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 Califf, 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:
“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, 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.”
Califf was followed by FDA commissioner, Scott Gottlieb, MD, in 2017 who also brought some drug makers 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 and deliberations 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.
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.
Another industry friendly choice
In 2008, then-President-elect Obama chose Tom Vilsack as his nominee to be secretary of agriculture. The choice was lauded by industry players such as the Corn Refiners Association, the National Grain and Feed Association and biotech organizations. In fact, Vilsack, a former governor of Iowa, “was named Governor of the Year by the Biotechnology Industry Organization, an industry lobbying group,” reports Wikipedia.
Vilsack did not disappoint.
When Vilsack was asked during a 2010 trade mission in Canada if cloned cows or their offspring were in the North American food supply, he said,”I can’t say today that I can answer your question in an affirmative or negative way. I don’t know. What I do know is that we know all the research, all of the review of this is suggested that this is safe.” The USDA secretary doesn’t know what’s in the food supply but he does know it’s safe?
In 2016, under the USDA’s watch, animal treatment at the U.S. Meat Animal Research Center in Nebraska was so shocking that the late Rep. Louise Slaughter (D-NY) wrote Vilsack, “Such heinous examples of egregious cruelty, which would violate the minimum standards of any approved research protocol … should not occur anywhere for any reason.” Details of the disturbing taxpayer-funded animal experiments are found here. In January, Biden renominated Vilsak,
After Vilsack’s term ended and before Biden re-nominated him as USDA secretary, Vilsack served as the president and CEO of the US Dairy Export Council, a worldwide lobbying group that promotes sales for the U.S. dairy industry. No conflict of interest there!
How can FDA or USDA officials who shamelessly serve industry also regulate industry and protect consumers? Clearly they can’t and Biden should be ashamed of these retrogressive nominations.
Martha Rosenberg is a freelance journalist and the author of the highly acclaimed “Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health,” published by Prometheus Books. Check her Facebook page.