synthes

Medical device maker Synthes has signed a settlement agreement with New Jersey attorney general Anne Milgram to resolve allegations that the company failed to disclose financial conflicts-of-interest among doctors conducting clinical testing on its products. Milgram says that FDA approved the company’s PMA without picking up any of the financial conflicts and demanding more information.

A state news release said Milgram’s investigation focused on allegations that most doctors conducting clinical trials for the Synthes ProDisc Total Disc Replacement System, ProDisc-L, and ProDisc-C had a financial stake in the outcome.

Under the agreement, Synthes will monitor, collect, and disclose all clinical investigator payments and investments held by investigators in products they test on the company Web site and to FDA; prohibit clinical investigator compensation tied to a trial’s outcome, including company stock and stock options; pay clinical investigators “fair market value compensation” for their clinical trial work and other consulting services; and disclose all financial interests directly to healthcare facilities serving as clinical trial sites.

“It is outrageous that doctors who are testing and, in many cases, recommending the use of certain high-risk medical devices are being compensated with stock in the very companies that make the devices,” Milgram said. She said the Synthes agreement should serve as a template for the industry.

In a 5/5 letter to FDA acting commissioner Joshua Sharfstein, Milgram said the company had failed to disclose financial conflicts to FDA during ProDisc clinical testing. “Despite the fact that Synthes’ failure to adequately disclose these interests should have been obvious from even a cursory review of its FDA submissions, FDA did nothing to regulate these conflicts,” she said. “A number of the disclosure forms were signed and dated, but were otherwise left blank. Others indicated that the clinical investigator had a significant equity interest in the product, but did not attach the requisite details. But FDA approved Synthes’ application for premarket approval without any delay or further inquiry into the issue.”

Milgram said that she is “gravely concerned about the conflicts of interest that pervade the medical device industry, particularly with respect to high-risk devices, and their deleterious effects upon consumers.” She called on FDA to (1) heighten its oversight authority in this area and rigorously enforce conflict-of-interest disclosure rules and regulations and (2) promulgate regulations requiring all medical device manufacturers and pharmaceutical companies to adequately disclose the clinical investigator conflicts of interest to the public.