Yet another medical device maker has been called on the Congressional carpet. Sen. Charles Grassley is asking Synthes, which makes an artificial spinal disk known as Prodisc, whether doctors whose research led to its FDA approval also had a financial interest in its success.
Last month, The New York Times reported on financial relationships between Prodisc's developer, Spine Solutions, and the doctors who helped test it. A New York investment firm financed R&D on the device via investment funds in which many of the clinical investigators owned an interest. Spine Solutions later was sold to Switzerland-based Synthes.
Grassley asked Synthes for information on the company's financial disclosures to the FDA and for details about the clinical researchers' interests in Prodisc. The senator also wrote to the FDA, asking whether the agency knew about the financial relationships between those doctors and the device's developer. "If FDA found out the investment interests did not raise serious questions about the study's integrity," Grassley wrote, "why not?"
- read the article from the New York Times