David Tuller

Trial By Error: Lightning Process Star Complains About NICE; Struthers Nudges Cochrane to Keep Up

3 December 2021 by David Tuller 4 Comments

By David Tuller, DrPH

Another Anti-Science Campaigner Takes Aim at NICE

The anti-science zealots do not give up easily. Now Live Landmark, the Norwegian Lightning Process practitioner, has written an opinion piece blasting the new evidence-based guidelines for ME/CFS from the National Institute for Health and Care Excellence (NICE). I assume she is not just upset that the document bars standard interventions like graded exercise therapy (GET) and a form of cognitive behavior therapy (CBT) but that it also specifically bars the Lightning Process (LP), her personal specialty.

Landmark and her comrades in the GET/CBT/LP ideological brigades have been humiliated publicly by NICE, so it is understandable that they are throwing tantrums–even one as divorced from reality as this article. Landmark’s arguments can’t be taken seriously–except perhaps by those whose core financial and reputational interests are threatened by NICE’s in-depth analysis of the deficiencies of the evidence.

Here’s what Landmark opines: “Unfortunately, the recommendations made in the new NICE guidelines for chronic fatigue were not based on the published research. This means that the Norwegian Directorate of Health can be confident in ignoring their suggestions.”

The NICE decisions were based on the fact that the evidence in support of the interventions was found to be of poor quality. Landmark might not agree with that assessment and she might prefer her own country’s health authorities to dismiss it as unwarranted. But she can’t rewrite what happened, nor should the Norwegian Directorate of Health pay attention to her rant. The recommendations against CBT, GET and LP were based on the dramatic shortcomings of the research, which NICE outlined in voluminous detail.

Psychologist Brian Hughes, a professor at the National University of Ireland, Galway, dismantles much of Landmark’s argument in this twitter thread.

Amazingly, at this late date, Landmark links to the 2011 Lancet publication of the PACE trial as if it offers legitimate evidence and hasn’t been widely debunked in academic and professional quarters, and not just by NICE. She also links to the PACE team’s reprise in a just-published paper called–without a hint of irony–“Evidence‑Based Care for People with Chronic Fatigue
Syndrome and Myalgic Encephalomyelitis.” In this self-justifying whine, Professors Michael Sharpe, Trudie Chalder and Peter White, the three lead PACE investigators, insist that criticism of their work reflects a big misunderstanding on the part of everyone else. Citing these two articles does not bolster Landmark’s credibility or the case she is trying to make.

I guess it’s been a disappointing year for Landmark, given that Norwegian research ethics authorities rejected her long-gestating proposed trial of the LP for ME/CFS patients—a project she was pursuing as part of a doctoral program in psychology. The ethics authorities determined that the study was likely to generate biased results and that Landmark’s role was fraught with conflicts of interest. Although Landmark fancies herself an expert whose opinions on research should be shared, this official assessment of her work doesn’t induce confidence that she is qualified to pass judgment on or even assess NICE’s methodology.

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Caroline Struthers Renews Pressure on Cochrane

In recent years, Caroline Struthers, who describes herself on twitter as “a serial ‘healthy control’ research participant, citizen scientist, and patient-directed research enthusiast,” has politely but rigorously nudged Cochrane to take appropriate steps with regards to its problematic reviews of exercise and cognitive behavior therapy for what it has called CFS. The exercise review in particular has been a controversial document, and the saga has taken multiple twists and turns that are too complicated to enumerate here.

Struthers has posted her various missives about Cochrane on her blog, Healthycontrol.org. Because she understands the details of Cochrane’s processes, she knows how to frame the arguments for maximum leverage and impact. Last month, Struthers sent another well-constructed and cogent letter to Cochrane, triggered by recent developments involving NICE.

Here’s what she wrote on her blog:

“On 26 November 2021 I wrote to Toby Lasserson, Cochrane’s Deputy Editor-in-Chief, copying in in Gill Leng the Chief Executive Officer of NICE. My letter was prompted by the announcement that NICE and Cochrane have signed collaborative agreement. Among a few other issues, I am seeing reassurance that NICE will manage the risk posed by potentially delegating important decisions about the quality of evidence influencing NICE’s recommendations to an outside, self-regulated organisation.“

It is important to hold organizations to account when they fall short of expectations, as Cochrane has in how it has handled these two published reviews. Until recently, it had allowed the GET/CBT ideological brigades full authority over how the illness was handled. That has changed. In her latest letter, Struthers is appropriately asking Cochrane to clean up after itself and keep up with developments, among other requests. You can read it here.

Trial By Error: An Interview with Adam Lowe, a Member of the NICE Guideline Committee for ME/CFS

27 November 2021 by David Tuller 9 Comments

By David Tuller, DrPH

Adam Lowe, a patient, was one of five lay people on the committee pulled together by Britain’s National Institute for Health and Care Excellence to work on the new ME/CFS guideline. He and I spoke recently on Zoom about his role in the process.

Trial By Error: New Paper From PACE Authors Repeats Bogus Arguments and Defenses

20 November 2021 by David Tuller 7 Comments

By David Tuller, DrPH

The October 29th publication of the new guideline for ME/CFS from Britain’s National Institute for Health and Care Excellence (NICE) represented an enormous and humiliating repudiation of the PACE trial and the many related studies of cognitive behavior therapy (CBT) and graded exercise therapy (GET) as treatments for the illness. That means it also represented an enormous and humiliating rejection of the persistent claims by the PACE authors, and their colleagues, that this research documents meaningful improvements in patients.

Trial By Error: Some National Health Service Branches Fail to Respond to New NICE Guidelines for ME/CFS

16 November 2021 by David Tuller 11 Comments

By David Tuller, DrPH

In late October, the UK’s National institute for Health and Care Excellence (NICE) released its new ME/CFS guideline, which specifically recommend against graded exercise therapy (GET) and a specialized form of cognitive behavior therapy (CBT). Last week, I wrote about how King’s College London continues to host a page on “CBT and chronic fatigue syndrome,” which boasted that “our researchers were among the architects of bespoke talking therapy for chronic fatigue syndrome, which is now one of two treatments recommended in the UK.” (This page is still live as of this writing.)

Trial By Error: Is Something Shifting at the Science Media Centre?

15 November 2021 by David Tuller 11 Comments

By David Tuller, DrPH

For years, London’s Science Media Centre has fiercely promoted research into graded exercise therapy (GET) and cognitive behavior therapy (CBT) for the illness or cluster of illnesses variously referred to as chronic fatigue syndrome, myalgic encephaloymyelitis, CFS/ME, ME/CFS, and other names. Some of the prominent experts in this field have had close relationships with this specialized public relations agency.

Trial By Error: Authors Alicia Butcher Ehrhardt and Nasim Marie Jafry Discuss Their Novels

10 November 2021 by David Tuller 3 Comments

By David Tuller, DrPH

It is hard enough to write when you’re feeling healthy. So I’m in awe of people who manage to write despite suffering from a debilitating chronic illness—especially one that messes around with cognitive functioning. That number includes some ME patients who have written novels. (I don’t write fiction; I have a hard enough time keeping up with real life.)

Alicia Butcher Ehrhardt and Nasim Marie Jafry have both accomplished this impressive feat–their novels, respectively, are Pride’s Children PURGATORY and The State of Me (links are to Amazon.com). Both books feature a sympathetic central character who struggles with her illness. The portrayals clearly draw credibility and granularity from the authors’ own intimate engagement with the issue.

I’ve asked these authors to offer some thoughts on their books.

Trial By Error: King’s College London Is Still Hyping “Bespoke” CBT for CFS as “Recommended” in UK

5 November 2021 by David Tuller

By David Tuller, DrPH

A week ago, Britain’s National Institute for Health and Care Excellence published its new, evidence-based guideline for ME/CFS, which recommended against graded exercise therapy and cognitive behavior therapy offered as curative rather than as supportive care. Not surprisingly, this event creates some public relations problems for members of the CBT/GET ideological brigades, who have spent years promoting their dysfunctional beliefs that their favored interventions can cure the illness.

Trial By Error: Losers in NICE Guideline Fight Remain Defiant Despite Public Repudiation of Their Claims

31 October 2021 by David Tuller

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.

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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.

Trial By Error: NICE Liberates New ME/CFS Guideline After Two-Month Hijacking Nightmare

29 October 2021 by David Tuller

By David Tuller, DrPH

After much drama, the National Institute for Health and Care Excellence (NICE) has finally liberated its hijacked ME/CFS clinical guideline. As many know, in August the agency abruptly called off the planned publication of this new document, which was developed over four years. This decision occurred in the wake of fierce objections from members and allies of the graded exercise therapy/cognitive behavior therapy (GET/CBT) ideological brigades—those who now find themselves on the losing side of a paradigm shift.

In reviewing the relevant research, NICE assessed the quality of the main evidence for the effectiveness of GET and CBT for ME/CFS as of either “very low” or merely “low” quality. In contrast to NICE’s 2007 guidance for what it then called CFS/ME, the new version recommends against psychological and behavioral interventions positioned as curative rather than simply supportive, as well as against interventions based on the theories that patients’ symptoms were perpetuated by deconditioning and/or faulty illness beliefs.

Enabled by NICE’s previous guideline, many health care professionals have profited for years from their purported expertise in this purportedly “evidence-based” therapeutic strategy. Now the agency has changed course and determined this approach to be without merit, leaving these professionals in a bit of a lurch. As Brian Hughes, a psychology professor at the National University of Ireland, Galway, has noted, the history of this field has represented the triumph of “eminence-based” over “evidence-based” medicine. That era is hopefully ending.

Before and after the delay of the August publication date, some of those with reputational and other interests in maintaining the status quo expressed their discontent with the proposed new NICE guideline in blustery and embarrassing public statements. NICE followed up the publication delay with an announcement that it would hold a “round-table” discussion in October in order to allow various parties to air their concerns. That event, which occurred on Monday, was itself a source of much controversy because it represented a departure from NICE’s usual publication processes, among other issues.

Despite the anticipation of fireworks, the roundtable appears to have been rather anti-climactic and largely congenial, according to published comments from participants, with broad support for the version of the guideline produced by the appointed committee. Opponents of the guideline apparently failed to make any convincing arguments for their position. On Thursday, the agency made known that it was planning to publish the document today—as it did. With that, NICE dealt a severe blow to the authority and credibility of the cabal of medical grandees who concocted and promoted the GET/CBT paradigm for this illness in the first place, starting three decades ago.

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So…NICE’s about-face is good news in a field where there often isn’t any. This event is also occurring six years to the week since Virology Blog published my 15,000-word investigation of the PACE trial. At that time, an authoritative repudiation of all the evidence for GET and CBT from a major UK agency would have been inconceivable.

But the two-month delay has been excruciating for the patient community. And no one should view publication of this improved guideline as a panacea or as something that will immediately improve the lives of patients, much less those who have already suffered for years under the prevailing but anti-scientific medical attitudes and beliefs, as a regular Virology Blog commenter (“Lady Shambles”) recently explained in response to a post.

Many others also argue that the new guideline will not prevent the same potentially harmful interventions from being renamed and rebranded in the guise of “supportive” rather than curative care. Invest in ME, which supports biomedical research, today issued a particularly scorching response to NICE about this and other issues raised by publication of the guideline.

It is hard to dispute the validity of many concerns raised by critics, including the tally of the damage caused by long-standing policies. Like any clinical guideline, this one is open to abuse by health care professionals who choose to ignore or misinterpret or mis-apply its recommendations. Nonetheless, as another patient noted on Facebook, the publication is a way to “bank some of the progress” that has been made in correcting the scientific narrative—and can serve as an impetus for seeking related changes in medical practice and research.

Trial By Error: PACE Authors Now Blame “Misunderstandings” for GET/CBT Criticisms

23 October 2021 by David Tuller

By David Tuller, DrPH

It is hard to know what to make of the news that a peer-reviewed journal has actually accepted a PACE-reunion paper from the three lead investigators—Professors Michael Sharpe, Trudie Chalder, and Peter White. Even more so for a paper titled–without irony, it seems–“Evidence based care for people with chronic fatigue syndrome and myalgic encephalomyelitis.” This surprising event occurred on October 1st, according to a notice on the website of King’s College London, Professor Chalder’s home base.