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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.
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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.
Obfuscation in Full Force
Calling the decision “disportionate 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.
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.”
Data not politics was clearly behind Cochrane’s move to withdraw the GET review
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 doubt 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.
Tide Turning?
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 report 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 a discussion of the problems of the PACE trial.
- In 2017 White published mediocre results from the 200 plus person GETSET trial. (Other than the Rituximab trial no non-behavioral 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 is, thanks to the lax editorship of Richard Horton, 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 journal to such ridicule is astonishing.
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 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, the biopsychosocial field will have lost a valuable crutch.
Another issue is the PACE trail authors who received funding for the trial also got paid income to do it. Their fight is not just about damaged egos, It’s also about altering data to get more funding, which is corruption. I wonder if they also received ‘back hander’ money from the medical insurance industry to try keep this a mental illness in order not to payout millions to ME/CFS patients who are biologically ill. I vaguely remember the infamous Simon Weasley (a co author of the PACE trial) may have been a spokesman for a medical insurance company or the industry? Is that correct?, if so he needs to be criminally investigated for fraud and corruption. And the medical insurance industry needs investigated too.
I didn’t know about the income. My guess is that one reason Horton and Lancet are so dug in is because if the PACE trial falls a lot will fall with it – including the reputations of the PACE authors, future funding for this area, etc. After ponying up millions of dollars for the biggest trial ever in ME/CFS – who would want to support these researchers again? Given the controversy who would even want to be in this field? I imagine recruitment is not high.
Simon Wessley was not a co-author, but he was involved. I think he managed one of the treatment centres.
Hi Brendan, British researcher Mo Stewart has done some valuable work on the links between the biopsychosocial model, the insurance industry, the UK’s Department for Work and Pensions (DWP) and its remodelling of the disability-related benefits system, which has been associated with the premature deaths of many thousands of disabled people in the UK over the past decade. The ‘work capability assessment’ which determines eligibility for support has made it increasingly difficult for people with ME/CFS (and other invisible, fluctuating conditions) to qualify for benefits.The DWP has *never* before funded medical research, yet it part-funded the PACE trial. The DWP’s involvement has been interpreted by many of us to be deliberately using people with ME/CFS ultimately to subvert the broader support of disabled people too ill to work and to undermine the whole tenet of the social security system. PACE is ideological, not just within medicine but within a neoliberal dismantling of the state.
I had no idea about DWP – a disturbing development indeed…Thanks for passing that on.
We were warned that this would happen. A California insurance commissioner stated, “unumprovident is an outlaw Company”. Unum vice-president was jailed. With that they were invited to the UK to join the DWP. Unimpressed ?
What normally happens with grant income is it is paid to the universities who are collaborating on a project. This is separate from the income any academic is paid to work in a university. Some universities also pay an academic a fee for any consultancy work they do on top of their salary. There is though an expectation that academics will bring in research grant funding particularly when they have a research centre to run.
I just want to jump up and down and say, “Yay! Get them! I ( and the uncountable numbers with this condition) am not bonkers.” I live in NZ, and have never felt supported by the medical profession. But I never felt threatened by them, either, as so many in the UK must have felt. This is good news.
Hi Cort I’m from the UK. Basically the pace trial was partially funded by the department of work and pensions (DWP) to remove people with Me/cfs from our benefits system(welfare). It only came out who funded the trial after the freedom of information act was used to obtain the data. This was the main reason why the data wasn’t released, because it has led to a political storm here. As they basically liked about their own results to save on the welfare bill of people that are expensive to treat.
I hope this clears up why the people up high are unwilling to admit any wrong doing!
This is basically correct. There isn’t any mystery about why a British government department would fund this study if you relate it to the overall Neoliberal agenda dismantling the welfare state and privatising its more profitable parts. The British National Health Service (NHS) is the largest emplyer in Europe.
It is a very juicy target for the huge global, ie largely US based, health care and insurance companies. But before it could be sold off to ‘for profit’ companies it had to be stripped of its less profitable parts especially the ‘burden’ of the costs of long term chronic illness. I.e. it had to focus on ‘acute’ i.e. highly profitable services and changed to an insurance funding model instead of tax based public funding model. Excluding large number of its most costly patients was essential to this transition. If they couldn’t prove they were ill they wouldn’t be a cost to the health budget.
The interests pressing for wholesale disestablishment of the UK’s extremely popular National Health Service promised huge savings of billions of pounds from the health budget by removing the ‘work shy’ from the health budget and forcing them ‘back to work’. In the UK’s this meant moving ME patients from the Health budget onto the budget of and Department of Work and Pensions (DWP) where they could be forced back to employment. This has been instituted. People in the UK with ME have been subject to very harsh ‘work ready’ tests by DWP. Fatigue and pain are NOT judged to be valid reasons not to be in employment. The PACE results justified and underpined this approach.
It has 3 benefits for the Neoliberal agenda. 1. It reduces the role of the Sate by reducing government budgets overall. 2. It reduces the ‘burden’ of cost of the chronically sick on the National Health Service budget and makes it much more attractive to the privatisers 3. It makes it compatible with, and attractive to, an insurance based system instead of a tax based system. Making large chunks of the UK health service MUCH more likely to attract ‘investment’ from the global giants of the US based insurance industry, whose share holders do NOT want to carry the ‘burden’ of chronic illness.
So those who scent the involvement of the global insurance companies are half right.
Wow…It’s amazing to see how a disease group can get caught in the machinations of these huge corporations. If the PACE trial gets retracted I wonder what effect it would have on all this.
Unfortunately Cort the process of dismantling the British Welfare State is now well advanced. Large parts of the NHS, especailly the infrastructure which supports it, has already been contracted out or ownership privatised. In the case of clinical services this is less obvious although it is happening in areas such as Radiology and Laboratory services. But the funding has been heavily reduced so that what patients see are fewer, less comprhensive, less accessible services ie. longer wait times or ovewhelmed Emergancy services.
This is parparing the health market for the deregulated environment which will follow the UKs departure from Europe and its opening up to overseas competition ie open slather for the bigest meanest international companies to cherry pick public assetts and leave the public sector with the dregs. The public are being taught through the diminuation of availablity that they cant have a comprehensive free health service, even thought it provides a better outcome more efficiently over all.
Its the same neoliberal agenda that has been followed throughout the world but there was more robust resistence in Eurpope where all the member countries had functoning publicly owned and funded health care ( what Americans call ‘socalised medicine ie tax payer funded) of which the British NHS, Swedish and Norwegian srvices were the most comprehenisve. Of course opening up the Eurpoean market has been a neoliberal goal.
Phillida, your post cleared up the confusion I had about the British Health Service. I had thought it was designed as universal, comprehensive coverage on a not-for-profit basis, but from you describe, it is now this more in name only, in publicly admitted, idealistic intention—in its sales pitch, so to speak—rather than in the realities of its workings, which are increasingly subverted to a for-profit system, with the most obviously disabled and the long term patients given the least possible support.
Our situation is doubly ironic in that a real illness is magicked away as fictional, psychogenic—a mental condition—and, not only that, but a “common” one too! “Common” with its derogatory meaning of low social status.
Britain was the hub of the industrial revolution and, along with Western Europe the origin of the capitalist system, so it makes sense that this pattern would overthrow or subvert the more socialistic intentions and forms which arose after WWII. The war decimated nearly everyone and made people realize more how they were interdependent, “one people”, becoming a springboard for socialistic modifications of capitalistic democracies.
But, the world is still a competitive place and with fears of falling behind, of “losing”, the “weakest” are sidelined or jettisoned overboard. The few rise to the top and organize the rest of us either to serve them or cause them no trouble. While the advertising and public relations’ pitch is geared to whatever people will like, accept or believe—
I think those are the headwinds we face, not only for those with this illness but for people everywhere. It is not a hopeless battle but one which good-hearted, purposeful, intelligent individuals working together can change. And that is what is happening in the research and patient communities now..
First they ignore you, then they laugh at you, then they fight you, then you win. Mahatma Gandhi
Let hope we win!
I also live in the UK. There is still stigma here with our illness due to corrupt and immoral interests in trivialising it through labelling it psychosocial in origin. I am so angry and saddened by the approach in the UK. I have all my hope in the Open Medicine Foundation and their collaborators. I long for the day that these patronising, arrogant people will be discredited once and for all.
It was so good to see the Dutch Health Council not recommend GET and to see the leadership of the Research Council, I think it’s called, of the UK be lead by a person with a biological bent.
If we can get the UK to reduce its funding for CBT/GET and the like, the field should slowly die away. Given how “hot” it is I wonder who in their right mind would want to follow Wessely, White, Sharpe et. al. ?
When does it get withdrawn? The link to it still works suggesting it is still on their site.
Hmmm – that’s interesting! I don’t know.
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 doubt on virtually every major finding from the trial.
Please don’t forget to give credit to Carolyn E Wilshire
She after all lead author, and did a tremendous job for us all. Experimental psychologist from New Zeland, with no ME-experience, but with a conciencens, that took on outing the bad science.
Thanks for mentioning Carolyn – Kudo’s for Carolyn for her commitment to good science 🙂
The more the biological evidence emerges (ex. the Younger brain inflammation data), the more the witch doctors will continue to fade. And good riddance.
Is it true that Prof Wessely also was involved in the British Science Media center, in control of what studies should be promoted to the press…? This is what I have heard years ago. Also that BCMC probably controlled by mediamogul Murdoch, with interest in the insurance companies.? Anyone that knows facts about this?
There is an error in your report – the quote about “little or no difference” from the main results section is about the comparison of GET vs CBT, and not about GET vs control, which the quote from the conclusions is about.
Thanks! I removed that part of the blog. That was a big boo-boo and thanks for pointing it out. It was a long, long results section and I didn’t read it carefully enough.
There is Laws under Uniform Commercial Code Laws all of these Bogus institutions putting out their fraud are liable to be sued with Commercial Liens including these Authors the liens can be so high in
monetary value that it also puts liens on their liability insurance Bonds & they would not be able to continue to work in their fields it 100% ties up these bonds I am now in touch with a few people & we are
planning to sue numerous Groups even individuals are liable in Commerce they are all actually Corporations…Warning to NIH CDC NHS WHO you are all liable under Uniform Commercial Code Laws & Commercial Liens are
actually, Arrest Warrant under these Laws your total assets can be linked 100% & reported to credit agencies worldwide. These Authors with their fraud their Homes Bank Accounts & all moveables can be seized &
their credit would become non-existent they would be lucky enough to get a job in McDonald’s washing floors no-one would hire them they could not be Bonded while a Lien is in place watch what my people are
now going to do I would even forward copies of the Liens to all Banks & they would not get any credit until the Lien is paid in full…Their credit cards including work ones would be stopped from working…I will
also, sue Simon Wessely he is not getting away with the harm he has done that is certain…I also think we should also get others involved in filing more Commercial Liens Arrest them all in Commerce seize their
assets make them become non-functional like many millions on ME/CFS patients neglected for decades…I know Uniform Commercial Law inside out I also know all the in/outs of Labor Laws as well & the violations
these Corporations have created is Millions in damages I can also easily take a Bond after 90 days & convert its Value into Research monies & these Liens are filed through the IMF it goes right across the
World in Commerce. Alien lasts 99 years or until it is Paid in full & a Common Law Court with 12 Juries are the only ones who can throw out a Lien & it will not be me lifting any of these Liens, enough is enough
watch what I will do now I even have the right people in place now to serve these liens including some good Notaries I am going to ruin some of these Morons & even a few Judges
Wishing everyone on the planet a great holiday season.