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David Tuller returns to provide an update of his investigative work to expose the methodological and ethical problems with the PACE trial for ME/CFS.
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If you appreciate the articles written here by David Tuller on ME/CFS, please consider supporting him financially at Crowdrise.
David is an investigative reporter with a doctorate in public health from the University of California, Berkeley. Since the fall of 2015, David has waged a determined effort to expose the methodological and ethical problems with the PACE trial for ME/CFS. He started this effort because he came to understand that the PACE treatments, graded exercise therapy and cognitive behavior therapy, were not just useless but could actually cause serious harm. Although patients had spent years documenting the trial’s unacceptable flaws, the larger scientific world had dismissed and ridiculed their legitimate concerns. Up until this point, David was able to pursue his investigation as a public service project because of his academic job at Berkeley. But now he needs your help, and your tax-deductible contributions, to continue the effort and try to bring it to its desired conclusion — correction of the scientific record.
Debunking PACE
In October 2015, Virology Blog posted David’s 15,000-word investigation of the PACE trial, the largest-ever study of treatments for the ME/CFS. The findings were published in prestigious journals like The Lancet, Psychological Medicine, PLoS One and others. His investigation and multiple follow-ups revealed how the PACE researchers violated major scientific and ethical principles. Because of these multiple flaws, the trial’s reported findings—that graded exercise therapy and cognitive behavior therapy are effective and can lead to recovery—cannot be taken seriously.
David’s continuing investigation has had a major impact in the debate around PACE and the CBT/GET ideological movement. Here is some of what has happened:
*His work has received coverage in many mainstream and other publications, including The Guardian, Slate, Science, The Wall Street Journal, StatNews, and NPR. In March, The New York Times published an opinion piece about the issue that he co-wrote with Julie Rehmeyer. (Please also support Julie’s terrific new book, Through the Shadowlands, about her own struggle with ME/CFS.)
*Based on his investigation, Virology Blog published open letters to The Lancet and Psychological Medicine, demanding that journal editors address the serious problems of the published papers. Dozens of scientists and other experts signed these open letters, which received widespread attention..
*Last summer, a British court cited the open letter to The Lancet as evidence that an “impressive roster” of experts, not just irrational patients, had serious concerns about the PACE trial. The court ordered the release of the raw trial data, which has proven what patients have known all along and what David documented on Virology Blog–that the published findings are misleading and unreliable.
*In the U.S., advocates have used David’s work to pressure federal agencies to review their recommendations for GET and CBT. Based on their appeal, the Agency for Healthcare Quality and Research reassessed the literature and significantly downgraded the evidence for CBT and GET.
*David’s efforts seem to have rattled the PACE investigators and their colleagues. At least, they have slipped up when they try to defend themselves and their methodological decisions. Most recently, Dr. Esther Crawley accused David in a public lecture of writing “libelous blogs.” With this false accusation, she not only created a public relations nightmare for herself and her associates but has provided David with a wealth of blogging material.
David has pursued this investigation because of his deep concern for patients and his dismay at the poor quality of the study. He has been able to devote a lot of time to this rewarding project because of the security of his half-time academic position at Berkeley. Unfortunately, his current Berkekely position is ending on June 30th, after nine years. The University of California is in poor financial shape, and grant money is scarce this year.
Current Ask
That’s why David is seeking your tax-deductible contributions for another year of investigating and blogging about the PACE trial and ME/CFS on Virology Blog. He will also continue to write articles for other publications, when possible. There is much, much more investigating, blogging and hammering away to do–about conflicts of interest, about the FINE “sister” trial, about Cochrane’s misleading systemtatic reviews, the false PLoS One claim that the treatments are “cost-effective,” etc, etc.
David wants to be clear that he will continue this effort no matter what he receives through this five-week crowdfunding campaign, which ends June 30th. The question is how much time he will be able to devote to it.
Where the Money Goes
The money raised will be sent to the Center for Scientific Integrity, a non-profit which publishes the terrific site Retraction Watch and has agreed to serve as fiscal sponsor for this campaign. (That agreement does not mean the Center for Scientific Integrity necessarily endorses or agrees with any output of this project, which is editorially independent.) The Center will transfer 100% of the net funds — after credit card fees and Crowdrise fees — to the School of Public Health at UC Berkeley, which will create a position focused on investigating the PACE trial and others issues related to ME/CFS.
Goal
David’s goal is ambitious: $60,000, the approximate value of his current half-time salary/benefits package at Berkeley. That will allow him to continue to spend the same amount of time he has been spending on investigating, writing, helping organize open letters, and other activities related to PACE and ME/CFS.
David understands that many patients have few resources to spare. But any donation, no matter how small, will help bolster what has turned into an epic struggle to correct the scientific record. (Crowdrise charges a modest fee and provides donors with the option of having that fee added to the donation or taken from the donation.)
If anyone would prefer to support his efforts by donating off-line directly to the School of Public Health at UC Berkeley, please e-mail David for further information: davetuller@berkeley.edu
David Tuller returns to discuss the continuing saga of the UK’s PACE trial for chronic fatigue syndrome, including the accusation that he is engaging in libelous blogging.
You can find this TWiV Special at microbe.tv/twiv, or listen below.
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by David Tuller
By David Tuller, DrPH
I have spent two weeks hammering the CFS/ME Research Collaborative about “Renal-gateâ€â€”that is, vice-chair Esther Crawley’s recent lecture at a conference of kidney disease experts, in which she falsely accused me of writing “libellous blogs.†The CMRC’s chair, Stephen Holgate, recently assured me that Dr. Crawley had the “full support†of the executive board—a statement I dutifully conveyed to Virology Blog readers.
To be clear, I don’t know what Dr. Crawley actually said in the lecture, or if she mentioned my name. The slide live-tweeted from her talk, which featured the phrase “libelous blogs†near a screen-shot of one of my Virology Blog posts, speaks for itself. (Esther, if I’ve misunderstood and you meant to highlight my post instead as an example of an accurate, non-libelous blog, let me know ASAP.)
Despite the claim that Dr. Crawley enjoyed “full support†from the board, one of the CMRC’s charity members, ME Research UK, announced a few days later that it was withdrawing from the collaborative, “with immediate effect.†ME Research UK’s announcement did not mention Dr. Crawley, but the meaning was clear given the timing and abruptness of the move. So it appeared that the “full support†of the board for Dr. Crawley was likely less than “full†even as Dr. Holgate made the claim.
I am now trying to ascertain what prompted Dr. Holgate to issue such a statement. I had assumed he canvassed every single member of the executive board to gauge whether there was in fact “full support†for Dr. Crawley. Perhaps he did—and perhaps ME Research UK affirmed support for Dr. Crawley yet decided to leave days later for unrelated reasons. But that just seems unlikely.
On the Phoenix Rising forum, Renal-gate has generated a huge amount of interest. The Renal-gate thread has received more than 31,000 views. One commenter suggested that Dr. Holgate was urged to make the statement by the Science Media Centre’s Edward Sykes, an observer on the CMRC executive board. I have no idea if this is true. I have written to both Dr. Holgate and Dr. Sykes to find out how this statement of “full support†arose. I have asked if in fact every member of the CMRC board was canvassed before Dr, Holgate spoke on their behalf. I don’t expect a response, but will provide an update if I hear from Dr. Holgate or Dr. Sykes or anyone who can shed light on what happened.
**********
In other news, Action for ME also issued a statement last week. The statement came out of a board meeting that took place in April—that is, before these most recent events. So no one should expect it to have addressed the public relations nightmare that Dr. Crawley has since presented to all those within her circle, including Action for ME.
(I want to stress that conscientious organizations really do need to take time in responding to challenges. It is much easier for me to immediately blog and shoot darts than it is for those who run big groups to consult each other and address difficult issues in a responsible way.)
On the positive side, the Action for ME statement noted the ongoing controversy surrounding the PACE methodology and trial conduct, and stressed that the questions and concerns need to be addressed “as a matter of urgency.†The statement highlighted the recent reanalysis of the reported recovery findings from the 2013 Psychological Medicine paper, quoting the new study’s conclusion that “the claim that patients can recover as a result of CBT and GET is not justified by the data.”
The statement also urged NICE, which is re-visiting the issue of clinical guidelines for ME/CFS, to “take full account of emerging biomedical research, the views and experiences of people with ME, and clearly reflect nuances around findings and re-analysis related to the PACE trial.†And it included a strong endorsement of the need for sharing of research data. These are important messages that deserve to be widely disseminated.
But the statement falls short in rejecting the call to sign onto an open letter to Psychological Medicine, which was posted on Virology Blog in March. The open letter requested retraction of the reported recovery findings and was signed by more than 140 scientists, academics and other experts, as well as ME/CFS organizations. The open letter’s retraction request was based on the reanalysis of the recovery data, which documented how the PACE investigators weakened their recovery criteria in ways that jacked up their reported results. Although Action for ME was not informed of the open letter before it was originally posted, it was asked to add its name afterward. The organization declined.
In last week’s statement, Action for ME explained that decision by noting that Psychological Medicine had already refused the retraction request. “Therefore signing now will have no impact,†the statement noted. This is fallacious reasoning. I doubt many of us who signed the open letter believed it would magically result in retraction—certainly I had no such delusion. The decision-makers at journals like Psychological Medicine and The Lancet have long shown themselves to be impervious to arguments based on logic, common sense and scientific integrity.
From my perspective, the function of the open letter was to demonstrate to the journal editors, the PACE authors and the UK medical establishment that the larger scientific world rejects the kind of upside-down evidence cited by members of the CBT/GET ideological brigade. Action for ME’s argument that it “will have no impact†at this point to support the call for retraction is just silly. The opposite is true. An endorsement of the open letter by Action for ME would be viewed as a turning point in the debate, and I assume the organization’s trustees understand that.
I hope Action for ME will rethink this decision. I also believe the organization, given its close association with Dr. Crawley and her work, should specifically address the concerns raised by her lecture, although that seems unlikely to happen. In fact, having been pressed by patients to take a stand on the issue, the organization has already stated the following: “Action for M.E. had no input into this presentation and none of our team were present at the talk, so we cannot comment on its content.â€
Unfortunately for those who have allied themselves with Dr. Crawley, however, she has been caught leveraging her prestige and her public platform at a professional gathering to portray those seeking the truth about questionable research as “vexatious†and “anti-science.†She has been caught slandering me personally, along with my friend and colleague, Dr. Racaniello. I doubt she expected her slides to go viral. But they did.
Dr. Crawley has created a real mess for herself and for everyone around her, and she refuses to clean it up. Someone really needs to stage an intervention.
By David Tuller, DrPH
For the last couple of weeks, I have been hammering the CFS/ME Research Collaborative to take a position on the actions of its deputy chair, Libelous Esther—better known as Dr. Esther Crawley. As I reported in several previous posts, Dr. Crawley falsely accused me of writing “libelous blogs†and Dr. Racaniello of posting them. To keep members of the CMRC board in the loop, I have sent them e-mails with links to these posts. In these e-mails, I have tried to be direct and pointed, but reasonably polite. I have mostly succeeded, although the recipients might have their own perspective.
At first, the CMRC refused to respond at all. Then the chair of the board, Stephen Holgate, sent me what could only be interpreted as a “f**k off†message. He told me that Dr. Crawley’s actions had nothing to do with the CMRC because it was just a “voluntary†group of colleagues with “no official standing.†Therefore, he wrote, I had to pursue my concerns through “other avenues.â€
To me, “other avenues†meant more blogging about the false accusations of libel and the CMRC’s inadequate response, among other things. So I wrote yet another post about L’Affaire Crawley, noting the CMRC’s explanation that it could not possibly take a position because it was only a voluntary group with “no official standing.†I duly sent this post to the CMRC board.
And on Friday, I finally received from Dr. Holgate an enthusiastic endorsement of Dr. Crawley and her work. The statement made no mention of her recent multi-media spectacle, including her false libel accusation and her portrayal of legitimate requests for information as “vexatious.†In other words, the CMRC has sent me its second “f**k off†message. Happy International ME Awareness Day!
Here’s Dr. Holgate’s e-mail:
Dear David,
Prof Esther Crawley has the full support of the CMRC Executive Board in her role as Vice-Chair. The CMRC exists to promote the highest quality of basic and applied evidenced-based and peer-reviewed research into CFS/ME and Prof Crawley helps us to do this. Prof Crawley’s science is tested through the demanding procedures that all scientists must face when seeking grant-funding and publication in leading journals. The high quality of her research is recognised by her peers and she is a Professor of Child Health at the University of Bristol and an NIHR Senior Research Fellow. She is the clinical lead for the specialist child CFS/ME service at the Royal United Hospital in Bath and, sadly, is one of very few scientists in the UK actively trying to find a way to help children affected by CFS/ME. Contrary to some claims this collaborative is not fixated on any one cause, therapy or branch of science – our only goals are to improve our understanding of this serious illness and help alleviate suffering. In the meantime, our work remains focused on increasing collaboration and funding for more research and we will continue to work with all key stakeholders to achieve this.
Yours,
Stephen
I wrote back to Stephen and other board members that I took his answer to be an endorsement of Dr. Crawley’s actions and her false libel accusation. I noted that PACE, like Dr. Crawley’s research, had also been “tested through the demanding procedures†required of scientists. Given that PACE was a disaster, I pointed out, I didn’t hold those “demanding procedures†in as high regard as he did. I again noted the serious flaws in Dr. Crawley’s research.
Finally, I let Stephen and the CMRC board members know that I would be discussing the PACE mess and the Crawley situation, including their own role, during my talk on June 1 at the Invest in ME conference dinner. I included a link to the dinner information, in case any of the CMRC board members wanted to attend.
*****
On a related issue, a number of people have urged me to sue Dr. Crawley. I have made it clear I’m not going to do that. Not because she doesn’t deserve it, but because I don’t deserve it. Lawsuits are hell for everyone. The opportunity costs in time, money, and energy are incalculable. Except for Donald Trump and attorneys, no one who has ever been involved in a lawsuit would ever want to be involved in another one. (Of course, not filing a lawsuit does not mean I can’t file complaints with her university and medical regulators.)
There are other excellent reasons not to pursue that route. For one, by taking legal action off the table, I occupy the moral high ground. That allows me to slam Dr. Crawley and the CMRC for their awful behavior as much as I want.
For another, and here’s the real challenge, I would have to prove that Dr. Crawley’s false accusation has actually caused me harm. Dr. Crawley has had tremendous influence over the health and lives of people with ME/CFS, especially in the U.K., but she has no power over me. I cannot honestly argue that her behavior, however distasteful, has damaged my reputation, caused me anxiety or led to economic loss. On the contrary, she’s given me great material to blog and talk about, complete with an excellent slide-show that documents her unprofessional behavior. Going forward, this stunt of Dr. Crawley’s and the resulting visuals are likely to haunt her career and inflict permanent damage on her reputation.
Now If I were to suffer a renal emergency in the UK and no nephrologists would see me because they had heard Dr. Crawley’s false accusation of libel, then I might be able to argue that I had suffered actual damage. Until then, no. (I do have a history of kidney stones and I am coming to the U.K. soon, but I don’t think she‘s gotten to the urologists yet.)
by David Tuller, DrPH
Well, not in those words, of course. It was all very polite. But that was the message.
Here’s what happened. On Monday, I posted an open letter to the members of the board of the CFS/ME Research Collaborative. The letter involved the false accusation of libel that the CMRC’s deputy chair, Esther Crawley, disseminated against me at a conference of renal experts two weeks ago. Because the accusation involved a blog post I wrote for Virology Blog, the accusation of libel also extended to Dr. Racaniello, who hosts this site.
I sent a link to the open letter to Stephen Holgate, the CMRC’s chair, and other members of the collaborative’s board. Dr. Holgate is a public supporter of Dr. Crawley’s work—he appeared with her at a press conference organized by the Science Media Centre to promote her latest venture, FITNET-NHS, a trial of online cognitive behavior therapy for adolescents with ME/CFS. (I wrote about this flawed proposal in the purportedly libelous blog that Dr. Crawley displayed on screen during her infamous presentation to the British Renal Society. In that post, I criticized Dr. Holgate for supporting Dr. Crawley’s research, given that she has a tendency to conflate “chronic fatigue†and “chronic fatigue syndromeâ€).
I did not hear back after e-mailing the link to the open letter. However, Dr. Racaniello received a cryptic response from Dr. Holgate, apparently in error. It popped up in his in-box shortly after I sent my e-mail about the open letter to Dr. Holgate and other CMRC board members. After receiving my e-mail, Dr. Holgate sent the following message to the CMRC board members:
Friends, I hope you do not feel it necessary to respond to this.
Kindest Regards,
Stephen
I had cc’d Dr. Racaniello on my original message; I presume that’s why he received a copy of Dr. Holgate’s e-mail. I wrote to Dr. Holgate, asking if he sent the e-mail to Dr. Racaniello in error, or if it was an indirect way of letting us know the CMRC would remain silent. I soon heard back from Dr. Holgate. He explained that the questions I have raised “are not the business†of the collaborative, which after all is a “voluntary†group and has “no official standing.†He told me I needed to pursue any concerns through “other avenues.â€
So that is the CMRC chair’s response to the news that his deputy chair falsely accused two other academics of libel at a professional gathering, at which she also appeared to be advising medical professionals on effective ways of avoiding their legal obligations under the freedom of information law. Dr. Holgate apparently feels this has nothing to do with the CMRC itself because it is just a “voluntary†group with “no official standing.†(What does that mean? “Official standing†with whom? The CMRC has enough “official standing†to organize conferences, issue statements, and have a board, which includes a deputy chair who makes false libel accusations  and a chair who doesn’t think that’s a problem.)
Apart from her defamatory libel claim, Dr. Crawley also appears to think that the filing of freedom of information requests related to ME/CFS is tantamount to conducting a harassment campaign. And she continues to make this ridiculous argument, even though last year’s First-Tier tribunal decision on one such request dismissed this claim in harsh terms. With all due respect to Dr. Holgate’s assurance that Dr. Crawley’s actions have nothing to do with the CMRC, Dr. Crawley’s leadership role with the group has been well promoted. It is natural for observers to assume that she speaks for many if not most of the other board members, especially when she talks about research into ME/CFS.
Unlike Dr. Crawley, the rest of the scientific world is moving fast in the direction of open access to data. Although Dr. Holgate believes the CMRC has nothing to say about Dr. Crawley’s recent performance, other board members should certainly speak up if they don’t agree with the deputy chair’s view that freedom of information requests constitute harassment. And if they don’t think Dr. Crawley should disseminate false accusations of libel against those raising legitimate and still-unanswered questions, they should speak up about that as well.
It is hard to understand why Dr. Holgate and the CMRC board think the public or funders should support a research collaborative whose co-leader falsely accuses critics of libel and publicly advocates shielding trial data from scrutiny. I do hope Dr. Holgate and his colleagues find a way to improve on their current non-response going forward.