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.)