FDA questions role of payments in Zimmer study

Federal health officials say an implant from Indiana-based 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-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.

The FDA said one analysis of the company’s results showed a positive
relationship between financial payments and clinical success for the device.

"However, all correlations were
far from being statistically significant," the agency said, in documents posted online. "Therefore, there is only
a trend which suggests the possibility of bias from compensation."

A spokesman for Zimmer had no immediate
comment Monday evening.

The FDA will ask its panel of outside panel of orthopedic specialists to weigh in on the
company’s study and whether additional data is needed.

The agency is not required to follow the group’s advice,
though it usually does.