A biologic without guidelines: The YODA project and the future of bone morphogenetic protein-2 research

Spine Journal

Volumn 12, Issue 10, 2012, Pages 877-880

  Carragee, Eugene J ^a   Baker, Ray M ^b   Benzel, Edward C ^c   Bigos, Stanley J ^d   Cheng, Ivan ^a   Corbin, Terry P ^e   Deyo, Richard A ^f   Hurwitz, Eric L ^g   Jarvik, Jeffrey G ^h   Kang, James D ⁱ   Lurie, Jon D ^j   Mroz, Thomas E ^c   Öner, F Cumhur ^k   Peul, Wilco C ^l   Rainville, James ^m   Ratliff, John K ^a   Rihn, Jeffrey A ⁿ   Rothman, David J ^o   Schoene, Mark L ^p   Spengler, Dan M ^q   Weiner, Bradley K ^r   more..

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Evergreen Health Kirkland   (United States)

^c LERNER RESEARCH INSTITUTE   (United States)

^d Del Mar ^*  (United States)

^e Minnesota Shared Decision Making Collaborative   (United States)

^f OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^g UNIVERSITY OF HAWAII   (United States)

^h UNIVERSITY OF WASHINGTON MEDICAL CENTER   (United States)

ⁱ UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

^j DARTMOUTH INSTITUTE FOR HEALTH POLICY AND CLINICAL PRACTICE   (United States)

^k UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^l LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^m NEW ENGLAND BAPTIST HOSPITAL   (United States)

ⁿ THOMAS JEFFERSON UNIVERSITY HOSPITAL   (United States)

^o Stanford University School of Medicine ^*  (United States)

^p BackLetter   (United States)

^q VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^r HOUSTON METHODIST HOSPITAL   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT BONE MORPHOGENETIC PROTEIN 2;

BACKACHE; BONE DISEASE; BONE TRANSPLANTATION; CANCER RISK; CERVICAL SPINE; COMORBIDITY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FOOD AND DRUG ADMINISTRATION; HUMAN; INFLAMMATION; LEG PAIN; METHODOLOGY; OSTEOLYSIS; PRIORITY JOURNAL; RADICULITIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK ASSESSMENT; SIDE EFFECT; SPINAL GANGLION; SPINE FUSION; SPINE SURGERY; SURGICAL TECHNIQUE; SYSTEMATIC REVIEW (TOPIC); TRACHEA; URINE RETENTION;

EID: 84870289086     PISSN: 15299430     EISSN: 18781632     Source Type: Journal    
DOI: 10.1016/j.spinee.2012.11.002     Document Type: Editorial

References (17)

1. J. Even, M. Eskander, and J. Kang Bone morphogenetic protein in spine surgery: current and future uses J Am Acad Orthop Surg 20 2012 547 552
2. D.K. Riew, and E.J. Carragee Commentary: despite reports of catastrophic complications, why recombinant human bone morphogenetic protein-2 should be available for use in anterior cervical spine surgery Spine J 12 2012 900 901
3. United States Food and Drug Administration, Department of Health and Human Services, Center for Devices and Radiological Health. Medical Devices/Premarket Approval (PMA). InFUSE- Bone Graft/LT-CAGE- Lumbar Tapered Fusion DevicesdP000058. Available at: http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cftopic/pma/pma.cfm?num5P000058. Accessed November 18, 2012.
4. Medtronic. Medtronic engages Yale University to oversee independent, systematic reviews of recombinant bone morphogenic protein-2 [press release]. Aug 3, 2011. Available at: http://wwwp.medtronic.com/Newsroom/ NewsReleaseDetails.do?itemId=1312401868058&lang=en-US. Accessed November 18, 2012.
5. Krumholz HM, Gross CP, Ross JS, et al. Yale University Open Data Access (YODA) Project. Available at: http://medicine.yale.edu/core/projects/yodap/ index.aspx. Accessed November 18, 2012.
6. E.J. Carragee, A.J. Ghanayem, and B.K. Weiner A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors Spine J 11 2011 463 468
7. E.J. Carragee, E.L. Hurwitz, and B.K. Weiner A critical review of rhBMP-2 trials in spinal surgery: emerging safety concerns and lessons learned Spine J 11 2011 471 491
8. T.E. Mroz, J.C. Wang, R. Hashimoto, and D.C. Norvell Complications related to osteobiologics use in spine surgery: a systematic review Spine 35 9 suppl 2010 S86 S104
9. N.E. Epstein Pros, cons and costs of INFUSE in spinal surgery Surg Neurol Int 2 2011 10
10. T. Zdeblick Science please! Spine J 11 2011 686
11. J.R. Dimar 2nd, S.D. Glassman, and J.K. Burkus Reply to "A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned Spine J 11 2011 1082 1083
12. S.D. Boden The ABCs of BMPs Orthop Nurs 24 2005 49 52
13. J.R. Dimar, S.D. Glassman, and J.K. Burkus Clinical and radiographic analysis of an optimized rhBMP-2 formulation in an autograft replacement in posterolateral lumbar spine arthrodesis J Bone Joint Surg Am 91 2009 1377 1386
14. United States Food and Drug Administration. Food and Drug Administration. Executive Summary for P050036 Medtronic's AMPLIFY-rhBMP-2 Matrix Orthopaedic and Rehabilitation Devices Advisory Panel. June 2010. Available at: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/ medicaldevices/medicaldevicesadvisorycommittee/ orthopaedicandrehabilitationdevicespanel/ucm220081.pdf.
15. E.J. Carragee, E.L. Hurwitz, and B.K. Weiner Carragee el al respond (Reply to Dimar et al). Spine J 11 2011 1083 1086
16. E.J. Carragee, E.L. Hurwitz, and B.K. Weiner Authors' and editors' combined respons to Zdeblick letter Spine J 11 2011 687 690
17. R.H. Gelberman, D. Samson, and S.K. Mirza Orthopaedic surgeons and the medical device industry: the threat to scientific integrity and the public trust J Bone Joint Surg Am 92 2010 765 777