16 SEPTEMBER 2019
By David Tuller, DrPH
I have posted a batch of letters about the Lightning Process study that have been sent to Dr Fiona Godlee, editorial director of BMJ,
here,
here and
here. I have been impressed with how direct these scientists and clinicians have been in expressing their dismay at BMJ’s failure to adhere to its own editorial standards. I get the feeling some of the writers have been inspired by the earlier messages to Dr Godlee.
Anyway, here are three more: from Steven Lubet, a law professor at Northwestern University in Chicago; Robert Garry, a microbiology professor at Tulane University in New Orleans; and Philip Stark, a statistics professor at UC Berkeley. Thanks to all of them for their support. That makes 14 letters so far.
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Dear Dr Godlee: I am a legal ethicist, rather than a physician or scientist, so I will not weigh in on the various methodological and other problems that have been identified regarding “Clinical and cost-effectiveness of the Lightning Process.” I do want to comment, however, on one aspect of the “Correction” recently published in Archives of Disease in Childhood, which accepted “an assurance from the authors that the change in primary outcome was not influenced by (positive) findings in the feasibility phase.” Having spent many decades studying and evaluating conflicts of interest in both academic and professional settings, I find it extremely troubling that a respected scholarly journal would discount acknowledged research irregularities based upon such an obviously self-interested conclusion by the investigators themselves.
To put it bluntly, conflict of interest principles exist because it is impossible to rely upon affected individuals to provide objective assessments of their own decisions. In this instance, the “Lightning Process” authors have a quite evident stake in avoiding retraction of their article, which they only now admit “was not fully ICMJE compliant.” Thus, no matter how sincere they may be in defending their work, they should never have been the ones to determine whether the change in primary outcome had been influenced by their earlier positive findings.............
