The North American Spine Society released a statement responding to the Yale Open Data Access Project that published two studies in the Annals of Internal Medicine showing lower degrees of efficacy and higher rates of adverse effects with the use of rhBMP-2 than originally reported by industry-sponsored studies.In the statement, NASS President Charles A. Mick, MD, applauds the transparency and calls for more data sharing and reanalysis to encourage ongoing critical thought.
"While this transparency is laudable, it is overdue," wrote Dr. Mick. "Neither the original investigators nor industry were exonerated by this repeated data scrutiny, which led to conclusions quite disparate from those in their many published studies on their rhBMP-2 product. Open access post-market analysis may very well help identify mistaken conclusions and foster new creative analysis for existing data. But even the editors of Annals acknowledge that it is not feasible to apply these rigorous, costly and time-intensive methods of analysis to every clinical question."
Medtronic underwrote the $2.5 million project after originally funneling millions of dollars to the original research. In the statement, NASS recommends post-publication efforts combined with efforts to improve the reporting of original research, including financial disclosure, authorship responsibilities and increased non-industry based funding.
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"While this transparency is laudable, it is overdue," wrote Dr. Mick. "Neither the original investigators nor industry were exonerated by this repeated data scrutiny, which led to conclusions quite disparate from those in their many published studies on their rhBMP-2 product. Open access post-market analysis may very well help identify mistaken conclusions and foster new creative analysis for existing data. But even the editors of Annals acknowledge that it is not feasible to apply these rigorous, costly and time-intensive methods of analysis to every clinical question."
Medtronic underwrote the $2.5 million project after originally funneling millions of dollars to the original research. In the statement, NASS recommends post-publication efforts combined with efforts to improve the reporting of original research, including financial disclosure, authorship responsibilities and increased non-industry based funding.
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5 Ways Spine Cases Can Improve Profitability in Poorly Performing Surgery Centers