Mr. Chairman, Distinguished Committee Members, thank you for this opportunity to review with you the Department's health initiatives for our Persian Gulf veterans. President Clinton promised that we would explore all avenues for understanding the Gulf War illnesses; that we would take care of the veterans who believe their Gulf War experience has resulted in a degradation of their health; and that this Administration would put its resources into scientific research to find explanations for these illnesses. We have been doing just that, and we will continue to do so.
My testimony will specifically address the Department's programs caring for our Persian Gulf veterans, and which seek to find scientific answers to their health problems.
It is important to briefly trace the growing awareness of Gulf War Illnesses and the programs DoD has undertaken to address them. The Gulf War had been over for two years when the Clinton Administration took office. In that period, the voices of Gulf War Veterans who were experiencing a variety of symptoms believed to have been a result of their service in the Gulf War, reached the national level of hearing and concern. President Clinton promised that his Administration would help the veterans of the Gulf War, and the Congress echoed that promise to ensure help and to find answers.
Comprehensive Clinical Evaluation Program
In Defense, our most immediate concern was, and is, to help those Gulf War veterans who are sick to regain their health. With that as our primary goal, and with strong support from the Secretary of Defense, on May 11, 1994, I announced a three-point plan to address the clinical concerns of Gulf War veterans. The plan included first, an aggressive, comprehensive, standard, clinical diagnostic program offering thorough, systematic examinations and follow-on health care to service members who served during the Gulf War and who had concerns about possible health consequences of that service. This program is titled the Comprehensive Clinical Evaluation Program (CCEP), and very closely parallels the clinical evaluation program of the Department of Veterans Affairs (VA). In developing the evaluation protocol and series of tests to be conducted, we felt it imperative to retain an open mind regarding potential causes, including chemical warfare agent exposure. For that reason, a broad spectrum of tests comprise the CCEP, including neurologic examinations and cognitive testing. Upon completion of the CCEP evaluation, an appropriate course of treatment is initiated and followed for each participant when medically indicated.
Since 1994, the DoD leadership, without precedent, reached out to service members to encourage them to participate in the CCEP. Outreach efforts continue, significantly strengthened by the efforts of Dr. Rostker and his staff. Addressing the health concerns of our Gulf War veterans, our outreach includes direct correspondence with service members; meetings with numerous organizations representing Gulf War veterans; speaking, at their request, to gatherings of veterans; and conducting numerous media interviews to continuously update the veterans on what we were learning through the CCEP and medical research. Our openness on Persian Gulf Illnesses marks a great contrast to previous experiences, such as Agent Orange.
Also in the spring of 1994, we initiated the second element of our three-part plan: an independent evaluation by an individual with recognized credentials in the fields of epidemiology and infectious disease. This was to examine the Department's existing and proposed plans pertaining to Persian Gulf Illnesses and to recommend additional epidemiological studies.
The independent evaluation was conducted by Dr. Harrison Spencer, then Dean of Tulane School of Public Health and Tropical Medicine. Doctor Spencer recommended that DoD continue with the comprehensive diagnostic program, that the frequency of unexplained illnesses among different groups that had been reported be estimated, that care not be dependent upon establishment of a "case definition," that testing for clustering of reported symptoms in time and space be considered, and that the Department develop a strategy to manage similar situations in the future. Each of Doctor Spencer's recommendations has been accomplished or is underway.
Finally, the three-part 1994-plan called for a forum of national medical and public health experts to advise the Department and to offer a channel for broader public comment and suggestions.
The Institute of Medicine of the National Academy of Sciences, under contract to DoD, established an advisory committee composed of ten clinical experts in the fields of internal medicine, infectious diseases, allergy and rheumatology. This committee assisted in the interpretation of the clinical findings from the comprehensive diagnostic examinations of the CCEP and advised on other clinical studies that the Department should pursue. The Institute of Medicine continues to assist us as an independent panel of experts monitoring our efforts and advising us on specific issues or questions.
The evaluations and care of our Persian Gulf veterans continue. To date, over 38,500 are on the DoD registry. Through the CCEP, over 25,000 individuals have been extensively examined, with about 4,000 in the process of evaluation. As the CCEP participants complete their evaluations, military physicians develop appropriate treatment regimens to ensure their patients receive the care they need to regain their health. Not all Gulf War veterans who wish to be on the DoD registry want to have the CCEP evaluation; just over 9,000 have placed their names on the registry, but declined the evaluation. The VA registry has over 63,000 individuals who have completed the evaluation and about 3,700 who are in the process of being evaluated.
Looking at the results of the evaluations of those who participated in our clinical evaluation program, we identified several findings. CCEP participants report a wide variety of symptoms spanning multiple organ systems in no consistent, clinically apparent pattern. Symptoms such as fatigue, joint pain, headache, or sleep disturbances are common. The distribution of primary diagnoses spans many different organ systems. The majority of CCEP participants have diseases which are concentrated in three broad diagnostic groups: "psychological conditions;" "symptoms, signs, and ill-defined conditions;" and, "musculoskeletal and connective tissue diseases;". In each of our in-depth analyses of the CCEP -- at the 1,000, 2,000, 10,000, and 18,500 case points -- the results were similar. Our efforts within the Department to care for the Gulf War veterans have reinforced to us the seriousness of their health complaints, and our military physicians fully recognize that theses veterans are experiencing real symptoms and illnesses with real consequences.
One of most striking findings of our clinical work has been the recognition of psychological conditions and stress-related symptoms as a major diagnostic category among veterans cared for in our facilities. Our clinicians have been impressed that stress experienced during the Gulf War and in its aftermath appears to be a major contributing factor in the development of psychological conditions as well as the manifestation of symptoms associated with non-psychological conditions. This observation is consistent with the findings of special review panels of the National Institutes of Health, Institute of Medicine and Presidential Advisory Committee on Persian Gulf Veterans' Illnesses. We agree with the PAC finding: "Stress is known to affect the brain, immune system, cardiovascular system, and various hormonal responses. Stress manifests in diverse ways, and is likely to be an important contributing factor to the broad range of physiological and psychological illnesses being reported by Gulf War veterans."
Our Persian Gulf veterans deployed prepared for war. Once in the Gulf, they endured a daily anticipation of hostilities including possible chemical warfare, austere living conditions and indefinite family separation. For some, the waiting continued for six months. It was a period, a place, an environment conducive to anxiety and stress.
Our CCEP clinical experience to date reveals no evidence for a single, unique illness or syndrome. A unique illness or syndrome among Persian Gulf veterans evaluated through the CCEP, capable of causing serious impairment in a high proportion of veterans at risk, would probably be detectable in the population of over 25,000 evaluated. However, we agree with the IOM, which cautioned that an unknown illness or a syndrome that was mild or affected only a very small proportion of veterans at risk might not be detectable in a case series, no matter how large.
Formal research involving appropriate comparison populations is necessary to determine the degree to which certain kinds of symptoms or diagnoses may, or may not, be more common among Gulf War veterans. We have that research underway. Further, in an unprecedented step, we have made the CCEP database --with appropriate privacy precautions taken -- available to scientists interested in conducting additional analyses. To gain access to the database, scientists are encouraged to submit an institutionally approved protocol which may be done electronically via the Internet. Guidance on how to accomplish this is on the DoD Health Affairs Homepage. Once the request process has been completed, the database is made available.
Persian Gulf Illnesses Research
Let me turn now to a discussion of our health research programs. Quality scientific investigation, in parallel with the clinical program, broadens efforts toward a more complete understanding of the health issues related to service in the Persian Gulf War. Our research efforts are proceeding at a rapid pace with extensive openness and breadth of evaluation. However, quality scientific investigation is deliberate and does take time. It is very important to note that DoD's research program is conducted with extensive collaboration with the Departments of Veterans Affairs and Health and Human Services. Our interagency collaboration extends to scientists from the civilian research community, to state and other federal scientists, as well as to respected international scientists.
The Departments of Defense, Veterans Affairs, and Health and Human Services, through the Persian Gulf Veterans' Coordinating Board, have established a comprehensive research program concerning Persian Gulf illnesses. This research is complex, involving multiple approaches and health indicators. Although each Department has its own distinct capability and capacity for conducting formal scientific medical research, the three Departments have developed an integrated research approach. The objective is to coordinate all federally-sponsored research in a way that relevant research issues are specifically targeted and at the same time, unnecessary duplication is avoided.
Since the earliest days of seeking explanations for the causes of Persian Gulf Illnesses, we have acted on the recommendations of the IOM and, later the Presidential Advisory Committee. We have required that all research be externally peer-reviewed and thoroughly coordinated with the Persian Gulf Veterans Coordinating Board.
To demonstrate our commitment to the research effort, the Deputy Secretary of Defense has pledged $27 million for FY 97. This research responds to the recommendations of the Presidential Advisory Committee, and will include studies of chemical warfare agents, as I mentioned above, other toxins, and studies of possible health effects of combinations of inoculations and investigational new drugs; it will include studies on the potential health effects of stress. Other research included in this will be work on the geographic information system, toxicology clinical investigations, mycoplasma, sleep disorders, infectious diseases and fibromyalgia. Additionally, the series of 7 large scale epidemiology studies underway at the Naval Health Research Center are included.
Action Steps as a result of Khamisiyah
When we became aware that the Khamisiyah demolition operation had the potential of chemical exposure for units operating in and around that area in March 1991, I immediately issued instructions for additional measures to assess specific health implications.
To date, we have identified 1,194 CCEP participants out of about 20,000 service members from Army units which were within 50 kilometers of Khamisiyah. We have conducted preliminary descriptive analyses to determine how their reported symptoms and diagnoses compare with other Army CCEP participants who were not present in the Khamisiyah area. Interpretation of such analyses is limited because of the relatively small numbers of CCEP participants in the Khamisiyah group identified to date, uncertainty regarding the exact location where members may have served, and differences in the demographic and occupational characteristics of the Khamisiyah group compared against any other group within the CCEP. Preliminary results indicate that the frequencies of self reported symptoms of the CCEP participants identified as having served within 50 km of Khamisiyah are similar to other Army CCEP participants. Additionally, the distribution of primary diagnostic categories of the Khamisiyah group is similar to that of other Army CCEP participants. We plan to do further analyses.
b. The second step was to contact individuals who were assigned to the involved units to inform them of the known details, to confirm their unit locations, and to remind them of the availability of medical evaluations through the CCEP or Department of Veterans Affairs program. This has been accomplished.
c. Next, we conducted a review of information regarding DoD hospitalizations since the Persian Gulf War, accumulated by the Naval Health Research Center, to identify any unusual patterns involving members of these units. Results to date reveal no unusual hospitalization patterns.
d. The Armed Forces Epidemiology Board (AFEB) conducted a comprehensive literature review and critique regarding the issue of chronic or delayed health effects resulting from low-level exposures to chemical agents. The Board completed a review of scientific, peer-reviewed works, and found virtually no research linking chronic or delayed health effects to prior low-level exposure to chemical agents, in the absence of acute clinical effects. An important aspect of this review is that it focused on scientific, peer-reviewed works. Because the body of research is not substantial, more research is needed and will be funded.
e. The Department established as a top priority and rapidly funded expedited peer-reviewed research concerning the subject of potential chronic health effects caused from low-level exposures to chemical agents. Three research proposals, external to the Department, have been funded for a total of $2.5 million. Additional research is under consideration and includes targeted epidemiological, applied toxicological, and clinically related studies.
f. Finally, I asked the Institute of Medicine to re-examine our CCEP to determine if, in light of the Khamisiyah information, DoD should again evaluate some individuals or conduct further tests.
There were no chemical casualties reported during any of the demolition operations at Khamisiyah. An evaluation of medical logs of units in the area did not show any increase in clinic visits or any reports of chemical exposure symptoms. With that lack of clinical evidence and no physical evidence to substantiate that chemical agents were present, the Department turned its attention to the question of whether there might have been very low (below detector sensitivity) levels of chemical agents present. Preparing to look for whatever evidence there might be, the scientific evidence on consequences of possible exposure to very low levels of chemical agent was reviewed first. Very little was found to direct the investigation.
To date, no controlled human studies have been found in which measured doses, designed to avoid symptoms, were utilized, and subjects monitored over extended periods of time. However, reasonable extrapolations can be made from two controlled human studies, a few accident investigations, and several animal studies, all of which, however, involved exposure at levels sufficient to produce symptoms.
Some of these studies were described to the Presidential Advisory Committee on Gulf War Veterans' Illnesses. These included the largest controlled study known, lasting over decades, finding no long-term (over years) effects from short-term low-level exposure to chemical warfare agents. The second controlled study was one in which acute symptoms were produced in volunteers. Cholinesterase levels were examined, but no long term follow up was done on the subjects.
The controlled studies were complemented by studies which included large numbers of inadvertently exposed personnel as well as individual exposures. In general, the accidental exposure patients, where the individual initially showed acute symptoms, were followed through short-term recovery periods. At the end, the EEGs of some subjects showed non-specific changes, but the individuals exhibited no other symptoms. Long-term follow-up (over years) was not reported in the accidental exposure studies.
Many animal studies have been done, but very few involved low level chemical agents. To date we have not been able to identify human or animal studies that have directly addressed the issue of short term low level nerve agent exposure followed by chronic symptomatology or disease. The existing literature, though limited, consistently indicates that in humans and animals receiving short-term exposure to agent levels which do not produce symptoms, no long-term (months to years) clinical effects are found.
The limited amount of research on low level exposure has caused us to initiate more research into this area.
Presidential Advisory Committee Recommendations
The Presidential Advisory Committee on Gulf War Veterans' Illnesses (PAC) provided substantial thought, important findings and very constructive recommendations throughout its process and in its final report. Consistent with the Committee's recommendations, we will submit an action plan outlining the steps, including those already partially or fully implemented, being taken by the Department. Let me give you a sense of what steps we have taken, or that we expect to take.
2. DoD strongly agrees with the importance of pre-deployment health assessment. The Department is developing a medical surveillance policy for deployments which specifies a uniform concept for health screening. This policy was partially implemented in Bosnia and is being fully implemented for Southwest Asia. We expect the new medical surveillance policy to be formally adopted during 1997.
3. DoD already does some orientation and training for new troops on the chemical and biological threat and on the counter measures which may be needed. More needs to be and will be done. The goal of DoD is that every Service member is fully informed during orientation and training of the health risks, benefits, and proper use of all medical countermeasures, and, when used, documented and maintained as a part of the individual's health record. Given the potential for serious chemical and biological threats for future conflicts, both using countermeasures and having our Service members fully informed are critical to effectively protecting them.
4. DoD agrees with the need for FDA to solicit timely public and expert comment on rules that permit waiver of informed consent for use of investigational products in military exigencies. DoD intends to work with FDA on ways to more expeditiously process such rules in order to ensure that we have effective countermeasures to deal with existing and new chemical and biological warfare threats. DoD agrees that, to the full extent feasible, there should be disclosure to Service personnel, good record-keeping, and other procedures which enhance understanding, oversight and accountability.
5. DoD continues to actively develop an automated medical records system that is used during deployments and when Service members are at their home base health facilities. Major portions of that system are already being used in Bosnia. Further refinements, including the addition of an automated patient record and "meditag" record, are being made as quickly as is feasible. These systems will be compatible with the records systems being used worldwide.
6. The Department will review the clinical staffing needs required to satisfy Gulf War veterans' health needs, including mental health, and ensure that those staffing needs are met. With respect to future deployments, the Department has in place its Comprehensive Clinical Evaluation Program, including support to all military treatment facilities, to assist with the evaluation and care of illnesses that may result from those deployments and are difficult to diagnose.
7. DoD provides reproductive health care for its Service members and their families and has made reproductive health concerns a higher priority for all beneficiaries in their reproductive years. Currently, the Department is putting into place performance metrics to better assess reproductive health outcomes and the associated health care and to assist in the overall management of that care. Special efforts are being made for Gulf War veterans in the areas of evaluation and care and epidemiological and other research.
8. DoD is currently writing a DoD Directive which addresses the recognition and management of combat stress. When this policy directive is published, the Services will be expected to publish implementation instructions within 120 days. These instructions will focus on stress reduction programs particularly for deployed troops. Meanwhile, special combat stress coping units have deployed to Bosnia and conduct critical incident stress debriefings for catastrophic incidents that occur in the Services. Through the forthcoming Directive on Combat Stress, DoD will set the policy to have senior commanders and non-commissioned officers be involved in stress management programs.
9. Principal Investigators (PI) conducting large epidemiologic studies have been encouraged to establish Public Advisory Committees (PACs). Future Requests for Proposals will require PIs to incorporate PACs into the study design and results dissemination phases of the research.
10. DoD has initiated several new research studies and recently published a Request for Proposals specifically addressing the health issues of sub-clinical or low level exposures to chemical warfare agents. We are asking the scientific community to help us determine what mix of human population and animal model studies will provide the best understanding of this complex issue.
11. DoD agrees that long term mortality follow-up studies are important and should be funded.
12. DoD initiated an effort in the fall of 1996 to identify, verify and notify Service members who were within a 50km radius of the Khamisiyah weapons demolition site during the demolition operations. Any of these Service members who are ill or have health concerns have been encouraged to sign up with the DoD Comprehensive Clinical Evaluation Program for evaluation and care or the VA Persian Gulf Health Registry for evaluation. In order to better understand any relationship between the demolitions, potential exposure and subsequent illness, DoD and VA are carrying out epidemiological studies and funding research. For any other sites which are identified and for any other Service members who may have been exposed in these cases, similar steps will be taken with respect to notification, evaluation, care, and research as for Khamisiyah.
13. DoD agrees that research on causes and methods of prevention and treatment of musculoskeletal conditions and stress disorders are important areas for investigation. In funding future research, DoD will look for opportunities which would increase understanding of causes, prevention and treatment of these health problems.
At this time, in collaboration with the Departments of Veterans Affairs and Health and Human Services, we are finalizing the response to the PAC and plan to submit it to President Clinton shortly.
Implications for the Future
The CCEP protocol and process represents a new and innovative system to evaluate the health status of service members who participate in operational deployments, such as in Bosnia and others in the future. Modification of our policies and processes will allow the Department to administer health questionnaires and conduct medical examinations of groups of deployed personnel, and collect the information through an automated process for entry into a centralized database for subsequent analysis and interpretation.
The Department's experiences with the Persian Gulf War illnesses indicate that there are initiatives which can be implemented today to better provide for our service members in the future. Among those initiatives is the Medical Surveillance Program.
Medical Surveillance Program
More than a year ago, the Department embarked on an ambitious program to expand its capability to conduct medical surveillance to monitor the health and well being of men and women in uniform, especially in situations where they deploy to hazardous areas in the interest of national security, as they are presently doing in Bosnia. Medical surveillance involves the ongoing systematic collection, analysis, and interpretation of health data for use in preventing and controlling illnesses and injuries. Today, the Department is in a better position to protect the health of the force as a result of progress made in promoting an expanded concept of medical surveillance, and placing strong emphasis on the readiness posture.
A number of "lessons learned" have emerged following Operations Desert Shield/Storm which have provided the impetus for many medical surveillance initiatives. The Department takes pride in the fact that the Gulf War was associated with a lower disease and non-battle injury (DNBI) rate than any major conflict in U.S. history. However, the inability to resolve uncertainties regarding long term, chronic health sequellae of veterans is due in part to a deficiency of objective measures of individual health status at the time of deployment and exposure information needed to evaluate potential health risks. These observations have led to major changes involving health screening, exposure assessment, risk communication, and assessment of health outcomes after deployments. Clearly, essential medical surveillance functions must be continuous and fully integrated throughout pre-, during, and post-deployment phases of military operations.
We are in the final stages of coordinating this new medical surveillance policy, major elements of which have already been implemented in Bosnia. The policy focuses on ways to better define and document the deployed population, their unique exposures, countermeasures used to protect the force, and health outcomes as a result of the deployment. The policy describes an integrated framework for monitoring the physical and psychological health of the deployed force and includes the following major components:
The Department's enhanced medical surveillance approach will evolve further in response to new and emerging health threats and assessment of lessons learned from actual application of surveillance concepts in military operations.
In summary, our strategy towards developing an integrated medical monitoring program for deployments involves multiple components. Our experience in providing care to Persian Gulf War veterans has provided clinical insight into the types of medical problems that may arise from the stressful physical environment and psychosocial demands of operational deployments. The deployment to Bosnia provided an opportunity to field test the feasibility of new concepts regarding pre-, during, and post-deployment medical surveillance activities. In addition, multiple Persian Gulf related research studies are in progress or being planned, the results of which may identify new areas requiring preventive intervention. Research findings will be merged with clinical and operational experience to further refine medical surveillance programs.
The Department is making significant progress in expanding its capability to assess the health status of personnel prior to deployment, evaluate environmental hazards in a theater of operations, and identify adverse health outcomes which may result from their participation. The surveillance reflects careful consideration of recommendations from a variety of sources including:
Consultation provided by Dr. Harrison C. Spencer, National Institute of Health Technology Assessment Working Group, Defense Science Board, Task Force On Persian Gulf War Health Effects, Institute of Medicine, Committee On The DoD Persian Gulf Syndrome, and Presidential Advisory Committee on Gulf War Veterans' Illnesses.
Many actions are still in progress. Nevertheless, the Clinton Administration rapidly and effectively created a comprehensive, well-organized, cross-departmental program designed, first and foremost, to take care of service members. Further, there is strong commitment to pursuing the science and using investigative tools to find answers to remaining questions. The President re-affirmed his commitment by retaining the Presidential Advisory Committee on Gulf War Veterans' Illnesses to ensure that everything possible is being done to understand the health consequences of service in the Persian Gulf.
The Department's clinical and research efforts will continue. As President Clinton has vowed to leave no stone unturned in the search for answers to Persian Gulf War veterans' health concerns, we are committed to providing quality, compassionate care to service members who are Persian Gulf veterans and to their families, and to conducting the appropriate research to gain greater understanding of these issues.
Like the Presidential Advisory Committee, we recognize that the issues surrounding Gulf War illnesses are very complex. Since the end of the Gulf War, concerns have been raised as to whether there is a relationship between illnesses being experienced by some Gulf War veterans and their family members, and exposures to various hazards during Gulf War service. These concerns are of particular importance to our Gulf War veterans and their families. We share these concerns, and continue taking unprecedented steps to determine the causes of these illnesses and to provide care for those who are ill.
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