Monday, September 21, 2015

Nominee for FDA Commissioner Has Massive Conflicts of Interest and is Not an Appropriate Choice

President Obama's nominee for the position of FDA Commissioner - Dr. Robert Califf - has massive financial conflicts of interest that I believe should preclude him from being eligible for this position.

Because the FDA regulates drug companies, it is essential that the Commissioner of this agency not have severe conflicts of interest by virtue of having financial relationships with pharmaceutical companies; in particular, recent financial relationships. In fact, Dr. Califf's conflicts of interest are both severe and recent.

In his most recent disclosure in 2014 from his position as director of the Duke Translational Medicine Institute, Dr. Califf reported the following financial relationships with Big Pharma:
  • Research funding from: Amylin, BMS, Ely Lilly, Janssen, Merck, and Novartis;
  • Consulting fees from: Amgen, Bayer, BMEB Services, Medscape, Merck, Novartis, Regado, and Roche; and
  • Equity in N30 Pharma, and Portola.
In his most recent published paper, which appeared just last week, Dr. Califf provided the following disclosure:

"Dr Califf currently holds the post of Deputy Commissioner for Medical Products and Tobacco, US Food and Drug Administration. Prior to holding this post, Dr Califf received grant funding from the Patient-Centered Outcomes Research Institute, the National Institutes of Health, the US Food and Drug Administration, Merck, Roche, Aterovax, Bayer, Janssen Pharmaceuticals, Eli Lilly & Company, and Schering-Plough; grants and personal fees from Novartis, 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,–Bayer, Medscape, Pfizer, Regeneron, TMC, GlaxoSmithKline, Genentech,–Daiichi Sankyo, and Amgen.
Dr Califf also reported holding equity in Nitrox/N30 and Portola. A full listing of disclosure information for Dr Califf for this interval is available at" 

The Duke Clinical Research Institute, for which Dr. Califf worked prior to joining the FDA as a deputy commissioner, reports receiving recent funding from more than 100 companies, most of them in the pharmaceutical or device business. According to an article in the New York Times, the multi-million dollar institute that Dr. Califf ran at Duke received more than 60% of its funding from industry.

According to the same article, Dr. Califf "has deeper ties to the pharmaceutical industry than any F.D.A. commissioner in recent memory...".

The article notes that: "“He has amassed an extensive record of close collaboration with industry, through consulting fees, speaking fees and research grants supporting his salary,” said Dr. Michael Carome, the director of the health research group at Public Citizen, a consumer advocacy group. “This will color his views when it comes to making regulatory decisions.”"

The Rest of the Story

According to the New York Times article: "Through the F.D.A., where he has served as a deputy commissioner since March, Dr. Califf declined a request for an interview. A spokesman for the Department of Health and Human Services, Kevin Griffis, said that Dr. Califf had been through “a comprehensive screening process for conflicts of interest,” and that officials had “put in place measures to ensure that he is appropriately recused from matters that would give rise to conflicts,” including the new cholesterol medicines."

If this is what FDA's comprehensive screening process for conflicts of interest looks like, I would hate to see the agency's trimmed down screening process looks like. I could understand an agency missing one or two conflicts of interest, but how can you miss more than 20 of them?

The idea that these conflicts of interest can be managed by having Dr. Califf recuse himself from matters that would give rise to conflicts is inane. His conflicts do not only hold for new cholesterol medicines. They hold for all issues related to the regulation of pharmaceutical products. He would essentially have to recuse himself from every decision the FDA makes. It would be a plum job, as he wouldn't have to do anything. I should try that with my job. "I'm sorry, but I have to recuse myself from all of the work you've asked me to do." 

This does not bode well for electronic cigarettes because they represent a huge threat to pharmaceutical smoking cessation products.

To remind readers, this has nothing to do with Dr. Califf's integrity, character, or qualifications. It simply has to do with existing conflicts of interest, which in my opinion preclude him from occupying this position. The commissioner of the FDA clearly has to be an individual who does not have conflicts of interest with Big Pharma. We can't have someone with severe pharmaceutical conflicts of interests regulating the very companies from which he has received hundreds of thousands of dollars. It is like the fox guarding the hen house.

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