By David Tuller, DrPH
*For more about the significance of the new NICE guideline for ME/CFS, the blog ME/CFS Skeptic has this excellent summary. Also, psychologist Brian Hughes covers the deep concerns of leading medical groups that the guideline recommends against the Lightning Process.
It is not surprising that esteemed experts whose research has been publicly exposed as a bunch of crap would push back quickly, and that promoters of the debunked work would rally round in defense. That’s what we’ve seen in the wake of Friday’s publication of a new ME/CFS guideline from the UK’s National Institute for Health and Care Excellence (NICE). The document, which reverses the recommendations of a 2007 guideline, specifically advises against the two long-standing first-line treatments—graded exercise therapy (GET) and a specialized form of cognitive behavior therapy (CBT). Both interventions have long been promoted as cures for the underlying condition, based on the theory that patients’ symptoms were perpetuated by a combination of unhelpful illness beliefs and severe deconditioning rather than any organic dysfunction.
Two of the three lead authors of the now-discredited PACE trial, which was once billed as the “definitive” investigation of this approach, offered peevish responses that failed to address NICE’s concerns. In the statements, provided by the Science Media Centre as part of a round-up of comments about the new guideline, they mainly re-bleated past assertions about the benefits of their beloved treatments. (The Science Media Centre’s decision to offer a wide range of comment, rather than just statements overwhelmingly in support of the GET/CBT approach, represents a big shift in how it handles this issue. Perhaps it realizes it needs to cut its losses rather than go down with the GET/CBT ship.)
Professor Trudie Chalder, for example, declared the following: “The NICE guidelines for CFS/ME are at odds with the research evidence. Researchers from different Institutions [sic] in different countries have found graded exercise therapy and cognitive behaviour therapy to be effective for some patients with CFS. Evidence has shown they reduce fatigue and improve functioning without harm, if delivered by trained therapists in specialist clinics.”
Poor Professor Chalder! She seems incapable of grappling with the humiliating fact that the NICE review found the evidence for the effectiveness of these interventions on fatigue and physical function, including from the PACE trial, to be of “very low” or merely “low” quality. This was the case whether the research took place in the UK or other countries. As Professor Brian Hughes, a psychologist at the National University of Ireland, Galway, and I documented in this paper in the Journal of Health Psychology, Professor Chalder’s 2020 paper in the Journal of the Royal Society of Medicine on clinic outcomes for patients undergoing CBT relied on serious data misrepresentation in arguing for the effectiveness of the intervention. (Professor Sir Simon Wessely was one the co-authors.)
Given Professor Chalder’s record, nothing she says in this domain can be considered credible. As part of the Science Media Centre round-up, her PACE colleague, Professor Peter White, made equally silly remarks in the same vein. They’re not worth discussing.
Statement from medical “leaders”
Not to be outdone, other NICE dissenters have issued an incoherent statement of defiance, posted on the website of the Royal College of Physicians under the following headline: “Medical leaders sign joint statement in response to NICE guidance on ME/CFS.” The groups listed, in addition to the Royal College of Physicians, were: the Royal College of Physicians of Edinburgh, the Royal College of General Practitioners, the Royal College of Psychiatrists, the Academy of Medical Royal Colleges, Faculty of Sport and Exercise Medicine, and Faculty of Occupational Medicine
The statement bemoans what it maintains is the guideline’s under-emphasis on “the importance of activity and exercise” in the management of ME/CFS. Among other foolish declarations in pushing this perspective, the “leaders” note the following:
“Graded Exercise Therapy) [sic] as defined in the guidance is not reflective of the personalised paced exercise programmes that are currently used in the NHS and termed GET. These have provided benefit to many patients and should not be discontinued. However, we recognise that the phrase GET is unhelpful and this terminology should be dropped to allow clinicians to work with their patients in a more productive way.”
Let’s parse this weirdness. First, they assert that the NHS is no longer doing GET in the way described in the NICE guideline. The guideline, of course, took its description of GET as well as CBT from PACE and related research, which are explicit about the theoretical bases underlying the interventions and the proper method of implementing them. The framing of GET in the guideline should therefore not be a surprise to anyone. (I wonder how Professors Chalder and White would respond to the news that the NHS has discarded the GET outlined in PACE.)
These medical “leaders” provide no explanation for why NHS services no longer offer GET as proposed and researched by the leading experts in this field. The only logical conclusion would be that they realized it didn’t work. Otherwise, they would presumably have kept doing it in its original form. But if they aren’t offering GET as described in the literature, how do they know what to offer instead? In particular, what is the evidence in favor of the “personalised paced exercise programmes” that the NHS now apparently refers to as GET?
And if the “leaders” acknowledge that the NHS is no longer using GET as described in PACE and related research, presumably because clinicians have realized it doesn’t work, why haven’t they made this absolutely clear to the public before now? Moreover, why are they angry at NICE for highlighting in the new guideline that GET doesn’t work? Apparently they agree that GET shouldn’t be offered; they also agree that the name is tainted and should be dropped. In short, they’re conceding that GET is an inappropriate intervention. So what’s their complaint about the NICE guidance? Why are they throwing a temper tantrum?
Then there is this comment about CBT: “CBT remains a valuable treatment for alleviating symptoms in ME/CFS and services should ensure patients have access to this and other psychological therapies.”
The NICE guideline allows for CBT when it is offered as a supportive rather than a curative intervention, so the beef on the part of the “leaders” appears to be that this modality is not specifically promoted as beneficial. If the “leaders” have evidence that CBT can actually result in recovery, as has been claimed by the PACE authors and others, or plays a “valuable role for alleviating symptoms in ME/CFS,” they should provide it. Significantly, they have not.
A psychological intervention like CBT should probably have the same role in ME/CFS that it has in other chronic medical conditions—to help patients cope with their disease as well as to address co-morbid anxiety, depression and related mental health issues. These “leaders” might believe CBT tackles the underlying illness mechanisms in ME/CFS and deserves an especially prominent place in the treatment arsenal, but they do not seem to have mounted a viable case on that front.
Four of the “leaders” who signed the letter were present at a key roundtable hosted by NICE last Monday to air concerns raised by those objecting to publication. Yet the minutes of the roundtable, which NICE released along with the guideline, include no indication that these eminent professionals presented robust or indeed any evidence for their categorical claims of benefit from their “personalised paced exercise programmes.” If they possess such data, they have had ample opportunity to make it available. If they don’t, they should stop wasting everyone’s time with empty assertions of benefit. The groups they represent have had as much chance to be involved in the guideline development process as everyone else.
The “leaders” report “disquiet” over NICE’s evaluations of the available evidence and data–even though that evidence and data is not about the “personalised paced exercise programs” they are now touting. As far as this revamped strategy, they seem to expect the right to do whatever they want without having to provide any rationale beyond that they themselves believe it offers benefits. That is not how “evidence-based medicine” is supposed to work. The “evidence-based” approach was intended as an alternative to clinicians’ own positive but often unreliable assessments of the results of favored medical interventions.
These medical “leaders” are jabbering in circles. They don’t like how NICE assessed the evidence, the evidence has nothing to do with what they’re offering anyway, and they have no evidence to support what they’re doing beyond their clinical impressions. That’s pretty much their argument. Either they’re stupid, or they think everyone else is stupid, or they’re trapped in some mental bubble that remains impervious to facts and logic. Their display of petulance is childish, unattractive and anti-scientific, but not surprising.