by Robin Cook
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Exactly what the “gross abrogation of human rights” involves is not known, although the strange sequence of events surrounding Dr. Philips’ disappearance has stimulated serious speculation. Dr. Philips’ area of expertise involves computer interpretation of medical images, which hardly seems open to gross violation of experimental ethics. However, the reputation of Dr. Philips (his winning this year’s Nobel Prize in Medicine is considered inevitable by most reputable researchers) guarantees him a large and attentive audience. Obviously the affair had to deeply offend Dr. Philips’ sense of morality for him to jeopardize his career by taking this drastic and dramatic step. It also suggests that the field of medicine is not immune to having its own Watergate.
AUTHOR’S NOTE
Human experimentation since World War II has created some difficult problems with the increasing employment of patients as experimental subjects when it must be apparent that they would not have been available if they had been truly aware of the uses that would be made of them.1
That comment was made by an esteemed Professor of Research in Anaesthesia, Harvard Medical School, at the outset of an article describing twenty-two examples of experiments which he felt violated medical ethics. He chose these examples from a group of fifty, and he cited a Professor in England, Dr. M. H. Pappworth, who had amassed a list of five hundred.2 The problem is not an isolated, infrequent episode. It is endemic, spreading from the basic value system inherent in the physician/experimentor image spawned by the current research-oriented medical community.
Consider some examples . . .
One experiment which has been in the news in recent years and a subject of a television video essay by Sixty Minutes involved various U. S. Government agencies experimenting on unknowing servicemen in an attempt to determine the effects of hallucinatory drugs. Perhaps more disturbing and closer to the story line of Brain was an experiment in which live cancer cells were injected into elderly patients without their informed consent.3 At the time of the study the researchers did not know if the cancers would take or not. Apparently they took it upon themselves to decide that the patients were already so old that it didn’t matter!
There are numerous examples of radioactive materials being injected into unknowing, unsuspecting people, primarily institutionalized mental defectives, but even new-born babies have not been immune.4 There is no way that these studies can be justified for the therapeutic benefit of the individuals and there is no doubt that these unknowing people were subjected to the risk of injury and disease, not to mention discomfort and pain. On top of that, the results of studies of this kind are often of little consequence, serving more to augment the bibliographies of the involved researchers than advance medical science. Many of these studies were knowingly supported by the U.S. Government agencies.
Another experiment involved the purposeful injection of seven to eight hundred mentally retarded children with infected serum in order to produce hepatitis.5 This study apparently was approved and supported by the Armed Forces Epidemiological Board, among others. Consent was mentioned to have been obtained from the parents but the circumstances lead one to wonder how the consent was obtained and the degree to which it was “informed consent”; and, even so, did this consent by the parent protect the rights of the subjects? The question remains: would any of the researchers have allowed a mentally retarded member of their own family to participate, or in the other experiments mentioned, would the researchers have allowed a family member or themselves to be involved as subjects? I sincerely doubt it. The intellectual elitism that medicine and medical research fosters creates a sense of omnipotence and with it, a double standard.
It would be irresponsible to suggest that the majority of research involving humans in the United States is based on unethical standards, because it is definitely not true. However, the fact that there is a significant minority is frightening and demands attention from the public. The pressure for research within our academic medical centers is as strong as ever and the ensuing investigative enthusiasm and air of professional competition can cause people to lose sight of the negative consequences for patients. Besides, the confusion of values between patient/subject risk and possible societal benefit has not been unequivocally settled.6 And the idea that patient consent will obviate abuses has proved to be false. Take for instance the case of fifty-one women used as subjects for a study of an experimental labor-inducing drug. They all signed consent forms but apparently under less than ideal conditions. An investigation of the study reported that many gave their consent during the duress of the admitting procedures or in the delivery room itself.7 After the fact, the patients were interviewed and almost forty percent had no idea they’d been the subject of research even though they had purportedly given “informed consent.” One of the subtle ways consent was obtained was by saying the study involved a “new” drug, not an “experimental” drug, the researcher knowing full well that the adjective “new” would imply that the experimental drug was better than the “old” drug.
Subterfuge need not be necessary to obtain consent. Subtle innuendos suggesting that the care of the individual will be less than maximum if the person does not “cooperate” is the most frequent ploy. Next in frequency is for the researcher to cleverly imply that the experimental procedure might benefit the individual even if that possibility is negligible. Finally there is the method by which the researcher fails to inform the potential subject that there are alternative and, frequently, established modes of therapy.
All this is not new. Lip service has been given to violations of medical ethics involving human experimentation for more than twenty years in the medical journals. The fact that it still exists to the extent that it does is a tragedy of major proportions. And now that the decade of the eighties has arrived with medicine beginning a new love affair with physics, the opportunities for abuse reach a new and horrifying potential. The center stage for the marriage of medicine and physics is neuroscience, and the chief actor will be the human brain, considered by many to be the most mysterious and amazing creation in the universe. The ethical and moral issues involving human experimentation have to be solved before . . .
. . . before fiction and fantasy become fact.
ROBIN COOK, M.D.
1. Beecher, H. K., “Ethics and Clinical Research,” New England Journal of Medicine, vol. 274, 1966, pp. 1354-60.
2. Pappworth, M. H., Human Guinea Pigs: Experimentation on Man, Beacon Press, Boston, 1967.
3. Barber, B., “The Ethics of Experimentation With Human Subjects,” Scientific American, vol. 234, no. 2, February 1976, pp. 25-31.
4. Pappworth, M. H., op. cit.
5. Veatch, R. M., Case Studies in Medical Ethics, Harvard University Press, 1977, pp. 274-77.
6. Jonas, H., “Philosophical Reflections on Experimenting with Human Subjects,” Experimentation with Human Subjects, P. A. Freud, ed., George Braziller, 1969.
7. Barber, B., op. cit.
This is a work of fiction. Names, characters, places, and incidents are either the product of the author’s Imagination or are used fictitiously, and any resemblance to actual persons, living or dead, business establishments, events or locales is entirely coincidental.
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