WASHINGTONMedical 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.
The Food and Drug Administration approved InFuse in 2002 for use in spinal, oral and dental graft procedures, but most of the time it has been used in neck surgeries and other procedures. Physicians are allowed to use drugs and medical products off-label as they see fit, but companies cannot market their products for off-label uses.
Use of InFuse in neck surgeries can lead to problems swallowing, breathing and speaking. Some patients had to have other surgeries because of those problems.
Senate investigators said Medtronic staff inserted language into studies of InFuse suggesting the product was less painful than alternatives. In one 2005 incident, a Medtronic staffer helping draft a medical journal article recommended against publishing "significant detail" about adverse events reported with InFuse.
The Senate's findings echo earlier reports published in The Spine Journal last year, alleging researchers involved in key studies of InFuse did not disclose serious side effects. The Spine Journal is the official publication of the North American Spine Society.
The group said in a statement it is "hopeful that future research sponsored by Medtronic and others will adhere to much higher standards."
The Senate Finance Committee launched its investigation in June 2011, following the publication of The Spine Journal's report. Senate investigators say Medtronic cooperated with the investigation, turning over 5,000 documents.
for more features.