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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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A study conducted on the Alpha heat-treated variant Profilate recorded that it was produced from plasma pools of between 5,000 amd 32,000 donors per batch.

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A report included in the initial product licence application for Kryobulin by Serological Products Ltd recorded that the pool size used was 1,000 donors between the ages of 18 and 65, whose plasma was obtained from centres in Austria and West Germany.

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The figure of 1,000 donors appeared on a product label for Kryobulin Red (made with European plasma) in the mid 1970s.

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The figure of 1,000 donors appeared on a draft product label for Prothromplex.

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The draft label provided with the product licence application for heat-treated Kryobulin did not give a donor pool size figure.

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At an NIBSC Infectious Hazards of Blood Products meeting Dr Rodell gave a summary of the commercial pool sizes and stated that one donor probably would not contribute more than four units to a particular pool.

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Hepatitis B tests were not sufficiently sensitive to detect every infected unit for over a decade after screening first became available.

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Dr John Craske's article "An Outbreak of Hepatitis Associated with Intravenous Injection of Factor-VIII Concentrate" was published in The Lancet. It said: "Testing the pooled plasma or the factor-VIII concentrate by the current radioimmunoassay techniques is not a reliable method of excluding hepatitis-B virus. Individual donations should be screened by R.I.A. before being pooled."

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Roderick Murray wrote the article "Viral Hepatitis", published in the Bulletin of the New York Academy of Medicine, which established that increasing pool sizes did not have the effect of dilution (and that any infectious particles would infect the whole pool).

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A report of the Meeting of Blood Products Advisory Committee on the Safety and Purity of Plasma Derivatives records that Dr Rodell warned that one donor infected with AIDS may make several contributions. He suggested that as few as four donors infected with AIDS could infect the whole world supply of factor concentrate.

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