Informed Consent and Truth-telling: Changing Realities and Present Challenges

1. Informed Consent and Truth-telling: Changing Realities and Present Challenges 醫生、病人關係的世界性轉變：病人私隱有否限制？ 譚傑志教授JOSEPH THAM, MD, PHDSchool of Bioethics, Regina Apostolorum, Rome, Italy

2. Truth telling and Informed Consent Historical Background Principlism, Autonomy Multiculturalism Implications for China Advance Directives 病情告知和知情同意 历史背景 原则主义，自主权 多文化主 在中国的应用 預設醫療指示(遺囑) Outline 概要

3. J G W S Wong, Y Poon and E C Hui, “I can put the medicine in his soup, Doctor!” Journal of Medical Ethics 2005; 31:262-265. A young man with schizophrenia. His mother had been giving him antipsychotic medication covertly in his soup. Should the doctor continue to provide a prescription, thus allowing this to continue? Truth telling and the balance between individual versus family autonomy. 一个还有精神分裂症的年轻患者 患者母亲长期将安定药物放进患者所食用的汤里 在这种情况下，医生应该继续给患者家属开具处方吗？应该允许此类情况继续发生吗？ 告知真相以及在个人和家庭自主权之间的平衡 Case: "I can put the medicine in his soup, Doctor!“ 案例: “医生，我能把药放进他的汤里让他喝!"

4. Case: • 65 y.o. Mexican woman, immigrant dx with aggressive late stage ovarian cancer. Poor prognosis. • Her family explicitly told MDs that she would not want to hear any bad news. It may cause too much trauma • What should the MD do in this case?

5. Modern Medicine Curing and treatment options Better diagnosis, prognosis Paternalism to Patient’s rights Appearance of Bioethics Cultural changes in 1960s Scandals and abuses became public Right’s movements, distrust with authority figures Legal cases 现代医学 多种处理和治疗方式的选择 更好的诊断及预后 家长式作风对患者权利的影响 生命伦理学的出现 在1960s年代出现的文化改革 医学丑闻和陋习公开化 权利运动，对权威人士的不信任 诉讼案件 Historical Background历史背景

6. A bit of history • Abuses • Patients’ rights to know • Legal challenges • Ethics comes before the law? • Protect the patients or protect MDs • 濫用 • 患者的知情權 • 法律上的挑戰 • 倫理置於法律面前？ • 保障病人或保護醫生?

7. Principlism 原则主义 • Product of modern philosophy 现代哲学的产物 • Analytic philosophy 分析性哲学 • Normative ethics 规范伦理 • National Commission for the Protection of Human Subjects 1974-1978 • Abuses 滥用 • National Research Act 1974: 12 commissioners to identify ethical principles (Engelhardt's sin of his youth) • Belmont Report 1978 • Principles 原则 • Respect for persons 对人的尊重—informed consent 知情同意 • Beneficence行善原则—risk-benefit ratio 风险-利益比 • Justice 公平 —subject selection 受试者选择 • Quasi-official status 似乎获得官方正式的地位

8. Beauchamp and Childress: Principles of Biomedical Ethics Autonomy, beneficence, nonmaleficence, justice Prima facie principles Popularity and practicability: clinics, public policy, doctor-patient relationship Presumes common morality Intuitionism or emotivism Beauchamp 和 Childress: 生命医学伦理学原则 自主权，行善，不作恶，公平 初次印象原则 普及性和实用性：临床，公共卫生政策，医患关系 假定拥有共同的道德标准 直觉主义，动感情主义 Principlism 原则主义

9. Tyranny of autonomy Trumping all other principles No consensus Law (Patient Self-determination Act 1990) Anti-paternalism, anti-authority Individualism Inadequate: not all choices are good 自主权的 “独断专行” 以其他所有原则为幌子 无法达成一致意见 法律 (患者自主决策法案 Patient Self-determination Act 1990) 反家长主义，反权威主义 个人主义 不足之处：并不是所有的选择都是有好处的 Challenges to Principlism原则主义面临的挑战

10. Autonomy and informed consent Signing a paper Reasonable and prudent person standard. Patient’s right NOT to know? Autonomy and truth-telling Never lie to patient. Truth could never be harmful? Autonomy and family decisions Ambiguity of 4 principles and their secularized context 自主权与知情同意 签署某种文件 合适而谨慎的个人标准 患者拥有“不知情”的权利吗? 自主权与告知真相 永远不向患者撒谎 难道真相永远都不会造成伤害吗? 自主权与家庭决策 4项原则的模糊表述以及各自的俗世语境 Challenges to Principlism原则主义面临的挑战

11. Principlism Neo-casuistry Consensus ethics Engelhardt’s content-less consensus ethics Contextual ethics Pragmatic ethics Utilitarian ethics Liberalism and nihilism 原则主义 新诡辩论 共识伦理学 Engelhardt無內容的共识伦理学 背景性伦理学 实用主义伦理学 功利主义伦理学 自由主义和虚无主义 Challenges to Principlism原则主义面临的挑战

12. Controversial Inhuman and unrealistic Ignores the fact hat the person is not just an isolated individual, but has ties to family, friends, religion, society. Immigrants and multurculturalism: importance of family in healthcare decision-making 富有争议的 不人道而且不现实 忽略了人不是一个孤立的个体，而是与家庭、朋友、宗教、以及社会等紧密相连这一事实。 移民和多文化主义:家庭在医疗决策中的重要性 Challenges to Principlism原则主义面临的挑战

13. Autonomy • Autonomy = self-determination • No more “paternalism” • Tyranny of autonomy? • Must MD do everything patients request? Eg. female circumcision, etc. • 自治=自決 • 沒有更多的“家長式“ • 自主權暴的政？ • 醫師必須盡一切病人要求？例如。女性割禮等

14. Challenges • Becomes a piece of paper • How much information is needed? • Can informed consent be truly informed? • 變成了一張紙 • 需要多少信息？ • 知情同意是真正可以告知情況？

15. The enhanced patient autonomy approach requires the inclusion of family members in the decision making process. (Surbone, 2006) Patient autonomy = complex concept referring to both one’s capacity to choose and to one’s ability to implement one’s choices 得到提升的患者的自主权需要将家庭成员纳入到决策制定过程中来(Surbone, 2006) 患者的自主权 = 与个人的选择能力以及执行个人选择的能力相关的复杂概念 Relational Self 關係性自我

16. New paradigm • Autonomy as individual self vs relational self • Family, other members, etc. • Decision making • Truth telling • Breaking bad news • Placebo • 自治 = 個人自我還是關係自我 • 家庭其他成員等 • 決策 • 病情告知 • 壞消息 • 安慰劑

17. New Paradigm • Do patients want to know bad news? • Fear from MD > patient • Not to let hope die? Deception to maintain hope? • When to tell, how to tell (sequence), who to tell… • Family involvement can soften the impact • Rights to refuse to know? • 病人想知道壞消息？ • 醫師>病人害怕 • 不要讓希望死嗎？騙保持希望？ • 當告之，如何辨別真假（序列），誰告訴... • 家庭的參與可以軟化影響 • 有權拒絕知道嗎？

18. Multiculturalism • Challenging the individualist approach • Patient’s culture, religion, values system, etc. • MD’s knowledge of these systems, strategies to be culturally sensitive • 挑戰個人主義方法 • 病人的文化，宗教，價值觀系統等 • 醫師對這些系統的知識，在文化識相的戰略

19. In China 對於中国 • 家庭主义為成在中国的初次印象 • 家庭，村，县 ，省，国家，民族… • 原则主义的知情同意以及告知真相在实践中所遇到的困难 • 家庭主义与西方的關係性自我概念的趋同 • 挑战：逐渐缩小的家庭规模，个人主义 • Familism as prima facie in China • Family, village, province, nation • Difficulties with informed consent and truth telling practices of principlism • Convergence of familism with the relational self concept in the West • Challenges: smaller family units, individualism

20. 保持信任 尊敬他人 真相 避免强迫或操縱 維持联络的价值

21. Advanced Directives from a Catholic Perspective • Francisco de Vitoria • ordinary vs. extraordinary means 普通 vs. 特殊的手段 • Medical advances now gave doctors much more options to cure and prolong life, and even prolong the dying process. • Pope Pius XII in 1957.

22. Ordinary vs extraordinary means • Ordinary (proportionate相稱) means are those basic care and treatments which doctors are obligated to provide and which under normal circumstances, patients should not refuse—run of the mill medical treatment, hygiene, antibiotics, etc. • Extraordinary (disproportionate 不相稱) means are those medical measures that can cause undue burden on the patients and the family, and therefore patients are not obliged to undergo these (experimental) treatments, or if they have been started could ask for their withdrawal.

23. Ordinary vs extraordinary means • There are objective and subjective elements that the patients and doctors must weigh the risks and benefits in each case. • Objective elements such as the difficulties, pain risk, cost and success rates, etc. • Subjective elements include fear, anxiety, physical or psychological suffering, shame, the desire to live on, the time to settle affairs, etc. • Preferred term is proportionality, since some ordinary means can become disproportionate in very ill patients, and some extraordinary means can be proportionate to patient needs when the risk and benefits are weighed.

24.  Therapeutic obstinacy and Euthanasia • Two extremes to be avoided. • Therapeutic obstinacy 治療頑固: When all available treatments have been tried and patient is dying, doctors should accept this rather than employing all technology to prolong the dying process, thus causing more suffering and does not respect the dignity of the person. (Unrealistic expectations from patients, family and doctors: Medicine or doctors seen as saviors, failure). Pius XII: extraordinary means can be withheld or withdrawn.

25.  Therapeutic obstinacy and Euthanasia • CCC 2278 Discontinuing medical procedures that are burdensome, dangerous, extraordinary, or disproportionate to the expected outcome can be legitimate; it is the refusal of “over-zealous” treatment. “過分熱心” 治療 Here one does not will to cause death; one's inability to impede it is merely accepted. • The decisions should be made by the patient if he is competent and able or, if not, by those legally entitled to act for the patient, whose reasonable will and legitimate interests must always be respected.

26.  Therapeutic obstinacy and Euthanasia • Euthanasia: to end someone’s suffering by intentionally ending his or her life. • “By euthanasia is understood an action or an omission which of itself or by intention causes death, in order that all suffering may in this way be eliminated.” (Declaration on Euthanasia 1980, EV, CCC) • Level of intention, includes omission if the intention is there to provoke death. Could be voluntary or non-voluntary. • 安樂死：結束一個人的痛苦，故意結束她的生命。 • 意向的層次 • 包括不行動故意造成死亡 • 可能是自願或不自願的。

27. PVS and ANH 植物人, 人工營養與水分 • Water and nutrition are basic needs, not therapy. • Withdrawal with the intention to cause death, since PVS patients could live on indefinitely. That is, cause of death is starvation and dehydration. • Recent report form NEJM—some of them can have thought processes.

28. Historical Background on Advanced directives • Quinlan Case: Natural Death Act 1979 • Karen Ann Quinlan, PVS and on ventilator. Parents petitioned for withdrawal of respirator, but doctors refused. Court decided that ventilator is an extraordinary means, and can be withdrawn, citing Pius XII. • Natural Death Act: There is a right to express one’s will regarding life sustaining treatments, and the right to withdraw or withhold them. In the case of mental incapacity, these rights can be expressed by either Advanced Directives (written document) or durable power of attorney (proxy) by naming someone who could make the decision on behalf of the patient.

29. Historical Background on Advanced directives • Cruzan Case: Patient Self-determination Act 1991 • Nancy Cruzan also PVS, on artificial nutrition and hydration (PEG). Family wanted removal of tube feeding against doctor’s judgment. They were able to demonstrate retrospectively that this was the patient’s desire. • Patient Self-determination Act requires all health care institutions to advise all patients admitted to their facilities the availability of advanced directives. • Terri Schiavo

30. Context of the Living Will movement • Fear of technology: hooked up to machine and living an undignified existence • Euthanasia movement in the 1980s found it difficult to change the laws to permit euthanasia. • More emphasis on who decides rather than what is best for the patient. • Individualism: Self-determination often becomes the only criteria

31. Critiques • Difficulties in explaining to patients the medical conditions, and they could be subject to manipulation, undue fears and ideological pressures. Not truly informed consent. • Difficulty in foreseeing all possible future situations which can be complex. When circumstances change, people can change their minds (eg. Charles Kao) • Damaging relationships between doctors and patients: Doctors just execute the patient decision as a robot • Tyranny of Autonomy: Respect of the person includes looking for what is best for the patient. • Not all decisions are wise and good. One can choose the wrong thing. “No man is an island”—recent shift of emphasis that decision making is best when made in a wider “relational” context including family, friends, and co-religionists. Familism in Asia.

32. Legal frameworks • Legally binding (USA, Australia, UK, Holland, Belgium) or just consultative and indicative (Italy, Germany, Austria) • Existence of Catholic versions of “Advanced Directives” that respect the Catholic teaching (e.g. NCBC). In general, resistance to its use because of these problems.

33. Introduction of the Concept of Advanced Directives in Hong Kong • Terminal illness / irreversible coma / PVS, are very different conditions. Different principles apply here—for eg., any treatment in truly irreversible coma would be wrong, even ANH. Whereas in the case of PVS, withdrawal of ANH would be euthanasia. • Euthanasia defined as “direct intentional killing of a patient as a part of the medical care being offered.” Omission can also be a means of intentional killing. • Artificial vs. natural rather than proportionality the criteria. That is, artificial means are always inappropriate or burdensome… Definition of life-sustaining treatment includes ANH. (Catholic hospitals should not cooperate with this) • Family or relatives seen as enemies to patient self-determination. Elimination of proxy as an option. This is absurd in the Asian context, especially in view of the recent shift of opinion coming from the Western experience. • Options only to withdraw or withhold treatments, no mention of desire to continue treatments under these conditions. Doubt: cost saving measures?