Volume 7: Medicines and Cosmetics
4. Initial response on human medicines
Early knowledge of BSE within Medicines Division
July 1987
Meeting of the Biologicals Sub-Committee of the CSM on 9 September 1987

4.2 Before the MAFF Permanent Secretary wrote to the Chief Medical Officer about BSE in March 1988 ¹ (see vol. 3: The Early Years, 1986-88), Medicines Division had only indirectly been alerted to the new bovine spongiform encephalopathy. They were not members of the Biologicals Committee (BC) and had not been informed of the consideration already given to it by the MAFF veterinarians, nor indeed was that to happen until some months later.

July 1987

4.3 One official in Medicines Division who learnt early on of the emergence of BSE was Mr Sloggem, a Principal Pharmaceutical Officer in the Biologicals Unit, who reported to Dr Purves. In the late 1970s he had been involved with the procurement and quality control of pituitary gland hormones made for the NHS, and had become aware of potential CJD contamination. ²

4.4 In July 1987 Mr Sloggem was asked to assess an application for a Clinical Trial Certificate (CTC) for a drug made from bovine brain extract containing phospholipids. In the Clinical Trial Exemption (CTX) file he found that Medicines Division had as early as 1984 asked for evidence that 'slow virus' contamination was not a problem, in view of the bovine brain source, ³ a question which showed remarkable prescience.

4.5 Seeking more information, Mr Sloggem telephoned Dr David Taylor, a researcher into transmissible spongiform encephalopathies (TSE) at the Neuropathogenesis Unit (NPU) with whom he had previously worked, who told him that a bovine spongiform encephalopathy had recently been recognised. ⁴ At the end of August 1987 Dr Taylor wrote two letters to Mr Sloggem. In the first he confirmed that a disease newly reported in bovines was 'scrapie-like' and in the second, in response to a query from Mr Sloggem, he summarised what was known about oral transmissibility of scrapie, kuru and CJD. ⁵

4.6 Mr Sloggem also wrote to Mr Batho in the Animal Health Division of MAFF on 7 September 1987 in relation to the application for a CTC. ⁶ He wanted to know about standards for certifying healthy cattle, with a view to placing such conditions on the grant of a CTC. Mr Sloggem told us that his enquiry resulted in a telephone call from Mr Batho at the end of September, in relation to the health criteria for the selection of cattle for food consumption, which he thought might have relevance to the product he was assessing. ⁷

Meeting of the Biologicals Sub-Committee of the CSM on 9 September 1987

4.7 When he attended the next CSM/BSC meeting, on 9 September 1987, Mr Sloggem was therefore aware of the existence of BSE. The product Mr Sloggem was considering was not on the agenda for that meeting. However, one of the products that was discussed was composed of human dura mater. This was the meeting attended by Dr Little of the CVL (see Chapter 3).

4.8 Dr Little and Mr Sloggem have different recollections of what happened at, and immediately after, the meeting on 9 September.

4.9 Dr Little told us that he made a mention of the occurrence of BSE in cattle. He believed this was during the course of the formal meeting, possibly during discussion about the dura mater product. ⁸ When he gave oral evidence, Dr Little explained that he made a very simple statement that there was a 'condition in cattle, called BSE, which we, CVL, were involved in investigating'. ⁹

4.10 We asked a number of those present at the meeting about this, but neither Professor Collee, the CSM/BSC Chairman, nor any of the Medicines Division officials, among them Mr Sloggem, had any recollection of the matter being raised, ¹⁰ nor was it recorded in the minutes. ¹¹

4.11 Dr Little also recalled that he had an informal discussion about BSE at the end of the meeting. Someone from DH had approached him and told him that a product consisting of an extract of bovine brain was currently under review. This person had said that he was aware of the BSE problem. Dr Little, after considering documents for the purposes of our Inquiry, inferred that the person was Mr Sloggem. ¹²

4.12 Mr Sloggem had no recollection of any such informal conversation. He explained to us why he believed he would not have said the things Dr Little recalled. He thought that if the discussion had taken place, Dr Little's evidence would have jogged his memory: ¹³

I had, by 9.8.87, formed the impression from my contact with Dr Taylor that the bovine slow virus issue was a matter which was not widely known and should not be publicised. I do not believe that I would, therefore, have felt it open to me to approach someone I had not met before, ie Dr Little, to tell him what I knew. Neither . . . would it have been open to me to suggest that either I or someone else within DH would write to MAFF about the subject in general. I had already involved NPU and obtained the information I needed from Dr Taylor to put the issue to BSC in my paper on the bovine brain extract. Furthermore I agree with Dr Little that an issue of this significance would have been expected to have been dealt with at a more senior inter-departmental level. ¹⁴

4.13 Mr Sloggem's reference to DH writing to MAFF on this issue arises because, following the meeting, Dr Little reported to Dr Watson his understanding that DH was aware of the problems associated with BSE. Dr Watson, knowing that Mr Rees was preparing a progress report for Ministers, minuted the CVO on 10 September to inform him that: ¹⁵

DHSS are aware of the problem. Concern is being expressed about the possible human health risks due to products for human use which contain an emulsion of bovine brain.

4.14 By way of explanation Dr Watson added:

This matter was discussed by Dr Little with DHSS colleagues attending the Committee on Safety of Medicines Sub-Committee on Biological Products on Wednesday 9 September, and I understand that they will be writing to us. ¹⁶

4.15 Dr Watson had one of a series of meetings at the NPU in Edinburgh on 14 September 1987 to discuss BSE developments and research. ¹⁷ He made a note indicating that one of the issues discussed at the meeting was the use of lecithin in treating patients with neurological disease. ¹⁸ This related to the product Mr Sloggem was considering.

4.16 On 16 September Mr Rees sent a progress report on the handling of BSE to Mr MacGregor and Mr Thompson (see vol. 3: The Early Years, 1986-88). He incorporated Dr Watson's material and added his own gloss:

DHSS are aware of the problem and have informally expressed some concern about any possible human health risks due to products for human use which contain an emulsion of bovine brain. However, there would be no risk provided the brains are from clinical healthy cattle. ¹⁹

4.17 Mr Rees told the Inquiry that he believed the last sentence must have represented advice that had been given by Dr Watson. ²⁰

4.18 Memories are a poor guide to what took place as long ago as 1987. It seems to us unlikely that Dr Little referred to BSE in the course of the formal proceedings in such a way as to register with any of those present for no mention of it is made in the minutes. Equally, however, we believe that there must have been some informal conversation between Dr Little and Mr Sloggem after the formal meeting was over, in which Dr Little learnt that Mr Sloggem, at least, was aware of the existence of BSE and possibly also that he had written to a MAFF colleague. Such a conversation could be expected having regard to Mr Sloggem's current concern with the matter, and would explain what Dr Little told Dr Watson. If Dr Little simply confirmed what Mr Sloggem had already been told by Dr Taylor, it is, perhaps, not surprising that Mr Sloggem did not record it and no longer recollects it.

4.19 The unfortunate consequence of the exchange that took place between Dr Little and Mr Sloggem was that MAFF gained the impression that DH staff concerned with medicines were reacting to the potential dangers associated with the use of bovine materials in medicines. However, as we shall see, beyond the limited scope of Mr Sloggem's work in respect of an individual CTC, this was not in fact the case. In addition, MAFF Ministers were given the false impression that there was communication between MAFF and DH officials in relation to BSE.