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When the Edinburgh cohort were identified as having been infected with HTLV-3 through the use of PFC products, it was discovered that 4,000 donors had contributed to the implicated batch.

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Pool sizes for continuous thawing were between 600kg and 1,000kg, depending upon the size of freeze dryer available.

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Although the PFL produced a small number of batches from limited donor pools using plasma from a small number of plasmapheresis donors, this product still resulted in some hepatitis transmission.

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A paper published by Dr Peter Kernoff, Dr Christine Lee and others recorded that a cohort of patients followed up between April 1978 and March 1983 showed close to a 100% rate of infection after first exposure to clotting factor products, with those using NHS concentrates faring only slightly better than those using commercial concentrates.

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At a meeting of the Blood Products Advisory Committee of the Centre for Biologics Evaluations and Research, it was noted that paid donors had plasma collected from them between 40 and 60 times per year on average, and that 4 infected persons could contaminate "the entire world supply of Factor VIII" due to the large US pool sizes.

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At a meeting of the Blood Products Advisory Committee, it was noted that one infected donation could easily be represented in as many as 50 plasma pools in one year, with up to 250 million international units of Factor 8 activity potentially affected.

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A list of Factor 8 labels produced between 1985-1987 contained statements as to the maximum pool size (eg "Less than 7,500 plasma donations were used in the preparation of this batch"), and some indication as to risk ("The preparation is of human origin and cannot be assumed to be free of hepatitis virus").

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In 1978, Factor 8 products from PFC had labels warning that: "Product may carry the risks of transmitting serum hepatitis". PFC Factor 9 labels warned that: "none of these tests are of sufficient sensitivity to eliminate the possibility of transmitting hepatitis...the risk of transmission cannot be disregarded."

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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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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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