Department of Veterans Affairs
Federal Gulf War Illnesses Research Strategy Needs Reassessment Gao ID: GAO-04-767 June 1, 2004More than a decade after the 1991 Persian Gulf War, there is continued interest in the federal response to the health concerns of Gulf War veterans. Gulf War veterans' reports of unexplained illnesses and possible exposures to various health hazards have prompted numerous federal research projects on Gulf War illnesses. This research has been funded primarily by the Department of Veterans Affairs (VA), the Department of Defense (DOD), and the Department of Health and Human Services. GAO is reporting on (1) the status of research and investigations on Gulf War illnesses, (2) the efforts that have been made by VA and DOD to monitor cancer incidence among Gulf War veterans, and (3) VA's communication and collaboration with the Research Advisory Committee on Gulf War Veterans' Illnesses (RAC).
Most federally funded Gulf War illnesses research projects and investigations are complete, but VA--the agency with lead responsibility for coordination of Gulf War illnesses issues--has not yet analyzed the latest research findings to identify whether there are gaps in current research or to identify promising areas for future research. As of September 2003, about 80 percent of the 240 federally funded medical research projects for Gulf War illnesses had been completed. In recent years, VA and DOD funding for this research has decreased, federal research priorities have changed, and interagency coordination of Gulf War illnesses research has waned. In addition, VA has not reassessed the extent to which the collective findings of completed Gulf War illnesses research projects have addressed key research questions. The only assessment of progress in answering these research questions was published in 2001, when findings from only about half of all federally funded Gulf War illnesses research were available. Moreover, it did not identify whether there were gaps in existing Gulf War illnesses research or promising areas for future research. This lack of comprehensive analysis leaves VA at greater risk of failing to answer unresolved questions about causes, course of development, and treatments for Gulf War illnesses. In a separate effort, DOD has conducted 50 investigations since 1996 on potential hazardous exposures during the Gulf War. Generally, these investigations concluded that there were limited exposures by troops to some hazards and, at most, limited short- or long-term adverse effects expected from these exposures. As of April 2003, all investigations were complete. Federal agencies have funded seven research projects related to cancer incidence among Gulf War veterans. However, several limitations exist that affect research related to cancer incidence. For example, some cancers may take many years to develop and be detected. In addition, some research projects studying cancer incidence have not studied enough Gulf War veterans to reliably assess cancer incidence. Research may also be impeded by incomplete federal data on the health characteristics of Gulf War veterans. RAC's efforts to provide advice and make recommendations on Gulf War illnesses research to the Secretary of VA may have been hampered by VA senior administrators' incomplete or unclear information sharing and limited collaboration on research initiatives and program planning. VA and RAC are exploring ways to improve collaboration, including VA's hiring of a senior scientist who would both guide VA's Gulf War illnesses research and serve as the agency's liaison for routine updates to the advisory committee. However, most of these changes had not been finalized at the time of our review.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-04-767, Department of Veterans Affairs: Federal Gulf War Illnesses Research Strategy Needs Reassessment
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Report to the Chairman, Subcommittee on National Security, Emerging
Threats, and International Relations, Committee on Government Reform,
House of Representatives:
United States General Accounting Office:
GAO:
June 2004:
Department of Veterans Affairs:
Federal Gulf War Illnesses Research Strategy Needs Reassessment:
GAO-04-767:
GAO Highlights:
Highlights of GAO-04-767, a report to the Chairman, Subcommittee on
National Security, Emerging Threats, and International Relations,
Committee on Government Reform, House of Representatives
Why GAO Did This Study:
More than a decade after the 1991 Persian Gulf War, there is continued
interest in the federal response to the health concerns of Gulf War
veterans. Gulf War veterans‘ reports of unexplained illnesses and
possible exposures to various health hazards have prompted numerous
federal research projects on Gulf War illnesses. This research has been
funded primarily by the Department of Veterans Affairs (VA), the
Department of Defense (DOD), and the Department of Health and Human
Services. GAO is reporting on (1) the status of research and
investigations on Gulf War illnesses, (2) the efforts that have been
made by VA and DOD to monitor cancer incidence among Gulf War veterans,
and (3) VA‘s communication and collaboration with the Research Advisory
Committee on Gulf War Veterans‘ Illnesses (RAC).
What GAO Found:
Most federally funded Gulf War illnesses research projects and
investigations are complete, but VA”the agency with lead responsibility
for coordination of Gulf War illnesses issues”has not yet analyzed the
latest research findings to identify whether there are gaps in current
research or to identify promising areas for future research. As of
September 2003, about 80 percent of the 240 federally funded medical
research projects for Gulf War illnesses had been completed. In recent
years, VA and DOD funding for this research has decreased, federal
research priorities have changed, and interagency coordination of Gulf
War illnesses research has waned. In addition, VA has not reassessed
the extent to which the collective findings of completed Gulf War
illnesses research projects have addressed key research questions. The
only assessment of progress in answering these research questions was
published in 2001, when findings from only about half of all federally
funded Gulf War illnesses research were available. Moreover, it did not
identify whether there were gaps in existing Gulf War illnesses
research or promising areas for future research. This lack of
comprehensive analysis leaves VA at greater risk of failing to answer
unresolved questions about causes, course of development, and
treatments for Gulf War illnesses. In a separate effort, DOD has
conducted 50 investigations since 1996 on potential hazardous exposures
during the Gulf War. Generally, these investigations concluded that
there were limited exposures by troops to some hazards and, at most,
limited short- or long-term adverse effects expected from these
exposures. As of April 2003, all investigations were complete.
Federal agencies have funded seven research projects related to cancer
incidence among Gulf War veterans. However, several limitations exist
that affect research related to cancer incidence. For example, some
cancers may take many years to develop and be detected. In addition,
some research projects studying cancer incidence have not studied
enough Gulf War veterans to reliably assess cancer incidence. Research
may also be impeded by incomplete federal data on the health
characteristics of Gulf War veterans.
RAC‘s efforts to provide advice and make recommendations on Gulf War
illnesses research to the Secretary of VA may have been hampered by VA
senior administrators‘ incomplete or unclear information sharing and
limited collaboration on research initiatives and program planning. VA
and RAC are exploring ways to improve collaboration, including VA‘s
hiring of a senior scientist who would both guide VA‘s Gulf War
illnesses research and serve as the agency‘s liaison for routine
updates to the advisory committee. However, most of these changes had
not been finalized at the time of our review.
What GAO Recommends:
GAO recommends that the Secretary of VA conduct a reassessment of the
federal Gulf War illnesses research strategy, ensure that a liaison who
is knowledgeable about Gulf War illnesses research is appointed to
routinely share information with RAC, and ensure that VA‘s research
offices collaborate with RAC on Gulf War illnesses research program
development activities. VA concurred with the report‘s recommendations
and cited several actions it has initiated to address them.
www.gao.gov/cgi-bin/getrpt?GAO-04-767.
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Janet Heinrich at (202)
512-7119.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Most Federally Funded Gulf War Illnesses Research Projects and
Investigations Are Complete, but VA Has Not Collectively Analyzed
Research Findings to Determine the Status of Key Research Questions:
Some Efforts Are Under Way to Monitor Cancer Incidence among Gulf War
Veterans, but Research Limitations May Impede Reliability of Results:
RAC's Efforts to Provide Advice May Be Hindered by VA's Limited
Information Sharing and Collaboration, but Several Changes to Address
These Issues Have Been Proposed:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Scope and Methodology:
Appendix II: Key Gulf War Illnesses Research Questions:
Appendix III: Charter for VA's Research Advisory Committee on Gulf War
Veterans' Illnesses:
Appendix IV: Comments from the Department of Veterans Affairs:
Tables:
Table 1: Research Related to Cancer Incidence in Gulf War Veterans
(GWV):
Table 2: Twenty-one Key Gulf War Illnesses Research Questions:
Figures:
Figure 1: Evolution of Interagency Committees That Coordinated Federal
Gulf War Illnesses Research from 1993 through 2004:
Figure 2: DOD Entities Responsible for Gulf War Exposure Investigations
from 1995 through 2004:
Figure 3: Cumulative Number of Ongoing and Completed Federal Gulf War
Illnesses Research Projects by Year:
Figure 4: Funding Share for Gulf War Illnesses Research by Agency and
Fiscal Year:
Figure 5: Funding for Gulf War Research Projects, Fiscal Years 1994-
2003:
Figure 6: Organizational Relationships between VA and RAC, as of April
2004:
Abbreviations:
CRADO: Chief Research and Development Officer:
DHSD: Deployment Health Support Directorate:
DHWG: Deployment Health Working Group:
DOD: Department of Defense:
GWV: Gulf War veterans:
HEC: VA/DOD Health Executive Council:
HHS: Department of Health and Human Services:
MVHCB: Military Veterans Health Coordinating Board
NIH: National Institutes of Health:
NSTC: National Science and Technology Council:
OSAGWI: Office of Special Assistant for Gulf War Illnesses:
OSAGWI-MRMD: Office of Special Assistant for Gulf War Illnesses Medical
Readiness and Military Deployments:
PGIIT: Persian Gulf Illnesses Investigation Team:
PGIRCC: Persian Gulf Interagency Research Coordinating Council:
PGVCB: Persian Gulf Veterans Coordinating Board:
RAC: Research Advisory Committee on Gulf War Veterans' Illnesses:
RWG: Research Working Group:
VA: Department of Veterans Affairs:
United States General Accounting Office:
Washington, DC 20548:
June 1, 2004:
The Honorable Christopher Shays: Chairman:
Subcommittee on National Security, Emerging Threats, and International
Relations,
Committee on Government Reform:
House of Representatives:
Dear Mr. Chairman:
More than a decade after the end of the 1991 Persian Gulf War, there is
continued interest in the federal government's response to the health
concerns of Gulf War veterans. While about 700,000 U.S. military
personnel were deployed during this conflict, casualties were
relatively light compared with previous major conflicts. However,
approximately 80,000 veterans have reported various symptoms in the
years following the war, and scientists have agreed that many veterans
have unexplained illnesses. Gulf War illnesses are characterized by one
or more symptoms that do not conform to a characteristic diagnosis.
Such symptoms commonly include fatigue, muscle and joint pains,
headaches, memory loss, skin rash, diarrhea, and sleep disturbances. In
addition to concerns about unexplained illnesses, many Gulf War
veterans also have elevated concerns that possible exposures to
chemical or biological warfare agents, or environmental contaminants,
may be associated with an increased risk of developing cancer. Past
research projects have found associations between some of these
substances and different types of cancers.
Gulf War veterans' reports of illnesses have prompted numerous federal
research projects on the nature, extent, and treatment of Gulf War
illnesses. Federal Gulf War illnesses research projects have been
funded primarily by the Department of Veterans Affairs (VA), the
Department of Defense (DOD), and the Department of Health and Human
Services (HHS). Each agency separately sponsors and funds research
projects, though a few are conducted jointly. In 1993, the President
made the Secretary of VA responsible for coordinating research
activities undertaken or funded by the executive branch of the federal
government on the health consequences of service in the Gulf War. In
2002, a congressionally mandated federal advisory committee--the VA
Research Advisory Committee on Gulf War Veterans' Illnesses (RAC)--was
established to provide advice on federal Gulf War illnesses research
needs and priorities to the Secretary of VA. The committee is made up
of members of the general public, including non-VA researchers and
veterans' advocates.
Separately from this research, DOD has conducted investigations on
specific events that took place during the Gulf War to identify
possible exposures to potentially hazardous chemical agents, such as
sarin, mustard, and benzyl bromide. In addition, DOD has conducted
investigations of potential occupational and environmental hazards,
including depleted uranium from munitions, smoke from oil well fires,
pesticides, petroleum, and fuels. DOD has published a number of reports
that discuss the findings of these Gulf War investigations.
Because of these concerns, we are reporting on (1) the status of
federal research and investigations on Gulf War illnesses, (2) the
efforts that have been made by VA and DOD to monitor cancer incidence
among Gulf War veterans, and (3) VA's communication and collaboration
with RAC.
To examine these issues, we interviewed senior officials within VA and
DOD and senior managers with each agency's relevant research offices.
We analyzed pertinent agency documents, including annual reports to
congressional committees describing research priorities, ongoing and
completed projects, and agency funding. Additionally, we interviewed
RAC officials, attended a RAC meeting, and reviewed RAC reports and
recommendations. We conducted our work from September 2003 through May
2004 in accordance with generally accepted government auditing
standards. (See app. I for further detail.):
Results in Brief:
While the federal focus on Gulf War-specific research has diminished,
VA--the agency with lead responsibility for coordination of Gulf War
illnesses issues--has not yet analyzed the latest research findings to
identify whether there are gaps in current research or to identify
promising areas for future research. As of September 2003, about 80
percent of the 240 federally funded medical research projects for Gulf
War illnesses had been completed. In recent years, VA and DOD have
decreased their expenditures on Gulf War illnesses research and have
expanded the scope of their medical research programs to incorporate
the long-term health effects of all hazardous deployments. Interagency
committees formed by VA to coordinate federal Gulf War illnesses
research evolved to reflect these changing priorities, but these
entities have ultimately been dissolved or have become inactive. In
addition, VA has not reassessed the extent to which the collective
findings of completed Gulf War illnesses research projects have
addressed key research questions. The only assessment of progress in
answering these research questions was published in 2001, when findings
from only about half of all federally funded Gulf War illnesses
research were available. As a result, VA has not determined whether
previously identified research questions have been answered or whether
they remain relevant. This lack of comprehensive analysis leaves VA at
greater risk of failing to answer unresolved questions about causes,
course of development, and treatments for Gulf War illnesses. In a
separate effort, DOD has conducted 50 investigations since 1996 on
potential hazardous exposures during the Gulf War. Generally, these
investigations concluded that there were limited exposures by troops to
some hazards and, at most, limited short-or long-term adverse effects
expected from these exposures. As of April 2003, all investigations
were complete.
Federal agencies have funded seven research projects related to cancer
incidence among Gulf War veterans. However, several limitations exist
that affect research related to cancer incidence. For example, some
cancers may take many years to develop and be detected. In addition,
some research projects have not studied enough Gulf War veterans to
reliably assess cancer incidence. Research may also be impeded by
incomplete federal data on the health characteristics of Gulf War
veterans.
RAC's efforts to provide advice and make recommendations on Gulf War
illnesses research may have been hampered by VA senior administrators'
incomplete or unclear information sharing and limited collaboration on
Gulf War illnesses research initiatives and program planning. For
example, VA failed to inform RAC about its 2002 major research program
announcement that included Gulf War illnesses research. Similarly, VA
did not seek RAC's review of a draft of the 2002 annual report to
congressional committees describing current federally funded Gulf War
illnesses research. VA and RAC are exploring ways to improve
information sharing, including VA's hiring of a senior scientist who
would both guide VA's Gulf War illnesses research and serve as the
agency's liaison for routine updates to RAC. However, most of these
changes had not been finalized at the time of our review.
We are making recommendations to the Secretary of VA to improve federal
efforts to plan and coordinate Gulf War illnesses research.
Specifically, we recommend that VA conduct a reassessment of the
federal Gulf War illnesses research strategy to ensure its continued
validity and to identify promising areas for future research. We also
recommend that VA improve its sharing of research information and its
collaboration with RAC.
In commenting on a draft of this report, VA concurred with the report's
recommendations and said that it has begun a preliminary assessment of
the federal Gulf War illnesses research strategy, including an
evaluation of the 21 key research questions. The agency also noted that
it has undertaken various steps, such as coordinating its most recent
request for Gulf War research applications with RAC, in order to better
collaborate with the advisory committee.
Background:
Following Iraq's invasion of Kuwait in August 1990, the United States
and other allied nations sent troops to the Persian Gulf region in
Operation Desert Shield. In the winter of 1991, the allied forces
attacked Iraq in an air campaign and subsequent invasion by ground
forces (Operation Desert Storm). Despite the harsh environment,
illness, injury, and death rates among approximately 700,000 U.S.
military personnel were significantly lower than in previous major
conflicts. Yet, shortly after the war, some veterans began reporting
health problems that they believed might be due to their participation
in the war. VA, DOD, HHS, and other federal agencies initiated research
and investigations into these health concerns and the consequences of
possible hazardous exposures.
In 1993, the President designated VA as the lead coordinator of
research activities on the health consequences of service in the Gulf
War. Subsequently, in 1998, the Congress expanded VA's coordination to
include all Gulf War health-related activities. These activities
include ensuring that the findings of all federal Gulf War illnesses
research are made available to the public and that federal agencies
coordinate outreach to Gulf War veterans in order to provide
information on potential health risks from service in the Gulf War and
corresponding services or benefits. The Secretary of VA is required to
submit an annual report on the results, status, and priorities of
federal research activities related to the health consequences of
military service in the Gulf War to the Senate and House Veterans'
Affairs Committees. VA has provided these reports to congressional
committees since 1995. In May 2004, VA issued its annual report for
2002.[Footnote 1] VA has carried out its coordinating role through the
auspices of interagency committees, which have changed over time in
concert with federal research priorities and needs. The mission of
these interagency committees has evolved to include coordination for
research on all hazardous deployments, including but not limited to the
Gulf War. (See fig. 1.):
Figure 1: Evolution of Interagency Committees That Coordinated Federal
Gulf War Illnesses Research from 1993 through 2004:
[See PDF for image]
Note: GAO analysis of VA data, public laws, and presidential
directives.
[A] Federal agencies are VA, DOD, and HHS.
[End of figure]
Federal research efforts for Gulf War illnesses have been guided by
questions established by the interagency Research Working Group (RWG),
which was initially established under the Persian Gulf Veterans
Coordinating Board (PGVCB) to coordinate federal research efforts. From
1995 through 1996, RWG identified 19 major research questions related
to illnesses in Gulf War veterans. In 1996, the group added 2 more
questions regarding cancer risk and mortality rates to create a set of
21 key research questions that serves as an overarching strategy in
guiding federal research for Gulf War illnesses. (See app. II for the
list of key questions.) The 21 research questions cover the extent of
various health problems, exposures among the veteran population, and
the difference in health problems between Gulf War veterans and control
populations. In 1998, RWG expanded federal Gulf War illnesses research
priorities to include treatment, longitudinal follow-up of illnesses,
disease prevention, and improved hazard assessment; however, RWG did
not add any new research questions. With regard to veterans' health
status, the research questions cover the prevalence among veterans and
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.
With regard to exposure, the research questions cover:
* Leishmania tropica (a type of parasite),
* petroleum,
* petroleum combustion products,
* specific occupational/environmental hazards (such as vaccines and
depleted uranium),
* chemical agents,
* pyridostigmine bromide (given to troops as a defense against nerve
agents), and:
* psychophysiological stressors (such as exposure to extremes of human
suffering).
Separately from these research efforts, DOD is responsible for
investigating and reporting incidents of possible chemical and
biological agent exposures and other potential occupational and
environmental hazards. Within DOD, the entities responsible for
overseeing Gulf War exposure investigations have also evolved over
time. (See fig. 2.):
Figure 2: DOD Entities Responsible for Gulf War Exposure Investigations
from 1995 through 2004:
[See PDF for image]
Note: GAO analysis of DOD data.
[End of figure]
In 2002, VA established RAC to provide advice to the Secretary of VA on
proposed research relating to the health consequences of military
service in the Gulf War.[Footnote 2] RAC, which is composed of members
of the general public, including non-VA researchers and veterans'
advocates, was tasked with assisting VA in its research planning by
exploring the entire body of Gulf War illnesses research, identifying
gaps in the research, and proposing potential areas of future research.
VA provides an annual budget of about $400,000 for RAC, which provides
salaries for two full-time employees and one part-time employee and
supports committee operating costs. RAC's employees include a
scientific director and support staff who review published scientific
literature and federal research updates and collect information from
scientists conducting relevant research.[Footnote 3] RAC's staff
provide research summaries for discussion and analysis to the advisory
committee through monthly written reports and at regularly scheduled
meetings. RAC holds public meetings several times a year at which
scientists present published and unpublished findings from Gulf War
illnesses research. In 2002, RAC published a report with
recommendations to the Secretary of VA. It expects to publish another
report soon.
Most Federally Funded Gulf War Illnesses Research Projects and
Investigations Are Complete, but VA Has Not Collectively Analyzed
Research Findings to Determine the Status of Key Research Questions:
More than 80 percent of the 240 federally funded Gulf War illnesses
research projects have been completed. In recent years, funding for
this research has decreased, federal research priorities have expanded
to incorporate the long-term health effects of all hazardous
deployments, and interagency coordination of Gulf War illnesses
research has waned. In addition, with respect to the federal research
strategy, VA has not reassessed the research findings to determine
whether the 21 key research questions have been answered or to identify
the future direction of federal research in this area. In a separate
but related effort, as of April 2003, all of DOD's Gulf War
investigations were complete.
Most Federally Funded Gulf War Illnesses Research Projects Are
Complete, and Funding Is Decreasing as Research Priorities Broaden:
Since 1991, 240 federally funded research projects have been initiated
by VA, DOD, and HHS to address the health concerns of individuals who
served in the Gulf War. As of September 2003, 194 of the 240 federal
Gulf War illnesses research projects (81 percent) had been completed;
another 46 projects (19 percent) were ongoing. [Footnote 4] (See fig.
3.):
Figure 3: Cumulative Number of Ongoing and Completed Federal Gulf War
Illnesses Research Projects by Year:
[See PDF for image]
Note: GAO analysis of VA data.
[A] This total includes ongoing projects from 1991through 1994.
[End of figure]
From 1994 through 2003, VA, DOD, and HHS collectively spent a total of
$247 million on Gulf War illnesses research. DOD has provided the most
funding for Gulf War illnesses research, funding about 74 percent of
all federal Gulf War illnesses research within this time frame. Figure
4 shows the comparative percentage of funding by these agencies for
each fiscal year since 1994.
Figure 4: Funding Share for Gulf War Illnesses Research by Agency and
Fiscal Year:
[See PDF for image]
Notes: GAO analysis of VA data. Percentages may not add to 100 percent
because of rounding.
[End of figure]
After fiscal year 2000, overall funding for Gulf War illnesses research
decreased. (See fig. 5.) Fiscal year 2003 research funding was about
$20 million less than funding provided in fiscal year 2000.
Figure 5: Funding for Gulf War Research Projects, Fiscal Years 1994-
2003:
[See PDF for image]
Note: GAO analysis of VA data. Only direct costs for each agency are
included. Direct costs cover the actual research activities and
materials and have not been adjusted for inflation.
[End of figure]
This overall decrease in federal funding was paralleled by a shift in
federal research priorities, which expanded to include all hazardous
deployments and shifted away from a specific focus on Gulf War
illnesses. VA officials said that although Gulf War illnesses research
continues, the agency is expanding the scope of its research to include
the potential long-term health effects in troops who served in
hazardous deployments other than the Gulf War. In October 2002, VA
announced plans to commit up to $20 million for research into Gulf War
illnesses and the health effects of other military deployments. Also in
October 2002, VA issued a program announcement for research on the
long-term health effects in veterans who served in the Gulf War or in
other hazardous deployments, such as Afghanistan and Bosnia/
Kosovo.[Footnote 5] As of April 2004, one new Gulf War illnesses
research project was funded for $450,000 under this program
announcement.
Although DOD has historically provided the majority of funding for Gulf
War illnesses research, DOD officials stated that their agency
currently has no plans to fund new Gulf War illnesses research
projects. Correspondingly, DOD has not funded any new Gulf War
illnesses research in fiscal year 2004, except as reflected in modest
supplements to complete existing projects and a new award pending for
research using funding from a specific appropriation. DOD also did not
include Gulf War illnesses research funding in its budget proposals for
fiscal years 2005 and 2006. DOD officials stated that because the
agency is primarily focused on the needs of the active duty soldier,
its interest in funding Gulf War illnesses research was highest when a
large number of Gulf War veterans remained on active duty after the
war--some of whom might develop unexplained symptoms and syndromes that
could affect their active duty status.[Footnote 6] Since 2000, DOD's
focus has shifted from research solely on Gulf War illnesses to
research on medical issues of active duty troops in current or future
military deployments.[Footnote 7] For example, in 2000 VA and DOD
collaborated to develop the Millennium Cohort study, which is a
prospective study evaluating the health of both deployed and
nondeployed military personnel throughout their military careers and
after leaving military service. The study began in October 2000 and was
awarded $5.25 million through fiscal year 2002, with another $3 million
in funding estimated for fiscal year 2003.
VA's Coordination of Federal Gulf War Illnesses Research Has Lapsed,
and VA Has Not Determined Whether Key Research Questions Have Been
Answered:
VA's coordination of federal Gulf War illnesses research has gradually
lapsed. Starting in 1993, VA carried out its responsibility for
coordinating all Gulf War health-related activities, including
research, through interagency committees, which evolved over time to
reflect changing needs and priorities. (See fig. 1.) In 2000,
interagency coordination of Gulf War illnesses research was subsumed
under the broader effort of coordination for research on all hazardous
deployments. Consequently, Gulf War illnesses research was no longer a
primary focus. The most recent interagency research subcommittee, which
is under the Deployment Health Working Group (DHWG), has not met since
August 2003, and as of April 2004, no additional meetings had been
planned.
Additionally, VA has not reassessed the extent to which the collective
findings of completed Gulf War illnesses research projects have
addressed the 21 key research questions developed by the RWG. (See app.
II.) The only assessment of progress in answering these research
questions was published in 2001, when findings from only about half of
all funded Gulf War illnesses research were available. Moreover, the
summary did not identify whether there were gaps in existing Gulf War
illnesses research or promising areas for future research. No
reassessment of these research questions has been undertaken to
determine whether they remain valid, even though about 80 percent of
federally funded Gulf War illnesses research projects now have been
completed. In 2000, we reported that without such an assessment, many
underlying questions about causes, course of development, and
treatments for Gulf War illnesses may remain unanswered.[Footnote 8]
DOD's Gulf War Investigations Are Complete:
As of April 2003, DOD had completed all of its Gulf War health-related
investigations, which are separate from Gulf War illnesses research.
DOD began conducting investigations on Gulf War operations and their
implications for service members' and veterans' health in 1996.
Generally, DOD instituted an investigation after it received a report
of a possible exposure to a chemical or biological agent or some other
environmental, chemical, or biological hazard. From 1996 to 2003, DOD
conducted 50 investigations at a cost of about $68 million.
DOD published the 50 investigations in the form of 20 case
narratives,[Footnote 9] 10 information papers,[Footnote 10] 5 closeout
reports,[Footnote 11] and 5 environmental exposure reports.[Footnote
12] Additionally, the RAND Corporation was contracted by the Office of
Special Assistant for Gulf War Illnesses (OSAGWI) to publish 10 reports
reviewing the medical and scientific literature on the known health
effects of substances to which Gulf War veterans may have been exposed.
Some investigations focused on examining possible exposures to chemical
warfare agents or the presence of chemical weapons at specific sites.
Other investigations studied the possible linkage between environmental
hazards (such as contaminated water, equipment used during the Gulf
War, oil well fires, and particulate matter) and illnesses or health
effects.
OSAGWI published four annual reports summarizing the results of
investigations. Generally, these reports concluded that there were
limited exposures by troops to some hazards and limited or no short-or
long-term adverse effects expected from these exposures. The last
annual report was published in December 2000.
Some Efforts Are Under Way to Monitor Cancer Incidence among Gulf War
Veterans, but Research Limitations May Impede Reliability of Results:
As of April 2004, federal agencies had funded seven research projects
related to cancer incidence among Gulf War veterans, four of which have
been completed. Published results from the completed and ongoing
studies generally show that rates of cancer among Gulf War veterans
were similar to or lower than the rates among nondeployed veterans or
the general population. However, results of these studies may not be
reliable due to limitations in research related to cancer incidence in
Gulf War veterans. Future research efforts may also be hindered by
inadequate federal data on the health characteristics of Gulf War
veterans.
Few Research Projects Related to Cancer Incidence in Gulf War Veterans
Have Been Funded:
Of the 240 federally funded research projects on Gulf War illnesses, VA
officials stated that only 7 were related to cancer incidence in Gulf
War veterans--accounting for about 3 percent of the entire research
portfolio.[Footnote 13] Four of the seven research projects have been
completed; the other three are ongoing. Only two of the seven research
projects specifically studied cancer incidence. The remaining five
research projects did not focus on cancer incidence, but instead
included cancer as a component of a broader analysis of mortality,
hospitalization, or general health status of Gulf War veterans. (See
table 1 for more details on these studies.):
Table 1: Research Related to Cancer Incidence in Gulf War Veterans
(GWV):
1; Description: Postwar Hospitalization Experience of U.S. Veterans of
the Persian Gulf War;
Topic: Hospitalization;
Status: Complete;
Published: Yes[A];
Selected limitations: Sample was limited to hospitalized GWV in VA,
DOD, and some California hospitals. All other GWV were not included.
2; Description: Combined Analysis of the VA and DOD Gulf War Clinical
Registries;
Topic: General health;
Status: Complete;
Published: Yes[B];
Selected limitations: Sample was limited to GWV who self-enrolled in
DOD and VA Gulf War clinical evaluation programs. All other GWV were
not included.
3; Description: National Health Survey of Persian Gulf Veterans;
Topic: General health;
Status: Complete;
Published: Yes (interim)[C];
Selected limitations: GWV self-reported data may be subject to
overreporting of poor health status. Results were not supported by
objective data or documentation.
4; Description: Gulf War and Vietnam Veterans Cancer Incidence
Surveillance;
Topic: Cancer incidence;
Status: Complete;
Published: No;
Selected limitations: Due to the long latency period of cancer,[E] it
may have been too early to study cancer incidence in GWV.
5; Description: Deployment to the Gulf War and the Subsequent
Development of Cancer;
Topic: Cancer incidence;
Status: Ongoing;
Published: No;
Selected limitations: Due to the long latency period of cancer,[E] it
may be too early to study cancer incidence in GWV.
6; Description: Mortality Follow-up Study of Persian Gulf Veterans;
Topic: Mortality;
Status: Ongoing;
Published: Yes (interim)[D];
Selected limitations: Analysis only included GWV who have died of
cancer. Other GWV who have not died, but have been diagnosed with
cancer, were not included.
7; Description: Longitudinal Health Study of Gulf War Veterans;
Topic: General health;
Status: Ongoing;
Published: No;
Selected limitations: GWV self-reported data may be subject to
overreporting of poor health status. Results may not be supported by
objective data or documentation.
Sources: VA, DOD, and published manuscripts.
Note: GAO analysis of VA data, DOD data, and published manuscripts.
[A] G. C. Gray and others, "The Postwar Hospitalization Experience of
U.S. Veterans of the Persian Gulf War," New England Journal of
Medicine, vol. 335, no. 20 (1996), 1505-13, and G. Gray and others,
"Are Gulf War Veterans Suffering War-related Illnesses? Federal and
Civilian Hospitalizations Examined, June 1991 to December 1994,"
American Journal of Epidemiology, vol. 151, no. 1 (2000), 63-71.
[B] U.S. Department of Defense, Combined Analysis of the VA and DOD
Gulf War Clinical Evaluation Programs: A Study of the Clinical Findings
from Systematic Medical Examinations of 100,339 U.S. Gulf War Veterans
(Washington, D.C.: 2002); T. C. Smith and others, "Ten Years and
100,000 Participants Later: Occupational and Other Factors Influencing
Participation in U.S. Gulf War Health Registries," Journal of
Occupational and Environmental Medicine, vol. 44, no. 8 (2002), 758-68;
and T. C. Smith and others, "The Postwar Hospitalization Experience of
Gulf War Veterans Participating in U.S. Health Registries," Journal of
Occupational and Environmental Medicine, vol. 46, no. 4 (2004), 386-97.
[C] H. K. Kang and others, "Illnesses Among United States Veterans of
the Gulf War: A Population-Based Survey of 30,000 Veterans," Journal of
Occupational and Environmental Medicine, vol. 42, no. 5 (2000), 491-
501.
[D] H. K. Kang and T. A. Bullman, "Mortality among U.S. Veterans of the
Persian Gulf War," New England Journal of Medicine, vol. 335, no. 20
(1996), 1498-504; H. K. Kang and T. A. Bullman, "Mortality Among U.S.
Veterans of the Persian Gulf War: 7-Year Follow-Up," American Journal
of Epidemiology, vol. 154, no. 5 (2001), 399-405; and U.S. Department
of Veterans Affairs, Mortality among U.S. Gulf War Veterans Who Were
Potentially Exposed to Nerve Gas at Khamisiyah, Iraq (Washington, D.C.:
2002).
[E] Some cancers can take 15 years or more to develop and be detected.
[End of table]
Overall, the four published research projects found that deployed Gulf
War veterans did not have demonstrable differences in cancer-related
ailments compared with nondeployed veterans or the general population.
In addition, one of the published studies found that rates of
hospitalization among Gulf War veterans were similar or lower than
among nondeployed veterans, and another found that cancer-related
mortality rates among Gulf War veterans were similar or lower than in
the general population.
Research efforts are continuing for one of the two funded research
projects specifically related to cancer incidence in Gulf War veterans.
Researchers conducted a pilot project, scheduled to end in September
2004, which matched the cancer registries of six states and the
District of Columbia[Footnote 14] with a database of all Gulf War
veterans.[Footnote 15] In order to build on these efforts, the
researchers plan to expand the pilot study to include additional states
with cancer registries to obtain a more refined estimate of cancer
incidence in Gulf War veterans. While this approach appears promising,
the study's principal investigator said further efforts beyond
September 2004 would be limited to working with state cancer registries
that do not charge a fee or do not require on-site use of a registry.
Research Related to Cancer Incidence in Gulf War Veterans Has Several
Limitations That Could Affect Reliability of Findings:
A number of inherent limitations in research related to cancer
incidence in Gulf War veterans could adversely affect the reliability
of the findings from such research. (See table 1.) For example, since
some cancers can take 15 years or more to develop and subsequently be
detected, it may be too early to determine cancer incidence in Gulf War
veterans, as studies 4 and 5 in table 1 were designed to do.
Hospitalization studies of Gulf War veterans are applicable only to
those veterans who seek care in specific hospitals included in the
studies; veterans who use other health care systems are not included.
Mortality studies of Gulf War veterans are limited because only
veterans who have died of cancer are captured; other veterans who have
not died, but have been diagnosed with cancer, are not included.
Additionally, some general health studies of Gulf War veterans may use
self-reported data only, which may not be accurate unless validated by
objective physical or laboratory findings. Other research projects,
which have samples that are not representative of all Gulf War
veterans, such as studies 1 and 5 in table 1, may not reliably assess
the possibility of elevated levels of cancer incidence or related
ailments in Gulf War veterans when compared to the general population
or nondeployed veterans.
Research related to cancer incidence in Gulf War veterans may also be
hampered by incomplete federal data on the health characteristics of
Gulf War veterans. In 1998, we reported that VA and DOD did not have
data systems providing complete information on the health
characteristics of Gulf War veterans that could be used to accurately
estimate cancer incidence.[Footnote 16] For example, data from medical
records and files on disability claims, treatment, and pensions do not
include all Gulf War veterans. These data do not account for veterans
who are separated from the services and receive non-VA health care or
disability benefits. Furthermore, linking VA and DOD data systems still
would not overcome these shortcomings. VA officials have also stated
that existing data systems, such as medical record or pension systems,
are not adequate for determining cancer incidence and that
epidemiological research projects are needed.
RAC's Efforts to Provide Advice May Be Hindered by VA's Limited
Information Sharing and Collaboration, but Several Changes to Address
These Issues Have Been Proposed:
RAC's efforts to provide advice and make recommendations on Gulf War
illnesses research may have been impeded by VA's limited sharing of
information on research initiatives and program planning as well as
VA's limited collaboration with the committee. However, VA and RAC are
exploring ways to improve information sharing, including VA's hiring of
a senior scientist who would both guide the agency's Gulf War illnesses
research and serve as the agency's liaison to provide routine updates
to RAC. VA and RAC are also proposing changes to improve collaboration,
including possible commitments from VA to seek input from RAC when
developing research program announcements. At the time of our review,
most of these proposed changes were in the planning stages.
RAC Officials Cite VA's Poor Information Sharing and Limited
Collaboration as Impediments in Meeting Its Mission:
According to RAC officials, VA senior administrators' poor information
sharing and limited collaboration with the committee about Gulf War
illnesses research initiatives and program planning may have hindered
RAC's ability to achieve its mission of providing research advice to
the Secretary of VA. RAC is required by its charter to provide advice
and make recommendations to the Secretary of VA on proposed research
studies, research plans, and research strategies relating to the health
consequences of service during the Gulf War. (See app. III for RAC's
charter.) RAC's chairman and scientific director said that the
recommendations and reports that the advisory committee provides to the
Secretary of VA are based on its review of research projects and
published and unpublished research findings related to Gulf War
illnesses.
Although RAC and VA established official channels of communication, VA
did not always provide RAC with important information related to Gulf
War illnesses research initiatives and program planning. In 2002, VA
designated a liaison to work with RAC's liaison in order to facilitate
the transfer of information to the advisory committee about the
agency's Gulf War illnesses research strategies and studies. However,
RAC officials stated that most communication occurred at their request;
that is, the VA liaison and other VA staff were generally responsive to
requests, but did not establish mechanisms to ensure that essential
information about research program announcements or initiatives was
automatically provided to the advisory committee. RAC officials cited
the following instances in which VA did not fully collaborate with the
advisory committee or provide information that RAC considered
important:
* According to RAC's scientific director, bimonthly teleconferences
between the advisory committee's and VA's liaisons did not result in
full disclosure of relevant ongoing research activities. For example,
despite several months of discussions in which RAC's liaison requested
information about proposed research program announcements for Gulf War
illnesses research, VA's liaison did not inform RAC that VA's Office of
Research and Development was preparing a research program announcement
until it was published in October 2002. Consequently, RAC officials
said that they did not have an opportunity to carry out the committee's
responsibility of providing advice and making recommendations on
research strategies and plans.
* RAC officials stated that VA did not notify advisory committee
members that the Longitudinal Health Study of Gulf War Era Veterans--a
study designed to address possible long-term health consequences of
service in the Gulf War--had been developed and that the study's survey
was about to be sent to study participants. RAC officials expressed
concern that VA did not inform the advisory committee about the survey
even after the plans for it were made available for public comment.
Although the survey had been finalized, the study's principal
investigator provided additional time to allow RAC to recommend
additional survey question topics and incorporated RAC's suggested
changes into the survey.
* In May 2004, VA published its annual report that described the
results, status, and priorities of federally funded Gulf War illnesses
research as of 2002. However, RAC officials said they had not seen a
draft of this report and had not been asked to review or comment on the
document before it was published, even though the advisory committee
has a responsibility to advise the Secretary of VA on the state and
direction of Gulf War illnesses research.
According to RAC officials, there were also instances in which
information relevant to Gulf War illnesses research provided by VA's
liaison or other VA officials was unclear or incomplete.
Miscommunication about the purpose of the October 2002 research program
announcement and the details of a corresponding VA plan to increase
funding up to $20 million for research related to hazardous military
deployments, which would include the Gulf War, led RAC members to
believe that VA had committed a large portion of this $20 million to
Gulf War illnesses research for fiscal year 2004. Moreover, RAC
officials did not receive routine reports on Gulf War illnesses
research proposals that had been either received or funded by VA under
the October 2002 research program announcement. RAC officials said that
until VA administrators were asked to brief the advisory committee in
February 2004, advisory committee members were unaware that only one
new Gulf War illnesses research project had received funding for fiscal
year 2004 under this program announcement and that no other proposals
were under review.
Information sharing about these types of issues is common practice
among advisory committees of the National Institutes of Health (NIH),
which has more federal advisory committees than any other executive
branch agency.[Footnote 17] A senior official within NIH's Office of
Federal Advisory Committee Policy said that it is standard practice for
NIH advisory committees to participate closely in the development of
research program announcements. For example, some advisory committees'
members review preliminary drafts of announcements, and some discuss
program announcements during regular committee meetings. Furthermore,
this official stated that many NIH institutes require advisory
committee approval before issuing research program announcements. In
addition, NIH's advisory committee members are routinely asked to make
recommendations on both research concepts and priorities for research
projects, and are kept up-to-date about the course of ongoing research
projects. This official also stated that NIH advisory committee members
often review draft reports summarizing research findings or research
progress prior to their publication.
Additionally, RAC officials stated that VA's staffing choices for the
liaison position and more recent VA staff turnover have hindered the
development of working relationships and information flow. RAC
officials stated that the initial VA liaison--a senior official in one
of VA's four research services--was not very knowledgeable about
current Gulf War illnesses research developments. In early 2003, VA's
Chief Research and Development Officer (CRADO),[Footnote 18] whom RAC
officials said was knowledgeable about Gulf War illnesses issues, began
to serve as the VA liaison to RAC. (See fig. 6 for organizational
chart.) However, this individual left VA in December 2003, and
according to RAC officials, further communication with the advisory
committee was delegated to lower-level VA staff. After the advisory
committee's February 2004 meeting, the acting CRADO (appointed in
December 2003) and the deputy CRADO began to communicate regularly with
the advisory committee. However, the acting CRADO has additional
management responsibilities that can limit the amount of time available
to coordinate with RAC. Specifically, in early April 2004, this
official was named to temporarily head VA's health care system--the
Veterans Health Administration.[Footnote 19] For this reason, the
deputy CRADO more often has acted as a point of contact for the
committee.
Figure 6: Organizational Relationships between VA and RAC, as of April
2004:
[See PDF for image]
[End of figure]
VA and RAC Are Exploring Methods to Improve Information Sharing and
Collaboration:
In recognition of RAC's concerns, VA is proposing several actions to
improve information sharing, including VA's hiring of a senior
scientist to guide its Gulf War illnesses research and improving formal
channels of communication. In addition, VA and RAC are exploring
methods to improve collaboration. These would include possible
commitments from VA to seek input from RAC when developing research
program announcements and to include RAC members in a portion of the
selection process for funding Gulf War illnesses research projects. As
of April 2004, most of the proposed changes were in the planning
stages.
Since the February 2004 RAC meeting, VA and RAC officials said they
have had multiple meetings and phone conversations and have
corresponded via e-mail in an attempt to improve communication and
collaboration. VA officials said they have already instituted efforts
to hire a senior scientist to guide the agency's Gulf War illnesses
research efforts. The official assigned to this position will be the
RAC liaison and coordinator of VA's research on Gulf War illnesses and
health issues related to other hazardous deployments. According to VA
officials, this official will be required to formally contact RAC
officials weekly, with informal communications on an as needed basis.
In addition, this official will be responsible for providing periodic
information on the latest publications or projects related to Gulf War
illnesses research.
To facilitate collaboration with RAC, VA has proposed involving RAC
members in developing VA program announcements designed to solicit
research proposals, both specifically for Gulf War illnesses and
related areas of interest, such as general research into unexplained
illnesses. RAC officials stated that throughout March and April 2004,
VA and RAC officials had been jointly developing a new research program
announcement for Gulf War illnesses. In addition, VA has proposed that
RAC will be able to recommend scientists for inclusion in the
scientific merit review panels. VA also plans to involve RAC in reviews
of project relevancy to Gulf War illnesses research goals and
priorities after the research projects undergo scientific merit review.
This could facilitate RAC's ability to provide recommendations to the
CRADO on the projects that it has judged to be relevant to the Gulf War
illnesses research plan.
Conclusions:
While more than 80 percent of federally funded Gulf War illnesses
research projects have been completed, little effort has been made to
assess progress in answering the 21 key research questions or to
identify the direction of future research in this area. Additionally,
in light of decreasing federal funds and expanding federal research
priorities, research specific to Gulf War illnesses is waning. Without
a comprehensive reassessment of Gulf War illnesses research, underlying
questions about the unexplained illnesses suffered by Gulf War veterans
may remain unanswered.
Since RAC's establishment in January 2002, its efforts to provide the
Secretary of VA with advice and recommendations may have been hampered
by incomplete disclosure of VA's Gulf War illnesses research
activities. By limiting information sharing with RAC, VA has not fully
realized the assistance that the scientists and veterans' advocates who
serve on RAC could provide in developing effective policies and
guidance for Gulf War illnesses research. VA and RAC are exploring new
approaches to improve information sharing and collaboration. If these
approaches are implemented, RAC's ability to play a pivotal role in
helping VA reassess the direction of Gulf War illnesses research may be
enhanced. However, most of these changes had not been formalized at the
time of our review.
Recommendations for Executive Action:
With respect to the federal Gulf War illnesses research efforts, we
recommend that the Secretary of Veterans Affairs take the following
action:
* conduct a reassessment of the Gulf War illnesses research strategy to
determine whether the 21 key research questions have been answered,
whether they remain relevant, and whether there are promising areas for
future research.
To facilitate RAC's ability to provide advice on Gulf War illnesses
research, we recommend that the Secretary of Veterans Affairs take the
following additional two actions:
* ensure that a liaison who is knowledgeable about Gulf War illnesses
research is appointed to routinely share information with RAC and:
* ensure that VA's research offices collaborate with RAC on Gulf War
illnesses research program development activities.
Agency Comments and Our Evaluation:
We provided a draft of this report for comment to VA and DOD. In
commenting on this draft, VA agreed with the report's conclusions and
concurred with the report's recommendations. VA said that it has begun
a preliminary assessment of the federal Gulf War illnesses research
strategy, including an evaluation of the 21 key research questions, to
ensure the research strategy's continued validity and to identify
promising areas for future research. The agency also noted that it has
undertaken various steps, such as coordinating its most recent request
for Gulf War research applications with RAC, in order to better
collaborate with the advisory committee. VA's written comments are in
appendix IV.
DOD informed us that it had no substantive comments on the draft
report. Both VA and DOD provided technical comments, which we
incorporated where appropriate.
We are sending copies of this report to the Secretary of VA, the
Secretary of Defense, and the Secretary of HHS. We will also provide
copies to others upon request. In addition, the report will be
available at no charge on GAO's Web site at http://www.gao.gov.
If you or your staff have any questions about this report, please call
me at (202) 512-7119 or Bonnie Anderson at (404) 679-1900. Karen Doran,
John Oh, Danielle Organek, and Roseanne Price also made key
contributions to this report.
Sincerely yours,
Signed by:
Janet Heinrich:
Director, Health Care--Public Health Issues:
[End of section]
Appendix I: Scope and Methodology:
To describe the status of research and investigations on Gulf War
illnesses, we reviewed reports to congressional committees outlining
annually awarded and completed research projects and research funding.
We summarized data from the Department of Veterans Affairs' (VA) annual
reports to congressional committees, including numbers of funded
research projects and total funding by federal agency, in order to
determine the status of completed research. We interviewed VA's then-
Assistant Chief Research and Development Officer (CRADO) and the
Department of Defense's (DOD) Deputy Director of the Deployment Health
Support Directorate (DHSD) regarding the agencies' current and future
Gulf War illnesses research and investigation plans. We also
interviewed CRADO and DHSD staff and senior managers with DOD's medical
research offices, including Defense Research and Engineering and the
Army's Medical Research and Materiel Command. We reviewed other
relevant documents, including interagency coordinating council meeting
minutes, federal laws, presidential directives, and VA-and DOD-
published documents on Gulf War illnesses research and DOD
investigations.
To describe efforts made by VA and DOD to monitor cancer incidence
among Gulf War veterans, we interviewed VA's then-Assistant CRADO, a VA
senior research manager, and VA researchers, along with DOD's Deputy
Director of DHSD. We reviewed annual reports to congressional
committees describing federally funded Gulf War illnesses research,
published articles from peer-reviewed journals reporting research
findings, and other agency documents describing research projects.
To evaluate the VA's Research Advisory Committee on Gulf War Veterans'
Illnesses (RAC) efforts to provide advice on Gulf War illnesses
research, we interviewed RAC's Chairman and Scientific Director,
attended the most recent RAC meeting in February 2004, and reviewed RAC
reports and recommendations to the Secretary of VA. We also interviewed
officials with the National Institutes of Health's (NIH) Office of
Federal Advisory Committee Policy and officials within an NIH advisory
committee to identify common practices related to information sharing
and collaboration between NIH and its advisory committees. To determine
VA's efforts to improve information sharing and collaboration with RAC,
we interviewed VA's deputy CRADO and CRADO staff.
[End of section]
Appendix II: Key Gulf War Illnesses Research Questions:
From 1995 through 1996, the Research Working Group (RWG) of the
interagency Persian Gulf Veterans' Coordinating Board identified 19
major research questions related to illnesses in Gulf War veterans. RWG
later added 2 more questions to create a set of 21 key research
questions to serve as a guide for federal research on Gulf War
illnesses. (See table 3.):
Table 2: Twenty-one Key Gulf War Illnesses Research Questions:
Research question number: 1;
Key research questions: What is the prevalence of symptoms/illnesses in
the Persian Gulf veterans population?
How does this prevalence compare to that in an appropriate control
group?
Research question number: 2;
Key research questions: What was the overall exposure of troops to
Leishmania tropica?
Research question number: 3;
Key research questions: What were the exposure concentrations to
various petroleum products, and their combustion products, in typical
usage during the Persian Gulf conflict?
Research question number: 4;
Key research questions: What was the extent of exposure to specific
occupational/environmental hazards known to be common in the Persian
Gulf veterans' experience?
Was this exposure different from that of an appropriate control group?
Research question number: 5;
Key research questions: 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 Muthannna, or the demolition of a
weapons bunker at Khamisiyah?
Research question number: 6;
Key research questions: 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?
Research question number: 7;
Key research questions: What was the prevalence of pyridostigmine
bromide use among Persian Gulf troops?[A].
Research question number: 8;
Key research questions: What was the prevalence of various
psychophysiological stressors among Persian Gulf veterans?
Is the prevalence different from that of an appropriate comparison
population?
Research question number: 9;
Key research questions: Are Persian Gulf veterans more likely than an
appropriate comparison group to experience nonspecific symptoms and
symptom complexes?
Research question number: 10;
Key research questions: Do Persian Gulf veterans have a greater
prevalence of altered immune function or host defense when compared
with an appropriate control group?
Research question number: 11;
Key research questions: Is there a greater prevalence of birth defects
in the offspring of Persian Gulf veterans than in an appropriate
control population?
Research question number: 12;
Key research questions: Have Persian Gulf veterans experienced lower
reproductive success than an appropriate control population?
Research question number: 13;
Key research questions: Is the prevalence of sexual dysfunction greater
among Persian Gulf veterans than among an appropriate comparison
population?
Research question number: 14;
Key research questions: Do Persian Gulf veterans report more pulmonary
symptoms or diagnoses than persons in appropriate control populations?
Research question number: 15;
Key research questions: 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 nonspecific airway
reactivity in comparison to an appropriate control group?
Research question number: 16;
Key research questions: Is there a greater prevalence of organic
neuropsychological and neurological deficits in Persian Gulf veterans
compared to appropriate control populations?
Research question number: 17;
Key research questions: Can short-term, low-level exposures to
pyridostigmine bromide, the insect repellent DEET, and the insecticide
permethrin, alone or in combination, cause short-term and/or long-term
neurological effects?
Research question number: 18;
Key research questions: Do Persian Gulf veterans have a significantly
higher prevalence of psychological symptoms and/or diagnoses than do
members of an appropriate control group?
Research question number: 19;
Key research questions: What is the prevalence of leishmaniasis and
other infectious diseases in the Persian Gulf veteran population?
Research question number: 20;
Key research questions: Do Persian Gulf veterans have a greater risk of
developing cancers of any type when compared with an appropriate
control population?
Research question number: 21;
Key research questions: 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?
Source: VA.
[A] Pyridostigmine bromide is a drug that was supplied to troops for
use as a pretreatment for potential exposure to nerve agents.
[End of table]
[End of section]
Appendix III: Charter for VA's Research Advisory Committee on Gulf War
Veterans' Illnesses:
Source: RAC.
DEPARTMENT OF VETERANS AFFAIRS
CHARTER OF THE RESEARCH ADVISORY COMMITTEE ON GULF WAR VETERANS'
ILLNESSES:
A. OFFICIAL DESIGNATION: Research Advisory Committee on Gulf War
Veterans' Illnesses (RACGWVI).
B. OBJECTIVES AND SCOPE OF ACTIVITY: The Department of Veterans Affairs
(VA) Research Advisory Committee on Gulf War Veterans' Illnesses shall
provide advice and make recommendations to the Secretary of Veterans
Affairs on proposed research studies, research plans, and research
strategies relating to the health consequences of military service in
the Southwest Asia theater of operations during the Persian Gulf War.
The Committee shall not conduct scientific research.
The guiding principle for the work of the Committee shall be the
premise that the fundamental goal of Gulf War-related government
research, either basic or applied, is to ultimately improve the health
of ill Gulf War veterans, and that the choice and success of research
efforts shall be judged accordingly. The Committee shall assess the
overall effectiveness of government research to answer central
questions on the nature, causes, and treatments of Gulf War-associated
illnesses.
The Committee shall review all relevant research, investigations, and
processes for funding research conducted previously and assess their
methods, results, and implications. The Committee shall review all
proposed federal research plans, initiatives, procurements, grant
programs, and other activities in support of research projects on Gulf
War-associated illnesses. The Committee, consistent with law, shall
have access to all VA documents and other sources of information it
finds relevant to such review.
C. PERIOD OF TIME NECESSARY FOR THE COMMITTEE TO CARRY OUT ITS
PURPOSE(S): The Committee was established in compliance with statutory
instructions contained in Section 104 of Public Law 105-368. It has no
termination date.
D. OFFICIAL TO WHOM THE COMMITTEE REPORTS: The Committee shall report
to the Secretary of Veterans Affairs.
E. OFFICE RESPONSIBLE FOR PROVIDING THE NECESSARY SUPPORT TO
THE COMMITTEE: The Department of Veterans Affairs will provide support
for the Committee. A VA employee selected by the Secretary of Veterans
Affairs shall be the Designated Federal Officer, under the direction of
the Committee chair. Technical support for the Committee shall be
provided by a staff that reports to the Committee chair, who may
appoint a technical director for the staff to supervise its operation.
Staff members may be VA employees, employees of other government
agencies, or independent agents employed as temporary VA employees.
F. DUTIES FOR WHICH THE COMMITTEE IS RESPONSIBLE: The Committee shall
provide to the Secretary of Veterans Affairs, not later than December 1
of each year, an annual report summarizing its activities for the
preceding year. The Committee is authorized to develop additional
reports and recommendations regarding relevant research. During its
review of such research and in compliance with governing law, the
Committee shall have access to all VA documents and other information
sources it finds relevant to such review. Recommendations contained
within a formal Committee report shall be submitted to the Secretary
and other appropriate officials, as directed by the Secretary.
To augment the expertise of the Committee, the Secretary may authorize
the Committee to contract for the services of non-governmental
consultants who may prepare reports and background papers or prepare
other materials for consideration by the Committee, as appropriate.
The Committee shall be comprised of members of the general public,
including Persian Gulf War veterans, representatives of such veterans,
and members of the medical and scientific communities representing
appropriate disciplines such as, but not limited to, biomedicine,
epidemiology, immunology, environmental health, neurology, and
toxicology. The Secretary of Veterans Affairs may appoint non-U.S.
citizens as Committee members.
Members shall be appointed for two-or three-year terms. The Secretary
may renew the terms of members. The Secretary shall appoint the chair
of the Committee. The term of office for the chair shall be two years,
also renewable by the Secretary.
The Committee may establish subcommittees to carry out specific
projects or assignments. The Committee chair shall notify the Secretary
upon the establishment of any subcommittee, including its function,
members and estimated duration.
The Secretary may establish a panel of experts representing appropriate
medical and scientific disciplines to assist the Committee in its work.
Panelists may be called on by the Secretary for advice and
consultation, and may advise the Committee on research or conduct other
appropriate activities for the Committee, at the request of the
Committee chair. Panelists shall report directly to the chair or such
Committee members designated by the chair, but they shall not be
members of the Committee. Panelists will be nominated by the Committee
chair and appointed by the Secretary.
G. ESTIMATED ANNUAL OPERATING COSTS IN DOLLARS AND STAFF-YEARS: The
estimated annual cost for operating the Committee and its support staff
is $400,000 and 4 FTE. All members will receive travel expenses and a
per diem allowance in accordance with the Federal Travel Regulations
for any travel made in connection with their duties as members of the
Committee.
H. ESTIMATED NUMBER AND FREQUENCY OF MEETINGS: Meetings of the Committee
shall occur not less than twice annually at the call of the chair.
Meetings of the subcommittee(s) shall be convened as necessary. A
federal government official shall be present at all meetings.
I. COMMITTEE TERMINATION DATE: None.
J. DATE CHARTER IS FILED:
APPROVED:
--Signed -- 4/19/04:
[End of section]
Appendix IV: Comments from the Department of Veterans Affairs:
THE SECRETARY OF VETERANS AFFAIRS
WASHINGTON:
Ms. Janet Heinrich
Director, Health Care Team
U. S. General Accounting Office
441 G Street, NW Washington, DC 20548:
May 26, 2004:
Dear Ms. Heinrich:
The Department of Veterans Affairs (VA) has reviewed your draft report,
DEPARTMENT OF VETERANS AFFAIRS: Federal Gulf War Illnesses Research
Strategy Needs Reassessment (GAO-04-767) and agrees with your
conclusions and concurs with your recommendations.
VA has already begun its assessment of the existing Federal Gulf War
veterans' illnesses research strategy to ensure its continued validity
and to identify promising areas for future research. Each of the 21
research questions will be thoroughly
evaluated to determine which ones have been answered and require
additional study and what new questions should be added.
To date, reviews of four questions have been done. Once the initial
assessment is completed, VA will present it to the Research Advisory
Committee (RAC) and to the Research Subcommittee of the Deployment
Health Working Group for their comment.
VA has also taken numerous steps to ensure that an effective
relationship exists with the RAC. The Acting Under Secretary for Health
and the Deputy Chief Research and Development Officer regularly
communicate with the RAC Chairman. Since February 2004, VA has had a
designated liaison to the RAC scientific officer. However, since the
Department's liaison also has other duties, VA hopes soon to recruit a
full-time health scientist to serve as liaison and as portfolio manager
for Gulf War and deployment health studies.
In addition, VA coordinated its most recent Gulf War request for
application with the committee and will do the same with the planned
Gulf War veterans' illnesses request for proposal for autumn 2004. The
RAC provided valuable recommendations, and while
our coordination efforts may not have been seamless, we believe that
they have improved significantly over the past 2 years.
The Department's GAO Liaison passed several technical corrections to
GAO separately. VA appreciates the opportunity to comment on your draft
report.
Sincerely yours,
Signed by:
Anthony J. Principi:
[End of section]
FOOTNOTES
[1] See Deployment Health Working Group Research Subcommittee, U.S.
Department of Veterans Affairs, Annual Report to Congress: Federally
Sponsored Research on Gulf War Veterans' Illnesses for 2002
(Washington, D.C.: 2004).
[2] VA was required to establish RAC by the Veterans Programs
Enhancement Act of 1998, Pub. L. No. 105-368, § 104, 112 Stat. 3315,
3323.
[3] RAC's scientific director, a research associate professor, is also
an appointed member of RAC.
[4] Annual reports to congressional committees submitted by VA on
federally sponsored research on Gulf War veterans' illnesses identify
projects as completed when total project funding has concluded.
[5] The October 2002 research program announcement on deployment health
research remains open for researchers to submit proposals.
[6] DOD officials also told us that there are about 100,000 Gulf War
veterans currently on active military duty but these veterans generally
are in good health.
[7] DOD refers to medical research related to current or future
military deployments as its Force Health Protection Research Program.
This program focuses on prevention of illness, reduction of injuries or
the severity of injury, faster evacuation of casualties, and
enhancements to general medical capabilities.
[8] U.S. General Accounting Office, Gulf War Illnesses: Management
Actions Needed to Answer Basic Research Questions, GAO/NSIAD-00-32
(Washington D.C.: Jan. 6, 2000).
[9] Case narratives are interim reports of specific events that took
place during the Gulf War and were updated pending further
investigative efforts.
[10] Information papers are reports of what is known about military
procedures and equipment used during the Gulf War.
[11] A closeout report is used to close an investigation. The report is
issued after an investigation has been reviewed and recommendations
have been made to terminate the investigation.
[12] Environmental exposure reports are those that focus on exposure to
potential environmental hazards.
[13] Our review focused only on research related to cancer incidence
among Gulf War veterans; therefore, Gulf War illnesses research
projects studying other aspects of cancer, such as treatments for or
causes of specific cancers, were not reviewed.
[14] The pilot study included cancer registries from California,
Florida, Maryland, New Jersey, Texas, Virginia, and the District of
Columbia.
[15] A cancer registry is an information system designed for the
collection, management, and analysis of data on individuals with the
diagnosis of a cancer, which may include data on the occurrence of
cancer, the types of cancer that occur, the cancer's location in the
body, the extent of disease at time of diagnosis, and the kinds of
treatment patients receive.
[16] U.S. General Accounting Office, Gulf War Veterans: Limitations of
Available Data for Accurately Determining the Incidence of Tumors, GAO/
T-NSIAD-98-186 (Washington D.C.: May 14, 1998) and Gulf War Veterans:
Incidence of Tumors Cannot Be Reliably Determined from Available Data,
GAO/NSIAD-98-89 (Washington D.C.: Mar. 3, 1998).
[17] NIH is the largest funder of medical research in the United States
and maintains more than 140 chartered advisory committees. NIH has four
types of advisory committees--for the purposes of this report, we refer
to practices of two committee types: program advisory committees and
national advisory councils.
[18] The CRADO is responsible for oversight of research programs within
the four VA research services: the Biomedical Laboratory Research and
Development Service, the Clinical Science Research and Development
Service, the Health Services Research and Development Service, and the
Rehabilitation Research and Development Service.
[19] The Veterans Health Administration is the nation's largest
integrated health care system, employing more than 180,000 health care
professionals and operating more than 1,300 health care facilities. In
addition to its medical care mission, the veterans health care system
is the nation's largest provider of graduate medical education and a
major contributor to medical and scientific research.
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