Volume 2: Science
Part 3: Research into TSEs - a narrative account
Project funding and TSE research by others
DH-funded TSE research
TSE research by the Research Councils
MRC: the Murray Committee and the Allen Committee
The Wellcome Trust

6.204 In addition to the work on BSE carried out at the CVL and NPU, research into TSEs was funded by the Department of Health, the Medical Research Council (MRC), the Biotechnology and Biological Sciences Research Council (BBSRC) and The Wellcome Trust.

DH-funded TSE research

6.205 The need for research into an emergent disease of cattle was considered by DH to be a matter for MAFF, although the potential implications for public health were recognised. ¹ The two Departments agreed that most of the recommendations for research in the Tyrrell Report related to animal issues and hence were for MAFF to take forward. However, two studies fell within DH's remit: surveillance of CJD cases, and monitoring of occupational groups with high exposure to bovine tissues. A third area of research identified by the Tyrrell Committee involved the potential transmissibility of disease into mice from pharmaceuticals containing products of bovine origin, in particular bovine serum albumin. This was considered to fall jointly to DH and MAFF.

6.206 Volume 8: Variant CJD describes how the CJD Surveillance Unit (CJDSU) was set up in May 1990, to build on epidemiological work by Professor Bryan Matthews that had originally been funded by the MRC. The CJDSU was funded by DH and the Scottish Office. Its remit was to monitor the incidence and epidemiology of CJD with a view to detecting any changes in the pattern of the disease, and to provide neuropathological validation of any clinical diagnosis, both retrospectively and prospectively. The Unit was also asked to carry out a case control study to help identify epidemiologically any particular risk groups and factors associated with CJD. Prospective monitoring of specific occupational groups, a separate study recommended by the Tyrrell Committee, was not undertaken since it was not judged to be cost-effective. It was expected that changes in the occupational incidence of CJD would be detected in the general study.

6.207 Between 1992 and 1995, the CJDSU was nevertheless involved in investigating occupational risks from CJD, prompted by the deaths of four dairy farmers. Meanwhile studies at the NPU had been set up to examine the strain characteristics of CJD in farmers with BSE on their farms, of contemporary cases of CJD where no occupational link existed, and of cases of CJD occurring before the emergence of BSE. These studies were funded by the MRC. However, following the identification of vCJD, DH provided additional funds to the NPU, for work aimed at characterising the nature of the new disease.

6.208 What became of the recommendation for transmission studies specifically relevant to pharmaceutical manufacture is described in vol. 7: Medicines and Cosmetics.

6.209 DH also funded Professor John Collinge, at St Mary's Hospital, Paddington, to carry out molecular genetic studies of the human prion protein. In 1996 DH provided funding for expanded animal housing facilities both at the NPU and for the prion research group at St Mary's.

TSE research by the Research Councils

6.210 Most of the TSE work funded by the Research Councils took place at the NPU. The research initiated in response to the emergence of BSE was carried out within existing projects in collaboration with the CVL. It resulted in many key discoveries, but attracted no extra funding and other work was therefore delayed. ² However, when more funds became available in 1989, the AFRC set up the Biology of the Spongiform Encephalopathies Programme (BSEP) mentioned earlier.

6.211 BSEP was designed to build on the strengths developed at the NPU and to 'complement and underpin' MAFF's work on BSE and research on CJD funded by the MRC and the Health Departments. ³ It was funded partly from the AFRC's core budget and partly from additional funding for TSE research of £6.3 million (spread over three years, to 1991/92) secured in the PES round in 1989 ⁴ (subsequently extended to £9 million over four years ⁵).

6.212 The first research programme, BSEP-I, ran from 1991 to 1994. Research proposals were reviewed by external referees. The initial tranche of applications was assessed, and funding allocated, by a board chaired by Professor Bill Jarrett. ⁶ Thereafter, this task was performed by the BSEP Working Group.

6.213 When the initial funding was exhausted, there was a delay of one year. This was because of funding and policy uncertainties arising from the demise of the AFRC and the establishment of the BBSRC, and from the ongoing round of 'prior options reviews' of public sector research laboratories. ⁷ Professor Jeffrey Almond, who coordinated BSEP for the AFRC, told the Inquiry that the funding hiatus was disruptive: 'my lab essentially emptied at the end of BSEP I' because of the scientists' uncertainty about their future. ⁸ Recognising that further funds would have to be sought and justified in competition with other priorities, the Working Group considered how the AFRC should support research relating to spongiform encephalopathies in future. A number of points were agreed, including:

1. a new programme should support longer-term strategic studies related to BSEP and new areas of work;
2. the level of funding should be scientifically justified rather than limited by the current funding level;
3. the fundamental problems of the biology of spongiform encephalopathies and their wider ramifications should be emphasised; and
4. a five-year programme should be sought.

6.214 The MRC decided at that time to move from priority support to responsive mode support. ⁹

6.215 In March 1994 the newly established BBSRC affirmed its commitment to the programme ¹⁰ but, until the new funds were available, the salaries and research costs of staff employed under BSEP-I were funded largely by the IAH to avoid any hiatus in advancing the research. ¹¹ Applications for BSEP-II funding were invited in September 1994, and projects costing in total some £5.2 million were supported over the next four years. ¹²

MRC: the Murray Committee and the Allen Committee

6.216 The Coordinating Committee on Research on the Spongiform Encephalopathies in Man (the Murray Committee) first met in October 1990. Its remit was to:

(i) identify and as appropriate coordinate medical research in the UK relevant to the spongiform encephalopathies (SEs) in humans, and place it in the international context;

(ii) identify new opportunities for research and the individuals and teams that might be encouraged to undertake it; and specifically identify work the MRC might commission within the NPU; and

(iii) report not less than annually to the MRC through the Neurosciences Board.

6.217 Apart from its Chair, Professor Sir Kenneth Murray, the members included Professor Ingrid Allen, at that time Chair of the MRC's Neurosciences Board and also a member of SEAC; Professor Jeffrey Almond, who subsequently coordinated BSEP for the AFRC; and independent scientists. There were observers from DH, ¹³ the Scottish Home and Health Department (SHHD), and the AFRC. ¹⁴

6.218 The Murray Committee established a Clinical Subcommittee, chaired by Professor Allen, to coordinate:

1. current and future studies relating to SEs in man;
2. the follow-up of patients with, or at risk of, iatrogenic SE infection; and
3. the application of new methodologies and techniques to refine the definition of SEs in man and improve diagnosis. ¹⁵

6.219 Professor Allen told the Inquiry that:

We were particularly concerned with epidemiological monitoring and neuropathological definitions and debated whether atypical dementias should be included in the epidemiological studies. The importance of this debate was the possibility that if BSE affected humans the clinical presentation might be atypical for CJD. The subcommittee was also concerned with the difficulties of diagnosing dementia in the elderly and with the possibility that CJD might be missed in this age group. ¹⁶

6.220 Apart from identifying certain scientific issues, the Murray Committee concluded that:

(i) because methodological and logistical constraints were considerable, strengths in other relevant fields needed to be harnessed - ie, collaboration with groups and centres not then committed to TSE research; and

(ii) the Clinical Subcommittee should help coordinate epidemiological and clinical studies of sporadic CJD, familial CJD/GSS, iatrogenic CJD and atypical dementias.

6.221 It recommended that support for such work should be given priority within the MRC's normal competitive peer review system and that the Committee itself could have a useful continuing role in reviewing progress and priorities. ¹⁷

The Wellcome Trust

6.222 Although the Wellcome Trust did not have a TSE programme per se, funding was awarded to TSE-related projects through the Trust's declared interests in genetics, veterinary medicine and infectious disease research. ¹⁸

6.223 Since 1986 the Trust has provided funds for projects, studentships and fellowships mainly in prion research. In particular, one of the main thrusts of the Trust's TSE research has been through the funding of Professor Collinge's work, which began in June 1990. The other major effort of the Trust's programme has been through the funding of the Infectious Disease Epidemiology Group in Oxford. ¹⁹ Although the Group was not initially funded for TSE research, resources were diverted to this field, given the high priority of the work and the Group's extensive involvement in the analysis of the BSE epidemic.