TAB D-5 DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. DRAFT FOR DISCUSSION PURPOSES ONLY MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Rebecca Lowen DATE: April 4,1995 RE: Representation of Experiments Using Human Subjects in Newspapers and Periodicals, 1946-1981 This research is based on a survey of the representation of human experimentation in magazines and the New York Times between 1946 and 1981. Articles and editorials on human experimentation were located using the Reader's Guide to Periodical Literature and the Index to the New York Times. The newspaper and magazine articles are not understood to be a reflection of general, or "mass" opinion on the subject of human experimentation, but rather a guide to the range and tenor of publicly acceptable discussion about human experimentation over the years under examination. The period 1946-1981 has been broken into four sections. The first (Condemning the "Doctors of Infamy," 1946-1961) focuses on reportage and editorials related to human experimentation in Nazi Germany. The second (De-Stigmatizing Human Experimentation, 1946-1962) covers a period during which a number of magazines featured stories about "human guinea pigs." These stories may best be read as attempts to de-stigmatize the use of human subjects in experiments, in light of widespread knowledge of, and horror at, the use of human subjects by Nazi doctors. The third (Human Experimentation: Scandals and Debate, 1962-1968) discusses a period marked by the opening up of debate about human experimentation, following revelations, widely reported on in newspapers and magazines, of experiments conducted on humans without their informed consent. The fourth (Renewed Debate, 1972-1981) discusses new revelations about human experimentation and renewed debates about the ethics of experimentation as well as what constituted an "experiment." I. CONDEMNING THE "DOCTORS OF INFAMY," 1946-1961 The New York Times provided front-page coverage of the trial of Nazi medical practitioners at Nuremberg in 1946. In an editorial at the outset of the doctor's trial at Nuremberg ("The Nazi Doctors," 21 November 1946, p.30/1), the times condemned what it called "outrageous violations of the medical code" by Nazi doctors. The doctors deserved the same fate as that of the Nazi leaders who had recently been convicted at Nuremberg, according to the editorial, because the "real purpose" of the experiments was "mass killing and the destruction of a large block of humanity." The editorial implied that, had the doctors engaged in research for the "benefit of science and society," they might not be judged so harshly. The Times also linked experimentation on humans by the Nazis with genocide in an editorial at the conclusion of the doctor's trial ("For a 'Genocide' Treaty," 23 August 1947, p. 12/3) which called upon the United Nations to adopt a treaty to bind nations to act collectively against acts of genocide. An article in the Times on 20 March 1948 reported on the consideration in America among experimental biologists of the Nuremberg Code. At the annual meeting of the Federation of American Societies for Experimental Biology by University of Illinois, Andrew C. Ivy, M.D., who had testified at the Nuremberg trials, outlined the principles under which experimentation on humans in the U.S. might be justified. (This article appeared on p. 27.) In 1949, Doctors of Infamy: The Story of the Nazi Medical Crimes, by Alexander Mitscherlich, M.D. and Fred Mielke (head of the German Medical Commission at the Nuremberg Trials), was published in America, and reviewed prominently in the Saturday Review of Literature, and in the New York Times Book Review. In succeeding years, the Times reported on the capture and trials of other Nazi doctors, although did not provide front-page coverage. Attention to experimentation on human beings under Hitler was renewed in May 1959 in relation to the visit to America by thirty Polish women who had been victimized by doctors in the Ravensbruck concentration. "Of all the incredibly horrible stories that came to light" at the Nuremberg trials, wrote Times reporter Howard A. Rusk, M.D., "there were none so cruel and revolting as the so-called "scientific experiments on human subjects." ("Science In the Nazi Era," 31 May 1959, p. 62/4,5).) The decision of the West Germany government to compensate the Ravensbruck camp victims received front-page coverage in the Times on 13 November 1961. II. DE-STIGMATIZING HUMAN EXPERIMENTATION, 1946-1962 Between 1948 and 1960, magazines such as the Saturday Evening Post, Reader's Digest, American Mercury, and the New York Times Magazine ran "human interest" stories on "human guinea pigs." These stories generally focussed on specific groups among experimental subject--prisoners, conscientious objectors, medical students, soldiers--and described them as "volunteers." The articles described the ordeals to which the volunteers had submitted themselves ("Among these men and women you will find those who will take shots of the new vaccines, who will swallow radioactive drugs, who will fly higher than anyone else, who will watch malaria-infected mosquitos fed on their bare arms..." from "Why Human 'Guinea Pigs' Volunteer," New York Times Magazine, 13 April 1958, p. 62.), and discussed the reasons for volunteering to act as "guinea pigs." These explanations ranged from redemption (in the case of 2 prisoners), religious or other beliefs (conscientious objectors), the advancement of science (medical students), excitement and diversion, and service to society. ("The Most Unforgettable Character I've Met," Reader's Digest, May 1948, p. 30; "A Treasure In the Heart of Every Man," Reader's Digest, December 1954, p. 49 (condensed from the American Mercury); "I was a Human Guinea Pig," Saturday Evening Post, 25 July 1953, p. 27; "They Volunteer To Suffer," Saturday Evening Post, 26 March 1960, p. 33; "Why Human 'Guinea Pigs' Volunteer," New York Times Magazine, 13 April 1958, p. 62. These articles were uncritical toward experimentation on humans, and assumed that those involved in the experiments had freely volunteered to participate. This should not be seen as the viewpoint of the general public, however. A number of the articles and editorials on human experimentation in America in this period make clear that the general public was suspicious of human experimentation. A 1948 article, "Experiments on Prisoners," in Science News Letter (p. 117) opened with the statement that "at least one Soviet scientist had publicly criticized American medical scientists for using "Nazi methods when they use prisoners in medical experiments." The rest of the article was devoted to refuting this charge, emphasizing that prisoners had freely volunteered their services and received no rewards or reduction in sentences. In March 1953, the Times editorialized in response to a series of articles in Science on the ethics of human experimentation, arguing that "opponents of experimentation on human beings are too squeamish." The Times asserted that experimenters carefully followed particular guidelines when using human subjects: all subjects were volunteers, and the experiments were undertaken for the patient's immediate good. The Times supported experimentation, which it described as taking "a risk" on behalf of "the patient as well as of science." This editorial provoked a letter to the editor which challenged the claim by the Times that human subjects were always volunteers who were treated with proper respect by experimenters. The writer argued that human guinea pigs were drawn from among "the friendless, the unfortunate and the helpless" which included men in the armed services. A New York Times article, "Drugs and Prisoners," in November 1962, emphasized that all experiments on prisoners were voluntary and uncoerced, "contrary to the general impression." And a 1960 feature story in the Saturday Evening Post defended medical experimenters, while noting the public's objection to the use of human guinea pigs. "The doctors are extremely cautious too. They are aware that the public is suspicious of the use of human beings for medical experimentation, particularly so since the horrifying revelations of Nazi experiments on prisoners without consent, caution or regard for pain." During this period, some concern was voiced by religious leaders about the dangers posed to the health of volunteer "guinea pigs," particularly in relation to experiments involving radiation. October 1954 article in the New York Times reported that the Pope had urged doctors and nurses not to volunteer for medical experiments that might pose a danger to their health. That same month, the Christian Century commented on a group of conscientious objectors who were taking part in experiments (at the Fitzsimons army hospital in Denver and assessed by doctors at Fitzsimons and the University of Colorado) which required them to eat foods that had been exposed to cobalt radiation. The Christian Century called upon the Army to halt the experiments at the first sign of danger (while noting that it was possible that the experiments 3 could do "irrmediable damage before their damage is discovered.") ("C.O's Offer Selves for Atomic Experiments," Christian Century, 20 October 1954, p. 1260.) III. HUMAN EXPERIMENTATION: SCANDALS AND DEBATE, 1962-1969 The use of human subjects in medical/scientific experiments gained wide attention, became the subject of investigations, and began to be debated openly beginning in late 1962, in relation to the discovery that thalidomide, prescribed to patients on an experimental basis by their physicians, produced deformities in fetuses. In early 1964, the discovery that patients at the Jewish Chronic Disease Center in Brooklyn had been experimented upon without their consent made front-page news in leading newspapers. In response to these revelations and the debates about the ethics of human experimentation that followed, both the FDA and the USPHS introduced new regulations governing human experimentation. In late 1962, editorials in both the Christian Century and the Saturday Review responded to the Thalidomide tragedy, objecting to the use of human "guinea pigs" and focusing on the importance of informed consent. Outraged that the law permitted doctors and drug companies to use a drug for "investigational purposes at their own discretion whether or not the government or even the patient approves," "(Guinea Pigs and People," Christian Century 15 August 1962, p. 975), the Christian Century insisted that "the decision to be a guinea pig or not to be one should lie with the patient, not with the doctor or the drug company." The Saturday Review editorial, "Human Guinea Pigs and the Law," (6 October 1962, p. 55) expressed the same concern for individual rights, opening with a reiteration of the first rule of the Nuremberg Code, which stated that human subjects most give consent voluntarily. The SR went on to complain about the attempts of the drug companies and the medical profession to quell debate about this issue and to call on Congress to pass legislation to protect the patient's right to be informed of the nature of her medical treatment. Largely in response to the Thalidomide tragedy, the FDA began requiring that new drugs be tested in controlled experiments before sale to doctors and the public. Thus, in March 1963, the Saturday Evening Post featured yet another article on prison volunteers, pointing out that the use of prisoners for the testing of experimental drugs had assumed great importance since the FDA's ruling. This article differed from earlier ones of this genre in that it made plain that most prisoners, while volunteers, were rewarded (usually financially) for acting as guinea pigs. The issue of experimentation on humans made headlines in the nation's newspapers and magazines in January 1964 when it was discovered that elderly patients at the Jewish Chronic Disease Hospital in Brooklyn had been injected with live cancer cells as part of an experiments conducted by two eminent physicians at Sloan-Kettering. This experiment had first been conducted in 1956 on prison volunteers in the Ohio State penitentiary and had been reported on without comment by Time magazine and Newsweek at that time. ("Cancer by the Needle," 4 Newsweek, 4 June 1956, p. 67; "Volunteers for Cancer," Time, 4 June 1956, p. 48). The public outrage over the experimentation at the Chronic Disease Hospital stemmed from the discovery that the patients had not been told that the cells being injected were cancer cells, and had not given consent. (The doctors claimed to have obtained oral consent, but it was discovered that many of the patients in question were deaf, spoke only Yiddish, or were senile.) Further, the experiments were not conducted for the benefit of the patients involved, nor did the physicians experiment first on themselves. It is possible that public outrage over this incident was magnified because the patients in question were Jewish and mentally and physically impaired, suggesting some obvious parallels to human experimentation in Nazi Germany. ("Hospital Accused on Cancer Study, NY Times, 21 January 1964, p. 31; "State Broadens Cancer Inquiry," NY Times, 22 January 1964, p. 38; "Test on Cancer to Need Consent," 23 January 1964, p. 28; "Many Scientific Experts Condemn Ethics of Cancer Injection," 26 January 1964, p. 70; "Experimental Ethics," Time, 3 February 1964, p. 48.) The refusal of the Sloan-Kettering physicians or the director of the Chronic Disease Hospital to admit wrongdoing led to a court battle for release of the victimized patients' records as well as to a formal inquiry by the medical grievance committee of the professional conduct division of New York State's Education department, thus keeping this story in the papers intermittently from January 1964 to early 1966. The State's inquiry led to the discovery that the same doctors had injected close to 300 patients at Sloan-Kettering with cancer cells, again, without informing them of the nature of the cells and without obtaining written consent. On the recommendation of the medical grievance committee, the New York State Board of Regents found the two Sloan-Kettering physicians guilty of unprofessional conducts and of fraud and deceit in the practice of medicine. According to the Saturday Review, this case of human experimentation, involving as it did eminent researchers from Sloan-Kettering, "shook the complacency that had obscured experimental ethics." ("The Law on Human Guinea Pigs," SR, 3 April 1965, p. 56; "The Patient's Right to Know," SR, 26 June 1965, p. 20; "Research and Responsibility," Nation, 14 March 1966, p. 284). Following the revelations about experimentation on patients at the Jewish Chronic Disease Center, Dr. Henry K. Beecher, Professor of Research in Anesthesia at Harvard University, delivered a paper, "Ethics and the Explosion of Human Experimentation," at a March 1965 symposium sponsored by Upjohn. In this paper, Beecher, who had been researching the issue for the past decade, cited 50 documentable cases of experimentation on human subjects in the absence of informed consent and with no expected benefits to the patients involved. The New York Times reported on Beecher's talk, and noted Beecher's comment that his examples were "by no means rare but are almost, one fears, universal." (NY Times, 24 March 1965, p. 35.) The Times also noted in the article that some of Beecher's colleagues disputed his claims. In 1966, Beecher published "Ethics and Clinical Research" in the New England Journal of Medicine which documented 22 of the 50 experiments previously mentioned. The Boston Herald devoted one-third of its front page to reporting on Beecher's article; it was also covered by the New York Times and Time magazine. 5 Largely in response to the uproar over the Sloan-Kettering/Jewish Chronic Disease Hospital case, the US Public Health Service enunciated a new policy in 1966 regarding experiments conducted with support from the USPHS. All institutions receiving USPHS support were to establish independent review committees which would assure the USPHS that researchers proposing to conduct experiments with human subjects would protect the rights and welfare of the human subjects, and obtain informed, written consent from the subjects. ("Experiments on People-The Growing Debate," SR, 2 July 1966, p. 41; "U.S. Acts to Protect All Persons Used for Medical Tests," NY Times, 19 May 1966, p. 38.) Also, in August 1966, the FDA ruled that doctors could no longer test any drugs on humans without first obtaining the written, informed consent of their patients. (This regulation was softened considerably the following year after strong objections from medical researchers; "Doctors Must Experiment on Humans," NY Times Magazine, 2 July 1967, p. 12). In December 1966, attention again focussed briefly on the issue of human experimentation when New York State Senator Seymour Thaler charged that New York City hospitals were using their patients for experiments without their informed consent. ("State Opens City Hospitals' Investigation Today," NY Times, 28 December 1966, p. 24; "City Aides Deny A Thaler Charge," NY Times, 29 December 1966, p. 34; "Experiments on Man," Newsweek, 6 March 2967, p. 84). For the remainder of the decade, magazines and the New York Times dealt with the issue of human experimentation intermittently. After 1966, ethical concerns expanded from the previous focus on the necessity for informed consent to include discussions of the meaning of informed consent as well as concern for the welfare of particular groups of "volunteers"--prisoners, children, the seriously ill, and members of the armed services. In "Do We Need New Rules for Experiments on People?" Saturday Review drew attention to the use of public school children in psychological experiments without the consent of the parents. In "Experiments On Man," Newsweek reported on New York State Senator Thaler's effort to pass legislation providing special protection to children who might be used as research subjects. (6 March 1967, p. 84). Newsweek reported on the concerns of Dr. Wolf Wolfensberger of the Nebraska Psychiatric Institute that so-called "volunteer: guinea pigs--prisoners, armed forces personnel, medical students--were actually not fully free to decide whether or not to participate in an experiment. Even if prisons were told that participation in an experiment would not affect their chances of parole, prisoners believed it would and volunteered on that basis, in Wolfensberger's view. (6 March 1967, p. 84). In "Medical Experiments On Humans,' (New Republic 3 December 1966, pp. 10-12) this issue was raised by Michael Alderman, M.D., who pointed to the ambiguity in regulations requiring voluntary and informed consent. "Can prisoners, students or soldiers, all popular research subjects, ever be entirely free of pressure to consent?" Whether college students, prisoners, and soldiers could be considered "free" to volunteer was also raised by "Doctors Must Experiment on Humans, But What Are the Patient's Rights," (New York Times Magazine, 2 July 1967, p. 12), and by M.H. Pappworth, M.D., in Human Guinea Pigs: Experimentation on Man (Beacon Press, 1968), which included among 6 vulnerable "volunteer" groups the sick and the terminally ill. Pappworth's book also provided extensive documentation of experiments conducted without fully informed consent of the patients; it received a favorable review in the NY Times Book Review (14 July 1968, p. 30) and the Nation (27 January 1969, p. 117). In November of 1969, Senior Scholastic, a periodical distributed to secondary school students and designed to stimulate discussion and debate, focussed on the issued of experimentation on prisoners. IV.RENEWED DEBATE, 1972-1981 Beginning in 1973, a number of instances of experimentation on humans without their consent came to light, renewing discussions of the ethics of human experimentation, particularly regarding the use of prisoners, and leading to Congressional legislation to protect human subjects. In March 1972, "A Clockwork Orange in a California Prison," Science News (11 March 1972, p. 174) reported on experimental brain surgery and psychosurgery on inmates in California's Vacaville prison. The experiments at Vacaville received attention not only from the press but from the U.S. Senate Committee on Labor and Public Welfare. Further attention was brought to experiments using prison "volunteers" in January 1973, by Jessica Mitford's "Experiments Behind Bars: Doctors, Drug Companies and Prisoners," in the Atlantic Monthly. Mitford's article suggested not only that some experiments were dangerous and of no benefit to the prisoners, but also that some experiments were of questionable scientific value. In March 1973, "Cons as Guinea Pigs," Time reported that the Superintendent of the Oregon State Penitentiary had ended the use of prisoners in experiments, explaining that the poverty of prisoners and the fact of their incarceration meant that they could not be considered truly "free agents" when asked to volunteer. (Time, 19 March 1973, p. 45). By late 1973, the Christian Century was not only objecting experimental psychosurgery on prison inmates, but was also charging that the aim of these experiments was to subdue political dissidents. The Tuskegee syphilis study, an experimental program begun in 1932 by the USPHS in which treatment was denied to about 400 impoverished African-American men who had syphilis, also came to light in 1972, and received particular attention from Ebony and Christian Century. Following these revelations, The Institute of Society, Ethics, and the Life Sciences, in Hastings-on-Hudson, New York, issued an update on the work of Dr. H.K. Beecher, listing 43 questionable experiments involving the use of human subjects since H.K. Beecher's 1966 paper. Among the experiments listed by the Institute and reported on in Science News were those involving the use of LSD and those involving the use of children, prisoners, and the mentally imcompetent without informed consent. ("Medical Ethics and Human Subjects," Science News, 14 July 1973, p. 20) In February and March 1973, the Senate Subcommittee on Health began holding hearings on human experimentation, and in 1974, Congress passed the Protection of Human Subjects Act. 7 This did not receive as much attention from the press as did the revelations in 1975 of the experimental use of LSD on unknowing subjects. Experiments involving LSD, and the alleged suicide of one of the subjects involved, received coverage in Newsweek, Science News, Time, the Nation, US News and the New Republic. In "Science Atrocities," the New Republic editorialized that the LSD experiments" are no isolated series of events," and that experimentation on humans without informed consent was common. The New Republic viewed this as a knowing violation of ethical and scientific standards; "to the extent that we know these standards, it is clear we do not adhere to them." (New Republic, 13 September 1975, p. 5.) The issue of the use of human "guinea pigs" appeared intermittently in the press for the remainder of the decade, with some articles focussed on the rights of prisoners, others on new revelations regarding human experimentation, an one editorial in Christian Century proposing compensation for the victims of scientific and medical experiments. ("Compensating Victims of Medical Research," 29 November 1978, p. 1149.) The discussion of human experimentation was broadened from a focus informed consent and the violation of individual rights by a series of front-page articles titled "The War on Cancer: First, Do No Harm," in the Washington Post which drew attention to the ethical issues raised by the NIH-sponsored clinical trials for cancer patients. ("Experimental Drugs: Death in the Search for Cure," 12 October 1981; "Risk, Rivalry and Research--and Error," 19 October 2981; "The World of Shattered Hopes," 20 October 1981; and "Spark of Hope vs. Ordeal of Pain," 21 October 1981.) In "The Ethics of Human Experimentation," (New Republic, 9 December 1981, p. 16), Charles Krauthammer reviewed the history of human experimentation, discussed the Nuremberg Code, and then argued that experimental treatments for cancer patients raised existential but no ethical questions. 8