Volume 1: Findings and Conclusions
7. Medicines and cosmetics
Medicines

850 We turn now to the major topic of the safety of medicines and medical devices that use bovine tissues. Unlike food products, these did not attract a great deal of public attention and debate in connection with BSE. No doubt this was because their provenance was far less apparent.

851 As indicated in Chapter 2, bovine material was used in a variety of ways in the manufacture of medicines and medical devices. Some, like insulin, hormone treatments and sutures, contained bovine material as an ingredient. Others, in particular vaccines, were rather different. Although these did not directly use bovine ingredients, bovine material was widely used to grow cells and viruses. This material did not form part of the final product, but it was not known if its use at the earlier stages of preparation could transmit infection.

852 Officials speedily realised that medicines might offer a pathway for infection either between animals, or from animals to humans. Scrapie had in the past been inadvertently transmitted between sheep through a vaccine containing contaminated brain material. Pooled pituitary glands used to derive human growth hormone had also transmitted CJD between humans. Risk from 'biologicals' ¹ immediately occurred to the Chief Medical Officer (CMO) when he was told about BSE in March 1988.

853 We devote a large part of vol. 7: Medicines and Cosmetics to examining in detail the way matters were handled by the medicines licensing divisions in DH and MAFF.

854 There has recently been lively public interest in action on vaccines and the fate of existing stocks when their formulation was being changed so as to substitute non-UK for UK-sourced material. This interest seems to have been stimulated by the documents and statements collected and published by our Inquiry. From the documents made available to us, it was not possible to determine precise dates on which stocks of vaccines sourced from UK bovine material were used up. Although there is no evidence at this stage that medicinal products were implicated in transmitting the disease, the possibility cannot be ruled out. Accurate tracing of available products would then be helpful. We found frustrating the gaps in records and recollections about this.

855 We recognise that the relevant documents were bulky, highly technical and confidential. Witnesses spoke of files piled room high on individual products. The paper trail would have been difficult to follow at the best of times. However, matters were made worse by defects in the record-keeping systems used at the time that the implications of BSE were being considered. Questionnaires had to be sent out to all licence holders in 1989 seeking fresh information about the use of animal materials. The Medicines Control Agency (MCA) appears to have taken some years to put matters right and to have had difficulties keeping material up to date. In 1994 it was discovered that, although the information obtained via the questionnaire had been recorded on the database, it had not been updated with information from new licence applications received after that time.

856 We were able to piece together the main bones of the story from contemporary papers and minutes, together with evidence from witnesses. What follows looks at the most significant aspects of what happened. It begins with a brief outline of the medicines licensing system, which is very different from that covering food safety. Fuller details can be found in Volume 7.

857 We have recently seen papers from DH concerning a review by the Committee on Safety of Medicines (CSM) of BSE-related issues associated with the use of seedlots ² in the manufacture of vaccines. It will be apparent that a number of assumptions made by the CSM are open to question for reasons we have set out in our Report (see vol. 8: Variant CJD, Chapter 5). We hope that government will look at the topic again in the light of what we have said.