
pmid: 30523103
The News Feature “Hidden conflicts?” (C. Piller, 6 July, p. [16][1]) alleges that after serving as a member of a Food and Drug Administration (FDA) advisory panel for a nominal per diem payment, I later received inappropriate payments from the manufacturer (AstraZeneca) for serving on and chairing data monitoring committees (DMCs) overseeing AstraZeneca-sponsored research. Those assertions are inaccurate. The universities conducting clinical trials, not AstraZeneca, compensated DMC members for their time. More important, the OpenPayments database still reports inaccurate payments far in excess of the amount I received from the university. AstraZeneca has acknowledged that it mistakenly reported my name and attributed inaccurate amounts to me in its filing to the database and has agreed to correct these errors. Serving on a DMC does not involve conducting research, and I did not conduct research on any drug for AstraZeneca after serving on the FDA panel. The DMCs on which I served oversaw the safety of participants enrolled in two postapproval trials funded through research contracts with academic institutions, not contracts with AstraZeneca. Members of DMCs are required to act independently of trial sponsors; they are not investigators. Their responsibility is to ensure the safety of trial participants and scientific integrity of studies to advance research. In this case, the outcomes of both trials were unfavorable to AstraZeneca. Regardless of the outcome, however, I had no financial relationship with the company; the fees, which were nominal, came to me through the university. Serving on a DMC is not a conflict of interest but a public service. My role was to protect the interests of patients, science, and the public. [1]: http://www.sciencemag.org/content/361/6397/16
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