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The Nocebo Effect and Informed Consent—Taking Autonomy Seriously

Published online by Cambridge University Press:  11 March 2020

SCOTT GELFAND
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Abstract

The nocebo effect, a phenomenon whereby learning about the possible side effects of a medical treatment increases the likelihood that one will suffer these side effects, continues to challenge physicians and ethicists. If a physician fully informs her patient as to the potential side effects of a medicine that may produce nocebogenic effects, which is usually conceived of as being a requirement associated with the duty to respect autonomy, she risks increasing the likelihood that her patient will experience these side effects and therefore suffer (unnecessary) harm, a violation of the duty of nonmaleficence. If, on the other hand, she intentionally withholds side effect information in an effort to protect her patient from suffering unnecessary harm from side effects, which is consistent with the duty of nonmaleficence, she violates the duty to respect patient autonomy. In this paper, the author discusses several previous attempts to deal with the nocebo effect and explains their weaknesses. He then proposes a means of managing the nocebo effect and argues that it does not share the weaknesses found in previous approaches. He concludes with a discussion of a simple, yet practical tool that might help clinicians manage the tension resulting from the nocebo effect.

Keywords

nocebo effectnocebo dilemmapatient autonomyduty of nonmaleficenceside effectsduty of informed consentwithholding information
Type
Special Section: Causality and Moral Responsibility
Information
Cambridge Quarterly of Healthcare Ethics , Volume 29 , Issue 2 , April 2020 , pp. 223 - 235
Copyright
© Cambridge University Press 2020

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References

Notes

1. In an essay discussing the nocebo effect, Shlomo Cohen states that a search for ‘nocebo’ in the Philosopher’s Index “yields a striking zero result.” See Cohen, S. The nocebo effect of informed consent. Bioethics 2014;28(3):147–54, at 147CrossRefGoogle ScholarPubMed.

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3. A related problem associated with the nocebo effect is that when patients suffer side effects (as a result of the nocebo effect) or are aware that they may suffer side effects, the likelihood of nonadherence and/or discontinuation of treatment increases. See, Barsky, AJ, Saintford, R, Rogers, MP, Borus, JF. Nonspecific medication side effects and the nocebo phenomenon. Journal of the American Medical Association 2002;287(5):622–7CrossRefGoogle ScholarPubMed.

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5. Wells, RE, Kaptchuk, TJ. To tell the truth, the whole truth, may do patients harm: The problem of the nocebo effect for informed consent. American Journal of Bioethics 2012;12(3):22–9CrossRefGoogle ScholarPubMed.

6. Myers, MG, Cairns, JA, Singer, J. The consent form as a possible cause of side effects. Clinical Pharmacology & Therapeutics 1987;42(3):250–3CrossRefGoogle ScholarPubMed.

7. Although this study focused on participant withdrawal from clinical trials, it is reasonable to conclude that the same (or similar) results would obtain with respect to clinical encounters.

8. Wells and Kaptchuk, state: “Since the chief motivation behind informed consent is the protection of patients, then through the principle of beneficence, withholding self-fulfilling nocebogenic information may be appropriate through contextualized informed consent” (see note 5, Wells 2012;25). Although Wells and Kaptchuk imply that the principle of beneficence trumps the principle of autonomy because latter is motivated by the former, in their essay they describe a nuanced approach to informed consent–contextualized consent–that takes seriously both of these principles. They claim that the key to resolving (managing) the nocebo effect dilemma is balancing informed consent and nonmaleficence.

9. Beauchamp, TL, Childress, JF. Principles of Biomedical Ethics, 4th ed. New York, NY: Oxford University Press; 1994, at 142Google Scholar.

10. Gillon, R. Ethics needs principles–four can encompass the rest–and respect for autonomy should be “first among equals.” Journal of Medical Ethics 2003;29(5):307–12, at 310CrossRefGoogle ScholarPubMed.

11. Daniel Callahan, who was critical of the prominence placed on autonomy, nevertheless recognized the role it played among ethicists: “Autonomy is, then, in fact given a place of honour because the thrust of individualism, whether from the egalitarian left or the market oriented right, is to give people maximum liberty in devising their own lives and values.” Callahan, D. Principlism and communitarianism. Journal of Medical Ethics 2003;29(5):287–91, at 289CrossRefGoogle ScholarPubMed.

12. See note 1, Cohen 2014, at 149–52.

13. O’Neill, O. Some Limits of Informed Consent. Journal of Medical Ethics 2003;29(1):4-7 CrossRefGoogle ScholarPubMed.

14. See note 1, Cohen 2014, at 150.

15. See note 1, Cohen 2014, at 150.

16. See note 1, Cohen 2014, at 153.

17. Fortunato, JT, Wasserman, JA, Menkes, DL. When respecting autonomy is harmful: A clinically useful approach to the nocebo effect. The American Journal of Bioethics 2017;17(6):36–42 CrossRefGoogle ScholarPubMed.

18. See note 17, Fortunato et al. 2017, at 40.

19. See note 17, Fortunato et al. 2017, at 40.

20. Luanne Colloca makes this same point: “Having an ‘identikit of the nocebo responder’ is far from becoming clinically available.” See Colloca, L. Tell me the truth and I will not be harmed: Informed consents and nocebo effects. American Journal of Bioethics 2017;17(6):46–8, at 47CrossRefGoogle Scholar.

21. Hadley Bryan and Veljko Dubjevic make a similar point and claim that distrust of medical personnel may have the effect of increasing nocebogenic effects. See Bryan, H, Dubljevic, V. To disclose or not to disclose: When fear of nocebo effects infringes upon autonomy. American Journal of Bioethics. 2017;17(6):50–2, at 51CrossRefGoogle ScholarPubMed.

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23. Lawrence, RE, Curlin, FA. Autonomy, religion and clinical decisions: Findings from a national physician survey. Journal of Medical Ethics 2009;35(4):214–8CrossRefGoogle ScholarPubMed, at 218.

24. See note 23, Lawrence, Curlin 2009, at 218.

25. Fowler, FJ, Gallagher, PM, Bynum, JP, Barry, MJ, Lucas, FL, Skinner, JS. Decision-making process reported by Medicare patients who had coronary artery stenting or surgery for prostate cancer. Journal of General Internal Medicine 2012;27(8):911–6, at 914CrossRefGoogle ScholarPubMed.

26. See note 25, Fowler et al. 2012, at 914.

27. See note 25, Fowler et al. 2012, at 914.

28. See note 20, Colloca 2017, at 46.

29. Colloca, L, Miller, F. The nocebo effect and its relevance for clinical practice. Psychosomatic Medicine 2011;73(7):598–603 CrossRefGoogle ScholarPubMed, at 602.

30. Hadley Bryan and Veljko Dubljevic make a similar proposal. They assert that physicians should ask patients whether they want to know side effect information and then explain the nocebo effect. If patients want to be fully informed, physicians should attempt to minimize the possibility that patients will suffer nocebogenic effects. “One such method includes prescribing additional medication such as cholecystokinin (CCK) antagonists, which have been found to block certain nocebo effects. The prescription of CCK antagonists would offer a possible solution without sacrificing patient autonomy, increasing the complexity of provider–patient interaction, or causing any additional harm.” See note 21, Bryan, Dubljevic 2017, at 50.

31. See note 17, Fortunato et al. 2017, at 37.

32. I realize that at this point I am treating autonomy as having only instrumental value. Later in this essay I discuss how autonomy may have intrinsic value and how this affects Type 1 and Type 2 cases.

33. Significantly, if trust in physicians suffers as a result of nondisclosure, patients may be more inclined to do their own research (on the Internet). Hence, patients who do not learn about harmful side effects in their physicians’ offices will learn about them anyway. This last is dangerous in that no one is present to put this information into perspective, and patients (especially those with high somatization likelihood) may suffer harms from side effects that are of a greater magnitude than they would suffer if they obtained the information in a physician’s office.

34. I am confident that there are some other situations that may warrant overriding the default. This is unsurprising, given that medicine is an art form, and being a good artist or creating a fine piece of art cannot be reduced to a simple set of rules or algorithms.

35. In an essay addressing the issue of nudging and informed consent, I make a similar suggestion. See, Gelfand, S. The meta-nudge – A response to the claim that the use of nudges during the informed consent process is unavoidable. Bioethics 2016;30(8):601–8CrossRefGoogle Scholar.

36. The Wong-Baker FACES pain scale is preferred by both parents and children. Chamber, CT, Giesbrecht, K, Craig, KD, Bennett, SM, Huntsman, E. A comparison of faces scales for the measurement of pediatric pain: Children’s and parents’ ratings. Pain 1999;83(1):25–35 CrossRefGoogle Scholar.

37. I want to thank Mary Arpe for this idea.

38. As suggested above, this is a very rough sketch. Presumably, developing an autonomy scale would require significant empirical research, as some words or descriptions would likely be more anxiety producing than others. Clearly, the autonomy scale should not significantly increase anxiety in the way that ‘authorized concealment’ does.

39. It may be the case that patients would be more willing to share their honest beliefs if someone other than their physicians administered this test.

40. Although numerous studies have been conducted in an effort to discover ways to decrease implicit bias, there remains much to be learned. That said, research pertaining to decreasing implicit bias in hiring interviews suggests that structured interviews are beneficial. In one study, the authors conclude: “the unstructured interview tends to be where job-irrelevant information tends to emerge to influence interviewer decisions.” Purkiss, SLS, Perrewé, PL, Gillespie, TL, Mayes, BT, Ferris, GR. Implicit sources of bias in employment interview judgments and decisions. Organizational Behavior and Human Decision Processes 2006;101(2):152–67, at 164CrossRefGoogle Scholar.

41. See note 20, Colloca 2017, at 47.