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Dr Joseph Smith stated that he did not have any role in advising government on the response to AIDS. The extent of his input was in the capacity as Director of the NIBSC, Chairman of the CSM(B), a member of the CSM or other relevant committees or working groups, or Director of the PHLS.

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Dr Smith regarded Dr Fowler's paper as representing the DHSS Medicines Division's evaluation of the cause of the AIDS problem.

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In Dr Smith's written evidence, he described the CSM as having gained "some comfort" from being told that efforts were being made to secure UK independence of foreign suppliers of clotting factor concentrates.

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Dr Smith recalled asking the DHSS after a couple of months about progress, and that they had remained positive about progress whilst telling him that self-sufficiency had not yet been achieved.

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Dr Smith told the Inquiry that he had "the clear impression" that the UK's self-sufficiency was expected to be achieved within approximately two more months.

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Dr Smith observed that there were occasions when the CSM(B) or the CSM considered broader issues relating to the safety of blood products in the context of AIDS. This led to advice, recommendations or "remarks" being conveyed to the Medicines Division of the DHSS for consideration by the Licensing Authority.

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Dr Smith understood from what Dr Lane and the DHSS representatives said - that self-sufficiency was expected soon, and would be achieved "within a period of months".

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There was no statutory requirement for products to be tested by NIBSC as part of the application for a product licence.

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Dr Duncan Thomas observed in his statement to the Inquiry there was a close working relationship between NIBSC and the CSM(B) with mutual interaction and coordination; representatives from NIBSC would attend the CSM(B) meetings.

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Sir Michael Rawlins had a role as Senior Medical Officer in advising the CSM(B) between 1971 and 1974 whether it should recommend granting a licence. He noted that he was not influenced by other jurisdictions' licensing processes or decisions.

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Dr Thomas observed that "licences were often given with conditions which demonstrated the CSM spotted deficiencies and assured they were rectified before the product was released on the market."

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The Krever Report observed that "Neither the Food and Drug Administration in the United States nor the Department of Health and Social Security in the United Kingdom performed these studies. They were done by the pharmaceutical manufacturers themselves as part of the research and development involved in the manufacture and marketing of new drugs."

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The Dutch Association of Haemophilia Patients advised members that it was highly likely that Americans with haemophilia had been infected by using factor concentrates and provided guidelines to reduce the risk of AIDS amongst patients.

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Dr Joanna L'age-Stehr, of the Robert Koch Institute in Berlin reported in the Federal Health Bulletin (Bundesgesundheitsblatt) that AIDS appeared to be caused by an unknown infectious agent transmitted through blood and blood products.

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Mr Justice Krever reported that, "as early as January 1983, [the Ministry in the Netherlands] had discussed the possibility of prohibiting imports of factor VIII concentrate."

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In the Netherlands patients could continue after the start of 1983 to receive commercial concentrates provided there was written evidence of their consent.

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Dr Michael Rodell (vice-president of the Armour Pharmaceutical Company) estimated that as few as four infected persons could contaminate the entire world supply of Factor 8 concentrate (his analysis was confined to concentrates made from US plasma).

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A two-year study on HIV and blood supply was conducted in the US by a Committee, established by the Institute of Medicine.

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A report on HIV and blood supply was critical of the FDA in the way it had managed regulation of blood and blood products in the early 1980s, and for having relied too heavily on the pharmaceutical industry.

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The Penrose Inquiry Report concluded that, in relation to blood products, "subjecting UK products to a need for approval to the FDA before introducing them for use in Scotland would not have been a rational exercise of judgement by any UK or Scottish government agency".

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