The review also will focus on data submitted from industry-sponsored studies submitted to the Food and Drug Administration but which was never published.
"It's a big plus – it breaks the glass ceiling, where device and drug manufacturers have said for many years that it was legally, logistically or financially impossible to even consider having a third party look at their data summaries," says Carragee. "This breaks the 'never, ever, can't do it mantra," he says. "Clearly, if Medtronic can do it with their No. 1 spine product, it can be at least on the table for discussions with companies who produce data that doesn't seem right."
Medtronic plans to give to Yale researchers all available patient data on rhBMP-2 from clinical trials it sponsored, both published as well as unpublished, and FDA adverse event reports for a comprehensive review, the Minneapolis-based company has stated. The company plans to make its clinical trial data available on ClinicalTrials.gov. It also plans to retroactively register all premarket approval and post-market studies that were completed before a requirement for registering such trials was set in 2007.
"Integrity and patient safety are Medtronic's highest priorities," Omar Ishrak, chairman and CEO of Medtronic said in a statement.