Study Design Bias Suspected in Industry Trials on rhBMP-2

FDA shows high adverse event rates with recombinant human bone morphogenetic protein-2

FRIDAY, July 15 (HealthDay News) -- U.S. Food and Drug Administration documents and subsequent publications show that recombinant human bone morphogenetic protein-2 (rhBMP-2) is associated with a 10 to 50 percent higher rate of adverse events (AE) than reported in original industry-based trials, according to a review published in the June issue of The Spine Journal.

Eugene J. Carragee, M.D., from the Stanford University School of Medicine in Redwood City, Calif., and colleagues compared the safety and related efficacy data on rhBMP-2, published in 13 original industry-sponsored publications involving 780 patients, with that of available FDA data summaries, follow-up publications, and administrative and organizational databases.

The investigators identified no AEs in industry-sponsored publications, with a potential methodological bias against the control group. The FDA documents and subsequent publications revealed a 10 to 50 percent increase in AEs. Use of rhBMP-2 in anterior cervical fusion was associated with a 40 percent increase in AE risk, including life-threatening events. Rates of implant displacement, subsidence, infection, urogenital events, and retrograde ejaculation were increased after anterior interbody lumbar fusion with rhBMP-2 use compared to controls. Use of rhBMP-2 in posterior lumbar interbody fusion correlated with radiculitis, ectopic bone formation, osteolysis, and poorer global outcomes. The risk of AEs associated with rhBMP-2 use in posterolateral fusions was equivalent to or greater than that of iliac crest bone graft harvesting, with 15 to 20 percent of individuals reporting leg pain and early back pain. Higher rhBMP-2 doses correlated with an increased apparent risk of new malignancy.

"Studies suggest possible study design bias in the original trials, as well as a clear increased risk of complications and adverse events to patients receiving rhBMP-2 in spinal fusion," the authors write.

One of the study authors disclosed financial ties to the medical device and health care industries.

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