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During the licensing process, the licensing authority required references to heat treatment to be that it was intended to "reduce the risk of transmission of infectious agents" rather than making claims about it reducing the risks of HIV or non-A non-B Hepatitis by name.

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Cutter and the FDA discussed adding an AIDS warning to US product information, leading to the addition of such a warning in December.

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Cutter and the FDA noted that: "Isolated cases of Acquired Immune Deficiency Syndrome (AIDS) have been reported in hemophilics [sic] who have received blood and/or coagulation factor concentrates, including Factor VIII concentrates."

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Professor Arthur Bloom maintained to the annual general meeting of haemophilia centre directors there was no proof that commercial concentrates were the cause of AIDS.

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An AIDS warning was added to US product information in December 1983, however the earliest product warning in the UK which the Inquiry was able to identify was in March 1984.

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It was widely known that gay men in particular were at risk of developing a failure of the immune system, which was indeed called GRIDS (Gay Related Immunodeficiency Syndrome).

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Dr Kingdon wrote "Many of us have been involved in considering the problem and in discussions with the CDC on its implication for our blood products."

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Dr Kingdon recorded "we have been closely monitoring the issue at Hyland".

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Dr Evatt anticipated that a public meeting to be held at the instigation of the CDC would be a "pro forma stamp for action, that is, review the data, accept the evidence as significantly supporting the case for blood-borne infection and produce recommendations that high-risk groups be excluded from the donor pool and/or adopt a surrogate test."

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Dr Evatt and his colleagues "were now convinced that in spite of the absence of an identified agent, the pattern of the epidemiological evidence was sufficient to implicate a blood-borne disease."

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The Committee on Safety of Medicines advised against issuing a product licence for heat-treated Hemofil in September 1983 in part because of the absence of evidence that AIDS was transmitted by a virus and hence might be affected by heat treatment.

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Travenol Laboratories applied for a product licence for Antihaemophilic Factor (Human) Method Four-Heat Treated Hemofil-T.

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Peter Coombes wrote to David Watters enclosing a copy of a Kryobulin data sheet for non heat treated product.

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Ken Fitch wrote to Haemophilia Centre Directors stating that Armour had programmes in operation designed to help prevent the use of plasma obtained from high risk groups associated with AIDS in the production of clotting factor concentrates.

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A letter from Travenol Laboratories to the DHSS stated that "while the causative agent of [AIDS] remains to be identified, some evidence suggests it is caused by a virus that can be transmitted by blood and certain blood products."

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The Sub-Committee on Biological Products stated that on grounds of safety, quality and efficacy it was unable to recommend that the Product Licence be varied for Travenol Laboratories Ltd Hemofil product. It considered that justification should be provided for the inclusion and choice of the heat treatment step and that there was inadequate evidence as to the safety and efficacy of the product.

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CDC Epidemiological Notes and Reports Update on Kaposi's Sarcoma and Opportunistic Infections in Previously Health Persons documented that of the 355 cases reported then, 16% were heterosexual - and a quarter of these were women. Only about half were intravenous drug users.

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The FDA wrote to manufacturers of plasma products to tell them that "although the cause of this outbreak is unknown, the information suggests that a transmissible agent might be involved and concern about transmission through blood and blood products has been raised."

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The National Hemophilia Foundation broke the news to its members that the CDC believed that the immune deficiency might be caused by a virus transmitted through blood or blood products as was hepatitis, but advised that the risk of contracting this immunosuppressive agent was minimal.

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Dr Steven Ojala of Cutter wrote after one meeting in January 1983, quoting a colleague from Hyland, that 'it is unusual for us [the commercial companies] to come away wearing the white hats while the "volunteer" sector wears the black'

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