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Balancing the Surgeon’s Responsibility to Individuals and Society

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The SAGES Manual Ethics of Surgical Innovation

Abstract

While there are real dangers involved with surgical innovation, calling for vigilance in safeguarding patient well-being and autonomy, it is important not to overplay the dangers of innovation or underplay its benefits. One only needs to consider the history of surgical innovation to understand this point (Science 200:937–941, 1978). That history suggests that physicians should—to the degree possible—consider, suggest, and provide insightful, studied, and cogent innovative treatments that are peer-acknowledged—accepted, or—reviewed, while taking care to balance their obligation to respect patient autonomy and benefit their patients. To achieve this balance, it is essential for innovative practitioners to be thoroughly embedded in, and engaged with, their peers in the medical community. Certainly it would be awkward, if not almost impossible, for a reasonably prudent, competent physician to offer an unproven treatment as a lone wolf, acting in a manner radically afield from similarly situated practitioners, without some collegial involvement and support.

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Notes

  1. 1.

    Innovate (v.) means “to introduce something new.” Anne H. Soukhanov, exec ed (1992). The American Heritage Dictionary of the English Language. Boston: Houghton Mifflin Company, p. 931.

  2. 2.

    Experiment (v.) means “to test under controlled conditions that is made to demonstrate a known truth, examine the validity of a hypothesis, or determine the efficacy of something previously untried.” Anne H. Soukhanov, exec ed (1992). The American Heritage Dictionary of the English Language. Boston: Houghton Mifflin Company, p. 645.

  3. 3.

    Novel (adj.) means “strikingly new, unusual, or different.” Anne H. Soukhanov, exec ed (1992). The American Heritage Dictionary of the English Language. Boston: Houghton Mifflin Company, p. 1239.

  4. 4.

    It may be curious that the policy drafters at UCDMC would equate innovative care and compassionate care. Others would certainly disagree. Compassionate care may be used as an exception to carve out a deviation from nonconventional treatment because it is in the patient’s best interest to do so, but compassionate care to many implies a life-limiting or life-threatening situation that is not always essential for one to invoke an innovative care approach also to be used in the patient’s best interest.

  5. 5.

    From one of the surgeon’s own well-circulated accounts of the incident, he had conversation with a National Institutes of Health pediatric oncologist and ethicist about the project when soliciting IRB support; he worked energetically to identify the better bacterial culture option to implant and settled on a “locally-grown” product; he investigated the idea of commercially marketing the bacterial material; after treating two patients he elected to ignore IRB advice to seek an investigational new drug application (IND) before treating subsequent patients; and he was aware that other similarly situated investigators were operating under the authority of government-funded research protocols rather than any color of “innovative” intervention. [12]

References

  1. White BD, Gelinas LC, Shelton WN. In particular circumstances attempting unproven interventions is obligatory. Am J Bioeth. 2015;15(4):53–5.

    Article  PubMed  Google Scholar 

  2. Langer E. Edmund D. Pellegrino, prominent bioethicist, dies at 92. The Washington Post. June 19, 2013. http://www.washingtonpost.com/local/obituaries/edmund-d-pellegrino-preiminent-bioethicist-dies-aat-92/2013/06/19/34a3e97a-d82f-11e2-9d14-895344c13c30_s. Accessed 5 Jan 2015.

  3. Best M, Neuhauser D. Ignaz Semmelweis and the birth of infection control. BMJ Saf Qual Health Care. 2004;13(3):233–4.

    Article  CAS  Google Scholar 

  4. Mormile R, Quadrini I, Squarcia U. Milestones in pediatric cardiology: making possible the impossible. Clin Cardiol. 2013;36(2):74–6.

    Article  PubMed  Google Scholar 

  5. National Center on Complementary and Alternative Medicine. National Center on Complementary and Alternative Medicine. 2014. http://www.nccam.nih.gov. Accessed 6 Jan 2015.

  6. Institute for Healthcare Improvement. Institute for Healthcare Improvement. March 13, 2015. www.ihi.org. Accessed 13 Mar 2015.

  7. Pellegrino ED, Thomasma DC. For the patient’s good: the restoration of beneficence in health care. New York: Oxford University Press; 1988.

    Google Scholar 

  8. Toulmin S. Technological progress and social policy: the broader significance of medical mishaps. In: Mark S, Stephen T, Zimring FE, Schaffner KF, eds. Medical innovation and bad outcomes: legal, social, and ethical responses. Ann Arbor: Health Administration Press; 1987.

    Google Scholar 

  9. Richards RJ. How we got where we are: a look at informed consent in Colorado – past, present, and future. North Ill University Law Rev. 2005;26(1):69–99.

    Google Scholar 

  10. Slater v. Baker and Stapleton. (English Reports, 1767).

    Google Scholar 

  11. Lundstrom M. Impact, Ethics of Surgery Slammed. The Sacramento Bee. February 11, 2013. http://www.sacbee.com/news/investigations/article2576577.html. Accessed 16 Mar 2015.

  12. Muizelaar JP. Statement of J. Paul Muizelaar, MD, PhD, in Reply to Investigative Report. The Sacramento Bee. April 22, 2013. http://www.sacbee.com/incoming/article2556180.ece/BINARY/Dr.%20J.%20Paul%20Muizelaar%20statement. Accessed 16 Mar 2015.

  13. California Health and Human Services Agency Department of Health. Statement of Deficencies and Plan of Correction: University of California Davis Medical Center. California Department of Public Health. June 12, 2013. http://www.cdpa.gov/certlic/facilities/Documents/2567UCDavisMedCtr-1K5X11-SacramentoCounty.pdf. Accessed 16 Mar 2015.

  14. Jacobellis v. Ohio. (United States Supreme Court, 1964).

    Google Scholar 

  15. Johnson J, Rogers W. Innovative surgery: the ethical challenges. J Med Ethics. 2012;38(1):9–12.

    Article  PubMed  Google Scholar 

  16. Lewis MH, Gohagan JK, Merenstein DJ. The locality rule and the physician’s dilemma: local medical practices vs. the national standard of care. JAMA. 2007;297(23):2633–7.

    Article  CAS  PubMed  Google Scholar 

  17. Blalock A, Taussig HB. The surgical treatment of malformations of the heart in which there is pulmonary stenosis or pulmonary atresia. JAMA. 1945;128(3):189–92.

    Article  Google Scholar 

  18. Freedom RM, Lock J, Bricker JT. Pediatric cardiology and cardiovascular surgery: 1950–2000. Circulation. 2000;102(Supplement 4):IV-58–68.

    Article  CAS  Google Scholar 

  19. Kim HB, Fauza D, Oh JT, Nurko S, Jaksic T. Serial transverse enteroplasty (STEP): a novel bowel lengthening procedure. J Pediatr Surg. 2003;38(3):425–9.

    Article  PubMed  Google Scholar 

  20. Kim HB, Lee PW, Garza P, Duggan C, Fauza D, Jaksic T. Serial transverse enteroplasty for short bowel syndrome: a case report. J Pediatr Surg. 2003;38(6):881–5.

    Article  PubMed  Google Scholar 

  21. Boston Children’s Hospital. International STEP Data Registry. 2015. https://apps.childrenshospital.org/clinical/step. Accessed 29 Mar 2015.

  22. Fins JJ. Surgical innovation and ethical dilemmas: precautions and proximity. Cleve Clin J Med. 2008;75 Suppl 6:S7–12.

    Article  PubMed  Google Scholar 

  23. Epstein RA, Zimring FE. Legal liability for medical innovation. In: Siegler M, Toulmin S, Schaffner KF, eds. Medical innovation and bad outcomes: legal, social, and ethical responses. Ann Arbor: Health Administration Press; 1987. p. 162–83.

    Google Scholar 

  24. Mastroianni AC. Liability, regulation, and policy in surgical innovation: the cutting edge of research and therapy. Health Matrix. 2006;16(2):351–442.

    PubMed  Google Scholar 

  25. Annas GJ. Standard of care: the law of American bioethics. New York: Oxford University Press; 1993.

    Google Scholar 

  26. Thomas R. Lacey’s spring woman loses battle with cervical cancer. Decatur Daily. July 31, 2009. http://decaturdaily.com/news/local/lacey-s-spring-woman-loses-battle-with-cervical-cancer/article_e809812edb78-5c38-baad-591d16bdbd80.html. Accessed 17 Mar 2015.

  27. Grondahl P. Despite operation to cut her in half, angel laughs on. www.timesunion.com . October 21, 2011. http://www.timesunion.com/local/article/Despite-operation-to-cut-her-in-half-Angel-2227298.php. Accessed 17 Mar 2015.

  28. Miles SH. The hippocratic oath and the ethics of medicine. Oxford: Oxford University Press; 2004.

    Google Scholar 

  29. Annas GJ. The rights of patients. New York: New York University Press (An American Civil Liberties Union Handbook); 2004.

    Google Scholar 

  30. Lee Char SJ, Hills NK, Lo B, Kirkwood KS. Informed consent for innovative surgery: a survey of patients and surgeons. Surgery. 2013;153(4):473–80.

    Article  PubMed  PubMed Central  Google Scholar 

  31. The EC/IC Bypass Study Group. Failure of the extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke – results of an international randomized trial. N Engl J Med. 1985;313(19):1191–200.

    Article  Google Scholar 

  32. Moseley JB, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002;347(2):81–8.

    Article  PubMed  Google Scholar 

  33. Biffl WL, et al. Responsible development and application of surgical innovations: a position statement of the society of university surgeons. J Am Coll Surg. 2008;206(6):1204–9.

    Article  PubMed  Google Scholar 

  34. Reitsma AM, Moreno JD. Ethical regulations for innovative surgery: the last frontier? J Am Coll Surg. 2002;194(6):792–801.

    Article  PubMed  Google Scholar 

  35. Bunker JP, Hinkley D, McDermott WV. Surgical innovation and its evaluation. Science. 1978;200:937–41.

    Article  CAS  PubMed  Google Scholar 

  36. Centers for Disease Control and Prevention [CDC]. Centers for Disease Control and Prevention. Post-Treatment Lyme Disease Syndrome. August 11, 2014. http://www.cdc.gov/lyme/postLDS/. Accessed 3 Jan 2015.

  37. Centers for Disease Control and Prevention [CDC]. Interim U.S. guidance for monitoring and movement of persons with potential Ebola virus exposure. Centers for Disease Control. December 24, 2014. http://www.cdc.gov/vhf/ebola/exposure/monitoring-and-movement-of-persons-with-exposure.html. Accessed 3 Jan 2015.

  38. Jena AB, Prasad V, Goldman DP, Romley J. Mortality and treatment patterns among patients hospitalized with acute cardiovascular conditions during dates of national cardiology meetings. JAMA Inter Med (American Medical Associaton), December 2014.

    Google Scholar 

Further Reading

  • Chang RW, et al. Serial transverse enteroplasty enhances intestinal function in a model of short gut syndrome. Ann Surg. 2006;243(2):223–8.

    Article  PubMed  PubMed Central  Google Scholar 

  • Office for Human Research Protections, Department of Health and Human Services. Letter from Lisa R. Buchanan, Compliance Oversight Coordinator, to Richard B. Marchase, Vice President for Research and Economic Development, Univeristy of Alabama at Birmingham. Office of Human Research Protection, Department of Health and Human Services. March 7, 2013. http://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf. Accessed 17 Mar 2015.

  • Sacks CA, Warren CE. Foreseeable risks? Informed consent for studies within the standard of care. N Engl J Med. 2015;372(4):306–7.

    Article  CAS  PubMed  Google Scholar 

  • SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010;362(21):1959–69.

    Article  PubMed Central  Google Scholar 

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White, B.D., Gelinas, L.C. (2016). Balancing the Surgeon’s Responsibility to Individuals and Society. In: Stain, S., Pryor, A., Shadduck, P. (eds) The SAGES Manual Ethics of Surgical Innovation. Springer, Cham. https://doi.org/10.1007/978-3-319-27663-2_18

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  • DOI: https://doi.org/10.1007/978-3-319-27663-2_18

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