Payouts Clouding Zimmer Implant
July 28, 2016 at 4:25 p.m.
By Staff Report-
The FDA posted its review of the first-of-a-kind device Monday, ahead of a panel meeting to discuss the device today.
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.
The FDA raised questions, however, 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 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."
The FDA will ask its panel of outside panel of orthopedic specialists to weigh in on the company's study and whether additional data are needed.
Brad Bishop of Zimmer provided the following statement to the Times-Union this morning:
"As requested by the FDA, Zimmer included standard financial disclosure information in its pre-market approval application for the Dynesys® Dynamic Stabilization System. The company also conducted several analyses to determine whether bias could have been introduced through the financial interests of the investigators. As reported in the FDA's 'Executive Summary for Zimmer Spine's Dynesys Spinal System: Orthopedic and Rehabilitation Devices Panel,' there was no statistically significant treatment-by-compensation interaction found. Zimmer Spine is confident that the data is reliable and that there was no impropriety concerning financial arrangements involving any of the investigators."
The agency is not required to follow the group's advice, though it usually does.
Shares of Zimmer Holdings Inc. fell 4 cents Monday to $52.73 in after-hours trading, having closed earlier up 20 cents at $52.77.
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The FDA posted its review of the first-of-a-kind device Monday, ahead of a panel meeting to discuss the device today.
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.
The FDA raised questions, however, 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 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."
The FDA will ask its panel of outside panel of orthopedic specialists to weigh in on the company's study and whether additional data are needed.
Brad Bishop of Zimmer provided the following statement to the Times-Union this morning:
"As requested by the FDA, Zimmer included standard financial disclosure information in its pre-market approval application for the Dynesys® Dynamic Stabilization System. The company also conducted several analyses to determine whether bias could have been introduced through the financial interests of the investigators. As reported in the FDA's 'Executive Summary for Zimmer Spine's Dynesys Spinal System: Orthopedic and Rehabilitation Devices Panel,' there was no statistically significant treatment-by-compensation interaction found. Zimmer Spine is confident that the data is reliable and that there was no impropriety concerning financial arrangements involving any of the investigators."
The agency is not required to follow the group's advice, though it usually does.
Shares of Zimmer Holdings Inc. fell 4 cents Monday to $52.73 in after-hours trading, having closed earlier up 20 cents at $52.77.
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