Symposium: The Introduction of biologics in orthopaedics: Issues of cost, commercialism, and ethics

Journal of Bone and Joint Surgery

Volumn 89, Issue 7, 2007, Pages 1641-1649

  Obremskey, William T ^a   Marotta, James S ^b   Yaszemski, Michael J ^c   Churchill, Larry R ^d   Boden, Scott D ^e   Dirschl, Douglas R ^f  

^a Medical Center East   (United States)

^b Medtronic   (United States)

^c MAYO CLINIC   (United States)

^d VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^e School of Medicine ^*  (United States)

^f UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BONE MORPHOGENETIC PROTEIN; ERYTHROPOIETIN; HEPARIN; HUMAN INSULIN; PLATELET DERIVED GROWTH FACTOR; RECOMBINANT BONE MORPHOGENETIC PROTEIN 2; RECOMBINANT OSTEOGENIC PROTEIN 1; RECOMBINANT PROTEIN; THROMBOCYTE CONCENTRATE; TRANSFORMING GROWTH FACTOR BETA;

BONE ALLOGRAFT; COMMERCIAL PHENOMENA; CONFERENCE PAPER; COST; DRUG ELUTING STENT; FOOD AND DRUG ADMINISTRATION; FRACTURE HEALING; HUMAN; IMPLANT; INFORMED CONSENT; MARKET; MEDICAL ETHICS; MEDICAL PRACTICE; MEDICAL RESEARCH; NONHUMAN; ORTHOPEDICS; PATIENT AUTONOMY; PATIENT CARE; PATIENT SAFETY; PRIORITY JOURNAL; PROFIT; RISK BENEFIT ANALYSIS; SPINE FUSION; TECHNOLOGY; TIBIA FRACTURE;

EID: 34447289635     PISSN: 00219355     EISSN: None     Source Type: Journal    
DOI: 10.2106/JBJS.F.01185     Document Type: Conference Paper

References (53)

1. Declaration of Helsinki. Recommendations guiding doctors in clinical research. Adopted by the World Medical Association in 1964. Wis Med J. 1967;66:25-6.
2. Lubahn JD, Mankin CJ, Mankin HJ, Kuhn PJ. Orthopaedics, ethics, and industry. Appropriateness of gifts, grants, and awards. Clin Orthop Relat Res. 2000;371:256-63.
3. Crowninshield R. The orthopaedic profession and industry: conflict or convergence of interests. Clin Orthop Relat Res. 2003;412:8-13.
4. Epps CH Jr. Ethical guidelines for orthopaedists and industry. Clin Orthop Relat Res. 2003;412:14-20.
5. Zuckerman JD, Prasarn M, Kubiak EN, Koval KJ. Conflict of interest in orthopaedic research. J Bone Joint Surg Am. 2004;86:423-8.
6. Capozzi JD, Delsignore JL. Reimbursement incentives to physicians. J Bone Joint Surg Am. 2004;86:876-7.
7. Principles of medical ethics and professionalism in orthopaedic surgery. American Academy of Orthopaedic Surgeons. Revised 2002 May. http://www.aaos.org/ about/papers/ethics/prin.asp. Accessed 2007 May 18.
8. Clarification of Opinion 8.061 "Gifts to Physicians from Industry". Council on Ethical and Judicial Affairs of the American Medical Association. Del Med J. 2000;72:161-7.
9. AdvaMed: Advanced Medical Technology Association. Code of ethics on interactions with health care professionals. http://www.advamed.org/public-docs/ coe_with_faqs_4-15-05.pdf. 15 Apr 2005.
10. United States Food and Drug Administration. Humanitarian use device regulations. Final rule (21 CFR 814). Federal Register. 1996; 61:33231-48.
11. Shuren J. Definition of primary mode of action of a combination product. Federal Register. 2005;70:49848-62.
12. Pavlou AK, Reichert JM. Recombinant protein therapeutics - success rates, market trends and values to 2010. Nat Biotechnol. 2004;22:1513-9.
13. Manns BJ, Lee H, Doig CJ, Johnson D, Donaldson C. An economic evaluation of activated protein C treatment for severe sepsis. N Engl J Med. 2002;347:993-1000.
14. St John TA, Vaccaro AR, Sah AP, Schaefer M, Berta SC, Albert T, Hilibrand A. Physical and monetary costs associated with autogenous bone graft harvesting. Am J Orthop. 2003;32:18-23.
15. Ackerman SJ, Mafilios MS, Polly DW Jr. Economic evaluation of bone morphogenetic protein versus autogenous iliac crest bone graft in single-level anterior lumbar fusion: an evidence-based modeling approach. Spine. 2002;27(16 Suppl 1):S94-9.
16. Polly DW Jr, Ackerman SJ, Shaffrey CI, Ogilvie JW, Wang JC, Stralka SW, Mafilios MS, Heim SE, Sandhu HS. A cost analysis of bone morphogenetic protein versus autogenous iliac crest bone graft in single-level anterior lumbar fusion. Orthopedics. 2003;26:1027-37.
17. Burkus JK, Heim SE, Gornet MF, Zdeblick TA. 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. 2003;16:113-22.
18. Govender S, Csimma C, Genant HK, Valentin-Opran A, Amit Y, Arbel R, Aro H, Atar D, Bishay M, Borner MG, Chiron P, Choong P, Cinats J, Courtenay B, Feibel R, Geulette B, Gravel C, Haas N, Raschke M, Hammacher E, van der Velde D, Hardy P, Holt M, Josten C, Ketterl RL, Lindeque B, Lob G, Mathevon H, McCoy G, Marsh D, Miller R, Munting E, Oevre S, Nordsletten L, Patel A, Pohl A, Rennie W, Reynders P, Rommens PM, Rondia J, Rossouw WC, Daneel PJ, Ruff S, Ruter A, Santavirta S, Schildhauer TA, Gekle C, Schnettler R, Segal D, Seiler H, Snowdowne RB, Stapert J, Taglang G, Verdonk R, Vogels L, Weekbach A, Wentzensen A, Wisniewski T; BMP-2 Evaluation in Surgery for Tibial Trauma (BESTT) Study Group. Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients. J Bone Joint Surg Am. 2002;84:2123-34.
19. Jones AL, Swiontkowski MF, Polly DW, Duff SB, Ackerman SJ. Use of rhBMP-2 in the treatment of open tibial shaft fractures: do improved clinical outcomes outweigh the additional expense of rhBMP-2? Presented as a poster exhibit at the Annual Meeting of the Orthopaedic Trauma Association; 2004 Oct 8-10; Hollywood, FL.
20. Lowery GL, Kulkarni S, Pennisi AE. Use of autologous growth factors in lumbar spinal fusion. Bone. 1999;25(2 Suppl):47S-50S.
21. Whitman DH, Berry RL, Green DM. Platelet gel: an autologous alternative to fibrin glue with applications in oral and maxillofacial surgery. J Oral Maxillofac Surg. 1997;55:1294-9.
22. Marx RE, Carlson ER, Eichstaedt RM, Schimmele SR, Strauss JE, Georgeff KR. Platelet-rich plasma: growth factor enhancement for bone grafts. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998;85:638-46.
23. Slater M, Patava J, Kingham K, Mason RS. Involvement of platelets in stimulating osteogenic activity. J Orthop Res. 1995;13:655-63.
24. Greenwald AS, Boden SD, Goldberg VM, Khan Y, Laurencin CT, Rosier RN; for the Committee on Biological Implants. Bone-graft substitutes: facts, fictions, and applications. J Bone Joint Surg Am. 2001;83:S98-103.
25. Dugrillon A, Eichler H, Kern S, Kluter H. Autologous concentrated platelet-rich plasma (cPRP) for local application in bone regeneration. Int J Oral Maxillofac Surg. 2002;31:615-9.
26. Zimmermann R, Jakubietz R, Jakubietz M, Strasser E, Schlegel A, Wiltfang J, Eckstein R. Different preparation methods to obtain platelet components as a source of growth factors for local application. Transfusion. 2001;41:1217-24.
27. Appel TR, Potzsch B, Muller J, von Lindern JJ, Berge SJ, Reich RH. Comparison of three different preparations of platelet concentrates for growth factor enrichment. Clin Oral Implants Res. 2002;13:522-8.
28. Weibrich G, Kleis WK, Buch R, Hitzler WE, Hafner G. The Harvest Smart PRePTM system versus the Friadent-Schutze platelet-rich plasma kit. Clin Oral Implants Res. 2003;14:233-9.
29. Kevy SV, Jacobson MS. Comparison of methods for point of care preparation of autologous platelet gel. J Extra Corpor Technol. 2004;36:28-35.
30. Weibrich G, Kleis WK, Hafner G, Hitzler WE. Growth factor levels in platelet-rich plasma and correlations with donor age, sex, and platelet count. J Craniomaxillofac Surg. 2002;30:97-102.
31. Eppley BL, Woodell JE, Higgins J. Platelet quantification and growth factor analysis from platelet-rich plasma: implications for wound healing. Plast Reconstr Surg. 2004;114:1502-8.
32. Lieberman JR, Daluiski A, Einhorn TA. The role of growth factors in the repair of bone. Biology and clinical applications. J Bone Joint Surg Am. 2002;84:1032-44.
33. Aspenberg P, Jeppsson C, Wang JS, Bostrom M. Transforming growth factor beta and bone morphogenetic protein 2 for bone ingrowth: a comparison using bone chambers in rats. Bone. 1996;19:499-503.
34. Ranly DM, McMillan J, Keller T, Lohmann CH, Meunch T, Cochran DL, Schwartz Z, Boyan BD. Platelet-derived growth factor inhibits demineralized bone matrix-induced intramuscular cartilage and bone formation. A study of immunocompromised mice. J Bone Joint Surg Am. 2005;87:2052-64.
35. Arpornmaeklong P, Kochel M, Depprich R, Kubler NR, Wurzler KK. Influence of platelet-rich plasma (PRP) on osteogenic differentiation of rat bone marrow stromal cells. An in vitro study. Int J Oral Maxillofac Surg. 2004;33:60-70.
36. Cenni E, Ciapetti G, Pagani S, Perut F, Giunti A, Baldini N. Effects of activated platelet concentrates on human primary cultures of fibroblasts and osteoblasts. J Periodontol. 2005;76:323-8.
37. Choi BH, Im CJ, Huh JY, Suh JJ, Lee SH. Effect of platelet-rich plasma on bone regeneration in autogenous bone graft. Int J Oral Maxillofac Surg. 2004;33:56-9.
38. Butterfield KJ, Bennett J, Gronowicz G, Adams D. Effect of platelet-rich plasma with autogenous bone graft for maxillary sinus augmentation in a rabbit model. J Oral Maxillofac Surg. 2005;63:370-6.
39. Sarkar MR, Augat P, Shefelbine SJ, Schorlemmer S, Huber-Lang M, Claes L, Kinzl L, Ignatius A. Bone formation in a long bone defect model using a platelet-rich plasma-loaded collagen scaffold. Biomaterials. 2006;27:1817-23.
40. Weiner BK, Walker M. Efficacy of autologous growth factors in lumbar intertransverse fusions. Spine. 2003;28:1968-71.
41. Castro FP Jr. Role of activated growth factors in lumbar spinal fusions. J Spinal Disord Tech. 2004;17:380-4.
42. Carreon LY, Glassman SD, Anekstein Y, Puno RM. Platelet gel (AGF) fails to increase fusion rates in instrumented posterolateral fusions. Spine. 2005;30:E243-7.
43. BK050016 - FDA marketing authorization letter for the GPS II Platelet Concentrate Separation Kit w/ Plasma Concentrator. 2005 Mar 22. http://www.fda.gov/cber/seltr/k050016L.htm. Accessed 2007 May 18.
44. BK060004 - FDA Marketing Authorization letter for the Smith and Nephew Platelet Rich Concentrate (PRC) Preparation System. 2006 Jan 19. http://www.fda.gov/cber/seltr/k060004L.htm. Accessed 2007 May 18.
45. Edelstein L. The Hippocratic Oath: text, translation and interpretation. Bull Hist Med. 1943;Suppl 1:1.
46. Berkman ND, Wynia MK, Churchill LR. Gaps, conflicts, and consensus in the ethics statements of professional associations, medical groups, and health plans. J Med Ethics. 2004;30:395-401.
47. Churchill LR. Whose good? Rethinking beneficence in the era of managed care. Clin Ethics Rep. 1996;10:1-8.
48. Kassirer JP. Excerpts from: On the take. Physician Exec. 2005;31:28-32.
49. Abelson R. Whistle-blower suit says device maker generously rewards doctors. New York Times. 2006 Jan 24;Sect C:1.
50. Brennan TA, Rothman DJ, Blank L, Blumenthal D, Chimonas SC, Cohen JJ, Goldman J, Kassirer JP, Kimball H, Naughton J, Smelser N. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA. 2006;295:429-33.
51. Faden RR, Beauchamp TL, King NMP. A history and theory of informed consent. New York: Oxford University Press; 1986. p 200-25.
52. Federal policy for the protection of human subgroups. Notices and rules. Text of the common rule. 56 Federal Register 28012; 1991.
53. United States Department of Health, Education, and Welfare. Belmont Report: ethical principles and guidelines for the protection of human subjects of research. Report of the National Committee for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979 Apr 18. DHEW publication no (OS) 78-0013 and (OS) 78-0014.