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Title: Human%20Subject%20Experimentation


1
Human Subject Experimentation
  • The Nazis
  • Lessons for Contemporary Research
  • The Role of the Physician in Society
  • Martin Donohoe

2
  • When a doctor goes wrong, he is the first of
    criminals. He has nerve and he has knowledge.
  • - Sherlock Holmes to Dr. Watson, Arthur Conan
    Doyle

3
Nazi Medicine
  • Guiding philosophy Hegelian (rational utility)
  • Social Darwinism - parallels in American and
    British Eugenics Movement
  • medical journals relatively silent
  • Ethics reduces morality to efficiency, economics,
    and aesthetics

4
Nazi Medicine
  • An arm of state policy
  • Focus on racial purity
  • from eugenic sterilization (370,000)
  • to involuntary euthanasia (70,000)
  • to large-scale genocide (over 6 million)

5
Nazi Medicine
  • Individual worth stated in economic terms
    propaganda re obligations to the state
  • I Accuse
  • Mathematics in the Service of Political
    Education

6
Nazi Medicine
  • Doctoring the nation more important than
    doctoring individuals - Nazism as applied
    biology (Rudolph Hess)
  • Focus on preventive medicine and public health
    anti-tobacco and anti-alcohol campaigns,
    environmental toxins, organic farming -to
    improve Aryan stock
  • Nazi soldiers given anabolic steroids to increase
    aggresiveness

7
Nazi Physicians
  • 52,000 physicians
  • National Socialist Party Members
  • Jews ostracized replaced by young Aryans
  • today 0.2 of German physicians are Jews, c/w 17
    pre-Nazis
  • 5 of non-Aryans committed suicide 25 murdered

8
Nazi Physicians
  • Economic hard times, physicians salaries rise,
    academic perks
  • Blutkitt (blood cement)
  • Rare resistance
  • Catholics
  • Marxists
  • Dutch

9
Nazi Physician-Researchers(Torturers)
  • Dr. Sigmund Rascher - coagulation/amputation
    studies hypothermia experiments
  • Dr. Karl Gebhart heteroplastic transplantation
    experiments
  • c.f. Stalins attempts to create interspecies
    (half-men/half-apes) super-warriors
  • Drs. Karl Clausberg and Viktor Brack
    X-irradiation/sterilization

10
Nazi Physician-Researchers(Torturers)
  • Drs. Joachim Mrugowsky, Erwin Ding-Schuler, and
    Waldemar Hoven IV phenol and gasoline executions
  • Dr. Friedrich Wegener (Wegeners
    Granulomatosis) German pathologist, Nazi party
    member, autopsied a prisoner with oxygen injected
    into his bloodstream in an embolism study may
    have participated in experiments on concentration
    camp inmates

11
Nazi Physician-Researchers(Torturers)
  • Dr Hans Conrad Reiter (formerly Reiters
    Syndrome, now reactive arthritis) senior Nazi
    official
  • Dr. Joseph Mengele Septicemia/twin vivisection
    studies
  • Dr. Hans Eppinger - father of modern hepatology

12
Indirect Participants
  • Prof. J Hallevorden Look here now, boys, if you
    are going to kill all these people at least take
    the brains out so that the material could be
    utilized the more (brains) the better.I
    accepted these brains of course. Where they came
    from and how they came to me was really none of
    my business.

13
Doctors and Resistance
  • German invasion of Poland (1939)
  • Drs Eugene Lazowski and Stanislaw Matulewicz
    created a fake typhus epidemic, using a harmless
    bacterium to innoculate non-Jews, knowing that
    infected Jews would be summarily executed
  • Germans fooled, quarantined area, many Jews
    escaped death

14
Nuremberg Doctors Trial
  • 23 German physicians tried
  • 16 found guilty
  • 7 hanged (incl. Gebhardt, Brack, Hoven, and
    Mrugowsky)

15
Nuremberg Doctors Trial
  • Rascher died before trial
  • Mengele fled for Argentina (remains verified
    1985)
  • Hallevorden committed suicide before trial
  • Otto Ambros (chemist) invented sarin (nerve
    gas), convicted of mass murder at Nuremberg
    Trials, later freed and worked with US chemical
    industry on thalidomide

16
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17
Nuremberg Code
  • Voluntary consent is absolutely essential
  • Avoidance of unnecessary physical and mental
    suffering
  • Option to quit/responsibility to terminate
  • Other safeguards

18
Declaration of Geneva
  • I will not permit considerations of religion,
    nationality, race, party politics or social
    standing to intervene between my duty and my
    patient
  • I will not use my medical knowledge contrary to
    the laws of humanity.
  • It is unethical for physicians to employ
    scientific knowledge to imperil health or destroy
    life.

19
Declaration of Helsinki
  • Patients rights to respect, self determination,
    informed decision-making
  • Investigators duties primacy of subjects
    welfare, ethical considerations take precedence
    over laws and regulation
  • Allows for surrogate consent

20
Japanese Abuses in WW II
  • Extensive biological and chemical weapons program
    involving prisoners of war
  • Many participants later achieved positions of
    prominence in Japanese medical schools and
    societies
  • Japanese scientists brought to Fort Detrick, MD,
    to help establish U.S. biological/chemical
    weapons program

21
Post-WW II
  • Over 700 Nazi rocket scientists and their
    families brought to the U.S. (including Werner
    von Braun) to help build nuclear missile program
  • Operation Paperclip

22
Post-WW II
  • German Medical Association unanimously issues
    blunt, straightforward apology for its role in
    the Holocaust (2012)

23
Post-WW II Human Subject Experimentation
  • James Ketchum (psychiatrist), L Wilson Green
    (scientist), Van Murray Sim psychochemical
    warfare studies for US Army
  • Ketchum later joined faculty of University of
    Texas Medical School

24
Post-WW II Human Subject Experimentation
  • Tuskegee Syphilis Study
  • The mens status did not warrant ethical debate.
    They were subjects, not patients clinical
    material, not sick people.
  • Dr John Heller, Director of Venereal Diseases at
    PHS between 1943 and 1948 (interviewed in 1976)

25
Studies on Native Americans
  • Sterilizations
  • Radioactive iodine to study adaptation of thyroid
    gland to extreme cold
  • Forced removal of children to English language,
    religious schools (c.f., Australia)
  • Distrust and reluctance of minorities to
    participate in medical research

26
Research on Prisoners
  • 1905 cholera experiments on volunteers
  • 1915 Joseph Goldberger pellagra studies
  • Prisoners pardoned or paroled in exchange for
    participation
  • 1941 Physician William Black infects children
    with herpes virus, paper published by J Peds

27
Post-WW II Human Subject Experimentation
  • Pharmaceutical and government sponsored studies
    on prisoners
  • 1940s and 1950s esp.
  • Halted in mid-1970s after drug company executives
    admitted prisoners were cheaper to use than
    chimpanzees
  • WW II gonorrhea, gas gangrene, dengue fever,
    malaria

28
Post-WW II Human Subject Experimentation
  • Guatemala STD study (1946-8)
  • U.S. researchers deliberately infected 1,308
    prisoners, military conscripts, prostitutes,
    orphans (provided by Sisters of Charity), and
    mental health patients with gonorrhea and
    syphilis
  • Scientists treated 87 of those infected (10
    later required re-treatment), lost track of 13

29
Post-WW II Human Subject Experimentation
  • Guatemala STD study (1946-8)
  • Wives, children, and grandchildren treated, but
    sexual contacts not traced
  • Study approved by Guatemalan government
  • Received material for resource-starved
    institutions in return
  • Subjects received cigarettes for participating

30
Post-WW II Human Subject Experimentation
  • Guatemala STD study (1946-8)
  • U.S. apologized (2010), has pledged 1 million to
    study research ethics, 775,000 to fight STDs in
    Guatemala
  • Class action lawsuit against U.S. government
    filed on behalf of 700 victims/relatives (2011)

31
Post-WW II Human Subject Experimentation
  • Guatemala STD study (1946-8)
  • Dr. John Cutler (research coordinator) Unless
    the law winks occasionally, you have no progress
    in medicine
  • In 1943, Cutler infected volunteer federal
    prisoners in Indiana with gonorrhea in exchange
    for cash

32
Post-WW II Human Subject Experimentation
  • Guatemala STD study (1946-8)
  • After Guatemala, Cutler oversaw the Tuskegee
    Syphilis Study
  • Was acting dean at University of Pittsburgh in
    1960s

33
Post-WW II Human Subject Experimentation
  • University of Minnesota malaria study (1940s)
  • Drs. Thomas Francis, Jr. and Jonas Salk infect
    psychiatric hospital residents with influenza
    (?if consent adequate?)

34
Post-WW II Human Subject Experimentation
  • Atlanta, Alabama, and Terre Haute prison
    gonorrhea studies (1940s and 1950s)
  • Study evaluating effects of antibiotics on growth
    rate (1950s, Navy recruits, mentally disabled,
    Guatemalan schoolchildren)
  • Patuxent prison Asian flu experiment (1957)
  • U.S. govt.-sponsored radiation, LSD (MK Ultra)
    experiments

35
Post-WW II Human Subject Experimentation
  • Pentagon/CIA experiments on soldiers and
    civilians
  • Edgewood Arsenal Experiments (involving more than
    7,000 soldiers who were exposed to at least 250
    biological and chemical agents)
  • Including sarin, VX, LSD, ritalin
  • Caused long-term health effects
  • Deliberate release of Serratia over San Francisco
    Bay radioactive cadmium over St. Louis

36
Post-WW II Human Subject Experimentation
  • 1963 Dr. Chester Southam injects tumor cells
    into extremely infirm patients at Jewish Hospital
    for Chronic Disease in NY without informing them
    that the shots contain cancer cells
  • Southam later elected President of American
    Association for Cancer Research

37
Post-WW II Human Subject Experimentation
  • Willowbrook Hepatitis Experiments (1960s)
  • Pre-WW1 Joseph Goldbergers pellagra experiments
    on Mississippi prisoners
  • Henry Beecher, NEJM (1966)

38
Post-WW II Human Subject Experimentation
  • Ongoing sterilization programs
  • Buck v. Bell (USSC, 1927) 60,000 Americans
    sterilized
  • WI, NJ, CA, IN, NC, OR, others
  • Alabamas Governor Graves vetoed law in 1930s law
    citing hazard to personal rights
  • Oregon governor Kitzhaber apologized in 2002 for
    the over 2500 state-forced sterilizations that
    occurred between 1917 and 1983
  • 2012 NC to compensate victims

39
Post-WW II Human Subject Experimentation
  • Iowa elementary school race experiment (1968
    good or bad?)
  • Milgrams obedience studies (1963) Milgram redux
    (2008)
  • Soviet psychiatry
  • US military/pharmaceutical vaccine and medication
    trials in the developing world

40
GM foods, biopharmaceuticals
  • Largest uncontrolled trial in history of humanity
  • E.g., Chinese children with vitamin A deficiency
    used for feeding trials of Golden Rice by Tufts
    University investigators
  • Without preceding animal studies
  • ? Nature of informed consent
  • May violate Nuremberg Code

41
Research on Prisoners
  • gt90 of pharmaceutical industry research in early
    1970s
  • Rapidly curtailed by state/federal laws and new
    university regulations
  • 2006 IOM approves with safeguards
  • 2009 44 of jurisdictions allow compensation

42
Self-Experimentation
  • Albert Hoffman (LSD)
  • Werner Forssmann (right heart catheterization)
  • Barry Marshall (Helicobacter pylori)
  • Others

43
Disturbing Experiments
  • Inter-species breeding (ape-man, Ilya Ivanovich
    Ivanov, Guinea, 1927)
  • Two-headed dog (Vladimir Petrovich Demikhov,
    1950s, Russia)
  • Monster Study (Wendell Johnson, 1939, University
    of Iowa) deliberate induction of stuttering in
    orphan children

44
Contemporary Issues and Ethical Dilemmas
  • 90 of research dollars spent on diseases
    affecting 10 of the worlds population
  • Neglected tropical diseases
  • Research on special populations (cultural
    minorities, prisoners, developing world, etc.)
  • Ghostwriters
  • Contract Research Organizations
  • Role of institutional and for-profit IRBs

45
Contemporary Issues and Ethical Dilemmas
  • Use of placebo controls
  • Various drug trials
  • Anti-HIV medications and maternal-fetal
    transmission(sub-Saharan Africa)
  • Surfactant for neonatal RDS (Brazil, Bolivia)
  • Hep A vaccine (Thailand)
  • Trovan/meningitis/Nigeria (control inadequate
    ceftriaxone dose)

46
Contemporary Issues and Ethical Dilemmas
  • Large majority of phase 3 US drug company trial
    sites outside US, many in developing countries
  • Majority of developing nation trial sites without
    institutional review boards
  • Victims may seek redress under Alien Torts
    Statute
  • ICE drugging immigrants for deportation

47
Contemporary Issues and Ethical Dilemmas
  • Nerve-sparing clitoroplasty as substitute for
    female genital cutting
  • AAP reversal of position (2010)
  • Kennedy Krieger Institute (Johns Hopkins) lead
    paint abatement study (1992)

48
Contemporary Issues and Ethical Dilemmas
  • Uninsured become research subjects to receive
    needed care
  • Human guinea pigs (professional lab rats)
  • Parent investigators
  • Neonatal analgesia

49
Contemporary Issues and Ethical Dilemmas
  • Under-representation of women and minorities in
    clinical trials
  • Trust issues
  • Racial minorities often wary of participation in
    medical experiments

50
Organ Donation
  • 2009 survey
  • 50 of adults afraid that physicians will not try
    as hard to save their lives if they have agreed
    to donate organs
  • 44 fear their organs might be sold on the black
    market
  • May explain in part why only 45 of U.S. adults
    have registered as organ donors

51
Contemporary Issues and Ethical Dilemmas
  • Informed consent for treatment
    physician/patient negotiation vs. unilateral
    decision-making when treatment options limited
  • Relaxation of international research standards by
    eliminating Declaration of Helsinki standards
    (FDA, 2008)

52
Contemporary Issues and Ethical Dilemmas
  • 2003 Ban on industry experiments testing safety
    of pesticides/other potentially toxic chemicals
    in humans lifted by NAS and EPA
  • 2013 EPA adds safeguards, issues regulations
    prohibiting studies on pregnant women and
    children
  • Monsantos Roundup purchased by US government for
    aerial spraying in Colombia as part of War on
    Drugs

53
Contemporary Issues and Ethical Dilemmas
  • 2008 Former director of UCLA School of
    Medicines donated body program pleads guilty to
    5 year scheme to sell donated body parts to
    medical, drug, and research companies, netting
    more than 1 million
  • Clinical Trials Registry
  • Drug company noncompliance

54
Contemporary Issues and Ethical Dilemmas
  • Physician participation in War on Terror, Abu
    Ghraib, Guantanamo, Black Ops sites
  • Basic Science Consultation Teams
  • Co-optation of anthropologists in Iraq,
    Afghanistan
  • Nurses injecting psychotropic drugs to forcibly
    sedate deportees
  • AMA, AAP, APA oppose physician involvement in
    interrogation/torture

55
What to do with data acquired via unethical means?
  • Eduard Pernkopfs Atlas Dachau Hypothermia
    Experiments Phosgene gas experiments biological
    weapons data (offensive vs. defensive)
  • Japans Unit 731 and biological warfare
    experiments

56
What to do with data acquired via unethical means?
  • Move to rename Hallevordan-Spatz syndrome
    pantothenate kinase-associated degeneration or
    neurodegeneration with brain iron accumulation
  • Breast cancer cure scenario

57
What to do with data acquired via unethical means
AMA Policy E-2.30 Adopted 1998
  • All proposed experiments using human subjects
    should undergo proper ethical evaluation by a
    human studies review board before being
    undertaken.
  • Responsibility for revealing that the data are
    from unethical experiments lies in the hands of
    authors, peer reviewers, and editors of medical
    texts that publish results of experimental
    studies.

58
What to do with data acquired via unethical means
AMA Policy E-2.30 Adopted 1998
  • Each publication should adopt a standard
    regarding publication of data from unethical
    experiments.
  • If data from unethical experiments can be
    replaced by existing ethically sound data and
    achieve the same ends, then such must be done.

59
What to do with data acquired via unethical means
AMA Policy E-2.30 Adopted 1998
  • If ethically tainted data that have been
    validated by rigorous scientific analysis are the
    only data of that nature available, and such data
    are necessary in order to save lives, then the
    utilization of such data by physicians and
    editors may be appropriate.
  • Should editors and/or authors decide to publish
    an experiment or data from an experiment that
    does not reach standards of contemporary ethical
    conduct, a disclaimer should be included. Such
    disclosure would by no means rectify unethical
    conduct or legitimize the methods of collection
    of data gathered from unethical experimentation.

60
What to do with data acquired via unethical means
AMA Policy E-2.30 Adopted 1998
  • This disclaimer should
  • (1) clearly describe the unethical nature of the
    origin of any material being published
  • (2) clearly state that publication of the data is
    needed in order to save human lives
  • (3) pay respect to the victims
  • (4) avoid trivializing trauma suffered by the
    participants
  • (5) acknowledge the unacceptable nature of the
    experiments
  • (6) endorse higher ethical standards.

61
What to do with data acquired via unethical means
AMA Policy E-2.30 Adopted 1998
  • Based on both scientific and moral grounds, data
    obtained from cruel and inhumane experiments,
    such as data collected from the Nazi experiments
    and data collected from the Tuskegee Study,
    should virtually never be published or cited.
  • In the extremely rare case when no other data
    exist and human lives would certainly be lost
    without the knowledge obtained from use of such
    data, publication or citation is permissible.
  • In such a case, the disclosure should cite the
    specific reasons and clearly justify the
    necessity for citation.

62
What to do with data acquired via unethical means
AMA Policy E-2.30 Adopted 1998
  • Certain generally accepted historical data may be
    cited without a disclaimer, though a disclosure
    of the ethical issues would be valuable and
    desirable.

63
Ethical Perspectives on Scientific Research and
War
  • Denial of moral responsibility for consequences
  • Recognition of moral responsibility but competing
    obligations
  • Recognition of moral responsibility and refusal
    to participate
  • Responsibility to inform or lead public opinion
  • Publication of research on dangerous/novel
    pathogens

64
Scientists and War Research
  • Archimedes, da Vinci, Galileo, Haber, Fieser
  • Farraday
  • Nobel, Einstein, Szilard

65
Fritz Haber (Physical Chemist)
  • Played major role in development of chemical
    warfare in WWI
  • In violation of Hague Convention of 1907
  • During peacetime a scientist belongs to the
    world, but during wartime he belongs to his
    country

66
Fritz Haber (Physical Chemist)
  • 3 future Nobel laureates served in his unit,
    which developed Zyklon A (insecticide used in gas
    chambers)
  • Irony Jewish, fled Germany in 1933, ultimately
    took position at what is now the Weizmann
    Institute in Israel

67
Doctors as Terrorists
  • Pediatrician George Habash founder of Popular
    Front for the Liberation of Palestine
  • Behind aircraft hijackings of Black September
  • Dr. Fathi Shiqaqi founder of Palestinian
    Islamic Jihad

68
Doctors as Terrorists
  • Ayman Al-Zawahiri leader of Al Qaeda
  • Ikuo Hayashi chief of circulatory medicine at a
    leading Japanese hospital
  • Pleaded guilty to planting sarin gas on Tokyo
    subway
  • Radovan Karadzic (psychiatrist) on trial for
    war crimes against Bosnian Croats and Muslims

69
Doctors as Terrorists
  • Dr Bilal Abdullah convicted in bungled Heathrow
    Airport car bombing (2007)
  • Psychiatrist Major Nidal Hasan awaiting trial
    for Fort Hood shootings (2009)
  • Humam Khalil Abu-Mulal al-Balawi Jordanian
    suicide bomber, killed 7 CIA agents in
    Afghanistan (2009)

70
Doctors as Murderers
  • Bashir Assad (Syrian President, ophthalmologist)
    2011/12 civilian bombings and use of sarin
    nerve gas
  • Dr. H. H. Holmes, - "the torture doctor,"
  • Linda Burfield Hazzard - "the starvation doctor"
  • Dr. Marcel Petiot
  • GP Harold Shipman worlds most notorious serial
    killer (up to 400 victims)

71
Doctors as Murderers
  • South African cardiologist Wouter Basson (aka
    Dr. Death) ran Project Coast in 1980s
    (clandestine military program linked to chemical
    and germ warfare, assassinations, poisonings,
    kidnapping, and plots to sterilize the countrys
    black population)
  • Aquited of 67 criminal charges in 2002
  • Still practicing, Health Professions Council of
    SA considering revocation of medical license
  • Others

72
Physician Criminals
  • Violent crimes, including rapes of patients
  • Performance of unnecessary, dangerous procedures
  • Medicare fraud, kickback scams
  • Ethical violations through participation in
    executions

73
Doctors as Racists
  • Long history
  • Common slave era diagnosis drapetomania
  • The tendency to run away
  • More recent Ophthalmologist John Taunton
    anti-immigrant, white supremacist

74
War on Terror
  • Doctors involved in torture, extraordinary
    renditions
  • Investigations, outcry, but no real consequences

75
War on Terror
  • Capture of Osama bin Laden involved
    (unsuccessful) sham CIA hepatitis B vaccination
    project to collect DNA (violation of public
    trust, has harmed international efforts to
    eliminate polio and put health care workers lives
    at risk)
  • USAID social media program designed to overthrow
    Cuban government

76
Primo Levi
  • A country is considered the more civilized the
    more the wisdom and efficiency of its laws hinder
    a weak man from becoming too weak or a powerful
    one too powerful.
  • (U.S. largest maldistribution of wealth of any
    industrialized country)

77
The role of the doctor in society
  • Public health versus individual health
  • Roles, responsibilities, and obligations
  • patients
  • society
  • institutions
  • families
  • government
  • world

78
The role of the doctor in society
  • Theodore Billroth
  • If the whole of Social Medicine needs to be part
    of the curriculum of the medical student, it must
    not take more than two hours per semester
    during the last two semesters otherwise, it will
    surely be detrimental to his other studies

79
The role of the doctor in society
  • Rudolph Virchow
  • Doctors are natural attorneys for the poor If
    medicine is to really accomplish its great task,
    it must intervene in political and social life

80
The role of the doctor in society
  • World Health Organization
  • The role of the physician in the preservation
    and promotion of peace is the most significant
    factor for the attainment of health for all.

81
Ethical Issues Relating to Mixed Agency of
Military Physicians
  • Triage and return to combat
  • Confidentiality
  • Communication
  • Loyalties/Command
  • Experimentation
  • The Sea and Poison

82
Medical Education Lacking
  • 2007 survey 5,000 medical students at 8 medical
    schools, 35 response rate (Int J Hlth Serv
    200737(4)643-50)
  • 94 received lt 1 hr. instruction on military
    medical ethics
  • 3.5 aware of legislation already passed making a
    doctors draft possible
  • 34 did not know Geneva Conventions require
    physicians to treat the sickest first, regardless
    of nationality

83
Medical Education Lacking
  • 34 not aware Geneva Conventions prohibit ever
    threatening or demeaning prisoners or depriving
    them of food or water
  • 34 could not state when they would be required
    to disobey an unethical order (answer always)

84
The Death Penalty and Health Professionals
  • AMA, APHA, ANA, and ABA (anesthesiologists)
    oppose participation of health professionals in
    executions
  • Only 7/35 death penalty states incorporate AMA
    ethics policy, including barring doctors from
    taking an active role in the death chamber

85
The Death Penalty and Health Professionals
  • 2001
  • 3 of physicians aware of AMA guidelines
    prohibiting physician participation
  • 41 would perform at least one action in the
    process of lethal injection disallowed by AMA

86
Ethical Issues Relating to Mixed Agency of
Civilian Physicians
  • Physician participation in torture and executions
  • Most torturers never identified/held accountable
  • 2008 study at University of Illinois at Chicago
  • 35 of medical students said torture could be
    condoned under some circumstances
  • Pharmaceutical company provision of agents used
    in lethal injection executions

87
Contact Information
  • Public Health and Social Justice Website
  • http//www.phsj.org
  • martindonohoe_at_phsj.org
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