My Letter to Dr. Fiona Godlee, BMJ Editor-in-Chief

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.

In legal and judicial ethics, the applicable standard for disqualification is whether an individual’s "impartiality might reasonably be questioned." Let me kindly suggest that the standards of BMJ Archives of Disease in Childhood ought to be no less rigorous.

In this instance, the authors of the “Lightning Process” article cannot possibly appear impartial regarding the validity of their own study, much less the question of whether their outcome swapping had been influenced, consciously or otherwise, by the pre-registration findings. Applying the most basic conflict of interest principles, the decision to issue a correction, rather than a retraction, should not have been based, even in part, on the authors’ after-the-fact assurances.

Sincerely,

 

Steven Lubet

Williams Memorial Professor

Northwestern University Pritzker School of Law

Comments

[anon]

Your opinion advocacy is far more coherent and persuasive when you stay in your lane.

Good letter.