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In February 1985 the heat treated products of Baxter, Alpha, Armour, Cutter and Immuno were all licensed.

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CSM(B) was unable to recommend a product licence for Hemofil-T.

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The assessor for an application for a variation to Hemofil product licence noted that there was no evidence to confirm that AIDS was a viral mediated infection and the addition of heat treatment would destroy about 20% of the coagulant activity yield.

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A.W. Barrell (Travenol) wrote to Professor Bloom, other haemophilia centre directors and the DHSS to say that Travenol could not give an assurance that the heat treated product eliminated the risk of transmission of AIDS since the causative agent for AIDS had not been identified.

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Travenol applied for a UK Product Licence for Hemofil-T (Antihaemophilic Factor Human Method Four Heat Treated).

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In a letter to Dr Thomas (NIBSC), Pat Thomas (Hoechst) indicated that Hoechst intended to introduce Haemate P to the market, approximately two years after obtaining a product licence.

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In an assessment of Haemate P (Heat Treated Factor 8), Dr Fowler concluded that it was probable that Hepatitis B would be less likely with the heat-treated product than with comparable untreated products.

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A licence was granted for Haemate P (Heat Treated Factor 8), produced by Behringwerke, subject to a number of conditions.

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An application for high potency Factorate from Armour was declined in July 1984 on the grounds of safety, quality and efficacy.

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The CDC published a report on their study conducted on a heat-treated product produced by Cutter which recorded that the preliminary evidence of the effects of heat treatment was that it reduced the potential for transmission of the AIDS virus.

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At a meeting of the CSM(B), Dr Smith reported that preliminary evidence suggested that heat treatment would reduce the potential of transmitting AIDs via blood products.

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In a letter to R Nicholson (Immuno), M E Duncan (DHSS) confirmed that the Licensing Authority encouraged pharmaceutical companies to use a dry heat treatment process.

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An internal Cutter memo stated that AIDs had caused a virtual panic in the Department of Health, and that the Department had blocked every application for registration of heat-treated Factor 8 for a year.

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The DHSS began to collect data on the ability of heat-treated blood products to inactivate HIV.

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Immuno made an application for Kryobulin TIM 2.

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Dr Frances Rotblat (DHSS) was recorded as having told Cutter that it was extremely rare for the yellow card system for reporting adverse reactions to be used for hepatitis in blood products.

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Between 1970 and 1995 the Yellow Card reporting scheme for adverse drug reactions was limited to medical practitioners.

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In an affidavit, Professor Adolf Asscher stated that there was an established process of investigating reports of serious adverse reactions.

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The British Pharmacopoeia did not contain references the risk of AIDs associated with the use of commercial factor concentrates between 1983 and 1985.

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The CSM declined to grant a licence for Serum Cholinesterase.

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