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Doctors failed to reveal serious complications of back surgery product, reports Spine Journal
Milwaukee Journal-Sentinel/Medpage Today
Doctors who received millions of dollars from Medtronic systematically failed to reveal serious complications linked to the company’s lucrative back surgery product, Infuse, in 13 papers they co-authored for medical journals over the course of nearly a decade, according to a scathing new review.
The analysis is part of an unprecedented event in medicine: The entire issue of a medical journal devoted to a scientific and financial expose of a product, the practices of the company that markets it, and the financially conflicted doctors who tested and promoted it.
Blame also is heaped on the lax oversight of the Food and Drug Administration and failures by editors and reviewers of medical journals.
The main analysis, which was led by editors of The Spine Journal, found a systematic failure to report serious complications with Infuse, bone morphogenetic protein-2 or BMP-2, which is used in spinal fusion surgery. The researchers found complication rates that were 10 to 50 times greater than the estimated complication rates revealed in the medical literature.
The 13 papers reviewed in The Spine Journal were co-authored by doctors who received a median of at least $12 million to $16 million per study from Medtronic, the journal reported.
In each study, those conflicts of interest were either not reported or were unclear, the article said.
The analyses in the current issue of The Spine Journal come close on the heels of studies linking Infuse to retrograde ejaculation, a cause of infertility. The Spine Journal editors published those studies late last month.
