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Trial By Error: Jennie Spotila Tracks Down–and Busts–an Old Tale About “Death Threats” from Patients

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By David Tuller, DrPH

In early 2011, the first report of the PACE results in The Lancet drew widespread criticism from patients and advocates. Later that year, stories about unhinged, anti-science patients harassing and threatening leading researchers in the field appeared in high-profile UK outlets like BMJ and The Times. In the UK, this appears to have been orchestrated with the help of the so-called Science Media Centre, which has always backed the crap produced by the members of the biopsychosocial ideological brigades.

The rumors of “death threats” from ME/CFS patients were not, however, confined to the UK. In her blog Occupy M.E., Jennie Spotila last week excavated how the “death threats” meme traveled to the National Institutes of Health–and finally gets to the bottom of the story. You can read it here or below; I am re-posting it in full with her permission.

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The Death Threat Myth Exposed
Jennie Spotila
April 6, 2021

Update April 7, 2021: Further comment from Dr. Vicky Whittemore added to the end of this post.

Last week, an old story was recounted to a new audience. During the March 30, 2021 NIH telebriefing with the ME/CFS community, Dr. Vicky Whittemore said that there had been death threats against grant reviewers in the past, and that this was one reason why NIH is now withholding the names of reviewers on the ME/CFS Special Emphasis Panel (referred to as the “SEP”). This is not the first time that NIH has used the story of death threats to justify withholding the grant review rosters from the public. This excuse is overblown, and every repetition of it harms the ME/CFS community by perpetuating derogatory stereotypes of advocates and people with the disease.

I can say that the death threat story is exaggerated because I have documentation of what actually happened. I began investigating who serves on the ME/CFS SEP in 2012. Grant review panels are federal advisory committees, and the law requires that the membership of the committees be disclosed to the public. Despite this requirement, Don Luckett at the Center for Scientific Review told me in 2012 that they no longer posted the rosters online “due to threats some previous panel reviewers have received.” At his suggestion, I filed a FOIA request for the rosters, and I also requested evidence of the threats. NIH initially refused to release the information, but I appealed and in 2014 I won. NIH released the rosters to me, along with the evidence of the threats cited by Mr. Luckett.

Despite Luckett’s use of the plurals “threats” and “reviewers,” the documents show that there was only one isolated incident. Dr. Myra McClure, a retrovirologist from Imperial College London, was scheduled to serve on the SEP on February 22, 2011. On February 5th, she wrote to the Panel’s Scientific Review Officer:

You will by now be aware of the campaign building up on websites to have me removed from the Committee reviewing CFS grants. I have been subjected to a couple of nasty calls from the US yesterday. One was from a journalist, Robert Serrano who has been researching the CFS/XMRV issue for his local paper, News Sun, distributed in the Wisconsin/Illinois region. He phoned to warn me that he had found out that “some of the extremists are obtaining guns with a view to marching to NIH and CDC to look for me and others like me who might stop CFS funding.”

Dr. McClure did not express fear or alarm in her email. Instead, she referred to the call as “bullying/intimidation,” and withdrew from the Committee because, “I am too busy to put up with nonesense [sic] like this.”

Two days later, Mr. Luckett forwarded McClure’s email to a colleague with the following summary:

A group of chronic fatigue syndrome activists have objected to a scientist we appointed to a review panel and she has received a number of disturbing calls which has forced her to resign from the panel. This reviewer, Dr. Myra McClure, said that a reporter from the News Sun in Wisconsin/Illinois called to warn her that extremists were obtaining guns with the intent of using them against NIH, CDS [sic], and others. See below. (I called the News Sun and they said that had [sic] no reporter by the name given.).

The SEP meeting was subsequently canceled. A new panel was recruited and the meeting was held without incident on March 24, 2011.

To be clear, NIH decided to withhold the names of grant reviewers from the public despite the legal requirement that the names be disclosed. Federal advisory committees do their work in public, and committee members know that their names and contact information will be disclosed to the public. Nevertheless, NIH withheld the names for years, thereby shrouding the operation of the SEP in secrecy and preventing the public from assessing who was reviewing ME/CFS grants.

I can imagine a situation where death threats could be so specific, targeted and frequent that it may warrant special precautions of some kind. But that is not the case here at all. The sum total of evidence of “threats against reviewers” amounts to a single phone call in 2011 to a single reviewer, relaying a story of “extremists” with guns who were supposedly going to march on NIH and CDC at an unspecified date and time. As unpleasant and annoying as the call was to Dr. McClure, the statements do not appear to meet the criminal definition of a death threat. Her description of it as bullying and intimidation is much more accurate. And that’s all there is. There were no other threats; there are no extremists. It goes without saying that no one obtained guns and marched on NIH or CDC. Yet ten years later, NIH is still citing this incident as justification for withholding information from the public.

It’s easy to trace how the story of that single phone call to Dr. McClure was repeated and magnified over time. After I made my initial inquiry about the SEP rosters in July 2012, there was email correspondence among several people at NIH’s Center for Scientific Review. Included in a batch of material “relevant to why we’d prefer the ME/CFS rosters not be made public” was an August 2011 article from The Guardian relating stories from researchers in the UK about hate mail, crank calls, and at least one disturbing personal interaction. The article uses words like “extremists,” “militants,” and “dangerous,” but includes no evidence of any coordinated group or campaign. McClure’s withdrawal from the SEP is referenced in that article, but now it is described as “she had to withdraw from a US collaboration because she was warned she might be shot.” That is quite a bit more specific and disturbing than the way she described the phone call immediately after it happened.

Fast forward ten years to the ME/CFS telebriefing last week: Dr. Whittemore referred to the death threat story while delivering her update on grant review. She was discussing why NIH is not publishing the ME/CFS Special Emphasis Panel rosters, and she said:

[T]he NIH policy has always been that members of the special emphasis panels are–that the names are listed in aggregate for all of the special emphasis panels. And it’s my understanding that actually before I joined NIH in 2011, that there were death threats made to some of the reviewers. And then that’s in large part why, um, that plus many of the special emphasis panels review very small numbers of grants, that it would be very obvious to investigators who reviewed their grants and NIH peer review policy is to keep the review anonymous. So those, for those reasons, the actual identity of the reviewers is not released for each individual special emphasis panel, but is released in aggregate.

Dr. Whittemore, like Mr. Luckett in 2012, said “threats” and “reviewers,” when the documents show there was only one isolated incident. And once again, NIH is saying those “threats” justify withholding SEP meeting rosters.

I reached out to Dr. Whittemore for comment, and asked for details about the threats she mentioned. She replied,

I learned about the death threats from someone at CSR who is no longer at NIH. I was never told any specifics about how many or to whom the threats were made, or who made the threats, so I am unable to answer your questions below. My understanding is that it was more the effort to maintain confidentiality of reviewers that led to the aggregate rosters for the Special Emphasis Panels.

Dr. Whittemore made her comments last week based on a story she heard from someone else at NIH, a story which she says contained no specifics. This makes me wonder how often this story gets repeated at NIH, and how much it informs the way NIH sees people with ME. The story is still being told, and is being used as an excuse to withhold information from the public. That certainly suggests that NIH believes some ME/CFS advocates could be dangerous–otherwise, why would a story from ten years ago be so significant.

I spoke with several advocates, all of whom said that Dr. Whittemore’s repetition of the death threat story is harmful. Sharon Shaw told me the comment, “portrayed the ME/CFS community as dangerous and unstable. . . Comments like this vilify the ME/CFS community, and further stigmatize and disparage people living with ME/CFS.”

Advocate Kellyann Wargo told me:

NIH, stating that they have received death threats in regards to ME, sends a smoke signal to researchers that they should think twice about getting involved in ME research, a field that is already lacking funding and researchers. It reinforces the stigma and marginalization of ME to the general public. Once that stigma is broadcast, it is difficult to extinguish. NIH is punishing the ME community because of a rogue agitator. They are saying to advocates “why should we fund anything to do with ME if an instigator is sending NIH death threats?”

That idea was echoed by Denise Lopez-Majano, who said, “How can we trust NIH has our best interests at heart if they say things like this? If NIH is perpetuating this belief among themselves, how can they expect to encourage new researchers to enter the field?”

I asked Dr. Whittemore how she would respond to the concern that her comments could perpetuate the myth that people with ME/CFS are unstable and/or dangerous. She replied, “I am sorry that my comments may be harmful to individual [sic] with ME/CFS. This was not my intent.”

The death threat story has taken on a life of its own. One crank call to one reviewer in February 2011 became “threats to reviewers” that NIH still believes is sufficient justification to withhold the rosters of ME/CFS SEP meetings. NIH continued to use that justification for two years after I won my FOIA appeal. The story was repeated within NIH over the course of ten years, including to Dr. Whittemore. She then went on to repeat the story to the ME/CFS community as part of the reason why NIH once again decided to withhold the membership rosters of the ME/CFS review panels.

The repetition of this story by a leading member of the Trans-NIH ME/CFS Working Group does real harm. Dr. Whittemore’s comments lent gravitas to the stereotype that people with ME are mentally ill and dangerous, and makes it sound like there is still a threat to be concerned about. Dr. Whittemore presented the story as established fact–despite the fact that this single phone call occurred ten years ago; despite the fact that there is no evidence of “extremists,” “militants,” or any violent intentions among ME advocates; and despite the fact that she herself has no specifics about what occurred and when.

In light of the full picture, it appears to me that there is a persistent prejudicial view of ME advocates at NIH. Furthermore, it is obvious that NIH should not continue to recycle this story for any reason, including as a justification for preventing the ME community from evaluating who reviews ME/CFS grant applications.

Update April 7, 2021: Dr. Vicky Whittemore provided additional comment:

Dear Jennie,

I am truly sorry for the hurt and harm I have caused the ME/CFS community by raising the issue of death threats in my comments during the NIH telebriefing.  Since the telebriefing, I have heard from several individuals with ME/CFS who have expressed to me how hurtful my comments were. That was certainly not my intent and I sincerely apologize for making those remarks. I was wrong to have said those things.

NIH works to maintain the confidentiality of peer review of grant applications reviewed in all standing study sections, and in the Special Emphasis Panels that often review very small numbers of applications.  The main driving factor for the aggregate listing of members of the SEPs is to keep the identity of the reviewers confidential. 

For everyone’s information, the reviewers who participated in the most recent ME/CFS SEP were posted:  https://public.era.nih.gov/pubroster/preRosIndex.era?CID=101323&AGENDA=409493

I would appreciate it if you would post this apology to the community.

Sincerely, Vicky

Trial By Error: A Letter to Psychological Medicine about Error in MUS Paper from Sir Simon and Colleagues

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By David Tuller, DrPH

I have previously documented that some of the leading experts in “medically unexplained symptoms” (MUS) have regularly misstated a core finding from a seminal study in their field. The study—”The cost of somatisation among the working-age population in England for the year 2008–2009”—was published in 2010 in the journal Mental Health in Family Practice.

The same mistake has been repeated in journal after journal, and at least a couple of these instances have been corrected. It has recently been brought to my attention by a shrewd observer that the venerable journal Psychological Medicine published one such study two years ago, with Professor Sir Simon Wessely as a co-author.

Psychological Medicine is the journal that, in 2013, published the infamous PACE trial “recovery” paper, in which participants could get worse on the two primary measures and still be counted as “recovered.” At that time, the journal’s editors-in-chief—Professor Robin Murray from King’s College London, and Professor Kenneth Kendler at Virginia Commonwealth University–refused to acknowledge the paper’s methodological and ethical lapses.

In March of 2017, Virology Blog sent an open letter to the journal requesting retraction of the paper. More than 100 scientists, clinicians, and other experts signed the letter. The journal ignored it. Perhaps relevant to that decision was the fact that PACE lead investigator Professor Michael Sharpe is on the journal’s editorial board. For that matter, so is Sir Simon, who is also a King’s College London colleague of one of the journal’s two top editors, Professor Murray.

Given these links, and judging by the problematic results, it is easy to believe that the Psychological Medicine peer review process for papers from authors viewed as eminent is less than rigorous. Anyway, below is the letter I sent yesterday to Psychological Medicine.

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Dear Professors Murray and Kendler:

There is a serious factual error in a 2020 paper (epub 2019) published by Psychological Medicine called “Characteristics of patients with motor functional neurological disorder in a large UK mental health service: a case-control study.” The authors are O’Connell, Nicholson, Wessely, & David. 

In their introduction, the authors misstated the core finding of Bermingham et al, a seminal study in their field. They included this sentence: “Bermingham et al. (2010) reported that the incremental cost incurred by somatising patients is £3 billion per year, accounting for 10% of total NHS expenditure.”

This is definitely not what Bermingham et al reported. In fact, Bermingham et al reported that the costs of treating working-age patients assessed to be “somatising” accounted for 10% of NHS expenditures for people of working age–not for the overall populatio. For the year studied in Bermingham et al, total NHS expenditures were around £!00 billion–not the £30 billion implied by O’Connell et al in declaring that £3 billion represented 10% of the total. The statement in O’Connell et al had the obvious but unfortunate effect of more than tripling the apparent impact of the costs of these patients to the NHS.

Other experts in “medically unexplained symptoms” (MUS) have similarly cited Bermingham et al inaccurately. Both the British Journal of General Practice and BMJ Open have acceded to requests that the exact same error in papers they published be corrected (see here and here). That some of the most eminent scholars in the MUS field have made this significant mistake in multiple publications over the course of a decade is rather perplexing, as is the repeated failure of the peer review process at multiple journals to catch it.

I am writing to you directly because this does not seem to be a matter for correspondence or for an exchange of views with the authors. The statement about Bermingham et al is false and needs to be corrected. 

I have cc’d the corresponding author on this message. I have also cc’d the primary author of the mis-quoted study, Bermingham et al, in case there is any confusion over the meaning of the data.

Thank you for your prompt attention to this matter. 

Best–David

David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley



Trial By Error: Journal of Health Psychology Publishes Hughes-Tuller Critique of Wessely-Chalder CBT Claims

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By David Tuller, DrPH

What kind of researchers would publish obviously misleading figures about their favorite intervention in a study abstract? And who would make causal claims in a paper while simultaneously pointing out that the study design does not allow for causal claims? Well, it seems Professor Sir Wessely and Professor Trudie Chalder, along with three of their colleagues from King’s College London, would do both of those things.

Another question is why would the purportedly rigorous Journal of the Royal Society of Medicine publish a paper that included misleading figures in a study abstract and made unwarranted causal claims? What happened with the peer review process that such obvious failings were not noticed, or not revised if they were? Did the journal recognize that it would need to be especially rigorous when reviewing a paper co-authored by the sponsoring society’s immediate past president, and that any weaknesses exposed later on would reflect especially badly on all involved?

And beyond all those questions is this one: Why would the investigators, the journal or anyone put themselves in the embarrassing position of publishing a study as bad and misleading as “Cognitive behavioural therapy for chronic fatigue and chronic fatigue syndrome: Outcomes from a specialist clinic in the UK” in the first place? My epidemiology colleagues on the public health faculty at UC Berkeley would be horrified and wonder where they went wrong if their students turned in homework as abysmal as this Wessely-Chalder co-venture.

This paper was spectacularly easy to critique–it almost read like a parody. Once again, as with the PACE trial, core members of the biopsychosocial ideological brigades have produced something that seems designed for use as a case study of how NOT to conduct research. Why are they still foisting nonsense like this upon the public and seeking to influence medical practice with such flawed argumentation?

When the bogus Wessely-Chalder study first appeared last year, I gave it a tough critique in a blog post. After that, my friend and colleague Brian Hughes, a psychology professor at National Ireland University Galway, and I wrote what started off as a letter but ended up as a full-fledged commentary. We submitted it to the Journal of the Royal Society of Medicine, but it was politely declined. I don’t think either of us was surprised by the rejection, although it was nonetheless dispiriting–a sign that the journal, its editor, and presumably the investigators had no intention of taking responsibility for the problems we had documented. That failure to take responsibility represents a violation of the norms of proper scientific inquiry.

We were delighted that the Journal of Health Psychology was interested in reviewing our critique, and ultimately publishing it. As can be seen by comparing the version we posted on a pre-print server with the one released by the journal, we have added a strong critique of the deficient peer review process to which the Wessely-Chalder study was subjected. The authors have done themselves a real disservice by publishing their findings in a journal with such close ties to one of them, if that association was a factor in the inadequacy of the review process. As a result, the good professors and the journal have all scored an own goal.

Brian has written about the whole thing on his blog, The Science Bit. You can read our paper itself here.

A tapeworm drug to treat COVID-19?

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Niclosamide (pictured) is a drug that has been approved in humans to treat infections with a variety of tapeworms. It might be useful for preventing SARS-CoV-2 replication and COVID-19 pathogenesis by inhibiting virus-catalyzed membrane fusion.

Examination of the lungs of 41 patients who died of COVID-19 revealed, in addition to expected lung injury, the presence of syncytia. Such giant cells contain many nuclei and are produced when SARS-CoV-2 infected cells fuse with neighboring, uninfected cells. The fusion occurs when the spike protein of SARS-CoV-2, present on the plasma membrane of infected cells, attaches to the receptor ACE2 on a neighboring cell. This interaction would normally allow virus particles to fuse on entry into cells. In this case, the interaction leads to fusion of neighboring cells. Production of only the spike protein in cells in culture also leads to formation of syncytia.

These observations suggested that a drug that inhibits syncytium formation might help alleviate the severe lung injury observed in some COVID-19 patients. Screening of over 3000 small molecules for their ability to inhibit cell fusion identified a variety of candidates which had in common the ability to regulate intercellular calcium levels. Some of these compounds, such as Niclosamide, inhibited both membrane fusion and virus reproduction.

Niclosamide is an inhibitor of the calcium-activated TMEM16 family of chloride channels. Production of spike in SARS-CoV-2 infected cells leads to activation of TMEM16, which is required for syncytium formation. These observations explain why inhibition of TMEM16 by niclosamide impairs formation of syncytia.

Based on its known activities, activation of TMEM16 by SARS-CoV-2 infection might not only stimulate formation of syncytia, but could also promote inflammation, thrombosis, and diarrhea, the latter through promotion of chloride secretion from cells. Hence the drug might be useful for treating COVID-19 disease and might have efficacy later in infection when antivirals are not effective.

Trial By Error: Prof Sharpe Fact-Checks Comment on Blog About How George Monbiot Is Causing Long COVID

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By David Tuller, DrPH

*April is crowdfunding month at Berkeley. I conduct this project as a senior fellow in public health and journalism at the university’s Center for Global Public Health. If you would like to support the project with a donation to Berkeley (tax-deductible for US taxpayers), here’s the place: https://crowdfund.berkeley.edu/project/25504

In a surprising development, Professor Michael Sharpe has left a comment on a blog I posted yesterday. The blog was about Professor Sharpe’s apparent belief that Guardian columnist George Monbiot and Long COVID support groups, among others, are causing the wave of prolonged symptoms being reported by many thousands of people after confirmed or presumed cases of COVID-19.

Most of all, I want to thank Professor Sharpe for reading Virology Blog! His comment wasn’t even directly about the blog itself. He was actually correcting a misstatement made by a previous commenter. I’m impressed! When it comes to Virology Blog, at least, Professor Sharpe really gets in deep and whacks through the weeds. Even I don’t always make it through the comments–some can be quite long!!–so I am gratified that someone of his stature is fact-checking them. An honor, Professor!

I hope Professor Sharpe chooses to comment again in future. His contributions and observations are always welcome—especially during Berkeley’s crowdfunding period. (Have I mentioned yet that April is a crowdfunding month for campus projects?)

Professor Sharpe has intervened previously in Berkeley’s crowdfunding campaigns. Three years ago, he tweeted about how my existence created a burden that he and other researchers had to bear. To demonstrate the weight of the burden I represented, he retweeted a link to that year’s campaign. Many people responded by thanking Professor Sharpe for reminding them to donate. Total funds rose dramatically over the next couple of days.

Two years ago, Professor Sharpe starred as a heroic scientist battling unhinged and possible dangerous harassers in a Reuters article that portrayed me as an ME/CFS Pied Piper of sorts, raking in untold sums from gullible patients around the world. The Reuters article ran that year in March—right before the April crowdfunding campaign. Multiple donors mentioned the Reuters article as a factor in their decision to donate to Berkeley in support of my work.

When I first saw Professor Sharpe’s name among the commenters earlier today, I thought it must be a joke. I mean, someone recently donated to Berkeley’s crowdfunding campaign with the name Arnold Schwarzenegger. It was not, in fact, that Arnold Schwarzenegger. (Have I mentioned yet that April is a crowdfunding month for campus projects?)

However, when I checked into it, this Michael Sharpe’s e-mail was from Oxford University—so I figured it was indeed that Michael Sharpe. Here’s what he wrote: “I do believe the word ‘hysterical’ is Dr Tuller.“

Weird. I didn’t understand. What was he trying to say? Was he accusing me of being the hysterical one? As I scanned the comments preceding his, it became clear what had happened. This paragraph in my post was the source of the problem:

“Here’s what seems to be Professor Sharpe’s basic point: We wouldn’t be hearing from all these anxiety-ridden, depressed, hysterical and deluded people (mostly women) if they weren’t being convinced that there’s a thing called Long COVID by patient disinformation and fearmongers like George Monbiot.” (Italics in the original.)

One commenter misread what I wrote and seemed to impute the word “hysterical” to Professor Sharpe. After that, Professor Sharpe himself weighed in. So it seems that, in response to what he read in the comments, he was correcting the record: ‘hysterical’ was a word I, David Tuller, used, not one he used in his presentation.

In other words, here’s what he meant to write: “I do believe the word ‘hysterical’ is Dr Tuller’s.” He left off the apostrophe and the ‘s.’  Got it! We’ve all done that. I’m sure I’ve done worse!

Ok, then. No disagreement from me. I used “hysterical” in a passage that I presented as how I interpreted Professor Sharpe’s point. I didn’t suggest or indicate “hysterical” was his word. Any misunderstanding on the commenter’s part was unintentional, and Professor Sharpe did not suggest otherwise. As I gather, he was just making sure everyone knew what was what.

I’m glad Professor Sharpe clarified that point. I am also perplexed, tickled and touched that he felt such a compelling need to correct an insignificant comment under a post of mine on Virology Blog. But hey, why not?

Maybe now Professor Sharpe can also finally clarify why 13% of the PACE sample was already “within normal range” or “recovered” on the key outcome measure of physical function at baseline, and why that statistical anomaly was not disclosed in the trial reports. Does Professor Sharpe understand that failure to disclose such a salient fact seems to meet standard definitions of research misconduct? .

Professor Sharpe—please feel free to comment!

Oh, and have I mentioned that April is a crowdfunding month for Berkeley campus projects?

Trial By Error: Guardian Columnist George Monbiot Is Causing Long COVID, Says Professor Michael Sharpe

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By David Tuller, DrPH

*April is crowdfunding month at Berkeley. I conduct this project as a senior fellow in public health and journalism and the university’s Center for Global Public Health. If you would like to support the project, here’s the place: https://crowdfund.berkeley.edu/project/25504

In a remarkable display of—well, I’m not even sure what to call it–Professor Michael Sharpe has blamed Guardian columnist George Monbiot and Long COVID support groups, among others, for the wave of people reporting prolonged symptoms after acute bouts of COVID-19. And during the same February presentation in which he made those observations, Professor Sharpe warned viewers of “poor quality research” while still citing his beloved but discredited PACE trial as if it offered meaningful evidence. The event was an “Expert Forum on secondary COVID-19 impacts” organized by Swiss Re, a major reinsurance company.

Monbiot himself has experienced what he has referred to as a mild case of Long COVID. He has expressed empathy and support for those who have been whacked by this much, much worse than he has. And the situation has brought to his attention the years-long neglect of the ME/CFS patient community. Here’s part of what he wrote in January in a compelling column:

“In some cases, long COVID could mean lifelong COVID. The effects can be horrible. Among them are lung damage, heart damage and brain damage that can cause memory loss and brain fog, kidney damage, severe headaches, muscle and joint pain, loss of taste and smell, anxiety, depression and, above all, fatigue. We should all fear the lasting consequences of this pandemic.”

That passage apparently didn’t sit well with Professor Sharpe. In his presentation, he cited it—if I understand his argument–as the sort of thing likely to trigger other people into reporting exaggerated or imagined symptoms they insist are manifestations of Long COVID. This assertion is the same argument he and his comrades in the biopsychosocial ideological brigades have made for decades about the purportedly pernicious social influences that convince ME/CFS patients that they’re ME/CFS patients.

Here’s what seems to be Professor Sharpe’s basic point: We wouldn’t be hearing from all these anxiety-ridden, depressed, hysterical and deluded people (mostly women) if they weren’t being convinced that there’s a thing called Long COVID by patient disinformation and fearmongers like George Monbiot.

That’s the argument. That’s it. Really. Sharpe allowed in his presentation that some post-COVID patients might need medical investigation. But he also noted that seeking medical attention is a coping mechanism for the psychological distress that patients experience as physical symptoms. So he likes having it both ways.

For months, Professor Sharpe and his colleagues have been deploying the Long COVID phenomenon in a campaign to shore up their cherished but collapsing CBT/GET approach to ME/CFS and related conditions. Accompanying this campaign has been an effort to rehabilitate the credibility and authority of the PACE trial itself. In his presentation, Professor Sharpe included a slide of the purportedly positive results for the trial’s fatigue and physical function outcomes. In a Long COVID webinar sponsored by the Royal Society of Medicine in September, one panelist suggested that PACE merely suffered from poor public relations; he was of course overlooking the methodological and ethical lapses that likely qualify the study as an example of research misconduct, at least according to standard definitions.

And now the PACE rehabilitation project has jumped across the Atlantic onto The Wall Street Journal’s opinion page. Two weeks ago, the news organization published a piece that described both Long COVID and ME/CFS as manifestations of mental illness and linked to the PACE trial as representative of the “prevailing view” in the medical profession. Luckily, the case against PACE is well documented, so the notion of restoring it to its glory days is a non-starter. It is and will always be a piece of crap.  

There’s a lot more nonsense from Professor Sharpe’s presentation. My friend and colleague Brian Hughes, a psychology professor at National University Ireland Galway, took aim at it earlier, so I’ll leave the rest to him. You can read his analysis here.

Trial By Error: Northwestern Law Professor Steve Lubet’s View of that Wall Street Journal Editorial

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By David Tuller, DrPH

I’ve already posted my thoughts about the ill-informed opinion piece by a psychiatrist-in-training that The Wall Street Journal published two weeks ago. The author’s dismissal of the Long COVID phenomenon as a result of delusions and mental illness elicited a lot of sharp responses online. The Wall Street Journal itself published a strong rebuttal from one of the author’s peers–a psychiatric resident in New York. He answered a few of my questions here.

My friend and colleague Steve Lubet, a law professor at Northwestern University in Chicago, wrote his own response, which was posted today on a site called Social Science Space. Here’s a description of the site itself: “Social Science Space brings social scientists together to explore, share and shape the big issues in social science, from funding to impact. This online social network features blogs with the most current thinking from key players in social science, a forum for discussions, a resource center with free videos, reports and slides that support these discussions, as well as funding and job opportunity notices.“

You can read Professor Lubet’s article at Social Science Space here. I have also re-posted it in full below, with his permission.

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Fear of Listening to Patients: Short-sighted on Long Covid
By Steven Lubet

It would be mistaken to suppose that disdain for patients is an actual requirement of psychiatric training in North America, but you would have good reason to wonder about it after reading a recent op-ed in the Wall Street Journal by Dr. Jeremy Devine, a psychiatry resident at McMaster University in Canada. According to Devine, the phenomenon known as “long Covid,” in which COVID-19 patients continue to experience perplexing symptoms for weeks or months, is actually nothing more than the “invention of vocal patient activist groups” who, for unexplained reasons, have irrationally chosen to deny their need for psychiatric care.

Devine’s essay shows scant regard for the experience of patients, who are unable, in his opinion, to comprehend their own physical state. Rather, he opines that tens of thousands of people have been misled by a little known organization called the Body Politic COVID-19 Support Group into demanding biomedical research into their condition, when they really should deferentially accept that they are suffering from an “underlying mental-health issue.” After all, Devine explains, “a central feature underlying many psychosomatic-symptom disorders is a fixed belief that one is ill and unlikely to recover.”

Strangely enough, the victims of this remarkably successful disinformation campaign apparently included Dr. Francis Collins, director of the National Institutes of Health, and Dr. Anthony Fauci, chief medical advisor to President Biden, neither of whom agree with Devine’s description of long Covid as produced by “patient denial of mental illness and psychosomatic symptoms.”

The problem, as Devine sees it, is that patient advocacy groups are just too mouthy. Instead of politely acknowledging that long Covid reflects psychologically generated symptoms, the Body Politic has insisted on “cultivating patient led research.” The chauvinistic scare quotes are Devine’s, signifying his horror at the prospect that patient-directed research might pollute psychiatry’s pristine turf.

Nor is the Body Politic Devine’s only bête noire. He is equally ill-disposed toward Solve ME/CFS, a group that seeks to encourage research into the poorly understood condition variously called myalgic encephalomyelitis or chronic fatigue syndrome. Among its other offenses, as Devine sees them, Solve ME/CFS had the temerity to hire “a lobbyist to pressure federal agencies to commit more funds to research.” Lobbyists are a fixture in Washington, D.C., seeking to influence virtually every federal agency. In 2020, according to OpenSecrets.org, at least 2120 organizations employed lobbyists on health issues (behind only expenditure and tax issues). In 2018, the American Psychiatric Association spent $957,300 on lobbying.

Whatever the Solve ME/CFS lobbyist has been able to accomplish in Washington, D.C., the word has evidently failed to reach McMaster University. Devine maintains that his psychiatric theory of ME/CFS is the “prevailing view among medical practitioners,” but that has not been true for many years. In 2015, the U.S. Institute of Medicine (now the National Academy of Medicine) issued a report finding that ME/CFS, is a “serious, chronic, complex, systemic disease”— not a psychiatric or psychological disorder. Key U.S. health agencies, including the Centers for Disease Control and Prevention and the National Institutes of Health, have taken a similar approach. The 2011 PACE trial, a British study of psychologically oriented treatments for ME/CFS – the only source cited or linked by Devine in his oped – has been methodologically discredited. Psychological treatments were also rejected last fall in a new draft of ME/CFS clinical guidelines from the UK’s National Institute for Health and Care Excellence. As a 2017 graduate of the University of Toronto medical school­, Devine has little excuse to be so poorly informed about the current state of ME/CFS research.

Devine worries that “a large group of impressionable patients” has been bamboozled into thinking that “they are helpless victims of an unrelenting sickness,” when in fact they are suffering only psychosomatic symptoms that can be resolved through psychiatry. If so, it would also mean that highly credentialed physicians such as non-psychiatrists Dr. Collins and Dr. Fauci, and even some psychiatrists, have likewise yielded to “pseudoscience” that will “more harm than help patients.”

One would hope for more humility from a new physician in training for a specialty that once diagnosed homosexuality as a mental illness, blamed autism on refrigerator mothers, and attributed asthma to cries for help from a smothering parent. There is much yet to learn about long Covid and ME/CFS. If Jeremy Devine truly wants to be a healer, he ought to stop slighting patients and their advocacy groups and begin listening to them.

Trial By Error: GETSET Study Reports Null Results for Self-Help Graded Exercise–but Declares Success Anyway

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By David Tuller, DrPH

The Journal of Psychosomatic Research (JSR), an influential publication. recently published an article that made a crucial point—in clinical trials, subjective outcomes are at “a greater risk of bias due to any unblinding.” The article, which I wrote about here, was authored by the journal’s current editor and two previous editors, both of whom are still on the journal’s advisory board.

The article involved whether or not a well-blinded clinical trial of homeopathy, which the journal had published years earlier, should be retracted. The details were complex and of little consequence here, beyond this: The journal’s decision not to retract the study rested on the assessment that the blinding remained robust despite one investigator’s efforts to undermine it. Given the article’s editorial provenance, it would likely be fair to assume the following passage represents the journal’s position:

“Reporting on the integrity of the blind has merit and is especially valuable when dealing with subjective outcomes for which there is a greater risk of bias due to any unblinding…Subjective outcomes are frequently used in studies that fall within this journal’s scope, at the interface of psychology and medicine. We recommend assessing the integrity of the blind for any clinical trial, particularly those utilizing subjective outcomes.”

One obvious corollary of this point is that extra care must be taken in interpreting subjective outcomes when intervention assignment is not blinded. Another is that, when blinding is not secure, objective outcomes do not present the same risk of bias as subjective ones.

Unfortunately, at least two members of JSR’s advisory board—Professors Michael Sharpe and Peter White, two of the three lead PACE investigators–do not share this cautious view, at least judging by their research history. Now JSR has provided Professor White and several colleagues yet another opportunity to misinterpret findings of their research.

The new study is called “Guided graded exercise self-help for chronic fatigue syndrome: Long term follow up and cost-effectiveness following the GETSET trial.” This was essentially a home-based version of the GET intervention tested in PACE. The primary outcomes were self-reported fatigue and physical function. In 2017, the investigators reported in The Lancet that those in the graded exercise self-help (GES) arm reported modest but positive results at 12 weeks post-randomization, compared to those who received so-called standard medical care (SMC) alone. (The GES arm also received SMC.) Professor White was the senior author.

The study was hyped by the UK’s Science Media Centre, a beehive of support for the biopsychosocial ideological brigades. For the SMC’s round-up of “expert reaction,” some of the usual suspects presented cheery comments. “This study contributes to a body of evidence that graded exercise can help to improve functioning and reduce fatigue in people with chronic fatigue syndrome,” declared Professor Trudie Chalder, the other lead PACE investigator along with Professors Sharpe and White.

The SMC also solicited a comment from Professor Chris Ponting, a geneticist at the University of Edinburgh. Here’s what he said: “The beneficial effect [of GES] was for fewer than 1 in 5 individuals, for an unblinded trial, and there was no consideration of long-term benefit or otherwise. The study could also have exploited actometers that would have more accurately measured participant activity.”

As Ponting noted, the reported benefits were not impressive. The fact that the study was unblinded, he appeared to imply, raised questions about the credibility of even those meager results. In mentioning the decision to forego actometers, he was also highlighting the risk of bias inherent in relying on subjective outcomes in the context of unblinded research. In effect, he was drawing attention four years ago to a significant problem that the journal’s current and former editors addressed last month.

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GETSET Follow-Up Fails Upwards

According to the new study, posted on April 2 with Professor White again as senior author, the GES intervention provided no benefits at one-year follow-up over SMC. Yet here’s how the findings were described in the “highlights” section describing the paper on the ScienceDirect site:  “Guided graded exercise self-help (GES) can lead to sustained improvement in patients with chronic fatigue syndrome.”

Given the null results, this was deceptive. In the abstract, the conclusion was marginally less dishonest but still unacceptable: “The short-term improvements after GES were maintained at long-term follow-up, with further improvement in the SMC group such that the groups no longer differed at long-term follow-up.” (I have not yet been able to access the full study through the Berkeley library; I’m not sure why. Also, it is not clear to me if the investigators or others involved in the publication process wrote the “highlights” section.)

In sum, the findings were presented as if the study had proven the intervention to be effective over the long-term period–even though the findings documented the exact opposite. The fact that the non-intervention group caught up is treated as a secondary matter–ignored completely in the “highlights” section and downplayed in the abstract’s conclusion.(Another of the four “highlights” is significant but for some reason is not mentioned anywhere in the abstract: “Most patients remained unwell at follow up; more effective treatments are required.”)

As usual with these people, this is not the proper or transparent way to report the results of a clinical trial. The main outcome of a clinical trial—and the first that should be reported, even in a follow-up study—is the comparison between the intervention and non-intervention groups. So let’s be clear: At one year, the GETSET study produced null results for the only important comparison—between the group that received GES and the group that received SMC alone. The only conclusion possible from this study is that GES had no documented long-term benefits.

Any other way of framing the findings—such as the way the investigators have framed them—is spin. And egregious spin at that. Only investigators aware and perhaps scared that their findings undermine the foundational theories of their entire approach to intervention would try to disguise the bad news in this clumsy and anti-scientific manner.

Incidentally, Professor White and his PACE colleagues used this same silly parlor trick when they faced a similar dilemma a few years ago. The long-term PACE results, published in Lancet Psychiatry in 2015, showed no benefits for the CBT and GET interventions over the two comparison groups. As with GETSET and other follow-up studies of these psycho-behavioral treatments, the non-intervention study participants had caught up. And what did the PACE investigators do? As with GETSET, they declared success based on within-group findings. Then they tried to explain away the disastrous fact that they themselves had uncovered: Their prized intervention had no long-term benefits.

In this case, the GETSET follow-up’s hyping of its null results appeared to diss the journal’s own recent admonition that subjective findings have “a greater risk of bias due to any unblinding.” That common-sense wisdom has apparently not yet tempered the continuing passion of the most devoted biopsychosocial brigadiers—a group that includes Professor White–to make unfounded claims of success.

In addition to its fake-news presentation of the GETSET results, the study also suggests that the intervention might be “cost-effective.” Huh? What does it mean for an intervention that produces null results to be cost-effective? Cost-effective at what? I’ll let others dissect that particular claim.

Trial By Error: Long COVID, the Long COVID Alliance, and ME International

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By David Tuller, DrPH

The advent of Long COVID has brought an enormous amount of attention to the illness or cluster of illnesses collectively known these days as ME/CFS. That attention is not always positive, as we saw recently with a Wall Street Journal opinion piece that dismissed both ME/CFS and Long COVID as forms of mental illness. The trainee-psychiatrist who penned that piece of crap even referred to PACE as representing the “prevailing view” of the medical profession.

Many other articles have explored the overlaps between Long COVID and ME/CFS in more thoughtful ways. A major problem, of course, is that both categories grapple with definitional issues. What has been dubbed Long COVID has been officially named “post-acute sequelae of COVID-19” (PASC), which at least recognizes that the term covers a diversity of symptoms and conditions. With ME and ME/CFS, various currently used definitions—the 2003 Canadian Consensus Criteria for ME/CFS, the 2011 International Consensus Criteria for ME, and the US Centers for Disease Control and Prevention’s 2015 definition for what it called “systemic exertion intolerance disease”–identify different albeit overlapping populations. That can create difficulties in implementing studies and interpreting the findings.

All three of these definitions require the presence in some form of post-exertional malaise (PEM), which is a core symptom of the illness. The 1994 CDC definition for CFS, which does not require the presence of PEM, is also still widely used in research and treatment.

ME/CFS patients are not monolithic on their views toward Long COVID. Many are hopeful that research into the latter will shed light on some or many of the pathophysiological processes underlying ME/CFS. They also want to ensure that some of the research funding being allocated to Long COVID specifically takes ME/CFS into account. Given the apparent overlaps in symptoms, an unknown number of Long COVID patients will end up with an ME/CFS diagnosis.

Nonetheless, some patients are extremely concerned that those who have waited decades for proper biomedical research will be subsumed and lost within a large and heterogeneous Long COVID wave. Among this group are patients who specifically identify themselves as diagnosed with ME by the ICC criteria. They argue that this case definition most clearly delineates people with the clinical entity of interest, and they seek research initiatives that incorporate patients identified through the diagnostic procedures outlined in the ICC Primer. (Others disagree with this approach for multiple reasons.)

In February, fifty organizations and patients groups, including leaders in the ME/CFS field, announced the formation of the Long COVID Alliance. The stated goal is “to transform the current understanding of Long COVID and related post-infectious illnesses such as: myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), postural orthostatic tachycardia syndrome (POTS), other forms of dysautonomia, Ehlers-Danlos syndrome (EDS), hypermobility spectrum disorder (HSD) and mast cell activation syndrome (MCAS), autoimmune diseases and other related illnesses.”

According to Oved Amitay, president and CEO of Solve ME, one of the founders of the alliance:  “The Long COVID Alliance is a critical collaboration based on the current reality that doctors and researchers are reporting that millions of COVID-19 patients continue to experience chronic and often debilitating postviral symptoms…Even though tests might reveal that no virus remains in the body, COVID-19 ‘long haulers’ continue to struggle, often alone. Our community brings past experiences that are relevant to the current crisis.”

The US National Institutes of Health has committed more than $1 billion to Long COVID research initiatives. The Long COVID Alliance has issued some recommendations for how these funds should be spent.

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Organizations operating in any domain often have to make a choice about whether to argue for change from outside the metaphorical tent or from inside. These options are often not cut-and-dried; both have benefits and costs. Advocates for the ME-ICC as the case definition that most accurately captures their illness often view their interests as diverging from those of patients diagnosed through other criteria. These sorts of differences can lead to intra-community tensions even as all are seeking related goals—more funding for research and better care for patients, however defined.

ME International, which represents patients identified through the ICC, joined the dozens of other entities signing on as part of the Long COVID Alliance—a choice that the group’s president called “challenging” in a recent letter posted on its website. I thought the letter represented an interesting demonstration of the kinds of factors that inform this kind of organizational decision-making:

Dear fellow ME patients,
 
The ME International (ME-I) Board recently made a challenging decision to join the Long COVID Alliance. This Alliance, led by Solve ME/CFS, has a goal of making sure that ME/CFS patients are considered in the upcoming NIH Long COVID research funding awards. The US Congress appropriated $1.15 billion to the NIH for this research. At this time there are 50 organizations including ME-I who have signed this Alliance.
 
We are participating in this alliance BECAUSE it is important for:  The ME patient population as defined by the IC Primer NOT be confused with the ME/CFS patient population. 

There are valid concerns raised by the patient community since little progress has been made with respect to differentiating ME from CFS. We are aware that the decision may be viewed as diffusing our emphasis on ME. It is definitely not the case. ME-I remains committed to the position of supporting ME patients as defined by the IC Primer.
 
ME-I views the IC primer as a strong foundation for defining what ME is and how best to diagnose and treat it. We believe that this foundation provides a solid framework that can be built on with international patient input.
 
In making the decision to join the Long COVID Alliance, we considered the following benefits and challenges:

Benefits

  • Advocating that research dollars are allocated to addressing ME as defined by the ME- ICC patient community
  • Identifying clinicians and researchers that are best suited to represent ME patients
  • Enhancing communication with other organizations who are confounding ME with CFS

Challenges

  • ME-ICC definition is not recognized
  • ME-I patient community voice is diminished in Long COVID Alliance communications
  • Cycling back to what happened previously to the ME-ICC Community

 ME-I is committed to managing these challenges by:

  • Directly communicating our position to NIH, CDC, clinicians, and researchers independent of the Alliance
  • Partnering with medical societies and other patient advocacy groups as appropriate
  • Exiting the Alliance if our voice is not heard

At the end of the day, we felt it was important to have a voice at the table so we can collaboratively encourage NIH funding to be spent in a way that will benefit the ME community.

If you have questions or concerns, please email them to admin@me-international.org. We look forward to your insights and will be requesting further input on ME-International social media sites.

Jim Lutey, President
ME-International
 

Trial By Error: More on that WSJ Opinion Piece; and Q-and-A with Author of this Week’s WSJ Rebuttal

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By David Tuller, DrPH

Last week, The Wall Street Journal published a passionate but clueless opinion piece from a psychiatric resident at McMaster University in Ontario, Canada. The author, Jeremy Devine, portrayed the entire category now being referred to as Long COVID as a fiction foisted on the world by a committed commando of deluded and illness-obsessed queer feminists (or maybe queers and feminists–I’m not sure). And patients, no less! The column’s mean-spirited tone made it difficult to read. Repellent, actually. I wrote about it here.

Devine presented snark instead of viable evidence for his argument, which appeared to emerge from his own deficit of compassion and empathy for patients. He showed no interest in the views of those experiencing the debilitating symptoms he was glibly interpreting as psychosomatic. Instead, he dismissed survey data based on his negative attitudes toward the researchers’ status–whether as patients, queers, feminists or members of wellness collectives seeking to identify links between discriminatory social structures and health inequities. His anger and dismay at their unwillingness to acknowledge the psychosomatic nature of their symptoms and submit to his diagnostic authority were palpable.

Poor guy! He really seemed to be struggling with some stuff.

Devine also accused experts who are taking these prolonged symptoms seriously of being bamboozled. In his view, this powerful queer-feminist coven has brewed pseudoscientific spells and cast them upon the decision-makers at the National Institutes of Health, in the process enchanting them into offering more than $1 billion for nefarious patient-influenced research projects. (The article made no mention of whether potions from frog entrails, elephant dung, and the menstrual blood of queer feminist patients were used.)

In laying out his case, Devine chose to link to the PACE trial as the epitome of medical wisdom on the issue of the purported psychogenic origins of post-viral symptoms. If he can spare a few minutes, I can tell him a story about the PACE trial in about 15,000 words.

Lots of people–not just young and arrogant psychiatry residents at McMaster University–say stupid things. Luckily, most people don’t say their stupid things in The Wall Street Journal. It would be interesting to know how Devine ended up being the sucker to take responsibility for this disaster. Was it commissioned, or was it a submission out-of-the-blue, or is Devine a friend of someone who knows someone on the opinion page? In any event, it would have been better for all involved had a wise editor prevented this frightened young man from making a public spectacle of himself. Well, too late for that!  

Anyway, I was glad to see The Wall Street Journal follow up this week with a cogent rebuttal to the Devine mess. Even better, it was from a peer of Devine’s—another psychiatric resident, Yochai Re’em, who is at New York-Presbyterian Hospital, Weill Cornell Medicine. Re’em acknowledged in the opening lines of his piece that he himself had contracted COVID-19 and subsequently experienced persistent symptoms. His perspective is very different than Devine’s.

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My Q-and-A with Yochai Re’em

I reached out on twitter yesterday to Yochai Re’em, the author of the second Wall Street Journal piece. In addition to his psychiatric work, Re’em, is also a researcher with Body Politic’s Patient-Led Research Collaborative. (That’s the same group dissed by Devine for having a queer and feminist orientation–or something like that, anyway.) I sent Re’em a few questions. Here’s our exchange:

What was your reaction when you saw Devine’s piece?

I wasn’t surprised a piece like that was written, but I was a little surprised it managed to pass through WSJ given the gross inaccuracies and sweeping generalizations with insufficient citations. In retrospect, I may have been a little naïve. The further I read, the more it became clear the piece was a result of an emotional reaction about the Long COVID community, lazily invoking “mainstream medicine’s” views despite these points being far from mainstream. My initial surprise gave way to disappointment as I realized the author is a fellow psychiatric resident. Arguments were presented in order to substantiate his thesis that Long COVID is a psychogenic phenomenon with patient-led organizations fueling the fire.

Unfortunately, these arguments were narrow pieces of the puzzle, omitting much of the picture, and placed out of context. The general tone – referencing patient advocacy groups as though the nature of their involvement alone would prove their untrustworthiness- is not the psychiatry I know. I was also somewhat shocked that it seemed he was trying to diagnose an entire group of individuals with a psychiatric disorder without examining them (there was no mention of him encountering Long Covid patients in his clinical practice). This left me feeling disappointed and feeling that psychiatry was misrepresented in the piece.

I will not deny that the current state of Long COVID research leaves much to be desired (after all, it’s been only a year since the pandemic started). I am still confused, though, by why so many people seem so hellbent on critiquing the existing evidence and using that critique as proof that Long covid doesn’t exist or is psychogenic (criticizing the current evidence is hardly proof of that), instead of running adequate trials to try to better understand it.

How did your piece come about and how did it end up in the WSJ?

Early in the pandemic, there were many reports among long-haulers of patients being told that their symptoms were all due to anxiety and/or depression. Some of these patients had a history of anxiety/depression and were able to identify this was not consistent with their own experience–which goes against Devine’s point that this is due to societal bias against mental health disorders. Some were psychiatrists themselves.

I began thinking about why doctors tell patients their symptoms are due to psychological issues, often without backing it up with evidence, and often as a diagnosis of exclusion. Many of the reasons may be due to psychological factors in the doctors themselves, which I tried to outline in my piece. I had been working on this and attempting to get it in a medical journal when Devine’s piece came out. I reached out to an editor at WSJ to see if it may be possible for me to respond to this piece via an opinion piece myself, and sent a draft of what I had been working on.  I received significant support from fellow Body Politic members who read through my draft, offered feedback, guidance, and edits.

Did you already feel this way or did your own experiences change your mind?

My own experiences played a large role. There is a lot of skepticism in medicine, and much of that permeates into the way things like chronic Lyme or fibromyalgia are addressed in medical school.  I think I only learned about chronic fatigue syndrome once I developed Long COVID myself. My own experience made me more sensitive to the patient experience, and in particular the psychological effects of being dismissed by a provider. While there is an innate empathy in most who choose psychiatry as a profession, becoming a patient yourself has a special way of increasing empathy for other patients.