The financial ties between clinical researchers who conducted studies on a product used in spine surgery and the manufacturer of the product have come under fire, raising questions about the integrity of this industry-sponsored research. (Image: JAMA, ©AMA)
The editorial is part of a special issue of the journal that focuses on a product containing synthetic bone growth factor, recombinant bone morphogenetic protein-2 (rhBMP-2), manufactured by Medtronic under the name Infuse Bone Graft. The product is intended to allow surgeons to bypass harvesting bone graft material directly from their patients.
In another section of the special issue, a review article assessed published reports of 13 original industry-sponsored studies of safety and efficacy of rhBMP-2 in 780 patients. In these studies, the researchers reported no adverse events such as unintended bone growth. But the authors of the review, using US Food and Drug Administration data summaries, follow-up publications, and analyses from administrative and organizational databases, estimate that 10% to 50% of patients should have experienced an adverse event, including life-threatening events. The authors also said that as of March 2011, Medtronic had paid the clinical investigators of the 13 studies amounts ranging from $560 000 to $23.5 million per study.
The special issue comes 1 week after Senate Finance Committee Chairman Max Baucus (D, Mont) and senior committee member Chuck Grassley (R, Iowa) sent a letter to Medtronic asking for documentation of conversations with medical journals about adverse events or medical complications related to rhBMP-2 and for a detailed account of payments made to all clinical investigators.
In the editorial, the editor of The Spine Journal, Eugene J. Carragee, MD, of the Stanford University School of Medicine and colleagues wrote that the “choirboy defense”—the belief that theirs is an honest profession with unimpeachable integrity and the highest ethical standards—can no longer apply to researchers in the spine community. “It harms patients to have biased and corrupted research published,” they wrote. “It harms patients to have unaccountable special interests permeate medical research. It harms patients when poor publication practices become business as usual.”
