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Medtronic CEO moves to defuse Infuse controversy

Medtronic Inc. CEO Omar Ishrak isn’t wasting any time in responding to articles published in Spine Journal about the company’s controversial bone-graft product Infuse.

The New York Times reported Tuesday that a group of spine specialists alleged that researchers who have been compensated by Medtronic have not reported the serious risks associated with Infuse — a spine fusion product also known as rhBMP-2.

At the same time, according to the report, they have exaggerated its benefits. The article noted that Spine Journal devoted an entire issue to repudiating the research behind Medtronic’s best-selling product and that decision “marks a watershed in the long-running debate over conflicts-of-interest for the sponsorship of scientific studies by makers of drugs and medical devices.”

In a statement released Tuesday afternoon, Ishrak said:

“Integrity and patient safety are my highest priorities. While the Spine Journal articles raise questions about researchers’ conclusions in their published peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold.

“Based on that data, we strongly believe that the safety profile reported to the FDA and summarized in the product label support the safe use of rhBMP-2 for the identified indications. We remain committed to ongoing study of the safety and efficacy of rhBMP-2, especially in 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. 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 Medtronic statement also noted that Infuse received the Prix Galien USA 2008 Award for Best Biotechnology Product, “considered the industry’s highest accolade for pharmaceutical research and development.”

Still, evidence against the use of Infuse, especially its off-label use, is piling up. In late May, a Stanford professor published a study that showed that Medtronic’s Infuse posed a risk of male sterility. The Senate Finance Committee is also investigating Medtronic’s Infuse product.

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