NASS to Companies, Surgeons: Stop Inaccurately Promoting Bone Growth FactorsWritten by Laura Miller | June 28, 2011
A panel of spine experts is calling for surgeons to re-examine and reduce the use of recombinant bone morphogenic protein-2 in an editorial published in a special edition of North American Spine Society's The Spine Journal, which focuses on rhBMP-2.
Early industry-sponsored clinical research of rhBMP-2 failed to report the adverse events and complications experienced by hundreds of patients participating in the clinical trials. Various studies published in recent years associate the product with early inflammatory reactions, cancer, osteolysis, infection, implant dislodgement, male sterility and other complications.
While some of these complications, such as male sterility, were revealed by the companies, the more recent studies suggest that the incidences of these events were more prevalent than previously described, according to the report. The journal recently published an investigation into 13 original industry-sponsored studies, which found that patients were 10-50 times more likely to experience complications than the original published reports suggested.
"The history of rhBMP-2 research is a cautionary tale for all medical professionals, researchers and patients," said Christopher M. Bono, MD, of Brigham & Women's Hospital in Boston, acting editor-in-chief of the current issue of The Spine Journal. "As this matter demonstrates, the spine care field is currently at a precarious intersection of professionalism, morality and public safety. As physicians and journal editors, we felt an obligation to present a thorough examination of the controversial issue."
He also said the product may be of great benefit to some patients who have serious problems in healing bone, and the issue features an exploration of alternative dosing and delivery methods of rhBMP-2 that may have fewer complications and adverse events in the future.
The issue also includes:
• A review of a study on posterior iliac crest pain after posterolateral fusion with or without harvesting iliac crest graft, disputing the idea that the pain associated with iliac bone crest graft harvesting is too high.
• A review article highlighting some of the deleterious effects, at the cellular level, of rhBMP-2 on the central and peripheral nervous system.
• A clinical study that is among the first to determine the incidence and resolution of osteolysis, which is a side-effect of rhBMP-2 usage. Whereas the area and rate of osteolysis did not significantly impact the rate of fusion, which was 83 percent, only 24 percent of vertebral bodies with evidence of osteolysis at 3-6 months were eventually completely resolved.
Read the release about BMP.
Related Articles on rhBMP-2:
NASS: BMP Use in Spinal Fusion May Cause Male Infertility
Medicare Advisory Committee Votes Against Off-Label BMP Use
Senate Investigates Medtronic's Influence Over Surgeons Studying Infuse
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