Prodisc Clinical Trials Scrutinized by LawmakerFeb 28, 2008 | Parker Waichman LLP Prodisc, an artificial spine disc now made by the Swiss company Synthes, is at the center of a congressional investigation into the close financial ties between doctors and the makers of drugs and medical devices. Senator Charles Grassley (R-Iowa) sent a letter to Synthe's American headquarters citing concerns over the possibility of “a dangerous conflict of interest" posed by the financial ties many doctors involved in Prodisc clinical trials had with the company that developed Prodisc. The Food & Drug Administration (FDA) also received a similar letter from the Senator.
Prodisc was approved by the FDA in 2006. It had been developed by Spine Solutions, which was eventually sold to Synthes. According to The New York Times, a New York investment firm, Viscogliosi Brothers, helped found Spine Solutions and financed the disk's development and research through a number of investment funds in which many of the clinical trial doctors were also investors. As a result, the very doctors charged with overseeing the clinical trails that would determine its approval had a high stake in the success of Prodisc.
“Clinical investigators play a critical part of the FDA approval process,” Grassley wrote in the letters to the FDA. and Synthes. “These physicians are expected to act objectively in testing the safety and effectiveness of the drug or medical device under consideration. But when they stand to profit from FDA. approval of the product they are testing, the investigator’s objectivity is called into question."
Grassley’s letters asked the FDA and Synthes to provide accounts of what the company had disclosed to regulators about the researchers before the Prodisc approval in 2006. Mr. Grassley also asked how the agency and company handled potential conflicts among clinical investigators.
Grassley's letter is part of a bigger congressional probe looking into the financial ties between drug and device makers and doctors. Recently, two medical device makers, Zimmer Holdings and Stryker, that were among manufacturers that had recently settled with the Justice Department over accusations that they used consulting agreements and other means to persuade doctors to back their products. Last year, Grassley and several other lawmakers introduced legislation that would require corporations to disclose any money they give to doctors.
According to The New York Times, Synthes says it will comply fully with Grassley's requests. The newspaper also reported that the FDA has said it is looking into whether adequate disclosures were made about the Prodisc researchers’ potential financial conflicts.