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Outrage of the Month: More Reasons for Obama to Withdraw his Nominee for FDA Commissioner

Health Letter, November 2015

By Michael Carome, M.D.


If you’re not outraged,
you’re not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

In September, I voiced strong opposition to President Barack Obama’s ill- considered nomination of Dr. Robert Califf to be the next commissioner of the Food and Drug Administration (FDA), citing Califf’s well-documented history of extensive financial ties to multiple drug and medical device companies during his tenure at Duke University. Having established cozy relationships with these two FDA-regulated industries over more than two decades, Califf is an unfit candidate to head the agency.

Since the announcement of Califf’s nomination, investigative journalists have uncovered additional information that further disqualifies him from being FDA commissioner. For example, on Oct. 7, The Boston Globe disclosed Califf’s troubling decision to quietly remove his name as co-author of three articles before they were published last month in the scientific journal Clinical Trials. The articles, most of which apparently were completed before Califf joined the FDA, explore various issues regarding so-called pragmatic clinical trials, research studies designed to compare the risks and benefits of treatments commonly used in medical practice. One article advocated loosening — and in some cases completely waiving — the FDA’s requirements for informed consent for such trials.

Confusion reigns over how Califf came to remove his name from the papers he helped write. The Globe reported that a co-author on one paper, speaking on the condition of anonymity, said that “Califf had been told to mask his authorship by the FDA.” However, an agency spokeswoman said, “Dr. Califf requested that his name be removed as a co-author from these three articles out of an abundance of caution to avoid any perception that he would be commenting as an FDA official through these articles.” Regardless of who instigated the decision to remove his name from the papers, the collective effort by Califf and the agency to mask his authorship of papers expressing views that could be construed as controversial is deceptive and raises serious ethical concerns.

More recently, on Oct. 15, the online investigative media outlet The Intercept revealed additional little-known ties between Califf and FDA-regulated industries: From 2006 through this year, Califf served as a board member and consultant to Faculty Connection, a company that offers a wide array of services to the pharmaceutical, biotechnology and medical device industries. Among the many services promoted by Faculty Connection to industry is regulatory consulting, including strategic input on regulatory interactions with the FDA. In one of the company’s promotional videos archived on YouTube, a board member asserts, “We have worked with over 175 different pharma, biotech and medical device firms.” These disclosures further highlight the extensive and intricate web of professional and financial relationships that Califf established and nourished with the pharmaceutical and medical device industries for many years before joining the FDA. Such extensive relationships are unprecedented in an FDA commissioner nominee.

As my Public Citizen colleague Craig Holman, an expert on government ethics, told The Intercept, “Though he is attempting to divorce himself from his conflicts of interest with the industry, Dr. Califf’s ties are far too extensive to be manageable as an FDA commissioner.”

Given this ever-growing list of problematic disclosures, the time has come for Obama to withdraw Califf’s nomination to be FDA commissioner.