The ME Association petition calling for a complete review of the NICE guideline for ME/CFS has been supported by 15,180 people. We understand it represents the biggest expression of no confidence in a NICE guideline ever recorded.

Many supporters left comments and heartfelt pleas demonstrating to NICE that changes to the current guideline are urgently needed, while others recounted personal experiences showing how the clinical application of its’ recommendations had been detrimental to their health.

NICE began a stakeholder consultation two weeks ago, but following advice from their expert panel, it is recommending no action be taken with regard to the content of the existing guideline other than taking it off the static list pending the outcome of ‘ongoing research’.

Unfortunately, the only example of such research was the FITNET trial of internet-based CBT for young people. No biomedical research was considered relevant in the surveillance proposal document and US reports on ME/CFS like that from the Institute of Medicine – which many in the community had hoped would lead to desperately needed change – were dismissed:

“Topic experts agreed with the conclusions of the surveillance team about the 3 US reports which were that no impact on the guideline was anticipated. They indicated that until and unless further research suggests otherwise, the NICE diagnostic criteria for CFS/ME remain valid.”

Indeed much of the review appears to have dwelt on evidence deemed supportive of the recommendations for cognitive behavioural therapy and graded exercise therapy.

The expert panel behind the surveillance proposal may have reviewed material from opponents of the PACE Trial – and other CBT/GET research studies – but they appear to have paid such reanalysis and criticisms scant regard.

Despite the 56 page document, the clinical guideline on ME/CFS will receive no update to any of the information and advice it contains – unless NICE determines that stakeholder submissions warrant a reconsideration of the expert recommendations.

The surveillance document proposes only two changes:

1. To remove the guideline from the static list – enabling a further review and consultation in two years time, which could be a welcome move if we were reassured that stakeholder, clinician and patient contributions might actually have an effect,

2. That NICE liaise with Cochrane to update a review it made of CBT in CFS from 2008 with data from the PACE Trial – presumably because they believe it will improve those authors’ conclusions.

This last proposal seems very odd and one wonders if NICE has ever been directly involved in updating research or recommending that published research be updated. The experts behind this document really are keen to demonstrate their support for these therapies, but markedly less keen to overturn out-of-date or unhelpful information in the guideline itself.

The NICE guideline, which is used by many GPs and other medical professionals in the NHS to determine how they diagnose, treat and care for people with ME/CFS, will not have been altered since it was published 10 years ago.

This is a situation that the ME Association, other patient representative organisations, and many people with the disease find completely unacceptable, and we will continue to do our very best to change.

Sir Andrew Dillon, Chief Executive, NICE

Yesterday we followed up our own submission to the NICE consultation with a letter to Sir Andrew Dillon (pictured).

It outlined our concerns and drew his attention to the petition – to all the comments and support it has received – and to its demands.

Some extracts from the letter:

“The ME/CFS patient community have made their views very clear. NICE must acknowledge that they have produced a guideline that is not meeting the needs of the people it is designed to help.”

“When evidence from clinical trials is either weak or inconsistent and there are significant differences between patient reports and clinical trial evidence – it is even more important to listen to what patients who use specialist clinics, for example, are telling you about the effectiveness and safety of the NICE endorsed recommendations.”

“The NICE guideline was published in 2007 and it has not been changed in 10 years despite advances in our knowledge-base and its testing on many thousands of people with ME/CFS.”

“In our opinion, it is fundamentally failing to serve the need of patients and we call on you to help us work with NICE to achieve something demonstrably better.”

The letter also included the following comments from Dr William Weir – a well-respected specialist in infectious diseases with a longstanding interest in ME/CFS:

“I think that the single most damaging misconception perpetrated on ME patients is the idea that deconditioning is the problem and that exercise is the antidote. “I have seen many people now, well-motivated, who have made themselves much worse with exercise, often on the advice of their GPs who have been gullible enough to swallow the deconditioning hypothesis. “I think this needs to be properly emphasised with NICE, otherwise their advice concerning graded exercise will always be assumed to be “exercise to fitness” which is always destructive. “Sadly, the people who get worse with exercise, because they exceed their anaerobic threshold on multiple occasions with further reduction of the latter, are then assumed to be imagining their disability and treated accordingly. “It would be farcical if it wasn’t so serious.”

We will let you know as soon as soon as we receive a response and if we are able to arrange a meeting with Sir Andrew.

Copies of the letter and petition have been sent to:

The Countess of Mar – House of Lords and Chair of the Forward-ME Group (of which the ME Association is a contributing member)

Professor Mark Baker – Centre for Guidelines Director, NICE (who met with Forward-ME and expressed sympathy with our position back in 2014)

Dame Sally Davies – Chief Medical Officer for England at the Department of Health

Dr Martin McShane – Director of Long Term Conditions at NHS England

You can also read the letter to Sir Andrew Dillon, here.

Update: Since this blog was published we have received a reply from Sir Andrew and will be following up on our meeting request in due course.

NICE review consultation submissions

ME Association

Last Friday, we made our written submission to NICE as stakeholders to the consultation process. For the purposes of this blog, we have reproduced some highlights below:

“The MEA consistently takes the position that key parts of the 2007 NICE guideline on ME/CFS are unfit for purpose. In particular, recommendations relating to the use of cognitive behavior therapy (CBT) and graded exercise therapy (GET) for everyone with mild or moderate ME/CFS are inappropriate and need to be revised.

“The principle reason we believe the NICE guideline must be reviewed is because it is no longer ethical to produce a ‘one size fits all’ guideline to the management of ME/CFS.

“Ethically speaking, we believe the only way forward is for NICE to revise the 2007 guideline on ME/CFS to ensure that:

(a) physicians and patients are fully informed about the reality of the international debate on the acceptability, effectiveness and safety of CBT and GET

(b) people with ME/CFS are provided with information and guidance on approaches to management that they consistently report as being helpful and

(c) there is meaningful information and guidance on the assessment and management of people with severe ME/CFS.

“The current UK guidance from NICE on the management of ME/CFS is ‘stuck in the past’, is unethical, and is not acceptable to the patient community.

“Delays in diagnosis, resulting in no clear guidance, or even harmful guidance on management, creates a very distressing and unsatisfactory situation for patients.

“Despite the NICE guidance being in place for almost 10 years, recent patient evidence collected by the ME Association indicates that less than 20% of people are diagnosed within 6 months of symptoms occurring. Over 60% are waiting a year or more.

“Use of the NICE diagnostic criteria increases the possibility that people who do not meet one of the stricter research or clinical diagnostic criteria for ME or CFS can be diagnosed as having ME/CFS without proper consideration being given to other possible explanations for having ME/CFS like symptoms.

“Around 25% of people with ME/CFS are severely affected – being wheelchair, house, or bedbound. This group faces a number of serious problems that are not being addressed in the current guideline. [We then go on to list quite extensively the problems faced by people severely affected].

“Problems relating to late diagnosis and misdiagnosis, along with the difficulties in accessing both medical and social care are two key issues that must be re-visited by NICE. The only way to do so is through a proper review and update of the 2007 guideline.

“The NICE expert group appears to have ignored or dismissed the fact that outside the UK, especially in America, there has been a very significant shift in official guidance on management of ME/CFS away from the use of CBT and GET.

“The expert group has not given proper attention to the widespread and serious criticisms of the methodology and presentation of results from the PACE trial from academics, clinicians and patients.

The full submission from the ME Association is also, here.

Forward-ME Group

The ME Association is a member of the Forward-ME Group (FMG) and it has also submitted a response to the consultation. It was largely based on ethical arguments following a meeting earlier this month with Dr Diane O’Leary from the Kennedy Institute of Ethics in Washington D.C. and in light of the cumulative effect of positive developments seen in America.

FMG argue that UK patients should be informed of the conflict over the employment of biological testing, CBT and GET i.e. that it is wrong to simply include in the guideline the conclusions of the expert panel – the guideline should reflect the fact that not all experts agree. The submission also states that:

“Failure to inform physicians and mental health practitioners of the US conclusion that ME/CFS is a biological medical condition that requires biological care obstructs patients’ access to biological care. This obstruction singles out ME/CFS patients as somehow uniquely undeserving of access when facing a demonstrable possibility of need.”

And,

“Our request, is not that the guideline be revised to reflect a change of opinion in the UK, but rather that it be revised to present a truthful, neutral picture of the difference of opinion between UK and US health authorities about the nature and management of this condition.”

You can read the full submission from Forward-ME Group, here.

NICE Submissions from other UK charities and support groups

We have tried to maintain a listing of all other submissions to NICE and these can be found, here. Please get in touch if your submission does not appeared.