Senate committee report: Medtronic altered bone graft substitute studies

Medtronic does not agree with many of the findings in the report.

Medtronic employees collaborated with physician authors to edit, and in some cases, write, segments of published studies on its bone-growth product InFuse without providing disclosures in the published articles, according to a U.S. Senate Committee on Finance Report released today.

“Medtronic’s actions violate the trust patients have in their medical care. 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,” Senate Finance Committee Chairman Max Baucus (D-Mont.), stated in a press release. “Patients everywhere will be better served by a more open, honest system without this kind of collusion.”

Insufficient disclosures

The report, which was the result of the Senate Finance Committee’s 16-month investigation, analyzed 13 different studies using the Infuse device. The committee found that Medtronic did not disclose a significant amount of Medtronic royalties and consulting fees paid to physician consultants, which totaled $210 million from November 1996 to December 2010.

Baucus and senior Senate Finance Committee member Chuck Grassley (R-Iowa) also revealed an email exchange in which a Medtronic employee recommended against publishing some adverse events for the device in a 2005 article in the Journal of Bone and Joint Surgery. Furthermore, the investigations reported that Medtronic officials inserted language into studies that promoted InFuse as a better technique by highlighting the pain associated with an alternative technique.

The investigation also concluded that the company prepared an expert’s statements to an FDA advisory meeting panel, and the physician was later hired by Medtronic in 2007 as a vice-president.

“The findings also should prompt medical journals to take a very proactive approach to accounting for the content of the articles along with the authorship of the articles and studies they feature,” Grassley stated in the release. “These publications are prestigious and influential, and their standing rests on rigorous science and objectivity. It is in the interest of these journals to take action and the public will benefit from more transparency and accountability on their part.”

Medtronic statement

Medtronic officials stated in a press release that “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 states in the release that Medtronic reported to the FDA the potential adverse events addressed in the report, and the risks were reflected on the product’s FDA-approved label. The company also notes that royalty payments for consulting physicians were for intellectual property rights and not consulting payment, and are “commonplace and appropriate practice in the medical device industry.”

“Medtronic agrees with many of the recommendations in the staff report to ensure increased transparency for industry interactions with physicians, and indeed has played a leadership role in this area,” according to the Medtronic press release.

The InFuse product is approved in the United States for certain spine fusion surgeries and is designed to eliminate the need for hip bone harvesting. According to the Senate report, the InFuse product has been used to treat in more than 500,000 patients to date.

NASS response

In a press release, the North American Spine Society (NASS) recognized the Senate report and noted that Medtronic’s internal documents the Senate committee accessed showed a “more detailed and disturbing picture.”

In the press release, NASS representatives wrote, “If surgeons had known that the lead authors of the 13 original studies on InFuse had received payments ranging from $1.7 to $64 million from Medtronic and that its marketing employees were co-authors and co-editors, would they have been as eager to use InFuse on their patients?”

According to the release, the findings also confirm what was reported in the June 2011 editorial in Spine by Eugene J. Carragee, MD, and colleagues in which they note that unsponsored recombinant-human bone morphogenetic protein 2 studies have detailed some complications with the treatment, including adverse back and leg pain events, radiculitis, inflammatory reactions, retrograde ejaculation, urinary retention, bone resorption and implant displacement.

References:

Carragee EJ. Spine. 2011; doi:10.1016/j.spinee.2011.04.023.

Carragee EJ. Spine. 2011;doi:10.1016/j.spinee.2011.06.001.

www.finance.senate.gov/newsroom/chairman/release/?id=b1d112cb-230f-4c2e-ae55-13550074fe86