REFILE-Senate report says Medtronic edited spine surgery product reviews

Thu Oct 25, 2012 4:20am EDT

Oct 25 (Reuters) - Medical device maker Medtronic Inc edited health journal articles and paid physicians for company-sponsored studies of its Infuse bone graft product used in spinal surgery, a U.S. Senate Committee alleged in a report published on Thursday.

"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," said the report by the Senate Committee on Finance.

It also accused the company of wrongly promoting Infuse, a genetically engineered protein used in spinal surgery, as a better technique than bone grafts from the pelvis and that Medtronic paid about $210 million in royalties and consulting fees to the authors of company sponsored studies between November 1996 and December 2010.

In reaction Medtronic said in a statement on its website that it "vigorously disagreed" with the allegations of influencing or authoring the publications or under-reporting adverse events.

"In addition, the report's characterisation of payments received by physicians is also misleading and unfair," Medtronic said.

The inquiry by the Senate Committee began in June last year, investigating whether surgeons paid by Medtronic did not report complications associated with Infuse.

The Spine Journal reported that 13 Medtronic-sponsored studies related to Infuse had reported no adverse events, in an issue published a week after the inquiry.

The Committee report was published after reviewing over 5,000 documents produced by Medtronic related to Infuse trials.

Infuse, which was approved by the U.S. Food and Drug Administration in 2002 for spinal surgery, generated sales of about $800 million in the fiscal year 2011.

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