January/February 1996
Vol. 52, No. 1


The Verdict:

No Harm, No Foul

By Danielle Gordon

A national panel says that thousands of men, women, and children were dosed with small amounts of radiation, to little lasting effect. Nonsense, say the critics.



After 18 months spent examining the records of 4,000 human radiation experiments and hundreds of intentional radiation releases, a 14-member "national ethics commission" found that only a few hundred people should get medical notification, compensation, or even a personal apology from the federal government. The committee concluded that most of the tens of thousands of subjects cannot be identified or came to little physical harm, although the ethical costs of these experiments were high.

Between 1944 and 1974, the federal government authorized and funded experiments to test the effects of radiation on humans. According to the report of the Advisory Committee on Human Radiation Experiments, released in October, the majority of research involved radioisotopes used as tracers to "map" human metabolism, with no harmful effect: "Often nonbeneficial experiments on unconsenting patients constituted only minor wrongs. Often there was little or no risk to patient-subjects and no inconvenience."

But some of the details found in 840,000 pages of documents collected by the committee clash with this overall assessment, according to critics of the report. For example, institutionalized children and adult prisoners were used in experiments, some cancer patients died after being given total body irradiation with no medical benefit, and 410 uranium miners died of lung cancer from a radon hazard that could have been avoided.

The committee was established in January 1994 by Energy Secretary Hazel O'Leary, shortly after the Albuquerque Tribune revealed that 18 people had been injected with plutonium in a secret Manhattan Project experiment begun in April 1945. The Tribune series won a host of awards including a Pulitzer Prize and captured the public's attention.

President Bill Clinton, members of Congress, and even critics of the committee's report agreed that it provided unprecedented insight into a murky area of American history. But activists are up in arms over the committee's "no harm, no foul" recommendations. They question why so few people will receive any notification or apology, why others will not be given compensation, and why certain subjects of radiation experiments were left out of the committee's consideration.

Instead of closing this ugly chapter in America's atomic history, "The committee's report constitutes a continuing conspiracy to conceal the facts," said David Egilman, a clinical assistant professor of medicine at Brown University. According to E. Cooper Brown of the Task Force on Radiation and Human Rights, a coalition of 30 organizations representing citizens exposed to radiation, "We refuse to accept the committee's conclusion that, for those who were put at risk, a warning would be of no benefit. These are the very kinds of determinations and judgments that made the radiation experiments possible in the first place."


American ethic

The experiments occurred at "one of those times in history in which wrongs were committed by very decent people who were in a position to know that a specific aspect of their interaction with others should be improved," the committee concluded. It praised the goals of the investigators: "The seeming likelihood that atomic bombs would be used again in war . . . meant the country had to know as much as it could, as quickly as it could."

But the means the radiation investigators used were another story. As far back as the 1940s, officials with the Atomic Energy Commission (AEC), Defense Department, and other agencies involved, should have known better, the report said: "So many of the ideas and values with which we are familiar were apparent then."

Under the Nuremberg Code of Medical Ethics adopted in 1949, researchers were required to get consent and could not conduct experiments in which the harm outweighed the potential benefit to an individual. The committee found "no evidence that any government statement . . . contained a provision permitting a waiver of consent requirements for national security reasons."

But researchers were rarely held to, or even informed of, these policies. For example, a stack of copies of the Nuremberg Code was found in Defense Department files, all stamped "top secret." Some doctors did not seek consent from sick patients because they viewed their experiments as justified medical tinkering. Even when there was no prospect of medical benefit, it was common for researchers to conduct experiments without patient consent.

While the committee could not determine if there were "systematic injustices" against certain groups, it found that "ethically troubling [experiments] were conducted on institutionalized children, seriously ill and sometimes comatose patients, African-Americans, and prisoners." Testimony before the committee showed that the poor were seen as appropriate subjects because, as Paul Beeson, a professor at Emory University in the 1940s, said, "We were taking care of them, and felt we had a right to get some return from them, since it wouldn't be in professional fees and since our taxes were paying their hospital bills."

Perhaps most important, the committee found that hiding experiments from subjects was simply the norm. While national security was often used as a justification, secrecy had more to do with "concern for embarrassment to the government, potential legal liability, and concern that public misunderstanding would jeopardize government programs." In some cases, secrecy lasted to the present day. About 250 intentional radiation releases near a Pueblo reservation in New Mexico between 1944 and 1961 were not made public until 1994.

That secrecy had devastating results for science, according to Jackie Kittrell, one of the founders of the American Environmental Health Studies Project and a lawyer representing about 200 women who accuse Vanderbilt University of giving them radioactive iron in what was called a "cocktail." She argued that legal and insurance concerns subverted medical findings: "A veil of secrecy was lowered over the medicine and science of radiobiology. The potential knowledge of that period was warped, subverted, and lost."

What harm done?

The committee found that most of the experiments involved radioactive tracers that caused little harm. In a few non-therapeutic tracer experiments with children, however, "Radioisotope exposures were associated with increases in the potential lifetime risk for developing cancer that would be considered unacceptable today." In some cases, "Patients died soon after receiving external radiation or radioisotope doses in the therapeutic range that were associated with acute radiation effects."

In the 1940s and 1950s, injections of radioactive isotopes, including plutonium and uranium, were given to more than 40 people to learn about the occupational dangers facing nuclear workers. The risks from these experiments were supposed to be low, since most of the people given injections were considered very sick. In fact, some patients had the potential to-and did-live more than 10 years. A few University of Rochester subjects injected with uranium isotopes were suffering from no more than alcoholism or malnutrition.

And the occasional choice of relatively healthy people may not have been accidental: "Although this protocol specified cancer patients as potential subjects, evidently the deliberate choice was made later by the experimenters to select patients without malignant diseases in the hope of ensuring normal metabolism," the committee said. "The uranium injections at Rochester were designed to produce detectable minimal harm-that was the endpoint of the experiment."

The government also sponsored 30 years of total body irradiation experiments. In the early years, total body irradiation was thought to be a legitimate treatment for cancer. But "dual-use" experiments continued even after evidence was found that other treatments were more effective-and less risky. "There was no indication that the army reviewers considered whether any therapeutic benefits to the patients outweighed the risks that the TBI treatments might pose," the committee said of one series of treatments. Total body irradiation "may have contributed to the deaths of at least eight and as many as 20 patients," according to contemporaneous reports.

Prisoners and institutionalized children were targeted in some radiation experiments. The committee found that 11 of 21 research projects they reviewed "exposed children to much higher risk than is acceptable today," partly because of an inadequate understanding of radiation. One of these experiments involved small amounts of radioactive substances with no medical benefit given to institutionalized mentally retarded children at the Fernald State School in Massachusetts. Between the late 1940s and 1961, researchers manipulated these children into participating in experiments by offering special treats like extra milk, occasional outings, and membership in a "Science Club."

In addition to medical experiments, government contractors released radiation into the environment on hundreds of occasions between 1944 and 1968, mostly around the nuclear weapons complexes where residents already were subject to numerous unintentional releases. The committee found that the scientists responsible knew intentional releases carried risks.

In the infamous 1949 "Green Run" release, radioactive gas was deliberately and secretly discharged from the Hanford site in Washington state. It is unlikely that the Green Run killed anyone, but it did increase the incidence of thyroid disease, including cancer. The committee added that the fact there was little harm was a matter of luck, not planning: "In 1949, at the time the Green Run was conducted, the most important environmental pathways for human exposure to radioiodine were unknown."

The committee also looked at the effects on uranium miners of exposure to naturally occurring radon. The miners were not part of a traditional experiment, but the committee concluded that in the 1950s, the AEC did not inform the miners of the hazards of this exposure or require ventilation systems to protect them, while collecting data on their health. This "intergovernmental buck passing and decades of study . . . resulted in the premature deaths of hundreds of miners." The committee added, however, that there was not "enough information to assess the moral responsibility of individual AEC and PHS [Public Health Service] employees and officials for these failures." By 1990, 410 of the 4,100 miners studied had died of lung cancer. Normally, only 75 lung cancer deaths would be expected in a group of miners this size.

Mostly harmless

"Damage is measured in the pain felt by people who believe that they or their loved ones were treated with disrespect for their dignity," according to the committee.

But this kind of damage alone does not warrant medical follow-up or financial compensation under the committee's recommendations to Congress. None of these recommendations, however, bar individuals from seeking compensation from private institutions or state government-if they learn of their exposure.

The committee concluded that to be eligible for medical notification from the government, a person must have an increased lifetime risk of dying from radiation-induced cancer of more than one in 1,000 (compared to the normal lifetime risk of 220 per 1,000).

One group exceeded this level of risk. Between half a million and 2.3 million schoolchildren throughout the country, according to the Centers for Disease Control and Prevention, were part of nasal radium experiments or received these treatments between 1945 and 1965 for ear and adenoid infections. The committee estimated they would have a 4.35 per 1,000 lifetime risk of incurring deadly tumors to the central nervous system-a 62 percent increase over the normal risk. Using these numbers, Stewart Farber, a consulting scientist and organizer of the Radium Experiment Assessment Project, concluded that between 2,368 and 10,241 people would die of cancer from this exposure.

But these subjects should not be notified because, according to the committee, they would not benefit medically from early detection and treatment of their cancers: "At greatest risk are the brain, and head, and neck tissues, for which there is neither an acceptable nor recommended screening procedure." Thus, the committee concluded there was "no subject of biomedical experiments for whom there is a need to provide active notification and medical follow-up for the purpose of protecting their health."

Subjects of other experiments will at least hear from the government-if their names are found. For the subjects of intentional releases and the uranium workers, the committee recommended changes in existing environmental exposure compensation laws to include additional subjects and diseases.

A select few should get personal, individual apologies and financial compensation, regardless of whether they suffered physical harm. This group includes the families of 18 people who received plutonium injections in the experiments described by the Albuquerque Tribune; one woman-known only as CAL-Z-who received a zirconium injection in 1948; and several who received total body irradiation during World War II. These people were singled out because the committee found conclusive evidence that the government kept information secret from them for the express purpose of avoiding embarrassment and liability. Only the identities of those who received plutonium are known.

Other individuals would be eligible for apologies and financial compensation-medical expenses and related harms-if they met two requirements: if they suffered physical harm, and if the experiments were misrepresented as conventional treatments or had no direct medical benefit. Some of the people that may meet these requirements, but will have to prove it in court, are the subjects of total body irradiation, iodine 131 and uranium injections, and a group of prisoners who received testicular irradiation.

The committee was divided on what to do about other experiments with no medical benefit and no physical harm. Early drafts of the report included recommendations that individual apologies be offered as "a symbol of the country's expression of regret to all others who were similarly situated but who may not now be identifiable." But three committee members did not support this recommendation.

In the end, the committee agreed to recommend apologies in cases where people were unjustly selected as subjects or there was clear and conclusive evidence they did not give consent. Under these requirements, only the Fernald children, prisoners, and some people who received radioactive injections will receive individual apologies.

The committee added that there are probably many other groups that deserve apologies, but "experiment-specific factual support is not currently available." Instead, they will have to settle for President Clinton's October 3 speech, which included a general apology to all subjects and to the American public.

Not far enough

Even before the committee's recommendations were released, critics attacked its decision to base compensation on the consequences of experiments rather than ethical transgressions. Under the committee's notion of harm, "If the government shoots someone and misses, they are under no obligation to apologize for the shooting. The bullet must have hit and seriously injured or killed someone in order to elicit an apology," Egilman of Brown University said. Plaintiff lawyer Leonard Schroeter called the recommendations a sellout that will result in the "betrayal of hundred of thousands of victims of radiation experiments," and decrease "confidence in an already beleaguered government."

In addition to dismissing many human rights claims, the committee did not consider precedents for compensation for non-physical harm or a legal theory for compensation based on the "rental" of an experimental subject's body, Anthony Roisman of the Human Experiment Litigation Project said. The committee report "essentially holds no one responsible or accountable for their actions," said Brown of the Task Force on Radiation and Human Rights.

"The government still is making decisions from its pocketbook, and is scared to look too deeply," lawyer Kittrell said. But Washington attorney Kenneth Feinberg, a member of the committee, defended the decision to limit compensation in a Washington Post op-ed piece. "These recommendations deserve consideration both by the public and policy makers all too eager to find wrongdoing and write a blank check to the victims. . . . The mere possibility of compensation breeds a proliferation of grievances-real and imagined."

Roisman argued that by limiting the possibility of compensation, the committee is "dispensing justice by political committee." The federal government is protected from lawsuits by sovereign immunity. "Whether by congressional act or executive order, justice requires that this shield be set aside, for it is only through the court-sanctioned discovery process that individual experiment victims and their families will finally gain access to the full truth," Brown said.

Sen. John Glenn, an Ohio Democrat, was more concerned with the lack of medical monitoring offered to subjects. "It seems to me that the government has a moral and ethical responsibility to provide health tests and monitoring to those people involved in these experiments-even if the risk of cancer is infinitesimally small," he said.

Brown University's Egilman also disagreed with the committee's decision to assess harm by looking at deaths rather than illness, and to notify only those people with a more than one in 1,000 increased risk of dying: "Given the committee's guidelines, a government experiment on 50,000 people attending a football game which is expected to cause 50 deaths is an acceptable form of covert experimentation." He compared this to Environmental Protection Agency standards for regulating hazards with risks of one in 100,000. "The committee's report will set risk assessment and regulatory efforts back several decades," he said.

Egilman added that by not providing notification and medical follow-up, the government has shifted the burden of proof to subjects, while refusing them necessary epidemiological studies. "The Nuremberg Code states 'the duty and responsibility for ascertaining the quality of consent rests upon each individual who initiates, directs, or engages in the experiment,'" he pointed out.

Other critics questioned whether the scientific knowledge to make decisions about risk is even available. Lawyer Kittrell argued that the committee recognized that government fear of litigation "led to the scientific and medical process not having integrity. But then it buys into the results of this distorted process without doing the necessary follow-up."

The issue of medical notification was particularly contentious for the subjects of nasal irradiation. Lorraine Marin, a board member of the North American Brain Tumor Coalition and a radiation oncologist, said although there is no cheap or simple screening tests for brain, head, and neck cancers, "there is a medical benefit to people knowing if they were subject to nasal radiation. They could alert their doctors and get more complete checkups." She added: "Ideally the government should sponsor an epidemiological study."

Geoffrey Sea, director of the Atomic Reclamation and Conversion Project, added that the increased risk to these children is actually much higher than the committee's estimate of 62 percent. "This estimate is just for brain cancer. The committee ignored the risks of thyroid, nasopharyngeal, and other cancers," he said.



Left out

The committee said that its "ability to review all the experiments and [intentional] releases was limited not only by time and resources, but even more so by the information available. For the majority of experiments identified, only the barest descriptions remain." But plaintiff lawyer Schroeter provided a different explanation: "It turned out to be a potential Pandora's box, [and] political expediencies appear to be prevailing."

Sea said that particular experiments were marginalized by the committee "because it was impossible, given the overwhelming evidence, to say they caused no harm." These experiments include the University of Cincinnati total body irradiation experiments-implicated in eight deaths-in which the committee refused to review the available medical records. In addition, the committee commissioned its own study of the doses given to fetuses at Vanderbilt when faced with an 1967 AEC epidemiological report that showed three children died of radioiron-induced cancers. "They couldn't accept the conclusion of harm, so they tried to make something out of the incomplete dosimetry data," Sea said.

Farber of the Radium Experiment Assessment Project contended that the committee ignored the 7,000 military personnel who received nasal irradiation in the 1940s for pressure-related ear problems. The committee originally contended they were not part of an experiment, although a February 1994 internal navy memo said that the initial use of radium on submariners was considered human- subject research. In the end, the committee said some of them were part of an experiment but they "did not attain our arbitrary 1/1,000 criterion for risk."

Jack Geiger of the City University of New York Medical School criticized the committee for focusing on intentional releases of radiation into the environment while ignoring the more common routine releases. He argued that these, too, were "experiments on public health without public awareness." He added that nuclear weapons plant and cleanup workers are the subjects of experiments in their daily work: "To put workers in situations of risk without information on the effects constitutes an experiment."

Kittrell, who has done archival work in the human radiation experiment field, said the committee could have identified more individuals. "Many of the names are out there, in the possession of private institutions. The government has not made the right effort to get at these names." She noted that Vanderbilt University has the names of about 400 women involved in radiation studies, which it has refused to release. "The committee should have been given subpoena power so it could have ordered private organizations to release information."

But Dan Guttman, the committee's executive director, said while the committee found few names, it opened thousands of records to the public. "We are making a database available, and the search for names will be a bottom-up rather than a top-down operation, which is the only practical way," he said. In addition to this database, the committee recommended that CIA records on human experiments become top priority for declassification. While it found no evidence of CIA-sponsored radiation experiments, "numerous documents, some of which remain partially classified, make reference to possible CIA interest in this area," the committee said.



The right committee?

For some critics, the shortcomings in these recommendations reflect the biases of the committee. Their backgrounds "interfered with their ability to objectively analyze the historical evidence," Egilman of Brown University said. Sea of the Atomic Reclamation and Conversion Project pointed out that there were no subjects of experiments on the committee, although the inclusion of a representative from the most affected community is a requirement for many presidential committees. The committee also had only one biostatistician and no epidemiologist: "It was heavily weighted toward radiation biologists, oncologists, and lawyers. It was weak in terms of public health," said David Rush, head of the epidemiology program at Tufts University.

"I have a suspicion that at root, there was too much deference to the experiment industry by this committee," Roisman of the Human Experiment Litigation Project said. Four of the committee's 14 members were from institutions where human radiation experiments were, and may still be, carried out. For example, committee chair Ruth Faden is director of the Bioethics Institute at Johns Hopkins University. In the 1940s, Johns Hopkins trained "the Army and Navy doctors who performed the initial experiment and popularized the radium nasal irradiation procedure," Farber wrote in a letter to Faden.

In addition, committee member Henry Royal co-authored two studies on the health effects of Chernobyl with Eugene Saenger, the chief researcher behind the total body irradiation experiments at the University of Cincinnati. Royal acknowledged this connection, but explained in a letter to Faden that they did not work together on the project and had only limited social interaction. The committee did not ask Royal to recuse himself from reviewing the Cincinnati experiments.

Committee Executive Director Guttman called the charges against these members scandalous. "The fact of the matter is that all experts in this field have some affiliation with some institute being investigated." Noting that the committee devoted a great deal of its time, and much criticism, to the research being done today with human subjects (see "Experimentation Continues," page 36), he said, "If there was a conflict for these people, they wouldn't have criticized current research at their own institutes."

Perhaps the most intense criticism was directed at committee member Feinberg, whose Washington law firm specializes in mediation and negotiation. Sea of the Atomic Reclamation and Conversion Project said that in the committee's public hearings, "Royal and Feinberg worked as a team. Royal the scientist would declare there was no harm, and Feinberg the lawyer would say well then, nothing need be done."

Feinberg was the settlement negotiator in the Agent Orange mass tort case. The case was settled in 1984 for $180 million or an average settlement for total disability or death of less than $5,000 per person, Washington-based public interest attorney Rob Hagen said. Schroeter, in a 1994 article for the Gonzaga Law Review, said Feinberg was "instrumental in disposing for a pittance, the claims of more than two million Vietnam veterans who had been exposed to Agent Orange." Tod Ensign, director of the veteran's group Citizen Soldier, told a House Veterans Affairs Subcommittee shortly after the committee was named, "There is a deep suspicion that [Feinberg] has been placed on the panel so that, once again, he can minimize the assistance provided to ailing veterans."

While a member of the committee, Feinberg sent a letter to San Francisco law firm Leiff, Cabraser & Heimann, which is representing the Vanderbilt subjects, offering his services as a mediator in their class action case against Vanderbilt University. Feinberg said offering his services in this human radiation case "does not present a conflict" because the negotiation would be non-binding and he would be willing to do this work for free. He has not received a response from the Vanderbilt lawyers.

The right thing

President Clinton accepted the committee's report in a White House ceremony on October 3. In his remarks he said-five times-that America must "do the right thing" for the subjects of radiation experiments. "Our greatness is measured not only in how we so frequently do right, but also how we act when we know we've done the wrong thing; how we confront our mistakes, make our apologies, and take action."

The committee no longer has the authority to decide what should be done for these people. Eighteen months and 925 pages later, its offices are closed and phones disconnected. And the subjects of human radiation experiments now look to Congress, which is expected to take up some of the committee's recommendations this year, to do the right thing.