‘No confidence’: Charities reject NICE ‘no update’ proposal for ME/CFS guideline

Adam Lowe

Charities in the UK have delivered a resounding show of ‘no confidence’ to NICE, the body which sets clinical guidelines for doctors in the UK.

NICE is currently reviewing the guidelines for mylagic encephalomyelitis (also known as chronic fatigue syndrome, or ME/CFS), which hasn’t been updated in 10 years. It has stated that it plans to go ahead with a ‘no update’ recommendation despite the review, which will mean the existing guideline will remain intact with no changes.

Charities and patient groups across the UK have accused NICE of ignoring new and compelling biomedical research from around the world, just days after the US Centres for Disease Control and Prevention’s decision to change its own clinical guidelines to remove outdated treatment recommendations. According to Action for ME, this may constitute a breach of the UN Convention on the Rights of Persons with Disabilities and a failure to offer ‘informed consent’.

In the submissions from Forward-Me, ME Action, Invest in ME Research, The Tymes Trust, Action for MEHope 4 ME & Fibro Northern Ireland and the ME Association, these groups detail a number of objections to the NICE guideline proposal. These include the inappropriateness of a ‘one-size-fits-all’ treatment to problems with the diagnostic criteria themselves, which they feel are too loose, and thus may apply to patients with vastly different illnesses.

‘On grounds of equality and human rights, as well as on grounds of effective healthcare, the NICE guideline must be reviewed and updated,’ said Action for ME.

On Monday, the ME Association wrote to NICE’s CEO Sir Andrew Dillon, delivering a petition signed by more than 15,000 people, which it calls ‘the biggest expression of no confidence in a NICE guideline ever recorded’. According to the MEA, ‘much of the review appears to have dwelt on evidence deemed supportive of the recommendations for cognitive behavioural therapy and graded exercise therapy’, which it feels gives ‘scant regard’ to the research which criticises these treatment methods.

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‘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this document really are keen to demonstrate their support for these therapies, but markedly less keen to overturn out-of-date or unhelpful information in the guideline itself,’ writes the MEA.

Support for CBT and GET, the treatments in question, is largely due to the claimed results of the UK PACE Trial. However, 42 experts wrote an open letter accusing the researchers of that trial of bias and misrepresentation.

‘The investigators violated their promise in the PACE protocol to adhere to the Declaration of Helsinki, which mandates that prospective participants be ‘adequately informed’ about researchers’ “possible conflicts of interest.” The main investigators have had financial and consulting relationships with disability insurance companies, advising them that rehabilitative therapies like those tested in PACE could help ME/CFS claimants get off benefits and back to work. They disclosed these insurance industry links in The Lancet but did not inform trial participants, contrary to their protocol commitment. This serious ethical breach raises concerns about whether the consent obtained from the 641 trial participants is legitimate,’ says the letter published at Virology Blog.

Invest in ME Research also rejects the trial’s claims, saying, ‘The PACE Trial is null science, bad science, discredited science, its worth is only to demonstrate how research should not be conducted.’

After a Freedom of Informational tribunal ruled that the authors of the PACE Trial had to publish their raw data, unusual changes to trial outcome measures were discovered, and the data was reanalysed by a number of different partiesCritics of the PACE Trial and GETSET trial have pointed out that only a small number of patients seem to improve with these treatments, and that a significant number report getting worse, especially after GET.

An open critique of the PACE Trial was also published by Rebecca Goldin, the director of Stats.org and Professor of Mathematical Sciences at George Mason University. Goldin writes, ‘The question of how all this happened and how the criticism is being handled have sent shockwaves through medicine. The results from PACE (including these) have been published in prestigious journals and influenced public health recommendations around the world; and yet, unraveling this design and the characterization of the outcomes of the trial has left many people, including me, unsure this study has any scientific merit. How did the study go unchallenged for five years?’

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ME Action wrote, ‘We would like to make clear that our concerns about methodology extend beyond the PACE trial to include the entire body of GET/CBT research, where it relies on the flawed combination of unblinded randomisation and subjective outcomes (Helmfrid, 2016). We ask that such clinical trials be excluded or downgraded.’

Children’s charity The Tymes Trust, meanwhile, writes, ‘To effectively censor one side of the current evidence on this disease, and the serious step taken by the CDC, is to present a partial, rather than impartial view to unsuspecting parents and their doctors – surely an unethical stance that is already reflecting poorly on NICE and its reputation. Once the medical profession learns that NICE is now, in effect, actively promoting one side of the medical debate and suppressing the other, this cannot fail to have consequences.’

ME Action’s position is similar, with its own statement reading, ‘The quality of evidence is lacking for us to feel safe in regards to the risk versus benefit of these treatments given the absence of theoretical justification.’

Action for ME writes, ‘The guideline’s core recommendation on treatment, that CBT and/or GET should be offered
to people with mild or moderate CFS/M.E, does not acknowledge that the results for these treatments are disputed. The guideline ought to reflect that there is a mixed evidence base for these treatments. They can help some patients, but the results demonstrating this are heterogeneous and not significant, except when a trial which is currently subject to scientific scrutiny as to the validity of its results is included. ‘

The charity also concludes that ‘it is unethical not to provide clinicians and patients with a balanced current understanding of the evidence base for treatment and management approaches, and that failure to do so prevents informed consent’, which may contravene article 25 d of the UN Convention on the Rights of Persons with Disabilities.

By NICE’s own admission, the survey of new research was by abstract only, meaning that the contents of new studies have not been thoroughly examined. Likewise, the current lack of consensus regarding CBT and GET as treatments for ME/CFS is not currently mentioned in the review proposals. This is a concern because many clinicians and clinicians’ associations turn to the NICE guidelines as an authority on healthcare excellence, including the British Association for CFS/ME, which claims to ‘champion’ the NICE guidelines.

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Forward-ME has accused NICE of ‘assuming that patients, physicians and mental health practitioners need only be informed of its own evaluation of research’ and that in doing so it ‘exceeds its authority’.

NICE’s current proposal not to update the guidelines comes with a caveat that the guidance will be moved from the ‘static’ list to the ‘active’ list – meaning that NICE will consider new research if it deems said research appropriate. Though NICE opened a stakeholder consultation two weeks ago, it announced that its view was to go ahead with a ‘no update’ decision based on the advice of ‘topic experts’ who currently remain unnamed.

According to Virology Blog, the Countess of Mar and the ME Association have both requested the names of these ‘topic experts’, which NICE has declined to provide, stating that it does not ‘routinely’ publish such information. Its response was:

‘The National Institute for Health and Care Excellence (NICE) routinely consults a range of topic experts as part of its surveillance review process. NICE is currently consulting on a review proposal for its clinical guideline on the diagnosis and management of chronic fatigue syndrome and myalgic encephalomyelitis. NICE does not routinely publish the names of topic experts as they are not part of the decision making [sic] process for the surveillance review.’

Responding to this, David Tuller, DrPH, says, ‘Given that topic experts have been consulted in this instance, it is bizarre to read that they are “not part of the decision-making process”? Is their advice then ignored completely? Are they just a fig leaf to create the appearance of consultation while NICE does what it wants? If their advice is reviewed and considered rather than tossed right in the trash, why does the statement declare that they are not part of the decision-making process?’

He concludes, ‘Given the enormous impact of these guidelines, it is imperative that the process be conducted as openly as possible.’

About Adam Lowe

Adam Lowe is an award-winning author, editor and publisher from Leeds, now based in Manchester. He runs Dog Horn Publishing and is Director and Writing Coordinator for Young Enigma, a writer development programme for LGBT young people. He sometimes performs as Beyonce Holes.