Prodisc Manufacturer Synthes and FDA Drilled Over Artificial Spinal Disk Approval
February 28th, 2008 amy
The FDA and medical device manufacturer Synthes are meeting the wrath of Senate Finance Committee member Charles Grassley over financial conflicts of interest in getting artificial spinal replacement Prodisc pushed through clinical trials for approval in 2006.
Lumbar disk replacement Prodisc was developed by US-based Spine Solutions, a start-up company funded by New York investment firm Viscogliosi Brothers LLC, then sold to Swiss manufacturer Synthes. Charles Grassley’s letter to the FDA states that according to an article published in the New York Times, the investment firm stood to gain $175 million should Prodisc obtain FDA approval.
But it doesn’t stop there. Not only did Viscogliosi Brothers and Synthes clearly stand to profit, many of the clinical investigators held substantial investment interests in Viscogliosi Brothers. Doctors at about half of the 17 research centers involved stood to profit from Prodisc’s success, according to confidential information from a patient’s lawsuit settled last year, the New York Times reported earlier this month.
Senator Grassley is on the warpath for answers to questions such as “Did Synthes disclose the investment interests of its clinical investigators in the Prodisc study to the FDA?” and “If the FDA found that the investment interests did not raise serious questions about the study’s integrity, why not?” He wants his answers by March 12.
Meanwhile, other concerns come to mind, such as the “unusually large number of patients” the New York Times reports were not included in the study results submitted to the FDA, specifically those patients who said they fared poorly. This was the case with Patricia Kennedy, whose recently settled lawsuit asserted her surgeon “seemed more concerned with the prospects for the Prodisc than for her medical care.” The New York Times reported that her surgeon, Dr. Richard A. Balderston of Philadelphia, was one of the researchers with a financial interest in the disk.
