Graham's finalised letter to NICE, January 2018

This letter will be sent to Sir Andrew Dillon, chief executive of NICE, on Monday 16th January. This thread is locked so that any replies and subsequent communication can be shown here. There is a parallel thread, called "Proposed letter to NICE", where you can comment if you wish.
Graham has also created a video in support of the open letter:

There will also be a petition which you can sign in support - https://www.change.org/p/sir-andrew...ommittee-for-me-cfs-is-transparently-unbiased.

If you have comment about this letter, please don't PM me, @Andy . Either use the thread linked above to comment on or PM the author @Graham , thanks.

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Dear Sir Andrew,

We welcome the decision by NICE to review the guidelines on ME/CFS.

As you are probably aware, many patients have always questioned the NICE advice that CBT and GET are effective treatments for the illness. It is widely accepted that the decision in 2007 to recommend these interventions was based on small studies and unreliable evidence, a consequence of the neglect of ME/CFS by the MRC in this country and the NIH in the USA. Indeed, one of the justifications for the large amount of public money spent on the PACE and FINE trials was the 'somewhat limited evidence in the form of fairly small clinical trials' previously available.

Patients were surprised by NICE's quick and unquestioning welcome of the PACE trial findings as published in The Lancet in 2011. Not only did the statement that in NICE's view the results confirmed its recommendations as appropriate seem unusual in itself, but the speed at which it followed publication appeared unwise. The suggestion that NICE had somehow been vindicated by the trial only strengthened the perception by patients that the organization had taken sides in the debate and had an interest in finding evidence to support the interventions. The alacrity of the reaction, before the trial as published could properly be scrutinized, equally gave the impression that NICE was not disinterested.

These feelings among patients were strengthened by the contrast between the fast and warm reaction to PACE and the silence of NICE (and many others) to the publication of the sister FINE trial. Not only is FINE important in itself, but it casts doubt on the model on which the interventions trialled in PACE are based. FINE found CBT and GET made no difference to those most severely ill with ME/CFS. NICE made no comment on its results.

You probably know of some of the controversy surrounding PACE. The trial was an attempt to give a definitive answer to the efficacy or not of CBT and GET. What is clear from PACE and cannot be disputed is that there is no evidence the vast majority of patients benefit at all from CBT or GET, whichever the measurements of recovery and improvement used. Any slight, subjective, self-reported benefit that there may have been for a small number of patients was only temporary. The lack of evidence for objective and lasting improvement is glaring.

Over the last couple of years, criticism of PACE has been extensive, and a good review of the major issues can be found in volume 22 of the Journal of Health Psychology. The trial's major flaws are a repeat of those consistently found in studies on ME/CFS in recent decades: the use of the Oxford criteria to select patients and the use of subjective outcomes in unblinded trials. Patients find it hard to understand how NICE's recommendation of CBT and GET on the back of this work fits its aim to improve "health and social care through evidence-based guidance".

Despite this lack of evidence, NICE guidelines not only recommend CBT and GET but seem to do so enthusiastically. While for multiple sclerosis, for example, there is a single sentence on CBT, and for anxiety and anorexia there are a couple of small paragraphs on CBT, the guidelines for ME/CFS include 120 lines on the benefits of CBT and GET.

Patients' doubts about NICE's position on ME/CFS were only strengthened by the obvious conflicts of interest of so many on the guideline committee. Of a committee of twenty-one members, five had a financial interest and another ten were known supporters of the model and the interventions. This is not to suggest any lack of integrity on the part of the committee members, but to recognize the growing awareness in science of the need to guard against not just financial interests but researcher allegiance.

The contrast in findings when neutral parties examine the evidence on ME/CFS and possible treatments is stark. Separate reports for the US NIH and the US IOM (now National Academy) rejected both the illness model favoured in this country and the claim that CBT and GET were effective. None of the US CDC, FDA and AHRQ any longer recommends CBT or GET. All have rejected evidence from trials, including PACE, that use the Oxford criteria, which are now considered as impairing progress and causing harm.

It is, of course, important in itself for NICE guidelines to be valid. The consequences, though, should these guidelines be wrong can be severe. The omission from recommended treatments of CBT and GET would not prevent patients from using CBT to help them manage the effects of the symptoms or from obtaining help with psychological problems that may develop as a result of suffering this awful illness. Those so minded would still be able to use any elements of GET that they may find helpful, such as establishing a daily routine or using one activity to measure any possible improvement over time. Everyone agrees that doing everything that symptoms allow, to maintain mental and physical health, is crucial.

However, a recommendation of treatment for which there is no evidence risks causing considerable pain: patients may be obliged to follow these interventions or face losing benefits or insurance payments. Although few harms are reported in closely monitored trials, where GET as practised may in fact be no more than a form of maximized pacing, patient surveys consistently report damage caused by GET, in particular, and CBT. Patients would find themselves faced with the choice of losing their only means of survival or making themselves more ill, possibly considerably worse.

Given the importance of getting the guidelines right and the clear difference allegiance to one model of ME/CFS makes, we would therefore ask the following of NICE:

First, the process to determine who decides the membership of the guideline committee should be open and involve stakeholders.

Second, whoever appoints the members of the guideline committee should not have any involvement in research into CBT-GET or be currently using these interventions to try to treat ME/CFS or be a colleague of anyone associated with the CBT-GET model.

Third, the selection of members of the guideline committee should also be an open process and involve stakeholders.

Fourth, no one who has previously sat on an ME/CFS guideline committee should be eligible to sit on the new guideline committee.

Fifth, no one with a conflict of interest should be allowed to be a member of the guideline committee, and that conflict of interest should include any financial interest or researcher allegiance (such as involvement in research of CBT-GET for ME/CFS or attempting to treat with these interventions) or close working association with someone linked to the CBT-GET model.

Sixth, stakeholders should have a right of appeal with cause against members selected.

There cannot be a repeat of a process in which many patients have no confidence. There cannot be a guideline committee which includes, for example, someone who makes money by offering CBT-GET privately, who has a clear allegiance to one particular model and who took part in the major piece of evidence to be considered by the committee, a guideline committee which then recommends a treatment that is rejected as without evidence by all the major US institutions.

Despite the somewhat wild claims that have been made, patients do not have any desire other than to find effective treatment for an illness which devastates their lives. There is no prejudice against any particular approach. We simply want NICE to take an unbiased look at the available evidence.

We realize that some of this request may not be standard practice, but there can be little doubt of the controversy surrounding ME/CFS and there is a clear need for members of the guidance committee to be one step removed from the debate. The investigations by the NIH and IOM/NA show how it is possible for independent scientists to consider the evidence.

You are aware no doubt of the great interest many ME patients have in this subject, so we shall be posting this email online for others to see. We shall also post your reply, unless you advise you would rather we do not.

Thank you for your time and consideration of this matter.

Yours sincerely,

Graham McPhee
John Peters
Sally Burch
Patricia Davis
Dr Elisabeth Blank
Kate Milford
Justine Railton
Vivien Pomfrey
Maggie Wallace
Peter Trewhitt
Carly Mayhew
Wendy Boutilier
Jan Johnson
Lyn Gillam
Lizzie Corran
Kate Behrend
John Wallace
Veronica Jones
Amanda Silver
Penelope Jane McMilan
Diane Ogilvy
Debbie Smith
Ann West
Linda Hending
Sean Kirby
Andy Hugh
Jan Sussex
Elisabeth Aveling
Scott Simpson
Gill Bigglestone

 

@Graham has had a reply to his letter.

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Thank you for contacting the National Institute for Institute for Health and Care Excellence (NICE) regarding the development of the myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management guideline.

I will address each of your points about the membership of the committee in turn.

The process to determine who decides the membership of the guideline committee should be open and involve stakeholders.

The committee will be appointed by open recruitment in line with NICE's policy and procedure for recruitment and selection to advisory bodies. The resulting committee should, as far as practically possible, reflect the range of stakeholders and groups whose activities, services or care will be covered by the guideline. The final composition of a topic‑specific committee is agreed by the developer and NICE staff with a role in guideline quality assurance and takes into account the final scope for the guideline. We are aware of the strength of feeling in the community and we will work to ensure a balanced and diverse committee, as we do for all our guidelines. With that in mind, for this guideline, there will be a lay member on the appointment panel for the chair and there will be double the usual number of patient representatives on the committee (4 instead of 2).

Whoever appoints the members of the guideline committee should not have any involvement in research into CBT-GET or be currently using these interventions to try to treat ME/CFS or be a colleague of anyone associated with the CBT-GET model.

We have commissioned the National Guideline Centre (NGC) to develop this guideline and they are responsible for managing the recruitment of the committee. Shortlisting and interviews are carried out by the chair or vice chair of the committee and the director of NICE’s Centre for Guidelines or an appointed deputy and/or a senior member of staff from the guideline developer. The NGC is a multi-disciplinary health services research team funded by NICE to produce evidence-based clinical practice guidelines on our behalf. It is hosted by the Royal College of Physicians (RCP) and it has governance partnerships with the Royal Colleges of General Practitioners, Nursing, Physicians and Surgeons and the RCP.

The selection of members of the guideline committee should also be an open process and involve stakeholders.

The committee will be appointed by open recruitment in line with NICE's policy and procedure for recruitment and selection to advisory bodies, with the addition of a lay member on the appointment panel for the committee chair.

No one who has previously sat on an ME/CFS guideline committee should be eligible to sit on the new guideline committee.

The selection process for committee members is objective, impartial and has to be applied consistently to all candidates. Each candidate must be assessed against the same published criteria. It would not be an open recruitment process if any one group of people were excluded from applying to be on the committee.

No one with a conflict of interest should be allowed to be a member of the guideline committee, and that conflict of interest should include any financial interest or researcher allegiance (such as involvement in research of CBT-GET for ME/CFS or attempting to treat with these interventions) or close working association with someone linked to the CBT-GET model.

Topic specific guideline committees by their nature are made up of people who have knowledge of the subject area, whether that is from a professional or patient perspective. Candidates are required to submit a declaration of interests, curriculum vitae (CV) and covering letter, or application form in the case of lay members when they apply to join a committee. NICE is open and transparent about the interests of those who are members of, or work with, our advisory committees, so that the effect of interests is known, understood and managed and you can read more about this is within the declaration of interests policy which is available to download through our website.

Stakeholders should have a right of appeal with cause against members selected.

We do need to follow our published methods and processes for guideline development, including for recruitment of the committee. They do not include a right of appeal against the selection of particular committee members.

NICE staff carry out quality assurance of the guideline to ensure that the process has been followed appropriately, and that the methods are clear and transparent. This includes ensuring that the reviews of the evidence and any economic analysis are up-to-date, credible, robust and relevant. We encourage all stakeholders to comment on the draft scope and draft recommendations and by enabling public access to advisory body meetings is part of NICE's commitment to openness and transparency. It enables stakeholders and the public to better understand how evidence is assessed and interpreted, how consultation comments are taken into account and how recommendations are formulated.



Yours sincerely,


Andrew Dillon

Chief Executive

National Institute for Health and Care Excellence

10 Spring Gardens London SW1A 2BU

020 7045 2048

www.nice.org.uk