FDA advisers were paid $10 000 to $1.9m for future industry workBMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k2942 (Published 05 July 2018) Cite this as: BMJ 2018;362:k2942
The Food and Drug Administration’s drug approval process may be tainted by financial conflicts of interest with drug companies that are based not only on present and past ties but also on future ones that may be created.
An investigation by the journal Science1 identified 107 physician advisers who served on FDA advisory committees and matched them with financial ties with industry that were declared in journal articles and other sources, including the federal Open Payments website during 2013-16.
It found that 40 of those advisers who had reviewed a drug application from a company or competitor later received over $10 000 (£7570: €8590) from drug companies in subsequent years; 26 received over $100 000; and seven received over $1m.
The payments covered a wide range of activities including participating in company advisory bodies and educational programs, as well as grants and product donations for research. The specifics were not broken down in the analysis but are available in supplemental data drawn from Open Payments (https://scim.ag/FDAanalysis).
Charles Piller, lead author of the Science investigation, told The BMJ, “What we’ve tried to do is show evidence that there is cause to be concerned—that there may be problems with conflicts of interest that are both undisclosed and occur after the fact that create an incentive structure that could cause people to adjust their views, even if it is not a quid pro quo.”
Carl Elliott, a medical ethicist at the University of Minnesota, asserted that such payments after the fact are a way of “postponing your reward.” The Science article quoted him as saying, “You do something positive for a company that you feel confident is going to pay you back for it later on. And they do.”
The largest payment after the fact that Piller uncovered was a $1.9m research grant that included the name of Jonathan Halperin, who served on a 2010 advisory committee that reviewed Brilinta, an anti-clotting drug made by AstraZeneca.
Halperin said that the grant for later research on Brilinta went directly to Duke University in Durham, North Carolina. He was based at the Mount Sinai school of medicine in New York, and his role in the study was to serve as chair of the independent data monitoring committee. Furthermore, the advisory committee unanimously voted for approval—a common outcome, which undercuts suggestions of a quid pro quo.
Piller asked the FDA and advisory committee members to supply copies of the conflict of interest statements that were submitted to the agency years ago, but they were unable to find or declined to supply them.
He commented to The BMJ, “What is up with the record keeping system, that they would not be able to locate those important documents?” He is troubled by “the reluctance of the FDA to engage in these issues and be willing to be talk to me about it.”
Adriane Fugh-Berman, who runs PharmedOut, a watchdog group at Georgetown University in Washington, DC, said, “Most FDA advisers got paid by makers or competitors of the drugs they approved. That’s why we should ban anyone with a financial conflict of interest from serving on an FDA committee.”