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Current Issue - March 2015, Volume 9, Issue No. 1

Official Journal of Malaysian Orthopaedic Association and ASEAN Orthopaedic Association

Conflicts of interest in orthopaedic surgery: The intertwining of orthopaedic surgery, peer review publications and corporate sponsorship

References

  1. Bernard Lo and Marilyn J Field. Editors, Committee on conflict of interest in medical research, education, and practice; Board on health science policy, Institute of Medicine USA 2009.
  2. Angell M. Is academic medicine for sale? New Eng. J Med 2000; 342(20): 1516-8.
  3. Deyo RA, Gray DT, Krenter W, Mirza S, Martin BI. United States trends in lumbar fusion for degenerative condition. Spine, 2005; 30(12): 1441-5.
  4. Martin BI, Mirza SK, Cromstock BA, Gray DT, Krenter W, Deyo RA. Are lumbar spine reoperation rates falling with greater use of fusion surgery and new surgical technology? Spine 2001; 32(19): 2119-26.
  5. Martin BI, Mirza SK, Cromstock BA, Gray DT, Krenter W, Deyo RA. Reoperation rates following lumbar spine surgery and the influence of spinal fusion procedures. Spine 2007; 32(30: 382-7.
  6. Deyo RA, Mirza SK, Martin BI, Krenter W, Goodman DC, Jarvik JG. Trends, Major medical complications, and charges associated with surgery for spinal stenosis in older adults. JAMA 2010; 303(13): 1259-65.
  7. Unneeded, risker spinal fusion on the rise. http://www.nbcnews.com/id/36197896/ns/healthhealth_ care/t/unneeded-riskierspinal-fusion-surgery-rise/#.UtPJh_QW0aA.
  8. Dmitriev AE, Lehman RA, Symes AJ. Bone morphogenetic protein-2 and spinal arthrodesis: the basic science perspective on protein interaction with the nervous system. The Spine Journal 2011; 11: 500-5.
  9. Heggeness MH. Commentary: Important considerations on bone morphogenetic protein-2 and neuroinflammation. The Spine Journal 2011; 11: 506.
  10. Poynton AR, Lane JM. Safety profile for clinical use of bone morphogenetic proteins in the spine. Spine 2002 Aug 15; 27 (16 suppl): 40-8.
  11. Carragee EJ, Hurwitz EL, Weiner BK. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. The Spine Journal 2011; 11: 471-91.
  12. Cahill KS, Chi JH, Day A, Claus EB. Prevalence, complications, and hospital charges associated with use of bone-morphogenetic proteins in spinal fusion procedures. JAMA 2009; 302: 58-66.
  13. Ong KL, Villarraga ML, Lau E, Carreon L Y, Kurtz SM, & Glassman S D. Off-label use of bone morphogenetic proteins in the United States using administrative data. Spine 2010; 35: 1794-800.
  14. Smoljanovic T, Cimic M, Bojanic I. Aggressive end plate decortication as a cause of osteolysis after rhBMP-2 use in cervical spine inter-body fusion. Spine J 2010; 10: 187-8.
  15. FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000.htm
  16. Vaiddya R, Weir R, Sethi A, Meisterling S, Hakeos W, Wybo CD. Interbody fusion with allograft and rhBMP-2 leads to consistent fusion but early subsidence. J Bone Joint Surg Br 2007; 89: 342-5.
  17. Carragee E, Wildstein M. A controlled trial of BMP and unilateral transpedicular Instrumentation in circumferential single or double level lumbar fusion. Spine J 2007; 7:8S-9S.
  18. United States Food and Drug Administration, Department of Health and Human Services, Centre for Devices and Radiological Health. InFUSE bone Graft/LT-CAGE? Lumbar tapered fusion Devices—P000058. 2002. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num5P000058.
  19. Haid RW, Branch CL, Alexander JT, Burkus JK. Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages. Spine J 2004; 4:527–38; discussion 538-9.
  20. Howard JM, Glassman SD, Carreon LY. Posterior iliac crest pain after posterolateral fusion with or without iliac crest graft harvest. The Spine Journal 2011; 11: 534-7.
  21. Staff Report on Medtronic’s Influence on InFuse Clinical Studies, Committee on Finance, United States Senate, October 2012. http://www.finance.senate.gov/imo/media/doc/Medtronic_Report1.pdf
  22. Bulstrode CJK, Murray DW, Carr AJ, Pynsent PB, Carter SR. Designer Hips. BMJ 1993; 306: 732-3.
  23. Neumann L, Freund KG, Sorenson KH. Long term results of Charnley total hip replacement: Review of 92 patients at 15 to 20 years. J Bone Joint Surg (Br) 1994; 76B: 245-51.
  24. Malchau H, Herberts P, Soderman P, Oden A. Prognosis of total hip replacement: Update and validation of results from the Swedish National Hip Arthroplasty Register 1979-1998 at http://www.mcminncentre.co.uk/pdf/update-validation-results-fromswedish-hiparthroplasty-registry.pdf.
  25. Sedrakyan A, Normand ST, Dabic S, Jacob S, Graves S, Marinac-Dabic D. Comparative assessment of implantable hip devices with different bearing surfaces: systemic appraisal of evidence. BMJ 2011; 343:d7434 doi:10.1136/bmj.d7434.
  26. Muirhead-Allwood SK. Lessons of a hip failure. BMJ 1998; 316(7132): 644.
  27. Thanner J, Freij-Larsson C, Karrholm J, Malchau H, Wessleu B. Evaluation of Boneloc. Chemical and mechanical properties and a randomized clinical study of 30 total hip arthroplasties. Acta Orthop Scand. 19955; 66: 207-14.
  28. Luites JW, Spruit M, Hellemondt GG, Horstmann WG, Valstar ER. Failure of the uncoated titanium ProxiLock femoral hip prosthesis. Clin Orthop Relat Res. 2006 Jul; 448: 79-86.
  29. Norton MR, Vhadra RK, Timperley AJ. The Johnson-Elloy (Accord) total knee replacement: Poor results at 8 to 12 years. Bone Joint Surg [Br] 2002; 84-B: 852-5.
  30. Gilbert RE, Carrothers AD, Gregory JJ, Oakley MJ. The St. Leger total knee replacement: a 10-year clinical and radiological assessment. Knee. 2009 Oct; 16(5): 322-5. doi: 10.1016/j.knee.2009.02.005.
  31. DePuy. DePuy ASR hip recall guide at http://www.depuy.com/countries list.
  32. Jones DA, Lucas HK, O'Driscoll M, Price CH, Wibberley B. Cobalt toxicity after McKee hip arthroplasty. J Bone Joint Surg Br. 1975 Aug; 57(3): 289-96.
  33. Ashford RU, Frasquet-Garcia A, De Boer P and Campbell P. Catastrophic failure associated with Wagner resurfacing prosthesis and the impact on subsequent revision. J Bone Joint Surg Br 2008 vol. 90-B no. SUPP I 10.
  34. Freeman MA, Swanson SA, Heath JC. Study of the wear particles produced from cobalt–chromium–molybdenum–manganese total joint replacement prostheses. Ann Rheum Dis 1969; 28(suppl): 29.
  35. Barceloux D. Cobalt. J Toxicol Clin Toxicol 1999; 37: 201-16.
  36. International Agency for Research on Cancer. IARC monographs supplement 7. 1990.
  37. Visuri T, Pukkala E, Paavlainen P, Pulkinen P, Risha E. Cancer risk after metal on metal and polyethylene on metal hip arthroplasty. Clin Orthop & Relat Res 1996; 329: S280-S289.
  38. Haynes DR, Boyle SJ, Rogers SP, Howie DW, Vernon-Roberts B. Variation in cytokines induced by particles from different prosthetic materials. Clin Orthop 1998; 352: 223-30.
  39. Cohen D. How safe are metal on metal implants? BMJ 2012; 344: e1410
  40. DePuy Hip. Recall of DePuy orthopaedic ASR hip replacement device.
  41. DePuy Hip. DePuy Hip developer says he wouldn’t use implant.
  42. Pearson FK, Ashmore AM, Malak TT, Rombach I, Taylor A, Beard D, Arden NK, Price A, Parieto-Alhambra D, Judge A, Carr AJ, Glyn-Jones. Primary hip replacement prostheses and their evidence base: systematic review of literature. BMJ 2013; 347:f6956 doi: 10.1136/bmj.f6956.
  43. U.S. Department of Justice, U.S. Attorney’s office, District of New Jersey, Office report 2002-2008.
  44. U.S. Department of Justice. Johnson & Johnson Agrees to Pay $21.4 Million Criminal Penalty to Resolve Foreign Corrupt Practices Act and Oil for Food Investigations. http://www.justice.gov/opa/pr/2011/April/11-crm-446.html.
  45. Cohen D. Out of joint: The story of ASR. BMJ 2011; 342: d2905.
  46. Nelissen RG, Pijls BG, Kärrholm J, Malchau H, Nieuwenhuijse MJ, Valstar ER. RSA and Registries: The Quest for Phased Introduction of New Implants. J Bone Joint Surg Am. 2011 Dec 21; 93 Suppl 3: 62-5.
  47. Schmitz M, Busch V, Gardeniers J, Hendriks J, Veth R, Schreurs V. Long term results of cemented hip arthroplasty in patients younger than 30 years and the outcome of subsequent revisions. BMC Musculoskeletal Disorders 2013, 14:37 doi: 10.1186/1471-2474-14-37.
  48. Fender D, Harper WM, Gregg PJ. Outcome of Charnley total hip replacement across a single health region in England: the results at five years from a regional hip register. J Bone Joint Surg Br. 1999 Jul; 81(4): 577-81.
  49. Krumholz HM, Ross JS, Prester AH, Egilman DS. What have we learnt from Vioxx? BMJ. 2007 January 20; 334(7585): 120–123. doi: 10.1136/bmj.39024.487720.68.
  50. Bombardier C, Laine L, Reicin A, Shapiro D, Ruben Burgos-Vargas R, Davis B, Richard Day R, Ferraz MB, J. Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ, for the VIGOR Study Group. Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis. N Engl J Med 2000; 343:1520-1528, DOI: 10.1056/NEJM200011233432103.
  51. Curfman D, Morrissey S, Drazen JM. Expression of Concern: Bombardier et al., “Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis,” N Engl J Med 2000; 343:1520-8. N Engl J Med 2005; 353:2813-2814, DOI: 10.1056/NEJMe058314.
  52. Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA. 2001 Aug 22-29; 286(8): 954-9.
  53. Bresalier RS, Sandler RS, Quan H, Bolognese JA, Bettina Oxenius B, Horgan K, Christopher Lines C, Riddell R, Morton D, Lanas A, Konstam MA, Baron JA, M.D. for the Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial. N Engl J Med 2005; 352:1092-1102, DOI: 10.1056/NEJMoa050493.
  54. Correction. Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial. N Engl J Med 2006; 355:221, DOI: 10.1056/NEJMx060029.
  55. Merck settles new Vioxx claim, to pay $23 million in settlement with consumers.
  56. Solomon SD, McMurray JJV, Pfeffer MA, Wittes J, Fowler R, Fin P, Anderson WF, Zauber A, Hank E, Bertagnolli M. Cardiovascular Risk Associated with Celecoxib in a Clinical Trial for Colorectal Adenoma Prevention. N Engl J Med 2005; 352:1071-1080March 17, 2005DOI: 10.1056/NEJMoa050405.
  57. Anesthesiology News. Fraud Case Rocks Anesthesiology Community: Mass. Researcher Implicated in Falsification of Data, Other Misdeeds at http://lcmedia.typepad.com/pharmola/2009/03/fraud-case-rocks-anesthesiologycommunity.html.
  58. The United States Attorney’s Office. Anesthesiologist sentenced on health care fraud charge. http://www.justice.gov/usao/ma/news/2010/June/Reuben%20Scott%20Sentencing%20PR.html.
  59. Blumenthal D. Doctors and drug companies. N Engl J Med 2004; 351: 1885-90.
  60. Moynihan R. Who pays for the pizza? Redefining the relationships between doctors and drug companies. 1: Entanglement. BMJ 2003; 326:1189-92.
  61. Relman AS and Angell M. How the drug industry distorts medicine and politics: America’s Other Drug Problem. The New Republic: December 16, 2002: 27.
  62. Committee to Advise the Public Health Service on Clinical Practice Guidelines / Institute of Medicine: Clinical Practice Guidelines: Directions for a New Program. Washington, DC: National Academy Press, 1990.
  63. The National Guideline Clearinghouse: The National Guideline Clearinghouse.
  64. The American Academy of Orthopaedic Surgeons: AAOS Evidence-based Clinical Practice Guidelines.
  65. Shaneyfelt TM, Centor RM. Reassessment of Clinical Practice Guidelines: Go Gently Into That Good Night. JAMA. 2009; 301(8): 868-869. doi:10.1001/jama.2009.225.
  66. Norris SL, Holmer HK, Ogden LA, Burda BU. Conflict of Interest in Clinical Practice Guideline Development: A Systematic Review. PLoS ONE. 2011; 6(10): e25153. doi:10.1371/journal.pone.0025153.
  67. Bindslev JBB, Schroll J, Gotzche PC, Lundh A. Underreporting of conflicts of interest in clinical practice guidelines: cross sectional study. BMC Medical Ethics 2013, 14:19 at http://www.biomedcentral.com/1472-6939/14/19.
  68. Choudhry NK, Stelfox HT, Detsky AS. Relationships between authors of clinical practice guidelines and the pharmaceutical industry. JAMA 2002 Feb 6; 287(5): 612-7.
  69. Gray BH, Gusmano MK, Collins SR. AHCPR and The Changing Politics Of Health Services Research. Health Affairs, no.(2003): doi: 10.1377/hlthaff.w3.283 at http://content.healthaffairs.org/content/early/2003/06/25/hlthaff.w3.283.citation.
  70. See above section on spine surgeon and the medical device industry.
  71. AAOS Evidence-Based Clinical Practice Guidelines: Frequently Asked Questions.
  72. Physician Charter: Advancing Medical Professionalism to Improve Health Care.
  73. AAMC Task Force Releases New Guidance on Managing Conflicts of Interest in Clinical Care August 2, 2010.

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The Malaysian Orthopaedic Journal is a peer-reviewed journal that is published three times a year in both print and electronic online version. The purpose of this journal is to publish original research studies, evaluation of current practices and case reports in various subspecialties of orthopaedics and traumatology, as well as associated fields like basic science, biomedical engineering, rehabilitation medicine and nursing.

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