Robert Califf, former head of Duke Clinical Research Institute, is new FDA Commissioner, but ties to pharma still an issue
Dr. Robert Califf
Photo courtesy of fda.gov
"Dr. Califf, it's no secret that during your time at Duke University, you received significant financial support from the pharmaceutical industry, both for you personally and for your research. And I know it's common practice for principal investigators on clinical trials, but it naturally raises questions about your relationship with the drug industry."
— Senator Elizabeth Warren at Robert Califf’s confirmation hearing for FDA commissioner
on Nov. 17, 2015
The Duke Clinical Research Institute is not shy about announcing itself. Its administrative offices sit on the eighth floor of a 15-story downtown office tower that is encased in reflective glass and in granite imported from Finland. Capped with a large sign that bears its name, the building is a defining feature of the city’s skyline.
The DCRI itself is also the defining accomplishment of Dr. Robert Califf, the Duke University cardiologist whom the Senate confirmed yesterday as the commissioner of the Food and Drug Administration.
Twenty years ago, Califf founded the institute as a place for Duke doctors and scientists to run clinical trials for hire. Under Califf’s watch, DCRI has grown to become the largest such academic research organization in the world. More than half of its research funding now comes from the drug and device companies.
These industry ties were the focus of much debate at last fall’s Senate hearings. Critics from presidential candidate Bernie Sanders to the consumer advocacy group Public Citizen challenged Califf over his long involvement with company-sponsored trials, questioning whether, if confirmed, he can do an honest job of overseeing the pharmaceutical industry.
Although, Califf has been under scrutiny for these financial ties, many experts, including fellow academic researchers and bioethicists, say these relationships are typical. Academic research institutes turn to pharmaceutical companies for money because of a lack of government and other public funding,
“Califf has more conflicts of interest than most, and on its face that’s unsuitable for the FDA,” said Dr. Howard Brody, a medical ethicist at the University of Texas Medical Branch at Galveston. But “industry money is necessary,” he added. “It appears to be the norm.”
Califf's conflict of interest forms: