Regulatory Focus™ > News Articles > Senate Investigation Claims Medtronic Edited, Influenced Studies

Senate Investigation Claims Medtronic Edited, Influenced Studies

Posted 25 October 2012 | By

A new report released by the Senate Finance Committee slams medical device manufacturer Medtronic for allegedly ghostwriting studies used to support its Infuse Bone Graft system and paying hundreds of millions of dollars to experts who authored company-sponsored studies.

The 2,300-page report (PDF, 150 MB) was triggered in part by a 2009 investigation conducted by Med Page Today and the Milwaukee Journal-Sentinel that found the company to have engaged in ghostwriting studies-the practice of drafting or completing a study and having someone else take author credit. At least one such expert received $34 million from Medtronic between 1996 and 2010, and in all, experts received approximately $210 million since 1996.

Investigators said they were particularly concerned about the possibility that the study authors had, at the urging of Medtronic officials, de-emphasized or eliminated mention of side-effects associated with the use of Infuse.

"Medtronic's actions violate the trust patients have in their medical care," wrote Senator Max Baucus (D-MT). "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. Patients everywhere will be better served by a more open, honest system without this kind of collusion."

The senator, along with Sen. Charles Grassley (R-IA), was a strong supporter of the Physician Payments Sunshine Act, a part of the 2010 healthcare overhaul legislation, which would require physicians to disclose payments received from industry. The implementation of the legislation has been subject to delay by the US Department of Health and Human Services (DHHS), and Grassley reiterated that such legislation could have avoided the sort of problems investigated by the committee.

The senators also called on medical journals to institute more stringent policies against accepting ghost-written studies. "These publications are prestigious and influential, and their standing rests on rigorous science and objectivity," wrote Grassley. It's in the interest of these journals to take action, and the public will benefit from more transparency and accountability on their part."

Medtronic Strongly Denies Findings

Medtronic, meanwhile, issued a strong denial of the committee's findings. "Medtronic does not agree with many of the findings in the staff report," it said in a statement released on its website. "In particular, 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 the risks associated with the studies were reported to FDA and ultimately made their way onto FDA's label, though it did not address whether the studies were edited to exclude the adverse events.

Medtronic said the committee's characterization of its payments to the physicians and study authors was, "misleading and unfair."

"The vast majority of such payments were royalty payments made to compensate physicians for their intellectual property rights and contributions, not consulting payments," it said. "In general, royalty and consulting payments are a commonplace and appropriate practice in the medical device industry."

However, the company also said it agreed with many of the report's recommendations, observing that increased transparency for industry-physician interactions would be beneficial, even as it believed that such interactions were useful for promoting innovation.

Read more:

Senate Finance Committee Report (PDF, 150 MB)

NYTimes  - Senate Panel Says Medtronic Edited Studies

Businessweek - Medtronic Manipulated Bone Product Data, Senators Say

WSJ - Medtronic Documents Spur New Questions

Med Page Today - The $34-Million Spine Surgeon

Finance Committee - Statement

Journal-Sentinel - Senate panel says Medtronic workers ghostwrote papers

Med Page Today - Medtronic Helped Write, Edit Positive 'Infuse' Spine Studies

Medtronic - Response to Senate Finance Committee Staff Report on INFUSE® Bone Graft

Reuters - Medtronic edited doctor reviews for product: Senate report

Regulatory Focus newsletters

All the biggest regulatory news and happenings.