The Spine Journal, the official publication of the North American Spine Society, has published a series of articles alleging that side-effects were downplayed or omitted in scientific articles about a Medtronic product used in spine surgery. The June issue of the journal focuses on the limitations of industry-sponsored research. It is also mooting transparency initiatives to protect the integrity of scientific publishing.
The latest issue is dedicated to a review of recombinant bone morphogenetic protein-2 (rhBMP-2), a controversial synthetic bone growth product often used in spine fusion surgeries. Early industry-sponsored clinical research on rhBMP-2, published in a variety of orthopaedic and spine-related medical journals, reported no adverse events or complications in hundreds of patients. However, in recent years, the use of rhBMP-2 has been associated with various early inflammatory reactions, cancer, osteolysis, infection, implant dislodgement and occasional life-threatening complications. A separate study also in the June issue of the Spine Journal suggests that rhBMP-2 usage could cause a higher incidence of male sterility than previously described by industry-sponsored researchers.
After reviewing the findings and articles in this special issue, a blue-ribbon panel of spine experts wrote an editorial titled 'A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors.'
Prompted by complaints to journal editors and media reports of questionable research and publishing practices, a review was conducted for the article titled 'A critical review of rhBMP-2 trials in spinal surgery: emerging safety concerns and lessons learned.' This comprehensive review of the 13 original industry-sponsored rhBMP-2 studies found that authors - many with financial ties to the sponsor - reported 10-50 times fewer complications with rhBMP-2 than were found in the original FDA summaries or other documents. The review was led by Eugene J. Carragee, MD of the Stanford University School of Medicine, Redwood City, CA and the editor-in-chief of the Spine Journal.
To access our daily STM news feed through your iPhone, iPad, or other smartphones, please visit www.myscoope.com for a mobile friendly reading experience.
