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The Ties

About a third of members of the US Food and Drug Administration panels that evaluated devices for use in cardiology, orthopedics, and gynecology between 2012 and 2014 had received compensation from medical device companies, according to the Wall Street Journal. Overall, about 10 percent of advisors had received something of value from a company whose product they were evaluating, and, the Journal's Joseph Walker notes, FDA disclosed just 1 percent of these conflicts.

"Undisclosed conflicts raise questions about the decision-making capacity of the committees and whether the public can have confidence in their recommendations," says Yale School of Medicine's Joseph Ross.

FDA says that it discloses advisors' financial interests if they need a waiver to be on the panels. Walker adds that doctors and researchers who've done paid work for a medical device company are still eligible serve on an advisory panel and don't have to disclose their ties if the work they did wasn't related to the panel's topic or focus.

According to the Journal's analysis of payments to cardiology, orthopedic and gynecology device panel members in 2014, most — 64 percent — hadn't received anything of value from device makers in the previous five years, and the rest received amounts ranging from less than $15 for food to more than $500,000 in research funding. A third of the doctors who received something from the companies received items worth less than $500 and just more than a quarter received something worth $10,000 or more.

Walker adds that prospective panel members who received more than $50,000 from companies are generally left off the panels, though FDA can grant an authorization if it deems the payment not to be a conflict.

"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," FDA Associate Commissioner Jill Hartzler Warner tells Walker.

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