A review of the current published spinal literature regarding bone morphogenetic protein-2: an insight into potential bias.

Abstract

Recombinant human bone morphogenetic protein-2 (rhBMP-2) is a potent biologic agent that carries both osteoinductive and osteoconductive properties. Its potential as an autologous bone graft substitute in spine surgery led to its approval by the United States Food and Drug Administration (FDA) in 2002 following a series of industry-sponsored trials. Although approved for a single level anterior lumbar interbody fusion from L4-S1 with a proprietary cage, the off-label use of rhBMP-2 rapidly escalated. Soon thereafter, reports of serious and potentially life-threatening complications associated with rhBMP-2 began emerging, which sparked concerns with regards to potential bias in the original FDA trials. Ultimately, an independent review of all published and unpublished data on the safety and effectiveness of rhBMP-2 by the Yale University Open Data Access (YODA) Project determined that while rhBMP-2 is as effective as iliac crest bone graft (ICBG) in potentiating spinal fusion, there was significant bias and conflicts of interests that resulted in an underreporting of complications in the original industry-sponsored trials.