Although more than ⅓ of the 122 doctors who sit on FDA advisory panels for medical devices received some form of compensation from medtech companies, the federal watchdog agency only discloses a fraction of those links, according to the Wall Street Journal.
Members of the panels, which evaluate devices used in cardiology, gynecology and orthopedics for the FDA, received compensation including consulting fees, research grants, food, travel and lodging from medical device makers from 2012 through this year, according to the newspaper. But those payments or gifts are not usually disclosed by the agency, the Journal reported.
And nearly 10% of the docs got something of value from the company with a product under evaluation, according to the report, but the FDA only disclosed about 1% of those links.
"Undisclosed conflicts raise questions about the decision-making capacity of the committees and whether the public can have confidence in their recommendations," Dr. Joseph Ross of the Yale School of Medicine told the newspaper.
"The problem with the FDA’s policy is you don’t know how they use their discretion," said lobbyist Celia Wexler of the Union of Concerned Scientists. "It’s very difficult for us to know to what extent the FDA probes, and the extent to which panel members take the disclosure requirements seriously."
The agency is not bound by its panels’ recommendations, but often follows their advice. The FDA said it discloses the experts’ financial interests at its own discretion, when it determines the physicians need a waiver to serve. Agency officials said that only happens when the doctors’ work is related to the issue being evaluated by the panel or when the physicians own a significant amount of the device company’s stock, according to the Journal. But if the agency thinks it can’t get that expertise anywhere else it can issue a waiver for the doctor, associate commissioner Jill Hartzler Warner said.
"Our challenge and our goal is to retain public confidence in the advisory-committee process and at the same time to obtain the very best advice," Hartzler Warner told the paper.
"If you have a financial interest with a sponsor or a related firm, but it’s not related to the product at the meeting, it’s not disqualifying," she said. "The firms are often large and diverse, and whatever position the FDA takes, it won’t affect the relationship between the firm and the [doctor]."
Doctors told the journal that their consulting work doesn’t affect their panel decisions.
"I’ve never sat there on a panel and thought, ‘I wonder what my friends at companies X, Y and Z would say.’ I just don’t view it that way," said Dr. David Kandzari, a cardiologist at Atlanta’s Piedmont Heart Institute. Kandzari, who the paper reporting receiving about $100,000 from Boston Scientific (NYSE:BSX) over 5 years, participated in an advisory panel hearing on Boston Scientific’s Watchman anti-stroke device in October. Kandzari voted to approve the device.
Kandzari told the newspaper that his work with Boston Scientific involved stents, not the Watchman device. Boston Scientific said that medtech companies "are not consulted, or engaged in any way in the selection of panel members," according to the report.
Orthopedist Dr. Edward Cheng of the University of Minnesota Medical School & Cancer Center said he would recuse himself from if he thought a conflict of interest existed in his participation on an FDA committee.
"[I]f I personally thought a conflict existed that would affect my ability to remain unbiased, I would decline to participate," Cheng said.