A Yale School of Medicine probe into the clinical data behind Medtronic’s (NYSE:MDT) Infuse bone protein will feature independent reviews by separate research teams in Oregon and the U.K.
The teams are from the Oregon Evidence-based Practice Center at Oregon Health & Science University in Portland and the Centre for Reviews and Dissemination at the University of York. They’ll issue separate reports, expected to drop next summer. Medtronic will have "no direct role" in the reports after it’s submitted the clinical data, according to a press release.
Medtronic sponsored the $2.5 million review after allegations surfaced last summer that paid consultants who conducted research on Infuse covered up or under-reported the risks of the product, which may include excessive bone-growth, heightened cancer risk and male sterility.
The Yale probe, led by rock-star scientist Dr. Harlan Krumholz, will get access to the entire data set from Medtronic’s trials of the Infuse compound, called recombinant bone morphogenic protein-2 (rhBMP-2).
"This project is setting a new standard of transparency and will ensure that all data about this product is made publicly available and scrutinized by those with an interest in the drug," Krumholz said in prepared remarks.
The controversy over the Infuse product, which includes allegations of marketing for off-label use against Medtronic, blew up over the summer when the Spine Journal dedicated its entire June issue (PDF) to exposing problems with growth proteins, including a repudiation of some of the research surrounding Infuse.
The journal’s investigation found that 13 studies (published by authors who collectively received millions from Medtronic) downplayed or omitted entirely evidence of safety risks from Infuse. The actual rate of “frequent and occasionally catastrophic complications” associated with the product was between “10 percent to 50 percent depending on approach.”
“For several years Medtronic has been leading the industry in reforms designed to eliminate or mitigate conflicts of interest. We will continue to investigate questions surrounding researchers’ potential conflicts of interest, refine our policies as warranted, and strive to lead the industry in ethical and transparent business practices,” Medtronic CEO Omar Ishrak said in a June statement.