A challenge to integrity in spine publications: Years of living dangerously with the promotion of bone growth factors

Spine Journal

Volumn 11, Issue 6, 2011, Pages 463-468

  Carragee, Eugene J ^a   Ghanayem, Alexander J ^b   Weiner, Bradley K ^c   Rothman, David J ^d   Bono, Christopher M ^e  

^a STANFORD UNIVERSITY   (United States)

^b LOYOLA UNIVERSITY CHICAGO   (United States)

^c HOUSTON METHODIST HOSPITAL   (United States)

^d College of Physicians and Surgeons ^*  (United States)

^e BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT BONE MORPHOGENETIC PROTEIN 2;

BONE GROWTH; CLINICAL TRIAL; DRUG DELIVERY SYSTEM; FOOD AND DRUG ADMINISTRATION; GLUTEAL PAIN; HUMAN; NEUROPATHIC PAIN; OSTEOLYSIS; PAIN; PRIORITY JOURNAL; PUBLICATION; RETROGRADE EJACULATION; REVIEW; SPINE;

EID: 79960025044     PISSN: 15299430     EISSN: 18781632     Source Type: Journal    
DOI: 10.1016/j.spinee.2011.06.001     Document Type: Editorial

References (50)

1. J.K. Burkus, E.E. Transfeldt, and S.H. Kitchel Clinical and radiographic outcomes of anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2 Spine 27 2002 2396 2408 (Pubitemid 35266228)
2. S.D. Boden, J. Kang, H. Sandhu, and J.G. Heller Use of recombinant human bone morphogenetic protein-2 to achieve posterolateral lumbar spine fusion in humans: a prospective, randomized clinical pilot trial: 2002 Volvo Award in clinical studies Spine 27 2002 2662 2673 (Pubitemid 35425320)
3. D.S. Baskin, P. Ryan, and V. Sonntag A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate Spine 28 2003 1219 1224 discussion 1225 (Pubitemid 36734609)
4. J.K. Burkus Bone morphogenetic proteins in anterior lumbar interbody fusion: old techniques and new technologies. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004 J Neurosurg Spine 1 2004 254 260
5. R.W. Haid, C.L. Branch, J.T. Alexander, and J.K. Burkus Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages Spine J 4 2004 527 538 discussion 538-9 (Pubitemid 40029169)
6. M. Boakye, P.V. Mummaneni, and M. Garrett Anterior cervical discectomy and fusion involving a polyetheretherketone spacer and bone morphogenetic protein J Neurosurg Spine 2 2005 521 525
7. J.R. Dimar, S.D. Glassman, and J.K. Burkus Clinical and radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral lumbar spine arthrodesis J Bone Joint Surg Am 91 2009 1377 1386
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. K.S. Cahill, J.H. Chi, A. Day, and E.B. Claus Prevalence, complications, and hospital charges associated with use of bone-morphogenetic proteins in spinal fusion procedures JAMA 302 2009 58 66
10. T. Smoljanovic, I. Bojanic, and M. Pecina The use of bone morphogenetic protein in lumbar spine surgery J Bone Joint Surg Am 91 2009 2045 2046
11. T. Smoljanovic, I. Bojanic, and Z. Vlahovic Safety of posterior interbody fusions of the lumbar spine using rhBMP-2 J Spinal Disord Tech 23 2010 78
12. L.M. Tumialán, and G.E. Rodts Adverse swelling associated with use of rh-BMP-2 in anterior cervical discectomy and fusion Spine J 7 2007 509 510
13. B.J. Williams, J.S. Smith, and K.-M. Fu Complications associated with BMP use in 11,933 cases of spinal fusion Spine J 10 9 Suppl 1 2010 S98 S99
14. US Food and Drug Administration US Food and Drug Administration Public Health Notification. Life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion 2008 US Food and Drug Administration Available at: http://www.fda.gov/cdrh/safety/070108-rhbmp.html Accessed June 1, 2011
15. 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
16. J.K. Burkus, M.F. Gornet, and T.C. Schuler RE: Six-year outcomes of anterior lumbar interbody arthrodesis with use of interbody fusion cages and recombinant human bone morphogenetic protein-2 J Bone Joint Surg Am 92 2010 2615 2616 [Letter]
17. J.R. Dimar, S.D. Glassman, K.J. Burkus, and L.Y. Carreon 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 31 2006 2534 2539 discussion 2540 (Pubitemid 44632234)
18. Food and Drug Administration Food and Drug Administration Executive Summary for P050036 Medtronic's AMPLIFY™ rhBMP-2 Matrix Orthopaedic and Rehabilitation Devices Advisory Panel Available at: http://www.fda.gov/ downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/ MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ P050036 2010 Accessed July 9, 2011
19. United States Food and Drug Administration, Department of Health and Human Services, Center for Devices and Radiological Health InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Devices - P000058 Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num= P000058 2002 Accessed January 20, 2011
20. J.K. Burkus, M.F. Gornet, C.A. Dickman, and T.A. Zdeblick Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages J Spinal Disord Tech 15 2002 337 349
21. J.K. Burkus, S.E. Heim, M.F. Gornet, and T.A. Zdeblick Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device J Spinal Disord Tech 16 2003 113 122
22. D. Armstrong Medtronic product linked to surgery problems Wall Street J 2008 Available at: http://www.memphisdailynews.com/editorial/Article.aspx?id= 38479 Accessed February 18, 2011
23. D. Armstrong, and T. Burton Medtronic says device for spine faces probe Wall Street J November 19, 2008
24. D. Armstrong, and T. Burton Medtronic paid the surgeon accused of falsifying study nearly $800,000 Wall Street J June 18, 2009
25. T.M. Burton Medtronic voluntarily discloses doctor pay Available at: http://online.wsj.com/article/SB10001424052748703957604575272881380685238.html 2010 Accessed January 18, 2011
26. Carreyrou J, McGinty T. Top spine surgeons reap royalties, Medicare Bounty. December 20, 2010. Available at: http://online.wsj.com/article/ SB10001424052748703395204576024023361023138.html?mod=WSJ-business-whatsNews; 2010. Accessed January 19, 2011.
27. J. Fauber Journal articles written by doctors with financial stakes in product questioned Milwaukee J Sentinel January 04, 2011 Available at: http://www.inhealth.org/wtn/Page.asp?PageID=WTN002283 Accessed June 15, 2011
28. J. Fauber Doctors question journal articles: Medtronic paid surgeons millions for other products Milwaukee Wiscosin J Sentinel 2010 Available at: http://www.jsonline.com/watchdog/watchdogreports/112487909.html Accessed January 23, 2011
29. J. Fauber Investigation links sterility to bone growth product Milwaukee Journal Sentinel/Medpage Today 2011 Available at: http://www.medpagetoday.com/ special-reports/SpecialReports/26677 Accessed June 17, 2011
30. B. Meier, and D. Wilson Medtronic bone product faces pressure from U.S. The New York Times 2011 Available at: http://www.nytimes.com/2011/04/12/ business/12device.html?-r=1&ref=medtronicinc Accessed April 22, 2011
31. B. Meier, and D. Wilson Medtronic's Infuse can make men sterile, study says The New York Times 2011 Available at: http://www.nytimes.com/2011/05/25/ business/25spine.html?-r=1&ref=barrymeier Accessed May 31, 2011
32. L. Richwine FDA staff: cancer a concern with Medtronic device Reuters 2010 Available at: http://www.reuters.com/article/2010/07/23/us-medtronic-spine- idUSTRE66M2U820100723 Accessed April 22, 2011
33. E. Walker Not enough evidence to use BMP off-label, panel says Medpage Today 2010
34. C. Grassley Letter to President, University of Wisconsin Available at: http://policymed.typepad.com/files/grassley-letter-to-university-of-wisconsin- january-12 - 2009.pdf 2009 Accessed February 20, 2011
35. J. Fauber Complication from spinal product omitted from articles: co-authors received royalties from manufacturer Milwaukee J Sentinel 2011 Available at: http://www.jsonline.com/features/health/122553058.html Accessed June 16, 2011
36. J. Fauber Journal editor gets royalties as articles favor devices Milwaukee J Sentinel 2009 Available at: http://www.jsonline.com/watchdog/ watchdogreports/80036277.html Accessed June 17, 2011
37. T.R. Kuklo, A.T. Groth, and R.C. Anderson Recombinant human bone morphogenetic protein-2 for grade III open segmental tibial fractures from combat injuries in Iraq J Bone Joint Surg Br 90 2008 1068 1072
38. J. Scott Withdrawal of a paper J Bone Joint Surg Br 91 2009 285 286
39. D. Armstrong, and T.M. Burton Spine surgeon didn't disclose Medtronic pay in testimony Wall Street J 2009 Available at: http://grassley.senate.gov/ upload/JULY-29-WSJ-article.pdf Accessed June 17, 2011
40. J.C. Dooren Medtronic spine device draws concern Available at: http://online.wsj.com/article/SB10001424052748703294904575385271544234334.html 2010 Accessed February 13, 2011
41. J. Goldstein The "Tootsie Roll" recipe: biotech managers charged with fraud Wall Street J 2009
42. 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
43. M. Roseman, K. Milette, and L.A. Bero Reporting of conflicts of interest in meta-analyses of trials of pharmacological treatments JAMA 305 2011 1008 1017
44. S.D. Glassman, J.R. Dimar, and K. Burkus The efficacy of rhBMP-2 for posterolateral lumbar fusion in smokers Spine 32 2007 1693 1698 (Pubitemid 47051857)
45. M. Angell Industry-sponsored clinical research: a broken system JAMA 300 2008 1069 1071
46. S.K. Mirza Folly of FDA-approval studies for bone morphogenetic protein Spine J 11 2011 495 499
47. R.V. Shah, T.J. Albert, and V. Bruegel-Sanchez Industry support and correlation to study outcome for papers published in Spine Spine 30 2005 1099 1104 discussion 1105 (Pubitemid 40663920)
48. R. Smith Medical journals are an extension of the marketing arm of pharmaceutical companies PLoS Med 2 2005 e138
49. D.M. Spengler Resetting standards for sponsored research: do conflicts influence results? Spine J 11 2011 492 494
50. E.J. Carragee, K.A. Mitsunaga, E.L. Hurwitz, and G.J. Scuderi Retrograde ejaculation after anterior lumbar interbody fusion using rhBMP-2: a cohort controlled study Spine J 11 2011 511 516