Conny, CC BY-SA 3.0 <>, via Wikimedia Commons

Thanks to the COVID-19 pandemic and the war in Ukraine, Senate approval of President Biden’s FDA Commissioner nominee Robert Califf, MD, was barely covered by news media.

But everyone who cares about conflicts of interest at the FDA will find the choice disheartening.

According to disclosures in a November 20, 2013 Journal of the American Medical Association (JAMA) opinion piece that Califf cowrote:

 “Dr Califf receives research grants that partially support his salary from Amylin, Johnson & Johnson, Scios, Merck/Schering-Plough, Schering-Plough Research Institute, Novartis Pharma, Bristol-Myers Squibb Foundation, Aterotiovax, Bayer, Roche, and Lilly … .Dr Califf also consults for, Johnson & Johnson, Scios, Kowa Research Institute, Nile, Parkview, Orexigen Therapeutics, Pozen, WebMD, Bristol-Myers Squibb Foundation, AstraZeneca, Bayer/Ortho-McNeil, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Gilead, GlaxoSmithKline, Li Ka Shing Knowledge Institute, Medtronic, Merck, Novartis, sanofi-aventis, XOMA, University of Florida, Pfizer, Roche, Servier International, DSI-Lilly, Janssen R&D, CV Sight, Regeneron, and Gambro; all income from these consultancies is donated to nonprofit organizations, with most going to the clinical research fellowship fund of the Duke Clinical Research Institute, Dr Califf holds equity in Nitrox LLC, N30 Pharma, and Portola.”

If much of the consultancy “take" goes to the Duke Clinical Research Institute, many would still call it a conflict of interest between medicine and industry.

After leaving the FDA in 2017, Califf became head of medical strategy at Google parent company Alphabet Inc. Before that, at Duke university, Califf presided over a subsequently-discredited drug trial of the blood thinner Xarelto. According to the Chicago Tribune, by 2017 there were more than 18,000 U.S. patient suits brought against Johnson & Johnson and Bayer, indicting the blood thinner for internal bleeding and accusing the drug makers of hiding the drug’s dangers. “The medicine also has been linked to at least 370 deaths, according to Food and Drug Administration reports,” the newspaper wrote.

Discussing the Vioxx scandal on PBS Califf 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.”

An elaborate fabricated data scandal related to experimental cancer treatments at Duke is also a black mark against Califf ––it occurred while he was Vice Chancellor at the university. According to CBS News, Duke University’s announcement that it found the way to match a patient's tumor to the correct chemotherapy drug was likely “one of the biggest medical research frauds ever - one that deceived dying patients, the best medical journals and a great university.”

More than ten years ago, FDA commissioner Margaret Hamburg, lamented that the government could not find enough experts who were not funded by drug makers to serve on advisory committees and recommended that the FDA’s conflict of interest rules be loosened. On the basis of the Califf approval, the same dearth of non-drug-maker-funded FDA Commissioner nominees exists –– and the rules have been similarly loosened.