Medtronic, Inc. Manipulated Bone Product Data: Senate

Medical device maker Medtronic Inc edited health journal articles and paid doctors millions of dollars for company-sponsored studies of its Infuse bone-grafting product used in spinal surgery, according to a U.S. Senate report published on Thursday. There were questionable ties between Medtronic and physician consultants who tested and reviewed the company’s product, the U.S. Senate Finance Committee said in the report, which concludes a 16-month investigation covering 5,000 documents relating to 13 studies of Infuse. Medtronic paid about $210 million in royalties and consulting fees to the authors of company-sponsored studies between November 1996 and December 2010, the report said. Those sponsored studies failed to mention complications from the product, including male sterility, an increased risk of cancer, infections, bone dissolution and worsened back and leg pain. “The company’s significant role in authoring or substantively editing these articles was not disclosed in the published articles. Medical journals should ensure industry role contributions be fully disclosed,” the committee’s report said.

MORE ON THIS TOPIC