Fridley-based Medtronic, Inc., recently received a letter from two U.S. senators requesting information about the use of the company's Infuse bone-growth product and payments it made to clinical investigators.
Senators Charles Grassley of Iowa and Max Baucus of Montana signed the letter, which is addressed to Omar Ishrak-who assumed the role of CEO at Medtronic last week.
The letter was sent on behalf of the U.S. Senate Committee on Finance, which oversees the Medicare and Medicaid programs. It states that the senators are "extremely troubled" by recent media reports suggesting that doctors conducting trials examining the safety and effectiveness of Infuse were aware that the product may cause medical complications but didn't report it in medical documentation.
The senators wrote that "severe side-effects of Infuse and similar bone-growth products developed by Medtronic may have been unreported or under-reported in clinical literature," and reports have linked Infuse to swelling in the neck and throat, radiating leg pain, and cancer.
One recent study suggested that back surgery patients treated with the Infuse product experienced higher rates of sterility in men, but Medtronic contends that not enough men experienced such complications to statistically link the problem to the Infuse product.
In an e-mailed statement to Twin Cities Business, Medtronic confirmed that it received the senators' letter and that it will respond. The company said that several of the adverse effects of Infuse are noted on the product's label-which was approved by the U.S. Food and Drug Administration (FDA).
Regarding the product's alleged "potential link to cancer," the company said that 44 clinical trials revealed that cancer rates were not statistically different between patients who were treated with the Infuse product and those who were not.
The senators' letter also states that the concerns about medical complications are "compounded by the fact that some clinical investigators have substantial ties to Medtronic."
Medtronic said that it provides the FDA with data regarding adverse effects "irrespective of any financial relationship between the company and the clinical investigator or study author."
The senators' letter, available here, asks Medtronic to supply a long list of documents and communications regarding post-surgery medical complications, as well as "a detailed account of payments that Medtronic made to all Infuse clinical investigators." The letter set a deadline of July 11.
Media reports surfaced in April indicating that the Department of Justice was investigating the marketing of the Infuse product.
And Grassley reportedly has written to Medtronic in the past. A story by the New York Times indicates that in 2007, Grassley raised questions about payments made to spine surgeons by Medtronic, which told the newspaper at that time that the payments were legitimate compensation for work performed by the doctors.