Senators Request Infuse Documents from Medtronic
BY LAUREN UZDIENSKI, JUNE 22, 2011
Last month, a review of data from Infuse's PMA study linked Infuse to sterility in men. It set off a new wave of concern about the product and its adverse events (off-label use in the cervical spine had previously been correlated with inflammation and respiratory distress), but it also raised questions about whether these risks had been sufficiently publicized. Implicit in the study and the surrounding media attention were allegations that Infuse researchers had intentionally excluded these events from published reports, attributing them to surgical technique rather than an inherent characteristic of Infuse, which raised questions about bias among physicians receiving payments for their work with Medtronic.
Now the U.S. Senate is getting involved. The New York Times reports that Senators Max Baucus and Chuck Grassley requested "extensive" documentation from incoming Medtronic CEO Omar Ishrak relating to Infuse consulting relationships and adverse event reporting. Specifically, the Senators want to see “all documents and communications” with researchers, medical journals, the FDA, advisory board members and other Medtronic consultants. The company has until July 11th to respond.
Medtronic told the newspaper that it would comply with the Senators' request. Further, Medtronic notes that certain complications, including abnormal bone growth, swelling in the neck and throat and sterility, are identified as potential side effects on the Infuse label.
