Senate Investigation Culminates In Report Criticizing Medtronic

The Senate Finance Committee alleges that the medical technology company played a hidden role in drafting studies about one of its products.

MPR: Senate Committee Report Highly Critical Of Medtronic
Some powerful U.S. Senators are leveling serious charges against Medtronic, releasing today a sharply critical report on the company's spine product, InFuse. The report, from Finance Committee Chairman Max Baucus, D-Mont., and senior member Chuck Grassley, R-Iowa, accuses Medtronic of failing to disclose the company's role in editing and writing medical journal articles to downplay the risks of the bone growth product. The allegations against Medtronic are not altogether new (Baxter, 10/25).

CQ HealthBeat: Senate Finance Report Shows Medical Company Had Input In Articles About Its Product
Medtronic Inc., one of the world's largest medical technology companies, helped write and edit articles about its product in journals and maintained undisclosed financial ties to the articles' authors, Sens. Max Baucus and Charles E. Grassley said Thursday. Medtronic also did not disclose its role in shaping the articles about its bone-growth product InFuse, the senators said. The findings are the result of an investigation that Baucus, chairman of the Senate Finance Committee, and Grassley, a member of the committee, started in June 2011. "Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has," said Baucus, D-Mont. (Ethridge, 10/25).

Reuters: Medtronic Edited Doctor Reviews For Product: Senate Report
In response, Medtronic said in a statement on its website it "vigorously disagreed" with the allegations of influencing or authoring the publications or under-reporting adverse events. "In addition, the report's characterization of payments received by physicians is also misleading and unfair," Medtronic said (Sherman, 10/25).

The Hill: Senate Report Finds Medtronic Manipulated Studies On Its Products
In one case, the report alleges, a Medtronic employee recommended that details on the adverse effects of InFuse not be published in an article in Journal of Bone and Joint Surgery. Those details were not ultimately not included in the piece. The report also charges Medtronic with pressuring study authors to make a "bigger deal" of the pain experienced by patients who chose a treatment other than InFuse. In a statement Thursday, Baucus said these practices pose a "serious risk" to patients (Viebeck, 10/25).