SECRET STATE EXPERIMENTS AND MEDICAL ETHICS

59

A. W. Galston and C. Z. Peppard (eds.), Expanding Horizons in Bioethics, 59-69.

© 2005 Springer. Printed in the Netherlands.

SECRET STATE EXPERIMENTS AND MEDICAL ETHICS

How does a liberal democratic society facing a national crisis decide what is and what is not permissible with regard to research on human beings—its own people and the citizens of other countries as well?¹ This question is especially apposite in an era of concern over biological and chemical terrorism, but it emerged much earlier and confronted our predecessors on numerous occasions over the past century. While we might imagine that deep concerns about issues of medical ethics are fairly recent—and indeed important dimensions of medical and research ethics have come to light in the past few decades—it is a mistake to underestimate the insights of those who came before us. This chapter demonstrates the history of human subjects research in government contexts, focusing primarily on the United States. History reminds us that vigilant attention to ethical questions is essential.

While we have learned much from our predecessors, we should not suppose that later generations, including our own, are any less susceptible to insufficient attention to questions of ethics than our predecessors.

Lessons about the ambiguities of history were brought home to me in 1994 and 1995 when I had the privilege of working as a senior analyst for the President’s Advisory Committee on Human Radiation Experiments (ACHRE).² In that capacity I was charged with identifying and evaluating the often-secret ethics policies of the United States government during the cold war in the area of radiation research.

However, it quickly became apparent that the history of human radiation experiments was closely tied to policies about biological and chemical weapons defense as well. Critical to the story of human subjects research during this era is the fact that, in the years during and immediately following World War II, the United States felt a sense of urgency about protecting liberal democracy. The analogy to our own troubled time is evident, so I will only note in passing that, since September 11, 2001, smallpox vaccine trials with healthy volunteers have been completed in order to rebuild a national stockpile for a suddenly sharpened terrorist threat.³

1 For an account of ethical problems in offshore human subjects research, see the essay by Marcia Angell in this volume, entitled “Cross-Cultural Considerations and Medical Ethics: The Case of Human Subjects Research.” Ed.

2 A fuller account of the interplay between government and military policy and human experimentation can be found in Moreno, Undue Risk.

3 “Volunteers Line Up to Test Smallpox Protection,” New York Times.

I. THE BEGINNINGS

The story of state-sponsored human experimentation through the lens of human subjects’ consent might be said to begin at the University of Virginia. In 1868 the University’s most famous medical school graduate, Walter Reed, completed his studies at the age of sixteen. He went on to become the country’s most important expert on infectious disease while pursing his army career and directing an important research laboratory in Baltimore. By 1900, a new American army detachment in Havana faced a grave crisis: a pandemic of yellow fever. Since the United States had just gained a foothold in Cuba following the Spanish-American war, the death toll associated with yellow fever posed a threat to national security.

Walter Reed was assigned the responsibility of stemming the spread of the disease.

At the time, a popular theory held that the vector of yellow fever was the female silver-backed mosquito. Several of Reed’s medical colleagues volunteered to “take the bite” in an effort to assess this theory, and hence to help ameliorate the pandemic. Two of these colleagues, a young doctor and a nurse, died of their exposure; this convinced Reed that in light of his advanced age (he was then forty- nine) he was a poor candidate for the experiment. Instead, to confirm the mosquito hypothesis in a larger population, Reed recruited slightly over two dozen American soldiers and local Cuban workers to participate in a yellow fever experiment.

Although human experiments were not unusual in those days, Reed introduced a novel element: He required each of these soldiers and workers who volunteered for the experiment to sign a contract that warned them of the risks of what they were about to do and specified that it was being done freely. The contract was translated into Spanish for the Cuban workers. Not to be denied is the fact that the volunteers were also offered compensation in gold, though it seems that the soldier participants declined this opportunity. The motivation for Reed’s innovative contract seems to have been a concern for propriety and immunity from criticism by the prominent Johns Hopkins medical professor William Osler. Reed and the U.S. Army Surgeon General were perhaps concerned that Osler, who had already attacked the ethics of an Italian who used human beings in yellow fever experiments, would turn his critical lens to them. They may also have been aware of a scandal in Prussia about a syphilis experiment that led to a government mandate against all human experiments that failed to attain prior consent from the subjects. Additionally, some United States Congressmen were interested in the issue of human experimentation and introduced a bill to constrain certain kinds of experiments in the District of Columbia.⁴

In addition, early twentieth century advances in medicine were accompanied by political and legal scrutiny about the way these advances were being applied by the medical profession (a pattern that continues in our own time). For example, courts were ruling in favor of patients who were subjected to surgical procedures such as hysterectomies without adequate consent.⁵

4 Lederer and Grodin.

5 Katz.

Nonetheless, Reed’s military research led to a medical breakthrough—the identification of the mosquito as the vector of yellow fever—as well as a fabulously successful public health intervention. The fact that this occurred within a research framework that was respectful of human beings destined Reed and his team to hold a distinguished place in the history of medicine and medical ethics.⁶ In spite of previous cultural reservations about human experiments (recall Mary Shelley’s Frankenstein and George Bernard Shaw’s term “human guinea pig”), the Reed adventure gave both medical and moral validity to the practice. To be sure, scandals about experiments both preceded and succeeded the Reed experience. By the late nineteenth century there were increasing public concerns about the ethics of human experiments and, as I have noted, early attempts at regulation. On the whole, however, the Reed experiment and its proto-consent forms showed that medicine, particularly military medicine, was compatible with medical ethics.

Walter Reed became a cultural hero (aided perhaps by his untimely death while on another assignment a few years later). His experiment largely “inoculated” both medical experimentation and military medicine from association with scandal. This happy condition lasted about fifty years, until the horrendous World War II experiments by German doctors in Nazi concentration camps were revealed.

II. NAZI DOCTORS AND THE NUREMBERG CODE

Following the discoveries of horrific abuses and human experimentation in Nazi concentration camps, many German officials were charged, tried and convicted at the Nuremberg war crimes tribunal. At the behest of the United States, West Germany focused on these experiments in the second of the thirteen war crimes trials at Nuremberg. Twenty-three defendants were implicated, including Hitler’s personal physician, Karl Brandt.

Brandt was among the defendants charged with planning or implementing several kinds of experiments, sponsored by the German military, which sought additional information for military pursuits. For example, during World War II the Luftwaffe (German air force) wanted to improve the treatment of hypothermia for its pilots, and they also wanted to know the altitude at which it was safe for pilots to eject themselves from damaged aircraft. Experiments involving freezing and explosive decompression, and many others aimed at benefiting the Nazi regime’s war effort, were conducted at the concentration camps. Another category of experiments simulated battlefield injuries: experimental surgeries attempted, e.g., to transplant portions of bone. As many as one hundred thousand people died as the result of these and other experiments in Nazi Germany. The human suffering caused by these experiments defies my limited powers of expression.

Seven of the Nuremberg defendants were hanged for their crimes, and another eight were sentenced to lengthy prison terms. Their Japanese counterparts went

6 For more information, see Lederer, Subjected to Science.

unpunished, even though at least ten thousand innocents died in biological and chemical experiments conducted by the Imperial Japanese army in Manchuria.⁷

However, the prosecution of the Germans did not run a smooth course. The Nazi defense lawyers were able to demonstrate that the World War II allied forces had themselves conducted experiments on people who might well be regarded as vulnerable to coercion. This refutation was surprisingly effective. For example, the defense introduced into evidence a Life magazine article from June 1945, which depicted a United States malaria experiment conducted with eight hundred federal prisoners who claimed to have volunteered for the experiment. Although (unlike the Nazi experiments) no one died of malaria and, in my view, these were genuine volunteers who were not facing sub-human conditions and the likelihood of extermination, it became clear that universally recognized rules of human experimentation did not exist. If there were no guidelines and if the allies had conducted similar experiments on imprisoned persons, the Germans’ lawyers argued, how could the Nazis be held to a higher standard?

Using this logic, the German lawyers forestalled conviction of the Nazi officials until, in the end, guilty verdicts were based upon the grounds of murder, conspiracy to commit murder, and the new charge of crimes against humanity. The Nazis were not found guilty based on the Nuremberg Code, for this would have been ex post facto justice. The Nazi defense of human experimentation succeeded in slowing the proceedings, and they also effectively raised the pressing question of human experimentation and coercion. Indeed, the issue of human experimentation was not lost on the three judges, all of whom were American. They understood that international medical ethics standards urgently required articulation. Hence they devoted a portion of their ruling to a ten-point statement that has come to be known as the Nuremberg Code.

With the help of American medical advisors, the judges crafted a document that begins with the phrase “The voluntary consent of the human subject is absolutely essential” to experiments on humans.⁸ Other points include the necessity of prior animal experimentation, the elimination of any undue risk, and the right of the subject to terminate his or her involvement in the experiment at any time. Finally, the document states that the medical scientist’s responsibility for the well-being of research subjects cannot be transferred to someone else.

III. THE ATOMIC ENERGY COMMISSION

The legal proceedings leading to the Nuremberg Code had a far-reaching effect, even before the trials were complete. In particular, the American Medical Association (AMA) felt compelled to develop its first specific guidelines on medical experiments, anticipating that international standards would indeed be an issue at the Nazi doctors’ trial. Andrew Ivy composed the AMA’s ethics code prior to the

7 For more information, see Moreno, chapter four, “Deals with Devils.”

8United States v. Karl Brandt et al., Vol. II, pp. 181-185. Cited in Moreno, 80.

conclusion of the Nuremberg trials; he was later interviewed during the trials as a key witness, and as a medical advisor to the Nuremberg judges his wording strongly influenced the content of the Code.

The U.S. government also took note of the proceedings. In late 1946 the new Atomic Energy Commission (AEC), headed by MIT engineer Carroll Wilson, was confronted with an experiment that was, unlike the malaria study, a closely held secret and one that would surely have fueled the Nazi defense case.

The AEC administrators discovered, in materials received from the Manhattan Project, that in 1945 seventeen hospitalized patients had been injected with plutonium, apparently without their consent. The scientific purpose of the experiment was to ascertain the human excretion rate of plutonium—a matter of grave concern at the time, since young physicists were exposed to quantities of plutonium daily in the course of developing the mechanisms to release atomic energy. In 1947 a decision was made to maintain the secrecy of the injections, despite repeated requests for declassification of the material by one of the scientists, in order to avoid embarrassment to the government and potential lawsuits.⁹

However, the AEC also decided that it needed to develop a policy to avoid future misuse of its radionuclides, particularly as it was interested in making them available to qualified medical researchers. The implications of the Nazi doctors’ trial constituted part of the AEC’s concern. Hence, a key element of the resulting policy, as written in a 1947 letter from Carroll Wilson, was that “informed consent” was to be elicited from the patient. The conditions, prohibiting use of a known or suspected harmful substance, are worth quoting in full:

(a) that a reasonable hope exists that the administration of such a substance will improve the condition of the patient, (b) that the patient give his complete and informed consent in writing, and (c) that the responsible next of kin give in writing a similarly complete and informed consent, revocable at any time during the course of such treatment.¹⁰

This seems to be the first time that the term “informed consent” appeared, as well as the first time that the standard of family member’s consent was established (though that guideline even today seems excessive). Importantly, the AEC established that radiation experiments were to be limited to therapeutic testing:

experiments must have the possibility of benefiting the patient, not just society at large.

If the AEC letters were meant to be taken seriously, this was surely a dazzlingly inadequate policy. The letters delineated neither a systematic articulation of the policy nor an oversight mechanism. Good intentions notwithstanding, there is reason to believe that the AEC rules were forgotten as soon as the ink was dry. For example, within several years of the statement about informed consent, the AEC, the Massachusetts Institute of Technology, and the Quaker Oats Company implemented a study at the Fernald School in Massachusetts. The Fernald School was a residential institution for young people with a range of objectionable behaviors. The purpose of the study was to determine that the healthful quality of the cereal was as advertised

9 For more information, see Moreno, chapter five, “The Radiation Experiments.”

10 Letter from Carroll Wilson to Robert Stone, 5 November 1947. Cited in Moreno, 141.

and, additionally, that this brand of cereal was superior to its competitors. The methods of the experiment were highly problematic: radiolabeled nutrients were placed in the students’ breakfast cereal. Although permission was sought from the parents, the relevant documents mentioned only that the children had been selected for a “science club” with certain special privileges.¹¹ The experimenters neglected to mention the trace levels of radiation in the children’s breakfast cereal.

Throughout the 1950s the AEC participated in a number of other radiation experiments that, at the very least, do not seem to have been compatible with the 1947 directives.

IV. BEYOND THE ATOMIC ENERGY COMMISSION

The AEC’s role in the human experiments issue extended to its relationship with other national security agencies. Between 1948 and 1951, an intense discussion took place in an inter-agency committee of the AEC and the Department of Defense (DoD). This joint committee, called “Nuclear Energy for the Propulsion of Aircraft,” debated the risks of radiation to the crew of a nuclear-powered aircraft.

One effusive proponent who seemed only concerned with short-term results (as opposed to potential long-term effects) was Robert Stone. He claimed that

“undetectable genetic effects” on blood or the lifespan were negated by the positive good that could come from learning more about radiation in the body and applying those lessons to military strategy.¹² Others were less sanguine about such approaches. Various possible groups of experimental subjects, including soldiers and long-term prisoners, were suggested and rejected on moral grounds. This process flowed into another fascinating debate within the DoD itself, which was concerned about the authority to conduct defensive atomic, biological and chemical weapons experiments.

The DoD feared that the Soviet regime was unfettered by ethical concerns in human experimentation, particularly when it came to unconventional weapons development. During its complex post-war reorganization, the DoD found that the Pentagon had no policy to govern human experiments. After much discussion, conducted under rules of secrecy, various Pentagon committees could not come to a consensus in favor of an ethics policy. In general, the officers and physician advisors on these panels believed that traditional rules of medical ethics, largely unwritten, had served the purpose of protecting human beings well enough. There was thus some reluctance to establish a written policy that would be subject to legal interpretation. Further, those opposed to human experimentation had a difficult time refuting the claim that human experimentation carried any different risk than normal military service, though some maintained that “it’s not very long since we got

11 For more information, see Moreno, 213-219.

12 Robert S. Stone, “Irradiation of Human Subjects as a Medical Experiment,” January 31, 1950. This document is included in the records of the Advisory Committee on Human Radiation Experiments, Record Group #220, National Archives and Record Administration, Washington, D.C. Cited in Moreno, 145.

through trying Germans for doing exactly the same thing [i.e., human experimentation].”¹³

Rampant offenses implicating the government occurred during this time: in January 1953, a New York City tennis pro named Harold Blaur died in a mescaline- derivative study at the New York Psychiatric Institute, where he was being treated for clinical depression. The study was sponsored by the Army Chemical Corps, which participated in a cover-up with New York State. This event underscored the need for a policy on human experimentation, but the general issue was controversial enough to discourage President Truman’s defense secretary from resolving the matter. However, immediately following his confirmation, President Eisenhower’s Secretary of Defense Charles Wilson, acting on the advice of the Pentagon’s legal counsel, adopted the Nuremberg Code verbatim as its policy to govern defensive experiments on atomic, biological and chemical warfare. The policy also included a written consent requirement. This directive was signed on February 26, 1953, and established the Nuremberg Code as the Pentagon’s human experiments policy. It was the first and last time that the code was adopted by a government entity as official policy. Unfortunately, the document was also classified as top secret.

Not surprisingly, given the top-secret status of the adoption of the Nuremberg Code, the results of this policy were mixed. In 1954, about a year after the policy was adopted, an air force officer in charge of flash-blindness studies complained to superiors that he had heard only rumors about a new rule for human experiments. He claimed that “no serious attempt has been made to disseminate the information to those experimenters who had a definite need-to-know.”¹⁴ It seems that several of the men in the study had experienced temporary blindness, which elevated this official’s concern about his ignorance of the specific policy. Clearly, the top-secret nature of the original document made the policy difficult to disseminate.¹⁵

The disappointing story of the actual effect of the DoD’s Nuremberg Code-based policy is, in my view, attributable to numerous cultural factors that characterized both the military establishment and the medical profession in the 1950s. Simply put, neither the military nor the medical profession was prepared to embrace a notion of written informed consent, nor was it clear to the protagonists exactly what that meant in practice. While a handful of human testing projects seem to have been accompanied by written consent (e.g., panic studies stemming from fear of radiation at atomic test shots), many others were not. Examples of the latter include the over two hundred thousand men who were deployed at Camp Desert Rock in Nevada for

13 Advisory Committee on Human Radiation experiments. Cited in Moreno, 148.

14 Advisory Committee on Human Radiation Experiments. Cited in Moreno, 292.

15 Parenthetically, no similar policy seems to have been adopted by the CIA, which was actively engaged in human experiments in the 1950s. For example, the infamous and legendary MKULTRA project was one of a number of activities intended to apply biological and chemical agents for undercover espionage and sabotage. One aspect of the project was an extensive network of financial support for LSD and behavioral experiments, often using “front” foundations and corporate entities to distribute funding. One victim of the project was a CIA scientist assigned to Fort Detrick in Maryland, Frank Olson, whose expertise was anthrax. Olson met his death when he tumbled from a New York City hotel room window in 1953. When details of his role were revealed in the 1970s, the government’s explanation of his death was a psychotic episode brought on by LSD dosing, but subsequent forensic investigations arranged by his family point instead to an assassination.

above-ground nuclear tests, the so-called “atomic soldiers.” This activity was classified as training and indoctrination rather than as a medical experiment.¹⁶ In a very different example, soldiers who were exposed to LSD (lysergic acid diethylamide) in the 1960s seem to have known they were going to be given a hallucinogen, but they were not aware of other details, such as when the exposure would take place, what quantity of LSD they would be given, or what the goals of the study were.¹⁷ On the other hand, the infamous case of Dr. Frank Olson (a doctor who was administered LSD and later appeared to have killed himself; the case was declassified in 1976) indicates that LSD trials were applied to unsuspecting persons who, as they were unaware of the LSD trials, were clearly unable to give consent.¹⁸

In 1975 the Army Inspector General reflected on twenty years of experience with the Nuremberg Code policy and concluded that there was a “startling lack of consistency” in interpretation of this policy.¹⁹ Further, when one of the soldiers affected by military medical experimentation attempted to sue the federal government for injuries sustained in the LSD experiments, the U.S. Supreme Court ultimately ruled against him. The Supreme Court, in Thornwell v. The United States of America, cited the doctrine that a member of the armed forces cannot sue for harms incurred in the line of duty.²⁰ The question, of course, is whether participation in human experimentation qualifies as “the line of duty.”²¹ Issues of informed consent and coercion arise in this context. This is particularly true since it seems that the Nuremberg-based policy was not systematically understood, much less implemented. I believe that the five-member Supreme Court majority gravely erred in this decision and, as a result, did substantial damage to the morale of members of the armed forces.

It seems clear that the DoD policy generally struggled. Yet, oddly enough, there was an apparently successful and highly publicized human experiments program at Fort Detrick from 1953 to 1974, where over two thousand soldiers who were members of the Seventh Day Adventist Church volunteered for assignment in Operation Whitecoat. These men participated in numerous studies involving potential biowarfare agents. Follow-up studies on two hundred veteran volunteers in 1998 did not suggest that the men suffered ill effects (though it is feasible that this group of volunteers is not a representative sample).

Operation Whitecoat was terminated in 1974 as part of Nixon’s directive to shut down the biological weapons program at Fort Detrick. However, the infectious disease institute (U.S. Army Medical Research Institute of Infectious Diseases) was not shut down but charged with developing medical treatment for dangerous contagious diseases. The cessation of Operation Whitecoat effectively eliminated the source of human subjects volunteers. Gradually the Medical Research Volunteer

16Moreno, 206.

17 Ibid., 251-254.

18Ibid., 191-192.

19 Ibid., 180.

20Thornwell v. The United States of America, 471 F. Supp. 344.

21 The details of this case are particularly disturbing. James Thornwell, while under investigation in France for an alleged document theft, was kept in solitary confinement and was refused meals and sleep before administered LSD to test its efficacy as a “truth serum.”

Subjects (MRVS) program was born, with participants recruited from groups of medics. The medics were assigned to Fort Detrick’s infectious disease institute with the understanding that, in addition to regular laboratory duties, they would make themselves available to volunteer as research subjects. I conducted interviews with MRVS volunteers, and these exchanges convinced me that the reserve volunteers were a highly motivated and well-informed group. Some had not volunteered for an experiment in nearly three years, while others had volunteered for many. Two features of the MRVS program stand out. First, the group had a representative on the ethics committee. Second, MRVS members were not allowed to receive remuneration for research participation; monetary incentive was therefore not an issue (unlike volunteers in various civilian locales, for whom payment might be decidedly coercive). It is fascinating and ironic that, following a decidedly mixed history of human subjects protections, the Army had created one of the most admirably ethical human research programs in the world.

V. CONCLUSION

The mid-1970s was a critical period in the story of research protections. It was then that the Army and CIA hallucinogenic experiments were revealed and the original Nuremberg Code-based DoD policy memorandum was fully declassified and the policy itself analyzed. Several individual cases were acknowledged, including those of Blaur and Olson, and compensation arrangements were made. But as dramatic as these revelations were, they were somewhat overshadowed by contemporary scandals in civilian medical experimentation, such as the Tuskegee Syphilis Study and the gradual shutdown of prison experimentation.

How do we explain the fact that the infamous Tuskegee Syphilis Study and other events in the civilian medical world have acquired a familiar role in bioethics scholarship, but the national security experiments have received only minimal attention? I theorize that a lack of familiarity with the national security history and context is the culprit, including both the military and foreign policy aspects. Of course, little historical investigation and reflection is possible on such matters until the declassification of various documents. In addition, the Nixon administration’s dismantling of the U.S. biological and chemical weapons programs removed this research area from the lens of inquiry just as bioethical debates were emerging on topics such as human experimentation. Indicative of this is the fact that the Nuremberg Code has long been recognized as a crucial document in research ethics, but its application and relevance to United States military research have remained oblique until very recently. Only now is this lacuna in the scholarship being corrected. As our knowledge and awareness of the history of human experimentation and human research protocols increases, we can no longer ignore the importance of military medical experiments in the bioethics corpus.

These issues are not outdated. The fine line between “the line of duty” and

“human subjects experimentation” in the military context arose again during the 1991 Gulf War. During Operation Desert Storm, informed consent requirements were suspended for several chemical and biological agents that were used by

soldiers in Desert Storm.²² At that time, few bioethicists commented on this transgression. Allegations about Iraq’s tests of chemical and biological agents on political prisoners resurfaced in 1998, when U.N. inspectors reported that they were about to encounter a paper trail documenting the use of prisoners in experiments by the regime of Saddam Hussein. In the events following September 11, 2001 and the expulsion of Saddam Hussein from Iraq, questions of national security and medical ethics have burst onto the national scene with fervor. One issue is the need for government approval of potential bioweapons therapies that cannot ethically be tested in humans, yet may have to be given to large numbers of Americans in the event of a widespread biological attack. Another issue is the testing of vaccines to prevent a catastrophic disease event among civilians (such as a recurrence of smallpox). It remains to be seen whether the field of bioethics will achieve the imaginative leap to critically assess and integrate this neglected area. If it does not, it will fail to provide a relevant critical voice to the confluence between modern politics and scientific weapons research.

22 See Moreno, chapter nine, “Once More Into the Gulf.”

REFERENCES

Katz, Jay. “Informed Consent—A Fairy Tale? Law’s Vision.” University of Pittsburgh Law Review 29 (Winter 1977): 137-174.

Lederer, S. Subjected to Science: Human Experimentation in America Before the Second World War.

Baltimore: Johns Hopkins University Press, 1995.

Lederer, S. and M.A. Grodin. “Historical Overview: Pediatric Experimentation.” In Children as Research Subjects: Science, Ethics and Law. Edited by Michael A. Grodin and Leonard Glantz. New York: Oxford University Press, 1994.

Moreno, J. Undue Risk: Secret State Experiments on Humans. New York: Routledge, 2003.

Stone, R.S. “Irradiation of Human Subjects as a Medical Experiment.” In the records of the Advisory Committee on Human Radiation Experiments, Record Group #220, National Archives and Record Administration, Washington, D.C.

Thornwell v. The United States of America, 471 F. Supp. 344.

United States v. Karl Brandt et al., Vol. II, pp. 181-185.

“Volunteers Line Up to Test Smallpox Protection.” New York Times. November 3, 2001.

Wilson, C. Letter to Robert Stone, 5 November 1947. ACHRE No. DOE-052295-A-1.