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VOL. 126 | NO. 127 | Thursday, June 30, 2011

Medtronic Responds to Spine Journal Report

By Aisling Maki

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Medtronic Inc. has responded to a series of articles published in Spine Journal claiming surgeons on the company’s payroll failed to disclose complications that arose during clinical trials of a bone-growth protein. Minneapolis-based Medtronic’s Spinal and Biologics Business is in Memphis.

Medtronic’s INFUSE Bone Graft is recombinant human Bone Morphogenetic Protein-2, whose purpose is to stimulate bone formation. According to information from the company, the protein first received U.S. Food and Drug Administration approval in 2002 and the product has been approved for three indications.

In 2008, Medtronic’s INFUSE Bone Graft received the Prix Galien USA Award for Best Biotechnology Product.

But the study published in Spine Journal claims researchers working with Medtronic failed to report complications related to the widely used spinal surgery product in more than a dozen research papers.

In a statement released Tuesday, June 28, Medtronic’s new chairman and CEO Omar Ishrak – who on June 13 took over executive leadership of the company from retiring chairman and CEO Bill Hawkins – acknowledged that the Spine Journal articles raise questions about the researchers’ conclusions in published peer reviews.

But, he said, the articles don’t raise questions about the data submitted to the FDA during the approval process or the information available to doctors using the product. Ishrak said his company remains committed to the ongoing study of the safety and efficacy of the bone-growth protein, especially in regards to applications not covered by FDA labeling.

“For several years, Medtronic has been leading the industry in reforms designed to eliminate or mitigate conflicts of interest,” Ishrak said. “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.”

The Wall Street Journal Tuesday reported 15 of the surgeons who conducted clinical trials on the bone-growth protein over the last decade received at least $62 million combined from Medtronic for unrelated work.

That article said the Senate Finance Committee last week began investigating whether the payments received by the surgeons were a factor in their decision not to report the health complications.

Medtronic has struggled to maintain earnings growth amid sluggish sales of two of its leading products, heart defibrillators and spinal implants, which have faced weakening sales because of safety concerns and the loss of health insurance by unemployed workers.

The Associated Press contributed to this report.

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