Gulf War Illnesses: Management Actions Needed to Answer Basic Research
Questions (Letter Report, 01/06/2000, GAO/NSIAD-00-32).

Pursuant to a congressional request, GAO provided information on
management actions needed to answer basic research questions about Gulf
War Illnesses, focusing on the: (1) amount of money the Departments of
Veterans' Affairs (VA), Defense (D0D), and Health and Human Services
(HHS) spent on research and investigation of Gulf War veterans'
illnesses and health concerns in the fiscal years 1997 and 1998,
including current and projected spending by the Office of the Special
Assistant to the Deputy Secretary of Defense for Gulf War Illnesses; (2)
productivity of this research spending, including the extent to which
the Coordinating Board has determined that federal research objectives
have been satisfied, and the extent to which the research has resulted
in peer-reviewed publications and the identification of the causes or
successful treatments for Gulf War veterans' illnesses; (3) extent of
coordination between the Research Working Group of the Coordinating
Board and the Office of the Special Assistant for Gulf War Illnesses;
and (4) Office of the Special Assistant for Gulf War Illnesses' contract
management.

GAO noted that: (1) during fiscal years (FY) 1997-1998, DOD, VA, and HHS
spent more than $121 million on research and investigation of Gulf War
veterans' illnesses, with DOD spending more than $112 million of that
total; (2) these funds supported a growing catalog of research and
investigatory efforts intended to address both veterans' health concerns
and their questions about hazards encountered in the conflict; (3) the
Office of the Special Assistant to the Deputy Secretary of Defense for
Gulf War Illnesses spent about $65.3 million in FY 1997 and FY 1998,
with another $65.4 million in spending planned for FY 1999 and FY 2000;
(4) basic questions about the causes, course of development, and
treatments of Gulf War veterans' illnesses remain unanswered; (5) as of
November 30, 1999, the Research Working Group of the Persian Gulf
Veterans' Coordinating Board had not published an assessment of the
extent to which the research program had answered the major questions it
identified as research objectives in 1995, and no date had been set to
publish such an assessment; (6) while federally sponsored studies have
resulted in some descriptive information concerning veterans' symptoms,
many basic questions remain; (7) although the question of causation is
unresolved, VA has begun recruiting patients for trials of antibiotic
and exercise-behavioral treatments for a set of veterans' unexplained
symptoms; (8) although the Office of the Special Assistant for Gulf War
Illnesses expends more than half of the federal funds supporting
research and investigation into Gulf War veterans' illnesses, its
activities are not effectively coordinated with those of the Research
Working Group; (9) the weak coordination between the Group and the
Office increases the potential to miss opportunities to leverage ongoing
and completed work by other agencies; (10) the Office rapidly developed
relationships with various contractors to support its mission; (11)
however, two of the largest task orders were awarded improperly, and the
Office discouraged competition for another task order by specifying a
preferred vendor; and (12) because the Office is likely to continue to
spend a significant part of its budget on support contracts, it needs to
ensure that its contracts fully comply with applicable requirements.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  NSIAD-00-32
     TITLE:  Gulf War Illnesses: Management Actions Needed to Answer
	     Basic Research Questions
      DATE:  01/06/2000
   SUBJECT:  Medical research
	     Veterans
	     Disease detection or diagnosis
	     Hazardous substances
	     Interagency relations
	     Chemical warfare
	     Biological warfare
	     Contract administration
	     Armed forces abroad
IDENTIFIER:  Gulf War Syndrome
	     Persian Gulf War

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Rev-LG logo.eps GAO United States General Accounting Office

Report to the Chairman, Subcommittee on National Security,
Veterans' Affairs and International Relations, Committee on
Governmental Reform, House of Representatives

January 2000 GULF WAR ILLNESSES

Management Actions Needed to Answer Basic Research Questions

GAO/NSIAD-00-32

  GAO/NSIAD-00-32

Page 1 GAO/NSIAD-00-32 Gulf War Illnesses

Contents Letter 3 Appendixes Appendix I: Research Objectives
Identified by the Research

Working Group of the Persian Gulf Veterans' Coordinating Board 26

Appendix II: Reports Received and Released by the Office of the
Special Assistant Under Research Contracts Examined by GAO 28

Appendix III: Sample Working Case Definitions Describing Symptoms
Experienced by Gulf War Veterans 31

Appendix IV: Comments From the Department of Defense 32 Appendix
V: Comments From the Department of Veterans'

Affairs 46 Appendix VI: Comments From the Centers for Disease
Control and Prevention 53

Appendix VII: GAO Contacts and Staff Acknowledgments 56 Related
GAO Products 58

Page 2 GAO/NSIAD-00-32 Gulf War Illnesses

Page 3 GAO/NSIAD-00-32 Gulf War Illnesses United States General
Accounting Office

Washington, D. C. 20548 National Security and International
Affairs Division

B-282454 Letter

January 6, 2000 The Honorable Christopher Shays Chairman,
Subcommittee on National Security, Veterans' Affairs, and
International Relations Committee on Government Reform House of
Representatives

Dear Mr. Chairman: Many of the approximately 700,000 veterans of
the Persian Gulf War have complained of illnesses since the war's
end in 1991, and over 10 percent have sought and completed health
examinations through the Department of Veterans' Affairs or
Defense. Some fear they are suffering from chronic disabling
conditions because of wartime exposures to one or more agents with
known or suspected health effects. In response to these concerns,
the government has funded research, investigation, and information
activities through agencies such as the Departments of Veterans'
Affairs, Defense, and Health and Human Services, which are
represented on the Persian Gulf Veterans' Coordinating Board, the
body that coordinates the federal response to Gulf War veterans'
illnesses.

As requested, we identified expenditures on these efforts and
evaluated their results. Specifically, our objectives were to
describe

 the amount of money that these three departments spent on
research and investigation of Gulf War veterans' illnesses and
health concerns in fiscal years 1997 and 1998, including current
and projected spending by the Office of the Special Assistant to
the Deputy Secretary of Defense

for Gulf War Illnesses;  the productivity of this research
spending, including the extent to which

the Coordinating Board has determined that federal research
objectives have been satisfied, and the extent to which the
research has resulted in peer- reviewed publications and the
identification of the causes or successful treatments for Gulf War
veterans' illnesses;

 the extent of coordination between the Research Working Group of
the Coordinating Board and the Office of the Special Assistant for
Gulf War Illnesses; and  the Office of the Special Assistant for
Gulf War Illnesses' contract management.

B-282454 Page 4 GAO/NSIAD-00-32 Gulf War Illnesses

Results in Brief During fiscal years 1997- 98, the Departments of
Defense, Veterans' Affairs and Health and Human Services spent
more than $121 million on research

and investigation of Gulf War veterans' illnesses, with DOD
spending more than $112 million of that total. These funds
supported a growing catalog of research and investigatory efforts
intended to address both veterans' health concerns and their
questions about hazards encountered in the conflict. The Office of
the Special Assistant to the Deputy Secretary of Defense for Gulf
War Illnesses spent the majority of the federal research and
investigatory funds we identified, about $65.3 million in fiscal
years 1997 and 1998, with another $65.4 million in spending
planned for fiscal years

1999 and 2000. Basic questions about the causes, course of
development, and treatments of Gulf War veterans' illnesses remain
unanswered. As of November 30, 1999, the Research Working Group of
the Persian Gulf Veterans' Coordinating Board had not published an
assessment of the extent to which the research program had
answered the major questions it identified as research objectives
in 1995, and no date had been set to publish such an assessment.
By the end of 1998, among the 151 research projects monitored by
the Group, 117, or 77 percent, were recorded as ongoing, including
29, or 47 percent, of the 62 that were scheduled for completion by
that time. Among those that were not recorded as complete

at the end of 1998, about one- third were later completed and the
remaining two- thirds had their estimated completion dates
extended. Group officials attributed the extensions either to
provisions to collect or incorporate

additional data or to unanticipated delays, such as difficulty in
securing approval to collect data or in locating and recruiting
veteran participants. Augmenting the research monitored by the
Group, DOD's Office of the Special Assistant to the Deputy
Secretary of Defense for Gulf War Illnesses had received 19 of the
20 reports due from its major research contractors by late 1999,
with 6 publicly released and the remainder largely in various
stages of interagency review. Fourteen reports had remained in
draft or review status for a year or longer.

While federally sponsored studies have resulted in some
descriptive information concerning veterans' symptoms, many basic
questions (such as the numbers of veterans with unexplained
symptoms and the course of their illnesses over time) remain.
Answers to more complex questions about the potential cause( s) of
veterans' unexplained symptoms have been difficult to derive in
part because problems in identifying veterans' specific exposures
persist. In addition, no working case definition or set of

B-282454 Page 5 GAO/NSIAD-00-32 Gulf War Illnesses

definitions of illnesses affecting veterans has been endorsed by
the Group. Perhaps because analytic epidemiological research
depends heavily upon exposure data and/ or case definition,
completed epidemiological research, which comprises a large
portion of the research portfolio, has been less likely than other
types to result in peer- reviewed publications and most of

these studies have been descriptive. Although the question of
causation is unresolved, in the interest of assisting ill
veterans, the Department of Veterans' Affairs has begun recruiting
patients for trials of antibiotic and exercise- behavioral
treatments for a set of veterans' unexplained symptoms. Although
the Office of the Special Assistant for Gulf War Illnesses expends

more than half of the federal funds supporting research and
investigation into Gulf War veterans' illnesses, its activities
are not effectively coordinated with those of the Research Working
Group. According to officials from both organizations, the Office
of the Special Assistant's activities involve investigations,
rather than research, and therefore are not subject to
coordination. However, the Group considered some of the Office's
activities to involve research and expressed concern about the
lack of an external review process. The weak coordination between
the Group and the Office increases the potential to miss
opportunities to leverage ongoing and completed work by other
agencies, and we found a few

examples of such problems. The Office rapidly developed
relationships with various contractors to support its mission.
However, two of the largest task orders were awarded improperly,
and the Office discouraged competition for another task order by
specifying a preferred vendor. Because the Office is likely to
continue to spend a significant part of its budget on support
contracts, it needs to insure that its contracts fully comply with
applicable requirements.

We are making recommendations to improve federal efforts to assess
and conduct research, coordination between the Office and the
Group, and the Office's arrangements with its support contractors.

Background Several federal agencies and offices have generated and
coordinated responses to veterans' complaints of illnesses
following the Gulf War. These have included the Departments of
Defense (DOD), Health and

Human Services (HHS), Veterans' Affairs (VA), and Energy, the
Central Intelligence Agency, the Environmental Protection Agency,
the National Security Council, and the Office of Management and
Budget.

B-282454 Page 6 GAO/NSIAD-00-32 Gulf War Illnesses

The formation of the Persian Gulf Veterans' Coordinating Board
(PGVCB) was announced in early 1994 for the purpose of
coordinating federal research and other activities in response to
illnesses reported by Gulf War veterans. This body, which is co-
chaired by the Secretaries of Defense, Veterans' Affairs, and
Health and Human Services, comprises working groups on research,
clinical issues, and compensation. The PGVCB Research Working
Group (RWG), which has no budgetary authority, does not directly
manage or distribute research funds. It describes its
responsibilities as (1) assessing the state and direction of
research and identifying gaps in factual knowledge and conceptual
understanding, (2) identifying testable hypotheses and potential
research approaches, (3) reviewing research concepts as they are
developed, (4) collecting and disseminating scientifically peer-
reviewed information, and (5) insuring that appropriate peer
review and oversight are applied to research the government has
conducted or sponsored.

Within DOD, initial efforts to respond to Gulf War veterans'
complaints were managed by the Assistant Secretary of Defense for
Health Affairs. In November 1996, following worsening public
relations, management of these efforts was transferred to the
newly created Office of the Special Assistant for Gulf War
Illnesses (OSAGWI), which became responsible for oversight of
DOD's efforts regarding illnesses being experienced by Gulf War
veterans. OSAGWI reported directly to the Deputy Secretary of
Defense. The Assistant Secretary of Defense for Health Affairs
continued to be responsible for managing and coordinating related
health programs, while DOD's medical research efforts were managed
largely by the Undersecretary of Defense for Acquisition and
Technology and the Army Medical Research and Materiel Command. DOD
established OSAGWI to restore public confidence in DOD's efforts
to deal with Gulf War illnesses issues. OSAGWI has focused its
efforts on (1) establishing effective two- way communications with
veterans and veterans' groups,

(2) investigating and reporting on incidents of possible chemical
warfare agent exposures, and (3) applying lessons learned from the
Gulf War experience to better protect U. S. servicemembers on a
contaminated battlefield.

The efforts of the various federal agencies have been met with
skepticism on the part of some veterans. This skepticism was
fueled by the delay, until 1996, in acknowledging potential
exposures to low levels of nerve agent at a munitions dump in
Khamisiyah, Iraq, during postwar demolition activities.
Additionally, veterans were upset by DOD's and VA's initial
emphasis on stress as a potential explanation for their symptoms.

B-282454 Page 7 GAO/NSIAD-00-32 Gulf War Illnesses

Congressional oversight of DOD's and VA's efforts has identified
problems in the agencies' clinical monitoring of veterans'
conditions and inaccuracies in agency statements about veterans'
potential exposures.

Spending on Research and Investigation of Veterans' Illnesses Is

Concentrated Within DOD

During fiscal years 1997 and 1998, HHS, DOD, and VA reported total
expenditures of at least $121. 3 million on research and/ or
investigation of Gulf War veterans' illnesses. 1 These
expenditures included $112. 4 million in DOD funds ($ 65.3 million
for OSAGWI and $47.1 million for non- OSAGWI expenditures), $7.2
million for VA, and $1. 6 million for HHS. 2 These amounts
excluded expenditures on examination and clinical care of ill
veterans during this time period. Because OSAGWI managed the
majority of DOD's research and

investigation expenditures, it was the single largest component of
the federal research and investigatory effort to respond to
veterans' concerns. The remainder of DOD's spending was attributed
to internal and external, DOD- sponsored research efforts
catalogued by the RWG. 1 The RWG records funds expended by VA,
HHS, and DOD based on the year in which they were appropriated.
Because these appropriations can be spent over 2 years, RWG data
for the most recently reported fiscal year (1998) were not
necessarily a complete representation of final spending for that
fiscal year. For this reason, fiscal year expenditures, which were
provided in December 1998, are likely to have increased during
fiscal year 1999.

2 These figures do not add to $121. 3 million because of rounding.
The costs for VA studies do not include overhead costs because
indirect costs are included under VA's medical care appropriation.
Similarly, the majority of HHS' expenditures represent direct
costs only. DOD's non- OSAGWI spending does not include overhead
costs for intramural studies but does for extramural ones. In
addition, the numbers reported for OSAGWI include overhead costs
and some spending on veteran outreach.

B-282454 Page 8 GAO/NSIAD-00-32 Gulf War Illnesses

OSAGWI was established in November 1996, when a staff of 110 and
an annual budget of $11.4 million were projected. The Office later
grew to a staff of slightly over 200, spending more than $65
million across fiscal years 1997 and 1998, and planning
expenditures of $35.9 million in fiscal year 1999 and $29.5
million in fiscal year 2000. 3 OSAGWI categorizes its spending as
research or support. During fiscal years 1997- 98, OSAGWI spent
$13.3 million, or 20 percent of its expenditures, on instruments
it characterized as research contracts and

another $47. 1 million, or about 73 percent of its expenditures,
on instruments it characterized as support contracts. The
remaining funds, about 7 percent of OSAGWI spending, covered
overhead, travel, conferences, computer equipment, and
miscellaneous other expenses. Many of its support costs are
difficult to separate from research and

investigation expenditures. For example, the objectives of
OSAGWI's support contracts ($ 21 million) with one contractor BDM
International include obtaining, documenting, and analyzing
information potentially related to Gulf War illnesses; documenting
the data and analysis in databases and other forms of storage;
developing questionnaires and surveys to collect data; rapidly
creating data analysis tools to aid in analysis efforts; and
developing and producing case studies.

Basic Questions About Causes, Course, and Treatment of Veterans'
Illnesses Remain

Unanswered The RWG has not assessed the extent to which the
research agenda has

satisfied the objectives it identified in 1995. The majority of
federal research projects remain ongoing or in review. Problems
identifying valid data on veterans' exposures persist, and basic
questions, such as how many veterans have unexplained symptoms and
whether those who have received care in VA facilities are getting
better or worse, remain unanswered.

3 Although OSAGWI officials are seeking the guidance of the
Special Oversight Board on DOD Investigations of Chemical and
Biological Incidents to determine what portion of its
investigation work should continue and how it should draw down the
Office, the Office is incorporated in DOD's budget through fiscal
2005, with twice the number of investigations

ongoing as have been completed.

B-282454 Page 9 GAO/NSIAD-00-32 Gulf War Illnesses

The Extent to Which Research Objectives Have Been Met Has Not Been

Assessed In April 1999, PGVCB officials told us they had not
finished assessing the

government's progress in answering the 21 major questions that the
RWG had identified in 1995. As detailed in appendix I, these
research objectives include questions about the prevalence of
various health problems and exposures among the veteran population
and the way the prevalence differs between Gulf War veterans and
appropriate control populations. With regard to exposure, the
research objectives cover Leishmania tropica

(a type of parasite), petroleum, petroleum combustion products,
specific occupational/ environmental hazards, chemical agent,
pyridostigmine bromide, and psychophysiological stressors. With
regard to veterans' health status, the research objectives cover
the prevalence among veterans

and appropriate control populations of symptoms, symptom
complexes, illnesses, altered immune function or host defense,
birth defects, reproductive problems, sexual dysfunction, cancer,
pulmonary symptoms,

neuropsychological or neurological deficits, psychological
symptoms or diagnoses, and mortality. Questions about exposure to
low levels of nerve agent were added in 1996, when DOD
acknowledged that U. S. troops might have experienced such
exposures during postwar demolition activities at Khamisiyah.

The research questions incorporate input from HHS, DOD, and VA but
do not formally constrain the research funded by these agencies.
Asked to identify which of the 21 research objectives had been
satisfied by late 1998, RWG officials wrote, Answers to some of
the research questions contained in the Working Plan have been
achieved to a greater degree of satisfaction than others. However,
at this time, it is accurate to say that no research question has
been answered to the extent that additional research would not be
able to shed more light on the question. In late 1998, an RWG
official noted that a draft analysis of research results as they
relate to these questions was anticipated in late spring or early
summer 1999 in preparation for publication of a revised working
plan for research on Gulf War Veterans' illnesses, but no deadline
had been established for publishing

this analysis and no such analysis had been published as of June
1999. While DOD noted that the analysis was in progress, it had
not been completed or a deadline established for its publication
when DOD and VA submitted their comments on our draft report in
August and September 1999, respectively.

Return on Research Investment Accruing Slowly Spending on research
was spread among various projects catalogued by the PGVCB's
Research Working Group and an additional set of projects

B-282454 Page 10 GAO/NSIAD-00-32 Gulf War Illnesses

sponsored by OSAGWI. While findings from this work are beginning
to accumulate, most of it is ongoing or in review.

Research Catalogued by RWG Although the research portfolio
monitored by the RWG includes over 50 projects that began in 1994
or earlier, only 34 of the 151 projects, or 23 percent of those
cataloged by the RWG, had been reported complete as of December
1998. This was 53 percent of the 62 that were scheduled for
completion by that time. Among the 47 percent of this group that
were not complete in December 1998, about one- third were later
completed and the remaining two- thirds had their estimated
completion dates revised (with extensions varying from a few
months to 10 years). RWG officials attributed the extensions
either to efforts to collect or incorporate additional data or to
unanticipated delays, such as difficulties in securing approval to
collect data or problems in locating and recruiting veteran
participants. 4 The officials identified four instances in which
additional funds had been provided. For example, the Centers for
Disease Control's health assessment of Persian Gulf War Veterans
from Iowa was extended to 2000 to provide for additional follow-
up of the survey sample. Similarly, DOD has committed to fund two
projects for the Army's Center for Health

Promotion and Preventive Medicine until 2003 and 2006. 5 4 For
example, some projects experienced delays in approval of their
plans by institutional review boards while others experienced
difficulty in recruiting subjects. Some survey efforts found that
it was more difficult than anticipated to track veterans'
whereabouts since the war. 5 Funding is extended through 2006 for
the Kuwait Oil Fires Troop Exposure Assessment Model, a project
responding to P. L. 102- 190 by characterizing the potential
carcinogenic and noncarcinogenic health risks to U. S. military
personnel exposed to the environment affected by the oil well
fires during and after Operation Desert Storm. Funding is extended
through

2003 for the Persian Gulf Veterans Health Tracking System, which
is intended to characterize exposures (other than airborne
contaminants from oil well fires) experienced by U. S. military
personnel during Desert Storm and to assess the potential health
risks/ consequences of those potential exposures.

B-282454 Page 11 GAO/NSIAD-00-32 Gulf War Illnesses

By June 1999, PGVCB reported only 1 of the 13 primary research
areas, leishmaniasis, had a majority of projects complete (four of
seven). 6 In one research area treatment no projects had yet been
finished. Among the 23 percent of federal research projects into
Gulf War veterans' illnesses that were completed by December 1998,
about two- thirds (22 of 34) had resulted in at least one article
published in a peer- reviewed journal. (We focused on this outcome
because publication in a peer- reviewed journal was suggested as a
surrogate marker for research quality in early

interviews with RWG officials and because publication in this form
insures more widespread access to research findings.) Some of the
other completed projects have had findings released in the form of
technical reports or summarized in an annual report issued by the
RWG. Additional peer- reviewed publications have been issued from
projects that are still ongoing.

Research Expenditures Managed by OSAGWI Five key contractors
accounted for about 72 percent of the $13.3 million

that OSAGWI attributed to spending on research contracts in fiscal
years 1997 and 1998. We reviewed the status of deliverables under
their contracts to determine whether they had been received in a
timely manner and had

been released to the public. We focused on timely provision of
deliverables as a basic measure of contractor performance and on
release of deliverables as an indicator of effectiveness, since
the contracts were often for developing public information and
doing so was a major part of OSAGWI's mission. As of December
1999, OSAGWI (or the responsible element at DOD) had received 19,
or 95 percent, of the 20 products due from the 5 research
contracts. Among those products received, 6 had been released to
the public, with the remainder largely in various stages of
interagency review when we ended our work in December 1999.
Fourteen products had remained in review or draft status for a
year or longer.

Appendix II contains detailed information on the research
contracts we examined, including the contractor, the contract
amount, the titles or topics of deliverables, and the
deliverables' status (i. e., whether they were due at the time of
our review, had been received, and/ or released, what 6 The RWG
cataloged the federal research portfolio by primary research topic
in March 1998.

At that time, there were 121 (instead of the current 151)
federally sponsored research projects. Because 30 research
projects that began after March 1998 were not categorized by the
RWG into primary research topics, our analysis by primary research
topic includes only the 121 that had been categorized. See the
RWG's report entitled Annual Report to Congress: Federally
Sponsored Research on Gulf War Veterans' Illnesses for 1997, March
1998.

B-282454 Page 12 GAO/NSIAD-00-32 Gulf War Illnesses

form they were in at receipt, what was the date of the earliest
known receipt, and whether they had been released).

With respect to other products of OSAGWI's spending, including
nonresearch spending, by January 1, 1999, OSAGWI had issued 13
case narratives (accounts of particular incidents during the war),
2 environmental exposure reports, and 4 information papers. 7 Work
on an additional 26 case investigations was ongoing. 8 As of
December 3, 1999, 1 additional case narrative and 3 additional
information papers had been issued.

7 Other accomplishments cited by OSAGWI officials in hearings
before the Senior Oversight Panel on DOD Investigation of Chemical
and Biological Incidents (held Nov. 19- 20, 1998) included
visiting five bases, answering 3,000 hotline calls, and responding
to 5,000 e- mail inquiries. Additional veterans were contacted via
the Office's programs to notify veterans of potential exposures or
survey veterans on particular topics. 8 For a review of OSAGWI's
investigatory activities, see Gulf War Illnesses: Procedural and
Reporting Improvements Are Needed in DOD's Investigative Processes
(GAO/NSIAD-99-59,

Feb. 26, 1999).

B-282454 Page 13 GAO/NSIAD-00-32 Gulf War Illnesses

Problems in Identifying Valid Exposure Data Persist

Absence of agreement or valid data on veterans' wartime exposures
has presented formidable obstacles to researchers in developing
definitive information about the causes of veterans' illnesses.
Although the nearly half of studies that are epidemiological
depend to some extent on the use of exposure data, researchers
continue to face difficulties in assessing and validating
veterans' exposures. These difficulties led us to conclude in our
1997 report that the many epidemiological studies being sponsored
would not provide definitive information on the causes of
veterans' illnesses. 9 Proceedings of conferences on federally
sponsored research also

document that researchers are experiencing increasingly difficult
problems in soliciting reliable self- reported data on exposures
as time from the original events increases. 10 Because of such
problems, the likelihood of misclassifying persons who received no
exposure as having had some or

significant exposure (or vice versa) will increase, reducing the
capacity of data analyses to identify associations between
exposures and health outcomes. Perhaps as a result, completed
research projects classified as epidemiological had a lower rate
of publication in peer reviewed journals than other types of
federally sponsored research. 11 To begin to identify the causes
of an unexplained illness, epidemiological

researchers normally define a set of criteria, known as a case
definition, that can be used to separate persons who have the
condition from those who do not. This permits researchers to look
into differences in their histories to gain insight into what may
have caused their illness. However, no such working case
definition or set of such definitions that might focus federal
research has been endorsed by the Research Working Group.

Working case definitions of unexplained illness among veterans
that have been proposed by individual researchers have been
similar to one another in emphasizing unexplained fatigue,
neurocognitive complaints, and

9 Gulf War Illnesses: Improved Monitoring of Clinical Progress and
Reexamination of Research Emphasis Are Needed (GAO/NSIAD-97-163,
June 23, 1997). 10 See the RWG, PGVCB, Proceedings: Conference on
Federally Sponsored Gulf War Veterans' Illnesses Research, June
17- 19, 1998 and June 23- 25, 1999. 11 Of the 22 completed
research projects classified as epidemiological, 12, or about 55
percent, had resulted in publication of an article in a peer-
reviewed journal. By way of comparison, 83 percent (10 of 12) of
the completed nonepidemiological projects had results published in
such journals. (We include projects originally classified by the
RWG as clinical epidemiology as well as those projects classified
as epidemiology in this total; after we recommended a shift from
epidemiological research in June 1997, the RWG reclassified
studies formerly designated clinical epidemiology as clinical
research projects).

B-282454 Page 14 GAO/NSIAD-00-32 Gulf War Illnesses

musculoskeletal complaints, symptoms reported more commonly by
Gulf War veterans than by veterans of the same era who were
deployed elsewhere (see app. III).

Descriptive Information Concerning Veterans' Symptoms Exists, but
Many Basic Questions Remain Unanswered

The government has had some success in cataloging data on the
illnesses suffered by Gulf War veterans. DOD and VA registries
gather such information, and studies have been funded to collect
data on veterans' symptoms. However, owing to the data collection
formats used in the registry process and the self- selection of
registry participants, the registries are not optimal sources of
information regarding the prevalence of various symptom clusters
among veterans, making it difficult to know which of the

various case definitions or symptom groups deserve closer
examination. For example, these registries are unlikely to record
sufficient data to determine whether a veteran meets criteria for
multiple chemical

sensitivity or chronic fatigue syndrome, for which recognized case
definitions exist, but not standard diagnostic categories, as
represented by international disease classification codes. Some
federally sponsored

research, notably VA's National Health Survey, might be able to
clarify this issue, but descriptive data from the survey remained
unpublished at the close of our review.

Although some progress has been made in cataloging veterans'
illnesses, the results generally describe only what illnesses a
veteran was suffering from at a particular point in time. As a
result of this and the limitations of

the DOD and VA registries, several basic descriptive questions
remain unanswered. For example, the Special Investigative Unit of
the Senate Veterans' Affairs Committee and others have identified
such open

questions as the following:  How many of those veterans who have
been examined have unexplained illnesses or symptoms?  How many of
those veterans are also receiving compensation for that condition?
How many are receiving health care?  What treatments have they
received?  Are those who have received care in VA facilities
getting better or worse?

Some data that might be helpful in answering such questions are
being collected, but an analysis of these data was not available
at the close of our review. An HHS- sponsored project, which began
in 1997, is assessing the

B-282454 Page 15 GAO/NSIAD-00-32 Gulf War Illnesses

persistence and stability of veterans' symptoms over time. This
study is planned to end in 2000. In addition, VA and DOD are
recruiting patients for cooperative trials of antibiotic and
exercise- behavioral treatments for a broad set of veterans'
unexplained symptoms. However, perhaps because there is little
understanding of the physical causes underlying veterans'
symptoms, VA and DOD officials note that the treatments to be used
in these trials are expected only to ameliorate symptoms, not to
eliminate them. RWG and OSAGWI Activities Not

Effectively Coordinated OSAGWI's activities have not been
effectively coordinated with those of the

RWG in order to maximize the efficient use of resources. We found
conflicting information about the nature of OSAGWI's work and
whether it should be coordinated. Specifically, RWG and OSAGWI
officials told us that

OSAGWI's activities involve investigations, not research, and
therefore are not subject to coordination. However, in an August
1997 letter to OSAGWI, the RWG raised questions about the
methodologies of three OSAGWIsponsored studies and expressed
concern over the lack of any external review process for these
studies and for OSAGWI's research efforts in general. OSAGWI
pursued these studies, but it has not published their findings.
The lack of effective coordination between the RWG and OSAGWI
increases the potential to miss opportunities to leverage ongoing
and

completed work by other agencies. Other examples illustrate the
need for better coordination. For example, in January 1998, the
National Academy of Science's Institute of Medicine presented a
proposal to VA, which was funded under a congressional mandate, to
pursue studies at a projected cost of $1.25 million to
comprehensively review, evaluate and summarize the available
scientific and medical information regarding the association
between exposures

during the Persian Gulf War and adverse health effects experienced
by Persian Gulf War veterans. However, in 1997, OSAGWI had
contracted with RAND at a cost of more than $1.5 million for the
preparation of literature reviews of key possible causal
hypotheses of GWI. 12 The Institute's assessments regarding the
links between exposures and health outcomes must be based, at
least partly, on the review of relevant literature, and RAND's
identification of this literature has required, at least, some
assumptions regarding potential exposure scenarios. Thus, it
should

12 OSAGWI eventually authorized RAND work valued at $3. 2 million.

B-282454 Page 16 GAO/NSIAD-00-32 Gulf War Illnesses

have been possible to use RAND's ongoing work for the Institute
study, and better coordination of these two efforts might have
saved both time and money. When we interviewed Institute staff in
June 1998, they were

generally aware of RAND's plan to perform literature reviews, but
they were not familiar with the content of RAND's work, noting
that none of it had been released. While RAND did seek approval of
a list of scientific peer

reviewers for its work from Institute officials, in the absence of
coordination mechanisms, these two efforts were pursued
independently. Similarly, at least three reviews of the health
effects of depleted uranium have been commissioned within a few
years - one by each agency represented on PGVCB. HHS' Agency for
Toxic Substances and Disease Registry first released a
toxicological profile for uranium in 1989 and issued an updated
draft toxicological profile on uranium (including depleted
uranium) on October 17, 1997. This draft, prepared by the Research

Triangle Institute, incorporated a plain- language public health
statement and reflected the Agency's assessment of all relevant
toxicological testing and information that had been peer-
reviewed. In addition, at OSAGWI's request, RAND performed a
review of the scientific literature regarding the health effects
of depleted uranium. Finally, IOM will conduct such a review as
part of its work for VA. The need for the additional review of
depleted uranium by RAND, which was submitted in August 1998,
after the Agency

had issued its draft, is questionable. Contracting for OSAGWI
Support Services Was Flawed

OSAGWI spent more than $47 million in fiscal years 1997 and 1998
on its support contracts. We reviewed four support agreements,
which made up more than 91 percent of OSAGWI's support spending,
and found problems with several of the task orders. Specifically,
two of the largest task orders were awarded improperly, and OSAGWI
discouraged competition on

another by naming a preferred vendor. Improper Task Orders
OSAGWI's support arrangements consisted largely of task orders
under

multiple- award contracts of other agencies and offices. OSAGWI's
largest support arrangement was based on two improper task orders
awarded to BDM. OSAGWI officials noted that they were directed to
establish the Office with all possible speed and explained that
they anticipated relying heavily on contractors for support. As
part of addressing this need, an initial task order covering a
broad range of services was awarded to BDM

under a National Guard Bureau (NGB) multiple- award task order
contract for information technology services.

B-282454 Page 17 GAO/NSIAD-00-32 Gulf War Illnesses

The BDM task order describes its objectives as including, but not
limited to:

obtaining, documenting, and analyzing information potentially
related to Gulf War illnesses; documenting the data and analysis
in databases and other forms of storage; establishing a program to
reach- out to veterans; developing questionnaires and surveys to
collect data; developing maps and other multimedia presentations;
plotting and analyzing troop movements and locations; rapidly
creating data analysis tools to aid in analysis efforts;
developing and producing case studies; preparing documents for
storage on GulfLINK; developing recommendations and long range
plans; writing papers; and, providing testimony.

The task order also required BDM to provide facilities, furniture,
telecommunications, equipment, and services, as needed. Orders
under multiple- award, task- or- delivery- order contracts are
required by law to contain a statement of work that clearly
specifies all tasks to be performed or property to be delivered
under the order. 13 In our opinion, this language means that a
task order must identify with reasonable specificity the task or
tasks that a contractor will be expected to perform, rather than
merely list categories of services. The task order awarded to BDM,
however, was basically a broad menu of services from which OSAGWI
could pick and choose as the occasion arose and lacked the degree
of specificity required. While we appreciate the exigent
circumstances under which this award was made, we do not believe
that

the award of this broad task order was proper because it did not
clearly specify the tasks to be performed. The DOD Inspector
General also cited concerns with OSAGWI's task orders to BDM. 14
When OSAGWI reached its allotted cost ceiling under the NGB
contract and the NGB did not increase the contract ceiling, OSAGWI
continued the

arrangement with BDM through an order under the General Services
Administration's Management, Organizational, Business Improvement
Services (MOBIS) schedule contract. The MOBIS schedule states that
it is intended to support business, management, and organizational

improvement through activities such as quality management,
benchmarking, reengineering, surveys, strategic planning, and
development of leadership and management skills. The General
Services 13 10 U. S. C.  2304c( c).

14 See DOD Inspector General , DOD Use of Multiple Award Task
Order Contracts - Report No. 99- 116, Apr. 2, 1999.

B-282454 Page 18 GAO/NSIAD-00-32 Gulf War Illnesses

Administration's summary of MOBIS services states that such
contracts are not intended for independent management or technical
studies. The task order to BDM was outside the scope of the MOBIS
contract. The

work identified in the task order supports OSAGWI's operational
functions and activities and does not fit properly within the
scope of the contract. Specifically, the objective of the task
order is to support OSAGWI's research and investigation into
potential causes of Gulf War veterans' illnesses, rather than, as
OSAGWI contends, to support efforts to improve managerial or
organizational processes of the type intended for the MOBIS

contract. In this regard, the MOBIS scope of work states that the
performance of operational activities and database planning are
not appropriate for purchase under MOBIS. Given the substantial
disparity between the purposes of this contract and the BDM task
order, we believe that the task order is outside the scope of the
MOBIS contract and should not have been awarded under that
contract. OSAGWI officials have informed us that this task order
will expire in January 2000, but that the need for the type of
support services that BDM is providing will continue for an
indefinite period.

Competition for Task Order Discouraged Under multiple award task
order contracts, all of the multiple award

contractors are to be given a fair opportunity to be considered
for the award of any particular task order, typically by
submitting proposals in response to agency announcements.
Competition is one of the means by which agencies insure they
obtain the best value from their contractors. OSAGWI's
solicitation for one task order opportunity, however, discouraged
competition among the multiple award contractors by naming Systems
Research and Applications Corporation (SRA) as the preferred
contractor.

B-282454 Page 19 GAO/NSIAD-00-32 Gulf War Illnesses

We have testified and reported that naming preferred contractors
in task order announcements discourages competition, frequently
resulting in just one proposal being received. 15 SRA was the only
multiple award contractor that responded to the announcement. 16
OSAGWI has not argued that SRA was uniquely qualified to perform
the required work.

Conclusions During fiscal years 1997- 98, the government expended
considerable funds on research and investigation into Gulf War
veterans' illnesses about $121 million. More than half of this
total was spent by the Office of the Special Assistant for Gulf
War Illnesses. Even though significant funding has been spent on
research and investigation of Gulf War veterans' illnesses, most
of the research is

ongoing and the Research Working Group has not completed an
assessment of the extent to which federal research objectives
identified in 1995 have been satisfied. While about two- thirds of
the 34 completed projects had resulted in peer- reviewed
publications, researchers face increasingly difficult problems in
identifying valid data on veterans' exposures. Moreover, little is
known about how veterans' conditions have changed over time, no
working case definitions have been endorsed in order to focus
research efforts, and research on treatments has begun only

recently. As a result, little knowledge exists concerning the
causes, courses, or successful treatments for Gulf War veterans'
illnesses. In addition, although the Office of the Special
Assistant for Gulf War Illnesses

has received most of the material requested of its research
contractors, the review process established by the Office can be
slow.

Coordination of planned efforts is key to maximizing the
government's investment into research on Gulf War veterans'
illnesses. However,

15 Defense Acquisition: Improved Program Outcomes Are Possible
(GAO/T-NSIAD-98-123, Mar. 18, 1998), and Acquisition Reform:
Multiple Award Contracting at Six Federal Organizations,
(GAO/NSIAD-98-215, Sept. 30, 1998). In response to our testimony,
the Office

of Management and Budget directed that the Federal Acquisition
Regulation be revised to prohibit the naming of preferred
contractors in task order announcements. The federal acquisitions
regulation was revised to prohibit the designation of preferred
awardees effective August 16, 1999.

16 After the initial award was made to the preferred vendor
identified in the announcement, succeeding awards were directed to
the same vendor under an exception to the fair opportunity
requirement for work that is a logical follow- on from prior work.
Thus, the

anticompetitive effect of directing the initial award was
magnified in subsequent awards.

B-282454 Page 20 GAO/NSIAD-00-32 Gulf War Illnesses

disagreement regarding which activities should be subject to
coordination exists. As a result, the Office of the Special
Assistant for Gulf War Illnesses, which spends more than half of
the federal funds supporting research and

investigation, has not effectively coordinated its activities with
the Research Working Group. DOD established the Office of the
Special Assistant for Gulf War Illnesses

to restore public confidence in DOD's efforts to deal with Gulf
War illnesses issues. While officials of the Office of the Special
Assistant for Gulf War Illnesses noted that they intended to seek
advice on drawing down the

office, they planned expenditures of $65. 4 million across fiscal
years 1999 and 2000, and the Office remains in DOD's budget
through fiscal year 2005. Because the Office spends a high
percentage of its budget on support contracts, it is important
that its contracting procedures comply fully with applicable laws
and regulations.

Recommendations With respect to the health research efforts
coordinated by the Research Working Group of the Persian Gulf
Veterans' Coordinating Board, we

recommend that the Secretaries of Veterans' Affairs, Defense, and
Health and Human Services direct the executive director of the
Research Working Group to  establish and achieve a target date
within fiscal 2000 for publishing its assessment of progress
toward addressing the research objectives it identified in 1995;

 compile data on the number of Gulf War veterans with unexplained
illnesses, the progression of their illnesses, the treatments they
are receiving, and the success of these treatments (recognizing
that application of some working case definitions or
categorization scheme may be useful for purposes of such an
accounting); and  effectively coordinate the efforts of the Office
of the Special Assistant

for Gulf War Illnesses with related activities of DOD, VA, and HHS
to prevent duplication and improve the efficiency of resource use.
We also recommend that the Secretary of Defense direct the Office
of the Special Assistant for Gulf War Illnesses to replace the
task order issued under the MOBIS contract with a proper
contracting arrangement as soon as practicable. In addition, the
Secretary should direct the Office of the Special Assistant for
Gulf War Illnesses that all future support contracts should comply
fully with applicable laws and regulations.

B-282454 Page 21 GAO/NSIAD-00-32 Gulf War Illnesses

Agency Comments and Our Evaluation

In written comments on a draft of our report, DOD and VA agreed
with some of our findings and recommendations but disagreed with
others, and CDC generally concurred with our findings and
recommendations. DOD

provided additional technical comments, which we incorporated as
appropriate. Also, CDC requested that we incorporate additional
information on two of its sponsored studies, which we did. (App.
IV, V, and VI contain the written comments of DOD, VA, and CDC,
respectively, and our evaluation of them.)

DOD commented that our report paints a pessimistic picture of the
research on Gulf War veterans' health. The Department cited
studies that compared the hospitalization in military facilities,
the birth outcomes in military facilities, and the mortality of
active duty Gulf War veterans to large groups of nondeployed
veterans as support for a more optimistic

perspective on veterans' health. However, DOD did not cite the
most consistent finding of the health research to date; that is,
Gulf War veterans seem to exhibit more of some symptoms, such as
fatigue, difficulty concentrating, and muscle and joint pain, than
do nondeployed veterans. 17 DOD believes that the failure to
identify a unique syndrome is an

optimistic sign of veterans' health overall. We disagree. Even if
the symptoms reported more often by Gulf War veterans are not
confined to those veterans, DOD needs to explain why Gulf War
veterans report these symptoms more frequently. Furthermore, none
of the studies DOD cited examined the possible existence of
significant differences in the health of Gulf War veterans based
on specific exposures to hazardous materials during military
service. 18 17 Institute of Medicine, Gulf War Veterans: Measuring
Health (Washington, D. C.: National Academy Press, 1999), p. 2;
Iowa Persian Gulf Study Group, Self- Reported Illness and Health
Status Among Gulf War Veterans: A Population- Based Study, Journal
of the American Medical Association, 227 (3), (1997), pp. 238-
245; and K. Fukuda, et al., Chronic Multisymptom Illness Affecting
Air Force Veterans of the Gulf War, Journal of the American
Medical Association, 380 (11), (1998), pp. 981- 88.

18 One study argued that the Gulf War veterans may have been more
fit than those not deployed; thus, the finding of no difference
between the two groups might suggest a significant decline in the
post- war health of the Gulf War veterans. R. Haley, Point: Bias
From the Health Warrior Effect' and Unequal Follow- up in Three
Government Studies of Health Effects of the Gulf War, American
Journal of Epidemiology, 148 (4), (1998), pp. 315- 23.

B-282454 Page 22 GAO/NSIAD-00-32 Gulf War Illnesses

DOD also said that we were incorrect in stating that little is
known about how veterans' conditions have changed over time.
However, our report is consistent with a September 1999 report of
the Institute of Medicine. The report notes that there has been no
systematic evaluation of whether or how veterans' health status is
changing. 19 Also, in a 1998 report to Congress, the Research
Working Group stated that no government research is specifically
directed toward understanding the progress of Gulf War veterans'
illnesses over time and that research should determine the
longterm health of these veterans. 20

DOD further stated that the effectiveness of government research
has been demonstrated in a variety of ways. We agree that the
research to date has added to what was known about Gulf War
veterans' health shortly after the war. Nevertheless, little
information is available on the extent or course of the
development of veterans' undiagnosed illnesses, basic information
on

the prevalence of veterans' symptoms is unavailable, and no
research on the treatment of such illnesses has been completed.
Although joint commands have revised joint policy on record-
keeping, and operational

changes have been made to improve environmental monitoring, these
changes do not serve as proof of research effectiveness. Rather,
they address problems that have challenged Gulf War researchers in
interpreting data on veterans' illnesses because they lack
accurate and precise information (i. e., duration and doses) on
veterans' exposures to hazardous

materials. Both DOD and VA concurred with our recommendation that
the Research Working Group set a date in fiscal year 2000 for
reporting its progress in addressing the research objectives it
identified in 1995. DOD confirmed, as we noted in our draft
report, that this report is in progress, but neither agency
provided a specific date for its publication.

Regarding our recommendation that steps be completed to compile
data on the number of Gulf War veterans with unexplained
illnesses, the treatments they were receiving, and the success of
these treatments, DOD partially concurred and VA did not concur.
Neither agency opposed the collection of information on the number
and health status of Gulf War veterans with

19 Institute of Medicine, Gulf War Veterans: Measuring Health
(Washington, D. C.: National Academy Press, Sept. 1999), p. 3, 35.
20 Persian Gulf Veterans' Coordinating Board - Research Working
Group , Annual Report to Congress - 1998 (Washington, D. C.: PGVCB
RWG, June 1999), p. 53.

B-282454 Page 23 GAO/NSIAD-00-32 Gulf War Illnesses

unexplained illnesses. However, VA stated that it could not
implement the recommendation as worded without specific case
definitions (that is, criteria to identify distinct illnesses). We
agree that some categorization scheme or set of working case
definitions would be useful in counting the numbers of veterans
that have unexplained illnesses of some type, and we

revised our recommendation accordingly. Although DOD concurred
with our recommendation that the Research Working Group coordinate
with the Office of the Special Assistant for Gulf War Illnesses on
activities related to Gulf War veterans' illnesses, DOD disagreed
that its current coordination was weak. It stated that
coordination was already occurring and that coordination on
Officesponsored

reviews of scientific literature was unnecessary because the
reviews were not research. VA did not concur with the
recommendation because most of the work of the Office of the
Special Assistant involves investigations of specific wartime
incidents rather than research.

Regardless of whether the work of the Office is considered
research or not, it describes the extent and nature of veterans'
possible exposures to hazardous materials. These descriptions are
important to researchers trying to identify the health
consequences of such exposure. Moreover, the law does not limit
the Working Group's coordination efforts to activities

that constitute research, however defined. Accordingly, we are now
recommending that the Research Work Group effectively coordinate
the activities of the Office of the Special Assistant with related
activities of DOD, VA, and the Department of Health and Human
Services to prevent

duplication of effort and optimize the use of resources. We are
making this recommendation to prompt these organizations to work
more closely on behalf of ill veterans. We believe that greater
cooperation, exchange of information, and coordination will help
expedite the process and help find solutions the veterans need.

Finally, DOD did not concur with our recommendation to replace an
improperly awarded task order as soon as practicable and to comply
fully with applicable laws and regulations in future contracting
activities. DOD noted that because its Gulf War illnesses office
does not have contracting officers, it relies on the professional
judgment of contracting professionals outside that office, who did
not object to the office's contract actions. DOD

contends that the office complied with all legal requirements in
effect at the time.

B-282454 Page 24 GAO/NSIAD-00-32 Gulf War Illnesses

We note that DOD did not disagree with our conclusion that the
task order was improperly awarded. The task order was for support
of office operations in developing information related to Gulf War
illnesses, even though the underlying contract prohibited its use
for the performance of

operational activities. The task order was therefore improper and
should be terminated, if practicable, as we recommended.

We recognize that the Office of the Special Assistant relies on
contracting professionals outside that office to execute its
support contracts. Nevertheless, the office is, at a minimum,
responsible for determining its requirements for support, a
process that in one instance resulted in naming a preferred vendor
and in another led to an overly broad statement of work. The
effect of these practices is to discourage competition. It is
important, therefore, that both requiring agencies, such as the
Gulf War illnesses office, as well as agencies that execute
contracts, adhere to the statutes and regulations designed to
maximize competition.

Scope and Methodology To determine how much DOD, HHS, and VA have
spent on research and

investigation of Gulf War veterans' illnesses and health concerns
in fiscal years 1997 and 1998, we reviewed budget documents,
contracts, and other relevant documents. We also interviewed RWG
members, as well as DOD, HHS, and VA officials managing the
respective agencies' budgeting for research, investigation, and
clinical care. During our interviews, we

inquired about spending levels and the distribution of funds
across activities. The expenditure estimates included in this
report are limited to DOD, VA, and HHS. Because we targeted key
entities within these agencies on the basis of the public profile
of their research and investigatory efforts, the expenditures we
identified may exclude related spending by entities that have not
been prominently identified with the federal effort. We did not
independently assess the estimates provided us by the various
agencies and offices apart from determining that they were
basically consistent with the contract documents examined.

To determine the status of research efforts and identify research
products, we reviewed research and investigatory objectives,
reports to Congress, agency documents, and articles appearing in
peer- reviewed journals. In addition, we interviewed researchers,
PGVCB officials, and officials at the sponsoring agencies. We did
not independently assess the appropriateness

B-282454 Page 25 GAO/NSIAD-00-32 Gulf War Illnesses

of federal research objectives, nor did we determine how well
federally sponsored research had addressed them. To investigate
the extent of coordination between OSAGWI and the RWG, we
interviewed members of OSAGWI; the RWG; representatives from DOD,
HHS, and VA; and researchers about the process. We reviewed agency
documents and the minutes of PGVCB and other meetings and examined
research protocols, contracts, and documentation of reviews
conducted by sponsoring agencies into research and investigatory
activities.

To determine the expenditures and resources OSAGWI had directed
toward veterans' health concerns and the way it managed its
contracts, we interviewed OSAGWI officials and contracting
officers and reviewed contracts, task orders, statements of work,
copies of deliverables, and

requested any assessments of contractor performance. For
efficiency, we limited the review to four support and five
research contracts, which accounted for 91 percent and 72 percent
of OSAGWI's expenditures in the respective areas.

Our work was conducted from May 1998 through December 1999 in
accordance with generally accepted government auditing standards.
As agreed with your office, unless you publicly announce its
contents

earlier, we plan no further distribution of this report until 30
days from its issue date. At that time, we will send copies of
this report to other interested congressional committees and
members.

If you have any questions or would like additional information,
please contact those listed in appendix VII. Sincerely yours,

Kwai- Cheung Chan Director, Special Studies and Evaluations

Page 26 GAO/NSIAD-00-32 Gulf War Illnesses

Appendix I

Appendi xes Research Objectives Identified by the Research Working
Group of the Persian Gulf Veterans' Coordinating Board Appendi x I

1. What is the prevalence of symptoms/ illnesses in the Persian
Gulf veteran population? How does this prevalence compare to that
in an appropriate control group? 2. What was the overall exposure
risk of troops to Leishmania tropica? 3. What were the exposure
concentrations to various petroleum products, and their combustion
products, in typical usage during the Persian Gulf conflict?

4. What was the extent of exposure to specific occupational/
environmental hazards known to be common in the Persian Gulf
veteran's experience? Was this exposure different from that of an
appropriate control group? 5. What were the potential exposures of
troops to organophosphate nerve agent and/ or sulfur mustard as a
result of allied bombing at Muhammadiyat and Al Muthanna, or the
demolition of a weapons bunker at Khamisiyah?

6. What was the extent of exposure to chemical agent, other than
at Khamisiyah, Iraq, in the Persian Gulf as a function of space
and time? 7. What was the prevalence of PB use among Persian Gulf
troops? 8. What was the prevalence of various psychophysiological
stressors among Persian Gulf veterans? Is the prevalence different
from that of an appropriate comparison population? 9. Are Persian
Gulf veterans more likely than an appropriate comparison group to
experience non- specific symptoms and symptom complexes?

10. Do Persian Gulf veterans have a greater prevalence of altered
immune function or host defense when compared with an appropriate
control group?

11. Is there a greater prevalence of birth defects in the
offspring of Persian Gulf veterans than in an appropriate control
population?

12. Have Persian Gulf veterans experienced lower reproductive
success than an appropriate control population? 13. Is the
prevalence of sexual dysfunction greater among Persian Gulf
veterans than among an appropriate comparison population?

Appendix I Research Objectives Identified by the Research Working
Group of the Persian Gulf Veterans' Coordinating Board

Page 27 GAO/NSIAD-00-32 Gulf War Illnesses

14. Do Persian Gulf veterans report more pulmonary symptoms or
diagnoses than persons in appropriate control populations?

15. Do Persian Gulf veterans have a smaller baseline lung function
in comparison to an appropriate control group? Do Persian Gulf
veterans have a greater degree of non- specific airway reactivity
in comparison to an

appropriate control group? 16. Is there a greater prevalence of
organic neuropsychological and neurological deficits in Persian
Gulf veterans compared to appropriate control populations?

17. Can short- term, low- level exposures to pyridostigmine
bromide, the insect repellant DEET, and the insecticide
permethrin, alone or in combination, cause short- term and/ or
long- term neurological effects?

18. Do Persian Gulf veterans have a significantly higher
prevalence of psychological symptoms and/ or diagnoses than do
members of an appropriate control group?

19. What is the prevalence of leishmaniasis or other infectious
diseases in the Persian Gulf veteran population? 20. Do Persian
Gulf veterans have a greater risk of developing cancers of any
type when compared with an appropriate control population?

21. Are Persian Gulf veterans experiencing a mortality rate that
is greater than that of an appropriate control population? Are
specific causes of death related to service in the Persian Gulf?

Page 28 GAO/NSIAD-00-32 Gulf War Illnesses

Appendix II Reports Received and Released by the Office of the
Special Assistant Under Research Contracts Examined by GAO Appendi
x II

Contractor Contract amount Topics/ titles Due Received

Form and date of earliest known receipt

Released (as of 12/ 15/ 99)

Mitre Corporation a $3, 185,000 Iraqi Chemical Warfare Study Yes
Yes Classified draft

report (4/ 4/ 97) b Partial (9/ 5/ 97) c RAND $3, 200,000 Oil
Fires: A Review of the Scientific Literature as It Pertains to

Illnesses of Gulf War Veterans Yes d Yes Partial draft (12/ 97).
Draft for agency

review (4/ 16/ 98). Yes e (11/ 5/ 98)

A Review of Scientific Literature as It Pertains to Gulf War
Illnesses, Volume V: Depleted Uranium Yes d Yes Draft for agency

review (8/ 4/ 98). Yes (4/ 16/ 99) A Review of the Scientific
Literature as It Pertains to Gulf War Illnesses, Volume VI:

Chemical and Biological Warfare Agents Yes d Yes Draft for agency

review (9/ 1/ 98). No A Review of the Scientific Literature as It
Pertains to Gulf War Illnesses: Volume III: Pyridostigmine Bromide

Yes d Yes Draft for agency review (6/ 10/ 98). Yes (10/ 19/ 99)

Stress: A Review of the Scientific Literature as It Pertains to
Health Problems of Gulf War Veterans Yes d Yes Draft for agency

review (4/ 23/ 98). Yes (5/ 19/ 99) Infectious Disease Yes d Yes f
Draft for agency

review (2/ 11/ 98). No Immunizations Yes d Yes Draft for agency

review (4/ 22/ 99). No Military Uses of Drugs Not Yet Approved by
FDA for BW/ CW Defense: Lessons from the Gulf War

Yes d Yes Draft for agency review (4/ 24/ 98). Yes (4/ 16/ 99)

Assessing the Health Effects of Military Deployments: DOD's
Activities Following the Gulf War Yes d Yes Draft for agency

review (9/ 15/ 98). No Notes on the history of stress Yes d No Not
received as of

12/ 20/ 99. No Pesticides Yes d Yes Draft for agency

review (11/ 3/ 98). No Institute for Defense Analyses

$389, 000 Full Dimensional Protection: Military Records and
Reports Dimension Yes Yes Draft for agency

review (12/ 10/ 97) Revised draft (7/ 28/ 98).

No f (Continued )

Appendix II Reports Received and Released by the Office of the
Special Assistant Under Research Contracts Examined by GAO

Page 29 GAO/NSIAD-00-32 Gulf War Illnesses

Safe and Timely Disposal in Wartime of Large Quantities of
Captured Chemical and Biological Munitions

Yes Yes Draft for agency review (11/ 8/ 97). No g

Protecting Against the Uncertain Risks of Exposure to Very Low
Concentrations of Chemical Warfare Nerve Agents

Yes Yes Draft received 9/ 99. No [A paper describing planned and
possible alternative approaches for improving DOD capabilities to

detect chemical agents on the battlefield and archive such data]

Yes Yes Report delivered 6/ 16/ 97. No National Academy of
Sciences

$2, 703, 809 h Force Protection: Lessons Learned from the Gulf War
No i No j No final report due

before 3/ 31/ 00. Birch & Davis Associates $176, 500 k Birth
Defects Among Children of

Gulf War Veterans and Potential Nerve Agent Exposure

Yes Yes Draft for agency review (8/ 21/ 98). No l

Comprehensive Clinical Evaluation Program Gulf War Studies and
Analyses: Report on Findings from a Telephone Survey of Persian
Gulf War Veterans Assigned to Demolition Units

Yes Yes Draft for agency review (12/ 1/ 97). No

Toxicity Assessment and Risk Evaluation for Exposure of U. S.
Troops to Chemical Agents at Khamisiyah Yes Yes Draft for agency

review (5/ 22/ 98). No Admissions to Field Hospitals During the
Gulf War and Potential Nerve Agent Exposures

Yes Yes Draft for agency review (7/ 16/ 98). No

Total $9, 654, 309 20 19 6 Contractor Contract

amount Topics/ titles Due Received Form and date of

earliest known receipt Released

(as of 12/ 15/ 99)

(Continued from Previous Page)

Appendix II Reports Received and Released by the Office of the
Special Assistant Under Research Contracts Examined by GAO

Page 30 GAO/NSIAD-00-32 Gulf War Illnesses

a Mitre contracted with the Assistant to the Secretary of Defense
for Intelligence Oversight, but the Office of the Special
Assistant for Gulf War Illnesses (OSAGWI) was directed to provide
$3,185,000 to support Mitre's work on the study. Although OSAGWI
does not have direct oversight of the effort, the status of the
study is shown here in the interest of tracking the products
associated with funds provided to OSAGWI. b The Office of the
Assistant Secretary of Defense for Intelligence Oversight reported
that no final report was available as of July 27, 1998.

c A declassified version of chapter 11 of this report was released
by OSAGWI on September 5, 1997, in response to a request from the
Presidential Advisory Committee on Gulf War Veterans' Illnesses.
An official of the Office of the Assistant Secretary of Defense
for Intelligence Oversight indicated on December 15, 1999 that he
expected the report to be transmitted to the Secretary on or
before December 25, 1999 accompanied by a recommendation for
release of a substantial portion in unclassified form.

d Products of the RAND contract were originally due in September
1997. A December 1997 modification to RAND's agreement with the
Department of Defense (DOD) reestablished due dates between
December 1997 and January 1998.

e In many instances, the deadlines on these products were extended
or the Office was slow to provide the official comment necessary
for the contractor to issue a final product. OSAGWI also
instituted a review process that incorporated comments from
various government agencies. This process has required months to
apply, and some deliverables spent a year or longer in unreleased
or draft form. OSAGWI officials indicated that they initiated the
external review process at the urging of the Research Working
Group (RWG), but Group officials said that they encouraged an
external, university- based review process, not the extensive
interagency review OSAGWI adopted. f OSAGWI officials told us that
this document was finalized in August 1999 and distributed to the
Office

of the Secretary in October 1999, but has not been publicly
released. g OSAGWI officials told us that this document was
finalized in October 1999 and distributed to the Office of the
Secretary in November 1999, but has not been publicly released.

h The total cost of this contract over the anticipated period of
performance, including option years, is expected to be $5,922,305.
i None of the report deliverables for this contract, apart from
progress and status reports, was due

before March 29, 1999, when a draft panel report was expected. A
final interim report is due on March 29, 2000, and a final
consensus report on September 29, 2000. j Subsidiary products from
this contract have been provided and released. The National
Academy Press has released the following documents in 1999 as part
of a series on Strategies to Protect the Health of Deployed U. S.
Forces: (1) Medical Surveillance, Record Keeping and Risk
Reduction; (2) Analytical Framework for Assessing Risks (and
Workshop Proceedings: Strategies to Protect the Health of Deployed
U. S. Forces: Assessing Health Risks to Deployed U. S. Forces);
and (3) Strategies to Protect Deployed U. S. Forces: Force
Protection and Contamination. k The total amount of funds OSAGWI
reported as supporting its research contract with Birch & Davis in
fiscal years 1997 and 1998. The total cost of delivery order 46
for contract number DASW01- 95- D0026 was $1,684,773, but this
order also covered substantial work for DOD/ Health Affairs and
its Deployment Surveillance Team to validate and analyze data from
the Comprehensive Clinical Evaluation Program and other
surveillance activities. Cost information is not available by
product. l An April 9, 1997, request by Birch & Davis Associates
for approval to disseminate and/ or publish

articles based on analyses conducted under delivery order 46 was
formally rescinded by an April 15, 1997, letter that cited a
conversation on the subject that led the contractor to understand
that any request to disseminate and/ or publish articles under the
referenced contract must be done on a case by case' basis and must
be accompanied by a definite publication plan. In explanation of
non- release of one or more of this contractor's products, OSAGWI
staff cited dissatisfaction with the deliverables as presented by
the contractor in July 1998. However, they provided no written
performance reviews for the contractor, explaining that the
products were developed under a task order that was part of a
contract with the Office of the Assistant Secretary of Defense for
Health Affairs, which was presumably responsible for evaluating
the contractor's performance.

Page 31 GAO/NSIAD-00-32 Gulf War Illnesses

Appendix III Sample Working Case Definitions Describing Symptoms
Experienced by Gulf War Veterans Appendi x III

a Memorandum from Jay P. Sanford, M. D. to MG Ronald Blanck, MC
USA, re: Gulf War Syndrome: Proposed Provisional Case Definition,
Jan. 27, 1994. b Robert W. Haley et al., Is There a Gulf War
Syndrome? Searching for Syndromes by Factor Analysis of Symptoms,
Journal of the American Medical Association, vol. 277 (Jan. 15,
1997), pp. 215- 222. c Keiji Fukuda et al., Chronic Multisymptom
Illness Affecting Air Force Veterans of the Gulf War, Journal of
the American Medical Association, vol. 280 (Sep. 16, 1998), pp.
981- 988.

d National Health Survey Research Team, Unique Cluster of Symptoms
Among Gulf Veterans, In The Research Working Group [of the]
Persian Gulf Veterans Coordinating Board, Conference on Federally
Sponsored Gulf War Veterans' Illnesses Research: Program and
Abstract Book, 1999, p. 99.

Origin Date Inclusion criteria Exclusion criteria

Sanford a 1994 (1) In theater of operations between 8/ 8/ 90 and
late July 1991 (2) New onset of a symptom complex with the
occurrence of at least five of eight minor criteria: fatigue,
arthralgia, headache, diarrhea,

neuropsychiatric complaints, difficulty sleeping, low- grade
fever, and/ or weight loss. Other clinical conditions with similar

symptomologies based on thorough evaluation, including history,
physical exam and appropriate lab studies.

Haley b 1997 The three primary syndromes are impaired cognition
(symptoms include distractibility, difficulty remembering,
depression, middle and terminal insomnia, fatigue, slurring of
speech, confused thought

process, and migraine- like headaches); confusion- ataxia
(symptoms include problems with thinking and reasoning processes,
getting confused, getting disoriented, problems keeping their
balance, posttraumatic stress disorder, depression, liver disease,
and sexual impotence); and arthro- myo- neuropathy (symptoms
include

generalized joint and muscle pains, increased difficulty lifting
heavy objects, muscle exhaustion after exertion, and tingling or
numbness of the hands, arms, feet, and legs). CDC c 1998 One or
more chronic symptoms (present for more than 6 months)

from at least two of the following three categories: fatigue, mood
and cognition (feeling depressed, difficulty remembering or
concentrating, feeling moody, feeling anxious, trouble finding
words or difficulty sleeping), and/ or musculoskeletal (joint
pain, stiffness, or muscle pain).

Other clinical conditions with similar symptomologies based on
thorough evaluation, including history, physical exam and
appropriate lab studies.

National Health Survey Team d 1999 Combination of blurred vision,
loss of balance/ dizziness, tremors/ shaking, and speech
difficulty (reported by 277, or 2.4 percent,

of surveyed Gulf- deployed veterans in contrast to 43 or 0.5
percent of surveyed nondeployed veterans).

Page 32 GAO/NSIAD-00-32 Gulf War Illnesses

Appendix IV Comments From the Department of Defense Appendi x IV

Note: GAO comments supplementing those in the report text appear
at the end of this appendix.

See comment 1. See comment 2.

See comment 3. See comment 4. See comment 5.

See comment 6. See comment 7. See comment 8.

See comment 9.

Appendix IV Comments From the Department of Defense

Page 33 GAO/NSIAD-00-32 Gulf War Illnesses

See comment 9. See comment 10.

See comment 11.

Appendix IV Comments From the Department of Defense

Page 34 GAO/NSIAD-00-32 Gulf War Illnesses

See comment 12.

Appendix IV Comments From the Department of Defense

Page 35 GAO/NSIAD-00-32 Gulf War Illnesses

See comment 10. See comment 11.

Appendix IV Comments From the Department of Defense

Page 36 GAO/NSIAD-00-32 Gulf War Illnesses

See comment 11. See comment 9.

See comment 12.

Appendix IV Comments From the Department of Defense

Page 37 GAO/NSIAD-00-32 Gulf War Illnesses

GAO Comments The following is GAO's response to the Department of
Defense's (DOD) comments dated August 19, 1999.

1. With respect to the refinement of future research direction, it
is important to note that a National Institutes of Health working
group assembled in 1994 noted the desirability of identifying one
or more case definitions or an evolving case definition to focus
research efforts. Our report notes that the Research Working Group
had not endorsed one or more case definitions that might focus
future research efforts on veterans' unexplained illnesses and
that problems with exposure data persist.

2. Our report notes that 8 years after the war, the Department of
Veterans' Affairs has just begun to recruit subjects for clinical
trials and no treatment research has yet been completed. We have
not evaluated the quality of these trials or the selection of
treatments to be evaluated. 3. Longitudinal follow- up of
mortality, cancer rates, and health status will require many
years. However, without accurate and precise exposure data (i. e.,
duration and dose), the interpretation of morbidity and mortality
data from these studies will remain challenging.

Appendix IV Comments From the Department of Defense

Page 38 GAO/NSIAD-00-32 Gulf War Illnesses

4. The facts and observations in this report are consistent with
those of the Institute of Medicine (IOM). The Institute noted in a
report issued in midSeptember 1999, the month after DOD provided
its formal comments, that no one has systematically evaluated
whether the health of Gulf War veterans is changing and, if so,
how. Similarly, it noted that no one had

determined the number of veterans who have symptoms of illnesses
that they attribute to service in the Gulf War, or whether the
health of these veterans is better than, worse than, or the same
as that of veterans who were not deployed to the Gulf War,
although some studies have found higher levels of reported
symptoms among Gulf War veterans. 1 In addition, RWG, in its
annual report to Congress for 1998 stated that, although several
individual research projectshave longitudinal components built
into them, no research is specifically directed toward
understanding the

progress of Gulf War veterans' illnesses over time. The RWG has
concluded that to the extent feasible, research approaches need to
be applied to determine the long- term health of Gulf War veterans
in contrast to the several cross- sectional epidemiological
research projects recently completed or still ongoing. 2

1 Institute of Medicine, Gulf War Veterans: Measuring Health. 2
Persian Gulf Veterans' Coordinating Board - Research Working
Group, Annual Report to Congress - 1998.

Appendix IV Comments From the Department of Defense

Page 39 GAO/NSIAD-00-32 Gulf War Illnesses

5. It has been difficult for researchers to progress from
descriptive to analytical epidemiology due partly to the absence
of accurate and precise data on the factors to which veterans were
exposed. None of the research DOD cited compared veterans on the
basis of their specific exposure history. Instead, results
generally describe the experience of persons who were on active
duty in the Gulf War theater (that is, the Persian Gulf, Kuwait,
Iraq, Saudi Arabia, the Red Sea, the Gulf of Oman, the Gulf of
Aden,

the northern portion of the Arabian Sea, Oman, Bahrain, Qatar, or
the United Arab Emirates) between August 2, 1990, and June 13,
1991, as compared to those who were on active duty elsewhere
during this time frame. As we noted in 1997, one might not find
differences between these large and diverse groups even if some
veterans have illnesses that are significantly related to specific
military exposures. Nonetheless, researchers have documented that
these two groups differ in their frequency of reporting various
symptoms and, even with poorly defined exposures, some
investigators have reported associations between certain exposures
and indicators of veterans' post- war health. 3 3 See, for
example, S. P. Proctor et al., Health Status of Persian Gulf War
Veterans: Self- reported Symptoms, Environmental Exposures, and
the Effect of Stress, International Journal of Epidemiology, 27
(6), 1000- 10. Unwin, C. et al. (1999.) Health of U. K. Servicemen
Who Served in Persian Gulf War. Lancet, 353, 169- 178. Haley, R.
W., & Kurt, T. L. (1997). Is There a Gulf War Syndrome? Journal of
the American Medical Association, 277 (3), 215- 22 and related
articles at 223- 37.

Appendix IV Comments From the Department of Defense

Page 40 GAO/NSIAD-00-32 Gulf War Illnesses

6. DOD's comments do not embrace the most consistent finding of
the health research to date. As IOM concluded, There does seem to
be a higher prevalence of some symptoms among veterans who served
in the Gulf War as compared to nondeployed veterans. The primary
symptoms include fatigue, difficulty concentrating, memory loss,
skin rash, headache, and muscle and joint pain. 4 Several studies
support this conclusion. For example, a study funded by the
Centers for Disease Control conducted

telephone interviews of a stratified random sample of 3,695 of
29,000 Gulf War- era military personnel listing Iowa as their home
of record and found that those deployed to the Gulf War were more
likely than those who served elsewhere during the war to report
symptoms suggestive of cognitive dysfunction, depression, chronic
fatigue, post- traumatic stress disorder, and respiratory illness
(asthma and bronchitis). 5 These symptoms appeared to affect the
functional activity and daily lives of the Gulf War veterans.
Similarly, a CDC study of Air Force personnel found that a
multisymptom case definition developed after clinical examination
of 158 veterans was, in its severe form, reported several times
more frequently

by sampled Gulf War veterans than by nondeployed personnel. 6
Mild- to- moderate cases, while more evenly spread, were still
well over twice as common in the Gulf War group. Gulf War veterans
classified as having mild- to- moderate and severe illness had a
significant decrease in functioning and well- being compared with
Gulf War veterans who did not fit the criteria for the
multisymptom illness. Similar findings were reported in a study of
3000 veterans from New England, a study of 525 women veterans, and
a study of 8,000 veterans from the United Kingdom. 7 Moreover, a
survey of Canadian veterans found significantly higher rates of
self- reported chronic conditions and symptoms of a variety of
conditions

among Gulf- deployed veterans compared to those serving elsewhere
during the Gulf conflict. 8 The conditions reported more
frequently by Gulf War 4 Institute of Medicine (1999). Gulf War
Veterans: Measuring Health, Washington, D. C.: National Academy
Press, p. 2. 5 Iowa Persian Gulf Study Group. (1997). Self-
reported Illness and Health Status Among Gulf War Veterans: A
Population- Based Study. Journal of the American Medical
Association, 277 (3), 238- 245.

6 See Fukuda, K. et al. (1998.) Chronic Multisymptom Illness
Affecting Air Force Veterans of the Gulf War. Journal of the
American Medical Association, 280, 981- 88. They report that 6. 0%
of 1155 Gulf War veterans they surveyed reported symptoms that fit
their working definition of a severe case of multisymptom illness,
while only 0.7% of the 2520 surveyed non- deployed personnel did
so. The investigators reported that the univariate association
between Gulf War veteran status and fitting the severe case
criteria was statistically significant (odds ratio =12.7 with 95%
confidence limits between 7. 5 and 21.5).

Appendix IV Comments From the Department of Defense

Page 41 GAO/NSIAD-00-32 Gulf War Illnesses

veterans included problems with bones and joints, allergies, and
limitations in activity due to health.

It is common throughout the epidemiological literature to accept a
statistically significant difference in the risk of an illness as
evidence of association. Even if the symptoms disproportionately
reported by Gulf War veterans are not confined to these veterans,
their increased frequency among Gulf War veterans needs to be
explained. IOM has similarly concluded that, It appears that
veterans who served in the Gulf are more likely than their
nondeployed comrades or civilians to experience a set of symptoms
that include cognitive, musculoskeletal and energy/ fatigue
elements. In some cases, the symptoms are severe enough to be
totally debilitating. Not all veterans experience the same cluster
of symptoms;

therefore, assuming a single underlying pathology or single cause
for the complaints would not be appropriate. 9

7 Wolfe, J. et al. (1998.) Health Symptoms Reported by Persian
Gulf War Veterans Two Years After Return. American Journal of
Industrial Medicine, 33, 104- 113. Unwin, C. et al. (1999.) Health
of U. K. Servicemen Who Served in Persian Gulf War. Lancet, 353,
169- 178. Pierce, P. (1997.) Physical and Emotional Health of Gulf
War Veteran Women . Aviation, Space and Environmental Medicine,
68, 317- 21.

8 Goss Gilroy, Inc. (1998.) Health Study of Canadian Forces
Personnel Involved in the 1991 Conflict in the Persian Gulf, vol.
1. Ottawa: Goss Gilroy. 9 Institute of Medicine (1999). Gulf War
Veterans: Measuring Health, Washington, D. C.: National Academy
Press, p. 33.

Appendix IV Comments From the Department of Defense

Page 42 GAO/NSIAD-00-32 Gulf War Illnesses

7. Veterans of the Gulf War differ from the general civilian
population with respect to fitness profile and other factors, so
it is not surprising that their mortality rate would also differ
from the rate for the general civilian population. Research found
the mortality rate of Gulf War veterans through

September 1993 to be slightly higher than that of veterans of the
same era who served elsewhere, with the difference explained
largely by greater mortality in motor vehicle accidents. 10 In the
published report of the

mortality study, the authors speculate that increased mortality in
automobile accidents might be attributed to increased risk- taking
among war veterans in general, but they note that the reasons for
the excess of deaths due to external causes among war veterans are
not well understood. The finding was replicated in a follow- up
study extending the observation period through December 1997. 11

10 The odds ratio for this difference was 1.09 with 95% confidence
limits between 1.01 and 1.16. See Kang, H. K. & Bullman, T. A.
(1996.) Mortality Among U. S. Veterans of the Gulf War. New
England Journal of Medicine, 335, 1498- 1504. See also Haley, R.
W., (1998.) Commentaries: Point: Bias from the Healthy Warrior
Effect' and Unequal Follow- up in Three Government Studies of
Health Effects of the Gulf War. American Journal of Epidemiology,
148 (4), pp. 315- 338.

11 The follow- up study found that the excess in deaths
attributable to motor vehicle accidents persisted among Gulf War
veterans observed through December 1997 (crude rate ratio = 1. 32;
confidence interval 1.23- 1. 41), while the risk of disease
related deaths did not increase or decrease over time. See Kang,
H. A. & Bullman, T. A. (1999). Mortality Among U. S.

Veterans of the Gulf War: Update Through December 1997. Conference
on Federally Sponsored Gulf War Veterans' Illnesses Research:
Program and Abstract Book, (June 23- 25, 1999). Washington, D. C.:
The Research Working Group of the Persian Gulf Veterans'
Coordinating Board, p. 28.

Appendix IV Comments From the Department of Defense

Page 43 GAO/NSIAD-00-32 Gulf War Illnesses

8. DOD does not note the methodological limitations of these
studies as their authors do in the respective published reports.
As noted by IOM, the studies of hospitalization (Gray et al.,
1996; Knoke and Gray, 1998) and

adverse birth outcomes (Araneta et al., 1997; Cowen et al., 1997)
have been limited to personnel remaining on active duty and to
events occurring in military hospitals. Conceivably, those
suffering from Gulf War- related symptoms might leave active duty
voluntarily or take a medical discharge. Hospitalizations for that
group would appear in VA or private sector

databases but not in the DOD database. The health or
characteristics of active duty personnel could differ from those
of personnel who have left active duty or who have been treated in
nonmilitary hospitals. Moreover,

economic and other non- health- related factors are likely to
affect use of nonmilitary hospitals and health care services. 12
However, through 1993, studies did not observe an increase in
hospitalization among deployed versus nondeployed veterans in the
active duty military. Knoke and Gray, analyzing the same database,
observed slightly more admissions for symptoms, signs and ill-
defined conditions among Gulf- deployed veterans than among
veterans deployed elsewhere during the same timeframe. They

attributed the difference to admissions for evaluation purposes
under the Comprehensive Clinical Evaluation Program, which offered
examination and diagnostic services to Gulf War veterans.

9. Whether OSAGWI performs medical research is not relevant to
determining whether the Research Working Group should coordinate
its activities. We see nothing in the law that would limit the
Group's coordinating efforts to activities that constitute
research, however defined.

DOD also contends that OSAGWI does not need to coordinate with RWG
and that it has coordination mechanisms. However, DOD's assertion
that close coordination is already occurring is difficult to
reconcile with our

finding that duplication has occurred. Federal agencies have
commissioned at least three reviews of the health effects of
depleted uranium in the last few years, one each by the agencies
represented on RWG. In addition, two

major efforts to review the health effects of Gulf War veterans'
exposures have been pursued more or less independently - one by
RAND, under contract to DOD, and another by the National Academy
of Sciences, under contract to VA.

12 Institute of Medicine (1999). Gulf War Veterans: Measuring
Health, Washington, D. C.: National Academy Press, p. 36.

Appendix IV Comments From the Department of Defense

Page 44 GAO/NSIAD-00-32 Gulf War Illnesses

Minutes of RWG meetings from April 1997 forward indicate that they
have been attended by a succession of OSAGWI professional staff,
as participants or observers, and we have revised the report to
reflect this.

Nonetheless, the working relationship between these organizations
appears far from seamless. For example, RWG felt it necessary to
write to OSAGWI to request a briefing on the literature reviews
the office had tasked RAND to conduct. Similarly, in a letter to
OSAGWI in April 1997, a VA RWG official expressed concerns about
the lack of external review for several of OSAGWI's proposed
research efforts.

We understand that OSAGWI is not responsible for DOD's medical
research programs. As noted in our report, we deliberately adopted
a broad scope, to include both research and investigation of
exposure scenarios, to comprehensively examine relevant efforts.
In any event, some of OSAGWI's projects (listed in app. II)
constitute research not only by the dictionary

definition that DOD cites but also by DOD's more restrictive
criteria. Whether these undertakings are regarded as research or
some other type of endeavor, our interest was in assessing their
productivity. Thus, the key point is that most of the contracted
projects are completed, but only a handful had been released.

10. While DOD and others have published various assessments of the
research program, none of them have directly addressed the status
of the research objectives identified in 1995. We requested this
information from RWG officials, orally and in writing, and did not
receive it. DOD contends that the effectiveness of these research
efforts is not yet fully measureable. However, what is needed is
not a final judgment but a simple accounting of where federal
efforts stand with respect to answering the basic questions

identified in 1995. 11. We have not called for an identification
of a single unifying case definition or a summary judgment of
treatment efficacy for heterogeneous conditions. However, it would
seem reasonable to expect an accounting of the status of veterans'
health over time and a description of the types of treatments they
have received. DOD suggests that it would be

unreasonably difficult to provide such information. We note in the
text that some basic questions about veterans' health may be
addressed by VA's national health survey. However, at this
writing, data from the survey have not yet been published. In mid-
September 1999, the National Academy of Sciences Institute of
Medicine Committee that VA commissioned to study

methodological problems issued a report that describes a method of
health

Appendix IV Comments From the Department of Defense

Page 45 GAO/NSIAD-00-32 Gulf War Illnesses

assessment. The law requires that VA continue this process by
reviewing the methods suggested by IOM and pursuing, to the extent
feasible, the collection of appropriate data.

12. With respect to the task order issued under the Management,
Organizational, Business Improvement Schedule (MOBIS) contract,
OSAGWI does not take issue with our conclusion that the order is
outside the scope of the contract. For the reasons stated in the
report, we continue to believe that the task order was improper.
Therefore, the order should be

terminated, if practicable, as we recommended and the office
should ensure that any subsequent support contract is properly
awarded. We recognize that OSAGWI relies on contracting
professionals outside that office to execute its support
contracts. However, that does not absolve the office of all
responsibility concerning how its contract support is acquired. At
a minimum, OSAGWI is responsible for determining and articulating
its requirements, a process that in one instance resulted in the
naming of a preferred vendor and in another instance led to an
overly broad statement of work. The effect of these practices was
to discourage competition for over $20 million in awards and
therefore to risk inefficient use of funds. It is important that
both entities that initiate requests for goods and services

(for example, OSAGWI) as well as agencies that execute contracts
for these goods and services ensure adherence to the statutes and
regulations designed to maximize competition.

Page 46 GAO/NSIAD-00-32 Gulf War Illnesses

Appendix V Comments From the Department of Veterans' Affairs
Appendi x V

Note: GAO comments supplementing those in the report text appear
at the end of this appendix.

See comment 1. See comment 2.

Appendix V Comments From the Department of Veterans' Affairs

Page 47 GAO/NSIAD-00-32 Gulf War Illnesses

See comment 2. See comment 3.

See comments 4- 6. See comment 5. See comment 6.

See comment 7. See comment 8. See comment 4.

See comments 7- 9.

Appendix V Comments From the Department of Veterans' Affairs

Page 48 GAO/NSIAD-00-32 Gulf War Illnesses

See comment 8. See comment 9. See comment 10.

See comment 11. See comment 12.

Appendix V Comments From the Department of Veterans' Affairs

Page 49 GAO/NSIAD-00-32 Gulf War Illnesses

GAO Comments The following is GAO's response to the Department of
Veterans' Affairs comments dated September 9, 1999.

1. VA acknowledges that complete answers remain unavailable to the
basic questions we identified in this report and in an earlier
report (for example, how many veterans have unexplained illnesses
and whether ill veterans examined by VA and DOD are better or
worse than when they were first seen). 1 A basically satisfactory
answer to the question of whether those ill veterans who have
registered with VA or DOD are in better or worse health than when
first examined involves only a periodic reassessment of their
health, which is part of routine medical care. 2 As we stated when
we first made such a recommendation 2 years ago, augmenting the
data on the

progress of ill Gulf War veterans with comparative data would add
valuable information. However, at a minimum, it seems desirable to
collect descriptive information on how Gulf War veterans'
conditions have

improved or worsened. In mid- September 1999, IOM issued its
report, which recommended a methodology to VA for measuring
veterans' health status (a longitudinal follow- up of a cluster
sample of Gulf War veterans with several comparison groups). This
approach is consistent with our recommendation that VA and DOD
select a strategy for answering this question and compile the
appropriate data.

2. Many of the efforts VA cites appear worthwhile, but VA does not
assert that any of these have answered or would answer the basic
questions we have identified about the prevalence of diagnosed and
undiagnosed conditions in Gulf War veterans, the treatments they
have received, and the course of any unexplained illnesses. The
Veterans' Health Administration's (VHA) intention to collect
longitudinal data on these veterans' satisfaction with VHA
services may provide a useful monitor of veterans' perceptions.
Early findings from this work suggest that Gulf War veterans, as a
group,

1 See Gulf War Illnesses: Improved Monitoring of Clinical Progress
and Reexamination of Research Emphasis Are Needed (GAO/NSIAD-97-
163), June 23, 1997. 2 For example, such an effort has been
pursued by one of the VA's Integrated Service Networks. Using a
standardized assessment of health- related functioning, the SF- 36
from the RAND medical outcomes study, researchers found that the
presenting Gulf War veterans scored lower than U. S. norms on all
dimensions of health status and that baseline scores were
significantly different from 6 month follow- up. See Powell- Cope,
G. M. & Roswell, R.

(1999). Health Status of Gulf War Veterans in VISN 8. The Research
Working Group, Persian Gulf Veterans Coordinating Board,
Conference on Federally Sponsored Gulf War Veterans' Illnesses
Research, Washington, D. C.: PGVCB/ RWG, p. 32.

Appendix V Comments From the Department of Veterans' Affairs

Page 50 GAO/NSIAD-00-32 Gulf War Illnesses

were somewhat less satisfied with VHA services than other veteran
groups. VHA's efforts to clarify the reasons for this through the
use of focus groups are also appropriate. Similarly, the health
services research efforts that VA identifies may help improve
service delivery but do not appear suited to developing much
longitudinal information because the projects are funded for only
2 years.

3. Among the conclusions the NIH Working Group reached in 1994 was
that, It is important that a more accurate estimate of the symptom
prevalence be established. In support of our finding that basic
information on the prevalence of various symptom clusters remains
unavailable, we note that VA and DOD registries of examined Gulf
War veterans also do not provide sufficient data for determining
which of various symptom clusters deserve the closest attention.
We agree that the registries may be valuable

for other purposes and that there are additional reasons that they
might be imperfect research tools. While the VA's national health
survey has collected much of the symptom data sought by the NIH
group, its results remained unpublished at the close of our
review. 4. In support of its objection to our criticism of the
coordination between the PGVCB RWG and the Office of the Special
Assistant, VA notes that the role of the PGVCB is one of
communication and coordination of its member agencies' activities;
it does not control these activities. For this

reason, our draft report noted that PGVCB has no budgetary
authority. Nonetheless, part of the function of communication and
coordination is to reach agreement on a plan of action to optimize
resources while meeting sometimes varied needs for information. We
observed that some projects sponsored by agency members of the RWG
are duplicative (see our comment 9 in app. IV.)

5. In support of its objection to our criticism of the
coordination between the PGVCB's RWG and the Office of the Special
Assistant, VA notes that OSAGWI is represented on the RWG's parent
organization, the Coordinating Board, along with other DOD
elements. We have revised the

report to reflect that professional staff from OSAGWI did attend
RWG meetings, as participants or observers, beginning in April
1997. We have not asserted that a coordination mechanism is
missing; our criticism is related to the effectiveness of this
mechanism in eliminating duplicative expenditures and ensuring
uniformly high confidence across agencies in the research
activities undertaken.

Appendix V Comments From the Department of Veterans' Affairs

Page 51 GAO/NSIAD-00-32 Gulf War Illnesses

6. While most of OSAGWI's expenditures appear to be focused on the
investigation of specific incidents for the potential exposures
that might have resulted, which would be germane to
epidemiological researchers, OSAGWI officials identified $13.3
million, a substantial amount of the office's expenditures, as
being devoted to research. It is worth noting that this amount,
while it represents a minority of OSAGWI's budget, exceeds the
total of VA and CDC Gulf War research expenditures over the period
we examined. 7. First, appendix II of the draft report noted that
only four of the nine

RAND reports submitted for interagency review had actually reached
publication by mid- 1999 and that publication had, in some
instances, occurred over a year following submission. After
receiving DOD's comments on our report, RAND's report on
pyridostigmine bromide was

released 16 months after its submission to interagency review in
June 1998. Similarly, RAND's report on stress was published
approximately a year after submission for review, and its report
on chemical and biological warfare agents was submitted for
interagency review 15 months ago. Thus, delaying the release of
these documents to IOM until publication occurs does not seem an
effective means of coordinating two such closely linked tasks.
Second, it is important to note that the Agency for Toxic
Substances and Disease Registry's report on uranium (including
depleted uranium) was

made available for public comment on October 17, 1997 (the public
comment period ended on Feb. 17, 1998, and revision was begun
based on comments received). Thus, the need for an additional
review of depleted uranium by RAND in 1997 was questionable. The
RAND review was not submitted until August of 1998, after the
Agency review had been issued in draft form. 3 We have added a
discussion of this matter to our report.

8. VA asserts that the goals and methods of these two studies are
different but does not explain how they are different. Because IOM
will not be conducting original research to make its
determinations, it will also rely on existing literature. Material
distributed by IOM in connection with a recent meeting of its
Committee on Health Effects Associated with Exposures

During the Gulf War indicates that, The purpose of this project
would be to conduct a review of the scientific and medical
literature regarding adverse

3 See Agency for Toxic Substances and Disease Registry (Sept.
1997). Draft Toxicological Profile for Uranium. Atlanta, GA: U. S.
Dept. of Health and Human Services, PHS/ ATSDR.

Appendix V Comments From the Department of Veterans' Affairs

Page 52 GAO/NSIAD-00-32 Gulf War Illnesses

health effects associated with exposures experienced during the
Persian Gulf War. Similarly, the preface to one of RAND's
literature reviews notes, The reviews are intended principally to
summarize the scientific literature on the known health effects of
given exposures to these risk factors. Accordingly, we find little
distinction between these two activities in terms of purpose or
basic methodology.

9. The issue we are raising is not whether IOM's work ought to
have been initiated but that its work has not benefited from
coordination with RAND's to save time and money in accomplishing a
goal that is widely regarded as important. Similarly, RAND's work
was not coordinated with that of CDC's Agency for Toxic Substances
and Disease Registry.

10. Even if the symptoms reported by Gulf War veterans are not
confined to these veterans, their increased frequency among Gulf
War veterans needs to be explained. Our report does not suggest
that a single case definition is appropriate; we note simply that
RWG has not endorsed one or more case definitions that might focus
research on veterans' undiagnosed

symptoms. 11. This recommendation has been reworded to refer to
the number of Gulf War veterans with unexplained illnesses. We
understand that, in implementing the recommendation, it may be
appropriate to characterize unexplained illnesses using some
groupings or working case definitions for the purposes of
counting.

12. We made this recommendation to prompt organizations to work
more closely on behalf of veterans suffering from these illnesses.
We believe that greater cooperation, exchange of information, and
coordination will help expedite the process and help find
solutions the veterans need. While VA indicates that RWG has
provided sufficient information on the scope of

activities it continues to coordinate among DOD, VA, and HHS, we
found substantially similar activities that fell outside this
scope. In addition, we find nothing in the law that would limit
the Group's coordinating efforts to this scope of activities.

Page 53 GAO/NSIAD-00-32 Gulf War Illnesses

Appendix VI Comments From the Centers for Disease Control and
Prevention Appendi x VI

Note: GAO comments supplementing those in the report text appear
at the end of this appendix.

See comment 1.

Appendix VI Comments From the Centers for Disease Control and
Prevention

Page 54 GAO/NSIAD-00-32 Gulf War Illnesses

See comment 2.

Appendix VI Comments From the Centers for Disease Control and
Prevention

Page 55 GAO/NSIAD-00-32 Gulf War Illnesses

GAO Comments The following is GAO's response to the Centers for
Disease Control and Prevention's comments dated August 20, 1999.

1. CDC's Air Force study was cited in appendix III of our draft
report along with the case definition it developed as one of a set
of overlapping working case definitions that have been advanced
since 1994. We have added information about these studies and
their findings to the final report and

have discussed them more fully in our response to agency comments
and also in our more detailed response to DOD's comments (see
comment 6 in app. IV). 2. Our draft report noted that the
extensions discussed were partially attributed to efforts to
incorporate additional data. We have added the

word additional before follow- up to specifically clarify that the
extension of the Iowa project was to provide for work not
initially anticipated, not to allow additional time for work
already planned.

Page 56 GAO/NSIAD-00-32 Gulf War Illnesses

Appendix VII GAO Contacts and Staff Acknowledgments Appendi x VII

GAO Contacts Sushil K. Sharma (202) 512- 3460 Betty Ward- Zukerman
(202) 512- 2732

Acknowledgments In addition to those named above, Margaret Best,
John Carter, Howard Deshong, and William Woods made key
contributions to this report.

Page 57 GAO/NSIAD-00-32 Gulf War Illnesses

Page 58 GAO/NSIAD-00-32 Gulf War Illnesses

Related GAO Products Gulf War Illnesses: Procedural and Reporting
Improvements Are Needed in DOD's Investigative Processes
(GAO/NSIAD-99-59, Feb. 26, 1999). Acquisition Reform: Multiple-
Award Contracting at Six Federal Organizations (GAO/NSIAD-98-215,
Sept. 30, 1998).

VA Health Care: Better Integration of Services Could Improve Gulf
War Veterans' Care (GAO/HEHS-98-197, Aug. 19, 1998). Role of the
Persian Gulf Veterans' Coordinating Board in Scientific Evaluation
of Research Proposals and the Funding Recommendations Made by Its
Research Working Group (GAO/NSIAD-98-170R, Aug. 10, 1998).

Gulf War Veterans: Limitations of Available Data for Accurately
Determining the Incidence of Tumors (GAO/T-NSIAD-98-186, May 14,
1998). VA Health Care: Persian Gulf Dependents' Medical Exam
Program Ineffectively Carried Out (GAO/HEHS-98-108, Mar. 31,
1998).

Gulf War Veterans: Incidence of Tumors Cannot Be Reliably
Determined From Available Data( GAO/NSIAD-98-89, Mar. 3, 1998).

Gulf War Illnesses: Federal Research Strategy Needs Reexamination
(GAO/T-NSIAD-98-104, Feb. 24, 1998). Gulf War Illnesses: Research,
Clinical Monitoring, and Medical Surveillance (GAO/T-NSIAD-98-88,
Feb. 5, 1998).

Veterans' Benefits: Improvements Made to Persian Gulf Claims
Processing (GAO/T-HEHS-98-89, Feb. 5, 1998).

Gulf War Illnesses: Public and Private Efforts Relating to
Exposures of U. S. Personnel to Chemical Agents (GAO/NSIAD-98-27,
Oct. 15, 1997).

Gulf War Illnesses: Reexamination of Research Emphasis and
Improved Monitoring of Clinical Progress Needed (GAO/T-NSIAD-97-
191, June 25, 1997).

Gulf War Illnesses: Enhanced Monitoring of Clinical Progress and
of Research Priorities Needed (GAO/T-NSIAD-97-190, June 24, 1997).

Related GAO Products Page 59 GAO/NSIAD-00-32 Gulf War Illnesses

Gulf War Illnesses: Improved Monitoring of Clinical Progress and
Reexamination of Research Emphasis Are Needed (GAO/NSIAD-97-163,
June 23, 1997).

VA Health Care: Observations on Medical Care Provided to Persian
Gulf Veterans (GAO/T-HEHS-97-158, June 19, 1997). Chemical and
Biological Defense: Protection of Critical Overseas Ports and
Airfields Remains Largely Unaddressed (GAO/NSIAD-97-9, June 13,
1997). Operation Desert Storm: Evaluation of the Air Campaign
(GAO/ NSIAD97- 134, June 12, 1997).

Defense Health Care: Medical Surveillance Has Improved Since the
Gulf War, but Results in Bosnia Are Mixed (GAO/NSIAD-97-136, May
13, 1997). Veterans' Compensation: Evidence Considered in Persian
Gulf War Undiagnosed Illness Claims (HEHS- 96- 112, May 28, 1996).
Chemical and Biological Defense: Emphasis Remains Insufficient to
Resolve Continuing Problems (GAO/NSIAD-96-103, Mar. 29, 1996).

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