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FDA commissioner's tenure ends with questionable appointment

FDA commissioner's tenure ends with questionable appointment

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Many had high hopes for the FDA when Margaret Hamburg was confirmed as Commissioner in 2009 because of her public health background. But she swiftly moved to loosen conflict of interest rules governing those who can serve on FDA expert advisory panels, claiming it was too hard to find experts without Pharma financial links. 

A few years ago, child psychiatrist Jorge Armenteros, a paid consultant to AstraZeneca, was on an FDA committee voting on the AstraZeneca drug Seroquel until a Philadelphia Inquirer reporter exposed the conflict of interest.

Last month, Commissioner Hamburg raised more questions about conflicts of interest with her appointment of Robert Califf, M.D., chancellor of clinical and translational research at Duke University, as the next FDA Deputy Commissioner for Medical Products and Tobacco despite a thicket of conflicts of interest. It was one of her last official acts before announcing her resignation last week.

A disclosure statement on the website of Duke Clinical Research Institute says "Robert M. Califf, MD, reports receiving research grant support from Novartis Pharmaceuticals, Johnson & Johnson/Scios, Lilly, Merck, and Schering Plough, and consulting fees from Annenberg, Aterovax, Bayer/Ortho McNeil, BMS, Boehringer Ingelheim, GSK, WebMd/theheart.org, Johnson and ohnson/Scios, Kowa Research Institute, McKinsey & Company, Medtronic, Merck, Novartis Pharmaceuticals, Sanofi Aventis, and Schering Plough, and has an equity position with NITROX, LLC."

In disclosure information for a 2013 article in Circulation, Dr. Califf's also lists financial links to Gambro, Regeneron, Gilead, AstraZeneca, Roche, others companies and equity positions in four medical companies. The medical website Medscape discloses that Dr. Califf "served as a director, officer, partner, employee, advisor, consultant or trustee for Genentech" as well as for Medscape LLC/theheart.org. Portola Pharmaceuticals says Dr. Califf served on the Board of Directors until he was appointed FDA Deputy Commissioner for Medical Products and Tobacco.

Appearing on PBS with Susan Dentzer after Vioxx was withdrawn because of its links thousands of heart attacks and stroke, Dr. Califf said, "Merck played by the rules from everything that I've seen." He also said, "many of us consult with the pharmaceutical industry, which I think is a very good thing. They need ideas and then the decision about what they do is really up to the person who is funding the study."

This is not the first time Dr. Califf's extreme Pharma links have not blocked him from consideration for a top government post. He was up for Dr. Hamburg's job itself, reported Reuters along with three others. At the time, some medical voices asked how someone who helps drug companies market their products could possibly be considered as the nation's chief watchdog over unsafe medications.

Industry conflicts at the FDA cost lives. Recently Senators Joe Manchin (D-W.Va.) and David Vitter (R-La.) questioned whether the FDA's approval last year of the synthetic opioid Zohydro stemmed from pay-to-play meetings with Big Pharma who allegedly shelled out thousands to meet with regulators. Big Pharma's hand in the opioid epidemic which causes 17,000 overdose deaths a year in the U.S. is well documented and egregious.

Commissioner Hamburg's appointment of Dr. Califf amounts to a sad legacy. It also suggests the FDA is no longer even making a pretense at policing industry/government conflicts of interest.

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