Orthopaedic surgeons and the medical device industry: The threat to scientific integrity and the public trust

Journal of Bone and Joint Surgery

Volumn 92, Issue 3, 2010, Pages 765-777

  Gelberman, Richard H ^a   Samson, David ^b   Mirza, Sohail K ^c   Callaghan, John J ^d   Pellegrini, Vincent D ^e  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Wolff and Samson PC   (United States)

^c DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^d UNIVERSITY OF IOWA HEALTH CARE   (United States)

^e UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; DRUG INDUSTRY; HEALTH CARE PERSONNEL; HEALTH CARE POLICY; LAW; LICENSING; MEDICAL DECISION MAKING; MEDICAL ETHICS; PATENT; PRESCRIPTION; PRIORITY JOURNAL; SURGEON; TRUST; APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; CONFLICT OF INTEREST; DECISION MAKING; ECONOMICS; GIFT GIVING; GOVERNMENT REGULATION; HUMAN; INDUSTRY; INTERPERSONAL COMMUNICATION; MASS COMMUNICATION; MEDICAL SOCIETY; ORTHOPEDICS; PUBLIC RELATIONS; SAFETY; UNITED STATES;

CONFLICT OF INTEREST; DECISION MAKING; DEVICE APPROVAL; DIFFUSION OF INNOVATION; DISCLOSURE; EQUIPMENT AND SUPPLIES; GIFT GIVING; GOVERNMENT REGULATION; HUMANS; INDUSTRY; INTELLECTUAL PROPERTY; INTERINSTITUTIONAL RELATIONS; LICENSURE; ORTHOPEDICS; SOCIETIES, MEDICAL; TRUST; UNITED STATES;

EID: 77950878012     PISSN: 00219355     EISSN: 15351386     Source Type: Journal    
DOI: 10.2106/JBJS.I.01164     Document Type: Conference Paper

References (84)

1. Leaf C. The law of unintended consequences. Fortune. 2005;152:250-2, 254, 258.
2. Campbell EG, Gruen RL, Mountford J, Miller LG, Cleary PD, Blumenthal D. A national survey of physician-industry relationships. N Engl J Med. 2007;356:1742-50.
3. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003;289:454-65. (Pubitemid 36119966)
4. Campbell EG, Weissman JS, Ehringhaus S, Rao SR, Moy B, Feibelmann S, Goold SD. Institutional academic industry relationships. JAMA. 2007; 298:1779-86.
5. Boyd EA, Bero LA. Assessing faculty financial relationships with industry: a case study. JAMA. 2000;284:2209-14.
6. McCrary SV, Anderson CB, Jakovljevic J, Khan T, McCullough LB, Wray NP, Brody BA. A national survey of policies on disclosure of conflicts of interest in biomedical research. N Engl J Med. 2000;343:1621-6. (Pubitemid 32162987)
7. Rothman DJ. Academic medical centers and financial conflicts of interest. JAMA. 2008;299:695-7.
8. Johns MM, Barnes M, Florencio PS. Restoring balance to industry-academia relationships in an era of institutional financial conflicts of interest: promoting research while maintaining trust. JAMA. 2003;289:741-6. (Pubitemid 37430369)
9. Studdert DM, Mello MM, Brennan TA. Financial conflicts of interest in physicians' relationships with the pharmaceutical industry - self-regulation in the shadow of federal prosecution. N Engl J Med. 2004;351:1891-900.
10. Campbell EG. Doctors and drug companies - scrutinizing influential relationships. N Engl J Med. 2007;357:1796-7.
11. 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.
12. Steinbrook R. Disclosure of industry payments to physicians. N Engl J Med. 2008;359:559-61.
13. Abelson R. Cleveland Clinic discloses doctors' industry ties. New York Times. 2008 Dec 3;B1.
14. Ehringhaus SH, Weissman JS, Sears JL, Goold SD, Feibelmann S, Campbell EG. Responses of medical schools to institutional conflicts of interest. JAMA. 2008;299:665-71.
15. U.S. Department of Justice. Press release: monitoring and deferred prosecution agreements terminated with companies in hip and knee replacement industry. 2009 Mar 30. http://www.usdoj.gov/usao/ nj/press/press/files/pdffiles/ hips0330%20 rel.pdf. Accessed 2009 Apr 20.
16. U.S. Department of Justice. Press release: five companies in hip and knee replacement industry avoid prosecution by agreeing to compliance rules and monitoring. 2007 Sep 27. http://www.usdoj. gov/usao/nj/press/files/pdffiles/ hips0927.rel.pdf. Accessed 2009 Apr 20.
17. Social Security Act, §1128, 42 U.S.C. 1320a-7b. Criminal penalties for acts involving Federal health care programs. 1997 Sep 23.
18. Harris G. Crackdown on doctors who take kickbacks. New York Times. 2009 Mar 4;A14.
19. Demske GE. Examining the relationship between the medical device industry and physicians. Testimony before the Senate Special Committee on Aging. 2008 Feb 27. Corrected 2008 May 22. http:// oig.hhs.gov/testimony/docs/2008/demske- testimony022708.pdf. Accessed 2009 Apr 20.
20. Rothman DJ, McDonald WJ, Berkowitz CD, Chimonas SC, DeAngelis CD, Hale RW, Nissen SE, Osborn JE, Scully JH Jr, Thomson GE, Wofsy D. Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest. JAMA. 2009;301:1367-72.
21. Association of American Medical Colleges. Industry funding ofmedical education: report of an AAMC task force. 2008 Jun. https://services.aamc.org/ publications/showfile.cfm?file=version114. pdf&prd-id=232. Accessed 2009 Apr 20.
22. Rubenstein S. Johns Hopkins bans free drug samples, gifts from industry. Wall Street Journal Blogs. 2009 Apr 8. http://blogs.wsj.com/health/2009/04/08/ johns-hopkins-bans-free-drug-samples-gifts-from-industry/. Accessed 2009 Apr 20.
23. Goldstein J. Harvard-affiliated hospitals to limit docs' industry ties. Wall Street Journal Blogs. 2009 Apr 10. http://blogs.wsj.com/health/2009/04/10/ harvard-affiliated-hospitals-to-limit-docs-industry-ties/. Accessed 2009 Apr 20.
24. Massachusetts Disclosure Law. Mass Gen Laws ch. 111N §§ 1-7. 2009 Jan 1.
25. Spector R. Stanford medical school to provide online disclosure of faculty's consulting activities. 2009 Apr 1. http://med.stanford.edu/news- releases/ 2009/april/disclosure.html. Accessed 2009 Apr 20.
26. Physician Payments Sunshine Act of 2009. S.301, 111th Cong.
27. United States v. Greber, 760 F.2d 68 (3rd Cir.), cert. denied, 474 U.S. 988 (1985).
28. United States v. Davis, 132 F.3d 1092 (5th Cir. 1998).
29. United States v. Kats, 871 F.2d 105 (9th Cir. 1989).
30. United States v. McClatchey, 217 F.3d 823 (10th Cir. 2000).
31. AdvaMed. Code of ethics on interactions with health care professionals. http://www.advamed.org/ NR/rdonlyres/61D30455-F7E9-4081-B219-12D6CE347585/0/ AdvaMedCodeofEthicsRevise dandRestatedEffective20090701.pdf. Accessed 10 Dec 2009.
32. Callaghan JJ, Crowninshield RD, Greenwald AS, Lieberman JR, Rosenberg AG, Lewallen DG. Symposium: introducing technology into orthopaedic practice. How should it be done? J Bone Joint Surg Am. 2005;87:1146-58.
33. Abelson R, Petersen M. An operation to ease back pain bolsters the bottom line, too. New York Times. 2003 Dec 31;A1.
34. Langreth R. Operation! Is elective surgery overdone? Forbes. 2003;172:246-54.
35. Bloche MG. Clinical loyalties and the social purposes of medicine. JAMA. 1999;281:268-74.
36. Luft HS, Bunker JP, Enthoven AC. Should operations be regionalized? The empirical relation between surgical volume and mortality. 1979. Clin Orthop Relat Res. 2007;457:3-9.
37. Luft HS. Health care reform - toward more freedom, and responsibility, for physicians. N Engl J Med. 2009;361:623-8.
38. Luft HS. Economic incentives to promote innovation in healthcare delivery. Clin Orthop Relat Res. 2009;467:2497-505.
39. Smith JW. The dignity of the medical profession is upheld. Illinois Med J. 1907;11:672-3.
40. Shah RV, Albert TJ, Bruegel-Sanchez V, Vaccaro AR, Hilibrand AS, Grauer JN. Industry support and correlation to study outcome for papers published in Spine. Spine (Phila Pa 1976). 2005;30:1099-105.
41. Bhandari M, Busse JW, Jackowski D, Montori VM, Schünemann H, Sprague S, Mears D, Schemitsch EH, Heels-Ansdell D, Devereaux PJ. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ. 2004;170:477-80.
42. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326:1167-70.
43. Changing patterns of pharmaceutical innovation. A research report by The National Institute for Health Care Management Research and Educational Foundation. Washington, DC: NIHCM; 2002. http:// www.nihcm.org/pdf/innovations. pdf.
44. Cain DM, Detsky AS. Everyone's a little bit biased (even physicians). JAMA. 2008;299:2893-5.
45. Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA. 2003;290:252-5.
46. Sollitto S, Hoffman S, Mehlman M, Lederman RJ, Youngner SJ, Lederman MM. Intrinsic conflicts of interest in clinical research: a need for disclosure. Kennedy Inst Ethics J. 2003;13:83-91.
47. Scott J. Withdrawal of a paper. J Bone Joint Surg Br. 2009;91:285-6.
48. Babcock L, Loewenstein G. Explaining bargaining impasse: the role of self-serving biases. J Econ Perspect. 1997;11:109-26.
49. Messick DM, Sentis KP. Fairness and preference. J Exp Soc Psychol. 1979;15:418-34.
50. Avorn J, Chen M, Hartley R. Scientific versus commercial sources of influence on the prescribing behavior of physicians. Am J Med. 1982;73:4-8.
51. Spingarn RW, Berlin JA, Strom BL. When pharmaceutical manufacturers' employees present grand rounds, what do residents remember? Acad Med. 1996;71:86-8.
52. Orlowski JP, Wateska L. The effects of pharmaceutical firm enticements on physician prescribing patterns. There's no such thing as a free lunch. Chest. 1992;102:270-3.
53. Palmisano P, Edelstein J. Teaching drug promotion abuses to health profession students. J Med Educ. 1980;55:453-5.
54. Gibbons RV, Landry FJ, Blouch DL, Jones DL, Williams FK, Lucey CR, Kroenke K. A comparison of physicians' and patients' attitudes toward pharmaceutical industry gifts. J Gen Intern Med. 1998;13: 151-4.
55. Steinman MA, Shlipak MG, McPhee SJ. Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical industry promotions. Am J Med. 2001;110:551-7.
56. Cain DM, Loewenstein G, Moore DA. The dirt on coming clean: perverse effects of disclosing conflicts of interest. J Legal Stud. 2005;34:1-25.
57. Biomet. Company consultants - identification and payments, 2008. http://www.biomet.com/cor porate/consultant-disclosure.cfm. Accessed 2009 May 12.
58. DePuy Orthopaedics. 2008 payment disclosure. http://www. depuyorthopaedics.com/Attachment%20 Documents/depuydisclosure.pdf. Accessed 2009 May 12.
59. Zimmer. Disclosure of U.S. hip and knee consultants and payments, 2007-2008. http:// www.zimmer.com/web/enUS/pdf/Company- Consultants-033109.pdf. Accessed 2009 May 12.
60. Smith and Nephew. Company consultants - identification and payments. http://www. smithnephewdpacompliance.com. Accessed 2009 May 12.
61. Stryker. Surgeon consultants. http://www.stryker.com/meetourconsultants/ consultants/ consultants.php. Accessed 2009 May 12.
62. Okike K, Kocher MS, Wei EX, Mehlman CT, Bhandhari M. Accuracy of conflict-of-interest disclosures reported by physicians. N Engl J Med. 2009; 361:1466-74.
63. Feder BJ. Subpoenas seek data on orthopedics makers' ties to surgeons. New York Times. 2005 Mar 31;C12.
64. AAMC Task Force on Financial Conflicts of Interest in Clinical Research. Protecting subjects, preserving trust, promoting progress II: principles and recommendations for oversight of an institution's financial interests in human subjects research. Acad Med. 2003;78:237-45.
65. AAMC Task Force on Financial Conflicts of Interest in Clinical Research. Protecting subjects, preserving trust, promoting progress I: policy and guidelines for the oversight of individual financial interests in human subjects research. Acad Med. 2003;78:225-36.
66. Association of American Medical Colleges. Protecting patients, preserving integrity, advancing health: accelerating the implementation of COI policies in human subjects research. A report of the AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Human Subject Research. Washington, DC: Association of American Medical Colleges; 2008.
67. AAMC Task Force on Financial Conflicts of Interest in Clinical Research. Protecting subjects, preserving trust, promoting progress - policy and guidelines for the oversight of individual financial interests in human subjects research. 2001 Dec. http://www.aamc.org/research/coi/firstreport.pdf. Accessed 2005 May 23.
68. Davidoff F, DeAngelis CD, Drazen JM, Hoey J, Højgaard L, Horton R, Kotzin S, Nicholls MG, Nylenna M, Overbeke AJ, Sox HC, Van Der Weyden MB, Wilkes MS. Sponsorship, authorship, and accountability. Lancet. 2001;358:854-6.
69. Cohen JJ, Siegel EK. Academic medical centers and medical research: the challenges ahead. JAMA. 2005;294:1367-72.
70. Drazen JM, Van Der Weyden MB, Sahni P, Rosenberg J, Marusic A, Laine C, Kotzin S, Horton R, Hébert PC, Haug C, Godlee F, Frizelle FA, de Leeuw PW, Deangelis CD. Uniform format for disclosure of competing interests in ICMJE journals. Lancet. 2009;374:1395-6.
71. Drazen JM, Van Der Weyden MB, Sahni P, Rosenberg J, Marusic A, Laine C, Kotzin S, Horton R, Hébert PC, Haug C, Godlee F, Frizelle FA, de Leeuw PW, Deangelis CD. Uniform format for disclosure of competing interests in ICMJE journals. Ann Intern Med. 2009 Oct 13 [Epub ahead of print].
72. Drazen JM, Van Der Weyden MB, Sahni P, Rosenberg J, Marusic A, Laine C, Kotzin S, Horton R, Hébert PC, Haug C, Godlee F, Frizelle FA, de Leeuw PW, Deangelis CD. Uniform format for disclosure of competing interests in ICMJE journals. JAMA. 2010;303:75-6.
73. Drazen JM, Van Der Weyden MB, Sahni P, Rosenberg J, Marusic A, Laine C, Kotzin S, Horton R, Hébert PC, Haug C, Godlee F, Frizelle FA, de Leeuw PW, Deangelis CD. Uniform format for disclosure of competing interests in ICMJE journals. N Engl J Med. 2009;361:1896-7.
74. Drazen JM, Van Der Weyden MB, Sahni P, Rosenberg J, Marusic A, Laine C, Kotzin S, Horton R, Hébert PC, Haug C, Godlee F, Frizelle FA, de Leeuw PW, Deangelis CD. Uniform format for disclosure of competing interests in ICMJE journals. CMAJ. 2009;181:565.
75. Institute of Medicine. Conflict of interest in medical research, education, and practice. A focus on medical research. Washington, DC: National Academies Press; 2009.
76. Crowninshield RD, Callaghan JJ. The orthopaedic profession and the industry partnership. Clin Orthop Relat Res. 2007;457:73-7.
77. Heckman JD. Patient care, professionalism, and relationships with industry. J Bone Joint Surg Am. 2008;90:225.
78. Khan MH, Lee JY, Rihn JA, Cassinelli EH, Lim MR, Kang JD, Donaldson WF 3rd. The surgeon as a consultant for medical device manufacturers: what do our patients think? Spine (Phila Pa 1976). 2007;32:2616-8.
79. The Blue Ridge Academic Health Group. Managing conflict of interest in AHCs to assure healthy industrial and societal relationships. Report 10. 2006 Sep. http://whsc.emory.edu/blueridge/-pdf/blue- ridge-report-10-2006sep.pdf. Accessed 2009 May.
80. National Institutes of Health. Frequently asked questions. Responsibility of applicants for promoting objectivity in research for which PHS funding is sought (42 CFR Part 50 Subpart F, grants; and responsible prospective contractors, 45 CFR Part 94, contracts). http://grants.nih.gov/grants/policy/ coifaq.htm. Accessed 2009 Mar.
81. Korn D. Council of Academic Societies workshop: academic and scientific society interactions with industry. 2007 Nov 2. Washington, DC.
82. Steinbrook R. Online disclosure of physician-industry relationships. N Engl J Med. 2009;360: 325-7.
83. Steinbrook R. Physician-industry relations - will fewer gifts make a difference? N Engl J Med. 2009; 360:557-9.
84. Association of American Medical Colleges. The scientific basis of influence and reciprocity: a symposium. Korn D, Ehringhaus S, editors. 2007 Jun 12. https://services.aamc.org/publications/showfile. cfm?file=version106. pdf&prd-id=215&prv-id=262& pdf-id=106. Accessed 2009 May.