You have probably heard "the FDA is too friendly to industry" but many would not believe how friendly. It took a reporter at the Philadelphia Inquirer to expose that a paid consultant to AstraZeneca was a voting member on the FDA committee voting on an AstraZeneca drug, Seroquel. Otherwise the vote would have gone through. Now you can barely find a trace that the AstraZeneca consultant, child psychiatrist Jorge Armenteros, ever graced an FDA committee much less headed one.
Many had high hopes for the FDA when Margaret Hamburg was confirmed as Commissioner in 2009 because of her public health orientation--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. What?
More recently Senators Joe Manchin (D-"W.Va.) and David Vitter (R-"La.) questioned whether the FDA's recent approval 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.
Last month a shocking FDA appointment suggests the FDA is no longer even making a pretense at policing industry/government conflicts of interest. Commissioner Hamburg appointed 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.
A disclosure statement on the website of Duke Clinical Research Institute says "Robert M. Califf, MD, reports receiving research grant support from NovartisPharmaceuticals, 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. "
And there's more! 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.
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. It sounded like a satire in the Onion. Six years later their concerns have come to pass: the fox is guarding the hen house.
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