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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 London physician and internationally known teacher of clinical medicine. In "Human Guinea Pigs" he revealed hundreds of cases involving thousands of patients, which he had uncovered simply by perusing British and American medical journals. He pointed out that the worst experiments, and all those that have caused damage and death, are obviously never reported by the "researchers".
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 Britain into a hospital where experimental treatment carried out on 122 premature babies resulted in the death or injury of 43 of them…..The inquiry, said "The Independent", will focus on whether the experiment was allowed to go on for too long and whether proper consent was obtained from parents,
The experimental treatment at North Staffordshire Hospital in central England involved the use of a new type of ventilator like a modern version of an iron lung to help the babies breathe.
Between 1989 and 1993, 122 babies had the treatment and 28 died and 15 suffered from brain damage, "The Independent" said."

 The ever-increasing number of cases of horrific human experimentation is a direct consequence of the vivisection mentality.  Carried out by trusted members of a supposed humane profession, the doctors who perform these experiments on the aged, infirm, and other powerless sections of society, prove full well that they know that experiments on animals can never give valid answers; that the results of such research is meaningless.
 
 
 
 A more detailed human experimentation (Rothman)

 

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 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 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 University College, London, openly declared in 1906 to Britain's Parliament at its investigation into vivisection pracises, "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 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 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 proceding 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 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 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 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 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 Meisner was condemned and fined by the disciplinary court of Breslau, he was rewarded by the West London Chirugical 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 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 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 shadowland 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 physicans, 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 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, 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 Encylcopedia 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 Nurmeberg Code, but did not think it applied to them--that code was for the barbarian Nazis. William Silverman of Columbia University, said:

"'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, 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 oubreaks of bubonic plague south of Shaghai." (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 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 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 Auschwtiz, 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 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 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 exprimentation, 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."


 

 

 

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."

 

History of experiments on humans - usually regarded as animals

[

 

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?


Alliance for Human Research Protection

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, 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 (1) the human subject is a minor or not competent due to other reasons; (2) the human subject has not given his unambiguous consent; (3) 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: U.S. Public Health Office induces pellagra in twelve Mississippi prisoners.

1919-1922: Testicular transplant experiments on five hundred prisoners at San Quentin.

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.

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.

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.

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.

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. 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 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 never 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."

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, 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 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 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 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 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 New York City minority children, boys aged 6 to 11 years old, were exposed to fenfluramine in a nontherapeutic 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 Decisionmaking Capacity. November 12, 1998 http://bioethics.georgetown.edu/nbac/capacity/TOC.htm

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 (five 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.
http://www.washingtonpost.com/wp-dyn/articles/A26797-2000Dec19.html


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. http://ohrp.osophs.dhhs.gov/detrm_letrs/nov01f.pdf

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 nontherapeutic 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. (http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf)

 

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 Edinburgh, was paid around £700 for being one of 50 Scots to
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 University of Pennsylvania, and a former adviser to the EPA on
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 US that estimates of how much humans
can withstand are too conservative.

A spokeswoman for the HSE in London said yesterday that 'the test was given
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 Pacific
northwest
, blueberries in Maine and sugar cane in the deep South. But it is
highly controversial, even in America.

In Louisiana in 1991, a flash thunder storm caused azinphos-methyl to run
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.