Volume 1: Findings and Conclusions
7. Medicines and cosmetics
Phase 1: the initial response on human medicines
The period up to March 1988
March-December 1988

875 We have looked at what was happening during the same 18 months within DH.

The period up to March 1988

876 As we have already seen, up to March 1988 DH had been neither informed nor consulted by MAFF about BSE. We looked at two occasions during the period when this might have happened.

877 The first was the BSC meeting on 9 September 1987, which Dr Little attended. Also present was a DH pharmacist, Mr John Sloggem, who had been researching an application for a Clinical Trial Certificate (CTC) for a product containing bovine brain extract. Fortuitously he had learned of BSE in August from Dr David Taylor at the Neuropathogenesis Unit (NPU) in Edinburgh, whom he had asked about the risk from 'slow viruses'. Dr Little told us that he mentioned BSE at the BSC meeting, although others present could not remember this. We think it 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. Equally, however, we believe that there must have been some informal conversation about it between Dr Little and Mr Sloggem after the formal meeting was over. From this Dr Little gained the impression that DH was aware of BSE and was giving it some thought. He reported this to Dr Watson, Director of the CVL, who in turn told the CVO, Mr Rees.

878 However, matters were not as Dr Little thought. He did not appreciate that Mr Sloggem was pursuing his interest individually, on the narrow front of the particular application in front of him, and had learned of BSE quite by chance. More generally DH was still in the dark.

879 Had Dr Little taken steps subsequently to follow up his conversation with Mr Sloggem, the true state of affairs might have emerged. Although we do not think Dr Little is to be criticised for not doing more, once he thought that DH had taken the matter on board, we do think it regrettable that the opportunity was lost for joint consideration of BSE at an early stage by those responsible for the safety of human and veterinary medicines.

880 We also considered whether Mr Sloggem might have shared the information he was collecting more widely at that stage. However, DH had not been formally notified about BSE. Mr Sloggem had learned of it only by chance in the process of a particular investigation and thought it was a slow virus. It was not incumbent on him to inform Medicines Division or DH generally about what he had learned.

881 The second occasion on which DH might have been alerted was at a meeting of the BSC on 6 January 1988, when Mr Sloggem presented his paper about the product he had been reviewing. This was the first time that a number of those present had heard of the new disease. The CTC was turned down, partly with the 'slow virus' risk in mind. We do not think it unreasonable that the subcommittee and the officials of MD did not identify any wider considerations.

882 However, we think it was a pity that no system existed to capture information of the sort acquired by Mr Sloggem on a readily accessible form of working database. We see such a database about concerns and queries as being of value to both the licensing authorities.

March-December 1988

Initial action by the CMO and MD

883 We have seen already that DH was formally notified of the emergence of BSE in March 1988. When the CMO, Sir Donald Acheson, heard about the disease, he had an immediate concern about the safety of bovine insulin and of vaccines prepared using bovine serum. No doubt the unhappy story of human growth hormone was fresh in his mind. He asked his deputy, Dr Harris, who had long experience of medicines licensing, to seek advice from the NIBSC.

884 It was also agreed that the safety of biological-based medicines was a priority question for the proposed group of experts - set up shortly thereafter as the Southwood Working Party.

885 During April officials in MD saw a submission from the CMO to DH Ministers alerting them to the disease, and minuted one another about its implications. We were told they knew 'virtually zero' at that time about TSEs. They decided to await the outcome of the Southwood Working Party's deliberations. Although some preliminary steps might usefully have been taken in the meantime, such as searching their database of licensed products, we thought the decision to await the views of the Working Party was a reasonable response by MD at this juncture.

The NIBSC discussion

886 On 16 May 1988 the NIBSC organised a discussion about BSE to consider what the disease might mean for medicines using biological material. The meeting was attended by Mr Wilesmith, the CVL epidemiologist, Dr Kimberlin from the NPU, Dr Rosalind Ridley and Dr Harry Baker from the MRC's Clinical Research Centre, and Dr A J Beale and Dr A J M Garland from Wellcome. Surprisingly, no one from MD attended. It has not been possible now to unravel why. Dr David Jefferys, the obvious candidate as head of the new drugs and biologicals branch of MD, believes he did not receive an invitation. Among the outcomes of the discussion was a recommendation that tests of the infectivity of calf serum should be undertaken. We return to this later.

Galvanising MD

887 In May Dr Pickles, the newly appointed DH joint secretary of the Southwood Working Party, moved into action. She summoned up some information from the existing database and suggested to Dr Jefferys that a number of questions should be put to the BSC. He was not in favour of doing so, noting that the BSC had already discussed BSE informally in January. He did, however, respond with some preliminary thoughts and suggested that others in MD should also be involved in any further discussions.

888 Dr Pickles returned to the charge on 21 June immediately after the first meeting of the Working Party. In a forthright minute intended to 'galvanise Medicines Division into action', she listed further questions needing answers and pressed for these to go to the BSC. Dr Gerald Jones, the senior medical officer in MD, told us that by now it had become clear that they had 'a serious problem'. They decided to refer the issue of BSE to the BSC and during July Dr Frances Rotblat, a Senior Medical Officer working for Dr Jefferys, and Dr John Purves, Pharmaceutical Assessor to the CSM and the BSC, were commissioned to write a joint paper for the BSC's November meeting.

889 We were concerned whether the matter was put to the section 4 committees sufficiently promptly, and whose responsibility this was. One of the defects identified by the Evans/Cunliffe report was the divided responsibility in MD and lack of clear management lines on many matters. BSE was inherently an awkward topic for MD to handle. It had implications across the different administrative, medical and pharmaceutical branches and potentially affected both new, and as yet unlicensed drugs, and drugs already on the market.

890 We accept that responsibility for BSE did not naturally fall to a single branch within these arrangements, but consider that good management pointed to a lead responsibility being assigned. We consider it fell to Dr Gerald Jones, having discussed the matter with senior staff, to decide the priority to be accorded to BSE in relation to other work within MD and to set in hand appropriate action.

891 We also consider that he should have asked for the paper to be prepared for the September rather than the November meeting. It seemed from the evidence we received that, even allowing for the logistics of preparing and distributing papers in good time, this could have been achieved had Dr Jones assigned the matter a higher priority. The consequence was that two months were lost when progress might otherwise have been made.

The paper for the BSC

892 The paper prepared by Dr Rotblat and Dr Purves served its purpose. It elicited advice from the BSC in November. The subcommittee made a number of recommendations, which were to apply to all licences for new products, including:

1. No immediate licensing action on oral products.
2. All bovine materials to come from appropriately certified healthy herds, not fed with animal protein. No brain or lymphoid tissue to be used in parenteral products.
3. Manufacturing processes for parenteral products to be capable of eliminating scrapie-like agents.
4. MAIL (Medicines Act Information Leaflet) article to request manufacturers to identify products in which bovine materials had been used. Serum to come from appropriately certified healthy herds.

893 These recommendations were subsequently endorsed by the CDSM, which among other things was responsible for sutures, the CRM, which was reviewing all the Product Licences of Right, and the subcommittee on Safety, Efficacy and Adverse Reactions (SEAR). They were then endorsed by the CSM itself on 17 November.

894 The Chairman of the CSM, Professor Sir William Asscher, told us that experience with human growth hormone and dura mater implants had made the Committee very wary of parenteral products. However, the fact that scrapie had not transmitted to man gave reassurance that BSE was unlikely to be acquired orally.

Sir Richard Southwood's concerns about biologicals

895 A copy of the recommendations was sent to Sir Richard Southwood. Sir Richard had been taking a continuing close interest in the question of the safety of biologicals. He had written to the CMO in August about this and had been reassured that the topic would shortly be coming before the CSM and other committees. He had written to Professor Asscher just before the CSM's November meeting pressing for any action to apply then to existing products and making a number of suggestions for the contents of informal advice to manufacturers. A round of further correspondence ensued, mainly consisting of Sir Richard's continuing concern that he was not getting his point across about existing products, and Professor Asscher's replies assuring him that he was. When he gave oral evidence Sir Richard told us that by existing products, he thought the Working Party meant products that were already licensed and stocks of those products. It is not at all clear whether Professor Asscher and the CSM appreciated that the second category was included.

896 Sir Richard Southwood also wrote in December to Dr Little about veterinary products, making similar points. It is plain from this letter that Sir Richard was unaware of the advanced preparation of MAFF guidance.

897 We have already noted that MAFF did not go out of its way to inform officials in MD, or involve them in the discussions about BSE in MAFF's Biologicals Committee. Equally, MD officials did not seek to find out the situation on veterinary medicines when the issue of BSE and human medicines arrived on their desks in April 1988, or when the MAFF draft guidelines were despatched to them in July 1988. The consequence was that DH had to catch up with several months' head start by MAFF before it could begin to address the problems.