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                    <text>Item ID Number

°1498

Author

Gough, Michael

Corporate Author
Report/Article TltlO Typescript: Chapter 9: The Political Assessment: A
Congressional View

Journal/Book Title
000

Year

°

Month/Day
Color

n

Number of Images

10

DOSCrlptOH Notes

Tnis

Tuesday, May 15, 2001

manuscript is a draft version of a chapter or section
from the following book: Agent Orange and its
Associated Dioxin: Assessment of a Controversy.
Young, A. L. and G. M. Reggiani, eds. New York:
Elsevier, 1988. This book is available in the NAL
collection, call no.: RA1242 T44 A3.

Page 1498 of 1514

�CHAPTER 9
"THE IMPORTANCE OF AGENT ORANGE AND DIOXIN WAS
ACKNOWLEDGED WHEN THE HIGHEST LEVELS OF GOVERNMENT BECAME
INVOLVED,"
THE POLITICAL ASSESSMENT:

A CONGRESSIONAL VIEW

MICHAEL GOUGII

In December, 1979, Congress passed and President Carter
signed Public Law 96-151, which instructed the Veterans Administration to carry out a study of possible long-term health
effects resulting from exposure to dioxin-containing herbicides
in Vietnam.
This was not the first time that Congress had considered
Agent Orange. Almost a decade earlier, in 1970, Senator
Philip Hart; of Michigan held hearings about the possibility
that spraying with Agent Orange was causing birth defects in
Vietnam and that the use of the same herbicides could be harmful for the population of the United States. In response to
those hearings, the Department of Health reduced the use of
2,4,5-T in the United States and the Department of Defense
stopped Agent Orange spray missions in Vietnam.
The law that was passed in 1979 mandating the Agent Orange
study resulted from veterans testifying before Congress that
Agent Orange had caused cancer, birth defects, and other health
effects. It directed the Veterans Administration to study
ground troops who had served in Vietnam to see if any long-term
health effects in veterans or their families could be related
to the use of Agent Orange. To prod the Veterans Administration
along, Congress said that the protocol for the study had to be
designed within 180 days or the Congress had to be told the
reason why.

9: 1

�The OTA (Office of Technology Assessment), which is a
technical support office of. Congress, was directed by law to
review and approve the plans for the Veterans Administration
study and to monitor the conduct of the resulting study. The
bulk of my presentation is about OTA's role, but before going
into that, I will discuss other major events in the Agent Orange
issue.
Some results are now available from the Ranch Hand
study, the mortality and morbidity study of the Air Force
personnel who flew the spray missions in Vietnam, which was
well underway in 1979. The Air Force had responded early to
Congressional inquiries and realized that they had an occupational
health problem. They moved ahead on their own without the
intense prodding Congress put on the Veterans Administration
for the ground troop study. George Lathrop has dismissed
those studies.
Also in December, 1979, President Carter established the
Agent Orange Working Group (AOWG), composed of Executive
Branch agencies with programs that touched on possible effects
on health of dioxin, Agent Orange, and herbicides. In February,
1980, the Office of Technology Assessment was invited to sit
with the Agent Orange Working Group as an observer, and it
became an active participant in this group. In August, 1981,
President Reagan placed the Agent Orange Working Group into
the Cabinet Council on Human Resources, elevating and enlarging the scope of the work group.
The Agent Orange Working Group has had profound effects
on Executive Branch efforts to try to better understand dioxin
and Agent Orange. Among the several studies coordinated by
the Agent Orange Working Group (ten major epidemiological
studies scheduled for completion by 1990 and five ongoing
health surveillance projects), one is complete. It is the
9: 2

�Birth Defects Study carried out by the Center for Disease
Control. This study has two conclusions: the tfirst conclusion was that there is no association between service in
Vietnam and birth defects. The second conclusion was th,a,t
there may be an association between opportunities for exposure,
to Agent Orange and a handful of birth defects, As soon a,s the
results of that study were released, at least one bill was
written in the Senate which was to provide compensation to all
veterans who had fathered children with spina bifida, a. colleC"
tion of tumors,and cleft lip with or without cleft palate,
That legislation never left the Senator's office. The
people who had clone the study at the Center for Disease Control, i.e., Dave Hricson and his colleagues, came to Congress.
They talked to congressional staff in great detail about the
structure of the study, its strengths and limits, and how to
draw conclusions from its results. They also went to the
American Legion, the Disabled American Veterans, the Vietnam
Veterans of American, and other veterans organizations, where
they explained the study and convinced those veterans that the
connections that had been shown, although theoretically valid,
woulcl not make a great deal of sense biologically. This was
a great achievement for solid scientific exposition and
convincing people not to be afraid and consequently do something foolish.
Some scientists still argue about the meaning of those
possible connections between exposure to Agent Orange and
birth defects. The Birth Defects Study, like many of the other
Agent Orange studies, was clone for political reasons. Politically, it has been examined and tried. The Congress looked at
the conclusions and decided no harm had been associated with
Agent Orange. So the CDC Birth Defects Study, from the point
of view of politics, is over. The Congress will not reopen it.
9: 3

�It is Interesting to note in this context that in the
Agent Orange lawsuit which was settled in the District Court
of New York in May, 1985, Judge Weinstein also considered the
CDC Birth Defects Study. He reached the same conclusion as
Congress, deciding that the study results were not sufficient
to sustain any association between Agent Orange and birth
defects. Thus, in the judicial system also, the CDC Birth
Defects Study has been weighed and found not to be convincing
in demonstrating any association between Agent Orange exposure
and b i. r th de f e c t s .
These are events which are very important. It should be
kept in mind that here we are not dealing with a purely scientific issue but with very sensitive and complicated political
and social issues. The scientific conclusions, therefore,
\vhile they are very important to us to understand whether or
not: d.i.oxin and Agent Orange cause disease, still are less
important to society than the decisions that are made in the
courtrooms and in the Congressional Hearing Rooms.
To come back to OTA, Congress wrote OTA into the Agent
Orange study because of disagreement between the Senate and
House Committees on Veterans' Affairs. Sensitive to veterans'
complaints that the Veterans Administration was indifferent
to their claims of harm from Agent Orange, the Senate wanted
the study to be carried out by some other agency. The House
Committee, on the other hand, had more faith in the Veterans
Administration and acted to preserve Veterans Administration's
responsibilities for research on veterans' health. The two
committees compromised, giving responsibility for the study
to the Veterans Administration and mandating that the Office
of Technology Assessment make periodic reports to the
committee, keeping Congress informed about progress or lack
o f i t.

9: 4

�This was an entirely new role for the Office of Technology
Assessment, and its constitutionality has been questioned. The
question arose a month after Congress directed the Veterans
Administration to do the Agent Orange study. At that time,
Congress passed another law directing the National Institute
for Occupational Safety and Health to do a study on dioxinexposed workers, and, again, Congress required that the Office
of Technology Assessment review and approve the protocol and
monitor the conduct of the study.
President Carter vetoed that law on the basis that
giving a congressional branch agency--the Office of Technology
Assessment—veto authority over the execution of an Executive
Branch study was a violation of separation of powers doctrine,
Executive Branch lawyers concluded after examining the case
that the bill was unconstitutional. Legislative Branch lawyers,
however, concluded that it was constitutional. Neither branch
has taken the case to court, and the issue is unresolved.
The veto of the NIOSH bill was successful.
President Carter's veto message also instructed the
Administrator of the Veterans Administration to ignore the
provisions of Public Law 96-151 which directed the Veterans
Administration to submit the study plan to the Office of
Technology Assessment for review. However, Senator Alan
Cranston, at that time Chairman of the Senate Committee on
Veterans' Affairs, wrote the Administrator that ignoring the
provision would not be a wise course. He pointed out that
Congress must provide funds for the Veterans Administration
study and that funding depended, on the Office of Technology
Assessment reviewing and approving the study plan. The Office
of Technology Assessment was part of the process, and it has
played an active role in Agent Orange issues ever since.

9: 5

�OTA assembled an Advisory Board to participate in its
Agent Orange activities. The panel includes academics--epidemiologists and statisticians, a toxicologist, a neurologist,
and a gynecologist. Then there are members who represent
stakeholders. There are three representatives from chemical
companies that made the Agent Orange components: Monsanto,
Dow Chemical, and American Cyanamid. They are neatly balanced
by representatives of the American Legion, the Disabled
American Veterans, and the Vietnam Veterans of America.
Despite the congressional requirement that a protocol
be written in 180 days, the Veterans Administration did not
produce one within that time. The Veterans Administration
was sued by veterans' groups because of some of its procedures.
There was a hearing before the General Accounting Office about
the methods used by the Veterans Administration to contract
for the protocol design. All of these events contributed to
the protocol's being late.
When the Office of Technology Assessment received the
first draft of the protocol, we rejected it as inadequate.
The basic plan of the protocol was to compare morbidity and
mortality rates between two groups of veterans, one which had
been exposed to Agent Orange and one which had not been.
In response to OTA's and others' criticisms, the protocol
was revised. The revision process just dragged along. It
was not until September, 1982, two and a half years after
Congress passed the law, that OTA approved the protocol.
By that time the Agent Orange Working Group Science Panel
had become convinced that it was really impossible to separate
exposed from not- exposed veterans, and they were urging that a
study be done to compare the health of veterans who had gone
to Vietnam with the health of veterans who have not gone to
to Vietnam, A study of that type would at least provide a

9: 6

�clue as to whether or not Vietnam veterans in general were
suffering from ill effects as a result of that experience.
The recommendation placed pressure on the Veterans Administration to do a "Vietnam Experience Study" even though the
Administration was planning an Agent Orange study.
Rather than making a decision between the two studies on
its own, the Veterans Administration asked for another review
of their protocol from the National Academy of Sciences. In
September, 1982, all the delay came to a head because Congress
had exhausted its patience. One hundred and: one representatives from the House of Representatives wrote a letter to the
Veterans Administration requesting that the study be transferred from the Veterans Administration to some other agency.
Dr. Vernon Monk of the Centers for Disease Control, in testifying before the House Veterans' Affairs Committee, said that
the Centers for Disease Control was well placed to do the
study. The Senate Veterans' Affairs Committee reaffirmed its
previously held conviction that the responsibility for the
study should be transferred somewhere else. The result was
that the execution of the study was taken from the Veterans
Administration and given to the Centers for Disease Control.
The Centers for Disease Control finally resolved the controversy about whether to do an Agent Orange Study or a Vietnam
Experience Study: they are doing both.
The CDC studies are the largest, probably the most compjLicated, and the most expensive epidemiology studies ever
conceived. They will cost at least $70 million, involve
interviews of 30,000 veterans, and 10,000 physical examinations to be carried out at the Lovelace Clinic.
The Vietnam Experience Study is relatively straightforward. Looking at the records easily establishes whether
or not a veteran went to Vietnam. The two cohorts can thus
9: 7

�be easily assembled, with the men who went to Vietnam on one
side and those who did not on the other; then their health
can be examined. The Vietnam Experience Study is underway and
on schedule. The same cannot be said about the Agent Orange
Study,because it is much harder to say whether or not a
veteran was exposed to Agent Orange. In January, 1985, the
Centers for Disease Control sent the Office of Technology
Assessment a summary of their efforts to resolve the exposure
problem. At that time the Centers for Disease Control were
able to identify the locations of battalions on the ground
in Vietnam,
A battalion is about 1,000 men, four maneuver companies
and a headquarters company. The battalion that the Centers
for Disease Control provided as an example was spread out along
a line of 40 kilometers. It was not possible to know where
the 1,000 men actually were. Were 990 at the middle of the
line or were they at one end? Were they spread out evenly
along the entire line? No one knows. One way to decide that
a battalion was exposed is to declare that any Agent Orange
spray mission within a fixed distance caused exposure. In
practice, AOWG and CDC have accepted that a spray mission at
a distance of two kilometers'might result in exposure.
Now consider an airplane spraying Agent Orange somewhere
within two kilometers of the battalion spread out on the 40
kilometer line. It is very hard to say who of the battalion
was exposed and who was not. Even assuming that exposure
could be ascertained, it is impossible to know how much
exposure took place.
OTA was very critical of the plans to decide a battalion
was exposed on the basis of such data. This criticism was expressed in periodic reports sent to the congressional committees.

9: 8

�Right: now, I think a majority o£ the OTA Advisory Board
feels that the study on Agent Orange should not go on because
of difficulties in deciding who was exposed and who was not.
The panel has not voted on this issue, and I could be wrong,
in my assessment, but I don't think so, If, after seeing
more details about exposure, OTA decides the study is impossible,
Congress could decide not to do the study. That would involve
an act of courage on the part of the Congress because it has
made a commitment that this study would be done. The Veterans'
Affairs Committees of the Senate and of the House may face the
dilemma, having promised the veterans to do the study, that
they have changed their mind. I used to think that, no matter
what the technical problems, the study would be done. I am
no longer so certain.
Congress has considered, over and over again, providing
compensation to veterans who claim ill effects from Agent
Orange exposure. At one time there was a list of over 20
diseases being considered as compensable. Congress finally
passed a law which provides compensation for chloracne and
porphyria cutanea tarda (PCT), if they occurred within one
year after .leaving Vietnam, Although there are very few
cases of either disease, the law was not a hollow gesture
on the part of the Congress. They wanted to do something
to compensate veterans who had been harmed, but, at the same
time, they wanted to limit compensation to diseases that
might be connected with Agent Orange,
Subsequently, Congress directed the Veterans Administration
to set up a special committee to review claims about diseases
resulting from Agent Orange exposure. That committee will
function only until the studies of the Centers for Disease
Control arc complete, because at that moment we expect to
have the answer to our questions.

9: 9

�Summing up, we can say that Congress is working out the
Agent Orange controversy. In 1979, Congress refused to make
a decision about whether or not Agent Orange had caused health,
effects. Instead, Congress directed the Executive Branch
to gather information for making a decision. By now, some
results have come in. The Air Force's studies on Ranch Hand
personnel provide no convincing evidence that Agent Orange
has affected human health. The Birth Defects Study, performed
by the Centers for Disease Control, also failed to provide
convincing evidence of a connection between Agent Orange and
human effects. Congress has directed the Veterans Administration to compensate two conditions which have been related to
dioxin exposure should they appear in Vietnam veterans. The
judge in the Agent Orange class action stated that the veterans
had failed, to prove their case in court that Agent Orange was
the cause of their illnesses. These points are convincing
many people that, regardless of all the fears about Agent
Orange and the toxicity which might reside in the dioxin
molecule, exposure to Agent Orange, if it occurred, has not
harmed the veterans.
However, that is not yet the end of the Agent Orange
controversy. Intellectually and emotionally the veterans
might accept that they have not been able to prove that their
diseases were caused by Agent Orange, but they can always
contend that no one could prove the contrary.
Probably, Agent Orange will pass away as a political
issue. Some veterans will continue to contend they were
harmed, but the decisions already made in Congress and in
the courtroom will convince many people that no detectable
harm was done. As more study results come in, if the results
continue to show no health effects, they will reinforce the
conclusions already made.

9: 10

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osoee

Author

D

NDtScam|BI,

Gough, Michael

Corporate Author
ROpOrt/ArtlClO TltlO Typescript: The CDC Epidemiologic Study of Vietnam
Veterans Will Cost Much, Buy Little, and Canceling it
Does not Leave Us Without Information, June 11, 1984

Journal/Book Title
Year

000

°

Month/Day
Color

D

Includes cover letter from Gough to Alvin L. Young, June 11,
1984.

Friday, February 22, 2002

Page 5066 of 5115

�June 11. 1984

Dear M ,
This is the paper that I mentioned to you. As we discussed on the
phone, I am a l i t t l e uncom-fortabl e attempting to scuttle the CDC study
so long as OTA is mandated a role in it, but I don't think that we w i l l
gain enough -from the study to justify doing it. I also have some pride
of authorship about the paper. H you or anyone else -finds it
convincing or use-ful , I'd l i k e someday to get credit for it, but that's
not uppermost on my mind,
Please -feel free to duplicate the paper as you want. If you have any
suggestions for additions or corrections to it, please call me
Sincerely,

michael gough

6404 e. halbert rd., bethesda, rnd.

20817

�The CDC Epiderniologic Study of Vietnam Veterans
W i l l Cost Much, Buy L i t t l e ,
and Cancelling It Does Not Leave Us Without In-formation
In December 1979, Congress passed Public Law 96-151 d i r e c t i n g the
Veterans Administration (VA) to study possible long-term health effects in
Vietnam veterans exposed to dioxin-containing herbicides. Now, four and a
half years later, the responsibility for the study has been transferred to
the Centers for Disease Control (CDC), and work has begun on a study that
is expected to produce its first results in about three years and to cost
$70,000,000 and perhaps much more. The CDC study is to examine three
possibilities!

(1) that exposure to d i o x i n present in Agent Orange is

associated w i t h adverse health effects among Vietnam veterans, &lt;2&gt; that
service in Vietnam is associated with adverse health effects, and (3) that
an elevated risk of developing certain cancers is associated w i t h service
in Vietnam and/or exposure to Agent Orange.
The first p o s s i b i l i t y w i l l be examined by comparing the health status
of three cohorts (groups): combat soldiers l i k e l y to have been exposed to
Agent Orange, combat soldiers not l i k e l y to have been exposed, and soldiers
of any sort who were not l i k e l y to have been exposed.

The second

p o s s i b i l i t y w i l l be examined by comparing the health of a cohort of Vietnam
veterans w i t h the health of veterans of service in other areas. Each
cohort w i l l consist of 6,000 men; all cohort members w i l l answer a detailed
questionnaire,

and 2,000 of each cohort w i l l undergo a detailed medical

and phychological examination.

By any measure, the CDC study w i l l be among

the largest cohort studies ever undertaken. The third p o s s i b i l i t y w i l l be
examined by a case-control study.

"Cases," men who have the types of

tumors being studied, w i l l be i d e n t i f i e d from cancer registries. The

P. 1
6/11/84

�frequency of Vietnam service among that group w i l l be compared to the
frequency among a group of "controls," men who l i v e in the same
geographical areas but who do not have the cancers.

M i l i t a r y records w i l l

be used to estimate veterans' exposure to Agent Orange.
Comparison of the levels of d i o x i n exposure in Vietnam to levels of
exposure in other situations convinces many (certainly most, and perhaps
almost a l l ) experts f a m i l i a r w i t h dioxin's effects that the CDC study w i l l
find no health detriment associated with Agent Orange.

Some veterans,

however, claim that the wartime nature of their exposures in Vietnam
accentuated the effects of d i o x i n , and that p o s s i b i l i t y is the strongest
argument for doing the CDC study.

Nevertheless, veterans have not

developed chloracne, a disease associated with r e l a t i v e l y h i g h d i o x i n
exposure. There were no cases of chloracne among Ranch Handers, the
veterans who were exposed to the highest levels of d i o x i n , and only one
possible case among the veterans who have enrolled in the VA's Agent Orange
registry. Therefore, the conditions in Vietnam were not sufficient to
cause the one v i s i b l e manifestation of d i o x i n exposure.
Veterans correctly point out that there is a p o s s i b i l i t y that
exposures to d i o x i n at levels too low to cause chloracne might cause cancer
or other effects.

There is no denying that argument on s c i e n t i f i c grounds;

it could be. However, there is now no convincing evidence for health
effects other than chloracne and some l i v e r and biochemical abnormalities
that have been seen in exposed chemical workers. Those symptoms did not
appear in chemical workers who were employed in non-contaminated areas of
plants.

It is reasonable to think that those workers were exposed to

levels of d i o x i n too low to cause chloracne, but s t i l l much greater than

P. 2
6/11/84

�levels most people are exposed to. Neither populations o-f workers who
developed chloracne nor others probably exposed to lesser levels o-f d i o x i n
have suffered -from unusually high rates o-f cancer or reproductive health
effects.

These observations argue against manifestation of any health

effects other than chloracne and the symptoms seen in chemical workers and
against manifestation of any other diseases in the absence of chloracne.
(The last statement is not make in ignorance of the higher than expected
rate of stomach cancer in one exposed occupational population or the
reported excess of soft tissue sarcomas in another exposed population.
However, those specific suggestions of associations are better investigated
in a case-control

study such as described below.)

The possible results of the Vietnam service study are more uncertain;
there may be significant effects on health. Nevertheless, the power of the
study to detect excess health deteriments is s u f f i c i e n t l y l i m i t e d that it
w i l l provide l i t t l e information for making decisions about compensating
i n d i v i d u a l veterans who claim adverse health effects.
The cohort studies have a good chance of detecting any 2-fold
increases in diseases that occur w i t h a normal frequency of 0.5 to 2.0
percent.

In males of the age of Vietnam veterans, the only diseases that

occur that frequently are common a l l e r g i e s and m i l d respiratory infections.
The likelihood of detecting rarer diseases is smaller.
Unfortunately, the absence of f i n d i n g any effects cannot be presented
as a f i n d i n g that there is no effect.

Instead, the study w i l l only be able

to say that Agent Orange-exposed veterans or Vietnam veterans are not
experiencing particular diseases at rates two or more times those seen in
other veterans.

P. 3
d/li/84

�The case-control study of some cancers, according to CDC, has a 95
percent chance of detecting a two-fold increase in soft-tissue sarcomas if
the excess is present. According to at least one review of the CDC study
plan, the study w i l l be unable to detect an increase smaller than four or
five-fold.

In any case, the study w i l l be unable to detect excesses

smaller than two fold; neither w i l l i t be able to rule them out even if
there is no excess. Nevertheless, the case-control study has the v i r t u e of
testing a hypothesis—that d i o x i n causes specific cancers. Although other
(National Cancer Institute) studies are examining the same question, they
are concentrated in non-industrial areas of the country and have less
chance of examining the possible effects of industrial exposures to d i o x i n .
Therefore, the case-control study might go ahead as an effort to settle
outstanding questions about soft tissue sarcomas and lymphomas.
As the recently negotiated settlement of the veterans-' case against
the chemical companies showed, science is not necessary to make policy
judgements &lt;or tradeoffs). Although some spokesmen for the veterans c l a i m
that the companies settled because the companies knew that they were at
fault, other interpretations are possible. Had the n i n e cases representing
the veterans'' class action gone to t r i a l , the veterans would probably have
won some, the companies some. The losers in both cases would have
appealed.

The cases could have wound on across the years and been resolved

who knows when.

By settling, the companies e l i m i n a t e d uncertainties about

future l i t i g a t i o n and l i a b i l i t i e s .

Each company's stock rose on Wall

Street the day the suit was settled. Furthermore, the settlement
stipulates that no causal l i n k was shown between herbicides and the
veterans' illnesses.

P. A
6/11/84

�A 1983 court case in Nova Scotia did consider what is known about
dioxin's health effects in a dispute between timber companies and citizens
of nearby areas. The judge who heard the case decided for the companies,
saying that the citizens had not shown that spraying w i t h dioxin-containing
herbicides would result in a risk to human health.
Either ignoring s c i e n t i f i c information or making use of what is
a v a i l a b l e , it is possible to make policy about d i o x i n s at the present time.
Given that the CDC study is l i k e l y to find no adverse health effects but be
unable to show that some small elevated risk does not exist, it w i l l not
materially assist pol i cyrnak ing or making compensation decisions.
The p o s s i b i l i t y that there might be "something really there," that
there are now-undetected disasterous health effects among veterans, makes
it d i f f i c u l t to consider c a n c e l l i n g the CDC study.

In fact, there is

l i t t l e risk of missing something that is really there. The CDC study of
b i r t h defects (results expected in mid-summer) w i l l provide much more
information about possible birth defects than w i l l the cohort studies. The
Air Force Ranch Hand study is underway and w i l l continue for 20 years w i t h
p e r i o d i c reports on the morbidity and mortality of those men.

If excess

adverse health effects appear in the Ranch Handers, veterans of the ground
forces in Vietnam could be examined for that particular condition or the
appearance of the disease in the Ranch Handers could be taken as
presumptive evidence that other veterans are suffering the same diseases.

P. 5
6/11/84

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