Radiation Experiments on Humans
Dave H
DOE Openness: Human Radiation Experiments: Roadmap to the Project
ACHRE Report
ACHRE Report
Part II
Chapter 5
Introduction
The Manhattan District Experiments
The AEC's Reaction: Preserving Secrecy while Requiring
Disclosure
Human Experimentation Continues
Conclusion Chapter 5: The Manhattan District Experiments
The First Injection
A few days after Hempelmann's March 26, 1945, recommendation
that a
hospital patient be injected with plutonium, Wright Langham, of
the
Los Alamos Laboratory's Health Division, sent 5 micrograms of
plutonium to Dr. Friedell, with instructions for their use on a
human subject.[20] The subject, as it turned out, was already in
the
Oak Ridge Army hospital, a victim of an auto accident that had
occurred on March 24, 1945.[21] He was a fifty-three-year-old
"colored male"[22] named Ebb Cade,[23] who was employed by an
Oak
Ridge construction company as a cement mixer. The subject had
serious fractures in his arm and leg, but was otherwise "well
developed [and] well nourished."[24] The patient was able to
tell
his doctors that he had always been in good health.[25]
Mr. Cade had been hospitalized since his accident, but the
plutonium
injection did not take place until April 10. On this date,
"HP-12"
(the code name HP--"human product"[26]--was later assigned to
this
patient and to patients at the University of Rochester) was
reportedly injected with 4.7 micrograms of plutonium. (It is
important here to distinguish between administered dose and
retained
dose; not all of the injected dose would remain fixed in the
body.
It was not known with certainty, however, how much of the 4.7
micrograms of plutonium would remain in his body.)
The small amount of material injected into Mr. Cade would not be
expected to produce any acute effects, and there is no
indication
that any were experienced. However, except for his fractures,
Mr.
Cade was apparently in good health and at age fifty-three could
reasonably have been expected to live for another ten to twenty
years. Thus, in Mr. Cade's case, the risk of a plutonium-induced
cancer could not be ruled out.
Dr. Joseph Howland, an Army doctor stationed at Oak Ridge, told
AEC
investigators in 1974 that he had administered the injection.
There
was, he recalled, no consent from the patient. He acted, he
testified, only after his objections were met with a written
order
to proceed from his superior, Dr. Friedell.[27] Dr. Friedell
told
Advisory Committee staff in an interview that he did not order
the
injection and that it was administered by a physician named
Dwight
Clark, not Dr. Howland.[28] The Committee has not been able to
resolve this contradiction.
Measurements were to be taken from samples of Mr. Cade's blood
after
four hours, his bone tissue after ninety-six hours, and his
bodily
excretions for forty to sixty days thereafter.[29] His broken
bones
were not set until April 15--five days after the injection--when
bone samples were taken in a biopsy.[30] Although this was
several
weeks after his injury, during this era when antibiotics were
only
beginning to become available, it was common practice to delay
surgery if there was any sign of possible infection. One
document
records that Mr. Cade had "marked" tooth decay and gum
inflammation,[31] and fifteen of his teeth were extracted and
sampled for plutonium. The Committee has not been able to
determine
whether the teeth were extracted primarily for medical reasons
or
for the purpose of sampling for plutonium. In a September 1945
letter, Captain David Goldring at Oak Ridge informed Langham
that
"more bone specimens and extracted teeth will be shipped to you
very
soon for analysis."[32] It remains unclear whether these
additional
bone specimens were extracted at the time of the April 15
operation
or later.
According to one account, Mr. Cade departed suddenly from the
hospital on his own initiative; one morning the nurse opened his
door, and he was gone.[33] Later it was learned that he moved
out of
state and died of heart failure on April 13, 1953, in
Greensboro,
North Carolina.[34]
The experiment at Oak Ridge did not proceed as planned. "Before"
and
"after" urine samples were mistakenly commingled, so no baseline
data on kidney function was available.[35] Thus, the subject's
kidney function would be difficult to assess. In May 1945,[36]
Dr.
Stone convened a "Conference on Plutonium" in Chicago to discuss
health issues related to plutonium, including the relationship
between dose and excretion rate, the permissible body burden,
and
potential therapy and protective measures.[37] Wright Langham
spoke
about the Oak Ridge injection at the conference, carefully
qualifying the reliability of the excretion data obtained from
Mr.
Cade. Langham observed that "the patient might not have been an
ideal subject in that his kidney function may not have been
completely normal at the time of injection"[38] as indicated by
protein tests of his urine.
The Chicago Experiments
On April 11, the day after the Oak Ridge injection, Hymer
Friedell
transmitted the protocol describing the experiment on Mr. Cade
to
Louis Hempelmann at Los Alamos. "Everything went very smoothly,"
he
wrote, "and I think that we will have some very valuable
information
for you."[39] He then went on to discuss the injection of more
patients: "I think that we will have access to considerable
clinical
material here, and we hope to do a number of subjects. At such
time
as we line up several patients I think we will make an effort to
have Mr. Langham here to review our setup."[40]
Subsequently, between late April and late December of 1945,
three
cancer patients, code-named CHI-1, 2, and 3, were injected with
plutonium. At least two and possibly all three were injected at
the
Billings Hospital of the University of Chicago. The doses to
subjects CHI-2 and CHI-3 were the highest doses administered to
any
of the eighteen injection subjects--approximately 95
micrograms.[41]
However, the amount of material injected was still below what
would
be expected to produce acute effects. Moreover, unlike Mr. Cade,
all
three of these patients were seriously ill and at least two of
them
died within ten months of receiving the injection. That the
selection of seriously ill patients was an intentional strategy
to
contain risk is indicated in a 1946 report on CHI-1 and CHI-2:
"Some
human studies were needed to see how to apply the animal data to
the
human problems. Hence, two people were selected whose life
expectancy was such that they could not be endangered by
injections
of plutonium."[42] It remains a mystery why CHI-3 was not
included
in this report.
On April 26, 1945, CHI-1, a sixty-eight-year-old man who had
been
admitted to Billings Hospital in March, was injected with 6.5
micrograms of plutonium. At the time of injection he was
suffering
from cancer of the mouth and lung. The patient reportedly
"remained
in fair condition until August 1945, when he complained of pain
in
the chest."[43] His lung cancer had apparently spread, and he
died
on October 3, 1945.[44]
The next injection took place eight months later. CHI-2 was a
fifty-five-year-old woman with breast cancer who had been
admitted
to Billings Hospital in December 1945 after the cancer had
already
spread throughout her body. The 1946 report recorded that "the
patient's general condition was poor at the time of admission
and
deteriorated steadily throughout the period of
hospitalization."[45]
She was injected with 95 micrograms of plutonium on December 27
and
died on January 13, 1946.[46]
There is little known about the condition of CHI-3, the other
subject who was injected with approximately 95 micrograms. He
was a
young man suffering from Hodgkin's disease, reportedly injected
on
the same date as CHI-2.[47] His condition at the time of
injection
remains unknown, as does his date of death. There is some
question
whether he was injected at Billings hospital or at another
hospital
in the Chicago area.[48]
There was no discussion of consent in the original reports on
the
Chicago experiments. However, a draft report on an interview
conducted with E. R. Russell for the 1974 AEC investigation into
the
experiments (Russell was coauthor of the 1946 report on the
Chicago
experiments) summarized Russell's description of consent as
follows:
"[H]e prepared the plutonium solutions for injection and acted
together with a nurse as witness to the fact that the patient
was or
had been informed that a radioactive substance was going to be
injected. The administration of this substance, according to
what
was said in obtaining consent, was not necessarily for the
benefit
of the patients but might help other people."[49] To say that
the
injection was "not necessarily" for the benefit of the patient
implies that there was some chance these patients might benefit;
in
fact, there was no expectation that this would occur.
Russell's account was obtained in the context of an official
inquiry
into his conduct and the conduct of the other investigators and
officials involved in the plutonium injections, an inquiry that
focused on whether consent was obtained from the subjects. We
have
no way of corroborating this account or of assessing what Dr.
Russell's motivations were in explaining the plutonium
injections to
the subjects in the way claimed.
The Rochester Experiments
By the time the war began, the University of Rochester, which
had a
cyclotron, had assembled a group of first-rate physicists and
medical researchers who were pioneering the new radiation
research.
Following the selection of the university's Stafford Warren to
head
its medical division, the Manhattan Project turned to Rochester
for
an increasing share of its biomedical research--including, in
particular, research needed to set standards for worker
safety.[50]
The university's metabolism ward, at what is now the Strong
Memorial
Hospital, became the central Manhattan District site for the
administration of isotopes to human subjects. The two-bed ward,
headed by Dr. Samuel Bassett, was part of the Manhattan
District's
"Special Problems Division," which worked on the health
monitoring
of production plants, the development of monitoring instruments,
and
research on the metabolism and toxicology of long-lived
radioactive
elements.[51] An experimental plan called for fifty subjects
altogether, in five groups of ten subjects each. Each group
would
receive plutonium, radium, polonium, uranium, or lead.[52]
Although
the exact number of subjects remains unknown, at least
twenty-two
patients were administered long-lived isotopes in experiments
with
plutonium (eleven subjects), polonium (five subjects), and
uranium
(six subjects).
At the time the experiment was being designed, the main
selection
criterion for the subjects chosen at Rochester for the plutonium
experiment was that they have a metabolism similar to healthy
Manhattan Engineer District workers. In a work plan for the
plutonium study based on a September 1945 meeting with a
representative of Colonel Warren's office and the Rochester
doctors,
Langham wrote:
The selection of subjects is entirely up to the Rochester
group.
At the meeting it seemed to be more or less agreed that the
subjects might be chronic arthritics [patients with serious
collagen vascular diseases, such as scleroderma] or
carcinoma
patients without primary involvement of bone, liver, blood
or
kidneys.
It is of primary importance that the subjects have
relatively
normal kidney and liver function, as it is desirable to
obtain a
metabolic picture comparable to that of an active worker.
Undoubtedly the selection of subjects will be greatly
influenced
by what is available. The above points, however, should be
kept
in mind.[53]
Although this protocol specifies 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.[54] Thus no cancer patients
were
included among the plutonium subjects at Rochester. Preference
appears to have been given to patients the doctors believed
would
benefit from additional time in the hospital.[55]
An additional perspective on the selection of subjects for the
plutonium experiments is provided in three retrospective reports
written by Wright Langham. In a 1950 report on the plutonium
project, including the experiments conducted at Rochester,
Langham
wrote that "as a rule, the subjects chosen were past forty-five
years of age and suffering from chronic disorders such that
survival
for ten years was highly improbable."[56] In subsequent reports,
Langham refers to the plutonium subjects as having been
"hopelessly
sick"[57] and "terminal."[58]
Documents retrieved for the Advisory Committee show that all but
one
of the plutonium subjects at Rochester suffered from chronic
disorders such as severe hemorrhaging secondary to duodenal
ulcers,
heart disease, Addison's disease, cirrhosis, and
scleroderma.[59]
One subject, Eda Schultz Charlton, did not have any such
condition.
According to the draft of the 1950 report, she was misdiagnosed:
"a
woman aged 49 years may have a greater life expectancy than
originally anticipated due to an error in the provisional
diagnosis."[60]
Most of the subjects at Rochester were not terminally ill, and
at
least some of them had the potential to live more than ten
years.
Three of the Rochester subjects were known to still be living at
the
time of the 1974 AEC investigation into the plutonium
experiments.
Whether the inclusion of subjects at Rochester with the
potential to
live more than ten years is an indication that the investigators
were not using Langham's criterion to select subjects or that
they
erred in their predictions is unclear. Judgments about the life
expectancy of the chronically ill are difficult to make and
often in
error, even today.
The likelihood that long-term risks can be altogether eliminated
does exist, however, if the subject is in the terminal stages of
an
illness and death is imminent. This was recognized by the
plutonium
investigators, and it led to the observation that the use of a
terminal patient permitted a larger dose, which would make
analysis
easier. The first terminal patient at Rochester was injected
toward
the end of that series, and the possibility of further
injections
into terminal patients was discussed explicitly. In a March 1946
letter, Wright Langham wrote to Dr. Bassett, the primary
physician-investigator at Rochester:
In case you should decide to do another terminal case, I
suggest
you do 50 micrograms instead of 5. This would permit the
analysis of much smaller samples and would make my work
considerably easier. . . . I feel reasonably certain there
would
be no harm in using larger amounts of material if you are
sure
the case is a terminal one [as was done in two of the three
Chicago injections].[61]
As was the case at Oak Ridge and Chicago, there was no
expectation
that the patient-subjects at Rochester would benefit medically
from
the plutonium injections. The Advisory Committee found no
documents
that bear directly on what, if anything, the subjects were told
about the injections and whether they consented. The
recollections
of at least some of those intimately involved have survived,
however, and these recollections all suggest that the patients
did
not know they had been injected with radioactive material or
even
that they were subjects of an experiment.
Milton Stadt, the son of a Rochester subject, told the Advisory
Committee the following at a meeting in Santa Fe, New Mexico, on
January 30, 1995:
My mother, Jan Stadt, had a number, HP-8. She was injected
with
plutonium on March 9th, 1946. She was forty-one years old,
and I
was eleven years old at the time. My mother and father were
never told or asked for any kind of consent to have this
done to
them.
My mother went in [to the hospital] for scleroderma . . .
and a
duodenal ulcer, and somehow she got pushed over into this
lab
where these monsters were.
Dr. Hempelmann, in an interview for the 1974 AEC investigation,
said
he believed that the patients injected with plutonium were
deliberately not informed about the contents of the
injections.[62]
Dr. Patricia Durbin, a University of California researcher who
in
1968 undertook a scientific reanalysis of the experiments,
reported
on a visit with Dr. Christine Waterhouse in 1971. Dr. Waterhouse
was
a medical resident at Rochester at the time of the plutonium
injections. Durbin wrote the following regarding the Rochester
subjects who were still alive:
She [Dr. Waterhouse] believes that all three persons would
be
agreeable to providing excretion samples and perhaps blood
samples, but they are all quite old--in their middle or late
70's and cannot travel far. More important, they do not know
that they received any radioactive material.[63]
In notes on a 1971 telephone conversation with Wright Langham,
Dr.
Durbin wrote: "He is, I believe, distressed by . . . the fact
that
the injected people in the HP series were unaware that they were
the
subjects of an experiment."[64] This recollection is even more
troubling than the recollections of Drs. Waterhouse and
Hempelmann,
as it indicates not only that the subjects did not know that
they
were being injected with plutonium or a radioactive substance,
but
also that they did not know even that they were subjects of an
experiment.
Even the doctors in charge of some of the injections at
Rochester
may not have known what they were injecting into patients. In
1974,
Dr. Hempelmann suggested that the physician who actually
injected
the solution quite possibly did not know of its contents.[65]
Further evidence suggesting that the patient-subjects were never
told what was done to them comes from 1950 correspondence
between
Langham and the physicians at Rochester. These
physician-investigators were looking for signs of long-term
skeletal
effects in follow-up studies with two of the subjects at
Rochester.
Langham wrote to Rochester that he was "very glad to hear that
you
will manage to get follow-ups on the two subjects. The x-rays
seem
to be the all-important thing, but please get them in a
completely
routine manner. Do not make the examination look unusual in any
way."[66]
Moreover, a letter from Langham to Dr. Bassett discussed the
undesirability of recording plutonium data in the Rochester
subjects' hospital records:
I talked to Col. [Stafford] Warren on the phone yesterday
and he
recommended that I send copies of all my data to Dr.
[Andrew]
Dowdy where it would be available to you and Dr. [Robert M.]
Fink to observe. He thought it best that I not send it to
you
because he wanted it to remain in the Manhattan Project
files,
instead of taking a chance on it finding its way into the
hospital records. I think this is probably a sensible
suggestion.[67]
Uranium Injections at Rochester
Under the Manhattan Engineer District program, physicians at the
Rochester metabolism ward also injected six patients with
uranium
(in the form of uranyl nitrate enriched in the isotopes uranium
234
and uranium 235) to establish the minimum dose that would
produce
detectable kidney damage due to the chemical toxicity of uranium
metal, and to measure the rate at which uranium was excreted
from
the body. To achieve the first objective, the experimenters used
a
higher dose with each new subject until the first sign of
minimal
kidney damage occurred. Damage occurred in the sixth and last
subject (at a calculated amount of radioactivity of 0.03
microcuries), indicated by protein tests of his urine. Unlike
the
plutonium injections, this was an experiment that evidently was
designed not only to obtain excretion data but to cause actual
physical harm, however minimal. Thus, although the investigators
could reasonably view the plutonium injections as an experiment
that
was extremely unlikely to produce acute effects, this was not
true
of the uranium experiment, which was intended to produce acute
effects. As with the plutonium injections, the uranium
injections
also posed a long-term risk of the development of cancer. The
Committee does not know in this case how long subjects survived
after injection; there is no documentation of follow-up with
these
subjects as there is for some of the subjects of the plutonium
injections.
The subjects of this experiment, like some of the
plutonium-injection subjects, were not at risk of imminent
death,
but did suffer from chronic medical conditions such as
rheumatoid
arthritis, alcoholism, malnutrition, cirrhosis, and
tuberculosis.
According to Dr. Bassett, again the primary investigator, the
subjects "were chosen from a large group of hospital patients.
Criteria of importance in making the selection were reasonably
good
kidney function with urine free from protein and with a normal
sediment on clinical examination. The probability that the
patient
would benefit from continued hospitalization and medical care
was
also a factor in the choice."[68]
The 1948 report on the experiment did not discuss the question
of
consent. We were not able to locate any documents that bear on
what,
if anything, the subjects were told about the uranium
injections,
nor have any relevant recollections about the experiment
survived.
Two 1946 documents, however, discussing whether Dr. Bassett
should
be permitted to give a departmental seminar on the excretion
rate of
uranium in humans, illustrate the secrecy that surrounded these
injections and suggest that the subjects were not informed of
the
experiment. By the time of this correspondence, the uranium
research
with animals at Rochester had been declassified. The first
document,
a letter written by Andrew Dowdy, the director of the Manhattan
Department at the University of Rochester, to a Manhattan
District
Area engineer requesting permission for Bassett to give the
seminar,
included the following: "I feel that there is no reason why he
should not discuss this matter, and I believe that the fact that
this information was actually obtained on his own patients is of
more concern to himself than to the District."[69] In the second
document, an intraoffice memorandum, the area engineer discussed
this point, and more:
Dr. Dowdy states that the patients were Dr. Bassett's, but
it
should be borne in mind that all the work performed by Dr.
Bassett was performed at the request of the Manhattan
District
Medical Section. This seminar is to be conducted for persons
who
are all Doctors of Medicine and it is doubtful if this
information would get out to any of the families of the
patients
or the patients on whom the experiments were performed. . .
.
At the time these experiments were started, this office was
given strict orders that the information should not be
released
to any but authorized persons. Almost all the correspondence
and
result of experiments were exchanged between Dr. Wright
Langham
at Santa Fe and Dr. Bassett of the University of Rochester.
This
rule is still in effect on some of the material that Dr.
Bassett
is using and knowledge of the experiments is kept from
personnel
at the Rochester Area.[70]
Polonium Injections at Rochester
In addition to the subjects injected with plutonium and uranium
at
Rochester, five subjects were chosen for an experiment with
polonium. The purpose of the experiment was to determine the
excretion rate of polonium after a known dose, as well as to
analyze
the uptake of polonium in various tissues. The primary
investigator
for these experiments was Dr. Robert M. Fink, assistant
professor of
radiology and biophysics at the University of Rochester. Four
patients were injected with the element, and one ingested
it.[71]
All five patients selected for this study were suffering from
terminal forms of cancer: lymphosarcoma, acute lymphatic
leukemia,
or chronic myeloid leukemia. It is unclear why patients with
malignant diseases were chosen as subjects in this experiment
but
excluded from the subject pools for the plutonium and uranium
experiments. There is no discussion in the 1950 final report on
the
polonium experiments of the possibility that patients with
malignant
diseases might have abnormal metabolism, and the excretion data
were
employed right away in the establishment of occupational safety
standards.[72]
The final report, unlike other reports on the Manhattan District
metabolism studies, briefly discusses the question of consent:
"the
general problem was outlined to a number of hospital patients
with
no previous or probable future contact with polonium. Of the
group
that volunteered as subjects, four men and one woman were
selected
for the excretion studies outlined below."[73] This statement
leaves
no clear impression of what the subjects actually were told;
like
the experiments with plutonium and uranium, the human polonium
experiment was a classified component of the metabolism program.
Still, this report provides a contrast to the contemporaneous
reports on the Manhattan District plutonium and uranium
experiments,
which make no mention of consent and which do not refer to the
patient-subjects as "volunteers."
The California Experiments
While the University of Rochester had been conducting
experiments
for the Manhattan Engineer District, a related effort was under
way
at the University of California at Berkeley.[74] Before the war,
Drs. Joseph Hamilton and Robert Stone had been exploring medical
applications of radioisotopes with the aid of the University of
California's cyclotron. Hamilton and his colleagues had
pioneered in
using radioisotopes to treat cancer, in particular iodine 131 in
the
1930s. At the time the United States entered the war, they were
investigating another isotope for cancer therapy, strontium 89.
Indeed, it was this area of Hamilton's expertise that attracted
the
interest of the Manhattan Project. While Stone moved to the
Chicago
Metallurgical Laboratory during the war, Hamilton remained at
the
University of California's Radiation Laboratory, or "Rad Lab,"
at
Berkeley. A colleague of both men, Dr. Earl Miller, a
radiologist at
the University of California, reported regularly to Stone on the
progress of the Berkeley plutonium project.
Under the Manhattan District contract, Hamilton's studies
originally
had involved exposing rats to plutonium in an effort to
determine
its metabolic fate and thereby project the risk to workers at
atomic
plants. Toward the end of the war, Hamilton began to conduct
plutonium studies on humans for the government.[75] Experiments
with
humans could be handled expeditiously, Hamilton wrote, because
of
the close relationship between the Rad Lab and the medical
school at
the University of California at San Francisco.[76] In January
1945,
Hamilton confirmed to the Manhattan District that he planned "to
undertake, on a limited scale, a series of metabolic studies
with
[plutonium] using human subjects."[77] The purpose of this work,
Hamilton wrote, "was to evaluate the possible hazards . . . to
humans who might be exposed to them, either in the course of the
operation of the [Chicago] pile, or in the event of possible
enemy
action against the military and civilian population."[78]
Subsequently, three subjects, two adults and one child (known as
CAL-1, 2, and 3), were injected with plutonium. In addition, in
April 1947 a teenage boy (CAL-A) was injected with americium,
and in
January 1948 a fifty-five-year-old female cancer patient (CAL-Z)
was
injected with zirconium.[79]
On May 10, 1945, Hamilton reported he was awaiting "a suitable
patient" for the plutonium experiment.[80] Four days later,
fifty-eight-year-old Albert Stevens, designated CAL-1, was
injected
with plutonium, becoming the first human subject in the
California
portion of the project.[81] Albert Stevens was chosen in the
belief
that he was suffering from advanced stomach cancer.[82] Shortly
after the injection, however, a biopsy revealed a benign gastric
ulcer instead of the suspected cancer. The researchers collected
excreta daily for almost one year, analyzing them for plutonium
content.[83] Evidently, by two months after the injection, Mr.
Stevens was considering moving out of the Berkeley area; this
would
have prevented further collection of excretion specimens. Dr.
Hamilton proposed to Drs. Stone and Stafford Warren that he be
permitted to "pay the man fifty dollars per month" in order to
keep
Mr. Stevens in the area. Hamilton recognized, however, that
there
were "possible legal and security situations which may present
insurmountable obstacles."[84] In response to this request, Dr.
Joe
Howland (who was reportedly involved with the Oak Ridge
plutonium
injection) wrote the following to the California area engineer:
Possible solutions to this problem could be:
a. Pay for his care in a hospital or nursing home as a
service.
b. Place this individual on Dr. Hamilton's payroll in some
minor
capacity without release of any classified information.
It is not recommended that he be paid as an experimental
subject
only.[85]
According to a 1979 oral history of Kenneth Scott, an
investigator
at Berkeley who evidently was responsible for the analysis of
Mr.
Stevens's excretion specimens, the patient was paid some amount
each
month to keep him in the area. However, Dr. Scott also recalled
that
he never told Mr. Stevens what had happened to him: "His sister
was
a nurse and she was very suspicious of me. But to my knowledge
he
never found out."[86]
In addition, an April 1946 report on the experiment records that
"several highly important tissue samples were secured including
bone."[87] It appears that these tissue specimens, which
included
specimens of rib and spleen, were removed four days after the
injection in an operation for the patient's suspected stomach
cancer.[88]
Four months after Mr. Stevens was injected, Dr. Hamilton told
the
Manhattan District that the next subject would be injected
"along
with Pu238 [plutonium], small quantities of radio-yttrium,
radio-strontium, and radio-cerium." The purpose of this
experiment
was to "compare in man the behavior of these three
representative
long-lived Fission Products with their metabolic properties in
the
rat, and second, a comparison can be made of the differences in
their behavior from that of Plutonium."[89] This research would
provide data to improve extrapolation from higher-dose animal
experiments.
Despite Hamilton's hope to have a second patient by the fall,
CAL-2
was not selected until April 1946. Simeon Shaw was a
four-year-old
Australian boy suffering from osteogenic sarcoma, a rare form of
bone cancer, who was flown from Australia to the University of
California for treatment. According to newspaper articles at the
time, Simeon's family had been advised by an Australian
physician to
seek treatment at the University of California.[90] Arrangements
then were made by the Red Cross and the U.S. Army for Simeon and
his
mother to fly by Army aircraft to San Francisco. Within days, he
had
been injected with a solution containing plutonium, yttrium, and
cerium by physicians at the university.[91]
Following his discharge on May 25, about a month after his
injection, the boy returned to Australia, and no follow-up was
conducted. He died in January 1947. In February 1995 an ad hoc
committee at the University of California at San Francisco
(UCSF)
concluded that probably at least part of the motivation for this
experiment was to gather scientific data on the disposition of
bone-seeking radionuclides with bone cancers.[92]
One piece of evidence indicating that there was a secondary
research
purpose for the injection of CAL-2 was a handwritten note in the
boy's medical record saying that the surgeons removed a section
of
the bone tumor for pathology and for "studies to determine the
rate
of uptake of radioactive materials that had been injected prior
to
surgery, in comparison to normal tissues."[93]
It is likely that the CAL-2 experiment was designed both to
acquire
data for the Manhattan District and also to further the
physicians'
own search for radioisotopes that might treat cancer in future
patients. The California researchers themselves noted the dual
purpose of their research at the time. Hamilton wrote in a
report to
the Army in the fall of 1945 that there were "military
considerations which can be significantly aided by the results
of
properly planned tracer research."[94]
As the February 1995 UCSF report on the experiments concluded,
however, the "injections of plutonium were not expected to be,
nor
were they, therapeutic or of medical benefit to the
patients."[95]
This corresponds with the evidence of a letter, written by
Hamilton
in July 1946, three months after the injection of CAL-2, to the
author of an article on the peacetime implications of wartime
medical discoveries:
To date no fission products, aside from radioactive iodine,
have
been employed for any therapeutic purposes. There is a
possibility that one or more of the long list of radioactive
elements produced by uranium fission may be of practical
therapeutic value. At the present time, however, we can do
no
more than speculate.[96]
Documentary evidence suggests that consent for the injections
likely
was not obtained from at least some of the subjects at the
University of California. A 1946 letter from T. S. Chapman, with
the
Manhattan District's Research Division, said the following
regarding
preparations for injections:
. . . preparations were being made for injection in humans
by
Drs. [Robert] Stone and [Earl] Miller. These doctors state
that
the injections would probably be made without the knowledge
of
the patient and that the physicians assumed full
responsibility.
Such injections were not divergent from the normal
experimental
method in the hospital and the patient signed no release. A
release was held to be invalid.
The Medical Division of the District Office has referred "P"
reports for project 48A to Colonel Cooney for review and
approval is withheld pending his opinion.[97]
Chapman does not specify whether the "injections" referred to in
this letter were injections of plutonium or of some other
substance.
It is unclear whether "'P' reports" refers to Hamilton's overall
progress reports on his tracer research, which had reported
mostly
on research with plutonium (but also on research with cerium and
yttrium), or whether "P" referred specifically to reports on
work
with plutonium. As we noted at the outset of this chapter,
Chapman's
claim that it was commonplace at the time to use patients in
experiments without their knowledge and without asking them to
sign
a "release" is correct.
In the case of Albert Stevens (CAL-1), no documentary evidence
that
bears on disclosure or consent has been found. Simeon Shaw's
(CAL-2's) medical file contains a standard form "Consent for
Operation and/or Administration of Anaesthetic." This form,
however,
was signed by a witness attesting to consent of Simeon's mother
one
week after the injection and therefore probably applies to a
biopsy
done a week after the injection, not to the injection
itself.[98]
On December 24, 1946, at the prompting of Major Birchard M.
Brundage, who was chief of the Manhattan District's Medical
Division, Colonel K. D. Nichols, commander of the Manhattan
District, ordered a halt to injections of "certain radioactive
substances" into human subjects at the University of
California.[99]
"Such work," Nichols wrote, "does not come under the scope of
the
Manhattan District Programs and should not be made a part of its
research plan. It is therefore deemed advisable by this office
not
only to recommend against work on human subjects but also to
deny
authority for such work under the terms of the Manhattan
contract."
The following week, the civilian AEC took over responsibility
for
all Manhattan District research and temporarily reaffirmed the
Manhattan District's suspension of human experimentation at the
University of California.[100] It is unclear why this action was
taken.
Dave H
Sourced at http://raleigh.dis.anl.gov/roadmap/achre/chap5_2.html.
DOE Openness: Human Radiation Experiments: Roadmap to the Project
ACHRE Report
ACHRE Report
Part II
Chapter 5
Introduction
The Manhattan District Experiments
The AEC's Reaction: Preserving Secrecy while Requiring
Disclosure
Human Experimentation Continues
Conclusion Chapter 5: Human Experimentation Continues
In March 1947, just as he was declaring that "public relations"
required the reclassification of plutonium data, Medical
Division
chief Major Brundage approved a 1947-48 "Research Program and
Budget" for Rochester that provided for metabolism studies with
polonium, plutonium, uranium, thorium, radiolead, and
radium.[117]
The program was put on hold by the AEC soon after.[118]
The future of the metabolism work at Rochester apparently was
decided when Shields Warren was named the first chief of the
AEC's
Division of Biology and Medicine in fall 1947. In his private
diary
for December 30, 1947, Warren tersely noted: "Ordered
abandonment of
human isotope program at Rochester."[119] The program at the
University of California at Berkeley, however, continued. On
December 4, 1947, Shields Warren had met with Hamilton and
Stone;[120] the decision to allow the program to continue
clearly
was not a hasty one. A 1974 recollection of Shields Warren
indicates
that his decision to allow the program to continue may have been
due
to Hamilton's assertion in December 1947 that it had been the
University of California's practice to obtain some form of
(undocumented) consent.[121]
According to Warren, Hamilton had said that subjects were told
"they
would receive an injection of a new substance that was too new
to
say what it might do but that it had some properties like other
substances that had been used to control growth processes in
patients, or something of that general sort."[122] Warren went
on to
observe that "you could not call it informed consent because
they
did not know what it was, but they knew that it was a new and to
them unknown substance."[123] Warren's observation does not go
far
enough, however. If Warren's secondhand account is accurate and
this
is indeed what the patient-subjects at the University of
California
were told, then they were more misled than informed. Analogizing
plutonium to substances that "control growth processes in
patients,"
even in prospect, might reasonably lead patients to believe that
they would be receiving a substance with some hope of treating
their
cancer. Certainly such a remark would not communicate to
patients
that the experiment to be performed was not for their own
benefit.
It would have been appropriate that these patients be told that
their participation might benefit future patients with the same
conditions. It would have been crucial to distinguish, however,
between this legitimate explanation of potential benefit to
future
cancer patients and misleading the patient into believing the
experiment might benefit him or her.
Human Experimentation Continues at the University of California
By the summer of 1947, human experimentation had resumed at the
University of California under AEC contract. In June, "CAL-A," a
teenage Asian-American bone cancer patient at Chinese Hospital
in
San Francisco, was injected with americium. An instruction in
the
patient's file by one of Hamilton's assistants specifies that
"we
will use the same procedure as with Mr. S,"[124] evidently a
reference to Albert Stevens. Dr. Durbin, Hamilton's associate,
believes that CAL-A's guardian was informed of the procedure
followed in that case.[125] The Advisory Committee received
incomplete records for CAL-A that contained no evidence of
disclosure or consent; UCSF has told the Committee that records
at
Chinese Hospital from the 1950s and earlier have been
destroyed.[126]
A thirty-six-year-old African-American railroad porter named
Elmer
Allen, code-named CAL-3, was believed to be suffering from bone
cancer and was injected with plutonium at the University of
California in July 1947. His left leg was amputated shortly
thereafter. There is a note in his medical chart signed by two
physicians, stating that the experimental nature was "explained
to
the patient, who agreed to the procedure" and that "the patient
was
in fully oriented and in sane mind."[127] It is likely that this
note was intended to fulfill one of the April 1947 conditions
for
human experimentation, which allowed for such a procedure as
documentation of having obtained the patient-subject's consent.
It
is not clear from the note, however, whether in explaining about
the
experimental nature of the procedure the physicians told the
patient
about the potential effects of the injection, as required by the
Wilson letter, or that the injection was not intended to be of
medical benefit to the patient. On this second point, the
injection
was in violation of the Wilson letter, which also required that
there be an "expectation that it may have therapeutic
effect."[128]
As acknowledged by the February 1995 UCSF report, there was
never
any expectation on the part of the experimenters that the
injection
would be of therapeutic benefit to Mr. Allen.
Mr. Allen lived until 1991. According to UCSF's 1995 review of
patient-subjects' medical charts, upon biopsy of his tumor a
pathologic diagnosis was made of chondrosarcoma, a type of
malignant
bone tumor. UCSF reported that patients with this type of tumor
"frequently surviv[e] many years beyond diagnosis if there is
complete excision of the primary tumor."[129] This pathology
finding
suggests that Mr. Allen was a long-term cancer survivor. A note
in
his patient chart recorded that the tumor was "malignant but
slow
growing and late to metastasize. Prognosis therefore moderately
good."[130]
On March 15, 1995, Elmerine Whitfield Bell, the daughter of
Elmer
Allen, told the Advisory Committee in Washington, D.C., that she
continue[s] to be appalled by the apparent attempts at
cover-ups, the inferences that the nature of the times, the
1940s, allowed scientists to conduct experiments without
getting
a patient's consent or without mentioning risks. We contend
that
my father was not an informed participant in the plutonium
experiment.
He was asked to sign his name several times while a patient
at
the University of California hospital in San Francisco. Why
was
he not asked to sign his name permitting scientists to
inject
him with plutonium? Why was his wife, who was college
trained,
not consulted in this matter?
On January 5, 1948, a fifty-five-year-old woman with cancer was
injected with zirconium at the University of California.[131]
The
patient record for this case has not yet been located, nor have
any
other documents that might bear on whether this experiment was
conducted in compliance with the consent requirements of the
Wilson
letters. We do know that the injection of zirconium was not
expected
to benefit the subject herself.[132]
A secret report on the zirconium injection was reviewed by the
AEC
in light of public relations and liability concerns. In August
of
that year, the report was denied declassification with the
approval
of Shields Warren, who wrote, "This document should not be
declassified for general medical publication [and] it would be
very
difficult to rewrite it in an acceptable manner."[133] Warren
was
responding to a memorandum from Albert H. Holland, Jr., medical
adviser at Oak Ridge, which specified that the concern about
rewriting had to do with public relations and the fact that the
report "specifically involves experimental human
therapeutics."[134]
Follow-up of the Patient-Subjects at Rochester
The investigators at Rochester and the AEC were interested in
obtaining long-term data from surviving subjects on excretion
levels
and the distribution of plutonium in various tissues. Follow-up
studies at Rochester continued at least through 1953 with two of
the
subjects in the HP series, Eda Charlton and John Mousso. We have
already noted Wright Langham's 1950 instruction to the
physicians at
Rochester suggesting that they were not to give these patients
any
indication of the true purpose of the follow-up studies.[135] In
addition, Langham sought help in early 1950 to locate Ebb Cade
(the
man injected at Oak Ridge Hospital) for follow-up excretion
studies.
Langham asked Dr. Albert Holland at Oak Ridge to try to locate
Mr.
Cade and to keep his "eyes open for a possible autopsy."[136] It
is
unclear to the Committee whether follow-up of any kind was ever
done
with Mr. Cade.
On June 8, 1953, Eda Charlton's rib was removed during
exploratory
surgery for cancer and analyzed for plutonium. Louis Hempelmann,
who
by that time had moved from Los Alamos to Strong Memorial
Hospital
at Rochester, wrote to Charles Dunham of the AEC's Division of
Biology and Medicine in advance of the procedure:
The patient in question was brought in for a skeletal
survey,
and turned out to have a 'coin-like' lesion inside the chest
wall. . . . It is undoubtedly an incidental finding, but she
must be explored by the chest surgeon here at Strong. In the
course of the operation, he will remove a rib which we can
analyze. Her films show the same type of minimal indefinite
change in the bone that the others have had.[137]
It was standard practice at the time to remove a section of rib
incidental to lung surgery. It is clear that the patient was
still
being followed for long-term effects of plutonium and that some
subclinical bone changes of unclear significance had already
been
observed by this time. Therefore, the examination of this rib
segment would have included special tests to determine whether
plutonium was present.
On August 31, 1950, an internal DBM memorandum recorded the
understanding of some AEC officials that Wright Langham and
Rochester doctors were engaged in follow-up studies.[138] In a
1974
interview, however, Shields Warren recalled that he had no
knowledge
that the patients were the subjects of follow-up studies: "I did
not
learn of this continuing contact while I was in office at AEC. .
. .
I had assumed because I had been told that they were incurable
patients that they all had died by the time we talked."[139]
Additional Follow-up Studies and the Argonne Exhumation Project
In 1968 Dr. Patricia Durbin undertook an investigation of the
plutonium-injection subjects, which included a reevaluation of
the
original plutonium data. Her goal was to pursue "some elusive
information on Pu in man and the information or assumptions
about
physiology needed to create a believable Pu model for man." She
"decided to look at all the old Pu patients as individuals
rather
than in a lump. . . . "[140] Durbin was surprised to find in her
search for the original experimental data that the University of
California data were drawn from three subjects who received
plutonium and one who received americium; the data from only one
plutonium subject from California had previously been reported
in
the open scientific literature.[141] Durbin asked the original
researchers why these data had not been analyzed. She wrote: "I
understand from Wright Langham that this problem has been
discussed
before and discarded as too messy."[142]
In 1972, after the classified report on the experiments had been
downgraded to "Official Use Only," she went on to publish
"Plutonium
in Man: A New Look at the Old Data," a landmark paper in the
plutonium story.[143] This was the first review in the open
literature to analyze Langham's results in light of the actual
medical conditions of the patient-subjects. Because of the
prolonged
secrecy surrounding the experiments, it was generally not known
that
two of the three University of California cases had been omitted
from the 1950 analysis. The report also revealed in retrospect
that
all the patients were not hopelessly or terminally ill, as had
been
suggested in Langham's later public references, that some were
still
alive, and that some had been misdiagnosed.
In December 1972, Argonne National Laboratory's Center for Human
Radiobiology (CHR), to whom Durbin had provided the names of
surviving subjects, began a review of the data from all eighteen
people who were injected with plutonium between 1945 and 1947.
CHR
was the national center designated by the AEC to do long-term
follow-up of individuals with internally deposited
radionuclides,
primarily the radium dial painters. Argonne's follow-up plan for
the
plutonium experiments was to uncover the postinjection medical
histories of all the subjects, obtain biological material from
those
still living, and exhume and study the bodies of those deceased
in
order to "provide data on the organ contents at long times after
acquisition of plutonium."[144]
In 1973, three patients--Eda Charlton, John Mousso, and Elmer
Allen--were admitted to the University of Rochester's metabolic
ward
for more excretion studies paid for by CHR. Elmer Allen had
first
been brought to Argonne, where an unsuccessful attempt had been
made
to detect plutonium by external counting techniques. In the
course
of his examination, however, CHR found subclinical bone
"changes"
that an Argonne radiologist characterized as "suggestive of
damage
due to radiation."[145]
Again there was no disclosure to the subjects that they were now
being followed because they had been subjects of an experiment
that
had been unrelated to their medical care, an experiment in which
there was continuing scientific interest. The 1974 AEC
investigation
concluded that, in the case of the surviving Rochester subjects,
Dr.
Waterhouse, who conducted the follow-up studies with these
patients
for Argonne, had not told them the purpose of the studies in
1973
because she believed "that disclosure might be harmful to them
in
view of their advanced age and ill health."[146] This suggests
that
Dr. Waterhouse had well-intentioned motivations for not being
straightforward with the Rochester subjects. It also suggests
that
these subjects had not been told the truth about the experiments
at
the time the injections occurred, or that they had forgotten.
According to Dr. Waterhouse, the studies were feasible without
the
subjects' knowledge of the true purpose of the research since
these
two patients "were accustomed to participating in clinical
studies,
unrelated to this matter, involving the collection of excretion
specimens."[147] Elmer Allen's physician was told by CHR that
the
purpose of bringing Mr. Allen to Argonne's CHR and the
University of
Rochester for follow-up was interest in the treatment he
received at
the University of California in 1947 for his cancer.[148] This
use
of the term treatment in the information provided Mr. Allen's
physician, which he presumably relayed to Mr. Allen and his
family,
was deceptive and manipulative; it implied that the injection
Mr.
Allen received had been given as therapy for his benefit.
The second component of this follow-up study was research on the
exhumed bodies of deceased subjects. The 1974 AEC investigation
concluded that the families were not informed that plutonium had
been injected. Instead, they were told that "the purpose of
exhumation was to examine the remains in order to determine the
microscopic distribution of residual radioactivity from past
medical
treatment" and that the subjects had received an "unknown"
mixture
of radioactive isotopes.[149] The investigation concluded that
such
disclosure "could be judged misleading in that the radioactive
isotopes were represented as having been injected as an
experimental
treatment for the patient's disease."[150] Thus, the families of
the
deceased subjects as well as those subjects still surviving were
deceived by officials of the AEC.
A December 1972 intralaboratory memorandum, written by an
Argonne
investigator, instructs that "outside of CHR we will never use
the
word plutonium in regard to these cases. 'These individuals are
of
interest to us because they may have received a radioactive
material
at some time' is the kind of statement to be made, if we need to
say
anything at all."[151] Robert E. Rowland, the author of this
memorandum, told Advisory Committee staff in 1995 that he had
written this after he had been instructed earlier that month by
Dr.
James Liverman, director of the AEC's Division of Biomedical and
Environmental Research, that "I could not tell the individuals
that
they were given plutonium. I protested that they must be given a
reason for our interest in them, and I was told to tell them
that
they had received an unknown mixture of radioisotopes in the
past,
and that we wanted to determine if it was still in their bodies.
Further, we were not to divulge the names of the institutions
where
they received this unknown mixture."[152] Dr. Rowland said he
had
received these instructions during a trip to Washington, D.C.,
to
obtain approval and funding for the study.[153] Dr. Liverman
told
Advisory Committee staff that he has "no recollection of
discussions
with anyone in which some stricture would have been placed on
what
could be discussed with the patients. That is a medical ethics
issue
which would have been left to the physicians."[154]
This study was not brought to the attention of the Argonne Human
Use
Committee until November 1973, even though it had been
established
in January 1973. (See chapter 6 for a discussion of human use
committees.) In a briefing for the 1974 AEC investigation, Dr.
Liverman attributed this failure to bring the study before the
Human
Use Committee to the following factors: "(1) [Argonne's] opinion
that the studies came under the scope of a protocol approved by
that
Committee in 1971. (2) The nature of the studies was to be
suppressed to avoid embarrassing publicity for AEC."[155]
In 1974 the AEC informed at least two of the four living
subjects--Eda Charlton and John Mousso--of the plutonium
injections
and had them sign documents to this effect. These documents did
not
provide any information on possible effects of the injections,
although they did describe the purpose as having been "to
determine
how plutonium, a man-made radioactive material, is deposited and
excreted in the human body."[156] One living patient, Jan Stadt,
was
not told, because it was her attending physician's opinion that
her
condition was precarious and that disclosure in this case would
be
"medically indefensible."[157] This judgment, like that of Dr.
Waterhouse's, exemplifies how physicians of the time commonly
managed the information they shared with their patients.
Physicians
typically told patients only what they thought it was helpful
for
them to know; if in the physician's judgment information might
cause
the patient to become upset or distressed, this was often
considered
reason enough to withhold it.[158] The judgment also suggests
that
Ms. Stadt, like Ms. Charlton and Mr. Mousso, had not been told
the
truth about the experiments at the time the injections occurred
or
that she had forgotten.
The AEC recommended that exhumations continue, but only with
full
disclosure to the subjects' next of kin.
The Boston Project Uranium Injections
Human experiments conducted to measure the excretion and
distribution of atomic weapons materials did not stop with the
last
of the injections at the University of California. The Boston
Project human uranium-injection experiments were conducted from
1953
to 1957 at Massachusetts General Hospital (MGH) as part of a
cooperative project between the hospital and the Health Physics
Division of Oak Ridge National Laboratory. Eleven patients with
terminal conditions were injected with uranium, although data
obtained from three of these subjects were never published.[159]
The
ORNL and the AEC undertook the Boston Project to obtain better
data
for the development of worker safety standards. One of the
investigators wrote that the Boston Project would provide "a
wonderful opportunity to secure 'human data' for the analysis
and
interpretation of industrial exposures."[160] The occupational
standards for uranium at the time were based on animal data and
on
the experiment conducted at Rochester in the 1940s. No autopsy
data
were obtained from this earlier experiment at Rochester,
however,
since none of the patients had terminal diseases. Thus, wrote a
Boston Project investigator, "the uncertainty, in so far as the
distribution of uranium was concerned, was not reduced [by the
Rochester experiment] or could not even be determined."[161]
The Boston Project involved a second purpose--the search for a
radioisotope that would localize in a certain type of brain
tumor--called glioblastomas--and destroy them when activated by
a
beam of neutrons. This had long been the research interest of
Dr.
William Sweet at MGH; at the time, these tumors were clearly
diagnosable and 100 percent fatal, and there was no effective
treatment. This research involved many radioisotopes over the
years,
most notably isotopes of boron and phosphorus. It is unclear
whether
Dr. Sweet would have tested uranium without ORNL's
involvement--or
whether it would have been made available to him by the AEC. Dr.
Sweet has indicated to the Committee that he was interested in
the
potential of uranium as a therapeutic agent prior to being
approached by the AEC about the possibility of conducting a
joint
project.[162]
The Boston Project produced data on the distribution of uranium
in
the human body that the earlier Manhattan District uranium
studies
had not provided. The data obtained indicated that uranium, at
least
at the dose levels used in the Boston Project, localized in the
human kidney at higher concentrations than small animal data had
predicted and that therefore the maximum permissible levels for
uranium in water and air might be unsafe. Recommendations made
by
the investigators of the Boston Project for more conservative
occupational standards were apparently not heeded, however. The
accepted occupational levels for uranium became less rather than
more conservative over the years, despite the findings of the
Boston
Project.[163]
Hopes that uranium would localize sufficiently in brain tumors
to be
of potential therapeutic use were unfulfilled. In a 1979
interview,
Robert Bernard, one of the health physicists at ORNL most
intimately
involved with the study, was asked if during the experiment
uranium
was showing any promise as a treatment. "No, it concentrated in
the
kidney just like Rochester said back in the '40's. . . . They
got
brain tumor samples. There was very little uranium present, but
Sweet was still wondering: maybe [it was] not a high enough
dose."[164]
In a 1995 interview, Karl Morgan, head of the Health Physics
Division of ORNL at the time of the Boston Project, indicated
that
the project was ultimately discontinued in 1957[165] because of
the
concerns of an ORNL health physicist:
He felt that the patients were given very large doses of
uranium
which our data had indicated--that is, the data we collected
[at
ORNL] in setting permissible doses--would be very harmful. .
. .
I immediately cancelled our participation in the program.
Apparently, they were given doses that were many times the .
. .
permissible body burden.[166]
In their application to their radioisotope committee, MGH
investigators clearly recorded that the proposed dose of 2.12
rem
per week "exceeds maximum permissible exposure rate of 0.3
rem/week
but [patients] are terminal."[167]
At least one of the subjects was selected for the distribution
part
of the study only. Reports describe the patients as "virtually
all"
having malignant brain tumors; newly available documents
indicate
that at least one patient injected with uranium did not have a
brain
tumor at all. An unidentified male, identity and age still
unknown
at the time of his death, became Boston Project subject VI when
he
"was brought to the Emergency Ward after being found
unconscious. .
. . No other information was obtainable."[168] According to his
autopsy report, this patient was suffering from a subdural
hematoma--a severe hemorrhage--on his brain. There was clearly
no
benefit intended for this patient from the injection of uranium,
but
there is evidence of harm attributable to the injection. His
autopsy
report records clinical evidence of mild kidney failure[169] and
pathological evidence of kidney nephrosis (damage to the kidney
tubules) from the chemical toxicity of uranium metal.[170] The
report also records that "the liver, spleen, kidneys and bone
marrow
showed evidence of radiation."[171]
Even for the patient-subjects with brain cancer, there was no
expectation on the part of investigators that the experiment
would
benefit the subjects themselves. The object of the experiment
was to
test whether uranium would localize sufficiently in brain tumors
to
be of therapeutic value in the future. In order for uranium to
have
had therapeutic potential for patient-subjects, exposure to a
reactor's neutron beam would have been necessary to then
activate
the uranium, if it had localized sufficiently in the tumors,
which
it did not. There was, however, no plan to expose these
particular
patient-subjects to a neutron beam; the goal was to see whether
the
concentration would justify further research that would involve
exposure to a neutron beam. Most of the subjects were already
comatose and "in the terminal phase of severe irreversible
central
nervous system disease."[172]
The doses used in the Boston Project were high; the lowest dose
was
comparable to the highest used in the earlier Rochester uranium
experiment--a dose that had caused detectable kidney damage in
one
of the Rochester subjects. One document records that at least
two
Boston Project subjects, in addition to subject VI, had kidney
damage at the time of death, although this document does not
directly link this damage to the uranium injections.[173]
There is no discussion of consent in any of the Boston Project
reports. It appears that ORNL left such considerations to Dr.
Sweet
and MGH. In an interim report, ORNL discusses the division of
responsibility in the experiment: "It was agreed that the Y-12
Health Physics Department [at Oak Ridge] would prepare injection
solutions and perform the analytical work associated with this
joint
effort. Massachusetts General Hospital agreed to select the
patients, perform the injections, and care for the patients
during
the period of study."[174]
Dr. Sweet told the Advisory Committee in 1995 that it was his
practice to obtain consent from patients or from their families
and
"scrupulously to give a patient all the information we had
ourselves."[175] The Committee has not been able to locate any
documents that bear on questions of disclosure or consent for
this
experiment.[176] The case of the Boston Project subject who was
brought into the hospital after being found unconscious, and
who,
according to his autopsy report, was never identified and never
regained consciousness, indicates that this rule was not applied
universally.