SUMMARY

  The terms of reference for your Inquiry with which this submission is concerned are:

—  why NICE's decisions are increasingly being challenged;

—  whether public confidence in NICE is waning; and

—  NICE's evaluation process and whether any particular groups are being excluded.

  We, the undersigned, are charities and support organisations working in the field of Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS). This neurological illness affects an estimated 250,000 people in the UK and is a multi-system, multi-organ illness. For the 25% of those who are severely affected, the illness is complex with many developing more disabling symptoms and neurological complications and some need to be tube fed. The estimated cost to the UK of this illness is £6. 4.billion per annum (AfME campaign research/Sheffield Hallam University).

  NICE has, for the last two years been preparing a new clinical guideline on the clinical assessment, treatment and management of ME/CFS. A draft of the guideline was sent to stakeholders for their comments late last year but our understanding is that it is unlikely that there will be any significant alterations as a result of this extensive consultation process. NICE now intends to publish a final version of the guideline in August 2007, without any further consultation with patients or their representatives. Throughout the development of the guideline we have placed before the guideline development group cogent evidence about the illness. This has been largely ignored.

  1.  The Government's own guiding principle for the NHS is that it must be patient-led (The Expert Patient, DoH 2001). Patients after all are the only people with direct physical experience of an illness. In an illness such as ME/CFS the input of patients is even more vital. Indeed for the severely affected, because they are too ill to participate in trials, the only management treatment must come from their own experience. There is no known agreed causation, no known cure, there are no universal diagnostic criteria. Diagnosis is therefore a difficult task for any doctor and treating the illness requires a close collaboration between doctor and patient.

  2.  From the publication of the two versions of the draft of the guideline issued by NICE it was apparent that not only had the voice of the patient been largely ignored but so were the views of those health professionals who understand the complex physical nature of this illness. We are under the impression that the united criticism of the guideline from patients, patients' support groups and their medical advisors is not going to result in any major changes to the overall recommendations. Recently NICE has changed its policy to using "consensus" and only have one consultative process, instead of the two previously held. We believe this is a mistake in the case of this guideline for ME/CFS where there has been much controversy and which has provoked, as NICE admits, one of the biggest feedbacks that it has ever received. We ask that you review this process and allow flexibility for a second consultation with stakeholders in such cases.

  3.  At the heart of the guideline is NICE's proposal for the treatment of ME/CFS. In using this word "treatment" it must be stressed that there is no known cure for ME/CFS and that in the context of the illness "treatment" refers to the management of some of the symptoms. The proposals on treatment are vital. It is what the GP in his surgery will turn to after he has diagnosed a patient with ME/CFS. The NICE guideline for the treatment of ME/CFS recommends the use of cognitive behaviour therapy (CBT) and graded exercise therapy (GET) as first line options for ME/CFS. This is a gross error by NICE and will be challenged, because:

  (a)  It is accepted that people with ME/CFS are a mixed population. They range from the severely affected who are either bed bound or house bound, to the moderately affected who may be housebound, to the mildly affected whose everyday activity is restricted. CBT and GET are only suitable for a part of that population. NICE has failed to offer other treatments for:

—  those patients with severe neurological and immunological problems, especially the severely affected group that comprises some 25% of those with ME/CFS;

—  children with ME/CFS who are a particularly vulnerable group in this respect.

In addition the treatments recommended by NICE pre-suppose the "fitness" of the patient to be able to undertake them thus excluding and gravely disadvantaging the severely affected group.

  (b)  The recommendations by NICE are based on a few research trials which had many shortcomings:

—  A flawed patient selection process.

—  A limited number of outcome measures.

—  No objective measure of activity levels to confirm that the aim of GET was achieved.

—  No evidence to show a significant increase in activity levels in patients. Indeed, in some cases, activity levels actually fell (eg the Friedberg trial).

—  It is also known that the outcomes of CBT and GET are usually transient. These approaches do not resolve the long term problem.

  (c)  NICE failed to consult with experts in the field of ME/CFS who have other views of treatment, which offer evidence based alternatives to GET and CBT, eg pacing. (Jason, Taylor, Goudsmit, Wallman, Ho-Yen).

  (d)  The guideline development group was dominated by supporters of the biopsychosocial model; few had direct clinical experience of the illness they were advising upon and the three patient representatives were outnumbered and their views effectively ignored.

  (e)  All experts in the field of ME/CFS (including those who wrote this guideline) accept that the illness affects different people in different ways. Some can increase activity and some cannot. Management recommendations need to cover a range of patients, not just the small minority of those who may benefit from the CBT and GET model.

  (f)  Biomedical research has shown that inappropriate exercise in people with ME/CFS can prove harmful or dangerous, eg it can cause cardiovascular problems, mitochondrial dysfunction, autonomic disturbance, oxidative stress and muscles responding differently to exercise. (We can provide research papers and data to support this.)

  4.  Representations were made to NICE querying:

    —  the findings of those trials upon which the treatments rely;

    —  the exclusion of the severely affected from those trials; and

    —  the effectiveness of the treatments proposed and the cost implications to the NHS.

  These representations were not examined with the scientific rigour that is to be expected from NICE. The process of CBT for each patient is lengthy and costly. It requires a great deal of energy on the part of the patient and energy is one thing that they do not have. CBT focuses on the illness beliefs and emotional aspects of illness and therefore does not address the severe neurological problems that patients have to cope with. CBT is not recommended as a first line treatment for physical illnesses in other NICE guidelines but merely as a coping strategy alongside the management of the underlying illness (eg in MS). (We can provide the Committee with data for controlled trials of CBT, GET and a multidimensional programme emphasising pacing, indicating that taking fatigue as the outcome measure does not support the superiority of CBT/GET.)

  5.  We do not advocate psychological management as a treatment for this illness. ME/CFS is a neurological illness, classified as such by the World Health Organisation under the category G93.3, and this is accepted by the Department of Health. We do however accept that symptomatic management advice may help some patients cope better with their illness. There is evidence from controlled trials that a simpler, cheaper and equally effective form of symptomatic management than CBT/GET is available (Goudsmit 1996, Ridsdale et al 2001. Taylor 2006)). These trials involved people with chronic fatigue which, whilst by no means the same illness as ME/CFS, has a few of its symptoms. The trials showed that a programme of pacing and counselling is as effective in addressing some of the symptoms of ME/CFS as the more expensive treatment recommended by NICE. Pacing is a common-sense approach that is automatically adopted by patients with chronic health problems. It does not require expensive medical guidance. Counselling helps patients cope in coming to terms with a chronic physical illness. The cost per patient of providing CBT as recommended by NICE is approximately £1,000 per course. The cost of a treatment programme consisting of counselling is approximately £700 per course. The total cost of assessing and treating the 180,000 people with mild to moderate ME/CFS using CBT and/or GET will be approximately £180 million. The alternative of pacing and counselling will be approximately £126 million. In the Research Paper "Chronic fatigue in general practice: economic evaluation of counselling versus cognitive behaviour therapy" (British Journal of General Practice, January 2001) the conclusion reached was that:

"The lower unit cost of counsellor's time, together with their greater availability and similar effectiveness may represent decisive factors for primary care groups and GPs when faced with the choice of which treatment strategy to pursue."

  Moreover not only is the latter option more cost effective but such counselling and pacing programmes are more acceptable to patients. The use of a programme of counselling and pacing is a "win-win" situation for the NHS in that:

  (a)  it will save the NHS (the Taxpayer) millions of pounds;

  (b)  it will be available to far more patients in a far shorter time; and

  (c)  it is far more acceptable and found to be more helpful to ME/CFS patients.

  6.  NICE is in effect recommending the most expensive option. Professor Richard Layard, an economist who advises the Government, acknowledged last year that CBT is appropriate for only 40% of the patient population overall. The Department of Health will surely want to know why NICE is recommending a form of treatment which is both more expensive and at the same time less appropriate than other more helpful and cost effective management strategies, ie symptom control, pacing and counselling. NICE proposes training therapists to deliver the treatments but this again will take time and money. CBT services are already in a position where they cannot cope with a rapidly increasing referral rate for common psychiatric conditions such as anxiety and depression—a steadily worsening situation that NICE has been well aware of for some time. In addition, if the expected outcome of the guideline is to help patients recover and get back to work or regain their previous quality of life and, by doing so come off benefits, then the net overall gain must be examined. If only a minority of patients have these outcomes then the reality is that there will be a "double spend", ie cost of treatment plus cost of benefits.

  7.  At a time when they are rejecting life saving and life prolonging drugs on the basis of cost, this decision in relation to ME/CFS is hard to understand and justify. Moreover, if the guideline is implemented:

—  There will be a huge outcry from the patients and patient organisations. MP's mail-boxes will be full.

—  Research has shown quite clearly that a significant number of patients have abnormal and sometimes harmful responses to minimal exercise, so graded exercise programmes can be completely inappropriate. This is especially so in the case of the severely affected. This has already been pointed out by the British Psychological Society, the organisation that represents most of the therapists who will be involved in providing the behavioural treatment proposed by NICE.

—  The potential fallout for NICE in recommending a treatment that then causes damage to patients, when NICE has been warned of this by the relevant professionals, is huge. Who is going to take responsibility for this?

—  Public confidence will be lost.

  8.  It is well known that "the devil is in the detail". It is most certainly with NICE. The "full guideline" runs to 269 pages. This contains many caveats, concerns and acknowledgements that the treatments recommended have not always been applied appropriately; that GET has not been researched for children and the severely affected and that patients must be given the opportunity to agree to the proposed treatment. But the medical professionals will not be sent this "full guideline". Instead they will a shorter version. In this "short version" those caveats, concerns and acknowledgements become much less clear. We say this is wrong and potentially dangerous. The final reading matter that is distributed to GPs must make crystal clear the concerns which are expressed in the "full guideline".

  9.  We believe that, because of its cost, limited availability and its potential for harm, the treatment regime recommended by NICE will add to the criticisms levelled against NICE. We are not alone in this and will produce in evidence a copy of the submission to NICE prepared by Dr Charles Shepherd, a world renowned expert on ME/CFS, on the unbalanced account of CBT and GET in the guideline. Dr Shepherd will be available for questioning by the Committee.

  10.  We believe that NICE has failed the ME/CFS population with this guideline. It has failed to:

—  Recognise that ME/CFS is a neurological illness.

—  Acknowledge and recommend the use of the Canadian Clinical Guidelines on ME/CFS (2003), which is a clinical guideline produced by international experts who have seen over 20,000 patients. Instead it has been listened to the voice of medical representatives who have little clinical experience of the illness.

—  Recommend urgent bio-medical research into the illness.

—  Recommend that ring-fenced funding for the 13 regional specialist ME/CFS clinics in England, of which many are under threat of closure, is continued.

—  Recommend the opening of new bio-medical clinics for patients with ME/CFS.

  11.  We believe that the competency of NICE is in question because:

—  It has paid lip-service to the principle of a patient-led NHS.

—  Patient representatives have sat at the table with NICE and patients and patient organisations have submitted evidence but NICE has sidelined their views.

—  It has chosen to ignore research trials and other evidence that do not uphold the basis of their preferred treatments.

—  It has chosen to listen to one view of the illness from a small part of the medical establishment instead of following the precedent set by the Chief Medical Officer's Working Party on ME/CFS which weighted patient evidence in a more balanced way.

—  Its own evaluation process has disadvantaged children with the illness and the 60,000 patients of the severely affected group.

—  The proposed "short version" guidance to GPs insufficiently covers the widespread concern over CBT and GET.

—  The guideline will not help medical professionals effectively diagnose and manage ME/CFS.

—  Stakeholder and patient evidence has not been adequately acknowledged in the guideline.

  12.  Oral evidence supporting our submission will be available should this be desired.

  The failings outlined above will all invariably result in further challenges to NICE and public confidence in NICE will wane further. We call upon the Select Committee for Health to investigate these failures.

Neil Riley, Chairman

ME Association

22 March 2007