Download Dr. Ewen Cameron

Dr. Ewen
Cameron
“Psychic
Driving”
research
http://www.royalcollege.ca/portal/page/portal/rc/
resources/bioethics/primers/research_ethics
Dr. Ewan Cameron’s CIA-funded experiments at the
Allan Memorial Institute in Montreal involved the
administration of LSD, other medications and
electroconvulsive therapy to subjects with minor
psychiatric disorders. Dr. Cameron’s work,
conducted in the 1950s and early 1960s, was part of
the CIA’s mind-control research program, Project
MKULTRA. The experiments were based on
Cameron’s “psychic driving” theory that a
damaged psyche could be rebuilt after erasing
previous memories.
In a paper published in the American Journal of Psychiatry
entitled “Psychic Driving,” Dr. Cameron describes his
brainwashing techniques and says, “Analogous to this is the
breakdown of the individual under continuous
interrogation.”
Psychic driving was a procedure carried out in two stages;
in the first stage, patients were depatterned, which meant
they were reduced to a vegetable state through a
combination of massive amounts of electroconvulsive
shock, drug-induced sleep, and sensory isolation and
deprivation. When fully depatterned, patients were
incontinent of urine and feces, unable to feed themselves,
and unable to state their name, age, location, or the
current date.
In the second stage, psychic driving was introduced. This
consisted of hundreds of hours of tape loops being
played to the patient through earphones, special helmets
or speakers in the sensory isolation room. The tape loops
repeated statements of supposed psychological
significance…
Dr. Cameron received a grant from Canada’s
Department of Health and Welfare for $57,750.00 for the
years of 1961 to 1964…Dr. Cameron’s brainwashing
experiments stopped in 1964.
Medical experimentation by the Department of
Psychiatry at McGill resulted in death, psychosis, getable
states, organic brain damage, and permanent loss of
memory among other damages. It resulted in the
creation of amnesia, identity disturbance, and
depersonalization among other dissociative symptoms.
Dr. Ewen Cameron was the main figure in these activities.
(excerpted from “Dr. Ewen Cameron” by Colin A Ross in Biomedical Ethics: A
Canadian Focus, 2nd ed., by Johnna Fisher (Oxford University Press, 2013); p.442-6)
Significant Research Codes
of Ethics
 The Nuremberg Code,
http://www.hhs.gov/ohrp/archive/nurcode.html
 The Belmont Report, 1979,
http://www.hhs.gov/ohrp/humansubjects/guidance/bel
mont.html
 The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ;
http://www.cirp.org/library/ethics/helsinki/
 Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans, 2014,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ;
 Chapter 1: Ethics Framework,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/
Additional Resources
 “Research Ethics,” by Andrew D. McRae, MD, FRCPC;
Royal College of Physicians and Surgeons of Canada
 http://www.royalcollege.ca/portal/page/portal/rc/resou
rces/bioethics/primers/research_ethics
 https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch
Respiratory Distress
Syndrome in Bolivian Infants
A Placebo Controlled Trial
Bolivia
Located in central South America, Bolivia is…one of
the least developed countries in South America.
About 2/3 of the population lives below the poverty
line, many as subsistence farmers…21% of the
population is undernourished and 15% lack access
to improved water sources…infant mortality remains
relatively high at 53 per 1,000 live births.
Respiratory distress syndrome, or RDS, is a common
and potentially fatal disease in premature infants
that is caused by insufficient surfactant in the
lungs…Surfactant replacement therapy is the
standard treatment for RDS in the Western
world…but its high cost, about US $1,100-2,400 per
child, precludes it as a viable option for most infants
in Latin America.
…A multicenter, double-blinded, randomized,
two-arm, placebo-controlled trial was proposed
to be conducted in Bolivia, and three other Latin
American countries. The study population was to
be 650 premature infants with RDS. The hospitals
chosen for participation in the study generally did
not have surfactant available for the treatment
of RDS. Discovery Labs, a private US drug
company, proposed to provide endotracheal
tubes, ventilators, and antibiotics for all study
participants.
In participating research centers, parents of infants
showing symptoms of RDS would be asked to give
consent for their infants to participate in the study.
With consent, a health care provider would
intubate the infants with an endotracheal tube.
After intubation, half the infants would receive air
suffused with Surfaxin [the experimental drug] and
half the infants would receive (“sham”) air without
any drug.
Endpoints for the proposed study were all-cause
mortality by day 28, and mortality due to RDS
(Excerpts from Rethinking the Ethics of Clinical Research: Widening the
Lens, by Alan Wertheimer, p.194)
Significant Research Codes
of Ethics
 The Nuremberg Code,
http://www.hhs.gov/ohrp/archive/nurcode.html
 The Belmont Report, 1979,
http://www.hhs.gov/ohrp/humansubjects/guidance/bel
mont.html
 The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ;
http://www.cirp.org/library/ethics/helsinki/
 Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans, 2014,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ;
 Chapter 1: Ethics Framework,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/
Additional Resources
 “Research Ethics,” by Andrew D. McRae, MD, FRCPC;
Royal College of Physicians and Surgeons of Canada
 http://www.royalcollege.ca/portal/page/portal/rc/resou
rces/bioethics/primers/research_ethics
 https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch
Halushka v University
of Saskatchewan
1965
Mr. Halushka learned about a study at the University
of Saskatchewan from the University’s employment
office in late August 1961. During his initial visit with
one of the researchers, he was told that the
research involved a new drug that was “perfectly
safe” and that “it had been conducted many times
before,” that electrodes would be put into his limbs
and head, than an incision would be made in his
arm and a catheter inserted. For his research
participation he would receive $50.00.
Mr. Halushka agreed to take part in the research
and signed a consent form that included a waiver
of liability for the University and the research in the
event of any “untoward effects or accidents.”
Two days later, Mr. Halushka arrived at the hospital.
Unbeknownst to him, the anesthetic drug to be used in
the research had never been tested before. The
researchers administered the fluoromar, and positioned
the catheter inside Mr. Halushka’s heart chambers. Shortly
thereafter, the level of the anesthetic became too deep
and Mr. Halushka suffered a cardiac arrest. To resuscitate
him, the researchers had to manually massage his heart
after making a large incision in his chest.
Mr. Halushka was unconscious for four days, and was
discharged 10 days after waking up. At that point Dr.
Wyant gave Mr. Halushka $50.00. When Mr. Halushka
asked whether that was all he was going to get, given
the adverse event he had suffered, Dr. Wyant offered to
give him more in exchange for a complete release of
legal liability from Mr. Halushka’s mother or older sister. Mr.
Halushka did not accept this offer and ultimately sued for
trespass on the person and negligence.
(Halushka v University of Saskatchewan, (1965), 53 DLR (2d) 436, [1965] WWR 608 (Sask CA); summary
prepared by Matthew Herder, in Health Care Ethics in Canada (3 rd ed) by F. Baylis et al. (Nelson, 2012))
In Court
In Halushka v. The University of Saskatchewan has
set the legal standard for disclosure of research risks
in consent discussions. Mr. Halushka, a student at
the University, experienced a cardiac arrest. He was
successfully resuscitated, but suffered irreversible
cognitive impairment.
The judge ruled that researchers are bound by a
higher standard of disclosure to research subjects
than are physicians who obtain consent for medical
treatment from patients. Justice Hall, in his ruling,
states that researchers are required to disclose any
and all information that a reasonable person would
require to reach an informed decision about
research participation.
http://www.royalcollege.ca/portal/page/portal/rc/resources/bi
oethics/primers/research_ethics
Significant Research Codes
of Ethics
 The Nuremberg Code,
http://www.hhs.gov/ohrp/archive/nurcode.html
 The Belmont Report, 1979,
http://www.hhs.gov/ohrp/humansubjects/guidance/bel
mont.html
 The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ;
http://www.cirp.org/library/ethics/helsinki/
 Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans, 2014,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ;
 Chapter 1: Ethics Framework,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/
Additional Resources
 “Research Ethics,” by Andrew D. McRae, MD, FRCPC;
Royal College of Physicians and Surgeons of Canada
 http://www.royalcollege.ca/portal/page/portal/rc/resou
rces/bioethics/primers/research_ethics
 https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch
The Jewish Chronic
Disease Hospital 1963
Summary provided by Jay Katz in Ethical Issues in Modern
Medicine by B. Steinbock et al. (McGraw-Hill, 2003) p. 706
“In July 1963, three doctors, with approval from the
director of medicine in the Jewish Chronic Disease
Hospital in Brooklyn, New York, injected “live cancer
cells” subcutaneously into twenty-two chronically ill
and debilitated patients. The doctors did not inform
the patients that live cancer cells were being used
or that the experiment was designed to measure
the patients’ ability to reject foreign cells—a test
unrelated to their normal therapeutic program.”
According to one study doctor, “The fact that these
cells were tissue-cultured cancer cells did not
measurably increase any risk inherent in the
procedure because, being foreign to the recipient
(the person injected), they bring about an
immunologic reaction…that ultimately causes their
destruction and elimination.”
Cancer, vol. 19, November 1966,
pp. 1743-1753
“[By] July 16, 1963 (the date on which the injections
were made in Jewish Chronic Disease Hospital)
approximately 600 persons had been studied by
means of the techniques employed at JCDH,
approximately 300 of whom were patients with
cancer and 300 health, normal persons. In every
health recipient of tissue-cultured cells, these
foreign transplants were rejected with uniform
promptness…”
According to the physicians, “we have simply
explained that the procedure was a test which had
nothing to do with treatment, that it involved the
injection of foreign material…and that its purpose was
to determine the rate at which the expected nodules
would develop and then regress…
“to use the dreaded word “cancer” in connection
with any clinical procedure on an ill person is
potentially deleterious to that patient’s wellbeing…therefore to withhold such emotionally
disturbing but medically nonpertinent details…is in the
best tradition of responsible clinical practice.”
This experiment had been partly funded by the
American Cancer Society. Two years later, the Cancer
Society elected the principal investigator (Dr.
Emmanuel Southam) as their Vice-President.
Significant Research Codes
of Ethics
 The Nuremberg Code,
http://www.hhs.gov/ohrp/archive/nurcode.html
 The Belmont Report, 1979,
http://www.hhs.gov/ohrp/humansubjects/guidance/bel
mont.html
 The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ;
http://www.cirp.org/library/ethics/helsinki/
 Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans, 2014,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ;
 Chapter 1: Ethics Framework,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/
Additional Resources
 “Research Ethics,” by Andrew D. McRae, MD, FRCPC;
Royal College of Physicians and Surgeons of Canada
 http://www.royalcollege.ca/portal/page/portal/rc/resou
rces/bioethics/primers/research_ethics
 https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch
Willowbrook
State Mental
Hospital for
Children
The Willowbrook
Hepatitis Studies
Staten Island, New
York – mid 1950s
http://www.museumofdisability.org/new
york_timeline_1960s.asp
Dr. Saul Krugman & Dr. Joan Giles
were infectious disease specialists
Their research was designed to
 determine the natural history of viral hepatitis – its
mode of infection and the course of the disease;
and to
 test the effectiveness of gamma globulin in
developing an inoculation against hepatitis
Krugman & Giles collected serum specimens before
exposure to hepatitis, during the incubation period,
and several times post-infection.
As the institutional population skyrocketed,
admissions were suspended unless parents agreed
to place their child in the hepatitis ward. New
children were deliberately infected with hepatitis to
provide optimal control in the study.
Willowbrook Hospital
was overcrowded serving 6,055 patients
though it was meant to
handle just 4,000 - and
understaffed.
Dr. Saul Krugman
opened a separate
unit within Willowbrook.
Children between the
ages of 3 and 11 who
could be enrolled into
his hepatitis study were
admitted to the school
at a time when no new
admissions were being
accepted.
Resources: https://philosophy.tamucc.edu/readings/ethics/willowbrookletters?destination=node%2F583;
https://philosophy.tamucc.edu/readings/ethics/handouts/willowbrook
“Therapeutic” Effect
Parents were misled by exaggerations of the potential
benefits of the study. The doctors claimed that the
conditions were so unsanitary that the children would
have developed hepatitis anyway.
Drs. Krugman & Giles claimed that deliberately infecting
the children was therapeutic because of their resulting
immunity to hepatitis and that the hepatitis strain was
mild.
Further, the doctors pointed out that the school had
optimum isolation facilities where there would be minimal
exposure to other infectious diseases.
Claiming that they had consent from parents, families
were informed that they could withdraw consent before
study was initiated in child.
Study physicians maintained that there would be
significant scientific progress resulting from the study.
Significant Research Codes
of Ethics
 The Nuremberg Code,
http://www.hhs.gov/ohrp/archive/nurcode.html
 The Belmont Report, 1979,
http://www.hhs.gov/ohrp/humansubjects/guidance/bel
mont.html
 The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ;
http://www.cirp.org/library/ethics/helsinki/
 Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans, 2014,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ;
 Chapter 1: Ethics Framework,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/
Additional Resources
 “Research Ethics,” by Andrew D. McRae, MD, FRCPC;
Royal College of Physicians and Surgeons of Canada
 http://www.royalcollege.ca/portal/page/portal/rc/resou
rces/bioethics/primers/research_ethics
 https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch
Residential School
Nutrition Experiments
1940s Experiments performed on
malnourished Aboriginal children
http://www.cbc.ca/news/canada/manitoba/hungry-aboriginal-people-used-inbureaucrats-experiments-1.1317051
Dr. Ian Mosby, Food Historian
"In the 1940s, there were a lot of questions about what are
human requirements for vitamins. Malnourished aboriginal
people became viewed as possible means of testing these
theories.“
“The first experiment began in 1942 on 300 Norway House
Cree. Of that group, 125 were selected to receive vitamin
supplements which were withheld from the rest.
“At the time, researchers calculated the local people were
living on less than 1,500 calories a day. Normal, healthy adults
generally require at least 2,000.
"The research team was well aware that these vitamin
supplements only addressed a small part of the problem,"
Mosby writes. "The experiment seems to have been driven, at
least in part, by the nutrition experts' desire to test their theories
on a ready-made 'laboratory' populated with already
malnourished human experimental subjects.“
http://www.cbc.ca/news/canada/manitoba/hungryaboriginal-people-used-in-bureaucrats-experiments-1.1317051
“The research spread. In 1947, plans were developed for
research on about 1,000 hungry aboriginal children in six
residential schools in Port Alberni, B.C., Kenora, Ont.,
Schubenacadie, N.S., and Lethbridge, Alta.
“One school deliberately held milk rations for two years to
less than half the recommended amount to get a
'baseline' reading for when the allowance was increased.
At another, children were divided into one group that
received vitamin, iron and iodine supplements and one
that didn't.
“One school depressed levels of vitamin B1 to create
another baseline before levels were boosted. A special
enriched flour that couldn't legally be sold elsewhere in
Canada under food adulteration laws was used on
children at another school.
“And, so that all the results could be properly measured,
one school was allowed none of those supplements.”
“[The research] began with a 1942 visit by
government researchers to a number of remote
reserve communities in northern Manitoba…They
found people who were hungry, beggared by a
combination of the collapsing fur trade and
declining government support. They also found a
demoralized population marked by, in the words of
the researchers, "shiftlessness, indolence,
improvidence and inertia."
“The researchers suggested those problems — "so
long regarded as inherent or hereditary traits in the
Indian race" — were in fact the results of malnutrition.
"They knew from the beginning that the real problem
and the cause of malnutrition was underfunding. That
was established before the studies even started and
when the studies were completed that was still the
problem."
Significant Research Codes
of Ethics
 The Nuremberg Code,
http://www.hhs.gov/ohrp/archive/nurcode.html
 The Belmont Report, 1979,
http://www.hhs.gov/ohrp/humansubjects/guidance/bel
mont.html
 The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ;
http://www.cirp.org/library/ethics/helsinki/
 Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans, 2014,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ;
 Chapter 1: Ethics Framework,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/
Additional Resources
 “Research Ethics,” by Andrew D. McRae, MD, FRCPC;
Royal College of Physicians and Surgeons of Canada
 http://www.royalcollege.ca/portal/page/portal/rc/resou
rces/bioethics/primers/research_ethics
 https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch
Syphilis
Experimentation
Guatemala syphilis experiment involved 1,300 people
“An investigation by Guatemalan authorities has identified
about 1,300 people who may have been involved in a
1940s U.S. syphilis experiment, a few of whom may still be
living, Vice-President Rafael Espada says.”
“Medical historian Susan Reverby of Wellesley College in
Massachusetts uncovered the experiment. It apparently
was conducted to test the effectiveness of penicillin,
which was relatively new then, in treating sexually
transmitted diseases.”
“Records uncovered in the United States in 2010
suggested that researchers in the program in the 1940s
attempted to infect about 700 prostitutes, prisoners and
mental patients with syphilis. About 770 tests subjects,
including soldiers, were exposed to gonorrhea.”
“Patients were treated with penicillin. Among the goals of
the research was to see how well differing dosages of
penicillin worked against different venereal diseases.”
"In addition to the penitentiary, the studies took
place in an insane asylum and an army barracks,"
Reverby said in a release.
"In total, 696 men and women were exposed to the
disease and then offered penicillin. The studies went
on until 1948 and the records suggest that despite
intentions not everyone was probably cured."
“The researchers induced the disease by allowing
inmates in the central penitentiary to have sex with
infected prostitutes [which was legal in
Guatemala], or gave the disease to the prisoners by
inoculating their arms, faces or penises with a
solution of the bacteria that causes syphilis.”
http://www.cbc.ca/news/world/guatemala-syphilis-experimentinvolved-1-300-1.1021108
http://www.cbc.ca/news/health/u-s-sued-over-syphilis-tests-inguatemala-1.981570
More from the Encyclopedia Britannica -
http://www.britannica.com/event/Guatemala-syphilis-experiment
“Approximately 1,308 soldiers, prisoners, sex workers, and
psychiatric patients, ranging from age 10 to 72, were
intentionally exposed to STDs during the study. Syphilis
exposure occurred through inoculation of the cervix in sex
workers; through injection or direct sexual contact with
infected sex workers in prisoners; and through injection,
inoculation (via abrasion) of the penis, cisternal puncture (the
insertion of a needle below the occipital bone at the back of
the skull to access cerebrospinal fluid), or oral ingestion in
psychiatric patients.
“Exposure to gonorrhea was carried out in sex workers through
cervical inoculation and in Guatemalan soldiers through
sexual contact with the sex workers and sometimes through
urethral inoculation; psychiatric patients were infected
through inoculation of the urethra, rectum, or eyes. Chancroid
was transmitted to Guatemalan soldiers and psychiatric
patients through abrasion and rubbing of inoculum into the
skin on the arms or back.”
Significant Research Codes
of Ethics
 The Nuremberg Code,
http://www.hhs.gov/ohrp/archive/nurcode.html
 The Belmont Report, 1979,
http://www.hhs.gov/ohrp/humansubjects/guidance/bel
mont.html
 The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ;
http://www.cirp.org/library/ethics/helsinki/
 Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans, 2014,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ;
 Chapter 1: Ethics Framework,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/
Additional Resources
 “Research Ethics,” by Andrew D. McRae, MD, FRCPC;
Royal College of Physicians and Surgeons of Canada
 http://www.royalcollege.ca/portal/page/portal/rc/resou
rces/bioethics/primers/research_ethics
 https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch
The Fernald School
“Science Club”
Walter E. Fernald State School, Massachusetts
From 1946 to 1956 nineteen mentally retarded teenaged
boys were fed radioactive iron and calcium in their
breakfast cereal. The experiment took place at a state
residential school in Fernald, Massachusetts. Parent's
consent form contained no mention of radiation. The
stated aim of the research was to gain information about
metabolism.
Beginning in 1949, the Quaker Oats Company, the
National Institutes of Health, and the AEC fed minute
doses of radioactive materials to boys at the Fernald
School for the mentally retarded in Waltham,
Massachusetts, to determine if chemicals used in
breakfast cereal prevented the body from absorbing iron
and calcium. The unwitting subjects were told that they
were joining a science club. The consent form sent to the
boys' parents made no mention of the radiation
experiment.
http://www.qcc.cuny.edu/SocialSciences/ppecorino/MEDICAL_ETHICS_TEXT/Chapter_
7_Human_Experimentation/Case_Study_Radiation_Experiments.htm
44 Years Later, the Truth About
the 'Science Club‘
http://www.nytimes.com/1993/12/31/us/44-years-later-the-truthabout-the-science-club.html
Published: December, 1993
BOSTON, Dec. 30— A 53-year-old man who learned this week
that he may have been among the boys who were fed
radioactive milk in 1949 at the Walter E. Fernald State School
in Waltham, Mass., expressed outrage at having been used
as a "guinea pig."
Some scientists, meanwhile, defended the experiments,
saying the research, which began in 1946, had involved only
low levels of radiation.
State and Federal officials are examining old school records,
correspondence and researchers' notes to try to determine
what happened when scientists from Harvard University and
the Massachusetts Institute of Technology fed the
radioactive milk to a group of boys who had been led to
believe that they were joining a "science club."
Paper Says Experiment Exposed 19
Retarded Youths to Radiation
Published: December 27, 1993
“The Massachusetts experiments, carried out from 1946 to 1956,
were done on retarded boys at the Fernald State School in
Waltham, Mass. Scientists from Harvard University and the
Massachusetts Institute of Technology fed radioactive forms of
iron and calcium to the boys, sometimes in their breakfast milk, to
study the body's ability to digest minerals…
“While one researcher said that the radiation levels to which the
boys were exposed were not harmful, other experts said there
was no such thing as a safe level of exposure. The experiment
exposed the boys to radiation that was at least the equivalent of
50 chest X-rays”…
The school sent a letter to parents but did not mention radiation.
"We are considering the selection of a group of our brighter
patients, including your son, to receive a special diet," said a
portion of the letter printed in The Globe. The boys were told that
they were part of a science club.
http://www.nytimes.com/1993/12/27/us/paper-says-experimentexposed-19-retarded-youths-to-radiation.html
Significant Research Codes
of Ethics
 The Nuremberg Code,
http://www.hhs.gov/ohrp/archive/nurcode.html
 The Belmont Report, 1979,
http://www.hhs.gov/ohrp/humansubjects/guidance/bel
mont.html
 The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ;
http://www.cirp.org/library/ethics/helsinki/
 Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans, 2014,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ;
 Chapter 1: Ethics Framework,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/
Additional Resources
 “Research Ethics,” by Andrew D. McRae, MD, FRCPC;
Royal College of Physicians and Surgeons of Canada
 http://www.royalcollege.ca/portal/page/portal/rc/resou
rces/bioethics/primers/research_ethics
 https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch
Real Knive,
Fake Surgery
Placebo surgery
Monday, Feb. 22, 1999
Real Knife, Fake Surgery
By Dick Thompson/Washington
“George Doeschner had been suffering from Parkinson's
disease for 12 years when his physician told him about an
experimental surgery that might offer a cure. Researchers
at the University of Colorado were taking cells from
embryos and putting them in the brains of Parkinson's
patients to replace cells killed by the disease. The 55year-old electrician applied to be a part of the
experiment and flew to Denver. He was prepped for
surgery and sedated. A hole was drilled through his skull.
Then his surgeons sewed him up and sent him home-without giving him those embryonic cells.
“Surgical error? Medicare fraud? No, …placebocontrolled surgical trials--are entering mainstream
medical research.
Double-blind placebo trials, of course, are standard
procedure for drug developers, who know from long
experience that 1 out of 3 test subjects feel better
with only a sugar pill. Scientists sidestep the placebo
effect in drug trials by dividing patients into two
groups--giving one the real drug and the other a
fake.
It turns out that the placebo effect is especially
powerful in Parkinson's disease. That's why Curt Freed
at the University of Colorado and Stanley Fahn at
Columbia University decided to create a control
group whose members could be fooled into thinking
they were getting the full surgical treatment. "When
you have something as major as surgery," says Fahn,
in defense of his experiment, "wouldn't it be best to
know there was some benefit?"
“[S]ome research administrators have concluded that the
scientific knowledge that may be gained justifies the risk.
They find reassurance in the fact that the dangers have
been reduced by advances in minimally invasive
surgery…
“The biggest factor driving these experiments, however,
may be that the easy questions--do patients survive or die
with a new therapy?--have already been answered.
Increasingly, scientists are looking for more subtle, and
often more subjective benefits. Is there less pain? Is it
easier to walk? These outcomes can be strongly
influenced by wishful thinking.
“Sorting the real benefits from the fake seemed a worthy
goal to patient Doeschner. "I wanted to do something
that would help everybody who has Parkinson's," he says.
Besides, once the experiment was over, he came back
for another operation. This time he got the real thing.”
Significant Research Codes
of Ethics
 The Nuremberg Code,
http://www.hhs.gov/ohrp/archive/nurcode.html
 The Belmont Report, 1979,
http://www.hhs.gov/ohrp/humansubjects/guidance/bel
mont.html
 The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ;
http://www.cirp.org/library/ethics/helsinki/
 Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans, 2014,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ;
 Chapter 1: Ethics Framework,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/
Additional Resources
 “Research Ethics,” by Andrew D. McRae, MD, FRCPC;
Royal College of Physicians and Surgeons of Canada
 http://www.royalcollege.ca/portal/page/portal/rc/resou
rces/bioethics/primers/research_ethics
 https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch
HIV Positive
Prison Inmates
Prisoners as Subjects in AIDS Research
Case Summary adapted from Cases for Analysis #3
in Ch. 6 of Healthcare Ethics in a Diverse Society by
M.C.Brannigan & J.A.Boss (Mayfield, 2001)
A disproportionate number of prison inmates are
HIV positive. In 1990, more than 20% of men
admitted to the New York State prison system were
HIV positive. Others become infected while in
prison, mainly as a result of intravenous drug use. In
1999, recently released prisoners accounted for
1/6th of AIDS cases in the United States. Because of
the difficulty in recruiting enough human subjects to
receive FDA approval for new drugs, the University
Center for AIDS Research, in collaboration with the
Apollo Pharmaceutical Company, approaches the
State Department of Corrections with a research
proposal.
Dr. Kim, leader of the research team, opens the
meeting by describing the experimental design.
“Half of the group—500 inmates—will receive the
new experimental drug,” she explains. “The others
will receive AZT, an existing treatment.”
Dr. Silva, the chief medical officer of the
Department of Corrections, nods. “There’s no doubt
that our prison medical facilities are overburdened.
Allowing the research to be carried out here would
provide a level of quality of medical care that we
are currently unable to give to our prisoners who
are HIV positive.”
“That may be,” responds Ms. Digby…”But I think the
solution is to improve the existing medical facilities…not to
take advantage of prisoners as research subjects…How
can a prisoner make a truly informed choice if it is his only
option for getting proper medical care or escaping the
boredom of prison life?”
“Mr. Potter from the ACLU adds, “It’s a denial of a basic
right to equal treatment to refuse prisoners access to
experimental treatments because of their confinement or
living conditions. To do so would be to add to their
punishment in a way that is undeserved…it’s even more
paternalistic to deny prisoners the right to give their
consent to take part in research.”
Mr. Potter adds, “Despite their limited options, it should be
the prisoners themselves who make the final decision.”
(adapted from a study in the Milbank Quarterly, Volume 67, Issue 2 (1989)
(pages 171–207) by Nancy Neveloff Dubler & Victor W. Sidel, “On
Research On HIV Infection and AIDS In Correctional Institutions”)
Significant Research Codes
of Ethics
 The Nuremberg Code,
http://www.hhs.gov/ohrp/archive/nurcode.html
 The Belmont Report, 1979,
http://www.hhs.gov/ohrp/humansubjects/guidance/bel
mont.html
 The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ;
http://www.cirp.org/library/ethics/helsinki/
 Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans, 2014,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ;
 Chapter 1: Ethics Framework,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/
Additional Resources
 “Research Ethics,” by Andrew D. McRae, MD, FRCPC;
Royal College of Physicians and Surgeons of Canada
 http://www.royalcollege.ca/portal/page/portal/rc/resou
rces/bioethics/primers/research_ethics
 https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch
Baby Fae
A Baboon Heart Transplant
People, December 03, 1984 Vol. 22 No. 23
“Baby Fae: A Child Loved and Lost” by
Howard Teresa
(excerpts from the article)
Born prematurely on Oct. 14 at 6:55 a.m., she was the
daughter of a 23-year-old, unemployed, unmarried woman
who had moved to California from her home in Kansas...
Though she and Baby Fae's father had lived together for five
years, they were separated at a critical moment—the baby's
birth. Worse still, the 5.9-pound girl was born with a crippled
heart. The left side of that organ was grossly underdeveloped
and nearly useless. Doctors wrote the child off and sent her
home to die.
Within four days, as the pediatrician predicted, her color
yellowed and her breathing became more difficult. It was just
at this time that doctors from the Loma Linda University
Medical Center called with the suggestion that she might be
saved by a transplant of a baboon's heart.
“Friday afternoon…Fae's pediatrician at Loma Linda
called and mentioned a Dr. Bailey, who…specialized in
transplants. He said something about the possibility of
transplanting a baboon heart in Fae…He said if I was
interested I'd have to bring the baby back to the hospital
for them to keep her alive, since she could die at any
time—any minute, any hour. He said Dr. Bailey would talk
to us as soon as we could bring Fae to the hospital, and
as soon as I could talk to Fae's father I called back the
pediatrician and said yes, we were interested.”
Dr. Leonard Bailey, a pediatric cardiac surgeon, inserted
the walnut-size heart of a 7-month-old baboon into the
infant's chest. The operation proved immensely
controversial, sparking demonstrations by outraged
animal lovers and vehement attacks by medical ethicists.
Baby Fae lived for 20 days after the heart transplant and
then died.
Writing a commentary on the experimental procedure,
George Annas quotes immunologist Dr. Sandra NehlsenCannarella: “Our hypothesis is that a newborn can, with a
combination of its underdeveloped immune system and
the aid of the anti-suppressive drug, cyclosporine, accept
the heart of a baboon if we can find one with tissue of
high enough comparability.”
Annas notes that the experimental surgery “used” Baby
Fae, a fragile and vulnerable person, to test out a
research hypothesis.
Annas concludes that the surgery constituted a
“premature experiment on an impoverished, terminally ill
newborn” and was “unjustified.”
(“Baby Fae: The “Anything Goes” School of Human Experimentation” by
George J. Annas in Ch.9 of Biomedical Ethics: A Canadian Focus (2nd ed),
ed. By Johnna Fisher)
Significant Research Codes
of Ethics
 The Nuremberg Code,
http://www.hhs.gov/ohrp/archive/nurcode.html
 The Belmont Report, 1979,
http://www.hhs.gov/ohrp/humansubjects/guidance/bel
mont.html
 The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ;
http://www.cirp.org/library/ethics/helsinki/
 Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans, 2014,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ;
 Chapter 1: Ethics Framework,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/
Additional Resources
 “Research Ethics,” by Andrew D. McRae, MD, FRCPC;
Royal College of Physicians and Surgeons of Canada
 http://www.royalcollege.ca/portal/page/portal/rc/resou
rces/bioethics/primers/research_ethics
 https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch
San Antonio
Contraceptive Study
Side Effects of Oral Contraceptives
Goldzieher JW, Moses LE, Averkin E, Scheel C, Taber BZ.
“A placebo-controlled double-blind crossover
investigation of the side effects attributed to oral
contraceptives.”
Journal of Fertility and Sterility 1971 Sep; 22(9):609-23
In the early 1970s, Dr. Joseph Goldziher (of the Southwest
Foundation for Research and Education) undertook
research among women who came to a birth control
clinic in San Antonio, Texas. Almost all of the women were
indigent, poor, had no regular medical care and were
Mexican-American.
The research was funded by Syntex Labs (an oral
contraceptive manufacturer) and the US Agency for
International Development.
The purpose of the experiment was to find out whether
reported side effects of oral contraceptives were
physiological or psychological in origin.
Goldzieher used a double-blind placebo-controlled
experimental design. In one group, 76 women were given
placebo pills; in four other groups, women were given various
hormonal contraceptives in various combinations and doses.
The women were monitored for nausea, vomiting,
headache, or breast discomfort, nervousness, or depression,
weight loss or gain, and variations in blood pressure. These
symptoms were recorded for each woman in a pretreatment
cycle and at monthly visits. Each woman began with a
pretreatment placebo cycle. - See more at:
http://www.popline.org/node/482707#sthash.mDaUfpC5.dp
uf
In a second stage of the research, the placebo group
women were switched to the hormonal contraceptives and
the contraceptive groups of women received a placebo. All
of the groups of women were also instructed to use a vaginal
cream with limited contraceptive efficacy in addition to the
daily pill.
The women were not informed that they were part of a
research study or that they would at some point be
receiving an inactive, non-contraceptive pill instead of
an active hormonal contraceptive pill.
As reported in a presentation to the American Fertility
Society conference, the women receiving placebo pills
and the women receiving contraceptive pills had very
similar side effects: nervousness, depression, breast
tenderness and headaches. With one oral contraceptive
(Oracon), women had increased nausea and vomiting.
With another (Ovulen), women experienced more
headaches. According to the researchers, the highest
incidence of complaints regarding side effects occurred
in the placebo cycle. The authors concluded that
placebo controls are necessary in contraceptive trials,
but the first cycle is not valid for comparison.
Ten of the 76 women who received placebo pills
became pregnant.
Significant Research Codes
of Ethics
 The Nuremberg Code,
http://www.hhs.gov/ohrp/archive/nurcode.html
 The Belmont Report, 1979,
http://www.hhs.gov/ohrp/humansubjects/guidance/bel
mont.html
 The WMA Declaration of Helsinki, 1964, https://www.aixscientifics.com/en/_helsinki64.html ;
http://www.cirp.org/library/ethics/helsinki/
 Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans, 2014,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/ ;
 Chapter 1: Ethics Framework,
http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter1-chapitre1/
Additional Resources
 “Research Ethics,” by Andrew D. McRae, MD, FRCPC;
Royal College of Physicians and Surgeons of Canada
 http://www.royalcollege.ca/portal/page/portal/rc/resou
rces/bioethics/primers/research_ethics
 https://uwaterloo.ca/research/office-researchethics/research-human-participants/frequently-askedquestions/evolution-protections-human-participantsresearch