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"Subjected to Science" by: David Pacchioli
(Research/Penn State, Vol. 17, no. 1 (March, 1996))
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.
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