Volume 1: Findings and Conclusions
12. Science and research
Research

1125 An important aspect of the response to BSE was the research that was undertaken in order to learn more about the disease. Before 20 March 1996 MAFF had funded over 120 research projects in relation to different aspects of BSE. Research work into TSEs, and more particularly BSE, was also funded by the Research Councils. We have not interpreted our terms of reference as requiring us to review the adequacy of all these projects. What we have explored are the broader questions of the funding, planning and coordination of BSE research. Our consideration of these topics is to be found in vol. 2: Science and vol. 11: Scientists after Southwood. Here we propose to do no more than set out a brief summary of our conclusions.

1126 BSE did not emerge at a propitious time so far as research was concerned. In 1985 Ministers had accepted a recommendation from the Priorities Board for Research and Development in Agriculture and Food that expenditure on research into animal diseases was disproportionate and should be reduced by 20 per cent. Implementation of this policy was resulting in staffing cuts at research establishments.

1127 The Neuropathogenesis Unit (NPU) in Edinburgh had been set up jointly by the Agricultural and Food Research Council (AFRC) and the Medical Research Council (MRC) in 1981 as an independent unit to study scrapie and the similar human diseases of the central nervous system such as CJD. The need to relocate staff and facilities and to build up suitable mouse colonies, coupled with financial constraints on the appointment of necessary new staff, meant that it had not yet been able fully to address this remit, although it had brought together a wide range of expertise in genetics, strain characterisation and transmission of scrapie. In 1986, however, it had been brought within the framework of the Institute for Research on Animal Diseases, later to become the Institute for Animal Health. Shortage of funding and the loss of independence had resulted in the disillusionment of its Director, Dr Alan Dickinson, who resigned in 1987, and for whom for a long time it proved impossible to find a suitable replacement. There was also uncertainty about where the various parts of the new Institute should be located. Thus the emergence of BSE found the NPU in a state of some disarray and with its future in doubt.

1128 Despite these problems, both at the NPU and more generally, research into BSE was not significantly impeded through lack of funding, although some research projects got off to a slow start. An application for additional funds from the Treasury Reserve was laboriously put together, finally presented in August 1989 and rejected. Alternative sources of funding were then identified, which involved the diversion to BSE of funding earmarked for other projects.

1129 Between 1987 and 1996 the Government spent over £60 million on research into BSE and other TSEs. Of this, £37.9 million was spent by MAFF and £27.4 million funded by the Research Councils. DH's expenditure was £1.6 million, largely spent on funding the CJD Surveillance Unit (CJDSU).

1130 Almost all the research funded by MAFF was carried out either at the CVL or at the NPU, with CJD research being carried out by the CJDSU. The BSE research programme was developed within the CVL by the BSE Group, headed by Mr Bradley, in consultation with the NPU. One project involved collaborative work between the two laboratories. Priorities were allocated by the Tyrrell Committee. The research that was carried out was extensive and wide-ranging, for example:

• It identified that BSE had the histopathology of a TSE.
• It quickly identified that BSE was transmissible to mice, both by inoculation and in feed.
• It identified that BSE was similarly transmissible to sheep and to goats.
• It confirmed the infectivity of brain and spinal cord and identified the infectivity of the distal ileum of calves.
• It identified that ½ gram would suffice to transmit BSE orally to a sheep and 1 gram to a calf.
• It identified the fact that BSE was a single and distinctive strain of TSE agent.
• It swiftly identified the emergence of a new variant of CJD.
• It identified the link between vCJD and BSE.

1131 In 1990 Sir Donald Acheson set in train an initiative to place the AFRC/MAFF/MRC research effort on BSE under the coordination of a single 'director'. This met with resistance on the part of the Research Councils, which saw it as a threat to their independence, and was supported by MAFF only on condition that the director would report to the MAFF Minister. The proposal foundered. Instead it was agreed that SEAC would perform a limited role in facilitating interchange between the various bodies responsible for research. The demands on SEAC for advice were so onerous that members did not have the time to carry out a review of the adequacy of the research effort and to identify gaps in the research programme. The most that they were able to do was to check that the projects recommended by the Tyrrell Committee as having high priority were under way. In June 1992 they published a paper that recorded that they were 'content with the progress of implementing the recommendations overall'.

1132 We have concluded that it might have been advantageous to have had an individual or committee with a remit to coordinate research and to draw attention to research needs. As it was, these were largely identified by the CVL, which then played the role of contractor in supplying much of the research identified. Thus most of the projects were awarded without competition and were not peer-reviewed. We have identified, with hindsight, areas where research could profitably have been started earlier or been pursued with more vigour. Also, an attempt might have been made with advantage to recruit expertise from the wider scientific community. It is at least possible that had an overview been kept of all BSE research, some of these issues would have been identified and addressed at the time:

1133 Scrapie-into-cattle transmission - Experiments to see if and how scrapie would transmit to cattle were begun in 1997. It would have been valuable to test the theory that BSE was caused by the scrapie agent or agents ten years earlier, although we accept that there were difficulties in the way of doing this.

1134 BSE in sheep - The possibility that BSE might have been transmitted to sheep was recognised as early as 1987. So too was the risk that, if it had done so, it, like scrapie, might become endemic in sheep. Research to check whether this has happened is now being carried out. It is perhaps the most important unanswered question about the BSE epidemic.

1135 Minimum infective dose - The NPU experiment to transmit BSE to sheep and goats, which was initiated in 1988, was, incidentally, a valuable test of whether a dose as small as that contained in ½ gram of material would transmit in feed across the species barrier. It was not, however, designed or used for the purpose of providing this information. The 1992 attack rate experiment was the first occasion on which MAFF sought to see how much infective material was needed to transmit BSE in feed, and even this was not designed to identify the minimum quantity. The results of the attack rate study were of great practical importance.

1136 Sensitivity of the mouse bioassay - the infectivity of different tissues in BSE-infected cattle was tested by bioassay in mice. Tests begun in 1993 have demonstrated that mice are at least 1,000 times less susceptible to BSE than cattle. It would have been advantageous if the extent of this species barrier had been identified earlier.

1137 Ante- and post-mortem tests for BSE - Simple ante- and post-mortem tests for BSE would have been of the greatest practical value. These are areas which could have been developed with greater vigour and in which a research 'supremo' might have stimulated open competition.

1138 ELISA test for ruminant protein in compound feed - Research was carried on 'in house' at a leisurely pace. This was in part because the importance of developing such a test was not appreciated until the significance of cross-contamination of feed was brought home in 1994. A research director might have identified external sources that would have advanced this area of research more rapidly.

1139 Epidemiology - One of the remarkable features of BSE research is that the epidemiology was left largely to Mr Wilesmith and the members of his small epidemiology department at the CVL. This perhaps reflected the lack of veterinarian epidemiologists in this country. There was, however, scope for human epidemiologists to address questions such as the cause of the BABs, the pattern of the epidemic and the number of subclinical cases going into the human food chain.