|Medtronic Response to Senate Finance Committee Staff Report on INFUSE® Bone Graft|
MINNEAPOLIS – Oct. 24, 2012 – A report by the staff to the Chairman of the U.S. Senate Committee on Finance, Max Baucus, and staff to Senator Charles Grassley, raises a number of questions regarding peer-reviewed medical journal articles related to INFUSE® Bone Graft. Medtronic cooperated with the inquiry, providing documents as requested and addressing questions raised by the Committee Staff. As Medtronic has repeatedly stated, patient safety and integrity are its highest priorities.
Medtronic does not agree with many of the findings in the staff report. In particular, Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events. In fact, Medtronic reported to the FDA the potential adverse events addressed in the staff report, and these risks were reflected on the product’s FDA-approved label. In addition, the staff report’s characterization of payments received by physicians is also misleading and unfair. The vast majority of such payments were royalty payments made to compensate physicians for their intellectual property rights and contributions, not consulting payments. In general, royalty and consulting payments are a commonplace and appropriate practice in the medical device industry.
Medtronic agrees with many of the recommendations in the staff report to ensure increased transparency for industry interactions with physicians, and indeed has played a leadership role in this area. Scientific and engineering collaboration between physicians and industry is vital to innovation and advancing patient care. In the context of publications and consistent with best practices, physician authors interact with Medtronic employees who have scientific or clinical backgrounds and deep expertise in data related to our products because this collaboration is important to patient care. Medtronic has worked diligently over many years to lead the industry in reforms designed to eliminate or mitigate potential conflicts of interest, including disclosure of payments to physicians. Medtronic was one of the first companies to voluntarily disclose payments to physicians on a public website, more than a year ahead of new federal disclosure requirements under the Affordable Care Act. And Medtronic recently commissioned the first-ever industry proposed program with Yale University to make data regarding a marketed product transparent to researchers and the public. The staff report recognized some of the significant steps that we’ve taken specifically related to transparency and disclosure.
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Medtronic’s spinal business, based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. Medtronic’s spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art therapies for spinal, neurological, orthopaedic and oral maxillofacial conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies.
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