By David Tuller, DrPH

October is a crowdfunding month at University of California, Berkeley. If you’d like to support my work, you can make a donation to the university (tax-deductible for US taxpayers) here.

Last week, Guardian columnist George Monbiot wrote another scathing column about the failure of the UK health care system to address the plight of people diagnosed with ME/CFS. (Monbiot’s previous column on the issue appeared in March; our interview about it is here.) The new column was pegged to the case of 27-year-old Maeve Boothby O’Neill, whose death in 2021 from complications of severe disease has received extensive media coverage in the UK (if not, unfortunately, in the US). But Monbiot also described at length the sorry history of London’s Science Media Centre, a PR agency masquerading as a purportedly neutral arbiter of research, in disseminating fraudulent research in this domain.

To be clear, I use “fraudulent” in the sense of “deliberately deceptive.” I have never claimed that the PACE investigators or their fellow travelers have engaged in the crime of “fraud.” I’m not a lawyer, so that’s not my area of expertise. Rather, I have argued that their research strategies are designed to generate false reports of success and mislead the medical and patient communities. These studies are the research equivalent of a Potemkin village–constructed to look impressive but, in reality, offering nothing of substance, or less than nothing, behind the glittering façade.

In response to Monbiot’s column, the lead PACE investigators (Professors Trudie Chalder, Michael Sharpe, and Peter White) have once again emerged from their cave with a letter defending their honor and promoting their bogus notions. Yet time and science have left these self-important grandees in the dust. They remind me of those ancient Japanese soldiers on obscure islands who didn’t know that World War II was over. Like rotten meat, their theories stink, and the investigators themselves passed their sell-by date long ago. If the PACE trial hadn’t been so awful and caused so much damage and human suffering, their plight would just be sad and pathetic.

Here’s the headline to their letter: “A dualistic view of illness doesn’t help those with ME/CFS.” In other words, this unholy trinity is regurgitating the same tired accusation they have trotted out over and over again–that anyone who challenges their shoddy work has bought into whatever it is they are calling “dualism.”

Their routine bleating about “dualism” is a deflection. Per the descriptions of the interventions–cognitive behavior therapy and graded exercise therapy–the PACE trial was based on the premise that “deconditioning” and “unhelpful beliefs” alone were responsible for perpetuating the devastating physical symptoms characterizing ME/CFS. Refusing to acknowledge that physical symptoms might be caused by pathophysiological dysfunctions sure sounds like dualism to me. Pot, kettle, anyone?

I’m a public health guy, not a biologist or clinician. Early in public health training, students learn about what are called “the social determinants of health.” It goes without saying that someone’s physical and social environment dramatically impacts their health status. But to extrapolate this self-evident concept and insist that a devastating illness can be attributed solely to “deconditioning” and “unhelpful beliefs” about illness—as the PACE authors have claimed for decades—is absurd.

The three professors dutifully note that Boothby O’Neill’s death was “tragic and should have been avoided.” But avoided how? Do they think she chose to starve herself to death—even as she was begging for hospital personnel to provide artificial feeding options? Do they believe she would be alive today if only she’d pursued a course of CBT or GET? Do they think these interventions are likely to save the other young women currently suffering at the hands of the National Health Service?They offer no suggestions on what treatment she should have received. Instead, they blame Monbiot for drawing “generalizations” that they claim are “outdated.”

Given that post-exertional malaise is a defining characteristic of ME/CFS, pushing people to ramp up their activity level despite a resurgence of symptoms is contra-indicated. Nonetheless, these “experts” refuse to acknowledge the harm their approach has caused to untold numbers of patients over the last 30 years. It must be hard to be told, later in your career, that the science to which you’ve devoted so many years is not only incompetent but has also made many patients worse. From that perspective, their reluctance to accept reality is understandable. But it is also unconscionable. In any event, their unwillingness to take responsibility for their errors and the indisputable flaws in their research doesn’t change the facts.

They write that “no relevant paper has been withdrawn and many systematic reviews and meta-analyses have found the approaches to be beneficial.” That statement presumes that the authors of these systematic reviews and editors of the relevant journals are honest brokers conducting honest research. That is not the case. Everyone involved is part of an insular cabal whose members praise and peer-review each others’ work and publish in journals with editorial boards populated by their cronies. This body of research is not science. It’s propaganda.

https://trialbyerror.org/2024/10/24/pace-authors-respond-to-monbiot-column-with-tired-arguments/

#Guardian #MichaelSharpe #monbiot #PACE #PeterWhite #TrudieChalder

By David Tuller, DrPH

*This is a crowdfunding month for Trial By Error. Donations (tax-deductible to US tax-payers) go to the University of Calinfornia, Berkeley, to support the project. The link to the crowdfunding campaign is here: https://crowdfund.berkeley.edu/project/42302

In the past, Professor Michael Sharpe, one of the lead PACE investigators, has intervened in my Berkeley crowdfunding and given my efforts a significant–although presumably unintended–boost. In the spring of 2018, I spent six weeks traveling around Australia, a trip that overlapped with that April’s crowdfunding campaign. During the campaign, Jennie Spotila endorsed it with a lovely post on her blog Occupy M.E., which included the link.

After Jennie tweeted it out, Professor Sharpe decided to retweet it and whine about the troubles I was causing with the following retort: “This is what researchers who are studying aspects of CFS/ME that activists don’t want studied are up against.” This was a spectacularly stupid move, since he’d in effect further disseminated the crowdfunding link. People began tweeting their thanks to Professor Sharpe for reminding them to donate. Let’s just say his efforts to criticize my efforts had some unexpected side benefits.

I had another fortunate turn of events that April. In Australia, I was interviewed for a TV documentary, and I cried while talking to the reporter. My unexpected and unplanned display of emotion—which I knew as soon as it happened would show up in the documentary–was apparently very moving to viewers. My donations shot up after the show aired.

From that campaign, then, I took two lessons about ways to boost the crowdfunding: 1) Cry on camera; 2) hope that Professor Sharpe pops up with criticism. Since then, I haven’t tried the first method again. But Professor Sharpe made his mark again the following spring, with a noble assist from Kate Kelland, Reuters’ former London-based health/science reporter—who was also a bestie of and unofficial PR voice for the so-called Science Media Centre.

In March, 2019, the month before that spring’s crowdfunding, Kelland published a purported expose about the supposed “harassment” of Professor Sharpe and others who, like him, were investigating ME/CFS. The article, grandiosely billed as a “Reuters Special Report,” was headlined “Sick and Tired: Online activists are silencing us, scientists say.” Kelland’s article was based solely on bogus complaints from Professor Sharpe and his colleagues, and she placed much of the blame for their woes on me and my dastardly behavior.

The article was loaded with nonsense, but I viewed it as a compliment. Obviously my work was creating some problems for these folks if they were going to such lengths to try to discredit me. I knew the effort to trash me would help me out during the following month’s crowdfunding—and it definitely did! Donors let me know they were outraged by Reuters unwarranted attack. So April, 2019, was a very successful crowdfunding month. Thanks again, Michael and Kate!!

(After that, with the advent of the pandemic, I began crowdfunding twice a year rather than once, so the totals have been lower.)

**********

Debate over the “fraudulence” of the PACE trial

This time around, unfortunately, Professor Sharpe hasn’t taken such an active role. But he did make an appearance on my Twitter (or X) feed in late April. Perhaps he was trying to boost my totals again but didn’t realize that I had shifted the crowdfunding this spring from April to May for various reasons? In any event, he noticed that I had posted a tweet–or an X–in which I referred to the PACE trial as “fraudulent.” His response on the platform: “So David—you are now making accusations of fraud. That is very serious. I hope you can prove it.”

I was surprised. Professor Sharpe blocked me on Twitter long ago, so I haven’t seen his tweets for years. Not reading his tweets has not been a great loss. I don’t remember why he blocked me in the first place, and I have no idea why or when he unblocked me, but hey, whatever!

In any event, I’m touched that he considers my thoughts important enough to warrant a comment, although what he wrote sounded like a potential legal threat. Professor Sharpe is fond of making such noises; I’ve noticed him send similar messages to others.

So let me answer. No, I am not accusing and have never accused the PACE authors of “fraud.” As I have said repeatedly, I am not a lawyer. I have no position on what constitutes fraud in the legal sense, either in the US or the UK. I have no idea whether the PACE trial would meet the criteria for the crime of fraud. That’s up to others to think about and decide.

However, I have regularly called the PACE trial “arguably fraudulent” or just plain “fraudulent”—a word that has a range of meanings. It can obviously be used to refer to a situation involving illegal activities. But it also can simply mean “deceptive” without explicitly conveying the notion of criminality. For example, one definition of “fraudulent” on the Cambridge Dictionary website is: “not what it claims or pretends to be.” The thesaurus section of the website lists “dishonest,” “untrustworthy,” “devious,” and “deceitful” as synonyms.

And that’s what I mean when I use the word “fraudulent” in reference to PACE–not that it is a case of criminality but that it is dishonest, untrustworthy, devious and deceitful.

What makes it so? Well, the most obvious example is that 13% of the participants had already met a key outcome threshold at baseline—a fact not mentioned in the key PACE papers. In the trial, these subjects were already “recovered” for physical function when the trial began—even as they were simultaneously disabled enough in physical function to quality for the trial. This anomaly—that these participants were simultaneously disabled and recovered on the same measure—obviously did not occur by accident. It renders the trial absurd and nonsensical. I’ve asked the PACE authors and Richard Horton, editor of The Lancet, to provide me with any examples of other trials in the literature in which a significant minority of participants met a key outcome threshold at baseline. They have never responded.

The information about this overlap in entry and outcome thresholds is clearly necessary to accurately interpret the meaning of the PACE trial’s results. Given that the authors chose to withhold this salient fact from readers, the trial is most definitely dishonest, deceitful, untrustworthy. In other words, “fraudulent.” I rest my case.

And hopefully this little post will boost my crowdfunding so I can once again thank Professor Sharpe for his help.

,

https://trialbyerror.org/2024/05/26/the-michael-sharpe-crowdfunding-effect/

#MichaelSharpe #PACE

George Monbiot explains the bad science around Graded Exercise Therapy etc.

Good to see awareness of this atrocity becoming more mainstream.

"Despite an overwhelming weight of evidence, the old believers, including Sharpe and Wessely, have continued to try to justify their model ... This is not how science should work."

https://www.theguardian.com/commentisfree/2024/mar/12/chronic-fatigue-syndrome-me-treatments-social-services

#MECFS #science #medicine #GeorgeMonbiot #SimonWessely #MichaelSharpe

"... Sir Simon Wessely, one of the most powerful figures in the British medical establishment.

"A man whose bad science, ego and ideology have for decades set back research into myalgic encephalomyelitis/chronic fatigue syndrome and treatments for the disease. ...

"Countless people were harmed... by following these junk cures."

https://donotpanic.substack.com/p/how-junk-science-set-a-countrys-health

#MECFS #BadScience #PACETrial #NHS #DWP #benefits #PEM #CBT #GET #LongCovid #SimonWessely #MichaelSharpe #ManselAylward