Eugene Carragee, MD, editor-in-chief of The Spine Journal of the North American Spine Society, has responded to the findings from the Yale University Open Data Access Project published in the Annals of Internal Medicine. The two studies review the safety and effectiveness of recombinant human bone morphogenic protein-2 for spinal fusion, finding low degrees of efficacy and higher rates of adverse effects than were originally reported in industry-sponsored studies. Some of the adverse events relate to cancer.
"A surgeon would need a truly exceptional case to use BMP-2 when data supporting its use are marginal and the scant complications data we have comes through potentially biased filters at every level," wrote Dr. Carragee in the statement. "If complications monitoring processes were as biased as the analyses and reporting process have proven to be, then data YODA was given fundamentally and systematically misrepresent the risk of BMP-2 use."
In 2011, The Spine Journal published a special edition with data and commentary about risks and potential for bone morphogenic protein. In this statement, Dr. Carragee further calls for examining the financial relationship between physician researchers and device companies.
The North American Spine Society has releases a response as well.
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"A surgeon would need a truly exceptional case to use BMP-2 when data supporting its use are marginal and the scant complications data we have comes through potentially biased filters at every level," wrote Dr. Carragee in the statement. "If complications monitoring processes were as biased as the analyses and reporting process have proven to be, then data YODA was given fundamentally and systematically misrepresent the risk of BMP-2 use."
In 2011, The Spine Journal published a special edition with data and commentary about risks and potential for bone morphogenic protein. In this statement, Dr. Carragee further calls for examining the financial relationship between physician researchers and device companies.
The North American Spine Society has releases a response as well.
More Articles on Spine Surgeons:
26 Awarded 2013 Scoliosis Research Society Awards and Scholarships
Reoperation for Spinal Fusion vs. Disc Replacement: 5 Things to Know
8 Defining Issues for Spine Surgeons Today