The Michigan Daily - Monday, April 18,_1994 - 5
sRADIATION
entinued from page 1
-The issue of consent becomes particularly trouble-
some when the test subjects are children, who are more
susceptible to radiation than adults and, because of their,
age, less able to give informed consent.
As a result, University radiation researchers have
become increasingly wary of using children in recent
years.
Current subcommittee members point out that they
have not reviewed an application for radiation research
0 involving children in more than a year.
During the 1960s, however, the subcommittee ap-
proved 102 applications involving patients younger than
18. Of these studies, 30 involved children under 6 and two
used volunteers younger than 18.
Records from the 1950s show that the subcommittee
approved 165 applications involving more than 1,570
humans.
The number of test subjects could be far higher, since
three-fourths of the applicants did not identify how many
humans they planned to use.
Because ofachangein application forms, most 1950s
applications do not denote age and 1960s applications do
not indicate the number of test subjects.
University Radiation Research
The experiments explored a wide range of medical
areas.
Many were diagnostic procedures that evaluated the
function of organs such as the kidney and the pancreas.
Other projects introduced tracers in order to calculate
,,patients' blood. volumes. Some aimed to locate tumors.
In one project, the researcher introduced tritium-
labeled steroids into the placenta of a baby delivered by
Caesarean section on Dec. 11, 1964.
The application and doctor's notes do not indicate the
baby's status, but other University fetal research con-
ducted around the same time used dead fetuses or fetuses
'om patients forced to undergo abortions for medical
Wreasons.
One experiment that carried a substantial risk had
tritium-labeled thymidine injected into the leg of a pa-
tient. A researcher from Brookhaven National Laborato-
ries cautioned against using thymidine, a hazardous pre-
cursor of DNA, in patients with long life expectancies.
But he estimated it would not pose a threat to the patient,
who already was terminally ill with a life expectancy of
less than a year.
In general, the patients who received the highest doses
of radiation already had advanced cases of terminal
diseases such as cancer or melanoma.
For these people, any possible benefits may have
outweighed the long-term risks the radiation posed, said
Dr. Thomas Koval, a senior staff scientist at the National
Council on Radiation Protection and Measurements in
Bethesda, Md.
"If an individual has a terminal cancer or a severe life-
* threatening disease, they might be willing to tolerate the
small risk associated with a moderate amount of radiation
from isotopic administration, having in mind the great
potential it might have if it destroys their tumor cells,"
Koval said.
In one of the earliest studies, infants and children were
used in a test that has since become a standard diagnostic
procedure in hospitals: the thyroid uptake.
The thyroid is a hormone-secreting gland located in
the upper chest, its two lobes flanking the windpipe.
By feeding a person radioactive iodine, researchers
can examine how well the thyroid secretes hormones.
According to the study, published in the journal Pedi-
atrics in 1949,26 children ingested 20 to 50 microcuries
of radioactive iodine 131 at University Hospitals. The
children ranged in age from one month to 14 years old.
The solution was fed to the infants through a stomach
tube.
Fourteen of the children already had abnormal condi-
tions, such as thyroid disorders, while 12 of the children
were healthy individuals used as test controls.
Michael Harrison, director of public relations for the
Medical Center, said in a statement: "This was early
research into the development of a standard method to test
decreased thyroid function in infants and children. Early
diagnosis is considered critical for optimal mental and
*hysical development."
The healthy children were chosen from patients in the
Radiation Experiments
These are ampng the hundreds of radiation research projects that have been
conducted at the University. The details vary with each application. Some of the
researchers described their projects at length while others simply said they were
performing a routine test or treatment. In many cases it is difficult to pinpoint
the exact radiation consequences because the applications list few details.
T -
0 1953: Twenty-five normal subjects and perni-
cious anemia patients ingest cobalt-60 labeled
vitamin B12 in a study of their absorption rates.
Each receives fewer than four doses of 0.5
microcuries.
0 1954: Phosphorous-32 in the form of sodium
phosphate is injected intravenously to brain tumor
patients prior to their operations, in an attempt to
indicate the tumor sites Each patient receives one
dose of 0.1 millicuries.
® 1955: Three melanoma patients receive several
therapeutic doses of up to five millicuries of
phosphorous-32 into their melanomata. Research-
ers want to determine P-32 concentration ratios in
skin and bone marrow.
k 1955: Burn patients freshly admitted to the
hospital receive a 200 to 400 microcurie dose of
P-32 sodium phosphate in an attempt to differenti-
ate severe burns. Investigators hope early detec-
tion would enable them to remove and graft burns
faster.
* 1956: Researchers measure the blood mass in
five infants and children with blood diseases by
injecting blood cells tagged with varying amounts
of chromium-51, depending on the patient's
weight. The application notes that the radioactive
side-effects pose no future hazard to the children,
who already have irreversible diseases.
® 1958: Five inmates at the State Prison of
Southern Michigan volunteer to receive 15
microcuries each of carbon-14 labeled L-Tyrosine
in an attempt to determine the lifespan of skin
cells.
N 1958: P-32 is administered to 100 patients
with leukemia and polycythemia, a blood disease.
Each receives variable doses of three to eight
millicuries each.
0 1958: Patients with a short life-expectancy
ingest or are injected with 0.5 millicuries of 1-131
in a sodium iodide solutions. The application does
not list the project's purpose.
8 1959: Researchers inject 10 microcuries of
tritium-labeled thymidine into the upper leg of a
terminally ill patient with a life expectancy of less
than one year. In a letter, a colleague estimates
the radiation would not harm the patient, but he
advises the researchers not to use the dosage in
somebody with a long lifespan.
1960: Researchers administer Cr-51 to patients
admitted to the emergency room in an attempt to
determine their blood loss. In justifying the need
for children, the investigator writes that because
children have less blood than adults, doctors need
accurate estimates of blood loss.
M 1960: Patients in the 6- to 17-year-old range and
higher, plus adult volunteers, receive intravenous
injections of 1-131 in the form polyvinyprollidone, in
an attempt to determine blood volume. Each
receives one dose of 10 to 25 microcuries.
1960: Up to 700 microcuries of mercury-203
labeled neohydrin is administered to an unknown
number of patients in an attempt to locate brain
tumors.
® 1961: Patients in the 6- to 17-year-old range and
older inhale krypton-85 gas in the study of human
circulation. Each receives 2 doses of 0.6 millicur-
les.
N 1961: Researchers inject a mixture of sodium-
22, bromine-82 and potassium-42 isotopes into
patients and volunteers. The purpose is to deter-
mine extracellular fluid volume, total exchangeable
sodium and total exchangeable potassium. Some
of the patients and volunteers are younger than 18.
® 1964: Researchers introduce 35 microcuries of
tritium labeled steroids into the placenta of a baby
delivered through Caesarean section on Dec. 11 in
a study of hormone metabolism. The application
and doctor's notes do not indicate the baby's
status; other fetal research was conducted on dead
fetuses or patients scheduled for abortions.
® 1966: Patients and volunteers, some younger
than 18, are administered .50 microcuries of C-14
labeled uric acid, in an attempt to determine uric
acid pool "and turnover.
served on the subcommittee since the late '70s. "Ten
years ago, there was no set form, just a set of guidelines.
For five years now, we've had all those points."
The earliest consent forms from 1956 stated simply:
"I, the undersigned, hereby assert that I am voluntarily
taking an injection of at a dose level
which I understand to be considered within accepted
permissible dose limits by the University of Michigan
Radio-isotope Human Use Sub-Committee."
Subsequent application forms in the late '50s re-
minded researchers to make sure volunteers had signed
release forms.
Between then and now, applications evolved from
sketchy one-page sheets to six-page packets covering
various facets of the research, such as risks and potential
benefits.
In the late '60s, the committee banned the use of non-
patient child volunteers. And in 1974, the U.S. Depart-
ment of Health, Education and Welfare issued regula-
tions for the protection of human subjects, which have
since been revised and expanded.
Today's procedures have grown elaborate, but as
Carey notes, "You've got to have these types of commit-
tees in place to protect the rights of the human subjects
and ensure informed consent."
The Federal Investigation
Since the Albuquerque Tribune reported last year on
18 patients in a New York hospital who were injected
with plutonium, grisly radiation stories have flourished in
the news media.
In Oregon and Washington, 131 inmates at two pris-
ons had their testicles bathed in a radioactive solution
during the 1960s.
In Tennessee, a lawsuit seeks damages against
Vanderbilt University on behalf of 829 women who were
fed radioactive iron while they were pregnant in the
1940s. One woman said she never consented to any tests,
but she remembered a doctor giving her "a little cocktail"
one day.
And in Massachusetts, 120 mentally retarded children
at a state-run school were fed radioactive iron in their
breakfast cereal in the 1940s and 1950s. Former students
recently said they had no knowledge of the tests.
"(The researchers) could have gone to Exeter Acad-
emy or to their own children," said Dr. Michael A.
Grodin, a professor of medical ethics at Boston Univer-
sity Medical School and editor of the book "Children as
Research Subjects."
"It's very clear in my mind why they went to the home
for retarded children - because they saw them as guinea
pigs," Grodin said.
Aside from a statement the University of Michigan
Medical Center issued in response to a Boston Globe
inquiry about the 1949 thyroid tests, the University has
received little attention regarding the federal investiga-
tion into radiation experiments.
Medical Center officials said they do not plan to
examine old University radiation testing on humans, and
declined comment on the research as a whole.
A federal advisory committee, meanwhile, is evaluat-
ing radiation experiments conducted from 1944 to 1974.
The committee will present a preliminary report to the
multi-agency task force in charge of the investigation
later this year.
One issue the advisory committee faces is whether
former radiation test subjects should be entitled to some
form of compensation. The federal government already
gives compensation to "downwinders," people exposed
to fallout from nuclear test sites in Nevada.
Confronted with thousands of complaints, the govern-
ment now has the formidable task of confirming claims,
said Dr. Steve Galson, chief medical officer of the Energy
Department's Office of Environment, Safety and Health.
"We'd have to find some documentation that what
people are claiming actually happened," Galson said. "I
don't see how we could proceed otherwise. They may be
hospital records, it may be someone's personal records,
but I doubt we'll be able to stake any action just on what
somebody says."
The University Medical Center's patient records date
back to the 1890s, although the older ones contain limited
information, said Joan Siefert Rose, a Medical Center
spokesperson.
"If somebody were to come forward and say, 'This
happened,' the hospital could verify that that person had
been treated here," Rose said.
While most of the University radiation research in 1950s tests involved low or negligible levels, the
International Commission on Radiological Protection acknowledges that any amount of radiation carries
the risk of harmful side-effects.
If you believe you or someone you know has been wrongly involved in radiation research, you may call the
federal hotline at:
1-800-493-2998
hospital's pediatric wards for unrelated conditions such
as fractures.
Radiation Research Today
Such selection procedures are unorthodox by current
standards.
"Today, in a modern university, in a modern hospital,
before you can use radioactive pharmaceuticals in pa-
tients, it's got to go through a number of rigid reviews that
are controlled by federal regulations," said James E.
Carey, a nuclear physicist and chair of the University's
Radiation Policy Committee.
Any proposal involving radiation research in humans
today must first be approved by a Medical Center review
board, followed by the Subcommittee on the Human Use
of Radioisotopes.
Both panels follow guidelines set by the U.S. Nuclear
Regulatory Commission, the Food and Drug Administra-
tion and the National Institutes of Health.
The subcommittee approves around six applications
per month, most submitted by researchers in the Medical
School and the hospital's nuclear medicine unit. Almost
all proposals must be revised.
Standardized procedures, such as x-rays and tracer
tests, do not need to go through the subcommittee.
The 10 subcommittee members come from different
fields of science and medicine.
Amiya Hajra, a biochemistry professor, looks at the
biochemical aspects of the research. Nancy Hopwood, a
professor of pediatrics, is consulted on proposals involv-
ing children. Kenneth F. Koral, a research scientist in the
nuclear medicine division's internal medicine depart-
ment, examines dosage levels.
Koral says he also makes sure volunteers aware fully
aware of the risks.
"I'm very careful about it," he said. "I'll tell people
that nobody can say, 'There'll absolutely be no possible
effects."'
Investigators draw up their own consent forms that
must adhere to a series of federal requirements.
"You have to tell people how long it's going to take,
they're free to turn it down, it won't influence their
(medical) treatment ... that if they do agree, they can back
out at any time, and what's involved," Koral said.
Researchers must make sure any women volunteers
are not pregnant.
The forms also must contain understandable explana-
tions, said Edward Goldman, a Medical Center attorney
who advises the subcommittee on legal matters.
"You don't want to say to them, 'We'll be using two
microcuries of iodine 131,'" Goldman said. "What we
want to say is, 'Federal guidelines say you can have X
amount and this is one-eighth of that amount.' You try to
figure out ways that can make it intelligible to the pa-
tients."
Applications today compared with those from the'50s
are a study in contrasts.
"They've gotten quite big," recalls Hajra, who has
THE BRIARWOOD RUN.
APRIL 24,1994.
(WHOA, HEY THAT'S JUST DAYS AWAY)
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