A critical review of 13 industry-sponsored studies on recombinant bone morphogentic protein-2 found that the actual risk of adverse events was 10-15 times higher than the study estimates originally reported, according to a release from the North American Spine Society.
According to the report, published NASS' The Spine Journal, rhBMP-2 was associated with infection, sterility and cancer risks, which were prominently discussed in the FDA documents and hearings on the trials when they were released. However, the published versions of the same trials lacked discussion of the clinical adverse events related to the product in used in nearly 800 patients. The adverse events include back and leg pain, cyst formation, disc space collapse, infection, retrograde ejaculation, implant displacement and malignancy.
The review found unreported conflicts of interest in each study, study design bias against common alternatives for spinal fusion and invalid claims about the risks associated with using bone harvested from the iliac crest for fusion. While the disclosure documentation was limited, the authors of the 13 studies had financial associates with the product maker ranging from $12 to $16 million per study.
"Medical professionals must be able to rely on the integrity of peer-reviewed literature to keep them informed of the safety and efficacy of treatments and medicine for the benefit of their patients," said Eugene Carragee, MD, of the Stanford University School of Medicine and editor of The Spine Journal, in the release. "Medical journals have an obligation to be watchdogs, not rubber stamps. We must have greater author and editor transparency and ask the hard questions every step of the way."
Read the release about BMPs.
Related Articles on rhBMP-2:
NASS: BMP Use in Spinal Fusion May Cause Male Infertility
Medicare Advisory Committee Votes Against Off-Label BMP Use
Senate Investigates Medtronic's Influence Over Surgeons Studying Infuse
According to the report, published NASS' The Spine Journal, rhBMP-2 was associated with infection, sterility and cancer risks, which were prominently discussed in the FDA documents and hearings on the trials when they were released. However, the published versions of the same trials lacked discussion of the clinical adverse events related to the product in used in nearly 800 patients. The adverse events include back and leg pain, cyst formation, disc space collapse, infection, retrograde ejaculation, implant displacement and malignancy.
The review found unreported conflicts of interest in each study, study design bias against common alternatives for spinal fusion and invalid claims about the risks associated with using bone harvested from the iliac crest for fusion. While the disclosure documentation was limited, the authors of the 13 studies had financial associates with the product maker ranging from $12 to $16 million per study.
"Medical professionals must be able to rely on the integrity of peer-reviewed literature to keep them informed of the safety and efficacy of treatments and medicine for the benefit of their patients," said Eugene Carragee, MD, of the Stanford University School of Medicine and editor of The Spine Journal, in the release. "Medical journals have an obligation to be watchdogs, not rubber stamps. We must have greater author and editor transparency and ask the hard questions every step of the way."
Read the release about BMPs.
Related Articles on rhBMP-2:
NASS: BMP Use in Spinal Fusion May Cause Male Infertility
Medicare Advisory Committee Votes Against Off-Label BMP Use
Senate Investigates Medtronic's Influence Over Surgeons Studying Infuse