Reply to “A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned”

Abstract

We appreciate the effort that it took to review and analyze 13 studies on recombinant human bone morphogenetic protein-2 (rhBMP-2) [ [1] Carragee E.J. Hurwitz E.L. Weiner B.K. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Spine J. 2011; 11: 471-491 Abstract Full Text Full Text PDF PubMed Scopus (1069) Google Scholar ] and understand that given this undertaking oversights and errors may occur. However, in an article that alleges intentional bias in the reporting of Food and Drug Administration (FDA) trials, it seems fair to expect scrupulous attention to factual detail. Thus, we would like to clarify several points regarding two articles [ 2 Dimar J.R. Glassman S.D. Burkus J.K. et al. Clinical and radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral lumbar spine arthrodesis. J Bone Joint Surg Am. 2009; 91: 1377-1386 Crossref PubMed Scopus (170) Google Scholar , 3 Dimar J.R. Glassman S.D. Burkus K.J. Carreon L.Y. Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/compression resistant matrix versus iliac crest bone graft. Spine. 2006; 31 (discussion 2540): 2534-2539 Crossref PubMed Scopus (258) Google Scholar ] that were cited in your article, “A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned” [ [1] Carragee E.J. Hurwitz E.L. Weiner B.K. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Spine J. 2011; 11: 471-491 Abstract Full Text Full Text PDF PubMed Scopus (1069) Google Scholar ]. We have reviewed data from the AMPLIFY FDA Investigational Device Exemption study, the two published articles [ 2 Dimar J.R. Glassman S.D. Burkus J.K. et al. Clinical and radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral lumbar spine arthrodesis. J Bone Joint Surg Am. 2009; 91: 1377-1386 Crossref PubMed Scopus (170) Google Scholar , 3 Dimar J.R. Glassman S.D. Burkus K.J. Carreon L.Y. Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/compression resistant matrix versus iliac crest bone graft. Spine. 2006; 31 (discussion 2540): 2534-2539 Crossref PubMed Scopus (258) Google Scholar ], and the FDA Executive Summary [ [4] Food and Drug Adminstration. Food and Drug Administration Executive Summary for P050036Medtronic’s AMPLIFY_ RhBMP-2 Matrix Orthopaedic and Rehabilitation Devices Advisory Panel. 2010. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM220079.pdf. Accessed July 9, 2011. Google Scholar ] that was cited. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learnedThe Spine JournalVol. 11Issue 6PreviewIncreasingly, reports of frequent and occasionally catastrophic complications associated with use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion surgeries are being published. In the original peer review, industry-sponsored publications describing the use of rhBMP-2 in spinal fusion, adverse events of these types and frequency were either not reported at all or not reported to be associated with rhBMP-2 use. Some authors and investigators have suggested that these discrepancies were related to inadequate peer review and editorial oversight. Full-Text PDF Carragee et al respondThe Spine JournalVol. 11Issue 11PreviewWe welcome the comments of Dr Dimar et al. regarding our review of recombinant human bone morphogenetic protein-2 (rhBMP-2) trials and safety [1]. Open dialogue and critical review are vital to ensuring that the best possible evidence base can be used as the foundation for patient care. Full-Text PDF