FDA questions role of payments in Zimmer study
Posted:
11/03/2009 2:05 AM
WASHINGTON (AP) — Federal health officials say an implant from Zimmer Holdings Inc. appears to be effective in treating spinal problems, but questions remain about whether company payments to doctors influenced the device's trial data.
Zimmer has asked the Food and Drug Administration to approve its titanium Dynesys implant to re-stabilize the spine.
The FDA posted its review of the first-of-a-kind device Monday, ahead of a panel meeting to discuss the device on Wednesday.
Agency reviewers said a Zimmer study of the device met its goal, showing results at least as good as the company's older Silhouette implant.
Patients implanted with Dynesys showed a 52 percent treatment success rate, compared with 40 percent for Silhouette.
However, the FDA raised questions about whether company payments to physicians conducting the trial may have influenced the results.
Most patients in the trial were treated by surgeons who had received consulting payments from Warsaw, Ind.-based Zimmer.
More than half of the patients in the trial were treated at medical centers that reported more than $100,000 in payments from the company, according to FDA's review.