In our December 1996 Final Report, the Presidential Advisory Committee on Gulf War Veterans' Illnesses reported the government largely had acted in good faith in handling Gulf War veterans' health concerns in comparison to the post-Vietnam War era. We took strong exception, however, to the Department of Defense's inquiries related to chemical and biological warfare agent investigations. We found DOD's actions had produced an atmosphere of mistrust surrounding every aspect of Gulf War veterans' illnesses.
President Clinton extended the Committee's tenure in January 1997, with a new charge to review the government's implementation of our previous recommendations and to continue our assessment of the government's investigations into possible chemical and biological warfare agent exposures. This Special Report assesses these issues. Based on our oversight activities, it also reports our analysis of the broader issue of the public's perception of the government's commitment to address Gulf War veterans' health concerns.
Ten months after the Committee concluded the government had a significant amount of ground to recover with the American public, we note the government's credibility on Gulf War veterans' illnesses continues to be challenged. The government's efforts have yielded and will continue to yield improved services and new knowledge. For example, we hope recently funded research on health effects of subclinical exposures to nerve agents and of interactions of multiple risk factors can address uncertainties surrounding Gulf War veterans' illnesses. Progress, however, is gradual. Regrettably, it now appears incremental advances will not address the pervasive perception of government neglect in handling Gulf War veterans' illnesses.
To address this perception, the Committee recommends that the Executive Branch work with Congress to establish a permanent program for Gulf War veterans' illnesses. We envision legislation that directs the Department of Veterans Affairs to contract with an appropriate organization for a periodic review-for benefits and future research purposes-of the available scientific evidence regarding associations between illnesses and service in the Gulf War. The Committee hopes a partnership among all concerned parties can establish this program. The legacy of the Gulf War should be a recognition by all Americans that the government acknowledges and honors its obligation to care for Gulf War veterans, not the perception the government cannot be trusted to candidly address their health concerns.
On May 26, 1995, President Clinton established the Presidential Advisory Committee on Gulf War Veterans' Illnesses to conduct an independent, open, and comprehensive analysis of health concerns related to Gulf War service ( appendix A). As mandated, we delivered our Interim Report on February 15, 1996, 22 and the Final Report on December 31, 1996. 23 Appendix B contains the Committee's findings and recommendations from both reports.
On January 7, 1997, President Clinton released the Final Report and extended the Committee's tenure. The President's new charge directed us to i) evaluate the government's implementation of our previous recommendations, and ii) oversee the government's ongoing investigations into possible chemical or biological warfare agent exposures during the Gulf War ( appendix C). In February 1997, the President also asked the Committee to evaluate the adequacy of the government's response to his concerns about the implications of then recently declassified documents associated with chemical munitions at Khamisiyah ( appendix D). We provided a status report of our efforts and addressed the President's additional task in a supplemental letter report, 24 delivered on April 30, 1997 ( appendix E).
This Special Report responds to the President's request that we assess by October 31, 1997, the government's progress in implementing our earlier recommendations on outreach, medical and clinical issues, research, and coordination. The document also reports our assessment of the government's efforts to investigate possible chemical and biological warfare (CBW) agent exposures. Finally, based on our oversight activities during the past 10 months, the Committee puts forth our recommendation to address the persistent perception that the government lacks the commitment to resolve issues surrounding the health consequences of service in the Gulf War.
Upon receipt of the Committee's Final Report, the President requested a response from the Department of Defense (DOD), Department of Health and Human Services (DHHS), and Department of Veterans Affairs (VA) within 60 days. On March 7, 1997, the departments forwarded their implementation plan. 21 This plan has served as the basis for the Committee's evaluation of the government's implementation of our previous recommendations ( appendix B), which encompassed five broad areas: outreach, medical and clinical issues, research, CBW agent investigations, and coordination. In this section, we provide our assessment of the current progress of the departments' implementation of the Committee's recommendations related to outreach, medical and clinical issues, research, and coordination. The Committee assesses the government's efforts concerning chemical warfare (CW) agent incidents later in this report.
The implementation plan described DOD's, VA's, and DHHS's individual, joint, ongoing, or proposed initiatives to address the Committee's recommendations. In that document, the agencies concurred with all recommendations except two, about which they concurred in part. One partial concurrence involved our recommendation for VA's examination program for spouses and children of Gulf War veterans: 21 "VA should formulate what it intends to do with the results and consider mechanisms to reimburse travel and other costs." VA's partial concurrence related to its specific, limited authority under Section 107 of Public Law 103-446; Congress did not provide VA the authority to reimburse travel and other costs. The second partial concurrence involved a recommendation pertaining to chemical weapons, which we discuss later in this report.
Since the Committee issued the Final Report, DOD and VA have expanded and refined their outreach initiatives. In particular, DOD's communication efforts have improved considerably. DOD's Special Assistant for Gulf War Illnesses conducted, and continues to conduct, roundtables with representatives from veterans service organizations (VSOs). He also held a series of open meetings with concerned veterans in 11 cities, and recently announced a new series would be convened. VSOs now are routinely briefed in advance of major announcements. DOD's toll-free incident reporting line was significantly expanded, improved, and standardized, with debriefings by trained interviewers.
Former Secretary of Veterans Affairs Jesse Brown personally stepped up VA's outreach to Gulf War veterans. He conducted public forums in six cities to highlight Gulf War veterans' initiatives and to receive input on VA's undiagnosed illnesses compensation program for Gulf War veterans. VA also continued publishing its Gulf War Review, public service announcements, and community-based outreach.
Additionally, although the Committee's recommendations on outreach did not specifically encompass the Central Intelligence Agency (CIA), the agency recently has been a prominent participant in DOD's and VA's outreach to Gulf War veterans. Over the past 10 months, CIA also has issued its own reports to veterans and the public. The Committee commends CIA's unprecedented efforts in this regard.
The March 1997 implementation plan directed the Persian Gulf Veterans Coordinating Board's (Coordinating Board) Clinical Working Group to develop a comprehensive risk communication plan. Both government and nongovernment risk communication experts were engaged to assist in the development and implementation of this effort; the targeted completion was May 1, 1997. In April 1997, the Clinical Working Group convened a 1-day workshop of risk communication experts from the private and governmental sectors. Participants included recognized experts from the U.S. Public Health Service who have dealt with similar risk communication situations surrounding toxic waste sites or occupational exposures, and these experts continue to consult with and provide training via the Coordinating Board.A follow-up meeting on risk communication planning and training also was held for DOD and VA staff directly involved in matters related to Gulf War veterans' illnesses. To ensure consistency of information provided to Gulf War veterans on the government's World Wide Web sites, the Clinical Working Group also is coordinating the development of plain language fact sheets on: depleted uranium, illnesses of Gulf War veterans, the Coordinating Board, medical care programs, case series registries, research, and pyridostigmine bromide. Fact sheets on 10 additional topics are planned. 19
Finally, the deployment of U.S. forces to Bosnia has offered an opportunity to test new approaches to predeployment and in-theater risk communication. Deployed troops have received individual briefings and have been provided with specific pamphlets on the infectious and environmental health threats of the region, and on the appropriate medical countermeasures and how to access needed care. Environmental and occupational health experts have done extensive air, soil, and other monitoring, and have communicated results to troops. 3,19,25
While the effectiveness of the efforts in Bosnia to reduce adverse health effects in this population is yet to be fully evaluated, the services' improved efforts in outreach and risk communication are commendable. Similarly, the government's expanded sensitivity to outreach issues is noteworthy-especially the improvement by DOD and CIA. And, while the Coordinating Board's May 1997 target to implement its work was too ambitious and several milestones remain, the Committee finds the initiatives as currently described are responsive and appropriate. We recommend:
In the Final Report, the Committee noted with approval the government's plans for implementing the Interim Report's recommendations concerning provision of care, particularly follow-up care, for ill Gulf War veterans. DOD and VA continue to operate their clinical evaluation programs and access to these programs appears to be satisfactory. The Committee continued, however, to receive input from veterans and their families that indicates follow-up care in both programs, but particularly with VA, remains problematic. Lack of active coordination of Gulf War veterans' follow-up care by knowledgeable health care providers contributes to this situation. In their implementation plan, both DOD and VA indicated they were actively reviewing staffing to fully accommodate the needs of ill veterans.
Related to staffing and improving follow-up care, VA has testified to the Committee about its effort to implement a case management system at its medical facilities. Under the plan, VA would provide a holistic approach in caring for Gulf War veterans with complex medical problems. Each patient will be assigned a case manager, who will be a member of a primary care team and who will be responsible for coordinating the entire spectrum of each veteran's health care across home and family, community, ambulatory, and hospital settings. The Committee endorses this activity, which has great potential for addressing many of the current difficulties that some Gulf War veterans report they encounter when seeking follow-up care.
VA and DOD continue to recognize the critical need to keep their care providers apprised of the latest scientific developments related to Gulf War illnesses. In June 1997, VA sponsored a third continuing education conference-involving VA, DOD, and DHHS health care professionals-on the health consequences of Gulf War service.
Finally, while not directly related to our recommendations, the Committee is pleased to note VA extended the window that permits Gulf War veterans to receive VA disability compensation for undiagnosed illnesses. The timeframe of 2 years after the conflict has been modified to 10 years post-war-i.e., through the year 2001 (62 FR 23138)-and efforts are underway to review the records of veterans who previously had been denied compensation. This expansion complements VA's policy for providing medical care to Gulf War veterans, which is broader and remains in place.*
A complete evaluation of VA's and DOD's current medical programs awaits full achievement of the implementation plan. Efforts are ongoing, though many are understandably incomplete given the short time since the plan was adopted. Currently, the Committee believes the government has been appropriately responsive in addressing our recommendations. We elaborate in the next sections on two specific areas-DOD's medical surveillance and the use of investigational products during deployments. Overall, however, we recommend:
Medical surveillance. The Committee's earlier reports stressed the importance of improving the government's efforts to collect medical assessment data related to future troop deployments. Adequate pre- and post-deployment screening of individuals is critical to determine medical eligibility for deployment and to serve asbaseline information for monitoring health effects associated with a deployment. In August 1997, DOD published a directive on medical surveillance policy for deployments that specifies a uniform concept for health screening. Additionally, the directive specifies:
o Medical and personnel data systems will be designed and integrated in order to maintain, assess, and protect the physical and mental health of service members;
o The data systems shall be in effect throughout any period of military service, but specifically during deployments;
o Service members will be made aware of any significant health threats and corresponding preventive countermeasures (unit and individual), and commanders are to ensure medical support and training for countermeasures is provided;
o Medical surveillance pre-, during, and post-deployment will encompass: monitoring environmental, occupational, and epidemiologic threats and stressors; assessing disease and non-battle injuries, stress-induced casualties, and combat casualties, including those caused by chemical, biological, and nuclear weapons; assessing and reinforcing the use and effectiveness of command-directed and personal countermeasures; and the delivery of optimal medical care during, and after, deployment;
o Operational commanders will be kept informed before, during, and after deployment of the health of the force, health threats, stressors and risk, and available countermeasures;
o A serum repository will be maintained for clinical diagnosis and appropriate epidemiologic studies; and
o Joint technologies, practices, and procedures will be used to ensure consistency among the services. 9
In addition to involving uniformed service personnel, these surveillance activities will include DOD civilian and contract personnel when appropriate. 31 DOD and the military services have begun formal implementation of the policy requirements.
In testimony before this Committee, DOD reported improvements in medical surveillance since the Gulf War, but also acknowledged the pretest of these surveillance procedures in Operations Joint Endeavor/Joint Guard, the Bosnian peacekeeping mission, has been problematic. 31 In May 1997, the U.S. General Accounting Office also noted progress, while identifying problems with medical surveillance in Bosnia that DOD did not dispute. Special difficulties involved the newness of the policy and the failure to incorporate the elements of medical surveillance into operational doctrine, as well as deficiencies with respect to medical recordkeeping. 15
We approve of the basic thrust of the policy directive, but remain concerned about implementation. The Committee recognizes conflict is inherently chaotic and compromises must be made. We have acknowledged "the military's goal is to successfully carry out the mission of the war, not to collect research data." 22 But the deployments of U.S. forces since the Gulf War (Somalia, Haiti, Bosnia) have been more in the nature of police actions. It is in these relatively stable circumstances that DOD's proposed medical surveillance policies, procedures, and responses need to be sharpened and made automatic and instinctive among the military command and service members. Only by such indoctrination can policy transfer successfully into sound medical surveillance practice during combat situations. We recommend:
Use of investigational products. During combat or peacekeeping missions, U.S. troops need and deserve access to state-of-the art drugs and biologics designed to protect against disease or chemical or biological warfare agents; some of these products could have investigational status. In some cases a drug or biologic could be approved by the Food and Drug Administration (FDA) for one use, but not another. For example, FDA has approved the drug pyridostigmine bromide (PB) for use in treating myasthenia gravis. As such, PB is routinely administered in the United States at doses up to 17-fold greater than suggested for the short-term, pretreatment against CW agents-a use of PB that is not FDA-approved. Investigational products also can be approved by and used in other countries, but may not be routinely used on U.S. troops unless FDA-approved. The use of tick-borne encephalitis (TBE) vaccine in Bosnia is an example of this situation.
In the Gulf War, DOD used two investigational products as prophylactic measures against CBW agents: PB and botulinum toxoid (BT) vaccine. Although already used in the United States, these two products were investigational for the anticipated use in the Gulf War. Under normal circumstances, neither could have been administered without the informed consent of the individuals who received them. In December 1990, FDA issued (at DOD's request) an Interim Final Rule permitting DOD to use investigational products without informed consent during military exigencies; FDA granted waivers of informed consent for BT vaccine and PB shortly thereafter. Under the waiver, DOD stipulated it would adhere to specific FDA requirements as a matter of policy, as well as comply with other federal regulations that govern the use of investigational products, but that are not related to informed consent.
The Committee's concern the past 2 years has been two-fold: the protracted interim status of FDA's rule and DOD's medical recordkeeping in-theater, which we found needed wholesale improvement.
Status of the Interim Final Rule. The Committee's Interim Report and Final Report did not comment on the merits of FDA's regulation permitting a waiver of informed consent for investigational products used during specific military circumstances. Rather, we focused on those actions related to the Interim Final Rule that we believed FDA should address for the future. Specifically, the Committee recommended that FDA solicit timely public and expert comment on any rule that permits waiver of informed consent for use of investigational products in military exigencies. We called attention to five areas that FDA specifically should revisit: adequacy of disclosure to service personnel; adequacy of recordkeeping; long-term followup of individuals who receive investigational products; review by an institutional review board outside DOD; and additional procedures to enhance understanding, oversight, and accountability.
Over the past 18 months, FDA had professed on multiple occasions to the President and the Committee that it was moving forward to address the interim status of the policy governing waiver of informed consent for investigational products during military emergencies. The Committee has been frustrated by the inordinate amount of time that passed with no obvious progress by FDA toward finalizing or eliminating the Interim Final Rule.
In July 1997 testimony before this Committee, FDA identified, for the first time in 7 years, specific steps and an approximate timeframe to address this issue. In July 1997, FDA also published in the Federal Register "Accessibility to New Drugs for Use in Military and Civilian Exigencies When Traditional Human Efficacy Studies are Not Feasible; Determination Under the Interim Final Rule that Informed Consent is not Feasible for Military Exigencies; Request for Comments" (62 FR 40996). Further in July 1997, FDA sent DOD a letter of deficiency that details DOD's failure to carry out its legal and ethical obligations for the use of investigational products during the Gulf War. In addition to documenting deficiencies related to the use of BT vaccine and PB during the Gulf War, FDA also enumerated DOD's violations of federal regulations for its use in Bosnia of TBE vaccine. (We elaborate on this matter in the next section.)
Despite our dissatisfaction with the time it took FDA to make progress on this matter, the Committee assesses that FDA is now appropriately and adequately responding to our recommendations. At the time of FDA's testimony, however, some specifics on the timing of FDA's implementation remained uncertain. We recommend:
Medical recordkeeping and investigational products during deployments. FDA's regulatory requirements governing the use of a drug or biologic under an investigational new drug application (IND) in any circumstance extend well beyond informed consent considerations. In particular, recordkeeping requirements are pivotal to assessing whether the drug or biologic is safe and effective for the intended use.
With respect to the Gulf War, DOD has acknowledged that it did not comply with the letter or spirit of its agreement with FDA for use of BT vaccine or PB and that conducting an IND during a combat deployment might not be feasible. 18 DOD concurred with our recommendations to improve medical recordkeeping in-theater-generally, as well as specifically for investigational products. Moreover, the Committee noted the special importance of improvements in this area by finding "the issue of accurate medical and vaccination records is central to the concerns of many ill veterans, and the absence of records has been suggested by some as evidence that the government is engaging in a cover-up of its own predeployment practices." 22
DOD has stated to several parties on multiple occasions that it had learned from its experience in the Gulf War, had improved its medical recordkeeping and investigational product policies, and had implemented new procedures and safeguards for the Bosnian deployment. 3,17,25,31 In fact, DOD's performance in Bosnia with the investigational TBE vaccine has been an abysmal failure. DOD's failure, however, is unrelated to a waiver of informed consent, which DOD did not seek for TBE vaccine in Bosnia.
As determined by FDA, DOD's use of TBE vaccine during Operations Joint Endeavor/Joint Guard has violated federal regulations pertaining to investigational products on several accounts, including: recordkeeping failures; failure to monitor fully the study's progress; failure to ensure the protocol was followed so safety and efficacy can be assessed; promotion of safety and efficacy for the investigational product; and failure to obtain Institutional Review Board approval of informed consent documents. FDA also expressed uncertainty about whether there had been a violation of Army recordkeeping and documentation requirements, which mandate that service members' permanent records accurately reflect TBE immunizations. FDA concluded the deviations "do not give us confidence that DOD is at present capable of carrying out its obligations [under an investigational new drug (IND) application] for drugs and biologics that are intended to provide potential protection to deployed military personnel." 14
DOD and the Office of the Army Surgeon General, which is responsible for the TBE vaccine IND, fully acknowledge they underestimated the difficulties of complying with FDA regulations and experienced problems with legal and ethical execution of the IND during deployment. DOD intends to respond in detail to FDA's letter and also will submit formal comments stating that continuing the authority of the Interim Final Rule is important to ensure a range of options are available to policymakers. Additionally, DOD has entered into discussions with FDA and other agencies to assess the availability and use of investigational products that are of potential importance to military and domestic terrorist threats. In July 1997, DOD announced the formation of a committee, to be co-chaired by the Assistant Secretary of Defense (Health Affairs) and the Army Surgeon General, to address future work with investigational products. DOD stated its initiative will include other government agencies and civilian experts. 1,18,20
We are less sanguine than FDA about DOD's capabilities with respect to evaluating investigational products during deployments. The Committee concludes DOD currently is incapable in this area; it's actions with TBE vaccine leave no room for any other interpretation. The Committee recognizes deployments present unique barriers to evaluating investigational products, but these obstacles are not insurmountable. Moreover, Bosnia is a peacekeeping mission, not a war. As with medical surveillance, if lessons from the Gulf War could not be implemented in Bosnia, the Committee wonders about the possibility of success during future conflicts. Moreover, we are concerned about related issues raised by the evaluation of investigational products by the military in both deployment and non-deployment settings-such as the concept versus practice of obtaining informed consent from U.S. service members.
As we mentioned earlier, however, U.S. service personnel deserve to be offered the best possible medical prophylaxis and treatment opportunities. To deny such opportunities during deployments could be a threat to health and unethical on other grounds. The Committee believes the internally-directed effort DOD has proposed will not be perceived as credible in evaluating DOD's ability to conduct an IND during a deployment-regardless of the capabilities of the military and civilian experts involved in the proposed effort. We recommend:
In the Interim Report, the Committee found the major epidemiological studies undertaken by DOD, VA, and DHHS were well-designed and appropriate. We noted, however, there appeared to be an inadequate response to external peer review, less than adequate regard for the importance of allocating scarce research dollars to the best designed studies, and inattention to the need to communicate effectively with veteran participants. For the Final Report, we concluded the government had been largely responsive to our earlier recommendations, but problems still remained in two areas: the use of public advisory panels for epidemiologic studies and the utility of the Persian Gulf Registry of Unit Locations. The Committee offered new recommendations on these issues, but the primary focus of the Final Report's recommendations on research involved better management of the research portfolio.
Since January 1997, the government has made commendable progress in implementing the Committee's Interim Report and Final Report recommendations pertaining to research. We note the December 1996/January 1997 round of DOD/VA-funded competition targeted new research proposals in three specific groups: i) the feasibility of epidemiological studies involving human subjects, including those thought to be near Khamisiyah, Iraq, in early March 1991 and animal studies to assess possible long-term or delayed clinical effects of low-level or subclinical exposures to CW agents; ii) potential health consequences of exposure to multiple risk factors; and iii) studies of historical war syndromes and physiological manifestations of stress.
In October 1997, DOD announced that under the competition for this pool of research funds, approximately $2.8 million was awardedfor four projects on low-level health effects of CW agents and approximately $9.2 million for eight projects on multiple interactions of Gulf War risk factors. All awards were subjected to competition and peer review, then selected for funding based on scientific merit scores and relevancy. 13 An insufficient number of meritorious proposals addressed the solicitation (approximately $4.5 million available) for research on historical war syndromes and stress-related sequelae, and the Research Working Group currently is assessing how to handle this situation.
Additionally, the Centers for Disease Control and Prevention (CDC) issued a request for proposals in May 1997 to address two programmatic priorities: i) research that enhances the understanding of conditions and symptoms reported to be more prevalent among Gulf War veterans, and ii) research that adds to the scientific knowledge needed to further develop a case definition of illness among Gulf War veterans. CDC expects approximately $1.2 million annually (for up to 3 years) will fund no more than two cooperative agreements. Peer review for scientific merit and relevancy was conducted in August 1997, and CDC anticipates announcing the awards in late October 1997. 10
With respect to federally funded research on Gulf War veterans' illnesses, we conclude the government is adequately and appropriately responding to our recommendations. The Committee particularly commends the government for its new initiatives targeted on health effects of low-level exposure to CW agents. As noted in the Final Report, "the amount of data from either human or animal research on low-level exposures [to CW agents] is minimal," but we believe the planned research may address any uncertainties and inconclusiveness identified in our December 1996 report. We hope this research can clarify some of the conundrums surrounding Gulf War veterans' illnesses.
While the Committee approves of the government's targeted solicitations and the process used to make such awards, we have grave reservations about a significant degradation in DOD's overall funding mechanism for research related to Gulf War veterans' illnesses. We note with serious concern that a substantial amount of research-$6.5 million for three projects-recently has been funded without undergoing external competition and peer review; it is immaterial to us that these funds did not come from the allocation set aside for the most recent solicitations and awards. The Committee is particularly troubled because not only had our 1996 reports stressed the importance of peer review and the award process, but the Institute of Medicine's 1995 report also had been particularly pointed in its criticisms on this matter. 16
Competition and external peer review of research proposals are essential to guarantee scientific merit, relevance, and level of priority generally. They are especially crucial when spending involves the public's money during times of shrinking budgets; the interests of veterans are not well served by research that is not meritorious. Funding decisions for research projects should be insulated, to the maximum degree possible, from the appearance of conflicts of interest and political agendas. We recommend:
The Committee is not inflexible on this matter. We acknowledge benefit can accrue from small-scale, short-term funding on a sole source basis for pilot projects or to address narrow scientific questions-e.g., DOD's recent funding of $100,000 for technical issues related to a Mycoplasma test. Any protocols still should be peer reviewed prior to funding. Overall, such funding should be rare, limited in the amount of funds released, and not subject to renewal without competition.
The Committee's Final Report noted the many positive efforts of the Coordinating Board's Disabilities and Benefits, Clinical, and Research Working Groups to address issues specific Gulf War veterans. Additionally, the Coordinating Board intends to establish a fourth working group, the Deployment Working Group. We identified, however, a need for a more forward looking initiative to coordinate post-conflict health concerns following other military deployments.
In April 1997, a Presidential Review Directive instructed the National Science and Technology Council to develop an interagency plan to address health preparedness for and readjustment of veterans and families after future conflicts or peacekeeping missions. The President's Committee of Advisors on Science and Technology and other non-governmental experts will review the report, which is scheduled for delivery in April 1998.
The Committee concludes the government is addressing our recommendation concerning coordination.
In addition to assessing the departments' implementation of the Committee's recommendations, the President directed the Committee to continue our oversight and evaluation of the government's investigations related to possible CBW agent exposure incidents during the Gulf War. In February 1997, the President also specifically asked the Committee to address the adequacy of the government's response to his concerns about the implications of then recently declassified documents associated with chemical munitions at Khamisiyah. The April 30, 1997, supplemental letter report contains the Committee's analysis of that task ( appendix E).
This section reports the Committee's views and recommendations based on our oversight of DOD's and CIA's investigatory efforts and on the Committee's own inquiries. For this Special Report, we have opted to emphasize three broad aspects of the many facets of the government's ongoing work related to CW agent investigations: the technologies, the doctrine, and the investigation process. We do not elaborate on issues related to biological warfare (BW) agents in this document; the Committee's oversight since January 1997 has revealed no information that changes the assessments of our previous reports.
Over the past 10 months, the Committee primarily used individual case investigations as a means to identify the macro issues that decisionmakers should attend to because of their importance for current and future policy. By adopting this approach, it should not be inferred the Committee considered the individual investigations insignificant. In fact, these investigations were critical to shaping our recommendations on what we believe the government's next steps should be to fulfill its commitment to Gulf War veterans.
As the Committee's Interim Report discussed, the United States deployed several types of CW agent detectors. M8A1 automatic chemical agent alarms served as the primary U.S. early warning system. Fox reconnaissance vehicles with MM-1 mass spectrometers were deployed, and M256A1 chemical agent detector kits and hand-held chemical agent monitors also were used. Each service member had access to M8 or M9 paper, which are sensitive to liquid chemical agents. Finally, M272 kits were available to detect the presence of chemical agents in water.
Despite the array of technologies available to U.S. troops during the Gulf War, the Interim Report also noted all CW agent detectors and warning systems deployed detected only nerve agent concentrations that would cause acute symptoms or death, not subclinical concentrations. M8A1 alarms-troops' primary warning system-could not detect mustard agent at any concentration. We expressed concern that "battlefield detectors could not measure the types of low-level exposure that DOD regulations guard against in non-battlefield situations," 22 and recommended that DOD devote more attention to developing the capability to monitor subclinical exposures to CW agents. Yet, as we noted in the Final Report, "DOD has not accepted or implemented the Committee's recommendation to develop and implement low-level CW agent monitoring." 23
The Committee's recent oversight activities have served to underscore the fact that developing appropriate CW agent detection technologies and deploying them with well-trained personnel are imperative. During the Committee's review of individual case investigations, which involve various technologies, new problems with CW agent detectors were opened to public scrutiny-particularly for the Fox vehicle. Additionally, while our Interim Report noted deficiencies in the M8A1 alarms, we observe here that M8A1 alarms were so non-specific that some units actually were ordered to ignore or disable them.
First, and of over-arching concern for all detectors: CW agent detectors used during the Gulf War were designed only to detect immediately toxic, incapacitating, or lethal concentrations of agent. Even if circumstances indicated the need for low-level detection capability, the detectors available to U.S. troops lacked the technological capability to be adjusted for such a purpose. Second, there is a real possibility that the Fox vehicle technology used by U.S. forces would have overlooked an actual, verifiable chemical weapons attack during the contaminated battlefield conditions in the Kuwaiti Theater of Operations-including detection of CW agent concentration where medical symptoms first appear.† DOD rejects this concern and suggests the initial Fox alarm was, in and of itself, sufficient to alert U.S. troops to don their highest level of personal protective gear (so-called "MOPP-4").8 Thus, according to DOD, service members were not endangered even though the MM-1 mass spectrometer's full spectrum mode could falsely conclude the initial alarm was not a CW agent. The Committee disagrees with such reasoning, and further notes such a position also misses the point of separating detections and health effects. As we highlighted in the Final Report, fusing these two issues is analytically flawed. We recommend:
The Committee's oversight and investigation of possible CW agent incidents not only revealed technological deficiencies, but also raised questions about certain aspects of military doctrine during the Gulf War that related to chemical and biological weapons. Testimony, interviews, and written submissions from DOD and service members whose primary responsibilities involved CW agent-related matters were particularly useful to our deliberations about doctrine.
The Committee realizes the problems with CW agent-related doctrine for the Gulf War have implications for future force protection and should be addressed. We elected to focus on the direct, adverse impact that doctrine, or lack thereof, has had on the abilityof veterans and the public to receive a full and valid accounting of possible CW agent exposure incidents. In this section, we emphasize three areas of particular concern to us. We encourage DOD to examine the broader universe of concerns about Gulf War doctrine governing CW agent issues.
In-theater documentation and records management. Reporting of and recordkeeping for possible detections of chemical or biological weapons were not systematic or standardized during the Gulf War, making the reconstruction of events from operational logs and/or intelligence a challenge. The Committee recognizes the difficulty of imposing burdensome reporting requirements in the face of rapidly shifting combat priorities. Our principal concern centers on the lack of doctrine on the retention of CBW agent-related Gulf War records once they were created. For example, doctrine did not require that the services keep Fox vehicle MM-1 mass spectrometer tapes, which were detector-generated written records of possible CW agent detections. That such information now appears unrecoverable significantly hampers current investigations into possible CW agent detections and contributes to perceptions that the government destroyed or misplaced documents to avoid accountability.
Fox vehicle operation, detection, and confirmation. The Fox vehicle's MM-1 mobile mass spectrometer was widely used and highly regarded by the U.S. military during the Gulf War. When operated as an initial alert detector, it could, in theory, simultaneously monitor for the presence of several chemical compounds, including CW agents. The Fox vehicle's actual technological capability proved less than ideal for combat situations. Its technical performance did not live up to theory, nor did DOD doctrine pertaining to Fox vehicles compensate for these technical deficiencies.
Doctrine required that following an initial alarm for CW agent(s), the Fox vehicle's full spectrum capability should be engaged. 30,32 To complete a full spectrum analysis, however, required that U.S. military personnel stop the Fox vehicle, return to the site where the MM-1 alarmed, and then perform a 20-minute process. Fox vehicle personnel recognized the danger that stopping in the midst of battle would pose to themselves and their fellow service members, and so they did not. As a consequence, full spectrum analyses rarely were performed during the Gulf War. Yet doctrine is clear it is impossible to confirm a detection without a full spectrum. Because doctrine did not accommodate the actual conditions of use, a post-incident evaluation of an incident that lacks a full spectrum cannot be validated. 30,32 We disagree with such a dismissal. In the midst of combat, the series of events to obtain a full spectrum were impossible to follow. Doctrine was incompatible for battlefield use of, and confirmations from, Fox vehicle detectors.
Low-level exposure to chemical warfare agents. Existing military doctrine only addresses exposure to debilitating or lethal doses of nerve or mustard agents. Notable by its absence is doctrine specific to low-level exposures-i.e., exposures not leading to first health effects but greater than the general population limit recognized by DOD.
The government's investigations of CW agent incidents provide clear lessons to improve doctrine. We recommend:
In the Final Report, the Committee recommended ". . . further investigation of possible chemical or biological warfare agent exposures during the Gulf War should be conducted by a group independent of DOD. Openness in oversight activities-including public access to information and veteran participation-public notice of meetings, opportunity for public comment, and regular reporting are essential." 23 In one of two instances (see also implementation), DOD partially concurred with this recommendation. DOD's response accepted oversight, but it indicated, "the expertise and knowledge to investigate, analyze and to understand what happened resides in the Pentagon." 21
DOD has expanded significantly the resources it is devoting to Gulf War veterans' illnesses. As noted earlier, the Committee recognizes the considerable improvement DOD has made in outreach to Gulf War veterans, particularly VSOs; this section addresses DOD's investigatory process per se. We first discuss one significant, but more focused, matter that had not been resolved in the Final Report: exposure modeling for the demolition of CW agent rockets at the Khamisiyah pit area. We then report the broader evaluation of our oversight efforts during the past 10 months, focusing on DOD's efforts; as with the Final Report, we note CIA has been responsive to the Committee's concerns.
In assessing DOD's performance with respect to investigating CW agent detections, the Committee's standard in this Special Report was our earlier finding that DOD's efforts were unlikely to provide credible answers to veterans' and the public's questions. In other words, the Committee based our new recommendations on the question: Is the current DOD initiative perceived as credible?
Exposure modeling of Khamisiyah pit demolition. The Committee has expressed on multiple occasions our dissatisfaction with the time it took to complete modeling for the pit area. We are pleased that in July 1997 CIA and DOD completed modeling for the March 10, 1991, demolition at the Khamisiyah pit. 2 The Committee is convinced that the fact the modeling was completed demonstrates the value of oversight through public meetings. We commend CIA's and DOD's efforts, but believe the scope of DOD's notification efforts should be expanded.
Currently, DOD has targeted individuals identified as being under the exposure plume.‡ Based on consultation with risk communication experts, the Committee concludes there is also significant merit in notifying other troops in the vicinity of Khamisiyah-which has received such widespread media coverage-that currently available evidence indicates they were not under the plume. Done properly, such a notification can be reassuring, and not alarming as has been suggested. Moreover, it would emphasize the government's commitment to reach out and communicate with Gulf War veterans. We recommend:
Bias in fact finding and analysis. DOD's current investigatory approach and reporting of specific incidents through case narratives has been less superficial than the many earlier attempts that purported to address the possibility of presence or release of CBW agents during the Gulf War. Nevertheless, we note that during the past 10 months, DOD has failed to thoroughly and promptly investigate all detections by the best available chemical agent detectors the United States fielded during the Gulf War-Fox vehicle MM-1 spectrometers and M256 kits-as we recommended. Moreover, the Committee already has documented in the preceding sections how the deficiencies in technology and doctrine create a built-in bias against viewing any detection as credible.
DOD posits it is gathering all the facts without bias, about which individuals might then disagree on interpretation. DOD emphasizes one function of its case narratives is to seek additional information. On face value, the Committee could conclude we have no disagreement with either message. For the past 10 months, it has been our observation that many individual analysts who follow elements of a case on a day-to-day basis do so without bias; we commend their efforts. At some point, however, the evaluations succumb to an institutional culture and pervasive inclination to reimpose DOD's longstanding position that there is no evidence that CW agents were present in southern Iraq-except Khamisiyah (acknowledged June 1996) and Ukhaydir (acknowledged July 1997).§ We note bias is not limited to analyses, but also can extend to fact finding. Lack of due diligence and objectivity mean only certain facts come to light.
As noted earlier, the Committee's intent in this Special Report is to present our findings about DOD's investigative process and to make policy recommendations, not to provide a detailed review and point-by-point accounting of each difference the Committee has with DOD's fact finding, presentation, or interpretation. We briefly highlight three specific examples to illustrate our concerns, but it should not be inferred these represent the boundaries of our concerns about bias:
o DOD's failure to present balancing, but conflicting, statements by its own CW detection experts; and
o the Office of the Special Assistant for Gulf War Illnesses' (OSAGWI) failure to pursue, acknowledge, or account for information identified and analyzed by MITRE Corp., under a contract to the Assistant to the Secretary of Defense (Intelligence Oversight) (ATSD(IO)).**
First, until the Committee's existence, DOD maintained categorically there was no credible or verifiable evidence that CW agents were used or present during the Gulf War. As we noted in the Final Report, DOD belatedly acknowledged a mustard exposure to Army Sergeant Fisher. Similarly, following revelations about the Khamisiyah munitions depot in June 1996, DOD began to qualify its statements to include Khamisiyah. In July 1997, DOD acknowledged as many as 6,000 mustard shells had been present at Ukhaydir, requiring DOD to further qualify its statements; this latter acknowledgment came after UNSCOM called attention to Ukhaydir. Early reviews by DOD staff had been to dismiss or attempt to minimize the situation to Committee staff and others as being limited to a handful of shells; exposure modeling is now underway for two events of Coalition bomb destruction of more than 200 mustard shells at Ukhaydir. 33, ††Time after time over the past 10 months, the Committee has battled with DOD about its fact finding and interpretations related to possible CW agent incidents-an approach we believe serves to exacerbate DOD's credibility problems.
The second example centers on DOD's recently released case narrative for the Marine Corps minefield breaching. 5 Part of DOD's assessment involved reporting on the judgment its technical experts rendered as to whether conclusions could be drawn from Fox vehicle detection tapes-in this example, tapes available for and associated with an alarm reported on February 24, 1991, by the 2d Marine Division. In its narrative, DOD quotes the U.S. Army Chemical and Biological Defense Command (CBDCOM), as follows: "Because of the presence of high concentrations of interferents and the short time span between these responses, we conclude that the presence of the three chemical warfare compounds is highly unlikely." 5 Yet DOD's narrative disregarded its own expert's next sentence, which concluded: "On the other hand, we cannot with great certainty conclude that they were not present."12,‡‡
Finally, our third illustration centers on OSAGWI's investigations of the Marine Corps minefield breaching, Al Jaber Air Base, and Ammunition Supply Point/Orchard. 5,6,7 Highly damaging to DOD's credibility from our perspective, was how OSAGWI failed to pursue, acknowledge, or account for information from a DOD contractor that was directly relevant to its Marine Corps narratives. MITRE is under contract to provide support and analysis to the ATSD(IO) for his investigation to determine what intelligence and operational information concerning Khamisiyah and other similar sites was available to DOD, and what was done with that information. MITRE's overall work focuses on information flow and analysis of data via review of approximately 55 million intelligence and operations records. Early MITRE drafts included one chapter related to Marine Corps activities during the Gulf War, but this specific material was transferred by the ATSD(IO) to the Special Assistant for Gulf War Illnesses in June 1997.
The Committee judges that DOD's case narratives failed to acknowledge or account for facts uncovered by MITRE-even though, for example, OSAGWI had the document for nearly 2 months prior to releasing its Marine Corps breaching narrative. OSAGWI maintains it incorporated MITRE's work, "as appropriate" and "fully." 28,29 OSAGWI considers the draft MITRE report, which has yet to be released and contains some highly classified information, of poor quality. We disagree. Committee staff has reviewed two versions of MITRE's work: MITRE's full report represents an impressive, high-quality investigation and analysis. Moreover, the Office of the ATSD(IO) is to be commended for its role in identifying the approach, aswell as executing and overseeing the MITRE contract; its efforts to ensure MITRE's access to the necessary intelligence; and its unbiased assistance and cooperation in facilitation of the Committee's work.
In the Committee's estimation, DOD cannot itself lead an investigation on possible CW or BW agent exposures that will be viewed as credible. We recommend:
The Committee believes strong consideration should be given to an investigative effort that takes advantage of the database developed for the ATSD(IO) and that builds on the existing expertise and analyses. A non-governmental entity, such as MITRE, could be retained for such purposes, but it should report to an entity outside DOD. Regardless of the specific entity leading future investigations, such an effort should review and analyze intelligence pertaining to: biological warfare agents; reported incidents involving the Marine Corps; and Coalition bombing and demolition activities at sites identified as having the highest probability of presenting a Khamisiyah-like scenario, including, but not limited to, Ukhaydir, Al Jazair, Rumaylah Ammunition Storage Facility 1, and Ash Shuaybah. We do not intend this list to be exhaustive. Rather, the Committee takes note of these priority areas as additions to the Final Report's recommendation that stressed the importance of investigating all reports of positive detections from M256 kits and Fox vehicles.
We emphatically emphasize that our recommendation that an entity other than DOD (e.g., the President's Foreign Intelligence Advisory Board or, again, the National Academy of Sciences) perform oversight is not intended to reflect negatively on the ATSD(IO)'s exemplary handling of his tasks. The Committee's view, however, is that prudence dictates any opportunity that could be perceived as a conflict of interest should be avoided whenever possible.
Finally, we realize one factor contributing to the timeliness and success of the ATSD(IO)'s approach to his assigned task was his instruction that MITRE produce a thorough report without a priori addressing classification issues of source material. The Committee's recognition that the strength of MITRE's work depended heavily on highly classified information does not undermine our view about the paramount importance of a publicly accessible process. Our view that openness is essential for any evaluation of the government's continuing investigations on possible CBW agent exposures cannot be overstated. We are firmly convinced that much of what has been revealed about CBW agents and the Gulf War would have remained concealed without the pressure of public accountability.
Objective standards. The Final Report criticized DOD for first failing to articulate any objective criteria for assessing possible CW agent detections and then for adopting a military standard that requires a valid detection and physical symptoms of poisoning. In response to this criticism, DOD stated in March 1997 it would rely on a "best evidence" rule to establish "preponderance of the evidence" as its standard. 26 In our April 1997 supplemental letter report, the Committee noted that for matters involving the presence or release of CW agents during the Gulf War, adherence to courtroom standards of evidence was inappropriate.
Following the release of the Committee's supplemental letter report, DOD announced it was employing a "common sense" approach 27-i.e., DOD has abandoned an objective standard (albeit one with a high threshold) in favor of a subjective decisionmaking process. The Committee disapproves strongly of this approach. In response to our repeated requests for clarification on what constitutes "common sense," and whose "common sense" serves as the determinant, DOD further articulated its standard for assessment is: "Do the facts available lead a reasonable person to conclude that CW agents were or were not present?" 4
We do not find the "reasonable person" construction to be any less subjective or more appropriate than "common sense" for evaluating the presence or release of CW agents during the Gulf War. Like "best evidence" and "preponderance of evidence," the Committee finds the linkage to the courtroom origins of a "reasonable person" standard troubling and not appropriate for matters involving investigations pertaining to possible CW agent exposures during the Gulf War. For more than 17 months, the Committee has attempted repeatedly to impress upon DOD the importance to its credibility of a consistent, objective standard based on a verifiable process and criteria. We recommend:
Public distrust of government and large institutions has been on the rise since the mid-1970s. Such skepticism is not, of course, limited to issues raised by Gulf War health issues, but this spreading atmosphere of suspicion has fueled speculation about cover-ups and conspiracies surrounding governmental actions related to Gulf War veterans' illnesses-especially with respect to CW agent matters. Addressing the systemic nature of increased public misgivings about government falls beyond our scope. The Committee's oversight of investigations of possible CW agent exposures leads us, however, to believe the government must reinforce and renew its commitment to Gulf War veterans in order to begin erasing the perception of governmental inattention to them.
In the Final Report, the Committee reported that, for the most part, the government has largely acted in good faith and improved its handling of Gulf War veterans' health concerns in comparison to the post-Vietnam War era. We took strong exception, however, to DOD's inquiries into possible chemical and biological warfare agent incidents.
We noted DOD's denials, delays, and actions had strained public trust and that, understandably, an atmosphere of government mistrust surrounded every aspect of Gulf War veterans' illnesses. The Committee emphasized full public accountability would be essential in trying to restore public confidence in the government's, not just DOD's, commitment to Gulf War veterans.
Ten months after making this assessment, the government's credibility in addressing the health concerns of Gulf War veterans continues to be challenged. To be sure, room for improvement exists. The government's efforts have yielded significant improvements in services and essential, new knowledge-but, still, progress is gradual. Unfortunately, however, such progress now often is viewed skeptically, at best. There remains a widespread and deeply held view that the government is failing to adequately address the health concerns of Gulf War veterans. In fact, the Committee perceives public mistrust about the government's handling of Gulf War veterans' illnesses not only has endured, but has expanded since the Final Report. This persistent atmosphere of distrust ill serves the Nation.
The Committee concludes the credibility gap between the public's views of the government's efforts to address concerns about Gulf War veterans' illnesses and the reality of its initiatives cannot be bridged without bold policy action. Incremental policy refinements are, and have been to date, important. Regrettably, it now appears they will not address the pervasive belief of government neglect or wrongdoing in handling Gulf War veterans' illnesses. At the same time, the primary focus of the government's efforts needs to shift from investigations to the nth degree of individual incidents, to a process that will ensure that research data and clinical improvements with a direct impact on veterans' lives can be regularly accounted for and integrated into VA's disability compensation and medical benefits programs. As a policy mechanism, advisory committees like our effort are not well-suited for such tasks. We recommend:
The legacy of the Gulf War should not be the perception the government cannot be trusted to candidly address legitimate concerns that veterans have raised�and often have been borne out�about their experiences during Operations Desert Shield/Desert Storm. Rather, the legacy should be a recognition by all Americans that the government acknowledges and honors its obligation to care for the men and women who served in the Gulf War. This Committee has appreciated the opportunity to serve Gulf War veterans, their families, and President Clinton.
†The Fox vehicle contains a variety of sophisticated chemical detectors. The Committee's analysis on matters related to the Fox vehicle centers on its MM-1 mobile mass spectrometer. Following an initial alarm for a CW agent or other compound, the MM-1 can be manually switched to acquire a full spectrum. In theory, the full spectrum should provide a more accurate and comprehensive analysis of the compound. In fact, the full spectrum option used during the Gulf War would have analyzed and reported only on the compound present in the highest concentration. Hence, under polluted and contaminated battlefield conditions, significant levels of CW agent-subclinical or even first health effects-could have been present and led to an alarm, but would have been ignored by the Fox vehicle's MM-1 mass spectrometer in the follow-up full spectrum analysis if the concentration of another interfering compound, for example oil-well fire smoke, was higher than the amount of CW agent that had triggered the alarm. The full spectrum analysis in such a case would report on the chemical composition of the oil-well fire smoke and miss reporting entirely the presence of the CW agent. The MM-1 has the technological capability to evaluate a full spectrum for more than the most concentrated compound present. Fox crews did not receive this training, however, because DOD was unaware of this additional capability at the time of the war. 32
‡Beginning in August 1996, DOD notified approximately 20,000 individuals that they could have been exposed to low levels of CW agent. Based on the July 1997 modeling, 10,075 of these troops now have been identified as being outside the area of the plume; DOD notified these individuals of their change in status. This notification was separate from the one DOD undertook for the 97,828 individuals currently presumed to be under the plume.
§To date, the United Nations Special Commission on Iraq (UNSCOM) has not found evidence of chemical weapons south of Khamisiyah. UNSCOM's mission, however, is not to assess the presence, release, and detection of CW agents associated with incidents that involved U.S. troops during the Gulf War. UNSCOM's charge is "ridding Iraq of its weapons of mass destruction programs and putting in place some monitoring system to detect potential efforts to reconstitute such programs." As UNSCOM noted in briefing the Committee, "our resources are very limited. [W]e have only three [full-time] experts in New York who work in the chemical weapons field, and their task has been to eliminate one of the world's largest arsenals of chemical weapons." UNSCOM's inspectors can only report "our best understanding of the moment," since "extracting information from Iraq is not necessarily a smooth or even process." UNSCOM stressed to the Committee that its responsibilities are far different from the scope of the Committee's concerns and DOD's inquiries. 11
‡Beginning in August 1996, DOD notified approximately 20,000 individuals that they could have been exposed to low levels of CW agent. Based on the July 1997 modeling, 10,075 of these troops now have been identified as being outside the area of the plume; DOD notified these individuals of their change in status. This notification was separate from the one DOD undertook for the 97,828 individuals currently presumed to be under the plume.
**We focus on the ATSD(IO)'s effort because i) MITRE's work is an independent analysis of information related to CW agents, Khamisiyah, and similar sites; ii) the process and product has progressed further than those of DOD's Inspector General, CIA's Inspector General, and the Army Inspector General ( appendix E); and iii) drafts were available to the Committee. Currently, delivery of MITRE's final report is anticipated in late 1997. Based on this work, the ATSD(IO) will forward his recommendations to the Deputy Secretary of Defense.
††In September 1997, CIA testified before the Committee on one preliminary Ukhaydir modeling plume at the general population limit. Based on troop locations provided by DOD, the data indicate U.S. troops were not under the plume for mustard rounds bombed on February 13-14, 1991. The current footprint extends approximately 125 km, and DOD reports the closest U.S. forces were approximately 300 km from Ukhaydir. Modeling for agent release by mustard shells hit by Coalition air strikes on January 20, 1991, is pending. Additional modeling by DOD to account for weather variability for both events is expected by November 1997.
‡‡DOD also sought analyses from NIST and Bruker Daltonics, the manufacturer of the Fox vehicle's MM-1 mass spectrometer. DOD's Marine Corps breaching narrative reports that NIST concluded the detections "likely" were false positives and that Bruker Daltonics found the detections "consistent with" a conclusion that interferents led to false positive alarms for CW agents. 5 Again, however, the Committee's follow-up discussions with NIST and Bruker similarly acknowledged the uncertainty expressed by CBDCOM.