By David Tuller, DrPH
When I was in Australia for the first time in 2018, it was clear that the country’s general practitioners were fervent supporters of the biopsychosocial ideology when it came to ME/CFS. That hasn’t changed, according to a recent exchange of views published in the Australian Journal of General Practice.
The debate centers around the Royal Australian College of General Practitioners (RACGP) and its recommendation for “incremental physical activity” for what it calls CFS/ME. This recommendation is outlined in an article in the RACGP’s Handbook of Non-Drug Interventions (HANDI). The article was first published in 2015 and updated in 2024. (I wrote about HANDI in May of last year.)
The HANDI article includes a blanket endorsement of the fraudulent PACE trial, citing it with zero reference to the study’s egregious methodological and ethical flaws. The HANDI article even recommends the trial’s work products as useful tools, noting: “The PACE trial has produced a comprehensive graded exercise therapy (GET) therapist manual (and a manual for patients), which can be downloaded free of charge by going to the PACE trial website and selecting the relevant manuals from the trial information section.”
A March commentary in the journal—“Is the RACGP HANDI recommendation of incremental physical activity for chronic fatigue syndrome/myalgic encephalomyelitis harming patients?”—questioned the safety of the approach. As the authors write in their cogent and well-argued critique:
“The RACGP guideline lists the benefits of exercise therapy. However, these benefits have been demonstrated in other fatiguing conditions, not in ME/CFS. This is concerning, because the research consensus now recognises post-exertional symptom exacerbation (PESE) as the defining feature of ME/CFS. The RACGP guideline acknowledges PESE and the consequent reports of harm from patients with ME/CFS undergoing exercise therapy. However, the guideline dismisses the reports of harm without providing evidence for the dismissal…
“Graded exercise therapy misconstrues ME/ CFS as deconditioning combined with a psychological fear of exercise. Therefore, therapists actively suppress reports of harm, and worsening symptoms are not recorded…If therapies were subject to the same requirement to report adverse reactions as medications, it is likely that graded exercise therapy would have been contraindicated for ME/CFS in Australia, as it has been in the UK and the US.”
Not surprisingly, HANDI dismisses these claims. In an invited response, Dr Daniel Ewald, the chair of HANDI’s editorial committee, provides the same sorts of unconvincing arguments that have become standard in this domain. Here’s a sample:
“For CFS/ME, all the studies reviewed by the HANDI editorial committee (and Cochrane review) are RCTs or systematic reviews of RCTs. The evidence offered for harm from exercise is from surveys at high risk of bias. Clinicians should be aware that some patients with CFS/ME cannot tolerate graded activity, but some may have been poorly guided in correct exercise implementation, triggering exacerbation of symptoms.”
Dr Ewald rejects all the surveys for being at “high risk of bias.” But he fails to acknowledge that the exact same charge could be fairly made of PACE and pretty much every trial of GET and CBT for ME/CFS. These studies are unblinded and rely solely on subjective outcomes for their claims of success—a study design that is a recipe for an unknown amount of bias. The all produce exactly what you’d expect from bias alone—modest reports of benefit. The 2019 Cochrane review of exercise interventions, also cited by HANDI as authoritative, included only such trials, rendering it as uninterpretable as the studies themselves.
However, objective measures—when they have been used—have not supported these positive subjective reports. In the PACE trial, for example, all four objective measures failed to match the subjective findings. To address this embarrassment, the authors rejected their own objective measures by declaring them not to objective after all—for a variety of bogus reasons. This is not proper science–a self-evident fact that HANDI, to its discredit, refuses to acknowledge.
Furthermore, Dr Ewald repeats a claim that the PACE authors have made repeatedly—despite lack of supportive evidence. He presumes that any bad experiences with GET occurred because patients “may have been poorly guided in correct exercise implementation, triggering exacerbation of symptoms.” In other words, GET itself is fine. Problems arise only if it is done incorrectly.
And then there is this paragraph:
“The 2023 NICE guideline retraction was highly controversial and not aligned with research evidence, resulting in members of its writing group resigning. Details of the aberrant interpretation of evidence are outlined elsewhere.”
This passage contains two major factual mistakes. First, the new NICE guideline for ME/CFS was published in 2021, not 2023. Second, it was not a “guideline retraction.” The 2021 document was a new guideline developed from scratch. It did rescind the recommendations for graded exercise therapy and for curative forms of cognitive behavior therapy that were included in an earlier guideline from 2007, but there was no formal “retraction” of anything.
The HANDI article was revised two years ago. That no one at HANDI and the RACGP has noticed and corrected such basic errors during that extended period of time makes it hard to take anything they state seriously. Uncorrected factual errors are a mark of sloppy thinking, sloppy implementation, or both.
Moreover, I am tired of the argument—routinely made elsewhere and repeated here by Dr Ewald—that the departure of some members of the NICE committee invalidates the final product. The committee had 21 members. Four left. (One of those departures involved conflict-of-interest issues, not the content of the guideline.) That means 17 members remained on the committee. These 17 “remainers” included some strong biopsychosocial proponents. We can only assume they were on board with the guideline.
Dr Ewald also suggests that the NICE committee engaged in an “aberrant interpretation of evidence.” To support this point, he cites the whine de coeur signed by the PACE authors and dozens of members of the GET/CBT ideological brigades about the “eight anomalies” that purportedly marred the NICE guideline development process. Of course, Dr Ewald did not reference the robust rebuttal to those bogus charges from NICE itself.
All in all, more crap from HANDI. A shameful performance.