By David Tuller, DrPH
I have written two more letters and have posted them below.
The first letter is a nudge to BMJ’s research integrity department, which missed a deadline this week for providing me with an update on the status of that music therapy study from Norway. You know, the one that started off as a fully powered trial but failed on multiple metrics and ended up being published as a feasibility study seeking data to support the need for a fully powered trial, as I recently documented. I sent the letter this morning.
The second letter, sent yesterday, is to the lead investigator of the study on “health anxiety” and CFS/ME that I critiqued earlier this week. Like the PACE authors and so many other CBT proponents, she appears to interpret equivocal findings in ways that suit her narrative but strain or even violate common sense. At my own academic institution, PACE has already been distributed in epidemiology seminars as an excellent case study of poor research; perhaps the health anxiety study or others from this cohort of investigators can be put to similarly good use.
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Letter to BMJ’s Research Integrity Department (July 3, 2020)
Dear Ms Ragavooloo–
It has been more than two weeks since our previous exchange, so I wanted to reach out again and check in on the status of the cognitive behavior therapy/music therapy study conducted by Norwegian investigators and published earlier this year by BMJ Paediatrics Open. I have cc’d several colleagues from Berkeley, Columbia, and University College London; they also signed the initial letter to BMJ and are also eager to see this matter properly resolved.
As we indicated in that letter more than a month ago, a proper resolution would mean withdrawing the study pending a second review by someone who promises to read the paper–unlike the original second reviewer. The new reviewer should be asked to compare the published work with the trial protocol and statistical analysis plan. Should the reviewer and BMJ confirm the identified methodological and ethical lapses outlined in our letter and on Virology Blog, the study should be retracted.
In reality, it should take an experienced reviewer no more than an hour to scrutinize the trial materials and assess how the paper itself diverged from what was laid out in the trial protocol and statistical analysis plan. It might take longer to determine why the investigators made the decisions they did and where BMJ’s peer review process fell apart.
In the meantime, you might have seen this excellent article in the Norwegian press about the BMJ Paediatrics Open study. The article mentions the unusual downgrading from full-scale trial to feasibility study, which the investigators themselves chose not to mention in the published paper. The article also highlights the negative results for daily steps taken–the primary and only objectively measured outcome–and the key fact that the intervention group did even worse on that measure than those who did not receive the intervention.
The Norwegian article does not mention that post-exertional malaise, an outcome highlighted in the paper, was not included in either the protocol or statistical analysis plan. Nor does it mention that one of the two BMJ Paediatrics Open reviewers acknowledged not having read the paper. Overall, however, the article raises troubling issues that remain unanswered. (I have also cc’d the journalist, Ingrid Spilde, on this message.)
Before touching base with BMJ about this study, I wrote directly to the senior investigator and invited him to respond to my concerns, offering to post his full comment on Virology Blog. He did not respond.
I also wrote to the first reviewer. Unlike the second reviewer, she apparently read the paper and raised smart, pertinent questions about whether the research was designed to be a full-scale trial or a feasibility study. I wanted to find out whether she realized that the investigators, in response to her request for clarity about the goal of the research, falsely presented it as having been designed as a feasibility study. I did not hear back from her either.
My colleagues and I look forward to learning what BMJ plans to do about this problematic paper, which unfortunately has the potential to influence the treatment of children with serious illness–a highly vulnerable group. Given the paper’s multiple methodological and ethical anomalies and the fact that BMJ published it after a peer review process that clearly violated recognized standards, we urge you to reach an acceptable decision quickly.
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
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Letter to Lead Investigator of “Health Anxiety” and CFS/ME Study (July 2)
Subject line:
Invitation to respond to my critique of your study on Virology Blog
Dear Dr Daniels–
I am a journalist and an academic fellow at the School of Public Health at the University of California, Berkeley. I frequently write about research in the domains of CFS, ME and other so-called medically unexplained symptoms. Much of my work appears on Virology Blog, a science site hosted by Professor Vincent Racaniello, a microbiologist at Columbia University. (I have cc’d Professor Racaniello on this e-mail.)
Yesterday, I posted a critique of your recent article €œPrevalence and treatment of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis and co-morbid severe health anxiety,” which was published by the International Journal of Clinical and Health Psychology. You can read my post here.
In summary, I believe the suggestion that health anxiety in CFS/ME “exacerbates” the symptoms of the illness and should therefore be a specific target of intervention is a very generous interpretation of the evidence. It is also unconvincing. The data presented do not lead me to the same conclusion.
In the interests of fairness and open debate, I want to offer you a chance to respond in the venue where my critique appeared. If you send me your remarks, at whatever length you choose, I will be happy to post them in full on Virology Blog, without interruption or editorial comment. (If I decide to respond, I will do so in a separate post.)
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
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