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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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Dr Thomas Cleghorn noted that plasma to manufacture initial supplies of Hemofil for the UK had not been individually RIA tested and had come from Puerto Rico, where they Hyland a blood bank.

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At a CSM(B) meeting, the Sub-Committee was informed that the manufacturer of Kryobulin PL/0215/0003 had not been visited recently, but the licensing authority intended to ask the Austrian authorities to carry out an inspection.

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The CSM accepted the recommendation from its Sub-Committee, and advised the grant of a product licence for Hemofil.

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Product licence was granted for Hemofil.

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Dr Thomas commented regarding the Kryobulin licence application that despite precautions being taken, "the risk of transmission of serum hepatitis can only be diminished and not completely eliminated.

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Austrian Inspectors conducted an inspection of the manufacturing facilities regarding the Kryobulin licence application.

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Dr Thomas visited Immuno factories in Vienna.

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In a journal article it was reported that the risk of causing hepatitis from blood taken from paid donors was markedly higher than that of blood from unpaid donors.

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