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

  • Spine: BMP (K Singh, Section Editor)
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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 Ultimately, an independent review of all published and unpublished data on the safety and effectiveness of rhBMP-2 by the Yale University Open Data Access (YODA) Project determined that while rhBMP-2 is as effective as iliac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.

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Acknowledgments

Sheeraz A. Qureshi has received grant support from the Cervical Spine Research Society.

Compliance with Ethics Guidelines

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Conflict of Interest

Branko Skovrlj, Alejandro Marquez-Lara, and Javier Z. Guzman declare that they have no conflict of interest.

Sheeraz A. Qureshi has board membership with MTF, Zimmer SAB, Orthofix SAB, and Pioneer DSM, and has been a consultant for Orthofix; Medtronic; Stryker; and Zimmer.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

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Authors and Affiliations

  1. Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA

    Branko Skovrlj

  2. Department of Orthopaedics, Rush University Medical Center, Chicago, IL, USA

    Alejandro Marquez-Lara

  3. Department of Orthopaedics, Mount Sinai School of Medicine, 5 East 98th Street, Box 1188, New York, NY, USA

    Javier Z. Guzman & Sheeraz A. Qureshi

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  1. Branko Skovrlj
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  2. Alejandro Marquez-Lara
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  3. Javier Z. Guzman
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  4. Sheeraz A. Qureshi
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Correspondence to Sheeraz A. Qureshi.

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Skovrlj, B., Marquez-Lara, A., Guzman, J.Z. et al. A review of the current published spinal literature regarding bone morphogenetic protein-2: an insight into potential bias. Curr Rev Musculoskelet Med 7, 182–188 (2014). https://doi.org/10.1007/s12178-014-9221-3

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  • DOI: https://doi.org/10.1007/s12178-014-9221-3

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