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Bone growth safety

Posted on 6 December 2011

CRD to review the effectiveness and safety of bone growth product

The Centre for Reviews and Dissemination (CRD) at the University of York is to conduct a major independent review of the effectiveness and safety of bone morphogenetic protein-2 (BMP-2), a product used in spinal surgeries to promote bone growth.

After competitive tender, Yale School of Medicine has chosen CRD and the Oregon Evidence-based Practice Center at Oregon Health & Science University in Portland, Oregon, to conduct two separate reviews. Both are world leaders in the analysis of individual patient data from clinical trials.

Yale previously entered into an unprecedented agreement with the producers 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.

CRD and Oregon will work independently of each other, and in addition to reanalysing the raw data from all of Medtronic’s clinical studies, will also carry out a review all other known trials of BMP-2.

Once the reviews are complete, both teams 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.

CRD Director, Professor Lesley Stewart who has been undertaking individual participant data (IPD) meta-analyses for over 20 years said “We are delighted to have been selected to carry out this ground breaking project. As well as addressing an important clinical question, it demonstrates proof of concept that could well set a new standard in transparency and release of trial data for independent scrutiny, a development that is in the public interest.”

Harlan M. Krumholz, M.D., leader of the Yale project, added: “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.”