Attribution: Eugene J. Carragee, MD, editor in chief of The Spine Journal
EMBARGOED FOR RELEASE
August 3, 2011 at 10:00 p.m. EST
(Burr Ridge, IL)—In response to research published in the June 2011 issue of The Spine Journal* and investigations by the US Senate Finance Committee and the US Department of Justice, Medtronic , Inc. has announced a $2.5 million grant to Yale University to independently review the safety and effectiveness of its rhBMP-2 product.
Without knowing the specifics of the proposed review process, I can say this appears to be a big first step in the right direction. As we called for in the June 2011 issue of The Spine Journal, patients and their health care providers deserve no less than a fully-transparent accounting of the various rhBMP-2 trials with analysis by non-conflicted reviewers.
However, three major challenges for true transparency and patient safety remain:
1. When a study is designed, it must be created without bias. Later analysis of original flawed data, such as in some of the industry-sponsored rhBMP-2 studies, will have little value. Unfortunately, the Yale University researchers will not be able to fix the study design flaws and assessment biases that were used in some of the original studies.
2. Because the original Medtronic-sponsored articles did not report any rhBMP-2 adverse events, the voluntary reporting of FDA-recognized adverse events (male sterility, bladder dysfunction, back and leg pain events, cancer, etc.) by practicing surgeons was handicapped by surgeons and patients not recognizing many of the complications were rhBMP-2--related in the first place.
3. The number-one use of rhBMP-2 now is posterior lumbar interbody fusions (or its variants). The randomized trial on this particular use was never completed— it was halted early on because of complications and adverse events. Consequently, the Yale group will still have very little controlled data to judge actual safety of the product.
Today, we know that rhBMP-2 may be a useful addition to spinal fusion techniques in a small group of patients, particularly those who have serious problems in healing bone, but we do not have an accurate assessment of safety in 85-90% of the people receiving the product. Obviously, this remains a big problem.
The Spine Journal editors are pleased that our investigation into rhBMP-2 has served as a catalyst for this move by Medtronic to introduce transparency into the medical device and drug research and development process. I have been in touch with Harlan Krumholz, MD, the leader of this project at Yale University, and The Spine Journal would welcome the opportunity to provide input into the process as needed.
* Press release on June 2011 issue of The Spine Journal and the study “A critical review of rhBMP-2 trials in spinal surgery: emerging safety concerns and lessons learned.”