Wall Street Journal – August 3, 2011 – by Ron Winslow – Medtronics and Infuse in the news.
Medtronic Inc. said Wednesday that it is giving Yale University a $2.5 million grant to conduct an ambitious,independent review of the safety and effectiveness of its controversial spine treatment called Infuse Bone Graft.
Under terms of the pact, the company will release to Yale and eventually the public what participants described as an unprecedented amount of clinical trial and other data. The university will select two research teams from other organizations to perform separate analyses of the data.
The announcement comes in the wake of a paper in June in the Spine Journal, which found that several clinical studies of Infuse, conducted by surgeons with strong economic ties to Medtronic, failed to report serious complications that arose in the trials. The critical paper also found that many of the studies were designed in ways that favored Infuse over a treatment given to a control group.