LAW EXAM 1-2.pdf

Introduction to Ethics and Ethical Theory Definitions Ethics: study of principles of right and wrong behavior Moral Philosophy: consists of a series of behavioral recommendations – synonym of ethics – broken down into 3 branches: Meta-ethics: defines ethical concepts...

Introduction to Ethics and Ethical Theory Definitions Ethics: study of principles of right and wrong behavior Moral Philosophy: consists of a series of behavioral recommendations – synonym of ethics – broken down into 3 branches: Meta-ethics: defines ethical concepts (how moral philosophy is defined, examining moral concepts as right, wrong, justice, etc) Normative ethics: commonly-held principles or theories that can be used by everyone Applied “or professional” ethics: applies ethical principles within a particular professional group (pharmacy ethics belongs here and deals with issues that might not be relevant to other disciplines) Ethics and morality are closely related: terms are used interchangeably – something unethical, is also immoral Morality: specific set of norms or principles by which people live by Empirical statements are declarative – ex: clinical pharmacy is an empirical science (uses clinical research and observation) & ethical statements are imperative Moral Responsibility: requires freedom of action → a person can be held morally responsible for an action only if they had the freedom to choose and act otherwise Freedom of action: free moral agents are able to choose; idea that there are 3 possible levels of moral duty involved with every human action Morally permissible/neutral: actions with no ethical import; neither mandated nor forbidden (ex: choice of color for your clothes, coffee vs tea, or time you go to bed at night) Morally obligatory: actions that must be done or must be avoided – failure to do these duties brings moral blame (ex: lying for selfish personal gain, causing avoidable harm on purpose) Morally heroic: actions that exceed minimal obligations, that go “above and beyond” mere duty – these acts are not morally required, but are universally recognized as noble and sacrificial; may involve personal costs or sacrifice (ex: donating a kidney to a total stranger) Organizing Ethical Theories – The Trolley Problem A) You are alone and can throw the lever to avoid killing 5 people, but you would be killing 1 Example of consequentialist reasoning B) You are next to a heavy man that you can push into the tracks and save everyone but you would be killing this 1 heavy man Example of deontological reasoning Theories based on principle Deontological: rely on core principles, no matter what the outcome is = “It’s the law, period” In example B) of the trolley, the idea of harming a man who was not previously threatened, even to save others, is wrong Morality independent of results Theories based on outcome  Consequentialist: only relies on results as the sole determinant of right and wrong = “The end justifies the means” In example A) of the trolley, allowing 1 person to die to save 5 more makes sense Utilitarianism is one example The problem with this approach is not every theory fits perfectly into those 2 categories and for this reason, a different framework has been proposed to categorize ethical rules: Reason: Natural Law and Kantian Ethics Tradition: Divine Command Theory and The Hippocratic Oath Relationships: Utilitarianism and Virtue Ethics Reason-Based Theories Natural Law Proponents ○ Thomas Aquinas (Roman Catholic) ○ John Locke (17th Century British political philosopher) Characteristics ○ Morality can be derived from nature of the universe and the nature of human beings ○ There are universal moral standards that all humans have and they govern our reasoning and behavior ○ May provide a helpful perspective for those who just don’t “feel right” about specific actions ○ This idea is “theistic” – based on the existence of God, and related to Christian religion; naturalists say that even though the bible is important, non-Christians also know “deep down” what is right and wrong ○ Immoral = anything that interferes with the natural order of things Limitations ○ Not everyone will agree on what is “natural” or “built-in” in human nature ○ Our sinful nature (from falling from heaven) distorted our natural understanding of morality Example ○ “A patient is in a persistent vegetative state (PVS). He can breathe on his own but has no conscious interaction with his environment. He has a feeding tube in place to maintain nutrition and hydration. Can the feeding tube be removed on a patient, or is continuing the feeding tube morally obligatory?” ○ Natural law says: do not discontinue nutrition and hydration because providing food and water is part of the minimal ethical duty we owe to one another since it is required for survival. Kantian Ethics Proponent ○ Immanuel Kant (18th century philosopher) – his philosophy is based on pure reason, apart from God Ethics consists of imperative statements in the form of recommendations from proper behavior Kant teaches there are 2 types of imperative statements: ○ Hypothetical imperatives: ★ Simple “if.. Then” statement; conditional command ★ Example: if you wanna pass the exam, then you should study ★ This has nothing to do with morality, but good judgment to help someone get ahead (prudence) ○ Categorical imperatives  ★ Acting ethically depends on this ★ Morality = only do an act if it can be made a universal law for everyone else (binding on everyone) ★ Very deontological idea ★ Example: stealing (morally wrong; will lead to chaos if everyone does it) + doctors lying to their patients (cannot be generalized because it destroys trust) Advantages ○ It matches most people’s ideas about moral right and wrong ○ Objective standard of moral truth, making us less prone to rely on our feelings and emotions Limitations ○ Why act this way? Implies an ideal person motivated by just duty (not devotion to God) ○ Cannot handle ethical conflicts: what happens when categorical imperatives conflict? ○ Consequences are important Example: ○ “Should a doctor lie to their patient about their cancer diagnosis just because she can go on her cruise and enjoy life, but then he will tell her about it” ○ According to Kant: no Tradition-Based Theories Divine Command Theory Characteristics ○ Moral obligation comes directly from God; his will determines right and wrong Advantages ○ It helps avoid the problem of relying too heavily on flawed human reason ○ Allows shared decision-making with people that think the same (spiritual counselors, priests) ○ No action is morally arbitrary ○ Morality is embedded in nature of God and universe (related to universal law) ○ Ethical rules written in Scripture are grounded in God’s very nature Limitations ○ “Is something right because God commands it, or does God commands us to do what is right because it is right?” ○ Whose bible? ○ Whose interpretation? ○ Relevance? ○ Some religions take portions of sacred texts and translate them, leading to conclusions never intended by original writers Example ○ “A pharmacists tells a religious couple to abort their unborn child with down syndrome” ○ According to the DCT: the pharmacist should respect their religious sensibilities and should present risks and benefits for each option available The Hippocratic Oath Will be discussed in depth separately (coming up) Relationship-Based Theories What Would Jesus Do? Not the same as Divine-Command Theory Based on a preconceived mental image of Jesus Very popular in post-modern society Utilitarianism Proponent ○ John Stuart Mill (British philosopher) Characteristics ○ The morally right action is the one that produces the most happiness for the greatest number of people; focuses on results ○ Intellectual and moral pleasures are more important than physical ones: happiness > pleasure Advantages ○ Very “democratic”: the happiness of one person is no more important than that of another ○ Fits in with our intuitions Limitations ○ Can we really predict the ultimate outcomes of any particular action? ○ Might fail to protect minorities and their rights Example ○ “A doctor wants to save the short-supply vaccine only for high risk children who are the ones most affected by the virus” ○ According to classical utilitarianism: this is a good thing because it would bring the best outcome for the most patients Virtue Ethics Characteristics ○ Based on reputation or character; strength of character is the key, more important than actions themselves ○ Virtue as the “golden mean” – taught by Aristotle – between deficiency and excess Example: “a soldier should not be reckless in a way that he risks his own life and others, but he cannot be a coward either that fails to fight” – the “golden mean” is just simple courage Limitations ○ The definition of virtue is culture-dependent ○ Does not examine actions themselves so it does not give guidance for specific ethical problems; instead it assumes that the virtuous person “will know what to do” Example ○ “A patient goes up to a pharmacist asking what he would do: if to use probiotics daily to avoid diseases or not” ○ According to virtue ethics: he should leave the decision up to her but also state his own opinion, assuming that he has examined the evidence Hippocrates and Medical Principlism Hippocrates (c. 400 BC) The most famous of all physicians  Countercultural ideas Along with his followers, founded a school based on the Oath The Oath I swear by Apollo the physician, and Aesculapius, and Hygeia, and Panacea and all the gods and goddesses, making them my witnesses, that I will fulfill according to my ability and judgment, this Oath and covenant Characteristics Rich source of healthcare wisdom for medical professionals Based on “tradition”, but easily compatible with Christianity Very deontological Fiduciary relationship: a relationship in which one person places special trust, confidence, and reliance in and is influenced by another person who has a duty to act for the benefit of the first person Covenant (a duty) – more than a contract: high level of responsibility Duties to patients (prima facie rules: starting point for decision-making) Principle #1: Beneficence – having a patient’s best interest in mind Principle #2: Non-maleficence – do no harm ○ Confidentiality is included here Principle #3: Distributive justice – treat all patients equally Principle #4: Autonomy – the right of competent patients to make informed decisions about their own medical care – based on informed consent; implies decision-making capacity Decision-Making, Informed Consent, and Other Matters Decision-Making Capacity (Decisional Capacity) Critical difference between competence and capacity – often confused Competence ○ Legal determination, made by a judge ○ Requires a court order and designation of a guardian Capacity ○ A clinical determination, made by a physician ○ A patient may temporarily lose decision-making capacity due to illness, anxiety, or pain Example: “A woman has IVs inserted and she is complaining that she doesn’t want any needles or hospitals. Husband says to doctors to ignore her, that she is not herself. Doctors acted on husbands request and continued to treat her” ○ This did not require a court order, just a clinical decision Informed Consent Contractual Clinician explains, patient agrees (but more complex) Elements Disclosure ○ Reasonable clinician standard vs reasonable patient ○ Includes complete description of the patient’s current clinical status, explanation of possible treatments, along with risks and benefits of each, and recommendation based on clinician’s judgment Comprehension ○ Did the patient understand?  ○ Barriers: language, education, health literacy, patient denial, embarrassment, fear… Documentation ○ On the medical record ○ It’s just more than having a signature on file; it requires multiple forms of documentation Levels of Consent Highest level ○ Informed consent by a patient with decision-making capacity Next level ○ Substituted judgment – surrogate decision-making when patient lacks decision-making capacity ○ Applies to: adults with mental disabilities, minors, temporarily or permanently comatose patients, patients with dementia or otherwise incapacitated Lowest level ○ Best interests standard – basis for implied consent ○ Applies to medical emergencies when no one is available to give legal consent ○ Logical outcome of beneficence Special Case: Consent of Minors A minor is not legally able to give informed consent for treatments in the US, so parents are typically the surrogates In select cases, it may be necessary to ask a local court to intervene if the parent’s wishes are in conflict with the child’s best interests Even if a child cannot consent, their “assent” is essential for therapeutic benefit ○ Help child understand their condition and what to expect Exceptions (state laws differ) ○ Contraception, abuse, abortion, STDs ○ Emancipated minor: lives independently from parents or married, serving in the military ○ Pregnancy does not always confer emancipated status (but sometimes) ○ Mature minor: 15 YO and older that appears to make reasoned judgements + proposed treatment is for patient’s benefit, justifiable by medical opinion, parental consent cannot be obtained Truth Telling Lying or withholding vital information would lead to a breakdown in the trust relationship of healthcare professionals and patients Various ethical theories point to the same conclusion: non-maleficence, kantian ethics, virtue ethics Do not confuse discomfort at giving bad news with justification for withholding the truth Sensitive disclosure promotes autonomy Exceptions Patient declines to know more information Examples: “i don't want to know any more details, just do the procedure”, “tell my husband all the info, he will make the decisions” Special case: Placebos Many patients respond favorably to the “placebo effect”; this idea comes from a beneficent intent Example: “elderly woman is abusing zolpidem. Pharmacist gives her a vitamin and calls it a sleeping pill” → not ethical, pharmacist needs to control problem directly Misleading the patient violates their ability to make autonomous decisions about their health Placebos in research are ethical because patients sign a proper consent Confidentiality Privacy of medical information Contained in the Hippocratic Oath Health Insurance Portability and Accountability Act (HIPAA, 1996) Not absolute – must be balanced against other interests Human Value Personhood What is a person? A member of the “moral community” Another word for person is “moral agent” – one who has moral rights and duties Implies status and moral value Who is a person? Cognitive adults (at least) Other candidates: aliens, intelligent machines, higher animals (apes, whales, etc) Other human candidates: infants and children, cognitively disabled, elderly with dementia, unborn Approaches to personhood Scripture: ○ God said “let us make man in our image, after our likeness” ○ “Image” and “likeness” both imply that man resembles God, but not in any physical or visible sense, and not so as to make man equal to God Philosophy: in both of these, personality is attributed to unborn child & it’s an intimate and personal process ○ Empirical functionalism ○ Ontological personalism Personhood & Conception Conception view of personhood A human being is a person from the moment of conception and at every subsequent moment (professor’s view); Human being = genetically human Moment of conception means the union of sperm and egg – fertilization vs syngamy (fusion of 2 cells during reproduction) Every subsequent moment → Death only ends personhood for the physical body. As christians, we think there is no true end of personhood The Bible does not directly state that personhood begins with conception, but this is warranted by an appeal to common sense and continuity Two Major Theories of Human Personhood Empirical Functionalism The view that human personhood may be defined by a set of functions or abilities It’s “empirical” because it comes out of the scientific method and refers to directly measurable traits Present in actual, not potential form As cognitive abilities increase, so does the degree of personhood Advantages: ○ Concrete, can be measured empirically and it matches many intuitive ideas about moral status  ○ Example: half americans support the legality of abortion, but that support decreases significantly with progressive stages of fetal development Disadvantages: ○ Goes against commonly held values of fairness and equality ○ To claim that some human beings do not have moral worth because they lack cognitive abilities may seem to violate the principles of a just society Fletcher (1974) established the criteria for human “humanhood” (personhood), in which the minimum essential requirement was the full functioning of the human neocortex = neocortical function ○ Neocortical functions The “higher brain” processes of the cerebral cortex are necessary for active consciousness and volition This is different from whole-brain functioning (includes activities of the brainstem as well) Note: no disagreement over “whole-brain” definitions of personhood as related to death → when the entire brain has ceased to function, personhood is lost in death Brain Death (Harvard) ○ No reflexes (ex: pupil reaction) ○ No spontaneous breathing ○ Flat EEG ○ Requires: no drugs, normal temperature Disagreement: neocortical functioning as determining factor Brainstem and other ANS functions may still be intact PVS (deep, irreversible coma) ○ End of “meaningful personhood” ○ Law does not permit declaration of death ○ Some secular bioethicists have proposed neocortical definition of death to be adopted ○ Basis: presumed loss of personhood Unborn child ○ Functionalists deny that the unborn has personhood Lack of rationality or self-awareness Counterargument: adults who are asleep or under anesthesia also lack self-awareness ○ To fight this counterargument, we can use the idea that only “continuing selves” have personhood, which includes both self-awareness and a sense of the future Proposed by Peter Singer (Princeton philosopher) Justifies induced abortion Singer even advocates for infanticide (also called “after-birth abortion”) because if the fetus has no right to personhood because it is not self-aware yet, then neither does the unwanted newborn with various congenital disabilities On his view, the unborn fetus or cognitive-impaired adult has a lower moral status than that of an adult chimpanzee or ape, because giving preference to the life of a being just because they’re a member of our species, would puts us in the same position as racists who give preference to those who are members of their race Counterargument: there is a difference between beings with a potential capacity for rationality and those with a developed capacity, and both are entitled to a right to life; this idea implies degrees of personhood (ex: Some human beings have more of it than  others. For example, a fetus that is becoming a whole human being has less personhood than a full formed human); there can be such an entity as a human non-person Clinical implications ○ Should we have healthcare policy limitations for patients with cognitive disabilities? Some down syndrome adults, some impaired elderly nursing home residents ○ Should we change our rules for organ transplantation? Availability of organs from the disabled, harvesting of organs from patients in a PVS ○ If the above are persons, then this violates distributive justice (from medical principlism) ○ Through proposed, these scenarios are not yet a reality in the US Ontological Personalism All human beings are human persons Personhood is an intrinsic quality, begins at conception and is present throughout life Derived from reason and logic alone: no potential persons or “becoming” persons – humans are persons by their very nature No such thing as a “human non-person” Implies the conception view of “personhood” ○ All human beings are persons from conception forward ○ The new entity created at the union of sperm and egg is a fully human organism Terms ○ Ontology: relating to or based upon being or existence – the nature of being ○ Substance: a human being is a substance – a distinct unity of essence that exists ontologically prior to any of its parts; traditional concept of Aristotle and Thomas Aquinas Empirical vs Ontological The empirical concept says that a human being is just a collection of parts and functions, or a “property” thing, that you put together in the right way to have a human being ○ It’s like building a car – philosophically, it makes no difference The ontological concept is based on the premise that a human being is a substance that exists prior to any of its parts Example 1: a restored 1957 Chrysler ○ Many of its original parts have rusted away and have been replaced, so this vintage car is a collection of old and new ○ Some will say it’s the same car, but intuition tells us this is not the case because if you remove the wheels, motor, seats, and body, or add any other parts, it results in a whole different car ○ Therefore, there is no continuity of essence between the new vs old vehicle Example 2: taking apart a person ○ Remove an arm or a leg from John Doe, amputate all his extremities or even remove organs, and he remains the same person = essence has not changed, he will never become Jane Smith ○ This shows that human beings are substances, not property-things, they are not defined by parts Argument From Continuity Cells of the human body are constantly replaced All the chemical parts are completely replaced every few years Yet, persons have continuity over time Same person as one week ago, one year ago, or ten years ago Memories give continuity with present state; even if person lacks memories because of disease or injury, person has a continuing self that is identical to the earlier self Relates to childhood: can give the date of birth  Applications to the Unborn Common sense and continuity arguments (natural law) ○ Francis Schaeffer No prima facie (at first impression, or self-evident) reason to assume that a baby changes its essential nature by virtue of geography (in the womb or out of it) In the womb, the baby is the same as out of it Almost all people recognize a newborn baby as having moral value No reason not to extend such humanity further back in time The continuity argument argues for the personhood of the fetus back to the moment it first became a substance (moment of conception) The Ethics of Contraception Normal Reproductive Physiology The Corpus Luteum Stimulated by LH, produces progesterone, estrogen, and other hormones Progesterone and estrogen stimulate blood vessels in endometrium Lifespan: 2 weeks If no fertilization, corpus luteum degenerates Withdrawal of progesterone = menstruation Pregnancy  If the embryo successfully implants (5-6 days after fertilization), it releases human chorionic gonadotropin (hCG) hCG takes the place of LH, preserving the corpus luteum Progesterone levels remain elevated, which maintains the endometrium and the pregnancy Eventually, the corpus luteum does degenerate, but by then the developing placenta produces its own progesterone The Ethics Debate Religious Objections Early church: opposed any interference with the “natural” conjugal act, hormonal birth control goes against the way God intended for procreation to take place Pope Pius XI: should do abstinence – gave approval for Catholic married couple to avoid pregnancy by engaging in intercourse only during the infertile times in a woman’s monthly cycle (rhythm method) Conservative Catholics: say that contraceptives promote an immoral lifestyle and increase STIs Liberal Protestant groups and various branches of Judaism and Islam: are generally more accepting of contraceptive use Final concern about contraceptives include that they might fail as contraceptives, and instead can destroy early embryo and be abortive Important Assumptions Sanctity of human life ○ Human personhood: moral valuing of human beings ○ Personhood begins at conception/fertilization ○ Destroying an embryo = abortion and is immoral Permissibility of contraception ○ Limiting family size may be a part of reasonable stewardship of lives and resources ○ Preventing conception may be permissible for Christians ○ Roman Catholic Magisterial teaches that hormonal contraception is immoral Definitions Contraceptive ○ Prevents pregnancy by preventing contraception either by suppressing ovulation or by preventing sperm from reaching ovum Abortifacient ○ Definition #1: interrupts an established pregnancy (beings with implantation) ○ Definition #2: prevents implantation of an embryo – many have challenged use of this term in this context (research in the past 20 years has failed to prove any interceptive effect) Abortifacient Drugs 1. Mifepristone followed by misoprostol: 1st line ○ Mifepristone (Mifeprex) Competitive inhibitor of progesterone receptors in the endometrium Leads to arteriolar vasoconstriction, ischemia (fetocidal) 200 mg given PO  ○ Misoprostol Prostaglandin, induces uterine contractions Given 24-48h after mifepristone (800 mcg, buccal administration) ○ 98.3% effective through 59 days gestation ○ Common early 1st trimester regimen ○ Note: used for 2nd trimester abortions in Canada, most of Europe, China and India 2. Misoprostol alone ○ Second line agent when mifepristone not legally available or difficult to access ○ Given for gestations through 70 days ○ Less effective ○ Note: misoprostol can be used to manage a spontaneous abortion (miscarriage), to avoid the need for a D&C 3. MTX followed by misoprostol ○ Not 1st line ○ MTX given PO or IM ○ Vaginal misoprostol 3-5 days later ○ Used through 63 days gestation ★ US, currently: ○ 54% of 1st trimester abortions are medical abortions ○ 96% of 2nd trimester abortions are performed surgically Contraceptives Combined Oral Contraceptives (COCs) ○ Contain an estrogen (ethinyl estradiol – amounts vary) + also contain a progestin (various: norethindrone, levonorgestrel, desogestrel, ethynodiol diacetate – amounts vary) ○ Mechanism #1: Inhibit release of gonadotropin-releasing hormone (GnRH) from the hypothalamus, which reduces LH and FSH levels (negative feedback) Without FSH, a dominant follicle does not develop in the ovaries, therefore estrogen levels do not rise Progestin blocks the LH surge = inhibits ovulation Breakthrough ovulation and implantation are rare ○ Mechanism #2: Alters cervical mucus, making it less hospitable for sperm penetration Occasionally, ovulation does occur – called “breakthrough” or “escape” ovulation Fertilization is unlikely ○ Mechanism #3: The “hostile endometrium” theory Over time, the pill induces a thinner, less glandular, less vascular endometrial lining Therefore, if breakthrough ovulation occurs, implantation is less likely A true “abortifacient” effect – if one holds to the moral status of embryos ○ Package insert info COCs lower the risk of becoming pregnant primarily by suppressing ovulation Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce likelihood of implantation ○ Evidence Some women get pregnant on the pill (~3%)  Higher EP/IUP ratio for pill users ○ True only of POPs and nexplanon – not seen in COCs ○ IUP rate decreased d/t abortions Thinner endometrium on the pill ○ MRI studies: 40-60% thinner; but only on anovulatory cycles ○ If ovulation occurs: Hormone milieu (environment) different than in an anovulatory cycle: ○ FSH-LH surge present; corpus luteum formed ○ 10 to 20 fold increase in estradiol and progesterone output ○ 7 days later, endometrium should now be receptive to implantation ○ No evidence to the contrary “The tyranny of rare events” ○ 1000 woman-years of compliant COC use = 13,000 cycles ○ Result = 15.5 ovulations, one pregnancy ○ What happened to the other eggs? 10-15% infertile (out of 15.5, leaves 13.5 eggs) Spontaneous loss (fert. To 6 weeks) = 73% Leaves 3.5 eggs Cervical mucous factors block sperm 80% of the time Result = one pregnancy (observed) Position Statements Focus on the Family ○ “Two years of deliberation and prayer” ○ Majority of experts: no abortifacient effect Christian Medical and Dental Association ○ Further investigation needed, cannot “confirm or refute conclusions” – will continue to monitor new developments Center for Bioethics and Human Dignity ○ “A disputable matter” among believers (Rom. 14) ○ Potentially “divisive question”, where scientific information is incomplete How Should We Respond? Many people of faith believe that abortion is immoral There are many concerns about COCs ○ But not on sanctity of life reasons alone ○ No christian should sin against conscience Abstinence, barrier methods, and NFP do not lead to these concerns Emergency Contraception John Menges, RPh ○ Licensed Illinois pharmacist dismissed by Walgreens in 2005 ○ Refused to sign an “emergency contraceptive policy” that violated his religious beliefs ○ Refused to dispense Plan B, claiming its action was abortive Core Issues ○ Autonomy Patients have a right to legal medications Patients have a right to their own religious convictions ○ Distributive Justice  All patients should be treated equally regardless of gender, ethnicity, religion, etc All patients should have equal access to legal medications, and should not have to undergo undue hardship to obtain them ○ Non-Maleficence Pharmacists must protect their patients from harm: harmful or inappropriate meds, unanticipated side effects, wrong dosages or inept prescribing ○ Key issue: to refuse to dispense a drug, is opinion enough, or must it be guided by medically verified science? Emergency Contraception ○ Post-coital contraception; the morning after pill; the 72h pill ○ Used up to 3-5 days after sexual intercourse to prevent pregnancy ○ No contraceptive, contraceptive failure/misuse, condom breakage/slippage, missing/forgotten hormonal pills, IUD misplacement, failed coitus interruptus Drugs ○ High-dose combined oral estrogen/progestin: Yuzpe (oldest method) 2 doses of 100 mcg ethinyl estradiol/0.5 mg levonorgestrel; 12 hrs apart (Ovran 50) ADRs: N/V (high dose estrogen), bleeding ○ Progesterone-only: Plan B One Step, Levonelle (Eur) 1.5 mg levonorgestrel x 1 within 72h of intimacy Previously Plan B was a 2-dose (0.75 mg/dose) regimen administered 12h apart Post-Fertilization Effects of Levonorgestrel ○ Animal data shows no evidence for post-ovulation effects of ECs ○ NOTE: progesterone from the corpus luteum, post-ovulation, promotes implantation… how could levonorgestrel, a progestin, not do the same? ○ A statement of post-fertilization effects is still in the approved FDA labeling of the product More Data from Multiple Studies ○ Pregnancy rate in treatment groups (using EC) compared to control groups (absence of EC) ○ Fully explained by ovulatory inhibition ○ Observed congruence between observed vs expected pregnancy rates ○ Controversial study (Sweden, 2007)  Created an endometrial construct in the lab; shown to be a good model (embryos implanted) Construct treated with mifepristone: embryos did not implant, antiprogestin effect Construct treated with levonorgestrel: high doses, embryos implanted, no difference between experimental and control groups Conception/Implantation Logistics ○ Availability of egg to be fertilized lasts about 24 h after ovulation ○ Spermatozoa can survive for 5-6 days after being deposited in uterus ○ Bonus mechanism: thickening of cervical mucus = barrier for sperm entry into cervix Evidence of “abortifacient” effect ○ Numerous studies support the notion that the high dose, high powered steroids found in emergency abortion drugs like Plan B are abortifacient 75 to 89% of the time. Rarely will a drug like Plan B work to suppress ovulation and truly prevent the meeting of the male and female gametes PRIOR to the moment of conception ○ Documentation: opinion (often from pro-life activists) and review articles (which reference opinion) Problem with these claims ○ Based on broad assumptions Plan B compared to older, less effective preparations Extrapolation from oral contraceptive discussion (equivocal at best) Assumption that package insert warnings are based on evidence ○ Ideological bias of pro-life movement ○ Marketing bias of pharmaceutical companies To the pro-lifers ○ Let’s remove the bias and evaluate the claims objectively ○ If there truly is scientific evidence for an abortifacient effect, then publish this in the medical literature ○ If not, then are healthcare professionals “falling on their swords” unnecessarily? ★ Ella  Newest research on Ella ○ Ulipristal acetate (UPA) 30 mg (Ella) acts as an EC by delaying ovulation – because it is a selective progesterone receptor modulator, an additional effect on interfering with implantation has been suggested ○ UPA-EC is not more effective at preventing pregnancy than chance alone if used after ovulation and does not increase miscarriage rates ○ Conclusion: an anti-implantation effect of UPA is highly unlikely at the dose used for EC. maintaining the warning on the FDA-approved label that “it may also work by preventing implantation to the uterus” might deter some women from using EC, leaving them no option to prevent unwanted pregnancy after unprotected sex ★ Counseling patients on these agents ○ This medication does not protect against STDs ○ It should be taken < 72-120h (depending on product) following unprotected sex ○ Plan B will not end an established pregnancy; however the data on Ella does not support such counsel (do not take if already pregnant) ○ Not intended for regular use to prevent pregnancy ○ ADRs: HA, N/V, potential for heavy bleeding ○ These are single-dose products ★ Ethical lessons from all of this ○ Common claim: “Plan B is immoral” More complicated than this It probably is not an abortifacient ○ But many believe that marketing of Plan B is immoral Teva pharmaceuticals trading on fear to sell an OTC product ○ Conscience claims should be based on facts, not opinions Moral dilemmas about birth control are common – health professionals and employers need to communicate better Ethics at the End of Life Definitions Terminal condition A disease or process that will result eventually in a patient’s death no matter what treatment is given May include cases where death is inevitable but far off, as patients with cancer who live for years Imminent death Death is expected within a short time, usually days or weeks Euthanasia Greek roots: eu for “good”, and thanatos for “death” Means a “good” or “gentle” death ○ “Active” euthanasia → overt, deliberately killing of a patient (ex: overdose of morphine, potassium chloride to stop the heart) Considered morally wrong even if a patient requests it  Focus is on the agent who gives consent, rather on the ethical merits of the act Physician-assisted suicide (PAS): variation of active euthanasia; the agent that causes the death is the patient herself, with means provided by the physician ○ “Passive” euthanasia → withdrawing or withholding of treatment while the disease process takes its course and cause death In other words, the distinction is between killing and letting die Withdrawing vs Withholding Withholding treatment: not starting it Withdrawing treatment: stopping an intervention already begun → this is more difficult than withholding, more psychological than real Case Study “A patient was admitted into the ICU with a diagnosis of chronic emphysema, with superimposed right lower lobe pneumonia and acute respiratory failure. Over the next several days, physicians treated him with antibiotics for his pneumonia. The lung infiltrates improved, and the patient’s temperature and WBC became normal. However, multiple attempts to wean him off the ventilator failed. Off the ventilator, he became restless and agitated, with severe SOB. His family and the physician agreed that continued long-term reliance on the ventilator was burdensome and that his condition was terminal. The patient was fully alert and aware; he and his family understood the implications of his illness fully. A DNR order was entered in the chart with the full agreement of the patient as his wife. After a night of rest, the physician removed the endotracheal tube, and respirator therapy took the ventilator from the room. The patient remained on supplemental oxygen. Ten hours after discontinuing ventilator support, and with his family present, the patient died.” Was cessation of therapy justified? ○ Yes. The patient’s condition was terminal and his death was imminent. There should be no reason to second-guess the physician’s judgment here. The patient was in respiratory failure and dependent on the ventilator because of end-stage lung disease from chronic emphysema. He had received the best aggressive medical therapy, and further such treatments might be considered medically futile (pointless). ○ Seems difficult because doctors withdrew treatment (the ventilator) as opposed to withholding it ○ Assumes medical competence and assumes patient cooperative with treatment Should we never have intubated the patient and placed him on a ventilator in the first place? ○ No, because this would have been a denial of an attempt to treat him, and inappropriate ○ Basis of a “trial of therapy” Assisted Suicide or Passive Euthanasia? ○ No to both Not PAS because the agent was th physician, not the patient Not passive euthanasia because intent was to relieve suffering, not to cause death Simplifying the discussion ○ Use “euthanasia” only when the intent is to treat the patient by causing death ○ Use “assisted suicide” only when the intent of the patient is to die (with medical help) “Intent” is the key ○ Robert Orr: withdrawing or withholding treatment or artificial means of life support in someone who is dying is not euthanasia at all – not even “passive” euthanasia – but acceptable, humane, and an often necessary part of everyday medical practice  ○ Henk Jochemsen: stopping disproportional medical treatment has always been good medical practice Principle of Double Effect (PDE) This concept gives significant weight to intentions in moral decision-making Obligated to BOTH preserve life and relieve pain Example of morphine: Two possible effects of morphine: relief of pain or suppression of respiratory drive Once again, the intent is important: if a treatment causes death, but this is an unintended consequence of the intent to relieve suffering, then the act may be morally permissible For the case study above: Neither the patient nor his physicians intended his death, but they did intend to relieve him from a burdensome treatment Death was an unintended consequence of a beneficent intent According to the PDE, the action was justified Quality of Life Considerations Quality of life (QOL) Personal satisfaction expressed by individuals about their own physical, mental, and social situation Based on autonomy Determination of QOL is best made by the patient herself (perhaps with her family), not by the healthcare provider Clinicians should, therefore, be very cautious in making judgements about QOL for their patients Brain Death Standard definition based on cessation of breathing and heartbeat Newer definition prompted b growing demand for transplantable organs The Dead Donor Rule (1960s) The retrieval of organs for transplantation should not cause the death of the donor Ethical foundation for the advent of cadaver organ transplantation The Harvard Criteria (1968) Based on brain stem function Uniform Determination of Death Act (President’s Commission, 1981) ○ An individual with irreversible cessation of circulatory and respiratory functions or irreversible cessation of all functions of the entire brain, including the brain stem… is dead Brain Death Protocol Better: “death by neurological criteria” Requirements: ○ No movement or reflexes ○ No spontaneous breathing (ex: failed apnea test) ○ Flat EEG x 2 ○ No cerebral blood flow by scan ○ Presupposes: no narcotic drugs and normal body temperature Other End of Life Issues Persistent vegetative state  After brain insult (stroke, trauma, etc) State of persistent unresponsiveness Sleep/wake cycles Not brain dead: cerebral cortex damaged (no consciousness) but brain stem intact (breathing, reflexes present) Mushroom analogy Not dependent on ventilator, only on tube feedings and hydration Withdrawing treatments Withholding and withdrawing are morally equivalent but only in an end-of-life context Older terminology: ○ Ordinary vs extraordinary (heroic) treatments Ordinary: food, water, antibiotics (maybe) – essential treatments and minimally invasive as to be mandatory in all cases (nutrition is never optional) Extraordinary: ventilator, renal dialysis, heart transplant – highly invasive treatments that should only be used when the patient’s condition warrants it and may be declined when death is near ○ Vague and confusing ○ Example: Ventilator use in 78YO man with end-stage lung disease might be “extraordinary”, but a ventilator in a 26 YO woman after a car accident would be “ordinary” Better terminology: ○ Proportionate vs disproportionate ○ Greater precision in a clinical context ○ Example: Ventilator use in a 78YO man with end-stage lung disease might be “disproportionate” for treatment goals, but ventilator use in a 26YO woman after a car accident would be “proportionate” to the goal of restoring her to a normal function Medical Futility Difficult terminology Vague, often abused concept: ○ When someone says, “continuing treatment in this case would be futile”, you should ask: “Futile for what? For what treatment goal? – this is where “proportionality” is helpful ○ You might say: “continuing this particular therapy would be disproportionate for our treatment goals” Robert Orr: “some treatments are futile, but care is never futile” Artificial Nutrition and Hydration (ANH) Prolonged nutrition via: ○ Surgically-implanted feeding tube (simple) ○ Large-bore permanent catheter for IV feeding (more complex) Ethical debate ○ Is ANH “basic care” that should always be provided? (natural law) ○ Or is ANH sometimes disproportionate and, therefore, may be withdrawn in terminally ill patients? ○ Most modern ethicists lean towards the second view Ethical Observations Three standard for decision-making in medicine:  ○ Informed consent ○ Substituted judgment ○ Best interests Assisted Suicide The Legal Context As of 2021, eight states and the District of Columbia have legalized PAS Typical requirements for PAS laws include the following: Patient eligibility ○ 18YO or older ○ Resident of state ○ Decision-making capacity ○ Terminal illness diagnosis, expected death within 6 months Physician protocol ○ Licensed in the same state as patient ○ Psychological examination not required ○ Must inform the patient of alternatives (ex: palliative care, hospice, pain management options) ○ Next-of-kin must be notified Timeline ○ First oral request, then 15 days waiting period ○ Second oral request to physician ○ Written request to physician ○ 48h waiting period before picking up prescribed medications from pharmacy ○ Physicians and health care systems are not obligated to participate The Social Context The “Biotech Century” Tech advances increased life expectancy (ex: hemodialysis), while not necessarily improving QOL Fear of tech advances → prolonged dying? Autonomy is replacing paternalism: many feel uncomfortable with the prospect of “prolonging the dying process” and a desire to exercise more control over personal decisions at the end of life Healthcare professionalism under increasing legal scrutiny American Medical Association (AMA): code of ethics state that PAS is incompatible with the physician’s role as healer Human Dignity At the heart of the debate – most state statutes permitting medical aid in dying are entitled: “death with dignity” Human dignity: characteristic of being human, quantified by function, diminished by suffering and disease Personal dignity: tied into being an individual, closely related to human equality, intrinsic to all human beings, cannot be diminished or lost If empirical functionalism is true: Human beings are no more than the sum of their parts Disease, loss of functions, and cognitive decline take away our humanity Such individuals have less dignity, and are therefore less in need of (or deserving of) clinical treatments and medical care  If ontological personalism is true: Human beings are much more than the sum of their parts Disease, loss of functions, and cognitive decline do not take away our basic human dignity All human beings deserve compassionate care, even when not all treatments are appropriate Is dignity subjective or objective? Who decides? Important note: religious arguments are not used here Arguments Against Assisted Suicide From History and Tradition Prohibitions against the direct taking of life are deeply embedded in our religious and legal codes The Hippocratic tradition of non-maleficence is a 2400 year old tradition of doctors preserving life ○ Medical Principlism – comes mostly from Hippocrates: beneficence, non-maleficence, distributive justice ○ Autonomy is more recent: legacy of Immanuel Kant, 18th century Kant: categorical imperatives 1. Act according to the maxim that it would become a universal law 2. Act so that you always treat others as an end, never as a means to an end PAS violates both categorical imperatives: ★ Not generalizable ★ Kant held suicide violates the end vs means distinction However: deontological approach, admits of no exceptions, cannot handle conflicting moral duties (example: PDE) The oath of Maimonides is similar, though not as ancient From Professionalism The fiduciary relationship of healthcare ○ A “gift of trust” from society ○ Relies on a covenantal duty of beneficence PAS erodes the clinician-patient relationship and has grave potential for misuse and abuse PAS is the wrong fix for the inadequacies of modern healthcare ○ True suffering is rare at the end of life ○ Needed: more timely referrals for palliative care and hospice The Slippery Slope Prescribed suicide is an immoral “slippery slope” Comment on slippery slope arguments: ○ Huge potential for abuse ○ Put simply, it’s dangerous: for physicians and other healthcare professionals, for our country and our healthcare system, and for every patient ○ Allowing the practice could lead to unintended and potentially harmful consequences, gradually expanding its application beyond the intended or morally acceptable boundaries ○ It may set a precedent that encourages broader criteria for eligibility Dr. Daniel Sulmasy (from a public debate): ○ Quoted from Martin Luther King, whose grandmother told him: “Martin, don’t let anybody ever tell you you’re not a somebody” ○ Everybody, black or white, healthy or sick, is a somebody ○ PAS has specific intention of making a somebody into a nobody (to make them dead) ○ Violates the intrinsic dignity of us all  Assisted suicide will lead to: ○ Pervasive medical killing ○ Endangering of vulnerable populations because it can lead to potential coercion or pressure on these individuals to choose death over living with their conditions: disabled, elderly, minority, or poor; anyone whose lives are seen as a burden on society ○ Undermining the foundational ethical principles of medicine, such as commitment to preserve life and the duty of care ○ A shift in societal attitudes towards life, suffering, and autonomy, leading to a diminished regard for the value of life and a normalization of death as a solution to suffering Why PAS is so dangerous: ○ Though pain is listed as the top rationale, it is rarely at the heart of a request for PAS ○ “Inadequate pain control” → 24% ○ Instead: loss of autonomy (89.9%), less able to engage in activities (87.4%), perceived loss of dignity (83.8%), loss of control of bodily functions (58.7%) and feelings of being a burden (38.3%) → these are disability issues Research ○ Euthanasia research in Belgium and the Netherlands show that “tired of living” was one of the main reasons and the majority of people approved for euthanasia were 80YO and older – the definition of “unbearable suffering” is expanding every year; fastest growing numbers were among women, elderly, lower education and nursing home residents ○ June 2015 New Yorker: people euthanized for autism, anorexia, and chronic fatigue syndrome Wesley Smith: ○ Will the “right to die” morph into a “duty to die”? ○ “A duty to die becomes greater as you grow older… to have reached the age of, say, 75 or 80 years without being ready to die is itself a moral failing, the sign of a life out of touch with life’s basic realities” Arguments In Favor of Assisted Suicide The Hippocratic Oath is Vague, Outdated, and Rigid Strong deontological focus, without philosophical underpinnings beyond mere tradition Religious overtones (greek), but we are now a mostly secular society Paternalistic and elitist Absence of autonomy is in stark contrast to modern emphasis on patient-centered care Pro-life emphasis does not represent the current diversity of ethical opinions Modern healthcare environment much more complex than the ancient context Appeals to Human Dignity are Unconvincing Opponents of PAS make vague appeals to human dignity, but not everyone can find meaning in suffering Hospice and palliative care specialists are often arrogant and authoritarian (?) 70% of Americans support PAS → “You want to support my dignity? Then respect my choices” Why is Death Bad? Dr. Peter Singer: death violates our autonomy, death is bad for those who care about us; therefore, we should not promote death But assisted suicide is an exception to all this: ○ Death becomes our autonomous choice ○ No more value to continued life (we cannot look forward to more life)  ○ Causing death is not the issue: withdrawing treatments is ethical, but the intent of providers is the key ○ But we shouldn't have to accept that morality More on Intention Consider 3 types of intervention at the end of life: ○ Withdrawal of a futile treatment ○ Terminal (palliative) sedation ○ Medical aid in dying (PAS or euthanasia) Each of these has the same end result What makes the first 2 legal/ethical? The key is intent But intent is subjective, unmeasurable, and largely irrelevant to the patient Why do we deny a comfortable death to those who don’t fit the requirements for the first two? Freedom and Our Democracy Integral to human freedom and liberty: ○ The right to die as one chooses ○ The right to decide when life is no longer worth living ○ Based on respect for personal autonomy Government and/or religious institutions: ○ Should not impose their own values on others ○ Especially on individuals who are not harming others As an option in end-of-life care, PAS would allow terminally ill, mentally competent individuals to retain dignity and bodily integrity in the face of huge amounts of pain and suffering Slippery Slopes Revisited Conflation fallacy: ○ Assume (for argument) that data from Belgium and Netherlands show worrisome trends ○ Claiming that the same thing will happen here is a logical fallacy (conflation: comparing apples to oranges) ○ Those small European countries are much more socially homogeneous than the U.S ○ Greater protections in our country ○ All of our existing PAS statutes have extensive safeguards to prevent abuse Slippery slope fallacy: ○ Some slopes are slippery, but a slippery slope without data is a logical fallacy Oregon data (since 1977) ○ PAS does not undermine hospice and palliative care ○ Rates of depression are lower in patients who request PAS than in other hospice patients Another kind of slippery slope: ○ Many dying patients are desperate and fearful ○ If PAS remains illegal, patients will choose other alternatives: shooting oneself, enlisting doctors or family to break the law, DIY suicide Other Compelling Arguments Pain is not the most important reason to request PAS Many patients just want control (cp. Earlier stats on autonomy) Some hoard certain drugs (ex: pain meds), then take an overdose early, fearing that they will lose the right as they become more incapacitated If PAS is legal, they will be offered more appropriate drugs at the right time Washington state: < 60% of pts given PAS drugs actually took them  Peace of mind was an important factor Summary Those who oppose PAS will argue: ○ PAS is an affront to intrinsic human dignity ○ It violates long established ethical traditions ○ Prescribed suicide erodes the doctor-patient relationship ○ PAS is an immoral slippery slope ○ The laws are dangerous to vulnerable minorities Those who support PAS will argue: ○ We should rethink our societal view of death ○ Opposing PAS is arrogant, and fails to respect autonomy ○ A majority of Americans support PAS ○ Providers can opt out, based on conscience ○ There is no evidence for a slippery slope Where both sides will agree: ○ To provide better training in pain management ○ To change narcotic laws to allow adequate pain control ○ To ensure that providers know how to Dx and Rx depression ○ To make hospice care available and fund it ○ To promote more careers in palliative care ○ Provide stronger training in end-of-life psychiatric, social, and pastoral care Executive Summary The PAS debate is a classical conflict of ethical duties Who is my patient? ○ Do I have an over-arching tradition that forbids medically-assisted death? → some pts will suffer, some pts will benefit ○ Do I have an over-arching tradition that allows medically-assisted death? → some pts will suffer, some pts will benefit