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Bioethics Timeline - Complex

Cleveland Clinic Lerner College of Medicine
by

Alex Grossman-McKee

on 5 March 2013

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Transcript of Bioethics Timeline - Complex

1940 1950 1950 1960 1960 1970 1970 1980 1980 1990 1990 2000 2000 2010 Nuremberg Trial and Code 1946-1947 First Kidney Transplant 1954 Fletcher's "Morals and Medicine" 1954 Willowbrook Experiments 1956 (Exposed 1972) Thalidomide Revelations 1962 Seattle Dialysis Selection Committee 1962 First Heart Transplant 1967 Harvard Definition of Brain Death 1968 The Hastings Center 1969 Thomson's "A Defense of Abortion" 1971 1972 (Began 1932) Roe v. Wade 1973 National Research Act 1974 Karen Ann Quinlan Case 1976 Baby Louise Brown - First IVF Birth 1978 Belmont Report 1978 U.S. Public Health Service Tuskegee Study Exposed Defining Death 1981 Baby Doe Case 1982 Barney Clark - First Artificial Heart 1982 Elizabeth Bouvia Case 1983 Larry McAfee Case 1985 Baby M Case 1987 Nancy Cruzan Case 1990 Human Genome Project Begins 1990 Planned Parenthood v. Casey 1992 Woman gives birth at 62 1994 Oregon Assisted Suicide Legislation 1994 Advisory Committee on Human Radiation Experiments 1994 Dolly the Sheep 1996 Human Embryonic Stem Cells 1999 Jesse Gelsinger Case 1998 HIV Vaccine Trials 1999 Dr. Kevorkian Convicted 1999 Bush Announces Limited Stem-Cell Research 2001 Human Genome Project Completed 2003 Partial-birth Abortion Ban Act 2003 Terri Schiavo Case 2005 Gonzales v. Carhart 2007

1946-1947: Doctors’ Trial at Nuremberg Tribunal - 20 Nazi physicians, three medical administrators
Charged with “murders, tortures and other atrocities committed in name of medical science”
Defense: no clear guidelines on human experimentation
1947: tribunal, led by American Dr. Andrew C. Ivy, proposes ten “basic principles that must be observed in order to satisfy moral, ethical and legal concepts” in medical experiments
1) “The voluntary consent of the human subject is absolutely essential.”
2) “The experiment should be such as to yield fruitful results for the good of society.”
Others: prior animal experiments, avoidance of unnecessary physical and mental suffering, qualified researchers
Significance: Hippocratic Oath’s “primum non nocere” – distinction between treatment, human experimentation Nuremberg Trial and Code, 1946-1947 Full text of the Code

NEJM article – “Fifty Years Later: The Significance of the Nuremberg Code”

WHO article – value and limitations of the Code Nuremberg Trial and Code, 1946-1947 – Further Reading 1940s 1950s 1960s 1970s 1980s 1990s 2000s Tarasoff v. Regents UC 1976 Beecher's NEJM "Ethics and Clinical 1966 Medicare and Medicaid 1965 Research" http://www.nejm.org/doi/full/10.1056/NEJM199711133372006 http://history.nih.gov/research/downloads/nuremberg.pdf http://www.who.int/bulletin/volumes/85/8/07-045443/en/index.html Feb 25, 1990: Terri Schiavo, 26, suffers massive brain damage from lack of oxygen from cardiac arrest
Diagnosed later with PVS, needed feeding tube
1998: Terri Schiavo's husband, Michael Schiavo, petitions to remove feeding tube
Opposed by her parents – taken to court
2001: court ruled in favor of husband, ordered tube to be removed
However, took until 2005 until tube removed permanently
Ended up in U.S. Supreme Court, subject of national debate
Congress and President Bush tried to step in unsuccessfully
After death: autopsy revealed extensive brain damage
Along with Quinlan and Cruzan, third major end of life case Terri Schiavo Case, 2005 Apr, 1999: after successfully avoiding conviction many times, Kevorkian convicted of second-degree murder based on 60 Minutes piece
Sentenced to 10-25 years in prison
Let out on parole in 2007, died 2011
Kevorkian’s efforts led to greater public awareness of issue
Doctors more likely to help patients in pain
However, also revealed dangers of euthanasia without thorough physical and psychiatric checks beforehand Dr. Kevorkian Convicted, 1999 (con’t) 1999: HIV Vaccine Trials Network (HVTN) established by branch of NIH
International collaboration of scientists working all over world, including developing countries
Ethical issues
Informed consent across cultural boundaries
Economic and social considerations in developing countries
Making sure not to create “double standards” of clinical trials (major differences between US, developing countries)
Use of placebo
If a treatment appears to be effective (even marginally), necessary to give to all in trial?
Controlled experiment, replicable data vs. best interest of study participants HIV Vaccine Trials, 1999 1990 NYT article on Larry and implications for right to die, care of disabled


2004 Theor Med Bioeth article – “Depression in the Context of Disability and ‘Right to Die’”

2003 J Health Polit Policy Law article about how those with disability view assisted suicide Larry McAfee Case, 1985 – Further Reading Mar 1983: At President Reagan’s request, Secretary of Health and Human Services Richard Schweiker issues new regulations to prevent deaths of children with disabilities
“Baby Doe Squad” at DHHS created
American Academy of Pediatrics challenged regulations, taken to U.S. Supreme Court
Supreme Court: “Federal Government has no power to overrule parental decisions”
Apr 15, 1985: Reagan signs law allowing federal funding to be withheld from states not complying with surveillance of neonatal intensive-care units
Ethical issue
Does anyone have right to decide baby’s life not worth living? Baby Doe Case, 1982 – Consequences July 1981: report issued by 1978-83 Presidential Commission for the Study of Ethical Problems in Medicine and Bioethical and Behavioral Research
“Defining Death: A Report on the Medical, Legal, and Ethical Issues in the Determination of Death”
Favors “whole brain” approach instead of “higher brain”
Defines death as “the irreversible cessation of cardio-respiratory functions or the irreversible cessation of all functions of the brain including the brain stem”
Basis for 1981 Uniform Determination of Death Act, now law in most states
Link to report
http://bioethics.georgetown.edu/pcbe/reports/past_commissions/defining_death.pdf Defining Death, 1981
Link to full text of decision

PBS article about Roe, cases that followed

The Hastings Center article on abortion

Huffington Post article about relevance of decision today Roe v. Wade, 1973 – Further Reading

2002 NPR article – “Remembering the Tuskegee Experiments” (see bottom for more resources)

2001 Soc Sci Med article about how Tuskegee still affects African Americans’ views on gov’t research

1991 Am J Public Health article examining how study affected AIDS education U.S. Public Health Service Tuskegee Study Exposed, 1972 – Further Reading Recent FDA blog about consequences of case

1997 CNN article about reemergence of drug

2010 NYT article on Dr. Kelsey

NYT article about recent GlaxoSmithKline settlement (illegal marketing, not reporting safety concerns) Thalidomide Revelations, 1962 – Further Reading 2005 JAMA article about case, ethics

2005 J Med Ethics article on Terri Schiavo

2005 PBS discussion of Terri Schiavo and medical ethics Terri Schiavo Case, 2005 – Further Reading 2000 paper – “Ethical Issues in HIV Vaccine Trials in South Africa”

2000 UNAIDS publication on HIV trials ethics

Article about ethical issues in clinical trials in developing countries

Recent NYT article about negative effect of HIV trial HIV Vaccine Trials, 1999 – Further Reading Link to 1998 article

Link to 2007 article

NIH website on stem cells

2007 NYT article about Dr. Thomson’s original ethical concerns, changing views on embryonic research

2009 NYT article about Obama’s reversal of Bush policy

NPR discussion about recent breakthrough of stem cell eye therapy Human Embryonic Stem Cells, 1998 – Further Reading 1998, Univ of Wisconsin: Dr. James Thomson and lab first to announce isolation of stem cells using human embryos
Major breakthrough in potential to study and treat diseases
However, public outcry over using human embyos, even ones donated with parents’ consent and destined to be discarded
Renews debate of when life begins
Feb, 2001: President Bush announces limited gov’t funding of stem cell research on existing stem cell lines
No new embryos allowed to be used
2007: Dr. Thomson part of team to publish article on induced pluripotent stem cells
Adult cells “reprogrammed” to stem cells
Diminished need for embryonic stem cells
Mar, 2009: President Obama signs executive order reversing Bush policy on embryonic stem cell research Human Embryonic Stem Cells, 1998 2004 UNESCO report on cloning

2011 NPR discussion about advances in human cloning, its ethics

Gov’t webpage about human cloning, its ethics

2007 NYT article about religious objections to human cloning Dolly the Sheep, 1996 - Further Reading Jul 5, 1996, Edinburgh: Dolly the Sheep born
First mammal cloned from adult cell – lived six years
Ian Wilmut, Keith Campbell of Roslin Institute created her using somatic cell nuclear transfer
Invalidates assumption that cell differentiation irreversible
New questions raised
Who can create life? How?
Should humans ever be cloned? Dolly the Sheep, 1996 Jan 15, 1994: President Clinton forms ACHRE, chaired by Dr. Ruth Faden
Result of DOE new openness policy, which involved release of 1.6 million classified records
Some describe radiation experiments from 194os-7os
Experiments – many people (including vulnerable) unknowingly injected with radiation to assess health effects for Cold War studies
Minorities, children, elderly, prisoners, hospital patients injected without consent
Often led to permanent harm or disability
1995: Clinton apologizes for tests
U.S. also settled suits from survivors
Again raises serious concerns about government-sponsored research Advisory Committee on Human Radiation Experiments, 1994

2011 J Med Ethics article about law’s impact on vulnerable groups

Recent Journal of Health Law article on ethics of law

2004 NYT article about Oregon man’s decision to use act

2011 J Palliat Med article about quality of death with physician-assisted suicide Oregon Assisted Suicide Legislation, 1994 – Further Reading 1994: Oregon approves Death with Dignity Act, becoming first state to legalize physician-assisted suicide with some regulations
Terminal illness with six months to live
1997: Oregon voters approve initiative
1998: First legal, physician-assisted suicide in U.S. when Oregon woman takes lethal drugs prescribed by physician
2002: Netherlands first nation to legalize euthanasia
Also legal now in Washington (2008), Montana (2009)
2006: U.S. Supreme Court, in 6-3 decision, upholds law in Gonzales v. Oregon
Ethical implications
Besides right to die and Hippocratic Oath issues, are vulnerable populations at risk?
Elderly, minorities, those with mental health issues, etc. Oregon Assisted Suicide Legislation, 1994 Five provisions of a Pennsylvania abortion act were challenged as unconstitutional under Roe v. Wade
Made it to U.S. Supreme Court
First case with serious chance of overturning Roe, since most justices appointed by Reagan and Bush
Supreme Court: upheld Roe by plurality for most part
Grounded in personal autonomy, equal citizenship (rather than privacy)
New issues addressed:
24-hour waiting period, “viability” of fetus, “undue burden”
Link to decision
http://www.law.cornell.edu/supct/html/91-744.ZS.html Planned Parenthood v. Casey, 1992 2010 NYT article about gene patenting ruling

2010 NYT two-part article about progress decade after draft


Recent WSJ article – “Soon, $1,000 Will Map Your Genes” Human Genome Project Begins, 1990 – Further Reading Government’s “Ethical, Legal, and Social Issues” of human genome project
See links at bottom for further information

OMIM article on the genetic basis of alcohol dependence

2009 J Health Polit Policy Law article on community-based discussions of genetic testing Human Genome Project Begins, 1990 – Further Reading Oct, 1990: 15-year, international project with goal of mapping entire human genome begins
Headed by NIH and DOE in US; scientists from UK, France, Australia, Japan, Spain; also private competition
3-5% annual budget for Ethical, Legal, and Social Implications (ELSI)
Mar, 2000: President Clinton announces genome sequence cannot be patented, should be made available to all researchers
2000: With “shotgun” approach successful, NIH and Celera Genomics announce completed draft of entire human genome (publ. 2001)
2003: Project completed (publ. 2004)
May, 2008: President Bush signs Genetic Information Nondiscrimination Act (GINA) Human Genome Project Begins, 1990 – Background 1990 NYT article after her death

Link to Supreme Court decision

Recent AACN Advanced Critical Care article about Nancy, end of life care since then Nancy Cruzan Case, 1990 – Further Reading 2007 “Surrogate Motherhood and the Politics of Reproduction”

2011 article about gay NJ couple, one of whom used sister as surrogate, and legal battle that followed for custody (Baby M cited)

Recent NPR discussion on surrogacy and law Baby M Case, 1987 – Further Reading 1985: Bill and Elizabeth Stern place ad for surrogate
Elizabeth had MS – worried about carrying child
Mary Beth Whitehead responded to ad, signed contract, artificially inseminated with Bill’s sperm
Mar 27, 1986: Baby M born
Day after giving baby to Sterns, Mary Beth asked for child back, claiming she was biological mother
Case taken to court
1987: NJ Supreme Court awards Sterns custody
“Best interest of child” analysis
1988: NJ Supreme Court invalidates surrogacy contracts
Sterns still keep the baby, Whitehead gets visitation rights
Question: what determines a parent? Baby M Case, 1987 1984 NYT piece on Elizabeth

1992 LA Times article about Elizabeth, her change of mind

2005 AMA summary and implications of case

Link to short article about legal aspects of case Elizabeth Bouvia Case, 1983 – Further Reading

2007 Columbia article about Barney
Discusses ethical problems of procedure

2007 J Med Ethics article – “The Ethics of Implantable Devices”

2008 Philos Ethics Humanit Med article about LVAD ethics challenges Barney Clark – First Artificial Heart, 1982 – Further Reading 1984 NYT article about activists trying to get rid of judge from case

2005 J Med Philos article arguing against Baby Doe regulations

2005 NYT Magazine article about guidelines for infant euthanasia

2009 GSU Law Review article about Baby Doe and the evolution of neonatal intensive care Baby Doe Case, 1982 – Further Reading April 9, 1982, Bloomington: Baby Doe born with Down syndrome and a life-threatening intestinal defect
Parents declined to have surgery for the child to correct the intestinal problem
Didn’t want child to grow up retarded
Hospital, uncomfortable with decision, took case to court
Indiana Supreme Court ruled in favor of parents, saying they made medically reasonable decision
Baby Doe died few days later on Apr 15, 1982 Baby Doe Case, 1982 – Background

NPR discussion about Louise, safety of IVF 25 years later

2010 NYT article after Dr. Edwards’s Nobel Prize – discusses challenges of discovery, controversy afterward

PBS interview with bioethicists about Louise, test tube babies, stem cell research
See left side of page for links to other articles on IVF

2009 article about difficulties gay and lesbian couples have gaining access to fertility treatments Baby Louise Brown – First IVF Birth, 1978 – Further Reading 1994 NYT article about finding from Karen’s autopsy several years later

2009 New Yorker article about Karen

2005 Bayl Univ Med article about medical, ethical, and legal issues in severe brain injury Karen Ann Quinlan Case, 1976 – Further Reading

Link to full text of decision

2005 APA article about Tarasoff, recent decisions about duty to warn

2002 JAAPL article about Tarasoff, critiquing it

2004 Stanford Bioethics article about Duty to Warn regarding hereditary diseases

2007 HEC Forum article about Duty to Warn regarding AIDS Tarasoff v. Regents of University of California, 1976 – Further Reading
Oct, 1969, UC Berkeley: Graduate student Prosenjit Poddar stalks and kills Tatiana Tarasoff
Poddar told a psychologist at Berkeley of his intention beforehand
The psychologist had contacted police, but never told Tatiana
Poddar detained briefly, then released
Tatiana’s parents attempted to sue the psychologist and UC
California Supreme Court – health professional had “duty to warn” Tatiana
"The protective privilege ends where the public peril begins."
Ethical issue: doctor-patient confidentiality vs. safety of others
Also, how far does duty extend?
Warning vs. protection Tarasoff v. Regents of University of California, 1976 Passed by Congress, signed into law on Jul 12, 1974
Largely in response to outcry from Tuskegee experiments
Led to establishment of 1974-1978 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, first national bioethics commission
Link to short history of U.S. bioethics commissions
http://bioethics.gov/cms/history National Research Act, 1974

CDC website devoted to study
Includes timeline, transcript of Clinton’s apology, and implications for research

NYT article day after story broke (Jul 26, 1972) U.S. Public Health Service Tuskegee Study Exposed, 1972 – Further Reading

Public outcry at time of heightened racial tensions
Other issues: government taking advantage of poor, vulnerable; informed consent problems; lack of benefits of research for participants
1973: Sen. Edward M. Kennedy holds congressional hearings
CDC and PHS appointed ad hoc panel soon after – study terminated
Led to 1974 National Research Act, 1974-1978 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Lingering distrust of African American community towards U.S. public health efforts
Major problem during AIDS epidemic
May 16, 1997: Bill Clinton formally apologizes to survivors U.S. Public Health Service Tuskegee Study Exposed, 1972 – Consequences

Link to original article


Article from Soc Sci Med – gives historical overview and analyzes significance and controversy of definition

2009 NYT article about unique case of declaring death

2009 NPR article about high rate of misdiagnosis of people thought to be in vegetative state Harvard Definition of Brain Death, 1968 – Further Reading Aug 5, 1968: NEJM publishes article “A Definition of Irreversible Coma: Report of the Ad Hoc Committee at Harvard Medical School to Examine the Definition of Brain Death”
Previously, death was defined as “an irreversible cessation of respiration and circulation”
Obsolete: modern respirators, heart transplant
Describes physical and neurological characteristics of irreversible coma
Unresponsiveness, no movements or breathing, no reflexes, a flat electroencephalogram indicating a state of permanent and irreversible coma
Paved groundwork for modern definition of death
Problem – no universal criterion for some years after this
State by state definitions often differed Harvard Definition of Brain Death, 1968 NYT obituary for Dr. Barnard

BMJ article: “Christiaan Barnard: his first transplants and their impact on concepts of death”

Recent CBS article about debate after Dick Cheney heart transplant First Heart Transplant, 1967 – Further Reading 2006 HHS article about significance of programs on medical profession

Recent NYT article about Medicaid expansion lowering death rate

Recent J Surg Res article about differences in insurance affecting outcomes after injury

Recent WSJ article about large number of doctors “shunning” Medicaid Medicare and Medicaid, 1965 – Further Reading Gov’t website about Affordable Care Act’s affects on Medicaid (see link to timeline)

NYT page on Medicaid

2011 J Law Med Ethics article – “The Ethical Implications of Health Spending: Death and Other Expensive Conditions”

The Hastings Center website and blog on health care cost Medicare and Medicaid, 1965 – Further Reading Medicare and Medicaid, 1965 Jul 30, 1965: President Lyndon Johnson signs Social Security Act of 1965 into law, establishing Medicare and Medicaid
Teddy Roosevelt, Franklin Roosevelt, Harry Truman, and John Kennedy had all pushed for similar programs at different points in their careers
Medicare: national program that guarantees health insurance for Americans 65 and older, those with disabilities
Medicaid: means-tested health program for families with low income
Jointly funded by state and federal gov’t , run by state
First national health insurance programs
Mar 23, 2010: President Obama signs Patient Protection and Affordable Care Act into Law
Among other things, mandates health insurance, eliminates pre-condition screening, provides greater subsidies for poor to buy insurance
June 28, 2012: U.S. Supreme Court upholds majority of law (not Medicaid expansion)
Some ethical issues
Who is responsible for paying for health care?
How does payment (or lack of) factor into quality of care?
Which diseases, treatments should be covered under these programs?

Link to original LIFE article


Excerpt from book by Albert Jonsen on article, its impact



Recent article from Stanford Hoover Institution: “Supply, Demand, and Kidney Transplants”

Recent NPR article about financial challenges to fair access of HIV drugs Seattle Dialysis Selection Committee, 1962 – Further Reading Overview, ethical dilemmas of Willowbrook

Journal of Pediatrics article about study, debate that followed regarding informed consent of minors

Recent article about lack of drug trials for children Willowbrook Experiments, 1956 – Further Reading 1956: Drs. Saul Krugman, Robert McCollum, and Joan Giles begin 16-year study of hepatitis at Willowbrook State Hospital
With consent of parents, intentionally infected mentally retarded children with live strain of virus
Reasoning: almost all children there eventually contracted hepatitis, induced infection would later immunize them, obtained parental consent, research led to vaccine
1972: a series of newspaper articles and an expose by Geraldo Rivera exposing abuses at Willowbrook lead to public outcry, end of study
Problems
Is informed consent possible for children, disabled?
Direct benefits from research ambiguous
Parents may have felt pressured to enroll their children in study to gain acceptance to Willowbrook
Medical institution taking advantage of unsanitary conditions instead of trying to improve them Willowbrook Experiments, 1956
NYT obituary of Fletcher


BBC overview of situation ethics Fletcher’s “Morals and Medicine,” 1954 – Further Reading NPR discussion about the surgery, 50 years later

Georgetown paper – “Organ Transplantation: Ethical Dilemmas and Policy Choices”

Recent NPR article about ethics of compensating organ donors First Kidney Transplant, 1954 – Further Reading Link to Gonzales decision

2006 NPR article on the procedure

2007 Boston Globe article about a doctor’s response to Gonzales Partial-birth Abortion Ban Act, 2003 – Further Reading Nov 5, 2003: President Bush signs partial-birth Abortion Ban Act of 2003 into law
Prohibits these late-term abortions (usually 2nd trimester)
Focused on method of abortion (as opposed to age, viability of fetus)
2007: In 5-4 decision, U.S. Supreme Court upholds ban in Gonzales v. Carhart
Beginning of move towards restriction of abortion rights Partial-birth Abortion Ban Act, 2003 1999 NYT article on Jesse

Oxford piece on Jesse, ethical implications

The Hastings Center article on Jesse, 10 years later

The Hastings Center article on conflicts of interest in biomedical research Jesse Gelsinger Case, 1999 – Further Reading Sep 13, 1999, UPenn: Jesse Gelsinger, 18, is injected with adenoviral vector in clinical trial
Jesse had ornithine transcarbamylase deficiency, under control with diet, meds
Trial to see if gene therapy would help babies with condition
Sep 17, 1999: Jesse dies, having suffered from massive immune response to vector
First gene therapy clinical trial death
Subsequent FDA investigation reveals improper procedures in clinical trial by UPenn scientists, raises issues of informed consent
Jesse included as substitute for another volunteer improperly
Failure to report serious side effects of two patients
Failure to report death of monkeys in animal trials on informed consent form
Potential financial conflicts of interest Jesse Gelsinger Case, 1999 Link to 1997 Detroit Free Press article

PBS timeline of Kevorkian

2011 NYT obituary of Kevorkian

2011 Am J Bioeth article on Kevorkian Dr. Kevorkian Convicted, 1999 – Further Reading 1990, Detroit: Dr. Jack Kevorkian helps woman recently diagnosed with Alzheimer’s commit suicide
Used euthanasia device – patient administers deadly cocktail of drugs to self
Not charged with murder (no laws on physician-assisted suicide in MI), but medical license revoked
1990-1998: Kevorkian assisted in deaths of estimated 130 people, all supposedly terminally ill
1997 Detroit Free Press article – doubts all were terminally ill, in pain; calls into question his psychiatric (and even medical) testing before procedure
Potential gender bias, too - most of his patients female
Nov, 1998: Kevorkian appears on 60 Minutes, which shows him delivering lethal cocktail to man with ALS Dr. Kevorkian Convicted, 1999

Link to summary of final report from ACHRE

1994 NYT article about experiments, formation of committee

PSU review of experiments, their significance Advisory Committee on Human Radiation Experiments, 1994 – Further Reading 1994: an Italian woman, 62, gives birth to healthy boy
Had used IVF
Oldest woman at time to give birth
Prompted condemnation from Catholic Church, debate on whether to set age limits on pregnancy
Link to recent UPenn Bioethics paper on age limits for pregnancy
http://www.bioethics.upenn.edu/documents/too_old_for_a_baby.pdf Woman gives birth at 62, 1994 Benefits
More personalized and advanced diagnosis, treatment, and prevention of diseases
Better understanding of human biology, evolution
Energy and environmental applications
Ethical concerns – see gov’t page for more info
Fairness of use (insurance, employers, courts, etc)
Reproductive issues (fetal genetic testing)
Gene testing, gene therapy
Property rights, commercialization
Other philosophical (genetic determinants of behavior, acceptable diversity) Human Genome Project Begins, 1990 – Consequences Jan 11, 1983, Missouri: Nancy Cruzan, 25, in automobile accident, lands face first in puddle
Oxygen deprivation caused permanent brain damage, declared in persistent vegetative state
Stuck in fetal position
Her doctor later described her existence as “living hell”
After four years of no further recovery, her parents and husband requested she be removed from feeding tube
State of Missouri refused, taken to court
1990: Case taken to U.S. Supreme Court
First right to die case heard by Supreme Court
5-4 ruling:
People have right to refuse medical treatment under Due Process
Need “clear and convincing” evidence of person’s wish (living will)
After family found more proof of Nancy’s desires, life support removed, and Nancy died on Dec 26, 1990
Her father committed suicide six years later from emotional toll of legal battle Nancy Cruzan Case, 1990 May 5, 1985, Georgia: Larry McAfee, 29, mechanical engineer and outdoorsman, paralyzed in motorcycle accident
Had to use ventilator to breathe, stuck in nursing home
1989: decided he wanted to die – case taken to court
1989: Georgia Supreme Court sided with him
However, after public attention, help getting out of nursing home and into job training, he changed his mind
Died in 1995 of pneumonia
Ethical dilemmas
Who has responsibility of caring for severely disabled?
Right to die if care, quality of life sub-par?
If gov’t rules in favor of right to die for someone with disability, does this send negative message to others living with same disability? Larry McAfee Case, 1985 Sep 3, 1983, Riverside: Elizabeth Bouvia, 26, paralyzed from cerebral palsy and suffering from severe degenerative arthritis, checks herself into hospital
Asks to be allowed to starve to death
Hospital refuses, case taken to court
Court sided with hospital
However, they need four attendants to hold her down to insert tube through nose
She claims this is battery and torture – case back to court
After losing once more and appealing, Elizabeth finally won right to have tube removed
After all this, reluctantly decided not to commit suicide – still alive today
Ethics issues
Right to die (for someone not terminally ill), quality of life, physician assisted suicide Elizabeth Bouvia Case, 1983 Sep 30, 1978: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issues Belmont Report
Commission created largely in response to Tuskegee study
Report: identifies three fundamental ethical principles for using human test subjects
Respect for persons (autonomy)
Beneficence, non-maleficence
Justice
Still in use today in line with IRB
Link to report
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html Belmont Report, 1978 Jul 25, 1978, Manchester: Louise Joy Brown born
First in vitro baby
Her mother had damaged fallopian tubes
Made possible by experiments from Drs. Patrick C. Steptoe and Robert G. Edwards
Edwards awarded 2010 Nobel Prize in Medicine for work
Ethical concerns raised
Should babies ever be created outside womb?
Possibility of “designing” babies now within reach
Who owns fertilized embryo? Who are rightful parents? Baby Louise Brown – First IVF Birth, 1978 First legal case about life support
Drew national attention to medical, ethical, and legal issues surrounding right to die
Technological progress allows life to continue
Results
Development of formal ethics committees in hospitals
Advanced health care directives
Ethical issues
What is meaningful life?
Who has right to decide? Karen Ann Quinlan Case, 1976 – Consequences Apr 14, 1975, NJ: Karen Ann Quinlan admitted to hospital in coma
Had ingested barbiturates, Valium, and alcohol
Declared in persistent vegetative state
Parents asked to remove breathing tube
Physician, threatened with prosecution, declined
Parents took case to court
Mar 31, 1976: NJ Supreme Court declares her life support can be removed by privacy rights, her parents can act as surrogates
After tube removed, Karen began to breathe on own
Lived in vegetative state in nursing home for 10 more years Karen Ann Quinlan Case, 1976 – Background

Jul 25, 1972: Washington Evening Star runs headline on front page exposing experiments
Study started in 1932 by Drs. Taliaferro Clark and Dr. Oliver Wenger of U.S. Public Health Service, ran for 40 years
Purpose: examine effects of syphilis on human body through autopsies
Mostly conducted on poor, uneducated black AL sharecroppers
Problems
400 men who were diagnosed with syphilis, never knew
Instead, were told they were being treated for “bad blood”
When Penicillin became treatment in 1947, those infected were never given drug or told about it, and study never terminated
On multiple occasions since study began, U.S. Public Health Service had reviewed it and given approval to continue U.S. Public Health Service Tuskegee Study Exposed, 1972 – Background Moral philosophy paper by Judith Jarvis Thomson, published 1971
Argues for permissibility of abortion
Even assuming personhood of unborn (“Violinist” example)
Precursor to Roe v. Wade, contemporary focus on ethics of abortion
Link to paper Thomson’s “A Defense of Abortion,” 1971 Founded by Drs. Daniel Callahan and Willard Gaylin
Incorporated Mar, 1969 as Institute of Society, Ethics, and the Life Sciences
Publishes bimonthly report and website on bioethical issues
http://www.thehastingscenter.org/
Some current topics Center addresses:
Health Care Cost
Conflicts of Interest in Research
Genetic Testing and Screening
Stem cells The Hastings Center, 1969 December 3, 1967, Cape Town: Dr. Chistiaan Barnard performs first successful heart transplant on 55-year-old Louis Washkansky
Washkansky died 18 days later
Donor Denise Darvall – “irreversibly fatal brain damage” from car accident, permission from father to use heart
Ethical concerns
Was donor truly dead?
Dr. Barnard admitted later to injecting heart with potassium to render her technically dead
Was heart taken without regard to wishes of source?
How do you define death?
Difference between heart death and brain death
Introduction of respirators in 1950s allows for distinction
Prolongation of life – quality vs. quantity First Heart Transplant, 1967

2001 WHO piece discussing Beecher’s impact (includes original article)

1987 NEJM article about “Ethics” significance

1999 ASA article about Beecher Beecher’s NEJM “Ethics and Clinical Research,” 1966 – Further Reading Jun 16, 1966: NEJM medicine publishes Henry K. Beecher’s “Ethics and Clinical Research”
Beecher: anesthesiologist, researcher on placebo-effect
“Ethics” presents 22 cases where human subject experimented on with no benefit to subject
Studies jeopardized “health or the life of their subjects” without their knowledge
Experiments carried out by mainstream and renowned researchers and institutions
CWRU, UPenn, OSU, Harvard, Duke, NYU, etc…
Article gained national attention – public outcry
Ultimately, led to NIH and FDA regulations concerning clinical research and informed consent Beecher’s NEJM “Ethics and Clinical Research,” 1966 Nov 9, 1962: LIFE publishes article, “They Decide Who Lives, Who Dies,” by Shana Alexander
About anonymous committee in Seattle (mostly non-physicians) who selected patients for entry into new chronic hemodialysis program
Controversy of using “social worth criteria”
Were patients with similar socio-economic backgrounds as committee members selected?
Ethical questions raised
Who should have access to scarce life-saving technology?
Who gets to choose these patients? How? Seattle Dialysis Selection Committee, 1962 July 15, 1962: The Washington Post publishes article about thalidomide causing limb deformities in human fetus
Merrell, manufacturer of drug, had waged premarketing campaign to influence physicians before FDA approval
Work by Dr. Frances O. Kelsey exposing dangers of drug and preventing it from reaching U.S. market led to Kefauver-Harris amendments to FDA
“Substantial evidence of efficacy”
Full and free consent of all subjects in drug trial
Significance: role of money and political influence in human experiments, drug approval process Thalidomide Revelations, 1962 Joseph Fletcher – Episcopal Priest and professor, founder of situation ethics
1954: “Morals” defends patient’s right to choose (instead of Church, doctor) in birth control, euthanasia, sterilization, artificial insemination, and abortion
"We need to educate people to the idea that the quality of life is more important than mere length of life. Our cultural tradition holds that life has absolute value, but that is really not good enough anymore. Sometimes, no life is better." Fletcher’s “Morals and Medicine,” 1954 Dec 23, 1954, Boston: first successful organ transplantation – Ronald Herrick donates kidney to dying identical twin, Richard
Led by Dr. Joseph Murray
Awarded 1990 Nobel Prize in Medicine for work
Richard survived eight more years
New concerns
Ethical to perform major surgery on healthy person, remove organ to save another?
Voluntary consent of donor First Kidney Transplant, 1954 Dec 1, 1982, Utah: Dr. Barney Clark, 61, becomes first man given total artificial heart
Had idiopathic cardiomyopathy with Class IV congestive failure, too old for transplant
Heart – Jarvik 7, designed by Dr. Robert Jarvik
Survived 112 days
However, suffered from blood clots, strokes, seizures, and ruptured valve on heart
Quality vs. quantity of life debate revived
Also, how do you assess costs and benefits of technology? Barney Clark – First Artificial Heart, 1982 Jan 22, 1973: In 7-2 decision, majority opinion by Justice Harry Blackmun, U.S. Supreme Court declares state law cannot restrict woman’s right to abortion in first trimester
States can enact some regulations in second and third related to health of mother, only in third related to life of fetus
Used 14th Amendment, Bill of Rights as justification
“We need not resolve the difficult question of when life begins.”
Significance – moved abortion debate to forefront of national politics, dividing country into two camps
Ethical issues raised
When does life begin? Who can decide this?
Who can decide if a woman has right to an abortion?
Health of mother vs. right to life of infant
Role of religion in law, politics, medicine Roe v. Wade, 1973 http://bioethics.georgetown.edu/pcbe/background/org_transplant.html http://www.npr.org/templates/story/story.php?storyId=4233669 http://www.npr.org/2012/05/22/153293669/the-ethics-of-compensating-organ-donors http://www.nytimes.com/1991/10/30/us/dr-joseph-f-fletcher-86-dies-pioneer-in-field-of-medical-ethics.html http://www.bbc.co.uk/ethics/introduction/situation_1.shtml Willowbrook Experiments, 1956 – Video http://science.education.nih.gov/supplements/nih9/bioethics/guide/pdf/Master_5-4.pdf http://www.sciencedirect.com/science/article/pii/S0022347606003702 http://news.yahoo.com/more-drug-trials-needed-conditions-affecting-kids-review-160408589.html?_esi=1 http://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-after-thalidomide-why-regulation-matters/ http://www.cnn.com/HEALTH/9709/04/nfm.thalidomide/index.html http://www.nytimes.com/2010/09/14/health/14kelsey.html http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all http://books.google.com/books?id=qUoEAAAAMBAJ&pg=PA102&source=gbs_toc_r&cad=2#v=onepage&q&f=false http://books.google.com/books?id=crh6QJWKg7AC&pg=PA7&lpg=PA7&dq=they+decide+who+lives+who+dies+life+magazine&source=bl&ots=f-bPS_yc9E&sig=1QcW0x1d_D6fP-1d1rnGuLFr0ug&hl=en&sa=X&ei=VNEWUIXYJsSkrQGB34DYDA&ved=0CFMQ6AEwAw#v=onepage&q=they%20decide%20who%20lives%20who%20dies%20life%20magazine&f=false‘ http://www.hoover.org/publications/policy-review/article/6060 http://www.npr.org/blogs/health/2012/07/26/157362343/treating-everybody-with-hiv-is-the-goal-but-who-will-pay http://www.medicaid.gov/AffordableCareAct/Affordable-Care-Act.html http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/medicaid/index.html http://onlinelibrary.wiley.com/doi/10.1111/j.1748-720X.2011.00582.x/pdf http://www.cmms.hhs.gov/Research-Statistics-Data-and-Systems/Research/HealthCareFinancingReview/downloads/05-06Winpg79.pdf http://www.nytimes.com/2012/07/26/health/policy/medicaid-expansion-may-lower-death-rate-study-says.html?pagewanted=all
http://www.ncbi.nlm.nih.gov/pubmed/22858381 http://online.wsj.com/article/SB10000872396390444246904577573531560195466.html http://www.who.int/docstore/bulletin/pdf/2001/issue4/vol79.no.4.365-372.pdf http://www.nejm.org/doi/full/10.1056/NEJM198711053171906 http://asatest.asahq.org/Newsletters/1999/09_99/beecher0999.html http://www.nytimes.com/2001/09/03/world/christiaan-barnard-78-surgeon-for-first-heart-transplant-dies.html?pagewanted=all
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1121917/ http://www.cbsnews.com/8301-504763_162-57404411-10391704/dick-cheneys-heart-transplant-at-71-spurs-age-debate/ http://www.hods.org/english/h-issues/documents/ADefinitionofIrreversibleComa-JAMA1968.pdf
http://www.sciencedirect.com/science/article/pii/S0277953696002663 http://www.nytimes.com/2009/12/20/magazine/20organ-t.html?pagewanted=all http://www.npr.org/templates/story/story.php?storyId=120784397 U.S. Public Health Service Tuskegee Study Exposed, 1972 – Videos http://www.cdc.gov/tuskegee/index.html http://select.nytimes.com/gst/abstract.html?res=F40616F6345A137B93C4AB178CD85F468785F9 http://www.npr.org/programs/morning/features/2002/jul/tuskegee/ http://www.sciencedirect.com/science/article/pii/S0277953600001787 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1405662/?tool=pmcentrez Roe v. Wade, 1973 – Video http://caselaw.lp.findlaw.com/cgi-bin/getcase.pl?court=us&vol=410&invol=113 http://www.pbs.org/wgbh/pages/frontline/clinic/wars/cases.html http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2400 http://www.huffingtonpost.com/2012/01/20/roe-v-wade-anniversary_n_1216869.html http://www.stanford.edu/group/psylawseminar/Tarsoff%20I.htm http://www.apa.org/monitor/julaug05/jn.aspx http://jaapl.org/content/30/3/417.full.pdf http://bioethics.stanford.edu/events/documents/pdfs/reporting_workshop/23_JAMA%20-%20Offit,%20Groeger,%20Turner.pdf http://www.springerlink.com/content/w35863j4l1472644/fulltext.pdf http://www.nytimes.com/1994/05/26/us/quinlan-case-is-revisited-and-yields-new-finding.html http://www.newyorker.com/reporting/2009/11/30/091130fa_fact_lepore http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1255938/ http://www.npr.org/templates/story/story.php?storyId=1355344 http://www.nytimes.com/2010/10/05/health/research/05nobel.html?_r=1 http://www.pbs.org/wgbh/americanexperience/features/interview/ethical-questions/
http://www.sciencedirect.com/science/article/pii/S001502820902473X http://www.nytimes.com/1984/10/04/us/group-seeks-ouster-of-judge-in-baby-doe-case.html http://jmp.oxfordjournals.org/content/30/4/331.long http://www.nytimes.com/2005/07/10/magazine/10WWLN.html?pagewanted=all http://digitalarchive.gsu.edu/cgi/viewcontent.cgi?article=2389&context=gsulr http://hnn.us/articles/44902.html http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2598199/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2527574/ http://www.nytimes.com/1984/01/03/us/quadriplegic-s-efforts-to-die-stir-deep-legal-and-ethical-issues.html?pagewanted=all http://articles.latimes.com/1992-09-13/news/vw-1154_1_elizabeth-bouvia http://virtualmentor.ama-assn.org/2005/02/hlaw1-0502.html http://books.google.com/books?id=tkorYKyJgF4C&pg=PA108&lpg=PA108&dq=elizabeth+bouvia+legal+case&source=bl&ots=rOC78v2AfB&sig=-8eMK8oCZTLjzQ9OfkbJ3L8NF7g&hl=en&sa=X&ei=rm4iUJ-YMoKC8ASS64DADQ&ved=0CFgQ6AEwBzgK#v=onepage&q=elizabeth%20bouvia%20legal%20case&f=false http://www.nytimes.com/1990/02/07/us/an-angry-man-fights-to-die-then-tests-life.html?pagewanted=all&src=pm http://www.springerlink.com/content/q82301lp607104h6/fulltext.pdf http://jhppl.dukejournals.org/content/28/6/977.long http://www.ucpress.edu/content/pages/10724/10724.ch01.pdf http://www.nj.com/news/index.ssf/2011/12/nj_gay_couple_fight_for_custod.html http://www.npr.org/2012/04/14/150586618/legal-debate-over-surrogacy-asks-who-is-a-parent http://www.nytimes.com/1990/12/27/us/nancy-cruzan-dies-outlived-by-a-debate-over-the-right-to-die.html?pagewanted=all&src=pm http://law2.umkc.edu/faculty/projects/ftrials/conlaw/cruzan.html http://www.ncbi.nlm.nih.gov/pubmed/22290096 Human Genome Project Begins, 1990 – Video http://www.nytimes.com/2010/11/02/health/02gene.html?_r=1&ref=myriad-genetics-inc http://www.nytimes.com/2010/06/13/health/research/13genome.html?scp=1&sq=%22human%20genome%22&st=cse http://www.nytimes.com/2010/06/15/business/15genome.html?_r=1&ref=business http://online.wsj.com/article/SB10001424052970204124204577151053537379354.html http://www.ornl.gov/sci/techresources/Human_Genome/elsi/elsi.shtml http://omim.org/entry/103780 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2800818/?tool=pmcentrez Oregon Assisted Suicide Legislation, 1994 – Video http://jme.bmj.com/content/37/3/171.long http://www.healthlawyers.org/Publications/Journal/Documents/Vol%2040%20Issue%201/Physician-Assisted%20Suicide-%20Legal%20and%20Ethical%20Considerations.pdf http://www.nytimes.com/2004/06/01/science/in-oregon-choosing-death-over-suffering.html?pagewanted=all&src=pm http://online.liebertpub.com/doi/full/10.1089/jpm.2010.0425 Advisory Committee on Human Radiation Experiments, 1994 – Video http://www.hss.doe.gov/healthsafety/ohre/roadmap/achre/index.html http://www.nytimes.com/1994/04/11/us/cold-war-radiation-test-on-humans-to-undergo-a-congressional-review.html?pagewanted=all&src=pm http://www.rps.psu.edu/mar96/science.html Dolly the Sheep, 1996 - Video http://unesdoc.unesco.org/images/0013/001359/135928e.pdf http://www.npr.org/2011/10/05/141089068/what-are-the-ethical-implications-of-cloning http://www.ornl.gov/sci/techresources/Human_Genome/elsi/cloning.shtml http://www.nytimes.com/2007/11/20/science/20tier.html?pagewanted=all http://www.sciencemag.org/content/282/5391/1145.full http://www.sciencemag.org/content/318/5858/1917.abstract http://stemcells.nih.gov/info/basics/basics1.asp http://www.nytimes.com/2007/11/22/science/22stem.html http://www.nytimes.com/2009/03/10/us/politics/10stem.html http://www.npr.org/2012/01/27/145990101/stem-cell-eye-therapy-shows-promise http://www.saavi.org.za/slack.pdf http://data.unaids.org/publications/IRC-pub01/jc072-ethicalcons_en.pdf http://www.hf.uib.no/i/filosofisk/ethica/who.pdf http://www.nytimes.com/2012/05/18/health/research/trial-vaccine-made-some-more-vulnerable-to-hiv-study-confirms.html Dr. Kevorkian Convicted, 1999 – Video
http://www.cbsnews.com/video/watch/?id=7368313n http://www.freep.com/article/20070527/NEWS05/70525061/SUICIDE-MACHINE-PART-1 http://www.pbs.org/wgbh/pages/frontline/kevorkian/chronology.html http://www.nytimes.com/2011/06/04/us/04kevorkian.html?_r=1 http://www.tandfonline.com/doi/full/10.1080/15265161.2011.596400 http://www.nytimes.com/1999/11/28/magazine/the-biotech-death-of-jesse-gelsinger.html?pagewanted=all&src=pm http://cirge.stanford.edu/May%209%20-%20Gelsinger%20vs.%20UPenn/Gelsinger%20-%20Oxford%20Textbook.pdf http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4034 http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2156 http://caselaw.lp.findlaw.com/scripts/getcase.pl?court=US&vol=000&invol=05-380 http://www.npr.org/2006/02/21/5168163/partial-birth-abortion-separating-fact-from-spin http://www.boston.com/yourlife/health/women/articles/2007/08/10/shots_assist_in_aborting_fetuses/?page=1 Terri Schiavo Case, 2005 – Video http://jama.jamanetwork.com/article.aspx?articleid=200885 http://jme.bmj.com/content/31/7/376.full http://www.pbs.org/newshour/bb/health/jan-june05/shiavo_3-25.html http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=3430&blogid=140 See "Human Embryonic Stem Cells, 1998" for more information See "Human Genome Project Begins, 1990" for more information See "Partial-birth Abortion Ban Act, 2003" for more information Power Point, Prezi by Alex Grossman-McKee, Intern at Cleveland Clinic Lerner College of Medicine, Jul-Aug 2012
Alex is studying Literary Arts, AB, and Economics, AB, at Brown University, Class of 2013
Thanks to Dana Patton for composing initial list of events with brief summaries
Thanks to Katherine Burke, MFA, for guidance using Prezi
Thanks also to Martin Kohn, PhD, Director, Program and Medical Humanities, and the bioethics staff at Cleveland Clinic Center for Ethics, Humanities, and Spiritual Care for their help Acknowledgements Baker, Robert, and Laurence B. McCullough. The Cambridge World History of Medical Ethics. Cambridge: Cambridge UP, 2009.
Evans, John Hyde. The History and Future of Bioethics: A Sociological View. New York: Oxford UP, 2012.
Jonsen, Albert R. The Birth of Bioethics. New York: Oxford UP, 1998.
Jonsen, Albert R. A Short History of Medical Ethics. New York: Oxford UP, 2000.
Primary source Sources – Books http://gxpperspectives.com/2011/02/13/informed-consent-questions-on-new-fda-requirement/
http://www.usatoday.com/news/health/2004-12-19-transplant_x.htm
http://andrewgoddard.squarespace.com/joseph-fletcher/
http://jeanbont.pbworks.com/w/page/37083492/Thalidomide
http://www.sciencedirect.com/science/article/pii/S0272638607001163
http://en.wikipedia.org/wiki/File:Lyndon_Johnson_signing_Medicare_bill,_with_Harry_Truman,_July_30,_1965.jpg Sources – Pictures https://www.countway.harvard.edu/chm/archives/iotm/iotm_2002-01.html
http://thelongestlistofthelongeststuffatthelongestdomainnameatlonglast.com/first288.html
http://www.hss.cmu.edu/philosophy/faculty-london.php
http://www.mit.edu/~philos/thomson.html
http://www.tuskegeecenter.org/TSS_frame.html
http://www.kansasfreepress.com/2010/01/37th-anniversary-of-roe-v-wade-a-time-to-be-thankful-for-our-doctors.html Sources – Pictures (con’t) http://www.wired.com/science/discoveries/news/2008/06/dayintech_0611
http://www.allvoices.com/contributed-news/6945645/image/64771703-louise-joy-brown
http://www.wired.com/thisdayintech/2009/12/dayintech_1202jarvikheart/
http://www.corbisimages.com/stock-photo/rights-managed/U2125484/elizabeth-bouvia-sitting-in-her-wheelchair
http://www.amazon.co.uk/The-Switch-DVD/dp/B000FFJVOG Sources – Pictures (con’t) http://www.tomfolio.com/bookdetailssu.asp?b=55979&m=40
http://law2.umkc.edu/faculty/projects/ftrials/conlaw/righttodie.htm
http://caveofknowledge.com/on-this-day/hgp/
http://alexa-dollythesheep.blogspot.com/2012/04/dolly-sheep.html
http://www.jesse-gelsinger.com/jesses-intent2.html
http://georgewbush-whitehouse.archives.gov/news/releases/2003/11/images/20031105-1_p35410-21-515h.html Sources – Pictures (con’t) http://philoscience.unibe.ch/bib2lib/pdf/gedankenexperimente/Thomson_abortion/Thomson_abortion.pdf http://abcnews.go.com/Archives/video/oct-21-2003-terri-schiavo-die-case-11606479 Acknowledgments, Sources
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