oversight

Gulf War Illnesses: Reexamination of Research Emphasis and Improved Monitoring of Clinical Progress Needed

Published by the Government Accountability Office on 1997-06-25.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                           United States General Accounting Office

GAO                        Testimony
                           Before the Committee on Veterans Affairs, U.S. Senate




For Release on Delivery
Expected at
9:30 a.m., EDT
                           GULF WAR ILLNESSES
Wednesday, June 25, 1997


                           Reexamination of Research
                           Emphasis and Improved
                           Monitoring of Clinical
                           Progress Needed
                           Statement of Donna Heivilin, Director of Planning and
                           Reporting, National Security and International Affairs
                           Division




GAO/T-NSIAD-97-191
             Mr. Chairman and Members of the Committee:

             We are pleased to be here today to discuss the result of our study on the
             government’s clinical care and medical research programs relating to
             illnesses that members of the armed forces might have contracted as a
             result of their service in the Persian Gulf War.1 Our report responds to the
             mandate of the fiscal year 1997 defense authorization act. Specifically, we
             will discuss three issues: (1) the efforts of the Department of Defense
             (DOD) and Veterans Affairs’ (VA) to assess the quality of treatment and
             diagnostic services provided to Gulf War veterans and their provisions for
             follow-up of initial examinations, (2) the government’s research strategy to
             study the veterans’ illnesses and the methodological problems posed in its
             studies, and (3) the consistency of key official conclusions with available
             data on the causes of the veterans’ illnesses.

             We will summarize our findings on the three issues we reviewed and then
             provide more detail. Regarding the first issue, although efforts have been
             made to diagnose veterans’ problems and care has been provided to many
             eligible veterans, neither DOD nor VA has systematically attempted to
             determine whether ill Gulf War veterans are any better or worse today
             than when they were first examined.

             On the second issue, we found that the majority of the research has
             focused on the epidemiological study of the prevalence and cause of Gulf
             War illnesses rather than the diagnosis, treatment, and prevention of them.
             While this epidemiological research will provide descriptive data on
             veterans’ illnesses, methodological problems are likely to prevent
             researchers from providing precise, accurate, and conclusive answers
             regarding the causes of veterans’ illnesses. Without accurate exposure
             information, the investment of millions of dollars in further
             epidemiological research on the risk factors (or potential causes) for
             veterans’ illnesses may result in little return.

             Regarding the third issue, support for some official conclusions regarding
             stress, leishmaniasis (a parasitic infection), and exposure to chemical
             agents was weak or subject to alternative interpretations.


             Before turning to the results of our work in detail, let me briefly provide
Background   some background information and discuss the methodology we used for

             1
             Gulf War Illnesses: Improved Monitoring of Clinical Progress and Reexamination of Research
             Emphasis Are Needed (GAO/NSIAD-97-163, June 23, 1997).



             Page 1                                                 GAO/T-NSIAD-97-191 Gulf War Illnesses
              our study. During their deployment associated with the Persian Gulf War,
              many of the approximately 700,000 veterans of the Gulf War may have
              been exposed to a variety of potentially hazardous substances. These
              substances include compounds used to decontaminate equipment and
              protect it against chemical agents, fuel used as a sand suppressant in and
              around encampments, fuel oil used to burn human waste, fuel in shower
              water, leaded vehicle exhaust used to dry sleeping bags, depleted uranium,
              parasites, pesticides, drugs to protect against chemical warfare agents
              (such as pyridostigmine bromide), and smoke from oil well fires.
              Moreover, DOD acknowledged in June 1996 that some veterans may have
              been exposed to the nerve agent sarin following the postwar demolition of
              Iraqi ammunition facilities.

              Many of these veterans have complained of a wide array of symptoms and
              disabling conditions since the end of the war in 1991. Some fear that they
              are suffering from chronic disabling conditions because of exposure to
              chemicals, pesticides, and other agents used during the war with known or
              suspected health effects. Accordingly, both DOD and VA established
              programs through which Gulf War veterans could receive medical
              examinations and diagnostic services. From 1992 to 1994, VA participants
              received a regular physical examination with basic laboratory tests. In
              1994, VA established a standardized examination to obtain information
              about exposures and symptoms related to diseases endemic to the Gulf
              region and to order specific tests to detect the “biochemical fingerprints”
              of certain diseases. If a diagnosis was not apparent, veterans could receive
              up to 22 additional tests and additional specialty consultations. In
              addition, if the illness defied diagnosis, the veterans could be referred to
              one of four VA Persian Gulf referral centers.

              DOD initiated its Comprehensive Clinical Evaluation Program in June 1994.
              It was primarily intended to provide diagnostic services similar to those of
              the VA program and employed a similar clinical protocol. However, the VA
              program was among the first extensive efforts to gather data from
              veterans regarding the nature of their problems and the types of hazardous
              agents to which they might have been exposed.


              To address our first evaluation question—the extent of DOD’s clinical
Methodology   follow-up and monitoring of treatment and diagnostic services—we
              reviewed literature and agency documents and conducted structured
              interviews with DOD and VA officials. We asked questions designed to
              identify and contrast their methods for monitoring the quality and



              Page 2                                    GAO/T-NSIAD-97-191 Gulf War Illnesses
outcomes of their treatment and diagnostic programs and the health of the
registered veterans.

The second objective concerns the coherence of the Persian Gulf Veterans
Coordinating Board’s (PGVCB) research strategy. To answer this question,
we conducted a systematic review of pertinent literature and agency
documents and reports. We also interviewed representatives of PGVCB2
Research Working Group and officials of VA, DOD, and the Central
Intelligence Agency. We surveyed primary investigators of ongoing
epidemiological studies.

Because different methodological standards apply to various types of
research and because the overwhelming majority of federally sponsored
research is categorized as epidemiological, we limited our survey to those
responsible for ongoing epidemiological studies. With the help of an
expert epidemiological consultant, we devised a questionnaire to assess
critical elements of these studies (including the quality of exposure
measurement, specificity of case definition, and steps to ensure adequate
sample size) and to identify specific problems that the primary
investigators may have encountered in implementing their studies. We
interviewed primary investigators for 31 (72 percent) of the 43 ongoing
epidemiological studies identified by PGVCB in the November 1996 plan. We
also reviewed and categorized descriptions of all 91 projects identified by
April 1997, based on their apparent focus and primary objective. Finally, to
review the progress of major ongoing research efforts, we visited the
Walter Reed Army Institute of Research, the Naval Health Research
Center, and two of VA’s Environmental Hazards Research Centers.

To address the third objective, we reviewed major conclusions of the
PGVCB and the Presidential Advisory Committee on Gulf War Veterans’
Illnesses to determine the strength of evidence supporting major
conclusions. The purpose of this review was not to critique PGVCB’s or the
Presidential Advisory Committee’s efforts, per se, but rather to describe
the amount of knowledge about Gulf War illnesses that has been generated
by research 6 years after the war. We reviewed these conclusions because
they are the strongest statements that we have come across on these
matters by any official body. The Presidential Advisory Committee’s report
was significant because the panel included a number of recognized
experts who were assisted by a large staff of scientists and attorneys. In
addition, the Committee conducted an extensive review of the research.

2
 PGVCB, comprised of the Secretaries of Defense, VA, and Health and Human Services, is charged with
coordinating the federal response to Gulf War veterans’ illnesses.



Page 3                                                 GAO/T-NSIAD-97-191 Gulf War Illnesses
                       Thus, we believed that evaluating these conclusions would provide
                       important evidence about how fruitful the federal research has been thus
                       far. We addressed this objective by reviewing extant scientific literature,
                       and consulting experts in the fields of epidemiology, toxicology, and
                       medicine.

                       Because of the scientific and multidisciplinary nature of this issue, we
                       ensured that staff conducting the work had appropriate backgrounds in
                       the field of epidemiology, psychology, environmental health, toxicology,
                       engineering, weapon design, and program evaluation and methodology. In
                       addition, we used in-house expertise in chemical and biological warfare
                       and military health care systems. Also, medical experts reviewed our
                       work. Moreover, we held extensive discussions with experts in academia
                       in each of the substantive fields relevant to this issue. Finally, we talked to
                       a number of the authors of the studies that we cited in this report to
                       ensure that we correctly interpreted their findings and had independent
                       experts review our draft report.

                       Our work was completed between October 1996 and April 1997 in
                       accordance with generally accepted government auditing standards.


                       Over 100,000 of the approximately 700,000 Gulf War veterans have
DOD and VA Have No     participated in DOD and VA health examination programs. Of those veterans
Systematic Approach    examined by DOD and VA, nearly 90 percent have reported a wide array of
to Monitoring Gulf     health complaints and disabling conditions. The most commonly reported
                       symptoms in VA and DOD registries include fatigue, muscle and joint pain,
War Veterans’ Health   gastrointestinal complaints, headache, skin rash, depression, neurologic
After Initial          and neurocognitive impairments, memory loss, shortness of breath, and
                       sleep disturbances.
Examination
                       Officials of both DOD and VA have claimed that regardless of the cause of
                       veterans’ illnesses, veterans are receiving appropriate and effective
                       symptomatic treatment. Both agencies have tried to measure or ensure the
                       quality of veterans’ initial examinations through such mechanisms as
                       training and standards for physician qualification. However, these
                       mechanisms do not ensure a given level of effectiveness for the care
                       provided or permit identification of the most effective treatments.3




                       3
                        See VA Health Care: Observations on Medical Care Provided to Persian Gulf Veterans
                       (GAO/T-HEHS-97-158, June 19, 1997).



                       Page 4                                                  GAO/T-NSIAD-97-191 Gulf War Illnesses
                    We found that neither DOD nor VA has mechanisms for monitoring the
                    quality, appropriateness, or effectiveness of these veterans care or clinical
                    progress after their initial examination and has no plans to establish such
                    mechanisms. VA officials involved in administering the registry program
                    told us that they regarded monitoring the clinical progress of registry
                    participants as a separate research project, and DOD’s Clinical Care and
                    Evaluation Program made similar comments. We believe that such
                    monitoring is important because (1) undiagnosed conditions are not
                    uncommon among ill veterans, (2) treatment for veterans with
                    undiagnosed conditions is based on their symptoms, and (3) veterans with
                    undiagnosed conditions or multiple diagnoses may see multiple providers.
                    Without follow-up of their treatment, DOD and VA cannot say whether these
                    ill veterans are any better or worse today than when they were first
                    examined.


                    Federal research on Gulf War veterans’ illnesses and factors that might
Federal Research    have caused their problems has not been pursued proactively. Although
Strategy Lacks a    these veterans’ health problems began surfacing in the early 1990s, the
Coherent Approach   vast majority of research was not initiated until 1994 or later. Much of this
                    research was associated with legislation or external reviewers’
                    recommendations. This 3-year delay has complicated the task facing
                    researchers and has limited the amount of completed research currently
                    available. Although at least 91 studies have received federal funding, over
                    70, or four-fifths, of the studies are not yet complete, and the results of
                    some studies will not be available until after 2000.

                    We found that some hypotheses received early emphasis, while some
                    hypotheses were not initially pursued. While research on exposure to
                    stress received early emphasis, research on low-level chemical exposure
                    was not pursued until legislated in 1996. The failure to fund such research
                    cannot be traced to an absence of investigator-initiated submissions.
                    According to DOD officials, three recently funded proposals on low-level
                    chemical exposure had previously been denied funds. We found that
                    additional hypotheses were pursued in the private sector. A substantial
                    body of research suggests that low-level exposure to chemical warfare
                    agents or chemically related compounds, such as certain pesticides, is
                    associated with delayed or long-term health effects.

                    Regarding delayed health effects of organophosphates, the chemical
                    family used in many pesticides and chemical warfare agents, there is
                    evidence from animal experiments, studies of accidental human



                    Page 5                                      GAO/T-NSIAD-97-191 Gulf War Illnesses
exposures, and epidemiological studies of humans that low-level
exposures to certain organophosphorus compounds, including sarin nerve
agents to which some of our troops may have been exposed, can cause
delayed, chronic neurotoxic effects.4

It has been suggested that the ill-defined symptoms experienced by Gulf
War veterans may be due in part to organophosphate-induced delayed
neurotoxicity.5 This hypothesis was tested in a privately supported
epidemiological study of Gulf War veterans.6 In addition to clarifying the
patterns among veterans’ symptoms by use of statistical factor analysis,
this study demonstrated that vague symptoms of the ill veterans are
associated with objective brain and nerve damage compatible with the
known chronic effects of exposures to low levels of organophosphates.7 It
further linked the veterans’ illnesses to exposure to combinations of
chemicals, including nerve agents, pesticides in flea collars,
N,N-diethyl-m-toluamide (DEET) in highly concentrated insect repellents,
and pyridostigmine bromide tablets.

Toxicological research indicates that pyridostigmine bromide, which Gulf
War veterans took to protect themselves against the immediate,
life-threatening effects of nerve agents, may alter the metabolism of
organophosphates in ways that activate their delayed, chronic effects on
the brain.8 Moreover, exposure to combinations of organophosphates and
related chemicals like pyridostigmine or DEET has been shown in animal



4
 Sarin has been used as a chemical warfare agent since World War II, most recently during the
Iran-Iraq war, and by terrorists in Japan.
5
 R. W. Haley et al., “Preliminary Findings of Studies on the Gulf War Syndrome,” Presentations to the
Intergovernmental Coordinating Board for the Gulf War Illness and the Staff of the Presidential
Advisory Committee on Gulf War Veterans’ Illnesses” (Sept. 16, 1995); R. W. Haley,
“Organophosphate-Induced Delayed Neurotoxicity,” Internal Medicine Grand Rounds, University of
Texas Southwestern Medical Center, Dallas, Texas (Oct. 10, 1996); and G. A. Jamal et al., “The Gulf
War Syndrome: Is There Evidence of Dysfunction in the Nervous System?” Journal of Neurology,
Neurosurgery, and Psychiatry, Vol. 60 (1996), pp. 449-451.
6
 This research, conducted at the University of Texas Southwestern Medical Center, has been
supported in part by funding from the Perot Foundation.
7
 R. W. Haley et al., “Is There a Gulf War Syndrome? Searching for Syndromes by Factor Analysis of
Symptoms,” Journal of American Medical Association, vol. 277 (1997), pp. 215-222; R. W. Haley et al.,
“Evaluation of Neurologic Function in Gulf War Veterans: A Blinded Case-Control Study,” Journal of
American Medical Association, vol. 277 (1997), pp. 223-230; and R. W. Haley et al., “Self-reported
Exposure to Neurotoxic Chemical Combinations in the Gulf War: A Cross-sectional Epidemiologic
Study,” Journal of American Medical Association, vol. 277 (1997), pp. 231-237.
8
 C. N. Pope and S. Padilla, “Potentiation of Organophosphorus Delayed Neurotoxicity,” Journal of
Toxicology and Environmental Health, vol. 31 (1990), pp. 261-273.



Page 6                                                    GAO/T-NSIAD-97-191 Gulf War Illnesses
studies to be far more likely to cause morbidity and mortality than any of
the chemicals acting alone.9

We found that the bulk of ongoing federal research on Gulf War veterans’
illnesses focuses on the epidemiological study of the prevalence and cause
of the illnesses. It is important to note that in order to conduct such
studies, investigators must follow a few basic, generally accepted
principles.

First, they must specify diagnostic criteria to (1) reliably determine who
has the disease or condition being studied and who does not and (2) select
appropriate controls (people who do not have the disease or condition).

Second, the investigators must have valid and reliable methods of
collecting data on the past exposure(s) of those in the study to possible
factors that may have caused the symptoms. The need for accurate,
dose-specific exposure information is particularly critical when low-level
or intermittent exposure to drugs, chemicals, or air pollutants is possible.
It is important not only to assess the presence or absence of exposure but
also to characterize the intensity and duration of exposure.

We found that the ongoing epidemiological federal research suffered from
two methodological problems: a lack of a case definition, and absence of
accurate exposures data. Without valid and reliable data on exposures and
the multiplicity of agents to which the veterans were exposed, researchers
will likely continue to find it difficult to detect relatively subtle effects and
to eliminate alternative explanations for Gulf War veterans’ illnesses.
Prevalence data can be useful, but it requires careful interpretation in the
absence of better information on the factors to which veterans were
exposed. While multiple federally funded studies of the role of stress in the
veterans’ illnesses have been done, basic toxicological questions regarding
the substances to which they were exposed remain unanswered.

We found that federal researchers studying Gulf War illnesses have faced
several methodological challenges and encountered significant problems
in linking exposures or potential causes to observed illnesses or
symptoms. For example:




9
 M. B. Abou-Donia et al., “Increased Neurotoxicity Following Concurrent Exposure to Pyridostigmine
Bromide, DEET, and Chlorpyrifos,” Fundamentals of Applied Toxicology, vol. 34 (1996), pp. 201-222
and M. B. Abou-Donia et al., “Neurotoxicity Resulting From Coexposure to Pyridostigmine Bromide,
DEET, and Permethrin,” Journal of Toxicology and Environmental Health, vol. 48 (1996), pp. 35-56.



Page 7                                                  GAO/T-NSIAD-97-191 Gulf War Illnesses
                      •   Researchers have found it extremely difficult to gather information about
                          exposures to such things as oil well fire smoke and insects carrying
                          infection.
                      •   DOD has acknowledged that records of the use of pyridostigmine bromide
                          and vaccinations to protect against chemical/biological warfare exposures
                          were inadequate.
                      •   Gulf War veterans were typically exposed to a wide array of agents,
                          making it difficult to isolate and characterize the effects of individual
                          agents or to study their combined effects.
                      •   Most of the epidemiological studies on Gulf War veterans’ illnesses have
                          relied only on self-reports for measuring most of the agents to which
                          veterans may have been exposed.
                      •   The information gathered from Gulf War veterans years after the war may
                          be inaccurate or biased. There is often no straightforward way to test the
                          validity of self-reported exposure information, making it impossible to
                          separate bias in recalled information from actual differences in the
                          frequency of exposures. As a result, findings from these studies may be
                          spurious or equivocal.
                      •   Classifying the symptoms and identifying illnesses of Gulf War veterans
                          have been difficult. From the outset, symptoms reported by veterans have
                          been varied and difficult to classify into one or more distinct illnesses.
                          Moreover, several different diagnoses might provide plausible
                          explanations for some of the specific health complaints. It has thus been
                          difficult to develop a case definition (that is, a reliable way to identify
                          individuals with a specific disease), which is a criterion for doing effective
                          epidemiological research.

                          In summary, the ongoing epidemiological research will not be able to
                          provide precise, accurate, and conclusive answers regarding the causes of
                          veterans’ illnesses because of these formidable methodological problems.


                          Six years after the war, little is conclusively known about the causes of
Support for Key           Gulf War veterans’ illnesses. In the absence of official conclusions from
Government                DOD and VA, we examined conclusions drawn in December 1996 by the

Conclusions Is Weak       Presidential Advisory Committee on Gulf War Veterans’ Illnesses. This
                          Committee was established by the President to review the administration’s
or Subject to             activities regarding Gulf War veterans’ illnesses. In January 1997, DOD
Alternative               endorsed the Committee’s conclusions about the likelihood that exposure
                          to 10 commonly cited agents contributed to the explained and unexplained
Interpretations           illnesses of these veterans. We found that the evidence to support three of
                          these conclusions is either weak or subject to alternative interpretations.



                          Page 8                                      GAO/T-NSIAD-97-191 Gulf War Illnesses
First, the Committee concluded that “stress is likely to be an important
contributing factor to the broad range of illnesses currently being reported
by Gulf War veterans.” While stress can induce physical illness, the link
between stress and these veterans’ physical symptoms has not been firmly
established. For example, a large-scale, federally funded study concluded
that “for those veterans who deployed to the Gulf War and currently report
physical symptoms, neither stress nor exposure to combat or its aftermath
bear much relationship to their distress.”10 The Committee has stated that
“epidemiological studies to assess the effects of stress invariably have
found higher rates of posttraumatic stress disorder (PTSD) in Gulf War
veterans than among individuals in nondeployed units or in the general
U.S. population of the same age.”

Our review indicated that the prevalence of PTSD among Gulf War veterans
may be overestimated due to problems in the methods used to identify it.
Specifically, the studies on PTSD to which the Committee refers have not
excluded other conditions, such as neurological disorders that produce
symptoms similar to PTSD and can also elevate scores on key measures of
PTSD. Also, the use of broad and heterogenous groups of diagnoses (e.g.,
“psychological conditions”—ranging from tension headache to major
depression) in data from DOD’s clinical program may contribute to
overestimation of the extent of serious psychological illnesses among Gulf
War veterans.

Second, the Committee concluded that “it is unlikely that infectious
diseases endemic to the Gulf region are responsible for long-term health
effects in Gulf War veterans, except in a small known number of
individuals.” Similarly, PGVCB concluded that because of the small number
of reported cases, “the likelihood of leishmania tropica as an important
risk factor for widely reported illness has diminished.” While this is the
case for observed symptomatic infection with the parasite, the prevalence
of asymptomatic infection is unknown, and such infection may reemerge
in cases in which the patient’s immune system becomes deficient. As the
Committee noted, the infection may remain dormant up to 20 years.
Because of this long latency, the infected population is hidden, and
because even classic forms of leishmaniasis are difficult to recognize, we
believe that leishmania should be retained as a potential risk factor for
individuals who suffer from immune deficiency.




10
 R. H. Stretch et al., “Physical Health Symptomatology of Gulf War-era Service Personnel From the
States of Pennsylvania and Hawaii, Military Medicine, vol. 160 (1995), pp. 131-136.



Page 9                                                  GAO/T-NSIAD-97-191 Gulf War Illnesses
                         Third, the Committee also concluded that it is unlikely that the health
                         effects reported by many Gulf War veterans were the result of
                         (1) biological or chemical warfare agents, (2) depleted uranium, (3) oil
                         well fire smoke, (4) pesticides, (5) petroleum products, and
                         (6) pyridostigmine bromide or vaccines. However, our review of the
                         Committee’s conclusions indicated the following:

                     •   While the government found no evidence that biological weapons were
                         deployed during the Gulf War, the United States lacked the capability to
                         promptly detect biological agents, and the effects of one agent, aflatoxin,
                         would not be observed for many years.
                     •   Evidence from various sources indicates that chemical agents were
                         present at Khamisiyah, Iraq, and elsewhere on the battlefield. The
                         magnitude of the exposure to chemical agents has not been fully resolved.
                         As we recently reported, 16 of 21 sites categorized by Gulf War planners as
                         nuclear, biological, and chemical (NBC) facilities were destroyed. However,
                         the United Nations Special Commission found after the war that not all the
                         possible NBC targets had been identified by U.S. planners. The Commission
                         has investigated a large number of the facilities suspected by the U.S.
                         authorities as being NBC related. Regarding those the Commission has not
                         yet inspected, we determined that each was attacked by coalition aircraft
                         during the Gulf War. One of these sites is located within the Kuwait theater
                         of operation in close proximity to the border, where coalition ground
                         forces were located.11
                     •   Exposure to certain pesticides can induce a delayed neurological
                         condition without causing immediate symptoms.
                     •   Available research indicates that exposure to pyridostigmine bromide can
                         alter the metabolism of organophosphates (the chemical family of some
                         pesticides that were used in the Gulf War, as well as certain chemical
                         warfare agents) in ways that enhance chronic effects on the brain.


                         Because of the numbers of Gulf War veterans who continue to experience
Recommendations to       illnesses that may be related to their service during the Gulf War, we
DOD and VA               recommended in our report that the Secretary of Defense, with the
                         Secretary of Veterans Affairs, (1) set up a plan for monitoring the clinical
                         progress of Gulf War veterans to help promote effective treatment and
                         better direct the research agenda and (2) give greater priority to research
                         on effective treatment for ill veterans and on low-level exposures to
                         chemicals and their interactive effects and less priority to further
                         epidemiological studies.

                         11
                           Operation Desert Storm: Evaluation of the Air Campaign (GAO/NSIAD-97-134, June 12, 1997), p. 2.



                         Page 10                                                 GAO/T-NSIAD-97-191 Gulf War Illnesses
           We also recommended that the Secretaries of Defense and Veterans
           Affairs refine the current approaches of the clinical and research programs
           for diagnosing posttraumatic stress disorder consistent with suggestions
           recently made by the Institute of Medicine. The Institute noted the need
           for improved documentation of screening procedures and patient histories
           (including occupational and environmental exposures) and the importance
           of ruling out alternative causes of impairment.

           Mr. Chairman, that concludes our prepared remarks. We will be happy to
           answer any questions you may have.




(713010)   Page 11                                   GAO/T-NSIAD-97-191 Gulf War Illnesses
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