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. Read more about 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.
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". Read more about 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".
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." Read more about 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."
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." Read more about 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."
Dr Robert Perry, the director of PFC, said in oral testimony that if pool sizes hadn't been increased in the early 1980s, then production in the UK wouldn't have kept up with demand and the only alternative would have been to buy more commercial product "which would have been the worst of all outcomes". Read more about Dr Robert Perry, the director of PFC, said in oral testimony that if pool sizes hadn't been increased in the early 1980s, then production in the UK wouldn't have kept up with demand and the only alternative would have been to buy more commercial product "which would have been the worst of all outcomes".
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"). Read more about 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").
Dr Terence Snape said in oral testimony that at PFL, product labels were generated and overprinted on commercially produced labels "even up to 1982". Read more about Dr Terence Snape said in oral testimony that at PFL, product labels were generated and overprinted on commercially produced labels "even up to 1982".
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. Read more about 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.
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. Read more about 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.
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. Read more about 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.