Human Guinea Pigs
Cohen, Morton Mintz and jerry S.
Human Guinea Pigs MORTON MINTZ and JERRY S. COHEN In the Twelfth Century, Moses Maimonides, a rabbi and physician, expressed succinctly and elegantly a view of the doctor-patient relationship in...
...They are also selected for another reason, as Mitford reported: "Since the studies are carried out in the privacy of prison, if a 'volunteer' becomes seriously ill, or dies, as a result of the procedures to which he is subjected, it is unlikely this will ever come to anybody's attention...
...Anything, therefore, that is done to the patient that is not directly intended to benefit him falls under the definition of human medical experimentation...
...The stated purpose was to determine what effect the hallucinogens might have on human subjects...
...A final chapter in this experiment was written when a lawsuit brought by seventy survivors both syphilitic and nonsyphilitic resulted in an award by a Montgomery, Alabama, court of $37,500 to each individual...
...And it never occurred to us to ask because the demand was so great for other people who needed it much more than they did the armed forces and people in civilian life...
...No agency outside the military exercised any control over the experiment's procedures or its safeguards...
...It's unfortunate that somebody died...
...Jay Katz addressed himself to this point: "To safeguard that dignity, subjects of research are now expected to be told of the proposed research procedures, of discomforts and risks, and of their right to ask questions and to withdraw at any time...
...He was weak...
...It should be noted as well that syphilis is a highly contagious infection spread by sexual contact, and that, if untreated, it can lead to blindness...
...But we had to know what these drugs could do to people and how we could use them...
...Downey also said that he and rthers became subjects because they would be paid...
...When the researcher wrote up the findings, he noted that the experiment confirmed findings which already had been well established...
...deafness...
...Clearly, human experimentation of some kind is needed to assess in some way the benefits and risks of various drugs and medical procedures before they are used on vast numbers of people...
...He believes some of this stemmed from LSD...
...Without his knowledge, it had been slipped into a cocktail...
...It is not altogether too cynical to suggest that some modern medical researchers might rewrite Maimonides's dictum this way: "May I never see in the patient anything but a subject for experimentation...
...He said he once had contemplated suicide...
...First, all the men involved in the experiment were black...
...In one prison experiment, several prisoners were exposed to scurvy...
...insanity, and even death...
...Copyright ® 1976 by Jerry S. Cohen and Morton Mintz...
...For two years following the experiment, he recalled, he had experienced deep depressions, sometimes had broken down in tears in front of his family, and had become moody...
...What Mitford was saying was that prisoners are selected for the explicit purpose of diminishing the possibility of accountability for the researchers for any injuries to the subjects...
...Often, the subjects have backgrounds similar to those of the men in the Tuskegee study poor, sometimes retarded, sometimes prisoners...
...The disease was allowed to take its course for many weeks...
...Yet in the twenty-six years since the Nuremberg judgment there has been a huge expansion of medical 'research programs' in many prisons in the United States, sanctioned by Federal health agencies and state prison administrations who do not choose to recognize these standards as applying to the captives in their custody...
...The jpportunity to earn money in prison to purchase cigar jttes and other items is limited, and while the mon ;y reward in being a human subject is small, it was mon...
...Inhumane experimentation has gone on for a number of years and it expands as science and technology expand...
...In other words, the prisoners could not break new medical ground by suffering the tortures of scurvy...
...While one might have expected the Army and the CIA to halt the experiments and reconsider their consequences, the only discernible reaction was to cover up what happened, something they managed to do for more than twenty years, until mid-1975...
...It has proceeded for so long and so far because there has been no accountability, no check-and-balance on what researchers want to discover by using human subjects, or their methods to achieve it...
...His daughter, on learning of the cause of her father's death more than twenty years after it happened, said emphatically that he had not volunteered to be a part of the experiment, and had not consented to the drug injection...
...Emphasis supplied...
...A: ter eleven days on the drug, Downey said, he began to fe ;1 quite ill...
...The late and distinguished Sir Robert Hutchinson addressed the growing number of human experiments when he wrote in 1953: "From inability to let well alone, from too much zeal for the new, and contempt for what is old...
...was not our ball of wax...
...from treating patients as cases, and from making 'the cure' of the disease more grievous than the endurance of the same, Good Lord deliver us...
...One way to obtain an uncomprehending consent is not to inform the subject that the procedure is experimental, and that its consequences are unknown...
...The lure was simple and effective...
...Many were tested in ignorance that they were being tested, and others were given only the slightest hint of the possible consequences to their minds and bodies...
...You take the objective...
...Some physicians characterized the Tuskegee experiment as one of the worst violations of medical ethics in modern times...
...This left the military accountable only to itself...
...Senator Abraham A. Ribicoff, Connecticut Democrat, called the Tuskegee experiment a "frightening instance of bureaucratic arrogance and insensitivity...
...This is troubling because a goal of the experiment was to compare men with untreated syphilis with men who had undergone treatment with the now-obsolete earlier drugs...
...It is neither unreasonable nor unfair to compare some of what was done in the name of "national security" by the military and the CIA with some of what was done in the human experiments revealed at the Nuremberg trials...
...there was no single predictable reaction...
...The Psychiatric Institute was under contract to the Army to perform these drug experiments...
...You have to look at these experiments like a combat operation," the officer said...
...One reason for the long-standing secrecy about these experiments was the restrictions imposed by the Army on participating servicemen...
...Another objective of the study was to compare the untreated syphilitics to an additional group of men with syphilis who were being treated with drugs which, at that time, contained heavy metals...
...The signing of a waiver by a prisoner or by anybody who consents to become a human subject in a medical experiment raises the question of informed consent, perhaps the most nettlesome legal question revolving around human medical experiments...
...In a sense, human experimentation is an ultimate step of technological evolution, because it erases one's control over one's own mind and body...
...In these tests, the great majority of human subjects were military men, but about 900 civilians also were tested...
...Finally Downey was so weakened that he was unable to work, and he stopped taking the drug...
...Since when is it not a physician's "ball of wax" to minister to the health of people with the best means at his disposal...
...Research was contracted at institutions including the University of Maryland, the University of Wisconsin, and the University of Washington medical schools...
...deterioration of the bones, teeth, and the central nervous system...
...This time there was no confusion over informed consent...
...there was no law against it...
...Washington Post reporter Bill Richards said in July 1975 that some of the LSD experiments were conducted with disturbed children and adult mental patients...
...John R. Heller, a PHS doctor who played a key role in the experiment, said in an AP interview following the disclosure of the experiment in 1972 that there were "absolutely no racial overtones to the study...
...Testing of LSD ended in 1967, but testing of other hallucinogenic drugs continued until it was suspended in mid-1975, following public disclosures of the testing...
...Under great public pressure, the Army admitted that a total of 6,940 servicemen had been involved in drug and chemical testing over a period of twenty years...
...It is also unfortunate that the officer did not distinguish between military men in battle and civilians in hospitals who were given these drugs under questionable circumstances and with sometimes fatal results...
...A board of inquiry consisting of several directors of the hospital, several surgeons, and the hospital's medical director decided that the procedure was warranted in order to increase the skill of the surgeons and to bring therapeutic benefit to subsequent patients...
...The psychological effect of signing the waiver, coupled with the general helplessness of prisoners, makes lawsuits a rarity," Mitford wrote...
...You start taking casualties in combat, and you don't stop...
...There is little to indicate what was told to the civilians before they became part of the experiment because the records are sketchy and incomplete...
...Tulane University's Department of Neurology and Psychiatry was another test lab...
...In the very first series of Army experiments in 1953, a mescaline derivative was administered to a man named Harold Blauer...
...The Air Force also financed at least five research projects on LSD...
...AII rights reserved...
...He appeared to be saying that because the poor are much dependent on government, the government is freer to rely on their bodies for experimentation...
...I was never sure that the epilepsy had anything to do with the LSD tests," he said, "but they never even told us there would be any aftereffects and no one bothered to check...
...Henry W. Foster of Meharry Medical College told a National Academy of Sciences forum in February 1975...
...from putting knowledge before wisdom, science before art, cleverness before common sense...
...And third, when penicillin became available in 1946, and when later it became the drug-of-choice in treating syphilis, the syphilitic men still did not receive the antibiotic...
...This article is adapted by permission from their new book, "Power, Inc.," to be published this month by The Viking Press...
...Thus, they fuel an insatiable demand for more information...
...This documented case shows not only the gaping loophole in the informed-consent provisions, but demonstrates a complete failure of accountability...
...Why it took twenty years and an incalculable human cost to determine that remains unclear...
...Frank R. Olson, a government biochemist, plunged to his death from a Manhattan hotel window after he had taken LSD...
...Blauer had not been in the Army he had been a civilian, a tennis professional from Long Island who had been at the New York Psychiatric Institute for treatment of depression...
...An Air Force sergeant, also interviewed by Richards, told of having been in an LSD experiment in 1957...
...Possibly 80 per cent of all human experimentation that has occurred in this country involved the poor," Dr...
...Human experimentation poses a severe dilemma that Jay Katz, adjunct Morton Mintz, a prize-winning investigative reporter for The Washington Post, and Jerry S. Cohen, a Washington lawyer, are the co-authors of" America, Inc...
...More significant than the laws and ethics of these experiments is the mentality of those who created them and allowed them to continue despite the obvious risks and hazards to the participants...
...heart disease...
...That is the way it was in these experiments...
...than could be earned in other ways...
...It becomes finally one of the most fundamental human issues facing our technological age...
...He testified also that he remains under a physician's care for his drug-induced liver problems...
...The Air Force research was carried out at the University of Minnesota, New York University, Duke University, and the University of Missouri...
...You press on...
...He cannot divest himself of it simply by means of an illusory or uncomprehending consent...
...In both cases, consent was coerced, even if with more abuse and cruelty in Germany...
...Notably, a prisoner signs a waiver which has dubious legal validity, but which has other benefits for the researcher...
...Effectively, the doctors were accountable only to themselveswhich, effectively, meant to no one...
...Some subjects were incapacitated for four days...
...It was too late to determine if the heart disease deaths were related to syphilis...
...He testified that of the fifteen prisoners in that drug experiment, eight got sick...
...Scientists constantly develop new medicines, new surgical techniques, and new medical devices...
...Because this happened on a weekend, he was inable to get adequate medical help for a couple of days When he finally got to see the researcher conducting the (rug experiment, he said, he was assured that his illness was not related to the drug...
...One is tempted to answer for him...
...He did not differentiate between combat, in which the risks are known, and medical testing, in which the risks are not known, or not fully known, particularly to the individual who is taking them...
...The circumstances under which Blauer got the drug are unclear...
...When he was asked if any attempt was made to get penicillin for them, he said: "No...
...Because he was not told of potential aftereffects, he had not understood the cause of his behavioral changes...
...In 1972, Jean Heller, then of the Associated Press, revealed in a series of articles that the United States Public Health Service had for forty years withheld all treatment from 399 syphilitic men in an experiment in Tuskegee, Alabama...
...In light of the potential harm, this confirmed the darkest suspicions about much human experimentation that the care of the patient becomes a minor consideration in the "advancement" of science...
...The patient's subnormal intelligence prevented informed consenr, nor were the family or other responsible persons informed of the procedure's purpose, which was of no possible benefit to the subject" (Emphasis supplied...
...One was James Downey, who had been a state prisoner in Oklahoma...
...They were very important to national security, and we pressed on...
...Some salient facts about the Tuskegee experiment are worth pointing out...
...Perhaps the best working definition was given in 1951 by a professor of experimental medicine in an address to the Royal Society of Medicine in Britain: "We should, I think, for present purposes, regard anything done to the patient which is not generally accepted as being for his direct therapeutic benefit or as contributing to the diagnosis of his disease, as constituting an experiment, and falling therefore within the scope of the term experimental medicine...
...Informed consent was considered to have been obtained, but his subnormal intelligence made this impossible particularly since he readily misconstrued as part of his treatment of varicose veins an incision in his groin permitting the passage of a catheter to the femoral artery and then to the heart In passing the catheter into the heart, a coronary artery was blocked, causing collapse and an acute coronary attack myocardial infarction in an otherwise normal heart...
...In 1963, Time magazine reported that doctors in Oklahoma where Downey was incarcerated were grossing some $300,000 a year from drug companies to test new drugs on prisoners...
...The very phrase human medical experimentation is subject to many definitions...
...Several of the prisoners, who were observed by the researchers, suffered excruciating complications, some of which were permanent...
...At that same meeting, Dr...
...The attitude of the officer who spoke to the issue reflects other problems and incongruities...
...As Edmond Cahn noted in an article in the New York Law Review, "One of the major malpractices of our era consists in the 'engineering of consent...
...In her book, Kind and Usual Punishment, Jessica Mitford said, "The Nuremberg tribunal established standards for medical experimentation on humans which, if observed, would end the practice of using prisoners as subjects...
...Sir Austin Bradford Hill has pointed out, "If the patient cannot really grasp the whole situation, or without upsetting his faith in your judgment cannot be made to grasp it, then in my opinion the ethical decision still lies with the doctor, whether or not it is proper to exhibit, or withhold, a treatment...
...A spokesman for the American Civil Liberties Union has estimated that about 20,000 prisoners or approximately 10 per cent of the total United States prison population are participants in medical and drug-industry experiments...
...This was a community responsibility in Tuskegee...
...The experiment having lasted forty years, this came to $2.50 a day per man...
...They were accountable to themselves cloaked in secrecy and anonymity, and able to proceed even when their research resulted in the death and disability of the humans they were experimenting with...
...We told them what they had," he said...
...After World War II, the Nazis' use of concentration-camp prisoners as subjects for medical experiments became an issue at the Nuremberg war-crimes trials...
...Katz and others have repeatedly pointed out, such disclosure of all risks by the researchers to the human subjects is not always forthcoming...
...In 1969, a follow-up study by the Center for Disease Control, in Atlanta, of 276 treated and untreated syphilitica involved in the Tuskegee study showed that seven had died as a direct result of syphilis, and another 154 had died of heart disease...
...Consequently, the denial of the antibiotic was at best negligent...
...Later, spots broke out on his body...
...Another way was documented in the book, Experimentation with Human Subjects, edited by Paul Freund, the distinguished Harvard legal scholar: "A twenty-eight-year-old man of subnormal intelligence was treated in a hospital because of varicose veins...
...Franz J. Ingelfinger, editor of the New England Journal of Medicine, remarked that the poor are more "administratively eligible" for medical experimentation because of their reliance on government-funded medical care...
...Similarly, the death from anthrax, a rare disease, of three Army civilian employes was not disclosed by the Army until September 1975 a long time after they had died during anthrax experiments...
...The peers exonerated them with the claim that the experiment with an uncomprehending patient furthered medical science a slender rationale, to be sure, but many medical experimerits have none at all...
...The state rationale was "national security" and the possibility that such drugs might be used to induce individuals to divulge secrets, or the possibility that the drugs might be used to disable this country's defenses so that a takeover by a foreign power could occur without the firing of a shot...
...Were the men informed as to the nature of the experiment they were participating in...
...The Army later admitted that some commanders apparently had coerced their men into becoming "volunteers...
...Those responsible never were reprimanded, the Senate Intelligence Committee said last April...
...The doctors were accountable to their peers at the hospital...
...The Army said those who "volunteered" for the testing at Edgewood Arsenal in Maryland would be given three-day passes and a $45 pay bonus, and could view movies showing girls on beaches...
...Yet, similar experiments often with official government sanction are carried out daily...
...The release form the soldiers signed before the tests were administered said in part "I recognize that in the pursuit of certain experiments transitory discomfiture may occur and when such reactions seem especially likely to occur, I will be so advised...
...In addition to the deaths of some of those who knowingly and unknowingly participated in the experiments, many others suffered serious aftereffects...
...What was learned was that these drugs produced different reactions in different individuals...
...The Army was empowered to proceed with such human experiments...
...They were told not to divulge the experiments and their part in them...
...But reliable safeguards for the human beings who run risks for the rest of us are essential...
...He told of having participated in a planned thirty-day program to test a potent new drug intended to cure liver ailments...
...He died as a result...
...Nor does Dr...
...Some of it can be obtained only from testing in humans who are, practically if not literally, helpless...
...William Jordan, a former Army colonel who in 1960 had been one of the young officers given LSD during an experiment at Fort Benning, Georgia, said in an interview with The Washington Post's Bill Richards that neither he nor any of the others in his test group had been apprised of the possible aftereffects of taking LSD...
...The researcher told him he had measles...
...Emphasis supplied...
...In a Senate hearing held by Senator Edward M. Kennedy, Massachusetts Democrat, in July 1975, a few prisoners testified about their experience as human subjects in medical experiments...
...Heller got to the heart of his explanation when he remarked, "Also, we were not responsible for getting it to them so we made no effort to get it...
...In her book, Mitford recalled one physician's remark that prisoners are ideal for medical experiments because they are "cheaper than chimpanzees" to experiment with...
...Furthermore, they repeated a study which had no real relevance because treatments of the disease were then available...
...Late , his illness was diagnosed as hepatitis drug-induce i hepatitis...
...It will take a major awakening, a major reappraisal of our attitudes and thinking, to slow down the momentum of human experimentation, to place limits on what it can and cannot do to people, and to make it accountable...
...No one ever told us anything about those tests except that they said right before we drank the LSD that we'd get a little high like you do when you drink," he said...
...Before the experiment, he said, he had considered himself happy-go-lucky...
...Perhaps the most serious flaw in the man's thinking, and in the thinking of those who profess to see few ethical problems with human medical experimentation, is the fact that the "objective" outweighs the concern for human life...
...Prisons have long supplied men and women for medical experimentation, despite the obvious ethical problem of using as experimental medical subjects persons who have few free choices available to them...
...The signing of this consent form consigned the soldier "volunteer" to the discretion of the researchers conducting the experiment...
...It is clear that many of the people involved in these drug experiments could not make such a determination for the simple reason that no one had offered them the opportunity to do so...
...professor of law and psychiatry at Yale Law School, has summed up this way: "The controversy over the use of human beings in medical experimentation demonstrates the difficulty of reconciling two values basic to Western society: the desire to benefit from the advances in medical knowledge, and the commitment to individual dignity and autonomy...
...The stated purpose of the experiment, begun in 1932, and carried out by the Public Health Service (PHS) in cooperation with local agencies, was to find whether the incidence of death and debilitation was higher in untreated syphilis than in a control group of 201 men who did not have syphilis...
...That is to say, the advent of penicillin obviated the need for such a comparison, and in fact eliminated the rationale for the study...
...She is correct...
...The Army also failed to provide any follow-up examinations...
...Human Guinea Pigs MORTON MINTZ and JERRY S. COHEN In the Twelfth Century, Moses Maimonides, a rabbi and physician, expressed succinctly and elegantly a view of the doctor-patient relationship in which accountability is implicit: "May I never see in the patient anything but a fellow creature in pain...
...Olson had had no knowledge whatever that he was being given this powerful hallucinogen...
...Downey said he was 'old it was a new "wonder" drug, and was assured it woul i have no adverse effects...
...A short while after Blauer's death, during a CIA test of LSD, another death occurred...
...Almost always the subjects are persons less able to protect themselves and therefore less likely to hold those who performed the experiments accountable...
...As Dr...
...No acknowledgement that they had participated was recorded in their service record...
...In the early 1950s, the Army and the CIA both engaged in extremely questionable secret experiments with hallucinogenic drugs that, we believe, were a logical outgrowth of unaccountability in civilian experiments with humans...
...the possible consequences to the individuals were uncertain and not fully thought out, and the concern for the dignity of human life was minimal...
...In essence, the FDA conceded the military full responsibility for the drug experiments and for the safeguarding of human life...
...In Michigan, two drug companies, Upjohn and Parke-Davis, have acquired exclusive rights at Jackson State Prison to make drug-toxicity studies on prisoners...
...Like the New York Psychiatric Institute arrangement, these experiments were carried out at university and research institutes under Government contracts...
...Some states have banned such experimentation on prisoners but more than twenty states allow it Great Britain has banned it for a very simple reason: Because a prisoner has limited choices, his consent to such experimentation cannot be obtained without at least the appearance of coercion...
...Although the Food and Drug Administration has the legal power to exercise close supervision of drug testing, it had waived that right in a memorandum to the Defense Department and had reaffirmed the waiver in 1974...
...A glimpse of that mentality was revealed by New York Times reporter Joseph Treaster when he quoted one of the few informed military officers willing to discuss the issue...
...In the months following the experiment, Jordan said,' he had experienced the first of a series of epileptic seizures and other "flashback" episodes...
...Some of the immediate reactions to the chemical included dizziness and vomiting...
...In fact, it is safe to say that in most cases, the human subject is not apprised of all the possibilities that might arise from his becoming a part of the experiment...
...Supreme Court Justice Benjamin Cardozo once wrote that "every human being of adult years and sound mind has a right to determine what shall be done with his body...
...The soldiers were told there would be "no hazards at all" in the experiment...
...The momentum to proceed with it has been growing, pushed by the sometimes mindless search for information and by the technology that guides it...
...The reason is simple: If subjects were to be told of the risks, and if they were able to comprehend the consequences, in many cases they probably would not volunteer...
...Heller's explanation answer the question why penicillin and other antibiotics, when they became widely available later, were not offered to the subjects of the Tuskegee study...
...Second, although the director of the study says the participants were told of the nature of the experiment, a black Tuskegee physician who attended some of the men says the participants were not informed that they were joining in a medical experiment...
...Because these drugs were available but were withheld from the 399 syphilitics, and because treatment was not denied for the purpose of diagnosis, the Tuskegee study falls well within the definition of human medical experimentation...
...The military found "volunteers" within its ranks all over the country...
...And there is no law against it now...
Vol. 40 • December 1976 • No. 12
