This program was recorded on May 3, 2002

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This program was recorded on May 3, 2002
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Objectives

• House staff will be able to define law and ethics
  as they relate to medical decision-making.
• House staff will be able to identify typical
  steps in the decision-making process that they
  would follow when faced with a question in
  medical practice that has legal and ethical
  aspects.
• House staff will be able to apply these steps to
  analysis and decision-making to case scenarios in
  the following areas genetics, assisted
  reproduction, emerging infections, organ
  transplantation, and end-of-life.

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Law, Ethics, and Medicine

• Zita Lazzarini, JD, MPH
• Director, Division of Medical Humanities,
• Health Law, and Ethics
• University of Connecticut Health Center

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Why Ethics and Medicine?

• Medical science and technology advancing rapidly
• What we can do far outstrips what we should do
• Ethics and its partner, law, place some limits on
  our newfound abilities
• Ethics explicitly based on values provides a
  counterweight to other powerful forces (the
  free market, the state, the political system)

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Ethics definitions / roles

• A discipline that seeks to answer the questions
  what is right? and what is good?
• An area of moral philosophy that deals with
  the principles of human duty or the logic of
  moral discourse (Shorter Oxford English
  Dictionary, 1993)
• A tool to assist clinicians and scientists
  identify and examine troubling dilemmas with the
  goal of choosing the alternative that best
  respects patients interests and supports
  societys norms

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Law definitions / roles

• Norms formally promulgated by a political
  authority and more or less enforced through a
  legal process based on adjudication. (Hazard,
  1995)
• Grants authority or sets limits for government
  and private action
• Sets a public agenda for policy
• Can act as a direct tool of health promotion or
• Can create barriers to healthy activity.

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How Do We Make Decisions?

• Know the law -- where it exists -- science often
  far ahead of law
• First Do No Harm (primum non nocere) -
  Beneficence/Nonmaleficence
• Respect the wishes, dignity, privacy of patients
  - Respect for Persons or Autonomy
• Treat like cases alike, fairly distribute the
  benefits and burdens - Justice
• Principled Approach to Medical Ethics
  (Beauchamp Childress, 1994)

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Overview

• Genetics
• Assisted reproduction
• Emerging infections
• Organ transplants
• End of life

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Genetics - Developments

• Human Genome Project will map the genome by 2003
• Identifying hundreds of genetic markers for
  diseases
• Coming, many new diagnostic tests
• Prenatal diagnosis
• Potential, gene therapy
• Commercialization of genetic information
• Germ line interventions?

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Genetics - Issues

• Informed consent
• Privacy and confidentiality
• Discrimination
• Genetic counseling and reproduction
• Social concepts of disease
• Potential misuses
• Commercialization

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Genetics Scenario

• Male subject in ongoing research for potential
  cancer-disposing gene carries the gene, but does
  not know it (as required by study)
• 5years into study, import of gene becomes clear
  it does dispose carriers to cancer
• Researcher knows the man has been a sperm donor
  and is engaged to be married
• What should the researcher do?

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Assisted Reproduction Developments

• In vitro fertilization (IVF)
• Sperm, egg, and embryo donation
• Traditional and gestational surrogacy
• Pre-implantation diagnosis
• Cytoplasmic transfer
• Parenting by same-sex couples using ARTs
• In the future cloning?

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Assisted Reproduction Issues

• Who are the parents? (gestational, biological, or
  intended mother/father)
• What is the legal status of embryos? (persons,
  property, or potential life)
• How do we apply the childs best interest
  standard to ARTs
• Avoid very high multiple births
• Prevent exploitation of women
• Avoid commodification of children can we
  guarantee the perfect child?

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Assisted Reproduction Scenario

• Infertile couple using egg donation and sperm
  donation conceive an embryo using IVF
• Embryo is implanted in the womb of a gestational
  surrogate
• Before the child is born the couple divorces
• Wife seeks child support order
• Husband argues he has no genetic relationship to
  the child
• Who are the parents, who must support the child?

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Emerging Infectious Diseases Developments

• Globalization of economies, travel,
• Climate change
• Increased populations
• War and internal displacement
• Changing food growth, processing, and marketing
• Changing behavior patterns
• Development of antibiotic resistance
• Crumbling public health infrastructure

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Emerging Infectious Diseases Issues

• Disease surveillance v. privacy
• Inequalities in health status and health care
• Discrimination
• Protecting potent drugs or denying some patients
  care?
• Freedom of movement
• Other human rights issues

• HIV/AIDS
• Tuberculosis (MDR)
• Toxic shock syndrome
• Mad cow disease (BSE)
• Malaria and dengue
• Hanta virus
• West Nile virus
• Antibiotic resistant staph
• ?????

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Emerging Infectious Diseases Scenario

• Mad cow disease (BSE) appears to be
  transmissible to humans and to cause a new form
  of Creutzfeld-Jacob Disease (CJD)
• Investigations of cases of CJD in the U.S. and
  U.K. reveal cases of persons who received blood
  from donors who later developed CJD (U.S.) or
  women who had surgical procedures using
  instruments used on someone with CJD (U.K.)
• Neither blood transfusion nor use of instruments
  is a proven means of transmission of CJD, merely
  possible
• Who should be told and what should they be told?

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Organ Transplants Developments

• Improved anti-rejection drugs
• Significantly increased survival rates for
  kidneys, livers, hearts, lungs, and other
• Aging population and prevalence of diseases such
  as hypertension, diabetes, hepatitis C, and
  smoking
• Growing demand for transplants
• Relatively static supply of organs
• Possible xeno-transplants (transgenic pig livers)
• Possible use of stem cells to grow organ tissue
  or organs
• Cloning?

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Organ Transplants Issues

• Resource allocation who gets the scarce organ?
• Resource allocation do we spend health care
  on organs rather than public health, seniors
  prescription coverage?
• Sale of organs? Barter? Private Contracts?
• How should we regulate living donors?
• Risk of trans-species infections
• Ethics of using animals as spare parts
  factories
• Ethics of using human stem cells or cloning
  technology

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Organ Transplants Scenario

• 2 couples, in each, one partner needs a kidney,
  the spouse is not a good match
• They find each other on the internet and want to
  exchange kidneys
• What about this worries you?
• Would it make a difference if one couple was
  rich, the other poor?
• If one couple was from the U.S., the other from a
  developing country?

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End of Life Developments

• Rapid advances in life-sustaining technologies
• More people die in the hospital than 50 years ago
• Few people have legal advance directives that
  express their wishes for medical care if they are
  incompetent
• Many people fear dying slowly without adequate
  pain relief
• Physician assisted suicide movement

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End of Life Issues

• Patient autonomy should patients be able to
  refuse any kind of care?
• What mechanism best reflects what patients would
  want, if they cannot speak?
• Physician beneficence should physicians be able
  to force care they think will be successful?
• Why do we not treat pain adequately?
• Futility should physicians be able to limit
  care they believe will do no good?
• Should physicians help some patients die?

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End of Life Scenario

• Patient comes into the Emergency Department with
  severe head injury
• After 3 months of treatment remains unconscious,
  comatose, and on a ventilator
• His wife wants to withdraw treatment - He never
  would have wanted to live this way.
• His mother and sister violently disagree That
  would be murder and it is against our religion
  and the way he was raised.
• He has no advance directive (living will)
• Who speaks for the patient?

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References

• Beauchamp TL, Childress JF. Principles of
  Biomedical Ethics, Fourth Edition. New York, NY
  Oxford University Press, 1994.
• Dubler N, Nimmons D. Ethics on Call. New York,
  NY Harmony Publishers, 1992.
• Hazard GC. Law, morals, and ethics. So. Ill.
  Univ. L.J. 199519447-458.
• Monagle JF, Thomasma DC. Health Care Ethics
  Critical Issues for the 21st Century.
  Gaithersburg, MD Aspen Publishers, 1998.
• "NIH's Bioethics Resources on the Web."
  www.nih.gov/sigs/bioethics
• Biomedical Ethics Readings on the internet
  www.uwc.edu/fonddulac/faculty/rrigteri/biomed.htm