Stakeholder Response to NICE CG53 three yearly review

Stakeholder Response to NICE CG53 three yearly review 
Greg Crowhurst 


Nov 13th 2010

In accordance with the stakeholder consultation process of 1 to 14 November 2010 concerning NICE’s scheduled 3 year clinical guideline review I write with reference to:

1.       The National Institute for Health and Clinical Excellence (NICE) Clinical Guideline 53 entitled ‘Chronic fatigue syndrome / Myalgic encephalomyelitis (or encephalopathy); diagnosis and management’ published in August 2007.

2.       The related ‘National Institute for Health and Clinical Excellence Centre for Clinical Practice Review consultation document’ dated 1 November 2010.

 For the reasons listed  below , I  am   greatly  concerned that Clinical Area 1, case definition, concludes that "no conclusive evidence was identified that would invalidate current guideline recommendations. " that  Clinical  Area 3, management,  concludes that : "There is currently no new published evidence that would invalidate current guideline recommendations ." 

  • the competing interests of the original GDG members were undeclared
  • the patients to whom the Guideline is meant to apply were not defined: the Guideline does not describe or distinguish the neurological disorder ME/CFS from “medically unexplained chronic fatigue” (a classified somatoform disorder)
  • patients were sent the Evidence Review, a massive 487 page document, only four weeks before receiving the Questionnaire on April 7th 2006,which had to be returned by May 5th
  • the Questionnaire only concerned itself with 18% of the issues under discussion, so the consultative process did not involve the full range of relevant issues. Misleading instructions to questions 29-61 made it likely that answers to those questions were erroneous. Out of a probable ME population of 240 000 patients, only 219 responses to the Questionnaire were considered, of which only 119 were from patients
  • NICE failed to include experts from all the relevant professional groups on the Guideline Development Group
  • Patients' / carers' views were not given equal weighting and status, as subsequently confirmed by two members of the GDG
  • NICE entirely failed to heed the submitted evidence and disregarded the published dangers of GET for patients with ME/CFS who have cardiovascular and respiratory problems
  • By limiting their consideration of the literature to that which supports the psychiatric paradigm of ME/CFS, NICE exhibited intrinsic psychiatric bias and failure to take account of the available published biomedical evidence about ME/CFS (over 5000 papers), without knowledge of which the Guideline fails to provide an aid to diagnosis (as was its remit)
  • The sole management recommendations, which are to be implemented across the nation, are based on weak and inconclusive studies of dubious quality on heterogeneous groups of people, the majority of whom are unlikely to have ME but may have suffered from any one of over 30 other disorders where "fatigue" is a symptom
  • The guideline was not based on a full and true picture of the severity of the illness and symptoms and itself concedes that its management strategy cannot be recommended either for the severely affected or for children
  • The Guideline's conclusions did not coincide with  the majority professional view of the international medical and scientific communities about ME/CFS
  • The Guideline  compromised the reality of ME/CFS by remaining  irrationally equivocal about the WHO classification of ME/CFS as a neurological disorder
  • NICE confused "CFS/ME" with other fatigue states and has 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.  This has led to a flawed document that meets no-one's real need
  • There are proven vested interests in portraying ME as a psychiatric syndrome, as opposed to a seriously debilitating  physical illness, with multi system dysfunction,  as highlighted by Ian Gibson MP in his Inquiry (2006)
  • The  GDG was selective in the symptoms listed (i.e. emphasising psychosocial symptoms whilst ignoring primary biomedical symptoms)
  • People with ME/CFS have been shown to be extremely sensitive to pharmacotherapy; this is denied in the Guideline, which is a complete rejection of the patients' experience as well as the scientific evidence
  • NICE placed unreasonable upon the seriously flawed and biased Systematic Review of the literature carried out by the Centre for Reviews and Dissemination (CRD) based at York. The York Review has research misconduct as one of its hallmarks, and this was brought to the attention of NICE but was ignored
  • The actual number of studies on which NICE relied to support its management recommendations is very small and therefore inadequate for these studies to be used as the "evidence-base" of the safety and efficacy of the regime recommended for implementation nationwide
  • NICE recommended  that laboratory tests which in other countries have established the organic nature of ME/CFS and which point to potential therapeutic interventions should be specifically forbidden in the UK
  • NICE 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 recommends  "CBT and GET "because it  believes that  "currently these are the interventions for which there is the clearest research evidence of benefit."(1.6.2.4). However, this “research”  (seven Random Controlled Trials (RCTs) of CBT and four RCTs of GET) is at "best inconclusive and at worse non-existent.  When measured objectively, the CBT trials delivered no statistical change. Regarding the graded exercise therapy (GET) trials,only two  RCTs   had positive results, but after 24 weeks there were no benefits at all    
  • There is no process in the Guideline to distinguish between when a patient with ME/CFS is extremely ill and when they are no longer so ill and may  be able to cope with gentle rehabilitation
  • NICE has produced Guidelines for 19 different clinical conditions. Only in the case of the organic disorder ME/CFS is CBT recommended as the primary treatment of choice. 


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