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Senate Panel Says Company Edited Studies of Bone-Grafting Product, Infuse
According to Reuters, The New York Times, The Wall Street Journal, and other leading news sources, the U.S. Senate Finance Committee has determined that the medical device maker Medtronic Inc. edited journal articles and paid physicians millions of dollars for company-sponsored studies of its bone-grafting product Infuse. The treatment uses a bioengineered protein (recombinant human bone morphogenetic protein-2) to fuse spinal vertebrae as a way to reduce back pain.
After a 16-month investigation, the Senate report alleges that Medtronic was “heavily involved in drafting, editing, and shaping the content of medical journal articles” about the product even as it was paying the physicians who wrote those articles a total of $210 million for unrelated work.
The company-sponsored articles failed to mention potential complications from treatment with Infuse, including male sterility, an increased risk of cancer, infections, bone dissolution, and worsened back and leg pain. Moreover, the company’s role in authoring or editing the articles was not disclosed in the published papers, the Senate report alleges.
The committee’s inquiry was partly spurred by the publication last year of a special issue of The Spine Journal, in which a group of spine specialists publicly repudiated 13 studies performed by Medtronic-financed researchers, saying that the articles had understated the serious adverse effects connected with Infuse.
The Senate committee also looked at internal Medtronic documents, which indicated that the company had inserted language into published reports claiming that Infuse was superior to bone grafts because it eliminated the pain associated with harvesting bone from a patient’s pelvis.
According to the committee’s investigation, Medtronic’s influence extended to preparing a physician's 2002 speech to a panel advising the FDA on whether to approve Infuse. The physician's disclosure to the panel suggested that his testimony was independent, but the company had in fact helped him draft the speech and had paid him as a consultant the previous year, company documents showed. Medtronic later hired the physician as an executive.
The FDA approved Infuse in 2002 to stimulate spinal bone growth in patients with a degenerative disease affecting the lower spine. However, the product is mostly used off-label, often for repairs to the cervical spinal area.
Medtronic has said on its Web site that it "vigorously disagreed" with the allegations of influencing or authoring the publications or of under-reporting adverse events.
Source: Reuters, October 25, 2012.