Volume 7: Medicines and Cosmetics
9. Consideration of an audit of the uses of cattle tissues
1996
SEAC says that an audit is urgent
The audit is 'high priority, and getting higher'

SEAC says that an audit is urgent

9.112 On 3 January 1996, Dr Matthews submitted a paper to SEAC entitled 'Review of Future MAFF Sponsored Research on TSEs' (SEAC 23/4). ¹ The paper asked SEAC to make recommendations on the provisional prioritisation of projects. Appended to the paper was an updated version of the table prepared by Dr Brown for the MAFF meeting of 22 December 1995. Under columns headed CSG and PG, the audit trail was given a priority rating of 2 out of 13 projects and accompanied by a note saying, 'Commission expert to prepare this. CSG to organise.' ²

9.113 The paper was tabled at SEAC's twenty-third meeting on 5 January 1996. The agreed minutes of the meeting record that SEAC considered the audit trail to be 'urgent'. ³ An earlier draft of these minutes had stated that this project was 'sensible'. ⁴ The agreed minutes added that, 'Further discussion would be necessary on research priorities once the Committee had had an opportunity to fully consider the paper (23/4) tabled at this meeting.' ⁵

9.114 On 8 January 1996, Mr Eddy sent Mr Meldrum a note of the main issues and action points arising out of the SEAC meeting. ⁶ Mr Eddy stated that SEAC 'agreed that projects 12, 6 and 9 [the audit trail] were sensible'. The minute also noted Mr Eddy's view that 'by and large the Committee seemed fairly uninterested in these projects', and that the bulk of the discussion concerned strain typing and transgenics. ⁷

9.115 Also on 8 January 1996, Dr Matthews sent a minute to Dr Brown, copied to Mr Eddy, Mr Meldrum, Mr Taylor and Dr Cawthorne.

We have briefly discussed the outcome of the discussion on future R&D at the SEAC meeting on 5 January. That discussion was very unstructured, and unfortunately our inability to table the paper prior to the meeting, coupled with the length of the agenda, meant that it was difficult to address all our needs in depth. Mr Eddy had agreed this morning that under the circumstances we should go ahead and approve the projects that we had provisionally approved for 1996/7, and Professor Pattison has since confirmed that he is happy with that approach. Indeed, he stated that he would welcome such position papers from all other funders of research in this area too. He also said that he was pleasantly surprised by the scale and range of the MAFF programme presented to him. ⁸

The audit is 'high priority, and getting higher'

9.116 On 1 February 1996, the twenty-fourth meeting of SEAC was held. ⁹ The minutes of the meeting record in relation to the 'Audit Trail of Cattle and Sheep Tissues (No. 9)': 'It was judged to be of high priority, and it was important to include sheep tissues in the study.' ¹⁰ An earlier draft of the minutes had stated in relation to this project, 'It was judged important to include sheep tissues in the trail.' ¹¹

9.117 On 2 February 1996, Dr Matthews sent a note to Dr Brown, copied to Mr Eddy, setting out 'SEAC's latest thinking on research priorities'. ¹² He said the audit trail was

high priority, and getting higher. They now require an audit of ovine as well as bovine. We explained the difficulties of doing any of it, particularly quickly, but they are unrepentant. ¹³

9.118 Mention of investigating other routes of transmission was made on 8 March 1996, by Dr Eileen Rubery of Health Aspects of Environment and Food Division (HEF) in a 'Next Steps' paper, which included the following reference:

Other routes of exposure need to be considered. Cat-gut and vaccinations are invasive activities that a large proportion of the population are exposed to. Could either of these routes be the actual route of exposure? What about gelatine capsules for pharmaceuticals, and gelatine capsules for health foods? Do we need to take any further action to control potential exposure via these routes? MCA, IID and HP need to be involved. ¹⁴

9.119 Apart from this mention in Dr Rubery's paper, the question of the audit did not resurface until after the Government's announcement of the likely link between BSE and nvCJD (see Chapter 7 of Volume 6). In a minute dated 21 March 1996 to Mr Eddy, Dr Brown said in relation to the audit:

You will recall that the need to provide an audit trail for bovine tissues was one of the recommendations of the TSE research review and that this was to be addressed by the Policy Group because it was accepted as a surveillance exercise and the necessary expertise was within AHVG [Animal Health Veterinary Group].

The issue was discussed again at the meeting on BSE research before Christmas when it was again agreed that this was of high priority. However, I understood that the Policy Group no longer intended to carry out the audit themselves but proposed to commission an expert to do this. This position was reflected in my table sent to Dr Matthews on 3 January. . . .

Belatedly, I now notice that the table returned by Dr Matthews following the January SEAC meeting has three additional words 'CSG to organise'. . . .

Conclusion

As previously agreed, it does not seem appropriate for CSG to organise a surveillance exercise particularly when most of the expertise rests with AHVG. However, if you wish to use research funds for this purpose I will try to clear this with Dr Shannon. If he agrees, I would be grateful if you would forward the names and contact addresses of suitable experts whom I could invite to tender for the audit. ¹⁵

9.120 On 26 March 1996, Dr Matthews emailed Dr Brown in response to her minute of 21 March 1996:

At the meeting at the end of December it was agreed that we had no money for this, and that it should be a research project. Names were discussed, and our understanding of the situation was that you were to commission that work. To a slight degree the position may have been slightly compromised because the CVO has asked the MLC for some information requested urgently by SEAC, but I still believe that we need to ask the right questions at grass roots level, and again this is urgent, particularly with respect to bovine MRM. It could be argued that this is now appropriate for DH funding, especially as detail is needed by John Wilesmith and Richard Kimberlin for risk assessments for SEAC, but most importantly it needs to be started urgently. ¹⁶

9.121 Although outside our terms of reference, we note for completeness that on 22 April 1996, Dr Simpson sent a minute to Mr Eddy and Dr Matthews concerning a meeting on 19 April 1996 between Dr Simpson, Dr MacOwan and Dr Brown, and representatives from Leatherhead Food RA with a view to their carrying out the audit. ¹⁷ The minute recorded agreement that Leatherhead Food RA would prepare and submit a proposal as soon as possible. Dr Simpson said that he would keep Mr Eddy informed of progress on the proposal.

9.122 On 6 June 1996, Dr Brown wrote to Leatherhead RA confirming that the project proposed by Leatherhead had been approved. ¹⁸ The letter was copied to Dr MacOwan, Dr Matthews, Mr Eddy and Dr Simpson.

9.123 The Leatherhead project was completed in May 1997. ¹⁹