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Conflict of Interest

  • Tessa London
  • Robert-Marlo F. BautistaJr
  • Avinash S. Bhakta
  • Vanessa Bazan
  • Joseph B. ZwischenbergerEmail author
Chapter
  • 21 Downloads

Abstract

A conflict of interest (COI) involves subjecting professional judgment to secondary interests. Influence from industry, funding, hospital administration, and the patient’s family, all risk creating complex COI. Surgeons must stay current with new technology as evidence accumulates and their skill sets evolve, necessitating a close understanding and relationship with industry. This relationship may extend to industry funding of scientific studies that guide best practices. External and increasingly internal funding sources both direct and indirect can influence income, research, medical education, and patient management. Additionally, discordance between the surgeon’s determination of the best therapeutic intervention (brand/treatments/procedures) and the hospital administration’s perception of the most fiscally responsible intervention is growing. Finally, we examine the role of family member influence on treatment decisions and how that may create COI for the surgeon.

Keywords

Conflict of interest Industry conflict of interest Medical administration Personal benefit Competing interests 

References

  1. 1.
    Institute of Medicine Committee on Conflict of Interest in Medical Research, Education, and Practice. In: Lo B, Field MJ, editors. Conflict of interest in medical research, education, and practice. Washington, DC: National Academies Press; 2009.Google Scholar
  2. 2.
    Zucker LG, Darby MR, Armstrong J. Geographically localized knowledge: spillovers of markets? Econ Inq. 1998;36:65–86.  https://doi.org/10.1111/j.1465-7295.1998.tb01696.x.CrossRefGoogle Scholar
  3. 3.
    Chatterji AK, Fabrizio KR, Mitchell W, Schulman KA. Physician-industry cooperation in the medical device industry. Health Aff. 2008;27:1532–43.  https://doi.org/10.1377/hlthaff.27.6.1532.CrossRefGoogle Scholar
  4. 4.
    Adair RF, Holmgren LR. Do drug samples influence resident prescribing behavior? A randomized trial. Am J Med. 2005;118:881–4.  https://doi.org/10.1016/j.amjmed.2005.02.031.CrossRefPubMedGoogle Scholar
  5. 5.
    Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA. 2003;390:252–5.  https://doi.org/10.1001/jama.290.2.252.CrossRefGoogle Scholar
  6. 6.
    Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283:373–80.  https://doi.org/10.1001/jama.283.3.373.CrossRefPubMedGoogle Scholar
  7. 7.
    Blumenthal D. Doctors and drug companies. N Engl J Med. 2004;351:1885–90.  https://doi.org/10.1056/NEJMhpr042734.CrossRefPubMedGoogle Scholar
  8. 8.
    Chren MM, Landefeld CS. Physicians’ behavior and their interactions with drug companies. JAMA. 1994;271:684–9.CrossRefGoogle Scholar
  9. 9.
    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.CrossRefGoogle Scholar
  10. 10.
    American Medical Association Council on Ethical & Judicial Affairs: Report of the council on ethical and judicial affairs. 2013. https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/public/about-ama/councils/Council%20Reports/council-on-ethics-and-judicial-affairs/ceja-2i13.pdf. Accessed 22 Mar 2019.
  11. 11.
    Association of American Medical Colleges: Industry Funding of Medical Education. 2008. https://www.aamc.org/download/482220/data/industryfundingofmedicaleducation.pdf. Accessed 9 July 2019.
  12. 12.
    Special Committee on Aging: Surgeons for sale: conflicts and consultant payment in the medical device industry. Hearing before the Special Committee on Aging. One hundred tenth Congress; Second Session. Washington, DC. 27 Feb 2008. 2008. https://www.aging.senate.gov/imo/media/doc/2272008.pdf. Accessed 25 Mar 2019.
  13. 13.
    Centers for Medicare & Medicaid Services Open payments. 2019. https://www.cms.gov/openpayments/. Accessed 22 Mar 2019.
  14. 14.
    Department of Veterans Affairs VHA Directive 2003–060: Business relationships between VHA staff and pharmceutical industry representatives. 2003. http://lib.ncfh.org/pdfs/PIRT3.pdf. Accessed 9 July 2019.
  15. 15.
    Kirschner NM, Sulmasy LS, Kesselheim AS. Health policy basics: the physician payment sunshine act and the open payments program. Ann Intern Med. 2014;161:519–21.  https://doi.org/10.7326/M14-1303.CrossRefPubMedGoogle Scholar
  16. 16.
    National Emphysema Treatment Trial Research Group, Fishman A, Fessler H, Martinez F, McKenna RJ Jr, Naunheim K, Piantadosi S, Weinmann G, Wise R. Patients at high risk of death after lung-volume-reduction surgery. N Engl J Med. 2001;345:1075–83.  https://doi.org/10.1056/NEJMoa11798.CrossRefGoogle Scholar
  17. 17.
    Fishman A, Martinez F, Naunheim K, Piantadosi S, Wise R, Ries A, Weinmann G, Wood DE, National Emphysema Treatment Trial Research Group. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med. 2003;348:2059–73.  https://doi.org/10.1164/rccm.201103-0455CI.CrossRefPubMedGoogle Scholar
  18. 18.
    Ries AL, Make BJ, Lee SM, et al. The effects of pulmonary rehabilitation in the National Emphysema Treatment Trial. Chest. 2005;128:3799–809.  https://doi.org/10.1378/chest.128.6.3799.CrossRefPubMedGoogle Scholar
  19. 19.
    Weinmann GG, Chiang Y-P, Sheingold S. The National Emphysema Treatment Trial (NETT). A study in agency collaboration. Proc Am Thorac Soc. 2008;5:381–4.  https://doi.org/10.1513/pats.200709-154ET.CrossRefPubMedPubMedCentralGoogle Scholar
  20. 20.
    AAP Section on Cardiology and Cardiac Surgery and AAP Section on Orthopaedics. Off-label use of medical devices in children. Pediatrics. 2017;139:e20163439.  https://doi.org/10.1542/peds.2016-3439.CrossRefGoogle Scholar
  21. 21.
    Sinha MS, Najafzadeh M, Rajasingh EK, Love J, Kesselheim AS. Labeling changes and costs for clinical trials performed under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012. JAMA Intern Med. 2018;178:1458–66.  https://doi.org/10.1001/jamainternmed.2018.3933.CrossRefPubMedPubMedCentralGoogle Scholar
  22. 22.
    Thaul S. Congressional Research Service. The Food and Drug Administration Safety and Innovation Act (P.L. 112–144) https://www.hsdl.org/?view&did=722255 (2012). Accessed 4 Apr 2019.
  23. 23.
    Fraterelli DA, Galinkin JL, Green TP, Johnson TD, Neville KA, Paul IM, Van Den Anker JN, American Academy of Pediatrics Committee on Drugs. Off label use of drugs in children. Pediatrics. 2014;133:563–7.  https://doi.org/10.1542/peds.2013-4060.CrossRefGoogle Scholar
  24. 24.
    Sutherell JS, Hirsch R, Beekman RH 3rd. Pediatric interventional cardiology in the United States is dependent on the off-label use of medical devices. Congenit Heart Dis. 2010;5:2–7.  https://doi.org/10.1111/j.1747-0803.2009.00364.x.CrossRefPubMedGoogle Scholar
  25. 25.
    Hwang TJ, Kesselheim AS, Bourgeois FT. Postmarketing trials and pediatric device approvals. Pediatrics. 2014;133:e1197–202.  https://doi.org/10.1542/peds.2013-3348.CrossRefPubMedPubMedCentralGoogle Scholar
  26. 26.
    Epstein RA. How conflict-of-interest regulations endanger medical progress and cures. Project FDA. Manhattan Institute. 2010. http://resource-cms.springernature.com/springer-cms/rest/v1/content/40190/data/v6. Accessed 25 Mar 2019
  27. 27.
    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.Google Scholar
  28. 28.
    AAMC Task Force on Financial Conflicts of Interest in Clinical Research. Protecting subjects, preserving trust, promoting progress II: policy and guidelines for the oversight of individual financial interests in human subjects research. Acad Med. 2003;78:237–45.Google Scholar
  29. 29.
    Accreditation Council for Continuing Medical Education. ACCME standards for commercial support. https://www.accme.org/sites/default/files/2019-01/174_20190118_ACCME_Standards_for_Commercial_Support.pdf (2019). Accessed 27 Mar 2019.
  30. 30.
    Council of Medical Specialty Societies. Code for interactions with companies. Chicago: CMSS; 2015. http://www.cmss.org/uploadedFiles/Site/CMSS_Policies/CMSS%20Code%20for%20Interactions%20with%20Companies%20Approved%20Revised%20Version%203-19-11CLEAN.pdf. Accessed 23 Mar 2019.Google Scholar
  31. 31.
    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.  https://doi.org/10.1001/jama.2009.407.CrossRefPubMedGoogle Scholar
  32. 32.
    Millikan JS, Trachiotis G, Sade RM. Should a surgeon comply with a hospital administration’s demand to change valve preference? J Thorac Cardiovas Surg. 2018;156:2210–25.  https://doi.org/10.1016/j.jtcvs.2018.07.044.CrossRefGoogle Scholar
  33. 33.
    Smieliauskas F. Conflicts of interest in medical technology markets: evidence from orthopedic surgery. Health Econ. 2016;25:723–39.  https://doi.org/10.1002/hec.3177.CrossRefPubMedGoogle Scholar
  34. 34.
    Relman AS. The new medical-industrial complex. N Engl J Med. 1980;303:963–70.  https://doi.org/10.1056/NEJM198010233031703.CrossRefPubMedGoogle Scholar
  35. 35.
    Relman AS. Dealing with conflicts of interest. N Engl J Med. 1984;310:1182–3.  https://doi.org/10.1056/NEJM198405033101809.CrossRefPubMedGoogle Scholar
  36. 36.
    Probst P, Huttner FJ, Klaiber U, Diener MK, Buchler MW, Knebel P. Thirty years of disclosure of conflict of interest in surgery journals. Surgery. 2015;157:627–33.  https://doi.org/10.1016/j.surg.2014.11.012.CrossRefPubMedGoogle Scholar
  37. 37.
    Kanaan Z, Galandiuk S, Abby M, Shannon KV, Dajani D, Hicks N, Rai SN. The value of lesser-impact-factor surgical journals as a source of negative and inconclusive outcomes reporting. Ann Surg. 2011;253:619–23.  https://doi.org/10.1097/SLA.0b013e31820d9b04.CrossRefPubMedGoogle Scholar
  38. 38.
    Patel SV, Yu D, Elsolh B, Goldacre BM, Nash GM. Assessment of conflicts of interest in robotic surgical studies: validating author’s declarations with the open payments database. Ann Surg. 2018;268:86–92.  https://doi.org/10.1097/SLA.0000000000002420.CrossRefPubMedPubMedCentralGoogle Scholar
  39. 39.
    Lopez J, Musavi L, Quan A, Calotta N, Juan I, Park A, Tufaro AP, May JW Jr, Dorafshar AH. Trends, frequency, and nature of surgeon-reported conflicts of interest in plastic surgery. Plast Reconstr Surg. 2007;140:852–8.  https://doi.org/10.1097/PRS.0000000000003683.CrossRefGoogle Scholar
  40. 40.
    Luce EA, Jackman CA. Disclosure of financial conflicts of interest in plastic and reconstructive surgery. Plast Reconstr Surg. 2017;140:635–59.  https://doi.org/10.1097/PRS.0000000000003683.CrossRefPubMedGoogle Scholar
  41. 41.
    Lopez J, Juan I, Wu A, Samaha G, Cho B, Luck JD, Soni A, Milton J, May JW Jr, Tufaro AP, Dorafshar AH. The impact of financial conflicts of interest in plastic surgery: are they all created equal? Ann Plastic Surg. 2016;77:226–30.  https://doi.org/10.1097/SAP.0000000000000834.CrossRefGoogle Scholar
  42. 42.
    Kavarana MN, Sade RM. Ethical issues in cardiac surgery. Futur Cardiol. 2012;8:451–65.  https://doi.org/10.2217/fca.11.91.CrossRefGoogle Scholar
  43. 43.
    Doyle CJ, Post H, Burney RE, Maino J, Keefe M, Rhee KJ. Family participation during resuscitation: an option. Ann Emerg Med. 1987;16:673–5.  https://doi.org/10.1016/S0196-0644(87)80069-0.CrossRefPubMedGoogle Scholar
  44. 44.
    Meyers TA, Eichhorn DJ, Guzzetta CE, Clark AP, Klein JD, Taliaferro E, Calvin A. Family presence during invasive procedures and resuscitation. Am J Nurs. 2000;100:32–42.  https://doi.org/10.2307/3521954.CrossRefPubMedGoogle Scholar
  45. 45.
    Grice AS, Picton P, Deakin CD. Study examining attitudes of staff, patients and relatives to witnessed resuscitation in adult intensive care units. Br J Anaesth. 2003;91:820–4.  https://doi.org/10.1093/bja/aeg276.CrossRefPubMedGoogle Scholar
  46. 46.
    Carroll DL. The effect of intensive care unit environments on nurse perceptions of family presence during resuscitation and invasive procedures. Dimens Crit Care Nurs. 2014;33:34–9.  https://doi.org/10.1097/DCC.0000000000000010.CrossRefPubMedGoogle Scholar
  47. 47.
    Overby K, Fins J. Organ transplantation for individuals with neurodevelopmental disorders. Camb Q Healthc Ethics. 2016;25:272–81.  https://doi.org/10.1017/S0963180115000572.CrossRefPubMedGoogle Scholar
  48. 48.
    Evans JM, Dharmar M, Meierhenry E, Marcin JP, Raff GW. Association between Down syndrome and in-hospital death among children undergoing surgery for congenital heart disease: a US population-based study. Circ Cardiovasc Qual Outcomes. 2014;7:445–52.  https://doi.org/10.1017/S0963180115000572.CrossRefPubMedGoogle Scholar
  49. 49.
    Fraser CD, Jaquiss RD, Rosenthal DN, Berlin Heart Study Investigators, et al. Prospective trial of a pediatric ventricular assist device. N Engl J Med. 2012;367:532–41.  https://doi.org/10.1056/NEJMoa1014164.CrossRefPubMedGoogle Scholar
  50. 50.
    Mehra MR, Canter CE, Hannan MM, International Society for Heart Lung Transplantation (ISHLT) Infectious Diseases Council, International Society for Heart Lung Transplantation (ISHLT) Pediatric Transplantation Council, International Society for Heart Lung Transplantation (ISHLT) Heart Failure and Transplantation Council, et al. The 2016 International Society for Heart Lung Transplantation listing criteria for heart transplantation: a 10-year update. J Heart Lung Transplant. 2016;35:1–23.  https://doi.org/10.1016/j.healun.2015.10.023.CrossRefPubMedGoogle Scholar
  51. 51.
    Karuppiah S, McKee C, Hodge A, Galantowicz M, Tobias J, Naguib A. Perioperative management of a child with hypoplastic left heart syndrome of the Jehovah’s witness faith presenting for hybrid comprehensive stage II procedure. J Extra Corpor Technol. 2016;48:141–7.PubMedPubMedCentralGoogle Scholar
  52. 52.
    Mavroudis C, Gaca J, Sade RM. Can a surgeon refuse to operate when an advance directive limits postoperative care? Ann Thorac Surg. 2016;102:1046–50.  https://doi.org/10.1016/j.athoracsur.2016.04.062.CrossRefPubMedPubMedCentralGoogle Scholar
  53. 53.
    Sade RM, Kavarana MN. Surgical ethics: today and tomorrow. Futur Cardiol. 2017;13:567–78.  https://doi.org/10.2217/fca-2017-0057.CrossRefGoogle Scholar
  54. 54.
    Swindell JS, McGuire AL, Halpern SD. Beneficent persuasion: techniques and ethical guidelines to improve patients’ decisions. Ann Fam Med. 2010;8:260–4.  https://doi.org/10.1370/afm.1118.CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  • Tessa London
    • 1
  • Robert-Marlo F. BautistaJr
    • 2
  • Avinash S. Bhakta
    • 1
  • Vanessa Bazan
    • 3
  • Joseph B. Zwischenberger
    • 1
    Email author
  1. 1.Department of SurgeryUniversity of Kentucky College of MedicineLexingtonUSA
  2. 2.General Surgery Residency ProgramUniversity of Kentucky Graduate Medical EducationLexingtonUSA
  3. 3.University of Kentucky College of MedicineLexingtonUSA

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