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Appendix D
Adequacy of the Comprehensive Clinical
Evaluation Program: Nerve Agents*
RECOMMENDATIONS
The charge to the committee was to determine whether the Comprehensive
Clinical Evaluation Program could adequately diagnose and treat possible health
problems among service personnel who may have been exposed to low levels of
nerve agents. The committee reviewed extensive clinical and research results
regarding the effects of nerve agents. No evidence available to the committee
conclusively indicated the existence of long-term health effects of low-level
exposure to nerve agents. Because film conclusions about these effects remain
elusive, the committee reviewed information about the types of health effects
that might exist as a result of exposure. Leading scientists presented information
suggesting that the possible effects might include neurological problems such as
peripheral sensory neuropathies and psychiatric problems such as alterations in
mood, cognition, or behavior.
Recent reports suggesting a possible toxic synergistic effect following
exposure to multiple agents known to influence cholinesterase activity will
require extensive research to determine their significance (Haley and Kurt,
1997; Haley et al., 1997a,b; Lottie et al., 1993~. The results of the research to
date, however, did not appear to indicate any additional possible health effects
should be considered by the committee other than those already identified.
This appendix is excerpted from the Institute of Medicine report, Adequacy of the
Comprehensive Clinical Evaluation Program: Nerve Agents, Washington, D.C.:
National Academy Press, 1997.
97
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ADEQUACY OF THE VA PERSON GULFREGISTRYAND UCAP
The committee concluded that the CCEP continues to provide an
appropriate screening approach to the diagnosis of disease. Most CCEP
patients receive a diagnosis and 80% of participants receive more than one
diagnosis. Although the types of primary diagnoses commonly seen in the
CCEP involve a variety of conditions, 65% of all primary diagnoses fall into
three diagnostic groups (1) psychological conditions; (2) musculoskeletal
diseases; and (3) symptoms, signs, ill-defined conditions or a fourth group
designated as "healthy." However, in view of potential exposure to low levels
of nerve agents, certain refinements in the CCEP would increase its value.
These refinements are viewed as part of a natural evolution and improvement
process and, therefore, need not be applied retrospectively. The committee does
encourage rapid implementation in order to provide the benefits of an improved
system to new enrollees.
The committee recommends improved documentation of the screening
used during Phase I for patients with psychological conditions such as
depression and posttraumatic stress disorder (PTSD). The DoD (DoD, 1996)
reported that depression and PTSD account for a substantial percentage of those
receiving a diagnosis of a psychological condition. In addition, if there are long-
term health effects of nerve agent exposure, it is possible that these effects could
be manifested as changes in mood or behavior. The committee will be
conducting an in-depth examination of the adequacy of the CCEP as it relates to
stress and psychiatric disorders at a later time; however, because of the
increased importance of ensuring that all possibilities are thoroughly checked,
better documentation in this area is encouraged. Primary physicians could use
any of a number of self-report screening scales, but consistent use of the same
scale across facilities would ensure consistent results.
The committee recommends improved documentation of neurological
screening done during both Phase I and Phase II of the CCEP. Concern
about nerve agent exposure as well as the number of nonspecific, undiagnosed
illnesses among CCEP patients makes documentation of neurological screening
extremely important. CCEP patients are referred to neuromuscular specialists if
they have complaints of severe muscle weakness, fatigue, or myalgias lasting
for at least 6 months that significantly interfere with activities of daily living.
These patients are evaluated by board-certified neurologists who have
subspecialty training in neuromuscular disease. Based on the description of the
tests administered and examinations conducted, the committee finds that the
CCEP is sufficient to ensure that no chronic, well-established neurological
problem is being overlooked. The documentation of the use of these tests and
procedures, however, could and should be improved. Such improvements would
engender confidence that neurological examinations and treatments across
facilities are comparable.
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APPENDIX D
99
Given the importance of thorough neurological and psychiatric screening,
the committee recommends that Phase I primary physicians have ready
access to a referral neurologist and a referral psychiatrist. As mentioned
earlier, patients are referred to neuromuscular specialists if they have complaints
of severe muscle weakness, fatigue, or myalgias lasting for at least 6 months
that significantly interfere with activities of daily living. Appropriate psychiatric
referrals could include those with chronic depression that is treatment-resistant,
an unexplained, persistent complaint of memory problems, or significant
impairment secondary to behavioral difficulties, such as not being able to
maintain productive work due to behavioral abnormalities. While patients
referred for Phase II consultations with a neurologist or psychiatrist are cared
for adequately, it is sometimes difficult for the primary physician to determine
whether or not a referral is appropriate. In such instances, the physician tends to
refer more frequently than not. It may be that, if the primary care physician had
neurological and psychiatric consultations readily available, referral decisions
could be made more easily and appropriately.
The committee recommends that physicians take more complete patient
histories, particularly regarding personal and family histories, the onset of
health problems, and occupational and environmental exposures. While
there currently is grave concern about exposure to nerve agents during
deployment in the Persian Gulf, other factors have an affect on psychological
and neurological disorders. Patients can perform below expectations on
neuropsychological tests for a number of reasons. In clinical assessments,
therefore, it is important to rule out alternative causes of impairment. In
addition, current and past exposures to occupational and environmental
toxicants are important. Detailed histories are a valuable tool in identifying the
etiology of a patient's problems.
The committee recommends that, to the extent possible, predeployment
physical examinations given to members of the armed forces should be
standardized among the services. The lack of uniform baseline information
about service members makes diagnosis and treatment of postdeployment
problems more difficult. To the extent that adequate baseline information is
unavailable, physicians must rely on self-reporting. Adequate predeployment
physical examinations, standardized across services, could prove an important
tool for both clinical assessment and structured research.
The committee recommends that DoD increase the uniformity of CCEP
forms and reporting procedures across sites. The CCEP system would benefit
from increased consistency and the knowledge that each service is collecting
and using the same information. Currently, each branch of service and each
facility use different forms to complete examinations, tests, and referrals.
Increasing the consistency of such forms and procedures would provide a more
reliable picture of the care given to patients in the CCEP. As was stated in the
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ADEQUACY OF THE VA PERSIAN GULF REGISTRY AND UCAP
1996 report on the Health Consequences of Service During the Persian Gulf
War, it is extremely important to create a uniform, continuous, and retrievable
medical record. In addition, the 1996 report stated that the information should
be collected according to standardized procedures and maintained in a
computer-accessible-format (IOM, 1996b). The committee concurs with those
findings.
For each patient, the physician should provide written evidence that all
organ systems were evaluated. The CCEP primary care physicians examine
patients, and, if there are problems requiring additional expertise, the patients
are referred to specialists. This is standard medical practice used across the
United States. It would be appropriate, however, for the CCEP primary care
physicians to document that their evaluations covered all organ systems. The
committee is not recommending the use of new or sophisticated testing
mechanisms. It is reinforcing the importance of the components of the basic
medical examination. This increased documentation could be completed by
noting the organ systems evaluated and whether each was normal or abnormal.
For those listed as abnormal, additional information could be provided.
The committee strongly urges the DoD to offer group education and
counseling to soldiers and their families concerned about exposure to toxic
agents. Following the revelation by the DoD of possible exposure to nerve
agents due to the destruction of the munitions dump at Khamisiyah,
approximately 20,000 service personnel received a letter Tom the DoD stating
that their units were in the vicinity during the demolition. Each recipient was
encouraged to contact an 800 number if he or she was experiencing health
problems believed to be a result of service in the Persian Gulf. Given this
revelation, there may be a heightened sense of insecurity and concern among
Persian Gulf veterans and their families about possible exposure to nerve agents.
Risk communication is an important clinical activity. Family and group
counseling can address heightened concerns about exposure as well as other
issues. Such an approach provides an appropriate public health mechanism for
imparting information and addressing concerns and should be made available to
all Persian Gulf veterans.
Although it is beyond the scope of the charge to this committee to
determine whether low-level exposure to nerve agents causes long-term health
effects, the committee believes strongly that this is an important research area
that ought to be pursued. Most of the literature regarding health effects of
exposure to nerve agents (i.e., sarin and cyclosarin) addresses exposures high
enough to cause clinically observable effects. These clinical effects are well
documented and include miosis, blurred vision, nausea, vomiting, muscular
twitching, weakness, convulsions, and death. Little known research has been
conducted regarding the long-term health effects of low levels of exposure to
these nerve agents. The application of findings from research on organo
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APPENDIX D
101
phosphate pesticide exposure to the area of nerve agent exposure has
limitations. However, even in such pesticide studies, long-term health effects
have been documented only for acutely poisoned individuals that is, persons
with immediate clinical symptoms.
The committee emphasizes that the CCEP is not an appropriate vehicle for
scientifically assessing questions about long-term health effects of low levels of
exposure to nerve agents. The CCEP is a clinical treatment program, not a
research protocol. It is important, therefore, not to attempt to use the findings of
the CCEP to answer research questions. Those questions must be addressed
through rigorous scientific research.
The committee notes that the CCEP could be useful in identifying
promising directions for separate research studies. Examinations of the health
effects if any-of various wartime exposures have been hampered by poor
information about the level of exposure and an inability to identify the
individuals who may have been exposed. It is often difficult to retrospectively
estimate exposure levels. However, information about where individuals were
and when they were there could be combined with data regarding the presence
of an exposure to develop surrogate measures. These surrogate measures could
then be linked to health information and used to examine potential associations
between exposures and health effects.
Although data from the CCEP cannot be used to test for associations, it can
be combined with other information to help identify areas for future research.
For example, the DoD identified approximately 20,000 service people
belonging to units that were within a 50-kilometer radius of Khamisiyah at the
time of the munitions demolition. Examining the health records of these people
may yield insights into whether those who participated in the CCEP (or a similar
program administered by the VA) have different illnesses or patterns of illnesses
than do CCEP participants outside the 50-kilometer radius. More detailed
o~scr~m~nat~on of proximity to Khamisiyah (e.g., within 20 kilometers or within
the units directly responsible for the munitions destruction) may provide
additional information.
It is important, however, to understand the limitations of such comparisons.
The results cannot be taken as research findings and generalized to the entire
population of those deployed to the Persian Gulf. Active-duty military personnel
participating in the DoD health registry may be either more or less healthy than
other nonparticipants on active duty. CCEP comparisons on this self-selected
group of patients should not be used to draw conclusions about the entire
population of Persian Gulf veterans.
More broadly, the committee notes that information that helps to identify
where individuals were in the Persian Gulf and when they were there will also
facilitate research into potential service-related health problems. This
information is currently needed to address the question of who might have been
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ADEQUACY OF THE VA PERSIAN GULF REGISTRY AND UCAP
exposed to nerve agents and who could be part of the (unexposed) comparison
groups necessary for epidemiological studies. Such information could also be
used to more quickly and easily identify the exposed and unexposed groups that
would be required to assess any future concerns regarding this or other
exposures.
Generating geographical and temporal information for all 700,000 people
who served in the Persian Gulf would be an immense endeavor. It would not be
prudent to undertake such a task without first thoroughly understanding the
effort required to complete it. It would, however, be appropriate to take steps
now to identify and preserve records that could assist in the generation of such a
database in the fixture. Records-based information is intrinsically superior to
personal recollections, especially several years after the fact.
COMMITTEE ON THE EVALUATION OF THE DoD
COMPREHENSIVE CLINICAL EVALUATION PROGRAM
*
Dan G. Blazer, Chair, Dean of Medical Education and Professor of Psychiatry,
Duke University Medical Center, Durham, North Carolina
Margit L. Bleecker, Director of the Center for Occupational and Environmental
Neurology, Baltimore, Maryland
Evelyn J. Bromet, Professor, Department of Psychiatry, State University of
New York at Stony Brook, Stony Brook, New York
Gerard Burrow, Dean, Yale University School of Medicine, New Haven,
Connecticut
Howard Kipen, Associate Professor and Director, Occupational Health
Division, Robert Wood Johnson Medical School, Piscataway, New Jersey
Adel A. Mahmoud, Chailman, Deparunent of Medicine, Case Western
Reserve University and University Hospitals of Cleveland, Cleveland, Ohio
Robert S. Pynoos, Associate Professor of Psychiatry and Dean of the Trauma
Psychiatry Service, University of California at Los Angeles, Los Angeles,
California
Guthrie L. Turner, Chief Medical Consultant, Office of Disability
Determination Services, State of Washington, Tummwater, Washington
Michael Weisman, Professor, Division of Rheumatology, University of
California at San Diego Medical Center, San Diego, California
Stay
Lyla M. Hernandez, Study Director
Sanjay S. Baliga, Research Associate
*Member, Institute of Medicine.
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APPENDIX D
David A. Butler, Senior Program Officer
Donna M. Livingston, Project Assistant
James A. Bowers, Project Assistant
Kathleen R. Stratton, Director, Division of Health Promotion and Disease
Prevention
-Constance M. Pechura, Director, Division of Neuroscience and Behavioral
Health
103
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Representative terms from entire chapter:
persian gulf
