WASHINGTON (AP) — Medical device maker Medtronic Inc. helped write and edit medical journal articles attributed to outside physicians, which downplayed the risks of the company's best-selling bone graft, according to a report by Senate investigators.
The Senate Finance Committee said Thursday that the world's largest device maker did not disclose its role in shaping 13 key studies of InFuse, which helped turn the bone graft into an $800-million a year product. The studies, funded by Medtronic, failed to mention serious risks of InFuse including male sterility, infection and increased back and leg pain.
Senate investigators also reported that Medtronic paid the study authors $210 million in consulting fees for unrelated work over 15 years.
"Medtronic's actions violate the trust patients have in their medical care," said Sen. Max Baucus, D-Mont, in a statement. "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."
The Minneapolis company said it disagrees with many of the findings in the report.
"Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events," the company said in a statement.
InFuse has been used in a half-million patients and had sales of about $800 million in fiscal 2011, according to Medtronic reports.
The committee's report is the latest in a series of federal inquiries into Medtronic's promotion of InFuse, which is widely used for procedures not deemed safe or effective by federal health authorities. Earlier this year the Department of Justice closed a four-year investigation into InFuse, after first subpoenaing the company in October 2008.