The journal scrutinized what it termed misleading and biased reports on the product, Infuse, a bioengineered material used mostly in spinal fusions, made by Medtronic, the nation's largest manufacturer of medical devices. The Journal noted that clinical studies of Infuse were conducted by surgeons who received millions of dollars from Metronic.
Medtronic estimates that Infuse is used in about one quarter of the more than 400,000 spinal fusions performed in the U.S. annually. The controversy over the clinical trials is being confronted head-on, and that is good for healthcare.
Responding to The Spine Journal reports, Medtronic earlier this month announced that it would pay Yale University $2.5 million to independently review the safety and effectiveness of its Infuse Bone Graft, which is supposed to stimulate bone growth. While critics have said the product has several side effects, including male sterility, company-sponsored researchers have blamed problems on surgeons, not on the products.
Medtronic's plan to pay Yale to evaluate its own product raises its own questions about conflict of interest.
"The financial arrangement, de facto, certainly creates a potential conflict of interest," Eugene J. Carragee, MD, editor-in-chief of The Spine Journal, and professor and vice-chairman of the Department of Orthopaedic Surgery at Stanford University School of Medicine, told HealthLeaders Media. "But the Yale group can put in certain safeguards to manage the risk of overt bias. I have no reservations about the integrity of the Yale group."
Although the Medtronic and Yale arrangement raises questions, there is widespread hope within academia and among physicians that Medtronic's decision to open for public review heretofore secretive results of clinical trials may have lasting, and positive consequences.