Biotech 4BS3 2024 Bioethics (Part 1) PDF

Welcome to… BIOTECH 4BS3/SEPT 6BS3: Biotechnology Regulations Image from: www.feedstuffs.com 1 BIOTECH 4BS3: Biotechnology Regulations Instructor: Dr. Rashid Abu-Ghazalah E-mail: [email protected] T.A.: Mr. Nicholas Damjanovi...

Welcome to… BIOTECH 4BS3/SEPT 6BS3: Biotechnology Regulations Image from: www.feedstuffs.com 1 BIOTECH 4BS3: Biotechnology Regulations Instructor: Dr. Rashid Abu-Ghazalah E-mail: [email protected] T.A.: Mr. Nicholas Damjanovic Email: [email protected] Office Hours: Please email to schedule a meeting. See Course Outline and Avenue To Learn for course dates, expectations and deadlines 2 Biotechnology Regulations Topics to be covered over the term: Bioethics Research & Development in Industry Regulations – Canada, U.S., international Documentation Quality Systems Safety regulations 3 What is expected? Read the course outline Attend on-line lectures There are no right and wrong answers during discussions: We all have differences in opinion We can discuss those without any pre- or post-judgement Healthy and respectful debates are expected You will have three assignments You will have one project You will have one midterm You will have a final exam We will discuss those in more detail soon. But today… 4 “Our knowledge can only be finite, while our ignorance must necessarily be infinite” Karl Popper 5 What is Ethics? 6  Ethics and Morals Derived from the Greek ethos, meaning “custom” or “habit” Ethics is the philosophical study of principles involved in making moral decisions Philosophy deals with life’s ”big” questions through logic, reflection, and critical reasoning Ethics is are external things, that can change over time, but morals are an internal things that might not generally change over time. A “dilemma-based discipline” Ethics differs from morals/morality in that ethics is the theory driving right/wrong while morals are personal Both have something to do with “right vs wrong” Many moral questions have been decided based on the general public and by the passing of laws Laws can be repealed ROE v WAY Public view of morals changes Rock music was frowned upon by preachers…now they use them Smallpox vaccination was viewed as “playing God”…now preachers’ kids are vaccinated 7 Ethics Bioethics deals with pertinent issues of our modern times: Research Euthanasia Pets included. For humans, medical assisted death Human cloning Genetic engineering Assisted reproduction Biggest pushback in our society Consent and confidentiality of patients Life and death Etc… https://base.imgix.net/files/base/ebm/industryweek/image/2019/05/industryweek_34260_ethics_graphic_1.png?auto=format&fit=crop&h= 432&w=768 8 What is Ethics? Major doctrines or theories include: Altruism Humanism Asceticism Individualism Cognitivism Moral Absolutism Consequentialism Moral Anti-Realism Cynicism Moral Nihilism Deontology Moral Realism Egoism Moral Relativism Epicureanism Moral Skepticism Ethical Naturalism Moral Universalism Ethical Non-Naturalism Non-Cognitivism Ethical Subjectivism Utilitarianism Eudaimonism Virtue Ethics Hedonism 9 www.philosophybasics.com/branch_ethics.html Ethical Decisions Three main ways for making ethical decisions: Consequentialism Utilitarianism Deontological Virtue ethics *Natural law: not used as much 10  Ethical Decision-Making Utilitarian Approach (Consequential Ethics) Developed by Jeremy Bentham (1748-1832) and John Stuart Mill (1806-1873) Greatest good for the greatest number “The ends justify the means” Puts a value on everything and quantifies What we do, the outcome should be the greater good for all people 11  Utilitarian Approach Considers net benefits and costs to all stakeholders Benefits Costs Utilitarian (+) (-) Decision How can stakeholders benefit and how The most benefit over could they be harmed by the action harm for the most stakeholders 12  Utilitarian Approach Emphasizes consequences, not actions Advantage: Calculation – “quantitative” method Disadvantages: We can’t predict the future, so how do you assign value to all factors? Who assigns the value and how do they remain unbiased? Individual rights? Justice? No moral judgement on the actual actions People that are not within the "greater good outcome" will be doomed. The person that assigns the value can be biased 13  Ethical Decision-Making Deontological (Kantian) Approach (Objectivism) Also known as “Duty Ethics” Typically associated with religions. I.e. "Thou shall not kill" Many contributors, but primarily developed by Immanuel Kant (1724-1804) From the Greek deon, meaning “obligation, duty” Focuses on absolute principles (definitive rules that cannot be broken) Follows a sense of duty to dictate our actions ***One absolute – Value of human life 14 Deontological Approach Kant: “We ought to treat others as ends in themselves, not as means to an end” Kant: “It is not the consequences of actions that make them right or wrong but the motives of the person who carries out the action” Immanuel Kant – Philosopher Credit: Wikipedia 15  Deontological Approach Associated with religious traditions Deeply held convictions are held as points of reference Advantage: Firm guidelines – providing clear-cut ethical formula Disadvantage: Firm guidelines – may be perceived as too rigid (consequences are not taken into account) Situations can differ Can be based on subjective opinions Self-defense? In some cases – no absolute or conviction exists How can there be conviction for things we do not know? 16 Virtue Ethics Give your seat to someone who requires a seat on the bus is an example of virtue ethics. Originates from the philosopher Aristotle Focuses on the inherent character traits of a person rather than on the nature or consequences of specific actions performed If someone is “good” then s/he would do good effortlessly! Use of practical wisdom (common sense) in decision-making Not commonly used in modern times; different people can have different ideas of what being “virtuous” is. Drawbacks: Self-centredness (selfish): focus on the moral “agent” Fails to consider what is right or wrong Going to a clinical trial for a 5 year old thinking you can save another 5 year old as an adult 17  Ethical Decision-Making A blend of those approaches along with other approaches exist… Key objectives in ethical decision-making: Gather information, and make an informed decision based on logic and careful thought Consider the statistical probability for “bad” event to happen and how negative the effect of that event would be? Respect another person’s decision – Keep an open mind 18  Ethical Decision-Making Example 1: Is stealing food morally acceptable? Consider: Desperately hungry person with no money Sees a loaf of bread on a table outside a store Utilitarian Approach: Need (food + availability of food) + Cost (minor loss to store) = OK to steal the food Benefit is higher than cost, since a human life is saved Not OK to steal will be: when stolen for a long period of time, store closes and the staff loses their jobs. Deontological Approach: Absolute: It is wrong to steal → NOT OK to steal the food Absolute: Preservation of human life → OK to steal the food You need to make a statement (an absolute statement you start with) 19  Ethical Decision-Making Example 2: Whose life is more “valuable”? Consider: A firefighter arrives at the scene of a car accident in a river 3 victims – 1 elderly adult who can’t swim and 2 small children Only enough time to go in once Who does he save? 20 Ethical Decision-Making The question is…Can you trade one life for theirs? Utilitarian? Ethical trade – one life for two young lives Deontologist? Duty Ethics Might consider that it is wrong to endanger or kill any human life, no matter the eventual consequences Do you have all of the facts in this situation? Are there other possible choices? 21 Ethical Decision-Making Example 3: Full Disclosure vs. Profit Consider: Small biotech company merger with a larger one Benefits to the small company: Multi-million dollar deal Benefits to the big company: Acquisition of a promising stem cell cloning technology that the small company developed Seems like a win-win… 22 Ethical Decision-Making Small biotech company merger with a larger one A caveat… CEO of the small company is aware of significant problem with the technology Should the CEO reveal the problem? 23  Ethical Decision-Making Utilitarian? Multi-million dollar deal would save the small company from its financial troubles and secure continued employment for the employees. The cost may be considered insignificant to the large company… Deontologist? Might consider that it is wrong not to say the truth… What do YOU think? 24 Moving into the area of Bioethics… 25  What is Bioethics? Ethics subspecialty that evaluates the implications of biological research and biotechnological applications - especially regarding medicine The term was coined in 1926 The field emerged in the 1970’s Bioethics considers social & moral aspects and potential outcomes of the use of biological and medical technologies NOT “Can this be done?”…but “Should this be done?” If YES…How can it be done the “right” way? 26 Bioethics We can create this… Should we? 27 Why Bioethics? Rapid advances in biomedical science Paternalism is between doctor and patient, its when Perceived inadequacy of traditional ethics doctors do not make the time to answer their patient. The Nuremberg war crimes trials Deference's example would be religious leaders. Decreasing paternalism and deference thus it means to not question the physician or the Concern for the environment religious leaders words. 28 29  Ethics and Biotechnology Development of new technologies in biology and medicine over the last 40 years has prompted society and government to evaluate and establish guidelines for bioethics Many bioethical issues have been debated even before technology has been developed Example: Scientists met at a conference in Asilomar, California in 1975 and called for a MORATORIUM until the safety and consequences of recombinant DNA technology could be assessed… Led to development of biosafety containment protocols currently in use 30 Ethics and Biotechnology – Early Days 1700s Smallpox vaccine discovered by Edward Jenner - 18th century physician by intentionally infecting a healthy boy Was the benefit worth the risk? Was this ethical then? No Is it ethical now? No 31 Ethics and Biotechnology Why is it OK for nature to conduct biotechnology experiments but not for humans? Is it OK for nature to swap chromosomes or cause deletions on some segments of chromosomes – thus leading to various types of syndromes in newborns? What if we have the technology to intervene and correct what nature caused? Is this ethical? 32  Ethics and Biotechnology Animals in Pre-clinical Studies: E.g. Thalidomide – morning sickness drug Tested in standard laboratory rodents → safe Humans → birth defects Marmosets (tested later) → birth defects Is it ethical to introduce a drug to humans based on animal studies? 33 Ethics and Biotechnology Should clinical trial data be publicly available? In 2002 the NIH launched http://clinicaltrials.gov to help patients and physicians find information on nearby clinical trials Voluntary registry Late phase only Industry refused to submit early phase – if early data is shared then funding may dry up. However, sharing could prevent the re-testing of a drug that has already produced negative results In 2007, a law was passed in the US that mandated that all clinical trials’ data be posted. In 2017 the FDA and the NIH tried again, but many still don’t https://www.sciencemag.org/news/2020/01/fda-and-nih-let-clinical- trial-sponsors-keep-results-secret-and-break-law Is the benefit worth the risk that sharing data may reduce funding for research? 34 Ethics and Biotechnology Millions of rodents are used each year for pre-clinical research Up to 50 % of results are never published Even if published, significant portion of them are unreliable Use animal registries: To improve animal research Enhance reproducibility Increase transparency Disadvantages: Administrative burden Ideas being stolen Targeted by animal rights activities https://www.nature.com/magazine-assets/d41586-019-02676- 35 4/d41586-019-02676-4.pdf Moral Principles for Bioethics Principlism: the use of principles to guide ethical decision making Autonomy Should not automatically Nonmaleficence assume one principle is more Beneficence important than another Justice All principles are prima facie Non-maleficence and Beneficence are consequentialness binding (Utilitarian approach) Drawback: does not consider Principles are more broad, rules are strict and specific. nuances and context of individual situations Another drawback: There is no systemic relationship between the four, they would clash in the real world. 36 Principle: Autonomy Able to make choices freely by a Elements of informed consent: rational person 1. Competence Individuals are fully informed to 2. Voluntariness make choices 3. Disclosure of information Cases where disclosure of 4. Recommendation of plan information can be withheld: 5. Understanding of the disclosure and recommendations Results may cause harm to patients 6. Decision Placebos (double-blind experiments) Important components of being autonomous Disclosure may affect integrity of a No external bias/pressure to make a decision research project (skew results) Having the capacity to make a decision/consent Freedom / free will Nonautonomous: Being informed of everything that is going to happen Risks Drug addicts Rewards Patients with serious psychiatric illnesses Infants and children 37 Principle: Nonmaleficence This principle is based on many moral rules Not to cause harm unto others by acts of commission or omission Subjecting patients to unnecessary risks, even if no harm was done, is not warranted One of the most prominent principles in bioethics Found in many rules and regulations Particularly tough for end-of-life treatment 38 Principle: Beneficence Not two sides of the same coin as nonmaleficence Prevent harm Remove harm Do good Rescue someone in trouble Help persons with disabilities The action of helping someone 39 Principle: Justice Treat people fairly Treat people equally Distribute benefits and burdens equally Distributive justice can be based on: Need Effort Contribution Merit Not equally but equity, to have everyone to have the same playing ground 40 Moral Standing To whom moral norms apply Moral principles Do all principles apply? Depends if human or not Depends on the condition of the human One of the critical questions that bioethics wants to answer is: who has full moral standing? The definition of what entails a person can be confusing 41 Definition of a Person Nonmoral definition: Humans with some critical features (physical) or mental capacities (e.g. self-awareness) This definition does not imply whatsoever whether the person has any moral status Moral definition: Humans who have full or maximal moral standing How about fetuses? Do they possess self-awareness? Argument: A fetus does not have self-awareness, as such, it is not a person and therefore does not have moral standing! To avoid such difficult discussion, we avoid using personhood language in debates We simply rely on firmly held beliefs (secular and religious) In short, we are unable to definitively agree on what characteristics give someone moral standing; leading to controversies surrounding: Death: when moral standing ceases Abortion: when moral standing begins Moral standing of non-human animals 42 Defining Death Important to define death, because this is when a person loses full moral standing Some legal and moral rights don’t apply When is a person ”dead?” There are three major definitions of death: Somatic death Whole-brain death Higher-brain death 43 Definition of Death: Somatic/Circulatory Traditional view of death When an integrated system stops working Cardio-pulmonary! So long as a person can maintain homeostasis, they are alive In this case the cessation of the said integrated system must be irreversible Suffering from cardiac arrest and being successfully resuscitated does not mean dead Case: terminally ill patient whose parents decided to stop life support. Heart stops and is retrieved for transplant. Transplant surgery was a success Was the heart irreversibly stopped when the doctors retrieved it? People who define death in a somatic way think this is homicide 44 Definition of Death: Whole-Brain More complicated view and is based on neurological principles An individual is dead when all brain functions (including the brainstem and some hormonal activity from the pituitary or hypothalamus glands) cease to function irreversibly This definition is part of the law in the majority of countries Example: If a patient is on a respirator and their whole brain ceases to function irreversibly, then in most jurisdictions, that patient is dead by this definition 45 Definition of Death: Higher-Brain If a patient is irreversibly unconscious and most of their brain functions are irreversibly gone, but some reflexes remain (brainstem functioning), they are dead under this definition Controversy is what is considered as “higher” functioning This definition is not legally adopted anywhere but is fiercely debated 46  Abortion and Life Determining when moral standing begins is even more difficult than when it ends Manipulating sperm, or eggs, is less controversial than fetuses and post-natal infants The moral standings are different Can we use the definitions of end of life to help us determine the beginning of life, hence having full moral standing? Higher-brain death: full moral standing when higher functions present (24 weeks of gestation (most liberal view) Whole-brain death: full moral standing begins earlier (8-12 weeks of gestation) Somatic/Circulatory death: full moral standing begins even earlier (most conservative view) Full pumping of blood occurs at the same time as some neurological functions Heartbeats begin much earlier..possibly at a time when even the individual does NOT know they are pregnant! https://images.agoramedia.com/wte3.0/gcms/fetal-development-sex-organs-722x406.jpg?width=414 47