Submission to Health select committee

1.0 INTRODUCTION

1.1 This submission is made by The North London ME Network (NLMEN), a self help support group for people with CFS/ME who live in the North London region.

1.2 The NLMEN has a hundred and twenty members and is closely in touch with the views of people with this condition. In addition to regular informal feedback and sharing of views by a variety of means, data is gathered from member surveys. In recent years we have conducted two surveys asking detailed questions about people’s experience of NHS services and their ability to access those services.

1.3 The NLMEN conducts detailed research into the services available to people with ME in North London and produces information sheets for members. We supported, with detailed submissions, bids for funding of services at The Royal Free and St Bartholomew’s Hospitals in 2004. One of our members worked with staff at St Bartholomew’s Hospital and Primary Care Trusts in North East London on a bid for community based services for people with CFS/ME. We have a patient representative on the Joint Management Board for CFS/ME at St Bartholomew’s Hospital, Barts and the London NHS Trust.

1.4 In making this submission we refer throughout to the draft NICE guidelines on the treatment of CFS/ME. We appreciate that certain aspects of these guidelines may be modified in the final version, but are given to understand that these changes are likely to be minor ones only (answers by Prof P Littlejohns and Dr E Crawley from NICE to questions at All Party Parliamentary Group (APPG) meeting on CFS/ME on 22nd February 2007) Our group submitted our views on these guidelines via the ME Association

Direct contributors to this submission:
Hazel Griffiths (Chair)
Richard Crossick (Treasurer)
Stephen Halpern (Committee member and Patient Representative at St Bartholomew’s Hospital, London)

We believe our experience shows serious shortcomings in NICE’s processes and that these have led to a loss of patient confidence in the Institution.

2.0 FAILURE TO PROVIDE A MEANINGFUL DEFINITION OF THE CONDITION ADDRESSED BY THE GUIDE

2.1 Disregard for established case definition
2.1.1 Although there is currently more than one case definition of CFS/ME in common usage and debate over which should be applied, in their guidelines NICE create an entirely new definition which considerably widens the existing criteria and, in the opinion of patient groups, renders the guidelines meaningless. NICE were asked to produce a guide on CFS/ME, not on chronic fatigue in general.

2.1.2 This will make it considerably harder for patients to receive quality healthcare according to their individual needs and also contradicts the recognition of the scoping document that “the management of CFS/ME depends on an accurate diagnosis”.

3.0 INSTITUTIONAL BIAS IN EVALUATING EVIDENCE

3.1 Disregard for the views and experiences of patients
3.1.1 The publication of the draft guidelines on CFS/ME has led to a unanimous outcry from patient groups who believe that their detailed, carefully considered and constructive submissions have been ignored. Patient groups are united on the great majority of concerns they have raised and have issued a joint statement.

3.1.2 The rejection by NICE of this wealth of patient evidence appears to demonstrate that the patient voice is not heard by NICE, nor is patient experience valued. The impression given is that lip-service only is paid to patient consultation. We understand (from answers by NICE representatives to questions at the APPG meeting of 22nd Feb) that even a unanimous rejection of a guideline by patient group stakeholders, including patient representatives of a guideline development group, is not sufficient to bring about further consultation on, or change of, a guideline before publication.

3.2 Disregard for World Health Organisation
3.2.1 Patient groups regard the WHO classification of an illness as important information which can help to guide medical practitioners. In the case of the CFS/ME guidelines it is omitted from mention. NICE representatives at the APPG meeting of 22nd Feb were unable or unwilling to say whether they accepted the WHO definition.

3.3 Disregard for government and other wide-ranging consultations
3.3.1 The Government Chief Medical Officer’s (CMO) working group report on CFS/ME of 2002 arose from wide consultation and contained information from the patient and carer perspective, as well as diverse specialist medical opinion, which is entirely absent from the NICE draft guidelines.

3.3.2 The Parliamentary Group on Scientific Research into Myalgic Encephalomyelitis (Gibson Inquiry) submitted its report as evidence during the development of the guidelines. This Inquiry took many hours of evidence and hundreds of submissions from patients and experts in the field. This work was disregarded and no mention made of the Inquiry recommendations.

3.4 Lack of recognition of the limitations of randomised control trial (RCT) evidence
3.4.1 The only evidence highly regarded by NICE appears to be the results of randomised control trials. However in the case of a poorly understood and investigated illness this has caused serious problems. NICE does not seem to recognise the limited conclusions which may be drawn from RCTs in the case of CFS/ME due to their:

• limited number,
• small sample size,
• selection of patients which tends to exclude the moderate to severely affected, especially those which cannot access hospital or clinic-based services
• high drop-out rates (not included in results)
• and inconsistent use of case definition (see paragraph 2.1.1)

3.4.2 Historically there has been a very poor level of funding of trials of non-psychological interventions in CFS/ME. NICE seems not to recognise that bias in the funding of trials has meant that randomised control trial data only exist for almost entirely psychological interventions. To give little weight to other evidence has therefore elevated the status of interventions investigated in this way and excluded others from mention.

3.4.3 Where NICE is drawing up guidelines for a condition that has limited research data we believe it essential that other trials, patient experience and other evidence is taken into account, particularly when RCTs have only been undertaken on one aspect of treatment and not other potential interventions. (See also sections 4.1, 4.4 and 6.0)

4.0 DISMISSAL OF PATIENT VIEWS AND EXPERIENCE

4.1 The potential for harm to patients
4.1.1 Patient groups submitted detailed evidence that certain therapies strongly recommended by NICE for the treatment of ME/CFS can cause serious deterioration of health in a significant proportion of patients. Patient groups identified those most at risk and made recommendations for appropriate treatment ofthese groups. This evidence was disregarded and no warnings given.

4.1.2 Patient groups also submitted that strong warnings should be given of the potential for relapse and/or extreme mood change caused by extreme sensitivity to drugs among some patients.

4.2 Inappropriate language
4.2.1 Phrases such as “where the [patient’s] main goal is to return to normal activities….” and “it is not known how much improvement is important for people with ME/CFS” have caused widespread offence and have seriously undermined patient confidence in NICE. The impression is given that NICE believes sufferers of this condition have adopted sick role behaviour and have no wish to recover. These would appear to be wholly subjective statements and based on a thinly disguised paradigm that ME is largely a psychological condition. The fact that these views were roundly dismissed by reports such as those of the CMO appears to have been ignored.

4.3 Omission of issues of the highest patient concern
4.3.1 The lack of any recommendation that further biomedical research be carried out into such a severely disabling and poorly understood condition has caused great anger amongst patients.

4.4 Severe restriction of patient choice
4.4.1 Consultation with our members shows that patients want wider choice and a range of options open to them. Indeed, we believe this to be government policy. Patient groups have presented evidence regarding the efficacy of a range of therapies and self-help strategies which receive no mention by NICE.

4.4.2 NICE states “There are no complementary therapies that treat CFS/ME”. This is incorrect. The Royal Homeopathic Hospital London, for example, combines specialist care with activity management, pain management, stress management, advice from a dietician and a range of complimentary medicine. Evidence from our members shows these interventions to be very helpful. We are concerned that NICE’s narrow view on medical intervention will threaten such programmes as GPs and PCTs will be unwilling to commission them.

4.4.3 We believe that, with a highly variable illness where an intervention which helps one patient may prove ineffective or even harmful for another, it is essential that a range of treatment options remain available. If not, the most vulnerable patients may be left with no accessible or effective treatment options at all.

5.0 NARROW SCOPE

5.1 Omission of proven strategies
5.1.1 Symptom control (e.g. pain management, dietary intervention, treatment of allergies) is highly relevant and there exists a wealth of evidence from patients and health service providers as to its value.

5.1.2 Reference is omitted to many commonly associated conditions (e.g. irritable bowel syndrome, fibromyalgia, allergies and sensitivities)and their own relevant guidance. These may help to relieve symptoms of the major condition if treated in their own right.

5.1.3 Patient evidence regarding self-help strategies, such as the Expert Patient Programme, is omitted.

6.0 POTENTIAL FOR COERCION INTO PARTICULAR FORMS OF MEDICAL TREATMENT

6.1 Lack of clear guidance to non-medical organisations
6.1.1 The guidelines state that a patient has the right to refuse any component of a care plan without detriment to other aspects of medical care. However we are deeply concerned that there are no safeguards preventing patients’ access to social care and state benefits from being jeopardised.

6.1.2 The guidance scoping document recognises that guidance will “be relevant to the work of” Social Services and the Department for Work and Pensions (amongst others.) It is essential, therefore, that strong and clear guidance be given that patients must not be forced by financial considerations into accepting any particular form of medical intervention. This is particularly the case where guidelines strongly endorse particular therapies which have been found by some patients to be harmful. It is essential that these governmental bodies are aware that interventions that work for some patients may not for others.

6.1.3 If there has been limited research into a condition the guidelines should explain this, and that understanding of the condition will be expected to change with time.

NICE’s evaluation process, and whether any particular groups are disadvantaged by the process;
The speed of publishing guidance

7.0 PATIENTS DISADVANTAGED BY PROCEDURE

7.1 Exclusion of all but national patient groups from consultation
7.1.1 Submissions are only permitted from national patient organisations, and then only those which have been sufficiently aware of process to register as stakeholders. Local or regional patient groups and individuals are not allowed to directly contribute. Preventing these groups from directly submitting their views excludes evidence from those with the closest contact with the needs and views of their members.

7.2 Heavy bias against patient groups in selection of stakeholders
7.2.1 In contrast, local NHS trusts and individual hospitals are invited to contribute, thus resulting in a list of stakeholders heavily weighted towards the NHS and away from patient groups. In the development of the guidelines on CFS/ME, only eight out of a list of 146 registered stakeholders were patient organisations representing those with the illness.

7.3 Exclusion by procedure of the sickest and most vulnerable patients and serious disadvantage to others
7.3.1 There seems to be little recognition that ill people may have difficulty with the processing of information. The consultation period was far too short to allow patients time to read, digest and make informed comment on such a weighty document. The use of technical language exacerbated this difficulty. These points apply even more strongly to severely affected patients who continue to be marginalised.

7.3.2 Some important points made in the full length guidelines were omitted in the shorter version. It is unlikely that patients (or busy doctors) would be able to read the weighty full-length document.

7.4 Lack of publicity of consultation process or attempts to involve marginalised groups
7.4.1 It falls to patient organisations, which may be small and have limited resources, to publicise the process to patients.

7.4.2 Given that the most severely ill patients currently receive the least healthcare provision and are frequently overlooked or dismissed, we think that the consultation process should seek to actively engage them. It would be difficult to find another condition where the ‘inverse care law’ operates so powerfully.

7.5 Speed of producing guidance valued above consultation issues
7.5.1 In answer to calls for greater consultation, at the APPG meeting of 22nd Feb Prof Littlejohns made several references to the need for the guidance to be produced speedily. This pressure for speed clearly did not arise from patient groups who were united in their view that time should be taken to address the serious concerns of patients and to produce a valuable, meaningful document. NICE spent a considerable length of time in setting up the process and some two and half years from receiving its remit to the publication of its draft guidelines. In view of this schedule we consider it unacceptable not to allow adequate time for patient groups to express their views.

7.5.2 Even where there is a wealth of submissions from patient groups and widespread serious concerns about the draft document, it appears that there is no opportunity for stakeholders to see, or further influence, the final guidelines before publication.

8.0 RECOMMENDATIONS TO GOVERNMENT
8.1 Underline the need for adequate funding of research across a range of medical disciplines to inform the work of NICE

8.2 Provide robust safeguards to prevent benefit entitlement and social care from being linked to undertaking particular kinds of medical treatment

9.0 RECOMMENDATIONS TO NICE
9.1 Reflect patient experience and views and give patient evidence equal weight to other evidence.

9.2 Where a range of specialist medical opinion exists on a condition, give a balanced account of this range

9.3 Respect WHO classifications and established case definition

9.4 Recognise the problems inherent in interpreting research data, especially where studies exist on particular interventions only, and recommend further research to redress these problems

9.5 Ensure that warnings are given where particular medical interventions have the potential to cause harm

9.6 Protect patient choice by including, in guidance, treatments where patient evidence clearly shows benefit.

9.7 Include strategies of proven benefit regarding symptom control, associated medical conditions and patient self-help

9.8 Recognise that guidelines are also used by non-medical bodies and include safeguards to prevent benefit entitlement and social care from being linked to undertaking particular kinds of medical treatment

9.9 Allow more patient bodies to make representations at the guideline development stage and ensure input from regional and local patient groups. Actively seek to redress the balance between patient and medical input.

9.10 Allow longer periods for patient consultation and use accessible language in all consultation documents.

9.11 Ensure that all important points raised in a full guideline are repeated in the shorter version

9.12 Take active steps to publicise the consultation process to patients, in particular to engage the sickest and most marginalised and vulnerable.

9.13 Where a condition attracts controversy, and/or there is a wealth of comment from patient organisations, produce a second draft for consultation before publication of the final guidelines.

EXECUTIVE SUMMARY

1.0 Introduction
The North London ME Network is a regional self help support group for people with CFS/ME. Reference throughout is to the draft NICE guidelines on the treatment of CFS/ME

2.0 Failure to provide a meaningful definition of the condition addressed by the guide
NICE has disregarded established case definition and created an entirely new, considerably wider, definition of CFS/ME. NICE were asked to produce a guide on CFS/ME, not chronic fatigue in general.

3.0 Institutional bias in evaluating evidence
NICE has disregarded patient evidence, the World Health Organisation, the government’s Chief Medical Officer’s working group and other wide-ranging consultations. Reliance on randomised control trial evidence has led to the recommendation of interventions so investigated to the exclusion of all others. There is no recognition that poor funding has led to limited research data in many interventions, or of the problems inherent in the RCT data that exist.

4.0 Dismissal of patient views and experience
Disregard for patient evidence has led to the use of inappropriate language, a failure to warn of potential harm of particular interventions and the omission of issues of the highest patient concern. NICE has restricted patient choice to the point that the most vulnerable patients may be left with no accessible or effective treatment options at all.

5.0 Narrow scope
NICE fails to make recommendations regarding symptom control, commonly associated health conditions or self-help strategies

6.0 Potential for coercion into particular forms of medical treatment
NICE fails to ensure that benefit and social care entitlement are not linked with undertaking particular medical interventions

7.0 Patients disadvantaged by procedure
There is heavy bias against patient groups in selection of stakeholders and exclusion of all but national patient groups from consultation. The sickest and most vulnerable patients are excluded by procedure and others seriously disadvantaged. There is a lack of publicity of the consultation process or attempts to involve marginalised groups. Speed of producing guidance appears to be valued above consultation issues

Evidence we have used to support this submission:
1. North London ME Network member survey (autumn '03): members' experiences of treatment for ME on the NHS

2. North London ME Network member survey (Apr.'04): members' views and experiences of GET, CBT