HUMAN EXPERIMENTATION, DRUG AND OTHER MEDICAL DISASTERS
French vivisector, Claude Bernard asserted that the "knowledge" he gained from brutalizing thousands of animals, should also be "confirmed" on humans. "The right to experiment on humans cannot be denied as a matter of principle," he opined. More recently an American chemist and avid seeker of knowledge, E.S. E. Slosson, proclaimed…" A human life is nothing compared with a new fact….. the aim of science is the advancement of human knowledge at any sacrifice of human life." This mindset has allowed the following atrocities:
· Senior citizens in a nursing home were injected with cancer cells to observe whether they would come down with cancer. When the scientist in charge of the experiment was asked why he allowed this, he replied that he couldn’t very well use scientists for these experiments because they were more valuable than ordinary people.
· Psychiatric patients in a Chicago Psychiatric ward called "Freud 11" were subjected to experimental brain surgery, removal of their adrenal glands, and sulphur shock and insulin overdose treatments.
· Blacks were injected with active syphilis germs and left untreated so that researchers could study the permanent effects of advanced syphilis even though the effects had already been observed in thousands of patients who already had the disease.
· Employees of Boeing Aircraft were secretly exposed to electromagnetic pulse experiments. The human guinea pigs were kept in the dark about these experiments until they developed fatal diseases.
The study of disease must begin and end with people but that should never mean the endorsement of secretive and manipulative human experimentation. Scientific inquiry must be conducted with the fully-informed consent of the subject.
· Unfortunately vivisection-based medicine means that we are all human
guinea pigs. No matter how many animal tests are done, the first two to three
generations of people who use a new drug or medical technique are the real
guinea pigs anyway because of the differences between us and animals. The drug
DES (stilboestrol) , for
instance, was thoroughly tested on animals and found safe. It caused vaginal
cancers in the daughters of women who took it to prevent miscarriage. Now it’s showing up in the third generation, as grandchildren
of the original users are being born with genital defects, Some other
"thoroughly tested" drugs which caused injury and death include
Thalidomide, Zomax, Accutane,
Eraldin, Phenformin , Clofibrate and, Feldene .
DRUG DAMAGE NOT PREDICTED BY ANIMAL TESTS
Eraldin (heart
disease)
corneal damage including blindness
Chloramphenicol ( antibiotic)
aplastic anemia, often
fatal
Ibufenac (
arthritis)
deaths from liver damage
Flosint
(arthritis)
several deaths
Zipeprol ( cough
suppressant)
severe neurological symptoms at high doses
Phenacetin (pain
killer)
kidney and red blood cell damage
Reserpine (
anti-hypertensive)
increased risks of cancer
Isoniazad ( tuberculosis
)
liver destruction
Clioquinol ( diarrhea
)
blindness, paralysis & death
Accutane (
acne)
birth defects
Plaxin & Pronap
(tranquilizer)
killed many babies
E Ferol
(vitamin)
killed premature babies
Maxiton (diet
pills)
damage to heart & nervous system
Trilergen
(anti-allergic)
viral hepatitis
Flamamil
(rheumatism)
loss of consciousness
Isopreterenol (asthma)
death
Methaqualone
(tranquilizer)
severe mental disturbances
MEL 29
(anti-hypertensive)
cataracts
Urethane (leukemia)
cancer of liver, lungs & bone marrow
Opren
(arthritis)
liver damage & deaths
Iproniazad
(tuberculosis)
liver damage
DRUG ACTIVITY IN ANIMALS ACTIVITY IN HUMANS
Aspirin
Kills cats. Birth defects in
dogs,
Analgesic & retards blood
monkeys, rats &
cats
coagulation
Amyl
Nitrate
Glaucoma
Reduces internal eye
pressure
Chymotrypsin
Corneal perforation &
severe
No serious complications
damage to rabbit’s eye
Depo-Provera
Cancer; breast &
uterine
Considered safe
infections in dogs
Digitalis
High blood pressure
in
Not so
dogs
Cortisone
Birth defects in
pregnant
No birth defects
mice & rabbits
Imipramine Depressant Antidepressant
Furosemide Liver damage in mice & others Not so
Iron sorbitol Cancer at injection site No cancers developed
Morphine
Renders cats
manic
Analgesic & respiratory
depressant
Penicillin Kills guinea pigs Very useful antibiotic
"Inevitably, the tortures society permits to be inflicted upon animals
fall back upon society itself, as if by the
workings of some mysterious moral law. So Pavlov’s
"conditioned reflexes" experiments, which caused pain or acute
distress to thousands of animals, are now being constantly repeated, with
variations, on human subjects. And, as usual, on such humans as are unable to
protest, strike back, or sue - the orphaned or abandoned children, the mentally
handicapped, the destitute dependent on public welfare; in sum, all those who
are as helpless as laboratory animals."
("Slaughter of the Innocent" by Hans Ruesch, who gives many examples of human experimentation
with babies, in cancer studies, on mental defectives, with transplants,
hallucinogens, tranquilizers and on living fetuses)
Experiments done on patients without their knowledge were denounced by Dr. M.H.
Pappworth, the
Everywhere, the cases of doctors deliberately putting human beings in danger,
inflicting maladies on hospital patients, or withholding drugs from them in
order to "study" a malady, have become so frequent as to be
unexceptional.
In February 1999,the following appeared in the press:
"Probe into deaths of babies"
"An inquiry has been launched in
The experimental treatment at
Between 1989 and 1993, 122 babies had the treatment and 28 died and 15 suffered
from brain damage, "The Independent" said."
Human Experimentation:
Before the Nazi Era and After
"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
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 practised
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
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 guage 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 virutally 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--nonsuspect societies love pets also."
The
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 syphili 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
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 Commision 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
In the United States, in
1913, the Pennsylvania House of Representatives recorded that 146 children had
been inocluated 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 instutionalized 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
"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 clonic
spasm; her eyes became fixed with pupils widely dilated; her lips were blue,
and she frothed at the mouth; her breathing became stertorous;
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 physican' be the ultimate safeguard of
the human research subject. But Gray's book shows
that 'honest, conscientious, compassionate' physicans
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,
Eileen Welsome's
book, "The Plutonium Files," (Dial Press, 1999), documents radiation
experiments on human beings in the
"'The connection bween those horrendous acts andour
every day investigation was not made for reasons of self inerest,
to be perfectly frank. As I see it now, I'm saddened tha
e didn't see the connection, but that's what was sone.
We wrapped ourselves in the flag....'" (p. 214.)
Welsome writes, "Physcians
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 nontherapeutic 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 exaples 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,
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
Exerpiments 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
"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 physicans 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
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."
To kill people you don't necessarily need bombs; and why should vivisectors/chemical companies worry about the effects of
their labours? Life is so cheap, isn't it? And the cover-ups go without saying.
Friends - this is real, this is ongoing:
Canadian Genocide - http://annett55.freewebsites.com/
"The pale rulers, and the leaders of their churches, and their
RCMP, all condoned and concealed these crimes, for they knew that if the truth
was ever revealed, the long history of mass murder of the People would also be
unearthed. For they were all implicated - pale and slave
Chiefs alike - and they would stand or fall together."
[
This is a brief history of Human Research which continues to this day - overtly upon everyone who takes an animal-tested drug. If we can't stop research on animals, how can we stop research on humans, research which may be disguised, covered-up, ignored?
AHRP is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to ensure that the human rights, dignity and welfare of human subjects are protected, and to minimize the risks associated with such endeavors.
Human Experiments: A Chronology of Human Research
by Vera Hassner Sharav
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,
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
1900:
1906: Dr. Richard Strong, a professor of tropical medicine at Harvard,
experiments with cholera on prisoners in the
1913:
1915:
1919-1922: Testicular transplant experiments on five hundred prisoners at San Quentin.
1931:
1931:
1932-1972:
1932: Japanese troops invade
1936:
1938:
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
1940: Poisonous gas experiments at Unit 731. One experiment conducted
1940-1941: Unit 731 used aircraft to spread cotton and rice husks
contaminated with the black plague at Changde and
1941: Sterilization experiments at
1941-1945: Typhus experiments at
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
1942: High altitude or low pressure experiments at
1942: Harvard biochemist Edward Cohn injects sixty-four
1942: Japanese sprayed cholera, typhoid, plague, and dysentery pathogens in
the Jinhua area of Zhejian
province (
1942-1943: Bone regeneration and transplantation experiments on female prisoners at Ravensbrueck concentration camp.
1942-1943: Freezing experiments at
1943 Refrigeration experiment conducted on sixteen mentally disabled
patients who were placed in refrigerated cabinets at 30 degree Farenheit, for 120 hours, at
1942-1943: Coagulation experiments on Catholic priests at
1942-1944:
1942-1945: Malaria experiments at
1943: Epidemic jaundice experiments at Natzweiler concentration camp.
1943-1944: Phosphorus burn experiments at
1944:
1944: Seawater experiment on sixty Gypsies who were given only saltwater to
drink at
1944-1946:
1945:
1945: Malaria experiment on 800 prisoners in
1946: Opening of
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
1946:
1946-1953: Atomic Energy Commission sponsored study conducted at the Fernald school in
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
1949:
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
1951-1960:
1952-1974:
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. I
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
1953-1960: CIA brainwashing experiments with LSD at eighty institutions on hundreds of subjects in a project code named "MK-ULTRA."
1953-1970:
1954-1974:
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
1958-1962: Spread of radioactive materials over Inupiat land in Point Hope,
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
1962:
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
1964: World Medical Association adopts Helsinki Declaration, asserting "The interests of science and society should never take precedence over the well being of the subject."
1965-1966:
1966: Henry Beecher's article "Ethics and Clinical Research" in New England Journal of Medicine.
1966:
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:
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."
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
1986: Congressional subcommittee holds one-day hearing in
1981-1996: Protocol 126 at
1987: Supreme Court decision in United States v. Stanley, 483
1987:” L-dopa challenge and relapse”
experiment conducted on 28
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, nonmaleficence 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
1994. The
1994. President Clinton appoints the Advisory Commission on Human Radiation Experiments (ACHRE) The ACHRE Report http://tis.eh.doe.gov/ohre/roadmap/achre/index.html
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. http://tis.eh.doe.gov/ohre/roadmap/experiments/0491doca.html#0491_List
1995: 19-year-old
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 nontherapeutic 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
1996. Cleveland Plain Dealer investigative report series, 'Drug Trials: Do
People Know the Truth About Experiments,'
1996:
1997. President Clinton issues a formal apology to the subjects of the
1997. Researchers at the
1997.
1997. Victims of unethical research at major
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 Decisionmaking Capacity.
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
1998:
1999: Nine month-old Gage Stevens dies at Children's Hospital in
1999: 18-year-old Jesse Gelsinger
dies after being injected with 37 trillion particles of adenovirus in gene
therapy experiment at
1999: Director of National Institute of Mental Health suspends 29 clinical trials that failed to meet either ethical or scientific standards.
2000:
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
http://www.washingtonpost.com/wp-dyn/articles/A26797-2000Dec19.html
2001: A biotech company in
2001: Ellen Roche, a healthy 27-year old volunteer, dies in challenge study
at
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. http://ohrp.osophs.dhhs.gov/detrm_letrs/nov01f.pdf
2001:
Sunday Herald
www.sundayherald.com
08 September 2002
He was used to test 'highly hazardous' pesticides ... then forgotten about
Company is using Scots test results in battle to reverse safety controls
By Jenifer Johnston
When Bruce Turnbull volunteered to take part in a drug trial at the Inveresk
Research laboratories in East Lothian in 1998 he believed he was helping
society. Three years later the company behind the tests stands accused of
breaking the Nuremberg Code -- established as a response to Nazi
experimentation on Jews -- and of using the results to boost profits.
Turnbull, from
take part in study 013219. The test seemed simple enough -- the subjects
were given a single dose of a substance called azinphos-methyl
(AM) and then
observed for seven days.
What they did not know was that the chemical, which they were given in
minute doses, was a pesticide deemed 'highly hazardous' by the World Health
Organisation. Nor did they know that the test had been commissioned by Bayer
as part of a forceful effort to get the US Environmental Protection Agency
to reverse pesticide controls introduced to protect children.
The 50 subjects have not been offered follow-up examinations to test for the
long-term effects of exposure to AM. Instead, the key finding of the
study -- that the pesticide test had 'no effect' on humans -- is now Bayer's
key weapon in its battle to raise the safety limit on the use of the
pesticide by US farmers.
Turnbull, now 51 and suffering ill-health he believes is connected to the
test, says he feels bitter and cheated. 'I was under the impression I would
be helping farmers, not helping a major company sell more pesticide that
would end up on food. I don't think I was told who was paying for the test.'
He claims he would never have volunteered for the test had he known of
Bayer's intentions for it and feels badly let down by his treatment during
and after the trial.
'The nurses called the substance a drug, not a pesticide. An information
pack was sent to my home before the trial but I didn't understand all of it.
Layman's terms jump out at you but it was heavy technical stuff,' he said.
'If you left the test early there was a financial penalty, and you would
never have got on another trial again. I received no follow-ups at all --
Inveresk never contacted me to see if I was fine.'
Documents given to the volunteers even predicted the outcome of the trial,
stating: 'The results of this study will confirm that use of azinphos-methyl
does not pose an un reasonable threat to either workers or consumers.'
Turnbull is the only one of the 50 subjects so far to blow the whistle on
what he now believes is a scandal. It is not known if the others even know
they were tested with a pesticide.
Just as Bayer is using the Inveresk test to lobby the
EPA, so its opponents
are very interested in Turnbull's testimony as the only known witness to the
experiment.
Erik Olson, a senior attorney at the American Natural Resources Defence
Council (NRDC), an organisation of scientists, lawyers and environmental
specialists dedicated to protecting public health, is fighting Bayer's
attempts to reverse the pesticide controls and believes Turnbull's
experience was 'shocking and unethical'.
'He wasn't told about conflicts of interest, long-term side effects, the
purpose of the test or the fact that the company's profits would be
boosted,'said Olson.
'If you don't look for any ill-effects then it's not surprising that you
won't find any. Along with the fact he was under the impression he would
suffer a financial penalty if he left the test early, there are clear
violations of international codes.'
The Nuremberg Code, along with other international human rights agreements
put in place after the Nazis used Jewish prisoners for medical experiments,
tightly govern what kind of tests can be performed on humans. Clause two of
the Nuremberg Code states: 'The experiment should be such as to yield
fruitful results for the good of society'.
The EPA is unequivocal in its stance on pesticides. A spokesman told the
Sunday Herald: 'There is nothing for individuals to gain -- no disease will
be cured because of this.'
And this position extends to its attitude to human pesticide testing. 'We do
not accept human data concerning pesticides. There is, however, a lot of
pressure from pesticide companies who would argue that we get a fuller
picture of pesticide use if we look at these tests [the Inveresk
trials],
but there are significant moral and ethical issues.'
This hasn't stopped Bayer presenting the test evidence as part of its
campaign to persuade the agency that azinphos-methyl
is safe. The company
also denies the test breached the Nuremberg Code, insisting that the use of
the pesticide benefits society.
Bayer spokesman Peter Kraus said he was satisfied that the test had been
carried out to the highest standards.
'There is a need for studies like these. They are designed in-house, and
then approved by an ethics committee. Inveresk also
has an ethics committee.
All the test subjects received full information about the test they were
doing.
'We only test products with a good safety record, products we know a lot
about, and which have measurable indicators that show harmful effects before
they occur.'
He added: 'We are doing tests like this for the good of society -- we are
part of the food chain and at the end of the food chain is a healthy apple,
not an apple with worms.'
It is a widely disputed claim. Dr Albert Caplan,
director of the Center for
Bioethics at
pesticides, told the Sunday Herald that the lack of follow-up highlights the
questionable nature of testing pesticides on humans.
'Testing these substances on humans is useless because you cannot do it
aggressively -- you can only use minute doses in the tests, which don't
necessarily relate to what exposure people working with the substance would
endure,' he said.
'The subjects are taking a risk for agriculture and business, not to find a
cure for a disease or develop life-saving practices. The lack of follow-up
tests on the Scottish subjects is not something that should go on in a test
of this nature.'
The NRDC is fearful that the Environmental Protection Agency will buckle
under pressure from Bayer. 'The EPA is not strong enough to withstand the
economic and lobbying onslaught of Bayer and other companies,' said Olson.
'Big companies will always come up with an excuse but this test did not help
Turnbull or anyone else -- it only helped the bottom line.'
The EPA has now commissioned the National Academy of Sciences to advise it
on whether or not human data in pesticide testing is acceptable. Bayer and
other pesticide companies have lost patience and are suing the agency in an
effort to get a decision on the increased use of azinphos-methyl.
Bayer spokesman Kraus said the EPA had to decide what kind of data it
wanted. 'In recent years the EPA has said children are more susceptible to
pesticides than adults -- they say that if we don't have the data to prove
otherwise then they will put in further safety factors to the product. What
we tried to do in this special case [the Inveresk
trial] is show that if a
human can tolerate the safe level for lab rats then it takes away a level of
uncertainty for the EPA.'
At the Inveresk trial in 1998 the amount given to the
volunteers was 100
times smaller than the 'safe dose' for lab rats. But the pesticide was
brought into the country only after the Health and Safety Executive (HSE)
gave the study the green light. The dose of azinphos-methyl
was set high
enough to demonstrate to the EPA in the
can withstand are too conservative.
A spokeswoman for the HSE in
a lot of thought and consideration and met all the very rigorous regulations
before it could go ahead'.
Bayer is one of the world's largest producers of GM food. Azinphos-
methyl
is one of its most widely used pesticides, sprayed on apples in the
northwest
highly controversial, even in
In
off sugar cane and into rivers, killing up to a million fish, along with
turtles, alligators, snakes and birds.
Three years ago the EPA reported that exposure to the pesticide caused
enzyme changes in the red blood cells of 127 Californian farm workers,
creating fears about potential nervous system damage.
Six weeks ago Canadian officials reported that azinphos-methyl
was found in
high concentrations in the Wilmot River, where up to 15,000 fish had died.