Medical device maker, Medtronic Inc., edited journal articles and paid physicians massive sums for Medtronic-sponsored studies of its Infuse® bone-grafting product, according to a U.S. Senate Finance Committee report. Over the last several years, Medtronic has been embroiled in controversies that have shed doubt on the safety of Infuse® and the company’s marketing of the product.
The Committee’s report—which followed a 16-month investigation involving 5,000 documents and 13 separate Infuse® studies—just revealed that ties between Medtronic and its physician consultants were questionable, said Reuters. Medtronic Inc. is being accused of ghost writing sections of 11 medical papers and of paying physician consultants in the hundreds of millions of dollars in so-called “consulting fees” in exchange for promotion of Infuse®, the U.S. Senate investigation found, said Bloomberg Businessweek.
“Medtronic was involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic,” Senator Max Baucus (Democrat-Montana), the Committee chair, and Senator Charles Grassley (Republican-Iowa), said in a statement, wrote Businessweek.
None of the 13 Medtronic-funded clinical trials reported Infuse® side effects, despite that data provided to the U.S. Food & Drug Administration (FDA) revealed that at least half of all patients treated with Infuse® suffered complications including infections, pain, cysts, and cancer, said Businessweek. The Committee inquiry initiated in June 2011 probed surgeons paid by Medtronic who had not reported Infuse®-related complications. Analysis was published in The Spine Journal one week after the inquiry.
According to the government report, the device maker paid some $210 million in royalties and consulting fees to the authors of its company-sponsored studies from November 1996 through December 2010, wrote Reuters. At issue is that none of the studies mentioned complications associated with Infuse®, such as male sterility, increased cancer risks, infections, bone dissolution, and increased back and leg pain.
“The company’s significant role in authoring or substantively editing these articles was not disclosed in the published articles. Medical journals should ensure industry role contributions be fully disclosed,” said the Senate Committee on Finance report, according to Reuters. “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,” said Chuck Grassley (Republican-Iowa). Senator Grassley is a senior member of the Committee, which has, explained Reuters, sole jurisdiction over Medicare and Medicaid.
The Committee also accused Medtronic of wrongly promoting Infuse® as better than using bone grafts from the pelvis, said Reuters. Medtronic issued a statement in which it said it “vigorously disagreed” with the Committee’s allegations that it either influenced or authored publications or minimized the reporting of adverse events. “In addition, the report’s characterization of payments received by physicians is also misleading and unfair,” Medtronic argued.
As we’ve explained, Medtronic Infuse®—approved by the U.S. food & Drug Administration (FDA) in 2002 to stimulate spine growth in patients suffering from lower spinal degenerative disease—is a synthetic form of recombinant human Bone Morphogenetic Protein (rhBMP-2) that is approved for use in one type of spinal surgery and some dental procedures. The product is used, for the most part, in off-label procedures.
“Medtronic’s actions violate the trust patients have in their medical care,” Senator Baucus said, wrote Businessweek. “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 Senator added.