Milgram described the Synthes settlement as the first of its kind because of its disclosure provisions, as well as its ban on compensating clinical researchers with company stock. She said the ban runs counter to widespread industry practice--a practice she called unacceptable.
Currently, she said, many clinical investigators stand to profit significantly if the trials in which they are involved are successful. Often, she explained, these financial interests are not disclosed to the public, including the patients participating in clinical trials.
She says ProDisc was developed by a start-up company known as Spine Solutions Inc. A New York investment firm, Viscogliosi Brothers, helped found Spine Solutions and financed the disc's development and research. The Viscogliosi Brothers offered the ProDisc clinical investigators substantial investment opportunities in Spine Solutions, as well as consulting contracts that included gifts of company stock and stock options. Synthes, Inc. bought Spine Solutions in 2003 and failed to fully disclose these conflicts of interest to the FDA, Milgram alleged. For example, she noted, a number of disclosure forms contained in the Synthes submission to FDA were signed and dated, but were otherwise left blank. Other forms indicated that clinical investigators had significant equity interests in the Synthes product they were testing, but offered no details.
Synthes' failure to adequately disclose "should have been obvious from even a cursory review of its FDA submissions," Milgram wrote, yet the FDA "did nothing" and ultimately approved Synthes applications for pre-market approval without delay or further inquiry into the apparent conflicts.
Under terms of the settlement, Synthes, Inc. has agreed to publicly disclose on its Web site any financial relationships with doctors conducting its clinical research trials. The company has also committed to disclosing such financial conflicts-of-interest to the research institutions that serve as clinical trial locations, and to the FDA.
The company has also agreed to:
* Prohibit compensation of clinical investigators tied to the outcome of the clinical trial
* Pay clinical investigators "fair market value compensation" for their clinical trial work, as well any other consulting services they provide to the company
* Collect information on financial interests from clinical investigators
* Create a Financial Interest Information Database that will record all relevant financial interests related to clinical investigators