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                    <text>Item ID Number

°1835

Author

Keller, Carl

Corporate Author
Report/Article Title Memorandum with several attachments: from
Chairman, Science Panel, AOWG, to Members of the
Science Panel, AOWG, with subject Meeting of the
Science Panel, dated February 5, 1985.

Journal/Book Tito
Year

000

°

Month/Day
Color

H

Number of Images

12

DOSCTipton Notes

Avn

' ' L- Young filed this item under "Vietnam Veterans
Twin Study." Memo gives notice of a science panel
meeting scheduled for February 21, 1985 with the
purpose of reviewing the VETS II protocol.
Attachments include inquiries about the possiblity of a
female Vietnam veterans study, and the minutes of the
November 29,1984 meeting of the Science Panel of
the Agent Orange Working Group.

Wednesday, July 11, 2001

Page 1836 of 1870

�"r

DEPARTMENT OF HEALTH &amp; HUMAN SERVICES

•

Date

Memorandum

February 5, 1985

From

Public Health Service

National Institutes of Health

Chairman, Science Panel, AOWG

Subject Meeting of the Science Panel
TO

Members of the Science Panel, AOWG
This is to announce that there will be a meeting of the Science Panel
of the Agent Orange Working Group at 9:30 a.m., February 21, 1985, in
room 729G of the Hubert Humphrey Building, Washington, D.C.
The purpose of the meeting will be to review the protocol for the
Veterans Administration Twin Study (VETS II). You will (or will have)
receive(d) a copy of this protocol under seperate cover. I am
enclosing some comments made by a special review group last summer for
your information. Please bring your written comments to the meeting
and we will summarize our review at that time.
We have also received additional congressional correspondence concerning female Veterans' needs. It appears that we are now being
requested to recommend what, if any, studies of the health of female
Vietnam veterans should be done and to examine proposed studies in
that light. I am enclosing appropriate materials and we will discuss
this at our meeting.
In addition, please find enclosed the minutes of our last meeting
(November 29, 1984) for your approval.

Carl Keller, Ph.D.

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COMMITTEE ON VETERANS' AFFAIRS
WASHINGTON, DC 20510

January 23, 1985
Honorable Charles Baker
Chair
Cabinet Council Agent Orange
Working Group
Department of Health and Human Services
Humbert Humphrey Building, 614-G
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Mr. Baker,
I have long had a strong interest in the issue of how the Federal
Government might conduct research to investigate the possible health
effects in female Vietnam veterans of their exposure to Agent Orange.
Enclosed is a copy of an October 16, 1984, letter to me on this
subject from Dr. James 0. Mason, the Director of the Centers for
Disease Control.
It is my understanding that the draft protocol outline mentioned in
Dr. Mason's letter is pending in the Agent Orange Working Group and
may be considered during the Group's next meeting, which is scheduled
to take place in early February. I believe that it is extremely
important that research be undertaken on this issue, and I strongly
urge that the Working Group undertake its review of the protocol
outline as expeditiously as possible. It is my strong hope that the
members of the Working Group will be able to report favorably on the
possibility of a study of female Vietnam veterans, either by endorsing
the protocol outline as developed by CDC or by suggesting whatever
changes to the outline the members believe are needed in order for a
study to go forward.
Thank you for your attention to my views on this issue. I would
appreciate hearing from you on this matter as soon as possible after
the Working Group's February meeting.
With best wishes,
Sin

Alah Cranston
Ranking Minority Member
Enclosure

�CTER

JUDICIARY
APPROPRIATIONS
VETERANS' AFFAIRS

WASHINGTON. D.C. 20SIO

January 4, 1985

The Honorable Margaret M. Heckler
Secretary
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Secretary Heckler:
I write regarding the government's epidemiological study on Agent Orange
being conducted by the Centers for Disease Control (CDC).
As a member of the Senate Veterans' Affairs Committee, I am very concerned
that CDC's study fails to include women who served in Vietnam. Approximately
20,000 women served there as members of the military or as civilians employed
by service organizations. Many of these women are now suffering from health
problems that may be associated with Agent Orange.
It is my sense that research is needed to assess the problems among women
who were in Vietnam to avoid excluding them from Agent Orange compensation
programs.
I urge that this omission be rectified by the Health and Human Services
Administration. Your consideration of this request is greatly appreciated.
Sincerely,

Arlen Specter
AS:gfs

_ *s •-

TRACER

�'DEPARTMENT OF HEALTH &amp; HUMAN SERVICES

Public Health Service
Centers for Disease Control

Memorandum
Date

'December 20, 1984

From

Director, Center for Environmental Health

Subject

Possible Study of Female Vietnam Veterans

To

Dr. Carl Keller
Chair, AOWG Science Panel

At the Agent Orange Working Group (AOWG) Meeting of December 4, 1984,
Dr. Brandt requested that the Centers for Disease Control (CDC) and the
AOWG Science Panel discuss what additional information the Science Panel
would need to assess the scientific utility of a study of female Vietnam
veterans.
As you know, CDC assessed the feasibility of a study of women veterans
and described the possible study approach in a protocol outline dated
June 25, 1984, copy attached. In that document and in the attached
memorandum to Dr. Brandt from Dr. James Mason, CDC Director, responding
to the Science Panel's initial critique, of the protocol outline, CDC
stated its belief that a comprehensive health assessment of female
Vietnam veterans motivates the study, rather than any specific
hypothesis. In addition, there are gender-specific issues that would not
permit generalization of male data to the female veteran.
CDC has also clearly stated that the proposed study is a "Vietnam
Experience" study rather than an "Agent Orange" study, per se. By that,
I mean we believe it will not be possible to estimate individual female
veterans' opportunity for exposure by relating their unit's location to
herbicide spraying missions. Like the "Vietnam Experience" study being
conducted in males, the study of female veterans would compare the health
of Vietnam veterans to comparable veterans who served elsewhere. Any of
the exposures women veterans experienced in Vietnam, (e.g. stress of
caring for a high volume of combat casualties, parasitic diseases,
whatever Agent Orange may have been ubiquitous in the Vietnamese environment, etc.) might influence the health of Vietnam veterans compared to
other female veterans.

�Page 2 - Dr. Keller
Given these two assumptions, that any health assessment of women Vietnam
veterans should be as comprehensive as that in male Vietnam veterans, and
that the study should look at all exposures in Vietnam, not exclusively
at the opportunity for Agent Orange exposure, I believe that the study
described in the protocol outline is appropriate. If the Science Panel
can provide CDC with a list of specific hypotheses that will address the
health concerns of female Vietnam veterans, I will request the resources
to develop a protocol to study these hypotheses.
I look forward to hearing from you in the near future. Please do not
hesitate to contact me if you have any further questions.

r,

~\": I
Vernon N. Houk, M.D.
Attachments

�MOV T!) 19M
Director
Centers for Disease Control
Possible Study of Female Vietnam Veterans
Edward N. Brandt» Jr.» M.D.
Chair Pro Tempore
Cabinet Council Agent Orange Working Group
Thank you for the opportunity to review and respond to the Agent Orange
Working Croup Science Panel*• critique of th« protocol outline for a study of
female Vietnam veterans. The Science Panel mentioned two Issues which they
felt must be carefully considered before proceeding further with development
of the study:
1) "the great potential for confounding exposures both during and after
Vietnam to teratogenlc agents other than herbicides and their
contaminants," and
2) "what a study of female veterans will contribute In the way of
scientific Information which Is not already being obtained from the
ongoing male studies."
Cf»C shares the Science Panel's Interest In having a research plnn which
addresses potentially confounding exposures* In this regard, it is important
to consider the purpose of the study. As stated in the protocol outline, the
proposed study is similar to the Vietnam Experience Study of men currently
being conducted. All the exposures unique to the Vietnam environment, from
parasitic diseases* to psychological stress, to waste anesthetic gases nay
influence the health of the Vietnam veteran cohort. Agent Orange Is only one
of many exposures Included In this experience.
For analyses of the effects of Vietnam service in general, exposure to t-xcese
waste anesthetic gases in field hospitals in Vietnam would not be a confounder
of the association of Vietnam service with health outcomes. Rather, the
anesthetic gases are but one of the many exposures that are part of the
Vietnam Experience* On the other hand, for analyses focusing on specific
exposures experienced in Vietnam, such as Agent Orange, waste anesthetic cfls
exposure might be • confounder* Such analyses would be expected to control
for operating room experience In Vietnam. Occupational exposures, Including
waste anesthetic gases, experienced after military service might also be
potential confounding factors since they could differ between the Vietnam and
non-Vietnam female veterans. Again, these exposures would be considered in
the analysis.
To respond to the general concern about confounding, CDC would deal with
potentially confounding factors in this study with the same approach used in
the recent Birth Defects Study and the ongoing study of male veterans.

�2 - Fdward K. Brandt, Jr., M.D.
retailed Information would be gathered from personal Interviews and record
revjf»we about potential conf minders, e.g., dorofirapltic, occupational, or other
risk factor* for disease that might occur with differing frequencies among
Vietnam and non-Vietnam veterans. In the analysis such factors would be
controlled for, eliminating any actual confounding effect of th&lt;:&amp;e variables.
The second concern of th« Science Panel related to the research questions
urique to women thut would beflr'dreftsedin the proposed study. As fitatf^
above, the study is primarily designed to look at military service in Vietnam,
in p.enrral, as the, «r.ain exposure of Interest, rather than estltiatee of /,pent
Orcn^e exposure. Two caveats should be mentioned regarding the study of Apcnt
Or/jT&gt;£e exposure, per so, in relation to the health of feraale Vietnam
veterans. First, because of the duties of t»oet women w^o served in Viet nan,
thfir livelihood of erposure to Agent Orange may bo less than that of c-.ale
Vletnan veterans. *o«t women who served In Vletnso ver*» stationed «t military
horprtals cr headquarter units that were at some distance frora the heaviest
&lt;\f&gt;fcnt Orange sprayings. Second, if, ns speculated by BOP.C scientists, A^cnt
Ornpfle residues became ubiquitous throughout Vletnan, female Vietn*a- veteror.s
way hav« been exposed throi^gh food supplies, drinking water, etc. 1'ofcovor,
these types of expoBurcs could not be quantified by relating the prrotii.ity c.f
the women'* units to the Ranch llnnd sprayinfc missions or other applications of
A.r.«?nr.
Throe ^road protipR of hoalth ontcoyfs would be studied In relattor to VJetvan
norvicei reproductive outcone«, psychologic outcotaen, and gercral
outconts for which T?otwsn may experience different risks than tnpn.
^productive outcomes would include fertility, spontaneous abortion*,
con^enltol irnlforciarlono as well as dlRRawcc of fetr^lo reproductive
Presnaney outcomes of the women are of pwrtJcular interest since maternal
are more c.onnonly aesocfnted with adverfle effects than p«r«rn3l
flseasps of reproductive organs nny be related to the Intiurnce of
various stresses *nJ insults to the delJcate hypothalarjic-pitultrry-ovarlan
ai:lp. Also of note in this repard, certain subclinical paraoitlc diseases,
ns iralrria nnd acicbiasie, rsy becowc nanifewt during the f;trrt;n of
outcoreo such as nnxlfty, dt-prrsslor, and font lYaur.atlc P
rirord«r and hehrtvloral outcomes nuch no substance abuse and crininal activity
r;ny crhihit different potternw In r.ole and frwnJc VlettJfln1 veterans. ^'Ith «
.l»r^e proportion of acute care nnrses onon^ female Vietnam vetor.^nH, special
c.o»&gt;6 iteration would he given to possible ntr«sr.ft*l effects of curing frr a
lorfc* volune of combat casualties. The psychosocial component of the fennle
study is also crucial to the cowplete evaluation and interpretation of t heother clitics! data to he collected, specifically in the determination of
outcwrs as a cause v«rnun on effect of plynlcal and Mochcrical
(e.R. hepatitis, cirrhosis, memory c!lsorder&amp;).
f'enrrsl health outcooca would Include n vnrlety of conditions of concern to
fenole vi«tnair. veterans* These outcomes are similar to those helnr. *ddr«BFct'
IP tie ongoing study of trale veterans. An was the case 1n the study of p-alc
v*»tcr«ns, there are few specific hypotheses based on previous scientific
studies. CPC believer* that a comprehensive health Interview and physical
exsii-« nation would he n?edcd f.o addrees the veterans' concerns thoroughly.

�Page 3 - Edward N. Brandt, Jr., M.D»

The Rtatifttlcal power of the propoeed atudy for Important health outconon
would be good. Tha Interview phase of the study la designed to detect
Increases of about twofold in the relative rieka for health outcomes occurrinr
with the frequency of 0.3Z» while the examination phaae is designed to detect
twofold incraaaea in conditions that occur with a frequency of 1*52 or greater
(power * 0.95, Alpha * 0*05, J-tail). With that level of statistical power,
moat conditions that ara of concern to women vho eerved in Vietnam will be
adequately addressed. Only relatively email incraaaea in uncoeaon conditions
would escape detection*
The Intent of the atudy which CDC was aaked to propoaa la to address the
health concama of female Vietnam veterans comprehensively and with sufficient
atatiatlcal precision* That haa determined the study design and sample oize,
rather than any single research hypothesis.
The coat of doing this atudy la significant. A decision to do this resenrch,
in a world of finite raeourc«a, aay aean that money for other activities may
not be available. We ara neutrsl on doing the atudy* However, if a decision
is made to proceed, wa ara confident that we can do a valid atudy, acceptable
to the yetarana groups, if we are provided the necaaaary resources.
We will he plen*«d to provide any further information you need.
&gt;****
Jamas ^rMaflon;"'V,f!#8fcP«H.
Assistant Surgeon General

cc:
OD
CEH
CDC/W
ES/PHS

Tracer 85084; CDC ID D19247; CEH #B-59
10/19/84
CDC:CEH!CDD:AOP:PLayde:dd/doc

�Minutes of the November 29, 1984 Meeting of the
Science Panel of the Agent Orange Working Group
The Science Panel of the AOWG met at 9:30 AM on November 29, 1984, in the
offices of the United States Army and Joint Services Environmental Support
Group (ESG) in room 210, Riddell Building, 1730 K Street, NW, Washington,
D.C. Attendees were as indicated on the attached attendance sheet.
The purpose of the meeting was to review in depth the procedures to be used
by the ESG to assign an Exposure Opportunity Index to individual Vietnam
veterans identified from other sources. Since the procedures had been
developed during the CDC Birth Defects Study, individual records of Vietnam
veteran participants in that study were available for review. Several
individual records were selected to illustrate the information available
and the method and steps used to assign an estimate of the likelihood of
exposure to Agent Orange while in Vietnam.
The method used in the CDC Birth Defects Study assigned a value from one to
five to each veteran depending on the recorded proximity of his unit to an
Agent Orange application while he was assigned to the unit. The value of
the assigned index also took into account the particular job classification
that the veteran had at the time. For example, a veteran whose job was
either clerical, administrative or logistical would not be expected to be
with his unit while on patrol away from the base, although he might be
expected to serve guard duty on the base perimeter. If exposure consisted
of a patrol approaching a Ranch Hand spray track, he would not be included,
but if exposure consisted of base perimeter spraying, he could have been
exposed.
A score of five (highly likely to have been exposed) was assigned to all
individuals in a unit which was known to have been within two kilometers
within 72 hours of an Agent Orange application and who held military occupational specialties (job classifications) implying that they should have
been with their assigned unit on such a mission. A score of five was also
assigned to all veterans known to have handled Agent Orange, such as Ranch
Handers or chemical personnel. A score of one (very unlikely to have been
exposed) indicated that the veteran was assigned to a unit which was
neither known nor expected to have been near an application site. Scores
of two to four indicated a range of possibility from probably not exposed
to probably exposed.
Although the methods used to develop these procedures involved considerable
subjective judgement on the part of the investigators, a description of the
Vietnam experience contained in the records of veterans classified as "very
unlikely to have been exposed" seems quite adequate to consider them as
much less likely to have been exposed to Agent Orange than those classified
as "highly likely to have been exposed". Members of the Science Panel unanimously agreed that the data and methods under consideration are adequate
to classify many of the veterans into groups which were highly likely or
very unlikely to have been exposed to Agent Orange while in Vietnam. Other
methods for assigning intermediate values need to be completed and may best
be adopted for specific studies where necessary.

�Some of the implications of using the Exposure Opportunity Index as defined
above were discussed as follows:
1) Some veterans cannot be classified because their records are not
available or are incomplete. It is thought that this will be a
small group if adequate search is undertaken.
2) Many veterans, such as would fall in groups two to four of the CDC
Birth Defects classification system, cannot be unambiguously
assigned to highly likely or very unlikely exposed catagories.
Several suggestions as to how to handle these were:
a) Classify them as unknown and drop them from further analysis.
This would have rendered approximately one half of the Vietnam
veterans in the CDC Birth Defects Study as unclassifiable.
b) Use five classes (as in the CDC Birth Defects Study) or
one or more intermediate classes. This system, would
retain larger numbers of classifiable study subjects,
but may reduce the statistical power of a study due to
missel ass ifications.
c) Attempt to classify all veterans with available records
into likely or unlikely exposed groups. This is also
almost certainly going to increase missclassification
and therefor reduce statistical power.
3) The index as currently developed is intended to be a measure of the
likelyhood that any exposure took place and presents some problems
during analysis since it is not a dose response statistic. Using
the computer methods now available, there is the possibility for
counting the number of encounters a given unit may have had and
trying to estimate the intensity of exposure. There is some support
for this since almost all of the encounters which a given unit has
had may be recorded in the quarterly reports (at least in those
units which have been specifically examined).
4) There is clearly an association between combat and Agent Orange
exposure since combat operations are a major factor in determining
opportunities for exposure at the individual as well as the unit
level. This must be considered in the light of specific study needs
e.g., it may not have been relevant for a Birth Defects Study, but
may be important in a Mortality Study.
5) While the methods which have been developed do provide for an estimation of the number of opportunities for exposure, there has been
no attempt to quantify the possible exposure amount. The index only
assigns a value to the likelihood that a given veteran was within
two kilometers within three days of an application of Agent Orange.
Whether this constitutes an effective toxic dose cannot be determined from the records and is the subject of ongoing health effects
research.
In order to assist in the usefulness of these methods for future research,
a subpanel was assigned the task of developing guidelines for the application of these alternative methods to specific studies. The meeting
adjourned at 1:30 PM, November 29, 1984.

�,

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U.S.

�Department of Medicine
and Surgery

Washington D.C. 20420

Veterans
Administration
JAN 3 0 1985
In Reply Refer To:

10A7

Dear Colleague:
Enclosed is a copy of the latest version of the Vietnam
Experience Twin Study Protocol. These are being distributed
at the request of Dr. Carl Keller—he will be in touch with
you in the near future to arrange a meeting to discuss his
plans for reviewing the protocol.
Sincerely,

BARCLAY M. (BHEPARD ,* M. D.

Director
Agent Orange Projects Office
Enclosure

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                    <text>Item D Number

°2034

Author

Young, Alvin L.

Corporate Author
RBDOrt/ArtiCle Title Letter: to The Honorable Mr. Justice Phillip Evatt from
Alvin L. Young, July 13, 1984

Journal/Book Title
Year

000

°

Month/Day
Color

D

Number of Images

1

DeSCrlptOn NOtBS

Letter is updating Evatt on the Agent Orange activities in the
United States, including several studies. Young also
expresses his opinion that the Royal Commission must
continue its work seeking a thorough assessment of the
scientific data so that the most accurate picture and answers
can be given to the veterans of both countries.

Tuesday, August 07, 2001

Page 2034 of 2084

�EXECUTIVE C
OFFICE OF SCIE

,/
-

--

OtOGY POLICY

WASH^UTON, D.C. 20506

July 13, 1984

Dear Judge:
It has been a few months since our last communication. I believe
it is important to bring you up-to-date on activities related to
Agent Orange. Currently, efforts are underway through the auspices
of the White House Agent Orange Working Group, to advance the
Veterans Administrations Identical Twins Study (VETS) and the
National Institute for Occupational Safety and Health's (NIOSH)
Dioxin Registry and accompanying mortality and morbidity studies.
In addition in mid-August the Center For Disease Control will
release its completed Birth Defects Study.
Although, much of the activity involving the Vietnam Veterans and
Agent Orange appears, at least in the press, to center on the
legal out-of-court settlement activities in New York, the Federal
Government continues to press for scientific answers to the critical
health questions posed by this issue. The dichotomy is that in
the United States we may not get the opportunity to place before
the public and the veteran and scientific communities a proper
assessment of the scientific information.
For that reason, I believe it is imperative that the Royal Commission
continues to seek a very thorough assessment of the scientific
data. It is only through a process of open and complete scientific
dialogue that we can hope to provide answers to the very complicated
situation that surrounds the men and women who so gallantly served
in Vietnam. I hope that the proposed epidemiologic study, planned
during my visit to Australia, can be conducted and the results
viewed by your Commission.
I feel that a trip to the United States to meet with the research
and veteran communities should clearly be taken before the Commission
completes its assessment. I will be pleased to assist in appropriate
arrangements.
Sincer
Alvin L.l YoCTng, Ph.D.
Senior Policy Analyst
for Life Sciences
The Honorable Mr. Justice Phillip Evatt, D.S.C.
Royal Commissioner
Royal Commission on the Use &amp; Effects of Chemical
Agents on Australian Personnel in Vietnam
G.P.O. Box 4842
SYDNEY, N.S.W., 2001 ,
AUSTRALIA

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01708

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LeVois, Maurice E.

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RBPOrt/ArtlClB TltlO Typescript: [Update on study protocol], September 20,
1982

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Monday, June 11, 2001

Page 1709 of 1793

�1. On 5 March 1982, the AOWG Science Panel approved a 4
December 1981 DOD/AAQTF conceg&lt;t. _jaaper on cohort selection.
Scecifically, what the Science Panel approved was the
genera1 jprinicj, ple

of selecting battalion, and then

company size, military units for exposrue analysis,
assigning the company A/O exposure score to each member of
that company.

If an individual was reported absent on a

day when his company received an exposure, that
individual's exposure score would be reduced accordingly.
This is a departure from the approach suggested by UCLA, in
which individual subjects were to be drawn at random and
exposure scores developed for each subject individually.

2.

On 5 March 1982, the Science Panel states:

"The

Science Panel will oversee this cohort selection process."
The 4 December 1981 DOD/AAOTF concept gaper was clearly not
a scientifically rigorous methodological protocol.

AOWG

approval of that document should not have been construed as
a signal to proceed with the actual selection of subjects
without first developing a step-by-step protocol with the
assistance of the Science Panel and othe qualified
scientists.

3.

On 10 June 1982, the VA submitted to the AOWG Science '

Panel a memorandum (attached) concerning AAOTF cohort
selection activities. That memo alerted members of the

�Science Panel to the fact that inappropriate and unapproved
decisions concerning cohort composition, exposure criteria,
and selection methods had been made independently by
DOD/AAOTF.

It was the VA's belief that, if the AAOTF

proceeded to select subjects as they proposed, their
efforts would produce unusable cohorts and no useful data
on the feasibility of conducting the larger study.

4. Between 4 December 1981 and 10 June 1982, meetings were
held on the topics of Agent Orange exposure and cohort
selelction and some important progress occured.
°It was generally agreed that a third cohort, roughly
comparable to the two Vietnam cohorts could be assembled,
if that were called for by the final study design.
°A general AAOTP cohort data automation contract was
developed by AAOTF.

It should be noted that general

functional capabilities, not specific data elements, were
approved by the VA.
°A Ranch Hand mission time/distance exposure matrix was
developed.
"Methods of equating the different modes of exposure were
proposed.

Work on this problem continues.

"The AAOTF proceeded with work on an augmented "services"
herbicide application record.

This work also continues.

The AAOTF was never asked by the AOWG or the VA to halt
work on the documentation of herbicide use in Vietnam.
This informiWon is essential to any cohort selelction
process.

�°On 8 April 1982, a letter was sent from VA Administrator
Nimmo to Secretary Weinberger addressing the need for the
support and cooperation of both agencies in this research
effort, (attached)
*J
°0n 8 April 1982, a memo was sent by Secretary Scheiker to
A

Secretary Weinberger, (attached) That memo recommended
that DOD assume responsibility for cohort selection in
support of the VA study.
"On 26 April 1982, Secretary Weinberger issued a tasking
memo to the Secretaries of Army, Navy and Air Force
authorizing full DOD support of this effort, (attached)

"The AOWG Science Panel created a subcommittee to 1. develop
an acceptable Agent Orange exposure index 2. develop a
cohort selection protocol for the AAOTF.
°On 8 September 1982, the Chairman of the Science Panel
forwarded to DOD a draft protocol for cohort selection for
DOD approval.

5.

The AOWG and the VA can not provide the kind of

continuous scientific supervision which is required for
proper cohort selection.

It has become clear that this

important, complex and costly effort cannot be adequately
supervised by a physiologist.

The AAOTF should obtain the

assistance of a qualified epidemiologist and/or
biostatistician before proceeding with their cohort
selection pilot work.

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&lt;p&gt;For more about this collection, &lt;a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a"&gt;view the Agent Orange Exhibit.&lt;/a&gt;&lt;/p&gt;</text>
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                    <text>°1703

Item ID Number
Author
Corporate Author

Report/Article Title Typescript: White Paper: Status of VA Epidemiologic
Study of Agent Orange, August 27, 1982

Journal/Book Title
Year

000

°

Month/Day
Color

n

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"DM&amp;S" typed next to date.

Monday, June 11, 2001

Page 1704 of 1793

�DM&amp;S 8/27/82
WHITE PAPER
STATUS OF VA EPIDEMIODOGIC STUDY OF AGENT ORANGE

The epidemiology protocol originally submitted to the VA by the U.C.L.A.
School of Public Health on April 29, 1982, has now been reviewed by the VA
Advisory Committee on Health-Related Effects of Herbicides, the White House
established Agent Orange Working Group (AOWG) and the Office of Technology
Assessment. All of these review groups have noted that further development of
the research protocol is needed in certain areas. For example, each of the
following topics has been mentioned by one or more of the protocol review
groups as needing additional attention: a clear statement of specific hypotheses
to be tested; the data reduction and analytic methods to be employed; the
rationale for a third cohort; and more exact statistical power calculations
associated with these refinements of the protocol.
The protocol is currently being reviewed by a committee of the National
Academy of Sciences (MAS). The VA has been advised that MAS is now in the final
stages of this review process. It is expected that the report will be completed
and forwarded to the Veterans Administration by the third week of September.
Further refinement of the protocol is underway and should be completed during
the month of October. Barring unforeseen complications, a contract for the
conduct of a pilot study of approximately 900 veterans (or 300 per cohort)
should be awarded in the January-February 1983 time frame.
A critical component of the pilot study will be to evaluate the cohort
selection procedures and the feasibility of developing cohorts for the full
scale study which will be twenty times larger than the pilot study cohorts.
This aspect of the protocol was not developed by U.C.L.A. and has become the
focal point of recent activity by the VA, the Army Agent Orange Task Force
(AAOTF) and the AOWG. The basic issue is whether the military records are
sufficiently complete and detailed so as to provide a reliable indicator of

�"likelihood of exposure" to herbicides. The present assessment of the records
suggest that identifying the cohort with a high likelihood of exposure will be
easier than identifying the cohort with low likelihood of exposure. The reason
for this is that the present records of herbicide missions, the HERBS Tape,
provide a reference point for estimating likelihood of exposure because
tracking a company in an area known to have been sprayed with herbicides on a
given day can be objectively determined by the records. When looking for units
considered "not likely exposed" the record searchers can only assume selected
units were not near herbicide targets; a subjective evaluation; thus, they
cannot document the absence of exposure to herbicides.

It is important

therefore to note that misclassifying an individual as to likelihood of exposure
can result in "diluting-out" any health effect that may be present and
associated with exposure.
The AOWG has appointed a subcommittee of its Science Panel to establish
procedures for cohort selection for the epidemiology pilot study. The VA has
brought in biostatistical consultants to work with this subcommittee and with
the AAOTF. The subcommittee is now in the process of preparing its final
report to the Science Panel. When this report is forwarded to the VA, a
recommendation will be made by the Chief Medical Director to the Administrator
as to whether the pilot study will focus only on Agent Orange or whether it will
center on the total Vietnam experience with Agent Orange as a major emphasis.
The pilot study itself is expected to be a major factor in the final
decision to broaden or limit the scope of the full scale epidemiology study.
That decision may not be made until the results of the pilot study are available
in late 1984 or early 1985.

2.

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&lt;p&gt;For more about this collection, &lt;a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a"&gt;view the Agent Orange Exhibit.&lt;/a&gt;&lt;/p&gt;</text>
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°1695

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LeVois, Maurice E.

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Roport/Artldo Title Memorandum: Agent Orange Research Predecisional
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July 29, 1982

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Monday, June 11,2001

Page 1696 of 1793

�Veterans
Administration
Director, Agent Orange Research
and Education Office (001E)

July 29, 1982
Administrator

Slll :

"

Agent Orange Research
Prcdec is iona 1 Memorandum

].. The Ayent Orange epidemiology research protocol has been reviewed
and approved, in general terms, by the White House Agent Orange
Working Group (AOWG) Science Panel, the Congressional Office of
Technology Assessment (OTA), and the VA Advisory Committee on
HeaJth~Related Effects of Herbicides. Although some differences
remain among the recommendations made by these committees, all three
of these review groups support tte idea of including a third cohort to
evaluate the effect of the "Vietnam experience" on the health of
veterans.
vi

2. The AOWG strongly endorses the three cohort research design as an
effective means of evaluating the health effects of both the Vietnam
experience and of exposure to Agent Orange.
3. The three cohort research design may have far reaching
implications:
a)

A third cohort will increase the cost of the study by nearly
50%;

b)

A throe cohort study design will increase the total number of
hypotheses to be tested and, therefore, will increase the
probability of finding both real and chance effects;

c)

Specific risk factors or exposures will be impossible to
identify in the "Vietnam experience" portion of the study.
Flealtii problems found to be associated with Vietnam service
niay require further research to identify causation and
establish the relative increase in risk for each health
problem;

d)

For the purpose of compensation, the assumption of exposure to
a general health risk factor by anyone who served in Vietnam,
without requiring documentation of a specific exposure, may
include very large numbers of veterans. This also applies to
the process of compensation based upon Agent. Orange results;

*•)

If common health problems are found to te weakly associated
with Agent Orange or service in Vietnam (i.e. only a slight
increase in relative risk) then the VA may want to consider an
"attributed risk" formulation for compensating veterans.

4. It is your decision whether or not the VA will conduct a study
of three or only of two cohorts, Public Taw 97-72 states that you
"may" broaden the scop} of the study to look at the general health
effects of service in Vietnam, You rrwy also limit the focus of the
study to the Agent Orange issue.

�'there are a nurnter o£ options available to you:
a)

Broaden the .scop:; of the study by including a third cohort as
the AQWG recommends. This option appears to be consistent
with the wishes of the veterans" service organizations and the
Congress;

b)

Limit the scope of the study to the health effects of Agent
Orange exposure and study only two cohorts. The U.C.L.A.
authors of the research protocol recommend this option on
scientific grounds, but do not present: a strong argument for
their position;

c)

Proceed with plans for a pilot study contract based upon three
cohorts. If the National Academy of Sciences (NAS) ^review
group recommends against the three cohort design drop the
third group and re-negotiate the pilot study contract;

d)

Proceed as in c) atovc. If NAS agrees that a three cohort
study is appropriate, then the pilot study can be used to
evaluate the feasibility of the three cohort design.
Participation rates may be lowest for the third, non-Vietnam,
cohort. If. fewer titan 70% of the potential subjects in that
group participate in the pilot study, the third group may have
to be dropped from the final design for statistical reasons;

e)

Ask the VA Advisory Committee on Health-Related Effects of
Herbicides and the VA Policy Coordinating Committee (PCC) to
consider the three cohort design issue and provide you with
their independent recommendations.

MAURICE E. r.EVOlS
Director, Agent Orange Research
and Education Office

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01694

Author

F| nn Peter A

y '

-

Corporate Author
Report/Article Titlfl Memorandum: VA Pilot Study Cohort Selection by the
Army Agent Orange Task Force (AAOTF), from Peter A.
Flynnto Chairman, White House Agent Orange Working
Group, July 19, 1982

Journal/Book Title
Year

°00°

Month/Day
Color

'

Number of Images

2

Descrlpton Notes

Monday, June 11, 2001

Page 1695 of 1793

�JUL 1982

MEMORANDUM FOR CHAIRMAN, WHITE HOUSE AGENT ORANGE WORKING GROUP

SOBJBCTj VA Pilot Study Cohort Selection by the Arny Agent Orange
Ta»k Forc« (AAOTP)
As you know, wh«n th« AOWG gave the VA the go~ah«ad to proceed
with their pilot epideialo logical study, we in DoD coiaraitted
ourselves to the AOWG to »e«tiny th«a January 1, 1903, date by
which the VA estimated it would ne«d naraaa for the study. This
date waa passed to the AAOYF and, as they had agreed in advance,
they began to work immediately. That date was felt to be a
reasonable on« with the programed personnel on board, in frtw
K«antiB@, we had secured additional active duty personnel frota th&lt;?
Air Force, Navy and Marine Corps as we had said we would. The
approach to the records u@«d by the AAOTF was basted on decisions
of the Science Panel of th« AOWC and sora« announced asauraptions on
our part whore there were no fira guidelineo.
Discussions over the last month have made it apparent that there
remain serious unresolved issues with regard to the 0CLA protocol
in both its scop« and focus and in regard to ao£t« aspects of
cohort selection. While the AAOT7 has been making excellent
progress, th«re is now a substantial likelihood that the cohort
selection process may not fully meet the VA's desires which ar«
still being articulated by the VA. Accordingly, I have directed
the AAOl'F to suspend its pilot study cohort selection activities
until such ti»« as the aforementioned issues are resolved and the
AAOTf can b« given clear and confirmed narching orders. We and
th« AAOTF stand ready to assist those individuals and groups who
are working with the protocol, particularly in those areas where
thft records have a direct bearing on what is possible in tho way
of data extraction. When definite new directions arcs aade
available, we will, of course, immediately resua« the selection
process for the pilot study. It is clear that the January 1,
1983, date can no longer be aet« A new date will have to be set
depending on when we corasence work and the scope of the required
records work.

�As a matter of incidental interest, the AACTF lias briefed tm&gt;
National Academy of Science review personnel as requested by the
VA.
We continue to stand ready to be of all possible assistance with
this important study.

S16HIB
P«t«r A, Plynn
Captain, J1C, QSN
Director for Professional
Servicoo
cc; Mr. R. Christian, AAOTF
Dr. Vernon Houk, CDC, Science Panel Cbairwan
Dr. Carl Keller, Research Panel Chairman

HAFile/Reading/Chron/HRMChron

COORDINATJOH;

Plynn/dcs/16Jul82/0788d
Dr. Bricker

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                  <text>&lt;p style="margin-top: -1em; line-height: 1.2em;"&gt;The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.&lt;/p&gt;&#13;
&lt;p&gt;For more about this collection, &lt;a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a"&gt;view the Agent Orange Exhibit.&lt;/a&gt;&lt;/p&gt;</text>
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°1684

Author

Spivey, Gary H.

Corporate Author
Roport/Artldo TltlO

Review

of the Draft Protocol for Epidemiological Studies
of Agent Orange

Journal/Book Title
Year

000

°

Month/Day
Color
Number of Images

D

22

Descriptor Notes

Wednesday, June 06, 2001

Page 1685 of 1688

�SUBJECT:

Review of the Draft Protocol for Epidetniological Studies of Agent
Orange
Submitted by Gary H. Spivey, M.D., MPH, Principal Investigator
Rogert Detels, M.D., MS, Co-Principal Investigator
Division of Epidemiology
School of Public Health
University of California
Los Angeles, California

Attached please find the individual comments of members of the Science Panel
of the Agent Orange Working Group. Basically, every member expresed concern
about the lack of details in the protocol to the point that it is not possible
to constructively review the proposal.
.
The following paragraphs taken from comments submitted by individual members
highlight these concerns:
General Comments
1.

"While we certainly appreciate Dr. Spivey1s concern that release of
certain specifics of his anticipated protocol might induce bias in the
eventual study, we cannot provide an effective analysis of a protocol
without such information. We suggest that at least a small subcommittee
of the Science Panel be supplied with all of the details of the protocol
and that the report of this subcommittee be held in confidence and not be
released to the general public. We believe that an informed evaluation
is absolutely essential before any further action is undertaken to
initiate any subsequent studies."

2.

"The section on proposed outcome measures is particularly weak. The
statement that an examination will be done because '...the veterans will
expect a physical exam1 is inappropriate. The inclusion of special
examinations for individuals with recognized disease unrelated to Agent
Orange, for example, an examination of the eye backgrounds and peripheral
pulses in subjects with a history of diabetes mellitus is of questionable
value in such a protocol. At the same time the protocol ignores entirely
the neurological examination, which both animal and human data suggest
may be of importance.
"Statements such as the one included on page 9 which opines that chloracna
is a 'self-limiting skin condition' raise further questions about the
authors' full understanding of the potential health effects of dioxins.
Chloracne can be a severe skin condition that in some individuals is
persistent for years even following discontinuation of exposure. The
statement on page 18 that 'Chloracne is the only established health
outcome associated with dioxiri exposure1 is not justified."

.3...

"It is clear that the current UCLA protocol is inadequate. Therefore, a
study is yet to be designed and conducted. Overall, it is our opinion
that two important factors must be present for the design and conduct of

�a study. First, it is critical that adequate epidemiologic expertise be
• available within the Group or Agency which assumes responsibility, and
second, there must be continuous interface with and cooperation from the
DOD and VA so that details of records and activities during the Vietnam
War are accessible to the researchers.
"Finally, any delay dependent upon further review of this UCLA protocol
should be avoided due to its incomplete nature. Any further review
should be postponed until an appropriate scientific protocol based upon a
complete iteration of exposure data and veterans' data is available."
4.

.

"In summary, prior to any further attempts to design a study on Vietnam
veterans, it is recommended that the Veterans Administration review the
morbidity data they have collected thus far, that the Department of
Defense establish information on exposure data and determine what the
sizes of prospective cohorts might be, and that the Veterans Administration
embark on a mortality study. Since any outside group is unfamiliar with
the record keeping system of the military, it would be redundant, wasteful,
and time-consuming to have outside groups do this preliminary work for
the military."
Specific Comments

Exposure
1.

"I am deeply troubled by this aspect of the report. On page 43, the
authors correctly surmise, 'We have not identified a mechanism which
would document actual exposure.1 Over the past year in our Committee, as
well as the Agent Orange Working Group in the White House, we have wrestled,
frankly unsuccessfully, with trying to establish some mechanism for
documenting exposure. I recall clearly our meeting with the members of
the National Academy of Sciences and their comments regarding any proposed
epidemiological study on Agent Orange exposure in Vietnam. The take-home
message was, 'If we cannot scientifically validate and document exposure,
we cannot do a scientific epidemiological study.1 Although Spivey's
approach suggests a mechanism by which we might overcome this problem, I
suspect we are justifiably due some criticism for the grouping approach.
I am now persuaded that we will never be able to do an epidemiology study
on individual veterans per se, but must examine military units serving in
specific spray areas. There is now some hope from recent DOD activities
that we might be able to document some segments of the military population
in Vietnam exposed to Agent Orange. Every effort then must be made to
work closely with Mr. Christian and his associates in DOD in meticulously
reviewing records and films to establish some case for exposure. I
recommend we do not fund any additional feasibility studies until a
thorough and comprehensive search and cataloging of available DOD records,
films, and reports are completed."

2.

"In conclusion, I atn not convinced that significant ground troop exposure
to 2,4,5-T containing herbicide occurred as a result of aerial application.
Other uses of the herbicide most likely represented a greater exposure.
Additionally, the study must address the question of did the Vietnam

�conflict participant incur a health decrement risk over and beyond that
which was expected and secondly, if a risk was incurred, is it service
connected? This protocol requires greater examination of the exposure
criteria and further discussion and refinement."
Use of Terminology
"Definition of Antipersonnel gas: Riot agents such as GS and CN used in
Vietnam were not antipersonnel gases since they do not kill or incapacitate
for an extended period of time. Both CS and CN have been used throughout
the world by civilian police to control riots of civilians and in prisons
without causing fatalities. This improper definition should be corrected.
"The substitution of 'riot control agents' in place of 'antipersonnel
gases' is suggested."
Conclusion
The members of the Panel had many other specific comments and only some of
their major concerns were quoted here, -ft—a-ppears that" the present proposal
is inadequate and it is recommended that a course of action be developed that
will not cause any further unnecessary delays in attempting to answer questions
about health issues of Vietnam veterans. A specific protocol should be -"Allayed
in which the size of the cohorts and their perceived exposures are characterized
and which will serve as the basis for the studies.

�&gt;;&amp;W&gt;*&amp;^i(&amp;X^
**iic«S»S*v.^

A
The major concern we have with this draft document is the lack of detail provided
by the authors in describing the protocol itself. This lack of detail makes
an informed critical review impossible. The investigators state that a detailed
protocol is not provided due to their inability to examine all relevant military
records on which the studies would be based and also because of potential bias
they fear might result from premature public release of a detailed study design.
The quality, scope, and availability of military records on Vietnam veterans in
addition to the ability to locate individuals in a time - space frame in Vietnam
have previously been major issues with regard to developing an epidemiologic
protocol. In our view, an adequate protocol requires a clear and detailed
evaluation of those military records that are available. While a preliminary
feasibility study might be indicated to evaluate the procedure of establishing
cohorts with differing exposure levels, a detailed and clear understanding of
what records are available may make this unnecessary. A thorough evaluation of
those records that exist, what the records contain, and how they might be used in
establishing appropriate cohorts must be performed before any protocol can be
properly reviewed.
We also strongly disagree that the full protocol should be withheld due to
potential bias. It is important that the full protocol receive adequate peer
review due to the importance of the investigation. The publicity which currently
surrounds the study has already influenced those individuals who will eventually
be included. A full presentation of the protocol in our view would have little
further adverse impact. To withhold pertinent details may cause far more harm
by seriously damaging public confidence in the credibility and independence of
the study.
...
,.
..--..
We do not agree that the "historical cohort study" should be limited to draftees
and one term enlisted men. Excluding individuals with longer service will
undoubtedly exclude some individuals with the greatest potential exposures.
Inadequate detail is provided about cohort selection by the authors. Full and
extensive discussion of the HERBS data, of the nature of troop movements through
Vietnam, and the pattern of likely exposures are critical in evaluating the
protocol. There is a fair amount of information offered on environmental persistence of agent orange, but no assessment of how the data affects presumed exposure to
ground troops. The concept of establishing low to high exposure groups based on
a "time - place - company exposure grid" is too vague as presented and it is
not clear that the authors have a fundmental understanding of the core issues
which need to be addressed in establishing such cohorts.
The sections in the protocol&gt;on potential confounding variables and control
groups are both non-specific and short on detail.
The section on proposed outcome measures is particularly weak. The physical
examination in our view can be a significant factor in this study in determining
ill health, since the potential end organ toxicity for a number of organ systems
can be identified and specifically evaluated through a physical examination. The
statement that an examination will be done because "...the veterans will expect
a physical exam" is inappropriate. The inclusion of special examinations
for individuals with recognized disease unrelated to agent orange, for example
an examination of the eye grounds and peripheral pulses in subjects with a
history of diabetes mellitus is of questionable value in such a protocol. At
the same time the protocol ignores entirely the neurological examination, which
both animal and human data suggest may be of importance.

�Statements such as the one included on page 9 which opines that chloracne
i is a "self-limiting skin condition" raise further questions about the authors'
! full understanding of the potential health effects of dioxins. Chloracne can
I be a severe skin condition that in some individuals is persistent for years
] even following discontinuation of exposure. The statement on page 18 that
"chloracne is the only established health outcome associated with dioxin exposure"
!
. is not justified.
The authors have devoted considerable effort to giving a review of basic epidemiologic principles and a superficial review of toxicity information. While this
information may be of interest as introductory material, the critical
task of-the contract was to establish a thorough, detailed, and scientifically
"~"fc.
defensible protocol.
"•••;'s;»;;i'-h:'"ii'...; :::j;PK.::^::':^
:^.Ex2rr::;v::r^

^^

It is our opinion that the current draft protocol is inadequate as presented and
that a major effort will be required to develop the protocol to a point where
further peer review can be meaningful.
;: We look forward to working with the Science Panel in responding to the VA on this
important proposed study.

••" " "

. .
1. While we certainly appreciate Dr. Spivey's concern -that
release of certain specifics of his anticipated protocol might
induce bias in the eventual study, we can not provide an effective
analysis of a protocol without such information. We do not support
blind trust in the correctness of Dr. Spivey's deductions and
selections. We suggest that at least a small subcommittee of the
Science Panel be supplied with all of the details of the protocol
and that the report of this subcommittee be held in confidence and
not be released to the general public. We believe that an informed
evaluation is absolutely essential before any further action is
undertaken to initiate any subsequent studies.
2. The following comments are provided with references to paragraphs and stamped page*numbers at the bottom of each page:
a. Pg. 007, Para. B, Method:
HERBS data. This has already been
defoliation missions with separate
Veterans Administration has such a

Calls for Computer mapping of
accomplished for both cropland
map overlays by year. The
set of overlays.

b. Pg. Oil, Last paragraph:' Our records show that all fixed
wing missions using herbicides blue and white were not stopped
until 31 October 197.1. The last helicopter mission with Herbicide
Orange was recorded on 9 June 1970. All fixed wing defoliation
missions with Orange ceased on 16 April 1970. The same paragraph
neglects to mention that.herbicides were also sprayed along the
sides of rivers, roads, and communication lines to prevent cover
to the enemy.

�c. Pg. 020, 1st Para.: For possibly highly exposed personnel
he might also wish to include chemical unit personnel at battalion
level charged with spraying base camp perimeters, riverine personnel
who sprayed the edges of rivers, and other personnel involved in
cleaning up herbicide spills after accidental releases.

d. Pg. 040, Ques. 1 posed: The discussion here is extremely
limited and does not mention the fact that many personnel both
Orange and non-Orange exposed may have had prior exposures to TCDD
through agricultural or home use during childhood and adolescence.
There is no reason to believe that commercially available herbicides
did not also contain TCDD. In fact, during the period when these
young men were children the TCDD concentrations in such compounds
may have been higher due ..to lack of perfection in the manufacturing
process. We believe this should be looked into and also considered.
If such is the case then an "unexposed" guaranteed population of
young adult males of that period may be impossible to find. We are
now researching the use of 2, 4, 5-T at posts and stations here in
the United States and overseas. Because of the long latent period
for carcinogenic effects, perhaps those persons claiming effects
such as testicular cancer may be reaping exposures which took
place while in childhood here in the United States and having
nothing to do with Vietnam service. Similarly, prior exposures
to other toxic environmental hazards may now be showing up as
diseases in the Vietnam veteran population. No mention is made
of possible other exposures to dioxin containing substances such
as pentacholophenol wood preservatives and hexachlorophene used
in surgical germicidal soaps. Thus unexposed Orange troops may
have gained dioxin exposure from other sources. Likewise, a
veteran who served in Vietnam say from 1967 to 1968 has had 12
years in which (depending upon his civilian work environment) he
may have been exposed to several other toxic and hazardous
compounds that are now producing disease symptoms and which have
no relation to Herbicide Orange in any way.
e. Pg. 041, Ques. 2, Other Exposure: Attachment 1 to these
comments lists possible other exposures encountered by military
members serving in Vietnam. It is by no means an exhaustive
list. We agree that these additional sources of exposure to
various substances and disease entities may be very important
confounding factors in relation to sorting out primary effects
caused by exposure to Herbicide Orange.
f. Pg. 043, Ques. 5: Comparison to veterans who served in
Korea and World War II may be exceptionally difficult since many
if not most of the personnel records were destroyed in the St.
Louis Records Center fire.
g. Pg. 047, 1st line, 1st paragraph: Suggest substitution
of "riot control agents" in place of "antipersonnel gases."

�^ f ' &amp; s ^ S f
Q e S ^ &amp; S ^ ^

;

h. Pg. 049, Para. E.I.: Why will the study be limited to
draftees and one term enlisted men? Why not include young troop
commander officers and senior enlisted personnel who were in the
field? Follow-up physical examination records for career
enlisted and officer personnel would probably be much more
extensive and easily obtainable than from civilians who left the
service at the end of one enlistment.

i. Pg. 052, Para. 3, Estimation of Exposure: We see no
reason to construct a second exposure index involving a long term
environmental persistence as many.studies have been already
directed at herbicide persistence, especially considering the
high rrtobility of the troop populations while in Vietnam and
decay studies of herbicides and TCDD such as Seveso. Also supporting this contention would be the long terra studies conducted at
Englin^Air Force Base at the loading hardstands where there was
exceptionally high concentrations of Herbicide Orange spilled and
trapped in the ground.
j
j. Pg. 052, last para.: What is proposed in this last paraj graph and onthe following page can amount to millions of dollars
,;• of labor time to locate a defined population with respect to the
:
HERB tapes. The already accomplished Battalion studies conducted
.1 by the Army and the Marine Corps have pointed out how laborious
and time consuming such a massive effort would be. The major
fallacy of such a study would be that the-major source of
contamination and/or exposure to ground troops may not be from
fixed wing Ranch Hand spraying. This is because of entrapment
of the herbicide in triple layer tree canopys, rapid absorbtion
of the herbicide into plant leaf tissue, vaporization of the
spray above the jungle canopy, rapid decay of dioxin due to
photo degradation (less than 6hr.half-life), and low or nonexistent volatility and very low solubility of dioxin in water.
A probable source of much higher contamination would be from
spraying of herbicides around the perimeters of camps and fire
bases through the use of helicopters, truck mounted decontamination spray units, backpack hand sprayers, and Buffalo turbines.
These types of perimeter spraying are very poorly documented at
best and only a tiny fraction of all helicopter spray missions
are documented in the HERBS tapes. Couple this lack of data as
to amounts, type and dates of perimeter spraying with the already
proven difficult task of placing troops with respect to physical
location by each day of the year at a specific grid location and
we have a very "iffy" situation at best. What the author
advocates in no way seems to be a solution. Finally after 18
months neither the Science Panel nor anyone else has been able to
establish just what constitutes an "Exposure" to Herbicide Orange.
k. Pg. 053, Para. 4, Establishing Cohorts: In this discussion we assume the -author is referring to single or multiple
exposures from Ranch Hand flights over or near the selected
company. There are many problems to this method of counting on a
company and its personnel being at a certain place at a certain
time with respect to an overflight by Ranch Hand aircraft. To
name a few, we have the following:

�(1) In the case of Marine records the troops were carried
on the Morning Reports (MR) as either Killed in Action (KIA),
Wounded in Action (WIA), Missing in Action (MIA), present for
duty, or transferred. Hence minor disabilities were not entered
' in the MR and consequently a Marine may have remained in base
camp while his platoon was out on patrol.
(2) Companies did not necessarily operate all together
and stay together. Marine units very frequently operated in
small 'patrols and platoon size units. Documentation as to their
day-to-day locations are very poor. In one Marine battalion study
for a .two month period only 4 exact unit locations could be
determined for an operational area of 10km long along route 9 and
width of 6.5km back from each side of this. road. We know that
patrols roamed all over this area to protect the security of the
.route from enemy ambushes but it is impossible to fix company,
platoon, or squad locations during this time.
(3) In the case of the 1st. Cav. units, platoons would
, be detached from a company for a period of time and assigned to
'• another infantry battalion far from the operating location of
thie 1st. Cav. parent company.
(4) In air mobile operations, it was not uncommon to
have helicopters drop a platoon of men into a landing zone and
then the platoon would go into a search mission through the
jungle with no documentation as to their day-to-day location.
Finally one or more days later the platoon would reassemble at
the landing zone and be airlifted out. In the mean time the
rest of the Company would be at the base camp or operating in
other areas.
(5) We have also found that there are errors in the
morning reports regarding the duty status of individuals. It
has been observed that as long as six months elapsed before a
correction was made to pick-up or drop an individual. Similarly
some people may have been detached from the units for short
periods of time (several days) without this showing up in the
Morning Report. We know of one case of an individual whose body
was in the mortuary in Tan San Nhut and his unit was unknown for
quite a while. When his unit was contacted they thought he was
still with them until they made a detailed search. He was, of
course, being carried on the Morning Report as present for duty
although he had been dead for several days. We cannot trust the
validity of these combat records in all cases.
(6) There was also a very high thruput of.personnel in
the Army battalions studied. For a battalion of about 971
persons over 2,300 personnel served for varing periods of time
in the one year period which was studied.
1. Pg. 063, last para.: It seeins wise to mention that a
preliminary review cost for pulling a record at the St. Louis
Records Center and determining minimum locator information will
be $5.17 per record. More detailed research could run the bill
up and overall costs of a major search could be very very expensive.

�m. Pg. 069, HERBS Tape Mapping: The National Academy of
Sciences report "The Effects of Herbicides in South Vietnam"
Part A, Summary''on page IV-104 shows just such a mapping as is
desired to be accomplished. We understand that it took the
computer at least 5 twelve hour runs to produce these maps.
Why should they be done over as they were made directly_from the
HERBS hard copy reports and should be available. This is a very
costly process to duplicate. As may be seen from the referenced
page, each spray track is shown on the map with the date of the
mission, number of gallons sprayed and the type of herbicide.
(Attachment 2 enclosed)

^

~ -.;; ^sssssz?..*'

n. Pg. 070, Major portion of page: This is an idealized
approach and is not at all typical to many units operating over
there, especially those which were air mobile, or to Marine .
units. We determined this when we looked at the same Marine
battalion that GAO had said was right under a spray track. In
one of the battalion studies no detailed unit records were found
for an entire six month period.
~
o. Pg. 089, 1st new para.: As mentioned earlier detailed
personnel records for Korean veterans may not be available
because of the St. Louis records center fire. We understand
reconstruction (costly) of about 35% might be possible. One
major factor has been overlooked in a possible comparison
between Vietnam and Korean veterans and that is Korea was not
in a jungle environment and units operated as units. Winter
fighting was common in portions of the Korean war while Vietnam
was in a jungle environment with many different types of disease
exposures and small unit operations involving living off the
land. Korea was not a s&gt;. unpopular as Vietnam.
p. Pg. 249, Definition of Antipersonnel gas: Riot agents
such as CS and CN such as used in Vietnam were not antipersonnel
gases since they do not kill or incapacitate for an extended
j
period of time. Both CS and CN have been used throughout the
j
world by civilian police to control riots of civilians and in
i
prisions without causing fatalities. This improper definition /
should be corrected.
""'
q. Pg. 249, Definition of Battalion: An idealized definition,
not. necessarily true in Vietnam type combat operations.

�As you requested, we have reviewed the "Draft Protocol for Epidemiologic
Studies of Agent Orange", G.H. Spivey and R. Detels, U.C.L.A., submitted to
the Veterans Administration (contract V101 ( 3 P-842).
9 )
It is our understanding'that the purpose of the contract was to procure an
epidemiologic protocol outlining specific plans for the study of Vietnam
Veterans exposed to Agent Orange. The protocol submitted, if it is a final
product, does not fulfill this goal. It is diffuse and nonspecific and does
not outline an approach particular to the problem being addressed. In fact,
numerous epidemiologic approaches to the study of veterans, are outlined, as
are numerous hypotheses which could be tested. Not included, however, is a
clear discussion of benefits and drawbacks of various approaches, and a
clear recommendation for a study addressing this issue.
The authors of the protocol note a number of problems which they encountered
including access to military data and the issue of bias if specific plans
for a study of Veterans a_re publicly discussed. To these problems should be
added the very limited time which the contractor had to fulfill the
assignment. The question of scientific bias, however, should not continue
to be a deterrant to the development and outline of specific plans for a
study of the Vietnam Veterans. In fact, any protocol for such a stiidy
should be specific and receive the widest review possible before a study is
initiated.
In response to Senator Cranston's letter, it is clear that the current UCLA
protocol is inadequate. Therefore, a study is yet to be designed, and
conducted. Overall, it is our opinion that two important factors must be
present for the design and conduct of a study, regardless of what Group or
Agency specifically carries out these tasks. First, it is critical that
adequate epidemiologic expertise be available within the Group or Agency
which assumes responsibility, and second, there must be continuous interface
with and cooperation from the DOD and VA so that details of records and
activities during the Vietnam War are accessible to the researchers.

k

ael?end&lt;int

" ° further review of this UCLA protocol
P°

should be avoided due to its incomplete nature. In uarHo.lar-P
the National *ca&lt;toay of Seizes should be P^tponed^t 1 «

�This review represents my own personal assessment of the protocol
and does not represent necessarily a.
(Department
jposition. Several fundamental comments are provided in
the way of general criticism. More specific, perhaps less
important, thoughts are then attached, Atch 1.
a. Confidentiality of Protocol Design
Since premature public disclosure could potentially jeopardize
the validity of the study, it is agreed that certain specific
details of the protocol design requires restricted public
access. However, this scientific panel must obtain a more
detailed discussion of the study design. The Veterans
Administration must develop a mechanism which preserves the
validity of the study while providing adequate scientific peer
review. Functionally it would be preferable to have the detailed
protocol made available .to this panel with a follow on discussion
with Dr Sprivey and the other principal designers some weeks
later.
b. Definition of the Fundamental Question to Be Answered.
The Vietnam veteran through some form of "collective wisdom"
perceives himself to have suffered an abnormal, unexpected health
decrement either in himself or his progeny following his
participation in the Vietnam conflict. One cannot determine why
this "collective wisdom" has singled out Agent Orange as the
causative .factor. However, the "collective wisdom" of a group of
persons occupationally exposed has often times proved correct.
Subsequently,'the scientific community has then through rigorous
examination determined the cause of the observed decrement. I
have not come to a conclusion regarding Herbicide Orange, the
"collective wisdom" of the veteran may prove to be correct on
both counts i.e. health decrement and cause. However, close
examination of the "occupational environment" of the Vietnam
conflict does not easily reduce to a single factor of exposure
but rather reveals a multiplicity of exposures which singularly
or in combination could produce the decrements described. The
fundamental question to be answered by the VA study is: . Did the
Vietnam conflict participant incurr a health decrement risk over
and beyond that which was expected and' secondly if a risk was
incurred is it service connected? The Congress, perhaps naively,
tried to address this question by directing the VA to conduct an
epidemiology study. Approximately a year later the Congress had
gathered additional information on the Vietnam experience. While
not yet an act of Congress, the newly proposed legislation has
enjoyed wide acceptance and support. . The so called broadening of
the VA study to include other possible causitive factors was
supported by this'scientific panel.

�Dr Spivey has concluded that "the original Agent Orange question,
# 1 page 30, addressed with suitable safeguards for confounding
by other exposures and factors, would seem to be the most
appropriate for this study". His discussion of this narrowly
definded question leave's the impression that a true decrement may
go unrecognized and that sequential study of other narrowly
defined exposures may be necessary to determine the existence of
a health risk. The Government and the veteran wants an answer to
the broader question in terms of what diseases and health
decrements are in excess of the norm and is the excess, if it
exist, service connected. For the purpose of prevention of
future disease the identification of the causative factor becomes
useful.
Dr Spivey's discussion of the broader question, fno. 4, page 33,
implies that the discrimination of an effect would not be
decernable. A properly .designed study could examine the
existance of disease excess in both broad categories of impacted
systems and specific disease end points. Identification of
exposure factors could be examined by use of a regression
matrix. The use of multivariate statistics may be ideal in this
study design instance. Further, a group of reasonably informed
individuals could develop a list of major independent variables
(occupational and environmental exposures) which given present
state of the art knowledge represent potential risks to human
health singularly or in combination.
c. Exposure Criteria
The Spivey design if adopted would be largely dependent on an
exposure which at this reading admittedly lacked definitive
objective criteria. Sole reliance on the Herbs tape and troop
headquarters location assumes that the aerial spraying of
herbicide was the principal route of exposure to 2,4,5-T
containing herbicides. This method functionally ignores the
application of herbicide by means other than aircraft and
helicopter. Additionally, it fails to observe the possible
presence of other 2,4,5-T containing herbicides 'which may have
been used by local commanders. The various agencies were free to
procure these herbicides through the Federal supply system; the
General Services Administration (GSA) regularly negotiated
contracts with private companies. Only the tactical herbicides
were controlled and even then local commanders obtained these
herbicides probably by barter. A list of commerically available
2,4-D and 2,4,5-T herbicides is attached, Atch 2. It is not
known how many of these were procured by the GSA. Attachment 3
lists some Federal Stock Numbers (FSN's) which were 2,4-D and
2,4,5-T containing herbicides other than Herbicide Orange. If
Herbicide Orange is the causative factor for the health
decrements claimed, the aerial application was not necessarily
the significant route of exposure. While the quantities applied
aerially were massive, the ground troop proximity was not
sufficiently close to represent a significant exposure. A more
likely exposure would have been 'the local application of
herbicide to base perimeters and associated undesirable
vegetation. Here some ground troops were immediately adjacent to
the spray. This is not to say that in certain instances that the
Ranch Hand aircraft application of herbicide to base perimeters
didn't occur. There is reason to believe that base perimeter
spraying by Ranch Hand did occur.

�Lastly/ if the Herbs tapes are to be used to establish exposure
then a consistent objective exposure model needs to be
developed. Such a model must consider wind direction, altitude
of dispersal, air temperature, particle size, volitility of the
herbicide and the type of vegetation targeted. If ground troops
were not directly below -the spray path, then the above parameters
become important in determining what residual material may have
been inhaled by personnel located some distance away from the
spray path. Obviously the greater the distance the less the
concentration of exposure. However, a simple plume dispersion
model may not be appropriate since local vegetation would
intercept the mist/vapors and incident radiation may degrade the
level of TCDD. It is suggested that local weather information be
used if available. Failing that, simplifying assumptions could
be made using seasonal information. Development of this
methodology may not prove definitive but would most likely
describe reasonable bounds for exposure.
d'. Proportionate mortality study
This short term study proposed by Dr Spivey's group has merit.
The proportionate mortality study should be undertaken even
though the results may be less than definitive.
ln conclusion, I am not convinced that significant ground troop
exposure to 2,4,5-T containing herbicide occured as a result of
!, aerial application.
Other uses of the herbicide most likely
represented a greater exposure. Additionally the exposure to
other occupational and environmental factors present in Vietnam
represent equivalent in greater risks of chronic disease. The
study must address the question of did'the Vietnam conflict
participant incurr a health decrement risk over and beyond that
which was expected and secondly, if a risk was incurred, is it
service connected? This protocol requires greater examination of
the exposure criteria and the futher discussion and refinment of
\question number four, page 33.

3 Attachments
1. Specific Comments
2. Formulations Containing
2,4,5-T

�^

Specific Comments
1.

Design of a Study Using Vietnam as the Exposure Criteria

The concept of a factorial experimental design could be used
to establish as independent variable matrix. This matrix could
have incorporated within it the Agent Orange exposure as well as
exposure to such factors as Dapsone, pentachlorophenol, other
2,4-D and 2,4,5-T herbicides, Malithion, illicit drugs, alcohol
consumption, riot control agents, DEBT and smoking.
Variables
which are not quantitative or quantifiable could have digital
descriptors applied as indicators of exposure.
The dependent variable matrix could access categories of
disease or specific disease end points. The independent matrix
could then be used to predict disease outcome via miltivariate
regression. If significant relationships were found,
examination would be required to determine plausibility before
causation could be assigned.
The control group of non Vietnam veterans would have
similiar independent and dependent matricies developed. A
comparison of the two dependent matricies would examine the
question of health decrement over and beyond what was expected.
All persons in the study matrix would receive a study
questionnaire and have their military and private medical
records examined. A random number of personnel in the large
matrix cells would be selected for physical examination. The
objective physical examination findings would flesh out and
validate the independent" and dependent matricies. Should
significant health decrements be found in certain matrix cells,
additional cell members would be physically examined to validate
the initial findings. Mortality analysis of the full cohort
would be undertaken.
2.

Personnel to be studied

While the greatest involvement of personnel did occur in the
time period 1965-1972, the greatest concentration of TCDD in
2,4,5-T containing herbicides occurred prior to 1965. Any
exposure criteria uniformly applied across the years of
involvement would indicate that .early year personnel would have
been exposed to greater levels of TCDD. Also, it would seen
advantageous to include people who had multiple year exposure.
Personnel who voluptered to go to Vietnam should be included
in the study. If desired the differentiation of volunteer/
draftee and enlis.ted/officer personnel could be entered into the
independent variable matrix. The illicit drug and alcohol
habits of the four possible groups may have been different.

�:£i:ji!iKVfcV^^

Note: The Marines had a policy of. no hard liquor while in
Vietnam. It is unclear if this was for all Marines.
3.

Cost of Study

At ,the present time cost is not a consideration of study
design. Only after the best possible scientific design has been
established must a judgement be made to accept the anticipated
cost. In this case it could seem cost acceptance becomes the
ultimate burden of the Congress after the Veteran's
Administration describes what can or cannot be done
scientifically.
4.

Assessing Herbicide Orange Exposure by Questionnaire

This technique frequently used in an occupational setting is
extremely risky in this case. Since the same aircraft sprayed
White and Blue, the recollection of a study participant that a
plane or helicopter "flew near or over him spraying something"
will not establish exposure to Herbicide Orange. The additional
observation that a camouflaged aircraft was used doesn't narrow
the possibilities.
The first Ranch Hand planes sent to Vietnam for defoliation
had bright silvery skins.
5.

Active Duty Deaths

One should not assume that an active duty death occurring
within one year was due to traumatic battle injury.
Additionally, the fact o_f contributory cause may be important if
the immune system were compromised. Lastly some deaths may have
occurred as a result of disease only.

�i^/w^.^&amp;rtSi^i&amp;fcC'rt.U.i.^yS^^

67346

.

Available Formulations Containing
' as of February 1, 1973
Arnchem Products, Ambler•, Pennsylvania 19002

Emulsamine 2,h,5~T
Alkjclamine salt

$8.9% act. ing.

33.7# a.e.

3 Ib/gal

Envert-T
Butoxyethanol ester

33.9* act.- ing.

Trinoxol
'
Butoxyethanol ester

59.7# act. ing. 1*2.9$ a.e. k Ib/gal

Trinoxol Super 6
Butoxyethanol ester

2h.3% a.e. 2 Ib/gal

•
8 . $ act. ing.
15

58.5£ a.e. 6 Ib/gal

57.2£ act. ing.

lil'.Qfc a.e.

h Ib/gal

. £8.3^ act. ing.

ijl.9^5 a,e«

h Ib/agl

Weedone 2,li,?-T ,3?pcial Air Snray Formula
Butoxyethanol ester
£8.7^ act. ing.

1^2,2^ a.e.

it Ib/gal

Weedar 2,h,?-T
Triethylamine salt
Weedone 2,!t,^-T
Butoxyethanol eater

gjlt-D and 2,&gt;-t,£-T mixtures
Dinoxol
Butoxyethanol-ester
Emulsamine HK •'
Alkylamine salts
./' '
'• Dinoxol Super 6
Butoxyethanol esters
Emulsaverb 100
acid 't anune salt
F^nulsavert 2h8
acid &amp; amine salt

2,i;~D 3 . a.i. 21.75? a.e. 2 Ib/gal
1^
2,U,5-T 30.2£ a.i. 21.735 a.e. 2 Ib/gal
2,U-D
2,^,5-T

3 . a.i, 16.93? a.e. 1.5 Ib/gal
1W
'29.5^ a.i. 16.5^ a.e. 1.5 Ib/gal •

2,h-D
2,fc,5-T

Ii3.?q' a.i. 29283 a.e.
la.755 a.i. 29.8* a.e.

3 Ib/gal
3 Ib/gal'

2,U-D
2,U,5-T

21.255 a.i. ..11.9^ a.e.
21.255 a.i. 11.92&amp;ra.e.

1 Ib/gal
1 Ib/gal

2,li-D
2,h,5-T

13.25C a.i.
6.1^ a.e.
19.3^ a.i. 12.255 a.e.

^Ib/gal
1 Ib/gal

�, / '' •^V;V\ •',:l'c7;'.; ;^
' •-

:.^..^^i^^^'^'';^-''^^^^

:.'•'•....-•' ' ' . . • '••", . !•' •.': • ^ .V.-«/.' '•

3.'

~ *- "
1

Envertf-.DT
Butoxyethanol ester

G7347

_ 2,h-D 1-7.1% a.i.
2,U,5-T ' 17.03.a.i.

12.2$ a.e.
12.2g ae.

lib/gal
1 Ib/gal

j'

Weedar Amine BK •
Dimethylamine salt
2,ij-D
Trimethylamine salt 2,U,5-T
V/eedone BK 6k
Butoxyethanol ester
Weedone IBK
Butoxyethanolester

2,/i-D
2,U,$~T
2,h-D
2,U,^rT

2k.5$ a.i. 2 . $ a.e. 2 Ib/gal
0[
2 . a.i. 2 . $ a.e. 2 Ib/gal
8^
01
19.7^ a.i. lh.2^ a.e. 1.33 Ib/gal'
lil.^- a.i. 28.6^ a.e. 2,6? Ib/gal
31.1^ a.i. 21.1$ a.e. 2 Ib/gal
29.7^ a.i. 21.k% a.e. 2 Ib/gal

Dow Chemical Co . , Midland^ ^ M i chiga n o 86ItO

Esteron 2h? Concentrate
Propylene glycol butyl ether ester

92.5'^ a.i. 60.2^ a.e'.

Esteron 2l
Propylene glycol butyl ether ester

69.2% a.i, U5&gt;»0$ a.e. k Ib/gal

Heddon
Propylene glycol butyl ether ester

20.1$ a.i. 13.3$ a.e. 1 Ib/gal

Veon
Trimethylamine salt

$6.1% a.i. 1 0 2 i.e. k Ib/gal
:,$

Verton 2T
Propylene glycol butyl ether ester

37.2$ a.i. 2lu2$ a.e. 2 Ib/gal

6 Ib/gal

* V

''

' 2 &gt; Ij-D and 2, Itf 5&gt;-T mixtures

Brush Killer LV 2-2
Isooctyl esters

3k.7% a.i. 23.03 a.e.
33-K a.i. 23.03 a.e.

2 Ib/gal
2 Ib/gal

6£.0$ a.i. 'k$,3% a.e,

k Ib/gal

Esteron Brush Killer
Propylene glycol butyl either esters
(PGBE)
2,h-D
•
36.0'&lt;a.i.
22.2^ a.e.
2,U,?-T
3U.1J6 a.i. 22.2% a.o.

2 Ib/gal
2 Ib/gal

Brush Killer LV liT
Isooctyl ester

Tippon 2-2
PGBE esters

2,h~D
2,U,5~T
2,U,$-T

2,h-D
2,ii &gt; £~T

36.3^ a.i.
3luW a.i.

22.1$ a.e.
22.k% a»e.

2 Ib/gal
2 Ib/gal

�.. ,
..;'•'• .;• i'Vii%'t'v'»'4'-$'*i'^'1:'1'1'' •;' V
.'...,• . • ; '••j.j ,:**^&gt;wfrn. !."..'--•'•••
•&gt; •

— 3 —

67543

Veori Brugh Killer
Dimethylamine
. Trimethylamine

2,4-D
2-,4,5-T

24.3% a.i.
2.8.2% a.i.

20.2% a . e .
20.2% a.e.

2 Ib/gal
2 Ib/gal

Verton CE
(PGBE)

2,4-D ' 36.0% a.i.
2,4,5-T
34.17o a.i.

22.2% a . e .
22.2% a.e.

2 Ib/gal
2 Ib/gal

10.3% a.e.
41.3% a.e.

1 Ib/gal
4 Ib/gal

TORDQN and 2,4,5-T Mixtures
Tordon 155
Isooctylester Piclorara
PGBE
.
2,4,5-T

15.1% a.i.
63.4% a.i.

Thompson-Ha yward
2.4.5-T
BED-WEED- LV-6

2,4,5-T

64.0% a.i.

44.4% a.e;.

4 Ib/gal

2,4,5-T

IsoocyCl. ester

83.5% a.i.

58.8% a.e.

6 Ib/gal

22".2% a . e .
22.2% a . e .

2 Ib/gal
2 Ib/gal

DED-WEED LV-9

Isoocytl ester

2.,4-D__ and 2,4, 5-X mixture
DED WEED LV-33
Isooctylester
Isooctylester

2,4-D
2,4,5-T

33.5% a.i.
31.9% a . i .

Transvaal Inc. , Jacks£nville, Arkansas

7207/?

2.4,5-T
Brush-Rhap A-4T
Triethylamine salt

2,4,5-T

. 57.0% a.i.

40.8% a.e.

4 Ib/gal

Brush-Rhap LV-4T
Ethyl hexyl ester

2,4,5-T

65.3% a.i.

45.4% a.e.

4 Ib/gal

Brush-Rhap LV-6T
Ethyl hexyl ester

2,4j5-T

87.0% a.i.

60.4% a.e.

6 Ib/gal

Brush-Rhap A-2D-2T
Dimethyl amine salt
Triethylamine salt

2,4-D
2,4,5-T

24.7% a.i.
28.67, a.i.

20.5% a.e.
20.5% a.e.

2 Ib/gal
2 Ib/gal

Brush-Rhap LV-2D-2T
Ethylhexyl ester
Ethylhexyl .ester

2,4-D
2,4,5-T

34.7% a.i. - 23.0% a.e.
33.1% a.i.
23.0% a.e.

2 Ib/gal
2 Ib/gal

�This document entitled "Draft Protocol for Epldemiological Studies of
Agent Orange" was prepared under the direction of Dr. Gary II. Spivey,
University of California, Los Angeles, California, Veterans Administration Contract V-101(.98)3P-842. It consists of three parts. The
first 19 pages are primarily an introduction. The second 65 pages
which are entitled "Research Methods and Proposed Protocol" primarily
represent a discussion of the difficulties normally faced in epidemiology
studies, and the rest of the document is a literature review covering
about 141 pages. In addition, an outline of a proposed cursory physical
examination is also attached.
From the information provided in this draft, it is not possible to
constructively criticize any proposed study since insufficient information
is provided to determine how this study is to be conducted. Apparently
the authors of this proposed protocol had a number of difficulties;
among them, the inability to obtain exposure data partly because they
did not have any security "clearance. Basically, the authors of this draft
document recommend that cohorts be established for follow up, that they
receive a basic physical examination, and that a questionnaire be administered.
The proposal in the document on how to determine exposure appears rather
cumbersome and will probably not be very rewarding. I, therefore, suggest
that battalions be identified and that the basic exposure of these
battalions be determined. The individual soldiers should then be assigned
to their respective battalions. In addition, the amount of time each
veteran spent in Viet Nam should be determined. It could then be
established on a subsample how great the variation is for the amount of
time that the different veterans actually spent within the battalion versus
the' amount of time spent in Viet Nam. If it turns out that the amount of
time per soldier spent away from his battalion in Viet Nam does not differ
a great deal, it is unnecessary to check for the presence or absence of all
soldiers in the morning report since the exposure for all of them will be
roughly the same. It is recommended that this be determined by the Department
of Defense under the supervision of the IIHS working..group and be reviewed
by an outside advisory group.
Since the sprayed Agent Orange is persistent in the environment, it is
assumed that, in addition to the exposure to spraying missions, the
soldiers had additional exposure while in sprayed areas. It is recommended
that it be determined whether battalions who were sprayed on were also
usually battalions that were in sprayed areas. In addition, all battalions
that were exposed to aborted missions should be identified and their special
additional exposure determined.

�While the Department of Defense is determining exposure levels of Viet Nam
veterans and identifying veterans who could be grouped into cohorts, it is
recommended that the Veterans Administration review the morbidity data
which have been collected in different Veterans Administration Hospitals
from Viet Nam veterans to determine whether any obvious clustering of
certain symptoms and signs can be identified, or any disease patterns
which are out of the ordinary. Concurrently with these efforts, a prospective and retrospective mortality study should be .conducted. Approximately twenty people should be trained to locate death certificates of
Viet Nam era veterans. Information about deaths of Viet Nam. era veterans
will have to be obtained from different sources since particularly in the
early part of the Viet Nam War, social security numbers were not used as
serial numbers. However, by using a multifaceted approach, it should be
possible to locate better than 95% of the death certificates within an
eight-month's period. Once death certificates have been located, the Viet
Nam veterans have to be separated from veterans who served in other areas
during the same time period. In addition, all casualties can be separated
before a retrospective mortality study is done. In addition to this
retrospective mortality study, a prospective mortality study can also be
initiated at the same time. A more detailed outline of this study will
be provided later.
. .
Since the Veterans Administration and the Department of Defense are most .
familiar with their own records and since this is merely a search for
records, no obvious bias could be introduced into this part of the study
or into the interpretation of the analysis of death certificates, particularly if the raw data are made available to a review group. There is,
therefore, no reason why this should be done by a group outside of the
military, particularly if outside help is solicited in areas where no
internal expertise is available.
It is stated on pciges 64 and 65 of the present draft document that from
the Viet Nam era veterans during the period from 1965 to 1972, there are
now 130,000 deaths and that approximately one-third (i.e., A3,000) of the
soldiers are expected to be Viet Nam veterans. These numbers should be
rechecked since there have been statements in the press that a total.of
about 50,000 veterans were killed in action in Viet Nam. One would have
to assume that there should be many more death certificates than 43,000.
In summary, prior to any further attempts-to design a study on Viet Nam
veterans, it is recommended that the Veterans Administration review the
morbidity data they have collected thus far, that the Department of Defense
establish detailed exposure data and determine what the sizes of prospective
cohorts might be, and that the Veterans Administration embark on a
mortality study. Since any outside group is unfamiliar with the record
keeping system of the military, it would be redundant, wasteful, and time
consuming to have outside groups do this preliminary work for the military.

�\

As requested at our last Advisory Committee meeting on Health Related Effects
of Herbicides, I have reviewed the Draft Protocol submitted by Dr. Gary H.
Spivey and Dr. Roger Detels of the Division of Epidemiology, School of Public Health, University of California, Los Angeles, California. I have read the
report, but I am not professionally qualified to comment on many of the
medical and epideraiological aspects of the Draft Protocol. It is my understanding that the Department of Health and Human Services (HHS) will provide
sufficient epidemiological expertise to comment on those segments of the report.
Dr. Spivey does make a good case, however, for the historical cohort design in
his proposed epidemiological protocol.
I am qualified to comment on two issues in the report, i.e., (1) Review "of
Environmental Behavior of Agent Orange, and (2) Exposure.
ExperimentalStudies
The section dealing with environmental studies is understandably brief and
should be so for a report: of th'is nature. The authors have done an acceptable
job of reviewing the major environmental issues. However, since the magnitude
of the literature is substantial, they have only treated it in a superficial
manner. Its major problem is that it presents a non-critical evaluation of
the literature. Consequently, it presents selected references without really
commenting on the relevance of such data to the proposed epidemiological study.
There are numerous typos in this section that should be corrected in the next
typing.
Exposure
.
^
I am deeply troubled by this aspect of the report. On page 43, the authors
correctly surmi.se, "We have not identified a mechanism which would document
actual exposure." Over the past year in our Committee, as well as the Agent
Orange Working Group in the White House, wo. have wrestled, frankly unsuccessfully, with trying to establish some mechanism for documenting exposure.
I recall clearly our meeting with the members of the National Academy of
Sciences and their comments regarding any proposed epidemiological study
on Agent Orange exposure, in Vietnam. Th2 take-home message was, "If we
can not scientifically validate and docur.cnt exposure, we csn not do a scientific epidemiological study." Although Spivey'a approach .suggests a mechanism
by which we might overcome this problem, I suspect we are justifiably due some
criticism for the grouping approach. I am now pursuaded that we will never
be able to do an epidemiology study on individual veterans per se, but must
examine military units serving in specific spray areas. There is now some
hope from recent DOD activities that we might be able to document some segments :
of the military population in Vietnam exposed to Agent Orange. Every effort then
must be m'ade to work closely with Mr. Christian and his associates in DOD in
meticulously reviewing records and films to establish some case for exposure.
;

�I believe Dr. Spivey and his associates hav.e made a start on identifying the
kind of epidemiology study needed and the information necessary to begin the •
project. I am not impressed, however,, that"we liave a working program that
could be used for the basis of funding a large epidemiological study mandated
by Congress. We have a long way to go, and a major problem is the quality of
the record of documented exposures that can be elicited from the DOD Record
I Center. I recommend we do not fund any additional feasibility studies until a
I thorough and comprehensive search and cataloging of available DOD records, films,
| and reports is completed.

&lt;v

I

.

H
As a concise detailed protocol this document is clearly only a preliminary
outline, primarily, as the authors stress repeatedly, because they have yet to
be able to assess the data sources on which the studies will depend. As a
result, the document consists mostly of extensive reviews of various aspects
of the Agent Orange/dioxin'issue, its history, and public reaction. It also
presents much material describing epidemiologic prinKJ^les and techniques.
The latter is well written, clear and concises a good statement of principles
and issues underlying the choice of cohort study approach.
Considering the lack of access as yet to data sources, the proposal as
presented seems quite reasonable: a retrospective cohort study, preceded by
some feasibility work and several preliminary studies using existing overall
veteran mortality/morbidity data. The cohort study itself would be a massive
effort, the details of which cannot be fleshed out until the investigators
examine first-hand the materials they will need to use. Until they get to
that point, however, one cannot expect them to produce a protocol document of
the sort we were able to construct for our birth defects/veterans study (given
the fact that data sources and methodology were all at hand and familiar to
us). Unfortunately, from our experiences with the "Smoky" cohort followup, I
would be pessimistic that the investigators will have easy and prompt access
to data or that tracing cohort members will go smoothly.

�</text>
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Descripton Notes

Wednesday, June 06, 2001

Page 1673 of 1688

�DR. MICHELE FLICKER
VAMC
4801 LINWOOD BLVD
KANSAS CITY,MO 64128
DEAR MICHELE
Thank you for sending the data from
Rappe's paper.
I hope that his present-ation and that of Hardell was worth
while.
I talked with Dr Houk today (Hay 14)
about contributing at Eayreuth on both
Risk Assessment and Status of CDC Studies on Agent Orange/Dioxin. We
had the opportunity to discuss the VAX
EPA ADIPOSE TISSUE STUDY- Without a
doubt he feels that he can contribute
and support the study,, Count on him
to furnish standards and quality control assistance., Thus? I believe that ono
the AOWG approves the protocol? it will be time to ask all three agencies for
the financial resources to conduct the
study.
Please keep me informed of your progress on the protocol and if you can draftup cost estimates to complete the task
it wouId be worth having them»
Best wishes.,
Sincerely

�</text>
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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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01469

Author
Corporate Author
Report/Article Title
Journal/Book Title
Year

0000

Month/Day
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32

DOSCriptOD NOtOS

Includes "Agent Orange Controversy: Is Agent Orange
Responsible for Health problems Reported Among
Vietnam Veterans?", OSTP Issue 1981-1988; Agenda
for the Domestic policy Council Agent Orange Working
Group at DHHS; "Air Force Health Study: Study
Overview and Update," Air Force Systems Command;
three articles, "Agent Orange: An American Tragedy",
Joe Cole, The Stars and Stripes National Tribune,
November 14,1988, "Legion Testimony Attacks CDC
Study of Agent Orange", The Missouri Veterans News,
"The Declassified War", Anthony L. Kimery, Veteran,
November/December, 1988; correspondence from
Congress to Donald M. Newman, Chairman, Agent
Orange Working Group, November 22,1988;
memorandum from National Vietnam Veterans
Coalition, November 1988, No. 48, "Agent Orange:
Pending New Legislation"

Tuesday, May 15, 2001

Page 1469 of 1514

�OSTP ISSUE
1981-1988

AGENT ORANGE CONTROVERSY

Is Agent Orange Responsible
For Health Problems Reported
Among Vietnam Veterans?

�BACKGROUND
From 1965 to 1970, USAF Applied in
Tactical Operations in South Vietnam,
&amp;

42 Million Liters of Agent Orange.

2.5 Million Military Personnel From the
U.S., Australia, New Zealand and South
Korea Served One-Year Tours During the
Same Period.

BACKGROUND (Cont'd)

�Beginning in 1978 Many Veterans Of
That Era Reported Medical Problems
That They Believed Stemmed From
Exposure To Agent Orange During Their
*»
Military Assignment.

Complaints Have Ranged From Tingling
In the Extremities To Skin Disfigurement
And Rare Forms Of Cancer. Some
Veterans Have Fathered Children With
Birth Defects.

�DPC AGENT ORANGE WORKING
GROUP (AOWG)
o

1981 President Reagan Established the
AOWG.
&lt;5&gt;

-

Chaired By Under Secretary Of HHS

-

Serves As Overall Coordinator,
Clearinghouse, And Evaluator Of The
Federal Research Efforts

o

Policy Group - HHS, DOD, VA, OMB, OPD
and OSTP

o

Science Panel - CDC, NIOSH, NIEHS, NCI,
Air Force, OSHA, EPA, USDA, DOS, &amp; OTA

�STATUS OF AOWG ACTIVITIES
o • In The Past 7 Years, AOVVG Provided
Oversight To 10 Major Health Studies And 5
Major Health Surveillance Programs.
• ' • • ' ' .

o

•

*

Federal Agencies Have Expended $200 M
On Human, ToxicologicJAnd Environmental
Studies.

o

i"

CDC/Air Force Developed State-Of-The-Art
Methods For Detecting And Verifying
•

• . - . - • .

:

• •

i

Exposure.
o

Serum Dioxin Studies Completed On
Ground Troops.

�Serum Dioxin Analyses Underway For
Cohorts In Air Force Health Study (The Men
Who Served in AF Defoliation Program In
SEA And Their Matched Controls).

�FINDINGS
To Date, No Major Health Effects (Mortality,
Cancer Or Birth Defects In Children) Can Be
»

Associated With Agent Orange Exposure in
Vietnam.

�RECOMMENDATIONS

Retain DPC Agent Orange Working Group
Retain HHS As Chair
Within 18 Months, CDC Rare Cancer Study
And Air Force Health Study Will Be

Completed.
Publish Findings, Brief Congress
Close-Out AOWG

�**
»
s
&lt;

DEPARTMENT OF HEALTH &amp; HUMAN SERVICES

office of the Secretary

\
*0

Washington, D.C. 20201

AGENDA FOR THE DOMESTIC POLICY
COUNCIL AGENT ORANGE WORKING GROUP
December 6, 1988

-

2:00-3:00 P.M.

Welcome and Introductions

Report from DOD

Chairman Don Newman

Admiral Edward Blasser ,DAS/Defense

A presentation by Major-General James Sanders, Air Force
Deputy Surgeon-General and the USAF Health Study (Ranch
Hand) team.

Report from Chairman Science Panel

Remarks from the Veterans Administration

Dr. Vernon Houk

Don Ivers

Other business from Members

Chairman Don Newman

Closing remarks

Chairman Don Newman

�DECEMBER 1988
BRIEFER:
COL WILLIAM H. WOLFE

EK-RT-i; -.1

�SERUM DIOXIN STUDIES

ASSAY DEVELOPED AT CDC TO DETECT DIOXIN IN SERUM
AT PARTS PER TRILLON LEVEL
JOINT USAF/CDC EFFORTS:
HALF-LIFE STUDIES (7.1 YEARS)
ASSAY OF AFHS PARTICIPANTS
PRETEST OF 200 DEMONSTRATED ASSAY VALIDITY
RANCH HAND MEAN = 48.0 PPT
COMPARISON MEAN =

4.8 PPT

EXPANDED STUDY OF 2010 PARTICIPANTS
TO BE COMPLETED IN 1989
FUNDED BY HQ AFSC WITH REIMBURSEMENT FROM
EXCESS VA^ FUNDS (S.11)

/

j

DETAILS OF TRANSFER BEING ARRANGED
FUNDS TO COVER COST OF ASSAYS AND ANALYSIS

J
EK-RT-12-11 881122

�STATUS TO DATE

SERUM DIOXIN VALUES IN AFHS PERSONNEL
GROUP

"NUMBER

MEAN

RANCH HAND

283

35.0

COMPARISON

246

4.8

RANGE
1.6 - 313
0 -

84

1 6

~313

RANCH HAND
ENLISTED GROUND

184

46 3

'

'

OTHER OCCUPATIONAL STRATA ARE TOO SPARSE
FOR ANALYSIS AT THIS TIME

J
SAM/LS-10-11 881122

�AIR FORCE HEALTH STUDY
250 -r

SERUM DIOXIN RESULTS

200--

COMPARISONS

150- -

RANCH HANDS

NUMBER OF
PARTICIPANTS
100:,

50--

•llllil

0-9

10-19

20-49

50-99

SERUM TCDD LEVEL (ppt)

100-199

200 or
^ more

�SCHEDULE OF REPORTS

REPORT

PUBLICATION DATE

1989 MORTALITY UPDATE
COMPARISON COHORT EXPANDED
(N=19, 101)

WINTER 1988/1989

BIRTH DEFECT REANALYSIS
BASED ON FULLY VERIFIED DATA

SUMMER/FALL 1989

THIRD MORBIDITY REPORT

FALL/WINTER 1989

SAM/LS-10-4

881122

�FUTURE PLANS

1989

COMPLETE SERUM DIOXIN ASSAYS

1990

ANALYZE SERUM DIOXIN DATA AND PUBLISH REPORT

1991

PREPARE FOR AWARD OF CONTRACT FOR THIRD
FOLLOWUP EXAMINATIONS

1992

CONDUCT PHYSICAL EXAMINATIONS

1993

ANALYZE DATA

1994

PUBLISH REPORT

SAM/LS-10-13 881122

�AFHS ADVISORY COMMITTEE
ISSUES

SCIENCE PANEL OF THE AOWG STRONGLY SUPPORTS KEEPING
THE CURRENT ARRANGEMENT WITHIN DHHS
USAF PRINCIPAL INVESTIGATORS STRONGLY FAVOR CURRENT STRUCTURE
ANY ACTION BY USAF OR DOD TO MANAGE THE COMMITTE OR
SELECT ITS MEMBERS WILL GENERATE CHARGES OF INTERFERENCE OR
CONFLICT OF INTEREST

INTENSE CONGRESSIONAL INTEREST EMPHASIZES NEED TO
MAINTAIN SCIENTIFIC INDEPENDENCE

SAM/LS-10-10

881122

�AFHS ADVISORY COMMITTEE
RECOMMENDATIONS

RENEW CHARTER OF THE ADVISORY COMMITTEE
RETAIN RESPONSIBILITY FOR THE COMMITTEE WITHIN DHHS
SELECT MEMBERS AFTER REQUESTING NOMINEES FROM
VETERANS GROUPS
SELECT CHAIRMAN FROM CIVILIANS CURRENTLY SERVING
DR LEONARD KURLAND
DR RICHARD MONSON

SAM/LS-10-14

881122

�ADIPOSE TISSUE TCDD LEVELS
IN EXPOSED PERSONS
MISSOURI 1986
0 - 100 PPT
EXPANDED
HORSE ARENA
RESIDENTIAL
WASTE HAULING
TCP PRODUCTION

20

50

150

250

350

450

550

PARTS PER TRILLION (PPT)

650

750

60

100

�SENT BY.'Xerox Telecopier 7020 ;12- 5-58 ; 8-52AM

4044884531^

2024723519I« 3

VIETNAM VETERANS
(646 MEN)

1 MAN

•4.

&lt;

•*.

&lt;

fc

*

NON-VIETNAM VETERANS
(97 MEN)

too
•
0
•
0
70
BO
•
0
40
•
0
BO
10
0

RANCH HAND
GROUND CREW
(147 MEN)
A. • 1 MAN

COMPARISON
GROUND CREW
(49 MEN)

TCDD (PARTS PER TRILLION)

�30000 1
27821
27032

DC
QC
LU
Q.

20000 '

CO
hQC

LU
&gt;
LU
_J

Q
O
O

10000 -

BACKGROUND
REFERENCE
RANGE (&lt; 20 PPT)

NO

NO

(.13)

(.16)

ND
NO
(.17) (.59)

137

PERSONS FROM
UNEXPOSED AREA
(ZONE S)

PERSONS FROM
EXPOSED AREA
(ZONE A) WITH
NO CHLORACNE

PERSONS FROM
EXPOSED AREA
(ZONE A) WITH
CHLORACNE

�to
CO
CM

OJ
O
CM

P P

30O-1
i
CO
CO

GOMPANY

25O-

TRUCKERS
PRODUCTION

20016OCM

If*

100
CO

u&gt;

I

ro
I

CSl

o
CM
o

o.
o
o

50-

c cc c c
o o o o o o o o o o

01

DA/S EMPLOYED IN PRODUCTION
X

o
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X

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04

100

90

IX

CD
O-J

80

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LU
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10
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CO

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70
60

so
40

RANCH HAND
GROUND CREW

(147 MEN)

30

^ - 1 MAN

20

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01

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ro

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COMPARISON

GROUND CREW
(49 MEN)

CM
CD

O
O

X
O

o&gt;
&gt;:

&gt;-

TCDD (PARTS PER TRILLION)

�"To C*r» For Him Who Stull
*n 6an&gt;« Th» Sctti* And
. Fo&gt; Ht* Wtahm And Ml. OrphtnAbrthMn Lincoln

.7

THE STARS AND STRIPES-THE NATIONAL TRIBUNE

14 NOVEMBER 1988

Agent Orange: An American Tragedy
In May 1983 officials of the Center for
Disease Control (CDC) recommend
evacuation of the Quail Run Mobile
Home Park near Times Beach, Missouri,
after EPA. officials find dioxin contamination in excess of four times that of the
town of Times Beach (1,100 ppb.). More
than 90 percent of the town of Times
Beach, located approximately 25 miles
southwest of SL Louis, Mo., was found to
be contaminated with more than 100 ppb.
of dioxin, according to a January 1983
report CDC officials warned the more
than 3,000 residents to stay away because
of health hazards.
Police were stopping the residents from
removing personal belongings out of fear
of spreading the contaminants to other
areas. Flooding of the Meramec River
may have further contaminated vast areas
of southern Missouri, Russell Bliss, owner of Russell Bliss

By Joe Cole
Drain Oil Service, has been identified as
the source of much of the contaminated
waste oils which were sprayed on over
100 sites in southern Missouri, including
Times Beach. The town of Times Beach
paid Bliss $4,800 for two applications of
the contaminated waste oils in 1971 and
1972. The federal government has since
paid a reported 34.5 million dollars for the
purchase of Times Beach, as pan of the
EPA Super-fund hazardous waste site
clean-up program.
Last April 1988, Mr. Brian Manza, a
disabled Vietnam veteran, visited the
Times Beach site, only to be turned away
by EPA officials, wearing "moon suits" as
Brian described them. Theentireareawas
fenced and posted as an extremely hazardous waste site. Brian's concerns are
obvious to Vietnam veterans who were
exposed to toxic chemicals in Vietnam.

Millions of gallons of Agent Orange,
contaminated with dioxin were sprayed
over vast areas of Vietnam. If two spray
missions using less than 5,000 gallons of
contaminated oil could do this to a town in
Missouri, what could millions of gallons
of oil-based herbicides contaminated
with dioxin at thousands of times the level
found in Times Beach do to a country
called Vietnam?
In 1986, the Centers for Disease Control
conducted blood serum studies of Vietnam veterans, as a possible method of
identifying those veterans who may have
been exposed to toxic chemicals while
serving in the Vietnam War. Their findings indicated that Vietnam veterans'
levels of dioxin in blood were similar to
those samples of persons who had not
served in Vietnam. Since the non-ex-

posed comparison group was selected
from the Times Beach and Southern
Missouri area, one can only speculate as to
the meaning of the studies results. Southern Missouri is no better nor worse than
Vietnam.
Last 7 July 1988, the Department of
Defense declassified documents which
revealed that the Defense Department-had
purchased a chemical plant at NVeldon
Springs, Missouri, which was to produce
8 million gallons of Agent Orange per
year by late 1969, over and above the
entire domestically produced product,
which was currently being used for defoliation in Vietnam.
Declassified USMACV reports indicate herbicide use in Vietnam during 1967
through 1969 was 11.9 million gallons per
year. V/eldon Springs, Missouri is located
approximately 25 miles west of SL
Louis.*

�THE MISSOURI VETERANS NEWS

PAGES

Legion Testimony Attacks
CDC Study of Agent Orange
WASHINGTON (ALNS) • smaller than the size of New
— The government has Jersey during the war. "It is
"fallen short of its responsi- absurd that the CDC says
bility" to compensate vic- that it cannot find enough
tims of Agent Orange expo- people to study," Sommer
sure, an American Legion said. He told the members
spokesman has told a House that the CDC developed a
subcommittee.
study that was "destined to
The statement submitted fail."
by John Sommer, director of
Basic research flaws were
the Legion's Veterans Af- committed by the CDC,
. fairs and Rehabilitation Di- Sommer said. Among the er1 vision, expressed serious rors made were what he
concern for the govern- called "cardinal sins of
ment's lack of responsibility epidemiology." First, the
in recognizing any problems CDC research diluted the efassociated with dioxin expo- fects of Agent Orange exposure. Sommer criticized the sure by including in the
Centers for Disease Control study group every person in
for its mishandling of re- Vietnam. For example,
search data, and for its about Lin every 5 men who
interpretation of the data the served in Vietnam actually
CpC researchers did gather. served in combat. The CDC
Sommer pointed out that "generalized" exposure to
the CDC study of Agent Agent Orange across the enOrange exposure was so tire service population in
limited by the restrictions Vietnam, so that the 20 per
upon just what veterans cent likely to be exposed
would be included that an was diluted by the other 80
accurate picture of these per cent of the non-exposed
veterans was not developed. men.
Veterans eliminated from
To further weaken the
the group which the agency . CDC's study, the veterans
looked at were those who who were not included in the
served more than one tour in . study took away the "statisVietnam, those who served tical power" of the potential
In a particular unit for fewer dioxin victims. "A knowthan 180 days, those who ledgeable epidemiologist
were above the rank of E-S, would try to optimize the
those who transferred from chance of observing an
one unit to another during effect by including, rather
their tour, and any veteran than excluding, the veterans
who served any number of who are most likely to have
days before or after the pro- suffered from exposures in
posed study window (Janu- question," Sommer said. '
ary, 1967-December, 1968).
Sommer also alleged that
The U. S. sprayed more the CDC would minimize any ..
flndlng^wWcnf^niuld^tte^
ffAgefir'Orange'16nvafci;area ^ Vietnam service to health

•" '

'

'

'

'

'

problems. Levels of combat
were not analyzed, nor were
other studies which showed
that levels of combat had a
great deal to do with health
problems of Vietnam veterans looked at. "It seems that
every time the CDC came up
with a positive finding, it
was interpreted to be either
negative or wrong," Sommer told the committee.
The CDC also failed to
avail itself of the compre;
hensive computer analysis
.of Vietnam service and
•where troops were during
different periods. He said
that the data, developed by
the U.S. Army and Joint Services Environmental Support Group, is one of the
most carefully developed
and extensive records of any
environmental exposure to
be found anywhere. He
chastised the CDC for opting
for a simplistic approach,
rather than using this vital
and readily available tool

Despite Congressional
mandates calling on the Veterans Administration to pay
a certain amount for certain
diseases, not one Agent
Orange claim has yet to be
paid. The VA also denied a
presumption for certain
problems to be related to
dioxin exposure, denying
even more veterans the right
to collect disability compensation.
Sommer's testimony also
endorsed a legislative initiative which would exclude
payments made to veterans
and their survivors under
the Agent Orange liability
settlement In 1984 from
being counted as income
when determining eligibility
for or entitlement to a veteran's or survivor's pension or
a veteran's medical care
under means test provisions.
He also called for the bill to
be extended beyond VA programs, to include any.
based government ass
tance program. •

�Declassified

War

Documents Disclose A/O Use
Counterproductive And Ineffective
By Anthony L. Kimery

I

has been nearly 20 yean since the last orangetripcd, 55-gallon drum of Agent Orange was
prayed on the green canopy of Southeast Asia.
Since that time, the debate about its use and lethal side
effects has appeared steadily throughout what are now
yellowing pages of newsprint, scientific journals, congressional hearings, and scholarly attempts to relate
' 'the history of its use. abuse, and deadly, devastating
consequences. Yet, after all that, there is still another
story to be told. It is the story about the internal policies, politics, and decision-making regarding the use
of chemical defoliants in Southeast Asia. The story is
based on reams of newly declassified military
records that -were recently released by the Army for
' storage at'the National Records and Archives Center
near Washington. DC.
This reporter spent weeks examining these records,
most of which were declassified for the first time since
being turned over to the National Archives. The documents show that America's use of defoliants in South
Vietnam—a program that would be expanded to include Laos and Cambodia in direct violation of MACV
directives governing the use of herbicides—was a holly debated and often strongly contested concept among
military and political planners, strategists, and analysts.
Agent Orange and its chemical cousin. Agent
White, were first introduced to South Vietnam in 1962,
albeit in limited quantities. According to the documents turned over by the Army to the National Archives, the defoliants were earmarked for three broad
purposes. First, they offered a means to destroy crops
and therefore deny foodstuffs to the burgeoning Vietcong movement in the coumryside';"second, they
offered a means to dampen infiltration by providing
observation corridors to South Vietmunete aerial spotters; and third, they offered support for allied
operations—by clearing out landing zones and firebases. Between its introduction in 1962 and the end of
the program in the early I970's, the U.S. government
dumped 20 to 40 million gallons of the chemical on
Southeast Asia, according to the documents. Exact
figures are hard to come by, in apparent reflection of
the willy-nilly planning of the U.S. program.
While actual day-to-day chemical operations were
under the titular control of the South Vietnamese government, it's clear the U.S. initialed and monitored the
program's effectiveness.
Contrary to popular belief, the most healed debates
about the use of defoliants were not over the dangers
they posed to human health, but over whether the
principal reasons for their being used were justified.
The Archives' records indicate that the military has long
been aware that the saturation of South Vietnam widi

herbicides was actually causing more problems than it
was solving.
The declassified records show that the horrific aftermath of Ranch Hand should have been avoided on the
grounds that the program was counterproductive with
respect to the objectives it hoped to achieve. Yet it was
allowed to continue. The documents also indicate that
within just a few years of their introduction to Vietnam, and continuing through the early I970's, there
was overwhelming evidence that the use of defoliants
was not hindering the VC by depriving them of foodstuffs.
A study conducted on the use of herbicides between
1%) and June 1967, for instance, found that there had
been nd effects of any significance from the use of the
herbicides. The study concluded that their use was
instead causing damage with respect to winning the
hearts and minds of the Vietnamese.
This report, and many others, clearly pointed to the
negligible benefits of the further use of defoliants. A
major policy review was convened in 1968 which,
while conceding that the risks of using the defoliants
did not outweigh the benefits, concluded that defoliation efforts should be intensified. As a result of this
study, a clause was built into subsequent directives for
using herbicides to permit their use in heavily populated areas, "in those cases of extreme military
necessity." More important stilt, the military documents show that economic considerations brought
about by the government's murd-million-dollar commitment to bringing on-line a government-run Agent
Orange production plant was an important factor in
escalating defoliation efforts.

I

n late 1967, prior to the broad-based policy review
on the use of defoliants in South Vietnam, the
American military command in South Vietnam
prepared a memorandum containing harsh language
about the "disadvantages" of using herbicides. "The
herbicide program carries with it the potential for causing serious adverse impacts on the economic, social,
and psychological .fields." the report concluded.
Nevertheless, the proponents of Agent Orange within
MACV continued to push for expanded use of Agent
Orange and other herbicides. Consequently, the debate
about their use continued to be rigorously fought in
Saigon, despite doubts about the herbicides' actual
effectiveness.
Probably no better illustration of the conflict within
the military over the use of herbicides is a July 1967
MACV memorandum setting forth new criteria for
defoliant use. "Crop destruction should continue to be
the highest priority for the use of herbicides." (he

memorandum states. It adds, "there has never been a
question as to the effectiveness of crop destruction."
This conclusion, however, is in glaring contrast to
what militarily contracted studies and intelligence reports were showing. A RAND Corporation report concluded in October 1967 that the VC required only three
percent of the total food consumed in the country, that
the crop-destruction operations were not in any major
sense denying food to the VC, and that Vietnamese
peasants, the target of long-range pacification objectives, bore (he brunt of the crop-destruction efforts,
and they held the U.S. and the Government of
Sourh Vietnam (GVN) responsible.
As of July 31, 1968. the VCand North Vietnamese
Army (NVA) had a daily food requirement of about
215 short ions, according to the documents. About 58
percent, or 124 short tons, could be internally procured
in South Vietnam. Of that, "only a small portion is
produced by the enemy in areas subject to herbicide
operations," a MACV report concluded. This report
added that "food shortages are reported in captured
documents, but they are temporary in nature and are
often the result of distribution problems. The enemy
usually meets the minimum food requirements of his
military forces."
Numerous internal MACV reports, memorandums,
and intelligence briefs support these conclusions. A
1968 MACV report on the RAND and other studies
states, "reported food shortages have been the result of
Allied sweep operations, not of herbicide operations.''
This had already been spelled out earlier, in a December 1967 field report to MACV, which states, "this
headquarters does not have empirical data on the
effects of herbicide operations on VC/NVA food
stocks, nor is there evidence that enemy combat operations have been cancelled because of food shortages
resulting from crop destruction. Such food shortages as
Continued on next page
Above: Three Air Force C-I.Ws spray Orange in
the A Shau. Right: A USAF airman operates spray
equipment during defoliation mission

NOVEMBnR/OECF.MRF.R |0«»

�are known (o exist among the VC arc the results of a
many-faceted program to deny resources to the
enemy." The report went on to stale that "the effort
and cost of employing crop destruction is insignificant
in comparison to (he troop effort required to control
and secure an equivalent area of rice."
(n a 1968 MACV evaluation of crop-destruction
programs which followed the final 1%8 herbicide policy review, Col. John Moran, chief of the Chemical
Operations Division, slated (hat "herbicide crop destruction is only one aspect of a comprehensive fooddenial program." Moran went on to stale that deprivation of food is due more to "Allied sweep operations"
and only "occasionally to herbicide operations."
The 196)1 MACV evaluation also emphasizes, as did
the contracted private studies, (hat "very few POWs
who have infiltrated ever mention the efforts of U.S.
herbicide operations. Some stale (hat they have seen
areas where vegetation has been killed but do not
mention any infiltration problems caused by (he defoliation. There are indications that U.S. herbicide
operations have had a negligible effect on NVA infiltration and combat operations."
Yet, while this report says, "herbicide operations
. . . appear to cause temporary food shortages in the
area defoliated, but have little lasting effect on
the VONVA food supply." it nevertheless states, "the
CINCPAC Scientific Advisory Group concludes,
without qualification, (hat the crop-destruction program is an essential and effective part of the total effort
in South Vietnam."
If there was ever any doubt about the ineffectiveness
of U.S. defoliation operations, however, they were put
firmly to rest in a MACV briefing paper dated December 1967. "Within the context of what has been studied, it would appear the crop-destruction effort may
well be counterproductive. The VC continue to feed
themselves, while the peasant bears the brunt_of the

deprivation and doesn't like it." In other words, the
U.S. policy of spraying Agent Orange over wide areas
of South Vietnam in order to deny the VC and NVA the
use of cover and food resources was not only not
working and unnecessary, it was actually harming the
American war effort.
ile it was agreed by military planners in
Saigon that the use of herbicides was sucT T cessful in denying the enemy cover, there is
abundant evidence that defoliants did not significantly
deprive the Vietcong access to food stores. One of the
most damning condemnations of the use of herbicides
found in the National Archives came in a November
20. 1968. letter from Robert II. Marian, USAID assistant director for economic planning and policy and
embassy counselor for economic affaire to U.S. ambassador Ellsworth Bunker.
Marian protested the expanding use of defoliants in
Quang Due and Phu Bon Provinces. "I feel compelled
to nonconcur in both proposals," Harlan wrote.
"Although crop destruction operations may have had
some successes, we suspect their effectiveness in hampering enemy military operations may have been exaggerated. The Report of the Herbicide Policy Review
Committee, itself, on Page 17 pointed out, 'herbicide
crop destruction is only one aspect of the efforts to
deny foodstuffs to the VONVA. The enemy relies on
commercial purchases, imports, taxation, requisition,
and confiscation for some 90 percent of his food
requirement.' "
The negligible contribution!! of herbicide operations
were equally evident with respect to the effect that
herbicide operations were having on the Vietnamese
population. In the early !960's. a herbicide evaluation
report noted, "the chief sufferer from crop-destruction
operations is the local worker." Such findings con-

At right: USAF sprayers in stables in South Vietnam; they
called for thousands of gallons. Below: Loading White on
an Irotjuois prior to defoliation mission. U.S. dispatched
special chemical teams

VETERAN

tinued (o mount through the balance of the 1960's and
up until (he 1968 policy review.
The same inconsistencies found in the debate about
the effectiveness of denying food to the VONVA were
just as replete in the debate over the psychological
effects (he defoliants were supposed to bring. One
MACV report. Advantages and Disadvantages of the
Use of Herhicides in Vietnam, states, "the herbicide
program dues not loom large as a public-opinion issue
at the present lime." At the same lime, a MACCORDS evaluation report was staling that "the herbicide program is one of the most widely known programs" among the population, and it "is a natural
topic of interest with people whose livelihood is in the
land."
"The principal effect on pacification is the animosity the peasant feels initially towards the U.S. for being
responsible for the damage," the MAC-CORDS evaluation says, "and then toward the GVN for its failure
to rectify the situation. There is nothing that can be
done beforehand lo head off the alienation the peasant
develops when his crops are destroyed." The MACCORDS report then summarizes the inadequacy of
South Vietnam government efforts to compensate antiVC peasants for the inadvertent loss of their crops.
"The present system is completely unsatisfactory
from the point of view of rectifying the economic
damage and its psychological impact by demonstrating
lo the peasant the concern of the government for his
welfare," (he report states.
"The slowness and unfairness of this system usually
result in further alienation of the peasant. He is left to
his own devices to find the means with which to replant
his crop, if there is enough time left in the growing
season, or lo find some other means of supporting his
family. Even if his claim were approved, the time lapse
between submission and payment and the fact that it
represents only a fraction of the actual damage, have
the result of leaving the peasant in the hole and bearing
the responsibility for an act he was helpless to prevent.
As long as the present system remains, the pacification
program is going lo suffer unpredictable .setbacks
which h is at present unable to alleviate wnh-^ny—'
effectiveness . . . The net effect is to alienate him
further from his government.
The report's conclusion seems to indicate that the
spraying of Agent Orange was having more than just a
slight impact on VC and NVA resources—it was
actually turning pro-government peasants into antigovernment guerrillas.
Col. Moran's report corroborates the MAC-CORDS
evaluation. "The vast majority of (he enemy's daily
food requirement is procured through taxation of the
people and purchases from the local markets," Moran
wrote. "While the enemy's production capability has
been reduced, his procurement efforts have enabled
him to sustain his forces. The taxes levied on the
people arc in the form of food, money, and services.
Through these measure!!, the enemy has been able (o.
procure enough food from outside his areas to nearly
offset his production losses.
"The obvious reaction of the peasant whose labors
have been destroyed is one of bitterness and haired. He
will frequently direct this hatred toward the U.SXJVN
for accomplishing the destruction. If he has previously
leaned toward the VC, he is likely to side with them
completely after the crop destruction.
"Captured documents and interrogation reports
indicate that the detrimental effects of herbicide operations far outweigh the beneficial effects." Moran
concludes. "Civilians living in VONVA-conlrolled
areas, whose crops are destroyed by herbicide operations, have no recourse but lo face famine and
possible starvation as a result of Allied destruction of
their crops."
The declassified documents clearly present a picture
which shows that the U.S.'s defoliation program nullified pacification efforts by alienating the Vietnamese
from not only the U.S.. but from their own government
as well. By the time the defoliation operations were
stopped, the damage was irreparable. The documents
also show that in other areas, the U.S. defoliation
campaign was counterproductive to the U.S. war
effort. The records show, for instance, that the destruction of valuable resources, such as harvestable limber
and rubber trees, was far greater than was reported or
admitted by the U.S. during (he war.

�s public concerns over the use of herbicides
intensified, the need for a policy was quickly
L recognized and embarked upon by (he U.S. It
is clear from (he minutes of those meetings (hat the
intent was to allay fears by not only continuing defoliation efforts, hut by expanding them.
The first meeting on this subject took place on January 17, 1968. under (he chairmanship of David
Carpenter, political officer at the U.S. embassy. In a
memorandum for the record distributed (he following
day by Col. Morin. he stresses thai Carpenter
"emphasized that if (here should be a leak of this
information to the press, (he embassy would receive
m a n y inquiries which would be d i f f i c u l t to
respond to."
Not only was the embassy keeping the true intent
and purpose of the policy review from the press, it was
also keeping it secret from the GVN. "Mr. Carpenter
cautioned the members of the committee that there
should he no release of the purpose and actions of the
committee (o the Republic of Vietnam," Moran wrote.
' 'There may be a need to call on officials of the Republic of Vietnam for certain data; however, such contacts
should be limited to (he specific subject area involved
without divulging any information of the policy review. He further requested that contacts with the Vietnamese government concerning these matters be conducted with his office."
Such secrecy contrasted with the U.S.'s repeated
assertion (hat herbicide operations were strictly under
the control of (he GVN. with (he U.S. providing only
support and logistic roles. This was again reiterated at a
September 20.l%8. background briefing for the press
in Saigon following the policy review.
The answers provided to questions raised by the
press during the briefing glaringly contradict information about the negligible effects of the defoliation programs. A memorandum to the secretary of stale from
Ambassador Bunker, drafted the week before the press
briefing, establishes that the press, public, and even

l*eft: Dr. James flrwn
inspects results tif
defoliant sprayin/t.
Below: Ranch hands
inspert chemical
Murage tank onboard
U.S. aircraft

In secret briefing papers prepared during late 1967, imum use of Orange."
at a time when the Department of Defense was purling
Another memorandum emphasizes the nerd to use
into motion an Agent Orange expansion program, it is ' 'Orange in lieu of White (o avoid further procurement
evident that orders for Agent Orange had consistently of White.'' Contracts for Agent Orange were having (o
far exceeded both the ability and capability for using be "terminated at msts in excess of 1.5 million dolthis herbicide, which had caused an enormous lars." with "ultimate" contract terminations costing
surplus—a surplus that was only going to get worse ihe government $19.1 million—a reflection of the US
with a new multi-million dollar, government-run government's inability lo draw-down the Agent
Agent Orange production plant soon to come on-line as Orange surplus.
a result of the expansion program.
' 'Considerable dollar savings may he expected from
One of the conclusions of these briefing papers, acceptable and maximum use of Orange." another
which helped to prepare the way for the pending policy memorandum stales. "Forestalling potential future
review, was that "MACV could be embarrassed if criticism of herbicide procurements should result if
[the) plant expansion is carried out, and the pro- Orange can be employed to a greater extent*... regrammed herbicide cannot be used."
quest review of requirements for both Orange and
A report prepared by USAF Col. H.F. Greenhow, White herbicides and recommendations concerning
Material Division, put the economic reasons for un- possible means to increase substitution of Orange for
precedented increase in the use of Agent Orange vivid- While."
ly in focus: "In view of the large inventory on hand,
Memorandum after memorandum reiterates Ihe sur(he huge investment in production capability, and the plus problem. "White is being consumed at higher
future low cost of Orange, it is imperative from an than forecast rates and is in short supply, while Orange
economic point of view (hat Orange be used to the is heavily overstocked." one report notes. "Every
maximum extent possible and that White be used only effort must be made lo schedule herbicide operations in
when there is a compelling operational requirement." such a manner that White will not be used in lieu of
Greenhow stressed that "the MACV staff computing Orange." another report says.
requirements need to be more accurate in (heir com"Considerations argue strongly for use of Orange,
putations and project their requirements into the future which is overstocked." wrote Army deputy assistant
and realize die dollar impact caused by changes in chief of staff. MACV. Brigadier General John G.
requirements."
Wheelock. 111.
By the time Greenhow prepared his report, howevFinally, on April 14. 1969, the U.S. embassy suser, MACVs "overstatement of requirements" had pended its policy requiring the use of Agent Orange on
caused "excess quantities (of Agent Orange) having certain restricted defoliation targets, such as rubber
been purchased." resulting in an 18-month supply on plantations and other valuable natural resources, and
hand in (he system, with an additional eight million allowed the "use of Orange herbicide on all defoliation
gallons per year to begin being produced in December targets." adding, "for economic reasons, the use of
1969 by the government's facility.
Orange is preferred."
The pressure was on. Twenty-eight million gallons
had been committed for the completion of this plant,
located at Weklon Springs. Missouri, as a result of the .
hen concerns about the dangers dioxin
deputy secretary of defense having, on erroneous information, ordered an Agent Orange expansion proposed to human health began to explode
gram on July 31, 1967, an order that came at a time
seven months later, in late 1969. there was
when MACV was well aware that the use of Agent still little attention paid to Ihe ramifications of the allOrange was far less than it was forecasting, or had the out effort to deplete Agent Orange stockpiles. A memcapability to use. It was also at a time when the MACV orandum from the deputy secretary of defense to the
the GVN. were being deliberately deceived about the secret briefing papers were pointing out that chairman of (he Joint Chiefs of Staff sent lo CINCPAC
"MACV could be embarrassed if plant expansion is carried concludes that "large-scale substitution for Orange
consequences of herbicide operations.
will not be permitted."
"We would prefer not to draw attention, even by out. and the programmed herbicide cannot be teed."
By early 1969. the problem with the surplus of
Despite (he fact that the memorandum points out
implication, to the serious shortcomings (he |policy|
review revealed in (he aspects of (he |hertncide| pro- Agent Orange was embarrassingly out of hand. Com- (even at this early lime) that the National Institutes of
grams." Bunker said.
munications traffic during this time period was frenetic Health had presented evidence that 2.4.5-T "can cause
Among the shortcomings (hat were being concealed with requests and discussions about reducing the sur- malformation of offsprings and stillbirths in mice,
was the growing concern over the economics of too plus of Agent Orange. Asa result. Agent Orange began when given in relatively high doses." and that "this
much Agent Orange having been procured. By (his to be used for every defoliation purpose. The use of all material is present in defoliant Orange." Ihe largetime, "the entire commercial production of Orange other herbicides was brought to an abrupt halt, while a scale, and apparently counterproductive, spraying of
(had been | diverted from domestic use to military re- number of policies governing the use of defoliants the chemical went forward.
.quirements in Southeast Asia."
were relaxed in order to deplete (he Agent Orange
Within a few years, though, (he outrage over using
Throughout the late I960'], beginning in 1967. surplus.
chemical defoliants had grown so intense, both back
Since "Agent Orange stocks were in long supply, home and in (he world community, that Ihe U.S. was
military records declassified for the Veteran began to
reflect that (here were pressing economic reasons and costly contract terminations were involved," one forced lo cancel its defoliation operations. But. by that
favoring (he apparent unjustified reason (o increase the memorandum states in communications used in the time, following a decade of having negligently satuse of defoliants, especially Agent Orange, which had decision to halt the use of other defoliants, the termina- urated Southeast Asia with the chemical, the damage
wrongly been ordered in vast quantities because of a tion of the use of other herbicides "should result in had already been done by a program, Ihe objectives of
considerable dollar savings from acceptance and max- which all along were not being achieved."
domestic shortage.

W

NOVF.MBF.R/DF.CEMBKR I

17

�Congreste of tfje ®mteb
JB.C. 20510

November 22, 1988

Honorable Donald M. Newman
Chairman
Agent Orange Working Group
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Don,
As Chairmen and Ranking Minority Members of the House and Senate
Veterans' Affairs Committees, we are writing to request that the
Agent Orange Working Group review and provide comments on five
studies recently published in "Environmental Research." (A copy of
the journal is enclosed.) The studies examine the health effects of
herbicide exposure and service in Vietnam based on questionnaires
completed by American Legion members. We would appreciate your
comments with respect to the scientific methods used, the validity
of the statistical analyses, and the strength of the studies'
findings.
As always, we appreciate your continuing cooperation and support.
We look forward to your response.
With warm regards,
Cordially,

^-»-A^ruc&lt;i
G.V. (Sonny) Montgomery
Chairman
' &lt;j y i f 1

ans't'on
Chairman

Solomon
nority Member

Frank H. Murkowski
Ranking Minority Member
Senate Committee on
Veterans' Affairs

,„/,„/„

BZ AOW e&lt;?
Q3A

House/Committee on
Vete/ans1 Affairs

�NATIONAL VIETNAM VETERANS COALITION
1000 Thomas Jefferson St.. Sixlh Floor
Washington. D.C. 20007
(202) 338 NVVC
J. IVmu* Hnrrh. Jr.

November 1988

.

No. 48

AGENT ORANGE
Pending New Legislation
The omnibus veterans benefits legislation
following new provisions on Agent Orange:

contains

the

(T)his agreement (i.e. the bill) would extend, from
September 30, 1989 to December 31, 1990, the authority to provide
basic VA health-care services for veterans' disabilities if it is
found that the veteran, during active duty, may have been exposed
in Vietnam to
any toxic substance
in a herbicide
or
defoliant. . . .
(T)he agreement also includes a provision that states that
amounts received as part of the settlement of the agent orange
product liability litigation will not be considered as income for
purposes of any of the needs-based programs administer by the VA,
including nonservice-connected VA pension.
(T)he proposed amendments would require the VA to conduct an
outreach program to Vietnam veterans oriented to notifying them
of health risks, if any, resulting from exposure to herbicides in

- 13 -

�Vietnam, as information on such health risks becomes known. In
order to facilitate such an outreach effort, the bill would
require the VA to take reasonable actions to organize and update
the information contained in the VA's agent orange registry,
particularly the addresses of veterans listed in the registry.
(Remarks by Rep. G.V. (Sonny) Montgomery, Congressional Record,
Oct. 19, 1988, H10353.)
The committee report accompanying the legislation includes
the following comments:
Section 1203 of the bill treats Agent Orange payments "as
reimbursement
for
prior
unreimbursed
medical
expenses."
(Id., H10338, 10555) (Ed. Note: The bill, however, does not make
a similar exception for Social Security disability pensions or
food stamp eligibility.) . . . .
&gt;
After February 28, 1989, not less than one-third of the
total number of members of the Ranch Hand Advisory Committee
shall be individuals selected by the Secretary of Health and
Human Services from among scientists who are recommended by
veterans' organizations . . . . (Id., H10334, H10339)
The House . . . rejected a Senate bill that, for the first
time, would award disability benefits to veterans exposed to
Agenent Orange during the Vietnam War [i.e., for soft tissue
sarcoma, no-Hodgkins lymphoma]
(Rep. Sonny) Montgomery said
further studies were needed to prove a connection between various
diseases and Agent Organge.
(Philadelphia Inquierer, Oct. 20,
1988)
"Sprayed and Betrayed" - Round II
More newly declassified documents emerge from the National
Archives:
The State Department was involved in policy-making re
spraying operations.
"On 14 April 1969, the U.S. Embassy
suspended its policy requiring the use of WHITE herbicide on
certain restricted defoliation targets and will now allow use of
ORANGE herbicide in all defoliation targets.
For economic
reasons, tfie use of ORANGE is preferred . . . . We respectfully
request that you assure WHITE stocks are kept available for use
should the policy be deinstituted."
(Memorandum for Col. Tran
Dinh Tho from Col. Harold C. Kerne (?) , Jr., "Use of Defoliants
ORANGE and WHITE (V), 17 April 1969).
LTC John A. Sullivan,
CONVSNACV notes in a memo to CINCPAC "Ambassador Sullivan's
approval has been requested for the use of CS in those areas of
Laos approved for spray operations.
("Use of Riot Control Agent
CS," undated)
MIAs.
During the week ending 4 Feb. 67, the following
defoliation missions were flown in Laos with C-123 aircraft:

- 14 -

�31 Jan 3 sorties . . . Acft 611 lost to ground fire. 5 KIA
(Ed. Note: the five men are now on the MIA list) (Memorandum
from Maj. Philip L. Boster, COMUSMACV to NMCC, "Herbicide Report
(V)," undated. Access Number (?) 0380818)
The Empty Drums. The New Jersey Agent Orange Commission
interprets other reports:
•
"It seems that as far as the US Government was concerned,
"empty" Agent Orange drums were the property of the,, ARVN, and
they could dispose of then anyway they chose. The problem was
the drums weren't really empty, and each contained about 2.2
gallons of Agent Orange that was not pumped o,ut. The ARVN, in
their constant quest to turn an extra buck, sold the drums to
anyone who wanted them, generally civilians for about $2 each.
The creative Vietnamese civilians used them for all sorts of
things, spilling the residual Agent Orange all over the place and
seriously damaging plants and shade trees throughout the city of
Danang. The defoliant was even killing the civilians' vegetable
gardens.
Since we were using about 1000 gallns per day of
herbicide out of Danang at the time, about 20 "empty" drums of
Agent Orange were hitting the streets of Danang every day!! to
compound this lunacy even more, it seems that the Vietnamese Navy
compound purchased some of the drums to store gasoline for their
generators.
The result is that they ended up fogging their
entire compound through the generator exhaust with Agent Orange,
effectively killing all vegetation in sight!!
"The report recommended that the practice of allowing the
ARVN to sell the drums be discontinued, but we're not sure that
ever happened. It also should be mentioned that Agent Orange was
also stored at Bien Hoa, Phu Cat, Nha Trang, and in Saigon and
was presumably disposed in the same manner."
(NJAOC, Agent
Orange Update, Oct. 1988)
Miscellaneous
1.
From studying the injuries among the tens of thousands
of Kurdish refugees, the doctors believe the Iraquis are using a
mixture of herbicide and a form of tear gas known as CS to drive
the Kurds from their mountain villages.
(Edmonton Journal, (?)
Sept. 21, 1988)
2.
(Vietnam veteran Ron Heiman) was 38 years
died in January of this year . . . . The doctor put
of death, on his death certificate, the type of
killed him, and added that it was a direct result of
poisoning. This is the first time such a statement
an official record.

old when he
as the cause
cancer that
Agent Orange
appeared in

Well, the Death Certificate on file at the County Medical
examiner's office has been changed!
Any reference to Agent

- 15 -

�Orange has been removed from the official files!
letter from George L. Claxton, Oct. 19, 1988)

(Attachment to

3.
Was the morbidity of women Vietnam-era veterans
affected by assignment in Vietnam? . . .
(N)o remarkable
differences
(between
a control group
of
720 U.S.-based
Vietnam-era veterans and a study group of 28 Vietnam veterans)
are seen in the percentage of those who had an acute illness, GYN
condition or miscarriage.
However, three interesting differences are observed. First,
a higher percentage of those who were assigned in Vietnam have
chronic conditions and disabilities, and they have more of them.
Second, a higher percentage have been told they have cancer.
Third, although a smaller percentage of Vietnam-assigned women
ever had a baby, a higher percentage of those who did have
children born with defects and/or die before their first
birthday.
(Le Donne, Trends in Morbidity and Use of Health
Services by Women Veterans of Vietnam, Navy Medicine. May-June
1988, p. 24)
4.
What's Evidence?, by Joe Cole (Mahess Productions, Inc.
states: "blows the lid off") Send $15.00 to Joe Cole, 6806 36th
Ave., S.E., Olympia, Washington 98503
5.
As part of a budget austerity program in Massachusetts,
the state's funding of its prestigious Agent Orange Commission
has been reportedly "substantially reduced."
6.
The Washington (Me) Sunrise Memorial; Made of two
large, rugged stones, standing like the tattered pages of an open
boo, the memorial carries three messages: one for those who are
still missing in action or prisoners of war; one for all the men
and women who served in Southeast Asia; and one for the veterans
who have died, and the veterans and their families who continue
to suffer, from medical and psychological problems associated
with exposure to the chemical defoliants, such as Agent Orange,
used in the war. (Bangor Daily News, Oct. 24, 1 9 8 8 ) ( E d . N o t e :
This is claimed to be the first memorial in the country to honor
Agent Orange victims .
J

•-14 -

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