1.  EXECUTIVE SUMMARY

  1.1  This submission is relevant to three issues identified by the Health Select Committee. These are:

—  why NICE's decisions are increasingly being challenged;

—  whether public confidence in the Institute is waning, and if so why;

—  NICE's evaluation process, and whether any particular groups are disadvantaged by the process.

  1.2  These are addressed considering the Institute's evaluation process as it operated in the development of the recent draft guideline on diagnosis and management of "CFS/ME",[128] to illustrate how the guideline development process can produce unacceptable results.

  1.3  Myalgic encephalomyelitis (ME) charities and voluntary groups have comprehensively condemned this document, seriously challenging the suitability of the Institute's draft guideline. These concerns give rise to a lack of confidence in the Institute. The main issues are:

  1.4  Diagnostic guidance—The Institute's guidance conflates ME—a neurological illness with a unique and distinctive clinical presentation—with chronic fatigue due to mental health problems. These conditions are classified separately by the World Health Organisation. Furthermore, management approaches which may help the latter group of patients are contra-indicated in respect of those with ME This basic flaw renders the guidelines unsuitable for their purpose.

  1.5  Composition of Guideline Development Group (GDG) —It is notable that few, if any, of the GDG had direct clinical experience of the illness they were advising upon. Authoritative medical professionals and researchers with in-depth experience and understanding of the neurological disorder ME were absent from the GDG, while representatives with a belief in a "biopsychosocial" theory (which does not stand up to critical scrutiny) were many.

  1.6  Eligibility and assessment of evidence—Difficulties arise from the narrow view taken as to what constitutes admissible evidence, with the consequent potential for a broad range of relevant information being disregarded. This can lead, as with proposed document on "CFS/ME", to false conclusions and inappropriate and dangerous guidance.

  1.7  Evaluation: disadvantaged groups—Certain aspects of the consultation process were unsuitable for stakeholders suffering from a debilitating illness.

  1.8  Comparison with other processes of evaluation—Elsewhere, superior results have been achieved by following a quite different process of guideline development.

2.  SCOTME

  2.1  ScotME represents a small but highly committed group of ME patients and carers who seek detailed, authoritative information on ME and related issues. Our aim is to share this with patients, decision makers, and other interested parties, striving to ensure that decisions affecting the lives of ME sufferers—such as the development of clinical guidance through the Institute—are based on the best quality information and understanding, taking due cognisance of patients' experience.

  2.2  ScotME includes members who have a background in social policy and research. A qualified nurse with specialist knowledge and experience in delivering cognitive behavioural therapy is also represented. All have direct experience of living with ME, either as a sufferer or as the carer of one or more close relatives with this illness.

3.  NICE'S EVALUATION PROCESS

  3.1  In the case of the draft clinical guideline on "CFS/ME", the Institute's development process has produced a document that many believe will significantly harm rather than help people with myalgic encephalomyelitis (ME).

Diagnostic Criteria

  3.2  The heterogeneous nature of the label "CFS/ME" as currently applied in the UK is widely recognised. For example, A Report of the CFS/ME Working Group: Report to the Chief Medical Officer of an Independent Working Group[129] clearly acknowledges this. Disappointingly, the Institute has made no attempt to acknowledge concerns about, far less resolve the issue of, the unsuitability and considerable dangers of attempting to construct a definitive guideline for patients suffering with a broad spectrum of disorders unscientifically subsumed under the category "CFS/ME".

  3.3  The "CFS/ME" draft guideline conflates ME, the neurological illness with a unique and distinctive clinical presentation, with chronic fatigue (ie fatigue due to mental health problems). This has led to patients with different disorders being viewed and treated similarly, to the serious disadvantage of ME patients. The overlap of the common symptoms of both disorders is being exaggerated whilst the vital differences are being ignored, resulting in the present draft guideline being fundamentally flawed.

  3.4  It is essential that the Health Select Committee is aware of the significance of the relevant World Health Organisation (WHO) classifications. In 1969 the WHO determined that the neurological disorder ME was a distinct disorder from chronic fatigue/neurasthenia.

  3.5  Accordingly, the WHO classified ME at G93.3 under Diseases of the Nervous System in the International Classification of Diseases [ICD], with chronic fatigue/neurasthenia remaining in the mental health chapter at F48.0. These classifications remain in place to this day, with the current version [ICD 10] indexing the chronic fatigue syndrome (CFS) directly to ME at G93.3, since ME is now often referred to in this way.

  3.6  It is also noteworthy that the WHO stipulates that no illness or condition may appear in more than one category. In accordance with the WHO ICD10, ME(CFS) is an exemption to chronic fatigue.

  3.7  The UK Dept of Health formally accepts, and therefore must adhere, to all ICD classifications.

  3.8  This is a crucial point in relation to our submission to the Select Health Committee Inquiry, as this fundamental problem renders the draft guideline fatally flawed and unfit for purpose with regard to the clinical care of ME patients.

  3.9  The unsatisfactory composition of the Guideline Development Group (GDG) is relevant here. This failed to represent the views of clinicians and researchers who understand the complex physical nature of ME/CFS [ICD10 G93.3]. At the same time, those with a belief in a "biopsychosocial" explanation for this condition—a model which consideration of the full range of relevant evidence does not support—were well represented. Few, if any, of the GDG had direct clinical experience of the illness they were advising upon, and the three patient representatives were outnumbered and their views effectively ignored.

Eligibility of evidence and assessment of evidence

  3.10  Difficulties arise from the narrow view taken as to what constitutes admissible evidence, with the consequent potential for relevant information to be disregarded. This can lead, as with proposed document on "CFS/ME", to false conclusions and inappropriate and dangerous guidance.

  3.11  Evidence from controlled trials is given enormous weight. On the face of it this may seem reasonable, since such trials are generally considered to represent the "gold standard" of research evidence. However, the controlled trials which indicate positive outcomes for the management approaches recommended in the draft guideline—ie graded exercise and cognitive behavioural therapy (CBT)—selected participants using broad fatigue criteria and as such are unsuitable as a basis for management guidance on strictly defined ME/CFS.

  3.12  In this and other respects interpretation is crucial. In this instance patient' groups and well informed academic and clinical commentators have questioned the conclusions drawn. Unfortunately, "Papers, commentaries and editorials that interpret the results of a published paper" are not deemed admissible in evidence.[130]

  3.13  The beneficial effects recorded in respect of behavioural interventions have undoubtedly become exaggerated in translation, with the clear implication that these can result in a return to normal pre-morbid levels of activity.[131] A close reading of the original source material[132] fails to bear this out.

  3.14  Stringent conditions are in place concerning the forms of evidence that are acceptable. These specifically exclude results from clinical practice and patients' own accounts of outcomes "unless assessed as part of a well-designed study or a survey".[133] It is neither appropriate nor safe to disregard or play down the significance of such evidence.

  3.15  Government directives to develop patient led services and treatments have not been fulfilled in this instance. Material submitted by stakeholders regarding the findings of patient' surveys was set aside and overridden by other forms of evidence, specifically controlled trials on chronic fatigue, the findings of which are quite the opposite to ME patients' experience in respect of the behavioural management regimens concerned.

  3.16  By way of contrast, the Chief Medical Officer's Working Group, presented with survey findings indicating a high incidence of adverse responses to graded exercise and CBT, astutely observed that these "clearly indicate that... [the results of the research review] do not reflect the full spectrum of patients' experience."[134]

  3.17  The Institute has alleged irrelevance of management and treatment options where controlled trials have not yet been conducted, rather than accepting that it is not yet possible to evaluate such approaches by this type of evidence-base. The absence of evidence is not evidence of lack of efficacy unless a reasonable effort has been made to establish such evidence in the first place.

  3.18  The Institute's method, in particular the reliance on research trials, may fail to discriminate between different reactions occurring even within well defined patient groups if the methods used are insufficiently sensitive. Thus, on the basis of average findings, those who respond well to a certain treatment may be denied it, while patients who do not may be subjected to inappropriate intervention.

  3.19  A final and fundamental problem regarding the evidence base on which the "CFS/ME" guideline has been drafted is the failure to take due cognisance of the biomedical evidence regarding aetiology and pathogenesis. In line with the GDG's terms of reference, the literature review conducted is confined to papers on diagnosis, treatment, and management.[135] The draft guideline fails to properly address the significance of biomedical evidence, both in discussing aetiology and in attempting to formulate information requirements for professionals and the patients in their care. Instead, the views of "a few individuals"[136] on the GDG who assert a biopsychosocial perspective are overtly stated, and indeed underpin the draft guideline document.

  3.20  Nonetheless, a wealth of biomedical evidence does exist: this evidence fundamentally challenges the relevance and appropriateness of the Institute's proposed management guidance for strictly defined ME (CFS) patients.

Comparison with existing published guidelines

  3.21  In North America, superior results have been achieved by following a quite different process of guideline development. The resulting publication—Carruthers B et al Myalgic Encephalomyelitis/Chronic fatigue syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols[137]—sets out evidence-based clinical guidelines developed from the best available research evidence provided by a panel of world experts.

  3.22  In this instance an expert subcommittee of Health Canada established terms of reference and selected an expert medical consensus panel of world leaders in research and clinical management.

  3.23  Based on the panel's collective clinical experience diagnosing and/or treating more than 20,000 ME/CFS patients a clinical case definition encompassing the pattern of positive signs and symptoms of ME/CFS was developed to encourage a diagnosis based on characteristic patterns of symptom clusters reflecting specific areas of pathogenesis. A short overview of both biomedical as well as management and treatment research is given.

  3.24  The consensus panel present a reasoned and incisive critique of the putative relevance of behavioural management strategies to patients with ME/strictly defined CFS.[138]

  3.25  In the light of the prior publication of this authoritative diagnostic and treatment protocol it is astonishing that the Institute's GDG "reviewed the current diagnostic criteria, but did not find any one of them particularly helpful in managing the condition or in making a definitive diagnosis".[139]

The Consultation Process

  3.26  A serious lack of consideration was given to patients wishing to participate. The process included an unreasonably large and heavy questionnaire (488 pages) that was unsuitable for people who are sick and disabled with ME to complete. In addition, the allotted completion time was too short.

  3.27  The development process includes an eight week stakeholder consultation period, but once a draft guideline has been released and faces fierce and trenchant criticism—as in the case of the "CFS/ME" draft guideline—there is no method in place to allow stakeholders an opportunity to comment further on the document with the proposed changes in place. This contrasts unfavourably with the Institute's former procedure ie two consultation periods of four weeks each, the second for responses to the amended draft. This retrograde change was introduced in March 2006.

4.  WHY NICE'S DECISIONS ARE INCREASINGLY BEING CHALLENGED

  4.1  This submission focuses on the reasons why the Institute's decisions in relation to ME (CFS-ICD10) are being challenged.

  4.2  The Institute's website asserts that:

"Patients and members of the public, whether as individuals or members of organisations, have the opportunity to help ensure that the guidance that NICE produces is actually used by the correct people, in the most appropriate way, for the right groups of people. "

  4.3  The recent draft guideline on "CFS/ME" cannot be deemed to target "the right people. " Any attempt to do this in respect of the mixed collection of patients commonly referred to as "CFS/ME" sufferers would have required sub-grouping of patients with a view to developing individualised guidelines to suit any and all homogeneous groups of patients discovered within the unscientific label "CFS/ME".

  4.4  Thus in the guideline in question the Institution has flouted its own recommendation that "Patients about whom a Guideline is intended must be specifically described". It has instead produced a "one size fits all" guideline for a non-specific, artificially created diagnostic label ie "CFS/ME".

  4.5  It is of deep concern that the draft guideline recommends what many consider to be unsafe management regimens for ME patients, approaches which wrongly assume that such patients are physiologically de-conditioned and can return to normal functioning by gradually increasing activity levels.

  4.6  Such approaches have been tested on "fatigued" patients rather than on strictly defined ME (CFS ICD-10) patients. ScotME profoundly disagree with the Institute's assessment regarding graded exercise ie that "the overall research evidence is that the benefits outweigh any harmful effects".[140] There is, on the contrary, reason to believe that graded exercise is harmful to patients with strictly defined ME/CFS.

  4.7  This disturbing situation reflects an underlying failure to root the guideline in a basic understanding of the clinical presentation of ME, a disregard for the findings of patient' surveys, and a failure to engage with the wealth of published research evidence regarding the biomedical basis of this illness. Biomedical research evidence supports the inappropriateness, and at worst harmfulness, of graded exercise to people with ME.[141]

5.  WHETHER PUBLIC CONFIDENCE IN THE INSTITUTE IS WANING AND IF SO WHY

  5.1  There is no surer way of establishing and strengthening a lack of confidence in an organisation than a personal negative experience.

  5.2  Many ME patients now lack confidence in the Institute because they are aware of the implications of the draft guideline. Simply put, there is immense concern among ME patients because they know, from their own experience of their illness, that the management regimens recommended in the draft guidelines exacerbate their symptoms making them more ill. Many have tried carefully paced increases in exercise and have suffered serious and lasting deterioration. An abundance of research exists to support what these patients are saying—but did the Institute give either biomedical evidence or patient' survey findings due consideration?

  5.3  As noted above, the fundamental flaw underlying the guideline is the endorsement of the unsatisfactory non-specific label of "CFS/ME". The development of a one size fits all guideline for what is widely recognised to be a heterogeneous cohort of patients was destined to lead to unsatisfactory results.

  5.4  The unsatisfactory make up of the Guideline Development Group, as discussed above (see para 3.9), underlies this problem and in itself gives rise to a lack of confidence in the Institute.

ScotME

March 2007

129   London, Department of Health, 2002. The relevant extract is enclosed as supplementary material [Enclosure 1]. Back

130   "The guideline development process: an overview for stakeholders, the public, and the NHS" National Institute for Health and Clinical Excellence, 2nd edition September 2006. See "Stakeholder material not eligible for consideration by the GDG" page 23, box 7. Back

131   See, for example, page 21 of the draft guideline: "When the adult or child's main goal is to return to normal activities then the therapies of first choice should be CBT or GET because there is good evidence of benefit... " Reference: as per note 1. Back

132   As referenced in the literature review which forms Appendix 1 of the draft "CFS/ME" guideline. See note 8 for full review reference. Back

133   Reference: as per note 3. Back

134   This statement is contained in an unpublished section of the report-"Annex 3: Patient evidence", page 3. Unpublished annexes are available to download from the Department of Health website (http://www.dh.gov.uk). Back

135   The diagnosis, treatment and management of chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) in adults and children: work to support the NICE guidelines A Bagnall et al, Centre for Reviews and Dissemination, University of York, October 2005. Back

136   See page 133. Reference: as per note 1. The guideline then devotes two pages to "A conceptual framework for patients and health professionals when making a diagnosis of Chronic Fatigue Syndrome", which explicitly sets out a biopsychosocial model, and is followed by what can only be described as an exceedingly partial list of references. Back

137   Journal of Chronic fatigue syndrome, Vol 11 [1] 2003, pages 7-115. The description which follows is taken from this guideline and the accompanying editorial: De Meirleir, K & McGregor, N Editorial: Chronic Fatigue Syndrome Guidelines The Journal of Chronic Fatigue Syndrome, Vol 11 (1) 2003, pp 1-6. Back

138   In view of the central importance of this issue, a relevant extract from the paper is enclosed as supplementary material with this submission [enclosure 1]. Back

139   See page 124. Reference: as per note 1. Back

140   Page 204: see note 1 for reference. Back

141   See Is Graded Exercise Safe for People with ME?, enclosed as supplementary material [Enclosure 3]. This ScotME document cites many examples from scientific research indicating that exercise is contra-indicated. It was submitted to the Parliamentary Inquiry into progress in the scientific research of ME chaired by Dr Ian Gibson MP. Back