By David Tuller, DrPH
This is the beginning of a new phase for “Trial by Error.” I initially assumed that my work on PACE and ME/CFS (or ME, or CFS/ME, or CFS) would be a one-off investigation, and then I’d move on to other projects. But after my 15,000-word series was posted on Virology Blog in October of 2015, the story kept going and going. I couldn’t stop myself—there was always more to write about. But it was all very complicated and I didn’t know where it would lead.
And then the issue gained traction and momentum, especially after the release last year of the trial data, which revealed how much the investigators had inflated their findings by relaxing their outcome measures. The data release itself occurred thanks to the heroic efforts of Australian patient Alem Matthees, who doggedly pursued his freedom-of-information request and defeated Queen Mary University of London’s high-powered legal team. Despite this success, there’s still more work to do, and I’m glad to have the opportunity to pursue the issue further. I owe that opportunity to all the amazing contributors to the crowdfunding campaign, and to the support of Professor Vincent Racaniello, the host of Virology Blog, and my colleagues at the School of Public Health at the University of California, Berkeley.
Going forward, I will drop the word “Continued” from the headline of this series and just use “Trial by Error.” I decided to keep “Trial by Error” because, well, I really like the name. And I think it accurately describes both the PACE trial specifically and the larger effort to impose the CBT/GET paradigm on this patient population. I have relied on my friends Valerie Eliot Smith and Robin Callender Smith for their legal insight throughout this effort, but I also need to thank them again for suggesting this perfect title two years ago.
Other than that, I expect things will more or less continue as before–some investigating/blogging on Virology Blog, some writing for other publications, some orchestration of open letters from academics, some use of social media, etc. Overall, the project should cover about half my work time. I have previously mentioned some things I want or plan to examine. Unforeseen topics will also emerge, of course—before Esther Crawley libeled me, who knew I’d write multiple blogs about her unscholarly behavior?
I won’t manage to do everything, but I hope to get enough done to help further blunt the authority and credibility of the CBT/GET ideological crusaders. Their position has been considerably weakened, given the willingness of many in the international scientific community to criticize the PACE study’s conduct and methodology. Yet the PACE investigators still present themselves as victims of an organized campaign of anti-science zealots, as Professor Michael Sharpe implied recently in his abstract for an “ethics” talk at Oxford. (Professor Sharpe’s position was artfully deconstructed last week on Virology Blog by Northwestern University law professor Steven Lubet.)
I can understand why the PACE investigators might have trouble acknowledging that the theory to which they have devoted decades of their lives has been undermined by the evidence of their own highly promoted trial. But the dereliction of editorial responsibility by The Lancet and other prestige journals, which have enabled the PACE/CBT/GET charade by publishing poor-quality work, is perhaps even more disturbing. It is not surprising that The Lancet has just published another flawed study from this school of research, a trial of self-help graded exercise for what the researchers still call “chronic fatigue syndrome.” In effect, The Lancet was doubling-down on its defense of PACE.
The Lancet editor, Richard Horton, has invested his reputation in the proposition that the PACE trial was methodologically sound and that the critics were not only wrong and irrational but were in fact harming the scientific enterprise. Yet he has also recently positioned himself as a high-profile scourge of poor-quality science. Given that, his refusal to acknowledge the flaws with the PACE/CBT/GET approach promoted by his journal represents enormous hypocrisy or a great talent for self-delusion.
In fact, The Lancet’s publication of the self-help graded exercise paper has occurred as the CBT/GET paradigm continues to lose ground elsewhere. Early this month, the Centers for Disease Control revised its website for the illness, in the process eliminating recommendations for these therapies (more on that below). In contrast, Dr. Horton and his journal remain mired in this swamp of bad science. So does the rest of the U.K. academic and medical establishment.
Just as The Lancet has published more “evidence” for graded exercise, the CDC has moved decisively in the opposite direction. In revamping the information on the part of its website geared toward the general public, the agency has “disappeared” all mention of CBT and GET as treatment or management strategies. Patients and advocates have long pushed for this step, as did Julie Rehmeyer and I in a New York Times opinion piece in March. Although the revised text is dated as having been reviewed on May 30th, it apparently went live sometime during the first week of July. (The CDC has still not revised the pages designed for health care providers, although old information has been removed. The agency calls the illness ME/CFS.)
For advocates, the CDC’s removal of the CBT/GET recommendations represents a major victory. “I think it’s huge,” said Mary Dimmock, an advocate who has long pressured the CDC to revise its website. Given the agency’s stature, she added, the decision could have widespread impact, not just in the U.S. but internationally as well. Many health care providers and institutions here and abroad look to the CDC for guidance in public health matters.
“So many patients have been made worse by the treatments,” said Dimmock, who became an advocate after her son became seriously ill several years ago. “While there is more to be done, removing these recommendations is a significant step forward in protecting ME patients from harm.”
In the revision, the CDC website has dropped the agency’s 1994 definition of the illness. The new definition, based on the one proposed in a 2015 report from the Institute of Medicine (now the Academy of Medicine), requires the presence of “post-exertional malaise.” In the 1994 definition, that was only one of eight optional symptoms. The immediate implication of the shift is that GET should likely be considered contraindicated, given the premium this intervention places on steadily boosting activity levels. The form of CBT prescribed in PACE could also be contraindicated, since the ultimate goal of that intervention is likewise to increase activity. (The CDC has not adopted the name proposed by the IOM report, “systemic exertion intolerance disease.”)
In addition to symptomatic relief, the revised CDC website suggests such management strategies as a balanced diet, nutritional supplements and complementary medicine. Here’s some of the new language on managing the illness that has displaced the previous sections on GET and CBT:
*Avoiding ‘push-and-crash’ cycles through carefully managing activity. “Push-and-crash” cycles are when someone with ME/CFS is having a good day and tries to push to do more than they would normally attempt (do too much, crash, rest, start to feel a little better, do too much once again). This can then lead to a “crash” (worsening of ME/CFS symptoms). Finding ways to make activities easier may be helpful, like sitting while doing the laundry or showering, taking frequent breaks, and dividing large tasks into smaller steps.
*Talking with a therapist to help find strategies to cope with the illness and its impact on daily life and relationships.
Of course, avoiding “push-and-crash” is what patients already do when they practice pacing. The “push-and-crash” language itself appears to be closely aligned with the arguments provided by the PACE investigators and their colleagues; many patients might describe their experiences differently. Nevertheless, removing the CBT/GET recommendations is a welcome step, if overdue. For years, patients and advocates pointed out the problems with PACE and related research, and also cited the evidence that too much exertion caused harm because of physiological abnormalities, not the deconditioning presumed by CBT and GET. But until now, the agency refused to make the necessary changes.
The CDC’s longtime promotion of these therapies has had a widespread negative impact, as I reported at length last fall in the MIT-based online magazine Undark. So it is not enough now to merely tweak the website quietly. The agency should publicly announce the changes and explain the reasons for making them. By removing CBT and GET, the CDC is conceding the truth of what patients and advocates have repeatedly told them—the evidence does not support recommending these therapies for this illness, either as treatments or as generic management strategies. Agency officials should now apologize for having gotten it so wrong and for having failed to address these legitimate and often-expressed concerns.
Many U.S. health care organizations continue to recommend CBT and graded exercise for ME/CFS, in part or in whole because of the CDC’s guidance. This approach still causes many patients to suffer serious and permanent deterioration along with the stigma and blame that come with the illness, said Mary Dimmock. She hopes CDC officials will now strongly promote awareness of the changed recommendations not just among the public but specifically among medical societies, medical education providers, state health commissioners and others involved in health care delivery.
“I want them to take a leadership position to disseminate this information proactively,” said Dimmock. “They have a responsibility to reach out and fix this problem.”
The CDC has another urgent obligation: To communicate with the U.K.’s National Institute for Health and Care Excellence, which develops clinical guidelines for various medical conditions. NICE is currently debating whether or not its recommendations for the illness—which it calls CFS/ME–need to be reviewed; of course, these recommendations include CBT and GET as indicated treatments. NICE is soliciting input this month from stakeholders, but the expert panel assessing the situation has apparently made a provisional decision that no review is required.
The CDC has a long history of collaborating with key members of the PACE team and others in the U.K. medical and public health establishments; it is not surprising that prescribing CBT and/or GET should have become standards of care in both countries. It is now incumbent on U.S. public health officials to alert their British colleagues, including those at NICE, that they have just abandoned these longstanding recommendations. They should also explain why they have taken that major step, and why NICE should consider doing the same. (More on the NICE guidelines later this week.)
22 responses to “The CDC Drops CBT/GET”
Thanks for all the work you’ve done and will do.
Andrew Gelman wrote a dismal review of Julie Rehmeyer’s book in the New Yorker, focusing primarily on PACE. He has history with this issue and is generally/willfully ignorant of the politics informing the disease and the issues surrounding its definition. Weaknesses in his view of PACE and M.E. have been thoroughly discussed on PR, with several choice criticisms offered by Jonathan Edwards. This latest expression really deserves a good thrashing, if you’re up to it.
Many thanks yet again. Step by precious step we are getting there!
I moved a week ago today and pushed the perimeter of my symptom/severity envelope to unpack as many boxes as I could then hide the rest in closets. Payback hit me 48 hrs later. This is Day 6 and I can hobble painfully to the fridge and watch TV. I suppose hiding my “to do” list in the closets is equal to CBT.
I’m not too sure what to expect from NICE in the UK. They didn’t invite the stakeholders until 10 days prior to the start of review. It was the taxpayer’s dollars that funded the PACE Trial Study. To remove GET & CBT might be admitting fault. These people are like Teflon. Nothing sticks to them.
The CDC has been masterful in doling out “victories” for the ME/CFS community.
Which somehow always manage to leave them “behinder” than they were in 1990.
Chronic Fatigue Syndrome Finally Gets Some Respect
By LAWRENCE K. ALTMAN
Published: December 4, 1990
AFTER years of dismissing chronic fatigue syndrome as yuppie hypochondria and little more than a figment of the imagination, doctors in growing numbers are coming to believe that it is a distinct condition and one that may reflect an overcharged immune system.
But just what agent may be switching the immune system into overdrive is still an enigma. Scientists around the world who are seeking to solve the mystery say infectious organisms and chemicals are their prime suspects. But before they can clinch the case they are trying first to develop a reliable test to distinguish the syndrome from the many other conditions with which it is easily confused.
Marking the seriousness with which the illness is now taken, the Federal epidemiological agency, the Centers for Disease Control in Atlanta, has started an investigation that officials say is more comprehensive than those the agency initially carried out for AIDS.
Although the new research is providing some tantalizing clues, experts like Dr. Stephen E. Straus, chief of medical virology at the National Institutes of Allergy and Infectious Diseases in Bethesda, Md., cautioned that the clues could join a list of leads that evaporated after more extensive research.
Chronic fatigue syndrome began receiving widespread attention in the mid-1980’s after reports of about 100 cases in the Lake Tahoe area of California. Questions immediately arose as to whether the ill-defined mix of symptoms amounted to a discrete disease at all, and if so, whether it was a new condition or was merely an old malady like the neurasthenia of the 1860’s, since known by other names, including Icelandic disease.
Now that some of the dust has settled, chronic fatigue syndrome appears to be the same as what is called low natural killer cell syndrome in Japan and myalgic encephalomyelitis in England. In the United States, chronic fatigue syndrome has also been called Epstein-Barr virus syndrome, chronic mononucleosis and yuppie flu.
That the CDC does no longer recommend CBT/GET could be useful to demonstrate to Cochrane leadership that there is a problem with its GET review for CFS.
It is big news when the CDC removes CBT/GET from its website. I suppose, had they mentioned their removal, it may have been some sort of admittance of their having been wrong, maybe?
Not to put a damper on it as it’s a massive step in the right direction but the use of the IOM definition is not the best one to use. Yes, they now have PEM, which is great. But there’s so much more. I didn’t notice any neurological symptoms (but I could have missed them?). Nor did I notice any mention of immunological dysfunction. These are worrying omissions.
In reading it, I do not see myself and so many other severe M.E. patients. I had a period when I went to a moderate level and maybe would have seen some aspects of my illness in their new guidelines. But they would still be lacking.
They are still not describing or defining M.E. [Thankfully they didn’t adopt the name suggested by the IOM]
When I see talk of ‘yoga’, etc., all I hear is lifestyle. This is not an illness that a change of lifestyle will cure.
The U.S. and every other country needs to use the proper name for our illness, M.E. They also need to stop conflating M.E. with CFS, as if they are one and the same illness. Until that is done, there will always be problems. Also, there is no such illness as ME/CFS or CFS/ME.
I, and thousands like me, have M.E. At some point, all health authorities and governments will accept the full definition of this illness. Can’t guarantee that I’ll still be around for that, sadly!
It is a move in the right direction – pity it wasn’t a bigger move.
As regards Richard Horton, well, the mind boggles!
I was feeling rather despondent today after all the information about the NICE review – or rather the lack of a review, and therefore the lack of progress on removing CBT and GET from the CG53 guideline for “CFS/ME”. You give me hope that one day things might change.
I would suggest that you could set as your end-points for Trial by Error, when the Lancet retracts the PACE (and any subsequent papers based on its erroneous data), and the NICE Guidelines are revised to drop GET/CBT as suggested treatments. I’m confident that those things will, in fact, occur before pigs sprout wings, but then, I’m an optimist by nature.
Personally, I think the best news for patients about the new CDC ME/CFS website is that the section for physicians links to the Myalgic Encephalomyelitis Primer for Clinicians published by International Association for Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis.
I suppose it’s the review in the link above. I don’t find this review dismal, it mentions the problematics of PACE and the problematics with possible subgroups in CFS/ME. Overall, could be better, but from a person that’s not an expert in CFS/ME, that’s more or less what I expected him to say.
The psychological damage done by the CDC having this on their website is incalculable. I have had CFS for 27+ years, KNOW GET/CBT is wrong and fake and damaging, and STILL wonder, when I see the CDC – and the MAYO CLINIC – having this as ‘the’ treatment. It hurts my stomach. Mine. Not just because I worry about new people, and less sturdy people, and their families and ‘caregivers’ – which I do, but because people from doctors to hospitals can use this against me, personally, supported by the CDC, any time they want to dismiss my symptoms or concerns.
It’s a tiny step – but symbols are often tiny.
Its too early to be sure of the outcome, but one patient who has contacted the Mayo Clinic reported they are in the process of reviewing their advice on ME and CFS.
I am a critic of the process used in the IOM report, given that it relies on assumptions about the state of science. Indeed at least one author of that report has stated they would prefer it were done a year or more later as new science was emerging. The problem with many of the symptoms is the published evidence fell short of what is needed in an evidence based review. This does not mean that the problems are not real, it means the science is not sufficiently advanced.
In an under-researched field, always short of funds, with few researchers who are dedicated to this subject, the science is decades behind where it should be. So things that are self evident to patients, like symptoms, are not adequately investigated in the scientific literature. In turn, the medical discipline tends to ignore or dismiss symptoms they cannot explain or understand or measure, while ironically ignoring major tests that do indeed verify problems, from the tilt table test to the two day cardiopulmonary exercise test.
Thank you for helping those of us who have been abandoned by research and science.
The way I see it, the CDC have ignored the CCC and then ICC and stuck with Fuduka (their own ‘newer criteria’ having fallen flat). The IOM list is basically Fuduka with PEM as mandatory, so much easier for them to accept as it is basically a revision of their own thing done by the IOM so it is easier for them to accept it rather than something totally external.
“I can understand why the PACE investigators might have trouble acknowledging that the theory to which they have devoted decades of their lives has been undermined by the evidence of their own highly promoted trial.”
The reality is that their own research has proved their hypotheses wrong over and again over many years, but they always choose to ignore the data that is shouting at them, and, instead, use elaborate statistics to tease the tiniest bit of ‘significance’ to support their obsession with CBT/GET.
Typical is this paper from 2005, that was drawn to my attention, yesterday, in which White proves that ‘CFS’ patients have a real lower tolerance of exercise, which is *not* due to fear of exercise, anxiety, or deconditioning, but he simply concludes he must adjust the behaviourist hypothesis in order to recapture the patients he’s just proved don’t fit his main contention! (The year before he had, similarly, done a trial on immune activation that found levels of TNF beta orders of magnitude higher in patients than controls, but that did not pique his scientific curiosity, either, let alone suggest a useful biomarker.).
From the 2005 paper:
“Graded exercise therapy (GET) has been advocated for CFS, on the basis that CFS is maintained by both the avoidance of activity and deconditioning. Two systematic reviews have concluded that there is high quality evidence of efficacy of GET in adult outpatients. Yet, many patients can drop out of GET or not even start it. This may be related to a *fear of exercise, which is reported by the majority of CFS patients*. [WTF! 😮 ] Fifty percent of 2338 members of an ME self-help charity held the belief that GET was damaging. Of 105 patients reporting their experience of exercise, 55% believed that their recovery would be facilitated by limiting their physical activity. Even some doctors have deep concerns over the current application of graded exercise programmes…
…The lack of a significant difference in physical activity in anticipation of the exercise test, both on the day of and the day before the test, suggests that there was no more anticipatory avoidant behaviour in CFS patients compared with healthy controls. However, there was a trend for the CFS group to have a shorter time on the treadmill, consistent with their perceived exertion being significantly higher at all three stages. This indicates that the CFS group found the exercise more of an effort than the controls; a consistent finding in past studies. This was not associated with excessive physiological arousal, and therefore, we would conclude that it does not support the presence of an exercise phobia. Because patients with comorbid psychiatric disorders were excluded, it is still possible that kinesiophobia is important in comorbid patients. This might explain why kinesiophobia, as measured purely by self-reported questionnaires, was found to be important in two previous studies that did include comorbid patients. The close correlation reported by Silver et al. between the kinesiophobia questionnaire score and the HADS depression and anxiety scores would suggest that the kinesiophobia maybe primarily related to comorbid mood disorders, rather than CFS itself. Our data suggest exercise phobia is unlikely to be a maintaining factor in CFS alone, without the presence of a comorbid disorder. The other contrast with previous work is that we used objective rather than subjective measures of avoidance and arousal…
…As both groups were equally sedentary and inactive, this suggests that fatigue was not caused by current levels of inactivity. The results from the psychological measures lend support to some of the perpetuating factors suggested by the cognitive–behavioural model for CFS being related to mood and somatic focusing. Avoidance of exercise maybe caused by beliefs (or cognitions) that, in their current state of health, exercise is damaging or could exacerbate illness, rather than a phobia itself. CFS patients had a lower exercise tolerance than did the controls, although they were no more deconditioned than were the sedentary controls. Somatic focusing and sensitisation are more likely explanations for the excessive perception of effort. We conclude that CFS, without a comorbid psychiatric disorder, probably is not an exercise phobia, and fear avoidance is perhaps less important in CFS than chronic pain disorders. The cognitive behaviour model may need to be adapted to include beliefs and interoceptive sensitivity for avoiding activity.”
Thus he starts off by offering up the fact that members of M.E self help groups and ‘even’ some doctors ‘believe’ [on the evidence] that exercise may be harmful, as his starting known FACT that most M.E patients are *afraid* of exercise!
Then, when he finds that ‘CFS’ patients had lower skin resistance than controls [which he doesn’t mention] and this proves they are not afraid, he says ‘this must be because this time we used objective measures rather than subjective’ questionnaires; and, instead of concluding that the questionnaires are wrong, and saying so, he, presumably, just makes a mental note not to use objective measures next time! 🙂
He actually finds that ‘CFS’ patients do perform worse in the exercise test, AND that it’s not due to deconditioning, even though they are matched with controls and less scared than them, and had no pre test anxiety the previous day: yet, instead of concluding this is the illness *actually being measured*, he just says they only ‘perceive’ they are fatigued: which is back where we started!
Then he finishes by saying, essentially, they ought to drop the fear of exercise mainstay of their theory, and replace it with the idea that we are ill because we believe what the help groups tell us, instead of what he tells us! By this reckoning, M.E could not have occurred before the charities were set up to help those suffering from it!!!
I also might add, that they say they excluded one person because he had a ‘fatigue score of 0’. This highlights another often forgotten point: people with M.E are often people who were high end exercisers, who found their abilities failing dramatically for no good reason. They experience problems long before they would be measured as unfit in the general population. Yet they would be disbelieved and turned away from help until their ‘fatigue score’ rose above zero too. By which time they could–and do–suffer years of misery and patronising disrespect from the medical profession. Trial by questionnaire is a bloody outrage that should not be allowed.
I expect that you will find similar ignoring of data that proves the opposite of what they want, in many of their papers, if you look particularly at those that have tended to be forgotten in the furore over PACE.
I agree that this is a positive move by the CDC. Anything that doesn’t recommend GET to people with M.E. is welcome because the harm it can cause can be extremely damaging and in many cases, life changing. However the cynic in me says that this is a bit of a sop to us, but I know you are aware of that David so I wont dwell on it. I’m not the type to settle for the crumbs off the table so we keep ploughing on and push for proper funding for this disease so that many of the good studies that are out there can be funded in replication studies.
Yes, unfortunately the poor practices of Cochrane’s psychology group is dragging the entire Cochrane reputation through the mud currently. Some of the rationality for their conclusions was blatantly nonsensical.
This is truly excellent news. CBT and GET have done so much damage over the decades, and it’s also a huge step in the right direction for the CDC to implement a criteria which requires PEM. Hopefully higher quality research and the funding for it will follow.
Have you read the full IOM document? It goes into symptoms quite a lot. It’s just the diagnostic criteria that are kept simple so that doctors can handle it, and it’s not too exclusive for a clinical setting.
Thank you David. For those interested in NICE-gate CG53, this is the Surveillance proposal consultation document. It makes interesting reading if up to it: https://www.nice.org.uk/guidance/CG53/documents/surveillance-review-proposal
The above link is via this page on the official history of NICE Clinical Guideline 53 for ‘CFS/ME’:
Thank you so much for all your hard work, which has been absolutely invaluable- this news is but one proof of that!
You may well have saved lives by playing your part in getting it off the CDC website (as well as the other victories, such as NIH’s revocation of its recommendation). As you know, GET is literally a prescription to nearly ensure increased morbidity and mortality since PER (PEM) is the hallmark of the disease. This has been a many decades-long battle (that will continue) but this is truly a day for celebration! We will look back on this as a crucial turning point! We will overcome.