An unusual study led by a Stanford scientist found that a bone growth protein widely used in spinal fusion surgeries - and repeatedly declared safe by industry-sponsored research - in fact may cause a variety of complications, some permanent or even life threatening.
The study, and several related papers published in Tuesday's issue of the Spine Journal, called into question the validity of years of research that was paid for largely by the manufacturer of the protein and the device that delivers it to the spine, reports San Francisco Chronicle.
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, informs MedPage Today.