International New York Times

But supporters view cardiologist’s research expertise as a major asset

”The question is whether he can transcend those relationships as commissioner and advocate for a strong F.D.A.”Even well-established drugs can become more expensive overnight when businesses buy old, neglected medications and market them as highpriced ”specialty drugs.” At a Double Tree Hotel in Durham, N.C., in May 2014, Dr. Robert M. Califf gave a presentation to a group of biomedical researchers, lawyers and industry experts. He spoke about ways to quicken the pace of biomedical innovation by transforming research. Toward the end he showed a slide that noted one barrier: regulation.It was just a passing reference, barely noticed by the small group in the room. But now, after President Obama nominated Dr. Califf on Tuesday to become the next commissioner of the Food and Drug Administration, his thoughts on the subject are suddenly taking on importance.Dr. Califf, a cardiologist, is a renowned clinical researcher who has deep respect for the system in which he works, and no one who knows him thinks he wants to weaken the regulatory agency he has been chosen to lead. But he has deeper ties to the pharmaceutical industry than any F.D.A. commissioner in recent memory, and some public health advocates question whether his background could tilt him in the direction of an industry he would be in charge of supervising.The answer is important because, if confirmed, Dr. Califf would be steering a vast and powerful federal agency that regulates about a quarter of every dollar spent in the United States. It is at the center of some of the most difficult health policy questions facing the country. A crucial decision on how to regulate electronic cigarettes is expected this fall, and Congress is halfway through a substantial overhaul of the way the agency approves drugs and medical devices.While the previous commissioner, Dr. Margaret A. Hamburg, a former top health official in New York City, came from the field of public health, Dr. Califf ran a multimillion-dollar clinical research center at Duke University that received more than 60 percent of its funding from industry.He has written scientific papers with pharmaceutical company researchers, and his financial disclosure form last year listed seven drug companies and a device maker that paid him for consulting and six others that partly supported his university salary, including Merck, Novartis and Eli Lilly. A conflict-of-interest section at the end of an article he wrote in the European Heart Journal last year declared financial support from more than 20 companies.”In a sense, he’s the ultimate industry insider,” said Daniel Carpenter, a Harvard political science professor who has written extensively about the F.D.A.Sanofi and Amgen are among the companies Dr. Califf has advised, in their case on costly new cholesterollowering drugs that the agency approved just this summer.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.Mr. Griffis said Dr. Califf had been donating all his consulting fees to nonprofits since the mid-2000s. According to Pharma Shine, a database of payments to health care professionals, and the federal government’s Open Payments database, Dr. Califf received about $215,000 in consulting fees from 2009 to early 2015.Arésumé studded with industry funding is not unusual in academic medicine, Dr. Califf’s supporters note. Doctors are paid consulting fees all the time, and universities routinely conduct clinical trials on behalf of companies. Those contracts help support university researchers’ salaries, a standard practice. Many emphasize that it does not imply an inherent conflict.His supporters contend that Dr. Califf’s vast experience in the clinical science world could be a major asset in his new post.”Drug companies fund a lot of clinical trials, and he’s a world-renowned trials expert,” said Dr. Aaron S. Kesselheim, the director of the Program on Regulation, Therapeutics and Law at Brigham and Women’s Hospital in Boston. ”The question is whether he can transcend those relationships as commissioner and advocate for a strong F.D.A.”Supporters and former colleagues say Dr. Califf’s background makes him perfectly suited to the job of commissioner. He has spent years improving the way clinical trials are conducted, coming up with groundbreaking trial designs for medicines against blood clots.”His integrity in scientific matters is impeccable, and his innovation in clinical trial design is legendary,” said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, who has been an outspoken critic of both the F.D.A. and drug companies.Dr. Califf is often in the gym on the StairMaster before 6 a.m., said a former colleague at Duke, Dr. Adrian Hernandez. He often invites younger doctors to join him in golf and has a passion for Duke basketball that he expresses by wearing the team colors on game days.Dr. Califf founded and ran the Duke Clinical Research Institute, a $200 million center that manages clinical trials in more than 65 countries involving more than 1.2 million patients. Supporters say that management experience should serve him well at the helm of the drug agency, which oversees everything from prescription drugs and pacemakers to peanut butter and pet food.But his position at the institute, whose budget is 37 percent government grants and 63 percent from the private sector, has also caused some concern.”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.”Dr. Califf’s supporters say he has taken many positions against the interests of industry, for example pushing for the right to publish any result without companies reviewing – or approving – the manuscript first, as they often want to do.”This is a long-held, steadfast position that has cost his groups research in the past,” said Dr. Robert Harrington, a professor and the chairman of the department of medicine at Stanford, who worked with Dr. Califf at Duke.(A spokeswoman for the Duke Clinical Research Institute said the funder or sponsor is given a period of time to respond to the results, but has no rights over what is published.)”He was really passionate about ensuring we were independent,” Dr. Hernandez said. ”I’ve seen plenty of times when a company wanted to do something in a certain way and his answer was no.”Dr. Califf had been mentioned for the commissioner’s post in the past and has been popular among Republicans but not Democrats (though he is a registered Democrat). His selection now is seen as a sign that the president has little stomach for a confirmation fight in a Republican-controlled Senate during a bitter period between the parties. Liberal Democrats have been largely silent on his nomination so far.Dr. Califf’s slide show in North Carolina was titled ”Disrupting Clinical Research: Transforming a System.” It said the drug and device development system was in crisis, and included a downward-sloping chart that illustrated the number of drugs approved per billion dollars spent on research over time.”Regulation provides barrier to disruptive innovation,” said the second-tolast slide, called ”Disruptive Innovation in Health Care.”Mr. Griffis, the Department of Health and Human Services spokesman, said Dr. Califf was using the slide as a means of ”identifying the challenge and the tension inherent in the F.D.A.’s charge” between encouraging innovation and protecting the public’s health. He said the slide was not a suggestion to deregulate – far from it.”Dr. Califf doesn’t think of regulation as a zero-sum game, where either the F.D.A. or industry wins,” he said.Professor Carpenter said he believed it was too early to tell what kind of commissioner Dr. Califf would be. ”How does he think? We won’t know until we see how he behaves,” he said.As for the slide: ”I think it illuminates his thinking.”