Presidential Advisory Committee on Gulf War Veterans' Illnesses
The President assigned the Committee two principal tasks:
We initially addressed these questions in our Interim Report, which was delivered in February 1996. In the sections of this chapter on outreach, medical and clinical issues, research, and chemical and biological weapons, we include an assessment of how the government has responded to the Committee's Interim Report recommendations.
To complete our work, the Committee continued evaluating outreach regarding benefits and services available to Gulf War veterans and also evaluated the departments' risk communication efforts. Committee and staff also conducted a series of site visits to DOD and VA medical facilities, and evaluated the government's ability to respond to reproductive health concerns and the stresses of war. For this Final Report, the Committee has assessed the scope of the federally funded research portfolio and the award making process.
We make recommendations for improvement in each of these areas-outreach, medical and clinical issues, and research. Overall, however, the Committee commends the government's response to the range of health-related problems experienced by Gulf War veterans. Lessons were learned from our country's experience with the Vietnam War and the health effects of exposure to Agent Orange. For the most part, the government has acted in good faith and drawn on that experience to significantly improve its handling of Gulf War veterans' concerns.
The Committee is less sanguine about the government's investigation of incidents of possible exposure of U.S. troops to chemical and biological warfare (CBW) agents. Investigatory efforts have been slow and superficial, and no credible attempts to communicate with the public on these investigations have been made. Our most severe criticisms are reserved for this issue. Regrettably, DOD did not act in good faith in this regard.
The most striking feature of our evaluation of the government's response to Gulf War veterans' health issues has been the parallels between the experiences of these veterans and veterans of previous conflicts. We believe the government can do a better job of anticipating and preparing for post-conflict health problems. Thus, in assessing the government's coordination efforts, the Committee recommends an approach that would ensure all of the government's expertise is brought to bear on this issue of critical national concern.
In our Interim Report, the Committee examined some of the outreach programs of DOD and VA. We found they had used a number of progressive techniques-from establishing telephone hotlines for the health care programs that serve veterans to posting declassified documents on the Internet-to educate veterans and other citizens concerned about Gulf War veterans' illnesses. Neither department, however, had adopted performance measures sophisticated enough to evaluate the success of these programs. Our analysis revealed some relatively simple ways for DOD and VA to receive feedback on the utility of various outreach programs and a critical need to present information more clearly to veterans. As a result, our Interim Report included the following recommendations:
The following section of the Final Report includes the Committee's assessment of the government's response to our Interim Report recommendations and includes additional findings and recommendations concerning outreach.
The departments have been responsive to these recommendations. Full implementation will require a long-term commitment that the Committee is not in a position to evaluate.
Issues New to This Report
To complete our work, the Committee continued the evaluation of outreach to Gulf War veterans concerning benefits and medical services. In addition, we examined the issue of risk communication and whether DOD and VA are communicating effectively with Gulf War veterans about the health risks associated with service in Southwest Asia.
Outreach Concerning Benefits and Medical Services
For this report, the Committee evaluated outreach efforts (i.e., education and publicity) associated with special government-sponsored readjustment programs, outreach to specific populations of Gulf War veterans, and military broadcasts.
Outreach component of readjustment programs. Immediately following the Gulf War, VA's Vet Centers and Persian Gulf Family Support Program (PGFSP) provided services to assist Gulf War veterans and their families in the post-conflict readjustment process. VA's staff for these programs performed a significant amount of outreach about the readjustment services available to active duty and veteran populations. As veterans began to report illnesses and as the government established clinical procedures to evaluate Gulf War veterans, the outreach aspects of Vet Centers and PGFSP continued to educate the public. Both programs quickly mobilized comprehensive outreach efforts and offered a more targeted and directed approach than subsequent DOD or VA efforts, which focused on hotlines and PSAs.
Vet Centers. Congress authorized Vet Centers in 1979. The centers initially offered a range of services to Vietnam veterans, including psychotherapy and counseling, referral and aftercare for substance abuse, crisis intervention for acute symptoms, employment and educational counseling, assistance with upgrade of military discharge, education of community professionals and the public, consultation and input into VA assessments and service decisions at VA Medical Centers (VAMCs), and intensive networking and referral interactions with other community agencies.* VA's Readjustment Counseling Service (RCS) administers the Vet Center program.
All veterans of conflicts are eligible for Vet Center services. In 1991, RCS irected Vet Center staff to educate themselves about the Gulf War experience by setting up briefings with recent active duty and veteran returnees.
Information gathered via the briefings was presented to an RCS committee, which decided to place programmatic emphasis on meeting the special needs of women veterans and families of veterans. Vet Center staff have seen more than 69,000 Gulf War clients since May 1991. Gulf War clients comprise the largest percentage of the post-Vietnam era group of clients during this period.297
Vet Centers operate with considerable autonomy. Each center is staffed by a team leader-typically a social worker or clinical or counseling psychologist-two or three counselors, and an office manager staff. Most centers are nonthreatening spaces located away from the local VAMC (which continues to provide administrative support in the form of supplies, personnel, fiscal processing, and other logistical services). Most staff at Vet Centers have military experience.
Persian Gulf Family Support Program. Congress established an additional resource for readjustment counseling through Public Law 102-405, which directed VA to provide readjustment assistance specifically to Gulf War veterans; the department established PGFSP on October 1, 1992. VA's Social Work Service designed and implemented PGFSP based on recommendations from a task force of officials from VA, DOD, the American Red Cross, and the National Guard. The task force recommended PGFSP include: aggressive community outreach and coordination with National Guard and Reserve Units; case management of clinical services** available at VAMCs, Vet Centers, community agencies, and through contract services not provided by VAMCs; staff training and education components; program evaluation; and national clinical coordination. Acknowledging the essential role families play in the readjustment process, PGFSP architects included marriage and family counseling in the program and provided these services to spouses and children of veterans.26
Congress appropriated $10 million per year for PGFSP for a 2-year period. VA initiated the program at 36 VAMCs in the 26 states with the largest populations of formerly activated National Guard and Reserve troops. The size of the Gulf War veteran population within a VAMC region and empirical projections of the regional need for post-conflict readjustment counseling dictated staffing and funding at each site. A member from each participating VAMC's social work staff was designated PGFSP Coordinator and attended a one-week training session. Training emphasized developing effective working relationships with community agencies, establishing clinics appropriate for the client population, creating outreach goals and strategies, developing assessment and treatment goals, using therapies based on clients' needs, and providing counseling services to veterans and their families. Following training, coordinators integrated PGFSP into their VAMC infrastructures and educated hospital personnel about the evolving policies pertinent to Gulf War veterans.
Initially, the program provided services to assist veterans with readjustment difficulties. In response to concerns about emerging illnesses among Gulf War veterans, coordinators also conducted regional Gulf War illness-related outreach and enrolled clients into VA's Persian Gulf Health Registry (1-800-PGW-VETS). In conducting regional outreach, coordinators briefed National Guard and Reserve units, local veterans service organization (VSO) chapters, state veterans services offices, and grassroots family support groups. Coordinators focused on general information about PGFSP, the illnesses experienced by some Gulf War veterans, and VA's Registry. They also prepared PSAs and gave interviews to local civilian and military media.
Most coordinators appeared to develop close relationships with and personal knowledge of the veterans and active duty community within the region. They tailored appropriate outreach efforts, such as periodic newsletters, brochures distributed throughout the area, and hotline numbers for contacting the local PGFSP. Coordinators also organized "Persian Gulf Health Days" for veterans and the general public, holding them on weekends to maximize attendance. These day-long events often offered educational seminars on illnesses, traumatic stress, and VA benefits, and brought in representatives from VSOs, state and municipal veterans affairs offices, and interested community groups. Participating veterans had the opportunity to enroll in VA's Registry and, at some sites, the Registry examinations were conducted on the weekend as well.
PGFSP coordinators at the 36 sites closely monitored the services provided under the program during its first two years. More than 2,800 outreach briefings were conducted for approximately 70,000 persons, and approximately 22,000 PGFSP outpatient visits were made by veterans and family members nationwide.166 Funding for the program ended September 30, 1994. Some VAMCs continued to fund aspects of PGFSP, incorporating them into the facility's general budget. Most coordinators, however, returned to their original positions, and after the program ended, spouses and children had to contact Vet Centers to receive free counseling services.
Transition Assistance Program. The National Defense Authorization Act of 1991 (Public Law 101-510) authorized DOD, VA, and the Department of Labor (DOL), to provide comprehensive transition assistance for service members separating from active duty. The departments developed a Memorandum of Understanding (MOU) that established the three-day Transition Assistance Program (TAP) and assigned each department responsibilities for its implementation: DOL coordinates implementation; DOD arranges the participation of service members and provides logistical support; and VA presents veterans benefits information. TAP workshops continue to be held periodically at major U.S. military institutions in the United States and overseas, and service members are directed to attend within a 180-day period before separation.
TAP's main objective is to prevent and reduce long-term unemployment problems among veterans by educating them about goal setting, decisionmaking, labor market information, and job search techniques. The interdepartmental MOU, however, also established a high priority for informing veterans about VA benefits. Benefits briefings typically take four hours, during which benefits and application procedures are discussed; there is no standard syllabus for this discussion. It is plausible that briefings include information about DOD and VA clinical programs designed for evaluating Gulf War veterans and their families, but no evidence exists to suggest these programs are mentioned.
Outreach to women veterans. More than 40,000 women served in the Kuwaiti Theater of Operations (KTO). Cognizant of the increased role of women in the armed forces and the specific medical needs they could have, Congress authorized-through the Women Veterans Health Program Act of 1992 (Public Law 102-585)-new and expanded services for women veterans. Every VAMC has a Women Veterans Coordinator, who coordinates outreach and clinical services. Vet Centers also are active in providing outreach about specific VA programs for women and in building referral networks for non-VA medical and social services. RCS has a Women Veterans Working Group that has published information on specific health issues related to women veterans and guidance for outreach to this population.299
Outreach to Latino veterans. New Mexico, Texas, California, Arizona, Florida, and Illinois, as well as the metropolitan areas of Boston, New York City, Chicago, and Milwaukee, have large Latino veteran communities. Vet Centers and VAMCs in these regions typically have a Spanish-speaking staff member who can bridge potential language difficulties and potential cultural barriers to full utilization of the Vet Centers by the Latino veterans community. VA outreach unique to this population includes establishing relations with Latino VSOs, working with Spanish language media to publicize VA programs, and acting as a liaison with other VSOs and VA personnel for assistance in filing disability compensation claims. 298
The American Forces Information Service (AFIS) and its broadcasting arm, the Armed Forces Radio and Television Service (AFRTS), comprise the bulk of DOD's internal information services. AFRTS delivers radio and television programming for service members overseas and aboard ships. AFIS oversees the European and Pacific editions of the Stars and Stripes newspapers and the approximately 1,100 military-funded newspapers in the United States and overseas. AFIS also has produced several media products on Gulf War veterans' health issues. Military media have undertaken the following activities related to Gulf War veterans' illnesses:
The Committee first examined the government's outreach programs designed to inform veterans about their benefits. Outreach cannot stop there, however, when veterans have so many questions about the health risks of service in the Gulf. Thus, the Committee also focused attention on another aspect of the government's outreach efforts, namely risk communication.
Risk communication is a multi-step process that involves building a communication plan with specific short- and long-term objectives and using language understandable to lay persons. Risk communication also requires analyzing the affected community to determine effective methods of presenting health information, sustaining the communication process over a period of time to give the community an opportunity to increase its awareness and understanding, and establishing an open process of information exchange between the communicating agency and the affected community. Finally, any strategy must include evaluation of the performance of particular programs.23,38,48,223,258
In terms of information requirements, the scenario of Gulf War participants, who were subjected to various potential risk factors during a specific length of time, is analogous to an industrial setting, where workers are exposed to potentially hazardous agents. Additionally, the epidemiologic and clinical studies designed for Gulf War veterans are analogous to studies in which appropriate worker notification measures would be considered. Although a military conflict can be a far more complicated operation than the typical industrial setting, the risk communication experiences of several federal agencies and private institutions provide a suitable framework against which risk communication efforts for Gulf War veterans can be evaluated and compared. Thus, while risk communication in this situation is a challenge, there is a broad theoretical and experience base on which DOD and VA can draw.
Several federal agencies, including the Environmental Protection Agency (EPA) and DHHS's Agency for Toxic Substances and Disease Registry (ATSDR), have developed programs for risk communication with the public about environmental issues and health risks.30 The National Institute for Occupational Safety and Health (NIOSH) conducts a function of risk communication known as worker notification, in which at-risk industrial workers participating in epidemiologic studies are informed of the results. This step provides the participants probabilistic information regarding the possibility, i.e., risk, of experiencing health effects from exposures.223 The National Academy of Sciences (a private sector body that often prepares reports for the government) has published several theoretical and practical guides that emphasize the importance of risk communication in public health.173,176,177
Federal risk communication with Gulf War veterans. Most DOD and VA outreach efforts concentrate on publicizing the clinical evaluation programs and then referring participants to them. While serving a valuable function, these efforts do not fully educate veterans or sufficiently build their trust that the government's efforts to help them are comprehensive.
In addition, the target population for risk communication related to Gulf War veterans' illnesses extends beyond military service members. Members of the affected community also include family members, civilians who served in the Gulf in support roles, state veterans service officials, and national and local VSOs. Individuals who provide services to the affected community, including social workers and health care providers who come into contact with Gulf War veterans and their families and support groups, are also important risk communication targets.
Some of the departments' outreach efforts provide educational information to veterans. For example, VA publishes the Persian Gulf Review, a quarterly newsletter sent to those veterans who have participated in the VA Health Registry or have received other health services from a VAMC. The newsletter carries brief segments of one or two paragraphs about recently released information from reports and studies of Gulf War veterans' illnesses, developments concerning eligibility for medical services and disability compensation regulations, and common questions and answers about how to receive medical care. VA's Persian Gulf Veterans' Ill nesses Internet site also provides brief, general information similar in content to the newsletter. Neither the newsletter nor the Internet site, however, provide comprehensive risk communication information about exposures or epidemiologic studies underway.
DOD's Internet site, GulfLINK, attempts to provide more salient information, such as an assessment of health effects from organophosphateexposures and reports of detections of chemical agents during the Gulf War.
However, DOD has been slow to post information, and the tone of some of the posted reports is patronizing and dismissive of veterans' concerns. DOD's growing lack of credibility-attributable largely to chemical warfare (CW) agent exposure investigations (discussed in a following section)-compounds its difficulties with effective risk communication with Gulf War veterans and others. DOD faces a complex challenge in conducting investigatory activities that require contacts with individuals who may face health risks associated with their service in the Gulf. Early efforts, such as the initial Khamisiyah telephone survey, sorely neglected the risk communication element of DOD's responsibilities.
Effective risk communication requires a dialogue-a two-way flow of information, opinions, and perceptions.258 DOD and VA have not established clear pathways for veterans to provide feedback about clinical programs and/or about concerns regarding exposures; nor have they canvassed the Gulf War veterans' community regarding better methods of communication. It appears the only way in which a veteran could provide feedback would be through contact with the clinical personnel at local VAMCs or military hospitals. This, however, does not appear to be a likely route for transmitting concerns to decisionmakers. VA does conduct periodic interactive video teleconference sessions on Gulf War health topics for clinical and social work staff, but this format is designed for staff education, not as a formal, publicized mechanism of interaction with veterans and other members of the public.
Likewise, the telephone hotlines also are designed for a one-way flow of information. VA and DOD health care hotlines are for referrals only. DOD's Incident Reporting Line (1-800-472-6719) and Khamisiyah investigation telephone survey have been used to collect-not disseminate-information. For example, there often has been no follow-up response from DOD to Incident Line callers about reported incidents, nor has there been adequate disclosure through any existing outreach methods concerning the overall progress of the investigation into CBW agent incidents.
Another opportunity for DOD and VA to interact with members of the target community is in the design and execution of epidemiologic studies. In the Interim Report, this Committee found that public advisory committees might improve communications with veterans who are asked to participate in epidemiologic studies, and we recommended DOD, DHHS, and VA urge their principal investigators to use public advisory committees in epidemiologic studies of Gulf War veterans' health issues. Departmental response to this recommendation has been half-hearted, at best.
DOD and VA need to emphasize feedback procedures in their outreach programs. Creating a dialogue with a disparate veterans population is central to effective risk communication and warrants increased attention from the departments.
Role of veterans service organizations. There appears to be a role for VSOs in developing and implementing risk communication strategies for Gulf War veterans, since many VSOs have extensive networks in place throughout the country. VSOs represent veterans in social and legislative matters at the national, state, and local levels. Many VSOs-including the American Legion, Veterans of Foreign Wars, and Vietnam Veterans of America-have been chartered by Congress. VSOs already have an established working relationship with the VA in many areas, including working with Vet Centers on readjustment issues, sitting on the Persian Gulf Expert Scientific Committee, and providing advocates for the disability compensation claims process. Currently, some VSOs are working on behalf of Gulf War veterans, mostly with assistance in the disability compensation claims process. Several VSOs recently have emerged in various regions of the country specifically to serve Gulf War veterans. The interests of many of these groups are represented in Washington, DC, by the National Gulf War Resource Center, which was organized in 1995.
An example of VSOs implementing useful risk communication is the Self Help Guide for Veterans of the Gulf War,178 developed by the National Veterans Legal Services Program (NVLSP) and distributed by the American Legion. The Guide provides an overview of the nature of Gulf War veterans' illnesses, explains some health risk factors associated with Gulf War service, and describes eligibility requirements for receiving VA medical benefits. In a different vein, an example of VSOs as a credible resource for veterans is their work in the complicated disability compensation process. Concerned about the 95 percent denial rate for undiagnosed illness claims, the American Legion developed an undiagnosed illnesses application addendum for the VA disability compensation claims process. When completed, the addendum provides a comprehensive description of the veterans' clinical profile and military operational history, which are important factors in the claims process.
The issue of risk communication will only increase in relevancy as studies with specific findings about the nature of Gulf War veterans' illnesses are released. These findings might be unclear to the veterans and, indeed, some conclusions could offer a message some veterans would prefer be different. In such cases, trust, credibility, interaction, and community involvement are key to successful risk communication-but it is not clear whether DOD or VA will have personnel in place to conduct effective risk communication when findings from various reports are ready for dissemination. VA has Persian Gulf Coordinators assigned to each medical center, but these personnel have other responsibilities and typically are more involved with clinical case management.
To date, DOD and VA have not devised a plan with specific objectives for effective health risk communication.216,217 There are many messages to exchange in a health risk communication process, especially one as complicated as the possible health consequences of service in the Gulf War. A process that adequately addresses risk communication in this area would by necessity involve the following: educating members of the community about the certainties and uncertainties of the health risks of various exposures, using the media as a conduit of information, having frequent and sustained contact with the affected community, and validating the information and the source of information with appropriate external reviews.
Findings Regarding Outreach
Based on its analysis of the government's programs for outreach concerning services available to Gulf War veterans and for communicating with veterans about the risks of Gulf War service, the Committee makes the following findings:
The Committee's recommendations for governmental actions based on these findings appear on page 50.
MEDICAL AND CLINICAL ISSUES
In our Interim Report, the Committee focused on medical treatment issues that surfaced during the deployment and demobilization of troops. We found DOD's policies and procedures were not adequate to prevent some service members with preexisting conditions from being deployed or to identify health problems extant at the time of demobilization; we noted these conditions could have contributed to some current health concerns.
The Committee also found that DOD and the Food and Drug Administration (FDA) deliberated carefully before enabling, through rulemaking, DOD to require troops to take pyridostigmine bromide (PB) and botulinum toxoid (BT) vaccine as pretreatments for possible CBW agents without FDA approval of the products for that purpose.304 We were concerned that FDA had failed, in the five years since the Gulf War, to devise better long-term methods governing military use of drugs and vaccines for CBW defense. We also found DOD's inability to produce records of who received PB or BT indicative of much need for wholesale improvement in the government's performance on medical recordkeeping during military engagements. As a result, our Interim Report made the following recommendations:
This section of the Final Report includes the Committee's assessment of the government's response to our Interim Report recommendations and includes additional findings and recommendations concerning medical and clinical issues.
DOD has been responsive to Committee recommendations about medical treatment policies governing pre-, during, and postdeployment of U.S. troops. DOD has not been responsive, however, to the Committee's recommendation that prior to any deployment, DOD should undertake a thorough health evaluation of a large sample of troops to enable better postdeployment medical epidemiology.
One of the overriding difficulties of research on Gulf War veterans' illnesses is the absence of baseline data-on health and on exposure to environmental hazards. DOD testified it has improved its approach to gathering such data and has incorporated new policies and procedures in its medical surveillance and environmental monitoring programs.40,213 Although DOD has introduced these techniques in the Bosnia peacekeeping mission, they have not been tested in a large-scale conflict. Laying the groundwork for post-conflict medical surveillance could be perceived by some as a low priority in a war-fighting environment. There is no evidence that DOD has identified a standardized set of tests or physical examination procedures and applied them to a large sample of troops across all services to ensure that medical epidemiology can be conducted in the aftermath of an operation.
With regard to using investigational new drugs, DOD has made the effort in Bosnia to provide information about the risks of tick borne encephalitis (TBE) and the investigational TBE vaccine being administered, with informed consent, to U.S. troops in that region. However, DOD has made no specific response to the Committee's recommendation on educating troops about investigational pharmaceuticals-i.e., given that the Interim Final Rule is still in effect, DOD should develop enhanced orientation and training procedures to alert service personnel they could be required to take investigational drugs or vaccines not fully approved by FDA if a conflict presents a serious threat of exposure to CBW agents.
With respect to our Interim Report recommendation concerning medical recordkeeping, the Committee observes that DOD has made progress in working toward improving medical recordkeeping in-theater and stateside. However, increased commitment from DOD's Joint Chiefs of Staff and Commanders in Chief is essential for increasing the priority of this effort.
FDA has testified that it is now considering the Interim Final Rule in conjunction with guidelines for CBW agent prophylaxis approval; it is also considering how it should address military and civilian use.132 The Committee remains concerned, however, about the amount of time FDA is taking to move forward with opening up the Interim Final Rule-which was issued almost six years ago-for public comment.
Issues New to This Report
To complete its work on medical and clinical issues, the Committee assessed whether Gulf War veterans currently receive access to quality medical care under programs established by the government for their care. We specifically examined the availability of reproductive health care because of the high degree of concern expressed by Gulf War veterans and their families in this regard. Finally, the historically important role of post-conflict stress reactions on the health of veterans132 led us to give particular scrutiny to this issue.
Access to Health Care
Beginning with our first meeting in August 1995, the Committee heard frequent public comment about the difficulty of gaining access to health care in VAMCs and, to a lesser degree, DOD medical facilities. Inadequate information, delays in scheduling appointments, insensitive personnel, and inadequate followup topped the list of complaints. The Committee decided a series of site visits and interviews could help inform our deliberations in determining whether problems with access to care persist or largely preceded establishment of VA's Registry and DOD's CCEP. Facilities for site visits were selected to vary geographically and represent ini- tial evaluation sites (Phases I and II) and referral centers. Between November 1995 and February 1996, Committee members and staff visited the following sites:
Site visits included interviews with medical facilities' commanders or chiefs of staff, Registry or CCEP coordinators, medical and nonmedical staff assigned to the program, and veterans undergoing evaluation. Committee members and staff also took walking tours of dedicated facilities and reviewed randomly selected medical records of Gulf War veterans.
Clinical evaluation programs. In August 1992, VA established its Registry for veterans who had returned to civilian life. DOD established the CCEP in June 1994 for Gulf War veterans remaining on active duty. These clinical programs are available, free of charge, to any Gulf War veteran. Both the Registry and CCEP are treatment programs, not research protocols, but the data have been used to generate research hypotheses.
VA and DOD maintain databases for their clinical care programs. The databases for the Registry and CCEP can generate information useful for patient care-both for diagnosis and for risk communication.
Quality of care. The VA Registry originally consisted of a medical history, a thorough physical examination, and basic laboratory tests. If indicated, participants received specialty consultations as Phase II of the evaluation. While the Phase I and Phase II examinations essentially were equivalent to a good internal medicine evaluation, initially no uniform protocol existed for the assessment of participants in the Registry. As the program developed, VA established requirements for certain specialty examinations for all participants and standard questions regarding possible exposures while in the Gulf. By early 1994, a uniform assessment protocol, which is in use today, was in place systemwide. As of October 1996, approximately 62,000 Gulf War veterans had completed physical examinations in VA's Registry program. The most frequently cited symptoms, which have remained consistent over time, include fatigue, headache, skin rash, muscle and joint pains, and memory loss. The majority of participants receive a diagnosis, but approximately 20 percent of veterans who describe symptoms during the physical examination(s) complete the Phase I and/or Phase II examinations without receiving a diagnosis.
DOD uses the same examination protocol for its CCEP.*** Initially, any CCEP participant who wanted a Phase II evaluation was given one without a specific referral from his or her physician. DOD modified this policy in January 1995 and now requires a physician referral for Phase II. As of October 1996, approximately 34,000 individuals had requested physical examinations in the CCEP. DOD has published information derived from more than 18,000 CCEP examinations,277 and the findings are similar to those for VA's Registry. The most frequently cited symptoms have been fatigue, headache, skin rash, joint pain, and memory loss. All CCEP participants receive a diagnosis, but approximately 18 percent of the primary diagnoses fall into the category "ill-defined symptoms and signs," with no specified cause.
VA designated medical centers in Washington, DC, Houston, TX, Los Angeles, CA, and Birmingham, AL, as Referral Centers for evaluating veterans who have unexplained illnesses after the Phase I and II examinations. DOD established a Specialized Care Center at Walter Reed Army Medical Center for the evaluation, treatment, and rehabilitation of Gulf War service members with chronic debilitating symptoms.
Appointment scheduling. VA offers the Phase I examination at any VA medical facility; Phase II examinations are performed at any secondary or tertiary care facility. Phase I evaluations through the CCEP can be done at any military treatment facility. DOD's Phase II evaluations are conducted at one of the 14 tertiary care medical facilities (one for each of the 13 geographic regions except region 6, which has two) with the required specialty staff.
When VA's Registry began in 1992, veterans often encountered significant delays throughout the system in scheduling appointments-chiefly because of the large number of veterans requesting examination, the newness of the program, and the need to reassign space and personnel within facilities. Experience gained over time, the development of streamlined procedures, and the decreasing rate of veterans entering the Registry largely have eliminated major delays in scheduling an initial examination. Delays-usually less than 30 days-can occur in scheduling Phase II evaluations depending on the availability of specialists.4 Evaluations at one of VA's four Referral Centers entail administrative delays associated with medical records preparation and consultations with referring physicians. Referral Centers follow a more rigorous protocol requiring a greater commitment of time and specialty resources and limits the number of participants at any one time. Delays of three months or more are not uncommon.
The Committee heard fewer complaints about initial appointment scheduling in the CCEP program and found that delays in scheduling
Phase II referrals seldom exceed two weeks. The Specialized Care Center at Walter Reed, a rigorous 30-day program, requires advance scheduling and consultation, but at the time of our visit we heard of no delays.
Personnel and space. By the time Committee members and staff initiated our site visits in November 1995, all facilities had a designated Gulf War Veterans Program coordinator and support staff who were responsible for scheduling and conducting the evaluations. Committee and staff interviewed these individuals and found them knowledgeable about the Registry or CCEP programs and their individual responsibilities. Staffing at the facilities we visited is currently sufficient to conduct Phase I and Phase II evaluations, although the variability of available specialists to conduct portions of the Phase II evaluation causes some delays in a few of the facilities visited.
The large numbers of service members who registered in the CCEP initially threatened to overwhelm the resources of the Internal Medicine Department at Fort Knox. A significant backlog of participants awaiting Phase I evaluation existed in February 1995, when DOD mandated that all requested workups nationally would be completed by April 22, 1995. Because Fort Knox had only three internists at the time, CCEP registrants consumed all of their clinic time. In response, two physicians from Wright-Patterson Air Force Base were detailed to Fort Knox to assist with the evaluations. Contract arrangements also were made with the University of Louisville to conduct Phase I evaluations from Fort Knox beginning July 26, 1995. Participants requiring Phase II evaluations are still referred to the U.S. Air Force Hospital at Wright-Patterson Air Force Base, Dayton, OH, but Phase II evaluations now also are conducted at the University of Louisville.
The Fort Knox example of clinic overload was the most extreme example of clinical disruption at facilities visited by the Committee. Eligible beneficiaries who were not on active duty, other than Gulf War veterans, who requested appointments at the Fort Knox Internal Medicine Clinic in the spring of 1995 were referred to civilian care under DOD's Civilian Health and Medical Program of the Uniformed Services (CHAMPUS). All other facilities we visited maintained they had extended hours and worked harder to avoid interfering with the usual hospital routine. In our conversations with clinic and program staff, they noted there had been some disruption in the early part of both clinical care programs, but that the problems had not been severe. The most frequently mentioned effect was the pressure on clinical and program staff to complete the evaluations in a timely manner-particularly at the DOD facilities during January to May 1995.
Most facilities did not designate a separate clinic space for Phase I evaluations, seeking to mainstream participants as much as possible and reduce the possibility of symptom sharing. Some facilities (e.g., VAMC, Durham, NC), have set aside specific clinic hours for the Gulf War evaluations and report no evidence of symptom sharing among their group of veterans. With the significant reduction in numbers of Gulf War veterans seeking evaluation, all clinical spaces we visited are more than adequate to handle current demand. As was noted earlier, however, the extent to which this remains true is unclear, given recent heightened media attention to Gulf War illnesses.
Staff education. In contrast to the extensive knowledge of staff assigned directly to Gulf War-related programs, the knowledge level of staff not specifically assigned to the Registry or CCEP at both VA and DOD medical facilities was problematic. For example, the existence of the CCEP was largely unknown among staff at the VA facilities we visited. Moreover, it was astonishing in one instance to find that a physician treating Gulf War veterans in his VA post-traumatic stress disorder (PTSD) research was unaware of the VA Registry. There have been scattered Continuing Medical Education (CME) programs for DOD and VA medical facility staff about the government's Gulf War programs, but these are intermittent, usually limited to a single department, and not well attended.
At the time of the Committee's site visits, some staff at the VA medical facilities complained they were receiving less information about the program from VA Central Office than they felt they needed. While recognizing the educational outreach concerning the Registry program undertaken by the Central Office, they wanted more information about results of the Registry evaluations and about research being undertaken. Staff at DOD's facilities expressed general satisfaction with the feedback they received.
Staff attitudes. The Committee heard public comment at each meeting citing insensitive attitudes on the part of staff at both DOD and VA medical facilities. Frequently, these reports by veterans and their families centered on a dismissive or cynical approach to the veterans' problems-i.e., the message received was that problems were "not real" or "all in your head." Veterans who sought care after the Gulf War but before the establishment of the Registry and CCEP appeared to suffer most from this treatment.
In our interviews with staff at the eight medical facilities, we encountered a range of views about the problems being experienced and reported by Gulf War veterans. Some VA and DOD staff members expressed the belief that the thorough, structured evaluations in the Registry and CCEP were overkill and were exacerbating any problems that existed through the reinforcement of a sick role. Others felt constrained by the rigidity of the evaluation protocol-that it did not allow for flexibility of clinical judgment-and felt this was "not the way I would practice medicine." No VA or DOD staff members interviewed stated they believed that these veterans were not actually ill.
Patient satisfaction surveys carried out at several of these facilities find a greater than 80 percent approval rate by all patients, including Gulf War veterans.
Adequacy of medical records. Medical records of Registry and CCEP participants at each facility are maintained separately from other patient records, and there is a final, common pathway for determining when the records are complete and ready to be certified by a physician's signature. When completed, patient data are reported to either VA Central Office or DOD Health Affairs.
Committee staff reviewed a ten percent sample of randomly selected medical records of Gulf War veterans at each facility visited. Records were reviewed for completeness, adherence to protocol and, particularly, documentation of diagnoses by specialty consultation and/or laboratory reports.
In its reviews, Committee staff found only minor deviations from completeness and adherence to protocol. In each instance where Committee staff noted missing documentation for a discharge diagnosis, facility staff was able to locate the necessary documentation. It appears that, overall, medical records for these veterans are complete.
Follow-up treatment. After completing a Registry or CCEP examination, Gulf War veterans are, in most instances, returned to their local medical facility for follow-up care. Despite the general medical adequacy of the VA and DOD evaluation programs, follow-up treatment-particularly where mental health visits are involved-are problematic. Staffing constraints often result in long delays in scheduling appointments in some specialties. Psychiatric staffing is particularly overloaded at some sites.
Many Registry and CCEP participants are receiving follow-up care from a number of physicians, both federal and private sector. No single case manager is guiding their care. The absence of a case manager can lead to confusion and, in some cases, over medication of patients.
Follow-up treatment of active duty veterans also is made more difficult by command resistance to granting the necessary time off to maintain an adequate treatment program. This is true for all chronic illnesses, but especially so for psychological diagnoses.
Reproductive Health Services
The birth of a child with a disabling, disfiguring, or lethal condition is devastating to the parents and family of that child. Likewise, the inability to produce a wanted child is usually unexpected and almost always anguishing. Most people want to know why this has happened to them and their family. Understanding what caused, or at least did not cause, the problem can often bring relief.
Care provided to active duty service members. When a couple experiencing infertility, a woman in a high risk pregnancy, or an infant with a birth defect enters the military health care system, a comprehensive range of services-from primary to tertiary care-are available. Beneficiaries who experience fertility problems can use their benefits to obtain a variety of reproductive health services, including infertility testing and treatment. A
child with special health needs receives a full range of medical and related health care benefits to the full extent of his or her disability. In addition, a child with a disability and incapable of self-support remains eligible for care in the military's medical services system as a family member of an active duty member or retiree, even after the age of majority.256
Care provided to veterans who have separated from service. Reproductive-related medical care and counseling for individuals no longer on active duty stands in stark contrast to coverage for active duty service members. With the exception of children with spina bifida born to in-country Vietnam veterans, VA currently lacks the authority to provide benefits or services on the basis of adverse health effects in children-even if the effects are shown to result from their parents' service experience. Evaluation and treatment for infertility of veterans is limited to a small number of situations in which the cause of the infertility could have been detected and treated while on active duty (e.g., diabetes in women or service-related spinal cord injury in men). In general, obstetrical services are not offered to female veterans through the VA medical system-except for care relating to a pregnancy that is complicated or in which the risks of complication are increased by a service-connected condition. VA has no policies in place to systematically address the concerns of Gulf War veterans regarding reproductive health.
Prevention of Combat-related Stress Reactions
Building on research on veterans of Korea, Vietnam, and the Gulf, DOD has undertaken an ambitious program to proactively address combat-related stress. The U.S. Army, through the Department of Military Psychiatry, Walter Reed Army Institute of Research, has instituted a Human Dimensions Research Program. One important observation has been that strong leadership and unit cohesion are firmly associated with reduced severity of stress reactions. U.S. Army doctrine embraces this finding and emphasizes it in its field manuals.
Combat Stress Control Detachments have been established (six in the Active Army and nine in the Reserve), each consisting of a psychiatrist, psychologist, social worker, psychiatric nurse, clinical nurse specialist, occupational therapist, and two enlisted technicians. These detachments provide predeployment briefings that address all known health hazards, including stress, that individuals might face during the deployment. During deployment, members of the detachments are instructed to be highly visible to the commanders and troops. One of these detachments has been deployed to Bosnia.
Combat Stress Control Detachments provide briefings for units newly arrived, provide special training in stress management techniques and, most important, they conduct unit survey interviews throughout the deployment. Unit interviews are a systematic tool for gathering information from the troops and then reporting to the command what is troubling the troops and how well leadership is functioning. When critical events occur, the trained individuals in the detachments debrief personnel directly involved, provide consultation to the leaders and chaplains, and provide any special education that could be needed. At the end of a deployment, all units, including those in which no critical events occurred, receive an end-of-tour debriefing by the Combat Stress Control Detachment. Those units exposed to particularly critical events receive special attention to ensure that unit members have a chance to talk through events and reach appropriate closure prior to returning home.
Follow-up plans for the Bosnia deployment include studies that will take place six months after veterans return. Plans also are under discussion to continue to follow the same individuals, with appropriate informed consent, over the long term.
Tertiary prevention programs, such as Vet Centers within the VA medical system, also can help minimize stress-related conditions before they become too severe. As noted earlier in this chapter, Vet Centers were established after the Vietnam War to provide support for Vietnam veterans with PTSD and other mental health concerns. There are 205 centers located around the United States, and since 1991, more than 66,000 Gulf War veterans in over 210,000 visits have availed themselves of these centers.8
Findings Regarding Medical and Clinical Issues
Based on the government's response to the recommendations in the Committee's Interim Report and additional interviews, site visits, briefings, and testimony, the Committee makes the following findings regarding medical and clinical issues:
The Committee's recommendations for governmental actions based on these appear findingson page 52 of the printed version of the Final Report.
In our Interim Report, the Committee found most of the major epidemiologic studies sponsored by DOD, VA, and DHHS to be well designed and appropriate to determine if Gulf War veterans have mortality, symptoms, or diseases that could be attributable to service in the Gulf War. We were concerned, however, that inadequate response to scientific peer review, disregard for the importance of allocating scarce research dollars to the best designed studies, and inattention to the need to communicate effectively with veteran participants were undermining the effectiveness of the government's research efforts. Finally, we found that the lack of data about exposure to various risk factors was hampering ongoing research. The Committee's Interim Report included the following recommendations based on our preliminary analysis of the government's research programs:
The following section of the Final Report includes the Committee's assessment of the government's response to our Interim Report recommendations and includes additional findings and recommendations concerning research.
The government has been responsive to these recommendations in general, but the Committee notes continuing problems in two areas: the use of public advisory panels for epidemiologic studies and the utility of the Persian Gulf Registry of Unit Locations.
Public advisory panels. While VA and DOD have encouraged their principal investigators to convene and consult scientific advisory committees, they have not taken serious steps to encourage the formation and use of public advisory committees. Although public advisory committees will be recommended for epidemiologic studies recently funded by DOD and VA, their use is given low priority by program administrators. The Committee believes this practice is unfortunate because, as is evidenced by the experience of the Centers for Disease Control and Prevention (CDC), public advisory committees can greatly facilitate incorporation of veterans' concerns into study design, dissemination of results, and risk communication.
Persian Gulf Registry of Unit Locations. DOD has made its congressionally mandated Persian Gulf Registry of Unit Locations available to govern
ment and private researchers, but the database lacks the precision and detail necessary to be an effective tool in the investigation of exposure incidents. More to the point, the unit locator database has failed in its application to the single CW agent incident investigated by DOD in any detail to date-i.e., Bunker 73 and the pit at Khamisiyah.
In its Khamisiyah investigation, the Persian Gulf Veterans' Illnesses Investigation Team (PGIT) has not relied on reports provided from the database because the assumption on which the database is premised-that individuals remain with their units-was the exception rather than the rule in the theater of operations. Instead, PGIT went to the operational records and has engaged in a series of interviews to try to piece together a more accurate picture of troop locations. PGIT found that, in the field, individuals performed duties while assigned to discrete groups that might or might not be represented by one of the database's unit identification codes. In addition, records of unit locations, which still are maintained manually, were sometimes incomplete and/or inaccurate. For these reasons, the Committee concludes the unit locator has not proved to be a valuable tool for investigating exposure incidents. The effort has been no more successful than the effort to compile similar information following the Vietnam War to examine possible exposures to Agent Orange. Regrettably, DOD raised expectations about the potential utility of the database far beyond reason, given the data available to developers of the computer database. Better data-whether acquired through rigorously enforced manual methods or new technologies such as devices that interact with the Global Positioning Satellite system-should receive higher priority from DOD.
Issues New to This Report
To complete its evaluation of federally funded research on Gulf War veterans' illnesses, the Committee assessed whether the government's research portfolio is well managed and whether federally funded research addresses an appropriate range of questions relevant to Gulf War veterans' illnesses.
Management of the Federally Funded Research Portfolio
The Committee focused on four areas related to the government's management of federally funded research in Gulf War veterans' illnesses: coordination, research centers, prioritization, and external review.
Coordination. The Persian Gulf Veterans Coordinating Board (Coordinating Board) manages the government's Gulf War veterans' health research. Established in January 1994, the interagency Coordinating Board is comprised of the Secretaries of Defense, Health and Human Services, and Veterans Affairs, and its Research Working Group (RWG) has primary responsibility for research related to possible health consequences of Gulf War service. The RWG's tasks include coordinating studies to avoid unnecessary duplication, ensuring a focus on high priority research, assessing the status and direction of federally funded research, identifying possible gaps in understanding
Gulf War veterans' health issues, recommending future research directions, and generating periodic reports to Congress. Oversight of individual projects within the government's portfolio rests within the funding agency. Each department has its own established funding and management procedures for its intra- and extramural research programs.
DOD and VA have historical roles in research on the health of active duty service members and veterans, and they take the lead in the RWG partnership. DHHS has historical strengths in public health (e.g., CDC) that are brought to bear in this effort. However, except for the National Institute of Environmental Health Sciences, DHHS's many basic biomedical research intramural activities and extramural projects that could contribute substantial expertise to Gulf War health issues are peripherally involved in RWG's activities, if at all.
Research centers. The government has developed some innovative approaches to address Gulf War veterans' health research. For example, in October 1994 it launched three Environmental Hazards Centers in Portland, OR, East Orange, NJ, and Boston, MA. At the outset, the goal was to bring together teams of highly qualified researchers with relevant expertise in veterans' health issues. The centers are joint VA-university endeavors-each funded at approximately $500,000 per year for five years-and they support interdisciplinary collaborations and interactions between VA and academic scientists.
Testimony before the Committee and staff site visits indicate each of the centers brings a different array of expertise to the broad set of questions relevant to Gulf War veterans' illnesses. To date, the centers have produced some well-designed studies. Moreover, the range and depth of research at the centers suggests these studies will provide useful contributions to understanding Gulf War-specific health concerns, as well as those that could arise with future conflicts.
The possibility that reproductive health problems and birth defects might be tied to service in the Gulf War is of special concern to many veterans and their families. VA solicited applications in May 1996 to establish a research center for epidemiologic, clinical, and basic science studies of environmental hazards and their effects on reproductive and developmental outcomes. In November 1996, the VAMC in Louisville, KY was selected as the site for this multidisciplinary center. The center may collaborate with federal and state agencies that collect birth outcome data and that have experience with relevant chemical exposures. The center is not specific to reproductive issues related to Gulf War veterans, but has the broader mission of analyzing reproductive health research for all veterans.
Prioritization. In addition to developing the center-based approach, RWG also established priorities for federally funded research on Gulf War veterans' illnesses. Research priorities were published first in August 1995.294 These evolved over the next few months, and in response to questions from the Committee in May 1996, the RWG identified and ranked priority research areas.149 In order of priority, these were:
The Committee commends the effort to set priorities and notes these priorities were applied to the most recent round of the government's research awards. We have identified a more narrow range of priorities for research on Gulf War veterans' health concerns. Specifically, the Committee views the principal uncertainties about Gulf War veterans' illnesses as: the long-term health effects from low-level exposure to CW nerve agents, the long-term health effects from stress, the long-term health effects from exposure to known carcinogenic and mutagenic compounds (such as mustard agent), and the long-term health effects of interactions between PB and other agents. We note that RWG's new priorities, published in November 1996, emphasize clinical investigations of service members who may have been exposed to CW agents.295 The Committee agrees with the RWG that research on other (former) priority areas could be important for future conflicts.
External review. The departments have incorporated external scientific merit review into their research selection processes. Proposals for funding through DOD's fiscal year 1995 Broad Agency Announcement (BAA) were reviewed for scientific merit and relevancy by the American Institute of Biological Sciences.
To maximize the validity and interpretability of study findings, and as recommended in the Committee's Interim Report, external scientific review has been incorporated for most studies. External scientific review for smaller studies supported by indirect cost accounts is more variable.
Each agency of the RWG has its own standing advisory committees charged with overseeing research generally, including VA's Persian Gulf Expert Scientific Committee, the Armed Forces Epidemiology Board, the Defense Science Board (DSB), and study groups at the National Institutes of Health (NIH). None of these groups, however, has interagency appointments and/or responsibilities. Moreover, none is charged specifically with overseeing post-conflict health research.
Content of the Research Portfolio
The U.S. government funds a broad range of research in Gulf War veterans' illnesses. Figure 2-1 illustrates the distribution (by numbers of studies) of the federal research commitment specifically dedicated to Gulf War veterans' health. These studies are not equivalent in terms of cost, number of participants, or likely contribution to understanding Gulf War veterans' health. Appendix F categorizes the research portfolio by type of study and lists the health issue(s) under investigation, research institution, funding agency, anticipated completion date, and publications to date.295
Epidemiologic studies. As of Fall 1996, the federal government has funded 23 epidemiologic studies (22 percent of the total number of studies). These projects are intended to evaluate the occurrence of disease in Gulf War veterans and the factors that influence their occurrence, severity, and outcome. Individual studies examine different groups of veterans and different diseases and health outcomes. For example, subgroups include women veterans, servicemen and women from countries other than the United States, veterans who have enrolled in the VA Registry, veterans who now live in specific states, veterans who have been hospitalized, and specific veteran groups such as the Seabees. Health outcomes under investigation include cancer rates; rates of infertility, birth defects, and miscarriages; causes of death since return from the Gulf War; general well-being; current health status; and operational case definitions that have been empirically developed for specific subgroups of veterans.
Most of the major, federally funded epidemiologic studies were reviewed in the Committee's Interim Report. Upon completion, this epidemiologic research aims to answer some fundamental questions about the health of Gulf War veterans: Are Gulf War veterans as a population exhibiting specific symptoms, diseases, and death at a greater rate than seen in veterans who did not serve in the Gulf War? If so, what are the specific diseases or causes of death that are increased? Results from this epidemiologic research will be crucial for identifying future research needs, as well as which risk factors should receive additional research attention.
Gulf War risk factors and health outcomes. Health outcomes for Gulf War veterans under investigation in Fall 1996 included reproductive health; diarrhea and gastrointestinal disorders; irritable bowel-like disorders; immunological function; respiratory function; fibromyalgia; musculoskeletal symptoms; sensitivity to chemicals; fatigue, stress, mental health, and neurophysiologic and neuropsychologic status (including PTSD and Chronic Fatigue Syndrome (CFS)). Many of the projects on specific health outcomes also are based on epidemiologic approaches.
Currently, stress is the risk factor funded for the greatest fraction of total studies-32 studies (30 percent). Other federally funded research investigating possible health effects of specific Gulf War risk factors-often involving animal models-include projects assessing mustard agent; organophosphorus (OP) nerve agents; DU; infectious disease, especially leishmaniasis; oil-well fire smoke; leaded fuels; and PB in combination with insecticides and other agents (figure 2-1).
As summarized in figure 2-1 and appendix F, the government's research portfolio on possible health consequences related to Gulf War service has directed significant effort toward addressing uncertainties specific to Gulf War veterans. Other portions of the research portfolio, however, can only be justified as anticipating health issues in future conflicts-i.e., the general health consequences of military service.
Low-level effects of chemical warfare agent exposure. Newly released information has affected the relative importance of certain risk factors. Prior to June 1996, DOD ignored calls from its own DSB279 and others for research on the possible long-term health consequences of low-level exposure to CW agents. DOD's intransigence in refusing to fund such research until Summer 1996 has done veterans and the public a disservice.
The recent revelations about possible exposure of some U.S. service personnel to low levels of CW agents during the destruction of Iraqi chemical munitions at Khamisiyah have elevated this research issue, however, and altered DOD's posture toward funding such projects. As of November 1996, the RWG was developing the government's approach to fund research in this area. The RWG will need to consult with experts in and out of government to ensure that difficulties (e.g., institutional barriers, inadequate access to expertise, and lack of a clear management strategy) do not impede progress in this important research area.
DOD has committed $5 million from fiscal year 1996 funds for collaborative DOD/VA research-as identified by the RWG-on possible low-level effects from CW agents. Projects initially slated to receive funds ($2.5 million) include three previously unfunded proposals based on animal model experiments. Current plans are to identify and fund additional clinical and epidemiologic studies on this topic with the remaining $2.5 million. DOD's recently announced plans to increase funding for all research on Gulf War veterans' illnesses could result in additional funds for study of low-level exposures to CW agents. In early December 1996, DOD issued a solicitation for proposals for such research.
Findings Regarding Research
Based on the government's response to the recommendations in the Committee's Interim Report, a review of the federally funded research portfolio for Gulf War veterans' health, and a parallel, but independent, review of potential health risk factors that could be associated with service in the Gulf War (see chapter 4), we make the following findings:
The Committee's recommendations for governmental actions based on these findings appear on page 53 of the printed version of the Final Report.
CHEMICAL AND BIOLOGICAL WEAPONS
At the time the Committee issued its Interim Report, we were still in the initial stages of reviewing information gathered by the United Nations Special Commission on Iraq (UNSCOM) since the end of the Gulf War about Iraq's advanced CBW capabilities. UNSCOM's work, which continues today, has played a critical role in discovering the extent of possible exposures of U.S. troops to CBW agents during the Gulf War.262`
In our Interim Report, we found the decisions of DOD and the Central Intelligence Agency (CIA) to reopen their investigations of chemical and biological weapons in the Gulf War to be constructive steps and urged DOD and CIA to draw fully on their resources to answer some of the
war's most controversial questions. We stated our intention to monitor their progress carefully. Additionally, we found that improved technology to detect the presence of CBW agents would improve the health surveillance of troops involved in future conflicts. The Committee made the following recommendations related to chemical and biological weapons in the Interim Report:
This section of the Final Report includes the Committee's assessment of the government's response to our Interim Report recommendations and includes additional findings and recommendations on issues related to chemical and biological weapons.
DOD AND CIA RESPONSES
As described more fully later in this chapter, CIA has systematically reviewed classified and open source information related to CBW agent exposures during the Gulf War. In contrast, DOD has failed to take advantage of its unique access to both classified and routine military operations and intelligence records. DOD has not accepted or implemented the Committee's recommendation to develop and implement low-level CW agent monitoring. DOD has not made substantial progress in fielding a real-time biological agent detector.331
The Committee notes that in a series of studies since the end of the Gulf War in 1991, the U.S. General Accounting Office (GAO) has identified several inadequacies in the U.S. military's preparedness for chemical or biological attacks, and GAO has briefed the Committee on these matters.66,307,308 While DOD has agreed with virtually all of GAO's findings and recommendations, the Committee is concerned that the equipment, training, and medical shortcomings still persist and could result in needless casualties and a degradation of U.S. war fighting capability.
Issues New to This Report
To complete its evaluation of information related to reports of possible detections of CW or BW agents during the Gulf War, the Committee focused on two questions:
The Committee purposely separated these issues from its assessment of the possible health effects of CBW agents, which is discussed in chapter 4.
Evidence of Exposure
Drawing from a number of sources, including interviews with veterans, operational and intelligence logs, UNSCOM reports, and testimony, briefings, and reports from CIA and DOD, the Committee reviewed evidence of exposure to CBW agents. Ultimately, we identified three possible exposure scenarios for analysis: intentional use of CBW agents by the Iraqis; theater-wide contamination from air war bombings in Iraq; and site-specific exposures related to bombings or demolition activities.279,313 The Committee has drawn its conclusions with full knowledge that ongoing investigations could disclose additional evidence and does not intend for our work to foreclose full consideration of new information.
Exposure to biological warfare agents. The Committee's review of U.S. Army hospital admissions records identified only one admission for anthrax (a disease indigenous to the Gulf region) and none for botulinum poisoning. Stateside laboratory analyses also have not indicated BW agents were present in the KTO. Reports of dead animals that could have succumbed to biological warfare agents have been investigated by DOD, and the evidence does not implicate biological warfare. Finally, Iraqi officials have denied any use of biological weapons during Operations Desert Shield/Desert Storm. Thus, the best evidence available to the Committee indicates U.S. personnel were not exposed to biological warfare agents during the Gulf War.35,51,52,119,148,274
This conclusion is based on imperfect information. For instance, UNSCOM cannot verify the quantities and weaponization status ofIraqi BW agents because Iraq claims it unilaterally destroyed all of its biological weapons.51,162 Additionally, the United States did not deploy a real-time BW agent detection system to the Gulf.
Intentional Iraqi use of chemical warfare agents. Iraq successfully used chemical weapons in its war with Iran, with massive casualties not seen in the Gulf War. A DOD review of U.S. Army hospital admissions records identified no admissions for CW agent exposures. The U.S. Army officer responsible for CBW agent medical surveillance during the war has testified to the Committee that only one, accidental casualty was treated (discussed below). Additionally, UNSCOM reported to us that Iraqi officials have denied to them any use of chemical weapons during the war. Lastly, veterans groups testifying before this Committee concede there were no widespread chemical attacks. Based on information compiled to date, there is no persuasive evidence of intentional Iraqi use of CW agents during the war.35,51,52,119,148,249,261,274
Again, the best available information is less than ideal. Iraqi representations cannot always be taken at face value. And, some veterans have not received satisfactory explanations for wartime incidents they believe involved chemical weapons.74,144,249,323
Theaterwide chemical warfare agent contamination from air war bombings of Iraq. During the Gulf War, Coalition forces conducted air attacks on suspected Iraqi CW agent manufacturing and storage facilities. Some veterans and independent researchers have suggested that fallout from Coalition bombing of these sites led to large-scale nerve agent contamination in the KTO.261,313 The Committee looked at evidence of the effects of Coalition airstrikes on Iraqi chemical munitions storage sites to examine this hypothesis.
In late January and February 1991, Coalition forces conducted aerial bombings that damaged chemical munitions stored at two sites in central Iraq: Muhammadiyat and Al Muthanna. Subsequent UNSCOM investigations indicate these are the only sites (among 11 known storage sites) where Coalition airstrikes actually damaged or destroyed chemical agents. At Muhammadiyat, munitions containing 2.9 metric tons of sarin/cyclosarin and 15.2 metric tons of mustard were damaged during the air war. At Al Muthanna, munitions containing 16.8 metric tons of sarin/cyclosarin were damaged during the air war.35,51,148,274
To assess possible hazards to U.S. forces from CW agent releases at Muhammidiyat and Al Muthanna, atmospheric modeling was conducted for the CIA for all possible bombing dates at each site. This modeling indicates that on the bombing date when southerly winds were most pronounced, Muhammidiyat releases, at worst, would have resulted in downwind contamination for up to 300 kilometers (km) at general population exposure levels established by DOD. This modeling also indicates that on the bombing date when southerly winds were most pronounced, Al Muthanna releases, at worst, would have resulted in downwind contamination for up to 160 km at general population exposure limits. (The general population exposure is a threshold at which one would not expect to see characteristic signs and symptoms of CW agent exposure.) During the air war, the nearest U.S. personnel were in Rafha, Saudi Arabia-more than 400 km from Muhammadiyat and Al Muthanna. Figure 2-2 depicts the locations of the damaged munitions and the closest U.S. forces during the Gulf War.35,51,148,158,162,274
The Committee frequently heard the suggestion that air strikes on An Nasiriyah caused CW agent contamination as far away as King Khalid Military City, Saudi Arabia.261,313 Onsite inspections by UNSCOM, however, found no evidence that chemical munitions were damaged at An Nasiriyah. Iraqi officials also have stated to UNSCOM that chemical munitions stored there were moved to Khamisiyah when An Nasiriyah was first subjected to airstrikes, although the Iraqis have not cooperated fully with the UNSCOM investigations.51 The best evidence available, indicates theaterwide contamination with CW agent fallout from the air war is highly unlikely.35,158,274,281,330
Site-specific chemical agent exposures. During the period U.S. forces were deployed in the KTO, incidents occurred at specific sites that resulted in confirmed exposure, detection, or release of CW agents. In testimony and submissions to this Committee, DOD has taken the position that chemical agent exposures can be confirmed only through physical symptoms.119,148 The Committee believes this approach is analytically flawed and that medical symptoms should not drive a determination of presumed exposure/nonexposure.
Confirmed mustard agent exposure. On March 1, 1991, a soldier exploring a captured bunker in southern Iraq suffered a burn that DOD now confirms was caused by mustard agent. Two mass spectrometer tests by Fox vehicles detected mustard agent on the flak jacket worn by U.S. Army Sergeant Fisher, who was diagnosed as suffering from a chemical agent burn. DOD does not view negative results from subsequent laboratory tests on the jacket and urinalysis as inconsistent with the signs of low-level exposure exhibited by the soldier. DOD now acknowledges the site-specific exposure of mustard agent of this individual.13,52,148,279,323
Confirmed nerve and mustard agent detections. On January 19, 1991, shortly after the beginning of the air war, Czech units reported detecting nerve agent at two locations northeast of Hafir al Batin, Saudi Arabia. On January 24, 1991, Czech units also reported detecting mustard agent at a site 10 km north of King Khalid Military City, Saudi Arabia. DOD has verified the reliability of the Czech equipment and regards these detections as valid, but cannot identify a source of the CW agents for either detection.13,148,281,330 The Czech detections represent unrebutted evidence of the presence of CW agents at these sites, and low-level exposure-at the detection sites-must be presumed.
As noted earlier in this section, worst-case modeling of known CW agent releases at Muhammadiyat and Al Muthanna indicates potential contamination would not have reached the Czech forces. Although there is no evidence of CW agent release from bombing of An Nasiriyah, worst-case modeling conducted for CIA also eliminates this hypothetical release as the source of the Czech detections-i.e., evidence indicates An Nasiriyah, Muhammadiyat, and Al Muthanna were not the CW agent sources for the positive Czech findings. This inability to identify a source for the Czech-detected CW agents precludes modeling the range of exposures around the detection sites. CW agents also were not detected by U.S. troops sent to confirm the Czech findings. Currently, it is not possible to identify low-level exposure of any U.S. troops associated with these two Czech detections.13,35,51,148,158,274,281,330
Confirmed nerve agent releases at Khamisiyah. In the ceasefire period after the ground war concluded, U.S. personnel used explosives to destroy captured munitions and other materiel throughout occupied areas of southern Iraq so that enemy forces could not use them to rearm. One such site was a major storage depot at Khamisiyah, where more than 100 large bunkers containing artillery rounds, rockets, and other munitions were destroyed in March 1991.119,147,148
DOD has testified to the Committee that on March 4, 1991, U.S. personnel destroyed munitions containing 8.5 metric tons of sarin/cyclosarin housed in Bunker 73 at Khamisiyah. On March 10, 1991, U.S. personnel destroyed an as yet unknown number of sarin/cyclosarin rockets at a pit area at Khamisiyah.119,148
Atmospheric modeling conducted for CIA indicates CW agent release from Bunker 73 would result in downwind contamination for up to 25 km at general population exposure limits35,158 (figure 2-3). U.S. personnel with the 37th Engineering Battalion, 307th Engineering Battalion, 60th Explosive Ordnance Detachment, 146th Explosive Ordnance Detachment, 450th Civil Affairs Battalion, and other components of the 82nd Airborne Division were within 25 km of Khamisiyah.58,119,147,148 The footprint of the March 10, 1991, release and other possible releases at the Khamisiyah pit area are still under investigation.230,331
The evidence of CW agent release at Khamisiyah is overwhelming. The Committee concludes exposure should be presumed for nearby troops, although the exact levels are unknown. The presumption of exposure does not include a presumption of long-term health effects (see chapter 4). As of this writing, DOD has initiated an effort to notify all troops within a 50 km radius around Khamisiyah between March 4 to March 13, 1991, that they could have been exposed to low levels of CW agents.331 These actions appear prudent in light of what is known about the destruction of Bunker 73, but additional steps could be necessary once the full extent of Khamisiyah demolition activities is known.
Search for Evidence
The U.S. government has relied on CIA and DOD internal investigations to report evidence of exposure of U.S. troops to CBW agents. CIA was assigned two responsibilities: reviewing intelligence information relevant to possible CBW agent exposures and performing downwind hazard modeling for possible CW agent releases.35 DOD's investigatory efforts have been led by PGIT, which reports to the Assistant Secretary of Defense (Health Affairs). PGIT's scope spans the broad range of issues related to Gulf War veterans' illnesses. Additionally, a DOD Senior Level Oversight Panel for Gulf War veterans' illnesses coordinates the declassification and release of documents related to CBW agents and other potential risk factors.104,119,325
CIA's investigation. In March 1995, CIA began a de novo review of intelligence related to CBW agents and the Gulf War; its work in atmospheric modeling began in early 1996. To date, CIA has aggressively pursued information related to possible CBW agent exposures from classified and open sources. With respect to downwind hazard modeling, CIA has been responsive to the Committee's concerns about potential low-level contamination and has modified modeling assumptions and parameters to reflect these concerns. In August 1996, CIA reported on the bulk of its analysis but the agency has yet to complete atmospheric modeling for the March 10, 1991, destruction at the Khamisiyah pit area.35,158,230,274
DOD's investigations. Since 1991, DOD's public position has been there was no use or presence of chemical weapons in the KTO, and no U.S. troops were exposed to CBW agents during the Gulf War. DOD maintained this position throughout a series of congressional investigations in late 1993 and early 1994. In June 1994, a DSB Task Force concluded there was "no evidence that either chemical or biological warfare was deployed at any level against us, or that there were any exposures of U.S. service members to chemical or biological warfare agents in Kuwait or Saudi Arabia." The DSB Task Force was silent on the issue of exposures to service members in Iraq, but its conclusion was interpreted by DOD as inclusive.119,279,313
Persian Gulf Veterans' Illnesses Investigation Team. PGIT's 12-member staff includes intelligence officers, members of the Chemical Corps, pilots, chemists, physicians, and one trained investigator. Reflecting its staffing, PGIT has devoted substantial resources to literature reviews and scientific studies, rather than collecting first-hand evidence of possible CBW agent exposure incidents from eye witnesses, battlefield intelligence, unit logs, diaries, and other original documents. By doing so, PGIT has failed to take advantage of its unique access to classified and routine military records to fully investigate and help answer the public's questions about possible CBW agent exposures.119,148,163,169 PGIT's investigation of the Khamisiyah incidents represents the sole exception to this situation.
Khamisiyah first appeared on PGIT's list of incidents under investigation in October 1995 material supplied to the Committee. Yet, PGIT conducted no interviews with possible eyewitnesses until June 1996. PGIT had knowledge of documents, including UNSCOM reports and declassified intelligence reports posted to GulfLINK, that suggested a sufficient basis to initiate investigatory interviews long before UNSCOM confirmed in May 1996 its initial reports about the presence of CW agents. PGIT's recent eyewitness interviews and its efforts to ascertain troop locations have been valuable, however, in trying to find answers about the Khamisiyah incidents.119,325
More importantly, other possible CW agent incidents also merit a thorough review and full investigation. Chief among these are positive readings recorded by two types of detectors fielded to verify chemical agent alarms: Fox reconnaissance vehicles equipped with mobile mass spectrometers and M256 kits, which employ enzymatic tests for nerve agents and chemical tests for blister agents. Fox reconnaissance vehicles detected blister and nerve agents at various sites in Kuwait and Saudi Arabia, and M256 kits also detected the presence of CW agents during the ground war.74,144,249,323 Rather than thoroughly investigate these site-specific incidents, PGIT plans to include them in a theater-wide time/distance analysis.119,148
In response to our questions in May 1996 about potential low-level CW agent exposures, PGIT first reported it had no formal, objective standard(s) for assessing whether CBW agent detections should be confirmed or not confirmed. Two months later in July 1996, PGIT reported to the Committee that it had adopted military CBW agent detection standards to confirm the occurrence of an exposure. This standard requires both agent detections and physical symptoms of poisoning.119,148
The Committee faults PGIT on two counts in this regard: first, for its delay in adopting standards until, as PGIT admitted, it was pressed by the Committee more than a year after it began its work; and second, for confusing the matter of potential CW agent exposure with the separate issue of possible health effects of CW exposure. Adherence to this standard-even when assessing possible low-level exposures that do not cause immediate physical symptoms-has severely undermined public confidence in DOD's work on CBW agent issues. PGIT's analyses related to CBW incidents have lacked vigor, fallen short on investigative grounds, and stretched credibility.
In November 1996, DOD introduced some organizational changes related to its work on Gulf War veterans' illnesses. As part of this reorganization, DOD announced plans to revamp its investigatory and research programs related to low-level CW agent exposure.331 These efforts, combined with publicly visible, independent, high-quality oversight, could begin to restore public confidence in the government's investigations of possible incidents of CW agent exposure.
Enhancing public access to information. DOD's slow and erratic efforts to release information to the public have further served to erode the public's trust. As of December 1996, 5 of 54 PGIT investigations have generated reports posted on DOD's GulfLINK Internet site. DOD typically has posted testimony before this Committee on GulfLINK, but the department has not posted status reports on its investigations that it prepared for the Committee in August 1996.119,325 Public access to more information could only enhance DOD's reputation among parties interested in these issues.
DOD's pledge to post copies of relevant declassified documents to GulfLINK also has proved problematic. In November 1995, DOD officials instructed that before declassifiers posted sensitive documents, they should forward the material to PGIT "to allow the investigation Team time to begin preparation of responses on particular 'bombshell' reports".324 Separately in February 1996, nearly 400 declassified documents were removed from GulfLINK due to security concerns of CIA.230 DOD reported to the Committee that the documents were not reclassified, but the documents were not restored to GulfLINK until November 1996.331 These actions clearly have created the impression that the government, particularly DOD, has failed to live up to repeated assertions and commitments to openness in its work related to CBW agent investigations and the Gulf War.119,144,163,249,325 Nationwide, there has been an increasingly strongly held view that DOD is still withholding relevant information from concerned veterans and the public.
Findings Regarding Chemical and Biological Weapons
Based on interviews with veterans, review of operational and intelligence logs, UNSCOM reports, testimony, briefings, and reports from CIA and DOD, the Committee makes the following findings:
The Committee's recommendations for governmental actions based on these findingsappear on page 54 of the printed version of the Final Report.
The President established the Coordinating Board on January 21, 1994, to provide direction and coordination on health issues related to the Gulf War within the executive branch of the federal government. Earlier in this chapter, we reviewed the role of the Coordinating Board's RWG in managing the Gulf War veterans' health research of DOD, VA, and DHHS. Here we analyze the RWG's other tasks and also evaluate the Coordinating Board's two other working groups: the Clinical Working Group (CWG) and the Disabilities and Benefits Working Group (DBWG). Finally, we have assessed the government's ability to respond to the broad range of issues-from the need for medical care and outreach services, to the need for research on general and specific health concerns-likely to arise after future conflicts.
Coordinating Efforts Specific to Gulf War Health Issues
The Secretaries of DOD, DHHS, and VA head the Coordinating Board. The Coordinating Board's three primary missions are:
The Coordinating Board established a working group to oversee each primary mission. As a preliminary matter, the Committee found the assistance of the Coordinating Board and participants in the working groups invaluable. In addition, we recognize the difficulty of integrating the activities of large departments with disparate missions to achieve a whole greater than the sum of its parts. The Committee commends the dedication of the staff involved in these efforts.
Clinical Working Group. The CWG oversees delivery of care to Gulf War veterans. The Committee found that, overall, high-quality health care is provided. We recommend, however, some improvements in CME and a regular review of staffing requirements to ensure adequate access to follow-up care.
VA introduced its clinical Registry program in 1992 and refined the physical examination and associated questionnaires over the next two years; DOD and civilian medical professionals were consulted as the program matured. DOD adopted VA's standardized evaluation protocol for its CCEP in 1994, and both departments continue to use the same protocol. This Committee and others have judged the protocol to be an excellent tool for diagnosing illness.
The CWG serves as a useful counterpart to the RWG by ensuring coordination of the research plan with interesting hypotheses that might emerge from the clinical programs. The CWG also has an important role to play in disseminating information about the clinical programs and in communicating the results of the research program to health professionals in DOD and VA medical facilities.
Research Working Group. In its Interim Report, the Committee identified the need for a more aggressive stance by the RWG in emphasizing the importance of utilizing peer review committees when planning and conducting research and in coordinating the design of epidemiologic surveys. Overall, the RWG has been responsive to our recommendations. A peer review process was used to identify scientifically meritorious proposals that were funded in 1996 (in response to DOD's BAA issued in 1995). Ongoing government-sponsored epidemiologic surveys of Gulf War populations include a core set of similar questions regarding symptoms and exposures that should enable appropriate comparisons among study groups. Future investigators will be encouraged to incorporate the RWG-developed set of core questions in their work.
The RWG has set priorities for new research on Gulf War veterans' illnesses. And the group has overseen the publication of research compendiums and efforts to cooperate with U.S. allies in the Gulf War in future health research.
Disabilities and Benefits Working Group. The DBWG initially addressed itself to a broad range of issues, including case definitions for disabilities with vague symptoms, care for family members of Gulf War veterans, and DOD's outreach program on Gulf War veterans' health issues. Late in 1994, this working group took as its primary responsibility coordination of the executive branch response to Public Law 103-446, which authorized compensation to Gulf War veterans for disabilities resulting from undiagnosed illnesses. VA issued an implementing regulation (38 CFR 3.317) in February 1995. The DBWG continued to meet through June 1995 to discuss the impact of the new legislation and regulation. The only meeting in 1996 to date occurred for the purpose of briefing this Committee's staff on pay and benefits for individuals separated from service; DOD's disabilities evaluation process; military retirement and separation for disability; comparison of the departments' use of VA's schedule for rating disabilities; and VA's compensation and evaluation procedures.
VA currently is reviewing how effectively it has managed its program of compensation for undiagnosed illnesses. A randomized case review by VA's Compensation and Pension Service (prompted, in part, by a GAO report310) disclosed frequent instances of miscategorization in the tracking system and failures to develop evidence-particularly lay observations-that might affect the outcome of a claim. As a result of this review, VA reported to the Committee that as of July 1996, it had undertaken a complete second review of all 11,000 cases in the tracking system to ensure full evidentiary development, correct adjudication, and accurate coding in the tracking system. VA also issued more detailed instructions emphasizing these points. VA expected the review of 11,000 cases to take six months and reported its intent to work closely with DOD.
Anticipating Post-conflict Health Concerns
Several concerns identified during the Committee's examination of Gulf War veterans' illnesses-issues related to research, outreach, and clinical programs-have surfaced after previous conflicts (e.g., effective epidemiology in the absence of baseline exposure and health information; risk communication with veterans concerned about environmental hazards; and uncertainties about the health consequences of environmental exposures). Responsibility for resolving concerns that invariably arise in the aftermath of military conflicts lies within the domain of several departments, yet appears to be a principal focus of no agency. Following a military operation, effort is exerted in a reactive, rather than proactive, manner.
The departments principally involved in Gulf War veterans' illnesses-DOD, VA, and DHHS-have had historical responsibilities for other, similar post-conflict issues, but a number of other agencies also have important expertise and interest. These entities include EPA, CIA, the Department of Energy, the National Science Foundation, the Department of Commerce, and the Department of State. Along with DOD, VA, and DHHS, all are members of the National Science and Technology Council (NSTC), an interagency coordinating body established to ensure cross-agency attention to matters of critical national importance.
The lessons learned from the Committee's analyses of Gulf War veterans' health concerns point toward post-conflict health needs of veterans as precisely such a matter. A Presidential Review Directive to the NSTC could be used to ensure the government formulates a comprehensive strategy to deal with key concerns that arise following significant military operations, including:
Any plan developed by NSTC should be reviewed by appropriate nongovernmental experts to ensure that these recurring concerns receive attention at the highest national levels.
Finding Regarding Coordination
Based on its analysis of the government's efforts to coordinate the response to Gulf War veterans' illnesses, the Committee makes the following finding:
The Committee's recommendation for governmental action based on this finding appears on page 55 of the printed version of the Final Report.
The President asked that we review the full range of government activities relating to Gulf War veterans' illnesses. In the Interim Report, we organized our analyses of the government's efforts into four broad areas: outreach, medical and clinical issues, research, and chemical and biological weapons. In this document, we make additional findings and recommendations to complete our initial assessments in these areas; we also address coordination for the first time.
With the exception of DOD's investigations in matters related to incidents involving chemical weapons and possible exposure to U.S. troops, we believe the government has acted in good faith and drawn on a somewhat checkered experience with Agent Orange to significantly improve how it has addressed Gulf War veterans' health issues. Hence, we note that although our recommendations are many, they are offered to improve the government's generally commendable response. Their number and scope should not be viewed as a wholesale condemnation or cause for a complete overhaul of the government's approach to addressing the health concerns of Gulf War veterans.
The Committee's evaluation of the government's response to concerns about Gulf War veterans' illnesses led us to findings in outreach, medical and clinical issues, research, chemical and biological weapons, and coordination. Based on our analyses and these findings, the Committee makes the following recommendations:
Medical and Clinical Issues
Chemical and Biological Weapons
*These services were designed to manage post-traumatic stress disorder, which was the primary readjustment concern.
**Initially, treating post-traumatic stress disorder was the PGFSP's primary focus of clinical services.
***At DOD's request, the Institute of Medicine (IOM) evaluated the CCEP, and IOM judged the clinical protocol (also used by VA) excellent for the diagnosis of illnesses. 95