“The mere mention of
experimental medical research on incapacitated human
beings—the mentally ill, the profoundly retarded, and
minor children—summons up visceral reactions, with
recollections of the brutal Nazi experimentation....
Even without the planned brutality, we have had
deplorable instances of over-reaching medical research
in this country.”
Justice Edward Greenfield
T.D. v. NYSOMH, 1995 |
Contents
A
Chronology of Human Research
from
AllianceForHumanResearchProtection
Website
-
6th century B.C.: Meat and
vegetable experiment on young Jewish prisoners in Book of
Daniel.
-
5th century B.C: “Primum non
nocere” (“First do no harm”), medical ethics standard attributed
to Hippocrates. This Oath became obligatory for physicians prior
to practicing medicine in the 4th century AD
-
1st century B.C. Cleopatra
devised an experiment to test the accuracy of the theory that it
takes 40 days to fashion a male fetus fully and 80 days to
fashion a female fetus. When her handmaids were sentenced to
death under government order, Cleopatra had them impregnated and
subjected them to subsequent operations to open their wombs at
specific times of gestation. [http://www.jlaw.com/Articles/NaziMedExNotes.html#1]
-
12th century: Rabbi and
physician Maimonides’ Prayer: “May I never see in the patient
anything but a fellow creature in pain.”
-
1796: Edward Jenner injects
healthy eight-year-old James Phillips first with cowpox then
three months later with smallpox and is hailed as discoverer of
smallpox vaccine.
-
1845-1849: J. Marion Sims,
“the father of gynecology” performed multiple experimental
surgeries on enslaved African women without the benefit of
anesthesia. After suffering unimaginable pain, many lost their
lives to infection. One woman was made to endure 34 experimental
operations for a prolapsed uterus.
http://www.coax.net/people/lwf/jm_sims.htm
-
1865: French physiologist
Claude Bernard publishes “Introduction to the Study of Human
Experimentation,” advising: “Never perform an experiment which
might be harmful to the patient even though highly advantageous
to science or the health of others.”
-
1896: Dr. Arthur Wentworth
performed spinal taps on 29 children at Children’s Hospital,
Boston, to determine if the procedure was harmful. Dr. John
Roberts of Philadelphia, noting the non-therapeutic indication,
labeled Wentworth’s procedures “human vivisection.”
-
1897: Italian bacteriologist
Sanarelli injects five subjects with bacillus searching for a
causative agent for yellow fever.
-
1900: Walter Reed injects 22
Spanish immigrant workers in Cuba with the agent for yellow
fever paying them $100 if they survive and $200 if they contract
the disease.
-
1900: Berlin Code of Ethics.
Royal Prussian Minister of Religion, Education, and Medical
Affairs guaranteed that:
-
“all medical interventions for other
than diagnostic, healing, and immunization purposes, regardless
of other legal or moral authorization are excluded under all
circumstances if,
-
the human subject is a minor or
not competent due to other reasons;
-
the human subject has not given
his unambiguous consent;
-
the consent is not preceded by a
proper explanation of the possible negative consequences of
the intervention.”
http://www.geocities.com/artnscience/00berlincode.pdf
-
1906: Dr. Richard Strong, a
professor of tropical medicine at Harvard, experiments with
cholera on prisoners in the Philippines killing thirteen.
-
1913: Pennsylvania House of
Representatives recorded that 146 children had been inoculated
with syphilis, “through the courtesy of the various hospitals”
and that 15 children in St. Vincent’s House in Philadelphia had
had their eyes tested with tuberculin. Several of these children
became permanently blind. The experimenters were not punished.
-
1915: A doctor in
Mississippi, working for the U.S. Public Health Office produces
Pellagra in twelve Mississippi inmates in an attempt to discover
a cure for the disease
-
1919-1922: Testicular
transplant experiments on five hundred prisoners at San Quentin.
-
1927: Carrie Buck of
Charlottesville is legally sterilized against her will at the
Virginia Colony Home for the Mentally Infirm. Carrie Buck was
the mentally normal daughter of a mentally retarded mother, but
under the Virginia law, she was declared potentially capable of
having a “less than normal child.”
By the 1930s, seventeen states in
the U.S. have laws permitting forced sterilization The
settlement of Poe v. Lynchburg Training School and Hospital
(same institution, different name) in 1981 brought to an end the
Virginia law. It is estimated that as many as 10,000 perfectly
normal women were forcibly sterilized for “legal” reasons
including alcoholism, prostitution, and criminal behavior in
general.
-
1931: Lubeck, Germany, 75
children die in from pediatrician’s experiment with tuberculosis
vaccine.
-
1931: Germany adopts
“Regulation on New Therapy and Experimentation” requiring all
human experiments to be preceded by animal experiments. This law
remained in effect during the Nazi regime.
-
1931: Dr. Cornelius Rhoads, a
pathologist, conducted a cancer experiment in Puerto Rico under
the auspices of the Rockefeller Institute for Medical
Investigations. Dr. Rhoads has been accused of purposely
infecting his Puerto Rican subjects with cancer cells. Thirteen
of the subjects died. A Puerto Rican physician uncovered the
experiment an investigation covered-up the facts.
Despite Rhoads’ hand written
statements that the Puerto Rican population should be
eradicated, Rhoads went on to establish U.S. Army Biological
Warfare facilities in Maryland, Utah, and Panama, and was later
named to the U.S. Atomic Energy Commission. Rhoads was also
responsible for the radiation experiments on prisoners, hospital
patients, and soldiers. The American Association for Cancer
Research honored him by naming its exemplary scientist award the
Cornelius Rhoads Award.
-
1932-1972: U.S. Public
Health Service study in Tuskegee, Alabama of more than 400 black
sharecroppers observed for the natural course of untreated
syphilis.
-
1932: Japanese troops invade
Manchuria. Dr. Shiro Ishii, a prominent physician and army
officer begins preliminary germ warfare experiments.
-
1936: Japan’s Wartime Human
Biowarfare Experimentation Program.
-
1938: Japan establishes Unit
731 in Pingfan, 25 km. from Harbin. Unit 731, a
biological-warfare unit disguised as a water-purification unit,
is formed outside the city of Harbin.
-
1939: Third Reich orders
births of all twins be registered with Public Health Offices for
purpose of genetic research.
-
1939: Twenty-two children
living at the Iowa Soldiers’ Orphans’ Home in Davenport were the
subjects of the “monster” experiment that used psychological
pressure to induce children who spoke normally to stutter. It
was designed by one of the nation’s most prominent speech
pathologists, Dr. Wendell Johnson, to test his theory on the
cause of stuttering.
-
1940: Poisonous gas
experiments at Unit 731. One experiment conducted September
7-10, 1940, on 16 Chinese prisoners who were exposed to mustard
gas in a simulated battle situation.
-
1940-1941: Unit 731
used aircraft to spread cotton and rice husks contaminated with
the black plague at Changde and Ningbo, in central China. About
100 people died from the black plague in Ningbo as a result.
-
1940’s: In a crash program to
develop new drugs to fight Malaria during World War II, doctors
in the Chicago area infected nearly 400 prisoners with the
disease. Although the Chicago inmates were given general
information that they were helping with the war effort, they
were not informed about the nature of the experiment. Nazi
doctors on trial at Nuremberg cited the Chicago studies as
precedents to defend their own research aimed at aiding the
German war effort.
-
1941: Sterilization
experiments at Auschwitz.
-
1941-1945: Typhus
experiments at Buchenwald and Natzweiler concentration camps.
-
1941: Dr. William c. Black
inoculated a twelve month old baby with herpes. He was
criticized by Francis Payton Rous, editor of the Journal of
Experimental Medicine, who called it “an abuse of power, an
infringement of the rights of an individual, and not excusable
because the illness which followed had implications for
science.” Dr. Rous rejected outright the fact that the child had
been “offered as a volunteer.”
-
1942 - 1945: Unit 731. Ishii
begins “field tests” of germ warfare and vivisection experiments
on thousands of Chinese soldiers and civilians. Chinese people
who rebelled against the Japanese occupation were arrested and
sent to Pingfan where they became human guinea pigs; there is
evidence that some Russian prisoners were also victims of
medical atrocities.
-
“I cut him open from the chest
to the stomach and he screamed terribly and his face was all
twisted in agony. He made this unimaginable sound, he was
screaming so horribly. But then finally he stopped. This was
all in a day’s work for the surgeons, but it really left an
impression on me because it was my first time.” NYT
These prisoners were called ‘maruta’
(literally ‘logs’) by the Japanese. After succumbing to induced
diseases - including bubonic plague, cholera, anthrax - the
prisoners were usually dissected while still alive, their bodies
then cremated within the compound. Tens of thousands died. The
atrocities were committed by some of Japan’s most distinguished
doctors recruited by Dr. Ishii.
-
1942: High altitude or low
pressure experiments at Dachau concentration camp.
-
1942: Harvard biochemist
Edward Cohn injects sixty-four Massachusetts prisoners with beef
blood in U.S. Navy-sponsored experiment.
-
1942: Japanese sprayed
cholera, typhoid, plague, and dysentery pathogens in the Jinhua
area of Zhejian province (China). A large number of Japanese
soldiers also fell victim to the sprayed diseases.
-
1942-1943: Bone regeneration
and transplantation experiments on female prisoners at
Ravensbrueck concentration camp.
-
1942-1943: Freezing
experiments at Dachau concentration camp.
-
1943: Refrigeration
experiment conducted on sixteen mentally disabled patients who
were placed in refrigerated cabinets at 30 degree Farenheit, for
120 hours, at University of Cincinnati Hospital., “to study the
effect of frigid temperature on mental disorders.”
-
1942-1943: Coagulation
experiments on Catholic priests at Dachau concentration camp.
-
1942-1944: U.S. Chemical
Warfare Service conducts mustard gas experiments on thousands of
servicemen.
-
1942-1945: Malaria
experiments at Dachau concentration camp on more than twelve
hundred prisoners.
-
1943: Epidemic jaundice
experiments at Natzweiler concentration camp.
-
1943-1944: Phosphorus burn
experiments at Buchenwald concentration camp.
-
1944: Manhattan Project
injection of 4.7 micrograms of plutonium into soldiers at Oak
Ridge.
-
1944: Seawater experiment on
sixty Gypsies who were given only saltwater to drink at Dachau
concentration camp.
-
1944-1946: University
of Chicago Medical School professor Dr. Alf Alving conducts
malaria experiments on more than 400 Illinois prisoners.
-
1945: Manhattan Project
injection of plutonium into three patients at Billings Hospital
at University of Chicago.
-
1945: Malaria experiment on
800 prisoners in Atlanta.
-
1946: Opening of Nuremberg
Doctors Trial by U.S. Military Tribunal.
-
1945: Japanese troops blow up
the headquarters of Unit 731 in final days of Pacific war. Ishii
orders 150 remaining “logs” (i.e., human beings) killed to cover
up their experimentation. Gen. Douglas MacArthur is named
commander of the Allied powers in Japan.
-
1946: U.S. secret deal with
Ishii and Unit 731 leaders cover up of germ warfare data based
on human experimentation in exchange for immunity from
war-crimes prosecution.
-
1946-1953: Atomic Energy
Commission sponsored study conducted at the Fernald school in
Massachusetts. Residents were fed Quaker Oats breakfast cereal
containing radioactive tracers.
-
1946: Patients in VA
hospitals are used as guinea pigs for medical experiments. In
order to allay suspicions, the order is given to change the word
“experiments” to “investigations” or “observations” whenever
reporting a medical study performed in one of the nation’s
veteran’s hospitals.
-
1947: Colonel E.E.
Kirkpatrick of the U.S. Atomic Energy Commission issues a secret
document (Document 07075001, January 8, 1947) stating that the
agency will begin administering intravenous doses of radioactive
substances to human subjects.
-
1947: The CIA begins its
study of LSD as a potential weapon for use by American
intelligence. Human subjects (both civilian and military) are
used with and without their knowledge.
-
1947: Judgment at Nuremberg
Doctors Trial sets forth “Permissible Medical Experiments” -
i.e., the Nuremberg Code, which begins: “The voluntary consent
of the human subject is absolutely essential.”
-
1949: Intentional release of
radiodine 131 and xenon 133 over Hanford Washington in Atomic
Energy Commission field study called “Green Run.”
-
1949: Soviet Union’s war
crimes trial of Dr. Ishii’s associates.
-
1949-1953: Atomic Energy
Commission studies of mentally disabled school children fed
radioactive isotopes at Fernald and Wrentham schools.
-
1940s-1950s: “psychic
driving” and “mental departterning” experiments conducted by Dr.
Ewen Cameron, depriving patients of sleep, using massive ECT
combined with psychoactive drugs such as, LSD. After his
“treatments” patients were unable to function. In the 1950’s
Dr.Cameron’s experiments were sponsored by the CIA.
-
1950: Dr. Joseph Stokes of
the University of Pennsylvania infects 200 women prisoners with
viral hepatitis. 1950: U.S. Army secretly used a Navy ship
outside the Golden Gate to spray supposedly harmless bacteria
over San Francisco and its outskirts. Eleven people were
sickened by the germs, and one of them died.
-
1951-1960: University of
Pennsylvania under contract with U.S. Army conducts
psychopharmacological experiments on hundreds of Pennsylvania
prisoners.
-
1952-1974: University of
Pennsylvania dermatologist Dr. Albert Kligman conducts skin
product experiments by the
hundreds at Holmesburg Prison; “All I saw before me,” he has
said about his first visit to the prison, “were acres of skin.”
-
1952: Henry Blauer injected
with a fatal dose of mescaline at New York State Psychiatric
Institute of Columbia University. U.S. Department of Defense,
the sponsor, conspired to conceal evidence for 23 years.
-
1953 Newborn Daniel Burton
rendered blind at Brooklyn Doctor’s Hospital due to high oxygen
study on RLF.
-
1953-1957: Oak
Ridge-sponsored injection of uranium into eleven patients at
Massachusetts General Hospital in Boston.
-
1953-1960: CIA brainwashing
experiments with LSD at eighty institutions on hundreds of
subjects in a project code named “MK-ULTRA.”
-
1953-1970: U.S. Army
experiments with LSD on soldiers at Fort Detrick, Md.
-
1954-1974: U.S. Army study of
2,300 Seventh-Day Adventist soldiers in 157 experiments code
named “Operation Whitecoat.”
-
1950s - 1972: Mentally
disabled children at Willowbrook School (NY) were deliberately
infected with hepatitis in an attempt to find a vaccine.
Participation in the study was a condition for admission to
institution.
-
1956: Dr. Albert Sabin tests
experimental polio vaccine on 133 prisoners in Ohio.
-
1958-1962: Spread of
radioactive materials over Inupiat land in Point Hope, Alaska in
Atomic Energy Commission field study code named “Project
Chariot.”
-
1962: Thalidomide withdrawn
from the market after thousands of birth deformities blamed in
part on misleading results of animal studies; the FDA thereafter
requires three phases of human clinical trials before a drug can
be approved for the market.
-
1962 to 1966, a total of 33
pharmaceutical companies tested 153 experimental drugs at
Holmesburg prison (PA) alone.
-
1962-1980 Pharmaceutical
companies conduct Phase I safety testing of drugs almost
exclusively on prisoners for small cash payments.
-
1962: Injection of live
cancer cells into 22 elderly patients at Jewish Chronic Disease
Hospital in Brooklyn. Administration covered up, NYS licensing
board placed the principal investigator on probation for one
year. Two years later, American Cancer Society elected him Vice
President.
-
1962: Stanley Milgram
conducts obedience research at Yale University.
-
1963: NIH supported
researcher transplants chimpanzee kidney into human in failed
experiment.
-
1963-1973: Dr. Carl Heller, a
leading endocrinologist, conducts testicular irradiation
experiments on prisoners in Oregon and Washington giving them $5
a month and $100 when they receive a vasectomy at the end of the
trial.
-
1964: World Medical
Association adopts Helsinki Declaration, asserting “The
interests of science and society should ever take precedence
over the well being of the subject.”
-
1965-1966: University of
Pennsylvania under contract with Dow Chemical conducts dioxin
experiments on prisoners at Holmesburg.
-
1966: Henry Beecher’s article
“Ethics and Clinical Research” in New England Journal of
Medicine.
-
1966: U.S. Army introduces
bacillus globigii into New York subway tunnels in field study.
-
1966: NIH Office for
Protection of Research Subjects (“OPRR”) created and issues
Policies for the Protection of Human Subjects calling for
establishment of independent review bodies later known as
Institutional Review Boards.
-
1967: British physician M.H.
Pappworth publishes “Human Guinea Pigs,” advising “No doctor has
the right to choose martyrs for science or for the general
good.”
-
1969: Judge Sam Steinfield’s
eloquent dissent in Strunk v. Strunk, 445 S.W.2d 145, the first
judicial suggestion that the Nuremberg Code should influence
American jurisprudence.
-
1969. Milledgeville Georgia,
investigational drugs tested on mentally disabled children. No
institutional approval.
-
1969: San Antonio
Contraceptive Study conducted on 70 poor Mexican-American women.
Half received oral contraceptives the other placebo. No informed
consent.
-
1973 Ad Hoc Advisory Panel
issues Final Report of Tuskegee Syphilis Study, concluding
“Society can no longer afford to leave the balancing of
individual rights against scientific progress to the scientific
community.”
-
1974: National Research Act
establishes National Commission for the Protection of Human
subjects and requires Public Health Service to promulgate
regulations for the protection of human subjects.
-
1975: The Department of
Health, Education and Welfare (DHEW) raised NIH’s 1966 Policies
for the Protection of Human subjects to regulatory status. Title
45 of the Code of Federal Regulations, known as “The Common
Rule,” requires the appointment and utilization of institutional
review boards (IRBs).
-
1976: National Urban League
holds National Conference on Human Experimentation, announcing
“We don’t want to kill science but we don’t want science to
kill, mangle and abuse us.”
-
1978: Experimental Hepatitis
B vaccine trials, conducted by the CDC, begin in New York, Los
Angeles and San Francisco. Ads for research subjects
specifically ask for promiscuous homosexual men.
-
1979: National Commission
issues Belmont Report setting forth three basic ethical
principles: respect for persons, beneficence, and justice.
-
1980: The FDA promulgates 21
CFR 50.44 prohibiting use of prisoners as subjects in clinical
trials shifting phase I testing by pharmaceutical companies to
non-prison population.
-
1981: Leonard Whitlock
suffers permanent brain damage after deep diving experiment at
Duke University.
-
1986: Congressional
subcommittee holds one-day hearing in Washington, called by Rep.
Pat Williams of Montana, aimed at determining whether U.S.
prisoners of war in Manchuria were victims of germ-warfare
experimentation. Hearing is inconclusive.
-
1981-1996: Protocol 126 at
Fred Hutchinson Cancer Center in Seattle.
-
1987: Supreme Court decision
in United States v. Stanley, 483 U.S. 669, holding soldier given
LSD without his consent could not sue U.S. Army for damages.
-
1987:” L-dopa challenge and
relapse” experiment conducted on 28 U.S. veterans who were
subjected to psychotic relapse for study purposes at the Bronx
VA.
-
1990: The FDA grants
Department of Defense waiver of Nuremberg Code for use of
unapproved drugs and vaccines in Desert Shield.
-
1991: World Health
Organization announces CIOMS Guidelines which set forth four
ethical principles: respect for persons, beneficence, non-maleficence
and justice.
-
1991: Tony LaMadrid commits
suicide after participating in study on relapse of
schizophrenics withdrawn from medication at UCLA.
-
1993: Kathryn Hamilton dies
44 days after participating in breast cancer experiment at Fred
Hutchinson Cancer Center in Seattle.
-
1994. The Albuquerque Tribune
publicizes 1940s experiments involving plutonium injection of
human research subjects and secret radiation experiments.
Indigent patients and mentally retarded children were deceived
about the nature of their treatment.
-
1994. President Clinton
appoints the Advisory Commission on Human Radiation Experiments
(ACHRE)
The ACHRE Report
-
1995. U.S. Department of
Energy (DOE) published Human Radiation Experiments, listing 150
plus an additional 275 radiation experiments conducted by DOE
and the Atomic Energy Commission,
during the 1940s-1970s.
-
1995: 19-year-old University
of Rochester student Nicole Wan dies after being paid $150 to
participate in MIT-sponsored experiment to test airborne
pollutant chemicals.
-
1995. President Clinton
appoints the National Bioethics Advisory Commission.
-
1995: NYS Supreme Court rules
(TD v NYS Office of Mental Health) against the state’s policy of
conducting non-therapeutic experiments on mentally incapacitated
persons - including children - without informed consent. Justice
Edward Greenfield ruled that parents have no authority to
volunteer their children: “Parents may be free to make martyrs
of themselves, but it does not follow that they may make martyrs
of their children.”
-
1995: Thirty-four healthy,
previously non-aggressive New York City minority children, boys
aged 6 to 11 years old, were exposed to fenfluramine in a
non-therapeutic experiment at the New York State Psychiatric
Institute. The children were exposed to this neurotoxic drug to
record their neurochemical response in an effort to prove a
speculative theory linking aggression to a biological marker.
-
1996. Cleveland Plain Dealer
investigative report series, ‘Drug Trials: Do People Know the
Truth About Experiments,’ December 15 to 18, 1996. The
Plain-Dealer found: of the “4,154 FDA inspections of researchers
testing new drugs on people [since 1977]... more than half
the researchers were cited by FDA inspectors for failing to
clearly disclose the experimental nature of their work.”
-
1996: Yale University
researchers publish findings of experiment that subjected 18
stable schizophrenia patients to psychotic relapse in an
amphetamine provocation experiment at West Haven VA.
-
1997. President Clinton
issues a formal apology to the subjects of the Tuskegee syphilis
experiments. NBAC continues investigation into genetics,
consent, privacy, and research on persons with mental disorders.
-
1997. Researchers at the
University of Cincinnati publish findings of experiment
attempting to create a “psychosis model” on human beings at the
Cincinnati VA. Sixteen patients, experiencing a first episode
schizophrenia, were subjected to repeated provocation with
amphetamine. The stated purpose was to produce “behavioral
sensitization. This process serves as a model for the
development of psychosis, but has been little studied in humans.
Symptoms, such as severity of psychosis and eye-blink rates,
were measured hourly for 5 hours.”
-
1997. U.S. government
sponsored placebo-controlled experiment withholds treatment from
HIV infected, pregnant African women. NY Times, Sept. 18.
-
1997. Victims of unethical
research at major U.S. medical centers - including the NIMH -
testify before the National Bioethics Advisory Commission, Sept.
18.
-
1997. FDA Modernization Act
gives pharmaceutical companies a huge financial incentive - a 6
month patent exclusivity extension - if they conduct drug tests
on children. The incentive can yield $900 million.
-
1998.
National Bioethics
Advisory Commission (NBAC) Report. Research Involving Subjects
with Mental Disorders That May Affect Decision-making Capacity.
November 12, 1998
-
1998: The Japanese government
has never formally apologized for Unit 731’s activities, and did
not even admit to its existence until August 1998, when the
Supreme Court ruled that the existence of the unit was accepted
in academic circles.
-
1998. Complaint filed with
OPRR about experiments that exposed non-violent children in New
York City to fenfluramine to find a predisposition to violence.
-
1998: Boston Globe (four
part) series, “Doing Harm: Research on the Mentally Ill” shed
light on the mistreatment and exploitation of schizophrenia
patients who have been subjected to relapse producing procedures
in unethical experiments.
-
1999: Nine month-old Gage
Stevens dies at Children’s Hospital in Pittsburgh during
participation in Propulsid clinical trial for infant acid
reflux.
-
1999: 18-year-old Jesse
Gelsinger dies after being injected with 37 trillion particles
of adenovirus in gene therapy experiment at University of
Pennsylvania.
-
1999: Director of National
Institute of Mental Health suspends 29 clinical trials that
failed to meet either ethical or scientific standards.
-
2000: University of Oklahoma
melanoma trial halted for failure to follow government
regulations and protocol.
-
2000: OPRR becomes Office of
Human Research Protection (“OHRP”) and made part of the
Department of Health and Human Services.
-
2000: President Clinton
implement the Energy Employees Occupational Illness Compensation
Act of 2000, which authorized compensation for thousands of
Department of Energy workers who sacrificed their health in
building the nation’s nuclear defenses.
-
2000: The Washington Post (6
part) series, “Body Hunters” exposes unethical exploitation in
experiments conducted by U.S. investigators in underdeveloped
countries.
Part 4 dealt with U.S. government funded, genetic
experiments conducted by Harvard University in rural China.
-
2001: A biotech company in
Pennsylvania asks the FDA for permission to conduct placebo
trials on infants in Latin America born with serious lung
disease though such tests would be illegal in U.S.
-
2001: Ellen Roche, a healthy
27-year old volunteer, dies in challenge study at Johns Hopkins
University in Baltimore, Maryland.
-
2001: April 4, Elaine
Holden-Able, a healthy retired nurse, consumed a glass of orange
juice that had been mixed with a dietary supplement for the sake
of medical research. This Case Western University Alzheimer’s
experiment, financed by the tobacco industry, wound up killing
her in what was called a “tragic human error.” Federal Office of
Human Research Protections did not interview hospital staff,
mostly accepted hospital’s internal report, imposed no penalty,
and
closed the case and did not mention the death in its letter
of determination.
-
2001: Maryland Court of
Appeals renders a landmark decision affirming “best interest of
the individual child” as a standard for medical research
involving children. The Court unequivocally prohibited
non-therapeutic experimentation on children. (Higgins and Grimes
v. Kennedy Krieger Institute).
The case involved exposure of
babies and small children to lead poisoning in EPA funded
experiment.
Back
to Contents
A History
of US Secret Human Experimentation
2000 - Health News Network
3-25-2003
from
Rense Website
-
1931 Dr. Cornelius Rhoads, under the
auspices of the Rockefeller Institute for Medical
Investigations, infects human subjects with cancer cells. He
later goes on to establish the U.S. Army Biological Warfare
facilities in Maryland, Utah, and Panama, and is named to the
U.S. Atomic Energy Commission. While there, he begins a series
of radiation exposure experiments on American soldiers and
civilian hospital patients.
-
1932 The Tuskegee Syphilis Study
begins. 200 black men diagnosed with syphilis are never told of
their illness, are denied treatment, and instead are used as
human guinea pigs in order to follow the progression and
symptoms of the disease. They all subsequently die from
syphilis, their families never told that they could have been
treated.
-
1935
The Pellagra Incident. After millions of individuals die
from Pellagra over a span of two decades, the U.S. Public Health
Service finally acts to stem the disease. The director of the
agency admits it had known for at least 20 years that Pellagra
is caused by a niacin deficiency but failed to act since most of
the deaths occurred within poverty-stricken black populations.
-
1940 Four hundred prisoners in
Chicago are infected with Malaria in order to study the effects
of new and experimental drugs to
combat the disease. Nazi doctors later on trial at Nuremberg
cite this American study to defend their own actions during the
Holocaust.
-
1942 Chemical Warfare Services
begins mustard gas experiments on approximately 4,000
servicemen. The experiments continue until 1945 and made use of
Seventh Day Adventists who chose to become human guinea pigs
rather than serve on active duty.
-
1943 In response to Japan's
full-scale germ warfare program, the U.S. begins research on
biological weapons at Fort Detrick, MD.
-
1944 U.S. Navy uses human subjects
to test gas masks and clothing. Individuals were locked in a gas
chamber and exposed to mustard gas and lewisite.
-
1945
Project Paperclip is initiated.
The U.S. State Department, Army intelligence, and the CIA
recruit Nazi scientists and offer them immunity and secret
identities in exchange for work on top secret government
projects in the United States.
-
1945 "Program F" is implemented by
the U.S. Atomic Energy Commission (AEC). This is the most
extensive U.S. study of the health effects of fluoride, which
was the key chemical component in atomic bomb production. One of
the most toxic chemicals known to man, fluoride, it is found,
causes marked adverse effects to the central nervous system but
much of the information is squelched in the name of national
security because of fear that lawsuits would undermine
full-scale production of atomic bombs.
-
1946 Patients in VA hospitals are
used as guinea pigs for medical experiments. In order to allay
suspicions, the order is given to change the word "experiments"
to "investigations" or "observations" whenever reporting a
medical study performed in one of the nation's veteran's
hospitals.
-
1947 Colonel E.E. Kirkpatrick of the
U.S. Atomic Energy Commission issues a secret document (Document
07075001, January 8, 1947) stating that the agency will begin
administering intravenous doses of radioactive substances to
human subjects.
-
1947 The CIA begins its study of LSD
as a potential weapon for use by American intelligence. Human
subjects (both civilian and military) are used with and without
their knowledge.
-
1950 Department of Defense begins
plans to detonate nuclear weapons in desert areas and monitor
downwind residents for medical problems and mortality rates.
-
1950 I n an experiment to determine
how susceptible an American city would be to biological attack,
the U.S. Navy sprays a cloud of bacteria from ships over San
Francisco. Monitoring devices are situated throughout the city
in order to test the extent of infection. Many residents become
ill with pneumonia-like symptoms.
-
1951 Department of Defense begins
open air tests using disease-producing bacteria and viruses.
Tests last through 1969 and there is concern that people in the
surrounding areas have been exposed.
-
1953 U.S. military releases clouds
of zinc cadmium sulfide gas over Winnipeg, St. Louis,
Minneapolis, Fort Wayne, the Monocacy River Valley in Maryland,
and Leesburg, Virginia. Their intent is to determine how
efficiently they could disperse chemical agents.
-
1953 Joint Army-Navy-CIA experiments
are conducted in which tens of thousands of people in New York
and San Francisco are exposed to the airborne germs Serratia
marcescens and Bacillus glogigii.
-
1953 CIA initiates
Project MKULTRA.
This is an eleven year research program designed to produce and
test drugs and biological agents that would be used for mind
control and behavior modification. Six of the subprojects
involved testing the agents on unwitting human beings.
-
1955 The CIA, in an experiment to
test its ability to infect human populations with biological
agents, releases a bacteria withdrawn from the Army's biological
warfare arsenal over Tampa Bay, Fl.
-
1955 Army Chemical Corps continues
LSD research, studying its potential use as a chemical
incapacitating agent. More than 1,000 Americans participate in
the tests, which continue until 1958.
-
1956 U.S. military releases
mosquitoes infected with Yellow Fever over Savannah, Ga and Avon
Park, Fl. Following each test, Army agents posing as public
health officials test victims for effects.
-
1958 LSD is tested on 95 volunteers
at the Army's Chemical Warfare Laboratories for its effect on
intelligence.
-
1960 The Army Assistant
Chief-of-Staff for Intelligence (ACSI) authorizes field testing
of LSD in Europe and the Far East. Testing of the European
population is code named Project THIRD CHANCE; testing of the
Asian population is code named Project DERBY HAT.
-
1965 CIA and Department of
Defense begin Project MKSEARCH, a program to develop a
capability to manipulate human behavior through the use of
mind-altering drugs.
-
1965 Prisoners at the Holmesburg
State Prison in Philadelphia are subjected to dioxin, the highly
toxic chemical component of Agent Orange used in Viet Nam. The
men are later studied for development of cancer, which indicates
that Agent Orange had been a suspected carcinogen all along.
-
1966 CIA initiates Project MKOFTEN,
a program to test the toxicological effects of certain drugs on
humans and animals.
-
1966 U.S. Army dispenses Bacillus
subtilis variant niger throughout the New York City
subway system. More than a million civilians are exposed when
army scientists drop lightbulbs filled with the bacteria onto
ventilation grates.
-
1967 CIA and Department of Defense
implement Project MKNAOMI, successor to MKULTRA and designed to
maintain, stockpile and test biological and chemical weapons.
-
1968 CIA experiments with the
possibility of poisoning drinking water by injecting chemicals
into the water supply of the FDA in Washington, D.C.
-
1969 Dr. Robert MacMahan of the
Department of Defense requests from congress $10 million to
develop, within 5 to 10 years, a synthetic biological agent to
which no natural immunity exists.
-
1970 Funding for the synthetic
biological agent is obtained under H.R. 15090. The project,
under the supervision of the CIA, is carried out by the Special
Operations Division at Fort Detrick, the army's top secret
biological weapons facility. Speculation is raised that
molecular biology techniques are used to produce AIDS-like
retroviruses.
-
1970 United States intensifies its
development of "ethnic weapons" (Military Review, Nov., 1970),
designed to selectively target and eliminate specific ethnic
groups who are susceptible due to genetic differences and
variations in DNA.
-
1975 The virus section of Fort Detrick's Center for Biological Warfare Research is renamed the
Fredrick Cancer Research Facilities and placed under the
supervision of the National Cancer Institute (NCI) . It is here
that a special virus cancer program is initiated by the U.S.
Navy, purportedly to develop cancer-causing viruses. It is also
here that retro-virologists isolate a virus to which no immunity
exists. It is later named HTLV (Human T-cell Leukemia Virus).
-
1977 Senate hearings on Health and
Scientific Research confirm that 239 populated areas had been
contaminated with biological agents between 1949 and 1969. Some
of the areas included San Francisco, Washington, D.C., Key West,
Panama City, Minneapolis, and St. Louis.
-
1978 Experimental Hepatitis B
vaccine trials, conducted by the CDC, begin in New York, Los
Angeles and San Francisco. Ads for research subjects
specifically ask for promiscuous homosexual men.
-
1981 First cases of AIDS are
confirmed in homosexual men in New York, Los Angeles and San
Francisco, triggering speculation that AIDS may have been
introduced via the Hepatitis B vaccine
-
1985 According to the journal
Science (227:173-177), HTLV and VISNA, a fatal sheep virus, are
very similar, indicating a close taxonomic and evolutionary
relationship.
-
1986 According to the Proceedings of
the National Academy of Sciences (83:4007-4011), HIV and
VISNA
are highly similar and share all structural elements, except for
a small segment which is nearly identical to HTLV. This leads to
speculation that HTLV and VISNA may have been linked to produce
a new retrovirus to which no natural immunity exists.
-
1986 A report to Congress reveals
that the U.S. Government's current generation of biological
agents includes: modified viruses, naturally occurring toxins,
and agents that are altered through genetic engineering to
change immunological character and prevent treatment by all
existing vaccines.
-
1987 Department of Defense admits
that, despite a treaty banning research and development of
biological agents, it continues to operate research facilities
at 127 facilities and universities around the nation.
-
1990 More than 1500 six-month old
black and Hispanic babies in Los Angeles are given an
"experimental" measles vaccine that had never been licensed for
use in the United States. CDC later admits that parents were
never informed that the vaccine being injected to their children
was experimental.
-
1994 With a technique called "gene
tracking," Dr. Garth Nicolson at the MD Anderson Cancer Center
in Houston, TX discovers that many returning Desert Storm
veterans are infected with an altered strain of Mycoplasma
incognitus, a microbe commonly used in the production of
biological weapons. Incorporated into its molecular structure is
40 percent of the HIV protein coat, indicating that it had been
man-made.
-
1994 Senator John D. Rockefeller
issues a report revealing that for at least 50 years the
Department of Defense has used hundreds of thousands of military
personnel in human experiments and for intentional exposure to
dangerous substances. Materials included mustard and nerve gas,
ionizing radiation, psycho-chemicals, hallucinogens, and drugs
used during the Gulf War .
-
1995 U.S. Government admits that it
had offered Japanese war criminals and scientists who had
performed human medical experiments salaries and immunity from
prosecution in exchange for data on biological warfare research.
-
1995 Dr. Garth Nicolson, uncovers
evidence that the biological agents used during the Gulf War had
been manufactured in Houston, TX and Boca Raton, Fl and tested
on prisoners in the Texas Department of Corrections.
-
1996 Department of Defense admits
that Desert Storm soldiers were exposed to chemical agents.
-
1997 Eighty-eight members of
Congress sign a letter demanding an investigation into
bio-weapons use & Gulf War Syndrome.
Back
to Contents
Human Experimentation Before the Nazi Era and After
by
Roberta Kalechofsky, PhD.
from
MicahBooks Website
"First animals, then
orphans, then the mentally retarded."
David J. Rothman
Strangers At The Bedside.
In 1907, Dr. Albert Leffingwell
concluded his booklet, Illustration of Human Vivisection, with this
chilling prophecy:
"At the beginning of a new century
we are confronted by great problems. One of these is human
vivisection in the name of scientific research. We appeal, then,
to the medical press of America to beak that unfortunate silence
which seems to justify or, at least, to condone it. Now and
henceforth, will it not join us in condemning every such
vivisector of little children, every such experimenter upon
human beings? We make this appeal to it in the name of Justice
and Humanity and for the sake of millions yet unborn."
The intellectual and philosophical
rationalizations, as well as much of the practice of human
experimentation, was well advanced by the end of the nineteenth
century, and presents a continuing danger to human rights today,
particularly when faced with the stimulus of crisis and war.
The history of human experimentation in the West is usefully divided
into two eras: before the Nazi era and after. Human experimentation
neither arose with the Nazis, nor ended with them. But the Nazi era,
to paraphrase Samuel Johnson's famous statement that "Nothing
concentrates a man's thoughts so much as the knowledge that he is to
be hanged on the morrow" - the Nazi era concentrated our thoughts
about human experimentation and, to some extent, halted its
momentum. But it did not end the practice of what Dr. Leffingwell
called at the beginning of the century, "the secret creed."
Vivisection was practiced in the Roman era on gladiators and slaves.
But this vivisection, monstrous to the living victim, was sporadic.
The real history of vivisection begins in the nineteenth century
with the rise of the experimental method in science, and
subsequently in medicine. It arises from and accompanies animal
experimentation which, with the work of Claude Bernard in the
mid-nineteenth century, became the standard methodology in modern
medicine. As soon as animal vivisection became standard practice,
the question arose about experimental research on human beings.
Animal researchers recognized that an
inescapable problem had been created: the only way animal research
could really be validated for human medical problems was to finally
conduct the experiment on human beings, for there is no assurance
from animal research itself that a given drug would be valid for
human application. A famous example is the fact that aspirin kills
rabbits, and if researchers had been guided in their use of aspirins
by this laboratory research, human beings would have been denied a
valuable drug.
Michael Krater summarizes the process in his book,
Doctors Under Hitler.
"One of the prerequisites that
turned into a sort of fetish of this exact-scientific attitude
was the experiment--it, too, a child of rationalization in the
past century. At the universities, the theories had to be
validated by experiments. It was unquestioned that advances in
medicine (as in natural science) could be achieved only through
the inductive method of formulating a hypothesis and testing it,
by subjecting it to revision and verification in a controlled
series of empirical observations."
However, Michael Krater's further
statement is only partially true:
"Throughout the 1920s and well into
the Third Reich, German medical scientists were ruled by a
consensus that as desirable as human experiments were, for moral
reasons animals had to suffice as objects of empirical
experimentation."
That was the desideratum, but by the
turn of the century experimentation on human beings was on its way
to becoming respectable. The famous chemist, E.E. Slosson wrote on
Dec. 12th,1895, in the New York Independent,
"A human life is nothing compared
with a new fact in science....the aim of science is the
advancement of human knowledge at any sacrifice of human
life....We do not know of any higher use we can put a man to."
Professor Starling of University
College, London, openly declared in 1906 to Britain's Parliament at
its investigation into vivisection practices, "The last experiment
must be on man."
What animal research does is to provide a seemingly safety net and
guidelines for procedure with human beings. Sometimes this safety
net works, sometimes it doesn't; sometimes it's misleading, but it
is standard procedure, so that animal and human experimentation are
two sides of the same coin.
An article in The New Republic (April 26
and May 2, 1999) by Jerome Groopman, quixotically entitled "Merciful
Medicine," describes the system very well:
"After extensive testing in small
animals, drugs are tested for toxicity in human beings during
what is known as Phase I trials. This first phase is designed to
gauge the side effects of the drugs, usually on groups of three
or four people that get very low doses of the drug, followed by
groups that receive successively higher doses until intolerable
toxicity is reached [like LD50 drug testing in animals]. There
is no expectation of clinical benefit in this first phase.
Furthermore, Phase I studies take virtually all comers."
Groopman goes on to describe Phase II
and Phase III of human experimentation, in an article intended as a
plea to allow those who wish to to volunteer for human
experimentation. It was only a matter of time until medicine would
arrive at this point where the need for volunteers for human
experimentation would become inescapable and would mandate a
"merciful plea."
As Michael Krater describes the escalation under
Nazi Germany,
"Because animal experimentation was
known to be a poor substitute for experiments on humans, for
only analogous inferences could be drawn, the crossover to human
experimentation during the war became a logical consequence of
prior practices that had been fettered."
The evolution from animal
experimentation to human experimentation is a logical consequence of
laws governing the experimental process, whether in Nazi Germany, or
elsewhere, and not the result of preferring humans to animals.
As Krater writes,
"...the often-encountered theory
that Nazis spurned human life in preference for that of animals,
in particular house pets, is without basis in fact--non-suspect
societies love pets also."
The Weimar law passed in 1931 with
respect to animal and human experimentation required that German
and, subsequently Nazi, doctors must first conduct their
experimental procedures on animals before proceeding to human
beings. This law was never abrogated in Nazi Germany and is similar
to laws in the United States today. All experiments with human
beings are and were first conducted on animals, and experimenters in
and out of Nazi Germany had to validate this procedure.
Thus, when Dr. Karl Rascher made his
request on May 15, 1941 to the Reich Leader Himmler, "for two or
three professional criminals," for high altitude test experiments of
eighteen thousand meters, he pointed out that this experiment had
been tried on monkeys, but that monkeys outlived their usefulness at
12,000 meters, and he now had to proceed to the use of humans.
Research on animals does not protect human beings from becoming
experimental guinea pigs.
The literature of the nineteenth century illustrates a continuing
increase in the use of human beings for medical experiments,
beginning in the last two decades of that century. With the rise of
the germ theory and of the pharmaceutical companies, testing on both
animals and humans proliferated at dizzying speeds.
In her book,
Subjected to Science: Human Experimentation in America Before the
Second World War, Susan Lederer writes:
"The science of bacteriology
engendered substantial experimentation on human beings and
animals....Isolating and identifying a disease germ under the
microscope was the first step. After growing the microorganism
in a pure culture, the physicians needed to use the germ to
produce the disease in a healthy organism.
"The use of human beings to confirm that a microbe caused a
particular disease to demonstrate the mode of transmission was a
harsh legacy of the germ theory of disease. Unable to find a
suitable animal model in which to study the disease, physicians
turned to human subjects. Before the discovery that monkeys
could be infected with syphilis and gonorrhea, the search for
microbes of venereal disease prompted more than forty reports of
experiments in which individuals were inoculated with the
suspected germs of gonorrhea and syphilis. In 1895 New York
pediatrician Henry Heiman... described the successful gonorrheal
infection of a 4-year-old boy ("an idiot with chronic
epilepsy"), a 16-year-old boy (an "idiot") and a 26-year-old man
in the final stages of tuberculosis"
This information is in the medical
journals of its time, The American Journal of Syphilis of 1943, and
the Journal Cut. Genito-Urinary Diseases of 1895. It is germaine to
the problem of informed consent that two of the subjects are
described as "idiots," therefore presumably incapable of giving
informed consent. Who then gave it for them, and should others have
the right to give such consent for others? Should a parent in need
of money have the right to give consent for a child to be
experimented upon? Would this be considered "selling" a child to
science. These are problems that degrade the integrity of the
concept of informed consent.
Usually the human beings used for experimental purposes were--and
are-- the disenfranchised, populations of prisoners, orphans, the
mentally retarded, charity patients of all kinds. Dr. Leffingwell's
study uncovered decades of experiments on human beings in charity
wards and on children in orphan asylums. None of these experiments
were as horrific as those conducted by the Nazis, but they were
quite serious enough.
Leffingwell documented experiments by Dr.
Sydney Ringer of University Hospital of London, who experimented
with poisons, such as overdoses of salicin, nitrate of sodium,
gelseminum and other toxic agents, often on children under the age
of ten. Due to the experiments, the children suffered from severe
headaches, vomiting, twitching of limbs, burning sensations in the
eyes, and other painful symptoms.
Dr. Leffingwell commented:
"A distressing feature of many of
these experiments is the fact that the men and women upon whom
they were performed were not only ignorant, but under
constraint. In this horrible case certain patients in the
hospitals were not merely poisoned once, but were obliged 'on
compulsion' to undergo the convulsive paroxysms and all the
other agonizing symptoms a second time"
Dr. Ringer's experiments were published
in a book called Handbook of Therapeutics. Far from receiving
criticism for his experiments on children, Dr. Ringer's book went
through eight editions and was regarded as a respectable medical
book.
In 1906, the British Parliament conducted The Second Royal
Commission into Vivisection Practices. H.H. Levy, the Honorable
Secretary of the Personal Rights Association, told the Commission,
"These experiments are not confined
to animals and never have been confined to animals; they have
always been performed on human beings, as well as on animals."
Indeed, the Commission uncovered decades
of evidence of routine human experimentation. Some of these
experiments were published in 1949 in E. Westacot's book, A Century
of Vivisection and Anti-Vivisection. Westacott's book describes the
experiments of Professor Neisser of Vienna who, on March 29, 1899,
reported in the Medical Press of Vienna, how he had inoculated eight
healthy children with syphilis.
Three of the children developed symptoms
of the disease, and a fourth suffered later in life from a cerebral
tumor. While Professor Neisser was condemned and fined by the
disciplinary court of Breslau, he was rewarded by the West London
Chirurgical Society in England in 1911, with the Cavendish Gold
Medal for his research, and a reception was held in his honor. Apart
from the Nazi doctors, it is hard to find a single doctor who was
seriously punished for human experimentation, and who was not in
fact professionally rewarded.
In the United States, in 1913, the Pennsylvania House of
Representatives recorded that 146 children had been inoculated with
the syphilis virus, "through the courtesy of the various hospitals"
and that 15 children in St. Vincent's House in Philadelphia had had
their eyes tested with tuberculin. Several of these children became
permanently blind. The experimenters were not punished. Moreover,
this case further illustrates that the doctrine of "informed
consent" proves to be practically inoperable in the case of
institutionalized people, particularly children, because in most of
these circumstances it is the institution's supervisor who is
responsible for giving "informed consent" and usually gives it.
Experimentation on human beings was not confined to bacteriological
research. J. Marion Sims, the "father of gynecology" performed
experimental surgery, before the days of anesthesia, on several
slaves, and performed thirty-four experimental operations on a
single black female slave for a prolapsed uterus.
One of the most famous cases in human experimentation involves an
Irish servant girl, Mary Rafferty, who entered Good Samaritan
Hospital in Cincinnati in 1874, with an ulcerated tumor on the side
of her head, which had been caused by a bad burn.
Mary Rafferty's case demonstrates the
characteristics usually inherent in cases of human experimentation:
the ambiguity involved in determining whether informed consent had
been obtained, the shadow land between experimentation and therapy,
the fact that only the attending physicians really know the truth of
what occurred. Her physicians diagnosed the ulcer on her scalp as
cancerous and apparently attempted to treat her condition
surgically. When they believed that her situation could not be
remedied, they proceeded to experiment on her. One of Mary's
physicians, Roberts Bartholow was interested in experiments Dr.
David Ferrier had made with dogs using electric shock to determine
the localization of epilepsy.
The experiments with Mary are described
as follows:
"When the needle entered the brain
substance, she complained of acute pain in the neck. In order to
develop more decided reaction, the strength of the current was
increased by drawing out the wooden cylinder one inch. When
communication was made with the needles, her countenance
exhibited great distress, and she began to cry. Very soon, the
left hand was extended as if in the act of taking hold of some
object in front of her; the arm presently was agitated with
chronic spasm; her eyes became fixed with pupils widely dilated;
her lips were blue, and she frothed at the mouth; her breathing
became stertorus; she lost consciousness and was violently
convulsed on the left side. The convulsion lasted five minutes,
and was succeeded by a coma. She returned to consciousness in
twenty minutes from the beginning of the attack, and complained
of some weakness and vertigo."
The Mary Rafferty Case illustrates a
persistent pattern in issues of human experimentation: she died a
few days later, and her death certificate stated that she died from
cancer. There was criticism of Dr. Bartholow's experiment: it was
condemned by the American Medical Association, but Dr. Bartholow did
not suffer professionally. Indeed, he advanced professionally.
Scandal arises, then scandal subsides, and the researcher is
rewarded.
The second issue is that while Dr. Bartholow conceded that his
experiment had perhaps gone too far, he asserted emphatically that
Mary had given informed consent and that his experiments did not
cause her death. But even if the experiments did not cause her
death, she was entitled to die without unnecessary pain. The
argument that "the patient was going to die anyway" is a gross
argument, and one that was used by the Nazi doctors. Bad enough the
patient is going to die; it is no excuse for the patient to be
tortured while dying.
We do not permit condemned prisoners to
be tortured on the excuse that they're going to die anyway.
(However, there are constant proposals from research medicine that
prisoners on death row be used for experimental purposes. Would such
"experiments" constitute torture or not?)
The third issue is that of Mary Rafferty's consent. Dr. Bartholow
argued that she was not feeble-minded and understood his questions
to her. There is a contradiction in this argument. If Mary Rafferty
really understood Dr. Bartholow's description of what he was about
to do, common sense tells us she would not have consented. This is
the crux of the issue with most "informed consent" problems.
Examination of particular experiments
invariably suggests that the patient did not understand what he or
she was consenting to. "Informed consent" proves to be a treacherous
deception in many cases. At a conference on "The Nazi Doctors and
the Nuremberg Code" at Boston University in 1989, Dr. Arthur Caplan
stated that the principle of informed consent, which is the
cornerstone of protection for human rights in a medical context, is
now so eroded that it has evolved into "protection of the
researcher" and a license to experiment.
"Informed consent" does not respond to the more common types of
experimentation on human beings, where the area between therapy and
experimentation is blurred, and where it is difficult to pass
judgment on medical procedure. An article in The New York Times
(Nov., 1996) by Gina Kolata, demonstrates the ubiquity of the
problem. The Food and Drug Administration gave permission to lift
the requirement of informed consent for patients who have been
brought into a hospital, suffering from a head injury which has
rendered them unconscious, and who have no identification. Who is to
give consent in this case?
Though this step marks a grave departure
from the Nuremberg Code, it has aroused little public reaction. Of
course, the argument in defense of the lifting of this ban is the
necessity to treat a patient, even experimentally, who cannot speak
for him or herself. But how many people are wandering about without
any identification? The population of "unidentifiable" people is
immediately identifiable: the homeless and probably illegal
immigrants.
Even with alert and identifiable patients, as Jay Katz observed at
the Boston University Conference, informed consent is meaningless
unless the patient is educated and medically very knowledgeable, but
most sick people, as Dr. Katz pointed out, are not in a position to
argue with their physicians: they are "coerced by disease," by pain,
by fear of death, and often by ignorance.
In real practice--not theoretical practice--the concept of "informed
consent" has led to the duplicitous practice of what Bradford H.
Gray calls in his book, Human Subjects in Medical Experimentations,
"the engineering of consent." His study unsurprisingly reveals that
"informed consent" is often a mirage, often coerced from frightened
people who are in too much pain and confusion to withstand a request
from a doctor.
In the introduction to Gray's book,
Bernard Barber exposes the myth of medical experimental outrages as
the aberration of a "few bad doctors."
"There is a mistaken belief held by
some medical researchers, and even by those who deplore the
defects in present practices in this field, that the
shortcomings and scandals that occur can be traced to a handful
of individuals who lack the requisite personal qualities. They
recommend that 'the honest, conscientious, compassionate
physician' be the ultimate safeguard of the human research
subject. But Gray's book shows that 'honest, conscientious,
compassionate' physicians have been led into bad practice by a
bad system."
Experimentation on human beings is not
the work of a few aberrant doctors; it is systemic, because it is
the system by which modern western medicine works. Exposés of
outrageous experiments, such as Dr. Henry Beecher's book, Research
and The Individual, written in 1966, often endorse research on human
beings. Dr. Beecher wrote,
"The well-being, the health, even
the actual or potential life of all human beings, born or
unborn, depend upon the continuing experimentation in man.
Proceed it must; proceed it will. 'The proper study of mankind
is man.'"
The Nuremberg trials brought to light
the horrors of medical experimentation on human beings, and tried to
articulate a restraining formula by stressing the concept of
"informed consent," but the trials also recognized that
"Medical science cannot, unless it
is to be brought to a standstill, dispense with the application
in suitable cases of new remedies and procedures not yet fully
tested. Nor can it do entirely without scientific experiment on
human beings itself."
In 1931, Germany already possessed a
good bioethical code which contained almost all the points of the
Nuremberg Code. Yet it failed to curb the rapacious desire to
experiment. By the time of the Nazi experiments, the legal procedure
and conduct of experimentation with human beings had been laid down
in Germany, the United States and England. Experimentation on human
beings was not condemned. What was condemned in Germany was the
political and racial uses of human experimentation, and its
excesses.
The defense of the Nazi doctors rested
on the argument that their procedure was standard Western medical
practice, and they submitted cartons of documentation of experiments
on human beings in Western hospitals to prove their case, including
an exhaustive volume, entitled, Experiments on Human Beings in World
Literature, by Dr. Erich H. Hahlbach, which describes such
experiments as those conducted on "eight hundred convicts from three
American prisons" artificially infected with malaria, who presumably
volunteered for this experiment, prisoners in Turkey sentenced to
death, infected with typhus, prisoners sentenced to death infected
with plague, etc.
The defense pointed out that,
"Out of fifty-three printed sources
quoted, seventeen state that the subjects consented. In
thirty-six the matter was not mentioned in any way and in
several of these cases it appeared that the subjects might not
have presented themselves willingly."
The defense's argument was that
experimentation with human beings had been accepted medical
procedure.
The question, they asked, is whether
"medical experimentation can be considered a crime." The prosecution
did not argue this, but condemned the experiments because they had
been used for political and racial purposes. A half hour's reading
in The Encyclopedia of Bioethics , under "human experimentation,"
"minority subjects," reveals that it had been thus for half a
century. The Encyclopedia documents cases of experimentation on
human beings of minority populations and Third World populations.
Eileen Welsome's book, "The Plutonium Files," (Dial Press, 1999),
documents radiation experiments on human beings in the United States
from the 1940s, after the exposure of Nazi experiments and the
articulation of the Nuremburg Code. Some of the doctors who
conducted these experiments and were later interviewed about them,
confessed that they knew of the Nuremberg Code, but did not think it
applied to them--that code was for the barbarian Nazis.
William
Silverman of Columbia University, said:
"'The connection between those
horrendous acts and our every day investigation was not made for
reasons of self interest, to be perfectly frank. As I see it
now, I'm saddened that I didn't see the connection, but that's
what was sone. We wrapped ourselves in the flag....'" (p. 214.)
Welsome writes,
"Physicians performed experiments on
healthy people and sick patients without informing them of what
was going on or getting their consent. Sick patients were preyed
on most frequently. They were convenient, plentiful, and
vulnerable, since non-therapeutic procedures could be
administered easily under the guise of medical
treatment.... Terminally ill patients were perhaps the most
vulnerable group of all.... Women, children, unborn fetuses,
minorities, the mentally retarded, schizophrenics, prisoners,
alcoholics, and poor people of all ages and ethnic groups were
targets." (p. 214-215)
There are examples of experimentation on
human beings that is more democratic. Ed Regis' book, "The Biology
of Doom: The History of America's Secret Germ Warfare Project," (
Henry Holt & Co., 2,000) writes of those experiments when U.S. Nay
ships,
"without, it seems the knowledge of
Congress, sprayed the Virginia coastal communities of Norfolk,
Hampton and Newport News with BG (bacillus globigii--used to
stimulate the spread of anthrax) [and] 800,000 people around San
Francisco ay were exposed to clouds of these microbes."
("The New York Times Book Review,
Jan. 22, 2,000).
Prior to this, in October, 1940,
"Japanese planes dropped a mixture
of grains and fleas over Chinese towns, causing two major
outbreaks of bubonic plague south of Shanghai." (Ibid)
The race to develop genetic medicine has
opened new temptations for doctors to experiment on human beings.
The death of Jesse Gelsinger, 18 years old, who suffered from a
non-threatening liver ailment, and was induced to undergo genetic
treatment for it at the University of Pennsylvania, has exposed
appalling practices that are now a century old: the cavalier
behavior of the experimenters, the hasty patched-together "informed
consent" form --after his death--- other procedural misconduct. ("The
New York Times, Jan. 27, 2,000, page. 1, " Youth's Death Shaking Up
Field of Gene Experiments on Humans.)
The philosopher Hans Jonas proposed that experimentation on human
beings must be reserved not for the disenfranchised, but for the
scientists and intellectuals themselves -- both for scientific and
moral reasons. Scientifically, because the class that designs the
experiments can best report on the probity and results of the
experiments.
There were outstanding examples of this
procedure in the nineteenth century, and occasionally one still
hears of a medical doctor experimenting on himself (or a member of
his family), but as human experimentation went from what David
Rothman called "a cottage industry" in the nineteenth century to its
present dimensions as an indispensable part of modern medicine
requiring ever larger populations, "voluntary science martyrs"
disappeared. The reasons for this are not hard to find: If Mary
Rafferty had understood what she presumably was consenting to, she
would not likely have consented. Some who do consent are usually
those in desperately dependent positions.
Jerome Stephens offers another, more chilling reason why the medical
research community does not seek out "volunteers' from the higher
socio-economic brackets. Researching on the ignorant and the disenfranched allows the researchers to maintain control of the
research process.
"Medical researchers, of course, are
quite aware of the social, economic, and political backgrounds
of those who serve as subjects, and while the researchers are
interested in developing an ideology that does imply societal
authority for experimentation, the primary goal seems to be to
maintain their power over the neglected. It is highly unlikely,
for example, that researchers would even want to include large
numbers of educated and affluent individuals as subjects,
because to do so would almost certainly threaten the status quo
by requiring that more information be imparted, and by requiring
research to be better designed to avoid the completely useless
experiments now conducted.
It is also obvious that more
stringent regulations would emerge to control experimentation if
groups with well-defined and powerful constituencies were used.
At the present, the researchers, by confining their experiments
primarily to the neglected, are potentially useful to the more
affluent in that they may discover new knowledge, and the
researchers provide no threat to the middle class. Tacit consent
to exercise power, then, does reside in researchers, but it is
the exercise of power, not individual choice to submit to
experimentation or overt societal authority that is the core to
understanding the whole process of human experimentation."
Not quite. Animal experimentation is
"the core to understanding the whole process of human
experimentation," for if the poor, the mentally retarded, the
homeless, the orphaned and the imprisoned have little voice, the
animals have no voice, and it is voicelessness and rightlessness
that invests the whole procedure from animal to orphan to the
mentally retarded.
We are not done with Auschwitz and Nuremberg. Their shadows are
long. The silence of the medical communities in Germany and the
United States after the Second World War revealed the desire of the
medical communities to distance themselves from the outrages of
Auschwitz, by silence and by spreading the myth that the German
experiments was the work of deranged scientists.
In his anthology, When Medicine Went
Mad, Arthur Caplan asks why bioethics has so little so say about the
Holocaust:
"There has been almost no discussion
of the roles played by medicine and science during the Nazi era
in bioethic literature. Rather than see Nazi biomedicine as
morally bad, the field of bioethics has generally accepted the
myths that Nazi medicine was either inept, mad, or coerced. By
subscribing to these myths, bioethics has been able to avoid a
painful confrontation with the fact that many who committed the
crimes of the Holocaust were competent physicians and health
care professionals acting from their moral convictions.... A fog
of excuses, lies, and exculpation has been laid over the
crematoria and laboratories of the concentration camps."
When the Nazi doctors were asked in the
Nuremberg trials how they could have brought themselves to perform
such experiments, they responded that they had been trained by doing
them on animals. Time is exposing the desperate myth that animal
experimentation replaces or disposes of the need for human
experimentation, and that the work of the Nazi doctors was that of
"mad scientists." Some of it was bad science, but some of it wasn't,
and the work of the Nazi doctors has been entering mainstream
Western medicine for decades.
The Columbus Dispatch in 1984 revealed
that a researcher in British Columbia had been using the information
from Nazi experiments on hypothermia. The Jerusalem Report of Feb.
22, 1996 revealed that Dr. Howard Israel, an oral surgeon at
Columbia Presbyterian Medical Center in New York was dismayed to
discover that his valuable and trusted book, Pernkopf's
Topographical and Applied Human Anatomy contained illustrations that
may be based on the cadavers of concentration camp victims. Caplan's
question in When Medicine Went Mad, "Should Nazi data from the
experiments be used?" has been answered: Nazi data has been used by
many scientists from many nations.
Our moral horror at the Nazi medical experiments was dissipated by
our government's decision not to prosecute the Japanese for almost
identical experiments on an almost identical number of victims,
three thousand (many of whom were American prisoners), in exchange
for the information from those experiments.
As Raoul Hillburg wrote in The
Destruction of the European Jews,
"If the world was so shocked at what
it discovered to be the extremes to which experimental medicine
would go, it has yet to condemn the method or find the means to
control it."
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The
Nuremberg Code (1947)
Permissible Medical Experiments
from
CircumcisionReferenceLibrary
Website
BRITISH MEDICAL JOURNAL No
7070 Volume 313: Page 1448,
7 December 1996.
CIRP Introduction
The judgment by the war crimes tribunal at Nuremberg
laid down 10 standards to which physicians must conform
when carrying out experiments on human subjects in a new
code that is now accepted worldwide.
This judgment established a new standard of ethical
medical behavior for the post World War II human rights
era. Amongst other requirements, this document
enunciates the requirement of voluntary informed consent
of the human subject. The principle of voluntary
informed consent protects the right of the individual to
control his own body.
This code also recognizes that the risk must be weighed
against the expected benefit, and that unnecessary pain
and suffering must be avoided.
This code recognizes that doctors should avoid actions
that injure human patients.
The principles established by this code for medical
practice now have been extended into general codes of
medical ethics. |
The great weight of the evidence before us to effect that certain
types of medical experiments on human beings, when kept within
reasonably well-defined bounds, conform to the ethics of the medical
profession generally. The protagonists of the practice of human
experimentation justify their views on the basis that such
experiments yield results for the good of society that are
unprocurable by other methods or means of study.
All agree, however, that certain basic
principles must be observed in order to satisfy moral, ethical and
legal concepts:
-
The voluntary consent of the
human subject is absolutely essential. This means that the
person involved should have legal capacity to give consent;
should be so situated as to be able to exercise free power
of choice, without the intervention of any element of force,
fraud, deceit, duress, overreaching, or other ulterior form
of constraint or coercion; and should have sufficient
knowledge and comprehension of the elements of the subject
matter involved as to enable him to make an understanding
and enlightened decision.
This latter element requires
that before the acceptance of an affirmative decision by the
experimental subject there should be made known to him the
nature, duration, and purpose of the experiment; the method
and means by which it is to be conducted; all inconveniences
and hazards reasonably to be expected; and the effects upon
his health or person which may possibly come from his
participation in the experiment.
The duty and responsibility for ascertaining the quality of
the consent rests upon each individual who initiates,
directs, or engages in the experiment. It is a personal duty
and responsibility which may not be delegated to another
with impunity.
-
The experiment should be such as
to yield fruitful results for the good of society,
unprocurable by other methods or means of study, and not
random and unnecessary in nature.
-
The experiment should be so
designed and based on the results of animal experimentation
and a knowledge of the natural history of the disease or
other problem under study that the anticipated results
justify the performance of the experiment.
-
The experiment should be so
conducted as to avoid all unnecessary physical and mental
suffering and injury.
-
No experiment should be
conducted where there is an a priori reason to believe that
death or disabling injury will occur; except, perhaps, in
those experiments where the experimental physicians also
serve as subjects.
-
The degree of risk to be taken
should never exceed that determined by the humanitarian
importance of the problem to be solved by the experiment.
-
Proper preparations should be
made and adequate facilities provided to protect the
experimental subject against even remote possibilities of
injury, disability or death.
-
The experiment should be
conducted only by scientifically qualified persons. The
highest degree of skill and care should be required through
all stages of the experiment of those who conduct or engage
in the experiment.
-
During the course of the
experiment the human subject should be at liberty to bring
the experiment to an end if he has reached the physical or
mental state where continuation of the experiment seems to
him to be impossible.
-
During the course of the
experiment the scientist in charge must be prepared to
terminate the experiment at any stage, if he has probable
cause to believe, in the exercise of the good faith,
superior skill and careful judgment required of him, that a
continuation of the experiment is likely to result in
injury, disability, or death to the experimental subject.
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