By David Tuller, DrPH
After Reuters ran that PACE/CBT/GET propaganda piece last month, I sent an e-mail expressing two concerns to Kate Kelland, the reporter, and the two editors listed as having worked on the story.
The first concern was that the story falsely said I published my investigation on the blog of a Berkeley colleague. Since Kelland had sent a list of questions about my work to Professor Racaniello, the host of Virology Blog and a Columbia professor, she knew this wasn’t the case. Given that, I assumed the misstatement was an accident–the kind of stupid screw-up that’s really easy to do. All journalists have been there.
In that communication, I also pointed out that Kelland’s story had omitted any mention of my current academic position at Berkeley, suggesting instead that I was running some sort of rogue operation. Yes, I crowdfund, but the crowdfunding site is clearly marked as a Berkeley thing–which was of course not mentioned. (I let Kelland and her editors know I would be submitting a more extensive bill of particulars in the near future.)
The factual error was fixed pretty quickly. That wasn’t a surprise. I mean, there really was no way to contest it. In cases like that, you just cringe and make the correction. But regarding the omission of my professional status…well, my professional status has remained omitted from the published version. I did not hear back from Kelland or her editors, so I didn’t get a chance to ask about their reasoning.
I had other stuff going on in mid-March, so after that initial message I let the issue go for a while. Recently, I finally found the time to formulate and send a more official response through the appropriate channels. So I formulated and sent a more official response through the appropriate channels. Now we’ll see what happens.
The Reuter story was awful in so many ways. Two of my major concerns have been about how the story misrepresented my professional status and how it misrepresented the current state of the debate over PACE and the CBT/GET treatment paradigm. The second issue is far more important and substantive than the first, but the first is obviously something that I (and only I) can speak to personally.
Below are some of my thoughts about these two issues.
The story misrepresents my professional status
Kelland starts her description of me by referring to me as a former journalist. This phrase puzzled me. I was a reporter and editor at The San Francisco Chronicle from 1988 to 1998. These days, I regularly write articles that have nothing to do with ME/CFS for Kaiser Health News, Health Affairs, and elsewhere. I also consider my ongoing examination of ME/CFS research to be an investigative journalism project as well as a public health project. Had Kelland described me as a former newspaper reporter or former full-time journalist at a news organization, that would have been fine. But it is false to call me a former journalist. And in the context of this story, the reference comes across as dismissive.
I am an academic appointee at the Berkeley campus of the University of California. I have been employed in various academic positions at Berkeley since 2009, at either the Graduate School of Journalism, the School of Public Health, or both. My University of California positions have ranged from half-time to full-time and have always included salary and full benefits. In my current half-time position at the Center for Global Public Health, my main responsibility is to conduct the ME/CFS-related investigation that Kelland has written about.
Yet Kelland never mentions that I am a Berkeley employee and that my ME/CFS investigation is an official Berkeley project. In fact, Kelland never mentions that I am employed anywhere at all. Reuters readers would be forgiven for assuming that I am a rogue actor with no apparent current academic or professional affiliation. (Remember, I€™m also presented as a former journalist.) Kelland does mention that I received a doctorate in public health from Berkeley at some point; the inclusion of that detail does not justify the erasure of my present academic and employment status.
Kelland highlights my crowdfunding and accurately notes that last year€™s total was more than $87,000. Yet she omits the salient fact that I crowdfund on Berkeley€™s own crowdfunding platform to support my academic position at the School of Public Health. Berkeley€™s crowdfunding platform is reserved for approved Berkeley projects. The money raised goes directly to Berkeley, not to me. The Center for Global Public Health uses those funds to pay my regulated University of California salary and provide me with health insurance and the other benefits I receive as a state employee. In exchange, I investigate and report on research and other issues involving ME/CFS.
In fact, April is a crowdfunding month at Berkeley, so I am crowdfunding right now for the fiscal year running from July, 2019, through June, 2020. I am seeking $95,000 to support my Berkeley position at 60% time. As is clear from this link, the effort is prominently sign-posted as being under the Berkeley umbrella.
Within the University of California system, many non-tenure-track academic appointees, like me, survive partly or fully on outside support for their projects. This is not remotely unusual. The only difference here is that my support comes in the form of hundreds of individual donations rather than larger gifts or grants from traditional institutional sources. In the university€™s view, I am doing what academics are expected to do, bringing in funding. Kelland is free to disapprove of my innovative and resourceful fundraising strategy, but that does not give her and Reuters the right to withhold from readers that I have a bonafide academic position at one of the world€™s leading institutions of higher education.
When it comes to the PACE/CBT/GET defenders, Reuters does not mention where they received their diplomas but provides their current professional titles and places of employment–information readers have a right to expect. To exclude parallel information about me breaches all sorts of tenets of even-handedness and fairness, and Kelland’s decision to do so should raise a few questions about her intentions. The effect of stripping me of my current status in this manner is self-evident–to reduce my perceived credibility as a sharp critic of these eminent scholars, who are presumably my moral and intellectual betters.
After all, as someone with no legitimate academic institution or media organization apparently willing to provide me with a professional home, who am I to challenge Professor Michael Sharpe of Oxford University and call his beloved PACE trial a piece of crap? I acknowledge that I can speak in terms that are at times provocative, inelegant and, to some, off-putting. But Kelland has focused on my occasional use of flamboyant language while refusing to examine the substance of my critiques and failing to identify me properly.
The story misrepresents the current state of the debate over PACE and related research
Kelland generally limits her discussion to what she frames as bad behavior and ignores the substance of the scientific issues involved. Here€™s her account of the enormous range of concerns that I (and many others) have raised: His [Tuller€™s] argument is that the therapies evaluated in the PACE trial are based on a misguided hypothesis that CFS/ME patients suffer from unhelpful beliefs that they have a biological disease, and that their symptoms of fatigue are made worse by deconditioning due to inactivity. He also says he thinks the trial€™s methodology was flawed. The scientists involved reject those arguments.
That€™s it–the full extent of what Kelland writes about the flaws of the PACE trial. First of all, to clarify: The PACE trial itself states clearly that the therapies are based on the hypothesis mentioned, so it is not just my personal “argument” that the therapies are based on that hypothesis. It is my “argument” that this hypothesis is “misguided.”
This is not the place to recap the voluminous debate over PACE except to make one point that captures some of the trial€™s absurdities. In the study, 13% of the participants were defined as disabled for physical function, one of the primary outcomes, based on their answers to a questionnaire, even as they were simultaneously defined as recovered for physical function based on those same questionnaire answers. How could that be? Because the score for being considered recovered on physical function was lower and represented worse health than the score for being considered disabled on the same measure.
You read that previous sentence correctly, but the point is bizarre and hard to grasp so I will repeat it–the score for being considered recovered on physical function in the PACE trial was lower and represented worse health than the score for being considered disabled on the same measure. Specifically, to be considered “disabled” enough on physical function for trial entry, you needed to score 65 or below on the questionnaire’s 100-point scale; to be considered “recovered” for physical function at the end you needed to score a 60 or above on the same 100-point questionnaire scale. So there was a five-point overlap in these critical thresholds.
In other words, participants could be recovered for physical function at the beginning of the study, before any treatment at all–even as the exact same score defined them as disabled enough to be in the trial in the first place. Since these participants were already “recovered” on this key variable, it is hard to understand why they were in the trial in the first place. In fact, patients could drop from a score of 65 for physical function at trial entry to a score of 60 at the end yet still be considered recovered. This anomaly was just one of PACE trial’s many troubling features. Kelland does not mention it.
Moreover, Kelland frames the argument as my personal opinion against those of her protagonists. As she notes, David Tuller “thinks” the study has problems; these researchers understandably “reject” my thoughts on that. Yet in the story, I am portrayed as a rogue nobody while those I am criticizing are highly positioned somebodies. My only apparent allies in this struggle are aggressive, hostile patients akin to climate-change-deniers and one other non-patient campaigner. In addition to omitting any mention of last summer€™s open letter to The Lancet with 100+ expert signatories, Kelland overlooks the abundant evidence of extensive scientific and medical opposition to PACE and the entire CBT/GET treatment paradigm.
Here is some additional information that Reuters readers might have found useful in considering the issue:
*Kelland mentions that I was co-author of a critique of the PACE trial. However, she doesn€™t mention that this paper was more than a critique, it was a robust reanalysis and full refutation of all the main PACE findings. The reanalysis was based on the PACE authors€™ own trial protocol, in which they spelled out before patient recruitment how they would conduct their analyses. After collecting their data, they abandoned their main pre-specified outcome measures in favor of weaker ones that produced better-looking results. Does it matter to Reuters that the scientific literature now includes a convincing, peer-reviewed debunking of PACE in a quality journal, but that Kelland did not provide readers with this information? I would hope so.
*Many dozens of readily accessible experts recognize that PACE is a piece of crap, as I have called it, and have said so publicly (although they have avoided use of the word crap). Kelland could have sought comment from any of the 100+ experts who signed last August€™s open letter to The Lancet. Bruce Levin, a biostatistician at Columbia, has called PACE the height of clinical trial amateurism. Racaniello, the Columbia microbiologist who hosts Virology Blog, has called PACE a sham. Jonathan Edwards, a rheumatologist at University College London, has called it a mass of uninterpretability. Ronald Davis, a geneticist at Stanford University, said: I€™m shocked that The Lancet published it€¦I don€™t understand how it got through any kind of peer review.
*In 2017, the Journal of Health Psychology published an entire issue with multiple critical commentaries about the controversy it called “PACE-gate.” (Disclosure: I wrote one of these critical commentaries.) Here€™s what the journal€™s editor, psychologist David Marks, wrote in a subsequent essay called “The PACE Trial: A Catalogue of Errors”: “The PACE Trial team were operating within a closed system or groupthink in which they ‘know€™ their theory is correct. With every twist and turn, no matter what the actual data show, the investigators are able to confirm their theory….Furthermore, critical analysis suggests that the PACE investigators involved themselves in manipulating protocols midway through the trial, selecting confirming data and omitting disconfirming data, and publishing biased reports of findings which created a catalogue of errors.” The Reuters story demonstrates Kelland’s transparent allegiance to the same “closed system or groupthink” as the PACE investigators.
*Two days before Reuters published Kelland€™s story, I posted an interview on Virology Blog with Steve Olson, medical director at Kaiser Permanente for northern California. He explained that the organization is overhauling its entire approach to ME/CFS because it now recognizes that patients and advocates have been right about the science all along–that PACE and other CBT/GET studies are examples of poor research and should never have been used as the basis for clinical guidelines. Here€™s what Olson, a family physician, told me about his change of views: “I began to meet people involved in patient advocacy and found that they were all very grounded, looking at the current information and research about ME/CFS in a pretty objective manner…They rejected the GET and CBT framework because they found the science to be inadequate. I concluded they were right.” Kelland and the CBT/GET defenders have concluded the opposite. They are wrong.
*Kelland conveys, without skepticism, her protagonists€™ suggestion that the US Centers for Disease Control and Prevention removed its CBT/GET recommendations and its references to PACE because of patient pressure rather than scientific concerns. Similarly, Kelland allows authors of a disputed review of exercise therapies to claim, without evidence, that the publisher planned to withdraw it because of patient pressure rather than genuine scientific concerns. (Cochrane, the organization involved, is an international collaborative that publishes systematic reviews of medical treatments.) Yet for some reason, Reuters has not provided patients who pushed for these actions at the CDC and Cochrane with any opportunity to explain why they believed such changes were necessary for scientific and medical reasons.
*Regarding the Cochrane exercise review specifically, Kelland does not address any of the methodological concerns that patients, I, and many others have raised. She mentions that I pressed Cochrane on the issue, which is true. She does not mention that I organized and posted on Virology Blog an open statement of support for Cochrane€™s decision, which noted in detail the exercise review€™s disqualifying flaws; this statement of support for Cochrane was signed by 40+ experts from Harvard, Columbia, University College London, Stanford, Dartmouth, etc. And Kelland does not mention a key document–Cochrane€™s own internal report about the exercise review, which makes clear that scientific deficiencies prompted the decision to seek its withdrawal.