cryoprecipitate should no longer be used. It is an important letter, because it shows that haemophilia centre directors could, using their initiative, reduce (although not eliminate)[1351] the risks of viral transmission:

“Initially because of concern about chronic liver disease in haemophiliacs, and, more recently, with HTLV-III also in mind, we have for the past five years tried to restrict the exposure of our patients to large donor pool concentrates. Cryoprecipitate has played a major part in this policy, being used in the treatment of patients with von Willebrand’s disease and those with mild to moderate haemophilia. Children with severe haemophilia are also treated with cryoprecipitate until they go on to home treatment. Even so, we used 1 million units of factor VIII concentrate in 1984, 60% in the form of commercial concentrate. This exposure is limited by buying as much as possible of a batch from a single commercial supplier. In this way patients have been treated for as long as 18 months using 100 000 units or more of the same batch.

This policy has resulted in a low prevalence of HTLV-III antibody in our patients. We recently tested 76 patients (including 27 children) who have received blood products at this centre during the past five years. Seven of the 28 who had received commercial concentrate were HTLV-III antibody positive (25%). There were no positive results from patients treated with NHS factor VIII concentrate only (5), NHS factor IX concentrate (12), cryoprecipitate (28), or fresh frozen plasma (3). The seven positive patients all have severe haemophilia A ... and constitute 37% (7 of 19) of this most at risk group. All are adults, aged 23 to 54 years ...

Recurrent treatment with blood products is hazardous ... The best approach seems to us to be a treatment policy which is designed to reduce, as much as possible, all the risks associated with blood products and which is tailored to the needs of each individual patient.” [1352]

An eighth patient later tested positive, who also had severe haemophilia. Dr Mitchell’s recollection was that no patient at Leicester with mild or moderate Haemophilia A or with Haemophilia B or with von Willebrand disorder tested positive, nor any child.[1353]

Commentary

Professor Tuddenham rightly said in his evidence to this Inquiry that“Everything that we give to a patient has to be subjected to the most intense scrutiny.[1354]

Blood products above all should be given the closest scrutiny to ensure they are as safe as can reasonably be: for it is given that one person’s blood or plasma may contain something that is harmful to a recipient just as it may also be beneficial. That should have been the guiding principle when dealing with blood products in the 1970s and 1980s. It is clear from earlier sections of this Report that blood was not always as safe as could reasonably be, and that making products from pools of blood from different sources made them less safe still.

Haematologists treating patients needed to be alert to newly emerging risks, and be prepared to modify the treatment offered to patients so as to minimise the prospect of those risks becoming reality for them.

The evidence shows that clinicians should all have been alert to a risk of AIDS by the end of 1982, if not earlier. It was by then already a substantial concern in the US, the likeliest candidates for transmitting its cause were blood or sex, and thus whether AIDS was caused by a virus, an overload of foreign proteins, or a combination of the two, large pool factor concentrates were likely carriers of them.

In the light of this awareness, what were the steps that could and should have been taken by haemophilia centres? They could and should have:

  1. Ceased to use the commercial concentrates, which carried the greatest risk.
  2. Adopted a conservative approach to treatment, using less concentrate (or cryoprecipitate), and treating only where strictly necessary.
  3. Reverted to the use of cryoprecipitate in place of concentrates (commercial or NHS), or fresh frozen plasma for the treatment of Haemophilia B.
  4. Suspended home treatment.
  5. Ceased prophylactic treatment where that was provided.
  6. Avoided treating patients with multiple products and multiple batches: “batch dedication” could have been adopted more widely than it was.
  7. Deferred elective/non-essential surgery.
  8. Maximised the use of DDAVP and tranexamic acid.
  9. Provided advice and encouragement as to measures that could be taken by individuals to reduce the risk of bleeds.

Above all, it was important to discuss the risks and alternatives (and be straightforward about the gaps in knowledge) with each patient individually, as fully as reasonably possible, and be guided by their view of what mattered to them.

It is important to appreciate that these measures did not have to provide a satisfactory permanent or even long-term solution: they needed to be implemented only until such time as the risk of transmission was eradicated, through viral inactivation, vaccination (until it could be discounted as being a possibility) and donor screening, or until knowledge expanded to a state where it could be shown that taking factor concentrates was safe. If, for instance, there had been a policy to use only NHS concentrate or cryoprecipitate, it would have reduced risks. It would not have eliminated them, as the Edinburgh experience demonstrates, but it would have taken steps in the right direction. What should not have happened was waiting for proof (rather than reacting to the risk, which was already established) that concentrates were unsafe before acting, for this is a recipe for inaction, delay, and the growth in numbers of infections and those carrying them which turns a public health problem into a public health crisis.

It is clear from what has been said about the individual centres that they each responded (if they responded at all) to different extents but, with notable exceptions such as Leicester, did not sufficiently respond as they might have done. Though knowledge of the extent to which patients with Haemophilia A became infected is inevitably retrospective, the policies which led to differences in result were made prospectively. What was applied in one centre with a view to keeping risk low could have been applied elsewhere, unless there was some compelling reason why it could not have been. None is obvious.

These failures lie with the haemophilia centres and their directors, in particular the reference centre directors, who failed to provide guidance when it was required. It is important to recognise, of course, that as set out elsewhere in this Report the blame for them goes well beyond clinicians, who in some respects were dealt a difficult hand[1355] – products were licensed, as they should not have been; NHS concentrates, undoubtedly safer, were not produced in sufficient quantities as they should have been; pool sizes from which products were made were allowed to grow and grow, and with them the risks they posed; research into viral inactivation was inadequately resourced and not sufficiently encouraged; domestic products were made from pools containing plasma donated by prisoners and other high risk groups, and insufficient was done to avoid this; the official rhetoric was that of reassurance rather than realism; decisions as to continued importation of factor concentrates were deeply flawed in the manner they were taken and the logic applied to take them; there was no review of these decisions as had been promised; dumping of riskier commercial products was permitted. It is clear that clinicians such as Dr Parapia (Bradford) and Dr Chisholm (Southampton) would have welcomed guidance and were not given it. Individual directors – in particular reference centre directors – contributed to some of these failings, quite apart from failures in their own treatment of patients, for they influenced a number of those decisions. They influenced the rhetoric. They influenced the fierce dismissal of messengers of bad news such as Susan Douglas writing in The Mail on Sunday. They contributed to a climate in which other treating clinicians understood the guidance to be simply to carry on as before.

The complex web of shortcomings described in brief above which led to infections occurring when they should not have done is addressed elsewhere in this Report. It means that others share some responsibility for what occurred. Nonetheless, the “front line” of treatment was the haemophilia clinician. Difficult hand though they might have been dealt, most fell short. They failed to adjust treatment policies as should have occurred; failed to tell patients adequately of the risks to them as individuals; and when infections were known, frequently failed to tell the patient concerned as soon as they reasonably could, or appropriately.

Haemophilia B

Much of what has been set out in this chapter so far has focused on the treatment of Haemophilia A, not least because of the extensive use of imported commercial factor concentrates in the treatment of people with Haemophilia A. Imported concentrates were not usually a feature of the treatment of people with Haemophilia B in the 1970s and 1980s because the UK was largely self-sufficient in its supply of Factor 9.

Haemophilia B, originally referred to as “Christmas disease”,[1356] is a bleeding disorder caused by a deficiency of Factor 9. “The biological roles of Factors 8 and 9 are closely related ... and so the clinical picture that is caused by these deficiencies is near identical.[1357] Prior to 1952 patients were categorised under a generic diagnosis of haemophilia, but by 1952 it was possible to identify Haemophilia B as separate from Haemophilia A. Haemophilia B is, however, less common than Haemophilia A.[1358] As with Haemophilia A, Haemophilia B can be classed as severe (<1% Factor 9), moderate (levels of 1-5%) and mild (>5%): there are roughly six times as many people with severe Haemophilia A as suffer from severe Haemophilia B.

Prior to the availability of Factor 9 concentrates, treatment of Haemophilia B was with fresh frozen plasma (“FFP”).[1359] Tranexamic acid (but not DDAVP)[1360] could also be used in the treatment of Haemophilia B.

Treatment practices in the 1970s and 1980s

Factor 9 concentrates were first used in the UK in 1960. They were prepared by Dr Biggs, Dr Ethel Bidwell and colleagues at the Blood Coagulation Research Unit in Oxford using residual material derived from the plasma fractionation process at BPL.[1361]

According to Dr Rizza in his report for the HIV Haemophilia Litigation:

“Throughout the 1960’s supplies of NHS Factor IX were limited and were reserved mainly for patients undergoing surgery. From 1969 onwards there was a slow increase in the availability and use of NHS Factor IX in the UK from approximately 0.5M units in 1969 to 18M in 1988. The United Kingdom has been self sufficient in Factor IX since about 1970 and there has been little usage of commercial Factor IX except for a short period in 1985 when some Directors of Haemophilia Centres purchased commercial Factor IX in preference to NHS Factor IX because the commercial material had undergone heat treatment.” [1362]

As availability of NHS Factor 9 increased, its regular administration became a possibility. At the haemophilia centre directors’ annual meeting in April 1971, there was a general feeling among directors “that regular administration of factor IX to severely affected Christmas disease patients was beneficial.” Regimes of “weekly, fortnightly or even monthly administration had been tried with success”and such treatment “was to be recommended for the very severely affected Christmas disease patient whenever this was possible.[1363]

As the 1970s progressed, home therapy with Factor 9 concentrates became a feature of the treatment of people with Haemophilia B.[1364] So too, to an extent, was prophylaxis.[1365] The usage per person increased year by year.

In January 1977, Dr Bidwell of PFL reported that whilst she had in 1972 estimated the Factor 9 requirements to be about 5,000 bottles a year, by 1976 nearly 10,000 bottles were used. She explained to those directors whose Factor 9 requirements had increased substantially that “present arrangements for production of factor IX and level of funding did not allow for prophylactic treatment except for occasional short periods of time.” However, “prophylaxis for severely affected patients may not be excluded if it were shown not to result in substantial increased usage.[1366]

By 1976 Factor 9 concentrate was the dominant treatment with comparatively little use of FFP.[1367] By October 1977 the amount of Factor 9 concentrates being issued from the PFL at Oxford was said still to be rising although showing signs of levelling off,[1368] and in 1978 and 1979 there were increases in total usage, though at a much smaller rate. The average amount used per patient stabilised at 20,300 units (compared to just under 19,000 in 1976).[1369] The increase in overall usage was possibly due to the number of children who were growing and therefore requiring more treatment “but in general there was no clear-cut reason for the increase in usage.[1370] By 1978 there were approximately 87 Haemophilia B patients on home therapy.[1371]

There was then an increase in 1980 both of the overall amount used and the average per patient. 367 patients were treated (including 12 carriers of Haemophilia B), with a total of 8,387,000 units of Factor 9: mostly with NHS Factor 9 (8,307,000 units), with a tiny amount of FFP (3,000 units) and an increase in commercial Factor 9 concentrates (77,000 units), though the usage of this remained less than 1% of the total. The average used per Haemophilia B patient was now 22,853 units.[1372] Patients on home treatment (of whom there were 143 during the year – an increase of over 60% from 1978, a significant increase over two years) received an average of 29,685 units.

1981 saw a further increase. 378 patients (including 10 carriers) were treated with 9,899,000 units of Factor 9: again mostly with NHS Factor 9 (9,874,000), with a tiny amount of FFP (2,000 units) and 23,000 units of commercial concentrates (less than one quarter of 1% of the total). The average amount used per Haemophilia B patient was 26,188 units – representing an increased use of Factor 9 concentrates[1373] despite this being the year following the Glasgow symposium (which should, as described earlier in this chapter, have reinforced to clinicians the risks of hepatitis transmission). Patients on home treatment (of whom there were 157 during the year) received an average of 33,210 units. This upward trend continued in 1982-84, as detailed in the next three paragraphs.

In 1982, 379 patients (including 9 carriers) were treated with 9,281,000 units of Factor 9, all of which was NHS concentrate apart from 5,000 units of plasma used to treat carriers. The average used per patient with Haemophilia B was 24,488 units, a slight decrease from the previous year. There were 164 patients on home treatment, who received an average of 32,927 units.[1374]

In 1983, 382 patients (including 12 carriers) were treated with 10,895,000 units of Factor 9, all of which was NHS concentrate apart from 9,000 units of FFP. The average used per patient with Haemophilia B was 29,241 – an increase on the previous year. There were 167 patients on home treatment, who received an average of 37,569 units.[1375]

In 1984, 403 patients (including 12 carriers) were treated with 12,114,000 units of Factor 9, all of which was NHS concentrate apart from 17,000 units of FFP. 7,000 units of Autoplex were also used. The average used per patient with Haemophilia B was 30,060 units, an increase on the previous year. There were 186 patients on home treatment, who received an average of 36,392 units.[1376]

The picture changed markedly in 1985, no doubt in consequence of the AIDS Advisory Document. 401 patients (including 15 carriers) were treated with 10,675,000 units of Factor 9. The amount of FFP used remained low (27,000 units). Most patients were still treated with NHS Factor 9 – much of which would not have been heat treated – totalling 7,750,000 units but a substantial quantity of treatment (2,898,000 units) was with commercial concentrates, presumably those which had been heat treated. The average used per patient with Haemophilia B was 26,621 units. 193 patients were on home treatment, receiving an average of 32,119 units of Factor 9.[1377]

In summary, the average usage of Factor 9 per patient rose from 21,000 units in 1978 to 30,060 units in 1984 (a figure almost half as much again). The numbers on home therapy rose from 87 to 186. Almost all of the treatment during that period was provided by NHS concentrate. What followed in 1985 might suggest that treatment at that level was more than was thought strictly necessary, for the average amount per patient dropped by 12% overall and for those on home treatment. The largest criticism, however, is that the figures show that the heightened awareness of serious long-term consequences caused by hepatitis as a result of using pooled concentrates demonstrated in the Glasgow symposium had had no obvious effect on practice. To the contrary, as the risk of long-term disease grew greater, so did prescription of the amount of product causing it.

Numbers of patients with Haemophilia B

Year Patients treated
Total patients Patients with Haemophilia B Carriers Patients on home therapy
1978 337 330 7 87
1979 342 331 11 125
1980 367 355 12 143
1981 378 368 10 157
1982 379 370 9 164
1983 382 370 12 167
1984 403 391 12 186
1985 401 386 15 193

Treatment for patients with Haemophilia B, including carriers

Year Average number of units per patient
Total units NHS Factor 9 Fresh frozen plasma Commercial Factor 9 For patients on home treatment
1978 20,300 20,175 92 33 Data not available
1979 20,273 20,269 4 0
1980 22,853 22,635 8 210 29,685
1981 30,060 26,122 5 61 33,210
1982 28,521 24,475 13 0 32,927
1983 28,521 28,497 24 0 37,569
1984 30,060 30,017 42 0 36,392
1985 26,621 19,327 67 7,227 32,119

Scotland

In Scotland, the supply of Factor 9 concentrates from the PFC was, according to a January 1981 report from Dr Cash, “always more than adequate”.[1378] The amount of PFC Factor 9 (DEFIX) supplied doubled from 500,000 international units in 1975 to 1,000,000 international units in 1980. Dr Cash continued: “Several reports have implied that the risks of transmitting agents likely to cause hepatitis is higher for factor IX than VIII concentrates. The evidence is not firm but may relate to differences in pool size (the former usually being larger). Nevertheless, continuing efforts are being made to improve matters and a stage has been reached at P.F.C. when clinical studies will soon be required.” Haemophilia B patients were described as “a high risk group for hepatitis”.[1379]

The report also recorded that a new Factor 9 product – Supernine – was at an advanced stage of development: “Further purification of DEFIX has led to a product which we believe may be both safer with regard to virus transmission and thrombogenicity.[1380]

The Scottish Haemophilia and Blood Transfusion Working Group discussed, at its meeting on 4 March 1981, the setting up of clinical studies of Supernine. The West and South East Regions were reported to have access to a limited amount of Supernine and a licence had been given for clinical trials. The “main aim was to obtain a product licence.” A discussion also took place about ways of determining quantities of Factor 9 concentrates used in Haemophilia B and non-Haemophilia B patients on an annual basis, Dr Cash expressing concern about the inadequate tracing of patients and lack of available data. It was agreed that “there should be an effective method of monitoring blood products, recording what product is given to a patient and how the products are used.[1381]

The minutes of the meeting of SNBTS directors and haemophilia directors on 21 January 1983 reported that the supply position of DEFIX over the last five years “had remained strong and the demand reasonably stable.” The clinical studies on Supernine “had produced excellent results” and it was not thought necessary to obtain a separate product licence, as a variation of the DEFIX licence on a named patient basis was considered sufficient. It was also reported that studies of heat treatment, to reduce hepatitis risk, were currently underway using Supernine, but the rate of progress would be slower than with Factor 8 because of the need to submit the heated Factor 9 concentrate to intensive animal studies to assess thrombogenicity.[1382]

Hepatitis

Hepatitis (both B and non-A non-B) was transmissible by Factor 9 concentrates in the same way as Factor 8 concentrates. This is illustrated by a study undertaken at Oxford on the epidemiology and chronic sequelae of Factor 8 and Factor 9 associated hepatitis in the UK.[1383] The second annual report on this study explained that, in addition to the follow up of 148 patients at Oxford receiving long-term Factor 8, Haemophilia B patients on NHS Factor 9 therapy had also been assessed. A table in Appendix II to the report provided details of changes in liver function tests in Oxford patients on regular treatment with Factor 9 concentrate in 1980: of 16 patients, 7 (44%) had persistently abnormal Aspartate Aminotransferase (“AST”) levels. Two of those (12.5% of the total cohort) had a persistently abnormal AST level of more than 70 international units per litre, double the upper range of normal for the study.[1384]

Three features emerge from the above narrative. The first is that as the 1970s progressed treatment for patients with Haemophilia B was increasingly with Factor 9 concentrates rather than FFP, ie with a product made from large donor pools rather than from single donations. The second is that the pools used for the production of Factor 9 were at times larger than the pools used for the domestic production of Factor 8.[1385] Thus, Dr Rainsford (at Treloar’s), writing in 1975 to a consultant at Great Ormond Street about the increased incidence of jaundice amongst boys with Haemophilia B, remarked that: “We have always assumed that this is due to the fact that the Christmas boys are almost invariably transfused with high potency factor IX prepared with material from large donor pools. However, I think this is a debt we shall have to continue to pay, since this high potency concentrate is so effective and no case of hepatitis that we have experienced can be regarded as even moderately severe[1386] and in 1976 Dr Maycock gave Dr Bidwell authorisation to increase the pool size for Factor 9 beyond that for Factor 8 so that one batch reached the capacity of the freeze dryer.[1387] The third is that the increasing use of home therapy and, to some extent at least, therapy on a prophylactic basis, meant that Haemophilia B patients were being treated with progressively greater amounts of concentrates than was previously the case – with, inevitably, a progressively increasing risk of hepatitis.[1388]

As discussed earlier in this chapter, the risk of hepatitis was well known and by the late 1970s, if not earlier, the potential for non-A non-B Hepatitis to have serious effects should have been appreciated in relation to Factor 9 concentrates just as much as in relation to Factor 8. It may be that, as a consequence of the combination of two elements, infections were less visible. First, the numbers of those who had Haemophilia B were significantly fewer than those who had Haemophilia A, and those whose condition was classed as severe only one-sixth as many. Second, though, and possibly most significant of all, the UK was self-sufficient in Factor 9 almost throughout the entire period. Though some commercial concentrate was procured, the percentage of it was so small that it can confidently be said that 99% or more of the product used was NHS (until heat treatment led to commercial concentrates filling the gap for a while).

Less visible though cases of infection in those with Haemophilia B may have been in comparison with Haemophilia A, many similar issues contributed to infections continuing to arise, and the numbers in which they did. Viral inactivation was as necessary; so too was giving thought to the size of the pool from which Factor 9 concentrates were made. Pool sizes increased for both Factor 8 and Factor 9 during the 1970s, to the extent that the pool sizes in the late 1970s were at least seven times, and often more, than they had been at the start of the decade, and well in excess of the figures regarded from 1952[1389] as the highest to secure reasonable safety. There is one point to note here though: whereas with Factor 8 pursuing a goal of self-sufficiency led to a desire to have larger pools, in the case of Factor 9 production this reason could not apply. This is because self-sufficiency was effectively secured. Pool sizes nonetheless were increased relentlessly.[1390]

Notwithstanding the growing knowledge, in the second half of the 1970s and into the early 1980s, of the potential seriousness of non-A non-B Hepatitis, there was no appreciable change in the approach to treatment of patients with Haemophilia B.

The advent of AIDS

The minutes of the special meeting of haemophilia reference centre directors on 13 May 1983 contain no reference to the use of Factor 9 concentrates or the treatment of patients with Haemophilia B at all.[1391] However, the recommendations subsequently circulated on 24 June 1983 by Professor Bloom and Dr Rizza referred to two matters having been drawn to their attention since the 13 May meeting: “The first concerns the treatment of patients with haemophilia B. The evidence to incriminate factor IX concentrates in AIDS is even less than with factor VIII and it seems logical to continue to use our normal supplies of NHS concentrate.[1392]

This is both a revealing and disappointing comment. There was no logical reason for thinking that Factor 8 could transmit the virus responsible for AIDS but that Factor 9 could not: the route of transmission was identical. There was reason, knowing that Factor 9 concentrates were made domestically from plasma which had been voluntarily donated, to think that it might be safer for that reason though it would not necessarily make the products entirely free of virus: but the words used combine a “continue as before” approach for Factor 9 with an emphatic dismissal of the idea that there was any substantial evidence to implicate Factor 9, which was irresponsible at the time.

In other words, “no change”: clinicians should go on treating patients with Haemophilia B with Factor 9 concentrates, even though careful and conscientious consideration of the position should have led to the conclusion that Factor 9 was capable of infecting patients with the cause of AIDS.

No further advice at all was issued by UKHCDO until the production of the AIDS Advisory Document, following the meeting at Elstree on 10 December 1984.[1393]The AIDS Advisory Document recorded that various commercial heat-treated Factor 9 concentrates were available:“Profilnine (heated) (Alpha), heated Konyne (Cutter) and Immuno (heated Prothromplex) are available at prices up to 20p a unit but the effects on efficacy and thrombogenicity are unpublished. Since AIDS and laboratory changes seem (controversially) to be less common in Christmas disease than haemophilia A no firm recommendation can be given on heated factor IX.[1394]

The following treatments for Haemophilia B were recommended:

  1. “(a) Mild Christmas Fresh Frozen plasma if possible (otherwise NHS Factor IX).
  2. ‘Virgin’ Patients and those not previously exposed to concentrate use fresh frozen plasma (or NHS factor IX concentrate if essential)
  3. Severe and Moderate Christmas Disease previously exposed to factor IX concentrate continue to use NHS factor IX.”

It was further generally advised that “In individual patients there may need to be a choice. In general heated concentrate appears to be the recommendation of virologists consulted but individual Directors may wish to make up their own minds. This is particularly true of unheated NHS material.[1395]

Some clinicians began to switch from unheated NHS Factor 9 to commercial heat-treated Factor 9. The AIDS Group of haemophilia centre directors, at their first meeting on 11 January 1985, recorded “some difference of opinion with regard to factor IX. Some Centres had stopped using NHS factor IX and were now using heated commercial factor IX while others intended to continue for the meantime with the unheated NHS factor IX.[1396]

By the time the AIDS Group held its fifth meeting on 17 June 1985, it was reported that most reference centres had transitioned to using commercial heat-treated Factor 9, and at this meeting the Group agreed that a recommendation should be made to haemophilia centre directors to use only heat-treated products.[1397] Professor Bloom switched at this time to heat-treated Factor 9.[1398]

The annual returns data which the Inquiry has examined confirm that heated commercial Factor 9 concentrates began to be used on a named patient basis in centres in the course of 1985, but that centres also continued to use unheated NHS Factor 9.[1399]

It was not until October 1985 that all Factor 9 issued by BPL had undergone heat treatment. Dr Snape explained that:

“BPL was more cautious in the evaluation of heat treatment on our Factor IX concentrate (the unheated concentrate was coded ‘9D’, the heated product ‘9A’). Although the programme of work began at the end of 1982, the heated product 9A was only released for clinical trial in selected centres in July 1985, three months after the first trial batches of 8Y. We were especially concerned to rule out the potential for thromboembolic sequelae that might be caused by activated factors produced on heat treatment of the 9D product. Prothrombin complex concentrates in general had a history of association with problems of this sort and we were concerned that the risk might be increased by heating the concentrate.”[1400]

He confirmed that heated Factor 9 (9A) was first issued by BPL in July 1985 (for a limited clinical trial of safety and efficacy only), and that all Factor 9 issued after 2 October 1985 was heat treated. Dr Snape’s understanding was that during the first nine months of 1985 most treatment centres continued to use the BPL unheated product, although heat-treated commercial Factor 9 products were available.[1401]

Commentary

28 people with Haemophilia B were infected with HIV, 18 of them with severe Haemophilia B, 9 with moderate Haemophilia B and 1 with mild Haemophilia B.[1402] Many more were infected with Hepatitis C.[1403]

Given that the ratio of people with Haemophilia B to Haemophilia A in the UK is, and was, roughly 1:6, this indicates that commercial concentrates were more dangerous than NHS products: the ratio of those who were infected was 1:9, meaning that people with severe Haemophilia A, who as a group were treated with a mix of commercial and NHS products, were nine times more likely to be infected than people treated predominately with NHS products for severe Haemophilia B.[1404] There is a noticeable echo here of observations made by Professor Joseph Garrott Allen in his writings and letters in the late 1960s and 1970s. In 1966, he compared the rates of hepatitis of those receiving blood from people who had sold it with those receiving it from people who had freely donated. He concluded that it was around ten times more likely that the first group would suffer hepatitis than the second.[1405] Of course, this related to the US. Of course, it related to blood, not to blood products manufactured from plasma. Of course, since then some testing had been required by the FDA, which required radioimmunoassay screening of plasma. And of course, this was a different virus. But the essential message remained the same: buyer beware. A product made from pools which had been contributed to by people who had sold their blood was inherently less safe.[1406]

The consequences in terms of the numbers of infections that occurred may have been known only in retrospect. However, the purpose of referring here to Professor Garrott Allen’s work is to show that it was entirely predictable. It supports the importance of seeking self-sufficiency.

It is also worth noting that although there was much less to be said in favour of fresh frozen plasma as a form of alternative treatment than there is to be said for considering cryoprecipitate as an alternative to Factor 8 concentrate (it had to be administered in large volumes to be effective, and that created its own risks), nonetheless in the guidelines circulated after 10 December 1984 it was recommended as the treatment of choice for mild cases of Haemophilia B, previously untreated patients, and children. There was plainly some role for it, even if relatively limited.

A step that could and should have been taken, but was not, would have been to limit home treatment and suspend prophylaxis using unheated Factor 9 concentrates at least until it either became clear that there was in truth no real risk that unheated NHS Factor 9 concentrates could transmit the cause of AIDS (although as we now know, that moment never arrived) or until (as happened in 1985) it became possible to provide a reliably safe heat-treated product. Other steps that, as with Haemophilia A, could and should have been taken included adopting a conservative approach to treatment, deferring elective/non-essential surgery, and most importantly discussing the risks and alternatives with each patient individually so that they could take an informed decision as to whether or not to accept the risks of treatment.

By the time heat-treated Factor 9 concentrates became widely available, it was too late
for some.

Von Willebrand disorder

Von Willebrand disorder (“VWD”) is the most common inherited bleeding disorder and affects people who have a deficiency of functional von Willebrand Factor (“VWF”). VWF is a protein. Its job is both to carry Factor 8, and to enable it to take effect when a clot is needed. Without sufficient VWF, the Factor 8 in the bloodstream cannot play an effective part in the clotting process. People affected by von Willebrand disorder thus have most of the symptoms of a shortage of Factor 8. Their blood will not clot, or if it does, will take longer to do so. Symptoms include easy bruising and mucous membrane bleeding (mouth, nose, gastrointestinal tract, menstrual bleeding).

Because VWF is responsible for carrying Factor 8, some people also have low Factor 8 levels, which also hinders clotting. Von Willebrand disorder affects thousands of people in the UK.[1407] Whereas haemophilia is inherited (caused by a defective X chromosome, and thus much more prevalent in males) VWF disorder affects males and females equally, though women may experience a greater number of problems linked to periods, pregnancy and childbirth.[1408]

There are three main classifications of VWD:

Treatment practices in the 1970s and 1980s

Prior to the 1970s, treatment of patients with von Willebrand disorder was mainly with FFP or cryoprecipitate.

In January 1977, haemophilia centre directors agreed, following a suggestion from Professor Bloom, that their annual returns to the haemophilia database would include data relating to patients with von Willebrand disorder.[1410] The annual returns for 1976, which were the first to be supplied in respect of VWD, show that cryoprecipitate was at that stage the dominant treatment, with some use of concentrates (including commercial ones) and comparatively little use of FFP.[1411]

In 1977 it was reported, following a trial, that desmopressin (“DDAVP”)[1412] infusion caused a marked increase in Factor-8-related properties in patients with moderate and mild haemophilia and von Willebrand disorder. The administration of DDAVP before dental surgery and in the early postoperative period was followed by a two- to threefold rise in Factor 8 coagulant activity and led Professor Pier Manucci to write in The Lancet that DDAVP could be “a promising pharmacological alternative to plasma concentrates in the management of some patients with haemophilia and vWd.[1413] Professor Hay, who in 1977 was working as a senior house physician in Sheffield, recalled “administering probably the first dose of DDAVP we had used in Sheffield for this indication in 1977 to correct von Willebrand’s disease prior to a minor procedure.[1414]

By the end of 1978 the total number of patients with von Willebrand recorded on the annual returns had increased to 240. Cryoprecipitate was still the most common treatment, although there had been a significant increase in the use of NHS factor concentrates from 41,025 units in 1976 to 171,000 units. The average amount used per patient increased from 4,282 to 6,000 Factor 8 units.[1415] By the end of 1979, although the average amount of Factor 8 units used per patient had decreased slightly to 5,250 (for 233 patients treated), the number of units of cryoprecipitate had decreased markedly (673,500 in 1979 compared with 1,030,000 units in 1978) and there was a considerable increase (fourfold) in the number of units of commercial concentrates used (334,000 units in 1979 compared with 79,000 units in 1978).[1416]

At the haemophilia centre directors’ meeting on 20-21 November 1979, it was unanimously agreed that a working party on von Willebrand disorder should be set up. It was noted that the first problem for the working party “would be to define what von Willebrand’s disease was” due to difficulties in diagnosing people with the disorder and the variants of the disorder which had been reported. Centre directors were also reminded that the computer file at Oxford contained only the details of people with von Willebrand disorder who had been treated, but the number of those with the disorder who had not received treatment was unknown.[1417]

In 1980 data on home treatment for patients with von Willebrand disorder was collected for the first time from haemophilia centres. The annual returns for that year show that 271,000 units were used for home treatment, out of a total of 1,427,000. Cryoprecipitate was still the most common treatment and the number of units had increased again to 1,052,000 – a level similar to the amount used in 1978. However, the amount of commercial concentrates used (258,000 units) was more than twice the amount of NHS Factor 8 (113,000) and the amount of FFP continued to reduce (4,000 units).[1418] This trend continued into 1981, where the annual returns show that FFP usage was down to 3,000 units, cryoprecipitate accounted for 1,327,000 of the total of 2,193,000 units used to treat 282 patients with VWD, and commercial concentrate continued to be the next treatment preference (601,000 units) whereas NHS concentrate accounted for 262,000 units. This overall increase in the amount of product used meant the average amount used per patient rose to 7,776 units.[1419]

In a letter to Stanley Godfrey of the DHSS in October 1981, Professor Bloom outlined that cryoprecipitate (either frozen or freeze-dried) “is still the treatment of choice in most patients with von Willebrands disease.” The letter sought to correct a set of meeting minutes which seemed “to imply that intermediate-purity concentrate would be generally acceptable to treat von Willebrands disease rather than cryoprecipitate.” Professor Bloom thought the minutes ought to be amended to reflect that concentrate should be viewed as an “acceptable substitute”.[1420]

In 1982, 258 patients were treated with 2,329,000 units of Factor 8, which consisted of 1,254,000 units of cryoprecipitate, an increase to 45,000 units of FFP, 650,000 units of commercial concentrate and 380,00 units of NHS concentrate. The average amount used per patient rose to 9,027 units – an increase on the previous years. There were 14 patients on home treatment who received an average of 43,286 units (26% of the total units used).[1421]

The annual returns for 1983 reported for the first time the number of patients with VWD known to haemophilia centres in the UK. This was also the first year that data relating to the patient’s age and Factor 8 level were included within the annual returns. Patients were treated with 1,373,000 units of cryoprecipitate, 49,000 units of FFP, 408,000 units of NHS concentrate and almost the same number of units of commercial concentrate (428,000 units) – a decrease from the previous year. 1,570 patients were registered with haemophilia centres, of whom 314 were treated. 17 were on home treatment and received a total of 691,000 units which accounted for 30% of the total number of units used. The average amount used per patient decreased to 7,260 units.[1422]

DDAVP was licensed for the treatment of haemophilia and VWD in 1982, but was available to be used (and was used in some centres) on a “named patient” basis prior to that.[1423] Professor Hay recalled that during the late 1970s and early 1980s, centres explored and learned how to use DDAVP and learned its strengths and limitations: “Its use was well established in Sheffield when I joined in 1983 and it was used wherever the response was considered adequate.[1424]

Risks of viral transmission

In the haemophilia centre directors’ meeting on 30 September 1980, Dr Craske reported that “Large pool concentrates appeared to give a higher risk of hepatitis than small pooled concentrates”. He felt that increased usage of small pooled concentrates would help reduce the incidence of hepatitis in the haemophilic population and reported that “First-time exposure to large pooled factor VIII concentrate resulted in many cases of hepatitis, especially in von Willebrand’s disease patients.” In response, Professor Bloom “wondered whether cryoprecipitate would be a better product to use for mild haemophiliacs and von Willebrand’s disease but pointed out that there was a problem over the amount of factor VIII in these materials.” Dr Craske agreed and said that the NHS material was “certainly better” than commercial products “because of the screening of the blood donors and the regular donor panels which were used in the UK.[1425]

At the haemophilia centre directors’ annual meeting in September 1982, at which AIDS was mentioned for the first time, there was a discussion about the treatment of von Willebrand disorder with commercial Factor 8. Professor Bloom commented that much of the commercial concentrate used in such treatment had been for a patient with inhibitors in Cardiff. He felt that the figures for the usage of commercial concentrate in von Willebrand disorder in the annual returns were heavily biased by the treatment for this one patient. At the same meeting Dr Tuddenham presented the Working Party’s report which involved a survey of the condition in the UK. Clinical and laboratory information had been received so far on 557 patients with von Willebrand disorder.[1426]

The recommendation in the letter (discussed earlier in this chapter) from Professor Bloom and Dr Rizza to all haemophilia centre directors on 24 June 1983 was that “For mildly affected patients with haemophilia A or von Willebrand’s disease and minor lesions, treatment with DDAVP should be considered.” The letter suggested that this was the usual practice of many directors, because of the “increased risk of transmitting hepatitis by means of large pool concentrates in such patients.[1427]

The treatment guidelines produced in Cardiff in May 1983 recommended that patients with von Willebrand disorder should be treated with DDAVP for minor lesions (such as teeth extractions), and cryoprecipitate or NHS Factor 8 “for other lesions as rational e.g. cryo for vWd and for in-patients; NHS FVIII conc. for outpatient mild haemophiliacs.[1428]

At the annual meeting of haemophilia centre directors on 17 October 1983, Dr Rizza presented a report on the 1982 annual returns, following which “The materials used for the treatment of von Willebrand’s disease patients was discussed and it was suggested that it would be useful for information on the use of DDAVP in von Willebrand’s disease patients to be included in the next report.” It was recorded that “There was a clear bias towards the use of cryoprecipitate for the treatment of Von Willebrand’s disease patients”and that “The majority of Directors limited the use of concentrate in von Willebrand’s disease patients to reduce the risk of hepatitis.[1429]

The AIDS Advisory Document produced following the meeting at Elstree on 10 December 1984 recommended directors to “Use DDAVP in mild Haemophilia A and vWd if possible.[1430]

The annual returns reveal a mixed picture. Some centres did not routinely record DDAVP usage on their return, and it is therefore difficult to gauge with precision the extent of its usage. It was noted in Dr Rizza’s annual returns report for 1983 that only some centres had used “other products” and that “Doubtless, this table does not reflect the full use of these products at Centres.” Centre directors were asked to ensure that all the products given to their patients were noted in the annual returns for 1984 onwards.[1431] The data for 1983 recorded 45 VWD patients as having been treated with DDAVP.

In 1984, 1,725 patients with VWD were registered with centres, 302 of whom were treated with 16 patients on home treatment. There was a significant decrease in the use of FFP (3,000 units) and the amount of cryoprecipitate used almost doubled (2,273,000). NHS concentrates accounted for 244,000 units and there was a further decrease in the amount of commercial concentrate used (137,000 units). The total number of units used was 2,657,000, which put the average amount used per patient at 8,857 units.[1432] The use of DDAVP was not included in Dr Rizza’s report for 1984.

In 1985, 1,877 patients with VWD were registered with centres, 273 of whom were treated, with 15 patients on home treatment. FFP accounted for 5,000 units and there was a significant decrease in the use of cryoprecipitate compared with the previous year, with 1,062,000 units being used. NHS concentrates accounted for 248,000 units (a slight increase on the year before). However, the amount of commercial concentrate used trebled (465,000 units). The total number of units used was 1,78,000 which put the average amount used per patient at 6,667 units.[1433] Again the use of DDAVP was not included in the annual returns report for 1985.

Treatment of patients with von Willebrand disorder

Year Number of patients Proportion of patients treated with DDAVP when recorded Average number of units per patient
Total Units Fresh frozen plasma Cryo-precipitate NHS Factor 8 Commercial Factor 8
1978 240 Not recorded 5,400 67 4,292 713 329
1979 233 Not recorded 5,249 28 2,891 897 1,433
1980 238 Not recorded 5,996 17 4,420 475 1,084
1981 282 Not recorded 7,777 11 4,706 929 2,131
1982 258 Not recorded 9,027 174 4,860 1,473 2,519
1983 311 14% 7,260 158 4,415 1,312 1,376
1984 300 Not recorded 8,857 10 7,577 813 457
1985 267 Not recorded 6,667 19 3,978 929 1,742
1986 271 Not recorded 7,229 18 5,812 768 631

This data can be seen in Figure 1.

The graph shows cryoprecipitate was the most used product, peaking in 1984. Commercial product usage increased from 1978 to 1982 and then reduced.

Figure 4. Treatment of patients with von Willebrand Disorder

Commentary

DDAVP gave rise to no risk of viral transmission: it was not a biological product. It was available from 1977 onwards, licensed in 1982 and was one of a number of alternative treatments which ethically required to be discussed with a patient in advance of treatment, together with the other possibilities. The meetings of haemophilia clinicians in 1980, 1982 and the advice given in June 1983 all show that haemophilia clinicians were alive to the risk that using concentrates, especially commercial concentrates, risked transmitting viral infection and should best be avoided if possible. Yet people with von Willebrand disorder were (like people with Haemophilia A or B) typically not given advice or information about the risks of treatment (insofar as those risks related to transmission of hepatitis or HIV) and were not given information about safer alternatives. The evidence available to the Inquiry indicates that DDAVP was not used to the extent that it should have been, given the risks of viral transmission, and that concentrates (including commercial concentrates) were used more frequently than they should have been for the treatment of people with von Willebrand disorder, particularly after the risks of AIDS had become apparent from mid 1982 onwards.

By way of example:

Pauline Nicholson received Factor 8 concentrate in November 1983: she was not aware of the time what treatment she was receiving: “I was given an injection, not being told what it was or what it was for.[1434]

One woman treated from the 1970s recalls first receiving snake venom, then cryoprecipitate. A letter in 1979 had recommended a trial use of tranexamic acid, which would avoid “the necessity of repeated injections of cryoprecipitate with the slight risk of hepatitis or plasma reactions.[1435] However, she was treated in 1981-82 with Factor 8 concentrates as a result of which she was infected with Hepatitis C.[1436]

Catherine Slater was infected with HIV, Hepatitis B and Hepatitis C following treatment with cryoprecipitate from the late 1970s; she began home treatment in 1980: “No information or advice was provided to me, my parents or my sister before treatment about the risk of being exposed to infections”.[1437]

Beryl Partington’s son Nick Anderton was treated with Factor 8 concentrates from the age of 4: “During the time that Nick was being treated with Factor VIII, I was never told about the risk of infection”. Nick was infected with HIV.[1438]

Ian Joy (who had “a diagnosis of von Willebrand’s disease, although he does not have any obvious bleeding tendency”) received prophylactic Factor 8 and cryoprecipitate during an operation in autumn 1984.[1439] His mother “had no idea that one treatment was a batch comprised of hundreds of donations ... He was just a child in 1984 and as his parents, we should have been fully informed of all possibilities and risks.[1440]

One woman with mild von Willebrand disorder was treated with prophylactic cryoprecipitate over a period of days in 1987 “just in case” and with no advice or information regarding safety. She was infected with Hepatitis C.[1441]

Melanie Richmond was treated with Factor 8 concentrate for the first time in 1989, having previously been given cryoprecipitate or DDAVP. In 1992 she was told casually, whilst admitted to hospital, having been “taken into an isolated cubicle which had contamination labels everywhere”, that she had been infected with Hepatitis C.[1442]

14 people with von Willebrand disorder were infected with HIV according to the National Haemophilia Database records.[1443] Many more were infected with Hepatitis C.

The use of PFC concentrates in Scotland 1985-1987

Heat-treated Factor 8 concentrate produced by PFC (known as NY) was available from December 1984. It was believed to (and did) inactivate HIV; it did not, however, prevent the transmission of non-A non-B Hepatitis. It was not until April 1987 that PFC produced a Factor 8 concentrate (Z8) that was effective against non-A non-B Hepatitis. By contrast the heat-treated concentrate produced by BPL (8Y) over the same period transmitted neither HIV nor non-A non-B Hepatitis.

Thus there was in Scotland a continuing need for particular care to be taken by clinicians in relation to people with bleeding disorders who were untreated or minimally treated and who thus had not been, or were unlikely to have been, previously exposed. Haemophilia clinicians should have been alert to this, so as to avoid such patients receiving NY unless absolutely necessary. Appropriate systems should have been in place to address this. If such a patient were to be offered NY, they needed to be told in advance of their treatment what the options were (including the possibility of alternative treatment eg with DDAVP or cryoprecipitate), what the risks and benefits were, and in particular they should have had explained to them what by now was on any view abundantly clear – that non-A non-B Hepatitis was a serious illness which could cause long term (and potentially fatal) liver disease and that treatment with NY would in all probability infect them with it.

In May 1986 Bill Wright, who had mild haemophilia and had not previously been treated with blood products, was treated at the Edinburgh Royal Infirmary with NY. He was not offered any alternative treatment. He was not provided with any information about the risks of the treatment. He was infected with non-A non-B Hepatitis in consequence of that treatment.[1444] That should never have happened.[1445] As recorded in a letter from Dr Frank Boulton to Dr Robert Perry in June 1986, “A young haemophiliac who previously had minimal[1446] therapy with factor VIII received an infusion of the current heat-treated product a month ago. He now shows signs of liver enzyme rises indicating non-A, non-B hepatitis. Christopher [Ludlam] is a bit ruthful with his own staff about this because he feels that this patient should have received VIIIY or an equivalent product.[1447]

8Y, the product developed at BPL, was heat-treated at a higher temperature and for longer than the PFC product, and there was evidence available by 1986 to suggest that it was showing itself to be effective against non-A non-B Hepatitis. There had been an initial report of encouraging signs in July 1985[1448] and an information sheet was sent to haemophilia centre directors and to regional transfusion directors in England and Wales (but not Scotland – although Dr Perry’s evidence to the Penrose Inquiry was that haemophilia centre directors in Scotland would have had access to it through their network of contacts and would have been aware of it).[1449] This information sheet explained that clinical trials at six centres were in progress to gain evidence of reduction or elimination of viral transmission “and several patients have safely passed the point at which first evidence of NANBH virus transmission would normally occur with unheated Factor VIII.” Haemophilia centre directors were asked to compile lists of their patients considered at risk; most centres had already done so. It was “the considered view at BPL” that if possible there should be liaison between haemophilia services and the blood services aiming to direct the supplies of 8Y to those patients considered to be “at risk”.[1450] Professor Ludlam told the Inquiry that he was unaware of this report.[1451]

In December 1985, at a meeting of the CBLA’s Central Committee for Research and Development in Blood Transfusion (attended by Dr Brian McClelland of SNBTS as well as by Dr Forrester on behalf of the SHHD) Dr Rizza reported on the progress of trials using 8Y which had been in use for some nine months: “none of his patients, including children, had become clinically ill and, therefore, the immediate signs were encouraging.[1452] There is no evidence of this information being shared more widely within Scotland. It should have been, probably by the SHHD.

On 10 January 1986 Dr Perry produced a report, intended for the March meeting of the SNBTS directors and Scottish haemophilia centre directors, which noted that “Directors will be aware that the Blood Products Laboratory are currently issuing a FVIII product which has been heated at 80°/72 hours and preliminary clinical data indicates that this material is non-infective with respect to HTLV III, NANB and Hepatitis B.[1453] The current PFC product could not, it was explained, be successfully treated under these conditions.

On 17 March 1986 a meeting between representatives of BPL and of SNBTS took place at the PFC. Dr Perry’s note of the meeting records that Dr Smith “outlined clinical trial results of the 8Y F VIII product so far. While results cannot be considered conclusive at this stage, he indicated that no cases of virus infection have occurred (attributable to 8Y material) after 12 months experience of 8Y in virgin haemophiliacs.[1454] Dr Perry told the Inquiry that it was at this stage that he thought it “likely” that 8Y was successful in terms of not transmitting non-A non-B Hepatitis; his view of the reports was “more optimistic than Dr Smith’s actually. He was always very cautious not to overestimate or be too optimistic about outcomes before the data was confirming it.[1455] SNBTS, which was aware that its own product continued to transmit non-A non-B Hepatitis, thus now knew that 8Y probably did not. They should have let haemophilia clinicians know this, and not assume (if they did) that they would find out by some other route.

Professor Ludlam did not attend the March 1986 meeting and did not think that he had read Dr Perry’s report.[1456] At some stage before 27 June 1986,[1457] he had a discussion in a corridor with Dr McClelland at which the latter told him he had been at a meeting recently when the preliminary encouraging results with the use of 8Y had been spoken about. Professor Ludlam said this led him to discuss it with other people in SNBTS, resulting in Dr Perry obtaining a small supply of 8Y from BPL.[1458] Professor Ludlam himself obtained a modest amount of 8Y from the Newcastle Haemophilia Centre.[1459] Dr Boulton and Dr Perry appear to have discussed the matter in early July and to have agreed that, whilst the PFC worked on producing a product equivalent to 8Y, “In the meantime, any Edinburgh ‘virgin’ h’philiacs requiring therapy could be given BPL 8Y.[1460]

All this was too late, however, for Bill Wright.

There was a culpable failure to ensure that haemophilia clinicians were kept informed of the progress of 8Y, and of the increasing confidence in the inactivation of non-A non-B Hepatitis, and to institute a system which would have enabled a small amount of 8Y to be made available to SNBTS or to the Scottish reference centres.[1461] This would have satisfied the requests for 8Y which would inevitably follow information that 8Y might well not transmit non-A non-B Hepatitis, such that if treatment with a Factor 8 concentrate were absolutely necessary for an individual who had received little or no previous concentrate therapy, that treatment could be provided using the product least likely to transmit it.[1462] There is no reason why such a system could not have been in place from July 1985, and there was no justification whatsoever for its absence after March 1986.[1463] Dr Perry reminded the Inquiry that Dr Forbes was then the chair of UKHCDO, an organisation which covered the whole of the UK, and he was a Glasgow clinician: so he would be aware of both the increasingly promising reports of treatment by 8Y, and that BPL could probably be prevailed upon to supply some to Scotland despite issues of finance and supply created by the border. UKHCDO should therefore have raised the issue; had it been raised, the DHSS and the other health departments should then have ensured that some supply of 8Y was provided for the sake of minimally treated children and adults in Scotland and Northern Ireland. Dr Perry (who rightly thought the failure to obtain a small supply of 8Y earlier than was achieved was a lost opportunity)[1464] considered that the primary responsibility for this rested on clinicians rather than manufacturers, because they had the choice of which products to use in treatment – and, in this case, had the information necessary to make this choice assuming a supply could be arranged, as Dr Perry (rightly) thought it could be.

Northern Ireland is mentioned because Belfast Haemophilia Centre used both commercial and domestic factor concentrates during this same period. Its domestic Factor 8 concentrate was NY, supplied by PFC;[1465] the first supplies of Z8 were received in Belfast in July 1987.[1466] Any such system ought therefore to have also involved Dr Mayne and Dr Dempsey. There is contemporaneous evidence which demonstrates that a child with mild haemophilia who was treated with NY was infected with non-A non-B Hepatitis as a consequence.[1467] It appears, furthermore, that this individual was treated with NY at a time (autumn 1987) when Z8 was available, suggesting that this was a case in which the “old generation product” was being used.[1468] This should never have happened. The action taken in response to the case was to “set aside product heated at 80° for future therapy of virgin/mild haemophiliacs.[1469] This was action that should have already been taken; had it been, this child would not have been put at risk of infection with Hepatitis C. Dr Perry recognised that the exposure at Belfast should not have happened – he recorded to Dr Boulton, once investigations had concluded that Z8 had not been involved, that it was “unfortunate that the boy was unnecessarily exposed to 68° material (NY).[1470]Unfortunate” was entirely the wrong word to use to describe a failure of treatment which was wholly avoidable.

It is worth noting that on the basis of such material as is available, there were at least 18 patients in the East of Scotland, 13 in the West, and probably a number attending Dundee centre, who were treated for the first time with a blood product between 1 September 1985 and 30 June 1987.[1471] Of those, a number were infected with non-A non-B Hepatitis.

Relationships with pharmaceutical companies

In the 1970s and 1980s there were regular, and often cordial, interactions between representatives of pharmaceutical companies and haemophilia centre clinicians. Sales representatives visited haemophilia centres, in particular the reference centres and other larger centres.[1472] As Dr Colvin described: “I, like many others, had commercial representatives knocking on my door, speaking to me trying to persuade me to use their products ... they had all sorts of argument for telling me that their products were better than anybody else’s”.[1473]

Sometimes gifts were provided.[1474] Sometimes the pharmaceutical companies provided sponsorship or monies for research.[1475] More commonly funding was provided to cover the costs of attendance at international conferences. There are many instances of a close relationship between haemophilia centre directors and pharmaceutical companies recorded in contemporaneous documents. Some illustrative examples are set out below.

Armour, in 1980, provided funding to the Newcastle Haemophilia Centre in respect of research being undertaken in conjunction with Treloar’s. Armour would reimburse Newcastle for certain costs incurred, as well as supplying some of the concentrates to be used.[1476] In 1981 Armour offered, in a letter to Dr Rizza, to “help in any way we can” regarding the preparation of a paper on inhibitor treatment.[1477] In 1983 Dr Kernoff, of the Royal Free, sent a proposal to Armour “requesting support for our AIDS-related project in haemophiliacs.[1478] Also in 1983 Armour provided funding to Sheffield Haemophilia Centre for research into AIDS.[1479] Donations were made by Armour to Dr Hill’s research fund at the Central Birmingham Health Authority in 1985.[1480]

Cutter, putting together a marketing strategy for 1981 with regard to Koate with the objective of establishing Cutter “as a major supplier with a good definable market image”, identified various “Supporting Activities” which included the provision of booklets and home care packs, and also “Support of/attendance at/involvement in ... a) Hospital meetings, staff and patient training. b) Haemophilia Society Meetings. c) National and International Meetings. d) Haemophilia Nurses Association.[1481] At a December 1980 board meeting, reference was made to “the promises ... to the Alton Centre where Doctor Aronstam had been promised some form of financial support for a research fellowship and had put in a great deal of time and effort in putting forward a representation to the Company. However, nothing materialised and it seems that this was causing the Alton Centre to have nothing to do with Cutter whatsoever.” It was agreed to look into this “with a view to the Company being in a position to offer some form of financial support for such a fellowship.[1482] A December 1984 sales report described that: “By far the most important happening this month is a very successful meeting with Dr. Wensley (MANCHESTER), when he promised me all of his business for the next contract. This is the period between January and April, 1985, depending on finances being available ... Dr. Wensley was promised a £10,000 sponsorship programme for research to be carried out over two years.[1483] In April 1985 Cutter invited Dr Kernoff “to visit Cutter in San Francisco around the San Diego meeting. I hope to arrange the visit after San Diego, staying in San Francisco over the weekend and visiting Cutter Monday and possibly Tuesday morning depending on flights home. Cutter would of course arrange your hotel and look after you during your stay in San Francisco.” Professor Bloom and Dr Wensley “will also be in the party.[1484] A Situation Report for April 1986 suggests that haemophilia centre staff were invited to attend concerts in the UK of the Bayer Philharmonic Orchestra.[1485]

An internal Cutter memo in May 1985 describes how the author “sought out and visited briefly with Prof. Bloom during the AIDS Conference in Atlanta. He asked if he could visit with Cutter the week following the San Diego meeting ... He will need room reservations in the city for Saturday, Sunday and Monday, plane reservations from San Diego. He will be accompanied by his wife.[1486]

Alpha provided funding for the 1986 annual meeting of haemophilia centre directors.[1487] Lothian Health Board records suggest that donations were received from Alpha and other pharmaceutical companies in the second half of the 1980s.[1488]

Writing in June 1980 to the area health authority, Dr Kernoff explained that:

“In common with the Directors of most other large Haemophilia Centres in the UK., I have in the past both sought and accepted financial support for research and educational purposes from all the companies now making tenders. We are currently receiving support from Immuno, who paid the publication costs of a Royal Free ‘Haemophilia Centre Handbook’ which we are now selling to augment our research funds. The maintenance of our academic programme has always depended to some extent on assistance from commercial companies and it is my intention to continue to seek such support and, if funds are offered, to accept them.”[1489]

Dr Kernoff added that it was inappropriate for a person in his position to make decisions on the way in which large sums of public money should be dispersed and that this was a responsibility he was pleased to relinquish. He nonetheless expressed the views of the medical members of the adjudication panel (himself and Dr Colvin) on the tenders that had been submitted, recommending a continuation for the remainder of the financial year the present buying policy, which was to share purchases between Immuno and Armour, whilst acknowledging that he could not be considered to be unbiased as regards choice of companies.[1490]

Two particular recollections from clinicians who gave evidence to the Inquiry stand out.

Professor Tuddenham, who had been a co-director at the Royal Free with Dr Kernoff, recalled hospitality from pharmaceutical companies that was:

“overwhelmingly lavish ... at various stages ... you would be going to the best -- to a conference on haemophilia, there would be the very best restaurants, the river cruises, the -- all the paraphernalia of marketing products. It didn’t go quite to the heights that it got in some areas with a bigger turnover like the, let’s say, cardiology and gastrointestinal diseases where people would go on cruises for so called -- for educational purposes, and make hundreds of thousands of pounds out of it, but it was -- it was remarkably lavish.”[1491]

Posing the question “why were they[1492] spending that money?”, the answer was “Because they could gain influence with it.[1493]

Professor Parapia, who had been director of the haemophilia centre in Bradford, described “Extravagant hospitality” being available “for Centres using large amounts of their products”,[1494] adding: “When we went to conferences, meetings and so on ... the directors that were most closely associated with companies would stay in the conference hotels and have five-star, et cetera, et cetera ... then there were gradations and you could see that as you went lower down the usage of Factor VIII in numbers or type of centre you were, then you may have to go into three-star and four-star hotels”.[1495] He added that for attendance at scientific meetings support from pharmaceutical companies was the only way for clinical staff to attend: “There was no money in the NHS”.[1496]

Professor Tuddenham also identified the conflict of interest that might be involved in being a paid consultant to a particular drug company: it was, he said, very difficult to “still keep completely independent in your thought ... there can be conscious and unconscious bias.” He considered that the standards now for declaring interests were much better than they used to be, with a requirement for complete transparency.[1497] One example of a haemophilia centre director providing consultancy services to pharmaceutical companies is Dr Jones. In November 1976, Dr Biggs wrote to Dr Jones regarding the “delicate and difficult” situation that arose at a haemophilia centre directors’ meeting, “representing the Newcastle Haemophilia Reference Centre while you are working for Hyland.” She wondered whether Dr Jones would consider “the Parliamentary procedure of ‘Declaring an Interest’ and possibly withdrawing from the meeting” when certain items were discussed.[1498] Dr Jones, in response, explained that this was “why I have gone out of my way to make it known to everybody concerned ... that I am at present acting as a Consultant to Hyland.” Whilst expressing a willingness to declare an interest and withdraw from meetings if necessary, he pointed out that “I could always argue that not a little of research and travel conducted by our colleagues is sponsored by commercial firms![1499]

Professor Michael Rawlins,[1500] giving evidence in October 1984 to the Royal College of Physicians Working Party on the Ethics of the Relationship between Physicians and the Pharmaceutical Industry, described the “fundamental ethical issue” as being based on the fact that “doctors spent very large sums of public money each year, and that the public could reasonably expect doctors to prescribe drugs with deference to their efficacy, safety and economy.” He felt strongly that “consultancies and their financial details” should be disclosed, that money should “not go to one person but to a department”, that the General Medical Council should give doctors “positive advice concerning their relationships with the Industry”, and that hospitality should be “totally divorced from promotion”.[1501] Professor Rawlins considered that guidance should be issued which included the following features: that physicians should be aware of the pressures that were placed upon them; that they should avoid placing themselves under an obligation to a particular company to promote its product or its image; and that they should act, and appear to act, impartially when discussing and prescribing the products of individual companies. He also thought that physicians should not accept any form of hospitality that accompanied drug promotion, and should not seek financial support from pharmaceutical companies for their expenses to attend scientific meetings.[1502]

In its report, published in March 1986, the Working Party acknowledged that a close relationship between doctors and the pharmaceutical industry was important for the treatment of patients and the future development and assessment of new drugs: because of the importance of this relationship, physicians should “ensure that their behaviour in relation to the pharmaceutical industry is always seen to be scrupulously impartial and honest.” The “overriding principle”was that “any benefit in cash or kind, any gift, any hospitality or any subsidy received from a pharmaceutical company must leave the doctor’s independence of judgement manifestly unimpaired.” It suggested that a useful criterion of acceptability was to ask “would you be willing to have these arrangements generally known?[1503]

The General Medical Council’s 1985 publication Professional Conduct and Discipline: Fitness to Practise advised that doctors should avoid accepting any pecuniary or material inducement which might compromise the independent exercise of their professional judgement in prescribing, and that the acceptance of “unreasonable sums of” money or gifts from pharmaceutical companies “may be regarded as improper.[1504]

The Medical Ethics Expert Group reported to the Inquiry, in response to a question regarding disclosure by clinicians of any commercial relationship with, or receipt of remuneration or assistance from pharmaceutical companies, that: “While there is an ethical obligation to declare, the way in which declarations are made has changed over 30 years. Previously declarations were not made to patients but to institutional bodies, committees, journals, colleges, grant awarding bodies, etc. In recent years there has been professional debate about the necessity of public declarations of interests, however, there is not yet consensus on this.[1505]

In light of all of the above, it is not surprising that many core participants expressed in their submissions to the Inquiry serious concerns about the relationship between haemophilia centre directors and pharmaceutical companies. Thus, for example, the submissions on behalf of the core participants represented by Saunders Solicitors suggested that there was “an unhealthy – and some might say, improper – relationship between clinicians (by no means all) and the pharmaceutical industry ... pharmaceutical companies afforded ‘lavish entertainment’ and the like on doctors because of an expectation that they might gain influence. The same is true of research funded by the pharmaceutical industry that might be affected by ‘conscious and unconscious bias’.[1506] The submissions on behalf of the core participants represented by Watkins & Gunn Solicitors spoke of a “conflict of interest at the epicentre” and of the “cosy relationships with pharmaceutical companies”.[1507]

It is clear, as set out in the submissions on behalf of the core participants represented by Collins Solicitors, that:

“there were close associations between prescribing physicians and pharmaceutical companies. These associations took many forms. They included hospitality, funded research (including free treatment to patients of the concentrate on trial), honorariums (whether paid directly to the researcher or to the hospital trust), and remunerated or non-remunerated roles as consultants or advisers to the companies. As Dr Geoffrey Savidge put it in his evidence to the Archer Inquiry, ‘such incentives could be recommendations for this [product] or recommendations for that [product].’ More subtly, clinicians may have been beguiled into thinking that free treatment to patients in trials would benefit both patients and the greater good.”[1508]

By way of comment, the value to the UK of public funding for UK attendees at international conferences is self-evident – healthcare is in many respects international, and UK clinicians can benefit from exchanging ideas and information with clinicians and academics from other parts of the world, just as those others may in turn benefit from association with UK clinicians. It is also true that pharmaceutical developments often help to advance the quality of care across the globe. It is that which essentially keeps pharmaceutical companies in business, for it is their efficacy in treatment which leads to their use, and their use leads to payment for it from which many such companies make their profit.

There was however a balance to be struck between the good to come from the use of “pharmaceutical money”, and the danger that it was used to influence the minds of those who had a role to play in purchasing.[1509] A simple answer would have been to make public funding available, at least for travel to conferences, for example, within a settled budget. If that was unavailable, because of other calls on the NHS for funding treatment, then the best answer would have been, and remains, publicity about the nature and extent of funding which is accepted to support clinicians. The passing of money to institutions such as hospital trusts or boards or charitable funds, where the proper use of it comes under the scrutiny of a number of people, and is more likely to come to public attention, is preferable to any payment – whether in cash or in kind – to an individual clinician or health administrator.

It is always difficult to ascertain the presence and, if present at all, the extent of bias – whether conscious or subconscious. At this distance of time, and in circumstances where those clinicians most prominently associated with pharmaceutical companies (such as Professor Bloom, Dr Kernoff, Dr Aronstam, and Professor Savidge) are dead, it is no longer possible to determine what impact these relationships and these offers of funding had on clinical decision-making. Acceptance of cash, or hospitality, by a clinician or hospital from a pharmaceutical manufacturer is likely to fuel distrust if use of their product later leads to results which were not highlighted beforehand by the clinician in discussions about risk, and the use of the product. Clinicians (and hospital boards or trusts) should be aware that this can do damage of a kind which makes their acceptance of the “benefit” look like a very poor deal indeed. A good mantra to have in mind is that if an individual healthcare professional is satisfied that they have no actual bias, they should then ask “might it, nonetheless, appear to others that I might have?” If so, steps need to be taken to change the appearance – and certainly, never, to try to hide what gives rise to it.

What can on any view be said, however, is that if clinicians accepted funding (whether it be for hospitality, for attending conferences, or for research) it was all the more incumbent upon them to ensure that their clinical recommendations and the risks and benefits of treatment were fully explained to those being treated. As described later in this chapter, the failure to do so was widespread and profound.

Research

Introduction

The organisation of haemophilia centres in the United Kingdom “made it possible to carry out collaborative research which was not so easily done elsewhere.” So said Dr Rosemary Biggs, of the Oxford Haemophilia Centre, at the first meeting of haemophilia centre directors in October 1968.[1510]

The “collection of 49 haemophilic patients at the Alton School makes this a unique opportunity to study the disease.”[1511] That was the view expressed by Dr Biggs in December 1970, referring to the boys with haemophilia attending Treloar’s.

They – the “almost unique group of haemophiliacs we have in Edinburgh because they have never received commercial concentrate” – “are, therefore ... useful material for a variety of studies in relation to liver disease.[1512] So said Dr Christopher Ludlam – newly appointed consultant haematologist in Edinburgh – to Dr John Craske of the Public Health Laboratory Service on 28 April 1980.

“Although initial production batches may have been tested for infectivity by injecting them into chimpanzees it is unlikely that the manufacturers will be able to guarantee this form of quality control for all future batches. It is therefore very important to find out by studies in human beings to what extent the infectivity of the various concentrates has been reduced. The most clear cut way of doing this, is by administering those concentrates to patients requiring treatment who have not been previously exposed to large pool concentrates.”[1513]

So said Professor Arthur Bloom and Dr Charles Rizza in a letter to all haemophilia centre directors on 11 January 1983.

So what are we? Are we human beings or are we just material?[1514]That rhetorical question, posed by campaigner Bruce Norval in his oral evidence to the Inquiry, conveys the understandable – and in many respects well-founded – feelings of many people with bleeding disorders who were infected in consequence of their treatment with concentrates: that they were, often without their knowledge or consent, objects of research.

Medical research is, of course, in general terms “a good thing”: as the Inquiry’s expert panel of medical ethicists noted in their report “Scientifically robust research is essential to maintaining global health and wellbeing.[1515]However, the value of such research to society is enhanced rather than undermined by undertaking research in an ethical and moral way.[1516]

As one clinician told the Inquiry, “The first ethical principle of research involving humans is the one we inherit from Hippocrates ‘First do no harm’. The second principle is that consent to take part in research must be a voluntary choice of the participant after a full explanation of the risks.[1517] The expert panel expressed the position in a similar way: “there are two basic ethical principles which protect participants even where direct benefit is not anticipated: reasonable risk and consent.[1518]

The requirement for informed consent to participation in research is fundamental. It was reflected in the terms of the Nuremberg Code in 1947:[1519] the Code’s first principle was that “The voluntary consent of the human subject is absolutely essential.[1520] Similar stipulations were set out in the 1964 Declaration of Helsinki. In cases where there is a therapeutic benefit to the participant arising from the research, the doctor should “obtain the patient’s freely given consent after the patient has been given a full explanation”; in cases where there is no therapeutic benefit to the participant, “The nature, the purpose and the risk of clinical research must be explained to the subject by the doctor” and clinical research “on a human being cannot be undertaken without his free consent after he has been informed.[1521]Over subsequent years guidance was issued by bodies including the Medical Research Council (“MRC”), the Royal College of Physicians, and the British Medical Association (“BMA”), emphasising the centrality of voluntary participation and informed consent.[1522] These principles also find their expression in the 1997 Oviedo Convention.[1523]

The reason why this is so important should be obvious but, not least because this principle was plainly not adhered to in relation to bleeding disorder patients in the 1970s and 1980s, it is re-stated here:

“Research brings the risk of causing harm, in the practical sense of possibly damaging or disadvantaging a patient, and of doing wrong, in the moral sense of ignoring the autonomy of that individual. People are wronged if they are deprived of choice or their values are transgressed on the assumption that the best clinical outcome is necessarily what is best for them. The possibility of harm cannot be entirely eliminated from research but by insisting that patients have adequate information and choice about participation, we minimise the possibility of wronging them.”[1524]

In practice, what this required was that the person undertaking the research should inform the patient about the potential benefits and risks of the proposed treatment, why it was proposed, the significance in terms of advancing knowledge and the researcher’s own stake in proposing the procedure. Further,

“Where patients are offered choices, they need information about the alternatives to the treatment recommended by their doctor. When a clinical study is proposed patients need to know about the advantages and shortcomings of conventional treatments as well as the options in the trial. In any situation, the more risky or invasive the procedure, the greater attention must be paid to the patient’s understanding of it and consent to it.”[1525]

Different kinds of research

Research can take different forms. In much of the contemporaneous documentation research was categorised as prospective or retrospective.[1526] Another distinction that was sometimes drawn in the evidence was between interventional and observational studies. Professor Charles Hay told the Inquiry that this distinction is not always clear cut and may be a matter of opinion. He suggested that in an observational study the intervention would have occurred anyway and that the intervention was not done for the purpose of research. An interventional study might, he said, involve a patient being given a concentrate that they would not have been given if they were not participating in the study.[1527] However, that distinction is often not easy to identify. Moreover, if there is to be study of this type, it becomes all the more important that care is taken when seeking the consent of the patient: for it may be exposing them to harm without there being any expectation they will benefit personally, whatever the benefit may be to medical science more generally. Where the research subject is a child, as a general rule they should not be exposed to research when there is no realistic prospect that this will benefit them in their present treatment. The ethics experts told the Inquiry that, in general, if the clinician is thinking of publishing the results, it is usually considered to be research – “if it’s been published in a journal, it’s original knowledge.[1528]

Oxford Haemophilia Centre

Much of the research undertaken in the 1970s involved the Oxford Haemophilia Centre. In 1967 the work in Oxford of the MRC’s Blood Coagulation Research Unit under Professor Gwyn Macfarlane had been reorganised:[1529] a new building housed the clinical work of the haemophilia centre and the fractionation work of the Plasma Fractionation Laboratory; the original building where the Blood Coagulation Research Unit had been based now housed a Research Laboratory, “concerned with developing research in all aspects of haemostasis and blood coagulation” which worked “in close cooperation with the Clinical and Fractionation departments.” The official opening of the new haemophilia centre “was celebrated by inviting the Directors of the 36 Haemophilia Centres of Great Britain and holding a meeting at which research projects were planned in conjunction with the M.R.C. Cryoprecipitate Working Party.” A progress report covering the period 1967-70 summarised a range of clinical and other studies that had been undertaken or were in progress.[1530]

Much of the research undertaken at Oxford was purely laboratory based. But clinical studies were a regular feature. Much of what was undertaken involved “surveillance” – studying data that was available about patients and their treatment. A document from around 1972 described that there were “124 items coded on the O.H.C. punch cards for each patient”– including name, age, severity of bleeding disorder, family history of bleeding, treatment, history of jaundice, and complications – most of which would be “useful for comparison”.[1531]

Where that research involved hepatitis, it was often, from the mid 1970s onwards, coordinated or organised by Dr Craske, a virologist from the Public Health Laboratory Service. As detailed below a number of research projects involved other centres, such as Newcastle and Treloar’s.

Hepatitis associated with Hemofil

Following an outbreak of hepatitis associated with the first use of Hemofil at the Bournemouth Haemophilia Centre in 1974, a retrospective survey of the use of this product was undertaken.[1532] The study was proposed at a 22 May 1975 meeting at Oxford, when Dr Craske explained that its purpose was to obtain “the most complete information possible about the incidence of hepatitis in patients who had received certain specific batches of Hemofil.” Dr Craske had already obtained data about the incidence of hepatitis in patients at Newcastle, Bournemouth and Alton,[1533] and his “impression” was that hepatitis had occurred most often in people who had been treated relatively little in the past. Haemophilia centre directors whose returns recorded that they had treated patients with Hemofil in 1974 were asked to report clinical details of hepatitis cases possibly associated with treatment with the product to the Oxford Centre. Haemophilia centre directors were told in September 1975 that henceforth they should make a specific return notifying each case of jaundice, and for those centres which used Hemofil there was a form which “should be completed for all Centres using Hemofil and will be forwarded to Dr. Craske so that he can complete his study.[1534]

Dr Craske reported the results of the retrospective study at the 13 January 1977 meeting of haemophilia centre directors, when he explained that he would like to continue with this study for the next two years to study the incidence of chronic sequelae as well as a comparison of jaundice associated with NHS Factor 8 and commercial products.[1535] Further detail was set out in a written report, authored by Dr Craske and Dr Peter Kirk. This explained that returns had been received from 24 haemophilia centres, and that 374 patients had received transfusions of one or more batches of Hemofil over this period.[1536] A total of 78 cases of hepatitis affecting 66 patients (17.7%) were considered to have been associated with transfusions of Hemofil, of which 48 were non-B Hepatitis and 30 Hepatitis B. The paper concluded that “the first introduction of Hemofil as Factor VIII replacement therapy in the U.K. was associated with an overall incidence of 17.7% of transfusion hepatitis.” It added, with considerable understatement, that since “this disease was commoner in patients with mild haemophilia it is possible that with hindsight alternative products might have been used to treat some patients and this might have reduced the incidence of hepatitis.[1537]

A paper with the results of the survey, in which Hemofil was referred to as “Brand ‘L’”, was published in 1978.[1538]

This study was retrospective – it looked back at treatment which had already been given – but it remains ethically problematic in two respects: firstly, it is clear that not only were patients being studied[1539] without their knowledge but the results of those studies were not shared with the patients themselves;[1540] secondly, it fuelled a desire to undertake more and more surveillance, including the proposal to study over the next two years the incidence of hepatitis due to Hemofil, Kryobulin and NHS Factor 8, with the potential to influence treatment choices and have an impact on clinical decision-making.[1541]

Hepatitis associated with Kryobulin 1976

As a continuation of the Hemofil survey, Dr Craske subsequently carried out a study of the incidence of hepatitis after treatment with Kryobulin in 1976 to compare it with that due to Hemofil.[1542] In a January 1977 protocol, Dr Craske proposed that the study last for two years, with hepatitis cases again to be reported to the Oxford Centre.[1543]

Results from the survey were subsequently presented to haemophilia centre directors at their 24 October 1977 meeting.[1544] The report containing the results, prepared by Dr Craske, recorded that the methods used were the same as in the first Hemofil survey. Six batches of Hemofil were studied and transfusion records were available for 16 batches of Kryobulin. Returns were received from 24 haemophilia centres. There was epidemiological evidence that 2/6 batches of Hemofil and 2/16 batches of Kryobulin contained Hepatitis B virus. 4/6 batches of Hemofil and 3/17 batches of Kryobulin were associated with cases of non-B Hepatitis. Of 371 patients transfused with Hemofil in 1974-75, 111 received further transfusions in 1976, and 77 patients received Hemofil for the first time. A total of 101 patients were transfused with Kryobulin of whom 31 had previously received Hemofil in 1974-75. It was noted that cases of non-A non-B Hepatitis associated with Hemofil had continued to occur, all in patients receiving Hemofil for the first time.[1545]

Whilst the original Hemofil study was retrospective, it is not clear whether this study was entirely so. The January 1977 protocol envisaged the reporting of cases of hepatitis associated with use of the products throughout the two year period 1976-77, although the report prepared in September 1977 for haemophilia centre directors studied Kryobulin given in 1976 only. Furthermore, the Kryobulin study involved some people being treated with Hemofil, and it is conceivable that those treatment choices may have been influenced by the knowledge of the first Hemofil study.

It was said to be essential to continue these studies. This would help to determine the incidence of further problems following acute hepatitis, and several more projects were proposed. These included a study of hepatitis following NHS concentrate and the compilation of a register of carriers of Hepatitis B surface antigen to be kept with the other patient data at Oxford. During a discussion of the paper at the directors’ meeting in October 1977, some directors “expressed concern about this data being included in the National Register as they were worried that the information might become available to unauthorised persons and be used in a manner detrimental to the interests of the patients.[1546]

Dr Craske’s research work

Some of those infected have discovered only on receipt of their National Haemophilia Database (“NHD”) records that they were part of “Dr Craske’s research work”. Each entry in the database was assigned to a centre, and in some cases this was “Dr Craske’s research work” rather than a physical centre. Individual records extracted from the NHD included a list of the centres where the individual received care and this could include “Dr Craske’s research work” if treatment or testing was linked in the database to his research but his work went wider than the entries with that code.

Lee Stay described his “complete shock” on reading this entry in his records. He was not aware of his participation in this, which related to treatment by the Hammersmith Hospital. Lee’s treatment with two different commercial concentrates – Kryobulin and Hemofil – in 1975 (when he was around 6 years old) and again in 1976 was recorded as part of “Dr Craske’s research work”.[1547]

Neil Weller told the Inquiry “It would appear that I was part of Dr Craske’s research work. I was not aware of this. I do not know who Dr Craske is.” His NHD records show treatment under the auspices of “Dr Craske’s research work” with Hemofil in 1974 – when he would have been only 3 years old – and with Kryobulin, BPL Factor 8 concentrate and Oxford Factor 8 concentrate in 1976.[1548]

Ruth Major described several entries in her late husband Peter’s database records referring to Dr Craske’s research:

“I was not familiar with this person and in fact had never heard mention of him. My Husband had also never mentioned him therefore I conclude that he had never heard of him. I decided to do some research into this person and discovered that he was a virologist who had been conducting research into Hepatitis Non-A and Non-B in the 1970’s and 1980’s. I also found an entry in my Husband’s medical notes dated 27th February 1979 which states ‘Blood taken for hepatitis project.’ As far as I know my Husband was never informed or consented for this research project.”

Peter’s NHD records show treatment with Hemofil in the category of “Dr Craske’s research work” in 1974 and 1975. Peter was a young man in his twenties at that time. A later entry in his medical records from the University Hospital of Wales refers, in 1979, to a “Hepatitis Project”.[1549]

Robert Hodgkins’ NHD records show treatment with Hemofil in 1974 (when he was around 6 years old) for “Dr Craske’s research work”.[1550]

Similar entries appear for Patricia Crowe’s father, David Gill. She told the Inquiry that “My father had no knowledge of this and was therefore unable to consent to it.[1551]

Rosamund Cooper’s NHD record similarly refers to Dr Craske’s research work. Neither she nor her mother had any recollection of being informed about this.[1552]

Haydn Lewis’ NHD records show treatment with Hemofil in 1974 again under the heading “Dr Craske’s research work.[1553] He queried this (and other entries) in 2006 and received a response from Dr Hay on behalf of the UK Haemophilia Centre Doctors’ Organisation (“UKHCDO”) which stated that “We believe that in the late 1970’s the UKHCDO Liver Disease Working Party conducted a retrospective survey of non-A, non-B hepatitis and that the data from this survey was kept in a file labelled treatment centre code 39 Dr Craske for the sake of convenience. Understandable [sic], this has caused quite a lot of confusion since.[1554]

Jonathan Evans’ son Jason told the Inquiry that “on my father’s [NHD] extract, there was an entry that said, ‘Dr Craske’s research work’ and I know, because having spoken to people and having seen it, that it appears on that of many others as well. It’s by no means unique to my father’s schedule.”In his written evidence, Jason Evans raised the question “what consent Dr Craske had or should have had to carry out such research work.[1555] Professor Hay suggested in response that the research was published in 1983 in the British Medical Journal and that it was “a retrospective study looking at the risk of developing non-A, non-B hepartitis [sic] after administration of concentrate.” He described it as a “non-interventional observational study.[1556] This was incorrect: the study published in 1983 related to patients attending the Oxford Haemophilia Centre and was clearly a prospective study: it is discussed further below.

However, in a written statement to the Inquiry Professor Hay pointed to “Commercial factor VIII associated hepatitis 1974-1975 in the United Kingdom: a retrospective survey[1557]as the only publication relating to:

“Dr Craske’s surveys conducted collaboratively with UKHCDO and the NHD. This was a retrospective survey of 371 people from 24 haemophilia centres who had been transfused with the same commercial factor VIII product (Hyland) thought to have been responsible for the hepatitis outbreak at Bournemouth Haemophilia Centre. New cases of hepatitis associated with this brand of factor concentrate were reported through the NHD. This was a non-interventional retrospective observational study, which at that time was not thought by the people undertaking this work to require individual patient consent.”

He contrasted this with the 1983 publication “Non-A non-B hepatitis after transfusion of factor VIII in infrequently treated patients, which he correctly described as “interventional clinical trial, conducted in Oxford.[1558]

The reference to “Dr Craske’s research work” in individual records on the National Haemophilia Database would indeed have referred to the studies relating to Hemofil and Kryobulin discussed above.[1559] It went wider than that. Though it seems clear that a major focus was on research into Hemofil, especially after the Bournemouth outbreak in 1974, and separate returns were sought from centres using it which were specific to that product, “Dr Craske’s Research Work” covered reports to him from 1973/74 onwards in respect of all the concentrates then licensed and in use, cryoprecipitate and plasma.[1560]

Nonetheless, once Dr Craske had decided in mid 1975 to gather and study data relating to such treatment and its effects, subsequent treatment decisions, in the second half of 1975 and in 1976, could have been influenced (consciously or otherwise) by the knowledge that research into the effects of the treatment was being undertaken. There is some support for this, though it stops short of declaring it clearly to be the case, in that Lee Stay, Neil Weller and Robert Hodgkins were all very young when given commercial factor concentrate at a time when for young children cryoprecipitate should have been the product of first resort, and NHS concentrate the second.[1561] Furthermore, it remains the position that the personal medical data of individuals was shared by haemophilia centres with Dr Craske; the patients so studied knew nothing about that; and the association with hepatitis which was revealed was not shared or discussed with them so that they could make an informed decision for themselves whether or not to continue with such treatment. This was wrong.

Hepatitis pilot study

In 1975 a prospective study on hepatitis in Haemophilia A patients was proposed, involving three centres: Treloar’s, Newcastle and Oxford. The study was discussed at a meeting at the Oxford Centre on 22 May 1975, attended by Drs Biggs, Rizza, Craske and others. It was noted that there were difficulties in planning a formal controlled study of various therapeutic materials: for example, “in Oxford material made from large pools was not given to patients who had received relatively little previous treatment or to small children (Dr Biggs and Dr Rizza). Thus patients could not be allocated to treatment in a random manner and patients thought to be most likely to develop hepatitis would not receive the commercial factor VIII.” It was said that the existing system of “using first one type of preparation and then another in the same patient could make it virtually impossible to attribute infectivity to any particular material.” A trial on a large scale would require to be sponsored by the DHSS, the MRC or by the haemophilia centre directors, and it was “felt that perhaps the best thing that could be done at present would be to arrange a pilot study at Oxford and at the Treloar College.” It was further “felt that restriction of materials to particular patients would greatly improve the definition of the cause of Hepatitis.[1562]

A protocol for the study – which would involve each patient being treated with one type of material – was subsequently introduced by Dr Kirk of Treloar’s at the 18 September 1975 meeting of haemophilia centre directors. It was proposed that those who were to participate should be 25 patients at the Oxford Centre (15 receiving Oxford Factor 8 and 10 receiving Hemofil), 35 at Alton/Treloar’s (20 receiving cryoprecipitate, 10 Kryobulin and 5 Elstree Factor 8), and 40 at Newcastle (all receiving Hemofil).[1563] The protocol recognised that treatment with Factor 8 concentrates exposed patients to a much larger risk of contracting transfusion hepatitis “since the fractionated product is processed from donor pools”; it was recognised too that commercial concentrates were made from “very large pools”. The protocol recorded that the study was intended to answer the following question: “Does the administration of factor VIII concentrates to haemophiliacs on regular replacement therapy, significantly increase the incidence of transfusion hepatitis?” It was also hoped that it would address a number of other points, including any difference in the attack rates between commercial Factor 8 concentrates and those produced at Oxford and Elstree, and further information on hepatitis “due to unknown viruses or agents other than hepatitis ‘A’, ‘B’, EB or cytomegalo virus.” It was preferable that on entry patients had normal liver function measurements (though abnormal results would not exclude a patient from admission). Each patient would be required to remain on the allotted therapeutic material for a minimum of 18 months.[1564]

Patients would be categorised as mild or severe in relation to their bleeding frequency[1565] and would, as far as possible, “be allocated evenly over the various treatment groups.” It was noted that in practice this would “not be feasible since there will be a tendency to use concentrates for patients having HBsAb or HBsAg and cryoprecipitate for those who are antibody negative”. Each patient would be treated with the same type of material throughout the study and, where possible, it was intended that batches be arranged sequentially in order that the patient receive the same batch of their particular brand over a three-month period.[1566]

Another eligibility criterion concerned consent:

“All patients or their parents/guardians must give their informed consent. The following points will be made clear:

  1. By limiting the transfused material to one type, the degree of donor exposure should be decreased[1567]
  2. That it will be necessary for blood samples to be taken at fortnightly intervals. In the Oxford and Newcastle groups local arrangements must be made to obtain the requisite samples, since these patients are all on home therapy.[1568]

Even if this information were provided to patients – and the Inquiry has uncovered no evidence to suggest that it was – this would be patently insufficient to enable the giving of informed consent. While it described an anticipated benefit of the trial – namely, reducing the degree of donor exposure by limiting the transfused material to one type – it failed to address the risks involved, including the risk that commercial concentrate would be more likely to transmit hepatitis than NHS Factor 8 or cryoprecipitate. The express endpoint for the study (to see if giving Factor 8 concentrates significantly increased the risk of hepatitis) shows that the study began with a proposition that giving them would cause recipients to be infected more than they would otherwise have been.[1569] It did not explain that one of the reasons for undertaking the study was to determine the relative likelihood of hepatitis infection from commercial and NHS concentrates, or that information was sought on hepatitis other than Hepatitis B. In other words, it did not even begin to discharge the obligation to ensure voluntary and fully informed participation and was plainly unethical.

On 1 April 1977, Dr Kirk wrote to the National Institute of Biological Standards and Control with an update on the study. In the 19 months or so in which it had taken place, “All the cases of clinical hepatitis and almost all the cases of asymptomatic hepatitis were confined to the patients restricted to commercial concentrates. There were no significant differences between the cases restricted to Hemofil and Kryobulin.” Dr Kirk proposed to continue the study and at the next stage it would restrict patients to either commercial concentrates as a group, or to cryoprecipitate, or to BPL Factor 8.[1570] This leads to the further comment that it was proposing restricting some patients to a product which he, Dr Kirk, had already identified as causing harm which the other two choices probably did not. This was unethical.

In a letter in October of that year, Dr Craske described the study as involving – at least with respect to Treloar’s pupils – “the prospective study of the incidence of hepatitis, and abnormal liver function tests associated with different forms of Factor VIII therapy.[1571]

The study appears to have continued (or been extended): Dr Kirk described the results of “the prospective survey on hepatitis carried out at Edinburgh and Alton” at the 14 December 1977 meeting of the Haemophilia Centre Directors’ Hepatitis Working Party,[1572] and the meetings of the Working Party on 14 March 1978[1573] and 7 November 1978 included further discussion of the prospective study.[1574]

Hepatitis Surveillance and chronic sequelae

In April 1978 Dr Craske applied to the DHSS for funding to cover two research projects, both involving the Oxford Centre and described as a joint project between the Hepatitis Working Party and the PHLS.[1575]

The first, described as “Hepatitis Surveillance”, would involve haemophilia centre directors notifying hepatitis cases thought to be associated with Factor 8 or 9 therapy to the Oxford Centre. The application explained that this had previously been done annually, but that centres were now being encouraged to notify cases immediately. It was proposed that the project take place over a three year period: “With the large number of brands of Factor VIII in use, it is anticipated that the most useful information about the incidence and types of hepatitis will be obtained over the next 3 years.” In cases of doubt as to the presence of hepatitis, queries would be clarified by correspondence with the centre: “If necessary, the patients notes are consulted, and, if necessary, Miss Spooner visits the Centre, with the agreement of the Director, and assists in obtaining any further information required.[1576] (This plainly involves the communication of personal, confidential, medical information, with no indication either of that fact being communicated to the patient, or the concerns about hepatitis being shared with the patient.)

The second project concerned the follow-up of “chronic sequelae of Factor VIII associated hepatitis”, which it was proposed would be carried out over two years at the Oxford Centre. In the first instance, it was intended to study 116 patients at the Oxford Centre who had received 6 infected batches of Hemofil in 1974/75, 4 of which were found to be positive for Hepatitis B. Each of these patients would be matched with a second group of patients receiving treatment with cryoprecipitate.[1577] The patient’s GP would be contacted “and invited to furnish details of the patient’s general health.” Patients would be visited at home or seen when they attended at the Centre: “A medical history will be taken, and, physical examination will be carried out with particular reference to liver disease.” It was also proposed to study the incidence of hepatitis in the patients’ close household contacts.[1578]

By the time of the 7 November 1978 meeting of the Haemophilia Centre Directors’ Hepatitis Working Party, the DHSS had agreed to provide the grant and work on both studies was underway.[1579]

An update was provided at the 29 January 1979 meeting of the Hepatitis Working Party. So far, 25% of the Oxford haemophilia patients who had been examined had been found to have persistent transaminitis.[1580]

These two studies were both retrospective. However, at the same meeting two protocols were discussed for the studies relating to ongoing study of chronic liver disease in Oxford patients: one concerning the effect of intravenous infusions of Factor 8 on serum enzyme levels in haemophilia patients; the other concerning the value of serum bile acid measurements in the investigation of haemophilia patients thought to have chronic hepatitis.[1581] The first of these protocols proposed that up to 20 Haemophilia A patients at the Oxford and Edinburgh Centres would be selected. An attempt would be made to include patients on home treatment, those receiving only cryoprecipitate and patients with a mild coagulation defect. Only patients over the age of 18 would be included. As for consent: “The object of the study will be explained to each patient before he is included in the study, and his informed consent obtained.[1582] The evidence does not confirm the extent (if any) to which this was done: and the extent in any event of what was to be said seems to be limited to telling the patient what the purpose of the study was, and not to require going further to tell them of other relevant matters such as the risks involved. The protocol for the second study explained that “As part of the investigation of patients in the chronic hepatitis study, it is proposed to measure the fasting blood bile acid levels in 40 patients attending the Oxford Haemophilia Centre”, as well as a similar group of patients from the Edinburgh Centre.[1583]

A further update was provided at a meeting of the Working Party on 20 August 1979. In relation to the chronic liver disease study, Dr Susanta Ghosh explained that, so far, 179 patients with severe haemophilia had been studied. 70 out of 174 patients for whom detailed records of liver function tests were available had persistently abnormal liver function tests. 32 of these had been seen at the liver clinic, and “20 of these had significant chronic liver disease, as judged by their clinical features.[1584]

Dr Craske also provided an update on the Hepatitis Surveillance study. He explained that the prevalence of hepatitis appeared to be about the same as the previous two years. Compared with 1974, “most of the overt Hepatitis occurred in mild Haemophiliacs many of whom had been transfused with concentrate for the first time to cover operations.” Two thirds of the reported cases were non-B Hepatitis, and over thirty of these had been confirmed as non-A non-B Hepatitis.[1585]

Dr Craske provided the DHSS with an annual report on the two studies – known together as “Project Number J/S240/78/7” – in late 1979. This explained that the Hepatitis Surveillance study included, in addition to reported hepatitis cases from 1977, a review of cases reported to the Oxford Centre since 1974. The “two most obvious results of the 1977 returns” were said to be: a “high association of Factorate with cases of hepatitis B compared with other brands of commercial concentrate”; and the “continued association of Hemofil and other brands of commercial concentrate with cases of non-B hepatitis”.[1586]

As for the second study, 179 haemophilia patients on long term Factor 8 and Factor 9 therapy at the Oxford Centre had been studied. The study was summarised as involving the examination of patients for clinical and laboratory evidence of chronic liver disease and their comparison with matched controls. The incidence of the “secondary spread of hepatitis B to household contacts of haemophiliacs” was also being assessed. Further detail was provided in an appended progress report.[1587]

Further progress reports were provided to the DHSS in the second and third (and final) years of the project.[1588]

Results were also shared with the UKHCDO Hepatitis Working Party at its 3 September 1980 meeting.[1589] Further results from the Hepatitis Surveillance study were presented by Dr Craske at the 11 September 1981 meeting of the Hepatitis Working Party. A total of 283 episodes involving 253 patients reported to Oxford since 1974 had been identified as probable cases of transfusion hepatitis, of which 197 were non-A non-B Hepatitis and 86 Hepatitis B.[1590]

Dr Craske presented a report on the final year of the study at the 9 October 1981 meeting of haemophilia centre directors.[1591] A total of 283 episodes of hepatitis related to Factor 8 or Factor 9 therapy had been reported by haemophilia centre directors, involving 253 patients. 197 were “non-B hepatitis and therefore probably non-A, non-B, and 86 incidents were hepatitis B.” It was suggested that the differing proportions of incidents related to each brand did not “reflect the relative incidence of hepatitis due to each product. Hemofil and Kryobulin were used in the U.K. 2 to 3 years before the other commercial products, and the relative amounts of other products have varied since due to market forces.” However, it was also noted that there was a 4-20 times higher incidence of overt non-A non-B Hepatitis associated with US commercial concentrate compared with NHS product. Further, 70-80% of cases of non-A non-B Hepatitis were associated with the first dose of concentrate the patient received.[1592]

A number of further research projects were outlined, including: the continuation of the Hepatitis Surveillance scheme; a prospective study comparing different products in relation to the incidence of sub-clinical hepatitis;[1593] and continuing efforts to assess the types and severity of chronic hepatitis resulting from Factor 8 or 9 replacement therapy.[1594]

Study of patients treated with concentrate for the first time

During the late 1970s and early 1980s, patients treated with concentrate for the first time (sometimes referred to as PUPs – previously untreated patients) were the subject of study. At the 20 February 1980 meeting of the UKHCDO Hepatitis Working Party, Dr Howard Thomas and Dr Peter Kernoff of the Royal Free Hospital described a prospective study they had carried out on patients receiving concentrate for the first time. 11 patients, most of whom had received commercial concentrate and who had been followed for periods of up to 4 years, had evidence of chronic hepatitis as judged by persistently abnormal serum transaminases. Dr Ghosh of the Oxford Centre reported that similar results had been seen in Oxford patients receiving mainly NHS concentrate for the first time. The meeting agreed that more information was needed “on the risk to patients of developing chronic non-A, non-B hepatitis by prospectively following patients first exposed to concentrate or other products, e.g., mild haemophiliacs undergoing non-emergency surgery. The value of other methods of treatment to cover operations needed reassessing.[1595]

This appears to have led to Dr Craske preparing a protocol, dated 2 July 1980, for a prospective study of the incidence of acute and chronic hepatitis in patients with bleeding disorders as a result of first exposure to Factor 8 concentrate or cryoprecipitate. This noted that Oxford’s hepatitis surveillance programme had shown that the group of haemophilia patients with the highest incidence of acute hepatitis were those exposed to concentrate for the first time. Most of these patients had mild haemophilia and “usually require few transfusions, usually of cryoprecipitate only.” The protocol added: “Since the risk of chronic hepatitis following an acute attack of non-A, non-B hepatitis after a transfusion of factor VIII concentrate is between 20 and 40%, it is important that an accurate estimation should be made of the incidence of transfusion hepatitis in this group.” It was noted that some of the operative or treatment procedures covered by concentrate transfusion were minor, and it seemed “possible that some could be carried out with the use of alternative methods of treatment.” Patients would be considered for the study if they had received less than two transfusions of Factor 8 in the previous year, and came within the following groups: newly diagnosed patients with Haemophilia A, Haemophilia B and von Willebrand disorder; and Haemophilia A patients, Haemophilia gene carriers, Haemophilia B patients and those with von Willebrand disorder who were “about to undergo an elective treatment procedure which will require cover with concentrate.” As for consent for patients admitted to the study: “The objects of the project will be explained to them, and their consent, or that of their parents if under 18 years of age obtained.” Patients would be followed for 12 months after their operation, with regular liver function and Hepatitis B tests during that period. The study was to last for 12 months and would involve, if possible, 40-50 patients.[1596]

At the 3 September 1980 meeting of the Hepatitis Working Party, Dr Craske circulated data “which suggested that NHS Factor VIII made at Oxford might be associated with a lower risk of non-A, non-B hepatitis than other batches of NHS factor VIII, e.g., Elstree or commercial factor VIII.” It was noted that Oxford Factor 8 had a pool size of 500 donations, whereas the Elstree product had a pool size of 3,500 donations, and it was “proposed to carry out a prospective study to evaluate the value of such a preparation for the treatment of mild haemophiliacs at operation, etc.[1597]

In February 1981, Dr Craske submitted a grant application for a prospective study of the incidence of acute and chronic hepatitis in haemophilia patients after treatment with Factor 8 or Factor 9 for the first time. It was proposed to carry out the survey over a period of 30 months on patients undergoing elective surgery “or other treatment requiring cover with concentrate”. It was estimated that around 15 patients would be suitable for study in any 1 year; overall it was hoped to include 30 to 40 patients. Patients receiving cryoprecipitate only would be studied as a control where possible. The purpose of the study was “to compare the incidence of acute hepatitis and chronic sequelae in patients transfused with both commercial and NHS freeze dried concentrate for the first time by means of a prospective study of patients treated at the Oxford Haemophilia Centre.” It was said to be important to undertake this investigation because it was possible that “a significant proportion of haemophiliacs on regular factor VIII therapy may become severely ill with chronic hepatitis in 10-20 years’ time.[1598]

Patients at the Oxford Centre who had received fewer than two transfusions of Factor 8 or 9 in the previous year would be considered for the study. Rather than newly diagnosed patients (of which there were very few), or infrequently treated patients with inhibitors, it was proposed to select patients with mild coagulation disorders who did not “usually require factor VIII or IX concentrate, but who are about to undergo an elective procedure which will require cover with concentrate.” Patients from this category who attended the Oxford Centre during the course of the study would be selected. The “objects of this study will be explained to them and their consent, or that of their parents if under 18 years of age obtained.” A clinical examination and blood tests would be carried out before the operation and patients would be followed up for 12 months.[1599]

At the 11 September 1981 meeting of the Haemophilia Centre Directors’ Hepatitis Working Party, it was recorded that the grant application had been made to the MRC “with a view to undertaking a prospective study of patients with mild coagulation defects undergoing treatment requiring concentrate cover.” The aim was to assess “the risk of contracting hepatitis on first exposure to concentrate and to provide a collection of sera from well documented cases of NANB hepatitis for the evaluation of new tests for this disease.” It was recorded that a preliminary study had been started at the Oxford Centre in March 1981 and so far 8 patients had enrolled.[1600] At the haemophilia centre directors’ meeting on 9 October 1981, Dr Craske reported that a multicentre prospective study of hepatitis in first time treated/seldom treated patients was planned, noting that this group of patients “seem to be running a higher risk of contracting Non-A Non-B hepatitis whatever type of material was used for their treatment.[1601]

Dr Craske provided an update at the 6 September 1982 meeting of Haemophilia Reference Centre Directors. 28 patients at the Oxford Centre had been entered into the study to date and followed for a period of 6 months or more after treatment. 9 of these patients had developed non-A non-B Hepatitis. It appeared that there was a “100% attack rate for first time treated patients who received NHS factor VIII concentrate and more than 80% chance of contracting hepatitis following treatment with any type of concentrate.” Dr Craske proposed that further trials of the type conducted at the Oxford Centre should be undertaken at other centres. He had also discussed with Dr Lane “the possibility of concentrates being made from pools of ‘accredited donors’ for the treatment of first time or seldom treated patients.[1602]

A further update was provided by Dr Craske at the 13 September 1982 meeting of the Hepatitis Working Party. He explained that the application to the MRC for funding had been refused and that the DHSS no longer had any funds available.[1603] Nonetheless, the preliminary study had been carried out at the Oxford Centre with the help of funds from the Haemophilia Society. 32 patients had so far been enrolled and 28 of these had been followed for at least six months. These were patients with mild coagulation defects who had fewer than two transfusions of Factor 8 or 9 concentrate during the previous year. 9 out of 9 patients treated with one batch of concentrate who had had no previous transfusions of Factor 8 or 9 developed non-A non-B Hepatitis with incubation periods of between 24 and 111 days. Some of these patients had received NHS Factor 8, one US commercial Factor 8 and the last patient NHS Factor 9. The pool sizes for NHS Factor 8 contained 1,536 - 2,504 donations.[1604] The study “implied that there was more than a 90% chance of contracting non-A, non-B hepatitis after first treatment with NHS or US commercial factor VIII concentrate.”[1605]

Dr Craske explained that it was proposed to extend this project to other centres to compare the attack rates of non-A non-B Hepatitis after transfusion with different brands of Factor 8 concentrate, “and to prospectively follow-up patients with a view to determining the long-term sequelae.” The meeting also discussed the possibility of using the prospective study to assess the effectiveness of evaluating new hepatitis reduced products. Dr Lane suggested that the “only way to evaluate the preparations for freedom from non-A, non-B hepatitis viruses was by chimpanzee inoculation, or in a prospective study of susceptible human subjects.” Dr Craske agreed to revise the prospective study protocol and circulate it for comment. It would then be open to any haemophilia centre director to use the protocol when evaluating any of the new concentrate products. They would be invited to report the results to the Working Party and “would be asked to retain serial samples of each patient’s serum so that a collection would be available to evaluate any new marker tests for non-A, non-B hepatitis viruses.[1606]

Dr Craske subsequently prepared an updated protocol, dated 23 September 1982, which proposed that other haemophilia centres undertake a similar study to that carried out in Oxford. As well as comparing the incidence of hepatitis after first exposure to Factor 8 or Factor 9 concentrate of different brands, it was recorded that there were also “several commercial products under development where attempts have been made to inactivate viruses present in the concentrate” using a variety of methods. It was said that the “only way of determining whether any of these methods is effective in inactivating hepatitis viruses in these products is by chimpanzee inoculation or a prospective study in haemophiliacs who have had no previous exposure to concentrate.” The protocol continued: “Chimpanzees are in short supply, so in the absence of laboratory tests for non-A, non-B, hepatitis trials in patients likely to be susceptible to non-A, non-B, hepatitis present the only possible way of evaluating this risk.[1607]

Two aims were described. First, to assess the risk of contracting non-A non-B Hepatitis and Hepatitis B after first exposure to Factor 8 or 9, both NHS and commercial, and to “compare this with the risk after treatment with cryoprecipitate or any other product which may have a reduced risk of transfusion hepatitis.” The second was to assess the risk of chronic sequelae after both Hepatitis B and non-A non-B Hepatitis. The selection of patients, study method and references to consent were otherwise similar to those described in Dr Craske’s February 1981 funding application.[1608]

However, it appears that, insofar as it was to be used by other haemophilia centre directors, Dr Craske’s protocol was to be amended further. The approach to be taken to trials of “hepatitis reduced” Factor 8 and 9 was discussed in detail at the 19 January 1983 meeting of the Hepatitis Working Party. The meeting was concerned in particular with the use of such products – which had not yet been licensed – on a named patient basis in the absence of coordinated trials by centre directors. It was agreed the Working Party would attempt to obtain the collaboration of haemophilia centre directors in organising a trial.[1609] The questions to be addressed included the “risk of non-A, non-B hepatitis when given to susceptible patients. In view of the results of the Oxford prospective study, these should be patients with no prior exposure to factor VIII or IX concentrate.” Dr Craske agreed to modify the prospective study protocol to include this and other points.[1610]

In September 1983 Dr Craske produced the Hepatitis Working Party’s 1982-83 annual report and appended a paper explaining that manufacturers would shortly be offering trial batches of hepatitis reduced products and referring to the risk of AIDS. The paper explained that, since the only way of ensuring the susceptibility to non-A, non-B viruses was by using patients who had not previously received concentrates, a choice would have to be made between using heat-treated products from commercial sources, which might carry a small risk of AIDS transmission, or using NHS concentrate which appeared to carry a 100% chance of transmitting non-A, non-B Hepatitis.[1611]

In December 1983 the results (relating to the first 30 patients in the study) of the prospective study on the incidence of hepatitis in infrequently treated patients was published in the British Medical Journal. The article asserted that all of the patients gave their informed consent.[1612] The Inquiry has found no evidence to support that, nor any evidence of ethics committee approval.[1613]

Malcolm and Violet Slater gave evidence to the Inquiry in October 2019. Malcolm Slater recalled being given Factor 8 concentrate pre- and post-operatively in November 1981,[1614] and that subsequently lab staff from the haemophilia centre (Oxford) would come to his home, take samples of his and his wife’s blood, and ask questions about their health. Disconcertingly, he said, the staff wore protective clothing and glasses. When he and his wife asked the reason for taking blood samples, “they would only tell us that it was for important research and they really would appreciate it if we would participate.” He had not been told about the risks of infection – had he been told, he would not have gone ahead with the operation because it was not essential.[1615] In their oral evidence, they confirmed that the staff who visited at home “wouldn’t say why, other than they were taking blood” – they said they were doing “some important research” but said “nothing about the research. It was all a bit of a mystery.” Violet Slater explained that “we never got a satisfactory answer apart from sort of a pat on the back and, ‘This would be really helpful for haemophiliacs in the future.’[1616]

What Malcolm and Violet Slater were describing to the Inquiry was their involvement in the prospective study of infrequently treated patients discussed above – Malcolm as an individual with haemophilia who had not been treated for a number of years and who was then given Factor 8 concentrate for the elective surgery in November 1981, and infected with Hepatitis C in consequence, and Violet as part of the associated study of household contacts.[1617] It is plain from their evidence that, contrary to the assertion made in the British Medical Journal publication, Malcolm Slater had not given informed consent to participation in that research. It also appears from his description of staff wearing biohazard protection that it was thought that giving him, and thereby exposing her, to the product being researched might involve a considerable transmissible health risk.

The evolution of this particular prospective study from its genesis in 1980 to its publication in 1983 has been set out in some detail above because the ethical implications of this research are so disturbing. It straddled the period from the Glasgow Symposium, where the risks of non-A non-B Hepatitis were starkly discussed, to the emergence of AIDS – a period when above all the focus should have been on a precautionary approach to the safety of each individual patient. The study involved the conscious decision to treat with concentrates those who, because they had received no or minimal previous treatment, were almost certainly not at that stage infected with Hepatitis B or C (or any other blood borne virus). The implication of the research was that participants would be exposed to the risks of infection, risks that were known to be high, as were the risks that this would progress to chronic liver disease. Evidence of ethical oversight is lacking. So too is the evidence of fully informed consent being sought, with all the implications being fully explained and explored in advance.

The objective of clinicians during this critical period should have been to take every conceivable step to avoid treating such patients with concentrates (still less with commercial concentrates). Instead this research did the opposite.

The culture of research

The minutes of UKHCDO meetings throughout the 1970s and early 1980s reveal that there was a powerful interest in research being undertaken.[1618] It was a regular topic of discussion – but with little or no emphasis on informed consent and patient involvement. Even where research was genuinely retrospective, the culture which it created, and the enthusiasm with which it was pursued, may well have had an impact on clinicians’ decision making and inclined them towards the greater use of factor concentrates, notwithstanding the greater risks associated with that use. Put another way, where there is a possibility that information which is being gathered will be used for a purpose other than the care of the patient, there is a risk that the care of that patient will be “compromised by measures taken more in the interest of the research objective (even sub-consciously) than the pure interests of the patient.[1619]

An example which illustrates the approach came as early as 1973. It relates to Newcastle and Dr Peter Jones. In April 1973 Dr Jones wrote to Pete Longstaff’s parents, who, he said, would have received a letter from Treloar’s asking for permission for Pete to participate in “the special trial of regular factor VIII injections.” Dr Jones was “in complete agreement with the trial, and that it could do nothing but good for the boys and other patients. It has been most carefully worked out, was discussed at the last meeting of the Haemophilia Directors in Oxford, and has the support of the Medical Research Council.[1620] Far from doing “nothing but good”, Pete Longstaff was infected with Hepatitis C and with HIV and died “a very painful death”, as a result of those infections, in 2005.[1621]

At the meeting of haemophilia centre directors on 20-21 November 1979, Dr Craske emphasised the view of the Hepatitis Working Party that it was “important for the incidence of chronic hepatitis in haemophilic patients to be assessed.” There was “much discussion regarding the incidence of chronic hepatitis in haemophilic patients, the possible value of liver biopsies and the type of information which Directors would be willing to give to the Working Party.[1622]

Did this engender a culture in which the focus on science, on research, rather than on the potential impacts of hepatitis on patients and securing the safest treatment for them as individuals shaped the decision making of clinicians?

The submissions made on behalf of those represented by Milners Solicitors point to the treatment, only a few days later, of a child, thought to have mild haemophilia,[1623] treated with Factorate. His medical records read “He will need twice daily cover with cryoprecipitate for at least 7 days to cover the operation”, but the words “or FVIII concentrate” have been added after “cryoprecipitate”.[1624] As the witness says in his statement, “It seems apparent to me that in 1979, at just four weeks old and ultimately misdiagnosed as a mild haemophiliac, I was treated with Armour FVIII and contaminated with HCV at a time when Dr Hill had been alerted to the dangers of NANB and chronic liver disease by Dr Craske.[1625]

In May 1979 Dr Craske wrote to Dr Anthony Aronstam at Treloar’s referring to a study of NHS Factor 8 that had been going on for almost a year; he suggested that for the second year of the study “some of this material should be used to treat mild haemophiliacs coming up for non urgent operations such as tooth extractions. We have found from observations at Oxford this is the best way of finding out whether the material is associated with cases of hepatitis, as most patients treated under these circumstances will be susceptible to non-A, non-B viruses in the transfused material.” It would, he said, “provide valuable information if you could use some of the material issued in the way I have suggested.[1626]

This was an astonishing suggestion: that people with mild haemophilia, undergoing non urgent operations (for which alternatives such as cryoprecipitate or DDAVP would be available), should deliberately be treated with Factor 8 concentrates in order to observe whether the material transmitted non-A non-B Hepatitis. Whilst it is right to note that Dr Aronstam expressed total disagreement with this idea, and indicated that he would use either DDAVP or cryoprecipitate,[1627] the fact that the suggestion could be made indicates that there was a culture whereby a determined focus on the pursuit of knowledge relegated the best interests of the individual patient to second place.[1628]

The Royal Free Hospital

As discussed earlier in this chapter, cryoprecipitate was used as a mainstay of treatment at the Royal Free in the 1970s for longer than in many other haemophilia centres, because of Dr Katharine Dormandy’s enthusiasm for it. But when she died, two new co-directors, Dr Kernoff and Dr Edward Tuddenham, “came in in 1978 and very rapidly changed everybody to concentrate.[1629] Dr Kernoff had, following work in the US, become “most interested in the aspect of hepatitis and treatment with Factor VIII or Factor IX products”, and according to Professor Tuddenham, “he came in with the knowledge of that and the intention to study it in detail.[1630]As described in the submissions on behalf of the core participants represented by Milners Solicitors, Dr Kernoff, having developed a special interest in hepatitis in people with haemophilia, “moved to the Royal Free where there existed a cohort of patients largely untreated with concentrates, and had then immediately transferred those patients’ treatment from the comparatively safer cryoprecipitate favoured by Dormandy, to large pool concentrates, with the intention of studying the known higher risk of infection.[1631]

Writing to Armour in March 1983 to seek funding for “research support into AIDS”, Dr Kernoff described the Royal Free’s haemophilia centre as having “an intensively-followed group of patients who have been exposed to a variety of different types of commercial and non-commercial blood products, and has comprehensive records of treatment extending back for many years. Many of these records are computerized, and the related problem of hepatitis is a major departmental research interest.[1632]

The British Journal of Haematology carried, in 1985, a report of a study undertaken at the Royal Free Hospital entitled “High risk of non-A non-B hepatitis after a first exposure to volunteer or commercial clotting factor concentrates: effects of prophylactic immune serum globulin”.[1633] The scope of this study was described in the following terms:

“During the 5 year period April 1978 to March 1983, 58 patients with congenital deficiencies of coagulation factors VIII or IX received 60 first exposures to factor VIII concentrate, factor IX concentrate or cryoprecipitate at the Royal Free Hospital Haemophilia Centre. Events following 31 of these first exposures, which included five episodes in which ISG was used in addition to concentrate, were prospectively studied by serial clinical assessment and blood sampling before and after exposure. In the remaining 29 instances, problems of patient accessibility and compliance prevented the acquisition of adequate prospective data. Evaluation of outcome in this latter group was therefore retrospective, and largely limited to analysis of clinical rather than biochemical or serological information. Unless otherwise stated, data given in this report refers only to prospectively studied patients.”[1634]

The report explains that of the patients studied, “Only a minority of the patients were ‘virgin’ – although most needed infrequent treatment, a majority had received blood, plasma or cryoprecipitate therapy before their first exposure infusions.” It is clear, therefore, that some of the patients were “virgin”or “PUPs” (previously untreated patients) and that most of the patients needed infrequent treatment. It was known to those conducting the study that “patients who have been infrequently or never previously exposed to blood products are at higher risk: the report expressly so states.[1635]

The report continues that

“Of the 30 patients who were studied prospectively (one patient received first exposures to both cryoprecipitate and concentrate), 13 had haemophilia A, four had haemophilia B, and 10 had von Willebrand’s disease. Three female carriers, two of haemophilia A and one of haemophilia B, were also studied. Five patients (six exposures) were aged less than 5 years at the time of their first exposure, and nine were aged between 5 and 20 years ... Of the patients with haemophilia A or B, seven were classed as haematologically severely affected, having less than 1 u/dl circulating factor. Treatment was given either to stop bleeding or as prophylaxis before surgery.”

It follows from this data that ten of those with Haemophilia A or B did not have severe haemophilia.[1636]

The extent of the participation of children speaks for itself.

In relation to each such patient, blood samples were taken and the patients clinically assessed immediately before their first exposure infusions, and thereafter at 1-2 weekly intervals for 3 months and 1-2 monthly intervals for a further 6 months. Biochemical liver function tests were carried out on all blood samples “and were normal in all patients before first exposure infusions.[1637] It is apparent from this – and explicitly recorded in the report in any event – that this was a prospective study: the patients were already being studied at the point in time at which the treatment was given. Yet there is no evidence whatsoever that the patients themselves were made aware of that.

Under the heading in the report “Ethical and legal considerations”, it is recorded that: “ISG and Kryobulin-G are unlicensed products in the U.K. and were used on a ‘named patient’ basis under the provisions of the Medicines Act 1968. The nature of the study, and the reasons for wishing to use these products, were explained in detail to all recipients and their verbal consent obtained. The study had institutional Ethical Committee approval.[1638] The clear inference from this paragraph, and in particular from the phrase “these products”, is that the explanation about the study and the seeking of verbal consent was only in relation to the patients (five in total) who were receiving the unlicensed products ISG (immune serum globulin) or Kryobulin-G (a product comprising a mixture of Factor 8 concentrate and ISG).[1639] The majority of the patients, accordingly, did not have the nature of the study explained to them, nor was their consent obtained.[1640] No evidence of any broader ethical committee approval has been found.

The results of the study were that none of the 5 patients treated with cryoprecipitate developed hepatitis; all 9 patients treated with commercial Factor 8 concentrate, and 10 of the 12 patients treated with NHS Factor 8 concentrate, developed acute non-A non-B Hepatitis (as did the 4 patients treated with NHS Factor 9 concentrate). A table within the report provides more details of the treatments administered to the patients on the study. A 4-month-old baby, an 8-month-old baby, a 27-month-old baby and a 4-year-old child, all treated with concentrates,[1641] all developed hepatitis. The 19-month-old baby treated with cryoprecipitate did not.[1642]

In its conclusion, referring to the importance of studies of new products of possible reduced infectivity, the report noted that critical to the evaluation of such new products would be patients who were “first exposure recipients”, but added “One problem of such studies will be patient accrual, since many patients with mild bleeding disorders, who in the past might have been considered suitable for therapy with concentrates, are now considered more appropriately treated with cryoprecipitate or desmopressin (DDAVP).” According to the report, the duration and dosage of therapy, and the choice of therapeutic product, “were influenced by clinical circumstances, local availability of products, and departmental policies which operated at the time treatment was given.[1643]It might be said, on the basis of this, that the study was not the driver of the choice of treatment.[1644] I have considered whether the patients were enrolled because they were receiving clinical treatment appropriately involving concentrate for the first time (or when they had received only little of it before), such that the study was merely incidental to “normal” treatment, but from all the material before the Inquiry this seems unlikely.. This was a prospective study (the report says so) run by a clinician, Dr Kernoff, who was keen to study the known “higher risk” of infection. Previously untreated patients, minimally treated patients, patients with mild haemophilia, and children were treated with concentrates at a time when safer treatments (in terms of viral transmission) existed. Research is the obvious explanation for their treatment with concentrates.

Professor Christine Lee argued in her evidence to the Inquiry that the study was “retrospective in the sense these people were not recruited to go into a study. They were people who came in with a bleeding problem, and then they were retrospectively identified. And because there had been the collection of the samples and the results of the liver function tests, it was possible to retrospectively analyse that information.[1645] I reject this description, which is not consistent in any event with the report of the study that was published, and which would not explain why so many participants were treated with concentrates when a different treatment would have been an obvious and safer choice.[1646]

The Inquiry heard evidence about three individuals who were in all likelihood patients treated as part of this study and infected with Hepatitis C in consequence of that treatment: Mark Stewart, his brother Angus, and their father, also Angus.[1647] All three had von Willebrand disorder – Angus senior’s condition being so slight that he went undiagnosed until his sons’ diagnosis as children.[1648] As noted in the submissions on behalf of the core participants represented by Milners Solicitors, “The idea that he required factor concentrates at the very point in the time of the study, having not had them during the first 30 years of his life, defies the credibility of any suggestion that the study was restricted to severe haemophiliacs, or those who had a significant need for the treatment.[1649] All were treated at the Royal Free for the first time with concentrate within the timeframe of this study.

Angus, Mark’s father, died in 2002, having developed hepatocellular cancer.[1650]

Mark’s brother Angus was diagnosed with liver cancer in 2008. He died in 2013.[1651]

Mark told the Inquiry that he lives “in fear of suffering the same fate and often feel it’s only a matter of time before something similar happens to me.[1652]

Neither Mark nor his brother nor his parents were warned of the risks of treatment with concentrate, nor that liver function would be tested and monitored. Mark learnt he had Hepatitis C only in 2007.[1653]

Professor Lee provided a written statement to the Inquiry in response to Mark’s own written evidence. Her statement said that treatment for von Willebrand disorder was (until the mid 1990s when treatment with large pool concentrates became possible because of improved von Willebrand factor content) with cryoprecipitate; that DDAVP was a treatment for mild to moderate von Willebrand disorder which came into use from around 1981;[1654] and that Mark was treated with Factor 8 concentrate in 1981.[1655] Her statement concludes as follows:

“it was not known at the time that the blood products used to treat patients with bleeding disorders resulted in these patients becoming infected ... We were certainly not conducting research on these patients. Importantly, we were using previously collected samples to conduct retrospective analysis of our data in order to understand the natural history of non-A non-B hepatitis to aid diagnosis and prospective treatment.”[1656]

For the following reasons, I do not accept this explanation. It was certainly known, at the time when this study was being undertaken, that blood products transmitted non-A non-B Hepatitis. The study described above was undoubtedly research and it was prospective in nature, rather than a retrospective analysis of data. I have no doubt too, from the facts set out already, that this research most probably influenced the choices of treatment, and that consequently participants in the study were treated with concentrates when they should not have been.[1657]

Edinburgh

In Scotland, as elsewhere, interest in people with bleeding disorders as objects of research was never far away. At a meeting of the Haemophilia and Blood Transfusion Working Group in Edinburgh in November 1983, for example:

“Dr [John] Cash reminded members about the collection of data on liver function tests of ‘virgin haemophiliacs’, and raised the question of the number of virgin patients available in Scotland. Dr [Charles] Forbes said that there were not enough virgin patients. He was however writing up his experience of hepatitis in 12 mild cases treated with PFC VIII. This data he would submit to Dr Cash. It was agreed to wait until Dr Forbes’ data was available before considering the use of English patients. When there was a sufficient amount of the new product available Dr Ludlam would be prepared to try it out.”[1658]

The group of bleeding disorder patients treated at the Royal Infirmary of Edinburgh was regarded as “unique” in being exposed to concentrate “only from the local blood transfusion service and not, as in other centres, commercial concentrate”. Abnormalities of liver function in these patients, and evidence of deterioration since the introduction of pooled concentrate, were “therefore of considerable interest”, according to a study published in the Journal of Clinical Pathology in 1981, assessing the liver function of “38 Edinburgh haemophiliacs” over a five year period from 1974.[1659] Furthermore, Edinburgh was one of the centres which had a “longitudinal sera store”.[1660]

Professor Ludlam, in his oral evidence to the Inquiry, accepted that a fundamental principle of medical research was that the participants or subjects give their informed consent.[1661] He suggested that most of the investigations that were being undertaken in Edinburgh, “although they were labelled as research, were in fact for the ongoing evaluation of the patient ... for the ongoing benefit of the patients. And patients were actually quite interested to learn a bit more about the research, and we were happy to tell them.[1662]

On 19 January 1983 Dr Ludlam attended the meeting of the Hepatitis Working Party in Oxford, where Dr Craske reported that ten cases of AIDS had occurred in Haemophilia A patients in the US (the youngest aged seven), five of whom had since died, and that it “seemed possible that factor VIII or other blood products administered to these patients might be implicated”; three cases associated with whole blood or platelet transfusion were also discussed.[1663] The main “defect” in these cases was “a disorder of cell mediated immunity” and there was discussion of studies of T-cell helper/suppressor ratios.[1664] Dr Craske suggested that “one study which might be contemplated was a prospective study of the effects of various factors of cell mediated immunity in haemophilia A patients, especially the comparison of the effect of NHS factor VIII treatment compared with that of U.S. commercial factor VIII.[1665]

Within a matter of weeks, in March 1983, Dr Ludlam embarked upon the “AIDS Study” (as the tests were labelled)[1666] in Edinburgh, supported by a grant from the Scottish Home and Health Department. In collaboration with a colleague at the Western General Hospital in Edinburgh (Dr Michael Steel), the immune function of haemophilia patients treated at the Edinburgh Centre was studied.[1667]

On 28 May 1983 a letter written by Dr Ludlam was published in The Lancet. It was in response to a letter in the same publication the previous month from Dr Robert Gordon of the National Institutes of Health in Maryland. Dr Gordon had encouraged studies of T-lymphocyte subpopulations in haemophiliacs treated with blood products.[1668] Dr Ludlam’s letter in response published the “preliminary results of a study of haemophiliacs in South-East Scotland”. The results showed immunosuppression in a number of those studied,[1669] and Dr Ludlam speculated[1670] that this might result from “foreign protein or a ubiquitous virus rather than a specific AIDS virus in the factor VIII concentrates”.[1671] As submitted on behalf of the core participants represented by Thompsons solicitors, “The fact that [Dr Ludlam] was contemplating that there was such a virus clearly meant that he knew that there was a risk that the products were harmful as a result of this putative virus, yet he continued to allow his patients to be exposed to that risk. They were a group which appeared at that time to be of interest in the emerging knowledge about the disease.[1672]

The final results of the immune function research were published in The Lancet in June 1984. The study found evidence of immunological abnormalities, which the authors thought resulted from intravenous administration of blood products; the report also recorded the presence of deranged liver function and chronic liver disease.[1673] Even if unrelated to AIDS, those studied should have been told of these findings. They were not.[1674] The continuation of the existing treatment regime should have been reviewed with the individual patients, in the light of the threefold risk that Professor Ludlam had recognised in early 1983. It was not. The fact, as it now appeared, that (whether or not it was a precursor of AIDS) the giving of blood products intravenously caused derangement of the immune system was known to the clinicians concerned (they reported it in The Lancet) and ought to have been shared with the patients first.

Following the publication of The Lancet study in June 1984, there was a further investigation of immune function in autumn 1984 to ascertain whether there were any significant changes in helper and suppressor numbers or the helper/suppressor ratio between 1983 and 1984. Patients remained in the dark that these investigations were being undertaken. They were published in The Lancet in August 1985. The conclusions in that publication included: that the chance of developing HTLV-3 was dependent upon, in addition to the helper/suppressor ratio, the number of transfused vials of infected Factor 8 and the total annual consumption of Factor 8.[1675] These conclusions were not shared with those being studied, so that they might understand how, when and why they had become infected.

There was no ethical committee oversight of the 1983 AIDS Study.[1676] Patients were not told that this study was being carried out and were unaware of it.[1677] Professor Ludlam thought this was not actually research, but rather was monitoring the health of his patients. I do not think he was right in this, for the following reasons. It was not part of the routine monitoring of their bleeding disorders. It involved the testing of the immune function of blood samples as well as skin tests (Professor Ludlam accepted that skin tests were research but he said they were also done to monitor the health of the patients, and contribute to their care).[1678] There is no tenable difference in principle between the skin tests and the taking of blood samples as he described them, because he said that both were done to monitor the health of the patient. A distinction volunteered by him in evidence was that the skin tests were intrusive. I cannot see that this is any more the case than blood tests, especially since both involve puncturing the skin.[1679] Further, his description of testing to monitor the health of patients makes little sense unless there was some yardstick which would enable a clinician to see that a particular result indicated a particular state of health or of deterioration in health. Yet as I understood his evidence, he was conducting the tests in order to find out if there was any correlation between results and states of health: this is a process which is research – in order to discover what results meant, not in order to check them against an established meaning. Finally, the fact of publication indicates this was research, as the medical ethics experts to the Inquiry pointed out.

It follows that I cannot accept Professor Ludlam’s evidence on this point.[1680] It was undoubtedly research, despite his suggesting otherwise.[1681] Patients were never informed of the results of the investigations and the studies led to no review of the treatment regime. It did, however, lead to publications in Dr Ludlam’s name and those of his colleagues.

His own description of the AIDS Study to the General Medical Council was as follows: “The background to this research project was to investigate the immune status of haemophiliacs in Edinburgh who had been treated exclusively with factor VIII concentrate prepared from Scottish blood donors ... The above research project was part of a more extensive research project into infections transmitted by clotting factor concentrate.[1682] It was set up “in direct response to the AIDS threat.[1683] Having discovered that some of the Edinburgh patients had “immune abnormalities”, it was, according to Professor Ludlam, “imperative to monitor their evolving immune status”, which was done “when they were having blood taken for other routine investigations.[1684] In other words, it was in essence more a process of discovery than of treatment.

This investigation, however, was undertaken without the knowledge or agreement of the individuals in question. Had they been informed about the studies being undertaken they would also have to have been told why, and would then have become aware of the dangers of the treatment they were receiving. Some or all may then have refused to continue to be treated with concentrates. They would not then have been infected with HIV.

In MRC News it was observed, of the “Edinburgh Haemophiliac Cohort”, that “we have had the opportunity to study a unique group of haemophiliacs who became infected in the Spring of 1984 by transfusion of a single batch of factor VIII concentrate ... This cohort of haemophiliacs has become one of the most extensively studied groups of HIV infected individuals in the world.” The “success” of the project was described as due to “the close collaboration between a group of investigators with a variety of medical and scientific skills.[1685] It is a sad reflection that this extensively studied cohort was for the most part left in ignorance of this work.

Glasgow

In Glasgow research was carried out in 1983 by Dr Forbes (with colleagues) on the “cellular immunity of a group of Scottish patients with haemophilia who were treated with factor VIII derived exclusively from Scottish donors and prepared by the Scottish Blood Transfusion Service.” Of the 19 patients so studied, 5 had also received commercial concentrate during the past two years and only 2 had never been treated with commercial concentrate. The results of the study, published in the British Medical Journal in October 1983, showed that they had immunological abnormalities “similar to those in their American counterparts”.[1686] Professor Lowe thought that this study commenced sometime in 1982 and that it was “very much” triggered by reports from the US of AIDS in people with haemophilia.[1687]

No evidence has been given to this Inquiry to suggest that the individuals involved in the study were told that their immune functions were being investigated, or of the purpose of the investigations.[1688] However, it is right to note that Professor Forbes told the Penrose Inquiry that patients “were just asked if they would mind giving a sample of blood, that we were going to look at some immunological tests that required fresh blood samples, to look at their cells and see if there was anything happening that we should know about.[1689]If this was what was said, it is not easy to describe it as “informed” consent, especially given the purpose of the investigations. Nor were patients told of the results of the investigations.[1690]

The final paragraph of the published article stated that “Whether these abnormalities in the T cell ratios and [a lymphocyte function test] are sufficient to render the patients immune-deficient and therefore, possibly, in a prodromal stage of the acquired immune deficiency syndrome, will become apparent as the patients are followed up clinically.[1691] Thus the authors recognised the possibility that the patients may already be infected (and infectious), yet nobody was told and there is no evidence to suggest any alteration in the treatment regime.

This was followed by the study, published in The Lancet in December 1984, which reported on the HTLV-3 testing of 77 Scottish haemophiliacs and 22 Danish haemophiliacs.[1692] The Scottish patients were not informed that they had been and were being tested, and were not informed of the results of these tests (11 Haemophilia A patients and 1 Haemophilia B patient were HTLV-3 positive), which must have been known by October 1984.[1693] The study also reported on a Scottish patient who had experienced symptoms typical of AIDS during his last seven months (in other words, since early 1984, as he died in late October 1984), a development which did not appear to lead to any change in the treatment regime in Glasgow or to the information provided to patients.[1694]

HPVIII/Liberate trials

In the early 1990s various clinical trials were conducted in relation to the SNBTS product HPVIII (high potency Factor VIII), also known as Tartan Factor 8 and licensed as Liberate.[1695] These trials included children as young as nine months old.[1696]

The patient information for trials HP012 and HP013 informed patients that the product was prepared from plasma collected from unpaid Scottish and Northern Irish blood donors, who were all tested for the presence of Hepatitis B surface antigen. It made no other reference to viral risks. In particular it did not refer to non-enveloped viruses such as parvovirus.[1697] The trial protocol for HP014 contained no patient information. The patient information for trial HP016 referred to donors being tested for the presence of antibodies to HIV and for the presence of Hepatitis B surface antigen but said nothing about other viral risks.[1698]

SNBTS’ application for clinical trial certificate exemption described the viral inactivation process as “designed to inactivate lipid enveloped viral pathogens.[1699]

A number of child participants in these trials seroconverted to parvovirus B19. These included children who were, at first infusion, aged 9 months, 11 months, 12 months, 18 months, 2 years (3 children), 3 years (2 children), 5 years, 6 years and 7 years.[1700]

At a meeting of haemophilia directors, SNBTS and Scottish Home and Health Department (“SHHD”) officials in May 1994 the trials were discussed and it was said that in general terms haemophilia directors and patients “were very pleased with this product.” But it was noted that “Concern had been raised in relation to viral safety, particularly of Hepatitis A and Parvovirus transfusion via solvent detergent virus inactivated products such as HP VIII.[1701]

Professor Ludlam described the importance of parvovirus in these terms to the Inquiry: “it can cause severe disease in some individuals (e.g. hydrops fetalis[1702] and severe arthropathy[1703]). It is also important because it is a non-lipid coated DNA virus that is resistant to some heat treatments and solvent-detergent action.[1704]

Thus, even in the 1990s – at a point in time at which lessons which should have been learned from the transmission of HIV and Hepatitis B and C, and the fundamental importance of providing clear and unequivocal information about risks of viral transmission to participants in research should have been at the forefront of the design of clinical trials, and that safety was paramount – children were being recruited to clinical trials being organised by SNBTS without proper information about the risks being provided. This was unethical and wrong.

Post mortem research

The Inquiry heard evidence from Mr AB, the father of twin boys treated at the Royal Hospital for Sick Children in Yorkhill – boys who were treated with commercial concentrates, prophylactically, from the age of three.[1705] That such treatment was utterly wrong – wholly unethical – will be apparent from the next section of this chapter which focuses on the treatment of children. Both boys were infected with HIV. One of them died of AIDS at the age of 17.[1706] Mr AB’s written statement to the Inquiry explained:

“It now appears from the records and from my boys’ diagnoses that they were being tested over a number of years for HIV, Hepatitis B and Hepatitis C. That my wife and I were not told about that makes me angry and upset that there was a lack of control over what was happening to our children and that they were being treated like lab rats. It has undermined my trust in doctors and the NHS.”[1707]

When he gave oral evidence to the Inquiry, he explained in addition how he and his wife were asked to give permission to a post-mortem.[1708] They did so, but understood that body parts including his brain would not be removed. This was, understandably, important to them.[1709]In summary”, he said, “we had not given informed consent to the post-mortem”.[1710] Subsequent to his oral evidence, Mr AB received previously undisclosed medical records. His response is best conveyed in his own words:

“I was shocked and uncontrollably distressed by the disclosure and content of these records, because until then I was unaware as to the nature and extent of the post-mortem, let alone the taking of so many samples of my late son’s body parts, and the fact that they had been circulated amongst various medical schools, individual researchers, and organisations unknown to me and all without my permission.”[1711]

He stated that the dignity of his late son had been abused and wanted the Inquiry to appreciate the catastrophic impact on him and his entire family.[1712]

Whilst the doctors in question have not accepted that there was a lack of informed consent to the post-mortem,[1713] the point made by Mr AB is a powerful one, namely that:

“The fact is though neither myself nor my late [wife] fully understood what we were being asked to agree to. Whilst I knew what a post mortem was I did not understand what was entailed, and I learn more about this when I see statements, reports and medical notes concerning my late son and his death ... It would be useful to set out in straightforward language, in writing, why a post mortem is required, the potential ‘benefits’; and the downside to not giving consent.”[1714]

In his submissions to the Inquiry he has emphasised “a lack of respect and dignity in the care and treatment that my family and late wife had to experience, as the medical model failed to respect victims and families. At the time research was being done without parental permission and this left a drastic impact on individuals and families’ lives. As one example of this, being informed through the Inquiry of the unauthorised post mortem distribution of body parts was devastating.[1715]

Dr James McMenamin and Dr Dermot Kennedy have told the Inquiry that at the time a consent form was signed by Mr AB neither of them was in possession of “full” information relating to the nature and extent of the post-mortem: the post-mortem itself and all associated decisions, before, during and after the post-mortem were in the full control of the pathologist and neuropathologist who were to perform it – and the doctors make the valid point that they could not pass on information they did not have. It seems that neither the treating doctors, nor Mr AB had the information which it was necessary for Mr AB to have had.[1716]

As to lessons to be learned from Mr AB’s distressing account, had the process of consent been that which is now seen as appropriate rather than the practice as it was in 1992, it seems likely there would not have been the lack of information which Mr AB needed to have, and that the system would have been such as to ensure that the doctors concerned were in a position to give more detail, more accurately, than happened. The last word, however, belongs to Mr AB. He said if only one lesson were to be learned from the Inquiry “this should be that the medical profession accepts that it must be honest and transparent at all times.[1717] That fundamental lesson is the entire message of this chapter.

Commentary

Medical research is important and its benefits can be immense. No-one should be frightened of research. Essentially it is about adding important knowledge to our existing understanding. Research may not produce a benefit in itself – but that does not mean it is worthless, for learning that something apparently promising, or even long accepted, actually does not work is a valuable addition to knowledge in itself.

People who participate in research should feel able to be proud of that fact. Researchers, whether academic or clinical, will not only feel proud that they have contributed to the store of human knowledge, but where their research is accepted for publication may gain professional kudos. That, as well as the public good, can be a powerful incentive. None should ignore the fact that without their patients, whose experiences then form part of the published research, there would be no research, and no publication. Those patients never get the kudos, though they may share the pride in advancing knowledge which benefits others – if they know that they have participated in research, what they have participated in, and what the results have been. If, as is now well accepted, the clinician-patient relationship is one of collaboration in the treatment of the latter informed[1718] by the expertise and expert knowledge of the former, then that is the least they should know. However, the evidence before the Inquiry has shown that in the great majority of cases they did not. They did not feel the pride they might have had where the research was useful: that pride, and the professional esteem that came with it, was the sole preserve of the clinicians who had conducted this research on them without their knowing (or in the case of Liberate, without being fully informed).

In particular, it should be clear what personal benefit patients should expect from research which involves them. If it does not potentially lead to an improvement in their own treatment, they should be told that in the clearest possible terms, for they will then potentially be prejudicing their health for the sake of improving the health of others. Ideally, the researcher or clinician who asks them to do this should not be one who is currently (or prospectively) treating them, for the power imbalance in the clinician-patient relationship may then make the patient feel obliged to accept participation in a study, or be fearful of damaging the relationship if they do not. It is much easier to say “No” to a third party than it is to someone much closer.

Where children are an obvious focus for research[1719] the need for it to be of benefit for the child in their own treatment becomes critical. Children cannot themselves consent to suffering harm in the hope that by their doing so other people might benefit, unless there is at the same time clear personal benefit in their own immediate treatment. The law is clear that the best interest of the child is a paramount concern. Parents should never be asked to provide consent for their child to undergo any such process: it is probably unlawful for them to give it, even in respect of their own child.[1720]

None of the research described in this chapter led to patient benefit. None of it led to safer treatment. Worse still, much was undertaken with no reasonable prospect of advancing the immediate personal treatment of the patient. At Treloar’s, for instance, a trial of prophylaxis involved one half of a cohort of children being given concentrate (which was known potentially to be harmful) at levels where it was believed it would probably do them no good, in order that it could be shown how much better children in the other half had fared.[1721] Giving children factor concentrate, known to transmit hepatitis, was likely to do them harm without any counterbalancing benefit to them. Dr Craske’s letter to Dr Aronstam, asking for previously untreated patients to be given factor concentrates even though their own treatment might not require it, was an invitation to him to cause his patients to suffer potential harm without any realistic expectation of personal benefit in their treatment. Of course, Dr Craske wanted treatment as a whole to be improved in the long run by the knowledge this would yield; and of course he recanted (under pressure from Dr Aronstam’s retort) from the suggestion in his letter, so far as Treloar’s was concerned, but his mindset was clear. He had already shown this in writing. And the implications are chilling.

There is a real danger that a desire to study a group of patients becomes the central focus rather than the interests of an individual patient in the progress of their treatment; that those interests, and patient safety, slip to become second best to the interests of research. Dr Craske’s letter, and the mindset it indicates, suggests that there was often pressure to provide treatments which both treated a bleed and serviced a general desire to help to progress research. It is not difficult to see how combining the two objects may lead to a treatment being given which would not (but for the fact of research) have been given. To an extent, an inclination to favour research may have been natural among many haematologists of the time, for haematology was principally a laboratory based discipline until the early 1970s, and was then becoming a more clinical one. It is understandable that those who had spent much of their professional lives working mainly in a laboratory setting might be more interested in research, and give it priority.

It may not entirely be surprising therefore that a heavy emphasis was placed on research by principal haemophilia centres: but being unsurprising does not mean it was acceptable to conduct it in many cases. Moreover, this chapter has shown that it was often conducted in ways that were unacceptable.

There is no doubt that patients were frequently viewed as research subjects rather than first and foremost as individuals with varying clinical needs whose informed consent should have been central to the studies that were undertaken. The Treloar’s chapter begins its section on Research by recording that it was in the 1960s that the “nearly 40 haemophiliacs in the College”provided“an opportunity for research”;[1722]which by 1979 had become a “necessity” since the “concentration of haemophiliacs found at Treloars is unique within Britain.[1723]

Core participants have emphasised this point. They are right to do so. As Thompsons submit “Campaigners from the bleeding disorder community have described themselves as ‘useful material’. They have done so in order to illustrate the extent to which they rightly feel dehumanised by this process. They reasonably interpret the way that they have been treated as being [as] the guinea pigs of a medical profession”.[1724] Importantly, they were regularly treated in this way without their knowledge or consent as if (again in the words of Thompsons) this was a part of treatment which had saved them “from an early death or life as a ‘cripple’” and the use of “their material [ie sera] without their knowledge or consent being the price they should pay for what they had received.[1725]

Patients were regularly monitored for the presence of diseases that might be transmitted by their treatment. Blood samples were taken from them repeatedly without any clear explanation of what they were for. Samples were retained, without the knowledge and consent of those whose blood it was. Some – possibly many – people with bleeding disorders were involved in research without their informed consent. Some of that research exposed them to greater risks. This was simply unethical.

There is limited evidence of any kind of effective oversight by ethics committees in the 1970s and early 1980s.

In short, this chapter has dealt with four major failings in relation to research:

  1. Research was conducted when it exposed patients to a greater risk of harm than they should have faced, in the light of the best available medical knowledge at the time, without there being any commensurate benefit for them.
  2. This was done without (a) (in many cases) telling patients that research was being conducted, and (b) (in most cases) giving the patient sufficient information on risks, benefits and alternatives to enable consent to be properly given. On occasion it is clear that it was imposed on the patient concerned, as where one clinician wrote to another to seek their permission to conduct the research on one of their patients, or to thank the other clinician for having given it with no record of the patient having been consulted.
  3. Patients were unaware that they were the subjects of studies and (in particular) of prospective research, such that:
  4. When results were received which showed that those patients had become infected, or had seriously compromised immune systems, they were not told. They did not know to ask, because they did not know they had been tested.

These failings have been aggravated by the way in which previously untreated patients – in particular children – were sought out to become the subject of research, and in some cases to be given treatments which were unnecessary, or conferred no advantage but only additional risk. The ethics of this are clear. It was, and is, unacceptable.

The result of people discovering that they were tested, made subject of research, and then not told the results, and might have been given risky treatment more to advance research than their own personal interests, has had two serious practical consequences. The first is loss of trust in the NHS, and in doctors generally, to the extent that many feel they may have been given treatments not because they needed them but rather to see what would happen, whether this can in their individual case be proved or not. The second is that the failures have seriously compounded the harm to which individuals had already been exposed, as has been powerfully conveyed by the evidence of Mr AB. An insult to patient autonomy, which the combination of these failings constitutes, is not something which is a concept burrowed deep in a textbook on Medical Ethics and nothing more. It has a real impact on personal lives; it aggravates the psychological impact of what has happened; it is dehumanising.

The treatment of children

It can easily be overlooked that, with rare exceptions, bleeding disorders like haemophilia and von Willebrand disorder are lifelong conditions. People have them from birth. Accordingly, throughout the periods of particular interest to the Inquiry, there has always been a continuous pattern of people needing treatment for the very first time, when particularly vulnerable. This simple fact argues eloquently that clinicians need to be particularly astute to ensure that as risks of treatment to those who are adult become apparent, clinicians learn – and, in the light of that learning – avoid those risks coming to affect those children who are new to treatment.

Safety is paramount for all patients. But nowhere is the need for it more visible, and a lack of respect for it of greater importance, than in the case of children.

Around 380 children with bleeding disorders were infected with HIV.[1726] Many of those died in childhood or young adulthood, having endured a level of pain and fear that no child or young person should ever have to face. Some survived but have lived their entire lives under the shadow of HIV and AIDS, with an appalling toll on their physical and mental health.

All those children who were infected with HIV were likely[1727] to have been coinfected with Hepatitis C. Others escaped HIV infection only to learn later that they had been infected with Hepatitis C, sometimes with deadly consequences; and those who survived have also suffered profound ill health and endured the horror of the early treatments with interferon. Some were also infected with Hepatitis B and with other viruses.

How did it happen that in the second half of the 20th Century so many children could be infected with fatal viruses from their NHS treatment? In seeking to answer this question, this next part of this chapter will look at the available evidence about treatment practices at seven paediatric haemophilia centres. Treloar’s is considered in a separate chapter.

Alder Hey

Alder Hey Children’s Hospital was the principal Liverpool site for the treatment of children with bleeding disorders from at least the late 1970s onwards, treating children from the Merseyside area and North Wales. In around their mid teens children would then transfer to the Haemophilia Centre at the Royal Liverpool Hospital.[1728]

Dr John Martin was the director from the mid 1970s. He was not a haematologist.[1729]

The annual returns for Alder Hey show a distinct shift from cryoprecipitate to concentrate from the late 1970s to the early 1980s for the treatment of patients with Haemophilia A. The Centre’s use of products in 1977 is unclear: the 1977 return recorded 643 packs of cryoprecipitate but in relation to concentrates, no figures were provided and the return contained the handwritten statement “as supplied by Dr F E Boulton Liverpool Royal Infirmary.[1730] The 1978 return, whilst also confusing, showed the use of cryoprecipitate and both NHS and commercial concentrate,[1731] as did the return for 1979.[1732] However, in 1980 the use of commercial concentrate (Factorate) increased[1733] and in 1981 Alder Hey treated its haemophilia patients almost exclusively with concentrate (both NHS and Factorate).[1734] This pattern continued in 1982 with the Centre using almost exclusively concentrate, most of which was commercial,[1735] and in 1983 where the return recorded the almost exclusive use of concentrate, mostly Factorate.[1736] In 1984 Alder Hey treated its Haemophilia A patients only with concentrates, both commercial and NHS.[1737] The 1985 annual return is missing. In 1986 Alder Hey treated its Haemophilia A patients only with concentrate.[1738]

Although the returns themselves are imperfectly completed, what is clear is that cryoprecipitate gave way to concentrate and that in 1983 and 1984, when it would be expected that haemophilia centre directors treating children would strive to avoid treatment with commercial concentrates, Dr Martin did the opposite. That this was his approach to treatment is all too apparent from two medical reports regarding Dr Martin’s treatment of a child patient, Stephen Hallwood. Stephen and his brother Brian were both infected with HIV as a result of their treatment at Alder Hey and died in childhood.[1739]

The first report was prepared by Dr Savidge in 1992. It reveals that Stephen, at the age of just two years old, was treated with US commercial concentrates on 32 occasions in the course of 1982.[1740] He was treated with US commercial concentrates repeatedly again in 1983 and 1984, including as late as December 1984.[1741] In early 1985 Stephen was twice treated with unheated US concentrates.[1742] Dr Savidge’s assessment of his treatment was scathing:

“There are two notable features of this case with respect to the adopted therapeutic approach. Firstly, there is no documentary evidence to suggest that single donor pool cryoprecipitate was ever contemplated in the management of this case, not even when the patient was initially treated. Secondly, there is evidence to indicate a defined preference to use U.S. commercial products (45 treatments) over NHS factor VIII concentrate (9 treatments) during the period 1982-1985 when initially only unheated, but subsequently heated products were available.

In the late 1970s and early 1980s, the majority of U.K. paediatricians treating infants and children with severe haemophilia considered cryoprecipitate obtained from single blood donations to be the therapeutic product of choice, but if not available NHS factor VIII concentrate should be used ... The lack of consideration and disregard of the then current therapeutic recommendations for the treatment of children under the age of 4 years regarding the use of cryoprecipitate in this case was negligent ... The overwhelming use of commercial U.S. concentrates in preference to cryoprecipitate or NHS factor VIII is remarkable, particularly in a large city such as Liverpool known to have an active BTS with facilities for cryoprecipitate production and regularly supplying plasma to Elstree for fractionation. The lack of a well-defined therapeutic policy regarding preferential use of domestic plasma derivatives in children at this time was negligent”.[1743]

As for Dr Martin’s decision to treat Stephen with unheated commercial concentrates in January 1985, after the issue of UKHCDO’s AIDS Advisory Document:

“Despite this information with which a competent practicing paediatric haematologist could be expected to be conversant, and a further report by Bloom in January 1985 (Lancet i, 336), which stated that at least 2 batches of NHS concentrate had transmitted HIV and urged the use of heat treated concentrates, Stephen ... was given two infusions of unheated US concentrate in January 1985 and two infusions of unheated NHS concentrates in March 1985. The infusion of these untreated therapeutic agents at these times when heat treated concentrates were commercially available was negligent”.[1744]

Sadly, there is no reason to think that Dr Martin’s treatment of Stephen was atypical. His brother Brian was treated with commercial concentrates from the age of two.[1745] Such treatment continued after the June 1983 letter sent on behalf of UKHCDO to all haemophilia centre directors and after the December 1984 meeting of reference centre directors and others at BPL.

The second report relating to Stephen’s treatment was prepared by Dr Ludlam. Dr Ludlam noted this:

“In Dr Martin’s evidence it is stated that he was aware of the risks of hepatitis transmission by concentrates, that cryoprecipitate was effectively phased out in 1980 and that treatment was advised by the Royal Liverpool Hospital (RLH). It is therefore necessary to know what policy was operated by the RLH. Dr McVerry’s evidence does not accord with this[.] Why was it decided to phase out cryoprecipitate in 1980? Was there a policy about which patients should receive NHS and which commercial concentrates? Why was concentrate purchased from Armour rather than another supplier? The patient could have been treated effectively with cryoprecipitate in the first few years of life whilst receiving treatment as an out-patient. If cryoprecipitate was not available then NHS concentrate would be the most appropriate therapy.”[1746]

The “evidence” of Dr Martin to which this report referred was a statement prepared for the purposes of litigation, in which Dr Martin said that “there was certainly no instruction to use cryoprecipitate for mild haemophiliacs or that it should be the treatment of choice in particular circumstances”. Cryoprecipitate was said to have been “phased out in the early 1980’s and was not generally available in the hospital.[1747] He did not regard the risk of hepatitis as a reason to alter any treatment regime.[1748] His aim was, he said, “to keep children out of hospital as much as possible.[1749]

His aim should have been to treat children as safely as possible. Instead he exposed them to wholly unnecessary risks.

Dr Martin had no recollection of the 24 June 1983 letter from Professor Bloom and Dr Rizza but accepted that he would have received it; however, in his own words: “There was no alteration in the treatment regime at this time as a result of the letter.[1750]

Dr Martin was the director of the haemophilia centre at Alder Hey. It was a separate, recognised centre, with its own centre number (065), and Dr Martin was clearly identified as the director on the annual returns which he submitted. Dr Martin did not attend any UKHCDO meetings in the 1970s and 1980s: that can only have been a matter of choice on his part[1751] and provides no excuse or justification for the utterly inappropriate treatment policies and practices at Alder Hey under his directorship. The minutes would have been sent to him and it was his professional responsibility to keep up to date.

Information from legal claims relating to other children treated at Alder Hey reveal the same approach to treatment.[1752] They detail a child treated with concentrates from an early age at Alder Hey until May 1984 and then from Glynedd Hospital, North Wales, on home treatment.[1753] Another child was treated with concentrates from 1978 onwards and this was described as “the policy at Liverpool Children’s Hospital”; the records did not identify the type of batch number (in itself a clear indication that no batch dedication policy was followed) and the child was treated with commercial concentrate in January and December 1983.[1754] A patient with mild/moderate haemophilia was treated with concentrates for elective surgery in September 1983. Their notes were “insufficiently detailed” to identify the products used but “Dr Martin’s statement confirms that no distinction was made at Alder Hey Hospital in terms of which product to prefer and the product he would have received would have been that which was available.[1755] Another child with mild haemophilia was treated with what appeared to be NHS Factor 8 in late 1982 and commercial Factor 8 between March and July 1983.[1756] A child born in 1980 (inferentially with severe haemophilia) “received a substantial amount of concentrate, the majority of it being commercial concentrate. The type of concentrate would have been dependant [sic] upon availability and treatment was standard.” It was said that there was “Nothing atypical about treatment given to this Plaintiff.[1757] That in itself is damning. A child with mild haemophilia had received “commercial Factor VIII in December 1983 for a tooth extraction; this treatment “would not seem to be justified.[1758] A child with severe haemophilia was regularly treated at Alder Hey with concentrate, “at least some of it commercial after mid-1983.[1759] Each of these children was infected with HIV in consequence of their treatment.

A medical report on a child born in 1981, with moderate haemophilia, shows that he was treated with concentrates from the age of one and received treatment with concentrates on four occasions in 1983. The report from Dr Ludlam raised the following questions:

“As small children with this degree of severity of haemophilia only bleed infrequently treatment should ideally have been with cryoprecipitate. Although this is lightly [sic] harder to give than factor VIII concentrate it was still the treatment of choice, and used by many Centres. If it was not available, as Dr. John Martin maintains, then he should have been treated with NHS factor VIII concentrate.

To justify the use of commercial factor VIII concentrate for this child it will be necessary for Dr. Martin to demonstrate that despite requesting cryoprecipitate from the Regional Transfusion Centre they refused to provide it. He will also have to demonstrate that there was no way in which he could reserve NHS factor VIII concentrate for the treatment of patients who only bled occasionally. Although Dr. Martin maintains that treatment policy was directed by the Royal Liverpool Hospital this does not accord with the statement of Dr. McVerry. I think Dr. Martin has to justify his treatment policy as an independant [sic] clinician.” [1760]

A report from the solicitors representing the defendant health authority in the litigation recorded that “We are unable” to show that cryoprecipitate and NHS Factor 8 concentrate were not available and that Dr Martin “says that he gave no consideration to alternative treatment.[1761] Dr Martin himself said that his treatment of the child was “consistent with the standard treatment being given to patients at the time.[1762]

Other evidence confirms that: DDAVP was not in use until after 1988/89;[1763] there was no system of batch dedication to reduce donor exposure;[1764] and (by 1989) a “large proportion of the clinical notes of children affected by HIV were on close inspection missing essential treatment and decision-making details.[1765]

The precise number of children infected with HIV as a consequence of their treatment at Alder Hey is unclear: data from UKHCDO suggests that 13 were infected; a July 1987 report recorded 16 cases; Dr Ball recollected approximately 12 boys who were HIV positive.[1766] Dr Ball’s recollection too was that, as a proportion of children registered per centre in the UK, “this was one of the highest (if not the highest) proportion of HIV positive haemophiliacs.[1767] To put those figures into their (horrifying) context, the 1983 return showed 16 patients with Haemophilia A treated that year; the 1984 return showed 14 patients.

Birmingham Children’s Hospital

Birmingham Children’s Hospital (“BCH”) was the largest centre for children in the UK: as at 1974 it had 120 patients registered.[1768] Children transferred to the QEH between the ages of 16 and 18.[1769] Dr Frank Hill succeeded Dr Mann as centre director in 1976.[1770]

In a statement Professor Hill made to the Inquiry he stated that in the late 1970s non-A non-B Hepatitis was thought to be a minor, self-limiting condition with no serious long-term consequences.[1771] If that was Professor Hill’s genuine understanding at the time, it was wrong, for reasons explored elsewhere in this Report.[1772] Whether it was in fact Professor Hill’s view may be debatable, given that in November 1976, at a meeting of the West Midlands Working Party on the Treatment of Haemophiliacs, he raised the hepatitis risk in respect of freeze-dried Factor 8 concentrates and asked whether it might be advantageous to reserve the NHS concentrate for children, leaving the concentrate “obtained from commercial sources, largely of foreign origin” for adults.[1773]

The annual returns for BCH reveal an increasing move away from cryoprecipitate and increasing reliance upon commercial concentrate. As at 1977 BCH treated its Haemophilia A patients predominantly with cryoprecipitate together with some commercial concentrate. No NHS Factor 8 was used that year.[1774] This was a change from 1976, in which no commercial concentrate had been used and treatment was predominantly with cryoprecipitate, with a small amount of NHS concentrate.[1775]

By the following year, 1978, Factor 8 concentrate outstripped cryoprecipitate, with more commercial concentrate being used than NHS. The use of cryoprecipitate had reduced substantially from the previous year.[1776]

By May 1979 BCH had 17 patients on home treatment (with a further 5 being trained), of whom 8 received NHS product and 9 received commercial product.[1777] Commercial concentrate usage in 1979 was almost double that of 1978.[1778] Factorate usage then more than doubled in 1980[1779] and remained the mainstay of treatment in 1981[1780] and 1982, with the latter year seeing a substantial fall in the use of cryoprecipitate.[1781]

In 1983, when the risks of AIDS should have led to a different and more cautious approach, Factorate usage increased again and there was no indication of any increased use of cryoprecipitate.[1782] And whilst 1984 saw a very modest increase in the amount of cryoprecipitate used, and an increase in NHS concentrate, the amount of Factorate used rose yet again to 1,669,266 units.[1783]

The numbers of patients treated over this period varied, but did not significantly differ from year to year.[1784]

It is right to note that at a meeting of the West Midlands Working Party on the Treatment of Haemophiliacs in November 1981 Dr Hill “raised the problem of the large amount of Commercial Factor VIII used at the Children’s Hospital, compared with NHS Factor VIII ... He referred to the high cost that this incurred for the Central Birmingham District and asked if NHS Factor VIII could be distributed on a more even basis.” The Working Party agreed to recommend to Dr Ala, the regional transfusion director, that NHS concentrate should be distributed in proportion to the number of patients treated.[1785] It does not appear that the idea of prioritising NHS concentrate for the treatment of children was pursued. At the June 1982 Working Party meeting, and in response to an anticipated temporary (six-month) reduction in the production of concentrate at BPL, Dr Ala recommended that all centres should endeavour to cut down on the use of Factor 8 and increase the use of cryoprecipitate. The Working Party however agreed that “any shortfall would have to be met by increased purchasing of Commercial Factor VIII.[1786] The annual returns for 1982 suggest that Dr Hill did not increase the use of cryoprecipitate at this time.

In his 1992 statement, Dr Hill claimed to have become aware of the possibility of AIDS being a condition encountered in people with haemophilia in early 1983, adding that he “had no knowledge of whether the condition was associated with a virus infection or could be associated with imported Factor VIII concentrates.” It was, he said, “not thought that there was any call for any treatment alteration because of the association between haemophilia and AIDS based on information available in 1983 and to withhold treatment of acute haemorrhages was considered more dangerous.[1787] This statement calls out for comment in a number of respects. First, Dr Hill was one of the attendees at the Heathrow hotel meeting in January 1983 and can have been under no illusions as to the nature and severity of the risk of AIDS transmission: to suggest that the information available in January 1983 merely conveyed the “possibility” of AIDS being a condition encountered in people with haemophilia is to misrepresent or misunderstand the position significantly.[1788] Second, in June 1983 he was sent a letter from Treloar’s informing him that one of his patients was exhibiting AIDS stigmata.[1789] It is unclear whether he took any action in response but again that should have been a matter of acute concern. Third, Dr Hill would have received the 24 June 1983 letter from Professor Bloom and Dr Rizza, following the special meeting of reference centre directors in May 1983. That should have alerted Dr Hill to the importance of avoiding treating children with commercial concentrates. Yet there is no evidence to suggest any significant change in treatment practice at BCH in response to the risks of AIDS before December 1984.

Nor is there any evidence to suggest that a batch dedication policy was in operation – indeed there is evidence to the contrary. A 1992 medical report (from Dr Savidge) was scathing about Dr Hill/BCH’s approach to treatment:

“It would seem that Armour was the sole supplier of commercial factor VIII to Birmingham Children’s Hospital at that time, and Dr. Hill was purchasing large amounts (0.25-0.5 million units) of low unitage (200 units) vials at any one time. However, instead of allocating an individual small group of patients on any one batch to ensure long-term continuity of management of such cases on the same batch, it would seem that, with a few exceptions, the vast majority of Dr. Hill’s patients received the same batch over a few months until the batch was used up. This rather bizarre approach to patient management resulted in the child receiving a relatively large number of batches of vials of material containing few units in a remarkably short time.”[1790]

The child referred to in the report was given commercial concentrate as a baby and Dr Savidge observed that “As cryoprecipitate treatment of infants was the recommended policy of the hospital and indeed nationally, the administration of this large donor pool commercial material in preference of cryoprecipitate or NHS concentrate without authorisation was negligent.[1791] The report detailed multiple treatments with commercial concentrates over the course of the period from 1981-1984. In relation to 1983-1984, the report continued:

“During 1983 and into early 1984, Armour concentrate was used exclusively although there is no satisfactory documentation to indicate that the boy had developed allergic reactions to cryoprecipitate uncontrolled by antihistamines, had shown any signs suggestive of reduced efficiency of cryoprecipitate or was established on a home treatment programme. This policy was pursued, with no reference to the availability of NHS concentrate at the hospital in the face of growing concern and increasing information in the public and medical press that AIDS was transmitted by blood products.”[1792]

Further:

“Although it would seem that Dr. Hill, as a number of haemophilia treaters in the U.K. at this time, believed that continued use of the same batch confined the risk of infectivity, this was clearly not practised in the case of this child. This is evident from the fact that between 1981-mid 1984, 20 different batches of Armour factor VIII were used, and during the relevant period (1981-1982) when infection with HTLV III most probably occurred, some 7 different batches comprising the total unitage of 5516 units of Armour factor VIII were administered. This very small unitage, however, carried a very high potential for possible infection as the material from all these batches was probably derived from at least 70,000 paid U.S. blood donors. From this aspect, cryoprecipitate and to some extent NHS concentrate if used consistently would have imparted a far lower infectious risk, particularly as the Armour material originated in the U.S. where paid blood donations were the commercial companies plasma source, and where AIDS was believed to have originated and had already started to become manifest as a clinical entity in U.S. haemophilia patients.”[1793]

There is no reason to think that Dr Hill’s/BCH’s treatment of this individual child differed materially from the approach to the treatment of children at BCH more generally.[1794] On the contrary, it is consistent with both the annual returns and the evidence which the Inquiry has received from those treated at BCH and their families. Dr Hill, in a statement produced for the purposes of litigation in 1992, made clear that cryoprecipitate was not favoured at BCH for use in home treatment,[1795] and was therefore used only for treatment on demand in the Centre. The introduction of the home treatment programme in 1976 required, he said, increased amounts of factor concentrate and commercial concentrates “were more available than NHS concentrates.[1796] Children were considered for home therapy at about three years of age, but it was not uncommon for it to be earlier.[1797] It is thus clear that children including infants as young as or younger than three years old would be treated at BCH with commercial concentrates.

The evidence of Andrew Evans, who, having been initially treated with cryoprecipitate and NHS concentrates, was then treated with US concentrates, casts light on Dr Hill’s attitude towards the risks of AIDS. In early 1983 the New Scientist published an article which referred to the possibility of AIDS being spread through Factor 8 concentrates.[1798] It was read by Andrew’s parents. This led to a meeting at BCH during which his mother asked Dr Hill outright whether there was a chance that her son and the sons of the other parents present would get AIDS from Factor 8 and Dr Hill’s reply was “Madam, your son has more chance of becoming debilitated with arthritis through not taking Factor VIII than he has of getting AIDS.[1799]

He developed AIDS.

It was not until after the Elstree meeting on 10 December, when the West Midlands Working Party held an extraordinary meeting on 17 December 1984 to discuss the implications of the deaths of two people with haemophilia from AIDS, that there was any significant change of approach and an interim treatment policy was agreed, whereby mildly affected patients with Haemophilia A and von Willebrand disorder should be treated with DDAVP or cryoprecipitate, newly diagnosed patients with severe haemophilia should be treated wholly with cryoprecipitate; patients with no previous exposure to commercial Factor 8 should continue on NHS Factor 8; and patients with previous exposure to commercial Factor 8 should continue on NHS product if available and heat-treated commercial product if not.[1800]

The commercial heat-treated Factor 8 product used at BCH in 1985 and 1986 was Armour’s product.[1801] It may or may not have been a coincidence that Armour made regular financial contributions to Dr Hill’s “research fund” as can be seen from a letter from Robert Christie of Armour to Dr Hill in March 1985.[1802] In April 1985 Robert Christie visited Dr Hill, to discuss a number of recent possible Hepatitis B cases and also to discuss Dr Hill’s “research on AIDS and Haemophiliacs”. The note made by Robert Christie recorded that Dr Hill continued to screen children for HTLV-3 antibodies, that just over 50% were positive and that “Dr Hill suspects that all children who have had a long exposure to concentrate may well be infected![1803]

In a report prepared by Dr Franklin and Dr Hill in April 1986, it was reported that 60% of the patients at BCH were positive for HIV.[1804]

In September 1986 Dr Hill reported to Armour that two children had seroconverted to HIV following their use of Armour heat-treated Factorate.[1805] In late October 1986 Dr Hill reported to Armour that a third child had seroconverted.[1806]

Royal Manchester Children’s Hospital

The director of the Royal Manchester Children’s Hospital (“RMCH”) in the 1970s and 1980s was Dr David Evans. The Centre treated children up to the age of 16 or 17 years.[1807] In 1977 Dr Evans was sufficiently concerned about the transmissibility of hepatitis to write to Professor Blackburn (then chair of UKHCDO) wanting to know what different laboratories were doing “about the potential hepatitis risk with haemophiliacs.[1808]

The annual returns between 1976 and 1982 show a clear move away from cryoprecipitate towards commercial concentrates for the treatment of children with Haemophilia A.[1809] Thus in 1976 the annual returns show the use of 270,970 units of cryoprecipitate, 32,973 units of commercial concentrates and 3,535 units of NHS Factor 8.[1810] Over the following years the balance shifted, such that by 1979 for the first time more units of concentrates (predominantly commercial) were used than cryoprecipitate;[1811] in 1980 significantly more units of concentrates (predominantly commercial) were used than cryoprecipitate;[1812] in 1981 and 1982 Haemophilia A patients were primarily treated with commercial concentrate (and no NHS concentrate was used at all).[1813]

Cryoprecipitate tended to be used for hospital treatment and concentrates for home treatment, at least as at September 1982[1814] when Dr Evans wrote “We normally give the young patients with haemophilia treatment with Cryoprecipitate rather than Factor VIII concentrates. In the past we found several developed jaundice when they were given Factor VIII concentrates and I think the incidence of hepatitis is much lower when we use North Western Cryoprecipitate than when we use the imported concentrates. We tend to keep the concentrates for use with patients who are on home treatment, and use Cryoprecipitate in hospital.[1815] Viewed from the perspective of safety rather than convenience, the logical flaw with such an approach is that patients on home treatment were being exposed to the greater risk of hepatitis. Home treatment with an element of prophylaxis had been introduced in the early 1970s and families were advised that “Some children may be able to have an injection to provide cover for a day or so for an important examination, or to tide them over a period when bleeds are particularly troublesome.[1816]

There was no policy of restricting patients to single manufacturers or batches of commercial concentrate.[1817]

The annual returns give no indication of any response to the developing knowledge of the seriousness of non-A non-B Hepatitis. There was no discernible change of approach in 1983 and 1984: at a time when the risks of AIDS should have been uppermost in any haemophilia clinician’s mind, the predominant treatment for the children at RMCH remained commercial concentrates, although NHS Factor 8 continued to be used as well.[1818] Dr Evans was a regular attender at UKHCDO meetings[1819] and attended the January 1983 Heathrow hotel meeting referred to earlier in this chapter. He was also the recipient of correspondence from Dr Aronstam at Treloar’s in July 1983 which would have alerted him to the fact that Treloar’s was undertaking “AIDS related tests” and looking for “the stigmata of AIDS”.[1820]

It is not clear when RMCH introduced heat-treated concentrates, but as at May 1985 it appears that the Centre had not provided BPL with a list of named patients to receive heated NHS Factor 8.[1821]

That Dr Evans did not make any significant adjustments to his approach to treatment in response to the risk of AIDS is apparent from an article he wrote in 1997: “It was apparent by 1983 that the risk of infection was greater with concentrates derived from large donor pools, and advice was given to change from large pool products to cryoprecipitate; but because AIDS was still rare, the cause was unknown, the benefits of home treatment with concentrate were substantial, and a change back to cryoprecipitate would have disrupted the arrangements for making freeze-dried concentrate in the UK, this advice was not followed.[1822]

In 1987 the RMCH produced a leaflet containing information on HIV for patients and their families, which stated “Some years ago some of the freeze-dried concentrate, imported from America, were infected by the virus. At this time no-one was aware that this was so. It took time before it was known that AIDS was carried by a virus, and longer before it was known that it was present in blood and blood products ... The hospital staff had no idea at the time that their treatment carried this risk.[1823] This was not a transparent or candid way in which to explain the position to patients. On the contrary, it was positively misleading. Certainly by (at the very latest) January 1983 Dr Evans did know of the risk of transmission from commercial concentrates.[1824]

UKHCDO data suggests that 16 patients were infected with HIV at RMCH.[1825]

Royal Belfast Hospital for Sick Children

In Belfast children with bleeding disorders were cared for at the Royal Belfast Hospital for Sick Children (“RBHSC”) until around the age of 14, when they transferred to the haemophilia centre at the Royal Victoria Hospital.[1826] Dr Stanley Dempsey was the consultant paediatric haematologist at the hospital from August 1980, taking over from Professor John Bridges.[1827] The cohort of patients under Dr Dempsey’s care in the 1980s all had either mild or moderate Haemophilia A; there were also some patients with von Willebrand disorder.

There were no separate annual returns for the RBHSC: the returns were amalgamated with the adult haemophilia centre at the Royal Victoria Hospital and sent to Oxford “as a unified whole.[1828]

When Dr Dempsey took up his post in August 1980, cryoprecipitate was used “fairly exclusively”; this was the policy of his predecessor.[1829] Following a “difficulty” with a child admitted in 1981 following an accident where cryoprecipitate “failed to do the job that was asked of it on that occasion”, Dr Dempsey’s “confidence in cryoprecipitate” was shaken[1830] and he began to use commercial concentrates in its place for the moderately affected patients, although cryoprecipitate remained the product of choice for mildly affected Haemophilia A and von Willebrand disorder patients. The commercial concentrates used were those in the blood bank at the time (Hemofil and Armour), which were ordered by Dr Mayne.

Looking back Dr Dempsey said the best decision would have been to go onto NHS material.[1831]

From late 1981 to June 1983 children at the RBHSC with moderate haemophilia were treated with these commercial concentrates; children with mild haemophilia were treated with DDAVP and tranexamic acid.[1832]

Dr Dempsey recalled that the pharmaceutical firms were “keen to emphasise the fact that they’d tightened up on the type of donor they looked to for their plasma source” and this gave him “reassurance” such that he was “disposed to look favourably on commercial concentrates at that point in time.[1833] Dr Dempsey said that he had to rely on the fact that these firms were telling the truth. He also got the impression from reading UKHCDO minutes that things had improved considerably in relation to the safety of commercial concentrates.[1834]

Dr Dempsey described batch dedication as “extremely difficult” and as something that ultimately did not work.[1835]

Notwithstanding the assurances from the pharmaceutical firms, Dr Dempsey was aware that there was still a risk of non-A non-B Hepatitis from commercial concentrates, but there was also a risk from NHS concentrates. He acknowledged that the risk with cryoprecipitate was “very much less.[1836] He recalled that non-A non-B Hepatitis was not thought sufficiently serious to merit withdrawal of “the only really effective treatment for severe/moderate haemophilia.[1837] Dr Dempsey suggested that “we” were “on a learning curve from 1980 on.” There was a “general feeling” amongst clinicians that it was not a major concern, but there were patients who did have evidence of chronic liver disease.[1838]

Following the circulation of the UKHCDO’s 24 June 1983 letter, Dr Dempsey switched from commercial to NHS concentrate (the SNBTS product). Had such advice been given earlier by UKHCDO, it is reasonable to assume that this switch would have taken place earlier.

In retrospect he would not have used concentrate at all “given what was likely – or what was going to happen further down the road”; looking back, the NHS product might have been a “better modality of treatment” to have employed back in 1981.[1839]

Dr Dempsey continued to use SNBTS concentrates until late 1984 when he became aware of the infection of patients in Edinburgh. The heat-treated Scottish product became available to him in late 1984 and he was using the heat-treated product NY until July 1987 when the next generation product Z8 became available. He was aware that non-A non-B Hepatitis could still be transmitted by NY.[1840] He was not aware, however, that BPL was producing a product at this time (8Y) which did not transmit hepatitis; had he known about it, he would have phoned BPL and requested a supply.[1841]

It is unclear whether any children treated at the RBHSC were infected with HIV in consequence of their treatment there, but Dr Dempsey’s understanding was that there were not.

All of his patients in the moderately affected category – who would have been treated with commercial concentrates and SNBTS concentrates – were infected with Hepatitis C.[1842]

Great Ormond Street Hospital

The director of the centre at Great Ormond Street Hospital (“GOSH”) was Professor Roger Hardisty from around 1968 to 1987, when he was succeeded by Professor Ian Hann.

Professor Hardisty told a meeting at the DHSS in 1970 that at GOSH the emphasis was on early treatment of minor bleeds in children to prevent crippling; that more treatments were being given per patient; and that some 30% of 69 registered patients attended frequently or fairly often.[1843] GOSH was regarded as being in a unique situation as a supra-regional children’s hospital, with patients drawn from a number of different southern/eastern regions.[1844] By 1976 all patients on home treatment were receiving commercial Factor 8 concentrates, through a special allocation from the DHSS.[1845] In September 1977 GOSH was complaining of a shortfall of NHS concentrate and a need to purchase more commercial concentrates.[1846] In September 1978 it was recorded that a shortage of factor concentrates for home therapy was leading to patients being transferred to other centres at a much younger age.[1847]

The annual return for 1976 shows substantial use of both cryoprecipitate and commercial concentrates, with very little NHS concentrate.[1848] By the following year the amount of cryoprecipitate used had reduced considerably, with some rise in NHS Factor 8 but with treatment being predominantly with commercial concentrates.[1849] 1978 showed a similar pattern.[1850] In 1979 Factorate was the main treatment,[1851] as it was again in 1980,[1852] and in 1982, although the amount used in 1982 showed a substantial increase from 1980.[1853] Whilst 1983 saw an increased use of NHS Factor 8, there was little use of cryoprecipitate, although the volume of Factorate fell substantially compared to the previous year.[1854] The position in 1984 was different: NHS Factor 8 concentrate was the product in greatest use, with a significant reduction in the amount of commercial concentrate.[1855] In February 1985, writing to Dr Snape with the names of seven patients who had tested positive for HIV (and a number of others whose results were awaited), Professor Hardisty indicated that he would like to switch to the heated NHS products for all patients, irrespective of their antibody status, as soon as supplies permitted.[1856]

There is comparatively little contemporaneous evidence regarding Professor Hardisty’s approach to treatment, beyond what is revealed by the annual returns. He was, however, a regular attendee of UKHCDO meetings. He was also at the January 1983 meeting at the Heathrow hotel, at which he was recorded as pointing out (along with Dr Hill) the ethical difficulties of using newly diagnosed children as first candidates in a trial of hepatitis-free Factor 8.[1857] Unfortunately, GOSH was unable to locate any stored relevant documentation from the 1970s and 1980s (except individual patient records) to provide to the Inquiry, and there was no personal paperwork of Professor Hardisty’s from the time to be found in storage.[1858] It is therefore not possible to conclude whether the use of products in 1984 represented a conscious decision to use less commercial concentrate or not.

UKHCDO data suggests that 11 patients were infected with HIV at GOSH.[1859]

Royal Hospital for Sick Children (Yorkhill)

The haemophilia centre at the Royal Hospital for Sick Children (“RHSC”) in Yorkhill, Glasgow, provided haemophilia treatment to children from the Glasgow area and across the West of Scotland. As at 1980 there were 55 patients with Haemophilia A, 14 with Haemophilia B and 1 with von Willebrand disorder registered with the centre.[1860] Children transferred to the care of the Royal Infirmary in Glasgow at around the age of 15 or 16.[1861] The centre director was Dr Michael Willoughby who was involved in the treatment also of children with haematological and non-haematological cancers. Dr Anna Pettigrew took up a post as a part-time clinical assistant there in May 1980.[1862] Dr Willoughby left in 1983 and was replaced by Dr (later Professor) Ian Hann.

Dr Pettigrew’s recollection was that the policy in practice (under Dr Willoughby) was that newly diagnosed patients and those with mild haemophilia were treated with cryoprecipitate, and those on home therapy and frequently attending patients with severe haemophilia not on home therapy would be treated with concentrate or cryoprecipitate depending on the severity of the bleeding episode.[1863] She recalled the commercial product as being more “user friendly” in that it dissolved more quickly[1864] and each box contained the necessary supplies and even child-friendly medical plasters. Parents administering home therapy often, she said, expressed a preference for this.[1865] If they had known that commercial products came with a greater risk for their child, it seems inconceivable they would have persisted with such a preference. The fact that Dr Pettigrew was able to recollect this therefore comes with the inference that parents were not told of the risks of the treatment their children were having.

Home therapy and prophylactic therapy were introduced by Dr Willoughby for what Dr Pettigrew described as both psychosocial and clinical reasons.[1866] She recalls the rationale for prophylaxis being explained to her by Dr Willoughby – that a twice weekly regular dose of Factor 8 would provide sustained though low levels of Factor 8 which would be sufficient to prevent spontaneous bleeding episodes. The effect of prophylaxis, of course, is that patients receive significantly more by way of concentrate (and in Yorkhill’s case, that would mean commercial concentrate) than they would if they were simply being treated as and when required. The risk of being infected with a virus was, therefore, all the greater.

There was no system of batch dedication.[1867]

The annual returns reveal the extent of Dr Willoughby’s use of commercial concentrate:[1868]

When Dr Hann arrived, he described a parlous state of affairs at the RHSC.[1875] He stopped the purchase of commercial Factor 8 and adopted a policy of using SNBTS concentrate and cryoprecipitate and DDAVP (and then only heat-treated concentrate).[1876]

Dr Willoughby did not attend UKHCDO meetings.[1877] He preferred commercial concentrate because (according to Dr Hann) of its purity and to a limited extent its availability. Dr Willoughby’s account to the Penrose Inquiry was that “We wanted to make things as easy as possible for the parents. So, for home therapy, we used a commercial source of Factor VIII ... It was much easier to reconstitute with its diluent.” He claimed that “We had no idea that we were exposing these patients to serious viral diseases”, believing “that problem only started coming to light in around 1983, after I had left the UK.[1878]

Dr Willoughby’s statement made no reference to availability, although Dr Pettigrew’s impression was that reliability of supply was a factor in his thinking, noting that the commercial concentrates tended to be used for patients on home therapy and NHS for patients who were not.[1879]

As to availability, Professor Hann’s evidence was that within days or a few weeks of taking up his post he contacted the Blood Transfusion Service and asked “what the score was, why are we using all this commercial concentrate” and he was told “If anything, we will give you priority. I can’t guarantee you absolute full supply but I think we can do”. And within days or weeks at most, Dr Hann stopped all use of Factor 8 concentrates from abroad.[1880] He knew that the type of donors used in the US were “very high risk in this context” and “could not contemplate continuing the use of commercial concentrate.[1881] Dr Hann also adopted a more conservative approach to the use of concentrates; after discussion with families, terminated prophylaxis in some patients; and encouraged the use of DDAVP.[1882]

The reality is that if Dr Hann could make those changes in 1983, Dr Willoughby could have made them in the preceding years.

It was Dr Pettigrew’s view that “All clinical staff involved, such as Dr Willoughby who instituted home therapy with Factor VIII concentrate, acted in what was thought to be in the best interests of their patients.[1883] Insofar as Dr Willoughby was concerned, I disagree. No steps were taken whilst Dr Willoughby was director to reduce or minimise the risk of patients being infected with a virus.[1884] He did not act in the best interests of his patients, nor can he have legitimately concluded that his treatment policy was in their best interests. It cannot possibly have been in the best interests of the children treated at Yorkhill to receive commercial concentrates, and to be treated on a prophylactic basis with such concentrates, in circumstances where commercial concentrates carried a higher risk of transmitting viral infection and cryoprecipitate and/or SNBTS concentrates could (and should) have been used.[1885] Contrary to the view that prevailed at the Yorkhill,[1886] cryoprecipitate, although certainly less convenient for use, was not impracticable for home treatment.

It makes little sense for Dr Willoughby to have committed Yorkhill to the purchase of commercial concentrates when throughout the period of interest Scotland was effectively self-sufficient in NHS factor concentrates: it is ensuring safety, not saving cost, which is and should be the governing principle. It could be anticipated at the time that his policies would be harmful. In retrospect it can be seen they were.[1887]

Dr Pettigrew described Dr Willoughby as a practitioner who acted autonomously (in contrast with his successors, Dr Hann and then Dr Gibson, who communicated more with the Royal Infirmary).[1888] It follows that responsibility for the policies which he adopted was his.

Twenty-one children with haemophilia were infected with HIV at the RHSC: nineteen with severe haemophilia and two with moderate haemophilia.[1889] Though much focus on HIV infection in Scotland has understandably been on “the Edinburgh cohort”, the numbers of those infected in consequence of the unsafe prescribing practices adopted at Yorkhill were greater, and the proportion of patients affected greater still.

Bristol Children’s Hospital

Although there were two distinct hospitals in Bristol – the Bristol Royal Infirmary and the Bristol Children’s Hospital – they were physically very close to each other and were sometimes referred to collectively as the Bristol Centre[1890] (or the Children’s Hospital was described as an associate centre), and the annual returns covered both hospitals. Dr Scott was the director at the Royal Infirmary from 1976; at the Children’s Hospital Dr David Burman was in post from 1978. Both were invited to UKHCDO meetings although in practice it appears that one or the other would usually attend rather than both. Dr Scott said that it was always his policy to use NHS products in preference to commercial products, because of the risks of infection, but that commercial blood products had to be purchased to make up the deficit as there was not sufficient NHS product to cover their needs. He also suggested that priority for NHS products was given to children and to adults who had previously received little treatment.[1891]

In 1979 Dr Scott complained to Dr Tovey of the regional transfusion centre about the insolubility of the BPL product, stating that “I cannot use this material for home treatment any longer and this will mean a considerable increase in the amount of commercial Factor VIII which has to be purchased.[1892]

Dr Burman instituted home therapy for children with severe haemophilia from the age of about four. Cryoprecipitate was not used, it being considered, according to Dr Helena Daly, as impractical for home therapy. DDAVP was not used until 1983.[1893]

Lee Turton was treated at the Bristol Children’s Hospital with Factor 8 concentrates in early 1982 when he was still a baby. His medical records contained an entry to the effect that the treatment was “swapped” from cryoprecipitate to Factor 8 in 1982 “because cryo not available.”[1894] Given the ease with which cryoprecipitate could be produced, that was not a proper reason for treating a baby with concentrates.

Dr Scott wrote to a patient and his wife in October 1983 as follows:

“As I am sure you know one of the patients attending the Bristol Haemophilia Centre has recently died of AIDS. The cause of this condition is still unknown but there is evidence to suggest that it is due to an infection which can be transmitted by blood or blood products. There is reason to believe that the source of the infection in this case was imported Factor VIII concentrates but this is not proven and it cannot be said with certainty that these were the source of infection. I can understand that you are extremely worried that you have contracted a similar condition by using imported blood products. However, I would like to make it clear that the risk of this is extremely small. Thousands of Haemophiliacs in Europe and America have been treated with Factor VIII concentrates for over ten years and the number of reports of AIDS have been extremely small. As far as possible we are avoiding the use of imported Factor VIII concentrates but there is not enough NHS produced Factor VIII available at the moment to meet our needs so we will have to continue to use some commercial Factor VIII for the time being. The production of NHS concentrate is being increased and hopefully we shall be self-sufficient in the not too distant future. In the meantime I think that the dangers of refusing treatment if only commercial concentrate is available is greater than the danger of contracting AIDS.”

Dr Scott expressed the hope that this “allays your fears”.[1895] When Lee Turton’s parents, Colin and Denise, became aware of news reports about AIDS and the possibility of it affecting the haemophilia community, they asked Dr Burman if there were any risks to Lee. He told them “that Lee was only having British Factor VIII so there was no risk.[1896]

UKHCDO data suggests that 3 patients were infected with HIV at the children’s hospital.[1897]

Sheffield Children’s Hospital

During the 1970s to 1990s the Sheffield Children’s Hospital (“SCH”) acted as the paediatric wing of the haemophilia reference centre for patients in the North Trent region, providing care to those aged 16 and under.[1898] Prior to 1975 the responsibility for treatment of paediatric patients with bleeding disorders was primarily that of Professor Blackburn; from 1975 to 1995 Dr John Lilleyman was the consultant haematologist at the SCH with responsibility for their treatment.

There were close links between the adult and paediatric treatment and the clinicians would meet at least weekly for journal reviews and discussion of clinical problems. There was also a close relationship with the regional blood transfusion centre; the regional transfusion director used to hold a formal clinical session with Dr Lilleyman weekly and “was a useful contact for the supply of blood products, in particular cryoprecipitate.[1899]

In contrast to the paediatric centres described above, Dr Lilleyman would reiterate frequently that:

“for children who were small and required less Factor VIII per dose than adults, cryoprecipitate had many advantages and for most admissions for joint bleeds, bumps and scrapes, heavy bruises and minor surgery, was to be preferred since it only exposed patients to a very small number of UK donors and reduced the risk of viral transmission that was becoming a recognised problem with large pool fractionation processing.”[1900]

DDAVP and tranexamic acid were also used. Cryoprecipitate remained the treatment of choice at the SCH for all but the most serious bleeds or surgery “particularly after the problems of viral transmission of NonA NonB hepatitis started to appear.[1901]

The annual returns show that for the period 1976 to 1981 cryoprecipitate remained in significant use at the hospital, although concentrates (both NHS and commercial – but with increasing use of NHS over commercial) were also used.[1902] However commercial concentrate ceased to be used to any significant extent after 1981 for the treatment of patients with Haemophilia A. The 1982 return recorded the use of both cryoprecipitate and NHS concentrates, but no commercial.[1903] The return for 1983 recorded the use mainly of cryoprecipitate and NHS Factor 8, with a small amount of Factorate.[1904] In 1984 and 1985 no commercial concentrates were used: cryoprecipitate and NHS concentrates were the main treatments provided.[1905]

The particular approach to treatment at SCH reflected the earlier (compared to many other centres and clinicians) realisation there of the potential seriousness of non-A non- B Hepatitis, with a study that was published in 1980[1906] reinforcing the view at SCH that cryoprecipitate was a safer product than concentrate.[1907]

Dr Lilleyman recalled becoming aware of the association between AIDS and blood products around the time the matter was raised at the UKHCDO meeting in September 1982.

Dr Lilleyman’s recollection was that no children at SCH were infected with HIV. Whilst that is consistent with the data received from UKHCDO,[1908] the evidence available to the Inquiry demonstrates that one child was in fact infected with HIV.[1909]

Commentary

The comparison between large children’s hospitals, one on one side of the Pennines (Alder Hey) and one on the other (Sheffield), is telling.

It is easy to look in hindsight at the facts that:

  1. at Alder Hey 16 patients with Haemophilia A were being treated in 1983 and, in 1984, 14 patients, and when a report was made in July 1987 it recorded 16 cases of children being infected there with HIV, though UKHCDO figures suggest 13,[1910] and Dr Ball recollected approximately 12.[1911] Whichever figure is correct, there is no doubt that it was a very high proportion of the children treated there.
  2. at Sheffield very similar, though slightly higher, numbers of patients were being treated. One child was infected.

However, the reason for the difference was not a matter of hindsight. It was the opposite. It was foresight. Dr Lilleyman expressly sought to use cryoprecipitate because he foresaw that using products made from the plasma of much larger numbers of donors who were from foreign countries would create more risk of infection. He deliberately chose to use as little concentrate as possible, favouring NHS concentrate where he could.

This shows that to focus on patient safety was not to ask too much of clinicians because of the benefits of hindsight. It shows that those who operated the paediatric regimes described above (and in particular at Alder Hey, Birmingham, Yorkhill, and Treloar’s, given the scale, in terms of numbers and proportions of those infected who were there) did so without sufficient regard for the dangers to their patients of what they were doing. They had all the information they needed to do better. They did not use it.

In consequence, children suffered. They did not need to do so.

Children treated elsewhere than at children’s hospitals

Not all children with bleeding disorders were treated at paediatric haemophilia centres. Some received their treatment through the centres that provided treatment to both adults and children. All too often they were treated as if they were adults, with devastating consequences.

Consideration of some individual cases will serve to illustrate this wider point.

Christopher Fowle was treated at the haemophilia centre at Harrogate General Hospital, initially with cryoprecipitate, from the age of two. Shortly after he started school he began to be treated with Factor 8 concentrates: both NHS and commercial concentrates (Factorate).[1912] His parents were pleased with this change, believing that it would be less painful and more convenient. As his mother, Christine, told the Inquiry “The doctors never said anything negative about the FVIII products and it did not cross my mind to question the hospital’s professional judgment [sic] as to whether or not the products were safe to use. I did not think doctors would use products on Christopher that were unsafe.[1913]When news media started to report about AIDS and blood, she asked the consultant about the safety of the products “and he assured me that I didn’t have to be [concerned] because it was generally in the homosexual community.[1914] This was false reassurance. When Christopher was about nine years old, his parents were told that he had been infected with HIV.[1915]

They decided to try to do everything they could to make his years happy ones, having been told that he might expect to live another 12 years or so.[1916] When Christopher was 15 years old, they told him of his diagnosis. He was angry as he got older, lost any sense of purpose, began not to care what was happening around him.[1917] In the last 18 months or so of his life, “he started to go down, started to lose weight ... and he just got worse”.[1918] He developed “ulcers, horrible ulcers, infected ulcers in his legs, and a lot of pain, a lot of pain.” Then he went blind: “that was the last thing I remember really of him not being able to see.[1919]

Christopher died the day after his 22nd birthday. His parents “have been denied seeing him get married, have children, travel and most of all sharing our lives with him as we get older. We do not think time will heal our pain because we forever think about what might have been.[1920]

Martin White was treated at Cardiff Haemophilia Centre. In 1978 and 1979 (then aged eight or nine years old) he was treated with commercial concentrates; from 1980 to 1985 he received NHS Factor 8.[1921] His parents were never informed of the risk of infection with hepatitis or HIV.[1922] Although he received cryoprecipitate in 1981, thereafter he was treated solely with concentrates, notwithstanding the increasing risk of AIDS. In March 1983, writing to the GP, Professor Bloom recorded that four days previously Martin had “had a routine dose of Factor VIII concentrate as part of his normal twice weekly prophylaxis.[1923]Normal twice weekly prophylaxis” means that Martin was being given Factor 8 not in response to a serious bleed, but to protect him against the possibility he might have one. It was to give him, therefore, more than was needed, and put him more at risk because of this. Martin had become unwell and was seen in Professor Bloom’s clinic, with “rather a worrying blood picture” which suggested “a virus infection or possibly some form of serum sickness as a result of the Factor VIII treatment.” At the present time, however, “there is certainly no evidence that he has developed the acquired immune deficiency syndrome recently reported in Haemophilia in the United States.[1924] This information, revealing clearly Professor Bloom’s understanding that concentrates could cause AIDS, was shared with the GP, not with Martin’s parents.

Martin’s mother, Valerie, told the Inquiry that there was nothing in his medical records “to say that he was being tested, when he was being tested, when he was diagnosed, or when we were informed of his infections. It seems as though one minute he was normal and the next minute his notes report that he was HIV positive. When I applied for them, I had hoped that Martin’s records would clarify what had happened to Martin for me, but to my disappointment, they did not.[1925]

Martin’s life “changed forever the day he was diagnosed with HIV.[1926] His family’s life too was shattered.[1927] Martin died in June 2003.

Colin Smith was born in 1982. He was treated with Factor 8 concentrate in July 1983, when he was less than 1 year old.[1928] An entry in his medical records for 21 July 1983 noted that Colin had fallen back and hit the back of his head that day; it recorded that he was a “Known Haemophiliac – Not Treated” and “Never given VIII conc or cryo.[1929] A letter from Professor Bloom to the GP, following a clinic on 28 July 1983, recorded that:

“I saw Colin in the clinic again this week. I understand that he turned up at the paediatric ward about a week ago having falling [sic] down and hit the back of his head. He received an intravenous injection of one bottle of 250 units of Factor VIII concentrate and made an uneventful recovery without any evidence of intracranial bleeding. The concentrate which we used was prepared from British blood from the Lister Institute. However, all these materials carry the risk of hepatitis, particularly non-A, non-B, but this is something that haemophiliacs have to accept.”[1930]

He added that Dr Hewlett (consultant haematologist at the Royal Gwent Hospital) and he “will keep a close observation on him as the months go by.[1931] Thus, a child who was no more than a baby was treated with factor concentrates, in the express knowledge that this carried the risk of transmitting non-A non-B Hepatitis – but also, given that this was July 1983, in the knowledge that this carried the risk of transmitting AIDS.[1932]

Colin’s parents were not told, whether by Professor Bloom or by any other treating clinician, that there was a risk of him developing non-A non-B Hepatitis.[1933] Nor was any information provided to them about possible risks of AIDS, or indeed any risks associated with the use of Factor 8 concentrates.[1934] Although Colin’s treatment in July had been with NHS Factor 8, in August and September 1983 he was treated with a commercial concentrate (Kryobulin) and in June 1984 with a different commercial concentrate (Armour).[1935] There was no discussion with his parents about the use of commercial concentrates; as far as they were aware “it was all the same product.[1936]

When Colin was about 2 or 2 ½ years old, in hospital with a bad chest, Professor Bloom told his parents, in a hospital corridor, that he was HIV positive.[1937] They were unaware that he had been tested.

Colin died in January 1990, just seven years old. His mother, Janet, told the Inquiry that “the devastation of having your child on your lap watching the rise and fall of his chest and waiting for it to stop is absolutely heart-breaking.[1938] His father, Colin, said “There’s no way a child should have to die the way he did. It wasn’t pleasant. It still affects us now ... I could cope with death but not with the death of my son. I still have trouble today with the fact that he’s in a grave on his own, and the guilt will never go away.[1939]

Lee Harding was born in 1978 and treated at the Cambridge Haemophilia Centre. From around 1979 to 1983 he was treated with cryoprecipitate in hospital. In 1983, aged five, he began home treatment, initially with cryoprecipitate and then with Factor 8 concentrates.[1940]In all of the time prior to Lee being diagnosed with HIV” his mother, Patricia, “was never told about the risks of the treatment.[1941] She discovered that Lee was HIV positive when she received a letter from Dr Seaman[1942] to that effect. When she went to speak to Dr Seaman, she was told that “there was more chance that Lee could get run over by a bus than developing anything from his HIV infection.[1943]

Lee died in 1988. He was ten years old. In the last months of his life his illness became worse and worse: “He was like a skeleton and he was getting more and more rashes and lumps on his body.[1944]

Steven Walker was treated with cryoprecipitate for the first 3-4 years of his life, but in December 1983 his family moved to Norfolk and responsibility for his treatment transferred to the Norfolk and Norwich Hospital. He was first given Factor 8 concentrates during 1984,[1945] when he was about four years old, and his mother, Gwynneth, was encouraged to try home treatment:

“I was provided with a sharps disposal box and understood the need to ensure sharps were disposed of safely but I cannot recall any information being shared, explaining that the medication could contain infections that might harm my little boy or that from receiving treatment, he could infect me or my younger child ... At no point was I given any information or advice regarding the risks of infection from the use of Factor VIII to Steven”.[1946]

In 1984/1985 Gwynneth was informed, by a nurse in a corridor at the hospital, that her son had tested positive for HTLV-3 but that it could be “a good thing” to have developed antibodies; the diagnosis was formally communicated by the GP in December 1985.[1947] Steven had also tested positive for Hepatitis B in 1985, which was transmitted to his mother. She had never heard of hepatitis prior to that, and the potential for infection had never been discussed.[1948] Steven’s health deteriorated over the years. Feelings of despair and hopelessness affected his compliance with treatment. He “struggled on quietly ... he didn’t want his own misery and hopelessness to sadden the rest of us.[1949]He experienced constant pain and his existence was “a daily struggle.[1950] In 2017, aged 37, Steven (“gentle, intelligent, generous of heart and witty”) died of a heart attack.[1951]

Rosemary Calder’s son, Nicholas, was treated at Northwick Park Hospital. He was initially treated with cryoprecipitate but from 1977 onwards – when Nicholas was not yet three years old – he began to be treated with Factor 8 concentrate.[1952] Rosemary “was advised by the hospital that the use of Factor VIII would be a great improvement in his care allowing us to eventually go on to home treatment.” She was “never asked if I was agreeable to the change and I was never informed that there was a risk of viruses being carried in the blood product.[1953] Although Nicholas was treated mostly with NHS concentrate, there were occasions when he received commercial products: Factorate in 1978 and 1982.[1954] By the time Nicholas was nine, in 1983, he was being treated prophylactically, with three injections per week.[1955] In early 1983, prophylactic treatment should have been known to increase the risks (of both hepatitis and AIDS). There would be no improvement in safety by doing so.

When Rosemary, having heard about AIDS in the news, sought advice from Dr Cecil Reid, the centre director, and from the Haemophilia Society, she was “told to carry on his home treatment as normal as the risk of him contracting an infection was minimal.” Rosemary was never given the option of a reversion to cryoprecipitate.[1956] Nicholas was infected with HIV from this treatment – a diagnosis that was communicated by letter, following a test undertaken without her knowledge and consent, when he was 11 years old.[1957] In the 1990s he developed AIDS and his condition deteriorated over a period of years. Nicholas died in 1999, aged 25.[1958]

Stephen Finney was first treated with Factor 8 concentrates in January 1974 at Oxford Haemophilia Centre. They were commercial concentrates: Hemofil. He was just two and a half years old at the time. Entries on the National Haemophilia Database record that this treatment related to “Dr Craske’s research work”.[1959] He contracted Hepatitis B as a result.[1960] In 1978-79 he was treated with Oxford Factor 8 (NHS). From 1979 he received his treatment at Bournemouth: sometimes with NHS concentrate from BPL, sometimes with commercial concentrates (Hemofil and Kryobulin; in 1985 he received Factorate).[1961]

Stephen’s parents were not given adequate information about the risk of exposure to infections to enable them to make a sufficiently informed decision: “The only information we received from official medical sources was about how to best manage my Haemophilia condition and that now this new FVIII treatment was becoming available, I should be able to lead a relatively normal life. It was never about the clear or present dangers of potentially deadly viral pathogens associated with FVIII.[1962] At the age of 14 he was told that he had been infected with HIV; five years later, he learned he had also been infected with Hepatitis C.[1963]

Stephen’s written statement to the Inquiry explains the enduring physical, mental and social impacts of being infected with Hepatitis B, Hepatitis C and HIV in the 1970s and early 1980s.[1964] As part of this, he describes spending a total of 28 weeks in four different hospitals in 2002. He lives with untreated post traumatic stress disorder. He told the Inquiry:

“Suicidal thoughts have crossed my mind but I have never considered going through with it. I believe if I had, then those who I believe are/were responsible for what happened to me and others would have got away with what they have done ... It is very rare, even to this day, that a day has gone by when I have not thought about it but the thought of just basically becoming another digit on the ever-increasing mortality statistics of this tragedy keeps me from giving in to it.”

Robert Hodgkins was first treated with Factor 8 concentrates in 1973/74. This too involved treatment with Hemofil for “Dr Craske’s research work”. He was five years old and developed Hepatitis B as a result.[1965] Thereafter he was treated, at the Hammersmith Hospital and in Bournemouth, with a range of different concentrates – sometimes NHS, but often commercial (Hemofil, Koate, Factorate and Kryobulin).[1966] His parents “put full trust in the doctors and merely accepted the change” from cryoprecipitate to concentrate: “They were not told this carried any risk of infection.[1967] He received treatment prophylactically from the mid to late 1970s to the early 1980s.[1968] Robert was about 15 years old when he was told that he was HIV positive. The dreadful toll taken on his physical and mental health, his education and his ability to work is detailed in his written statement to the Inquiry.[1969] He says: “I feel terribly let down by the health system. I cannot comprehend how this could be allowed.

Another man with mild Haemophilia A (described as “only very mildly affected[1970]) was treated with Factor 8 concentrates at a hospital on the Isle of Wight in 1983, when he was undergoing tooth extractions. He was not yet a teenager and had not previously received factor concentrates.[1971] A test in 1985 confirmed that he had been infected with HIV; he later learned that he had been infected with Hepatitis C as well.[1972] He told the Inquiry of his feelings of isolation and depression, and his lack of faith in the NHS: “I feel robbed of my life when I think of all the things I could have done and should be doing but I now cannot.[1973]

At Leeds, a boy was treated with commercial Factor 8 concentrates from the age of six or seven: even in 1983, when the risk of AIDS should have been plain, he was given Factorate. No information or advice was provided beforehand regarding the risks of exposure to blood borne infection. Both he and his two brothers were infected with HIV and Hepatitis C. He describes the feeling of being told that he had been diagnosed“as being struck by lightning.”Because of those infections he decided never to have children or get married.[1974]

Stuart Mclean was about nine years old when he was treated in 1978 with Factor 8 concentrate in the mistaken belief that he had a bleeding disorder.[1975] This treatment took place after he had been referred to a consultant haematologist at West Kent General Hospital, Dr Nalinda Naik, who was “interested in defects in blood clotting.[1976] She formed the view that he was suffering from von Willebrand disorder and wrote to the Oxford Haemophilia Centre to that effect.[1977] However, Dr Rizza wrote to her stating that he did not think too much significance could be attached to the level of Factor 8 coagulant activity; Dr Matthews (also from Oxford) informed her that the results were completely normal and there was no reason to suspect any coagulation abnormality.[1978] Notwithstanding these letters, Dr Naik wrote to Stuart’s GP in November 1977 reiterating her suspicion that he had von Willebrand disorder, even though “‘the King of Clotting’ does not support my hypothesis.[1979]

The following year, Stuart fell and injured his knee. He was taken to West Kent General Hospital where he was treated by Dr Naik and received fresh frozen plasma, cryoprecipitate and Factor 8 concentrates. She described this as being given as “prophylactic treatment”for a “possible” haemorrhage.[1980]

The treatment administered to Stuart showed a cavalier disregard for safety. He did not have von Willebrand disorder in the first place, and thus did not require such treatment. Dr Naik had been told this, by the “King of Clotting” and apparently thought she knew better. Even if he had von Willebrand disorder he did not require such treatment – with three different types of treatment – for what was only a possible haemorrhage. Prophylactic treatment was plainly unsuitable for a bleed which might develop from a specific injury, in any event, and multiplied the risks of infection; and even if he did require treatment, DDAVP would have been available, and concentrates should never have been used. In consequence of that treatment, Stuart was infected with Hepatitis C – a diagnosis he received for the first time in 2013, 35 years after the (wholly unnecessary) treatment which infected him.[1981] He has – rightly – been very angry about the treatment he was given.[1982]

Commentary

These examples discussed above reveal that, in general haemophilia centres, just as in the paediatric haemophilia centres:

  1. Children were treated with factor concentrates without their parents having been provided with any (or sufficient) information about the risks of treatment. They were thus treated without informed consent having been given. It was unconscionable to treat children with concentrates capable of transmitting serious viruses without explaining those risks clearly to their parents.
  2. Children were treated with factor concentrates when cryoprecipitate would have been a significantly safer option. No consideration was given by those treating them to reverting to cryoprecipitate in response to the risk of AIDS.
  3. Children were treated with imported commercial concentrates, which were rightly understood to carry a greater risk of infection.
  4. Children were treated on a prophylactic basis, thus increasing their exposure to viral infections.
  5. Children were treated with concentrates even where their haemophilia was mild, or where they did not have a bleeding disorder at all.

It is apparent that in the general haemophilia centres there was no clear or consistent understanding of who was to be regarded as a child for treatment purposes. That will no doubt be surprising to those reading this Report. It might be thought that it is obvious that “child” encompasses those who are under 18. However, for the purposes of centres’ treatment policies, the position is much less clear-cut. Children were, in effect, treated like adults, often after the age of four or five (or in the case of Colin, above, at an even younger age).

The Inquiry has received many more statements, detailing the treatment of children in haemophilia centres, which raise similar issues and themes to the eleven individual cases discussed above.[1983] This evidence, taken together with the evidence relating to the way in which children were treated at paediatric haemophilia centres, point to a single, inescapable conclusion: that clinicians failed in their duty to ensure that children were treated in a way that prioritised their safety above other considerations. Rather than taking steps to ensure that children, new to treatment, were not exposed unnecessarily to the risks of viral transmission, children were in practice treated in a way that starkly exposed them to those risks. Many died as a consequence; those who survived have lived lives that have been dominated by pain, suffering and stigma.

There can be fewer worse condemnations of any healthcare system than describing how it failed children. This section of the chapter has looked at failures which condemned children to a shorter expectation of life, one of debilitating pain and thwarted ambitions, robbing them of the fun and joys of youth, limiting the happy social interactions of childhood and early adolescence, and replacing growing up with wasting away. It condemned their parents to watch as it happened. It saddled some with guilt, and many with the stigma of being associated with an HIV victim, adding to the injustice. It need not have happened, as the Alder Hey/Sheffield Children’s Hospital comparison shows. It ought not to have done.

This report has drawn attention to the multiple failures which have led, as if in a complex jigsaw, to the treatment disasters the Inquiry has been investigating. Many are both serious and disturbing. But in my view, the way in which children were made victims, when they should not have been, is the worst of them all.

Ethical failings: consent and testing

Earlier parts of this chapter have looked at the treatments provided to people with bleeding disorders, treatments which led to infection with hepatitis and HIV. This part of the chapter looks at the information that was – or more usually was not – provided to people about the risks of treatment, about the undertaking of tests and about the results of those tests. It reveals a disturbing and sorry picture.

What information was provided to patients (or in the case of children, their parents or guardians) about the risks of treatment?

The evidence before the Inquiry[1984] overwhelmingly establishes that people were not properly advised of the risks of hepatitis or of AIDS. People with bleeding disorders had the right to know that factor concentrates (or other treatments made from blood) might infect them with a serious or fatal disease for which there was no treatment. Parents had the right to know that such treatments might infect their children with such a disease. In practice, either they were given no information at all about such risks, or they were falsely reassured that the treatments were safe.

Some examples will serve to illustrate the position.

Michael Saunders, whose son Andrew was infected with HIV and Hepatitis C following treatment with commercial concentrates at Birmingham Children’s Hospital, was given no information about the potential risks associated with Factor 8 concentrates.[1985]

Paul, as a young man with mild Haemophilia B, underwent an operation in 1984 to remove a birthmark, following which he received treatment with Factor 9 concentrate which infected him with Hepatitis C. At no stage was any cautionary information given: rather he was allowed to undergo an elective, non-vital procedure at a time when it was known that factor replacement therapy was potentially both HIV and Hepatitis C infectious.[1986] He only learned that he had Hepatitis C in 1999.

The mother of a boy whose treatment changed from cryoprecipitate to Factor 8 concentrate in around 1983 was given no warnings about the products at Charing Cross Hospital where her sons were treated but “was just told it was an amazing thing”.[1987] Both her sons were infected with HIV.

Sean Nevin, who has mild haemophilia and was given concentrate as part of training sessions in 1982 at the Royal Liverpool Hospital as a child, explained that his family was “told Factor VIII was safer, less bulky, easier to store and easier to use than Cryoprecipitate.[1988] Whilst ease of storage and use was correct, it was plainly incorrect to say that Factor 8 concentrates were safer than cryoprecipitate.

Paul, whose care was reviewed at Oxford, was switched from cryoprecipitate to concentrates in 1976: Dr Rizza wrote to his referring haemophilia clinician in Nottingham to suggest that it would be “wise to try as far as possible, to treat him with the N.H.S. concentrates ... As a last resort I think it might be justified to put him onto one of the commercial Factor VIII concentrates.” The reason for that recommendation was not specified, but in any event his parents were never told of any risk of infection associated with the use of factor concentrates.[1989]

Matthew Johnson’s treatment at the Oxford Haemophilia Centre, as a boy with severe Haemophilia B between 1981 and 1983, included the prophylactic use of concentrate. His parents were assured that if he were to contract hepatitis it would be no more severe than a bad cold. They were not told the true risks – rather they were assured and “were told that this product was ground-breaking, it was clean and it was as good as good can be.[1990]

Mr AN, who was treated with commercial concentrates at Birmingham Children’s Hospital from 1977 (having previously been on home treatment with cryoprecipitate), was told nothing of any risks, nor were his parents: “All we were told was that this was a groundbreaking medical development ... the miracle cure that would solve all of our problems”.[1991]

The widow of a man treated at QEH recalled how her husband was “really against switching to Factor VIII as he had seen an article in the Mail on Sunday in May 1983, which said that Factor VIII presented a risk of HIV transmission.” He took the newspaper cutting to the haemophilia centre and was told that it was “blown out of proportion” by the press. He expressly requested during 1984 to be treated with cryoprecipitate or NHS concentrate but was told that the risk of him developing AIDS from the US product was “a million to one.” He was infected with both HIV and Hepatitis C.[1992]

Nothing was said to the parents of Colette Wintle, a symptomatic carrier of Haemophilia A, about the risks of treatment when she was given commercial factor concentrates instead of cryoprecipitate at the age of 17 when her tonsils were removed in 1976. Nor was Colette told about the risks of factor concentrates, or offered the safer alternative of DDAVP, when she had a procedure under general anaesthetic in 1982; instead she was treated with commercial concentrates, as she was again in 1985, still without being advised of the risks or offered safer alternatives.[1993]

Irene Brierley’s husband, who had Haemophilia B, was expressly told in January 1985 in Liverpool that Factor 9 was safe to inject without fear of infection – although not heat treated it was “safe”.[1994] This is not an assurance that could properly or truthfully be given.

Simon and Nigel Hamilton, twin brothers treated in Belfast (one with mild, one with moderate Haemophilia A), were not given, nor were their parents, any information, warning or advice about the risks of blood-borne viruses associated with the use of factor concentrates.[1995]

A woman with mild Haemophilia B was first given Factor 9 concentrate in 1980 for dental treatment at Royal Stoke Hospital. She did not know she was being given a blood product; she was not told what it was and she was not told about any risks of infection. She had a second treatment with Factor 9 concentrates in 1987. On that occasion she had said she did not want to receive it because of the fear of HIV but she was given it whilst drowsy from pre-med and felt that she was not given a real choice.[1996] She was informed in 1992 that she had been infected with Hepatitis C.

A man with von Willebrand disorder was treated with Factor 8 concentrates for the first time in 1983 or 1984 at the Royal Hallamshire Hospital; he was never told of any associated risks.[1997]

Su Gorman’s husband, Steve Dymond, who had mild Haemophilia A, was led to understand that Factor 8 “was the future, it was the wonder drug, it would make life easier. As a mild haemophiliac he only ever needed treatment in case of accidents or medical emergencies ... Yes, it was very much it would improve the quality of our lives.” Neither she nor Steve were told of the risks of infection.[1998]

Alice Mackie recalled that her husband, Robert, who has severe Haemophilia A and was treated in Edinburgh, repeatedly asked about the risks of treatment and was reassured: “he trusted these doctors ... it was every doctor that he saw and they would always come out with the same thing, ‘Nothing to worry about, Robert’, and in the end he was actually told to stop asking, ‘You’re just causing trouble.’” When he asked about AIDS, “he was always told, ‘our blood donors don’t have AIDS. It’s safe. We don’t have the likes of that in this country’ ... he was told it was safe, we didn’t have AIDS in Scotland or HTLV-III in Scotland.[1999]

Carol Carruthers’ husband, Oliver, was treated at the Royal Victoria Infirmary in Newcastle and was given prophylactic Factor 9 when he had dental treatment in 1977 and 1979. He was never made aware of the risk of infection. In May 1989 he had a tooth extraction and was given Factor 9, despite having raised concerns about the need for, and safety of, such treatment; as his widow said in her oral evidence to the Inquiry he“trusted that the doctors wouldn’t knowingly put him at risk.[2000]

A woman with von Willebrand disorder was treated with Factor 8 for the first time in 1981 and 1982; she thought it unlikely that she was told of any risks as she would have questioned whether there were alternative treatments available. She was a qualified nurse.[2001]

Mr M, who was treated at the Leeds Haemophilia Centre, was not given any information about the risks of infection associated with treatment with factor concentrates, nor had his parents been advised of the risks. “We trusted the doctors and it was all about improvement. The message was that things were getting better. The nirvana was there would be a cure. The new boxes of product and kit were smaller and more convenient, leaving more room in our freezer for my mother to use. My brother and I thought our lives were getting better, not shorter.[2002]

Perry Evans was given no advice or information regarding the risks of the factor concentrates with which he was treated at the Hammersmith Hospital. A letter from the hospital written to his GP in July 1983 noted that “We have recently been inviting all our haemophiliacs to visit the clinic ... We have been particularly concerned because of the development of AIDS (acquired immune deficiency syndrome) in some haemophilia patients in the United States who have been using pooled factor products which have probably included donation from people who were incubating AIDS.” Perry himself was given no information regarding the risks of AIDS. He was not told of the particular concern of those treating him. He was infected with HIV following treatment in the first half of 1984.[2003] Perry died in April 2024.

The evidence which the Inquiry has received from people who were infected or affected is consistent with what some clinicians have said, either to the Inquiry or previously.

Dr Pettigrew acknowledged, talking about the children treated at the Royal Hospital for Sick Children in Glasgow, that there was no policy to inform parents about the risks of HIV and that in relation to hepatitis risks, the focus was on Hepatitis B.[2004] Dr Hann accepted that inadequate information had been provided to parents about the risks of AIDS and that rather than proactively contacting them to discuss risks of AIDS, the approach was reactive.[2005]

Dr Martin, the director at Alder Hey, “did not make it [his] practice to raise the hepatitis issue with families”. And when he first became aware of AIDS he did not “wish to worry parents with what at first seemed to be a tenuous link.[2006]

At Birmingham Children’s Hospital, Dr Hill claimed that it was his practice to keep patients informed of the risks “as we knew them.[2007] Whatever he meant by that phrase, people were not given adequate (or usually any) information about the risks of treatment, whether at the Children’s Hospital or at the adult Centre where Dr Hill also worked.[2008]

At the Royal Manchester Children’s Hospital there is evidence to indicate that there may have been very general references to hepatitis, but nothing specific about NANBH, or AIDS. In a document about home treatment, authored by Dr Evans in November 1978 and clearly designed for parents (or possibly for the older children), there were detailed instructions about how to administer the concentrate but the only reference to infection was a statement that “Used syringes and needles should not be put in the dustbin – they could infect anyone emptying the bins.[2009] An article in Nursing Times in 1981 by the haemophilia nurse at RMCH, Alex Susman-Shaw, referred to a patient who had been infected with Hepatitis B from a contaminated batch of Factor 8, but then contained the reassuring statement that “The problem of hepatitis B transmission owing to the use of large donor pools from a high-risk population has been now virtually eliminated. This has been achieved by routinely testing all donations and all batches of FVIII by radioimmunoassay and by using a lower-risk population.[2010] Quite apart from the debatable accuracy of the reference to a lower-risk population, and the exaggerated claims for the efficacy of screening tests, there was no reference at all to the risks of NANBH. It is reasonable to conclude, therefore, that parents and patients were not provided with the information that they should have been about NANBH transmission.

The information which Dr Bevan thought that Professor Flute would have provided to patients at St George’s Hospital about hepatitis risks was that:

“they would be likely to get a brief period where their liver function was affected, that there was a form of hepatitis was almost inevitable – as it was – very soon after first exposure to commercial pooled product. He would tell them about this, but he would tell them about it, and us, in a reassuring way: everybody goes through this, it doesn’t seem to cause any problem, people don’t get very sick with it, sometimes you don’t even have jaundice sort of thing.”

As Dr Bevan observed, therefore, patients were informed about it but not “fully” or “validly” informed.[2011]

To similar effect, Dr Colvin thought he did discuss whether liver function tests were abnormal or normal, but in response to the question whether he told patients that the treatment may carry a risk of a hepatitis virus that was not Hepatitis B and that might cause long-term chronic liver problems, he said “I think we could have done better” and “I think it’s possible that the patients didn’t get the advice or information that maybe they should have had.[2012]

Professor Bloom, writing in September 1991, expressed the view that “it was not necessary to inform patients or parents” of the risk of AIDS “at that time” (he was talking there of the period up to June 1983, but there is no evidence that it was his practice at any time thereafter in 1983 or 1984 to provide information to patients or parents about such risks).[2013]

Dr Al-Ismail, the centre director at Swansea, did not tell patients in 1983 or 1984 of the risks of AIDS. He believed that “haemophiliacs knew the risk.[2014]

Dr Al-Ismail was not alone in seeking to argue that patients themselves were well informed about the risks. Some clinicians argued in oral or written evidence that patients were well informed because they had access to information from the Haemophilia Society.[2015] It is certainly true that, in a general sense, many patients were familiar with the word “hepatitis”, and that it could be an illness which came with treatment. If their haemophilia was severe they came to meet and get to know other people who like them were severely affected, for they had treatment from the same centre, possibly several times a year. Many undoubtedly would talk about their treatments. However, the Haemophilia Society, rightly, advised its members to take their medical advice from their doctors: its information merely enabled those who wished to do so to know what questions to ask their clinician. The doctor was the person a patient would trust to give them information about theircase, the probability of infection for them, what the consequences of infection meant for them, and most important, perhaps, of all, what alternatives there might be to taking the treatment being offered. That was because a patient is, and is entitled to see themself as, an individual to whom risks in general may or may not apply – and it is their doctor who should most be trusted to give them that information, specific to their case, and in the cases of the patients who gave evidence to the Inquiry was trusted to do so (at first).

It lacked insight into the nature of the doctor-patient relationship for a doctor to think that a patient would get, and rely upon, information about their treatment given by anyone else than them.[2016] It not only was not insightful, but unbecoming for doctors – and to an extent an abdication of their role – to shift the ethical burden of providing sufficient information to the Society, or to fellow sufferers, or to the popular or medical press; or, for that matter, to avoid accepting their own professional failures to provide it. Yet there was a sense in some of the evidence that some doctors were doing that. That said, the Inquiry would itself be lacking insight if it did not accept that it must have been particularly difficult for doctors to be faced with their treatment having caused what was probably a terminal illness, and more besides, in a large proportion of their patients. This is especially so when it was the opposite of what they came into medicine to do. It is hard. It is not easy. But where it is, in truth, their responsibility, the only proper course of action is to face it, admit it, and deal with the consequences (which, after all, are worse for their patients, however hard it is for them).

An example which supports a sense of clinicians seeking to spread responsibility to others is provided by the actions of Professor Ludlam. He prepared a document for the Penrose Inquiry[2017] setting out a summary of the information about HIV available to patients in Scotland prior to 1 December 1984, over 17 paragraphs in 4 pages, followed by information about HIV available to patients in Scotland after that date, over 42 more paragraphs and 7 more pages, concentrating on what the Haemophilia Society said at the time, before saying (in 9 lines):

“In summary,[2018] whilst the above Haemophilia Society publications were sent to all members and copies made available at Haemophilia Centres, it was the contact with the Centre staff which offered the most personal and potentially applicable information and counselling. HIV/AIDS was a completely new and bewildering condition, which was very different from any previously known infection; information, arrangements for anti-HTLVIII testing, monitoring of immune function, prophylaxis against opportunistic infections and anti-HIV treatment evolved from 1982 onwards.”

He was absolutely right to suggest that it was what the clinical staff at the centre had to say, when (and if) providing information personally to a patient, that an individual patient had to rely on, whatever might elsewhere be said generally about others. Unfortunately, setting out at such length other sources of general information is unnecessary to convey that message. His doing so therefore gives the impression, rightly or wrongly, that he is seeking to hide behind the actions of others. It was at best ill advised.

Another example from another course is that in his book, Haemophilia Home Therapy, Dr Jones wrote “Every family knows that the use of human blood products carries the risk of hepatitis. They are aware that this risk has been linked particularly to commercial concentrates prepared from the blood of paid donors, and they know that these risks still exist despite the increased sensitivity of donor tests for hepatitis B.[2019]

The evidence available to the Inquiry does not support a conclusion that patients were well informed about the risks to them from the treatment which they were receiving or would receive.[2020]

Some people may have had a basic understanding that jaundice or hepatitis might be a consequence of treatment, but what they lacked – and what it was the responsibility of clinicians to provide – was information about (in particular) NANBH and the possibility of chronic and serious liver disease.

Some clinicians asserted to the Inquiry that patients were told that they would inevitably be infected with NANBH and that a substantial proportion could go on to develop chronic liver disease; see for example the statement of Dr Jones.[2021] That is not, however, consistent with the vast bulk of the evidence received by the Inquiry from individuals, which I accept.

In relation to AIDS, it was the responsibility of clinicians to tell their patients that treatment carried with it a risk of transmission of the virus/agent that caused AIDS and to explain that AIDS was a very serious, usually fatal, disease for which there was no treatment. The vast bulk of evidence received by the Inquiry from individuals, which I accept, was that they were not provided with that information. To the extent that reliance might be placed by clinicians on what was in Haemophilia Society publications, the material published by the Society in 1983, 1984 and 1985, which was authored by clinicians, provided a false reassurance as to the safety of treatment.[2022] It is truly astonishing – not in a good way – that at a time when potential blood donors were being told “Can AIDS be transmitted by transfusion of blood and blood products? Almost certainly, yes”, and in relation to people with bleeding disorders, “Should just one of the donors be suffering from AIDS, then the Factor VIII could transmit the disease”,[2023] that the recipients of products made from donated blood were not being given that same information.

It should be emphasised that the above are examples only. The evidence available to the Inquiry establishes overwhelmingly that the vast majority of people were not told about the risks of treatment, and that this was not merely something that went wrong in one or two haemophilia centres, but in centres across the entire United Kingdom. There are undoubtedly some examples of people being given sufficient information by their clinician, but these are few and far between compared to evidence given from many different people, from many different walks of life, with different capacities to recall what has or has not been said, who have said in oral testimony, in written statements, or through intermediaries that they were not told of the risks in any adequate form or at all.

Further, had information as to the risks of NANBH or AIDS been provided as it should have been, that should have been recorded in the medical records of the individual concerned. Such medical records as the Inquiry has considered in the course of reading and listening to the testimony of people infected and affected do not generally record advice being given about viral risks of treatment.

The testing of patients

The evidence before the Inquiry establishes that, in many (although not all) haemophilia centres, testing for HIV in the mid 1980s and for Hepatitis C in the early 1990s was undertaken without the knowledge – and, it follows, without the consent – of patients (or in the case of children, their parents).

In a number of centres, tests were undertaken using stored samples – in circumstances where people were unaware even that samples of their sera, or of their child’s sera, had been stored.[2024] This was, for example, done at the Royal Free where patients were tested for HIV without their knowledge.[2025] It was also done at the Edinburgh Royal Infirmary both in relation to the HIV testing that was undertaken in 1984 and in relation to testing for Hepatitis B with the second-generation tests.[2026]

Even where people were made aware that blood samples were being taken (as was often routinely done at appointments) or that some form of test was being undertaken, they were often not told what that test was for, still less offered any form of pre-test counselling. Thus, for example, in Inverness a letter sent in February 1985 stated “Because of the recent problems with AIDS, we are now producing new types of Coagulation Factors. Before this can be issued, we need to do a blood test on each of our patients.” This letter did not explain what the blood test was for and did not state that it would be a test for HIV.[2027]

One of the consequences of people not being told that tests were being undertaken – quite apart from the affront to their personal autonomy – was that the results of such testing then came out of the blue.

Bruce Norsworthy’s son had an operation on his ankle in 1982 or 1983 and he says“I do not know if he became infected [during the operation] or whether he had already been infected, but it was after Richard had that operation when we were notified that he was HIV positive. We were not even aware that a test was being carried out.” They learned that Richard was HIV positive when they received a telephone call from the hospital one evening. It was “a pretty awful blow.[2028]

Kathleen Algie recalls being told of her husband’s infection with HIV in or around May 1988:

“we were invited in for a seemingly normal review day ... At the end of this meeting they informed us that John had been diagnosed with HIV. I was not particularly surprised, as I had been under the impression for some time that haemophiliacs treated with these blood products might end up getting HIV or AIDS ... What was a shock however was that John was being tested for HIV at all, as we had not been informed of this previously. We were told at the meeting that he had been HIV positive for 3 years.”