Senate Committee: Medtronic Manipulated Infuse Studies

Senate Committee: Medtronic Manipulated Infuse Studies

A U.S. Senate Finance Committee report based on thousands of documents from Medtronic adds to the controversy surrounding the company’s bone-growth product Infuse, but Medtronic said that it “vigorously disagrees” with the committee’s claims.

A new report from the U.S. Senate Finance Committee accuses Fridley-based medical device giant Medtronic, Inc., of being “heavily involved” in the creation of medical journal articles about one of its products, which were authored by physician consultants who received millions of dollars in royalties and consulting fees from the company.

Medtronic, meanwhile, said that it disagreed with many of the report’s conclusions and found language regarding payments to physicians to be “misleading and unfair.”

The Senate committee, which oversees the Medicare and Medicaid programs, began investigating Medtronic in June 2011 over allegations that the company had improperly influenced peer-reviewed studies of its bone-growth product Infuse. In a letter to Medtronic CEO Omar Ishrak, two senators said at the time that they were “extremely troubled” by media reports suggesting that doctors conducting trials were aware that the product may cause medical complications but didn’t report it in medical documentation.

Also in June 2011, The Spine Journal published an extensive report suggesting that there was a pattern of academic surgeons with financial ties to Medtronic omitting dangerous side effects associated with Infuse. It cited 13 Medtronic-sponsored studies in which there were no reports of adverse events, but The Spine Journal’s report suggested that the actual patient risk could be between 10 times and 50 times greater than what the company-sponsored studies reported. On the heels of the report, Ishrak defended the company, saying, “Integrity and patient safety are my highest priorities.”

In its Thursday report, which is based on more than 5,000 documents obtained from Medtronic and follows a 16-month investigation, the committee said that the company was “heavily 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”—and the company’s influence on the articles was not disclosed in them.

Among the committee’s other findings: Between 1996 and 2010, Medtronic paid roughly $210 million to the same physicians who authored the studies for “consulting, royalty, and other miscellaneous arrangements.” E-mails indicate that a Medtronic employee recommended against publishing a complete list of possible adverse events in a 2005 medical journal article, and the committee also accused Medtronic of wrongly promoting the use of Infuse for spinal surgery as a better technique than bone grafts from the pelvis, by emphasizing the pain involved in the alternative technique.

Furthermore, the report suggests that Medtronic’s influence extended to the preparation of a physician’s 2002 speech before a U.S. Food and Drug Administration (FDA) advisory panel. The company allegedly helped prepare a presentation given by Dr. Hallet Mathew, whose disclosure to the panel implied that his testimony was independent. Medtronic paid him as a consultant the previous year and later hired him as a vice president of the company, according to the report.

To download the complete Senate committee report, click here.

Medtronic said in a statement that it “does not agree with many of the findings in the staff report.”

“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. “In fact, Medtronic reported to the FDA the potential adverse events addressed in the staff report, and these risks were reflected on the product’s FDA-approved label.”

The company went on to describe the report’s characterizations of payments to physicians as “misleading and unfair,” saying that the “vast majority” of payments compensated physicians for intellectual property rights and contributions, rather than consulting payments.

“In general, royalty and consulting payments are a commonplace and appropriate practice in the medical device industry,” the company added.

Medtronic said that it has been an industry leader in “reforms designed to eliminate or mitigate potential conflicts of interest, including disclosure of payments to physicians,” and it claims to have been one of the first companies to publicly disclose payments to physicians online.

Medtronic’s Infuse product involves a genetically engineered protein that stimulates bone growth for use in spinal fusion surgery. According to a report by The Wall Street Journal, the FDA approved Infuse in 2002 for use in just one type of surgery. It became widely used in other types of surgeries, however, after a series of medical journal articles described those uses as safe and effective.

Medtronic is among Minnesota’s 10-largest public companies based on revenue, which totaled $16.2 billion in its most recent fiscal year. The company’s spinal business is headquartered in Memphis, and sales for the division slid 4 percent to $3.3 billion for the fiscal year that ended on April 27. The company attributed the drop in part to an 18 percent decline in sales for Infuse.