Trial By Error: Letters to Fiona Godlee and Nigel Hawkes

By David Tuller, DrPH

This morning, I sent the following message to Dr Fiona Godlee, editor-in-chief of The BMJ and editorial director of BMJ. The subject heading: “My remaining concerns…”

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Dear Fiona,

Thank you for the quick changes to Nigel Hawkes€™ BMJ news story about the UK Heath Research Authority€™s letter on the PACE trial. I appreciate the addition of my Berkeley affiliation. (However, in the revised version, the PACE proponents are not described as activists for advocating strongly on behalf of their professional opinions, yet for unexplained reasons I am still assigned that label.)

I also appreciate the inclusion of the fact that other academics have criticized PACE, and the accompanying citation of last year€™s BMJ news story about Virology Blog€™s open letter to The Lancet. That open letter referenced the PACE trial€™s unacceptable methodological lapses and was signed by more than 100 academics, scientists and other experts from Harvard, Columbia, Berkeley, Queen Mary University of London, University College London, Stanford, etc. (The BMJ article, rather than relying solely on an activist like me to counter the views of eminent pro-PACE professors, could have benefited from the perspective of some of these well-regarded signatories.)

In any event, BMJ€™s prompt response suggests that editorial determination to ensure the accuracy of the public record can sometimes overcome institutional inertia and resistance. Given that, I thought it might be fruitful to raise several other unresolved issues involving BMJ and the illness variously known as CFS, ME, CFS/ME or ME/CFS, and sometimes other names.

While I have expressed these concerns previously, perhaps BMJ would now be more willing to address them. They include the following:

1) In its news item on The Lancet€™s 2011 PACE report, The BMJ indicated that around 30% of participants in the graded exercise and cognitive behavior therapy arms were cured of CFS. However, that was not one of the investigators€™ conclusions from the study itself but an opinion expressed in an accompanying commentary written by others. In presenting this claim as if it were in fact one of the study€™s own reported findings, the news item was inaccurate when written. It remains inaccurate eight years later. Even at this late date, it should be corrected.

2) Last June, Archives of Disease in Childhood published an editor€™s note related to its 2017 study of the Lightning Process as a treatment for children with CFS/ME. The editor€™s note revealed that serious questions had been raised about the study€™s methodology and that the journal was now engaged in a process of editorial consideration. This editor€™s note is not visible from the study itself.

In an e-mail to me in October, you indicated that BMJ€™s systems made it problematic to move this editor€™s note or its link from an obscure page to a more prominent location. You then assured me you were looking into whether this could be done anyway, despite this obstacle. In the four months since, nothing has happened; the editor€™s note is still sequestered in the medical journal equivalent of Siberia. In this case, have BMJ€™s systems impeded your efforts to increase editorial transparency?

Beyond that, my main concern about the Archives study is the journal€™s unwillingness or inability to conclude this prolonged period of limbo called editorial consideration. It is now eight months since the editor€™s note was published. The facts are undisputed: The Lightning Process study was not prospectively registered per BMJ€™s stringent guidelines; moreover, the investigators engaged in outcome-swapping that biased the reported results but was not disclosed in the paper.

This case is not complicated. The study should never have been published. It seems unreasonable and perhaps a bit cruel to impose this open-ended and inexplicable delay on worried parents, who, after all, might be relying on BMJ for the most current information about treatments for their very ill children. When does Archives intend to finish its editorial consideration of the matter?

3) When will BMJ Open accept responsibility for its poor judgement in publishing a 2011 study on school absence that the investigators exempted from ethical review on specious grounds? When will the journal apologize for its untrue claim that my reporting about this study was inaccurate? Why did BMJ Open tell the Committee on Publication Ethics that only anonymous data were used in this study even though the lead investigator conducted in-person interviews of participants?

As I have documented, this study was one of 11 that Bristol investigators exempted from ethical review based on a single research ethics committee letter. Five of those studies, including the school absence study, were published in BMJ journals. This suggests that BMJ€™s peer review processes might suffer from broader weaknesses. When does BMJ plan to investigate whether these five papers were properly or improperly exempted from ethical review?

In your October e-mail to me, you indicated that some matters were beyond [y]our immediate control, and that you were sure I would understand. I need to say, respectfully, that I do not understand. It is known that Bristol University is now investigating some of the papers that were exempted from ethical review. But BMJ€™s editorial functions are presumably within your immediate control, not beyond it. You can take appropriate action for BMJ€™s failures of oversight without having to wait for the results of an investigation from Bristol University or anywhere else.

Fiona, being reluctant to acknowledge errors is understandable. I empathize with your position. But it is past time for BMJ to swallow its embarrassment, confront its missteps in this domain, and make a good faith effort to clean up the mess.

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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Last Thursday, I sent science journalist Nigel Hawkes a follow-up e-mail after BMJ had made changes to the article that had referred to me as “a US activist” while omitting my academic credentials. The subject heading: “an apology, perhaps?”

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Dear Nigel–

I’m glad that your misleading BMJ article on the Health Research Authority report was amended/corrected promptly. However, had I been in your situation, I would have sent the academic involved–in this case, me–a note of apology. Identifying me as an “activist”–presumably because of my outspoken opinions about PACE–rather than actually checking my academic credentials was a pretty basic error. (Continuing to identify me as an “activist” while the other academics quoted were not slapped with this label was also an inappropriate editorial choice, but whatever.)

Next time, I suggest you pay more attention to people’s bylines so you notice the letters they put after their names. Another piece of advice: Don’t let your biases and assumptions guide your reporting, especially if those biases and assumptions are based on pronouncements emanating from members of the PACE team or their enablers at the Science Media Centre. Whatever exalted positions they occupy, these people are spinning the facts, and they are wrong–that is, in my professional opinion.

If you actually were to dig into this story, you might find it a lot more compelling than how you framed it last week and in previous writing on the matter. Don’t you wonder at all why more than 100 scientists, academics and other experts have expressed their dismay at PACE’s striking aberrations by signing an open letter to The Lancet slamming the study’s “unacceptable methodological lapses.” Or do you consider all of them “activists” whose views should be dismissed or ignored?

Over the last 3+ years, I have been surprised at how you and many of your British journalism colleagues have accepted the party line on this debate without–as far as I can tell–examining the details of the science itself. You and others have seemed curiously uninterested in why so many well-regarded professionals from the U.S. and elsewhere would find the PACE trial to be so egregious. Instead, as your recent BMJ article indicated, you are content to pump out the same tired anti-patient meme.

Why is that?

Best–David

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