The details, in the most egregious cases, are eye-opening indeed:
—In 1946 and 1947, in experiments conducted at the University of California at San Francisco, the University of Rochester, the University of Chicago, and Oak Ridge National Laboratory, 18 patients, most of them terminally ill, were injected with plutonium in an effort to determine how the radioactive chemical would spread through the body. In some cases, plutonium was injected into limbs which were amputated post-mortem for study. One of the subjects was a four-year-old boy.
—In a long-running experiment at the University of Cincinnati, ended in 1971, 88 poor, uneducated and mostly African-American patients with incurable cancers were exposed to heavy doses of full-body irradiation — a procedure that was largely abandoned as therapy by the 1960s. Lawsuits still in court allege that the subjects, some of whom died hours after treatment, were not provided palliatives against the side effects of nausea and vomiting because the researchers did not want the drugs to interfere with their data collection.
—During the 1940s, 800 pregnant women, the poor patrons of a pre-natal clinic at Vanderbilt University, were given a "cocktail" including a tracer dose of radioactive iron. The object of the experiment was to determine the iron requirements of pregnant women. Ongoing lawsuits point to a higher-than-usual incidence of malignancies in the children of the women subjected.
—At the Fernald School in Massachusetts during the 1950s, in experiments conducted in part by researchers from the Massachusetts Institute of Technology, mentally retarded boys in the school's "science club" were fed radioactive calcium and iron with their breakfast cereal. Boys who agreed to participate received club privileges, including extra milk and trips to baseball games and the beach.
Each of these experiments was sponsored by the federal government. In most cases, participation was unwitting: patients had no knowledge that they were being subjected to experimental radiation. In all, there were over 4,000 federally sponsored radiation experiments conducted between 1944 and 1974, when the Department of Health, Education, and Welfare issued rules for protecting human subjects in government-sponsored research. The patients involved numbered in the tens of thousands.
"We saw that a lot of people were affected by the nuclear age," says medical historian Susan Lederer. "And we had a chance to hear from many of them over the course of 18 months."
Lederer, associate professor of humanities at Penn State's Hershey Medical Center, was a member of the 14-person advisory committee appointed by President Clinton in January 1994 to investigate the human radiation experiments of the Cold War era. Chaired by Ruth Faden, director of bioethics at Johns Hopkins University, the committee included historians, ethicists, lawyers, and one representative of the public at large.
"Our mandate was several-fold," Lederer says. "First, to tell the story of the experiments — what happened and why. Next, to determine whether people were still at risk. And then to assess whether current protections are adequate."
The task turned out to be gargantuan. Over a year and a half, aided by a 60-person staff, the committee members retrieved millions of pages of documents from the Departments of Energy, Defense, and Health and Human Services, the CIA, and other agencies involved in radiation experiments. They pored over newspaper articles, court documents, and government memos, and held 20 public meetings in cities around the U.S., hearing testimony from former patients and their families, and conducted surveys of current hospital patients. When it was done, the committee had produced a 906-page document of its own. The report was formally presented to the President on October 3, 1995 — the same day, as luck would have it, as the reading of the O.J. Simpson verdict.
Human radiation experiments, then, didn't stand a chance — even though, as David Brown, writing for the Washington Post, put it, the committee's hefty final product "has rewritten the history of medical experimentation in the United States."
Actually, as Lederer points out, part of the problem in really understanding the why and how of the radiation experiments was that that history had never been properly written in the first place.
The radiation experiments hit the public consciousness in late 1993, with a Pulitzer-Prize-winning series of articles by Albuquerque Journal reporter Eileen Welsome that profiled some of the subjects of the post-war plutonium injections. These experiments had not been secret: Their results had been openly available in the medical literature for decades. In 1986, Congressman Edward J. Markey of Massachusetts had conducted hearings on "America's Nuclear Guinea Pigs," but those hearings were largely ignored. Following Markey's lead, however, Welsome was able to actually identify the individuals who received plutonium. "She put a human face on this," Lederer says.
This fresh revelation of these experiments, as Lederer writes in the introduction to her book Subjected to Science, combined with the recent disclosures of the infamous Tuskegee experiment — a 40-year study of untreated syphilis in African-American men — and of nerve and mustard gas testing conducted on U.S. soldiers during World War II, "has intensified many of the negative associations with human experimentation.
"At the same time, these disclosures have raised questions about the development of ethical standards for human experimentation. What, if any, were the rules of research involving human beings in the 1940s and 1950s? What ethical standards should we use to evaluate these earlier experiments?"
In order to better recreate the context in which these experiments were allowed to take place, the committee scoured the popular culture of the day, scrutinized decades-old memos and directives, and took oral histories from physician-researchers who were young practitioners in the years following World War II.
What they found, as Lederer relates, was an era that was in many ways a very different one for medical research.
Interviewee William Silverman, M.D., a pediatrician and researcher long affiliated with Columbia University, remembered a medical culture during the 1940s that firmly inculcated a paternalistic attitude among physicians, a relationship in which the patient was told as little as possible, and all risks were minimized. "The model was in religion," Silverman told interviewer Gail Javitt, a member of the committee staff. "That is, faith in the priest who will speak to God to get the answer. We were encouraged to behave like priests."
There was, given such a climate, a different understanding of the notion of informed consent. "In the '40s, '50s, and '60s," Lederer explains, "most investigators realized that when using healthy subjects, informed consent was important." But there was no such mandate to obtain consent from people who were already sick. "If you were a hospital patient in 1950, and an investigator wanted to conduct an experiment on you, he would not have felt that consent was necessary."
Still, she adds, "There were rules. Experimental ethics was 4not a terra incognita."
The term "informed consent," the committee found, shows up as early as 1947, in a memo by a top official of the Atomic Energy Commission regarding the Manhattan project. The so-called Nuremberg Code, a statement of ethical principles established during the trial of Nazi scientists after World War II, was adopted by Secretary of Defense Charles Wilson in 1953. Strangely, this directive was kept secret until 1975.
"There was a disconnect," Lederer says. "People at the policy level were articulating standards, but these were not communicated to the people in the field. Implementation was extraordinarily imperfect."
In Silverman's recollection, informed consent did not become an issue until 1966, when the U.S. Surgeon General, responding to a heavily reported case in which live cancer cells were injected into elderly patients in a Brooklyn hospital, issued a memorandum calling for the establishment of institutional review boards or IRBs, in-house panels which would impartially judge the ethical propriety of all clinical trials.
Before IRBs, Silverman recalled, the only consent required for a clinical trial was that of a researcher's department head. The Nuremberg Code was ignored in practice. "As I look back on it," Silverman told Javitt, "the interpretation of these codes was that they were necessary for barbarians, but not for fine upstanding people, especially at Columbia University. In this prestigious unit we had a very strong obligation to behave in a civilized manner. Everything was open — the results were reviewed and published in reputable journals. These, we told ourselves, were the patients's best safeguard."
Most of the radiation experiments, the committee found, involved very low dosages of radioactive material, tracers in amounts similar to those still used today. "Most," its report states, "were unlikely to have caused physical harm."
Furthermore, Lederer acknowledges, "a lot of the radiation experimentation that was conducted greatly advanced medical understanding and treatment. It did a lot of good." Nuclear medicine, with its advances in diagnostics, would not have been possible without these experiments, she asserts. Radiation therapies for various cancers also benefited. "The quality of images produced by external radiation was improved, which made possible angiography, and other imaging techniques."
"The cost," she adds, "was erosion of confidence in the government, and in researchers.
"One of the tensions in all of this is government secrecy. Much of the Energy Department's work was cloaked in secrecy — the whole nuclear power thing. Same with the Department of Defense."
The committee heard testimony from Navajo uranium miners who were not warned of the increased risk they ran of developing lung cancer by virtue of their daily exposure to the radioactive element. "The AEC actually had an agreement with the mine owners not to disclose," Lederer says, "and it didn't." These miners were nonetheless followed as data points, many for decades, by the U.S. public health service.
Surprisingly, she found, the rationale given for such secrecy was rarely national security. Rather, "It was fear of liability, or of making the agency look bad."
As a consequence, the Advisory Committee on the Human Radiation Experiments, "felt a responsibility to be very open with the public, to overcome decades of twilight." All the committee's deliberations were held in public. As well as in the nation's capital, the panel met in Cincinnati, Knoxville, Albuquerque, Spokane, and San Francisco. ("The Bay Area was a big center for radiation experiments.")
"We were open to those with grievances," Lederer says. "We had public testimony at every meeting." In Spokane, they heard from people who had lived in the vicinity of the Hanford nuclear power plant during the late '40s, when there were deliberate releases of Iodine 131 into the atmosphere as part of an effort to develop the means to measure releases by the Soviets. "The amounts released were very small," Lederer acknowledges. "Our reading of it was that there wasn't enough to cause physical harm. What was harmful, however, was the secrecy, and the element of distrust that grew up in the community. Some of that information is still classified. People have been worried about it for decades. It was disheartening to see them come up and talk about their uncertainty."
Although the culture in which the Cold War-era experiments were commissioned and conducted was indeed a different one, the radiation committee concluded, it was not so different as to justify what went on. Then as now, the committee wrote in its final report, it was wrong "to treat people as mere means, wrong to inflict harm, wrong to deceive people. Even 50 years ago, these principles were pervasive features of moral life in the United States."
On October 3, when the committee formally presented its findings to the President, chair Ruth Faden added, in her remarks: "What most troubled the committee was the lack of respect for the American people that seemed to permeate the conduct of research."
President Clinton, for his part, offered an apology "to the survivors and their families and to all the American people."
The committee's report, which begins by tracing the history of nuclear medicine all the way back to William Roentgen's discovery of x-rays in 1895, concludes with several recommendations for new laws and regulations promoting openness, informed consent, and ethical practice in biomedical experimentation. It suggests compensation for a total of about 30 individuals subjected to dangerous experiments without their knowledge, and establishes guidelines for providing compensation and/or official apology to other unwitting subjects. Clinton, in response, called for the establishment of a National Bioethics Advisory Commission to set policy for future experimentation.
Despite the existence of IRBs and other ethical safeguards now in place, the committee warned, research abuses can still occur. As Lederer explains, the concern expressed was not specifically directed toward experiments involving radiation, each of which must now pass muster, above and beyond an IRB, through an institutional safety panel specifically designated for work involving radioactive materials. Rather, "we were speaking more to research in general."
Today's experimental consent forms, Lederer notes, "often appear to overstate the therapeutic potential of the work. There is also a tendency to confuse research with treatment. It's important that patients be made aware that they may not benefit individually from an experimental treatment."
At the same time, risks are often not adequately explained. "When using vulnerable patients — pregnant women seeking care, children in institutions, prisoners — the question involved with consent is how do you maximize autonomous decisionmaking by providing adequate information." In the '60s, she notes, inmates at a prison in Washington state were paid for allowing their testicles to be irradiated. "Can prisoners give uncoerced consent?" she wonders. "And in a prison economy where they were offered five dollars a day against the usual pay of thirty cents an hour? Were the risks adequately disclosed?"
In a survey conducted among current hospital patients, the commmittee found that lay people tend to discriminate between terms like "experiment" and "clinical investigation" — terms that are often used interchangeably by medical researchers. (The term "experiment," not surprisingly, evokes a higher negative response in potential subjects.) This discrepancy hints at some of the legal and ethical complexity involved in providing for a consent that is truly informed.
The survey also found that the majority of lay people are kindly disposed, by and large, toward biomedical research: only 5 percent feel unfavorably toward it, while 52 percent feel "very favorable." For the historian, this result corroborates a trend that runs counter to the revelations of abuse.
"There's been an interesting shift in the value that society accords experimentation," Lederer says. "Before, it was regarded as irregular practice. Now, mistakenly, all experiments are perceived as providing great benefit.
"Over the course of this century," she adds, "medical experimentation has been transformed from a burden, to be borne by the socially marginal, to a benefit, for which people actively campaign to gain access. One of the ironies in that change is that all the protections instituted have made it more difficult for vulnerable people to get cutting-edge treatments."
Susan E. Lederer, Ph.D., is associate professor of humanities in the College of Medicine, The Milton S. Hershey Medical Center, Pennsylvania State University, 500 University Drive, Hershey, PA 17033; 717-531-8779. Copies of the report of the Committee on Human Radiation Experiments can be obtained by writing to the U.S. Government Printing Office, P.O. Box 371954, Pittsburgh, PA 15250-7954, or by calling 202-512-1800.