For many months, Stanford orthopedic surgeon Eugene Carragee, MD, has been closely examining a growth factor used in spinal fusion procedures that may cause troubling side-effects, including male infertility, that were previously unreported. The first findings in his long inquiry appear today in The Spine Journal, which Carragee edits, and have been widely covered in the media, including the New York Times.
The findings, based on a retrospective study of 240 patients at Stanford, show the product, known commercially as Infuse, carries a higher risk of male infertility than previously thought. Perhaps more troubling: Earlier published reports on the product, which were written by surgeons with ties to the company, cited no adverse events. In an accompanying article in the journal, James Kang, MD, from the University of Pittsburgh, wrote:
There does not seem to be any rational explanation for [these] observational differences other than the fact that Carragee et. al. had no commercial conflicts of interest whereas the original FDA studies were corporate sponsored studies.
The Milwaukee Journal Sentinel, which has run numerous investigative stories on the device, also has an in-depth article on the issue.