An extensive review of the data on a commonly used spinal fusion product, which found the Medtronic product causes vastly more complications than reported in previous industry-sponsored studies, has sparked a firestorm of media coverage. The paper (.pdf), written by Stanford orthopedist Eugene Carragee, MD, and colleagues, was published yesterday in The Spine Journal.
A Wall Street Journal article offers a detailed summary of the research, Medtronic’s response and the Senate Finance Committee investigation into whether surgeons’ financial relationships with Medtronic Inc. were a factor in adverse effects going unreported.
A New York Times piece noted that the analysis was a seemingly unprecedented event in medicine:
It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.…
Both Dr. Howard C. Bauchner, editor in chief of The Journal of the American Medical Association, and Dr. Gregory D. Curfman, executive editor of The New England Journal of Medicine, said they could not think of a time when a journal had devoted an entire issue to questioning an approved product.
And Forbes writer Matthew Herper explains what motivated Carragee to begin looking into claims about published studies on the spinal fusion product and how The Spine Journal intends to make disclosures of financial conflicts more prominent in future publications.
Omar Ishrak, chairman and chief executive officer of Medtronic, Inc, responded to the journal articles in a statement saying, “While the Spine Journal articles raise questions about researchers’ conclusions in their published peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold.”
Previously: Stanford orthopedist reveals problems with spinal fusion product, Stanford study links spine product to male infertility and Spine expert comments on dramatic increase in complex back surgeries