A New Crony Tsar—the Same Old, Same Old

P romises … promises. During the political season (when will it ever stop?) a lot of important issues are glossed over, but crony politics never stops. A crony is a close friend of someone powerful (such as a member of the political bureaucracy or a politician) who is unfairly given special treatment or favors. And promises continue.

On February 24th the Senate voted overwhelmingly to approve the nomination of Dr. Robert Califf as FDA Commissioner (see our editorial, “FDA Nominee Likes Drugs, but Not Supplements” in the December 2015 issue). How is this possible when Califf lines up to be quite possibly regulatory crony #1?

Here are sample statements from a couple of grandstanders who threatened to block a vote on Califf because of their concerns:

The Senate should reject President Barrack Obama’s nomination of Dr. Robert Califf to be the next commissioner of the U.S. Food and Drug Administration (FDA). His nomination undoubtedly comes as welcome news to the pharmaceutical and medical device manufacturers, but is bad news for patients and public health.

— Public Citizen

Last year, the pharmaceutical industry spent $250 million on lobbying and campaign contributions and employed some 1,400 lobbyists. The top three pharmaceutical companies made a combined $45 billion in profits last year and spent more on sales and marketing than they did on research and development.

—Senator Bernie Sanders

In the end, resistance to stopping the vote collapsed and everyone dropped out. Even the Senator from Vermont, who made some good points in exposing the hotbed of cronyism that the FDA is and who promised to block Dr. Califf’s nomination to lead the FDA. He didn’t.

The final tally was 89 votes in favor, seven no shows—and only four “no” votes. Both parties were represented among the four.

None of the presidential candidates, including Ted Cruz (R-TX) and Marco Rubio (R-FL), voted.

As we have pointed out before, Califf’s ties to the pharmaceutical industry are abundant and well known. When he was at Duke University, he ran a clinical research center that received the majority of its multimillion dollar budget from Pharmaceutical Goliaths.

Furthermore, in financial disclosures of last year, Dr. Califf reported received money for consulting with at least seven drug and medical device companies, and six other companies supported his university salary, including Amylin, Amgen, Bayer Healthcare, BMEB Services LLC, BMS, Eli Lilly & Company, Janssen Research & Development, LLC, Medscape LLC/heart.org, Merck, N30 Pharma, Novartis, Portola, Regado NJ, Roche. In other disclosures count AstraZeneca, CV Sight, LLCDSI - LilyGambro, Genentech, Gilead, GSK, HeartOrg-Diaichi Sankyo, Kowa, and Les Laboratories Servier, When it comes to cronyism this compilation is certainly a sticky wicket.

The conflict-of-interest section of a paper, “LCZ696: too good to be true?” he wrote for the European Heart Journal last year lists financial support from more than twenty companies: R.M.C. (Califf) reports receiving grant funding and personal fees from Novartis; grants from the Patient-Centered Outcomes Research Institute, the National Institutes of Health, the US Food and Drug Administration, the Clinical Trials Transformation Initiative, Merck, Roche, Aterovax, Bayer, Janssen Pharmaceuticals, Eli Lilly & Company, and Schering-Plough; grants and personal fees from Amylin, Scios, and Bristol-Myers Squibb/Bristol-Myers Squibb Foundation; and personal fees from WebMD, Kowa Research Institute, Nile, Parkview, Orexigen, Pozen, Servier International, Bayer Healthcare, Bayer Pharma AG, CV Sight, Daiichi Sankyo/Lilly, Gambro, Gilead, Heart.org–Bayer, Medscape, Pfizer, Regeneron, TMC, GlaxoSmithKline, Genentech, Heart.org–Daiichi Sankyo, and Amgen. R.M.C. holds equity in Nitrox/N30 and Portola.

The significance of the appointment of Califf to head the FDA cannot be understated. According to the New York Times, ­­the FDA regulates a quarter of every dollar spent in the United States—and now Big Pharma has its own cronymaster in this immensely powerful position.

Califf has promised to increase patient involvement in the drug approvals and communicate better with drug companies during the process. Crony medicine could not have done better, especially compared to everyone else, most of whom have received no meaningful promises.

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