[Senate Hearing 105-180]
[From the U.S. Government Publishing Office]
S. Hrg. 105-180
RADIOACTIVE FALLOUT FROM NUCLEAR TESTING AT NEVADA TEST SITE, 1950-60
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HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED FIFTH CONGRESS
FIRST SESSION
__________
SPECIAL HEARING
__________
Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.access.gpo.gov/congress/
senate
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U.S. GOVERNMENT PRINTING OFFICE
44-045 cc WASHINGTON : 1998
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For sale by the U.S. Government Printing Office
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COMMITTEE ON APPROPRIATIONS
TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont
SLADE GORTON, Washington DALE BUMPERS, Arkansas
MITCH McCONNELL, Kentucky FRANK R. LAUTENBERG, New Jersey
CONRAD BURNS, Montana TOM HARKIN, Iowa
RICHARD C. SHELBY, Alabama BARBARA A. MIKULSKI, Maryland
JUDD GREGG, New Hampshire HARRY REID, Nevada
ROBERT F. BENNETT, Utah HERB KOHL, Wisconsin
BEN NIGHTHORSE CAMPBELL, Colorado PATTY MURRAY, Washington
LARRY CRAIG, Idaho BYRON DORGAN, North Dakota
LAUCH FAIRCLOTH, North Carolina BARBARA BOXER, California
KAY BAILEY HUTCHISON, Texas
Steven J. Cortese, Staff Director
Lisa Sutherland, Deputy Staff Director
James H. English, Minority Staff Director
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Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
SLADE GORTON, Washington ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri DANIEL K. INOUYE, Hawaii
JUDD GREGG, New Hampshire DALE BUMPERS, Arkansas
LAUCH FAIRCLOTH, North Carolina HARRY REID, Nevada
LARRY E. CRAIG, Idaho HERB KOHL, Wisconsin
KAY BAILEY HUTCHISON, Texas PATTY MURRAY, Washington
Majority Professional Staff
Craig A. Higgins and Bettilou Taylor
Minority Professional Staff
Marsha Simon
Administrative Support
Jim Sourwine
C O N T E N T S
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Page
Opening remarks of Senator Arlen Specter......................... 1
Opening remarks of Senator Tom Harkin............................ 2
Prepared statement of Senator Harry Reid......................... 4
Prepared statement of Senator Patty Murray....................... 3
Opening remarks of Senator Larry Craig........................... 6
Prepared statement........................................... 6
Atmospheric tests................................................ 7
Statement of Hon. Richard D. Klausner, M.D., Director, National
Cancer Institute, Department of Health and Human Services...... 8
Prepared statement........................................... 10
Statement of Joseph Lynn Lyon, M.D., M.P.H., professor,
Department of Family and Preventive Medicine, University of
Utah School of Medicine........................................ 17
Prepared statement........................................... 20
No funding for study............................................. 25
Statement of Jan Beyea, Ph.D., senior scientist, Consulting in
the Public Interest............................................ 26
Prepared statement........................................... 28
Institute of Medicine............................................ 34
Statement of Timothy Connor, associate director, Energy Research
Foundation..................................................... 34
Prepared statement........................................... 37
Followup study................................................... 41
Statement of Andrea McGuire, M.D., staff physician, Veterans
Administration Hospital, Des Moines, IA........................ 42
Prepared statement........................................... 43
Tests............................................................ 44
Followup studies not made........................................ 47
Remarks of Senator Slade Gorton.................................. 52
Letter from Dr. Richard D. Klausner.............................. 58
Letters from Senator Tom Daschle................................. 58
Isotope.......................................................... 59
Statement of Arjun Makhijani, coauthor, article, ``Bulletin of
Atomic Scientists''............................................ 60
Prepared statement of Senator Dirk Kempthorne.................... 63
Prepared statement of Peter G. Crane............................. 63
RADIOACTIVE FALLOUT FROM NUCLEAR TESTING AT NEVADA TEST SITE, 1950-60
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WEDNESDAY, OCTOBER 1, 1997
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:04 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Gorton, Craig, Faircloth,
Harkin, Reid, and Murray.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Cancer Institute
STATEMENT OF RICHARD D. KLAUSNER, M.D., DIRECTOR
opening remarks of senator specter
Senator Specter. We will begin this hearing, which focuses
on the findings of the National Cancer Institute report on
radioactive fallout from nuclear testing at the Nevada Test
Site in the 1950's and 1960's. Dr. Richard Klausner, the
Director NCI, will begin the hearing, with the principal
investigators of this study, Mr. Bruce Wachholz and Mr. Andre
Bouville, available to answer questions. Then we will have four
witnesses who will evaluate the NCI hearing on a number of
grounds.
Atmospheric nuclear bomb testing in Nevada yielded
significant amounts of radioactive fallout. In 1982 Congress
passed legislation directing HHS to develop methods of
estimating the varieties of exposure to the American people, to
assess thyroid doses received by the individuals from across
the Nevada desert and individuals all the way across the
country who were impacted by the Nevada test, and to assess the
risks of thyroid cancers from these exposures.
This is a very important hearing. We had planned on the
subcommittee to do the hearing earlier, but it was impossible
to schedule it before October 1. This falls on the first day of
the new fiscal year and we have a meeting on our conference
report for Labor, Health, Human Services, and Education.
The subcommittee will ask you, Dr. Klausner--your full
statement will be made part of the record, as will all the
statements--if you can limit your testimony opening to 5
minutes, and we will ask the witnesses to speak 3 minutes,
limiting the rounds of questioning, depending on how many
Senators arrive, to 3 minutes as well.
I regret the time constraints, but I say we do have to
complete action on this legislation for important reasons,
including funding the National Cancer Institute.
My distinguished ranking member, Senator Harkin.
OPENING REMARKS OF SENATOR TOM HARKIN
Senator Harkin. Thank you, Chairman Specter, for your
leadership, for working to convene this hearing on an issue of
great importance to the people of my State and the country. I
am sorry about the time constraints because I think this needs
a full hearing, and there probably has to be some follow-up
hearings on this issue and the issue of other possible health
effects from radioactive fallout from nuclear testing in the
1950's.
We have a number of expert witnesses. Dr. Richard Klausner
of the National Cancer Institute, I thank him for being here. I
also want to welcome and thank Dr. Andrea McGuire for coming
from Iowa for the hearing today. Dr. McGuire is an oncologist
from Des Moines who will provide both a professional and
personal perspective about this issue.
This morning we are here to get answers, to try to get to
the truth. The report being released today by the National
Cancer Institute is an important step forward. The NCI study
details the health impact of iodine-131, a radioactive isotope
spread across the United States by the 90 above-ground nuclear
weapons tests conducted in Nevada during the 1950's. These
tests exposed millions of Americans, particularly children, to
large amounts of radioactive iodine-131, which accumulates in
the thyroid gland and has been linked to thyroid cancer.
Hot spots where the iodine-131 fallout was greatest
included many areas far away from Nevada, including New England
and the Midwest. Due to the character of iodine-131, those
exposed to the highest concentrations were those who drank
large amounts of milk from cows that grazed in fields with
large fallout. Because their thyroids are smaller and still
growing, children were most vulnerable.
Hot spots were identified as receiving 5 to 16 rads or
higher of exposure to iodine-131, with children being exposed
to a risk of up to 10 times higher. To put that in perspective,
Federal standards for nuclear power plants require that
protective action be taken for 15 rads. Or to compare it
another way, over 115 million curies of iodine-131 were
released in the U.S. above-ground tests. 7.3 million curies
were released from the Chernobyl disaster.
This issue hits very close to home for me. In the 1950's I
was growing up in south central Iowa, a small town. Along with
many Iowans, I lived in hot spots detailed by the NCI study.
And, like many of my neighbors, I drank milk from cows that
grazed in the fields.
My family has a history of thyroid problems, my brother
Chuck, myself. And I think Dr. McGuire will testify about
what's happened in her family.
When it comes to the Government and nuclear testing,
history shows the problem has not just been a fallout of
radiation, but a holdout of facts. Information has come to
light that officials of the U.S. Government were aware that
fallout from nuclear blasts would contaminate areas that were
hundreds, even thousands, of miles away.
An article by Pat Ortmeyer and Arjun Makhijani which will
appear in the upcoming issue of the Bulletin of Atomic
Scientists documents some of this in chilling detail. Start
first with the first nuclear test in New Mexico in July of
1945. The so-called Trinity test resulted in one hot spot all
the way in Indiana. How do we know that? Corn husks from that
area were used as packaging material for Kodak film, and a
month after the 1945 test consumers started complaining about
fogged film. A physicist at Eastman Kodak looked into it and
uncovered the cause: The corn husks were radioactively
contaminated.
Now fast forward 6 years to the first nuclear test in
Nevada. After a snowfall, the geiger counters at the Kodak
plant in Rochester, New York, registered readings 25 times
above normal. Kodak complained to the Atomic Energy Commission
and that Government agency agreed to give Kodak advanced
information on future tests, including ``expected distribution
of radioactive material in order to anticipate local
contamination.''
In fact, the Government warned the entire photographic
industry and provided maps and forecasts of potential
contamination. Where, I ask, were the maps for dairy farmers?
Where were the warnings to parents of children in these areas?
So here we are, Mr. Chairman. The Government protected
rolls of film, but not the lives of our kids. There is
something wrong with this picture.
Now, the NCI study has attracted a lot of attention, and
that is not surprising from a report detailing exposure to
millions of Americans. However, there is also a controversy
over the manner in which the study was conducted. Several
organizations and many of my constituents have expressed
concern over the apparent delay in the release of the study,
and I appreciate that Dr. Klausner is here to shed light on
that.
I believe there are three areas we need to explore: First,
what are the facts concerning the preparation and release of
the NCI report and why did it take 15 years to complete?
Second, what are the next scientific steps in investigating
radioactive fallout from atomic weapons testing? What other
fallout was there that could have affected us in terms of
childhood leukemia and bone cancer?
Last, what are the health policy impacts of the NCI study?
What should concerned citizens do if they live in a high-risk
area? What should the Federal Government communicate to
physicians and other public health officials? What should be
the role for the Center for Disease Control and Prevention in
alerting public health officials around the country?
Last, we should get to the bottom of why, why the
Government alerted the photographic industry? Why did they do
that when they had all the information about hot spots and
fallout, and yet they did not warn the people of this country
about the dangers inherent in radioactive fallout, especially
iodine-131?
Mr. Chairman, I did not mean to take so long. But I believe
this hearing is crucial to getting at the bottom of this and to
beginning a process, hopefully, of alerting public health
officials and others around the country as to just what should
be done. And I think we ought to get to the bottom, as I said,
of what was our Government's role in not alerting the public
during the 1950's and early 1960's.
Mr. Chairman, thank you.
Senator Specter. Thank you very much, Senator Harkin.
For the members who have just arrived, I had announced
earlier that Senator Harkin and I have a responsibility on the
conference. We are going to have to conclude the hearing in 1
hour. Ordinarily we move ahead on--while it is not the practice
of many committees, we do allow opening statements. But I would
ask that those be waived this morning so that we can proceed
with the hearing.
We are going to give Dr. Klausner 5 minutes and the 4
witnesses 3. Senator Craig may be able to stay longer. We may
have to reconvene the hearing and go into it in more detail.
But as I said earlier, this is the first day of the new fiscal
year and we are under constraints to get a conference report
done. We are meeting on that with House Members, so we have
that very substantial time constraint.
PREPARED STATEMENT OF SENATOR REID
Senator Reid. Mr. Chairman, may I ask unanimous consent
that my full statement be made part of the record?
Senator Specter. Absolutely, Senator Reid.
[The statement follows:]
Prepared Statement of Senator Harry Reid
HEALTH RISKS OF ATMOSPHERIC NUCLEAR TESTING
The National Cancer Institute was asked to respond to
legislation requiring a valid and credible assessment of
exposure of U.S. citizens to radioactive Iodine-131 resulting
from fallout from atmospheric testing of nuclear weapons.
It is no longer surprising that many American citizens were
placed at risk by atmospheric testing.
The surprises are in the nation-wide character of the
exposure and the levels of exposure experienced by citizens
living so far from the Test Site.
While the passage of time continues to reduce the threat
level, it is important to realize that the threat of exposure
from these tests is still with us.
The half-life of Iodine-131 is only about 8 days, so that
material that was not taken up by individuals within several
weeks of the tests is no longer of concern.
However, other fallout ingredients have much longer periods
of radioactivity. For example, Strontium-90 and Cesium-137 have
half-lives of about 30 years. These are also taken up by the
body and exhibit radioactive emissions very similar to Iodine-
131.
Consequently, the Iodine-131 study, which is continuing,
should continue. But this study addresses only a part of the
story. Other exposure threats and the resulting risk to
succeeding generations need to be considered.
The tools and methodologies developed for Iodine-131
exposure will provide much of what is needed to consider other
radioactive threats from this critical period in our nation's
pursuit of global peace and security.
I would be remiss if I did not point out the obvious: our
citizens were neither knowingly nor frivolously exposed to
risk. Well-meaning scientists and civic and political leaders
assured themselves and their constituencies that there was
negligible risk in these tests that were so important to our
national security.
It was not until much later that the magnitude and duration
of the risk became more and more evident.
We should learn from past mistakes.
The mistake in this case was one of proceeding with
terribly intrusive and risky actions before enough was
understood about all the uncertainties surrounding the
activity.
Underground testing could have been used from the outset.
It was not until the risks became more evident that the time
and expense of moving the tests underground was accommodated.
Well, we are in the process of once again trying to repeat
this kind of mistake.
Permanent disposal of spent nuclear fuel and high level
radioactive waste is subject to even greater uncertainties than
was the original atmospheric testing program.
Yet, some are making Herculean efforts to circumvent the
absolutely crucial process of understanding the suitability of
the proposed disposal site and methodology.
The amounts and intensity of radioactive materials that
would be dumped in Nevada far exceed that associated with all
of the nuclear weapons ever exploded anywhere * * * and there
is no guarantee that this dangerous stuff would be isolated
from the environment throughout its hazardous period of 10,000
years.
There is no national security crisis, nor is there any
other kind of emergency that would warrant doing anything at
all until the consequences of disposal actions are well and
confidently understood.
PREPARED STATEMENT OF SENATOR MURRAY
Senator Murray. I as well ask unanimous consent that my
full statement be made part of the record.
Senator Specter. Senator Murray as well.
[The statement follows:]
Prepared Statement of Senator Patty Murray
Good morning and welcome to all of our distinguished
witnesses. I want to say a special hello and thanks to Tim
Conner, Associate Director of the Energy Research Foundation of
Spokane, Washington who will be testifying later. Tim is an
active health and environmental researcher and was a founder of
a public interest organization that works on issues of nuclear
weapons production and environmental restoration. I hope I will
have the opportunity to hear his testimony, but I am also
looking forward to meeting with him personally later today. I
appreciate all of your work, Tim.
I also want to thank the chairman and ranking member for
holding this hearing. I share the concern of many constituents
and people across the nation who have been horrified to learn
of the radiation ``experiments'' on unknowing citizens
perpetrated by our government. Of course, it was a different
world in the 1940's and 1950's and we were fighting a Cold War.
The United States government made mistakes in its haste, fear
and ignorance.
But I cannot understand why the National Cancer Institute
has allegedly withheld information now, in the 1990's, after we
had won the Cold War. It is reprehensible that our citizens
were intentionally exposed to radioactivity and yet those who
knew remained silent--even in the face of evidence that said if
we provided treatment and information early, we might alleviate
suffering or prevent diseases.
In my home state of Washington, the Atomic Energy
Commission conducted its own tests and released radioactive
iodine into the air from the Hanford Nuclear Reservation. Many
people in central and eastern Washington were exposed. Despite
several major studies and research projects, we are still
uncertain about which direction to take. The Pacific Northwest
National Laboratory has compiled data on radioactive releases
and attempted to estimate the doses individuals received and
published its results in the Hanford Environmental Dose
Reconstruction study. The Centers for Disease Control and Fred
Hutchison Cancer Research Center are now completing a long-term
study on thyroid disease and are expected to finish that
enormous undertaking next year. The Agency for Toxic Substances
and Disease Registry has issued a medical monitoring plan, but
has yet to locate a source of funding to implement the plan.
The Hanford Health Information Network is trying to locate,
catalog and help educate potential victims. And these are only
a few of the studies and programs on-going to address the
Hanford downwinders problems.
While we have a lot of activity surrounding these issues,
we seem to be shorter on action. I believe the bottom line is
the federal government must accept responsibility for harming
its citizens. It must apologize. And it must help these people
with medical bills. These things are the very minimum we must
do.
I look forward to working with this committee to develop a
comprehensive policy to address the grievances of our citizens.
This is a complex area, but one that has been ignored for too
long. Let's figure out what our citizens need--and do it.
OPENING REMARKS OF SENATOR LARRY CRAIG
Senator Craig. Mr. Chairman.
Senator Specter. Senator Craig.
Senator Craig. Mr. Chairman, let me say only briefly that
preliminary releases of information in August suggest that four
out of the five counties with the greatest concern are in my
State of Idaho, and as a result of that there is a sense of
urgency for good accurate knowledge and understanding. I
expressed frustration then and you will hear me expressing
frustration throughout this hearing as the information unfolds.
PREPARED STATEMENT
Senator Harkin expresses his frustration about time and
length of time. While the citizens of Idaho and this Senator do
not want nor will we rush to judgment, there is certainly a
crying demand for knowledge and understanding of what may or
may not have happened.
I will ask unanimous consent that my full statement be a
part of the record, Mr. Chairman.
[The statement follows:]
Prepared Statement of Senator Larry Craig
Mr. Chairman, I am pleased to be here today and I thank you
for holding this hearing on an important issue--one especially
important to Idaho.
Today the National Cancer Institute releases its full
report on iodine-131 fallout from above ground nuclear weapons
tests. The report runs to some 100,000 pages, I am told. The
summary alone is 1,000 pages.
Since it is being released just today, neither I nor my
staff have yet had the opportunity to review these results.
According to preliminary results released by the National
Cancer Institute in August, however, the State of Idaho has
four out of the five counties in the nation with the highest
radiation exposure to iodine-131 from the fallout of these
weapons tests.
Individuals living in these five Idaho counties were
estimated to have received a cumulative average dose of 12 to
16 reds--with a 3 to 7 fold increase for children exposed
between the ages of 3 months and 5 years.
These results are of great interest and concern to me and
to my fellow Idahoans. They are eager and impatient to
understand what these results mean.
Unfortunately, in reviewing today's testimony and culling
from the vast public health resources available, I am afraid
this is a question we will not be able to answer today for
Idaho citizens and other exposed populations.
I hope we will not spend all our time today trying to
recreate the 14 year history of what the National Cancer
Institute did, or should have done, in producing this study.
I hope we will not spend our time today attempting to put
the decisions this Nation made at the height of the Cold War
under the microscope of our modern thinking.
What I do believe to be our charge here is to assemble all
the facts. This is what my constituents have asked of me.
Simply knowing what the fallout levels were--a figure such
as ``15 rads''--does not provide Idahoans with the information
they need about possible health consequences. Specifically, the
question that needs to be answered is:
``Do these levels of fallout result in an increased risk of
thyroid cancer or other complications?''
In reviewing the testimony of our witnesses, I know that
some of them have already reached their conclusions on the
health effects of these exposures, but there is a tremendous
diversity of opinion on this.
A number of health organizations are openly skeptical of
any link between iodine-131 fallout and increased thyroid
cancer.
As an example, let me quote from the position statements of
two national health organizations.
The American Association of Clinical Endocrinologists
states the following: ``Dozens of studies involving even much
larger doses of iodine-131 given to adults and children have
shown no correlation between iodine-131 and thyroid cancer. * *
* Over the past fifty years, hundreds of thousands of patients
have received iodine-131 for medical purposes, and there is no
increase of thyroid cancer in these patients.''
The American Thyroid Association states: ``Radioactive
iodine has been used for more than 50 years in almost 10
million individuals as part of routine thyroid function tests *
* * in amounts far greater than that delivered by the fallout
and careful long term follow-up studies of these individuals
have not shown any evidence of excess thyroid cancer
attributable to radiation exposure.''
Perhaps the strongly conflicting opinions on this issue
suggest the need for further and more conclusive study.
As tragic as the events at Chernobyl and the nuclear
contamination in the Former Soviet Union may be, the study of
these exposed populations may be able to add to our
understanding about the health effects of low levels of
radiation exposure.
I understand that cooperative research in these areas is
already ongoing. I encourage these efforts.
When we have completed more definitive work on this link
between weapons fallout and cancer incidents--at that time--I
believe Congress should look at any needed remedies.
One avenue of remedy may be an expansion of programs
already available to down wind exposed populations--or
``downwinders,'' such as the Radiation Exposure Compensation
Act of 1990.
Another idea that may have merit is the use of a voluntary
registry of individuals with thyroid health complications. It
could be similar to registries developed for some of the
Department of Energy dose reconstruction studies.
Such a voluntary registry would allow those who want to
participate in follow-up and long term medical monitoring to
contribute to our very sparse data on low radiation dose health
effects.
I want to close by emphasizing that the most important
thing right now is for those individuals who may have been put
at increased risk to be provided with the facts and information
they need to make informed decisions about their health, and
any medical monitoring that may be required.
Along these lines, I would like to see our national health
organizations and government health institutes working
together--and in cooperation with state and county health
organizations--on a public education campaign about the early
warning signs of thyroid disease.
Such an education campaign would raise people's awareness
and, hopefully, motivate them to seek early medical
intervention, if needed.
I am committed to seeing that populations exposed to this
radioactive fallout get the information they need on this
issue, in a timely way. I think our hearing today is a first
step in this process.
ATMOSPHERIC TESTS
Senator Reid. Mr. Chairman.
Senator Specter. Senator Reid.
Senator Reid. I would only say that I am probably the only
person here that actually watched those atmospheric tests go
off. We used to get up in the morning early and watch them
light up the desert sky.
Senator Specter. Just one note on the question of
governmental disclosure. That is a recurrent problem, of
greater intensity now than ever. We're fighting with gulf war
syndrome, where the Department of Defense did not make facts
available from a 1991 fallout until 1996. We are still in the
midst, after having extensive hearings, on Ruby Ridge; on
Khobar Towers, on the terrorist attack; and on INS and IRS.
This is a very fundamental failing which we find in our
Government today, which requires very intensive efforts.
Dr. Klausner, we welcome you here. You have been before
this committee many times. We thank you for your distinguished
service, and the floor is yours.
SUMMARY STATEMENT OF DR. RICHARD KLAUSNER
Dr. Klausner. Thank you very much, Senators.
One of the dark legacies of the above-ground nuclear tests
was that 160 million Americans alive during that period were to
varying degrees and unbeknownst to them exposed to radioactive
fallout. On August 1st we released our study estimating
exposures of thyroid doses of I-131 received by the American
people, and today we release the details behind those results.
This is a study of unprecedented magnitude, utilizing the
limited data available for each of the 90-plus tests between
1952 and 1958 responsible for 99 percent of the I-131 released
into the atmosphere. These data were coupled with detailed wind
patterns, rainfall patterns, grazing patterns of cows and
goats, transfer patterns to milk, milk distribution and
consumption patterns, and the results were then analyzed for
all 3,000-plus counties in the 48 contiguous States for 13 age
groups for multiple milk consumption patterns. The results are
now available for each test, each series of tests, and
cumulatively.
Before I describe some of the results briefly, I must
emphasize that there are significant uncertainties in these
numbers. Because there were so few direct measurements at the
time, much of the study relies on the development of
mathematical and statistical models to estimate patterns and
exposures.
The average cumulative dose to all Americans was 2 rads. By
county, the average cumulative exposure, as we heard, ranged up
to 15 rads. But, importantly, the average cumulative exposures
for children are between three and seven times those numbers,
while for adults it is about one-third to one-half. Children
who were heavy milk drinkers in certain areas may have been
exposed to 100 rads or more.
A rad, or a radiation absorbed dose, is a physical measure
of radioactivity. For comparison, during the 1950's diagnostic
thyroid scans used medically gave up to 300 rads of I-131.
What do we know about radiation and thyroid cancer? Most of
what we know is from external radiation sources, whereas the
fallout was largely due to internal, ingested radiation. At
external exposures of about 100 rads, there is about a seven to
eightfold increase in the incidence of thyroid cancer. This is
only seen for exposed children, primarily those exposed under
age five.
While it is virtually certain that internal exposure of I-
131 can predispose to thyroid cancer, there is much we do not
know. We do not know the dose-response relationship. We do not
know if the potency is the same as external radiation. If it
is, we have estimated that these tests may have resulted in as
many as 75,000 additional cases of thyroid cancer to the
children alive at that time throughout the course of their
lives, about a 20-percent increase from the expected number of
thyroid cancers.
Over this time, the NCI has funded several studies
attempting to get at this issue of the relationship between I-
131 and thyroid cancer. A large study of 35,000 individuals in
Sweden exposed to about 100 rads on average of I-131 failed to
show a statistically significant increase in thyroid cancer.
More directly pertinent was an NCI-funded study published
in 1993 following a cohort of nearly 2,500 children in Utah,
Nevada, and Arizona who had been exposed to fallout and were
examined in the sixties and again in the 1980's. In this study
there was a positive association between I-131 exposure and
about a 3- to 3\1/2\-fold increased risk of thyroid cancer. As
the authors of the study pointed out, the small number of
cancers observed limited the certainty of the exact
association.
Currently the NCI is engaged in an important series of
studies in Belarus and the Ukraine and following tens of
thousands of children exposed to fallout doses upwards of
thousands of rads, in radiation released during the Chernobyl
nuclear accident. We believe that this study will provide the
best single opportunity for establishing human dose-risk
relations as a function of age for thyroid cancer.
What about this study, the speed, its oversight, and the
openness? The length of this study as far as I can tell in
reviewing this was overwhelmingly a reflection of its
complexity, as well as the process of review and evaluation. It
was from its beginning overseen by an expert advisory panel
that guided its design and progress through open public
meetings.
Three interim reports to Congress were prepared by NCI, in
1984, 1986, and 1991. Progress and results were presented at
public meetings of the NCI Board of Scientific Counselors. It
was reported each year in the annual reports. Multiple papers
were presented at public scientific meetings in 1987-90, 1994-
95, and publications about the study resulted from these
presentations, including the extent and quantitation of the
average overall exposure and the level of increased exposure to
children.
There is always a tension between our desire to disseminate
and publicize the results of studies and the need to ensure the
integrity and quality of that information through the
scientific peer review process. That said, I believe in this
case that a more clear, more rapid, and more aggressive plan
for dissemination of the results to the public was called for.
Since I became aware of the study, over the past 6 to 8
months we have moved quickly to release the study in its
entirety, all 100,000 pages, in a form that would be
accessible, understandable, and useable. This plan is described
in detail in my written statement. But a unique feature I want
to point out is that the entire report and supporting data are
totally accessible as of today through the Internet, an
approach that was not even available 3 years ago.
Despite the tremendous interest in this study, let me
emphasize, as actually Senator Harkin has talked about in the
newspapers, that the results confirm widely discussed and
published ranges and extent of fallout exposure which have been
the subject of an enormous amount of attention, including by
the Congress, since the 1950's. This study provides, we
believe, both important new methodologies and much more
detailed exposure information than has been previously
available.
But the results ought not to be characterized as
unexpected. This particular study was not designed to directly
address the health consequences of these exposures. Estimates
of additional cases of thyroid cancer, as I said, that might
have arisen have been made, but again are subject to
uncertainty.
Preliminary analyses, which I can show you later, of cancer
incidence and mortality rates across age groups have been done,
and we have so far been not able to discern any obvious
correlation with areas of I-131 exposure. Let me emphasize,
however, that that does not rule out the likeliness that
individuals exposed in the 1950's were placed at increased risk
of thyroid cancer.
For now, the NCI agrees with the recommendation of the
American Thyroid Association that individuals concerned about
their risk should consult their physicians for a manual thyroid
exam.
While I have emphasized the uncertainties that surround the
health consequences of I-131 exposure, such potential
consequences should not be trivialized. HHS has requested that
the Institute of Medicine rapidly examine this study, how it
was done, its validity, and other available information and
independently report on its public health and medical
implications.
PREPARED STATEMENT
The NCI appreciates the interest and concern that you and
the public have expressed that high quality information be
provided about nuclear fallout. This is especially true in the
context of the legacy of the cold war, in which such
information was too often not provided or even hidden. We hope
this study will contribute to our knowledge about the release
and distribution of I-131 and how individual exposures can be
assessed.
I thank you for this opportunity to describe the study and
hopefully clarify its limitations, and I'm pleased to answer
any questions.
Senator Specter. Thank you very much, Dr. Klausner.
[The statement follows:]
Prepared Statement of Richard D. Klausner, M.D.
Good morning Senator Specter, Senator Harkin, and Members of the
Subcommittee. I am Richard Klausner, Director of the National Cancer
Institute (NCI), and today I am presenting to you, for the first time,
the completed NCI report estimating thyroid doses of Iodine-131 (I-131)
received by Americans as a result of atmospheric nuclear bomb tests
conducted at the Nevada Test Site. This study was conducted in response
to legislation enacted by the 97th Congress of the United States.
PUBLIC LAW
Public Law 97-414, in part, directed the Secretary of the
Department of Health and Human Services (DHHS) to conduct scientific
research and prepare analyses necessary to develop valid and credible
methods to estimate the thyroid doses of I-131 that are received by
individuals from nuclear bomb fallout, and to develop valid and
credible assessments of the exposure to I-131 that the American people
received from the Nevada atmospheric nuclear bomb test. The magnitude,
complexity and difficulty of such research is without precedent and the
fact that such a study was completed is testimony to the expertise and
commitment of a large number of government and non-government
scientists, and particularly of two NCI researchers--Dr. Bruce Wachholz
and Dr. Andre Bouville. The study was designed and carried out with the
help of an Advisory Committee with representation from the fields
relevant to radiation science. This study was not designed to evaluate
the health effects of I-131 exposure, so such risk estimates are not
part of this study.
I-131 RELEASE AND DEPOSITION
Ninety nuclear tests released almost 99 percent of the total I-131
entering the atmosphere from the bomb tests conducted at the NTS. These
90 tests released about 150 million curies of I-131, mainly in the
years 1952, 1953, 1955, and 1957. Some radio-iodine was deposited
everywhere in the U.S., with the highest deposits immediately downwind
of the NTS. The lowest deposits were on the west coast, upwind of the
NTS. In the eastern part of the country, most of the deposited I-131
was associated with rain, while in the more arid west, dry deposition
(where particles settle on the ground) prevailed. Because I-131 has an
8-day half-life, exposure to the released I-131 occurred primarily
during the first two months following a test.
DOSE RECONSTRUCTION
A major challenge of this study was the attempt, three to four
decades after the events, to retrospectively assess the exposure of
persons throughout the country. For most tests, however, it was
possible to estimate the amounts of radioactivity deposited on the
ground in fallout from the measurements of radioactive particles
collected on sticky surfaces (i.e., gummed film). These collection
units were geographically dispersed around the United States, and the
collections were made systematically as part of an environmental
monitoring program. These original data were re-analyzed in order to
estimate the I-131 component in the fallout. Beginning with such
measurements, the study used mathematical modeling of these and other
relevant measurable data to estimate the levels of thyroid exposure in
approximately 160 million Americans in the 48 contiguous states of the
country during the test period. In the absence of environmental
radiation measurements during some tests, meteorological dispersion
models were developed to calculate the amount of fallout deposits.
The assessments of thyroid exposure have two components: deposition
of I-131 and the exposure of persons. First, mathematical models were
developed to estimate the amount of I-131 deposited in each of 3,094
counties (and sub-counties mapped in a few areas) in the contiguous 48
States. This involved re-analysis of data from monitoring stations in
operation across the U.S. during the testing program and the use of a
meteorological model. This information, coupled with precipitation data
for each county during the time the fallout clouds were over the U.S.,
permitted estimates of I-131 deposition. The dispersion of the cloud
was tracked at four different altitudes in the days after each test to
determine distribution of radioactive clouds. This component of the
study was carried out in cooperation with experts from the Department
of Energy (DoE) and from the National Oceanic and Atmospheric
Administration (NOAA).
Second, thyroid exposure to the U.S. population resulting from this
fallout was assessed. It is well known that consumption of milk from
cows grazing on contaminated pastures is the principal route by which
I-131 is incorporated into human tissues, especially for children. Most
of the exposure to environmental I-131 resulted from the consumption of
this contaminated milk and, for some individuals, from the consumption
of fresh goats' milk. This component of the study, which was carried
out with the help of experts from the U.S. Department of Agriculture
(USDA), involved the compilation of extensive and detailed information
regarding pasture consumption and grazing patterns, the production of
milk by cows, and milk distribution and consumption patterns throughout
the country. These data were used in mathematical models to estimate
the transfer of I-131 from deposition on the ground to the intake by
humans of I-131 resulting from the consumption of contaminated cows'
milk of various origins. In addition, other exposure pathways such as
the consumption of contaminated goats' milk, eggs, leafy vegetables,
and cottage cheese were considered as well as the inhalation of
contaminated air.
Finally, thyroid dose was estimated on the basis of the exposures
that were assessed for each nuclear test and each county of the
contiguous United States. Thyroid doses from intake of I-131 vary
substantially as a function of age and depend mainly on the size of an
individual's thyroid gland and on the amount of fresh cows' milk an
individual consumed. For that reason, thyroid doses were estimated for
13 age categories, including four in-utero ages, four for infants under
one year of age, four for children under age 20, and adults. The
thyroid doses to adults were estimated separately for males and for
females. Also, because the origins of milk and the level of consumption
vary substantially from one individual to another, thyroid doses have
been estimated for people drinking average amounts of fresh cows' milk
with average I-131 contamination levels from commercial sources; for
people drinking large amounts of cows' milk with above-average I-131
contamination levels from commercial sources; for people drinking milk
from backyard cows; and for people drinking no cows' milk but consuming
other foodstuffs contaminated with I-131.
The calculation of these thyroid doses resulted in the production
of about 100,000 pages of data and analyses that show--by county, for
each weapons test, each series of tests, and the entire testing
period--average levels of predicted exposure for the 13 age groups and
for both genders, and for four milk consumption patterns. In addition,
detailed maps have been prepared, showing the deposition pattern of I-
131 on the ground and the average thyroid doses for the population of
each county of the contiguous United States after each weapons test and
series of tests. The overall average thyroid dose to the approximately
160 million people in the country during the 1950's is estimated to
have been about 2 rad. ``Rad'' means ``radiation absorbed dose.'' It is
a physical unit of energy deposition. To put this amount of exposure
into perspective, routine medical use of x-rays during the 1940's and
1950's exposed children to anywhere from 5 to several hundred rad, and
all persons receive doses from natural background radiation of about
0.1 rad per year.
Because the study relied on a limited number of measurements and
was based essentially on mathematical models, the uncertainties
associated with the thyroid dose estimates are fairly large, usually a
factor of three or more for averages pertaining to population groups;
for individuals the uncertainties might be greater. However, a
comparison of the results obtained in this study with those derived
from the few I-131 measurements that were carried out in the 1950s,
either in the urine or in the thyroids of people, or in cattle
thyroids, show a reasonably good agreement.
PUBLIC AWARENESS
It is important to note the context in which this study was carried
out. What was known publicly about fallout? During the late 1950's and
early 1960's a series of Congressional hearings were held and the
published scientific literature was introduced into the public record.
The preliminary results of the NCI study are remarkably consistent with
these early reports. For example, the range of estimated I-131 exposure
for children had previously been identified in the 1960's ranging from
4 to 120 rad; the NCI study places ranges between zero and 100 rad. The
results obtained in this study are also consistent with those obtained
by the DOE and the University of Utah for populations living in states
close to the Nevada Test Site.
As the preliminary findings of the NCI study took form in the early
1990's, NCI staff made a decision to prepare the data and formulae to
be useful, accessible, and user friendly. An interactive format, now
available on the World Wide Web, allows an individual to estimate his
or her own exposure. By designating a state and county, and date of
birth, users will receive a table of the estimated doses to the thyroid
after each nuclear test. Dosages are also calculated for four different
milk-drinking scenarios.
INTERIM REPORTS
During the time period of data collection, calculation, and
analysis, the NCI drafted status reports in 1984, 1986, and 1991 for
transmittal to the Congress by the Secretary, HHS. The methodologies
used in the study have been presented at scientific meetings since the
project's inception in 1983. Meetings of the I-131 Advisory Committee,
which was chartered in 1984 with experts in all relevant fields of
science to assist NCI staff in carrying out this study, were open to
the public. It served until 1993 as a place where presentations and
discussions of the latest findings of the study and more broadly in the
scientific arena could be aired. Updates were presented frequently to
the NCI's Board of Scientific Counselors and in open meetings. Papers
about the study have been presented at national and international
scientific meetings since 1987. Since 1990, preliminary results have
been published in the scientific literature.
THYROID CANCER AND RADIOACTIVITY
Thyroid cancer is uncommon, accounting for just one percent of all
cancers in this country. Each year about 16,000 cases are diagnosed in
the U.S., with an estimated 1,230 deaths. Thyroid cancer is very
curable, with the five-year survival rate at 95 percent. This type of
cancer occurs more often in women than in men, and is seen at ages as
young as 5. In men, incidence rises gradually with increasing age,
leveling off after about age 70, whereas in women the increase is
steeper, leveling off after age 30 or 35. Between 5 and 10 percent of
cases eventually result in death, usually after age 50 and usually
attributable to the relatively rare anaplastic and medullary forms of
the disease.
Scientists do not know what causes most cases of thyroid cancer.
One known risk factor is exposure to external radiation during
childhood. Commonly, during the 1940's and 1950's, children received x-
ray treatments to the head and neck for noncancerous conditions such as
enlarged tonsils, enlarged thymus gland, acne, and ringworm of the
scalp, and as a result these individuals have a higher-than-average
risk of developing thyroid cancer many years later. A compilation of
multiple studies has demonstrated that exposure during childhood to 100
rads of external radiation results in a 7-8 fold increased risk of
thyroid cancer. The vast majority of risk is seen for children who are
exposed below the age of 10.
While it is very likely that exposure to I-131 also increases the
risk of thyroid cancer, there is considerable uncertainty as to the
relative carcinogenicity of I-131 fallout exposure compared to external
radiation. Throughout the course of the fallout study being released
today, the NCI engaged in and funded studies attempting to evaluate the
risk of thyroid cancer from I-131, in order to fulfill the third
component of the legislation, which was to determine the risk of
thyroid cancer associated with I-131 exposure.
Thus far, studies of exposure to I-131 for medical purposes or from
fallout in areas downwind from the site of atomic bomb tests during the
1950's have not produced conclusive evidence that such exposure to I-
131 is linked to cancer. In 1992, the University of Utah reported a
statistically significant dose-response relationship between exposure
to radioiodines and occurrence of thyroid neoplasms (combined benign
and cancerous tumors) in a group of nearly 2,500 children in Utah,
Nevada and Arizona who had been examined in the 1960's and again in the
1980's. However, while the correlation between the I-131 radiation dose
and thyroid cancers alone was suggestive, it was not statistically
significant and therefore could have been due to chance.
The relationship between I-131 exposure and thyroid cancer
continues to be studied. In 1985, NCI collaborated with Swedish
scientists on a study of diagnostic I-131 received by 35,000 patients
who received an average dose of 100 rad to the thyroid. At this mean
dose an excess risk of thyroid cancer was seen only among persons
referred for examination because a thyroid tumor was suspected. The
study included 2,408 persons exposed before age 20, and 314 children
aged 10 and under. Among persons between 15-19 years of age, two cases
of thyroid cancer were observed compared to 1.5 cases expected. No
cases were seen in children under age 15.
It is perhaps too early to know, but it seems likely from
preliminary information that thyroid cancer increased in those
populations of Belarus, Ukraine, and Russia most affected by the
Chernobyl accident, and that I-131 exposure is the probable cause.
Assuming the eventual results are positive, the unresolved question
will be how the risk from I-131 exposure compares to the risk
associated with similar doses from x-rays. The Chernobyl nuclear
accident provides a tragic opportunity to obtain valuable information
needed to further develop these risk estimates. NCI staff recognized
the value of this opportunity to address that component of Public Law
97-414 that instructs the government to carry out research to make
assessments of the risk of thyroid cancer from I-131. Our studies,
supported jointly by the Department of Energy and the Nuclear
Regulatory Commission, include about 15,000 children in Belarus and
30,000-40,000 in Ukraine, a number of whom received doses in excess of
1,000 rad to the thyroid. The I-131 Advisory Committee as well as the
NCI believed that it was in the interests of the U.S., as well as the
world community, to invest the time and effort needed over the past
several years to accomplish the complex negotiations required to
undertake cooperative studies of thyroid disease with scientists in
Belarus and Ukraine.
NCI is currently analyzing thyroid cancer incidence in our SEER
(Surveillance, Epidemiology and End Results) Program and in nationwide
mortality data. Preliminary analyses of these data across age groups
have been done and we do not discern any obvious correlation with areas
of high I-131 exposure. However, these analyses do not rule out the
possibility that thyroid cancer risk has been elevated in exposed
individuals and we are continuing to evaluate these data to look for
more complicated patterns. We also are investigating the possibilities
of conducting other studies, and expect that further discussions along
these lines will be undertaken by the Institute of Medicine.
WHAT'S NEXT?
Communication plan
Since I became aware of this study last Spring, we moved as quickly
as possible to format and prepare the entire study for release in a
form that was accessible and understandable. The goal of the NCI has
been and continues to be to fully inform the public as to the results
of research while adhering to quality control procedures to assure that
information released is of high scientific quality and credibility.
We have established an infrastructure to provide technical
assistance to health care providers and health departments in
interpreting the report (see Help Line below), and to respond to
inquiries from patients and individuals exposed to radiation fallout,
and to the media. We are working with the American Thyroid Association
to provide interim education resources to physicians, patients and the
public. We are helping state health departments interpret the report
and respond to inquiries at the state and county level. We have
announced through the media the availability today of the full report.
The Cancer Information Service (CIS) has interim guidance and
background information for all target audiences about the incidence,
mortality and survival rates for thyroid cancer, and statistical
information about trends in mortality, incidence, and survival in high-
exposure areas.
Dissemination plan
NCI has announced today, through media channels, Congressional
channels, and through state health departments:
--the availability of the I-131 report, including appendices and
data, on the world wide web. The information is available at
the NCI web site (http://www.nci.nih.gov) and at its public,
patient and media sub-page (http://rex.nci.nih.gov). At either
site, click on ``What's New.''
--the availability of a technical assistance helpline (1-800-273-
7092) for health officers and health professionals. This
telephone number, to be operational beginning October 1, is 1-
800-273-7092.
--interim guidance with the American Thyroid Association for health
professionals on helping individuals concerned about fallout
exposure.
--the availability of background information on thyroid cancer for
members of the public and cancer patients from the Cancer
Information Service at 1-800-4-CANCER (1-800-422-6237).
--that the study's narrative report was express-mailed to state
health departments and other government agencies and select
congressional members.
Help line
NCI has established a toll-free technical assistance helpline (1-
800-273-7092) to assist professionals in interpreting the report. We
envision that support will be provided to health professionals such as
public health officials, researchers, radiation epidemiologists,
advocacy and special interest groups, and physicians and other health
care providers. Voice mail is available for after-hours calls. Staff
assisting with answering calls will have sufficient educational
background and knowledge to effectively triage the calls and respond
with credibility. We have also established a parallel system and
procedures for responding to e-mail requests for technical assistance.
Health officers and health professionals may send e-mail requests to
[email protected]. Public and patient inquiries and e-mail will continue
to be handled by the CIS. NCI staff will handle Congressional and press
inquiries.
Institute of Medicine
An NCI contract with the National Academy of Sciences-Institute of
Medicine (IOM) went into effect September 30, 1997. The IOM will
produce two substantive reports. The first, which is to be published in
April 1998, will assess the soundness of the I-131 study's dose
reconstruction, provide a preliminary assessment of the public health
implications, and provide information to enable DHHS to educate and
inform members of the public and the medical profession. The second
report, to be published in June 1998, will develop recommendations for
how we should address the public health implications (including
intervention, surveillance, education and information strategies and
clinical practice guidelines), and develop recommendations for research
strategies that could refine risk estimates and reduce uncertainty of
the effect of exposures.
There have been preliminary discussions within the Administration
about the formation of a workgroup to look at broader issues. DHHS will
convene a meeting before the end of the year to begin the process.
Until the IOM completes its report, we are suggesting that
concerned individuals consult with their physician during their next
visit. This recommendation is consistent with the position of the
American Thyroid Association, which says that individuals who believe
they may have been exposed to significant amounts of fallout and feel
they are at particular risk might wish to see their physician.
Closing
The NCI appreciates the great interest and concern that you and the
public have that high quality and fully disclosed information be
provided about nuclear fallout. This is especially true in the context
of the legacy of the cold war in which such information was too often
not provided or hidden. We hope that this study will contribute to our
knowledge about the release and distribution of I-131 and how
individual thyroid exposures can be assessed.
Thank you for this opportunity to describe this NCI study and to
clarify its limitations. I would be pleased to respond to questions.
Panel 1
NONDEPARTMENTAL WITNESSES
STATEMENT OF JOSEPH LYNN LYON, M.D., M.P.H., PROFESSOR,
DEPARTMENT OF FAMILY AND PREVENTIVE
MEDICINE, UNIVERSITY OF UTAH SCHOOL OF
MEDICINE
Senator Specter. I think that our discussion may be
facilitated if we call our expert witnesses now: Dr. Lyon, Dr.
Beyea, Mr. Connor, Dr. McGuire. Dr. Joseph Lyon is a professor
of family medicine at the University of Utah and was the
principal investigator of a study in the 1980's examining the
health impact of atomic fallout on citizens of Utah.
Dr. Lyon, we welcome you here. The floor is yours, Dr.
Lyon. Thank you for joining us.
Dr. Lyon. Thank you very much, Senator Specter and ladies
and gentlemen of the panel.
I want to perhaps rehearse again some of the history you
have already heard. Testing began 46 years ago this month in
the Nevada test site. I counted at least 100 tests that were
done above-ground, of which at least 25 distributed radiation
well beyond the test site, we now know, as far East as the east
coast of the United States. The most heavily affected areas
known at that time are the two southwestern-most counties of
Utah, containing about 10,000 people.
There was public concern expressed starting in the mid-
fifties over the health effects, principally by scientists.
This prompted two congressional hearings, and the result of the
second hearing in 1959 prompted the U.S. Public Health Service
to initiate a study to look at two of the diseases, one of
which we have talked about today, thyroid cancer. The other was
leukemia. The focus was on these two southwestern Utah
counties.
The studies, the initial studies, were carried out by Mr.
Ed Weiss of the Public Health Service. I think it is
instructive for the pattern that has been set by this study to
look at these. The leukemia study found about a threefold
excess of cancers among children who were under age 19 living
in these two southwestern counties. That result was known by
1964.
The thyroid study, which Dr. Klausner has referred to
because we carried out a second followup on that group, was
severely limited by the fact that there was no individual doses
on anybody. It found nothing. Now, what happened at that point
in time was that the thyroid study was published, highlighted,
and used to reassure the citizens of Utah of the adverse
effects. The leukemia study was buried in the files of HHS
after a high level meeting at the White House because of its
impact. That study remained virtually unfollowed up and
reassurances were offered to the citizens of Utah when
officials knew full well that there was a hint. It was found
exactly where they thought it would be and exactly the
population.
It became instructive because that is generally how the
Federal Government responds to the issues of citizens' concern.
That is, the negative was strongly emphasized, the positive was
suppressed or covered up, and those who found the positive were
frequently indicted. I do not know what this did to Weiss'
career. He never followed up the study, nor was there any
effort to obtain any dosimetric information.
Senator Specter. Did you say he was indicted?
Dr. Lyon. I say I do not know what ever happened to the
man, but he never followed up on that study, and I think he was
not permitted to.
We inadvertently stumbled on Weiss' study and replicated it
without knowing we were doing so, responding to newspaper
accounts by a local newspaper in 1977 that there was an excess
of leukemia. It was based on the National Cancer Institute
atlases. I was involved with the Utah Cancer Registry at the
time. I felt that this was an issue that kept surfacing, that
we ought to at least look at leukemia, but I felt that the
probability, based on the thyroid studies, was very low that
anything would be found.
Much to our surprise, we found about a two and a half fold
excess of leukemias among children in the southern parts of the
State. As I say, unknowingly we had replicated the study
already done by the U.S. Public Health Service and long since
suppressed.
That finding, which was published in 1979, created intense
controversy, as you can imagine. Efforts to follow up, that is
obtain funding, to try to obtain better dosimetry, to try to
obtain larger samples, thrust us into a political situation
that even the President of the United States at that time was
not able to, on his guarantee, to get us funding. It finally
took the personal intervention of Orrin Hatch, using a great
deal of clout.
The funding came to us in three hunks of money: one-third
from NCI, two-thirds from DOE and DOD. That study, which ran
for about 8 years, was essentially heavily influenced by both
of those Departments.
There were several things that came out of that study from
a scientific standpoint. First, we confirmed the leukemia
findings for the southern portions of the State and placed
dosimetry estimates on them. We also confirmed that, as Dr.
Klausner has mentioned, there was about a three and a half fold
excess of thyroid neoplasms in these school kids that had been
previously examined in the mid-sixties.
There were enough scientific findings to suggest that there
were adverse health effects. What happened personally and at a
political level was much different. Let me give you a couple of
examples.
We found excess leukemias that extended into northern Utah,
where there are a much larger number of people, where you have
got about 80 percent of our population. The site visit
committee with the Department of Energy and Department of
Defense representatives very busily revised all the dose
estimates downward for northern Utah after they saw the study
findings. Now, this is generally something that graduate school
students are failed out of graduate school for, but the Federal
Government was able to get away with it. So the finding was
confined to southern Utah.
When the study was slated for publication in the Journal of
the American Medical Association, someone at NCI or DOD or DOE
leaked the results to the local newspaper with the statement
the findings were inconclusive and did not support the earlier
associations. We were embargoed by the journal and could not
respond to those criticisms. My colleagues still to this day
who didn't read the study console me for the fact that I have a
negative study. I have to ask them to go and read the findings
and suggest that a sevenfold excess of leukemia is not a
negative study.
The third thing that Dr. Klausner may not have been aware
of is that the small numbers of the thyroid cohort study that
so concerned us also, prompted us to submit a grant to the
National Cancer Institute or to the NIH for followup. It was
approved and funded. Someone at the NCI intervened with the
Board of Scientific Counselors to make sure that the funding
was not available. We were thrown around between various
agencies, with the grant finally assigned to the National
Institute of Digestive and Kidney Disease--a very strange
place.
We were never given the ability to respond to any of the
criticisms which were made of that application after it had
been approved and funded.
Senator Harkin. What year was that?
Dr. Lyon. That happened in 1989. We have been trying to
fund that study for followup. The study needs more--we know the
people, we know their doses. We have not been able to obtain
any Federal funding to follow these people.
I think the handling of the studies is indicative, or at
least it seems to me indicative, of some of the behavior we
have seen with this NCI study: essentially, accentuate the
negative; if the negative looks too threatening, do not publish
it.
I guess in conclusion I would simply say that, given the
long and rather unfortunate history of the behavior on the part
of many Federal officials, I think studies of this nature need
to be assigned to an agency that has a strong public health
interest and that has substantial public involvement. There was
no public involvement in any of the studies we were involved
in. We had attempted to get a public group set up and basically
the advisory committee told us to not do so. I think it needs
to be placed in agencies.
In conclusion, I would have to say that if the NCI were to
call me tomorrow and say, Dr. Lyon, we will fund your thyroid
study, I would say: If it is at the NCI under the current
administration, I would really prefer to pursue my career in
other areas.
Senator Harkin. Prefer what?
PREPARED STATEMENT
Dr. Lyon. I would prefer to pursue research in other areas,
simply because I do not think that the current administration
is particularly interested. And we have already had ample--I
have already experienced ample problems with trying to carry
out research on this topic with a less than friendly Federal
Government, particularly within the scientific establishment.
[The statement follows:]
Prepared Statement of Joseph L. Lyon, M.D., M.P.H.
Good morning, I am Joseph L. Lyon. I am a full professor in the
Department of Family and Preventive Medicine, University of Utah School
of Medicine, Salt Lake City, Utah. I received my M.D. degree from the
University of Utah, and a Master of Public Health degree from Harvard
University. My professional research interests are in the causes of
diseases in human populations, and I am a chronic disease
epidemiologist. I am appearing before this committee to testify on the
health effects that arose from above ground nuclear testing at the
Nevada Test Site (NTS) between 1951-1958 and its relationship to the
recently released report by the NCI of extensive contamination of large
areas of the United States by radioactive iodine generated by these
tests. I shall comment on the activities of the U.S. Government also
through its' various agencies to inform the public about the health
risks associated with fallout from above ground nuclear testing at the
NTS. This is the fourth time I have appeared before committees of the
United States Senate investigating the cancers believed to be caused by
U.S. above ground nuclear weapons testing.
Between 1951-1958 the U.S. Atomic Energy Commission detonated over
100 nuclear weapons at its test site in the Nevada desert. At least 25
of these detonations produced measurable radioactive fallout in
populated areas of Utah and states further north and east. One test in
particular, Shot Harry, detonated about 5:15 a.m. on the morning of May
19, 1953, accounted for about 80 percent of the total radiation
deposited in southwestern Utah.
There were concerns among the public and scientists about the
increased risk of cancer to the Utah population from radioactive
fallout, but these were generally ignored. These concerns led to a
Congressional hearing in 1959. There was no evidence of any health
problems, but no studies of the people most heavily exposed had been
done. However, because of potential health concerns, the U.S.
Government decided to move all further nuclear testing underground.
History of a cover-up
In 1960 the Federal Government, responding to the health concerns
raised by the 1959 Congressional hearings, began two studies in Utah of
cancers associated with radioactive fallout. These studies were limited
to the southwestern most counties in Utah, Washington, and Iron
Counties, and an adjacent county in western Nevada. The diseases chosen
for study were leukemia and thyroid neoplasms. It was already well
established that exposure to gamma radiation could cause an increase in
leukemia mortality, and there was concern that the radioactive iodine
generated by a nuclear detonation would enter the food chain via milk
and expose the thyroid gland.
The U.S. Public Health Service investigated leukemia deaths between
1950-1964 in the two Utah counties closest to the NTS and found a 3.29
fold excess among those under age 19, and a 1.5 increased risk of
leukemia for citizens of all ages. No effort was made by the principal
investigator, Mr. Edward Weiss of the U.S. Public Health Service, to
link the extensive data gathered by the AEC on radiation doses received
by citizens of the two Utah counties to the location of the individual
children who died to determine if the excess leukemia deaths might be
related to radioactive exposure from the NTS. This would have been the
next step to determine if radioactive fallout was the cause of the
excess leukemia in southwestern Utah, but this was not done nor was it
even discussed in the written report of the study.
The study findings were written up in the form of a scientific
paper by Weiss and given to his superiors for their approval before
submission to a scientific journal. The manuscript was circulated
within the U.S. Public Health Service and the Atomic Energy Commission.
It was severely criticized as to the study size and choice of control
group. There was some division of opinion among the public health
officials who wanted the findings published and atomic energy officials
who did not. This was resolved at a 1965 meeting at the White House
presided over by the President's Scientific Advisor. The decision was
made not to publish the paper because the study was based on a small
number of deaths, and the officials of the Atomic Energy Commission did
not wish to unduly alarm the public with alarming but inconclusive
findings. Implicit in this decision to stop publication of the first
evidence of an association between fallout from above ground weapons
testing and leukemia was the impact such a finding might have on the
U.S. Government's continued nuclear weapons testing program.
The written reasons given for blocking publication of Weiss's
leukemia study were problems in study design and interpretation of
results. Rather than trying to correct these problems by adding more
years of observation, obtaining a local control group, and linking
radiation exposure by individual deaths, nothing more was done. The
decision to do nothing to follow up after finding excess leukemia
deaths among young people living in the two Utah counties that were
known to have been most heavily exposed to NTS was even more
reprehensible than the decision to suppress the original paper. It
meant that every Government official thereafter who offered
reassurances to the people of Utah that there had been no cancers
caused by radiation was knowingly or unknowingly lying to the public.
An interesting sidelight to this episode did occur. The U.S.
Centers for Disease Control was contacted by someone in the Public
Health Service and asked to investigate the excess leukemia deaths in
southwestern Utah to determine if they might have been caused by an
infectious agent. The CDC investigators were never informed that the
children who died of leukemia had received substantial exposure to
radiation from the NTS, and so no information was obtained during the
CDC investigation about the radiation exposure the dead children had.
Not surprisingly no cause for the excess leukemia deaths was found. The
hypothesis that an unknown infectious agent can cause leukemia
clusters, an idea popular in the 1960's, has not been substantiated by
further research, but exposing the children of a county to 5+ rads of
gamma radiation will cause extra leukemia deaths to appear within a few
years.
The second study of the carcinogenic effects of radioactive fallout
was conducted by the U.S. Public Health Service to determine if the
radioactive fallout had increased thyroid cancer rates among children
in southwestern Utah. About 3,000 school children living in the fallout
contaminated areas of Western Nevada and southwestern Utah (White Pine
County, Nevada and Washington County, Utah), and a control group of
2,000 children living in southern Arizona were identified and examined
for thyroid neoplasms.
This study was well designed and conducted. But despite suggestions
by internal and outside consultants, no information about the source
and amounts of fresh cow's milk that each child had drunk during above
ground testing at the NTS, the principle route of exposure to the
thyroid gland, was obtained. This made it impossible to assign a
radiation dose to any of the children. An error of this magnitude in an
epidemiologic study is simply not possible by chance. It is comparable
to conducting a study of lung cancer without asking about cigarette
smoking. Given this astonishing error, the study found no excess
cancers of the thyroid gland. Thereafter, the negative findings from
this study were often cited to reassure the public that no cancers had
resulted from above ground nuclear testing.
Both of these scientific studies commissioned by the U.S.
Government to determine if there were cancers associated with
radioactive fallout from the NTS failed to meet minimal criteria for an
epidemiolgic study, i.e., measure the exposure and determine if it's
related to a disease, by failing to measure exposure. Despite this
serious flaw, one of the studies found evidence that weapons testing
fallout had caused excess leukemia deaths in Utah. This politically
explosive finding was dealt with by a cover-up, while the study that
found no effect was publicized to reassure the citizens of Utah that
there were no cancers caused by fallout from the Nevada Test Site.
The basic pattern of how to deal with any scientific study that
might suggest that NTS fallout had caused cancer was determined for
future generations by Federal bureaucrats through their handling of
these two studies. The principles were as follows: suppress any data
that suggests a positive association between exposure and subsequent
cancer and mask your motives by stating that you do not want to unduly
alarm the people who were exposed. Cite only studies that found no
association to reassure people that their health concerns are
groundless. And finally, do everything possible to make sure that no
further scientific studies will be done that might contradict your
position.
In February 1979, responding to a newspaper article that reported
an excess of leukemia deaths in southwestern Utah, three other
colleagues and I published in the New England Journal of Medicine a
study of the association between childhood leukemias and radioactive
fallout generated from the detonation of nuclear weapons at the Nevada
Test Site. Children born in southern Utah between 1951-1958 experienced
2.44 more leukemia deaths compared to children born before and after
above ground bomb testing.
Unknowingly we had replicated and expanded the findings from the
earlier, unpublished study by the U.S. Public Health Service. The
publication of this paper immediately made us the focus of an intense
effort by the Federal Government to disprove our findings. University
employed scientists complain that industry hire scientists to refute
their findings when the findings might adversely impact the industry.
Let me assure you that when the Federal Government is the polluter, it
follows exactly the same strategy as any company. But the Federal
Government has far greater resources and power than are available to
companies. For example, our study was reanalyzed four times at
substantially more cost than was spent on the original study.
The publication of this study and the subsequent lawsuit filed by
citizens living in Washington County, Utah refocused attention on the
carcinogenic effects that have resulted from the fallout clouds
generated by above ground testing at the Nevada Test Site. The
Department of Energy not only continued to deny that any cancers had
resulted from the testing, but also set out to determine the extent of
contamination of Utah and the rest of the United States by the
radioactive fallout clouds. Crude measurements of fallout had been made
at widely dispersed monitoring stations across the U.S. but had never
been summarized or analyzed. It was the summarization and
computerization of these records that provided the dose estimates for
the study recently released by the NCI.
Re-examining the effects of fallout on Utah 1982-91
The findings from our 1979 leukemia study prompted a re-examination
of the potential adverse health effects that might have been caused by
exposure of the citizens of southwestern Utah to radioactive fallout
from the Nevada Test Site. My colleagues and I at the University of
Utah were funded in 1982 through the National Cancer Institute to
determine if the excess leukemia deaths in southwestern Utah reported
by us (and previously by Weiss of the U.S. Public Health Service) were
really related to radioactive fallout from the NTS. We were funded also
to locate the children previously examined for thyroid cancer and re-
examine them. We were to estimate a radiation dose to the thyroid gland
for each study subject. Our funding was administered by the NCI, but
two thirds came from the Departments of Energy and Defense, and these
agencies, via regular sites visits, exerted substantial influence on
our study's design, progress, and final interpretation of our results.
We published our findings for leukemia deaths in the Journal of the
American Medical Association in the July 31, 1990 issue (copy
attached). We found a 7.82 fold excess of leukemia deaths among those
less than age 19 who were living in southwestern Utah during the period
of above ground nuclear testing.
The public impact of this article was diminished when some of the
study findings were leaked a week prior to its publication date to a
newspaper reporter by someone at NCI, DOE or DOD with whom we had
shared the final manuscript of the article. The ``spin'' given by the
leaker was that the study findings were inconclusive and could not
confirm the earlier studies by Weiss, and my colleagues, and I. Since
our article was embargoed by the journal until the day of publication,
we could not respond to the media. We once again see the principles I
mentioned above being applied. When you can't suppress findings of
adverse effects from NTS fallout, publicly label the results as
inconclusive, knowing full well that the investigators cannot counter
your ``spin''.
Using estimates of radiation exposure to 57 Utah communities
provided by the U.S. Department of Energy and published in the journal,
Science, in January 1984, we found a statistically significant excess
of leukemia deaths in northern Utah also. But when these findings were
shared with the Department of Energy representatives on our site visit
committee, the published radiation exposure estimates were revised We
were informed that this revision was based on classified data. The
radiation exposure to northern Utah from the NTS was decreased by
assigning more of it to exposure from Russian nuclear testing. This
caused the association of leukemia with NTS fallout in northern Utah to
become non-significant. We were denied access to the classified data
that was used to make this dose reassessment, and the Department of
Energy never amended or retracted their original study of NTS radiation
exposure published in Science.
We published our findings on thyroid disease and fallout in the
November 3, 1993 issue of the Journal of the American Medical
Association (copy attached). We found a three fold excess of thyroid
neoplasms among those with the heaviest exposures to NTS generated
radioactive iodines. The small number of neoplasms we found (18
neoplasms of which 8 were carcinomas) means the findings must be
interpreted with some caution. We did not view the results as
inconclusive because as the amount of radiation increased the number of
neoplasms increased, and the number of neoplasm produced per unit of
radiation agrees with other studies of radiation and thyroid cancer.
Our finding, though based on a small number of new cases, was the
first to suggest that normal individuals who were exposed as children
to environmental contamination from radioactive iodines are at higher
risk of developing thyroid neoplasms. It cost us about $3 million to
estimate a dose of radiation to the thyroid gland of these subjects.
Most of the cost came from the need to identify and interview the
mothers of the study subjects about their children's milk drinking
habits from birth until age 18 and identifying and interviewing all
dairy farmers and milk processors in southwestern Utah.
Because of the importance of our finding of an excess of thyroid
neoplasms from radioiodine released into the atmosphere from nuclear
events to scientists studying similar exposures, in October 1987 we
submitted a grant application to the National Institutes of Health to
fund another cycle of examination of the former school children. This
request was prompted by the small number of neoplasms we identified and
the fact that a few more years of follow-up would resolve this problem.
It was prompted also by the fact that our subjects were just reaching
the highest risk period for the development of thyroid cancer, age 40
and above. The application was assigned to the National Institute of
Environmental Health Sciences, reviewed, and received a fundable
priority score. But the Board of Scientific Counselors at NIEHS
declined to fund the application (see the letter dated February 28,
1989). We were never given an opportunity to respond to the Board's
concerns were told the application had been reassigned to the National
Institute of Diabetes, Digestive, and Kidney Diseases. We were told
informally that our project officer for the 1982 NCI study, Dr. Bruce
Wachholz, had requested that the Board take this action. While I cannot
confirm Dr. Wachholz's intervention, the Board members had detailed
information about the administration, methods, and findings of our
study which were not provided by us. We submitted the application again
in 1991 to the NIH. The priority score was below the funding line, and
so no further follow-up of this group has occurred despite repeated
appeals to the Federal Government by me and the Utah Congressional
delegation for funding.
Once again we see the principles I mentioned above being applied.
When positive findings occur, label the findings as inconclusive, and
make sure that no further work is done to strengthen the findings.
Comments on the NCI iodine study
The release of the NCI report on radioactive iodine exposure of
people outside Washington County, Utah has once again raised scientific
and political interest in the findings of our thyroid study.
Reassurances were offered to the public in the press release put out by
the NCI that the Utah thyroid study findings were ``inconclusive''. The
use of the term ``inconclusive'' to describe our thyroid study is
disingenuous. We found a three fold increased risk between childhood
exposure to radioactive iodine and subsequent thyroid neoplasms with a
clear dose response relationship. Certainly no researcher would
consider exposing a group of children to radioactive iodine based on
such a finding. The only thing inconclusive about our study was the
small number of neoplasms detected, and we had proposed to remedy this
weakness in 1988 by adding another five years of follow-up, but had
been denied funding by the Federal Government.
I cannot understand why the findings from the NCI report were
delayed for so long. There have been prior studies of the distribution
of radioactive iodine from above ground weapons testing suggesting
extensive contamination outside of Utah, and a colleague at the
University of Utah, Dr. Victor Archer, reported an association between
NTS generated fallout and thyroid cancer in states remote from Utah in
the journal, Archives of Environmental Health, September/October 1987.
The findings from the NCI thyroid study were being discussed among
radiation researchers five years ago, yet no one had the power to force
the publication of the release until the press intervened this July.
After the NCI study completion in 1992 and as it was being edited,
there were no efforts by staff at the NCI to fund another cycle of
thyroid examination of the Utah thyroid group, though they are unique
in the world from a scientific standpoint: the only group of young
children accidently exposed to radioactive iodine with calculated
radiation doses to their thyroid glands and data from two cycles of
physical examinations spanning 30 years. Instead, the findings were
labeled as ``inconclusive''. The findings were offered to reassure the
public at the August 1, 1997 NCI press conference. This followed the
same pattern as the 1966-70 report on this same group when reassurance
was provided to the citizens of Utah that there was no need for concern
over radioactive fallout.
I contrast handling the NCI study with recent reports of increased
risk of pulmonary hypertension and heart valve damage from combination
drug therapy for obesity commonly referred to as the phen/fen diet.
Based on what would be labeled as ``highly inconclusive'' evidence, the
manufacturer withdrew the drugs from the market and took steps to set
up medical surveillance of those who might have been affected. If phen/
fen was being marketed by the Federal Government, what would have been
the Government's action? Surely there is little question that ingestion
of radioactive iodine can damage and destroy the thyroid gland. Yet, to
this day there is no medical surveillance of the heavily exposed
population of southwestern Utah. And officials of the Federal
Government have never met with these citizens to inform them of their
potential risk of thyroid cancer.
Finally, I believe that many of the problems I have detailed here
concerning the Federal Government's handling of the adverse health
effects from radioactive fallout could have been prevented had the
Federal Agencies handling these problems been willing to appoint and
work with committee-based citizens' groups. These groups need to be
involved at the initiation of any such study and be kept fully informed
of the study's progress and findings. Such has not been the case in any
of the studies of radiation carried out by the U.S. Public Health
Service in Utah between 1961-70 and the NCI funded study carried out
between 1982-91.
Conclusions
The adverse health effects associated with the release of
radioactive chemicals from the NTS have been a cause of public concern
for at least 40 years, prompting at least six previous Congressional
hearings. The responsible Federal agencies have consistently responded
to the public's concern with evasion, deceit, and cover-up garbed in
the cloak of scientific objectivity. They have expressed a desire to
obtain the truth so that wise decisions could be made, while all the
time trying to suppress or stop any scientific study that might confirm
the public's fears. When these tactics failed, the Federal officials
labeled any study that suggested cancer or leukemia might be associated
with fallout as ``inconclusive''. Much of this behavior was justified
by these officials the grounds of national security considerations, but
those considerations surely evaporated by 1991.
I was appalled to find that employees of one of the premier
research institutions in the world, the National Cancer Institute, in
August 1997, were using the same tactics that have been used for the
last forty years by officials from other Federal Agencies. Even more
upsetting to me was that these tactics had been used to obfuscate their
own research findings of potential excess risk of thyroid cancer for
many citizens of the U.S. Do these scientists not believe their own
research? I was also upset and angry that our study of thyroid disease
in Utah was being used to reassure people that the association between
exposure to fallout generated radioactive iodine and thyroid cancer was
``inconclusive''. I had hoped that by 1997, employees of the Federal
Government involved with the important public health issues of
radioactive contamination of U.S. citizens by the actions of the U.S.
Government had reached a point where candor and honesty were foundation
principles in dealing with the public. This was not the case at the NCI
in its handling and the recent radioactive iodine study and it saddens
me.
The credibility of the Department of Energy has been so severely
compromised by their handling of the adverse health effects of
radioactive materials that in 1992, all health related research with
the DOE was transferred to the Centers for Disease Control and
Prevention. I am a member of the Secretary of Health and Human Services
Advisory Committee for Energy Related Research that has monitored this
transfer. The attitude and behavior of the Federal employees within the
CDCP who are taking over these radiation related research programs is
in stark contrast to that exhibited by those at the NCI. The CDC
insists on citizen and/or worker involvement from the outset in every
study. For example, in the study of thyroid cancer in the citizens
around the Hanford reactor, the Federal project officer has
scrupulously avoided knowing any of the study findings so as not to
bias his administrative actions. Based on my observations of operating
procedures and scientific integrity of the radiation epidemiology
branch of the CDCP, I would recommend that all research within the
Federal Government that involves the effects of radioactive fallout on
human populations be placed under the control of the U.S. Centers for
Disease Control and Prevention. I would not be willing to accept a
grant to conduct another round of thyroid examinations on our Utah
study group if the administration of the funds was handled by the
current radiation staff at the NCI.
______
[From the Journal of the American Medical Association, Nov. 3, 1993,
vol. 270, pages 2076-2082]
A Cohort Study of Thyroid Disease in Relation to Fallout From Nuclear
Weapons Testing
(Richard A. Kerber, Ph.D.; John E. Till, Ph.D.; Steven L. Simon, Ph.D.;
Joseph L. Lyon, M.D., M.P.H.; Duncan C. Thomas, Ph.D.; Susan Preston-
Martin, Ph.D.; Marvin L. Rallison, M.D.; Ray D. Lloyd, Ph.D.; Walter
Stevens, Ph.D.)
Objective.--To estimate individual radiation doses and current
thyroid disease status for a previously identified cohort of 4,818
schoolchildren potentially exposed to fallout from detonations of
nuclear devices at the Nevada Test Site between 1951 and 1958.
Design.--Cohort analytic study.
Setting.--Communities in southwestern Utah, southeastern Nevada,
and southeastern Arizona.
Participants.--Individuals who were still residing in the three-
state area (n=3122) were reexamined in 1985 and 1986, and information
on the subjects' and their mothers' milk and vegetable consumption
during the fallout period was obtained by telephone interview (n=3545).
After exclusions to eliminate missing data and confounding factors,
2,473 subjects were available for analysis.
Main outcome measures.--Individual radiation doses to the thyroid
were estimated by combining consumption data with radionuclide
deposition rates provided by the U.S. Department of Energy and a survey
of milk producers. Relative risk models adjusted for age, sex, and
state were fitted using maximum likelihood to period prevalence data
for thyroid carcinomas, neoplasms, and nodules.
Results.--Doses ranged from 0 mGy to 4600 mGy, and averaged 170 mGy
in Utah. There was a statistically significant excess of thyroid
neoplasms (benign and malignant; n=19), with an increase in excess
relative risk of 0.7 percent per milligray. A relative risk for thyroid
neoplasms of 3.4 was observed among 169 subjects exposed to doses
greater than 400 mGy. Positive but nonsignificant dose-response slopes
were found for carcinomas and nodules.
Conclusions.--Exposure to Nevada Test Site--generated radioiodines
was associated with an excess of thyroid neoplasms. The conclusions are
limited by the small number of exposed individuals and the low
incidence of thyroid neoplasms.
______
[From the Journal of the American Medical Association, Aug. 1, 1990,
vol. 264, pages 585-591]
Leukemia in Utah and Radioactive Fallout From the Nevada Test Site
a case-control study
(Walter Stevens,. Ph.D.; Duncan C. Thomas. Ph.D.; Joseph L. Lyon. M.D.
M.P.H.; John E. Till, Ph.D.; Richard A. Kerber, Ph.D.; Steven L. Simon.
Ph.D.; Ray D. Lloyd, Ph.D.; Naima Abd Elghany, M.D. Ph.D.; Susan
Preston-Martin, Ph.D.)
Previous studies reported an association between leukemia rates and
amounts of fallout in southwestern Utah from nuclear tests (1952 to
1958), but individual radiation exposures were unavailable. Therefore,
a case-control study with 1,177 individuals who died of leukemia and
5,330 other deaths (controls) was conducted using estimates of dose to
bone marrow computed from fallout deposition rates and subjects'
residence locations. A weak association between bone marrow dose and
all types of leukemia, all ages, and all time periods after exposure
was found. This overall trend was not statistically significant, but
significant trends in excess risk were found in subgroups defined by
cell type, age, and time after exposure. The greatest excess risk was
found in those individuals in the high-dose group with acute leukemia
who were younger than 20 years at exposure and who died before 1964.
These results are consistent with previous studies and with risk
estimates for other populations exposed to radiation.
NO FUNDING FOR STUDY
Senator Harkin. Have you ever applied to the Centers for
Disease Control?
Dr. Lyon. We have approached them. They are interested in
carrying out the study, but have no funding for it, Senator.
Senator Specter. Dr. Lyon, we may not get to all the
details in the questions and answers, but to the extent you
have a suggestion as to what agency ought to do the research
and what kind of funding is necessary, this is something that
we might even be able to accommodate at this late date on our
conference report.
Dr. Lyon. We have a request for about $1.9 million in that
Senator Bennett has made.
Senator Specter. $1.9 million?
Dr. Lyon. $1.9 million per year for the next 5 years.
Senator Specter. That might be accommodated in a $79
billion budget.
Dr. Lyon. That also I believe covers research on the Indian
groups in Nevada also.
Senator Reid. Who does he recommend do it?
Dr. Lyon. I would suggest the Centers for Disease Control,
because of their long involvement with public health and with
public involvement in their research process.
Senator Specter. Let us move ahead now to Dr. Beyea.
Senator Harkin. I just want to say one thing for the
record, Mr. Chairman. I am with you on that, but I want to make
sure that any grant application that comes in does go through
the rigorous peer review process that has been established.
Dr. Lyon. Well, we survived that once, Senator.
STATEMENT OF JAN BEYEA, Ph.D., SENIOR SCIENTIST,
CONSULTING IN THE PUBLIC INTEREST
ACCOMPANIED BY LAWRENCE MAYER, M.D., BIOSTATISTICIAN AND CLINICAL
INVESTIGATOR, JOHNS HOPKINS AND ARIZONA STATE UNIVERSITIES
SUMMARY STATEMENT
Senator Specter. Our next witness is Dr. Jan Beyea, a
senior scientist at the firm Consulting in the Public Interest.
Dr. Beyea has written extensively on the radiation health
effects of Three Mile Island and other nuclear incidents. We
thank you for coming and look forward to your testimony.
Dr. Beyea. Thank you, Senators. I have asked Dr. Lawrence
Mayer, who is a biostatistician and clinical investigator at
Johns Hopkins and Arizona State University, to come in case
there are any questions to answer. He has also generously
agreed to hold up a poster here that I am going to show you in
a minute, if I could.
I have only a few points to make. First of all, as a dose
reconstructionist I think that the numbers in the NCI report
are somewhat understated.
Senator Reid. As a what? I could not understand.
Dr. Beyea. A dose reconstructionist, one who does the same
kind of work as done by the NCI researchers.
I think the numbers are probably understated to a certain
extent to make the things look a little better.
My second major point has to do with the actual health
effects. If I could have that poster, Dr. Mayer.
Dr. Mayer and I have both researched the world's literature
on thyroid effects, and what we are concerned about is that
attention has focused almost exclusively on cancer and there
are a number of other health effects that are probably more
likely to have occurred in the population than thyroid cancer.
What I have done here is I have listed under the first
column various cancer diseases, those which were mentioned in
the NCI report, when it was known scientifically when these
health effects would occur, and finally what the lowest dose
that has been confirmed in the literature. These numbers do not
mean that these effects cannot occur lower than that, but these
have been confirmed in the literature at these doses.
So we go over to cancer. That has been well discussed. But
nodularity, a lesser degree, which includes cancer, includes
adenomas. Sometimes these have to be surgically removed. You
are going to find more nodules than you are going to find
cancer.
Autoimmune thyroid disease includes hypothyroidism, chronic
thyroiditis. These are diseases that are relatively mild, but
they are still important. They are more likely to occur than
cancer. The most likely way they are occurring at low dose
radiation is through the autoimmune process, a process where
the radiation triggers in the body our own immune system and
our own immune system begins to attack our thyroid cells and,
after many, many years, causes thyroid disease.
In fact, these effects didn't show up in the A-bomb
survivors until 40 years after the bomb was dropped, which
means that these should just now begin to be showing up in the
population that was exposed in the fifties and sixties in the
United States.
This was all known. It has been known for many years now.
And I do hope, and Dr. Klausner assures me, that this now will
be looked at by the Institute of Medicine. But I do hope you in
this panel in front of us will also make some attempt to make
sure that this is considered in the assessment of what is done
as a follow-up to this.
It is my belief and Dr. Mayer's belief, having looked at
this, that we really do need a medical surveillance program
that will allow doctors to be acquainted with this effect,
which is fairly new, to look for these. It involves thyroid
scans and also some blood tests, the additional medical tests
that you would do to find these autoimmune thyroid diseases.
Senator Harkin. May I just interject, Dr. Beyea?
Dr. Beyea. Yes, please do.
Senator Harkin. The autoimmune thyroid disease, you just
said the lowest dose confirmed. What does that mean? Explain
that again, please?
Dr. Beyea. It means that at Chernobyl, for instance, there
were thousands of children who were irradiated. At 15 rads of
exposure, the population is showing excess elevated thyroid
antibodies, which are an indication that the autoimmune process
has started, has begun in those children, and that years later
they will develop, some of them, a fraction of them will
develop, hypothyroidism.
Now, not every scientist agrees with this, by the way.
There is some debate in the scientific literature about this.
But it is certainly something that needs to be considered in
any medical surveillance program. It is cheap to look for. It
is easy to find and it should be part of the process.
There is another study that was done in 1988 by Kaplan that
showed between 10 and 112 rads there was a doubling in this
kind of process. Nagataki did a study in 1994 at Hiroshima--at
Nagasaki, which showed an increase, a doubling increase in this
kind of disease in the atom bomb survivors at about 40 rads.
So the literature show somewhere between this range is
perhaps where you start, where you start looking for it.
Senator Harkin. So what you are saying is that the NCI
report looked just at cancer.
Dr. Beyea. That is right.
Senator Harkin. And that they did not look at nodularity or
autoimmune thyroidism?
Dr. Beyea. Let me clarify. In the materials--I see Dr.
Klausner shaking his head here. In the materials that have been
circulated about this report, there has been only mention of
cancer that I could find. There has been no mention that there
is likely three times as much adenomas. There has been no
mention of low dose autoimmune thyroid disorder.
Senator Specter. Dr. Klausner, you have shaken your head
no. We will give you a chance right now for a 1-minute response
to that.
Dr. Klausner. It is just that this particular report is
only looking at dose estimates and exposure estimates. As I
said, this report does not talk about thyroid cancer.
Dr. Beyea. But the materials you circulated, but the
material you circulated, in which you described, and I think
very rightly--you did a good job in talking about the issues of
thyroid cancer and that is naturally what most people focus on.
But my suggestion is that in future documents that you also
consider these other nodularities and autoimmune thyroid
conditions.
Senator Specter. Is Dr. Beyea right about that, Dr.
Klausner?
Dr. Klausner. Whether that in the future we ought to look
at these things? We have not limited the Institute of Medicine
in what they are looking at in terms of health consequences as
well as in terms of thyroid consequences.
Senator Specter. You have not limited it, but would you ask
them to include what Dr. Beyea has said?
Dr. Klausner. We are happy to do that, but we have asked
them to look at all health consequences.
Senator Specter. We will pick this up later in the
questions and answers. Dr. Beyea, you have some more to say?
Dr. Beyea. I have a quick conclusion, just a quick
conclusion. I would like to suggest that it is very important
that we look at what happened and why things maybe were a
little slow, but it is also important that we think about
taking action. That involves a medical surveillance program,
giving information to citizens as to what early science might
be of various kinds of diseases.
PREPARED STATEMENT
Finally, I think we have to be prepared to give medical
treatment to those areas where people are not adequately
protected by medical insurance.
[The statement follows:]
Prepared Statement of Jan Beyea, Ph.D. [1]
I have asked Dr. Lawrence Mayer [2] to accompany me here
today to answer any medical questions related to the work I
will be discussing. For this hearing, I reviewed the NCI's
exposure calculations based on the preliminary information
published by NCI on its study, [3] as well as other uses of the
databases relied upon by NCI. [4] In connection with litigation
over radioiodine releases from the Hanford production facility,
Dr. Mayer and I have also reviewed the scientific literature on
the health effects associated with low-dose exposure to
radioiodine, which has made us sensitive to disease risks other
than thyroid cancer.
Since NCI in its preliminary reports has only discussed the
possible connection between radioiodine exposure and thyroid
cancer, I will focus most of my attention on thyroid nodules
and autoimmune thyroid diseases. Based on my studies and those
by Dr. Mayer, I have reached a number of conclusions:
1. The ``gummed paper'' data, which NCI used to calibrate
its estimates of radioiodine exposure, are probably free from
the political pressures of the time and, therefore, can be used
as the basis for unbiased exposure estimates.
DOE's Health and Safety Lab (HASL, now EML), an institution
that has always prided itself on its independence and
integrity, carried out the measurements of fallout
radioactivity on gummed paper at the time. Having been privy to
EML practices as part of discovery in legal cases, [5] I have
seen evidence of HASL scientists resisting orders to suppress
information, finding ways to make the information public. There
may be mistakes and limitations in the underlying gummed-paper
data, but they are probably honest mistakes and limitations.
2. Nevertheless, there are a number of reasons to expect
that the current best estimates for exposure may be low.
Generating historical exposure estimates requires making
judgments, particularly in choosing values for parameters that
enter the exposure model. It is difficult, even without the
political pressure that radiological dose estimates have
engendered, to pick an unbiased set of best-estimate parameter
values. Thus, the choice of study members and the makeup of
advisory committees can play a crucial role in a study's
outcome, and hence can generate ferocious infighting. Usually,
there are many free model parameters to specify in a dose
reconstruction exercise. A member of the analytical team with a
strong particular bias, or a member of an advisory committee
who believes he or she knows the ``correct'' answer, not to
mention the employers of the team, can selectively, even
unconsciously, bias some of the results for non-scientific
reasons. Without countervailing critiques of the choices made
for important parameters, analysts may adjust parameters to
satisfy advisory committees, supervisors, or dominant team
members. Only if the advisory committees have a full
representation of independent scientists with varying points of
view can the choice of parameter values be kept from favoring
the perceived goals of one political faction or agency. I have
found some hints of this phenomenon in the early descriptions
of the work provide by NCI. [6] Congressional investigators
should scrutinize the makeup of the various advisory committees
over time, the process by which study leaders and members were
chosen, and whether or not independent scientists were
appointed as members. Investigators should also examine if NCI
was prepared to handle the heavy politicization that has
existed in this country over radiation health effects. I have a
very high degree of respect for NCI, based on personal
experience and knowledge of its work. NCI has done many
marvelous studies. It has a top notch, peer-review process for
scientific projects, but it may not have been prepared for the
hard-ball politics that was played with radiation health
effects by other government agencies and influential figures.
It would be a tragedy if public confidence in NCI were
undermined because of this incident. Full and open disclosure
at this point is the best way to protect the reputation of NCI.
[7]
3. The uncertainties in the dose estimates may have been
understated in the counties with lower exposure.
Published articles dealing with the underlying databases
have pointed out certain inconsistencies in estimates made
outside the highest dose regions. [8] The inconsistencies imply
that the uncertainties in the lower dose regions are likely to
be greater than stated in the NCI report. Thus, it may be
unwise to dismiss consideration of medical actions in these
areas, based solely on the dose ranges provided in the NCI
report.
4. The NCI reports published to date have ignored diseases
other than thyroid cancer.
Thyroid nodules, another known consequence of radiation
exposure, have been neglected by NCI, even though such nodules
require follow-up, and sometimes surgery. The authors of the
thyroid disease study carried out around the Nevada Test Site
were much more than ``suggestive'' when it came to induced
neoplasms:
``We conclude that in the cohort that was studied, an
excess of between one and 12 neoplasms (0 to six malignancies)
was probably caused by exposure to fallout radioiodines from
nuclear weapons testing.'' [9]
The NCI report is strangely silent on this consequence of
radioiodine exposure.
Of great concern is that physicians should be alerted to
watch for signs and symptoms of lesser diseases than thyroid
cancer, namely autoimmune hypothyroidism, mild thyroiditis, and
possibly hyperthyroidism incident to Graves' disease. These
diseases can be initiated by low to moderate radiation doses,
the recent literature suggests, presenting themselves years
after exposure. They are most likely caused by an autoimmune
reaction in susceptible individuals. Once triggered, the body
attacks its own thyroid cells, eventually causing clinical
disease. Such effects were not identified in the A-bomb
survivors by Nagataki et al. until 40 years after the bombing
of Japan. [10] This finding suggests that these diseases should
now be evident in the US population exposed to fallout doses of
about 40 rads, assuming that the A-bomb situation is
comparable. [11]
The extensive data collected on people living around the
1986 Chernobyl disaster show that radioiodine exposure at
surprisingly low doses--between zero and 30 rads, mid-point
equals 15 rads--leads to significant production of antithyroid
antibodies. [12] The dose response stays fairly flat as dose
increases up to a few hundred rads suggesting that a
susceptible subgroup exists that is sensitive to low doses.
Now, the presence of antibodies alone does not necessarily
imply any diseases are yet present in this population, neither
autoimmune thyroiditis, nor autoimmune hypothyroidism, nor
autoimmune hyperthyroidism. However, the presence of elevated
thyroid antibodies is a well-known risk factor for chronic
thyroiditis and hypothyroidism. [13], [14]
Most of these data on autoimmune thyroid disease are new
[15] and contradict some older published work. [16], [17], [18]
The major study of the Nagasaki population wasn't published
until 1994 [19] and the striking thyroid antibody study on the
Chernobyl population wasn't published until 1996. [20] Although
not yet appreciated or accepted by all scientists, the new
information contained in these studies needs to be communicated
to physicians and other health providers practicing in those
counties where exposures may have exceeded an appropriate
threshold, taken here to be 15 rads. Since exposure
uncertainties may be as high as a factor of ten, these diseases
could be appearing today in counties with average exposures as
low as 1.5 rads. [21]
5. I question if NCI has the full range of expertise
necessary to consider these non-cancerous, autoimmune diseases
in its contract with the Institute of Medicine.
An important question is whether or not the contract NCI
has developed with the Institute of Medicine will allow the
Institute to consider this new literature in detail, as well as
its importance for medical surveillance. Possibly, other
divisions of NIH with expertise in autoimmune diseases,
including immunology and endocrinology, should have a role in
the follow-up study NCI has commissioned.
6. A medical response program is in order for a significant
fraction of the United States population exposed to fallout.
Such a program should deliver medical information to
physicians, perhaps through medical societies or continuing
education. It should inform exposed persons of the early or
pre-clinical symptoms of disease. It should provide medical
surveillance in areas where the prior likelihood of disease is
likely to be significant. Finally, in such areas, it should
provide treatment for persons with a wide range of thyroid
diseases who do not have adequate medical care due to insurance
limitations.
Obviously, a great deal of thought needs to be given to
designing a proper medical surveillance program. However, based
on the review of the literature and on discussions with Dr.
Mayer, it seems clear that a carefully designed program would
provide tremendous health benefits for those who do not already
have, or do normally take advantage of, regular and thorough
medical care. [22], [23] The monitoring efforts required will
generally not entail a large individual expense, although the
total for the country will be significant. A surveillance
program might consist solely of regular thyroid palpations and
blood tests for thyroid dysfunction, including a ``TSH'' assay.
Diseases that should be monitored:
A. Thyroid cancer and its typical precursor, thyroid
nodularity.
As has been discussed by NCI, cancer risks are heavily
weighted towards those exposed as children, particularly those
exposed at the ages of 0-4 years. For external radiation,
cancer has been confirmed in the literature down to an average
dose of 9 rads, [24] and there is no evidence of a threshold to
suggest cancer cannot be caused down to lower doses. Even if
iodine-131 exposure were to be somewhat less of a risk factor
for cancer compared to external radiation, this reduced risk
would not change the fact that disease will result from the
weapons fallout. It would only change the expected number of
cases.
B. Autoimmune thyroid diseases should also be monitored,
particularly autoimmune hypothyroidism, autoimmune thyroiditis,
as well as hyperthyroidism incident to Graves' disease. [25]
The lowest dose in the literature shown to trigger the
autoimmune thyroid process is found in a study of Chernobyl-
exposed children. It is 15 rads. [26] An important goal of a
medical surveillance program for autoimmune thyroid diseases,
in addition to identifying any severe cases that have been
missed, should be to identify mild and subclinical cases of
hypothyroidism, which are difficult to detect and easily
confused with non-disease conditions. Studies show that people
with subclinical hypothyroidism benefit from drug treatment,
leading to improved quality of life. [27] Paradoxically, severe
cases are easily identified and easily treated with corrective
medicines. Mild cases can go on for long periods of time,
reducing the quality of life for people until symptoms get so
severe that the need for treatment is recognized.
Although it is now clear that those children who drank milk
at the time of exposure are the key population to monitor for
thyroid nodularity and cancer, the effects of exposure age on
the risk of autoimmune disease is not known. This uncertainty
complicates the picture for determining the scope of a medical
surveillance program for radiation-induced autoimmune diseases.
7. Information on the importance of the food chain for
radiation exposures has been known for a long time. Government
health physicists have known of the importance of the food
pathway as a source of exposure since 1946. [28] They knew
about the value of early intervention by, at least, 1958. [29]
By the time of many, if not all, of the weapons tests,
government officials knew or should have known that a
mitigation strategy would prevent injury. Advisories to the
public to avoid drinking fresh milk after weapons tests,
particularly after rain, could have significantly reduced the
expected number of thyroid cancer and nodules (and, as we now
know, non-functioning thyroids). Such advisories could have
been presented simply as a precaution, without having to admit
to the public that any harm would necessarily fall upon them.
Obviously, such a warning might have weakened public support
for nuclear weapons testing and, therefore, would have had to
be balanced against issues of national security. Somewhere,
there may exist records of high level discussions about this
difficult choice. Their content may be very revealing in
helping to determine the degree of responsibility owed by the
government to the public for the high exposures.
8. It was not necessary to know the full outcome of the NCI
study before making recommendations on medical surveillance. By
1982, when Congress asked NCI to undertake the fallout study,
the connection between thyroid cancer and radioiodine was well
known. At what point should NCI or DOE have taken steps to
inform the medical community about the potential risks to their
patients? Answering this question will, no doubt, be a key goal
of congressional investigations.
9. There may be other relevant studies languishing under
bureaucratic confinement
The fact that NCI has taken so long to report the essential
public health message in this work raises questions about other
studies that may be ongoing. [30] For instance, are political
pressures slowing reports of the NCI's Chernobyl study? Will
the Institute of Medicine have access to the preliminary
results? Are there pending studies in other government
agencies, such as DOE, that bear on the questions before the
committee?
CONCLUSION
There are a number of factors that suggest a medical
information, surveillance, and treatment program is in order
for those exposed to weapons test fallout. These factors are
(1) the magnitude of the projected radioiodine exposures, (2)
the large uncertainties in the estimates, and (3), the recent
findings that autoimmune thyroid diseases can be triggered at
relatively low doses of radiation.
I hope that the need for action not be forgotten as
attention focuses on why there has been such a delay by
government agencies in formulating a recommendation on medical
surveillance.
ACKNOWLEDGEMENTS
I thank Dr. Mayer for advising me on the medical aspects of
my statement and Joseph Wayman and David Beavers for collecting
some of the historical documents relating to the discovery of
the food exposure pathway for radioiodine
References
[1] Correspondence relating to this testimony should be
sent to Dr. Beyea at [email protected]. Dr. Beyea is Senior
Scientist at Consulting in the Public Interest, Lambertville,
NJ. Web page: www.cipi.com. He has performed dose
reconstructions used in epidemiology studies at TMI, e.g.,
``Cancer Rates after the Three Mile Island Nuclear Accident and
Proximity of Residence to the Plant'', (Hatch, Wallenstein,
Beyea, Nieves, Susser), American Journal of Public Health,
18(6), June 1991; ``Cancer Near the Three Mile Island Nuclear
Plant: Radiation Emissions'', (Hatch, Beyea, Nieves, Susser),
American Journal of Epidemiology, Sept. 1990.
[2] Dr. Mayer is a biostatistician and clinical
investigator currently on the faculty of Johns Hopkins Schools
of Public Health and Medicine, Baltimore, Maryland; Good
Samaritan Medical Center, Phoenix, Arizona; and Arizona State
University.
[3] National Cancer Institute, Press Kit, August 1, 1997.
[4] Thompson, CB and MacArthur, RD, ``Challenges in
Developing Estimates of Exposure Rate Near the Nevada Test
Site, Health Physics, 71: 470-476, 1996. See also: Kirchner et
al., ``Estimating Internal Dose Due to Ingestion of
Radionuclides from Nevada Test Site Fallout, Health Physics,
71: 487-495, 1996; Till et al., ``The Utah Thyroid Cohort
Study: Analysis of the Dosimetry Results,'' Health Physics, 68:
472-483, 1995; Simon, SJ et al., ``The Utah Leukemia Case-
Control Study: Dosimetry Methodology and Results,'' Health
Physics, 68: 460-471, 1995.
[5] I have reviewed internal EML documents in connection
with a pending class action suit at the Rocky Flats plutonium
finishing facility.
[6] Analysts had to pick a best estimate for the ``intake-
to-milk'' transfer coefficient. The NCI report states,
``Reported literature values range from 2 x 10-\3\
to 4 x 10-\2\ d L-\1\ but it seemed that
fallout studies yielded values in the lower part of the range.
For the purposes of this report, it is assumed that the median
value of fm for \131\I and for cows is 4 x 10-\3\ d
L-\1\.'' In my experience, such vague language is
sometimes a signal that decisions have been made for non-
scientific reasons. Although this may not be the case here, the
vagueness of the reasons given for using a lower than average
value provides justification for scrutinizing the decision
process that was used to choose parameter values.
[7] I am concerned, therefore, about the equivocal language
that still remains in the NCI's press material of August 1,
1997, particularly in the July 1997, ``Background Information
on Thyroid Cancer and Radiation Risk,'' which was included in
the new packet. It reads like a press release from the old
Atomic Energy Commission.
[8] Thompson et al., op. cit., p 473.
[9] Kerber, RA, Till, JE, Simon, SL, Lyon, JL, et al., ``A
Cohort Study of Thyroid Disease in Relation to Fallout from
Nuclear Weapons Testing.'' JAMA, 270: 2076-2082. 1993.
[10] In a dose range from 0- to 100-rads. The response
curve was non-linear. Nagataki, S. et al., ``Thyroid diseases
among atomic bomb survivors in Nagasaki.'' JAMA 272 : 364-371
(1994).
[11] Although some scientists maintain that Iodine-131 is
less effective than the external radiation delivered at
Hiroshima and Nagasaki, few scientists would maintain that
there is no effect. Furthermore, Chernobyl data on children
show the precursors of these diseases, namely antithyroid
antibodies in persons exposed to Iodine-131 (World Health
Organization, op. cit.).
[12] Levels of antithyroid antibodies have been measured in
thousands of children at Chernobyl, demonstrating that these
precursors of autoimmune disease have increased dramatically in
those exposed to 0 to 30 rads. I take the mid-point of this
region, namely 15 rads, as the practical threshold for a
medical surveillance program aimed at autoimmune thyroid
disease. (Souchkevitch, G.N. et al. eds. Health Consequences of
the Chernobyl Accident: Results of the IPHECA Pilot Projects
and Related National Programmes, Geneva: World Health
Organization, pp. 264-68 (1996).)
[13] I emphasize that the findings of antithyroid
antibodies do not prove disease is yet present, only that the
autoimmune process has started in the Chernobyl population.
Progression to autoimmune thyroiditis and hypothyroidism,
however, is expected based on epidemiological surveys of the
background incidence of thyroid disease in the general public.
(Vanderpump, M.P.J. and Tunbridge, W.M.G. ``The Epidemiology of
Thyroid Diseases'' (1996), in Werner and Ingbar's The Thyroid,
7th ed., eds. Braverman, L.E. and Utiger, R.D., Philadelphia:
Lippincott-Raven, pp. 474-482 (1996). Also, Vanderpump, M.P.J.
et al. ``The incidence of thyroid disorders in the community: a
20-year follow-up of the Whickham Survey.'' Clinical
Endocrinology 43: 55-68 (1995). Relevant information can also
be found in Weetman, A.P. ``Chronic autoimmune thyroiditis,''
in Werner and Ingbar's The Thyroid, op. cit., pp. 738-48 Also,
Geul, K.W. et al. ``The importance of thyroid microsomal
antibodies in the development of elevated serum TSH in middle-
aged women: associations with serum lipids.'' Clinical
Endocrinology 39 (3): 275-80 (1993). Also, Bilous, R.W. and
Tunbridge, W.M.G. ``The epidemiology of hypothyroidism--an
update.'' Bailliere's Clinical Endocrinology and Metabolism 2:
531-540 (1988).
[14] The existence of these antibodies is often considered
to be sufficient evidence of subclinical autoimmune thyroiditis
(Weetman, A.P. ``Chronic autoimmune thyroiditis,'' in Werner
and Ingbar's The Thyroid, 7th edition, eds. L.E. Braverman and
R.D. Utiger, Philadelphia: Lippincott-Raven, pp. 738-48
[1996]), because, for one reason, local thyroiditis is
correlated with such antibodies at autopsy (Vanderpump, M.P. et
al. ``The incidence of thyroid disorders in the community: a
twenty-year follow-up of the Whickham Survey,'' Clinical
Endocrinology 43: 55-68 [1995]).
[15] Although the early work by Malone and Cullen is
consistent with the Chernobyl antibody plateau. (The Lancet,
July 10, 1976, pp 73-75.)
[16] Morimoto et al., J Nucl Med 28:1115-1122, 1987 used an
earlier version of the A-bomb dosimetry, the so-called T65-
dosimetry, that is now thought to be inferior to later
dosimetry efforts (e.g., DS86). Morimoto is a 30-year follow-up
study compared to 40 years in the Nagataki study. Furthermore,
the Morimoto group only looked at two data points, the 0 rads
group and the 100+ rads group. In other words, Morimoto skipped
the dose region where Nagataki et al. found their greatest
excess. This choice reduces the number of cases compared to
Nagataki. For all these reasons, it is not surprising that
Morimoto did not find a detectable effect.
[17] Yoshimoto et al., ``Prevalence Rate of Thyroid
Diseases among Autopsy Cases of the Atomic Bomb Survivors in
Hiroshima, 1951-85, Radiation Research, 141: 278-286 (1995), is
an autopsy study of A-bomb survivors that looked at the
condition, ``chronic thyroiditis.'' This condition is similar
to the positive-antibody, subclinical condition studied by
Nagataki et al. Yoshimoto et al., assumed a linear response
curve, which would have made the response less statistically
significant. Although Yoshimoto et al. published their results
in 1995, they analyzed autopsies between 1951 and 1985. This
means that the average time since exposure was much less than
for Nagataki et al., who looked at live people in 1985-87. The
paper by Nagataki et al., clearly has a much longer study
period.
[18] As for the study of Utah fallout by Kerber et al., op.
cit., the lack of finding of an effect of low dose radiation on
the risk of hypothyroidism in Utah is not that surprising. The
doses covered by Kerber's study are quite low, and Maxon and
Saenger argue that the data may indicate a threshold around 10-
20 rads. (Werner and Ingbar's The Thyroid, op. cit. pages 342-
351.) Moreover, the results are neither inconsistent with
Nagataki nor the Chernobyl antibody data. Furthermore, the
Kerber study took blood samples on a narrower population than
did Nagataki. Kerber only took blood samples from those people
in the study group who first showed clinical evidence of
thyroid problems, a potential statistical bias, whereas
Nagataki took blood samples from the entire cohort.
Interestingly, a companion study of fetal exposures around the
Nevada Test Site by Lloyd, Tripp and Kerber, Health Physics,
70: 559-662, 1996, shows, according to my analysis, a similar
dose response curve for thyroiditis and hypothyroidism as found
in Nagataki.
[19] Nagataki, S. et al., op. cit. Kaplan et al. were the
first group to find indications that autoimmune thyroid doses
could be caused by moderate doses (around 60 rads): Kaplan M.M.
et al. `` Thyroid, parathyroid, and salivary gland evaluations
in patients exposed to multiple fluoroscopic examinations
during tuberculosis therapy: a pilot study.'' Journal of
Clinical Endocrinological Metabolism 66: 376-382. (1988)
[20] Souchkevitch, G.N. et al. eds. Health Consequences of
the Chernobyl Accident: Results of the IPHECA Pilot Projects
and Related National Programmes, Geneva: World Health
Organization, pp. 264-68 (1996). See Also: Vykhovanets, E.V.
``Association between increased doses of Iodine-131 to the
thyroid gland and autoimmune disorders in children living
around Chernobyl,'' Poster presented at the February 1997
annual meeting of the American Association for the Advancement
of Science.
[21] I do not mention here individual variability, which
increases the ranges of dose that need to be considered.
[22] See Danese, M.D. et al. ``Screening for mild thyroid
failure at the periodic health examination--a decision and
cost-effectiveness analysis.'' JAMA 276: 285-292 (1996).
[23] I do not consider here the question of whether private
health care companies should be reimbursed for treatments that
they provide for thyroid conditions in the highly exposed
counties, nor whether affected citizens should receive
compensation.
[24] Ron E, Modan B, Preston D, Alfandary E, Stovall M,
Boice JD Jr. ``Thyroid Neoplasia Following Low-Dose Radiation
in Childhood.'' Radiat Res 120: 516-531, 1989; Ron E, Griffel
B, Liban E, Modan B. ``Histopathologic Reproducibility of
Thyroid Disease in an Epidemiologic Study.'' Cancer 57: 1056-
1059, 1986.
[25] Effects have been seen at doses of 30 to 200 rads.
(Katayama, S.; Shimaoka, K.; Piver, M.S.; Osman, G.; Tsukada,
Y.; and Suh, O. (1985) ``Radiation associated hypothyroidism in
patients with gynecological malignancies.'' J. Med. 16: 587-
596.). Although there is less evidence in the literature for
the association with hyperthyroidism at low doses of radiation,
it seems plausible that autoimmune hyperthyroidism should
eventually result, once the autoimmune process has started, and
should also be monitored.
[26] World Health Organization, op. cit.
[27] Arem, R. and Escalante, D. ``Subclinical
hypothyroidism: epidemiology, diagnosis and significance.'' Adv
Intern Med 41: 213-250 (1996).
[28] As part of the production of the first atomic bombs,
large amounts of radioiodine were released into the atmosphere
at the Hanford weapons facility in Washington. Accumulation of
radioiodine in sheep was discovered around Hanford as early as
1946. (Healy, JW, ``Accumulation in the thyroid of sheep
grazing near HEW,'' Hanford report, HW3-3455, March 1946. See
also: Parker, H.M. 1946. Tolerable Concentration of Radio-
iodine on Edible Plants. Hanford Atomic Products Operation,
G.E., Richland, Washington. NTIS, HW-7-3217.) Beginning in
1950, scientists at the Experimental Animal Farm at Hanford fed
radioiodine to sheep and studied thyroid damage. This
information was all classified. By 1955, the food pathway had
been discovered, ``The principal hazard of iodine release to
the environs arises from deposition in vegetation and
subsequent ingestion by animals and humans'' (OM Hill,
``Symposium on Iodine Problem,'' Hanford report, HW-039073).
Limits were set on consumption of contaminated milk. These
findings were publicly stated at least by 1955: ``Two
significant routes of entry are consumption of fresh garden
produce, and drinking milk from cows on contaminated pasture.''
(Parker, H.M. 1955. Radiation Exposure from Environmental
Hazards. Hanford Atomic Products Operation, G.E., Richland,
Washington. NTIS, Prepared for International Conference on the
Peaceful Uses of Atomic Energy. p. 6.).
[29] By 1958, it was even known that intake of normal
iodine could block the uptake of radioactive iodine in sheep
(Bustad et al., American Journal of Veterinary Research, Vol
19, p. 250., October 1958).
[30] This is not the only time in recent years that efforts
have apparently been made to delay publication of politically
sensitive studies involving fallout hazards. As part of an
agreement over discovery in the Hanford litigation, I was
allowed to read a controversial draft manuscript by Musolino et
al. that recalculated exposure to the Marshallese following
early weapons tests in the Pacific. At the time, DOE's
Brookhaven Laboratory was withholding publication of this
report, and, to this date, we have still not been apprised of
its release. Only vigorous oversight by Congress can override
the bureaucratic temptation to delay unpleasant information as
long as possible, even though valuable time may be lost in
providing early detection of medical conditions.
INSTITUTE OF MEDICINE
Senator Specter. Dr. Beyea, would you specify in writing
for the subcommittee exactly what you think ought to be done
with respect to the particularities you just mentioned?
Dr. Beyea. To a certain extent I have done that in my
written statement. I would be glad to do that. I have a lot of
confidence in the Institute of Medicine if they have a contract
which is written properly that will allow them to look at all
these issues and if they bring in the right people.
So if we can do that and make sure there is a broad
representation on the Institute of Medicine's panel, I am
confident the Institute will bring this to the forefront.
STATEMENT OF TIMOTHY CONNOR, ASSOCIATE DIRECTOR, ENERGY
RESEARCH FOUNDATION
Senator Specter. We now turn to Mr. Timothy Connor,
associate director of the Energy Research Foundation in
Spokane, WA. Mr. Connor has published several articles on low
dose radiation and public health. Thank you for joining us, Mr.
Connor. The floor is yours.
Mr. Connor. Thank you, Senator Specter. Thank you, Senator
Harkin, for the invitation this morning. I will try to keep my
remarks to 3 minutes.
I come here this morning with the hope that today's hearing
brings us near----
Senator Specter. If you spill over a little, it is OK.
Mr. Connor [continuing]. Brings us nearer to closing the
circle of accountability and reconciliation around one of the
more difficult problems in our country's history. My mother's
family is from Pasco, WA, just a few miles downstream from the
Hanford Nuclear Reservation along the Columbia River.
And as it turns out, I was actually born at an Army
hospital at Hanford in 1956 while my dad was on active duty in
Korea.
It was not until the 1980's that the term ``Hanford
downwinder'' came into wide usage in eastern Washington. This
is because it was the spring of 1986 before citizen activists
and journalists finally succeeded in forcing the Federal
managers of the Hanford site to make public the historical
documents proving what many people in our part of the world
already suspected: In their haste to manufacture the plutonium
used in America's first nuclear weapons, the operators of
Hanford's plutonium processing plants had released hundreds of
thousands of curies of iodine-131 into the atmosphere.
The Hanford revelations had a profound effect on public
debate and public sentiment in eastern Washington and
throughout the Northwest. While scientists continue working to
better answer the question of how widely people were exposed
and how many cancers and other illnesses can be attributed to
the emissions, there is overwhelming sentiment that what
happened was wrong. Civilized governments are not supposed to
expose their citizens to radiation or other hazards without
bothering to warn them or, worse, go for decades without
alerting them to the continuing health risks of the exposures.
This conclusion is shared by people who have vastly
different views about nuclear weapons. Eastern Washington is a
rather conservative place and many people are understandably
proud of Hanford's historic role in forcing an end to the war
with Japan. Still, patriotism does not allow us to excuse what
happened to people living downwind of Hanford during the
forties and fifties.
Perhaps the hardest thing for people to accept was the
knowledge that the Federal Government hired and was paying
people at Hanford to study exposures and the biological and
health effects of radiation and yet for three decades the truth
about the Hanford releases was withheld. For three decades
people were regularly assured their health was being protected.
Even on the day that Federal officials released the documents
disclosing the radiation releases, one of them stood behind a
podium with a Federal seal on it and said: ``There is no reason
to expect observable harm.''
Regardless of how people in the Columbia basin felt about
plutonium, the bomb, the war, and the hundreds of millions of
dollars a year coming to Hanford, there is little question now
about how they feel about being lied to, even if the lies were
cleverly composed lies.
What happened at Hanford is relevant to today's hearing for
two reasons. The first is that the circumstances surrounding
the National Cancer Institute's handling of the radioactive
iodine fallout study are remarkably similar to those
surrounding the Hanford emissions. While it is true that NCI
did not create the fallout, it was charged with the important
task of telling Congress and the American people about what
happened.
The Institute failed in this responsibility. It failed
because its researchers some time ago had compiled and analyzed
enough evidence to realize that this was more than just a
science project. They knew or should have known that at least
thousands of infants and children throughout America had
received thyroid doses putting them at substantially greater
risk for thyroid cancer and other thyroid diseases. People had
a right to know and had they known that knowledge may well have
made a difference in their lives.
The hardest thing to accept is that once again Federal
scientists and officials chose to withhold information vital to
the health and wellbeing of citizens whose interests they are
supposed to be serving. Once again, people are outraged with
the knowledge that their illnesses might have been prevented or
their suffering diminished if only they had been told they were
at greater risk due to their exposures.
Once again, people feel like nuclear age guinea pigs or
mere statistics, as though the Government has infinitely more
interest in studying them than in helping them.
The second reason the Hanford experience is relevant to
this study is that we were supposed to have learned from
Hanford, and not only from Hanford, but from all the other
disturbing revelations of the 1980's and before about the way
Federal science has been compromised in the field of radiation
and health. We have known for many years that it was a mistake
to allow the Department of Energy and its predecessors to
dominate the avenues and processes by which the Government is
supposed to be protecting public health and the environment
from the effects of the Nation's nuclear weapons production and
testing activities.
Part of this domination involved the control of DOE and its
predecessors exercise over health and health-related research
activities involving radiation exposures to workers and the
public.
I want to conclude by mentioning that former Energy
Secretary James Watkins in 1990 acted on these criticisms by
signing a memorandum of understanding [MOU] with the Department
of Health and Human Services which transferred analytic
epidemiologic studies through this memorandum to HHS. Those
studies have been located in the Centers for Disease Control,
where the Center for Environmental Health looks at populations
and the National Institute of Occupational Safety and Health
looks at worker studies.
It is interesting that NCI was left out of these reforms,
and these reforms were intended to allow the kind of sunshine,
the public oversight and communication that was not present in
the study. This is a part of history we need to look at and
make sure that, even though it is important, as the two doctors
said, to look at the health consequences of this, it is also
important to keep our eye on the necessary reforms. We cannot
go through another round, yet another round, in our history
where the American people feel that the Government is holding
out on them and not sharing with them, not sharing the
responsibility for their experiences due to releases that the
Government is responsible for.
So I would highly second Dr. Lyon's comments. We have a
structure now that would allow us to provide this oversight and
openness. It is important that we use it. In fact, I think it
is time that we look at legislation to replace the so that
these studies are reconstituted at HHS, so that this kind of
study never happens again.
PREPARED STATEMENT
One of the truly unfortunate things about this study is
that it was headed by a former Department of Energy official
who managed it in much the way the Department of Energy managed
so many studies that were discredited. We cannot allow that to
happen again, and if there is one thing that we do on the
reform side, let us look at that and make sure this does not
happen again.
Thank you.
[The statement follows:]
Prepared Statement of Tim Connor
I come here this morning with the hope that today's hearing
brings us nearer to closing the circle of accountability and
reconciliation around one of the more difficult problems in our
nation's history. The problem, in a nutshell, is our profoundly
uneasy experience as a democracy facing the social,
technological, and moral challenges of building, testing, and
otherwise owning a large arsenal of nuclear weapons.
My mother's family is from Pasco, Washington just a few
miles downstream from the Hanford Nuclear Reservation along the
Columbia River. As it turns out, I was born at an army hospital
at Hanford in 1956 while my father was on active duty in Korea.
I live in Spokane, now, which is approximately a hundred miles
northeast of Hanford.
It was not until the 1980's that the term ``Hanford
downwinder'' came into wide usage in Eastern Washington. This
is because it was the spring of 1986 before citizen activists
and journalists finally succeeded in forcing the federal
managers of the Hanford site to make public the historical
documents proving what many people in our part of the world
already suspected. In their haste to manufacture the plutonium
used in America's first nuclear weapons, the operators of
Hanford's plutonium processing plants had released hundreds of
thousands of curies of radioactive iodine-131 to the
atmosphere.
The Hanford revelations had a profound effect on public
debate and public sentiment in Eastern Washington and
throughout the Pacific Northwest. While scientists continue
working to try to better answer the question of how widely
people were exposed and how many cancers and other illnesses
can be attributed to the Hanford emissions, there is
overwhelming sentiment that what happened was wrong. Civilized
governments are not supposed to expose their citizens to
radiation or other hazards without bothering to warn them or,
worse, go for decades without alerting them to the continuing
health risks of the exposures.
This conclusion is shared by people who have vastly
different views about whether we need large numbers of nuclear
weapons to defend ourselves. Eastern Washington is a rather
conservative place and many people are understandably proud of
Hanford's historic role in forcing an end to the war with
Japan. Still, patriotism does not allow us to excuse what
happened to people living downwind of Hanford during the 1940's
and 1950's.
Perhaps the hardest thing for people to accept was the
knowledge that the federal government hired and was paying
people at Hanford to study exposures and the biological and
health effects of radiation. And, yet, for three decades the
truth about the Hanford releases was withheld. For three
decades people were regularly assured their health was being
protected. Even on the day that federal officials released the
Hanford historical documents disclosing the large radiation
releases, one of them stood behind a podium with a federal seal
affixed to it. He said, and I quote, ``There is no reason to
expect observable harm.''
Regardless of how people in Pasco, Ritzville, Dayton,
Pendleton, Spokane, and in the fields above Eltopia felt about
plutonium, the bomb, the war, and the hundreds of millions a
year in federal dollars coming to Hanford, there is little
question now about how they feel about being lied to, even if
the lies were cleverly composed.
What happened at Hanford is relevant to today's hearing for
two reasons.
The first is that the circumstances surrounding the
National Cancer Institute's handling of the radioactive iodine
fallout study are remarkably similar to those surrounding the
Hanford emissions. While it's true that NCI didn't create the
fallout, it was charged with the important task of telling
Congress and the American people about what happened. It failed
in this responsibility. It failed because its researchers, some
time ago, had compiled and analyzed enough evidence to realize
that this was more than just a science project. They knew, or
should have known, that at least thousands of infants and
children throughout America had received thyroid doses putting
them at substantially greater risk for thyroid cancer and other
thyroid diseases. People had a right to know. And had they
known, that knowledge may well have made a difference in their
lives.
The hardest thing to accept is that once again, federal
scientists and officials chose to withhold information vital to
the health and well-being of citizens whose interests they are
supposed to be serving. Once again people are outraged with the
knowledge that their illnesses might have been prevented, or
their suffering diminished, if only they'd been told they were
at greater risk due to their exposures. Once again people feel
like nuclear age guinea pigs or mere statistics--as though the
government has infinitely more interest in studying them than
in helping them.
The second reason the Hanford experience is relevant to
this study is that we were supposed to have learned from
Hanford. And not only from Hanford but from all the other
disturbing revelations of the 1980's, and before, about the way
federal science has been compromised in the field of radiation
and health. We've known for many years that it was a mistake to
allow the Department of Energy and its predecessors to dominate
the avenues and processes by which the government is supposed
to be protecting public health and the environment from the
effects of the nation's nuclear weapons production and testing
activities. Part of this domination involved the control DOE
and its predecessors exercised over health and health-related
research activities involving radiation exposures to workers
and the public.
In 1990 the Department of Energy finally bent to
Congressional and public pressure when Energy Secretary James
Watkins signed a Memorandum of Understanding with Health &
Human Services Secretary Louis Sullivan. This agreement,
renewed last year, transferred funding and managerial control
over occupational and public health studies involving radiation
exposures to the Centers for Disease Control & Prevention and
the National Institute for Occupational Safety and Health.
Just as importantly, the 1990 MOU initiated a process to
enact long overdue reforms in the way health and health-related
studies involving public exposures were to be conducted.
Specifically, there were to be no more closed doors behind
which scientists worked without public oversight to decide how
to study communities and what, if anything, to tell citizens
about their exposures and health risks.
One glaring weakness in these reforms--a weakness vividly
exposed by NCI's mishandling of the I-131 fallout study--is
that there is still federally-funded radiation research, much
of it being done at the National Cancer Institute, which
proceeds outside of the reforms enabled by the 1990 MOU. What
is especially ironic in this instance is that the NCI fallout
study was requested by Congress for the purpose of furthering
the national accounting of health risks to the American people
caused by U.S. nuclear weapons test fallout. And yet, it was
managed by a former Department of Energy official in the same
closed manner--without public oversight and meaningful external
review--that brought such discredit to the DOE radiation
research program.
Surely, much work is needed to determine how the nation can
and should respond to those who were put at substantially
greater health risk due to the exposures that the NCI study
appears to document. But I'd like to encourage the Subcommittee
to pursue and insist upon the steps that are needed to ensure
that the important science that remains to be done in this area
is done openly, with public oversight and robust independent
peer review. The American people need to know, once and for
all, that federal scientific research addressing the health
risks and consequences of radiation and other hazardous
substances is really being done on their behalf and not on
behalf of the institutional or political interests of
government agencies and bureaucracies. While it is very late in
the day to institute these reforms, it is absolutely necessary
to see them through. It is an important part of making peace
with our past and, more importantly, with ourselves.
One of the more disturbing aspects of the way the NCI I-131
fallout study was conducted is that there was ample opportunity
for NCI administrators to know better. It is hard to imagine
how NCI officials could have missed the public controversy in
the late 1980's with regard to the conduct of radiation health
research funded through DOE. In August of 1989 Secretary of
Energy James Watkins announced to the Senate Governmental
Affairs Committee that he would empanel some of the nation's
top health experts to review the issues and status surrounding
DOE's radiation health research program and report back to him
with recommendations. At the time, there was legislation
drafted by members of both the Senate and the House that would
have formally transferred the radiation health research program
to the Department of Health and Human Services.
The body Secretary Watkins appointed--the Secretarial Panel
for the Evaluation of Epidemiologic Research Activities
(SPEERA)--was chaired by Kristine Gebbie, then Washington
state's Secretary of Health. SPEERA reported its findings to
Secretary Watkins in March of 1990 and recommended several
major reforms. A number of the principles and recommendations
advocated by SPEERA are worth revisiting in the aftermath of
NCI's mishandling of the I-131 fallout study. Among the
principles SPEERA articulated were the following: [1]
``The credibility of scientific research is essential and
is directly dependent upon openness. The benefit--credibility--
derived from maximum public access to health information
greatly exceeds the risks of misuse or misunderstanding.''
``The findings of any epidemiologic research must be
reported fully and promptly to all who are affected.''
``The public has a right to know about collective health
experiences and risks to which they were exposed.''
``Epidemiologic findings must be reported fully and
promptly to policy makers so that findings are integrated into
policy decisions.''
While the NCI I-131 fallout study was not an epidemiologic
study, it's obvious that the same principles would apply to
exposure assessment studies.
The SPEERA panels' recommendations were based on the above
principles. One of its recommendations was that representatives
of populations whose exposures were being studied (and health
officials who serve those communities) should be enlisted to
serve on community level advisory committees. But perhaps its
most important recommendation was for the creation of a new
national advisory committee, to be established by the
Department of Health and Human Services, that would oversee
epidemiologic research. It was this recommendation that was at
the core of the 1990 MOU between DOE and DHHS.
Among the other developments that should have gotten the
attention of NCI administrators were the findings and
recommendations of the Presidential Advisory Committee on Human
Radiation Experiments (ACHRE) in 1995. Although the Committee's
primary concerns were the abuses involved with the use of human
subjects in radiation experiments, it also commented critically
on how the culture of secrecy within the former Atomic Energy
Commission led to the suppression of information involving
exposures to the public from secret emissions at Hanford and
other AEC facilities.
``Where citizens are exposed to potential hazards for
collective benefit,'' the Advisory Committee observed, ``the
government bears a burden of collecting data needed to measure
risk, of maintaining records, and of providing the information
to affected citizens and the public on a timely basis.'' [2]
Moreover, the ACHRE panel recommended the following with
regard to future knowledge of environmental exposures:
``[the Administration] together with Congress, [should]
give serious consideration to amending the provisions of the
Radiation Exposure Compensation Act of 1990 to encompass other
populations environmentally exposed to radiation from
government operations in support of the nuclear weapons
program, should information become available that shows that
areas not covered by the legislation were sufficiently exposed
that a cancer burden comparable to that found in the
populations currently covered by the law may have resulted.''
(ACHRE Recommendation No. 5).
The reforms proposed by the SPEERA panel in 1990 are today
being implemented through the MOU between DHHS and DOE, with
cooperation from the Agency for Toxic Substances and Disease
Registry (ATSDR). Thus far, local or regional public advisory
bodies have been established at the Hanford, Fernald (Ohio),
Savannah River (South Carolina), and Idaho National Engineering
& Environmental Laboratory sites. Similar public advisory and
oversight bodies have been created by agreements between the
Department of Energy and the states of Tennessee and Colorado
to examine health issues surrounding the Oak Ridge and Rocky
Flats sites respectively.
While these community-based advisory bodies do not
guarantee a seamless resolution to the health issues and
concerns around these facilities, they do allow a truly
revolutionary opportunity for public involvement that simply
did not exist before the 1990 MOU. This is the way democracy
should work to resolve longstanding issues and grievances that
exist between a government and its people. This may seem like a
messy and inefficient approach for some scientists and public
officials but we've seen the alternative and know it hasn't
served us very well.
Given the strides we've made in communities around DOE
facilities to begin dealing openly with the unresolved public
health issues related to historic emissions and waste practices
at these facilities, the complete failure of the NCI to notify
and involve the public and public health officials in its I-131
fallout study is staggering. In my view, it represents a major
setback for public trust and confidence in what has otherwise
been a commendable effort by DOE and DHHS in recent years.
Spokespersons for NCI have suggested that the delay in
releasing the results of the NCI I-131 fallout study was due to
the fact that it is a large study and that researchers needed
to make sure the exposure estimates were both thorough and
correct.
The problem with this explanation is that it isn't just the
quality of the science that matters. It wasn't just livestock
and gummed film sample plates that were exposed to the
radiation NCI was asked to analyze. It was people. At some
point in the course of this study NCI researchers and officials
knew, or had reason to know, that thousands of American infants
and children had received thyroid doses that were orders of
magnitude greater than Congress and the American people had
been led to expect. [3] At the very least, this knowledge
should have led NCI to begin alerting and consulting with
federal and state public health authorities, especially those
responsible for public health in the areas hardest hit by the
fallout.
Why NCI chose not to take this course is a matter of great
concern and one for which the Subcommittee should seek a
thorough explanation and accounting.
In conclusion, I would like to propose that the
Subcommittee and Congress consider the following steps in
response to NCI's mishandling of the I-131 fallout study.
Consistent with the intent of the 1990 (and the 1996
update) of the MOU between U.S. DOE and DHHS, the National
Cancer Institute's radiation research projects--both domestic
and foreign--should be brought under the purview of the HHS
Advisory Committee on Energy-Related Epidemiologic Research.
This reform could be accomplished by a reorganization of an
open, accountable, and effective radiation health research
program within DHHS that would no longer be dependent upon
funding support from the Department of Energy.
This could be accomplished legislatively by replacing the
MOU with a law establishing a consolidated DHHS program charged
with conducting and coordinating federal research on the public
and occupational health effects of exposures to ionizing
radiation and other hazardous exposures related to nuclear
weapons production, testing and nuclear facility operation. The
program should have its own line item in the DHHS budget. Under
this initiative the charter of the HHS Advisory Committee on
Energy-Related Epidemiology should be amended and clarified. As
part of this reform, it should be clear that the radiation
health program that remains at the Department of Energy is
limited to those activities directly necessary to monitor the
exposure and to provide for the daily occupational health needs
of DOE employees, and DOE contractor and subcontractor
employees. All health studies of these workers should be done
through HHS. All international research--such as the current
Chernobyl studies NCI is conducting with DOE funds--should be
commissioned and funded through HHS and be accountable through
HHS processes. This change should provide better accountability
and enhanced credibility to the research.
If, for whatever reason, a legislative reform is not
enacted, an Executive Branch reform could be accomplished by
revising the Advisory Committee's charter (which is up for
renewal in February) and having the charter signed by the
Secretary of DHHS. At the very least this involves amending the
``Function.'' description in the ACERER charter to read:
``The (ACERER) shall advise and make recommendations to the
Secretary of DHHS, the Secretary of Energy, the Assistant
Secretary for Health of the Department of Energy, the Director
of the Centers for Disease Control and Prevention, the
Administrator of the Agency for Toxic Substances and Disease
Registry, and the Director of the National Cancer Institute, on
the establishment of the federal research agenda pertaining to
energy-related exposure and epidemiologic studies.''
Whether by legislation or by Executive Branch reform, it is
important the change be accompanied with a commitment from NCI
to participate with and be accountable to the Advisory
Committee. The NCI Director should be asked to designate a
high-level NCI official to be the liaison with the ACERER and
this liaison should commit to attending all regular ACERER
meetings and participating in the fashion that CDC, NIOSH, DOE
and ATSDR now participate in that process.
NCI should be given a deadline (within 30 days) to review
the reports of the 1995 Presidential Advisory Committee on
Human Radiations Experiments (ACHRE) and the 1990 Secretarial
Panel for the Evaluation of Epidemiologic Research Activities
for the Department of Energy (SPEERA), and from that review
propose a set of guidelines for public oversight, public
participation, and external peer review of NCI radiation health
studies that reflect the findings and recommendations of both
bodies. These guidelines should include language that requires
public notification and a public advisory process in
circumstances where there is known to be, or discovered to be,
exposures that pose a significant threat to public health.
These guidelines should be proposed to the Secretary of Health
and Human Services and should be reviewed by the ACERER.
In addition, there are at least two non-policy initiatives
that should occur as a result of the long-delay in releasing
the fallout data.
The General Accounting Office should be asked to
investigate and report back to Congress on such issues as why
the NCI failed to act on evidence indicating large numbers of
Americans received very high exposures, why the committee
advising NCI on the risk implications of the data was
disbanded, etc.
In preparing this report, GAO should be asked to provide
its own set of recommendations along with its findings.
NCI should agree to support a process whereby CDC and the
Agency for Toxic Substances and Disease Registry convene a task
force to examine the fallout data--including other
radionuclides such as strontium-90 and cesium-137--the risk
estimates, etc., and make recommendations to the Secretary of
HHS with regard to the education, medical monitoring, and
medical assistance steps necessary to adequately respond to
this information. This process should be coordinated with the
ACERER and should include some ACERER members as well as
representatives from state and county health departments,
citizen organizations with a history of interest in these
issues, other citizens who were exposed and who are
representative of exposed groups, and relevant medical experts.
It would also be wise to have DOE participate in this process
because, at the very least, they hold information that is
likely to prove valuable to the task force.
References
[1] Report to the Secretary, The Secretarial Panel for the
Evaluation of Epidemiologic Activities for the U.S. Department
of Energy, March 1990.
[2] Final Report of the Advisory Committee on Human
Radiation Experiments, 1995. Finding No. 19.
[3] The National Cancer Institute Study: ``Exposure of the
American People to Iodine-131 from Nevada Atmospheric Bomb
Tests,'' DRAFT memo, U.S. Department of Energy, July 29, 1997.
p. 3.
FOLLOWUP STUDY
Senator Specter. Mr. Connor, again, to the extent that your
prepared statement does not specify what you think ought to be
done by way of a followup study, the subcommittee would
appreciate it if you would give us a written precise statement
as to what you think ought to be done.
Mr. Connor. I believe those are in my written comments to
the subcommittee.
Senator Specter. Thank you very much.
Senator Murray. Mr. Chairman.
Senator Specter. Senator Murray.
Senator Murray. I have not made any statement yet. Mr.
Connor is from my State and I just want to have the opportunity
to thank him for coming and let you know that he speaks on
behalf of many Washington State citizens. I am the daughter of
someone who grew up in the Tri-Cities area, next to the Hanford
Nuclear Reservation.
I heard you talk, Dr. Beyea, about expanding the studies
beyond thyroid cancer. My father had multiple sclerosis, as do
a large number of people in eastern Washington and Idaho, and
no one has ever been able to connect that to radiation fallout.
But I do think the points being made are absolutely essential--
that people have a right to know, that people need the
information that we have a responsibility to help those people,
is absolutely essential.
Senator Specter. I quite agree, Senator Murray.
STATEMENT OF ANDREA McGUIRE, M.D., STAFF PHYSICIAN,
VETERANS ADMINISTRATION HOSPITAL, DES
MOINES, IA
Senator Specter. We now turn to Dr. Andrea McGuire,
physician at the Veterans Administration Hospital in Des
Moines, a graduate of Creighton University Medical School. Dr.
McGuire has seen many patients concerned about their fallout
exposure.
Thank you for joining us, Dr. McGuire, and the floor is
yours.
Dr. McGuire. Thank you, Senator Specter, and thank you,
Senator Harkin, for inviting me.
I am a nuclear medicine physician practicing in Des Moines,
IA. My profession involves the diagnostic and therapeutic use
of radioactivity and the treatment and diagnosis of thyroid
cancer. It is with this knowledge and my own personal knowledge
that I come to this committee today.
My interest in this subject has been increased beyond my
professional interest by some medical events that have happened
over the last 12 years to my family. Several years ago my
brother-in-law had a nodule found in his thyroid on routine
examination. After further evaluation with imaging studies,
there was suspicion this was thyroid carcinoma and therefore he
underwent a needle biopsy.
At that time it was found to be thyroid carcinoma and he
had a total thyroidectomy, which involves an incision across
the neck and dissection of the thyroid gland. He then underwent
thyroid ablation with radioactive iodine-131 and has routine
followup to make sure he does not have recurrence of his
disease.
Not long after my brother-in-law's diagnosis, my sister-in-
law also found a nodule in her thyroid. She too has been found
to have thyroid cancer and has undergone a total thyroidectomy.
Just recently, another one of my sisters-in-law has found a
nodule and has undergone a total thyroidectomy for thyroid
cancer.
When I first became aware of the results of the fallout
study, I understood that some areas in Iowa had higher doses
than others. When I discussed this with my mother-in-law, she
told me that she had lived in one of these areas during the
time when these children that had been exposed to this, when
they were young, and they have gotten the thyroid cancer since.
They also were on a farm at this time and drank cow's milk,
which would increase their dose instead of getting milk from
the dairy.
It worries me and concerns me that three of my husband's
family out of seven, all in the immediate age with each other,
have gotten thyroid cancer and would have gotten the highest
dose from this radiation fallout. As a physician, I am
concerned because I take care of these patients and I am not
sure what to do for them. Should I have a higher suspicion when
they come in the door if they have been in one of these areas?
I have heard a lot of information here today, but frankly
in my practice I have not heard this information. I am not sure
what to do as far as should I do more studies on these people
because they will have a higher incidence? We have the external
beam evidence that shows that there is a higher incidence in
those patients. In those patients we were very good about
making sure they have more testing and that we make sure that
they do not get lost in the system and that we make sure they
do not have thyroid cancer. Should we be doing that on these
patients?
I just do not have any information, Senators, to tell my
patients what they should do or tell my siblings what they
should do, and this concerns me greatly.
PREPARED STATEMENT
In summary, the committee has the ability to give the
physicians the information they need so that I can go to my
patients and tell them what they need to hear: whether there
are risks to people who are in the higher dose areas, what
screening needs to be done for these patients, are there
studies that say that there is an increase, and how we should
proceed to keep a higher cure rate for thyroid cancer in this
country.
Thank you.
[The statement follows:]
Prepared Statement of Dr. Andrea McGuire
My name is Dr. Andrea McGuire. I would like to thank the
committee for inviting me to participate today. I am a Nuclear
Medicine physician practicing in Des Moines, Iowa. My
profession is involved with the diagnostic and therapeutic use
of radioactivity. This includes many patents being diagnosed
and treated for thyroid carcinoma. The radioactive fallout in
the 1950's and the resultant radioactive contamination in Iowa
affects many of my patients. I am also a mother, and wife and
sister to people affected by this radiation fallout.
My interest in this subject has been increased beyond my
professional interest by some medical events that have happened
over the last 12 years in my husband's family. Several years
ago my brother-in-law had a nodule found in his thyroid on a
routine examination. After further evaluation with imaging
studies, there was suspicion this was thyroid cancer and,
therefore, he underwent a needle biopsy of his thyroid nodule.
This showed thyroid carcinoma and my brother-in-law underwent a
total thyroidectomy which involves an incision across his neck
and the removal of the thyroid gland. He then underwent thyroid
ablation with radioactive I-131. He continues on lifetime
replacement of thyroid hormone as well as continued yearly
follow-up of his disease for recurrence. Not long after my
brother-in-law's diagnosis with thyroid cancer, a physician's
examination revealed that a nodule was present in my sister-in-
law's thyroid. She also was eventually diagnosed with thyroid
cancer and underwent a total thyroidectomy and similar medical
procedures and additional treatments due to spread of her
disease. Recently, another one of my sisters-in-law was
diagnosed with thyroid cancer and underwent a total
thyroidectomy.
When I first became aware of the results of this study of
radioactive fallout and that some areas in Iowa had received
somewhat higher doses than others I discussed with my mother-
in-law where my husband's family was living at the times of
these fallouts. She informed me that at that time their family
had been living in an area with the higher levels. After
further discussion, I discovered that at the time of the
fallout her three children that now have thyroid cancer were
under the age of 5 years old. This is important for two
reasons: one, the amount of milk young children drink is much
greater than that which older children and adults consume and
two, the thyroid is thought to be more sensitive to radiation
effects at this younger age. She went on to tell me that at
that time they all lived on the farm and drank milk from their
own dairy cow. This is important because typically the milk
that goes to a dairy is consumed approximately 14 days from
when it is milked from the cow. But these children drank the
milk within 12 hours from when it was milked from the cow.
With I-131 having an 8 day half-life, this would have given
them approximately 4 times the dose of people who consumed milk
from the dairy. As a physician and scientist, I realize that
there is no definite evidence that my family's thyroid cancers
are related to the exposure they received as children. However,
the fact that the three children who received the higher doses
because of their location at the time of the nuclear test,
their age, and their ingestion of cow's milk have all had
thyroid cancer but none of their siblings that were not of that
age or received the cow's milk have cancer is of concern to me.
Are their other examples out there?
I have tried to obtain more information about the study
since that time and have not been very successful. Iowa state
cancer registry finds an increase in thyroid cancers from 1.7
cases per 100,000 in 1973 to 3.4 cases per 100,000 in 1995. The
registry states that many cancers have increased over this time
and that this is most likely from early detection. My concern
is that in this small example of my family none of them were
diagnosed or treated for the thyroid cancer in the geographical
area in which they were exposed and only one of them was
diagnosed and treated in Iowa. Therefore, I am concerned that
on a state basis it may be difficult to evaluate these
statistics.
This brings me to my second reason for concern over this
fallout issue. What do I tell my patients and my other family
members regarding areas that have this increased radioactive
fallout? Patients come to see their doctor to get answers and
to understand what is happening to them. I don't have enough
information to tell them. If they were living in these areas
known to have a higher rate of radioactive fallout, what should
they do? Should they have their thyroid examined? Should tests
be run? Should they have scans of their thyroid? It is
difficult to be their adviser when I have so little
information. It is known that external beam radiation which was
given to young patients in the neck area for various reasons
such as acne or an enlarged thymus have a higher incidence of
thyroid cancer. Physicians use this piece of information when
evaluating patients. This is because these patients with a
history of external beam radiation to the thyroid typically
receive screening for thyroid cancer because of this higher
incidence. On the other hand, as a physician I have no idea
whether this should be true for patients exposed in the higher
areas of radiation fallout. We do know that the thyroid is a
very radiation sensitive organ and that I-131 does give off a
relatively high radiation dose to the thyroid because of the
thyroid's ability to concentrate iodine. Because of the lack of
information about the fallout, I don't know whether I should be
more suspicious when examining their thyroid? Should I order
additional imaging tests on these patients as I most likely
would on patients exposed to external beam radiation? Should I
follow them more closely than a routine patient? I need for you
to understand that this lack of information makes me a less
effective physician to my patients, and therefore, I am here as
an advocate for their health. I also worry about people who do
not receive routine medical care. What should be done to
evaluate these people.
I also know that I don't want patients alarmed
unnecessarily. In adults, the incidence of thyroid nodules is
between 4 to 7 percent. This incidence tends to increase with
age and is greater in women. The vast majority of these nodules
are benign in nature and need no further evaluation. I can
appreciate the problems that could be created and the
unnecessary procedures that might be performed if this
situation is not handled properly.
In summary, this committee has the ability to give
physicians and patients the information they need. What are the
risks for people who were exposed to radioactive fallout? Do
the risks differ depending on factors such as location, age,
and ingestion of cow's milk? Has an increased incidence of
thyroid cancers been studied? What is the best way for
physicians to screen these patients if they are at higher risk?
Please do the necessary studies and disseminate the appropriate
information to physicians and patients so we can use our
medical knowledge to continue to have a greater than 95 percent
cure rate for thyroid cancer.
TESTS
Senator Specter. Thank you very much, Dr. McGuire.
Dr. Lyon, your charge is a very serious one, that you would
not trust the NCI or the administration to carry out these
tests. I appreciate the fact that you have had very extensive
experience in the field. Can you tell us why you would not, in
effect, trust NCI here?
Dr. Lyon. Well, at least under the current administration,
under the constraints placed on by Federal contract----
Senator Specter. When you say ``under the current
administration,'' could you be specific?
Dr. Lyon. Well, I say the current siting of radiation
studies at NCI.
Senator Specter. Are you talking about Dr. Klausner?
Dr. Lyon. No, Dr. Wachholz's group, who has the radiation
studies responsibility.
Senator Specter. Why do you say that about that group?
Dr. Lyon. Well, because of the long past history on the
earlier Utah study, where we had the continued, continued
problems that I've detailed in my testimony.
Senator Specter. Dr. Klausner, are they here today?
Dr. Klausner. Yes.
Senator Specter. Go ahead, Dr. Lyon.
Dr. Lyon. The other big concern is that there is no
commitment to any kind of public involvement in terms of
citizens advisory committees, informing the public of the
results. I have been beat up, beat up verbally, in meetings
with physicians and southwestern Utah on inconclusive results.
I have had videotapes played to me by various interviews given
by officials in the Federal Government saying it's
inconclusive, there is no effect. This is an area where we know
we have got people with radiation exposure of over 400 rads to
their thyroid. The physicians have never been informed of that,
and they have been told that the findings are inconclusive and
that there is no cause for concern.
There was no effort to create any kind of a public group,
any kind of a medical group that could even look at that. There
has certainly been no medical surveillance within the area, and
there was no willingness on the part of the NCI to even
consider those kind of public health-oriented programs.
For this reason, I think continued work without heavy
public involvement is simply going to be fruitless.
Senator Specter. Dr. Klausner, we will give both you and
the individuals who have been identified by Dr. Lyon a chance
to respond. Dr. Lyon's written statement is very forceful. It
says: ``I was appalled to find that employees of one of the
premier research institutions in the world, the National Cancer
Institute, in August of 1997, just a month ago, were using the
same tactics that had been used for the last 40 years by
officials of other Federal agencies. And even more upsetting to
me was that these tactics had been used to obfuscate their own
research findings of potential excesses of thyroid cancer for
many citizens of the United States.''
He also complains about the delay in releasing the
findings, and then at page 11 he says: ``Use of the term
`inconclusive' to describe our thyroid study is disingenuous.
We found a threefold increased risk between childhood exposure
to radioactive iodine and subsequent thyroid neoplasms, with a
clear dose relationship. Certainly no researcher would consider
exposing a group of children to radioactive iodine based on
such a finding.''
Dr. Klausner, how do you respond to that specific
scientific finding of a threefold increase and his statement
that he thinks it is disingenuous? Pretty tough criticism.
Dr. Klausner. Yes, it is, although it surprises me because
we have stated their finding, and just simply quoting their
publication, that they showed a 3.4-fold increase. It
represents, as they said, a difference of between 0 and 8
thyroid cancers and, as they said, because the range was
between 0 and 8, the standard scientific and medical response
to that is that there is some uncertainty about what the actual
rate is.
But we said that the point estimate, as they pointed out
and I have quoted them, was a 3.4-fold increase. We are not
trying--I am not sure why there is a perception that we are
trying to downplay this.
I must say I highly agree with Mr. Connor, that we need to
move to make sure that these sorts of studies--and we have been
doing that--have public oversight. What I have tried to do as
the new director of the NCI is, as I learned about this study,
to move to completely disclose it, to disclose all the
information, make it accessible to everyone.
We have a very extensive communications dissemination plan
with the CDC. We are developing a new memorandum of
understanding with the CDC for all of our radiation studies. I
think these points are very well taken, but I am not sure what
I can do about the past other than work very hard to try to fix
these things, and that is what we have done.
Senator Specter. Before we turn to Senator Harkin, I will
give you a chance to respond, Dr. Lyon.
Dr. Lyon. I just want to make one quick comment, that one
of the concerns was we had inconclusive findings. We recognized
that. Any rational researcher asks for additional years of
followup, because these people were just coming into their
period of highest risk.
The games that were played with our grant application were
appalling.
Senator Specter. What do you mean, ``games that were
played,'' Dr. Lyon?
Dr. Lyon. Essentially, after getting the grant funded,
someone went to the Board of Scientific Counselors, shares
information with them not in the grant application, and the
grant is put on hold. We were never given a response,
opportunity to respond. The grant is then bounced around from
institute to institute until finally it dies.
We have requested on separate occasions through our
congressional delegation some effort to try to get funding for
it, and the message comes back: This is of no scientific
interest, it has very low priority within the HHS structure.
It bothers me that when you have an inconclusive finding,
you know it is inconclusive and have a way to fix it, and it is
the important public health question that it is simply buried
within the bureaucracy of the HHS and you are told that it is
of limited scientific interest to the citizens of the United
States.
Senator Specter. What about that, Dr. Klausner?
Dr. Klausner. I just completely disagree. We have been
asking--I have been asking about, should we not do a followup
on this? The process by which grants come in, is that they do
not come in to the Institute. They come in to the NIH, they go
to the Division of Research Grants.
The Division of Research Grants actually, as I understand,
sent that to NIDDK. You were puzzled about that, but that
Institute is the Institute that oversees thyroid studies.
Dr. Lyon. It actually went to NIEHS, then was bounced to
NIDDK.
Dr. Klausner. I am sure these are complicated processes and
I am happy to look into it.
Senator Specter. Dr. Klausner, are you aware of the
specifics Dr. Lyon is talking about?
Dr. Klausner. No, sir; I am not aware of the specifics.
Senator Specter. I am just interested in what the facts
are.
Dr. Klausner. I am not aware of the specific allegation
that someone interposed and interfered with the process of peer
review or of granting. But it is not true that we are not
interested in funding followup to this. In fact, I must say we
have been discussing numerous times over the last several
months how interested we are in the opportunity to follow up
the Utah cohort study.
Senator Specter. Well, would you provide the subcommittee
with those specifics?
[The information follows:]
Funding Research Projects
During the October 1 hearing regarding the report of the
National Cancer Institute (NCI) on exposure of Americans to
radioactive fallout from the Nevada Test Site, Dr. Joseph L.
Lyon (University of Utah) alleged that Dr. Bruce Wachholz
(Chief, NCI's Radiation Effects Branch) intervened in some way
to influence the decision not to fund Dr. Lyon's research grant
application on thyroid disease resulting from exposure to
radioiodines. These same allegations were made in a recent
article that appeared in Nature. These are very serious
charges.
The application referred to by Dr. Lyon was titled, ``A
Cohort Study of Thyroid Disease from Radioiodines.'' The
original application was submitted to NIH in 1987 and assigned
to the National Institute of Environmental Health Sciences
(NIEHS). It was reviewed by the Epidemiology and Disease
Control Study Section (Subcommittee 2) in February/March 1988.
The application received a priority score outside the funding
range for NIEHS that year, so Dr. Lyon revised the application
and resubmitted it, this time receiving a priority score within
a fundable range. However, the application was given a
``Council Deferral'' at the February 1989 NIEHS council meeting
so that further information could be gathered.
At issue was the high cost of the study; whether other
studies addressed the research question; and maintaining
program balance within the NIEHS grant portfolio. As is done in
the normal course of determining whether scientific overlap
exists between two projects, NIEHS staff contacted Dr.
Wachholz, who was the project officer on an NCI research
contract to Dr. Lyon at that time, to determine if there was
any scientific overlap between the NCI contract and Dr. Lyon's
most recent grant application. Dr. Wachholz provided the
necessary information about the work scope of the NCI contract,
in a manner that is recalled by NIEHS staff as having been both
thorough and objective.
NIEHS made the evaluation as to whether there was
scientific overlap between the ongoing contract and the grant
application. Subsequently, it was decided by the Director,
NIEHS, not to fund the application. Dr. Lyon later submitted a
revised application on the same topic which did not receive a
fundable score. However, Dr. Lyon did have a grant funded by
NIEHS during this time period entitled, ``Radon Progeny and
Risk of Lung Cancer.'' The project period for this grant was
from September 1, 1988 to August 31, 1995.
FOLLOWUP STUDIES NOT MADE
Senator Specter. Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman, and I appreciate
your line of questioning. I think it kind of gets to the heart
of this. That is, we need to understand the past and why this
information did not get out and why followup studies were not
done. But I think to cut through it now and start looking at it
and get the followup studies done as soon as possible--but
there are people out there who are now in their forties,
fifties, sixties, and if you are going to study it for another
20 years, we do not have that time.
So it seems to me that we have a lot of information already
on which we can make rational, informed decisions on
information to practitioners and to public health agencies and
to the citizenry at large as to what they ought to do. I do not
know why we cannot cut through this and get this job done.
What I hope we can do here, Mr. Chairman, is to consider
how we bring together NIH or NCI as a part of NIH, the Centers
for Disease Control and Prevention, and the U.S. Public Health
Service in a working group to decide what basis do we have to
go on from the studies we have done. We have done a lot of
studies. And what can we do to take that information and get it
out as soon as possible.
I have been informed, Dr. Klausner--I noticed this over the
last few months--that the increase in the use of Synthroid in
this country has just skyrocketed in the last 10 to 15 years.
Why is that? Why are so many hundreds of thousands of people
now taking Synthroid?
Can I just throw that out and ask for one of you doctors or
someone to respond to that? Do we know? Anybody?
[No response.]
Senator Harkin. I feel like that guy in ``Ferris Buehler's
Day Off'': Anybody?
Dr. Beyea. I think it is premature to leap to conclusions
as to what the cause is, but I do know this, that we explored
the possibility of talking to the manufacturers and giving us
the statistics on the increase in sales by county. I could not
afford to do it, but it could be done. One could get those
statistics for every county in the United States, match them
up, correlate the increase in that drug, and it is a very
useful thing to do.
Senator Harkin. Why does a doctor prescribe Synthroid to a
patient?
Dr. Klausner. Overwhelmingly, the reason that a doctor
prescribes Synthroid is to treat hypothyroidism. Now, there are
many different ways in which people assess whether someone is
hypothyroid. One of the issues and controversies is the
definition of when a person is hypothyroid or slightly
hypothyroid and when they might benefit clinically from thyroid
replacement.
Senator Harkin. And would they also prescribe Synthroid if,
on giving an exam, they felt nodules?
Dr. Klausner. No; they should certainly not do that.
Senator Harkin. That is what was prescribed for me by a
doctor.
Dr. McGuire. It depends.
Senator Harkin. Pardon?
Dr. McGuire. There are people with goiters or nodular
thyroids that are put on Synthroid at times.
I have one question. When he was talking about----
Senator Harkin. I do not understand this. I have been
taking Synthroid for 17 years and I have been taking it because
I had nodules on my thyroid, and I have more nodules on my
thyroid. And I am just wondering why. You all say no, doctors
would not do it.
Dr. Klausner. Not automatically. That is often a correct
thing to do. What happens is the Synthroid is given and that
reduces the stimulus that is released from the brain for your
thyroid to grow. So the idea is that then that would reduce the
possibility of the nodules.
Senator Harkin. It is possible that doctors are prescribing
Synthroid because they feel nodules on a thyroid?
Dr. Klausner. Absolutely.
Senator Harkin. Thank you.
Dr. Beyea. They also may prescribe it because they are
seeing an increase in hypothyroidism. They also may be seeing
that as well.
Senator Harkin. That is true.
Well, again, the reason for that line of questioning for me
is that chart that you held up, you Dr. Beyea, that shows that
perhaps there is more happening out there than just cancer. Why
are so many people taking Synthroid? They did not 20 years ago,
they did not before that. But now all of a sudden it has
skyrocketed.
Dr. McGuire. Senator, if I may. They were talking about a
county, looking into where Synthroid was or looking into more
thyroid cancers in different areas. One concern I have is that
in Iowa there has been an increased incidence of thyroid cancer
and that may have been caused by many things, one of them
possibly this. But of my relatives, the Iowa registry would
have only known of one of them, because only one of them was
still living in Iowa, and then in a different part of Iowa,
when she was diagnosed.
Senator Harkin. See, that is a problem.
Dr. McGuire. So I am not sure State registries are going to
be very helpful in this area.
Senator Harkin. That is true. From my own personal case,
someone living in Pennsylvania getting thyroid cancer who grew
up on a farm in Iowa.
Dr. McGuire. Exactly.
Senator Harkin. How do you know?
Dr. McGuire. Exactly.
Senator Specter. Senator Harkin, let me just make an
interjection and I will yield back in just a minute. I am going
to have to excuse myself for this next session, but we will be
following up. We are going to yield to Senator Craig in a few
moments, who may be able to stay longer. Of course, he has not
had his round yet.
But we are going to pursue these matters. This subcommittee
is going to pursue the details as to what Dr. Lyon has said as
to what has happened on the NIH grant application. We want to
get very specific and know exactly what happened and who is
right and who is wrong. This ought to be subject to our
determination, because these are very serious charges about
this administration of NCI being unable or--let me use a
moderate word--inappropriate or not up to doing this job,
considering the $2.3 billion which we are appropriating again,
plus, for NCI.
We will go into the details as to what has been testified
about the cover-up in the past. As a result of what we see
here, we may schedule additional hearings of the subcommittee.
Senator Harkin, I yield back to you. At your conclusion,
Senator Craig, if you would proceed to chair the hearing. Thank
you.
Senator Harkin. I appreciate that very much, Mr. Chairman.
I think we may have to have some follow-up hearings on this.
Let me just again, Dr. Klausner, if I might ask: In terms
of public involvement, since we are on that topic right now,
there is currently in place some mechanism to ensure public
accountability in health studies. Dr. Klausner, did the study
research team have contact with the HHS Advisory Committee on
Energy-Related Epidemiological Studies, often referred to as
ACERS?
Dr. Klausner. I think this is the committee that--I am not
sure what the exact interactions were between that committee.
Is this the committee, Mr. Connor, that you are on?
Mr. Connor. Yes; here is your letter.
Dr. Klausner. So in 1996 I received a letter from Mr.
Connor asking about the overall activities of the NCI in
radiation-related studies. And this was transferred to the
staff, the appropriate staff, to respond. What happened, and
this was a problem, there were two, at least two, different
groups in two different divisions of the NCI that were doing
these studies. This was sent to one division and a collection,
a description of studies were sent, but it did not include this
study because it was in a different division. That was a slip-
up.
That was recognized later and then the information about
this study was transferred, as I understand.
There was, I gather, appended to this letter a resolution
that the committee had agreed upon in April of 1996, if I have
this right, to gather more information about the I-131 study.
That appended resolution was not referred to in the letter, and
again it was an oversight. When the individuals involved in the
study received an invitation to speak to this committee, that
was arranged, and they will be doing that at the next meeting.
Senator Harkin. Let me understand. My staff tells me we
have two members of the committee here. Are you a member of
that committee, Dr. Connor? ACERS, it is called?
Mr. Connor. Yes.
Dr. Lyon. And I, too, am.
Senator Harkin. I did not know who they were. Advisory
Committee on Epidemiological Radiation Studies, referred to as
ACERS. My staff tells me that this HHS-chartered body was
established as a step to ensure oneness and to help coordinate
between various research teams.
Again, I just want to know, did the study research team
have--I will ask you the same question. I am trying to get
through it. Did they have contact with this group, ACERS?
Mr. Connor. There is one letter that exists between Mr.
Wachholz and Jim Smith, the head of radiation studies at CDC.
It is a several-page letter and that is the contact, and it is
just very unfortunate.
Senator Harkin. When was ACERS set up? What year was it?
Mr. Connor. ACERS was set up--in my testimony I mentioned
the 1990 memorandum of understanding between DOE and HHS. That
memorandum of understanding calls for the creation of that
advisory committee, which is supposed to oversee the Center for
Environmental Health's activities and NIOSH's activities, to
focus on Department of Energy facilities and DOE releases.
So obviously one of the concerns of our committees was,
here was a major DOE release and a study about these releases
that we did not have access to. There was great concern on the
committee from Dr. Lyon and others that the study was being
suppressed, that the American people were not being told the
magnitude of the doses that the researchers were finding in
that study.
We were very concerned about that. That was one of the
reasons, not the only reason, but one of the reasons, we began
to make overtures to NCI to have a dialog and eventually get
this material out to the American people.
Senator Harkin. Dr. Klausner, does NCI consider itself
under the jurisdiction of ACERS?
Dr. Klausner. I am told that this was not, this study was
not considered under the jurisdiction of ACERS. I have since
had discussions with Dick Jackson and Henry Falk from the CDC
so that we can establish a memorandum of understanding, which
we are doing now, so that we can completely share all the
information of all the activities that the NCI is engaged in
related to radiation.
But my understanding is that this particular study was
interpreted as not under the purview of ACERS.
Senator Harkin. I am sorry to belabor this so long. I just
do not understand why. I mean, it concerns the public health.
It concerns the very reason why it was established, and that is
to get information out to the public when we have these health
studies. I do not understand that. I just do not, and I do not
know what we have to do to make sure this does not happen
again.
Dr. Klausner. Well, this is what we are moving on. For a
lot of this, I am in the position of----
Senator Harkin. Who would have made that decision, Dr.
Klausner, that NCI and this report was not under ACERS, that
study?
Dr. Klausner. Well, when I have spoken to the people at
CDC, they tell me that they did not expect that this study
would come under that jurisdiction, that the original
memorandum of understanding covered the studies that were being
moved from the DOE to the CDC, and the agreement as part of
that movement was that there would be an oversight.
So in the original charter, in the original memorandum of
understanding, there was not the expectation. As I have queried
the CDC officials to find out, well, where did this fall
through the cracks, they said their expectation was that this
was not under the purview of ACERS. Now, ACERS in this letter
asks for information about that, and I think that is quite
reasonable and that is why I have now moved to develop a
separate memorandum of understanding between the CDC and NCI.
Senator Harkin. So you say the basic responsibility lies
with--if CDC had said yes, this should be under ACERS, that
would have made all the difference in the world? Is that what
you are saying?
Dr. Klausner. Well, I assume that then that would have been
brought to the NCI at the time as their interpretation of what
should come under ACERS. That is the only thing I can surmise
from trying to understand the past history.
Senator Harkin. Do you have any observations on this, Dr.
Lyon? You are a member of that committee.
Dr. Lyon. My observations are more of an outsider, but the
sense was when this memo was put in place that there were still
other entities in the Federal Government that were pursuing
their own interests in radiation research. I think particularly
the Russian studies were viewed as an NCI preserve and did not
come under this, and that some of the residual studies, such as
this thyroid study, were pretty well considered.
So there was very little effort made to try to even bring
them under. We finally asked for a briefing on the matter.
Dr. Klausner. Right.
Senator Harkin. One last thing. Do you believe that we
should encourage you to move ahead, Dr. Klausner, in studying
the other two areas that Dr. Beyea spoke about? And that is the
nodularities and the autoimmune thyroid diseases that have not
been covered.
Dr. Klausner. I think the NIH ought to consider that. As
Dr. Beyea I think has pointed out, not all of this is under the
expertise of the NCI, and I think that would be a problem. I
think it is one of the reasons to try to move us to a new page
where this is very public, and why we have asked for a rapid
response from the IOM, so we can get a public hearing about
where we stand now, what studies are going to need to be done,
and, very importantly, to answer Dr. McGuire's most important
concern: What information do we give, the ``we'' being the
entire community, to health physicians, families, patients,
communities, public health officials, to answer the questions?
Not that we are going to have a perfect and definitive answer
to everything, but the answers; as much as we can, we have the
information there and it is available to everyone.
I think that is the most important thing and that is what
we are trying to do.
Dr. McGuire. Senator, right now, I went to the Internet to
try to get some information on this and called the 800 number
for the NCI, and I was told basically that there was no
problem, but if you were concerned you could go to your doctor.
So that is not what I am hearing here, so we definitely need to
get some information out.
Senator Harkin [reading]:
Even then, the number of children and grandchildren with
cancer in their bones, with leukemia in their blood, or with
poison in their lungs might seem statistically small to some in
comparison with natural health hazards. But this is not a
natural health hazard and it is not a statistical issue. The
loss of even one human life or the malformation of even one
baby who may be born long after we are all gone should be of
concern to us all. Our children and grandchildren are not
really statistics toward which we can be indifferent.
That is from President John F. Kennedy's speech on ending
the above-ground tests in 1963.
Senator Craig [presiding]. Senator, thank you.
Let me turn to Senator Gorton, who has just come in and
needs to be off to another committee. Senator.
REMARKS OF SENATOR GORTON
Senator Gorton. Thank you. I simply wanted to welcome my
constituent Mr. Connor here and say I am sorry. We are at the
very end of coming up with the Interior appropriations
conference report, but I have got to get back to that. But I
have read his testimony. I am obviously very much aware of the
concerns of the downwinders all over eastern Washington.
I think the presentation he has made is a thoughtful one
and the recommendations he has made are recommendations in the
alternative, at least, one or the other ought to be adopted. I
thank him for coming and sharing his experience and wisdom with
the committee here today.
Thank you, Senator Craig.
Senator Craig. Senator Gorton, thank you.
Questions of you, Dr. Klausner, and Dr. Lyon, and any of
the rest of you who would wish to comment. You have heard the
chairman and the ranking member speak of the frustrations that
I think all of this committee shares as to the flow of
information or the lack of flow or the unwillingness to provide
factual information or in some instances the allegations of
varying information.
As this information emerged in August, I mentioned in my
opening comments that four counties in my State appear at this
moment to have experienced elevated levels of fallout. Under
some weather scenarios, we are termed downwind of Nevada, and
of course Nevada is a bordering State.
Based on the current situation, the current knowledge, lack
of knowledge, coverup of knowledge, the failure to disseminate
and-or interpret, whatever it is we are trying to understand
here--and I am not sure what it is yet--what do I tell the
citizens of those four counties, Dr. Klausner, at this moment?
What should they know? What should they expect to know in the
future?
Dr. Klausner. I think the citizens should know that they
were exposed. They should know how to understand who was
exposed and try to--it depends on how old you were. What is
most important in the individuals who were exposed is children.
I think the public health officials need to know. We have
discussed with the public health officials of your State about
getting information and disseminating information about thyroid
cancer, about thyroid exams, about this study. We have been
working with them. We will continue to work with them. We have
asked them what their plans are in terms of monitoring and
public health activities in all of the most heavily exposed
States.
As I said, there is and will continue to be--and this is
very important--a tremendous amount of information and press
coverage and awareness about this, to reawaken awareness that
has sort of come and gone about radiation, to emphasize that to
those areas. And those individuals should consult with their
physicians.
Our recommendation now, along with the American Thyroid
Association, is that individuals who were exposed--and they can
find out their exposures by looking at those maps and knowing
what their ages were--should see their physicians, talk to
their physicians, and what we recommend is a manual thyroid
exam. Those remain, I think, the most reasonable interim
recommendations until we get as rapidly as possible a set of
broader national recommendations as to whether there are other
recommendations in terms of public health or medical
intervention or surveillance from the Institute of Medicine
study.
Senator Craig. Dr. Lyon.
Dr. Lyon. I would agree with Dr. Klausner. I think that is
a very responsible recommendation at this point in time. I do
want to add one very brief comment that I hate to bring up, but
one of the issues here is how is this going to be investigated
from a public health standpoint, what specific types of
scientific studies.
Again going back into the earlier era, part of our fallout
study in the 1980's included a case control study to examine
the risk of thyroid cancer in northern Utah that would have
been, we thought from the contamination, well outside the
southwestern corner of the State. We were well into the study,
developed the methodology, had not yet begun collecting cases,
and we were given a Hobson's choice on our funding, which was
basically you can do the cohort down in southwestern Utah or
you can have the case control. We chose the cohort.
I think in hindsight it is unfortunate, because that would
have provided a methodology well worked out that could be
applied to the rest of the United States. We probably can
resurrect some of that material from our files and we had
actually gotten to the point of writing a questionnaire and
defining exposures, and this may be helpful in terms of getting
fairly quick answers for what risk, what the actual risk may
be, at least on a State by State basis.
Senator Craig. Dr. Connor.
Mr. Connor. Senator Craig, one of the things about the
study that is most disturbing to me is that it was apparent
that, much earlier than the past year, the researchers had the
capacity to know where the highest risk people were. If I can
read from--this is a paper that Mr. Wachholz wrote for the
Journal of Health Physics in 1990 that was apparently based on
an earlier presentation at a conference: ``Completion of the
exposure and dosimetric segments of the study is anticipated in
1990-91.'' Which indicates to me that, much earlier than the
past year or two, that they have the capacity in-house and the
understanding in-house, or should have had the understanding,
to know where the people at highest risk were.
Why did they not contact public health officials and engage
in an immediate dialog to find out how they were going to
contact those people and their physicians, if only the advice
was, check with your physician on this at your next doctor's
visit, have your thyroid examined? Those things were very basic
things that could have happened, that could have made a
difference in people's lives, perhaps have prevented longer
illnesses or deaths. And it did not happen.
I would encourage you to look at this to find out what in
the protocol of NIH, NCI, prevented them from acting at that
threshold. Again, at some point this ceased being a scientific
study, when there was evidence to indicate that people were at
substantial risk and that we had the means to locate them,
perhaps not locate them directly in those counties, but knowing
that they were in those areas at the time of the exposure.
We have known who the vulnerable folks are. It is small
children and particularly the females that were at the highest
risk. Why were they not notified and why were they not given a
chance to do more for their health?
Senator Craig. Does anyone else wish to comment on that?
Dr. Beyea?
Dr. Beyea. I would just like to make one or two points.
First of all, I do not want to--I hope the impression is not
gotten across here that we have to do more scientific studies
before we will know what kind of recommendations to make to
medical health providers. There is a great deal of information
already available that can do that. It may be that later
studies will help refine those recommendations, but we do not
have to wait for that.
The other thing: I think you have a very difficult time,
Senator, in telling your constituents as to what they should
do. It seems to me I would feel in a very difficult position if
I were in your place, because the Government could have done
something a long, long time ago. They could have issued
advisories in the fifties and the sixties. They could have had
people not take fresh milk. They could have had farmers not
feed fresh food.
So I think that some apology is in order perhaps to the
American public for what has gone on during that cold war
period. We have to recognize that it was different times,
different concerns. But there are still some things that were
done that we probably will be ashamed of.
Senator Craig. Let me conclude with this, because the
American Thyroid Association has been mentioned. I am reading
from a copy off their web page, and this is a press release,
``Radiation exposure from past Nevada atomic bomb tests.'' The
second paragraph: ``Radioactive iodine has been used for more
than 50 years in almost 10 million individuals as part of
routine thyroid function tests in amounts far greater than that
delivered by fallout and careful long-term follow-up studies of
these individuals have not shown any evidence of excess thyroid
cancer attributed to radiation exposure.''
Senator Craig. Is that inconsistent with what we are now or
any of you are saying?
Dr. Beyea. No, because you have to make a distinction
between adults and children.
Senator Craig. And therein lies the difference?
Dr. Beyea. There lies the major difference. Now, you have
to recognize that the ratios are enormously different. As an
adult your risks are way, way down, maybe a factor of 10 times
lower, than if you are a child.
Plus I do not think the American Thyroid Association in
this country is the last word on thyroid health effects. They
after all, they are good doctors, they do good things. They do
not want, I think----
Senator Craig. The problem is the public might view them as
the last word. They pack an official title.
Dr. Beyea. That is right. But we have the various National
Academy reports that are put out periodically. It is a problem
that radiologists, particularly in this country, have a mind
set that radioiodine is good for you, and in many cases it is
good for you. If you have hyperthyroidism, radioiodine may be
very helpful to you.
But we can make that a choice. We do not have to have
individuals be given that against their will.
Dr. McGuire. Senator, typically as a physician, typically
the family physician or internal medicine doctor is going to be
the first person who is going to see a patient with a nodule,
and I am not sure they are reading the American Thyroid
Association's web page. So I think you are exactly right, that
information needs to go through different channels.
Senator Craig. Thank you.
Senator, do you have any further questions?
Senator Harkin. Senator, just a couple.
Senator Craig. I will let you follow up and conclude and
adjourn the hearing, if you would.
Senator Harkin. I appreciate that, and I will very shortly,
because I know staff has to get over to the conference
committee, and so do I.
I do have a question that Senator Daschle wanted asked. He
has an intense interest in this, has expressed it to me
personally, and he had a written question, which basically--I
will just read a summary of it. He says:
On July 27 I contacted you, Dr. Klausner, with four
straightforward requests, all of them directed toward providing
the public with the answers it was promised years ago and
assuring that future public mandates will be handled with more
accountability, responsiveness, and basic respect for the very
real concerns of people exposed to the iodine-131 fallout.
Specifically, I asked you to assess and report to the
Congress about the apparent delays surrounding the study
That is what we are talking about now----
Take whatever steps are necessary to ensure that similar
delays do not undermine future NCI projects, establish a date
certain for the Institute of Medicine's evaluation of the
appropriate medical response to the various exposure levels
associated with the fallout, and to evaluate whether there was
a significant change in the incidence of thyroid cancer in the
wake of the nuclear testing, particularly in hot spot areas.
Basically, he says: ``To my knowledge, you have not made
appreciable progress toward fulfilling any of these requests.''
I believe some of that has been done here today, but would you
please respond to Senator Daschle's questions that he wrote on
July the 27. I will make that a part of the record.
[The information follows:]
Letter From Richard D. Klausner, M.D.
Department of Health and Human Services,
National Institutes of Health,
Bethesda, MD, September, 30, 1997.
Hon. Thomas Daschle,
U.S. Senate,
Washington, DC.
Dear Senator Daschle: Thank you for your letters to Secretary
Shalala and to me pertaining to the release of the National Cancer
Institute (NCI) study on the iodine-131 fallout from atmospheric
nuclear weapons tests at the Nevada Test Site in the 1950's and early
1960's. I hope the following information is helpful.
We at NCI share your concern that the information available in this
report be made available to the public as soon as possible. Our
objective has been to provide the report in its entirety (several
hundred pages of descriptive text and mathematical models, and over
100,000 pages of data and results) no later than October 1, 1997. While
these technical arrangements are being completed, estimated average
thyroid doses of I-131 in every county of the 48 contiguous states were
released on August 1 in an ``Interim Final'' form on the NCI's World
Wide Web site (http://rex.nci.nih.gov; or http://nci.nih.gov) in the
``What's New'' link.
The data and mathematical modeling contained in the full report
were essential to reaching the national average estimated dose. They
will also serve as tools for public health officials and researchers to
use to determine exposures and to develop individual dose estimates. In
fact, it is widely known that fallout from atmospheric weapons tests
was indeed carried nationwide and that Americans in the contiguous 48
states at that time experienced some level of exposure. The fallout
report itself was not intended to provide risk assessments of thyroid
cancer from iodine-131.
Unfortunately, a determination of what, if any, health effects
might result as a consequence of I-131 exposure will require further
research. Although it has been widely known for many years that
radionuclides (including I-131) were deposited across the United States
following atmospheric nuclear bomb tests, what has never been clear is
the role these varying levels of fallout play in the development of
cancers, particularly among persons who might have been exposed as
children. It was hypothesized that if we knew the risk coefficient
correlating thyroid cancer to I-131 exposure and thyroid doses, and if
we knew how to estimate how much fallout each individual had been
exposed to, those population groups who might have been at highest risk
for developing cancer could be determined. They could then be provided
with information needed to monitor their health. A preliminary review
by NCI of regions estimated to have higher overall exposures to I-131
shows no increased rate of thyroid cancer incidence or mortality in the
40 years since the Nevada Test Sites began. Further followup is
underway, and our statistical and registry experts have provided advice
to state health departments interested in pursuing their own analyses.
With the passage of Public Law 97-414, NCI was asked to develop
methodologies to assess the amount of I-131 from fallout to which the
American people were exposed; to estimate the radiation dose to the
thyroid from the exposures; and to assess the risk of thyroid cancer
from this exposure. We have completed two of the three tasks--we have
successfully developed mathematical models using data and calculations
from many Federal and private sources. The human I-131 exposure data
and the few health consequences observed thus far among exposed
populations studied have not been adequate to calculate thyroid cancer
risk from these exposures. It had been anticipated that a follow-up
study of persons living downwind from the Nevada Test Site would
accomplish this; however, the results of that study, published in 1993,
were suggestive but not conclusive with respect to thyroid cancer. The
Chernobyl nuclear accident provides a tragic opportunity to obtain the
very information needed to make these risk estimates. These data
together with those from on-going epidemiologic studies in Hanford,
Washington may be sufficient to provide an estimate of cancer risk that
can be applied to the estimated doses from I-131 fallout from the
Nevada Test Site.
The NCI and the Department of Health and Human Services (DHHS) of
course recognize that there are potential implications of the I-131
exposure study for the health of the American people. There was never
any intention to conceal the results. In fact, the raw data and
preliminary formulae have been made available upon request during this
period of preparation and refinement. In addition, the methodologies
used in the study and preliminary results have been presented at
scientific meetings and published in the scientific literature since
1990. Updates to the NCI's Board of Scientific Counselors were frequent
and open to the public. Periodic progress reports to Congress were
drafted and forwarded to NIH for transmittal to the Secretary, HHS. The
Thyroid/Iodine-131 Assessment Committee was chartered in 1984 with
experts in all the fields of science relevant to this study to advise
the NCI staff on the conduct of this study. Meetings of the advisory
committee were open meetings, and it served until 1993 as a place where
presentations and discussions of the latest findings of the study and
more broadly in the scientific arena could be aired publicly.
As I mentioned earlier, the data available to link I-131 fallout to
specific cancers are not conclusive. All currently available data
relating to a statistically significant increased risk of thyroid
cancer are from external irradiation. Therefore, care must be taken to
craft a public health message to increase awareness of possible health
effects without creating alarm or undue harm. In the late 1970's, NCI
undertook a public health campaign to alert people to the possibility
of developing medical irradiation-related thyroid cancer. The campaign
was designed to: (1) brief physicians about how to examine, diagnose
and treat irradiation-related thyroid tumors, and (2) to urge the
special population in the United States that was at increased risk of
developing thyroid cancer to be examined by a physician. Because there
is no established risk coefficient for I-131 and thyroid dose exposure,
the Department of Health and Human Services has requested that the
Institute of Medicine (IOM) at the National Academy of Sciences review
the data to assess whether risks can be determined, and to develop
recommendations for physicians on how to identify, evaluate, and treat
persons who might be at risk of thyroid disease because of the
exposures to radioactive iodine. The IOM estimates that its
recommendations will be available in June 1998.
The Department has pledged to pursue the establishment of a task
force or working group of appropriate Federal agencies to discuss and
implement the next steps in addressing the public health concerns. In
the meantime, we are suggesting that concerned individuals consult with
their physician during their next visit.
The NCI will be pleased to keep you informed as these matters
evolve.
Sincerely,
Richard D. Klausner, M.D.,
Director, National Cancer Institute.
______
Letter From Senator Tom Daschle
U.S. Senate,
Washington, DC, August 27, 1997.
Hon. Donna Shalala,
Secretary, Department of Health and Human Services,
Washington, DC.
Dear Madam Secretary: Enclosed is a copy of my letter to Dr.
Klausner reiterating my concerns regarding NCI's handling of its 1982
congressional mandate to assess the impact of iodine-131 fallout
associated with open-air nuclear testing between 1951 and 1962. I feel
strongly that the Institute's inadequate actions in the face of a
potential threat to the health of thousands of individuals must be
investigated and explained, both to prevent the situation from
repeating itself and to demonstrate the government's fundamental
accountability to the public it serves. Most importantly, NCI must
fulfill an essential unmet requirement of its mandate: to provide
insight and guidance on the long and short-term health implications of
the nuclear testing.
I am requesting that you work closely with Dr. Klausner and the
National Cancer Institute to ensure that the public's interests are
being served from here forward, and to identify and address any
deficiencies that may account for the Institute's delayed and
incomplete response to this serious problem.
Thank you for your attention to this matter. Feel free to contact
me directly if you have questions.
Sincerely,
Tom Daschle,
U.S. Senator.
______
Letter From Senator Tom Daschle
U.S. Senate,
Washington, DC, August 27, 1997.
Hon. Richard Klausner, M.D.,
Director, National Cancer Institute,
Bethesda, MD.
Dear Dr. Klausner: As a follow-up to my inquiries over the past
several months, I would like to reiterate my concerns regarding NCI's
handling of its congressionally mandated assessment of iodine-131 (I-
131) fallout resulting from the 1950's radiation tests in Nevada. The
events leading up to and surrounding the release of the National Cancer
Institute's (NCI) study of I-131 raise serious questions about NCI's
commitment to its statutory mandate to investigate, on a timely basis,
the health impact of I-131 fallout.
As NCI's July 25 press release states, ``In 1982, Congress passed
legislation calling for the Department of Health and Human Services to
develop methods to estimate I-131 exposure, to assess I-131 exposure
levels across the country from the Nevada tests, and to assess risks
for thyroid cancer from these exposures.'' Fifteen years later, that
public mandate is still unfilled. Fifteen years later--more than 40
years after the initial tests--those exposed to the tests have
virtually no information about the probable impact of the tests on
their health or the steps they should be taking to protect their
health. Given NCI's proper emphasis on early detection of cancer and
other illnesses, this situation is especially troubling.
I am aware that the estimation process by which NCI calculated
average radiation dosage required a significant amount of data.
Nevertheless, that does not account for the lack of any information on
the progress of the study or any attempt to monitor the incidence of
thyroid cancer in high exposure areas during the 15-year interim
period. Neither does it justify NCI's failure, even now, to meet the
crucial requirement of the 1982 mandate: to access and inform the
public about the potential health risks associated with the iodine-131
fallout.
The stakes are too high to allow this situation to be perpetrated,
or to repeat itself. A delay in the delivery of crucial health
information has the potential to manifest itself in very real health
consequences. In this case, potentially exposed persons have neither
the direct health information they need nor precautionary health
guidelines that could serve them in the absence of such direct
information. Furthermore, inordinate delays such as those that have
plagued this study have a serious corrosive effect on public confidence
in the government's commitment to providing them with timely, objective
scientific information and protecting their health interests.
I urge you to assess, and report to Congress about, the events
surrounding the delays associated with this study, take whatever steps
are necessary to ensure that similar delays do not undermine future NCI
projects, and establish a date certain for the Institute of Medicine's
evaluation of the appropriate medical response to the various exposure
levels associated with the fallout. Finally, I ask that you evaluate
whether there was a significant change in the incidence of thyroid
cancer in the wake of the nuclear testing, particularly in ``hot spot''
areas. If this information is readily available, I ask that you share
it with Congress and the public immediately. If it is not yet
available, please estimate when it will be available and outline what
precautionary steps should be taken in the meantime by those
individuals who believe they may have been exposed to potentially
dangerous levels of radiation. The public deserves a much clearer
picture of the toll iodine-131 has taken on the Nation's health.
Sincerely,
Tom Daschle,
U.S. Senator.
ISOTOPE
Senator Harkin [presiding]. The last couple of questions.
We are talking here about one isotope. Are there other isotopes
out there that we have to be concerned about? And if so, what
are they? What do we know?
Dr. Klausner. Overwhelmingly, I-131 is the major isotope
released, but there are other isotopes: strontium-89,
strontium-90, cesium-137, barium-140, plutonium. And some of
those in aggregate were addressed by, I think, the important
Utah leukemia study. These other isotopes are even more
difficult to assess in terms of exposures, et cetera,
especially at this time.
The estimate that I have seen is that the amount of
radioactivity that individuals were exposed to for any of those
isotopes were much, much less, significantly less, than I-131.
That is why the major concern has been about I-131.
However, we are interested in health effects of these other
isotopes. There are studies about them. They are very difficult
studies. They are very controversial results. And we look to
see whether there are places where we can learn about the
health and risk estimates from these other studies, such as
surrounding the Mayac plant at the Techa River in the former
Soviet Union.
There are estimates about strontium in particular, about
its health effects. But as far as we can tell, the total
exposures from these other radionuclides, as I said, are much,
much lower to the American people than was I-131. Others here
may have more expertise about this than I.
Senator Harkin. Do we know about any other isotopes?
Cesium, for example, I am told mimics calcium, so it is taken
up in the bones and could lead to bone cancer. We have had
increased incidence of bone cancer, we know, in certain areas.
Dr. Lyon. We did very preliminary studies looking at
osteogenic sarcomas, which would be assumed to have been--and
tried to do it on a county by county basis. We found virtually
no signal coming from it. We abandoned it because it really
looked to be--the tumors are extraordinarily rare, very, very
difficult to study. So we backed off on that.
In our thyroid dose estimations, we took into account other
forms of iodine, so it becomes radioiodines. There are several
other, but they are much shorter-lived than iodine-131. 131 has
a 8-day half-life. These have much shorter half-lives. But they
were also included in our dose calculations.
To my knowledge, we have not looked at strontium or cesium
issues in any great detail.
Mr. Connor. The only comment I would like to make at this
time is that historically there was consideration of the total
number of estimated cancers that would be caused by strontium
and cesium during the time of the weapons tests, and the
numbers--the numbers of excess cancer were fairly significant.
That is one of the reasons that there was strong pressure for
the test ban treaty.
So there has been consideration in the past and recognition
that a number of cancers would be caused, distributed among the
population. But what was never recognized to the extent was
this milk pathway. Even though it was known privately, it was
never brought out publicly that this was a major issue.
Senator Harkin. Anything else on this specific thing, other
isotopes? I wanted to follow it up, and especially plutonium
also. Plutonium is highly carcinogenic and, even though it may
have been smaller releases, it is much higher and much more
carcinogenic. And its half-life is 24,000 years. So we still
have a lot of this stuff floating around.
I am just wondering, of what concern should that be in
terms of the amount of plutonium that was released in the
atmosphere during all these tests?
STATEMENT OF ARJUN MAKHIJANI, COAUTHOR, ARTICLE,
``BULLETIN OF ATOMIC SCIENTISTS''
Mr. Connor. Senator Harkin, Arjun Makhijani is here today
and he has done extensive research on isotopes and fallout. If
you would not mind, could I turn over the mike to him to have
him provide you with some information on this?
Senator Harkin. I have a time constraint. That is my
problem.
Mr. Connor. We can provide the information for the record.
Senator Harkin. Bring him up here, yes. I am interested in
this.
Just state your name and everything for the record here.
State your name.
Mr. Makhijani. My name is Arjun Makhijani, Senator Harkin.
My colleague Ben Franke actually is the dosimetric expert
in our shop, but since you called me. He actually compiled
these numbers in a book we published with the ``International
Physicians for the Prevention of Nuclear War in 1991.''
Senator Harkin. Excuse me. Are you not the one that wrote
the article for the ``Bulletin of Atomic Scientists?''
Mr. Makhijani. I coauthored it. The principal author is
back there.
Senator Harkin. I just wanted to make sure I knew who I was
talking to here. OK.
Mr. Makhijani. These numbers are compiled from the United
Nations Committee, Scientific Committee on the Effects of
Atomic Radiation, which calculated the doses from atmospheric
testing and published them. This is the authoritative committee
on the subject globally.
And if you take into account the testing from all
countries--United States, Soviet Union, France, England, and so
on, China--the cumulative global doses from radioiodine are
estimated to be about 2 percent of the total doses from all
radioisotopes released in atmospheric testing. The main
contributors to dose are--these are integrated dose to the year
2000 from the beginning of testing--are carbon-14, cesium-137--
in order; well, not quite in order; they are in different order
in different years. But carbon-14, cesium-137, zirconium-95,
strontium-90, ruthenium-106, tritium, cerium-144, iodine-131,
plutonium-239, and then there are a number of others.
Senator Harkin. All of these are--really, I do not know the
half-lives and stuff. But do we know any of the health effects
of all these?
Mr. Makhijani. Yes, sir; I think quite a lot is known about
the health effects of many of these isotopes.
Dr. Beyea. Yes; we do know a great deal about the health
effects, unfortunately, because of the A-bomb, the bombs that
were dropped on Hiroshima and Nagasaki, 50 years of followup by
the radiation health effects research. There is a huge body of
literature out there that tells us something about the health
effects of radiation.
Of course we do not know everything, and that is why we
need continued study of particularly some of these more obscure
health effects that have not been as carefully studied.
Senator Harkin. One last question. Why do you suppose it
was that the Government of the United States saw fit to inform
Kodak about fallout and to give them advance warnings on where
the hot spots would be, but would not do so for the general
public, especially in Utah and Idaho and places like that?
I am speculating here. Why would the Government not say:
Look, we are going to have an atomic bomb blast; for the next
couple of months, people in this area, you ought not to drink
milk. Why was that not done? I mean, they told Kodak to protect
their films.
Dr. Lyon. I can comment, Senator, on one other
inconsistency that is even more interesting, and that is that
the safety standards for the employees of the Federal
Government working at the test site were substantially
different than for the general population. The example of that
was the radiation monitor working in St. George on Shot Harry
on May 19, 1953, when almost 80 percent of the exposure
occurred, who spent the whole day out in the stuff, was told
when he got back that evening, after he put a geiger counter on
himself and found out he was clicking along at a pretty good
rate, to burn his clothes, to shower off very thoroughly, by
his superiors at the Atomic Energy Commission.
There was not one word said to the citizens that they could
have done exactly the same thing. I can only assume that there
was concern about the safety issue shutting down the test site.
But it would have been a very simple, effective way, and I
suspect if it had been done we would have found no excess
leukemia deaths in that county 20 years later.
Dr. Beyea. Mr. Harkin, I would like to comment on that,
because over the last few years I have been involved in looking
at documents, legal cases, discovery in legal cases, and have
read document after document that suggests to me that there
really needs to be a very important investigation, historical
investigation of what happened in this country in terms of
radiation and radiation research.
From what I can tell, there basically has been a
gentleman's agreement for a long, long time to keep from the
public what is known, to channel research into certain
circumstances, to make sure that an old boy network is always
in charge of who is assigning research contracts. I say that as
speculation. I say that based on limited access to documents.
But it is a story that some day must be told. How was it
that so much about radiation was kept from the public for so
long? And in fact, it actually backfired, because had people
been open from the very beginning I do not think we would have
had the same suspicion that we have today, and that is a
certain irony.
But I hope that you and other Senators will look into these
documents that we see in the plutonium injection cases, we see
in the Oregon prisoners cases, where prisoners were irradiated
and then had vasectomies. We see this in a number of cases. And
we read the documents where American officials kept things
very, very secret and did not pursue scientifically the right
answers.
I hope some day you will be able to help us find out the
total truth.
Senator Harkin. Well, I think this is the beginning of that
process.
Dr. McGuire. Senator, as a mother, I can only imagine what
my mother-in-law feels like. She is a very educated woman and
she would never have done anything to hurt her children, and
she feels like she did it by giving them the cow's milk. So I
think it certainly would have helped her if she had known.
Dr. Beyea. Senator, I have just been passed a note that I
think I should mention. I apparently have slandered the
American Thyroid Association inappropriately, and it is pointed
out to me that the American Thyroid Association has recently
been pushing for stockpiling of potassium iodide in connection
with reactor accidents. So I do want to mention that everything
about the association is not bad.
Senator Harkin. Well, I think I have a lot of other
questions, but I think the basic answer to them. But out of
this I hope comes follow up at least--and we will, my staff and
I am sure the committee staff, will follow up on this to ensure
that we put together, as I said, NIH, U.S. Public Health,
Centers for Disease Control and Prevention, to get this
information out to people. We have got enough information now
that at least people ought to be aware of it. And I think there
are certain guidelines that citizens can take right now in
terms of having checkups.
Beyond that, I am concerned about studies of other isotopes
and what may be out there, again in the way of letting people
know what they ought to do right now.
I think there is another subset of what we are starting
here, and that is what was just mentioned by you, Dr. Beyea,
and that is to try to find out, get some historical research
here, and find out just what happened and why. Why did it
happen that way--again, not as a way of self-flagellating
ourselves as a country, but to sort of set the stage for
something in the future. In other words, let us make sure we do
not repeat these kind of things again in the future in this
country. Enough suspicion and stuff out there of the Federal
Government. We do not need this kind of thing happening along
with it.
I am also concerned, following up, Dr. Lyon, with Senator
Specter on those grant proposals, and we will definitely follow
up on that.
PREPARED STATEMENTS
I ask unanimous consent to place in the record the
statement of the other witnesses who were not able to come
today, and other statements made by other Senators who were not
able to be here this morning also.
Prepared Statement of Senator Dirk Kempthorne
RADIATION EXPOSURE
I would like to thank Chairman Specter for holding this
important hearing. Today's testimony represents an important
step forward in our effort to get all of the facts on the
table.
The National Institutes of Health (NIH) has released the
results of a nationwide study of radioactive fallout from
above-ground nuclear tests conducted during the 1950's in
Nevada. A large amount of cancer-causing Iodine-131 was
released into the atmosphere during these tests, raising many
health concerns.
Much of the radiation from the tests traveled northward,
falling over the State of Idaho. In fact, four out of the five
most exposed counties in the entire country are in Idaho. I
find it appalling that only now are Idahoans discovering that
they may have been exposed to dangerous levels of iodine over
forty years after it occurred. This is simply unacceptable.
It has been shown that children exposed to radiation can
develop thyroid cancer later in life. Idahoans exposed to
radioactive fallout from these nuclear explosions in the 1950's
may be at risk. If this is the case, the federal government
must take responsibility for its actions. This responsibility
includes compensation for victims.
I have sent letters to Secretaries Shalala and Pena calling
on the Department of Health and Human Services to work with the
Department of Energy and the NIH to further investigate this
troubling disclosure to document all of the health impacts
resulting from these tests. An aggressive examination
dedicating all resources necessary is required to get to the
bottom of this outrage. All options of remediation must be
examined. At present, I have received a letter from Secretary
Pena pledging to provide whatever data is necessary. I have
also received an interim answer from the NIH. The NIH letter
proposes a plan in which HHS will establish a task force to
``discuss and implement the next steps in addressing public
health concerns.''
I applaud the efforts of the NIH to continue to work to
provide answers to Americans exposed during these tests.
Nonetheless, the Federal Government must be more responsive to
the questions that I and many others have asked about this
disturbing event.
------
Prepared Statement of Peter G. Crane
My name is Peter Crane, and I appreciate the opportunity to
submit testimony for inclusion in the record of this hearing.
The Subcommittee deserves the thanks of the American people for
holding this hearing, and for bringing the attention of the
public to the health effects of radioactive fallout on the
thyroid glands of Americans. There can be little doubt that
lives will be saved, and a great deal of human misery averted,
because this hearing will have alerted the public and the
medical community to be watchful for indications of radiation-
caused thyroid illness.
The purpose of my testimony today is to discuss an issue
closely related to the health effects of airborne
radioactivity, and that is the prevention of such illnesses by
means of the cheap and effective drug potassium iodide--``KI,''
in scientific shorthand. In submitting this statement, I am
acting in my private capacity, as an interested private
citizen, not in my official capacity as Counsel for Special
Projects at the United States Nuclear Regulatory Commission.
My interest in this subject began when I developed thyroid
cancer, at the age of 26, undoubtedly because of x-ray
treatments of my tonsils and adenoids when I was two. The
disease recurred nine years ago, and then it took extensive
radiation treatment--five hospitalizations over three years--to
eradicate it. Illnesses of this kind affect not just the
patient, but the whole family, as my wife could testify. Our
experience, and that of other thyroid patients whom I know or
have encountered, makes me believe that radiation-caused
thyroid disease is worth preventing, if prevention can be
achieved easily and cheaply--as it can.
Americans tend to assume that the protection given our
children is the most complete in the world. Where KI is
concerned, this is not true. Countries all over the world
stockpile the drug, in accordance with World Health
Organization guidance and International Basic Safety Standards
that the U.S. claims to support. The U.S. does not. And because
the Government has kept very quiet on the subject of KI,
comparatively few Americans realize that their children are not
as well protected against radiation from nuclear accidents as
children in France, Germany, Slovakia, Sweden, Canada, Japan,
Switzerland, Poland, and a host of other countries.
Stockpiling of KI was a major recommendation of the Kemeny
Commission, which investigated the accident at Three Mile
Island for President Carter in 1979. The Government promised to
implement that recommendation but later reneged.
In 1986, during the Chernobyl disaster, the Poles drew on
their stockpiles of potassium iodide, gave out 18 million
doses, and successfully protected their children. Side effects
were minimal. In the former Soviet Union, however, KI
stockpiling and distribution were haphazard. We are now seeing
the tragic consequences: an upsurge of aggressive childhood
thyroid cancer in children, frequently with spread to the lymph
nodes, which means extensive surgery. The photographs of the
young patients show incisions stretching from ear to ear. The
number of reported cases passed the 1,000 mark sometime in
1996.
First and foremost, this is a medical issue, but I am not a
doctor and do not pretend to be. What do the doctors say about
potassium iodide? The American Thyroid Association voted
unanimously last year to urge the Government to stockpile KI
for nuclear accidents. It has made that recommendation for
years, and its reasons are compelling. Here is a July 8, 1996,
letter from Dr. Jacob Robbins, a world-famous thyroid cancer
specialist with the National Institutes of Health.\1\
Describing KI stockpiling as ``long overdue,'' he explained:
---------------------------------------------------------------------------
\1\ He wrote this letter on behalf of the American Thyroid
Association, not in his official Government capacity.
---------------------------------------------------------------------------
``1. The Chernobyl experience has shown us that thyroid
cancer is indeed a major result of a large reactor accident,
even when evacuation is carried out;
2. The Polish experience has shown us that large scale
deployment of KI is safe;
3. The Three Mile Island experience has shown us that it is
not easy to obtain a good supply of KI in an emergency;
4. The shelf life of properly packaged KI is extremely
long;
5. The advantage of having a supply on hand for immediate
use far outweighs its moderate cost;
6. The problems attendant on predistribution are immaterial
for the matter of creating a stockpile;
7. No one questions the ability of KI to protect the
thyroid from radio iodine;
8. Even though KI administration before any exposure is
ideal, the Chernobyl experience also has shown us that the
exposure can continue for days; institution of KI blockade at
any time in this period is beneficial.''
As cancers go, thyroid cancer is one of the better ones to
have--the fatality rate is about five percent in children and
ten percent in adults. But no cancer is good, and the 1,200 or
so Americans who die of the disease each year are just as dead
as those who die of statistically more lethal types of cancer.
Moreover, even for those who survive the disease, it can have
major adverse effects on the quality of life.
You get to see a lot of fallout-caused disease in the
Marshall Islands, the Central Pacific island group that
includes Bikini and Eniwetok, where the United States tested 67
atomic and hydrogen devices in the 1940's and 1950's. I was an
administrative judge there in 1991 and 1992, serving as a
member of the Nuclear Claims Tribunal, which administers
compensation to Marshallese citizens harmed by the bomb tests.
By far the major health effect of the bombs exploded in the
Marshalls has been many hundreds of cases of thyroid disease.
This includes cancer, benign nodules, and hypothyroidism. The
last of these deserves special mention. Hypothyroidism--
underactivity of the thyroid--can cause irreversible
retardation in children.\2\ When that happens, the results are
tragic.
---------------------------------------------------------------------------
\2\ To combat retardation caused by diet-related hypothyroidism
(from iodine deficiency), the Kennedy Foundation, headed by Mrs. Eunice
Kennedy Shriver, has been doing extraordinarily valuable and effective
work in the Third World to promote iodization of salt. If there is a
more cost-effective health program anywhere--vast numbers of people
protected at minimal cost--I am unaware of it.
---------------------------------------------------------------------------
As for hypothyroidism in adults, a standard medical
textbook on the thyroid describes it as ``one of the most
insidious'' of all illnesses. Why? Because it can develop so
gradually and subtly that no one--not the sufferer, not the
family--realizes that there is a treatable medical problem.
In the Marshalls, for example, I was once presenting a
compensation award to a woman from Eniwetok, and as a courtesy,
asked her if there was anything she wanted to say. Yes, she
said, her life was miserable: she was always cold. ``Cold?'' I
asked, in some astonishment, for the Marshalls are near the
Equator, and the climate is torrid and steamy all year round.
``Yes,'' she said, ``even with my electric blanket on high I
shiver and shake all night long.''
It took only a few more questions to establish that she had
all the classic symptoms of hypothyroidism--thyroid
insufficiency. A Tribunal doctor tested her and prescribed
synthetic thyroid hormone, and before long she was living a
normal life. But for her, many years of her life had been
blighted unnecessarily. There are undoubtedly people very much
like her in this country too--people who are chronically cold,
weak, and fatigued, who might be living normal lives if they
and their families and their doctors knew what to look for.
If ever there is a major nuclear accident in this country,
there will probably be many more such people, with illnesses
that might have been prevented by a dime's worth of medication
sitting on the shelf of a hospital or fire station.
The Food and Drug Administration KI ``safe and effective''
for use in nuclear accidents some 20 years ago. The drug works
by saturating the thyroid with iodine in a harmless form,
thereby ``blocking'' it against the absorption of inhaled or
ingested radioactive iodine. It has a shelf life of at least
five years, and costs approximately ten cents for each person
protected. The NRC's technical staff estimated in 1994 that a
supply sufficient to protect the combined population around all
U.S. nuclear plants could be purchased for a total of a few
hundred thousand dollars--and indeed, that it would be cheaper
to buy stockpiles of the drug than go on studying whether to do
so.
That would seem to be the very definition of a ``no-
brainer.''
Nevertheless, official U.S. policy still holds that it is
more ``cost-effective'' to take a chance, and treat the cancers
if and when they occur, than to spend even that tiny amount on
prevention.
The pressing need for stockpiling KI first became apparent
during the Three Mile Island accident, in 1979. As this
Subcommittee's Chairman no doubt remembers well, the fate of
the plant hung in the balance for several nerve-wracking days.
While reactor operators and Nuclear Regulatory Commission (NRC)
officials fought to bring the plant under control, federal and
state officials, fearing a major release that would disperse
radioactive iodine from the reactor core into the atmosphere,
searched for supplies of KI and discovered that they did not
exist. A pharmaceutical company executive, responding to a
middle-of-the-night plea from the Food and Drug Administration,
started up the KI production line at 3 o'clock in the morning.
Supplies of the drug were in Pennsylvania 24 hours later.
Although the plant experienced a partial core meltdown, the
accident fortunately was brought under control without the KI
being needed--that time.
Afterwards, the President's Commission on the Accident at
Three Mile Island, headed by John Kemeny, was scathing in
condemning the Government's failure to keep supplies of the
drug available. Stockpiling, it said, was long overdue, and it
recommended prompt corrective action.
The NRC strongly endorsed that recommendation, and promised
to make KI a mandatory part of emergency planning for every
nuclear power plant. The Federal Emergency Management Agency
(FEMA) made plans to buy national stockpiles of the drug.
In the fall of 1982, however, FEMA and the NRC technical
staff, in the space of just a few weeks, reversed themselves--
180 degrees. FEMA dropped KI from its budget, and the NRC
technical staff hastily withdrew a pro-KI paper that it had
sent to the NRC Commissioners and replaced it with a paper
negative on KI. Why? The reasons were not given, but the
circumstances suggest strongly that politics, and pressure from
the nuclear industry, won out over health and safety.
In 1983, at a briefing for the Commissioners and the
public, senior NRC staff officials explained their new anti-KI
position. The nuclear accidents in which KI would be useful
were so rare, they said, and the consequences of a radiation-
caused thyroid ``nodule'' were so slight, that it would be
cheaper to treat such disease after it occurred than to prevent
it. One of the briefers was the Commission's Executive Director
for Operations--the head of the NRC's technical staff--who
offered the view that the staff's position was ``courageous.''
The NRC Chairman, Nunzio Palladino, was skeptical of the
briefers' presentation. He commented that if he survived an
accident because of twenty cents' worth of KI, he would think
it ``small change compared to the risk.'' One of the staff
members quickly corrected him, explaining that ``the surviving
question is not the question.'' Rather, he said, the issue was
one of ``averting an illness.'' The briefers made this illness
sound quite trivial, explaining: ``There's a few days' loss
from--it's a relatively simple operation that's involved in
removing the thyroid or removing the nodules.'' Another briefer
compared KI to an ``amulet,'' and to an insurance policy that
when read carefully, turns out to offer protection only against
death by stampeding elephant.
Given that some 40 percent of radiation-caused nodules are
cancerous, and that 5 to 10 percent of the cancers are fatal,
what the briefers were telling the NRC Chairman--their boss--
was poppycock. Only much later was it explained that in
referring to ``nodules,'' they meant benign nodules only.
This was as though you offered a public briefing on the
value of seat belts in car accidents without mentioning that
you were defining ``accidents'' as collisions occurring at
under 5 miles per hour. For compared to cancer, a benign
thyroid nodule is a fender-bender. And the briefers never
discussed cancer at all.
The NRC staff was successful in winning over the
Commissioners, and the ultimate result was a 1985 Federal
policy statement, still in place today, declaring it ``not
worthwhile'' to require KI stockpiling. Thus the recommendation
of the Kemeny Commission was quietly disposed of, at a time
when memories of Three Mile Island had faded--except, perhaps,
in Pennsylvania--and thoughts of nuclear accidents were far
from most people's minds.
It did not take long, however, for the Government's folly
and irresponsibility to be revealed. In April 1986, just 9
months after the policy statement was issued; the Chernobyl
accident sent a cloud of radioactive iodine and other fallout
across Europe. Inhaled and also ingested, through milk and
vegetables, the radioactive iodine lodged in the thyroids of
children and adults. In 1991, doctors in the vicinity of Minsk,
in Belarus, began to see a pattern of increasing numbers of
cases of childhood thyroid cancer.
The medical crisis in the former Soviet Union is far from
over. The number of childhood cancers continues to rise, and in
addition, the latency period for adult thyroid cancer is longer
than for children, so we can expect to see new thyroid cancers
appearing in the Chernobyl-affected areas even 30 or more years
from now.
Why did Chernobyl and the cancers resulting from it not
turn U.S. policy around? In an ideal world, they would have:
The Federal Government would immediately have acknowledged that
the President's Commission on Three Mile Island had been right
all along about KI, and would promptly have made stockpiling a
reality. But that didn't happen, perhaps because an admission
of error might have raised awkward questions about why the
recommendations of the President's Commission had been ignored
in the first place. So the Government hunkered down, saying and
doing nothing that would have raised public awareness of the KI
issue. It is hard to escape the conclusion that protecting
bureaucrats from embarrassment took priority over protecting
children from cancer.
In the years since Chernobyl, stockpiling of KI has become
routine in countries around the world. In April 1996, there was
an international conference in Vienna on the health effects of
the disaster. An American radiologist described the epidemic of
childhood thyroid cancer as a ``completely preventable
problem,'' and said that the use of KI ``ought to be No. 1 on
the list'' of the lessons of Chernobyl. He lamented that his
own country continued to lag behind in protecting its people.
The Government's silence ensures that most Americans are in
the dark. Just last year, on the 10th anniversary of Chernobyl,
a Congressional resolution called on the President to make sure
that the health lessons learned from Chernobyl were made
available to nations around the world. Congress clearly assumed
that the U.S. was in the lead in applying the lessons of
Chernobyl; I suspect that those who voted for the resolution
would be quite surprised to discover that we are actually at
the back of the pack. They might well ask why, if the Poles can
afford to keep 90 million doses of KI on the shelf, we can't
manage to do as well by our children.
Is this a disease so trivial that it is not worth
preventing? Ask some patients. They will tell you that thyroid
cancer can have major effects on the quality of life. First,
patients must take synthetic thyroid hormone daily for the rest
of their lives, which for many is a serious economic burden. In
preparation for diagnostic procedures and radiation treatments,
moreover, they must switch for several weeks to a different
thyroid hormone, with different physiological and psychological
effects. Then they must stop taking medication altogether,
which results in hypothyroidism. In this state, the patient--
like the Marshallese woman I described--is weak, chronically
fatigued, and abnormally sensitive to cold, often shivering
uncontrollably in temperatures that others in the same room
find comfortable. After treatment, the patient needs to be
reintroduced to medication, which for many is a difficult
process, because there is great variation from one person to
the next in the amount of hormone that the body needs.
The result of these various changes often is a physical and
emotional roller-coaster lasting weeks or months. Does anyone
remember when President George Bush could not speak in public
without dissolving in tears? It was just the ups-and-downs of a
thyroid patient, getting back on medication after a radiation
treatment.\3\ Some people never succeed in making the
adjustment. The widow of a member of this body, the late
Senator John East of North Carolina, was quoted as saying that
it was his doctors' inability to get his thyroid medication in
proper balance that drove him to take his own life.
---------------------------------------------------------------------------
\3\ President Bush, and Mrs. Bush as well, had Graves' disease, in
which the thyroid is overactive. It is an indication of how subtle and
hard to detect thyroid problems can be that the President's extreme
hyperthyroidism was not even noticed until it caused him to collapse
and be hospitalized.
---------------------------------------------------------------------------
Thyroid cancer, in sum, though it is usually curable--
emphasis on ``usually''--and though there are many much worse
illnesses, nevertheless can be extremely disagreeable. It is
also frightening to have any cancer. (If there are people who
do not find it frightening, they are braver than I am, or
dumber.) Is it worth preventing, if we can do so cheaply? Of
course it is.
Twice in recent years the Government has come close to
rectifying its long failure to ensure KI stockpiling. In 1994,
responding to a ``differing professional opinion'' that I had
filed 5 years earlier, the NRC staff at last acknowledged that
KI stockpiling was a ``prudent'' measure, and recommended a
change in Federal policy. The NRC staff estimated that a few
hundred thousand dollars would buy a stockpile of the drug
sufficient for the entire country.
Senators Joseph Lieberman and Alan Simpson--an Eastern
Democrat and a Western Republican--weighed in on the issue,
writing a letter to the NRC that made compelling arguments for
stockpiling KI. (A copy is attached to this statement.) The
Senators pointedly reminded the Commissioners of the
Government's ``moral responsibility to provide the public with
complete and accurate information regarding the risks from
federally licensed activities and ways in which those risks may
be reduced.''
But their bipartisan advice was not taken. The NRC
Commissioners divided 2 to 2, and under NRC rules, a tie vote
on a staff proposal means the proposition fails. The old policy
stayed in place, and the public remained no wiser than before.
This year the issue was back before the NRC. On June 30,
the Commissioners voted 3-2 in favor of a proposal under which
the Federal Government would fund the cost of KI pills for any
state requesting them. The two dissenters, who thought the
majority had not gone far enough, were the Commission's newest
members, Nils J. Diaz, a Republican, and Edward McGaffigan,
Jr., a Democrat. They voted to make KI stockpiling a mandatory
part of NRC emergency planning regulations.
The Commission majority's approach sounds better than it
is. Most states, having been assured by the Federal Government
for 15 years that KI is undesirable, do not realize that it
could be useful. So far, the NRC has not yet been willing to
say out loud that stockpiling KI is a prudent and sensible
measure, and to recommend in so many words that states avail
themselves of the free KI. Will states and the public
understand what the stakes are, when the July 1 NRC press
release announcing the majority's decision did not even mention
the word ``cancer?'' This was comparable to announcing the
availability of ``Sabin vaccine'' without mentioning that its
purpose is to prevent polio.
Moreover, the majority's approach relies on the fact that
the Government plans to establish caches of medicines and
supplies in 27 cities as a defense against terrorism. KI will
be among those medicines. But with no indication as to the
amounts of stockpiled KI, or their locations, it is not
realistic to expect that these stockpiles will be useful for
nuclear power plant accidents, when there has been no planning
at the state and local level to use the drug.\4\
---------------------------------------------------------------------------
\4\ In fairness to the Commission, I should note that it
specifically reserved judgment on whether to grant a petition for
rulemaking, filed by me, that would have amended NRC's emergency
planning rules to require facility emergency plans to make provision
for evacuation, sheltering, and KI. Thus the Commission has not yet
completed action on the KI issue, and it should not be assumed that it
is close-minded on the subject.
---------------------------------------------------------------------------
In Canada, nuclear utilities support stockpiling of KI in
part because they consider it good public relations to show
that they leave no stone unturned in protecting the public. The
U.S. nuclear industry, on the other hand, has fought
stockpiling adamantly, in part because--as it openly admits--it
thinks that KI will make the public more apprehensive about
nuclear power.
The vacuum of leadership from the Federal Government on the
KI issue has led some states to explore the question for
themselves. Last winter, the Maine Advisory Commission on
Radiation voted unanimously to recommend stockpiling of KI in
evacuation centers near the state's only nuclear plant, and the
Governor accepted that recommendation. Maine joins Tennessee
and Alabama, which have long maintained supplies of the drug.
New York and now Ohio have begun looking into the issue.
All too many states, however, remain steadfast in their
opposition to KI--an opposition often grounded in ignorance of
basic facts. For example, in 1996, at a meeting at the Federal
Emergency Management Agency on the subject, a representative of
the Illinois Department of Nuclear Safety justified his
opposition to KI by declaring, ``Loss of the thyroid is not
life-threatening.'' \5\
---------------------------------------------------------------------------
\5\ Curiously, the identical language appeared in the statement
submitted separately by a representative of the state of South
Carolina.
---------------------------------------------------------------------------
The quoted statement is true only in the same limited sense
in which it is true that loss of a breast is not life-
threatening. For the cancer that causes you to lose your
thyroid, or your breast, can kill you. If the officials of
Illinois and South Carolina still do not know that, it is a
reflection of how badly the federal agencies have failed in
their duty of giving states accurate and complete information.
Can taking KI during an accident prevent all the health
effects I have described? Yes, if you can get it to people in
time. But can you get it to people in time? That may depend on
the circumstances of the event. There is no guarantee you will
get it to everyone. But if there are no KI stockpiles, then it
is guaranteed that you won't get it to anyone.
The question that readers may be asking by now is this: If
the case for KI is as compelling as I have suggested, what are
the arguments against it? The arguments one hears against KI
fall into two classes. First, there are those that are just
plain invalid--factually incorrect. The second are the
objections that although they may be factually correct--for
example, that evacuation is generally the best option--are
still not a good reason to be without KI stockpiles.
I will start with the invalid arguments, which number six.
1. There is no new data challenging existing policy.--In
fact, there is a wealth of new data since Chernobyl, such as
the presentations at the April 1996 conference mentioned
earlier, suggesting that airborne radiolodines are more
dangerous to children's thyroids than previously suspected. But
even if there were no new data, the existing policy was
defective from the start, because it was based on
misinformation.
2. Loss of the thyroid is not life-threatening.--A March
1996 publication of the nuclear industry's own lobbying group,
the Nuclear Energy Institute, reported 550 cases of childhood
thyroid cancer in the former Soviet Union, with five
fatalities. (The numbers are higher now.) If it's life-
threatening in Minsk, it's life-threatening in Mason City and
Middletown. In any case, who says a disease has to be life-
threatening to be worth preventing? That's not the standard we
use when we have our kids immunized against mumps, measles, and
chicken pox.
3. KI is not cost-effective.--KI is an insurance policy--
backup protection in case of certain events that are unlikely
but have serious consequences when they do occur. Is it ``cost-
effective?'' The problem with framing the issue that way is
that if by ``cost-effective'' you mean ``likely to pay for
itself over time,'' no insurance policy meets that test. The
insurance companies would all be bankrupt if they didn't take
in more from the average buyer than they pay out. Rational
people, when deciding whether insurance is worthwhile, don't
ask whether it is sure to pay for itself, but whether it
provides valuable protection at a reasonable cost. Stockpiling
of KI meets that test.
4. KI could complicate evacuation.--You sometimes hear the
argument that KI will diminish safety in an emergency, because
people will ignore evacuation orders and go looking for KI
instead. That's very farfetched. In fact, if you wanted to
encourage evacuation, you might want to tell people over radio
and television that when they get to the evacuation center,
they will be checked out medically and given a medicine,
potassium iodide, that will help protect them against
radiation. And you add that this drug will not be available
locally. So KI should not be a hindrance to an orderly
evacuation; it might even be an incentive.
5. KI carries a risk of serious side effects.--The best
data on side effects comes from the Polish experience after
Chernobyl, which is documented in a medical journal article co-
written by a Polish health official and an NIH scientist. The
Poles gave out 18 million doses. Two people were hospitalized,
briefly. Both of them had known iodine allergies and took the
drug in spite of being warned not to. Our own FDA says the
benefit outweighs the side effects. The doctors of the American
Thyroid Association were well aware of the side effects issue
when they unanimously endorsed stockpiling in November 1996.
6. KI could increase state's risk of liability.--
Distribution of KI would take place only after an advisory from
the federal government that it was appropriate. In that
situation, with a state following federal directives and doing
the best it could under emergency conditions, who would find a
state liable? If I were a state, I would be much more worried
about the consequences of not having a KI stockpile, given all
that is known about the drug's value. If ever there were an
accident, and it turned out a state had no KI to give out
because it had taken its medical advice from lobbyists instead
of doctors, that would be the time to worry about liability.
The following are six arguments I consider factually
accurate, but still not persuasive reasons to forgo
stockpiling.
7. Evacuation is preferable.--The most common argument
against KI is also the most meritless: that evacuation is
better, so we don't need KI and shouldn't even have it around
as a precaution. The problem is that evacuation isn't always
feasible. The NRC and FEMA have never claimed it was. KI is
backup protection--Plan B--for those situations where
evacuation cannot be completed in time to avoid a substantial
radiation dose to the thyroid--for example, because of adverse
weather conditions, blocked roads, or widely dispersed
radioactivity. Also, people may be exposed to radiation while
they are evacuating--automobiles don't afford much protection.
Moreover, it is not an either/or proposition. You don't
choose between backing evacuation and backing stockpiling of
KI; you do both. The question is whether you have three weapons
in your arsenal--evacuation, sheltering, and KI--or only two,
in a situation when the third weapon costs only a pittance.
The lifejackets on a ferryboat are a pretty close parallel
to KI. Are ferryboat disasters common? No. Is the lifejacket
the best way of escaping harm if a ferry sinks? No, you're
better off being evacuated by lifeboat or helicopter--if that
is possible. But does that mean we should dispense with
lifejackets? Of course not. We have lifejackets because in the
rare instance in which you need them, you are in grave danger
without them. So we have lifeboats and lifejackets, because
it's the sensible and prudent thing to do.
8. Big accidents are unlikely.--It is true that big
accidents are unlikely. Generally speaking, a combination of
good design, good operation, and good regulation makes American
nuclear reactors quite safe. But there is a big difference
between saying that accidents are unlikely and saying that they
cannot happen. If we could be sure that accidents would not
happen, then all emergency planning--sirens, drills, and the
like--could go out the window. The cost of KI is a drop in the
bucket by comparison to what is already spent on emergency
preparedness. The reason we have sirens and drills and the rest
is that we know that accidents can happen. (So can acts of
terrorism.) If we accept the idea that emergency preparedness
makes sense, then our preparedness ought to be first-rate, not
second-rate.
9. Public confidence in the technology could be affected.--
That is a quotation from an industry ``White Paper'' on KI that
was sent to the Nuclear Regulatory Commission in 1993. The same
argument could be made to assert that we shouldn't have
containments or emergency core cooling systems at nuclear
plants, since both of those structures might remind people that
accidents can happen.
You don't hear the ferryboat operators complaining that
having lifejackets on board will diminish confidence in
ferryboat technology. If I were the industry, I would be
embracing KI, and making the point that even though it is very
unlikely that it would ever be needed, the industry is
committed to ensuring that Americans are protected to the
highest standard in the world.
10. The logistics of distribution need more study.--The
opponents of KI stockpiling sometimes try to change the subject
from whether KI is a valuable protective measure (an argument
they know they will lose) to the logistics of delivering the
drug in an emergency. The idea is to make the delivery of KI
sound just impossibly complicated, so as to put off, preferably
forever, the question of whether it makes sense to have the
drug at all. Those arguments were made at the June 1996 meeting
at FEMA, and answered by Dr. Jacob Robbins of the National
Institutes of Health, whom I quoted earlier. He observed that
there were two issues: whether to stockpile KI, and how to
deliver it to people in an emergency. He said:
``You're sort of asking the question: Which should come
first? If you remember back to the Three Mile Island incident,
there was no stockpile. It was requested. With a great deal of
difficulty, in a rather inadequate way, it was finally made
available. And it was ready to be used but with a delay. I
think we have to think of both aspects. And what the American
Thyroid Association has said is create the stockpiles, have
them available, and then have expert groups developing the
mechanisms of how to distribute this in time of need.''
It's hard to quarrel with that advice: make the decision in
principle that having KI makes sense, establish stockpiles, and
then work out the logistics of how you want to distribute it.
While you are thinking about logistics, the drug can be onsite
in schools, or hospitals, or fire stations, or all three.
11. The states don't want it.--This is an argument you hear
again and again at the federal level. The Federal Government
has been giving the states inaccurate and incomplete
information about KI for 15 years, and it is small wonder that
many of them believe that KI is undesirable. Once states begin
to get full and up-to-date information about KI, their attitude
toward stockpiling is likely to change, as Maine's did.
12. People can buy it for themselves.--The argument can be
made that people are free to buy the drug for themselves, and
that the states and the Federal Government should not be
involved. First, the drug is unlikely to be available locally.
Second, people will know to buy the drug only if the
authorities accept the obligation of informing them. It would
probably be cheaper to buy a stockpile than to take on the task
of telling people that they should consider buying it. Third,
in an emergency, some people--such as schoolchildren--will not
be at home. Fourth, do you really want to say that for the
people who didn't have the foresight or money to buy the drug,
it's their tough luck?
To leave it up to individuals would be like telling
ferryboat passengers that they are free to bring their own
lifejackets. It's simpler, fairer, and better health policy to
stockpile KI and bring it out for the entire affected
population in time of need.
In conclusion, Americans have a right, where nuclear
hazards are involved, to expect their Government to ensure that
they are protected adequately and that they are given accurate
and complete information. In the case of potassium iodide, the
Government has so far done neither. It is high time that the
Federal Government lived up to its responsibilities, so that we
can at last say that American children enjoy radiation
protection second to none.
Thank you.
Attachment:
------
Letter from Senators Joseph I. Lieberman and Alan K. Simpson
U.S. Senate,
Committee on Environment and Public Works,
Washington, DC, April 20, 1994.
Hon. Ivan Selin,
Chairman, U.S. Nuclear Regulatory Commission,
Washington, DC.
Dear Chairman Selin: We are writing to urge the Nuclear Regulatory
Commission (NRC) to revise its current policy regarding the
availability and use of potassium iodide (KI) in the event of an
emergency at a nuclear power plant.
The NRC's current policy is that state and local governments should
consider stockpiling KI for emergency use by emergency workers and
institutionalized persons, but not for the general public. This policy
was established in the early 1980's. Since that time, however, new
information has arisen and additional experience has been gained on the
costs and benefits of the prophylactic use of KI by the general
population. We believe that this new information and experience
requires a new approach to this issue.
It is well established scientifically that KI is extremely
effective in preventing the uptake of radioactive iodine by the
thyroid. If taken in the proper dose prior to exposure to radioactive
iodine KI can completely block the uptake of the radioactive iodine.
The distribution of KI to the general population in the event of
nuclear emergency is a widely accepted protective measure. The World
Health Organization has recommended its use for people living near a
nuclear power plant if radiation levels are expected to exceed a
predetermined dose. A number of foreign governments-- including the
United Kingdom, the Czech Republic, Switzerland, Canadian provinces
with nuclear power plants, and the former Soviet Union--stockpile KI
for distribution to and use by the general public in the event of a
nuclear emergency. In the United States, three States--Alabama,
Tennessee, and Arizona--have plans to distribute or already have
distributed KI to people living near one or more nuclear power plants
within those States.
A recent cost-benefit study of this issue conducted for NRC
indicates that the costs of stockpiling KI for people who live within
five miles of a nuclear power plant are minimal--approximately 10 cents
per person per year. This means that for a typical population of 10,000
people living within five miles of a nuclear power plant, it would cost
approximately $1,000 to make KI available for distribution. The NRC
staff projects that the cost of stockpiling KI for everyone in the
country within five miles of a nuclear power plant would be on the
order of several hundred thousand dollars per year. This is only a
small fraction of the expenses already spent on emergency planning. As
the NRC staff has noted, ``[c]osts in this range present no significant
barrier to stockpiling and are probably less than the cost of the
continued studies.''
Some concern has been expressed that public education on the use of
KI may result in a potentially significant negative public perception.
However, no evidence has been provided that any of the existing
policies in other nations or in the States that provide for the use of
KI by the general population has caused any undue panic or apprehension
to the general public. Moreover, the Federal Government has a moral
responsibility to provide the public with complete and accurate
information regarding the risks from federally-licensed activities and
ways in which those risks may be reduced.
In sum, therefore, KI can be an extremely effective countermeasure
to prevent damage to the thyroid in the event of a radiological
emergency. It can also be made available for the general population
living near a nuclear power plant for minimal costs. The NRC should
revise its policy to provide this additional potential protective
measure for nuclear emergency planning.
We thank you for your time and consideration.
Sincerely,
Alan K. Simpson,
Ranking minority member,
Subcommittee on Clean
Air and Nuclear
Regulation.
Joseph I. Lieberman,
Chairman, Subcommittee on
Clean Air and Nuclear
Regulation.
CONCLUSION OF HEARING
Senator Harkin. Anything else before we close the meeting
down? Dr. Klausner, any final last observations or requests,
advice, to this committee?
[No response.]
Senator Harkin. If not, we thank you all very much for your
time and for your information, that concludes our hearing. The
subcommittee will stand in recess subject to the call of the
Chair.
[Whereupon, at 10:40 a.m., Wednesday, October 1, the
hearing was concluded, and the subcommittee was recessed, to
reconvene subject to the call of the Chair.]
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