Infuse controversy:
If you have missed the blowup in the popular press about this topic, I have included a sampling of links for you to peruse. You can also just Google “spine journal” related to “news” and get many of the same links. This makes fascinating reading at multiple levels…FDA approval process, editorial process, conflict of interest management… to name a few. After the popular press hyperlinks, I have included the salient articles from the special issue of the Spine Journal. Do not miss the letter from Dr. Zdeblick and the accompanying response from the Editors of the Spine Journal. The level of vitriol is unprecedented in my experience.
Popular press:
http://www.nytimes.com/2011/06/29/business/29spine.html?_r=2&ref=research
http://www.startribune.com/business/125228219.html
Spine Journal articles: (the North American Spine Society press release can be found at http://www.spine.org/Pages/ConsumerHealth/NewsAndPublicRelations/
NewsReleases/2011/pressrelease1_062811.aspx)
Carragee, E. J., Ghanayem, A. J., Weiner, B. K., Rothman, D. J., & Bono, C. M. (2011). A challenge to integrity in spine publications : years of living dangerously with the promotion of bone growth factors. The Spine Journal, 11(6), 463-468. Elsevier Inc. doi: 10.1016/j.spinee.2011.06.001.
Carragee, E. J., Hurwitz, E. L., & Weiner, B. K. (2011). A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery : emerging safety concerns and lessons learned. The Spine Journal, 11(6), 471-491. Elsevier Inc. doi: 10.1016/j.spinee.2011.04.023.
Carragee, E. J., Mitsunaga, K. a, Hurwitz, E. L., & Scuderi, G. J. (2011). Retrograde ejaculation after anterior lumbar interbody fusion using rhBMP-2: a cohort controlled study. The Spine Journal : official journal of the North American Spine Society, 11(6), 511-516. Elsevier Inc. doi: 10.1016/j.spinee.2011.02.013.
Kang, J. D. (2011). Commentary: Another complication associated with rhBMP-2? The Spine Journal: official journal of the North American Spine Society, 11(6), 517-519. Elsevier Inc. doi: 10.1016/j.spinee.2011.03.022.
Mirza, S. K. (2011). Commentary : Folly of FDA-approval studies for bone morphogenetic protein. The Spine Journal, 11(6), 495-499. Elsevier Inc. doi: 10.1016/j.spinee.2011.05.009.
Spengler, D. M. (2011). Commentary: Resetting standards for sponsored research: do conflicts influence results? The Spine Journal, 11(6), 492-494. Elsevier Inc. doi: 10.1016/j.spinee.2011.05.001.
*Zdeblick, T. A. (2011). Science please. The Spine Journal. doi: 10.1016/j.spinee.2011.06.005. These letters are difficult to find on the website, so here is the more direct link: http://www.spine.org/Documents/TSJ_LettertoEditor_AuthorsReply.pdf
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