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.
These people got so much harm and suffering. It is disgusting. It is malpractice.
These people cause so much harm and suffering. It is disgusting. It is malpractice.
Thank you for writing about this David. I am very concerned about how the RACGP will influence the new Australian guidelines for ME/CFS that are currently being rewritten. Have you seen the RACGP response to the NHMRC ME/CFS guidelines scoping survey?
Thank you David and Janet. I was so distressed about all this. I easily deleted it online but the hard copy a friend sent was much more real I eventually realized and caused the distress so I turned the pages upside down and there was a beautiful blank deem piece of paper to write on. Having a bit of a chuckle now thinking of the other purpose I was thinking to use the sheets for but I thought they would be a bit rough for that. Oh, I’m referring to the racgp submission. I don’t seem to be distressed any more
I remember the old stuffed group but that’s many many many years ago.. suffering teenagers united to fight fatigue and end depression…the kids came up with that name. I remember…. yummy yummy cheezels, yummy yummy mini donuts. Such good memories. It’s so sad that things have gone backwards rather than forward. In the early days there was a paid social worker who worked with the group as I recall….. Tessa someone maybe. And Fred place collated a book in which many of the kids wrote about whatever they wanted to write about… similar to Peggy Munson book stricken. Oh, maybe you don’t want to hear about the old days. I wonder how old those kids are now.
As I recall I saw that one of them was 50 now
Gobsat…get with the times racgp how can the racgp be doing this in 2026.
s I said to a young doctor recently about another doctor… he’s a dinosaur. Exactly they are. How old are all these people supporting the handi guide etc. hand over to the younger generation and give up your power, look after your elderly parents as I did. Do what rotary did create another group for the old guard..probus as I recall
Professional reporting… join forces with other younger doctors….do it
Dr ewald, increase your humility! I’m nowhere near as educated as you but I was a primary school teacher so maybe I have a more balanced view of the world.
Is it the end of the world if young people eat cheezels and mini donuts at a party. And is it the end of the world if when my elderly dog developed arthritis and I was advised by the vet to take her for a brisk walk twice a day every day I only took her once a day three times a week for a sniffing around walk down the hill for about twenty minutes and then I tried to walk a bit quicker up the hill home…it worked. Come to think of it she refused to do those stupid brisk walks. And I realize now she enjoyed being tied up outside the me/cfs Vic office because she would have dug her heels in and she would have refused to walk in that direction if she didn’t enjoy being tied up on that big, beautiful grassed area outside old office. She was a kelpie she had lots of mental energy and enjoyed people watching and there were many people walking across that grassed area to the office in those days. I am thinking now of Dr Anne McIntyre 1989 book and something about who is healthier Mr fit or Mr laid back . The one who has a balanced life or the one who is obsessed with one aspect e.g
Mr fit
Thank you Anne for your wonderful book,.helped me so much
For a moment we had hope the HANDI guide would be retracted. That was short lived. Again we see pompous self-importance inflict itself on the lives of hundreds of thousands of Aussies. Yet in the current global climate, it’s not surprising… (It’s really hard not to let the cynicism win.)
Thank you David. I am relieved to read your clarity here. I felt excited reading the original article and then very disappointed reading Dr Ewald’s response.
One of the authors of the original article Jackie Stallard entered the Australian RACGP guidelines for review with theAGREE II instrument. It scored 28%.
Whereas the NICE guidelines scored 94%
‘The AGREE II instrument suggests that the RACGP guideline has very serious limitations and is not fit for purpose.’
https://mecfs.au/agree-ii-assessment-of-racgp-recommendation-of-incremental-physical-activity-for-myalgic-encephalomyelitis
I cannot fathom how some Australian GP’s and Professors are still defending such a deficient and dangerous guideline??
Another factual error in the RACGP’s HANDI committee reply: Daniel Ewald cited the wrong PACE paper. Ewald cited the trial protocol that was published in 2008, three years before the PACE trial. This protocol included objective measures and a reasonable definition of recovery. However, the 2011 PACE trial ignored the 2008 PACE trial protocol and went in a different direction. The cited 2008 paper is irrelevant to the PACE trial, or to the discussion. It is beyond belief that the chair of the HANDI committee supporting graded exercise therapy was unable to identify their main piece of “evidence”.
Furthermore, Ewald states that “The 2023 NICE guideline retraction was … not aligned with research evidence.” However, NICE included a 411-page document that assessed the evidence for graded exercise therapy and other non-pharmalogical therapies under the GRADE framework – https://www.nice.org.uk/guidance/ng206/evidence/g-nonpharmacological-management-of-mecfs-pdf-9265183028. NICE assessed the evidence for graded exercise therapy as low, because the lack of blinding and reliance on subjective measures left the trials at high risk of bias; trials failed to record or report harm; and the entry criteria did not require the presence of the defining feature of ME/CFS – post-exertional symptom exacerbation. Therefore, participants may have had fatigue caused by other diseases or lifestyle factors, not ME/CFS. As indicated in David Tuller’s article above, the date given by Ewald was also wrong – NICE published their ME/CFS guideline in 2021, not 2023.
Ewald’s error-filled reply displays the same lack of rigour as the HANDI committee’s guideline recommending graded exercise therapy.
I’m not aware of a union for any other profession that supports this level of behavior
But actually doctors are the ones with the mental health problems and we try to gently counsel and help them in a gentle caring way
I think the racgp is doing a disservice to doctors
It would seem that the whole purpose is that it would be rather convenient for them if we died and most of them probably wouldn’t be in the slightest bit bothered by that.. that doesn’t seem right to me but I m probably very silly and these doctors are very clever
I admire Karen Gordon