BMJ article on The Medtronic Affair

US firm accused of manipulating journal articles and paying millions to authors

The US medical device company Medtronic was “heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants,” who were paid hundreds of millions of dollars by the company through royalties and consulting fees, a US Senate Finance Committee staff investigation has found.1

The committee investigated 13 journal articles related to Medtronic’s product Infuse, a bone growth stimulating protein approved by the US Food and Drug Administration (FDA) in 2002 for use in spinal fusion surgery.2 The protein is used in conjunction with a Medtronic spinal fusion device for treatment of degenerative disc disease in the lower spine.

The protein, a genetically engineered version of bone morphogenetic protein 2 (rh-BMP2), has been used to treat more than 500 000 patients. In Europe it is known as dibotermin alfa and it is marketed under the trade name InductOs.

According to the report, Medtronic employees inserted language into medical journal articles that promoted the product without disclosing to the journals “the company’s significant role in authoring or substantively editing” the manuscripts. The company paid “approximately $210m (£130m; €163m) to physician authors of Medtronic sponsored studies from November 1996 through December 2010,” the report alleges.

The report also claims that Medtronic employees sought to downplay adverse events associated with the product while emphasising problems with competing procedures.

In a statement released with the report, committee chairman Senator Max Baucus, a Montana Democrat, said Medtronic’s actions had “violated” patients’ trust.

“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,” Baucus said.

In a statement, the company disputed the committee staff’s findings. “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.”3

The company also called the report’s characterisation of the company’s payments to physicians “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,” a practice that is “commonplace and appropriate in the medical device industry,” the company said.

However, the company said it agreed with “many of the recommendations in the staff report to ensure increased transparency for industry interactions with physicians.”

In reaction to the report, Michael Heggeness and Charles Mick, president and first vice president of the North American Spine Society, applauded the committee report. The Society’s journal, Spine Journal, published a series of papers in June 2011 challenging the validity of the industry sponsored rh-BMP2 studies.4

“If surgeons had known that the lead authors of the 13 original studies on InFuse had received payments ranging from $1.7m to $64m 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?” they asked.

Notes

Cite this as: BMJ 2012;345:e7299

http://www.bmj.com/content/345/bmj.e7299