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

https://www.virology.ws/2021/11/20/trial-by-error-new-paper-from-pace-authors-repeats-bogus-arguments-and-defenses/

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.

According to NICE’s thorough review of the data, the main evidence for the effectiveness of these interventions is of either “very low” or merely “low” quality—a salient detail not mentioned in a newly published article from the three lead PACE authors called “Evidence‑Based Care for People with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis.” This is in some ways a sad and revealing document. It is obvious that these three–Professors Michael Sharpe, Trudie Chalder and Peter White–have nothing new to say. The folly of PACE has been exposed. They insist it’s all a big misunderstanding. They repeat disingenuous arguments that have already been rejected.

The authors submitted this new article to the Journal of General Internal Medicine more than a year ago—in August, 2020. Although this was a few months before the draft NICE guideline was released in November of last year, it had become apparent by then that the GET/CBT paradigm was on shaky ground. For unexplained reasons, the article was not accepted until October 1st of this year. That was after NICE’s abrupt decision last August to delay publication of the new guideline because of fierce protests from members of the GET/CBT ideological brigades–but before the guideline’s final release at the end of last month.

The authors might argue that this complicated timing justifies the decision to omit all mention of the ongoing NICE debate, the conclusions of the NICE draft guideline, and the terrible results from NICE’s extensive evidence review. This argument would be highly problematic. Given the year-long lag, the authors could easily have waited just a bit longer to publish. their work until final release of the guideline, had they chosen. The absence of any of this context makes everyone involved in the publication of this article look ridiculous.

The abstract of this paper was posted on the website of King’s College London last month, after the paper was accepted. Here’s some of what I wrote at that time:

“First of all, note the decision to use CFS/ME throughout rather than acknowledge the term ME/CFS, which has been adopted by NICE and US agencies as well. This contrarian choice strikes me as petulant, defensive and unnecessary. Perhaps it represents the professors’ refusal to acknowledge that they have lost all control of the narrative–even naming rights to the disease…

“It is inaccurate and unwarranted at this juncture to call GET and CBT “evidence-based.” It is true that there is more evidence about these treatments than any others. But the evidence does not demonstrates what the professors claim, as has been documented most recently by NICE. The Journal of General Internal Medicine should know better than to allow self-interested parties to mis-characterize the current status and stature of critical evidence in an article’s title and abstract.

“It is also not the case [as the abstract stated] that “the controversy about them [the interventions] arises from misunderstandings about their nature and delivery.” The controversy revolves around the fact that, for decades, the highest levels of the academic and medical establishments accepted nonsense as if it were impeccable research—even though first-year epidemiology students at Berkeley have no trouble identifying disqualifying flaws. To pretend this is all due to some unfortunate miscommunications is ridiculous—a desperation move.”

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So. There are lots of issues here! Where to start? Well, there’s this: While ignoring the recent NICE debate, the authors reference the now-dethroned NICE guideline from 2007, as if it remains relevant and actionable. In other words, the article was outdated the moment it was published. This ensures that, to anyone following this long-running saga, the three professors come across as hopelessly out-of-touch and self-deluded. They’re reliving past glories, like Sunset Boulevard‘s Norma Desmond (“I am big, it’s the picture that got small”).

The GET and CBT interventions were developed and promoted as curative in nature based on the notion that patients had no underlying pathophysiology causing the prolonged symptoms. Instead, the PACE authors asserted that patients were severely out of shape because of their sedentary behavior, itself arising from their unhelpful beliefs of having an organic disease that caused them to deteriorate after exertion.

Here is what they say now: “Rehabilitation, including CBT and GET, for CFS/ME assumes that disability and symptoms, once established, are at least in part maintained by factors that are

reversible. The reversible factors include psychological and behavioural factors, such as the patients’ worries about their symptoms and how they cope with them.”

This is rewriting history–the authors have previously asserted that the condition was entirely perpetuated by these factors–not just “in part.” Furthermore, they have never provided any legitimate or satisfactory evidence that any purported “psychological and behavioural factors” contribute to disability and symptoms. That has always been pure speculation.

This wouldn’t matter if they were correct in asserting that the research demonstrates the effectiveness of the interventions. But they’re wrong—as NICE has decisively shown. All they do here is repeat arguments about the PACE results they have made over and over while refusing to acknowledge the egregious methodological and ethical flaws that many others have noted—including the 100+ experts who signed Virology Blog’s 2018 open letter to The Lancet about the trial. 

As they have previously, the authors also make a big fuss about the need to use subjective outcomes because of the lack of biomarkers for the illness. But as far as I know, no one has criticized them for not using a non-existent biomarker–that’s a straw-person argument. Instead, the issue is that they are pretending the lack of a biomarker is the same as lack of objective measures. It is not, and they know this.

Here’s what they write: “In the absence of any established objective test or ‘biomarker’ for CFS/ME, the condition is defined almost solely by patient report. It is therefore both appropriate and necessary to determine the outcome of treatment for CFS/ME by asking patients about the same symptoms and associated disability that were used to make the diagnosis.”

This statement begs the question of why the PACE authors themselves included four separate objective outcomes of function in their trial–a step-test for fitness, a six-minute walking test, whether people returned to employment (or resumed their education), and whether they were receiving social benefits. These findings were disastrous—none matched the subjective reports or documented clinically meaningful improvement. Oops!

The authors have since cited various reasons to dismiss the objectiveness of their own objective measures. They argued, for example, that changes in the economy meant that failure to return to employment or get off benefits were not in fact reliable measurements. They also argued that the six-minute test was administered differently in PACE than in studies of other diseases, so it was not fair to compare their results unfavorably against other results. Does anyone believe they would have made these post-hoc claims of non-objectivity had the results been better? Not to mention that they dropped a major objective outcome—use of actometers to measure actual movement—after they learned from Dutch colleagues that the measure produced disappointing results in comparison to subjective ones. (You can read an excellent account of this issue here on Lucibee’s Blog.)

True to form, in this new article Professors Sharpe, Chalder and White continue to overlook their own objective outcome results in assessing the value of their interventions. They seem to believe nobody will remember that they personally selected these outcomes and included them in their trial protocol. Unfortunately for them, they don’t get to toss their objective outcomes overboard just because they don’t like the results.

All in all, another shameful performance by a cabal of investigators very aware that they have lost their dominance in this domain and that their reputations are in rapid decline.

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