Medtronic, the manufacturer of spine fusion product Infuse, has hired Yale University researchers to review patient data and adverse event reports for the product.
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The review follows months of reporting by John Fauber for the Milwaukee Journal Sentinel and Medpage Today that have raised questions about the independence of doctors involved in clinical trials for the product.
The Wall Street Journal’s John Carreyou and Tom McGinty also used their paper’s Medicare data stockpile to look at the conflicts of interest and royalty money that drive the popularity of spine fusion treatments whose effectiveness has been disputed.
Serious complications involving Infuse have gone unreported in medical journal articles that were written by doctors who have financial ties to Medtronic.
The June issue of The Spine Journal was devoted to unreported complications related to Infuse, revealing that “complication rates … were 10 to 50 times greater than the estimated complication rates revealed” papers co-authored by doctors with financial ties to the company.
In a statement about the review by Yale researchers, Eugene J. Carragee, M.D., editor in chief of The Spine Journal, says “this appears to be a big first step in the right direction” but points out three challenges that lay ahead for the reviewers.