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Parliamentary questions discussed the issue of unscreened BPL plasma and said issuable blood products which might be contaminated with AIDS had been destroyed.

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Dr Robert Gerety and Dr David Aronson in an invited review said studies had been completed and others were underway to evaluate methods of stabilising clotting factors as heat was capable of inactivating both Hepatitis B and non-A non-B Hepatitis infectivity.

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Dr Lane reported that "a research project into the development of coagulation factor concentrates with reduced risk of hepatitis transmission, was an appropriate case for central funding."

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Dr Lane in his draft proof of evidence for the HIV Haemophilia Litigation, wrote "The documentation I have discussed above indicates our intention to define a heat treatment process capable of full virus inactivation, probably requiring more severe heating than was currently recognised."

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There were discussions at BPL about the degree of success commercial firms had in reducing hepatitis transmission, and answers being sought to questions about the safety and efficacy of those heat-treated concentrates which were being developed elsewhere.

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The "Proposal to Develop a 'Hepatitis-Safe' Factor VIII Concentrate" noted that "NANBH causes increasing concern, less on account of its acute effects (although deaths have been reported) than because of its association with chronic active hepatitis in later life", and that AIDS was "not yet proven to be of viral origin, but this is strongly presumed."

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Dr Lane's view was that "the risks of transmission of HIV were such that heat treatment should be employed even if it turned out to be a temporary expedient."

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There were fears that the Factor 9 concentrate in particular - but also Factor 8 - might give rise to a greater risk of thrombosis from the heat-treated product, although research facilities were limited, scientific staff were few, and BPL suffered from a lack of viral containment equipment.

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Dr Richard Lane recorded that no work was done by BPL during 1981 to research heat treatment.

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BPL planned to apply dry heat treatment to all the Factor 8 produced at BPL because it was shown that heat treatment appeared to inactivate the HTLV-3 virus which by then had been identified as the cause of AIDS.

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According to Dr Lane, a "requirement for central funding for research and development was a continuous theme in 1981."

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Dr Lane complained that the "Department of Health policy was that Regional Health Authorities were to all intents and purposes responsible for allocation of budgets, and the Department of Health would not intervene in the exercise of their discretion."

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Dr Lane's account of 1981 was one of his battles to secure a commitment from the government to redevelop BPL, and to fund the improvements necessary following an adverse Medicines' Inspectorate report.

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Dr James Smith proposed to Dr Lane some first outline proposals for programmes to research tackling the transmission of viruses by coagulation factor concentrates. This proposal, according to Dr Lane, marked "the start of a move towards a viral inactivation programme."

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It was apparent that there was some resistance by some clinicians to the use of heat-treated product.

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Professor Garrott Allen wrote to Dr William Maycock stating: "As you know" Cutter's Konyne was "extraordinarily hazardous".

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Dr Maycock stated: "DHSS, in order to be able to carry with confidence its responsibility for providing the transfusion service in England and Wales, should consider fostering the development of a central transfusion research laboratory."

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Capital funding was the preserve of central government, which considered that so far as the laboratory at BPL was concerned "expenditure on up-grading should be reviewed and minimised pending a decision on the laboratory's future."

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Dr James Smith wrote: "The significance of a product demonstrably free of hepatitis risk cannot be ignored and it is essential that BPL/PFL be well placed to take advantage of such developments."

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Dr Lane reported to the Scientific and Technical Committee of the Central Blood Laboratories Authority during the next month that "a research project into the development of coagulation factor concentrates with reduced risk of hepatitis transmission, was an appropriate case for central funding."

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