MINNEAPOLIS (AP) — Medtronic Inc. Chairman and CEO Omar Ishrak on Tuesday defended the data that his company submitted to federal regulators as part of the approval process for a bone-growth protein, saying they were sound and support the safe use of the spinal surgery product.
The executive’s statement came in response to a Spine Journal study scheduled to be published Wednesday that claims doctors on the medical device maker’s payroll failed to disclose complications that came up during clinical trials of the bone-growth protein.
The Spine Journal study claims researchers didn’t report the complications related to the widely used spine surgery product in more than a dozen research papers.
Ishrak acknowledged that the study has raised questions about the conclusions the researchers arrived at in their published reports.
But he stressed that the study didn’t conjure similar questions about the data Medtronic submitted to the Food and Drug Administration during the bone-growth protein’s approval process, nor on the information available to physicians using the product.
“We will continue to investigate questions surrounding researchers’ potential conflicts of interest, refine our policies as warranted, and strive to lead the industry in ethical and transparent business practices,” Ishrak said.
The Wall Street Journal reported on Tuesday that 15 of the surgeons who conducted clinical trials on the bone-growth protein over the past decade received at least $62 million combined from Medtronic for unrelated work.
The Senate Finance Committee is investigating whether the payments the surgeons received were a factor in their decision not to report the health complications.
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