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A Lancet article suggested that non-A non-B Hepatitis might be associated with Hepatitis B infection.

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Hyland had had a policy that any plasma collected from a donor who had a history of hepatitis was excluded from use in the manufacture of AFH. Plasma with anti-HBs collected from homosexuals was sold to Alpha.

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A letter from the Vice President of Hyland stated that within the past several months, they had made a commitment to withhold from AFH manufacture any plasma obtained as a result of specific recruiting activities aimed at the gay community and they no longer allowed that plasma to enter the pools leading to AFH manufacture.

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At Alpha, the standard practice for most but not all plasma was to use the same plasma pool for the manufacture of Factor concentrates.

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The Office of Biologics through Dr Donohue raised concerns with Hyland regarding the use of plasma obtained through recruitment aimed at the gay community and requested assurance that such plasma would not be used in the manufacture of AFH for the time being.

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Dr Donohue requested all AFH manufacturers to voluntarily refrain from fractionating plasma into coagulation products if the plasma came from centers known to have a high population of homosexuals. Cutter placed a hold for one month and confirmation would be obtained from management to continue the hold. Dr Donohue felt that the hold would not be necessary for more than 2 or 3 months unless more donors developed AIDS.

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Alpha voluntarily suspended until further notice the use of cryoprecipitated materials from hepatitis B surface antibody donors in the manufacture of AFH.

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Alpha had recently closed its San Francisco centre.

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Alpha's Executive Committee agreed to report to the FDA the products produced from three units of plasma obtained from the 'AIDS donor' and to wait for FDA's opinion on what should be done with them.

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In On the Role of Sexual Behavior in the Spread of Hepatitis B Infection, it was noted that homosexual men should be advised not to give blood due to the high prevalence of identified and unidentified, blood-borne and sexually transmitted diseases.

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The practice of using plasma intentionally obtained from gay donors in factor concentrates was strongly deprecated by Dr Donald Francis of the CDC during the US litigation.

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The introduction of FDA regulation #640.102(d) mandated large pools of at least 1,000 different donors for the manufacture of immunoglobulins, and the same large pools were then used to make factor concentrates.

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The Armour Factorate roundel highlighting their use of 1540 donors per pool was featured on the first page of a letter from from Christopher Bishop to Dr Rosemary Biggs.

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Christopher Bishop told the Inquiry that product literature was produced by Armour on the expectation that it would be read and considered by doctors rather than patients.

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In the absence of firm evidence of a product being implicated in the transmission of AIDS, Mr Bishop stated they he was not concerned about the absence of a product warning.

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Figures provided by Travenol in support of a product licence application for Proplex referred to a plasma pool size of approximately 6,000 litres; the number of donations was not specified, but would have been higher.

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During a product licensing application for Koate, Cutter noted that a pool consisted of 2,500 litres of plasma and approximately 4,000 human units or more, and from equal donations of at least 1000 individual donors. A given lot of Koate was usually made up from material fractionated from 3 to 5 pools.

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In a letter regarding a donor who had been diagnosed with AIDs, Dr Akin argued that the large pool dilution of the donor's plasma made it highly unlikely that transmission would occur to a recipient. It was also estimated that each pool contained plasma from as many as 7,000 to 15,000 individuals.

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In a letter to three British doctors, Linda Frith of the UK subsidiary of Cutter stated that Koate HT was prepared from pooled human plasma of at least 1,000 healthy donors.

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In an application for a renewal of the Koate HT product licence, it was noted that the product was prepared from pooled human plasma of at least 1,000 healthy donors.

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