Tuesday, January 27, 2015

New Head of Office of Medical Products and Tobacco at FDA Has History of Pharmaceutical Consulting

It appears that the FDA is following a pattern in seeking new directors and office heads. It is apparently looking to those who have financial conflicts of interest with Big Pharma. I have already discussed how Mitch Zeller - the head of the Center for Tobacco Products - came to FDA directly from a pharmaceutical consulting company. Yesterday, it was announced that the new head of the Office of Medical Products and Tobacco at FDA will be Dr. Robert Califf.

The press release describes Dr. Califf as follows:

"During his career, Dr. Califf has led many landmark clinical studies, and is a nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research. He is one of our nation’s leaders in the growing field of translational research, which is key to ensuring that advances in science translate into medical care. He was a member of the Institute of Medicine (IOM) committees that recommended Medicare coverage of clinical trials and the removal of ephedra from the market and of the IOM’s Committee on Identifying and Preventing Medication Errors. In addition, he served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. Currently, he is a member of the IOM Policy Committee and liaison to the Forum in Drug Discovery, Development, and Translation."

The Rest of the Story

Despite the seemingly exhaustive review of Dr. Califf's many highly recognized roles, there is one small piece of information that was not provided.

It turns out that Dr. Califf has a strong conflict of interest by virtue of his long history of grant funding and consultancies for Big Pharma. These are precisely the companies he will now be regulating.

In a recent article published in the journal Metabolism, Dr. Califf is a co-author of a manuscript that reported the results of a clinical trial which tested the efficacy of two pharmaceutical agents in treating metabolic syndrome. The manuscript notes that: "The NAVIGATOR study was supported by Novartis, Inc., and was designed by an academic executive committee in collaboration with the sponsor."

In addition to this pharmaceutical funding, Dr. Califf also disclosed personal conflicts of interest with Big Pharma: "RMC has received consulting fees from Bayer, Bristol-Myers Squibb, CV Sight LLC, DSI-Lilly, Gambro, theHeart.org, Janssen, Kowa, Novartis, Pfizer, Regeneron, and Roche." He also acknowledged that: "his institution has received research grants from Bristol-Myers Squibb, Novartis, Amylin, Merck, Schering-Plough, Scios, Johnson & Johnson, and Eli Lilly."

It does appear to me that there is a question about whether there might be a conflict of interest for a scientist with a substantial number of personal conflicts of interest with Big Pharma to be brought in to head a department which is involved directly in the regulation of those very pharmaceutical companies.

It may be that Dr. Califf has to recuse himself from varous decisions that directly affect these particular companies. However, the list of companies is so long that there may not be all that many drug reviews that do not pose a conflict of interest. Perhaps more concerning than this individual case is the pattern that seems to be emerging. Do we really want a rotating door between the FDA and the pharmaceutical industry and its consultants?

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