The Spine Journal is the scientific, peer review journal of the North American Spine Society, comprised of more than 6,200 members.
While the physician reviewers found no problems with Medtronic's Infuse product, The Spine Journal team said it uncovered plenty, characterizing the other physicians' reports as misleading and biased. Medtronic, the nation's largest maker of medical devices, is being scrutinized over promoting Infuse, a bioengineered material used mostly in spinal fusions. The company estimates that Infuse is used in about one quarter of the more than 400,000 spinal fusions performed in the U.S. annually.
Specifically, The Spine Journal report contradicts early industry-sponsored clinical research on rhBMP-2, a controversial synthetic bone growth product often used in spine fusion surgeries. That research reported no adverse or complications involving hundreds of patients over 10 years.
But The Spine Journal, in a series of reports comprising the June issue, asserts that the use of rhBMP-2 has been associated with various early inflammatory reactions, cancer, infections, implant dislodgement, and occasionally life-threatening complications. The dispute underscores what Carragee says is the search for "transparency" in a tangled web of money and potential conflicts involving physicians and device manufacturers, with patient care in the balance. Those issues are at the core of multiple federal investigations into what the five physician authors wrote in The Spine Journal as "biased and corrupted research" that reflect special interests and are potentially harmful to patients.