Trial By Error: That Whine De Coeur about NICE’s Rejection of GET/CBT Regimen, and ME Action UK’s Disappearing Rebuttal

By David Tuller, DrPH

On July 10th, the Journal of Neurology, Neurosurgery, and Psychiatry (JNNP) published what can only be called a whine de coeur from a bunch of academics and investigators on the wrong side of a dispute with Britain’s National Institute for Health and Care Excellence (NICE). Their article was called “Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis.”

The lead author was Professor Peter White, one of the three co-principal investigators of the PACE trial. The corresponding author was another of the PACE triumvirate, Professor Trudie Chalder, and the third, Professor Michael Sharpe, signed on as a co-author—along with four dozen of their colleagues. (Perhaps they should be referred to as co-signatories rather than co-authors; it is hard to believe they all had much of a hand in crafting the piece.)

The article was the latest effort of members of this cabal to push back against the 2021 decision by NICE to reject the psycho-behavioral treatments for ME/CFS (or CFS/ME, as the article calls it) that they have championed for three decades–specifically, graded exercise therapy (GET) and a specific form of cognitive behavior therapy (CBT). Given the extensive list of co-authors and the breadth of their argument, it is surprising that this declaration appeared in a specialized neurology journal rather than a more prominent and widely read general medical journal. (JNNP is published by the BMJ group but is far less well-known than The BMJ, the group’s flagship title.)

After all, The Lancet published the first PACE results in 2011. At the time, editor-in-chief Dr Richard Horton came out swinging in defense of the trial, publicly accusing patients who criticized it of harming the scientific process. You’d think he might be willing to provide the PACE authors with an opportunity to defend their work through this aria of collective opposition to NICE. The BMJ also has a history of strong support for the GET/CBT treatment paradigm.

Perhaps The Lancet and The BMJ, and others of that ilk, weren’t interested. Who knows?

Beyond that, the article underlines the strong links between the ME/CFS investigators and experts in the field of functional neurological disorder (FND). The latter generally have little record of publishing research on ME/CFS, although Professors Sharpe and Chalder have been involved with with high-profile research into FND and related disorders.  In any event, the list of co-authors of the JNNP article includes many known for their expertise in FND, not ME/CFS. More than one of these co-authors also have editorial roles at JNNP, which presumably helped to facilitate the publication process.  

So why are members of the FND field endorsing a letter involve NICE guidelines for ME/CFS?

Perhaps they see their own interests threatened by NICE’s explicit rejection of the psycho-behavioral approach for ME/CFS. These conditions fall under the larger rubric of “medically unexplained symptoms” (MUS)–a former buzzword that more recently seems to have receded in popularity. Investigators in these domains are devoted to conducting unblinded trials that rely on subjective outcomes—a study design that inevitably produces an unknown amount of bias. If NICE rejects these studies as inadequate for evidence of treatment efficacy, as it did with the ME/CFS guideline, that’s a huge problem for the FND investigators as well.

The JNNP article outlines eight purported “anomalies” in the NICE process for developing the new ME/CFS guideline, which reversed the recommendations of a 2007 version. Last December, a draft of this essay found its way online (via a German investigative journalist, Martin Rucker). To counter the arguments being made, I posted this conversation with Adam Lowe, one of the patient representatives on the NICE guideline development committee. (The draft referred to eight “errors”; it would be interesting to know why that word was downgraded to “anomalies.”) Brian Hughes, a professor of psychology at the University of Galway, has also addressed, with his usual finesse, all the objections raised by the JNNP piece on his blog, The Science Bit, here and here.

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The disappearing response from MEAction UK

The JNNP article spawned many spirited rebuttals. One of them, from MEAction UK, was posted as a rapid response—but was then mysteriously disappeared. (You can read it here.) By way of explanation, JNNP posted a statement on July 26th that a previously posted rapid response had been removed because of “inappropriate inflammatory language.“

Hm. The comment included some tough language and criticism, but “inflammatory” seems a bit hyperbolic. Certainly the inflammatory nature was not apparent to the JNNP staffer or staffers who initially read the response and decided to post it. On July 27th, MEAction UK sent to the BMJ editor-in-chief, the JNNP editor-in-chief, and the JNNP editorial office a letter suggesting that the journal might have violated its own policies about rapid responses. They posted the letter on their website; I have included it below:

“We are disappointed that the JNNP decided to remove our Rapid Response to, “Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis”.

“In the email from your editorial office ‘inappropriate inflammatory language’ is cited as the reason for removing our Rapid Response. However, our response was posted for several days and also edited without anyone in the editorial office considering it to be ‘inflammatory’. In your terms and conditions you say that, ‘If only a line or two of an otherwise OK response is defamatory or extremely abusive, we may delete the line and post the rest.’ As the original response was considered suitable to be published we find it surprising that editing wasn’t considered before removal.

“It is also intimated in the online notice that our response fell foul of the ‘hostile or hateful speech’ clause. This was not mentioned in the email to us and is a particularly egregious accusation in relation to a marginalised patient group who have repeatedly reported being gaslit by the medical establishment.

“In a 2013 post, Sharon Davies, the rapid responses editor for the BMJ, said ‘we adhere strictly to our policy of not deleting rapid responses once we have posted them. The only exception is when we’re told to do so by lawyers.’

“Is it the case that you have been instructed to take this exceptional step by lawyers or under pressure from the authors of the paper and supporters, rather than ‘inflammatory language’? We would be very disappointed if the JNNP had given in to outside pressure and ask that you engage in a constructive dialogue with us to find a way to reinstate our response. We intend to publish this response and any further correspondence unless you request that we do not.

“Finally, we would like to thank the editorial team who originally posted our Rapid Response and prioritised debate and openness.

Sincerely,

Denise Spreag
Janet Sylvester
Malcolm Bailey
– MEAction UK Trustees

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As of now, MEAction UK’s rapid response has not reappeared on the JNNP site. No other rapid responses have been posted, although a thread on the Science For ME forum indicates that some have been sent in.