Profilate had always been produced from US-only plasma. Read more about Profilate had always been produced from US-only plasma.
A ministerial submission from January 1976, relating to the product licence application for Factorate, set out what was known at that time about the sources of plasma for Factor 8 concentrates that were used in the UK, including whether the Medicines Inspectorate had visited facilities. Read more about A ministerial submission from January 1976, relating to the product licence application for Factorate, set out what was known at that time about the sources of plasma for Factor 8 concentrates that were used in the UK, including whether the Medicines Inspectorate had visited facilities.
Hyland stated that no products fractionated from plasma pools containing the donor's plasma had been shipped to customers in Europe. Hyland explained that it had taken this action unilaterally and not at the request of the FDA. Read more about Hyland stated that no products fractionated from plasma pools containing the donor's plasma had been shipped to customers in Europe. Hyland explained that it had taken this action unilaterally and not at the request of the FDA.
When Dr Francis suggested at the meeting that Hepatitis B core testing should be introduced, as a surrogate test for the presence of the putative virus, he was not supported by any of his superiors. Read more about When Dr Francis suggested at the meeting that Hepatitis B core testing should be introduced, as a surrogate test for the presence of the putative virus, he was not supported by any of his superiors.
A senior official at the American Red Cross wrote in a memorandum that: "it has long been noted that CDC increasingly needs [a] major epidemic to justify its existence ... In short, we can not depend on CDC to provide scientific, objective, unbias[ed] leadership". Read more about A senior official at the American Red Cross wrote in a memorandum that: "it has long been noted that CDC increasingly needs [a] major epidemic to justify its existence ... In short, we can not depend on CDC to provide scientific, objective, unbias[ed] leadership".
The Institute of Medicine Committee's report was critical of the CDC. Read more about The Institute of Medicine Committee's report was critical of the CDC.
It was agreed that the possibility of people with haemophilia contracting AIDS from blood products must be explored and that techniques should be developed immediately to reduce or eliminate the risk of infection from Factor 8 concentrates. Read more about It was agreed that the possibility of people with haemophilia contracting AIDS from blood products must be explored and that techniques should be developed immediately to reduce or eliminate the risk of infection from Factor 8 concentrates.
Material which would be excluded from any production of concentrate in the UK because of the high risk it posed was included in the concentrates Alpha exported to the UK. The FDA knew this was happening but sought to persuade rather than enforce. Read more about Material which would be excluded from any production of concentrate in the UK because of the high risk it posed was included in the concentrates Alpha exported to the UK. The FDA knew this was happening but sought to persuade rather than enforce.
The FDA had a Blood Products Advisory Committee ("BPAC") which, though it contained members drawn from a variety of scientific disciplines, in the 1980s had a substantial membership drawn from those involved in blood banks and fractionators. Read more about The FDA had a Blood Products Advisory Committee ("BPAC") which, though it contained members drawn from a variety of scientific disciplines, in the 1980s had a substantial membership drawn from those involved in blood banks and fractionators.
A formal compliance program for the plasma fractionation industry was established in 1977. The US Institute of Medicine committee noted that source identification for plasma (ie whether from a paid or voluntary donor) did not apply, though it did for whole blood for transfusion from 1978. Read more about A formal compliance program for the plasma fractionation industry was established in 1977. The US Institute of Medicine committee noted that source identification for plasma (ie whether from a paid or voluntary donor) did not apply, though it did for whole blood for transfusion from 1978.