Officials of Medtronic, the medical device maker, edited studies by outside researchers about a controversial spine treatment sold by the company, inserting claims that their product was superior to a competing one, according to a Senate finance committee report released Thursday.
Medtronic's LT-CAGE device, and Infuse, help in the treatment of back pain.
The treatment at issue, known as Infuse, uses a bioengineered protein to fuse spinal vertebrae as a way of reducing back pain. Spinal fusion procedures can also use a competing technique that employs real bone.
In recent years, critics of Infuse have charged that Medtronic overplayed its benefits in studies in medical journals that also played down its risks.
The Senate finance inquiry, which reviewed internal Medtronic documents, found that the company paid about $210 million from 1996 to 2010 in consulting fees, royalties and other payments to doctors involved in outside research on Infuse.
In a statement, Medtronic said it vigorously disputed any suggestion that its employees had improperly influenced or written any of the medical journal reports. The company also said those studies had accurately represented the procedure's risks and that the payments to researchers had been largely royalty fees that were in line with industry practice.
"Medtronic does not agree with many of the findings" in the report, the company stated.
The Senate inquiry was spurred in part by the release last year of a special issue of a medical publication, The Spine Journal. In that report, a group of spine specialists publicly repudiated the studies performed by the Medtronic-financed researchers, saying they had understated serious adverse effects connected with Infuse, including male sterility. The researchers involved defended their reports as accurate.
The Senate inquiry also found that internal Medtronic documents indicated that the company had put language into reports claiming that Infuse was superior to a bone graft because it eliminated the pain associated with harvesting bone from a patient's pelvis. Medtronic said that there was a medical debate about the complications of bone graft use and that any suggestions that it used that issue for marketing purposes was wrong.
"Patients everywhere will be better served by a more open, honest system without this kind of collusion," the chairman of the Senate Finance Committee, Max Baucus, Democrat of Montana, said in a statement.
Last year, after publication of The Spine Journal issue, Medtronic took the unusual step of giving a $2.5 million grant to Yale so that independent researchers could conduct a broad review of all Infuse studies to determine the facts. That review is still under way.
Infuse, which was approved in 2002, is used in about a quarter of the estimated 432,000 spinal fusions performed in this country each year. The vast majority of those procedures involve so-called off-label uses by doctors in spinal procedures not approved by the Food and Drug Administration.
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