Medtronic and Medical Device Safety

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In May 2006, Dr. David Polly testified before a U.S. Senate Committee concerning the importance of developing new medical devices to treat Iraqi war veterans, especially Medtronic’s Infuse Bone Graft. He told the committee that he was speaking on behalf of the American Academy of Orthopedic Surgeons. During his testimony, he spoke about his work at Walter Reed Army Medical Center as well as his work as a spine surgeon at the University of Minnesota. He didn’t mention that Medtronic Corp. had paid for the trip to Washington as well as his consulting services. According to the Wall St. Journal, Dr. Polly was paid $1.14 million by Medtronic from 2004-2007. Polly is a paid Medtronic consultant who is one of the doctors paid to promote Medtronic’s Infuse Bone Graft. In July 2008, the FDA issued an Infuse safety warning. Since that time, the federal government has been investigating the relationship between doctors and Medtronic. Dr. Polly is not the first paid medical consultant to come under FDA scrutiny. Dr. Timothy Kuklo, an Army surgeon, has been accused of falsifying Infuse research as well as plagiarizing the signatures of other doctors on a favorable Infuse medical journal article. These conflicts of interest demonstrate a safety concern for the general public as well as healthcare professionals who rely on scientific testimony to determine if a medical device is safe and effective. Doctors who are paid to promote a particular medical device and do not disclose such financial relationships to the public constitute a public health hazard. Scientific research on pharmaceutical drugs and medical devices must be objective and free of influence from financial gain.

Eva Bleich
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