On April 23rd, 2010 the Agency for Research and Quality released an assessment that found no evidence of improved health outcomes for most off-label use of BMP's to promote healing following a fracture. Off course, this research was conducted by BCBS Association Evidence Based Practice Center. This report assessed on-label and off-label use of INFUSE and OP-1.
Both Medtronic and Stryker have come under scrutiny in recent years for their off label use of these products. Medtronic has been subject to inquiries by the DOJ and the US Senate over off label use of INFUSE, while Stryker Biotech was charged by a federal grand jury with wire fraud, device misbranding and making false statements related to off-label use of OP-1. Last spring an FDA advisory panel recommended against approving a spinal fusion indication for OP-1 Putty.
So TSB must ask our readers, are you down with OPP, yeah you and me, who's down with OPP Stryker and me, You down with OPP, yeah you and me, Who's down with OPP, all my spine homies.