Yale School of Medicine has announced an agreement with two internationally renowned research centers that will independently review all clinical studies of bone morphogenetic protein-2 (BMP-2), a product sold by Medtronic that is used in spinal surgeries to promote bone growth.
Yale School of Medicine has selected Oregon Evidence-based Practice Center at Oregon Health & Science University in Portland, Oregon, and the Centre for Reviews and Dissemination at the University of York, United Kingdom. The centers were chosen after a competition held by the Yale Open Data Access Project.
Yale previously entered into an agreement with Medtronic to independently review BMP-2 studies after questions were raised about the product’s safety and efficacy.
As part of this agreement, Medtronic will release all of its human subject data on BMP-2 to Yale for distribution to the reviewing institutions. The centers will work independently of each other, and once their reviews are complete. They will issue separate reports, which will be made public in the summer of 2012. Medtronic will have no direct role in these reviews aside from providing data and supporting materials.
“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,” said Harlan M. Krumholz, M.D., leader of the Yale project.