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Edward Quan, Student Number: 110229389 Six Step Ethical Decision- Making Framework- Whether It is Morally Permissible for Doctors to Prescribe Placebos to Patients Introduction A placebo is a treatment without active therapeutic effects used to induce psychological responses in patients. The ethical issue of prescribing placebos is complex and contentious among healthcare professionals and ethicists. This paper discusses the moral permissibility of prescribing placebos and proposes using the 6-step Ethical Decision-Making Framework to tackle this issue. The framework involves identifying stakeholders, gathering information, and forming an intuitive view, followed by evaluating potential outcomes using ethical theories such as deontology, utilitarianism, virtue ethics, and relationship ethics. Further analysis is conducted based on ethical principles of benevolence, non-maleficence, autonomy, and justice in Step 5. A decision is made based on a sound ethical rationale, taking into account the best interests of all stakeholders. By using this framework, placebo use can be approached thoughtfully and systematically, upholding ethical standards in healthcare practice and promoting patient well-being. Step 1- Identifying Stakeholders Stakeholders are entities with a vested interest or potential impact from the decision or action being taken. Identifying stakeholders involves considering those affected and understanding their interests, needs, and concerns. In this case, stakeholders can be categorised into three levels: individual, organisational, and social, each with their unique involvement and associated issues. The patient is undoubtedly the primary individual stakeholder. They seek medical care, place trust in healthcare professionals, and rely on them for effective treatments. Healthcare professionals, especially doctors, are also stakeholders in this ethical dilemma as 1

Edward Quan, Student Number: 110229389 they are responsible for providing care and making treatment decisions (Tilburt et al. 2008, p. 1). At the organisational level, regulatory bodies such as the FDA may provide guidelines and regulations related to the use of placebos in clinical practice and research. They have a collective responsibility to ensure ethical principles are followed in healthcare practices and research involving placebos, including the principles of beneficence, non-maleficence, autonomy, and justice (Kamper & Williams 2012, p.7). Society and the public, specifically their cultural and social assumptions and beliefs about the use of placebos, can impact public trust in the healthcare system, shape patient expectations, and influence societal values related to the use of placebos in medicine (Schwarz, Pfister & Büchel 2016, p. 470). Additionally, socioeconomic factors such as affordability of medications can also impact healthcare professionals' decisions, and the overall ethical implications of using placebos in different socioeconomic contexts (Xu & Yuan 2020, 204). Step 2: Gathering Data The phenomenon of the placebo effect is widely acknowledged, although its complete understanding is still a work in progress. Recent research suggests that there are various types of placebo effects that operate through different mechanisms (Rajagopal 2006, p. 186). However, the key trigger for the placebo effect is the belief of receiving a treatment that will be effective. The ethical challenge of prescribing placebo consists of three issues- ethical distress, moral dilemma and locus of authority. For ethical distress, it is obvious that patients have the right to be informed about their treatment options and make autonomous decisions about their healthcare. They may be impacted by the use of placebos if they are prescribed a treatment that has no medical benefit, leading to potential harm, delay in appropriate care, and deception. 2

Edward Quan, Student Number: 110229389 Healthcare professionals may face ethical challenges when deciding whether or not to prescribe placebos. In reality, surveys show that up to 77% of GPs in Australia have prescribed placebos, making this a very common practice (Faasse & Colagiuri 2019, p. 876). Despite the potential medical benefits of the placebo effect, prescribing it without informing the patient may violate patient autonomy. The key to this problem is the conflict between the nature of placebo effect and patient’s informed consent. The argument of the placebo effect suggests that sometimes the absolute truth may not be medically beneficial for the patient, in fact quite the opposite as it may be the source of the illness. The dilemma of authority in prescribing placebos is complex. While it is not illegal, the primary responsibility lies with doctors who are expected to follow professional codes, guidelines, and regulations. For example, FDA rules state that patients should only receive placebo in addition to an established treatment (2019). However, these policies do not offer clear guidance on which placebo to use or for which presentations, leaving doctors with limited assistance. Moreover, the principle of patient autonomy suggests that patients should have ultimate authority in treatment decisions- American Medical Association permits placebo use only if the patient is informed (Kamper & Williams 2012, p. 7). However, this approach can undermine the purpose of prescribing a placebo, as the placebo effect relies on false belief. Thus, the locus of authority in prescribing placebos can be seen as a pseudo-proposition, involving complex ethical considerations on a case-by-case basis, and lacks clear-cut guidance to fully protect patients from potential risks associated with placebos. Step 3: Intuitive view The paper takes an intuitive stance that prescribing placebos may be morally permissible for doctors when motivated by beneficence, despite the violation of patient autonomy. In certain situations, the principle of beneficence may outweigh autonomy, according to the information gathered. Step 4: Ethical Analysis- Deontology, Utilitarian, Virtue Ethics & Relationship Ethics Deontology is an ethical theory centred on the morality of actions based on principles and duties. Kantian ethicists often argue for universal laws, known as "categorical imperatives," 3

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Edward Quan, Student Number: 110229389 that guide actions in all situations (Barrow & Khandhar, 2022). In healthcare, the four principles of benevolence, non-maleficence, justice, and autonomy may serve as universal laws (Crutchfield et al., 2016). From a deontological perspective, prescribing placebos involving deception violates patient autonomy and is therefore unethical. However, the limitation of this view is its lack of consideration for potential patient outcomes. The rigid nature of deontological ethics may prevent patients from receiving medical benefits by strictly adhering to the duty of honesty, creating an ethical dilemma that conflicts with the duty of beneficence in the context of placebo prescribing. One proposed solution is the use of open-label placebos, where patients are informed that they are receiving a placebo. However, critics argue that this still entails deception as patients may not fully understand the concept of a placebo due to high expectations during clinical consultations (Plowman & Spurr, 2021). Utilitarianism , a consequentialist approach, seeks to maximise benefits for the greatest number of people, in contrast to deontology. Medical decisions are made based on the balance of medical benefit and harm, with the aim of benefiting patients' best interests (Steiner, 2005). However, critics argue that deception in placebo use constitutes harm and violates patient autonomy and non-maleficence. Another drawback is the potential wastage of resources in predicting outcomes that may not be guaranteed by the choices made. Rule utilitarianism may offer a solution by guiding decisions based on pre-established rules backed by evidence, but it may not fully address the ethical principles of autonomy and lacks the flexibility of action utilitarianism (Mandal et al., 2016). Rule utilitarianism also differs from deontology, as utilitarian rules are determined based on the outcome rather than moral correctness. Thus, the utilitarian approach may face criticisms regarding deception, patient autonomy and resource utilisation. Virtue Ethics emphasises the moral character of individuals and the cultivation of virtues in ethical decision-making. Patients were traditionally encouraged to comply and obey, but Alfano (2015) argues that informed consent should not be overshadowed by compliance. Patients who are provided with accurate information can still comply with treatment and benefit from placebo effects. Proponents of virtue ethics may also highlight the importance of patient dignity, quoting Confucius' maxim ‘Do not do to others what you do not wish for 4

Edward Quan, Student Number: 110229389 yourself’. However, Gold & Lichtenberg (2013) argue that the doctrine of informed consent is overly emphasised in modern medicine. They suggest that prescribing placebos may be guided by a moral imperative and practical wisdom, known as ‘phronesis’, allowing physicians to balance patient autonomy and beneficence. This illustrates the individualistic and nuanced nature of virtue ethics in guiding ethical decision-making regarding placebo use. Relational Ethics , also known as ethics of care, is a moral framework that recognises the significance of relationships in ethical decision-making (Tomaselli et al. 2020, p. 3). This focus on individual care creates an ethical challenge when considering the use of placebos, as deception involved in placebo use may undermine the trust relationship between the patient and the physician, making it ethically questionable. However, open label placebos may offer a potential solution for relational ethicists. Greener (2018, p. 31) highlighted a real case study involving patients who were prescribed open label placebos. The open label placebo proved to be effective in managing symptoms, but it also allowed healthcare professionals to maintain a supportive relationship with their patients. Additionally, a relational view on autonomy may resolve the dilemma between autonomy and beneficence- patient is contending with the clinician therefore the autonomy is not broken. However , this cannot be applied to specific cases, what if the patient contends with the clinician but opposes placebos (Fortunato, Wasserman & Menkes 2017, p. 4)? Step 5: Weighing the Relevant Ethical Principles All four ethical principles of autonomy, beneficence, non-maleficence, and justice are potentially at stake in the ethical dilemma of placebo use, with a particular emphasis on the contradiction between autonomy and beneficence. Unfortunately, finding a perfect solution that fully aligns with all ethical principles may be challenging. When using a placebo, autonomy is compromised as the therapeutic effect is often based on deception, and even with open-label placebos, the patient's ability for self-determination may still be reduced. On the other hand, not using a placebo may align with autonomy but hinder beneficence, especially considering evidence that suggests placebo effects can be beneficial in reducing patient symptoms. 5

Edward Quan, Student Number: 110229389 The concern with non-maleficence is that clinicians may use placebos as a means to appease difficult patients, potentially causing harm. The issue of justice arises from the unpredictability of placebo effects and the lack of concrete facts on their efficacy. Patients who are prescribed placebos may be at a disadvantage compared to those receiving conventional treatments. In the ethical case of placebo use, determining the weighting of each ethical principle is complex, and other aspects of the issue should be considered, such as contextual factors of the patient. It is important to carefully evaluate the ethical implications of placebo use, taking into account the nuances of each case and striving for an ethical decision that balances the principles of autonomy, beneficence, non-maleficence, and justice, while considering other relevant factors. Step 6 : Resolution The ethical dilemma of placebo use presents a challenge due to the conflicting principles of autonomy and beneficence. Viewing this dilemma dialectically, taking into consideration the contextual factors of each case, is crucial. Patient understanding of the placebo effect and its potential impact on autonomy is important, and consideration should be given to patient response and cultural context. While Western morals prioritise autonomy and informed consent, patients from different cultural backgrounds may prioritise other values. Clinicians may benefit from a guideline, such as a flowchart proposed by Sokol (2007, p. 985), although it may have limitations. It is important for clinicians to prioritise beneficence and ensure the safety of the placebo based on their medical expertise (Lichtenberg, Heresco- Levy & Nitzan 2004, p. 553). A multifaceted approach that integrates contextual and therapeutic factors is recommended for ethical decision-making. Continuous research is also essential, as ongoing medical findings may provide further insights into the ethical aspects of placebo use. Conclusion: The Six-Step Framework employs a systematic application of relevant ethical theories to address the ethical dilemma of placebo use, while prioritising a stakeholder-centred approach. The inclusion of ethical theories such as deontology, utilitarianism, virtue ethics, 6

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Edward Quan, Student Number: 110229389 and relational ethics provides valuable insights in navigating the ethical complexities of placebo prescribing. It's important to note that ethical decision-making should not be confined solely to the theories discussed in this paper, as other ethical perspectives may also be relevant. Additionally, the four principles of healthcare ethics - autonomy, beneficence, non-maleficence, and justice - should be carefully considered, taking into account how these principles intersect and impact patient care when resolving the ethical dilemma of placebo prescribing. Word Count: 2000 7

Edward Quan, Student Number: 110229389 References: Alfano, M 2015, ‘Placebo effects and informed consent’, The American Journal of Bioethics , vol. 15, no. 10, pp. 3–12. Asai, A & Kadooka, Y 2012, ‘Reexamination of the ethics of placebo use in clinical practice’, Bioethics , vol. 27, no. 4, pp. 186–193. Crutchfield, P, Johnson, JC, Brandt, L & Fleming, D 2016, ‘The limits of Deontology in Dental Ethics Education’, International Journal of Ethics Education , vol. 1, no. 2, pp. 183–200. Faasse, K & Colagiuri, B 2019, ‘Placebos in Australian general practice: A national survey of physician use, beliefs and attitudes’, Australian Journal of General Practice , vol. 48, no. 12, pp. 876–882. Fortunato, JT, Wasserman, JA & Menkes, DL 2017, ‘Nonmaleficence, nondisclosure, and nocebo: Response to open peer commentaries’, The American Journal of Bioethics , vol. 17, no. 7. pp. W4-W5. Gold, A & Lichtenberg, P 2013, ‘The moral case for the clinical placebo’, Journal of Medical Ethics , vol. 40, no. 4, pp. 219–224. Greener, M 2018, ‘Placebo: A clinical, biological and Ethical Enigma’, Independent Nurse , vol. 2018, no. 12, pp. 28–31. Kamper, SJ & Williams, CM 2012, ‘The placebo effect: Powerful, powerless or redundant?’, British Journal of Sports Medicine , vol. 47, no. 1, pp. 6–9. Lichtenberg, P, Heresco-Levy, U & Nitzan, U 2004, ‘The ethics of the placebo in clinical practice’, Journal of Medical Ethics , vol. 30, no. 6, pp. 551–554. Mandal, J, Ponnambath, DK & Parija, SC 2016, ‘Utilitarian and deontological ethics in medicine’, Tropical Parasitology , vol. 6, no. 1, p. 5. Plowman, R & Spurr, S 2020, ‘Ethics of placebo use in clinical practice: Why we need to look beyond deontology’, Journal of Medical Ethics , vol. 47no. 4, pp. 271–273. Rajagopal, S 2006, ‘The placebo effect’, Psychiatric bulletin , vol. 30, no.5, pp. 185-188. Schwarz, KA, Pfister, R & Büchel, C 2016, ‘Rethinking explicit expectations: Connecting Placebos, social cognition, and Contextual Perception’, Trends in Cognitive Sciences , vol. 20, no. 6, pp. 469–480. Sokol, DK 2007, ‘Can deceiving patients be morally acceptable?’, BMJ , vol. 334, no. 7601, pp. 984–986. 8

Edward Quan, Student Number: 110229389 Steiner, T. J. 2005, Using placebo in headache management , Blackwell Publishing Ltd, London Tilburt, JC, Emanuel, EJ, Kaptchuk, TJ, Curlin, FA & Miller, FG 2008, ‘Prescribing “placebo treatments”: Results of national survey of US internists and Rheumatologists’, BMJ , vol. 337, no. oct23 2, pp. 1-5. Tomaselli, G, Buttigieg, SC, Rosano, A, Cassar, M & Grima, G 2020, ‘Person-centered care from a relational ethics perspective for the delivery of high quality and safe healthcare: A scoping review’, Frontiers in Public Health , vol. 8, pp. 1-11. Xu, C-Y & Yuan, C-M 2020, ‘The ethical dilemma of placebo use in clinical practice’, Frontiers of Nursing , vol. 7, no. 3, pp. 203–208. 2019, ‘FDA’s Guidance on Placebos’, blog post, RegDesk Blog , 4 September, viewed 13 April 2023, <https://www.regdesk.co/fdas-guidance-on-placebos/> 9

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