Reprinted with the kind permission of Cort Johnson and Health Rising.
By Cort Johnson
Our mission is to promote evidence-informed health decision-making by producing high-quality, relevant, accessible systematic reviews and other synthesized research evidence. Our work is internationally recognized as the benchmark for high-quality information about the effectiveness of health care. ~Cochrane
The Cochrane Reviews are the gold standard – highly respected and valued – they’re the go-to reviews doctors and medical websites use to get beyond the hype and learn how effective treatments really are.
In David Tuller’s superb Sept. 2018 piece Trial By Error: The Cochrane Controversy he pointed out how important a role the reviews play in bucking up the biopsychosocial view of ME/CFS, stating that “the CBT/GET ideological brigades and their enablers regularly cite Cochrane’s systematic reviews”. As long “as CBT/GET promoters can hide behind Cochrane’s skirts”, Tuller said, the biopsychosocial influence on ME/CFS research and treatment will continue.
Now in a potentially major event, the Cochrane is temporarily withdrawing the 2017 Cochrane Review on graded exercise in ME/CFS. That’s not the authors choice – they’re spitting mad at that idea – it’s coming straight from the Cochrane editors.
Several factors make this temporary withdrawal noteworthy – and suggest it might not be so temporary after all.
- Cochrane is withdrawing the review over the authors’ objections – an unusual occurrence.
Review withdrawal is usually based on new scientific evidence – but not in this case.
- The Cochrane editors appear to have decided that there’s a good chance that the original analysis was faulty.
Ironically, the review was not particularly laudatory. It concluded that GET was more effective at reducing fatigue than pacing, or no treatment at all, and did not worsen symptoms. It did not find evidence, though, that GET helped with pain, self-perceived changes in overall health, use of health service resources, and made little or no difference in physical functioning, depression, anxiety and sleep. The fact that the authors could not say that GET lessened an ME/CFS patient’s use of health care was important as one of the justifications for employing CBT or GET is that it will reduce doctor visits.
The CBT/GET field’s success is sowing the seeds of its decline. Years of federal funding from the U.K. and the Netherlands have produced enough studies to conclude that the therapies have limited efficacy at best. Why the U.K. or the Netherlands or anyone else would pour enormous amounts of money into a treatment with such little efficacy is baffling.
The Cochrane authors’ conclusion that further research is needed to determine the kinds of exercise that could be most helpful could, however, potentially set the stage for years of expensive studies. More money which could have gone to getting at the cause of ME/CFS being thrown down the GET rabbit hole.
The authors probably didn’t help themselves with their rather tortured attempts to find benefits. After stating in the main results section that:
“We observed little or no difference in physical functioning, depression, anxiety and sleep, and we were not able to draw any conclusions with regard to pain, self-perceived changes in overall health, use of health service resources and drop-out rate.” Authors
They reported in their conclusions section that:
“A positive effect with respect to sleep, physical function and self-perceived general health has been observed, but no conclusions for the outcomes of pain, quality of life, anxiety, depression, drop-out rate and health service resources were possible. Authors
Obfuscation in Full Force
Calling the decision “disprortionate and poorly justified”, the authors were not surprisingly rather upset to see their work removed from publication. A critic of the withdrawal responded to it in much the same way that Queen Mary’s College responded to ME/CFS advocates’ attempt to get at the PACE data: by ignoring the central issue – whether the original analysis was flawed – and going after the patient activists and then accusing the journal of folding to them.
Medscape reported that Colin Blakemore, a professor of neuroscience and philosophy at London University, said the withdrawal decision was basically a perversion of science that was done to mollify the “opinions of activists” and their “unsubstantiated views”. He accused Cochrane of capitulating to lobbying from small numbers of vocal patient groups.
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Medscape, to its discredit, missed the bad science theme and jumped on the angry patient theme, stating that, “Scientists conducting studies on potential therapies say they are often harassed and verbally abused by groups that disagree with their approach.”
The Cochrane editors fought back, stating that it’s decision was based on “extensive feedback” and a “formal complaint” which they felt raised “important questions”. Given how rare a withdrawal of a study over the authors’ objections from the Cochrane Library is, one can guess that the Cochrane editors felt substantial issue, indeed, had been raised.
Given the importance the huge PACE trial with its 640 participants must have played in the original analysis, any diminishment in that controversial trial’s effects might alone be enough to pretty well negate the already pretty mediocre conclusions the authors came to regarding GET. Earlier this year a re-analysis of the PACE trial data from a group which included David Tuller and other advocates such as Tom Kindlon and Alem Mathees cast dought on virtually every major finding from the trial.
Plus a highly critical paper which re-analyzed the Cochrane Review study data problems sharpened the Cochrane Editors’ focus a bit. It’s probably not often that the august Cochrane Reviews receive such an overt challenge. In July of this year, Mark Vink‘s and Alexandra Vink-Niese of the Soerabaja Research Center in the Netherlands re-analysis of the GET studies used in the Cochrane review concluded that the Cochrane GET review was wrong and that the studies do not show that GET is safe, and in fact the suggest that GET is “ineffective”.
A “Common Mental Disorder” No More
Let’s dispense with one issue right away: This illness should not be housed in the Common Mental Disorders group. Whatever the historical reasons for this arrangement, it undoubtedly must lead observers to assume that Cochrane as an organization endorses the framing of CFS as a psychiatric illness. David Tuller
Last year Tuller pointed out that Cochrane is aware of the PACE controversy; aware enough to have first given another ME/CFS exercise review to reviewers outside the Common Mental Disorders division (yes, Cochrane classified ME/CFS as a “common mental disorder”) who reportedly ripped it to shreds.
Cochrane just responded to Tuller’s and others complaints by moving the responsibility for reviewing these trials outside of their “Common Mental Disorders” division.
The biopsychosocial field has had a rough year. But is it enough to turn off the spigot that provides the funding which keeps the field alive?
This is just one in a series of wins by ME/CFS advocates seeking more relevant research and better treatment options than the biopsychosocial field offers. The overturning of CBT/GET recommendations for ME/CFS- they are starting to add up. It’s been a rough year for the biopsychosocial field….
- After Queen Mary University of London was ordered to release the raw data from the PACE trial, a re-analysis confirmed that the PACE authors reconfigured the trial in ways that produced dramatically better results
- A re-analysis by the U.S. Agency for Healthcare Research and Quality (AHRQ) of CBT/GET studies left it unable to recommend them for ME/CFS
- That prompted the Centers for Disease Control to remove recommendations for CBT/GET from its website.
- Remarkably, this year the Dutch Health Council, of all groups, recommended that GET not be used to treat ME/CFS
- In August of this year, a letter signed by over 100 academics, ten members of Parliament, and 70 patient and advocacy organizations urging an unbiased reanalysis of the PACE trial data was sent to Lancet.
- An editorial appeared in the London Times regarding that letter.
- Earlier this year Geraghty and Blease (who hails from the Harvard Medical School) argued that the “biopsychosocial framework currently applied to ME/CFS is too narrow”.
- Last year Geraghty used huge patients surveys to argue that CBT helps only a small percentage of people with ME/CFS and that GET often produces large negative outcomes.
- Last year the Journal of Health Psychology devoted an entire issue to the discussion of the PACE trial.
- In 2017 White published mediocre results from the 200 plus person GETSET trial. (Other than the Rituximab trial no nonbehavioral therapy trial has been able to come close to matching the size of the huge CBT/GET trials that litter ME/CFS treatment literature.)
The Journal of Health Psychology’s decision to devote an entire issue to the problems of the PACE trial raised the question when, if ever, a journal has devoted an entire issue to debunking a single trial? Citing the unwillingness of the PACE authors to engage with their critics at all, the editor of the the Journal of Health Psychology stated that
“the unwillingness of the co-principal investigators of the PACE trial to engage in authentic discussion and debate….(it) leads one to question the wisdom of such a large investment from the public purse (£5million) on what is a textbook example of a poorly done trial.”
Lancet, the publisher of the original PACE trial and the recent GETSET trial and others, under the editorship of Richard Horton, is at the epicenter of a veritable storm of protest. No one, it seems, can plausibly or convincingly stand up for the study. That Horton is willing to continue to subject his lauded Lancet to such ridicule is beyond puzzling.
It bears mentioning that Horton has been editor-in-chief of Lancet for over 20 years – longer than any editor since the 1940’s. He won’t be there forever. Perhaps Lancet will tire of his fact defying embrace of the PACE trial, decide he’s been in the chair long enough and give the editorship to a fresher face.
If the huge PACE study falls it will take others with it. The damage to the reputations of the authors – who have played a major role in the establishment of the biopsychosocial paradigm of ME/CFS and who have been so unyielding in their defense of the tarnished study – will likely be significant.
Whether these controversies will be enough to get funders in the UK, the Netherlands and elsewhere to point their dollars towards biological causes/treatments is unclear, but the Cochrane editors temporary withdrawal of their own GET review is a notable event. If that withdrawal becomes permanent or the review’s conclusions are dramatically altered, a chink in the biopsychosocial advocates’ armor will result. No longer will they be able to refer to a Cochrane review for validation.
About the Author: Cort Johnson has had ME/CFS for over 30 years. The founder of Phoenix Rising and Health Rising, Cort has contributed hundreds of blogs on myalgic encephalomyelitis, chronic fatigue syndrome, fibromyalgia and their allied disorders over the past 10 years. Find more of Cort’s and other bloggers’ work at Health Rising.