Department of Veterans Affairs: Federal Gulf War Illnesses Research Strategy Needs Reassessment
Published: 2004-06-01T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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).
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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.)
subsections: section_title: Background
paragraphs: 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. 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.)
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    chemical agents,    pyridostigmine bromide (given to troops as a defense against nerve    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.)
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. 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. 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.
section_title: 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
paragraphs: 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.
subsections: section_title: Most Federally Funded Gulf War Illnesses Research Projects Are Complete, and Funding Is Decreasing as Research Priorities Broaden
paragraphs: 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.  (See fig. 3.)
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.
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.
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. 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. 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. 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.
section_title: VA’s Coordination of Federal Gulf War Illnesses Research Has Lapsed, and VA Has Not Determined Whether Key Research Questions Have Been Answered
paragraphs: 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.
section_title: DOD’s Gulf War Investigations Are Complete
paragraphs: 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, 10  information papers, 5 closeout reports, and 5 environmental exposure  reports. 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.
section_title: Some Efforts Are Under Way to Monitor Cancer Incidence among Gulf War Veterans, but Research Limitations May Impede Reliability of Results
paragraphs: 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.
subsections: section_title: Few Research Projects Related to Cancer Incidence in Gulf War Veterans Have Been Funded
paragraphs: 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.  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.)
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 with a database of all Gulf War veterans. 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.
section_title: Research Related to Cancer Incidence in Gulf War Veterans Has Several Limitations That Could Affect Reliability of Findings
paragraphs: 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. 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.
section_title: 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
paragraphs: 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.
subsections: section_title: RAC Officials Cite VA’s Poor Information Sharing and Limited Collaboration as Impediments in Meeting Its Mission
paragraphs: 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. 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), 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. For  this reason, the deputy CRADO more often has acted as a point of contact  for the committee.
section_title: VA and RAC Are Exploring Methods to Improve Information Sharing and Collaboration
paragraphs: 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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.
section_title: Appendix I: Scope and Methodology
paragraphs: 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.
section_title: Appendix II: Key Gulf War Illnesses Research Questions
paragraphs: 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.)
section_title: Appendix III: Charter for VA’s Research Advisory Committee on Gulf War Veterans’ Illnesses
section_title: Appendix IV: Comments from the Department of Veterans Affairs