In 2011, FDA commissioner Margaret Hamburg, an Obama nominee, 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.
In 2015, prior to leaving the agency, Hamburg took her own advice and appointed Robert Califf, MD, to serve as FDA Deputy Commissioner for Medical Products and Tobacco. Months later, Obama nominated Califf as FDA commissioner and all but four senators approved the nomination.
Now, proving the dearth of conflict-free government officials in the pharmaceutical space, President Biden has again nominated Calif who left in 2017, to be FDA commissioner.
How conflicted is Califf from drug maker money, making a mockery of any firewall between the FDA and those it is charged to regulate? According to disclosures in a November 20, 2013 Journal of the American Medical Association (JAMA) opinion piece that Califf cowrote:
Robert Califf Conflicts
“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, Aterovax, Bayer, Roche, and Lilly … .Dr Califf also consults for TheHeart.org, 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 … Dr Califf holds equity in Nitrox LLC, N30 Pharma, and Portola.”
After leaving the FDA in 2017, Califf did a stint at Big Tech, becoming head of medical strategy at Google parent company Alphabet Inc. (Thomas Insel, MD, former director of the National Institute of Mental Health, also joined Big Tech, the Life Science division of Google X, now called Verily Life Sciences, upon leaving government.) The cozy relationship between Big Tech and drug makers has led to censorship, many charge.
While at Duke university, Robert Califf presided over a subsequently-discredited drug trial of the blood thinner Xarelto. A fabricated data scandal related to experimental cancer treatments at Duke under Califf’s watch was featured on Sixty Minutes.
Appearing on PBS he 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.”
Scott Gottlieb Conflicts
Califf was followed by FDA commissioner, Scott Gottlieb, MD, in 2017 who also brought some drug maker baggage. According to Fortune, Gottlieb had “received millions of dollars in compensation from some 20-odd biopharma and health firms” including GlaxoSmithKline and Bristol-Myers Squibb. He “poured cash” into health care startups and served as a venture partner at New Enterprise Associates, said Fortune.
As FDA deputy commissioner for medical and scientific affairs in 2005 before his FDA commissioner nomination was approved, Gottlieb had to recuse himself from decisions related to nine major pharma and consumer health companies including Roche, Sanofi-Aventis, Serono, Eli Lilly, VaxGen and Inamed. Lasting just a short time as commissioner, Gottlieb now promotes the benefits of COVID-19 vaccines as a TV pundit … and board member of vaccine maker Pfizer.
Margaret Hamburg Conflicts
Is Hamburg’s declaration of a shortage of experts who are not funded by drug makers true? Yes, and it applied to her also. Within two months of confirmation as FDA commissioner, Hamburg had to recuse herself from decisions related to dental amalgams because she was a board member of Henry Schein Inc. a leading distributor of dental products.