Questions Cloud Safety Findings for Proposed Zimmer Spinal Implant

The Food and Drug Administration is questioning whether Zimmer Holdings Inc. improperly paid doctors and hospitals in order to influence clinical trial results for the company’s proposed spinal implant.

Zimmer has asked the FDA to approve its titanium Dynesys implant, a first-of-its-kind medical device designed to re-stabilize the spine. An FDA advisory panel is set this week to consider whether to recommend approval of the Zimmer device, a decision that will be based at least in part on a clinical trial which found the Dynesys implant is more effective than the company’s older spinal implant, called Silhouette.

But now, the FDA says it has questions about those clinical trial findings and whether Zimmer shelled out cash to physicians conducting the trial and others involved in order to encourage them to reach positive results.

Doctor and Hospital Bias a Concern

Among the FDA’s concerns are that most patients who took part in the trial were treated by surgeons who were paid for consulting work with Zimmer. Also, more than half of the patients were treated at hospitals that received more than $100,000 in compensation from the medical device maker, the agency said.

“Therefore, there is only a trend which suggests the possibility of bias from compensation,” the FDA said, according to an Associated Press report.

The FDA’s advisory panel of medical experts will be asked to give a recommendation on whether the Zimmer spinal implant is safe. The panel also will be asked whether more clinical trial data is needed.

The FDA is not required to follow the recommendations of its advisory panels, but in most cases, it does.

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