INFUSE Review Leads To Discussion And Some Discord At NASS

Article preview from IN VIVO - November  12, 2013

Medtronic’s subdued showing at NASS in October revealed the sometimes rocky relationship among industry, clinicians, and academia:  The Yale University Open Data Access Project suggested rhBMP-2 didn’t fuse bone any better than standard-iliac crest bone graft, yet Medtronic executives found some vindication in the process, saying it supported on-label use of BMP, and suggested the Yale University-led process could be a model to settle future controversies in the medical industry.

INFUSE Review Leads To Discussion And Some Discord At NASS

Article preview from IN VIVO - November  12, 2013

Medtronic Inc.’s exhibit at the North American Spine Society (NASS) 28th Annual Meeting in October was a gap in the otherwise toothy bright smile on the technical floor. The company chose to set up only a few modest tables, a couch, and a booth, providing a stark contrast to the other exhibits on the floor, but that was the point. Medtronic executives sent a message. They were disappointed with the tone of the conference’s discussions regarding recombinant human bone morphogenetic protein-2 (rhBMP-2), the key ingredient in Medtronic’s INFUSE bone graft. The company kept its sales people away from the booth, making only medical affairs personnel available to answer clinical question from doctors. (See "Medtronic “Repurposes” Spine Convention Booth To Tell Its Side of BMP Story" — IN VIVO, October 2013.)

Medtronic’s subdued showing revealed the sometimes rocky relationship among industry, clinicians, and academia. Just a few months earlier, Medtronic stood side by side with researchers taking part in Yale University’s Center for Outcomes Research & Evaluation’s Yale University Open Data Access (YODA) Project, an independent evaluation model for clinical trials. The YODA analysis suggested rhBMP-2 didn’t fuse bone any better than standard – iliac crest bone graft. (See"No Advantage For Medtronic’s InFuse Versus Bone Graft In Spine Fusion" — "The Gray Sheet," Jun. 24, 2013.) Still, Medtronic executives found some vindication in the process, saying it supported on-label use of BMP, and suggested the Yale University-led process could be a model to settle future controversies in the medical industry.

According to a panel of researchers, physicians, and journal editors speaking at the NASS conference in New Orleans, the YODA study of INFUSE could serve as a model in efforts to verify the accuracy and influences of industry-led clinical research. The panel used the INFUSE controversy as a study focus to make the case that a new day is dawning for clinical research in orthopedics. Companies are beginning to see the value in opening their clinical trials to trusted academic partners that can help make data more available. (Yale, in fact, is close to signing up a second company for a YODA-like effort.) At the same time, non-medical advances such as electronic medical records and individual medical device identification tags will make it easier to track the performance of devices and procedures.

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