1996 Congressional Hearings
Intelligence and Security


PREPARED STATEMENT OF
KENNETH W. KIZER M.D., M.P.H.
UNDER SECRETARY FOR HEALTH DEPARTMENT OF VETERANS AFFAIRS
BEFORE THE
SENATE VETERANS' AFFAIRS COMMITTEE
AND THE
SENATE SELECT COMMITTEE ON INTELLIGENCE
A JOINT HEARING
WEDNESDAY, SEPTEMBER 25, 1996

Mr. Chairmen and Members of the Committees, I appear before you today to update you on the Department of Veterans Affairs (VA) Persian Gulf War-related programs, with a specific focus on VA responses to the possibility, and now probability, of low-level exposure to chemical warfare agents.

In the way of background let me reiterate a few points about VA's general response. Shortly after returning from the Persian Gulf conflict in 1991, veterans began to report a variety of symptoms and illnesses. In response, the Department of Veterans Affairs developed. the first of its several programs for these veterans. This was the Persian Gulf Veterans Registry health examination program. Ever since then, the Department has continuously tried to improve and expand its Persian Gulf War-related programs. Those programs now encompass a four-pronged approach that includes medical care, research, compensation, and outreach.

VA provides Persian Gulf Registry Health Examinations, Referral Center evaluations, readjustment and sexual trauma counseling, and special eligibility for outpatient and inpatient healthcare to Persian Gulf War veterans. VA's position since the Registry's inception has beenthat all Persian Gulf War veterans should participate in the Registry program. To date, more than 60,000 veterans have completed Registry examinations. Almost 187,000 have been seen in VA ambulatory care clinics, and more than 18,200 have been hospitalized at VA medical facilities.

Persian Gulf veterans participating in the Registry examination have commonly reported a diverse array of symptoms, including fatigue, headache, muscle and joint pain, memory problems, shortness of breath, sleep disturbances, nausea, diarrhea and other gastrointestinal complaints, rashes, and chest pain. Of note, 12 percent of the Registry examinees have no health complaints but wish to participate in the examination to establish a baseline should they develop future health problems that might later be found to be due to their service in the Persian Gulf War.

I would again reiterate that VA encourages all Persian Gulf War veterans, whether symptomatic or not, to avail themselves of the Registry examination program, especially if they are concerned about possible exposure to chemical warfare agents in light of DoD's recent announcements. Further, we would encourage persons who have been previously examined as part of the Registry program to request a follow up examination if they have symptoms or concerns.

VA has always remained open to the possibility that military personnel may have been exposed to a variety of hazardous agents, including chemical warfare agents, while serving in the Gulf War theater of operations.

In this regard, VA has recently been asked by some Members of Congress whether we listened to veterans who reported their belief that they had been exposed to chemical warfare agents during their Persian Gulf service. We did listen to those veterans. Illustrative of this,prior to the DoD announcement on June 21, 1996, VA designed its clinical uniform case assessment protocol to detect clinical signs and symptoms related to possible neurotoxic exposures. Neurologic examinations and cognitive testing were part of the earliest versions of this protocol. As a result of this, VA diagnostic protocols and treatment programs do not need any substantial revision in light of DoD's recent disclosures about the release of sarin at Khamisiyah in March 1991.

Likewise, in response to a Reserve Construction Battalion unit of PGW veterans from Alabama, Tennessee, North Carolina, and Georgia reporting adverse health effects, which they believed were due to exposure to low-level chemical warfare agents, VA established a pilot medical assessment program at the Birmingham VA Medical Center to evaluate their health status. As part of this special health care program, more than 100 veterans were evaluated. Included in this group

were 55 veterans who complained of cognitive problems; these veterans underwent extensive (7-8 hours) neuropsychological testing and clinical evaluations. These evaluations did not reveal the pattern of neurologic abnormalities typically associated with neurotoxin exposure.

A further demonstration of the fact that we were heeding what the veterans were saying can be found in the National Health Survey of Persian Gulf War Veterans where specific questions are asked about possible exposure to chemical warfare nerve toxins and mustard gas.

At this juncture, I believe it is worthwhile pointing out that there is no biomarker, laboratory finding or diagnostic test for chemical warfare agent nerve toxin exposure. The diagnosis of conditions related to nerve toxins, whether they be chemical warfare agents, pesticides or hazardous industrial chemicals, is based on two things: first, known or presumed exposure to the chemical agent, and second, symptoms or physical signs consistent with the known biological effects of the chemical. Absent definite exposure data and/or typical symptoms and signs, it is essentially impossible to make a definitive diagnosis of chemical related neurotoxicity. Furthermore, there is no curative therapy for the expected neurotoxic effects of these agents, although symptomatic treatments are available and represent the state- ofthe-art at this time.

These same problems apply to conducting research in this area. Indeed one of the most challenging problems in conceptualizing and designing valid scientific studies of potential longterm effects of low level exposure to chemical warfare agents is knowing what exactly one should measure and study when there were no symptoms or signs of acute toxicity. It is clear in my mind that if we are going to adequately research these questions a major investment will be needed to develop both the physical plant capabilities and the intellectual capital that are required to conduct these very difficult studies.

The results of our Persian Gulf Registry health examination program are similar to those reported by other investigators, including scientists in England and Canada. In reviewing these data, it is important to recognize that numerous scientists and advisory committees have reviewed the medical data collected in these programs and have concluded that a wide variety of illnesses, including the whole range of well-defined medical and psychiatric conditions, are being diagnosed among PGW veterans. Furthermore, VA physicians have found that only a relatively small percentage of PGW veterans have unexplained illnesses and that no single, unique disease explains the range of the illnesses being diagnosed in Persian Gulf War veterans. That is, there is no Gulf War Syndrome in the strict medical sense of the term. In saying this, though, it isimportant to emphasize that VA does not at all doubt that many veterans reporting unexplained illnesses are suffering from real illness, and some are seriously ill, and that the inability to make definitive diagnoses is very frustrating for our physicians and other practitioners, as well as our veteran patients.

We continue to search for answers, and we continue to strive to expand our understanding of the illnesses of Persian Gulf veterans. And while scientific answers are being sought, VA will continue to provide needed healthcare and other services, including disability compensation, for those veterans suffering from either diagnosed or undiagnosed illnesses.

With regard to research, I would remind you that the Registry and other similar examination program data are provided through medical records of self-selected individuals and, thus, may not be reflective of the entire population of Persian Gulf War veterans. In order to draw definitive conclusions about the health status of PGW veterans, a carefully designed and well-executed research program is necessary. VA has initiated such a research program.

VA's research program related to Persian Gulf veterans illnesses includes more than 30 individual projects being carded out by VA and university-affiliated investigators across the nation. And these projects are but part of the overall federal research effort.

VA established three Environmental Hazards Research Centers in 1994; all three centers are carrying out projects which address aspects of the potential adverse health outcomes of exposure to neurotoxins. In addition, VA's Environmental Epidemiology Service has completed a Persian Gulf Veterans Mortality Study and the first phase of the National Health Survey of Persian Gulf War Veterans and their Families. Details of these and other Government Federallysponsored research studies are included in the report, Federally Sponsored Research on Persian Gulf Veterans Illnesses for 1995. Copies of this report have been provided to the Committees.

In May, VA announced that it would establish a fourth Environmental Hazards Research Center. This center will study adverse reproductive health effects that may be associated with military occupational exposures in the Persian Gulf, Vietnam and elsewhere. The proposals were due to VA's Research and Development Service on September 16, and awards will be made in the next two months.

I would take this opportunity to also give you a status report on the progress of two major epidemiological efforts.

The first is the Persian Gulf War Veterans Mortality Study. This study analyzes the specific causes of all deaths among the 696,562 Persian Gulf veterans who served in the theater of operations between August 1990 and April 1991, and a comparison group of 746,291 veterans who served elsewhere. The follow-up period for this study went through September 1993. The Persian Gulf Veterans Mortality Study has been

completed and has been accepted for publication in a major scientific journal. While the study demonstrates an excess in deaths in PGW veterans due to external causes, such as automobile accidents, it does not demonstrate differences in death rates due to medical conditions, including deaths due to cancer. The results of this, and other scientific studies taken together, suggest that PGW veterans as a group are not suffering from life-threatening medical conditions at rates higher than veterans who did not serve in Operations Desert Shield and Desert Storm.

The second study is the National Health Survey of Persian Gulf Veterans and their Families. This is being carried out by the VA's Environmental Epidemiology Service. Phase 1, apostal survey of 15,000 Gulf War veterans and a comparison group of 15,000 Gulf era veterans, was completed in August. The questions on this survey asked veterans to report health complaints, medical conditions, and a wide variety of possible environmental exposures, including episodes of potential nerve gas, mustard gas, or biological warfare exposure. The response rate for Phase I of this survey was 57 percent. Phase II will consist of 8,000 telephone interviews and a review of 4,000 medical records. Phase II will address the potential for nonresponse bias, provide a more stable estimate of prevalence rates for various health outcomes, and verify self-reported health outcomes in medical records. The Phase III examination protocol is being finalized and examinations of veterans and their family members are expected to begin in Spring 1997. The protocol is being reviewed to determine if revisions are indicated based on our new knowledge of potential low-level chemical warfare agent exposures. Peer-review is being provided by a subcommittee of VA's Persian Gulf War Expert Scientific Advisory Committee. It is too early to discuss the results of this study as we have just begun our analysis of the Phase I results.

In January 1994, the Secretaries of VA, DoD, and HHS established the Persian Gulf Veterans Coordinating Board to provide interdepartmental coordination and direction of federal programs related to Persian Gulf War veterans. The Coordinating Board provides an interdepartmental means to share information on Persian Gulf War veterans health, to effectively allocate available resources, and to provide means of disseminating new research information. The Coordinating Board has three primary objectives:- To ensure that all veterans are provided' the complete range of healthcare services necessary to take care of medical problems that may be related to deployment in Operations Desert Shield and Desert Storm;

- To develop a research program that will result in the most accurate and complete understanding of the health problems experienced by PGW veterans and the factors that have contributed to these problems; and

- To develop clear and consistent guidelines for the evaluation and compensation of disabilities related to Persian Gulf service.

VA plays a central role in the Persian Gulf Veterans Coordinating Board through its participation in the Clinical, Research, and

Compensation and Benefits Working Groups. In particular, the research working group provides guidance and coordination for VA, DoD and HHS research activities related to Persian Gulf War veterans health. It coordinates all studies conducted or sponsored by these three departments to prevent unnecessary duplication and to ensure that important gaps in scientific knowledge are identified and addressed. The working group is actively involved in directing resources toward high priority questions and monitoring the results of Federally- sponsored research projects. It has produced two reports: the Report of Federal Research Activities Related to Persian Gulf Veterans Illnesses and the 1995 document A Working Plan for Research On Persian Gulf Veterans Illnesses. The 1996 update of the Working Plan was due to be released in September but will be delayed to allow incorporation of this new information.

One example of the Coordinating Board's proactive role in relevant research administration was its prioritization of the federal government and non-government researchproposals submitted for funding pursuant to DoD's Broad Agency Announcement. The American Institute for Biological Sciences (AIBS) performed peer-review of the 111 proposals submitted. The research working group reviewed those proposals judged scientifically meritorious by AIBS and prioritized them according to relevance and potential to fill research gaps in the existing Persian Gulf research portfolio. Twelve research projects encompassing the areas of reproductive outcomes, toxicology of pyridostigmine bromide, modeling of respiratory toxicant exposures from tent heaters, psychological outcomes, leishmaniasis, chronic fatigue, fibromyalgia, and neuromuscular function were given high priority for funding by the research working group.

Important to note is the fact that studies of low-level chemical warfare agent exposure were not given high priority in its 1995 Working Plan because military and intelligence sources had repeatedly stated that there had been no use, presence, or evidence of exposure to chemical warfare agents. Based on those repeated assertions, combined with a lack of clear cut clinical evidence to support a finding of chemical warfare exposure, the Coordinating Board focused its research resources on other questions. This decision was supported by the Institute of Medicine, VA Persian Gulf Expert Scientific Committee, the National Institutes of Health Technology Assessment Workshop, and others.

When DoD made its recent announcement regarding possible exposure of U.S. troops to chemical warfare nerve agents at Khamisiyah the Coordinating Board immediately began revision of its action plan.

VA, through the Research Working Group of the Coordinating Board, has developed an action plan to address possible long-term health consequences of low-level exposure to chemicalwarfare nerve toxins and mustard gas, based on the DoD's announcements regarding the demolition of a chemical munitions bunker and the destruction of a pit containing sarin and cyclosarin at Khamisiyah.

A recent literature review carried out by the Armed Forces Epidemiology Board, an advisory board of independent, non-government scientists, suggests that readily-identifiable, long-term adverse health effects due to nerve agent exposures only occur in humans who show signs of acute toxicity or poisoning. That is, the available literature does not contain clear evidence that long-term, chronic adverse health effects result from exposures that do not produce acute clinical signs and symptoms. However, I should note that the research in this area is sparse and in VA's judgment it should not be construed to mean that clinically important adverse health effects cannot or definitely do not occur in the setting of low-level neurotoxin exposures. The Coordinating Board has recommended that more research resources be allocated to address this question. I strongly agree with this approach.

The DoD announcement regarding the demolitions at Khamisiyah has caused VA to reconsider and intensify its efforts related to possible effects of low-level exposures to chemical warfare agents. I have asked the Research Working Group of the Coordinating Board to provide a plan for addressing this issue as a component of the 1996 Working Plan for Research. As it now stands, the research working group has recommended a plan of action to: (1) fund toxicological research proposals on low-level chemical weapons exposure from a pool of already peer-reviewed proposals that had been submitted through a competitive process to the Army; (2) solicit research on the feasibility of conducting epidemiological investigations of low-level chemical agent effects; and (3) review the ability to confirm the identities and locations ofindividuals in and around Khamisiyah with the goal of soliciting, if appropriate, an epidemiological investigation.

Based on the Coordinating Board's recommendation, $2.5 million dollars has already been allocated to three new, peer-reviewed, basic science research projects in this area, and an additional $2.5 million dollars has been identified for future studies. Funding for these new efforts will come from the DoD/VA collaborative research program that is funded as part of DoD's appropriation.

While these efforts represent a good beginning, I have asked VA's Research and Development Service to take a completely fresh and broad look at these issues in light of the new information now provided by DoD. This includes asking them to develop a strategic plan for an environmental health research agenda that specifically focuses on low- level exposures to neurotoxins that might result from chemical warfare agents or other military situations. Likewise, we are in the process of organizing an international scientific symposium that bridges potential military and civilian incidents involving exposure to those types of chemicals. Given the relative lack of worldwide scientific capability for assessing these issues in the traditional open and peer-reviewed manner in which the best science is carried out, we believe it is essential to bring together a multi-disciplinary group of experts to focus on finding innovative solutions to these perplexing issues. In this regard, I would again stress that if we are going to adequately research these questions a major investment of resources will be needed.

In conclusion, I would reiterate that research related to the illnesses of Persian Gulf War veterans is highly complex, and this is especially so for the investigation of concerns related to possible low-level exposure to chemical warfare agents. VA is committed to meeting thesechallenges and obtaining the most accurate answers we can concerning the health of PGW veterans and their families. In this regard we are grateful for the assistance provided by the Presidential Advisory Committee on Gulf War Veterans' Illnesses, particularly insofar as the Committee played a central role in bringing to light this new information about probable troop exposure to sarin and cyclosarin.

Thank you, Mr. Chairmen. That concludes my prepared testimony.