The result of the FDA meeting was reported by Dr Fowler in a memo. He noted that the possibility of banning all products made before the implementation of the March 1983 regulations was rejected. Read more about The result of the FDA meeting was reported by Dr Fowler in a memo. He noted that the possibility of banning all products made before the implementation of the March 1983 regulations was rejected.
Lord Glenarthur's office asked for a "fairly full draft letter" to respond to a parliamentary question asked by Baroness Masham. The draft response from the Department included the note that "we have confirmed with American manufacturers that future supplies of Factor VIII for this country will be manufactured only from plasma collected in accordance with US Food and Drug Administration Regulations introduced in March this year". Read more about Lord Glenarthur's office asked for a "fairly full draft letter" to respond to a parliamentary question asked by Baroness Masham. The draft response from the Department included the note that "we have confirmed with American manufacturers that future supplies of Factor VIII for this country will be manufactured only from plasma collected in accordance with US Food and Drug Administration Regulations introduced in March this year".
Professor Tedder stated "in veterinary medicine, products from one country would not get through incoming Customs of another country in the way that concentrates have come into the human market for haemophiliacs in the UK". Read more about Professor Tedder stated "in veterinary medicine, products from one country would not get through incoming Customs of another country in the way that concentrates have come into the human market for haemophiliacs in the UK".
Professor Bartlett in his oral evidence to the Archer Inquiry recalled that Dr Galbraith repeated his advice orally to the CSM(B). He commented further that although there were, by May 1983, only a small proportion of recipients of Factor 8 concentrate who had developed AIDS "the risk may not have been small" and added that "I think this last piece of evidence about the risk is one where other experts at the time disagreed". Read more about Professor Bartlett in his oral evidence to the Archer Inquiry recalled that Dr Galbraith repeated his advice orally to the CSM(B). He commented further that although there were, by May 1983, only a small proportion of recipients of Factor 8 concentrate who had developed AIDS "the risk may not have been small" and added that "I think this last piece of evidence about the risk is one where other experts at the time disagreed".
In a paper Dr Fowler questioned the theory of a single unknown virus and postulated that "haemophiliac AIDS may require years of repeated treatment with large quantities of concentrate [and so] be a function of the concentrate itself rather than a specific agent transmitted by homosexuals with or 'incubating' AIDS". Read more about In a paper Dr Fowler questioned the theory of a single unknown virus and postulated that "haemophiliac AIDS may require years of repeated treatment with large quantities of concentrate [and so] be a function of the concentrate itself rather than a specific agent transmitted by homosexuals with or 'incubating' AIDS".
CSM provided a suggested Agenda for discussion on AIDS in relation to licensed blood products which was to be held on 3 July 1983. CSM explained that the discussion was to help them decide if any action was needed in respect of AIDS and licensed blood products. Read more about CSM provided a suggested Agenda for discussion on AIDS in relation to licensed blood products which was to be held on 3 July 1983. CSM explained that the discussion was to help them decide if any action was needed in respect of AIDS and licensed blood products.
Professor Garrott Allen wrote that "it appears that at least two immunologically separate agents are capable of producing hepatitis from the transfusion of blood or the administration of many of its products". He also added that it was considered that the risk of causing hepatitis from blood taken from paid donors was markedly higher than that of blood from unpaid donors. Read more about Professor Garrott Allen wrote that "it appears that at least two immunologically separate agents are capable of producing hepatitis from the transfusion of blood or the administration of many of its products". He also added that it was considered that the risk of causing hepatitis from blood taken from paid donors was markedly higher than that of blood from unpaid donors.
Dr Holgate stated (when responding to the Speywood issue): "As I am sure you are aware one of the cornerstones of our philosophy for the licensing of 'biological' products is to have detailed knowledge of and control over early stages of manufacture and in-process control - this including source material." Read more about Dr Holgate stated (when responding to the Speywood issue): "As I am sure you are aware one of the cornerstones of our philosophy for the licensing of 'biological' products is to have detailed knowledge of and control over early stages of manufacture and in-process control - this including source material."
Professor Arthur Bloom expressed concerns to Dr Holgate (DHSS). Firstly that material produced by a US company had been sold "through brokerage or other means" to Speywood where it had been relabelled as a product of their own. A second concern was that it had been reported Inter-Pharma intended to market cut price Factor 8 obtained from Cutter and from Hyland". Read more about Professor Arthur Bloom expressed concerns to Dr Holgate (DHSS). Firstly that material produced by a US company had been sold "through brokerage or other means" to Speywood where it had been relabelled as a product of their own. A second concern was that it had been reported Inter-Pharma intended to market cut price Factor 8 obtained from Cutter and from Hyland".
Dr Maycock observed that the prevalence of hepatitis in the UK associated with UK blood and blood products had "long been smaller" than that in the US, but added "Until concentrate prepared from UK plasma is available, I would have said the benefits attaching to Hemofil and other similar concentrates of antihaemophilic factor, used with discrimination, outweigh the risk". Read more about Dr Maycock observed that the prevalence of hepatitis in the UK associated with UK blood and blood products had "long been smaller" than that in the US, but added "Until concentrate prepared from UK plasma is available, I would have said the benefits attaching to Hemofil and other similar concentrates of antihaemophilic factor, used with discrimination, outweigh the risk".