An investigative report from Charles Piller, a contributing correspondent in the News department at Science, uncovers little recognized and unpoliced potential conflicts of interest among those who serve on FDA advisory panels to review drugs are under-reported. Some members of such panels are later receiving significant payments from either the makers of drugs they previously reviewed, or from competitors. This is happening, Piller notes, despite the FDA's established system to identify possible financial conflicts of interest among those recruited for new drug advisory panels. Piller, for this investigation, analyzed records on the federal Open Payments website between 2013 and 2016. Among other findings, he reports that of 107 physician advisors who voted on FDA advisory committees during this time, 40 later took more than $10,000 from the makers of drugs, or from competing firms. As well, Open Payments suggests that 26 physician advisors gained more than $100,000 in post-hoc earnings or research support, Piller says. These potential conflicts of interest may be more widespread than commonly thought, his reporting - including through additional anecdotes -- suggests. In one such example, a physician was found to have received more than $200,000 dollars for accommodations, honoraria, and consulting from the maker of a drug he voted to recommend for approval, and from competing firms. Even though these payments might not be truly "quid-pro-quo," according to Vinay Prasad, an oncologist who also studies financial conflicts that exist in drug approvals, those asked to weigh in stand to gain tremendously in their further professional careers. "It's in their best interest to play nice with the companies." Pillar also found that the FDA may have missed or judged insignificant financial ties to the physicians had before their service on the advisory panels. The FDA's process for reviewing the financial interests among those asked to serve as advisers uses an honor system - one based solely on the disclosures by the members themselves - and it's nearly always hidden from the public view. Piller's investigation suggests that many conflicts of interest are falling through the cracks. (A second story looks at FDA staff members who leave the agency to work for companies whose drugs they once reviewed.) The FDA declined Piller's requests to comment.
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Journal
Science