Volume 1: Findings and Conclusions
7. Medicines and cosmetics
Research into pharmaceuticals

985 As the story of the way medicines, and in particular vaccines, were handled has shown, there was a pressing need to establish whether bovine serum was infective. The only way to do this was by research. In Chapter 7 of Volume 7 we look at what happened to proposals for research into this.

986 The need for this research had been identified at the NIBSC discussion in May 1988, though it appears that no studies into the infectivity of serum were carried out as a result of this meeting.

987 However, the subject was not forgotten. When the Tyrrell Committee prepared its Report on research in spring 1989, one of the items it identified as a top priority was research into which bovine tissues were infective. Given the limitations on the numbers of animals, staff and suitable housing to carry out this research, the Committee agonised over which items should be done first. In its Report it said: 'Nowhere else has the decision on priorities been more difficult.'

988 The decision it reached included ranking work on foetal calf serum and bovine serum albumin as a three-star (ie, top) priority.

989 In Chapter 7 of Volume 7 we trace the events that followed after the Tyrrell Report was presented to MAFF and DH. The proposal had a chequered history. In August 1989 Mr Gummer proposed and Mr Freeman agreed that it should be jointly sponsored and funded by both Departments, reflecting their joint responsibilities under the Medicines Act. Money was earmarked. However, following the first BSEWG meeting in September, Dr Pickles indicated to Mr Hagger that the MCA might want to consider whether the work was still needed, given that the action agreed by the BSEWG should ensure that contaminated material would not be entering pharmaceutical processing. She pointed out the need to secure Dr Tyrrell's support for such an approach. In January Dr Pickles informed Ministers, at the time the Tyrrell Report was being published, that the MCA was acting on the recommendation together with its experts.

990 When Mr Lawrence circulated a chart showing progress on the Tyrrell recommendations in April 1990, he noted that work on serum research was being carried out at the NPU with industry funding, adding that trade restrictions and industry sourcing from outside the UK had lowered the priority on research into serum.

991 It is plain now that MAFF and DH had to an extent been operating at cross-purposes. DH had been concentrating solely on the proposal allocated to it, namely to secure research on serum. The Tyrrell Report had identified this item as just one element in the general programme of tissue testing. That other general work was being taken forward by MAFF and the NPU.

992 Mr Bradley of the CVL had reached the judgement in December 1989 that foetal calf serum was one of the top priority items for the limited animal resources available. The CVO agreed with him and it was included in the quota of tissues for transmission studies in the first year of the project with the instruction that it was important to get these studies under way as soon as possible. MAFF emerges with credit for its purposeful handling of the matter.

993 The work was done by the NPU and the results were made available in 1993. No infectivity was shown in these tests of foetal calf serum.

994 Thus despite its apparent downgrading by DH, the work was actually done. However, it seemed to us that this outcome was in some respects achieved despite inconsistencies in approach and a degree of mutual misunderstanding. Four features struck us as having complicated the process:

• The notion that industry might voluntarily sponsor and share the results of the work.
• The compartmentalising of the serum and other tissue study items, first by the Tyrrell Committee and then by MAFF, in how they allocated responsibilities. This led to confusion about how the work was carried out thereafter and who was calling the shots.
• The detached attitude of the medicines licensing divisions, which had an interest in the outcome.
• The divergent perceptions of MAFF, DH and SEAC about what was actually happening on the Tyrrell proposals.