The Senate Finance Committee has begun investigating whether Medtronic's large payments to physicians played a role in the lack of reporting complications. Senate Finance Committee chairman Sen. Max Baucus, (D-MT), and senior committee member Rep. Chuck Grassley, (R-IA), have asked the medical device manufacturer to "produce documents related to its controversial bone growth product Infuse," the committee stated. The committee raised concerns in a letter sent to Medronic "over recent media reports that indicate medical researchers in charge of Infuse clinical trials may have been area of and failed to report evidence that the product may cause sterility in men and potentially-harmful growth." The letter notes "many of these investigators had substantial ties to the device manufacturer."
The product, officially called Infuse Bone Graft, represents about $700 million in annual sales for Medtronic. The Justice Department opened an inquiry into the off-label use of Infuse in 2008, according to The Wall Street Journal. Carragee says he's given the Senate Finance Committee "some documents ahead of (publication)," adding, "There are a lot of papers in the pipeline."
Investigators and the media are scrutinizing physician relationships with Medtronic, The Wall Street Journal further reported. Over the past decade, 15 surgeons have collectively received $62 million from the medical device company, for unrelated work, based on an analysis of Medtronic documents and financial disclosures.
Thomas Zdeblick, director of the University of Wisconsin-Madison Spine Center and professor and chairman of the Department of Orthopedics & Rehabilitation in Madison, is one of the physicians who allegedly wrote studies supporting Infuse without characterizing its potential detrimental impacts, according to The Spine Journal. He did not respond to a HealthLeaders Media e-mail.