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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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                <text>Typescript: An Evaluation of the Statistical Methods Used in EPA's "Report of Assessment of a Field Investigation of Six-year Spontaneous Abortion Rates in Three Oregon Areas in Relation to Forest 2, 4, 5 -T Spray Practices" (the Alsea II Report)</text>
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                    <text>Item ID Number

01708

Author

LeVois, Maurice E.

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

Journal/Book Title
Year

000

°

Month/Day
Color

a

Number of Images

3

Descriptor Notes

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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                  <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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°1695

Author

LeVois, Maurice E.

Corporate Author
Roport/Artldo Title Memorandum: Agent Orange Research Predecisional
Memorandum, from Maurice E. LeVois to Administrator,
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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&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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01735

Author

Keller, Carl A.

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RODOrt/ArtlOlO TitlO Typescript: Review of Vietnam Veterans Mortality
Study, September 14,1987

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Doscripton Notes

Monday, June 11, 2001

Page 1786 of 1793

�REVIEW OF VIETNAM VETERANS MORTALITY

STUDY

A study of proportionate mortality among U.S. Army and Marine veterans
who served between July 4, 1965 and March 1, 1973 and died before
March 1, 1982 was reported by the Veterans Administration. The study
included 19708 Army and 4527 Marine veterans who had served in Vietnam
and 22904 Army and 3781 Marine veterans who had not served in Southeast
Asia during tis period. The study included a random sample of about
one-third of the potentially elligible veterans who had died during this
period. The selection of study subjects and recovery of information on
them appears to have been unbiased and appropriate.
The major findings from this study included a statistically significant
excess of accidental and drug related deaths and paucity of suicides
among Army veterans who had served in Vietnam compared to those who
had not served in Southeast Asia. In addition, there was a statistically
significant excess of lung cancer and non-Hodgkins lymphoma among Marine
veterans who had served in Vietnam compared to those who had not.
Several other findings were not mentioned in either the conclusions
nor in the narrative, but are evident in the tables. These include a
statisically significant decrease in mortality due to genitourinary
diseases and cancer of the extra-cranial nervous system among Army
Vietnam veterans. In addition, there appears to have been a signifcant
decrease in cancer deaths among enlisted Army veterans with only one
tour of duty in Vietnam, and among similar Marine veterans before 1975.
There was also a significant increase in accidental poisonings among
enlisted Marine Vietnam veterans dying before 1975.
The authors computed Standardized Proportionate Mortality Ratios (SPMR)
and tested with the Chi-Square statistic (not presented in the tables).
According to the reference used to justify this procedure (ref # 13),
Professor Monson suggests using the Poisson approximation of the
variance of the expected deaths, i.e., that the expected number of
deaths approximates the variance. If this procedure is applied to the
information which can be deduced from the observed number of deaths
and the SPMR as given in the tables, several additional SPMRs appear to
be statistically significant. These include an excess of all cancer
deaths among Marine veterans who served in Vietnam, particularly single
tour enlisted Marines after 1975. Other possibly significant findings
would include a decrease in deaths due to infectious diseases and
diseases of the blood, an increase in deaths due to musculoskeletal
and connective tissue diseases, and a decrease in deaths from thyroid
cancer and non-Hodgkins lymphoma among Army Vietnam veterans.
While there is no way to determine which statistical procedures are
"correct", these results indicate that more significant findings are
available in these data than have been dicussed in the manuscript.
While this does not make it any easier to interpret the results, it
does serve to point out the selective nature of the findings which
have been emphasized in the manuscript. In particular, the inclusion
of one-seventh of the abstract and considerable dicussion in the
narrative to Agent Orange is misleading. Other possible explanations
for the findings should receive relatively more emphasis.

Carl A. Keller, Ph.D.
Epidemiologist, NIEHS

�</text>
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01353
Houk, Vernon N.

Corporate Author
Report/ArtidO TltlO Memorandum: to Ronald W. Hart, Chairman, Science
Panel, Agent Orange Workinh Group (AOWG), from
Vernon N. Houk, Assistant Surgeon General, with
subject Protocol for Women's Vietnam Veterans Health
Study, September 10,1987

Journal/Book Title
Year

000

°

Month/Day
Color

D

Number of Images

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DOSCrlptOn NOtBS

Memo discusses concerns that Houk has about the
study protocol. He wants the concerns addressed
before he will be willing to support conduct of the study.

Wednesday, July 11, 2001

Page 1854 of 1870

�DEPARTMENT OF HEALTH &amp; HUMAN SERVICES

Public Health Service
Centers for Disease Control

Memorandum
Date

.September 10, 1987

From

Director
Center for Environmental Health and Injury Control

Subject

Protocol for Women's Vietnam Veterans Health Study

To

Ronald W. Hart, Ph.D.,
Chairman, Science Panel
Agent Orange Working Group
We have reviewed the Women's Vietnam Veterans Health Study Protocol
submitted by the Hew England Research Institute, Inc. We have serious
concerns about this submission which we have listed below. Until these
concerns are adequately addressed, I cannot support conduct of the
proposed study. Detailed below are comments on the protocol for the
Women's Veteran Health Study.
A. Cohor^ Selection
1. Unlike the Vietnam Experience Study, there are differences
between the exposed group and the comparison groups in variables
other than experience in Vietnam. The presence of such
differences increases potential confounding and complicates the
analyses. Would it be more satisfactory to limit the scope of
the study and the selection of a comparison group (e.g., Limit,
the study to army cases and controls) to address the most
important hypotheses rather than try to do too much?
2. It is not clear how the VA developed its list of 5000 Army
Vietnam veterans—how complete is this list? How complete are
the lists of Vietnam veterans in the other services?
3. The sampling frame for the non-Vietnam veterans is not clearly
described.
4. How valid is their proposed capture-recapture method as a method
of documenting the completeness of the cohorts.
5. What duty stations will women veterans for Cohort B come from?
Will the Air Force sample of nurses be large enough for separate
comparisons?
6. pages 2-3: What does matched on occupation mean and how will this
be possible?
7. Consideration might be given to increasing the number of controls
(per case) in the overall study, especially in some of the
proposed substudies (e.g., reproductive health).

�Page 2 - Ronald W. Hart, Ph.D.
B. Reproductive Health
1. The expectation is to find major birth defects in 1% of
offspring; a more appropriate expectation is 2-3%. It would be
wise to compile a list of specific defects which are to be
considered "major" before the study begins.
2. Cases are defined as women who have had a baby with a defect or
"two or more spontaneous abortions not clearly attributable to an
identified cause." They propose excluding those with an
1
"unequivocal karyotypic abnormality", and those with a uterine
abnormality. Exclusion of women who themselves have a tcaryotypic
abnormality seems reasonable, but it is unlikely that any will be
found in the sample. If the reference implies that aborted
fetuses that have a karyotypic abnormality will be excluded, this
is not reasonable. An abortion associated with a chromosomal
anomaly is a health outcome worth considering in the study. In
general, more details are needed on why certain
diseases/conditions are being excluded.
3. Spontaneous abortions will be difficult to validate since they
are frequently not medically documented.
4. It is stated that women with diethylstilbesterol (DBS) exposure
would be kept in the sample. We would suggest exclusion since
they are excluding spontaneous abortions associated with uterine
abnormality, and DES exposed women have a higher rate of
abortion, usually from uterine abnormality.
5. We would suggest matching controls on age at the last abnormal
pregnancy, rather than the first. Spontaneous abortion is
strongly related to age and a woman's pregnancies may be
separated by many years.
6. At the time this study will be done, most women Vietnam veterans
will be 40 or more years of age. Therefore the evaluation of
prolonged amenorrhea should probably be deleted from the study.
7. A definition of fertility/infertility is needed.
C. PsycholoRical/KeuropsychoIoRical TestinR
1. The proposal to use the CDC Vietnam Experience Study (VES)
neuropsychological battery is inappropriate. That battery was
designed to assess primarily neuropsychological deficits which
might be expected from exposure to a toxin (e.g. TCDD). The
battery also included some assessment of psychological and
neuropsychological problems that might be related to stress.

�Page 3 - Ronald W. Hart, Ph.D.
This latter component is not included (as far as we can tell) in
the present protocol. Since TCDD exposure is unlikely to have
been a major problem for most nurses in Vietnam, it would
probably be better to give greater emphasis to long-term
psychological stress faced by these veterans while in Vietnam.
This would mean that the proposed battery should include some
measures of stress which have been well validated and accepted in
psychological research.
'

In addition, greater emphasis should be given to depression,
anxiety, and alcohol and drug use, which are possible sequelae of
stress. Also, consideration should be given to including the
Minnesota Multiphasic Personality Inventory (MMPI), and more of
the Diagnostic Interview Schedule (DIS) than just the Post
Traumatic Stress Disorder (PTSD) section.

2. Another concern in the psychological area is the testing in the
home of the participant. The VES battery was designed to be
administered in a standard testing environment by trained
technicians under close supervision. Quality control and
standardization will be difficult in the proposed setting.
3. The rationale for measurement of TCDD levels in the PTSD substudy
needs further clarification/justification.
4. With respect to the psychological area in general, we suggest
that advice be sought from experts in psychology/psychiatry to
evaluate the proposed psychological test battery. In addition,
staffing for the study should include a qualified psychologist or
psychiatrist.
D. Serum. Dioxin (TCDD) Measurement
1. The whole issue of Agent Orange exposure assessment/TCDD testing
becomes questionable now that the results of CDC's Validation
Study are known. If TCDD testing is to be done, is a whole unit
of blood necessary—if willing to accept some cut-off level (e.g.
20 ppt) less blood may be required. Also, if TCDD testing is to
be done, consideration should be given to using a sample of
Vietnam and non-Vietnam veterans—based on the results of a
sample, a decision could be made about testing other
participants.
2. Serum TCDD measurements are to be used as the measure of exposure
for both the Reproductive Outcomes Study and the Post Traumatic
Stress Disorder Study. Apparently about 550 serum analyses will
be needed for these two studies combined. The current proposal
does not involve flying the participants to a centralized
collection center but rather using local Red Cross Centers on
contract. These approximately 550 women will be located all over

�Page 4 - Ronald U. Hart, Ph.D.
the United States and the Red Cross is not even present in every
state, so obtaining the samples solely in this manner will not be
possible. A very large number (&gt;100) of Red Cross contracts will
be involved to obtain blood on persons near a Red Cross Center
under the current plan. The use of at least regional Red Cross
Centers would be a marked improvement and the quality of sample
acquisition would be significantly higher if only a few (even
one) Red Cross Center(s) were used.
3. T|he cost of the serum 2,3,7,8-TCDD measurement should be noted to
be $1000 apiece. Currently the protocol states that EHLS is the
only lab in the U.S. that can perform the measurements, but
clearance for such measurements at EHLS has not been obtained.
Similarly, has the American Red Cross been approached as to their
willingness to participate in this study?
E. Operational and Other Issues
1. The protocol anticipates a fair amount of dependence on both
interviews and military records. What are the limitations of
these data in terms of the questions addressed (e.g.,
ascertainment of spontaneous abortions by history)?.
2. The authors do not provide information on how they propose to
address the issue of name changes in female veterans and the
difficulties this might cause in locating these veterans.
3. The operational aspects of the pediatric examination component
are not clearly described. Has the Ranch Hand Study been
successful in this area? What end points will be looked at and
analyzed?
4. The choice of conditions to be validated might be expanded to
include same conditions which have been suggested to be
associated with TCDD exposure—e.g. skin conditions (chloracne,
hyperpigmentation, etc.), liver disorders including prophyria,
peripheral neuropathy, immunologic deficits.
5. Quality control of the physical and routine laboratory
examinations must be assured.
6. Has adequate effort been made to insure that the medical records
and pathology slides will be reviewed in a blinded manner?
7. What efforts are being made to insure quality assurance and
quality control of hormone blood testing?

Vernon H. Houk, M.D.
Assistant Surgeon General

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01734

Author

Houk, Vernon N.

Corporate Author
RepOrt/ArtiClB TltlO Memorandum: Review of VA Mortality Study, from
Vernon N. Houk to Ronald W. Hart, September 11, 1987

Journal/Book Title
Year

000

°

Month/Day
Color

D

Number of unaoos

2

Desorlpton Notes

Monday, June 11, 2001

Page 1785 of 1793

�DEPARTMENT OF HEALTH &amp; HUMAN SERVICES

Public Health Service
Centers for Disease Control

Memorandum
Date
From

.September 11, 1987
Director
Center for Environmental Health and Injury Control
Review of VA Mortality Study

Subject
To

Ronald W. Hart, Ph.D.
Director
National Center for Toxicological Research
i
The Veterans Administration (VA) has conducted a proportionate mortality
study (PMR) of 24,235 deaths among U.S. Army and U.S. Marine male
veterans who served in Vietnam and 26,685 deaths among male veterans of
the same two services who did not serve anywhere in Southeast Asia. All
deaths were identified from the VA BIRLS file and occurred between
July 4, 1965, and March 1, 1982. These deceased veterans had to have
served in the military sometime between July 4, 1965, and March 1, 1973.
Career and non-career, officers, and enlisted men, as well as reservists,
were included. In-service deaths occurring before 1974 and men dying
from war-related injuries were excluded. In service deaths after 1973
were included.
Within the group of Vietnam veterans, the fraction of all deaths
attributable to a particular cause was computed and compared to the
corresponding proportion for non-Vietnam veterans. The comparison was
done using the proportionate mortality ratio (PMR) technique in which age
at death, race, and branch of service were taken into account. There was
no adjustment for calendar year of death or rank. Altogether, PMRs were
computed for 18 major cause of death groupings and for 23 specific cancer
sites.
We will address our concerns in data collection, data analysis, and
interpretation.
Data Collection. Are the BIRLS tapes truly at least 94 percent
complete? From the CDC Mortality Study which used multiple sources of
mortality we found that BIRLS was less complete.
Data Analysis. Why do the authors emphasize only the statistically
significant positive findings? Why were not the significant decreases in
deaths from genitourinary diseases (Table 3) and the decrease in deaths
*. from all cancers for one-tour of duty veterans (Table 5) not discussed?
The lack of association between service in
be reevaluated in light of the CDC finding
in the first 5 years after discharge. CDC
discharge rather than year of death. This

Vietnam and suicide needs to
that they were increased only
used the time period since
subject was repeatedly brought

�Page 2 - Ronald W. Hart, Ph.D.
up with the VA prior to completion of their analysis. The CDC study
would indicate that grouping by 10 year periods would minimize the
effect.
The findings for lung cancer and NHL in Marine Vietnam veterans are
provocative, although similar observations were not made in other studies
of Vietnam veterans. The absence of unusual mortality from soft-tissue
cancers is consistent with some previous studies but at variance with
others. Because so many statistical tests were done on the data set,
these ^apparent findings could be due to chance. It would be helpful to
see a more detailed analysis in which mortality from these cancer sites
is examined by calendar year in Vietnam, rank, MOS, and principal duty.
These additional analyses would help in deciding whether some factor
related to the Vietnam experience is responsible for the apparent
association.
Interpretation. The authors suggest that these were major differences in
the findings of previous studies cited, but there are in fact few major
differences in the findings.
Referenced studies were not critically discussed. There has never been,
for example, an association demonstrated between lung cancer and phenoxy
herbicides except in the Zack Study (Ref. 29) where 3.6 cases were
expected and 6 were found in those exposed to 2,4,5-T. Those authors
state that they cannot evaluate trends in lung cancer deaths as they
relate to occupation because of "limitation in the data."
As noted above, it is not surprising to encounter the small number of
statistical departures from expected mortality seen in this study. These
could easily have arisen by chance alone. This study, as originally
designed, cannot conclusively clarify mortality risks for Vietnam
veterans, let alone elucidate possible causative factors within, or
outside of, the Vietnam experience. Reasons include lack of a defined
population-at-risk, incomplete ascertainment of deaths, and absence of
"exposure" data on individual veterans.
This PMR study appears to be well executed in mechanics. However, the
presentation and discussion of the results do not provide the necessary
caution in interpretation and allow the uninitiated to make causal
inferences where they do not exist.

Vernon N. Houk, M.D.
Assistant Surgeon General

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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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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

�</text>
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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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01731

Author

Fingerhut, Marilyn

Corporate Author
RdpOrt/ArtiClO TltlB Typescript: Comments on "Proportionate Mortality
Study of Army and Marine Corp Veterans of the
Vietnam War" by P. Breslin et al., Septembers, 1987

Journal/Book Title
Year

000

°

Month/Day
Color
Number of Images

D

1

Descrlpton Notes

Monday, June 11, 2001

Page 1782 of 1793

�Comments on "Proportionate Mortality Study of Army and
Marine Corp Veterans of the Vietnam War" by P. Breslin et_ al.
Marilyn Fingerhut
September 6, 1987
Use of BIRLS for a PMR study is reasonable.
Structure of PMR study is reasonable: Random sample of complete file of
BIRLS, with Vietnam exposure confirmed; death certificates obtained (96.9%
followup), adequate size (at least for Army).
PMR studies are usually used to generate, not test hypotheses. The
article appropriately recommends further work to evaluate etiological
factors. The media reports have not conveyed this information.
The problem at hand results from the timing of the release of the article,
and the inclusion of a sentence in the Abstract (inappropriately)
referring to Agent Orange exposure.
The structure of the study is appropriate; the scientific weakness of the
article lies in the analysis and interpretation of the results. The
authors can revise the article for submission to a journal.
The weakness of the article results from 1) the absence of data evaluating
elevations in other smoking related diseases in the Marines, 2) absence of
latency evaluations for the malignancy outcomes, 3) lack of data
evaluating the adequacy of the marine comparison group, and 4) inadequate
evaluation of the limitations of the PMR study design.
No evaluation of latency is presented for lymphoma or lung outcomes.
Service was '64-'73, deaths were '65-'82. The article does not evaluate
the relationship of time of exposure to time of death.
No data are provided to show whether other circulatory or respiratory
deaths were elevated in army and marines for conditions associated with
smoking.
It is unclear whether the cancer outcomes were obtained in the overall
PMR, or in a separate Proportionate Cancer Mortality Ratio (PCMR).
The results for deaths from external causes and accidental poisonings are
consistent with other studies of veterans and point out problems for
veterans following this war.
The nonVietnam comparison group for the Army is large, so the numbers can
be expected to be stable; the same may not be true for the marines. It
would have been helpful if, 1) the authors had carefully presented data to
show that the marine Vietnam vs. nonVietnam populations were truly
comparable, and 2) the authors had provided a table showing the expected
numbers for each cause of death if the national population had been used
as the comparison.

�</text>
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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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&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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      <description>A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.</description>
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        <element elementId="52">
          <name>Box</name>
          <description>The box containing the original item.</description>
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            <elementText elementTextId="19818">
              <text>063</text>
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          <name>Folder</name>
          <description>The folder containing the original item.</description>
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              <text>1701</text>
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          <name>Series</name>
          <description>The series number of the original item.</description>
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              <text>Series III Subseries III</text>
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        <description>The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.</description>
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            <name>Creator</name>
            <description>An entity primarily responsible for making the resource</description>
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                <text>Fein, George</text>
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            <name>Title</name>
            <description>A name given to the resource</description>
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                <text>Letter: from George Fein to Barclay M. Shepard, August 16, 1982</text>
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          <element elementId="49">
            <name>Subject</name>
            <description>The topic of the resource</description>
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                <text>Agent Orange Exposure Study</text>
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              <elementText elementTextId="19823">
                <text>study protocol</text>
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                <text>cohort study</text>
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              <elementText elementTextId="19825">
                <text>study criticism</text>
              </elementText>
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      <tag tagId="1">
        <name>ao_seriesIII</name>
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