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Dr Robert Perry, the director of PFC, commented in oral testimony that the leaflets accompanying Factor 8 and 9 concentrates were primarily targeted at the prescribing doctor "and, in a sense, they had a much closer working knowledge of risks of hepatitis non-A, non-B, hepatitis B and, latterly, HIV than the manufacturer of the products. So none of this information would have been a surprise to a treating doctor."

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The 1973 British Pharmacopoeia required "the number of donations in the pool from which the preparation was obtained" to appear on product labels. However between 1973 and 1978 the requirement for a label to identify the pool size disappeared from the British Pharmacopoeia requirements, to be replaced by a warning at least in terms that "the preparation is of human origin and cannot be assumed to be free of hepatitis virus".

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Dr Mauser-Bunschoten and others authored "Hepatitis C Infection and Viremia in Dutch Hemophilia Patients" published in the Journal of Medical Virology 1995 which demonstrated that in the Netherlands, the infection rate in those patients treated with cryoprecipitate was much lower than those treated with large pool concentrates.

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Dr Kernoff and others published "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". It showed there was a near 100% risk of hepatitis for first treatment with factor concentrates and that NHS concentrates were little better. The study followed patients between 1978-1983 when pool sizes used in the NHS were growing exponentially.

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Dr Fletcher, Dr Craske, Dr Rizza and others wrote "Non-A non-B hepatitis after transfusion of factor VIII in infrequently treated patients" published in The British Medical Journal in 1983. The study suggested there was a difference in infectivity of factor concentrates when pool sizes were smaller.

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Dr Rollag and others conducted the study which showed that people with bleeding disorders treated with factor products from "a relatively small and stable pool of domestic, non-paid donors" and the overall proportion with Hepatitis C was 41%, and for those with severe Haemophilia A or B it was 64% or 67%, respectively.

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Dr Colvin, Dr Craske and others conducted a study titled, "A prospective study of cryoprecipitate administration: absence of evidence of virus infection". A small cohort of patients were treated only with cryoprecipitate between October 1982 and July 1984 and none developed hepatitis.

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A memo from Marietta Carr to members of the Alpha Operations Committee noted the discussion at a National Institute for Biological Standards and Control meeting where it was suggested that "the 100% incidence of non-A, non-B hepatitis is recent and is related to increased pool size since 1978."

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At the National Institute for Biological Standards and Control meeting, the minutes recorded that there "was much discussion about the optimal size of plasma pools, but no agreement that reduction of pool size would be either a practicable or a successful way to reduce the transmission of either hepatitis or AIDS".

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In his written statement, Dr Foster said that a reduction in pool size around the early 1980s would have led to "an increase in importation of USA-donor derived Factor VIII concentrate which, in my opinion, carried a greater risk of HIV infection."

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BPL Factor 8 concentrate (Batch 1227), approved for clinical use on 29 September 1976, had a product label which noted that: "less than 1500 plasma donations used in the preparation of this batch".

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BPL Factor 8 concentrate (Batch 1237) was approved for clinical use. The product label noted that: "less than 1500 plasma donations used in the preparation of this batch".

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Dried Factor 8 Fraction from BPL (Batch 8 CRV 22344) was approved for clinical use. The product label noted that: "less than 7500 plasma donations used in the preparation of this batch".

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Dried Factor 8 Fraction from BPL (Batch 8Y 3607) was approved for clinical use. The product label noted that: "the preparation is of human origin. It has been heat treated, in the vial, to reduce the risk of infection by viral agents (including hepatitis and AIDS viruses) but it cannot be assumed to be free from the risk of transmission of viral infections."

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Dried Factor 8 Fraction heat-treated from BPL noted on its label that: "this product prepared from human venous plasma, is heat-treated in its final container to reduce the risk of viral infections (including HIV and hepatitis) but freedom from this risk cannot be assumed."

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In June 1985, a document about the BPL (specifically background and current information) about the facility was produced for members of the CBLA. It detailed its product list, manufacturing targets, revenue and its position on self-sufficiency and meeting the demand for plasma, amongst other topics.

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The product labels for BPL Factor 8 concentrate in March 1976 noted: "less than 1500 plasma donations used in the preparation of this batch".

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Dr Lane wrote to Thomas Dutton, of the DHSS, enclosing a paper on the requirement for hepatitis testing at BPL, in relation to the stop-gap provisions for plasma fractionation at BPL. He said the paper was to enable Mr Dutton to see what he thought about this matter prior to planned discussions with Dr Waiter and Dr Maycock at DHSS.

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A note of a discussion held at the DHSS (in January 1978) regarding RIA testing to contain hepatitis at BPL recorded agreement that Dr Lane would revise his paper to include information about the additional staff, accommodation and costs necessary to introduce RIA at BPL, and that this would be shown to the Medicines Division.

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Dr Lane wrote a letter to Professor Mollison enclosing the paper submitted to DHSS on "Stop Gap Provision for Plasma Fractionation at BPL". The paper outlined the problems of containing hepatitis in the preparation of concentrates and the programme to provide radioimmunoassay service to contain Hepatitis B.

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