The report reflects not only upon specifically research-related issues, it also notes the Group’s concerns about the draft NICE guidelines and the difficulties which people with M.E. experience in claiming their benefit entitlement.
Action for M.E. welcomed the invitation to give evidence to the Inquiry and supports many of its findings, while recognising that the scope of the report was limited by the constraints noted by Dr Gibson in his Foreword. A summary of the points made in the report is given below and a full copy of the report can be seen at www.erythos.com/gibsonenquiry
Commenting on the report overall, Trish Taylor, Acting CEO, Action for M.E., says:
“There is a real need for biomedical research into this debilitating illness and we welcome political support for this. As the World Health Organisation have already recognised, M.E. is a neurological illness.
“We are particularly pleased that the Gibson Inquiry has called for the UK to lead the way in encouraging biomedical research into the potential causes of CFS/M.E.
“A further inquiry by what the Group calls suitably qualified professionals, which takes into account international research, could enhance rather than delay this – as long as the professionals concerned are independent and do represent an appropriate balance of scientific and medical expertise.”
Summary of points raised in the Gibson report
Research issues
● CFS/M.E. can be a severe incapacitating illness and those who suffer from it may have their lives completely ruined… The World Health Organisation holds an internationally recognised classification that M.E. is a neurological illness
● the research areas defined by the CMO Report in 2002 have not been addressed. Further research is the single most important area in this field
● international evidence has not been seriously examined in the UK and a further Inquiry into the Scientific Evidence for M.E./CFS by appropriately qualified professionals is called for
● although some interesting biomedical research has been done in the UK precedence has been given to psychological research and definitions. The UK should take this opportunity to lead the way in encouraging biomedical research into the potential causes of CFS/M.E.
● more research into possible causes and treatments is vital… Government should fund more research into potential causes, which might lead to better diagnostic tests
● the necessary research must be funded immediately
● “we may inhibit discovery and make profound mistakes in the absence of a national, all round research policy”
● there is a lack of epidemiological data in the UK and existing treatment centres would be ideal places to undertake or initiate large-scale epidemiological research
● there is a need for diagnostic tests but this is likely to be dependent on a greater understanding of causes
● the great need for large scale trials
● more research into treatments and independent assessment of new treatments
● benefits of learning from international research, CDC CFS Toolkit and Canadian Clinical Criteria.
There are some aspects of the report that Action for M.E. would like to comment on further.
Although it says that “more study should be centred on the reasons why some individuals are susceptible to developing the illness,” the report does not mention the need for research into why the illness is more severe in some people with M.E. than others, or why some children and young people seem to recover faster than older people who develop the condition.
The Group accepts that CFS/M.E. is prevalent amongst teenagers and possibly in children but says, “it is very unlikely to occur in infants and young children” and that it “should not be confused with Munchausen by proxy for example.” Action for M.E. feels that this statement is unhelpful and contrary to the Group’s apparent acceptance of the biological basis of the illness, lack of epidemiological data, understanding of the need for accurate diagnostic tests and commitment to the need for further research. We ask the Group to reconsider this statement.
The figure of £3.5 billion, given in the Introduction (section 1.3) and quoted from Action for M.E.’s Cost to the Nation Report 2003, has recently been updated. The cost to the nation is now estimated at £6.4 billion (report by Sheffield Hallam University for Action for M.E.’s ‘M.E. – More Than You Know’ campaign 2006)
Role of the Medical Research Council (MRC)
The Gibson report says:
● the MRC has invested over £11 million in research into ME/CFS but studies have focused on the psychosocial aspects of the disease and in particular on controlled trials of psychosocial treatments
● from April 2003 to November 2006, the MRC turned down 10 biomedical applications relating to M.E./CFS because they considered they were not of high enough scientific standards to compete against the many calls on its funds. These included applications under the headings of pathophysiology, genetics, biomarkers, immunology and neuroimaging
● the MRC should do more to encourage applications for funding into biomedical models of M.E.
● internationally there have been a number of studies, which have identified clear areas for further research. The MRC should commission British versions of this research in order to advance possible treatments
● the MRC should call for research into M.E. recognising the need for a wide ranging profile of research. The Gibson Inquiry Group would like to see a similar arrangement to the AIDS programme funded previously by the MRC
The Gibson Group was concerned by the MRC’s CFS/M.E. Research Advisory Group, which advocates concentrating research effort on case management and potential interventions rather than cause, pathogenesis or means of confirming the diagnosis.
The Group felt that M.E./CFS cannot be viewed in the same light as other illnesses of unknown cause such as the malignant diseases which can be diagnosed with appropriate existing investigations. “The crucial issue with CFS/M.E. is to identify diagnostic tests for it even before its cause is clarified. Of course you can research the effects of treatment of a proven specific cancer without knowing its cause. The same does not apply to an illness where the diagnosis has not been positively confirmed.”
NICE guideline
The Gibson Inquiry report makes several references to the draft guideline on CFS/M.E. by the National Institute for Health and Clinical Excellence (NICE). Action for M.E.’s response to this guideline is available separately.
The Gibson report says that the NICE guideline:
● makes recommendations for research into the existing treatments but does not mention the possibility of organic causes
● recommends treatments for which only controlled trial evidence is available at present but… does not leave open the prospect that further research might lead to alternative therapies
● does not mention the WHO classification of M.E. / Post Viral Fatigue Syndrome as a disease of the nervous system
● makes little reference to the possibility of viral investigation in ME patients
● recommends Graded Exercise Therapy (GET), which ”is an area for particular concern” given the experiences of patients, particularly the severely affected. “The Group is concerned that the NICE guidelines are recommending these treatments without caveats” and, given the risk of heart trouble in patients with CFS/M.E., “the Group would recommend that the heart function is examined, especially in the severely affected, before GET is recommended”
● needs to recognise the inadequacy of our knowledge about causation, the spectrum of the illness over time, therapeutic interventions and models of care
● fails to accept that, as the causes and pathogenesis of M.E./CFS remain poorly researched, treatments are multifarious, empirical and only of marginal symptomatic help in some cases
● should not deny patients of treatments other than CBT and GET.
The Gibson report concludes that “despite the findings of the CMO’s Report some three years ago, there has been no massive investment in funding of research into ME. Instead, we have seen a review of treatment by NICE based on existing evidence and existing symptomatic techniques. We must research to find alternatives.”
It also notes that: “NICE will certainly benefit from listening to international experts.”
NHS services (“ treatment centres”)
The Inquiry felt that the NHS multidisciplinary service centres which had been set up in England “would be ideal places to undertake or initiate large-scale epidemiological research studies of the type the Group feel are vital in this field. Providing they were conducted according to an acceptable criteria.”
Although the Group were aware that the £8.5 million ring fenced funding provided by the Department of Health for treating CFS/M.E. had been used to establish 13 treatment centres, it did not acknowledge that the Government’s “commitment to continue allocated funding after 2007” has been undermined by funding issues within the NHS and that some centres have already closed or are under threat.
Action for M.E. supports the Inquiry’s recommendation that the centres are a source of data – which is already being collected as patients work with professionals – and is campaigning for the continuation of these services, as the patient feedback it has received has been largely positive. However, as Gibson states: “there is clearly a need for research into causation, the spectrum of the illness over time, therapeutic interventions and models of care.”
Action for M.E. supports the Gibson Inquiry stance that without a national all round research policy, discoveries in these areas will be inhibited - and profound mistakes will be made.
Benefit entitlement
The Inquiry acknowledged that people with M.E. often experience great difficulty in obtaining state benefits and that a very high proportion only succeed by going through stressful and bureaucratic appeals procedures.
It said:
● patients with CFS/ M.E., which is often an extremely long term condition, should be entitled to the higher rate DLA
● people with M.E. are at a massive disadvantage because of the controversy surrounding the cause of their illness and suggestion that it may be psychosomatic
● at present M.E./CFS is defined as a psychosocial illness by the Department for Work and Pensions (DWP) and medical insurance companies, therefore claimants are not entitled to the higher level of benefit payments
● if M.E./CFS remains as one illness and/or both remain defined as psychosocial then it would be in the financial interest of both the DWP and the medical insurance companies
● until a biomedical cause is researched and identified, M.E. patients will continue to find it difficult to receive higher rate DLA
● the DWP is reliant on medical opinion when determining benefit entitlement for DLA. “Until medical opinion is better informed as to the nature of this illness M.E. sufferers will have to live with the double burden of fighting for their health and their benefits.”
