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

Abstract

Because of the study design flaws and other limitations that Carragee et al. [ [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 ] have described in their critical review of recombinant human bone morphogenetic protein 2 trials in spinal surgery, the authors state that adverse experiences attributable to the product were underestimated, and that the risk of adverse events may be as high as 50 times that reported in industry-funded publications. This point cannot be overemphasized, and it is critical for the spine community to understand and appreciate this daunting possibility. 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 8PreviewWe thank Dr Woo for her important comments. In fact, the concerns of Dr Woo speak directly to the serious confusion caused by Drs Burkus's [1] and Zdeblick's correspondences [2] and articles [3–5] that categorically, but erroneously, claimed that their data demonstrated “there is no relationship between the use of rhBMP-2 in stand-alone interbody fusion cages and the postoperative development of retrograde ejaculation.” Full-Text PDF