Trial By Error: NICE’s Upcoming Draft Guidance on ME/CFS

By David Tuller, DrPH

*October is crowdfunding month at Berkeley. I conduct this project as a senior fellow in public health and journalism and the university’s Center for Global Public Health. If you would like to support the project, here’s the place: https://crowdfund.berkeley.edu/project/22602

The UK’s National Institute for Health and Care Excellence, or NICE, is planning to release a draft of its revised guidance for ME/CFS on November 10th. That will be followed by a six-week public comment period, which is expected to see a flood of responses from all sides. The final version is scheduled to be published in the first part of 2021.

The 2007 guidance for CFS/ME, concocted by a committee over-weighted with members and supporters of the biopsychosocial ideological brigades, recommended cognitive behavior and graded exercise therapy as the best treatments. When the bogus PACE results were published in 2011, they appeared to bolster the 2007 recommendations. Three years ago, NICE reversed its initial decision to leave the guidance as is after an outpouring of negative public comment. Now the revision process is coming to fruition.

I have no inside information, but I’m going to make a couple of guesses about the draft guidance.

*GET will be discarded.

*CBT will be recommended not as a treatment for improving or curing the condition itself but as adjunctive or supportive care, similar to how it is used in the context of other chronic medical diseases. (The language on this might be a bit squishy or ambiguous to accommodate all parties.)

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The demise of GET

I believe graded exercise therapy will be discarded because it has no scientific justification, and there are legitimate reasons to think it causes more harm than good. The credibility of the crown jewel of the evidence base—the five-million-pound PACE trial—has been demolished, even if The Lancet refuses to retract it and Professor Sir Simon Wessely continues to maintain his ridiculous posture that it is “a thing of beauty.” The Cochrane exercise review, a second line of defense for GET defenders, has been mired in controversy over the obvious bias and incompetence of the authors—and Cochrane itself has acknowledged that the current version is deficient.

In terms of harms, it is widely acknowledged that post-exertional malaise is a core symptom of ME/CFS. Given that reality, a course of graded exercise therapy as outlined in PACE and its accompanying therapist and participant manuals is self-evidently contra-indicated. If people suffer prolonged relapses after minimal exertions of energy, why would anyone believe that GET is the optimal approach? The concern is bolstered by multiple patients surveys, in which many more people report harms rather than benefits from GET. While these survey data are not representative, they are consistent with the apparent contra-indication of GET.

It is also widely accepted that underlying biological abnormalities of some kind are causing the debilitating symptoms—not deconditioning, as posited in the theory behind the PACE trial. Given that, the theoretical justification for GET would seem to have disappeared. If deconditioning is not the problem, then GET is not the solution.

In July, NICE issued a warning that the 2007 CFS/ME recommendation for GET should not be assumed to be relevant for those experiencing persistent symptoms after acute Covid-19. The statement did not mention CBT and noted that “the evidence for and against graded exercise therapy is one of the important issues the guideline committee is considering.” If NICE were planning to re-endorse GET as a safe and effective recommendation for ME/CFS, it seems unlikely that the agency would issue such an advisory. But who knows, really?

This isn’t the only bad news for GET in recent months. The Scottish government recently updated its health recommendations after a review of the evidence completed in August, and urged caution concerning GET for both ME/CFS patients and those suffering from post-Covid symptoms. Here’s an excerpt from this revised “Scottish Good Practice Statement on ME-CFS” (boldface from the original statement):

  • In light of a Cochrane systematic review and the NICE guideline revision, caution should be noted on the use of GET for ME/CFS until the updates are published, and
  • No published evidence on the use of GET for people experiencing persisting fatigue following Covid-19 was identified. NICE has made a statement cautioning against assumption that ME/CFS recommendations apply to people with fatigue following Covid-19.”

By the way, in Northern Ireland, health officials promised in 2017 to issue a similar advisory, said Joan McParland, founder of Hope 4 ME & Fibro Northern Ireland. The following year the government backed down from that commitment, said McParland. In July, the trustees of the charity* wrote to Robin Swann, the Northern Ireland health minister seeking to revive the effort, but has so far received no response. [*I initially wrote that McParland herself wrote to the health minister. I apologize for the error.]

“Our campaign for specialist M.E. services officially began in 2011, born out of the desperation only other M.E. patients will understand. Its been grueling, literally fighting from our beds, yet here we are nine years later, still waiting, forever hopeful of pledges and promises to be fulfilled by healthcare decision makers and government officials, and now in the midst of a global pandemic,” said McParland.

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The CBT dilemma

The situation with CBT is a bit more complicated. Members of the relevant ideological brigades have repeatedly asserted—falsely–that ME/CFS patients reject CBT because they have a prejudice against psychological interventions. In fact, the patient community rejects CBT because the research stinks and because the intervention has been presented as a cure for the underlying illness–not as adjunctive or supportive therapy to help them get through the day, the way CBT is used to help people with cancer and other chronic medical diseases.

One member of the NICE ME/CFS committee, Bath psychologist Jo Daniels, recently tweeted praise for CBT’s effectiveness in treating ME/CFS. (She disappeared the tweet quickly, but not before it was captured in screen shots.) Her comments seem to have represented a lapse in judgement, given that NICE requires committee members to refrain from engaging in public debates on topics they are reviewing. We’ll have to see whether Daniels’ statement has any bearing on the content of the CBT section of the draft guidance—hopefully not.

The PACE trial’s CBT findings, of course, are as bogus as its GET findings. Other studies in this domain are equally unconvincing. I have criticized many of them, including Daniels’ study earlier this year on a specific form of CBT targeting “health anxiety”—an apparent rebranding of hypochondriasis. This study appeared designed to generate a funding stream for further exploration of this purportedly separate psychopathology afflicting patients. It was nonsense; I hope enough other committee members have rejected any suggestion that so-called “CBT-health anxiety” be included in the ME/CFS guidance.

Despite the documented uselessness of CBT for treating the underlying condition, it is harder than with GET to make a case for potential harm. The theoretical framework is the same as that for GET—it is just that the remedial approach taken is psychologically oriented rather than behaviorally oriented. Because patients are theorized as suffering from unhelpful beliefs about having an organic illness, the CBT is designed to alleviate them of these dysfunctional cognitions. And since that cognitive restructuring is combined with admonitions to also increase activity, it creates serious potential for harm, just like GET.

However, the link is less direct. While patient surveys are clear when it comes to GET, the results for CBT are more equivocal. Perhaps, in the end, many sensitive practitioners provide regular CBT—helping patients adapt to circumstances as best they can—rather than the kind of CBT championed in PACE. It’s hard to tell. But in any event, discarding CBT completely seems more politically fraught and perhaps untenable.

I could be completely off the mark here. But the recent statement issued by the British Association for CFS/ME, which basically contradicts everything they have argued for years, suggests the CBT/GET ideological brigades are running scared and positioning themselves for the fall-out of a new NICE guidance. They seem to be seeking to promote softer, gentler versions of their problematic and disproven interventions. More on that next time.

Comments on this entry are closed.

  • Alicia Butcher Ehrhardt, PhD 25 October 2020, 9:23 pm

    I am coming up on 31 years of ME. It cost me my career in research plasma physics at Princeton.

    I use CBT all the time for producing the best I can with what I have to live with – that’s the standard use. I have been dismayed to see it used to make people think ME is all in their heads, and they can remove it with CBT, which is patently false.

    Physical illnesses are a continuous management challenge. All of them. But that comes AFTER acknowledging they ARE physical illnesses.

    Frankly, I would be amazed if I had the capacity to maintain an illness for 31 years because it was all in my head. The losses have been huge, and there have been no benefits I can see: everyone is tired of knowing I’m still ill, and has been for years, and I get nothing except “okay, I get that you’re ill, now would you please not talk about it?” And people who resent having to carry more of the load of family life because I can’t. Sigh.

  • CT 26 October 2020, 4:31 am

    David Tuller needs your support and, the way I see it, people in the UK really need HIS support at this critical time. He’s not giving up (yet), and we can’t afford to either -https://crowdfund.berkeley.edu/project/22602 .

    So come on Brits, give him the tools… (well, evoking Churchill seemed to work for Boris).

  • Chris 26 October 2020, 4:52 am

    Good piece, David.
    I suspect the BACME ‘position statement’ is also an attempt to save jobs, save their so-called clinics & to grab a slice of the promised gov’ment £10 million for Long Covid clinics!

  • jimells 26 October 2020, 5:16 pm

    It’s clear from past correspondence with “Invest in ME Research” that NICE intends to protect the useless “fatigue” clinics and all their people that need to be kept busy. The first instinct of a bureaucracy is survival, just like any other living organism. If patients actually benefit from a bureaucracy’s work, that is a happy side effect, not the primary endpoint.

    The sad part is that there is important work the clinics could do in terms of case management and receiving benefits and general support. For a while I had a case manager who made the medical appointments, drove me to them, and sat in the exam room. She also made sure I had groceries, etc. It was a very helpful benefit, so of course it had to be cancelled. Now there is zero followup on my illness by anyone (including the doctor) and I could be dead a month before someone would notice.

  • Ann 30 October 2020, 5:24 am

    Although I find it difficult to comment ,I look forward to every Friday to read your blogs David and the comments that follow. Please keep up the fantastic work.