By David Tuller, DrPH
Ten years ago this month, I launched Trial By Error with a 15,000-word investigation of the misbegotten and fraudulent PACE trial, which purported to prove that graded exercise therapy (GET) and cognitive behavior therapy (CBT) could cure what they then called chronic fatigue syndrome. And what an amazing ride it’s been for me—difficult and challenging at times, but always fascinating, rewarding and engaging, both intellectually and personally.
I have learned so much, have heard so many heartbreaking stories, and have met–whether in person or online—so many smart, funny, passionate and courageous people. I have also been deeply disturbed by the rampant and flagrant corruption in the editorial and peer-review practices of major medical journals, including those in the Lancet and BMJ stables. Not only have these august publications routinely failed to catch egregious methodological missteps, they have also routinely failed to take appropriate steps to fix problems once they’ve been pointed out. In many instances, their response to legitimate criticism can only be described as a blatant “fuck you.”
Back when, I never aspired to be the “chronic fatigue syndrome reporter” (or the “myalgic encephalomyelitis reporter”). I mean, who would have? But that’s what happened, and I am grateful that it did. Although I didn’t plan on spending an entire decade—basically, my 60s—on this project, it is hard now for me to imagine a more fulfilling or better use of my time.
The Lancet published the initial PACE results in 2011. Four years later, my initial PACE investigation appeared over the course of three days on Virology Blog, a popular science site hosted by my friend and colleague Vincent Racaniello, a microbiology professor at Columbia University. Given the length, the series was likely, for many patients, impossible to read without triggering major bouts of post-exertional malaise (PEM).
(As always, I need to point out that patients were aware of the trial’s fatal flaws long before I got involved; my work piggy-backed on their incisive and spot-on analyses of the research. I obviously owe enormous thanks to Professor Racaniello for supporting my project and allowing me to regularly hijack his site to disseminate my findings. I’m also grateful to Valerie Eliot Smith, a lawyer and longtime patient, and her husband, Robin Callendar; in addition to offering invaluable advice on legal matters, they suggested the name Trial By Error, which has stood the test of time.)
The publication of Trial By Error was very timely. A week later, Lancet Psychiatry published the PACE trial’s unimpressive long-term follow-up results, assessed on average 2.5 years after participants entered the trial. for the PACE trial. (The initial results were from the 12-month assessments.) This publication was another anti-scientific production from the high-powered triumvirate of lead authors—psychiatrists Michael Sharpe and Peter White, professors at, respectively, Oxford University and Queen Mary University of London, and Trudie Chalder, King’s College London’s factually and mathematically challenged professor of cognitive behavior therapy.
What was wrong with the follow-up study? Plenty. The authors chose not to focus on differences in long-term outcomes between the GET and CBT intervention groups and the comparison groups, since there were no such differences. Instead, they highlighted as their main finding that the intervention groups had maintained the (very modest) improvements claimed in the initial trial publication in The Lancet.
The fact that in the end the GET and CBT treatments provided no apparent advantage was relegated to a side-point—even though the results of interest in any clinical trial, even in follow-up, are the between-group differences, not whether the active intervention groups maintained their gains. In other words, presenting the follow-up findings as if they demonstrated the purported superiority of CBT and GET was a flagrant violation of scientific standards. It also represented a stark failure of the journal’s peer-review practices.
However, because Trial By Error had appeared the week before, some high-profile publications–such as Science (“Criticism mounts of a long-controversial chronic fatigue [syndrome] study”) and The Guardian (“Chronic fatigue [syndrome] patients criticise study that says exercise can help”)–reported on the Lancet Psychiatry paper and my expose in the same article. When these more balanced and nuanced media accounts appeared, it gave me great pleasure to imagine the dismay and shock they must have triggered in the three prominent academics in charge of PACE.
After all, these privileged and self-important investigators were used to glowing coverage of their work. From my perspective, some of this unwarranted praise could only be attributed to the British tradition of deference to authority—in this case, those who had risen to the level of. “professor.” In American English, “professor” is often used generically to designate anyone teaching students above the high school level. At Berkeley, for example, my students would routinely refer to me as their professor, even though I was officially a “lecturer.”
In the UK, it seemed to me, anyone anointed with an official professorship commanded unquestioning respect—whether deserved or not. In the case of the PACE authors and their colleagues, such respect was clearly not justified. Even so, patients challenging the study findings, no matter how cogent and accurate their arguments, were routinely portrayed as twisted and dangerous terrorists bent on tearing down the august domain of Science. In reality, the PACE authors and their ilk were the deluded batch, promoting bogus recommendations that posed enormous potential harm to patients, given the risk of prolonged bouts of PEM.
That an academic from a world-class research institution in the United States would call the trial “a piece of crap” and publicly rip a print-out of the trial to shreds was apparently outside these professors’ range of experiences and expectations. After the initial publication, QMUL declared that my work was triggering “internet abuse” and “reputational damage”—language that I interpreted as legal threats. Of course, I wasn’t sued then and I haven’t been since, even though British libel laws are far more biased toward the plaintiffs than in the U.S.
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Over the years, the PACE authors and their colleagues have made fools of themselves in trying to defend the indefensible. I could fill a book with tales of their stupidity and arrogance, but will just recount a couple of examples here.
Not long after the publication of Trial By Error, Professor Sir Simon Wessely, who had a major role in PACE although was not a listed author, immediately sought to support his colleagues with a misguided essay in The Mental Elf, a prominent site covering mental health issues. In the essay, called “The PACE Trial for Chronic Fatigue Syndrome: choppy seas but a prosperous voyage,” Professor Sir Simon compared the study to an ocean liner that sets out from Southampton to New York. After a few mid-course “corrections,” he noted, the “HMS PACE” arrived at last at its intended destination.
(The essay did not mention me or Trial By Error, although the post was clearly an effort to debunk what I had exposed.)
This was an idiotic and ill-advised analogy. Apart from calling to mind the Titanic, it represented a fundamental misunderstanding of the point of clinical trials—this from someone who fancied himself an expert in research methodology. As my friend and colleague Steve Lubet, a law professor at Northwestern University in Chicago (now emeritus), wrote in an open letter to Professor Sir Simon posted as a blog:
“You compare the PACE Trial to an ocean liner plotting a course from Southampton to New York, and express satisfaction that it made the trip “successfully across the Atlantic,” despite course corrections along the way. But surely you realize that a randomized controlled study is not supposed to have a fixed destination, but rather should follow wherever the evidence – or the current, to maintain the metaphor — leads. You thus virtually admit that the PACE Trial was always intended to reach a particular result, and that adjustments along the way were necessary to get it there. Just so.…”
Oops. Busted! In his response to Professor Lubet’s blog post, Professor Sir Simon dribbled out some drivel and nonsense, but the damage was done.
For his part, the hapless Professor Sharpe also tried to challenge Trial By Error’s reporting—to little avail. One of my sources, Columbia University’s biostats professor Bruce Levin, had referred to some of the PACE trial’s methodological missteps as “the height of clinical trial amateurism”—a potent phrase that made me laugh. Poor Professor Sharpe apparently took umbrage—and months after Trial By Error appeared, he e-mailed Professor Levin to ask whether he’d actually described the research in this manner.
Professor Levin informed him that, yes, he did indeed say what I’d quoted him as saying, and he shared with Professor Sharpe some of the other sharp criticisms he’d made as well. After Professor Levin informed me of their exchange, I e-mailed Professor Sharpe and offered to provide him with contact information for the other academic experts I had quoted. Perhaps, I suggested, he might want to vet all of their quotes in the story and assure himself that they all genuinely viewed his beloved trial as bullshit. Professor Sharpe declined my offer.
That was all quite a while ago now. To the discredit of The Lancet, PACE has not been retracted. It has, however, been discredited—and good riddance. Since those early years, the PACE authors and their colleagues have exhibited increasing desperation to protect their intellectual and academic turf. They continue to pretend their research has been robust and meaningful, and view all their critics as losers, creeps or charlatans. (I think they place me in the latter category, or perhaps even all three.)
Whatever. These academics are classic examples of what are known, in literature, as “unreliable narrators.” Nothing they say or write can be taken at face value. Everything must be presumed to be geared toward protecting their inflated reputations and their privileged status. However, they have lost control of the narrative. They know that, and they are scared. They continue to bleat in protest, but their three-decade hegemonic reign in this domain is over. The world is moving on—yet they refuse to budge.
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Thank you David, you mean such a lot to us all!
The BPS lobby are one of the main reasons that ME research worldwide is far behind what it could and should be, and why political, medical and social support are so appallingly prejudiced too. Whether or not they choose to acknowledge it publicly or to themselves, the BPS lobby’s insistence on maintaining their wrongful position on ME – something that is now impossible they don’t know – has long crossed the line to systemic, targeted abuse. They could give up the façade at any time, put the lives of those they continue to harm above themselves, but they choose not to. There are millions of people whose lives have been ruined by ME and far, far too many who have died from it; the BPS have blood on their hands.
It has been a pleasure to support you all these years, and read your carefully-worded and precise debunkings of the claims of the PACE brigade.
It is daunting, however, that you STILL have to do this, and at great frequency. We individual patients have no way of fighting back against such things as a fraudulent knighthood for Weasley based on the DAMAGE he has done. History will not be kind to him and his crew, but we who are sick have to live through watching people we love die because of them.
Thank you,, David for doing this work. Your blogs help me keep up, and encourage me that the nonsense is not going unchallenged. I am so glad you feel this has been worthwhile for you, too.
David – A seventh of your life (to date) is a huge commitment and I’m so glad you stuck with it and carried on way past what you had in mind to do. When you decide that you’re ready for a well-earned rest/retirement then I’m sure there’ll be a lot of very sad but extremely grateful people who, like me, have appreciated all the time and effort that you’ve spent on this arduous endeavour. (Of course, if you DID go another 10 years then that WOULD make it a quarter…..just kidding!)
Incorrect the trial was directed towards Chronic Fatigue Syndromes and Myalgic Encephalomyelitis. They literally used two sets of criterias. Then pretended the results are much the same for miscellaneous illnesses with fatigue as a core component and an acute onset brain and spinal cord infection by enterovirus, where viral persistence can occur. The dishonesty still persists even within this article too, as a kinda important fact to deliberately omit. Tuller has been larping for the patients miscategorized under CFS criteria for years. M.E. has always been EXCLUDED from this criterias. Tuller is complicit in the COVER UP as a journalist and clearly ignored the elephant in the room. On purpose.
David wrote:
“Even so, patients challenging the study findings, no matter how cogent and accurate their arguments, were routinely portrayed as twisted and dangerous terrorists bent on tearing down the august domain of Science. In reality, the PACE authors and their ilk were the deluded batch, promoting bogus recommendations that posed enormous potential harm to patients, given the risk of prolonged bouts of PEM.”
With ME management acting as a blueprint for the management of MUS, I’d argue that critics of MUS management i.e. patients or patient advocates who quite rightly question the MUS model/the recommendations of doctors who follow it, are likely now similarly regarded by the healthcare system as science deniers and/or dangerous actors, thus extending that potential harm to way more patients than much maligned and mistreated ME sufferers. The failure of doctors to challenge and scrutinize the MUS model may have led to them suspecting up to half of presenting patients of being a potential threat to all involved, (see -https://bjgp.org/content/67/656/106), with appalling consequences for both patient trust and sound unprejudiced medical decision-making across the board.
David also wrote:
“However, they have lost control of the narrative. They know that, and they are scared. They continue to bleat in protest, …”
It kind of looks that way to me.
Many thanks CT’s for your comment. I can add some more to this if that’s useful.
The MUS CBT model was debunked by a group of us in 2021:
https://www.researchgate.net/publication/355102181_Scott_Crawford_Geraghty_Marks_2021_MUS_concept_and_CBT_treatment_model_Editorial
Thankfully, this is not a concept used much now – not in the UK anyway.
This way of thinking has largely moved on to FND, which is in DSM-5. And to some extent – taken literally – has some merit – as in patients have some form of disruption/dysfunction of the neurological systems – BUT, and herein lies the problem, psychosocial overreach by many medical professionals, neurologists appear keen here, into underlying, unfalsifiable murky psychological models of FND. e.g. ‘panic without panic’ and other psychologically incoherent mumbo jumbo even with no objective evidence to support them.
As an example: CBT for FND conditions including Non-epileptic seizures, e.g., CODES trial, was not helpful in reducing objective measures such as seizure frequency. https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(20)30143-7/fulltext In this commentary Perez continue to believe that, “Thus, it is necessary to question whether this large, well-conducted clinical trial with a negative primary outcome proves that CBT is not incrementally effective for the treatment of dissociative seizures. In my opinion, CBT remains an effective treatment for dissociative seizures.” It beggars belief that post PACE-gate that any serious researcher believes that any modest gain in an unblindable clinical trail with subjective outcome measures is credible. But those that ‘believe’ must keep blundering on regardless, with large budgets, to the detriment of their patients. Sadly.
Perez goes on to justify this in the above editorial with: “I have witnessed how some patients with dissociative seizures can benefit greatly from a CBT approach that equips the patient with new psychotherapeutic tools, which in certain individuals can lead to robust and sustained clinical improvement.” Whilst this is great for the few stand out patients this applies to – it is Perez and colleagues responsibility to identify this subgroup and to not inflict what is essentially CBT/GET for ME/CFS and/or CBT for panic disorder onto patients with unclear or not yet understood biopathology. We know the harm this has done to pwME/CFS.
From a clinical perspective, when I meet patients with an FND label, it confers no additional value to the patient or in supporting patients to manage/cope with their symptoms as invariably there are no effective biomedical treatments. No patient of mine to date has been helped to overcome their FND and some are understandably bemused, insulted and angry about being psychologised / psychiatrised usually in a duplicitous and rather unclear fashion. It doesn’t fool anyone, although some clinicians seem to think this is a promising way forward. Dunno why as ‘it’ has been done to death over and over, ad nauseum. It would be far more helpful if clinicians were simply more honest (which they have an ethical responsibility to do) and told patients “we don’t know” rather than overreaching beyond the objective evidence.
David,
Thanks so much for your indefatigable work! The guidelines issued by the UK National Institute for health and care excellence (NICE) now treats ME as an organic illness and warns against graded exercise. The British Association for clinicians in ME (BACME) now follows suit, as do some of the (all too few) local NHS specialist ME services.
Not all, however. And, more importantly, the academic and medical establishments in the UK still largely regard ME as “not a real illness”. Living in Cambridge, UK, this was forcibly brought home to me when I welcomed a newcomer to our neighbourhood, an eminent professor of medical science at the university. Upon my announcing I ran an ME support group, they told me that people with ME are “either mad or depressed” and that “there’s really nothing there“.
This illustrates how deep prejudice within the establishment still runs. it is the reason so little money goes to ME research in the UK – as another researcher, who had discovered interesting overlaps between ME patients and his own field of cranial blood flow, told me when I offered to find him funding for a study specifically on ME: he dare not, because of the damage to his career it would cause.
You’ve done so much to change the tenor of the argument; sadly, it seems it will take yet more effort before rational argument penetrates the rhinoceros hide of the Establishment.
David,
We are so grateful you spent a decade in the trenches with us.
You wrote that you “could fill a book with tales of their stupidity and arrogance.”
Yes, please. Fill that book, publish that book, go on a book tour with that book. That book will give you a whole new world of media attention, a whole new level of media attention you have yet to get (Fresh Air with Terry Gross?!).
I only ask one thing about this (pending) (we hope) book: please make the connection to the USA and how the wrongful British thinking on ME/CFS has influenced US medical care and the (lack of) response from our federal health agencies (NIH, CDC).
You are uniquely positioned to write this book.
Next project? Yes, please!
Rivka
David, I am one of those patients who could not sit up and read the whole 15,000 word investigation or the subsequent posts, but I did spend many hours lying down in a dark room listening via my web reader at a reduced speed. In addition to learning about ME/CFS research, I gained hope and courage and improved my critical thinking skills. Thank you for everything you have done for us!
Also, I wholeheartedly agree with Rivka’s recommendation that you write a book about the whole ugly ME/CFS saga. I guarantee that you would have a volunteer book launch team like no other to promote it!
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without you – where would we have ended up,
thankyou for staying the voyage