Dr. Robert Califf, former vice chancellor of clinical and translational research, may soon be taking helm of the U.S. Food and Drug Administration, but not without resistance from organizations and politicians who argue that his experience at Duke has made him too close to the industry.
President Barack Obama announced his nomination of Califf—who is currently the deputy commissioner for Medical Products and Tobacco—for FDA commissioner in September. Since then, certain health and patient advocacy organizations and politicians have voiced concerns about Califf’s ability to lead the regulatory agency of the pharmaceutical industry, given his extensive history working with drug companies and leading clinical trials. Many in the medical community have endorsed him, however, arguing that his well-known expertise and scientific integrity make him the best candidate for the job, which involves decisions on whether certain drugs or medical products are safe and effective enough to bring to market.
“Rob has gotten almost uniform support from his academic colleagues, even some of which are very strongly anti-industry,” said Dr. Eric Peterson, executive director of the Duke Clinical Research Institute, who added that he considers Califf a mentor and a role model. “Dr. Califf is an incredible scientist and a wonderful doctor. Rob is considered incredibly knowledgeable and fair and a change agent in all of the things seen as needed by the FDA.”
Califf’s nomination awaits approval from the Senate Committee on Health, Education, Labor and Pensions. At his first confirmation hearing Nov. 17, most members seemed “largely friendly” and “set to support his candidacy,” according to the New York Times. Presidential candidate Bernie Sanders and Massachusetts senator Elizabeth Warren, both Democrats, were among those who voiced their opposition, with Sanders ultimately saying he would not vote for Califf.
“If you look at my record, you will find I have never been a proponent of lowering standards; if anything I’ve argued for raising standards,” Califf said in response to a question from Warren regarding the FDA’s regulatory standards, according to TIME.
Considered one of the world’s leading experts in clinical trials, Califf was the founding director of the DCRI, the largest academic clinical research organization in the world. With its $320 million in annual funding, the DCRI conducts clinical trials of medical products and pharmaceuticals to determine their safety and effectiveness. According to the DCRI’s 2014-2015 annual report, 63.3 percent of its projects fell under the “commercial” category—projects funded by pharmaceutical and medical companies—and 36.7 percent of its projects received funding from the federal government. As of 2007, industry accounted for nearly 60 percent of nationwide clinical research funding, and the federal government funded 33 percent.
“The realities of today are, if you look at where clinical research funding comes from in this country, a very high percentage does come from the commercial or industry side of the world, as opposed to only being funded by federal dollars,” Peterson said. “It’s a testament in part to Rob’s character, or at least to any worry of a perceived conflict, that Rob’s probably had more negative studies showing the product is not safe or effective than he’s had positive studies. He’s reported negative results with equal passion as he has the other side of the coin.”
Peterson said that he didn’t see a conflict between Califf’s potential role with the FDA and his work with the DCRI, adding that the organization has “always gone to great lengths” to establish contracts that allow the researchers to independently analyze and publish the results of their trials.
“The reason the DCRI has gotten as successful as they have is because companies know they do rigorous research,” said Dr. Peter Ubel, Duke physician and professor of business, medicine and public policy. “People really have to look, is there any record of Dr. Califf bending a little or massaging the science to benefit a company? I haven’t heard any of that, so that to me is the greatest evidence that he’ll be able to objectively evaluate things.”
Califf’s opponents have also pointed to his financial relationships with pharmaceutical companies as potential conflicts of interest. His financial disclosure statements to Duke show that he received personal income outside his University salary in the form of consulting fees from pharmaceutical companies, between $15,000 and $75,000 annually in 2014, according to TIME.
Califf’s previous role as a member and consultant with the group Faculty Connection LLC, formed by some of DCRI’s administrators, has also caused controversy. Faculty Connection LLC is a consulting company that informs pharmaceutical, biotechnology and medical device companies on regulatory requirements and clinical trial design and management, among other things.
After The Intercept first reported Califf’s involvement with this group, the AIDS Healthcare Foundation called upon Obama to “immediately withdraw Dr. Califf’s name from consideration,” with AHF president Michael Weinstein saying that Califf was, “pimping for the pharmaceutical industry’s efforts to avoid regulation,” through his involvement with Faculty Connection LLC,
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“We felt him as establishing and nourishing for many years a web of professional and financial relations with the pharmaceutical industry, which I think are unprecedented among any nominee previously for FDA commissioner and are disqualifying,” said Dr. Michael Carome, director of the Health Research Group of Public Citizen, a consumer advocacy group that strongly opposes Califf’s nomination. “It’s unrealistic to expect that with his almost career-long set of relationships with the industry and many companies, that it’s possible to fully divorce these prior conflicts with his role as commissioner. They no doubt will influence the decisions he makes, whether it’s subconsciously or consciously.”
The New England Journal of Medicine recently ran an editorial in support of Califf, saying “his confirmation as commissioner should proceed as quickly as possible.” It cited the negative outcomes of several industry-sponsored clinical trials he has reported since 2005 as demonstrating Califf’s lack of bias toward industry.
“Many parties have endorsed him, but they also have close ties to pharmaceutical industries, so one must take them with a grain of salt,” Carome said.
Califf’s expertise in clinical research sets him apart from recent FDA commissioners. Dr. Margaret Hamburg, the previous commissioner who stepped down in March, was the health commissioner of New York City and worked in the U.S. Department of Health and Human Services before she took on the role. Dr. Stephen Ostroff, the current acting commissioner, previously served as the FDA’s chief scientist and as the deputy director of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention.
“[Some politicians] want to see someone running the FDA who’s opposed to pharmaceutical companies,” Ubel said. “That would be absolutely awful. I want someone at the FDA who can really scrutinize products, not someone who comes out with [an anti-industry] bias immediately.”
Peterson added that Califf has ideas on stimulating better, faster and cheaper studies that will bring innovation to the process if he is confirmed as commissioner.
“It’s always a tough job—on the one hand, you want to be able to make America a place where innovation and new products can get to markets as soon as possible and help people, so you don’t want to make it too regulated,” Peterson said. “On the other hand, you want to ensure that you protect the public from drugs or devices that are unsafe or ineffective. It’s a fine line.”