Biomedical research in ME/CFS: issues and challenges
Author
Dr Vance Spence, Chairman of ME Research UK
Presentation
A presentation given on 2nd March 2005 at a reception for MSPs, members and scientists hosted by the Cross Party Group on ME (XPG) at the Scottish Parliament.
Part 3
While this is a central problem, it is not insurmountable. The key point, however, is that the patients selected for biomedical research studies must be well-categorised; i.e., have a full clinical examination (and there is good reason to believe that neuromuscular weakness can be found in patients if such assessments are made), and, ideally, be subsetted according to particular criteria — and the subgroups specified by the Canadian definition of ME/CFS devised in 2003 may come to be seen as a useful starting point for such work.
For there is clearly something different about these patients. Indeed, there is substantial evidence that, despite the apparent heterogeneity of the patient group, biomedical researchers can uncover a range of interesting anomalies, as described in “Advances in Biomedical Research” (1). Indeed, fascinating results continue to be published by research groups worldwide: these include reduction of brain serotonin transporters (2), delayed gastric emptying (3) and altered muscle excitability in response to exercise (4).
But how does such biomedical research get funded? The diagram below gives a very basic outline of the origins of medical research funding. On the left, we see the larger national agencies, such as the Medical Research Council (MRC), the Chief Scientist Office (CSO), and NHS research and development. On the whole, these allocate funds to established research groups with a track record of success in a certain area, on the basis of a reasonable scientific hypothesis. In recent years, these agencies have given millions of pounds to internationally-recognised groups of psychiatrists/psychologists to investigate the effect of psychosocial interventions on the management of the symptoms of ME/CFS.
In the same diagram, we see charity-funded research. Interestingly, in most diseases (cancer included) charity-funded research predominates — more than 80% of cancer research funding in the UK comes from charitable sources, for example. However, in ME/CFS, charities funding biomedical investigation are small and rare: the CFS Research Foundation, ME Research UK itself and the research fund of the ME Association. In effect, patients, carers and friends are having to fundraise at ground level to pay for research into the illness that affects their own lives. Yet, bizarrely, because research is so expensive to mount, the aggregated annual income of all three would barely pay for one medium-sized randomised controlled trial for one year. It’s worth thinking about.
Figure 6. Medical research funding
It is difficult to overestimate the anger among ME patients at this state of affairs, and it is well to remember that there are some 20,000 members of ME support groups in the UK alone, and that 28,000 people signed the petition in 2004 calling for urgent government-funded research into the physical causes of ME/CFS. There are two problems as they see it. First, the volume of overall research is paltry compared with that going on in other comparable illnesses, and second, there is an apparent selective allocation of funding for non-curative psychological management strategies — particularly cognitive behavioural therapy and graded exercise — without corresponding resources going to find the cause of the illness. The situation is particularly galling given the fact that the large-scale review of patient feedback submitted for the CMO report of 2002 showed that only 7% of people with ME/CFS found cognitive behavioural therapy to be “helpful”, and that around 50% of people reported that graded exercise had made their condition “worse”, and given the fact that ME and CFS are both classified as neurological disorders by the World Health Organisation in section G93.3 of their 10th revision of the International Classification of Diseases. The cartoon (by Trish Campbell of the Warwickshire Network for ME) illustrates what many patients say, that if healthcare professionals — GPs, psychiatrists, psychologists and opinion formers at the national agencies — contracted ME/CFS themselves, funding for biomedical research would not be long in coming.
Figure 7. Physician, heal thyself
For the future, then, what we should like to see is central (e.g., MRC, CSO, and NHS research and development) funding allocated for biomedical research to pump-prime the process, through a form of ring-fencing. Until that day dawns, the ME/CFS research charities have three tasks. First, to encourage established research groups into the field. Second, to spend their presently limited resources on novel clinical and biomedical studies that help to unravel the biology of the illness — innovative pilot studies or seedcorn projects are particularly important since they can give rise to the supporting data on which future applications to major funding bodies will have to be based (see diagram below). Last, we need to collaborate with anyone anywhere, particularly other ME/CFS organisations, who can help us to get these projects off the ground.
Figure 8. Pilot studies or seedcorn studies
Twenty-five years is a long time to be ill, but strangely I feel more confident of a breakthrough now than at any other time, and look forward to the day when (like in the cartoon below by Trish Campbell) committees of major funding bodies rejoice at the chance to fund the quest for the cause and cure of ME/CFS.
Figure 9. Just wishful thinking?
References
- Advances in the biomedical investigation of ME, by Drs Neil Abbot and Vance Spence.
- Yamamoto et al. Reduction of serotonin transporters of patients with chronic fatigue syndrome. Neuroreport 2004; 15: 2571–4.
- Burnet RB, Chatterton BE. Gastric emptying is slow in chronic fatigue syndrome. BMC Gastroenterology 2004, 4: 32.
- Jammes Y, Steinberg JG, Mambrini O, Brégeon F, Delliaux S. Chronic fatigue syndrome: assessment of increased oxidative stress and altered muscle excitability in response to incremental exercise. J Intern Med 2005; 257: 299–310.
