Greg Crowhurst November 2016
NICE are currently considering whether their guideline CG53 Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management requires updating.
IT MOST CERTAINLY DOES !!!
When CG 53, based upon a handful of low quality Randomised Controlled Trials , that were methodologically flawed, was published in 2007 almost all the UK ME Charities condemned it as unfit for purpose. This is hardly surprising given that the Guideline Development Group (GDG) excluded from its membership all NHS specialists experienced in treating adult ME patients .
As Kevin Short (2012) comments: “This is shocking by any standards: imagine the media outrage if a NICE guideline on infectious disease excluded all virologists from its production or a guideline on breast-cancer excluded all oncologists?”
The ME community greeted NICE’s guideline with disgust and widespread outrage that so much evidence about ME had been ignored.
Over twenty renowned ME experts later provided Statements to the Court (Judicial Review of the NICE Guidelines) challenging the validity of the research that NICE used for its Clinical Guidelines.
Here is a brief overview of the many ways NICE got it so wrong :
CG 53 :
- Failed to grasp the full nature of neurological ME and the implications for management, and also failed to provide adequate guidance for diagnosis.
- Failed to include experts from all the relevant professional groups on the Guideline Development Group ( GDG)
- Failed to give patients' / carers' views equal weighting and status, as subsequently confirmed by two members of the GDG.
- Recommended widespread use of the psychosocial rehabilitative treatments of CBT(Cognitive Behavioural Therapy) and GET (Graded Exercise Therapy) in spite of reports of harm from ME. At best this means that the main thrust of the guidelines are irrelevant for most people with ME, at worst dangerous.
- Failed to consider the relevant evidence about the illness. Did not study the aetiology and pathogenesis of ME, this meant that thousands of papers could not be discussed as part of the process. NICE ignored the international evidence that ME/CFS is a biomedical, not psychiatric, disorder, claiming that studying this evidence fell outside its remit.
- Placed undue emphasis on two treatments - cognitive behavioural therapy (CBT) and graded exercise therapy (GET) - for which the underlying evidence is inadequate and unrepresentative.
- Did not agree to recognise the World Health Organisation's classification of M.E. as a neurological illness.
- Did not convey or reflect the impact which the illness can have on the lives of those people who are most severely affected by M.E
- Relied upon an "evidence-base"which has been exposed as deeply flawed by virtue of the heterogeneous populations studied; the methodological inadequacy; the corrupted data; the high drop-out rates; the undeniable ineffectiveness of CBT/GET as shown by the outcomes measures, and the finding that the claimed benefits may have been illusory. (see: "Inadequacy of the York (2005) Systematic Review of the CFS/ME Medical Evidence Base" by Malcolm Hooper & Horace Reid at http://www.meactionuk.org.uk/FINAL_on_NICE_for_Gibson.html)
- Created a wholly inaccurate picture of ME : a serious disabling neurological and multi-system dysfunction disease; the Guideline more accurately describes patients suffering from idiopathic fatigue, as outlined by the WHO at ICD-10-f48.
- Limited their consideration of the literature to that which supports the psychiatric paradigm of ME and failed to take account of the available published biomedical evidence about ME, without knowledge of which the Guideline fails to provide an aid to diagnosis (as was its remit).
- Based its management recommendations on weak and inconclusive studies of dubious quality on heterogeneous groups of people, the majority of whom were unlikely to have ME but may have suffered from any one of over 30 other disorders where "fatigue" is a symptom.
- Its conclusions did not coincide with the majority professional view of the international medical and scientific communities about ME.
- Confused ME with other conditions and fatigue states and have poorly married together two opposing views : the psychiatric model which says "unhelpful illness beliefs", "thoughts, feelings, behaviours" and "over-vigilance to symptoms" perpetuate the illness and the biomedical model, which validates the physical illness. This has led to a flawed document that meets no-one's real need, with a predominance of psychiatric interpretation.
- Disregarded the fact that patients are almost universally opposed to CBT and to GET, because survey after survey has shown that GET can be harmful to people with ME.
- Disregarded the fact that patients are almost universally opposed to CBT and to GET, because survey after survey has shown that GET can be harmful to people with ME. NICE has produced Guidelines for many different clinical conditions. Only in the case of the organic disorder ME is CBT recommended as the primary treatment of choice.
- As Margaret Williams (2007) has extensively documented, NICE appears to be in breach of the AGREE guidelines, a rigorous methodological process it is expected to follow in drafting clinical guidelines.
- Significantly NICE proscribed the use of supplements and vitamins in the treatment of ME. Specifically it states : There is insufficient evidence for the use of supplements – such as vitamin B12, vitamin C, co-enzyme Q10, magnesium, NADH (nicotinamide adenine dinucleotide) or multivitamins and minerals – for people with CFS/ME, and therefore they should not be prescribed for treating the symptoms of the condition. (NICE Clinical guidance 53 )
Margaret Williams (2008) comments : “the proscribing by NICE of appropriate testing and its stipulation that any vitamin or mineral deficiency must not be corrected by prescription would seem to constitute a real and even life-threatening danger to people with ME/CFS.”
NICE’s proscription, although only guidance, is quite extraordinary , in light of the evidence.
The ME community has for many years suffered from the psychiatric takeover and denial of their illness, leaving doctors and patients floundering in a sea of misrepresentation,misinterpretation, mistreatment and misdiagnosis.
CG 53, as this document has outlined, is a prime example of how the physical tortuous reality of neurological ME is constantly denied, diminished, negated and ultimately neglected. The ME Community , we pray, will grasp this opportunity, especially building upon the recent exposure of the PACE Trial, to show how unfit for purpose the NICE Guideline is.
Short K(2012) A CALL FOR A PARLIAMENTARY SELECT COMMITTEE OF INQUIRY INTO UK ME & CFS POLICY http://www.angliameaction.org.uk/docs/wessely-misleading.pdf
Williams M (2007) Comments on the NICE Guideline on “CFS/ME”:
Williams M (2008) More potential dangers of the UK NICE Guideline on "CFS/ME" for people with ME/CFS Margaret Williams http://www.meactionuk.org.uk/Dangers_of_NICE_for_MECFS.htm