By David Tuller, DrPH
This morning I sent the following e-mail to Dr Fiona Godlee, the editor-in-chief of The BMJ and editorial director of BMJ. I cc’d Professor Vincent Racaniello, the host of Virology Blog, and Carol Monaghan MP, who sits on the House of Commons Health and Technology Committee.
Dear Dr Godlee—
I am seeking an apology for untrue claims about my reporting that BMJ Open made last fall in a statement to the Committee on Publication Ethics. The statement involved a study that investigated whether school absence records could help identify children who might be suffering from the devastating illness variously known as myalgic encephalitis, chronic fatigue syndrome, ME/CFS and CFS/ME. I am also appealing to you to address the study’s documented violations of ethical and methodological principles, since BMJ Open has failed to do.
The investigators exempted the study from ethical review on the specious grounds that it was “service evaluation” rather than “research” and therefore did not require this level of scrutiny. They supported this decision by citing an opinion from the regional research ethics committee, even though that opinion had nothing to do with the study in question.
In defending the publication of the school absence study in its anonymized statement to COPE, BMJ Open declared that my reporting about the issue was “inaccurate” and “misrepresentative.” Unless BMJ Open can provide evidence to support these serious charges, it should withdraw them and apologize. That apology should include my colleague, Vincent Racaniello, a professor of microbiology at Columbia and the host of Virology Blog. After all, if I am guilty of posting “inaccurate” and “misrepresentative” material on Virology Blog, he is guilty of publishing it. (The COPE statement also declared that my reporting was “damaging to the journal’s reputation.” I am not seeking an apology for or withdrawal of this particular BMJ Open claim.)
(I am cc-ing Professor Racaniello on this e-mail. I am also cc-ing Carol Monaghan MP, with whom I met this week. She serves on the House of Common’s Science and Technology Committee and has taken an interest in the poor quality of research involving this particular illness and has called the PACE trial “one of the biggest medical scandals of the 21stcentury.”)
In the last year, I have written more than 20 blog posts that discuss the deficiencies of the school absence study and another from members of the same research group—a trial of the pseudo-scientific Lightning Process published in Archives of Disease in Childhood, another high-impact BMJ journal. As with BMJ Open, Archives has demonstrated an unwillingness or inability to promptly resolve these problems. As I have stated previously, this delay has created the strong impression that BMJ is more concerned about reputational damage than about the health and well-being of children suffering from this illness.
The school absence study included a hypothesis, generalizable conclusions, and in-person interviews with study participants. These are all hallmarks of research requiring ethical review and not service evaluation, according to the UK Health Research Authority—the recognized arbiter of these matters. Any informed editor who took two minutes to read the abstract should have recognized immediately that it did not meet the criteria for service evaluation and should not have been exempted from ethical review. Even the title—“Unidentified Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME) is a major cause of school absence: surveillance outcomes from school-based clinics”–represented a generalizable conclusion. Moreover, the journal itself published it under the heading of “research.”
However, since last year BMJ Open has engaged in a pattern of obfuscation and denial rather than seeking to make things right. These evasive maneuvers began when a reader contacted the journal with valid complaints about the issue. After the journal brushed her off, she contacted me. I quickly verified the legitimacy of her concerns. I then wrote to Trish Groves, the journal’s former editor-in-chief. She replied that the journal had determined that the investigators “were entitled to reach the conclusions that they did concerning the need for ethical approval.” However, she promised to submit the issue to COPE.
In something of a scholarly version of Rashomon, the journal’s COPE statement presented a self-serving account of the events. In addition to characterizing my work as “inaccurate” and “misrepresentative,” the statement maintained that the data used in the study were collected anonymously. This claim was diametrically at odds with the fact that the lead investigator herself had met with participants, suggesting that the editors either did not read the study they had published in their journal or for some reason felt it was appropriate and acceptable to convey this “inaccurate” and “misrepresentative”–i.e. false–information to COPE.
In response to BMJ Open’s statement, COPE suggested that the journal should obtain more details about the conduct of the study to determine whether it could qualify as service evaluation. At that point, BMJ Open apparently closed the COPE case without further action. This decision seemed to contradict Dr Groves claim in her initial e-mail to me that BMJ Open, as a member of COPE, “follows its best practice guidance and policies.”
In February, Professor Racaniello sent an open letter to BMJ Open, signed by 15 experts* [see correction below] from Berkeley and elsewhere, to highlight the journal’s negligence. In response, Dr Groves defended the journal by arguing that BMJ Open had “thoroughly reviewed” the matter and had also submitted the issue to COPE for consideration. She did not explain why the journal had apparently rejected COPE’s counsel. Nor did she acknowledge that the “thorough review” must have been deficient if it determined that no ethical approval was necessary.
Dr Groves also suggested that we submit a letter for publication. Professor Racaniello and I saw no reason to do so, since we assumed that the journal would publish our letter, along with a letter from the investigators, and then declare the matter closed. This approach would have allowed BMJ Open to present itself as a neutral broker in an unresolved dispute about the merits of the argument. But there is no unresolved dispute about the merits of the argument, since what happened is indisputable: BMJ Open published a research paper that self-evidently breached federal guidelines regarding ethical review, and then repeatedly defended this indefensible decision. The real question in dispute is whether BMJ Open will finally acknowledge its editorial failings in this matter.
In her last message, Dr Groves explained that a publishable letter from us would allow BMJ Open to request a detailed response from the investigators and their institution. Professor Racaniello and I considered seeking such responses from the investigators and their institution to be an essential part of Dr Groves job. We did not understand why she appeared to suggest that she could only take this necessary step upon receipt of a publishable letter. In any event, we declined to participate in what seemed to be BMJ Open’s effort to extricate itself from this thorny situation while evading responsibility for publishing the paper in the first place.
To date, the investigators and their institution have not publicly addressed these ethical and methodological issues. That troubling recalcitrance does not absolve BMJ Open of its own independent obligation to clean up the mess it has created, apologize for its false statements about my work, and take appropriate action—unless for some reason the journal has decided to outsource major editorial and oversight functions to others.
Thank you for your attention to this matter.
David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley
*In the initial e-mail to Dr Godlee, I wrote that 21 experts signed the letter. I subsequently sent a second e-mail correcting this misstatement.