UPDATE 1-FDA staff note financial ties in Zimmer spine study

Mon Nov 2, 2009 6:36pm EST

* Researchers in study had financial ties-FDA staff

* No statistical evidence money led to bias-FDA staff

* Advisory panel to weigh wider use of Dynesys device

WASHINGTON, Nov 2 (Reuters) - U.S. health officials have raised the possibility of bias in the evaluation of a spine device made by Zimmer Holdings Inc (ZMH.N), saying most patients in the study were treated by researchers with a financial interest in the company.

In documents released on Monday, Food and Drug Administration reviewers said there was "a trend which suggests the possibility of bias from compensation" when payments or stock holdings were analyzed for any influence in the study of a proposed new use for the Dynesys Spinal System.

The FDA staff went on to say there was no "statistically significant evidence" showing the financial ties had any effect on how researchers evaluated patients -- meaning a bias noticed in one analysis of the results could have been due to chance.

The Dynesys system is already approved as an addition to spinal fusion for treating lower back and leg pain. Zimmer is seeking FDA clearance to market the device for use without fusion.

The FDA reviewers said they would ask an advisory panel that meets Wednesday if Zimmer's application provided reasonable assurance the proposed new use is effective. The panel's input is key as the agency usually approves applications that win support from advisory panels.

Zimmer had no immediate comment on the financial compensation issue. (Reporting by Lisa Richwine; Editing by Tim Dobbyn)

Related Quotes and News

Company
Price
Related News
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.