Comments on the NICE Guideline on “CFS/ME”
29 August 2007
The National Institute for Health and Clinical Excellence (NICE) was set up in 1999 and is funded by the Department of Health, to whom it as accountable. It is not therefore “independent” of the machinery of State.
Its “consultation” processes are, according to Christopher Booker, merely an empty exercise: the Government and its bodies pretend to “consult” those affected by their actions, then carry on doing exactly what they intended in the first place. In other words, the “consultation” period is a farce, as the Government is not remotely interested in looking at the evidence (Sunday Telegraph, 20th June 2004).
As noted by Peter Kemp, topics for the Institute’s work programme are selected by the Department of Health, but once a topic has been referred, the development and communication of the subsequent advice is entirely the responsibility of the Institute. As Kemp noted: “This seems to suggest that NICE can be told what to do. This does not sound like independence in the true sense of the word. The remit is so heavily loaded that I believe a truly independent institute would reject it out of hand. The remit is effectively telling NICE what to recommend; ie. ‘management of adjustment and coping’ and ‘rehabilitation strategies’. NICE have been told what to recommend for people with CFS/ME and judging from their draft guideline, have complied” (ME/CFS and FM Information Exchange Forum, 21st November 2006).
It was on 23rd February 2004 that the Department of Health and the Welsh Assembly formally requested NICE to prepare a clinical and service guideline. The remit was:
“To prepare for the NHS in England and Wales, guidance on the assessment, diagnosis, management of adjustment and coping, symptom management, and the use of rehabilitative strategies geared towards optimising function and achieving greater independence for adults and children of CFS/ME”.
On 29th September 2006 NICE issued a draft Guideline on “CFS/ME” for consultation. There were many serious problems with the draft Guideline, starting with incorrect and confusing information about the way in which responses to the consultation Questionnaire should be submitted. The problems of terminology and classification were not addressed; some Guideline Development Group members had a published track record of supporting the psychosocial model of “CFS/ME” favoured by the Wessely School; in clear contravention of the AGREE Instrument (see below), the vested interests of Guideline Development Group members were not declared (including the fact that one GDG member had spent 15 years working for the medical insurance industry and was Chief Medical Officer for a major medical insurance company); due to the narrow confines of the remit, there was a failure to heed the biomedical evidence that disproved the psychosocial model of ME/CFS; the names of the advisers to the Guideline Development Group were withheld (but were later confirmed by Carole Forbes, Systematic Review Project Manager at the CRD, to be the same people who had advised the Systematic Review team at the CRD, which included Simon Wessely, Anthony Pinching and Chris Clark from AfME — from which Clark resigned in March 2006); the Questionnaire contained a series of “misprints” relating to questions 29-61, making a nonsense of responses to those questions and meaning that answers to over one third of the questions were likely to be erroneous; the way in which answers were to be provided was changed in such a subtle way as to make it unlikely that patients with cognitive impairments would notice, thereby potentially achieving results that respondents did not intend; out of an ME/CFS UK population of between 0.2 to 0.4% (ie. up to 240,000 people), only 399 questionnaires were sent out and out of these, only 219 were completed, rendering such a tiny and unrepresentative response easy for NICE to ignore statistically; the Key Questions upon which the questionnaire was based (in order to fit the NICE scope, the scope being the document that set out what the Guideline will cover) seemed designed to preclude anything other than a psychosocial model; NICE relied upon the Systematic Review provided for it by the CRD at York, when that Systematic Review had already been exposed as flawed, even to the extent that it may have contained research misconduct in that it had deleted previously published evidence in order to cast the management regime favoured by the Wessely School in a good light.
Most importantly, NICE failed to conform to the AGREE Instrument (The Appraisal of Guidelines for Research and Evaluation) which requires that NICE is obliged to give equal weight to three main sources of data: “evidence-based” medicine, usually deemed to be random controlled trials (RCTs); the opinion and experience of physicians with expertise in the area, and the opinion and experience of the patient group for whom the Guideline is intended. This did not happen in its draft Guideline on “CFS/ME”.
Despite the fact that the UK medical defence unions have advised doctors that exercise regimes (which form part of a cognitive behavioural therapy regime) must be prescribed with just as much caution as pharmacological interventions, it seemed that NICE may have overlooked the implications of this advice: in its Draft Guideline on “CFS/ME”, the only recommended management regime was cognitive behavioural therapy (CBT), including graded exercise therapy (GET) and, for the severely affected, “Activity Management”.
Click on the link below for the full response from Margaret Williams in Word format