In a series of papers appearing this week in Spine, several experts publicly chastised other researchers for publishing misleading and biased trials on a spinal fusion product called Infuse, which surgeons can use to fuse vertebrae in the back to eliminate pain. During 13 clinical trials of Infuse that tested a total of 780 patients in the late 1990s and early 2000s,more than 20 researchers failed to report adverse side effects, and played up the advantages of Infuse over the traditional bone graft. According to the Spine papers, the researchers had received $60 to $70 million from Medtronic, Inc., the product’s maker, and many of the researchers did not disclose their financial agreements, The Chronicle reports.
Though Infuse had already been approved by the US Food and Drug Administration in 2002 for use in elderly patients whose hip bone cannot be harvested for a bone graft, the trials by researchers on Medtronic’s payroll touted the benefits of using it in a much wider population, and it is now used in a quarter of all spinal fusions, Time reports. Now, researchers are arguing the product shouldn’t be used except in a narrow patient population, pointing to studies performed by unaffiliated scientists that documented side effects including inflammation, male sterility, and unwanted bone growth.