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Appendix A
Health Consequences of Service During the
Persian Gulf War: Initial Findings and
Recommendations for Immediate Action*
FINDINGS AND RECOMMENDATIONS
In this report, the IOM Committee has attempted to highlight issues we
believe would benefit Tom immediate action. In reviewing the large volume of
documents and the progress of research currently underway, we have identified
areas that need prompt attention. -As the scope and extent of health problems of
Persian Gulf veterans have appeared to expand, the social response also has
grown. The committee believes that this has resulted in a fragmented attempt to
solve these problems. Thus we believe that sustained, coordinated, and serious
efforts must be made in the near term to focus both the medical, social, and
research response of the Government and of individuals and researchers. Hence,
the findings and recommendations that follow are offered with the intent to
focus and sharpen the debate, and to improve the quality of the data, and
thereby, scientific inference. Finally, we hope to impact in a positive way the
health in persons who served in the Persian Gulf War, as well as in those who
may follow in other military encounters.
Recommendations for immediate action follow based on the findings
presented here and the background information presented in the next chapter.
The recommendations are to be viewed as independent, and are not presented in
*
This appendix was excerpted from the Institute of Medicine report Health
Consequences of Service During the Persian Gulf War: Initial Findings and Recom-
mendationsforImmediateAction, Washington, D.C.: National Academy Press, 1995.
55
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ADEQUACY OF THE VA PERSIAN GULFREGISTRY AND UCAP
any priority order within categories. The recommendations are divided into
three categories: data and databases, coordination/process, and considerations of
study design needs.
DATA AND DATABASES
Finding I
The VA Persian Gulf Heals Registry is not a population database and is not
administered uniformly, therefore, it cannot serve He purposes of research into the
etiology or treatment of possible health problems. The Committee recognizes Hat
certain tabulated descriptions of affected persons may legitimately be carried out
for reasons other than the generation of scientific data. Specifically, there may be
medical reasons for collecting information about patients with certain kinds of
problems, especially diagnostic problems, particularly in medical settings where
the information may be subjected to more intense scrutiny. An example is the
establishment of the VA referral centers for Gulf War veterans. Since a limited
number of veterans have been referred to these centers, and because the sample is
self-selected, the Committee concludes Hat it is unlikely that productive scientific
research (especially of an epidemiological nature) can ever be based on the data
generated by the referral centers or the health registry as currently organized.
Recommendations
· The VA Persian Gulf Health Registry should be limited and specific to
gathering information to determine the types of conditions reported. The role of
this registry should be clearly defined as a means for identifying and reporting
illnesses among Gulf War veterans with concerns about their health. There should
be efforts to implement quality control and standardization of data collected by the
registry from other VA facilities. The VA registry data should not be promoted or
described as a means to determine prevalence estimates or identify the etiology of
a disease, but should be reviewed promptly for enrollment trends and potential
sentinel events.
· The VA should improve publicity regarding the existence of the Persian
Gulf Health Registry, and encourage all concerned POW veterans to be registered.
· Where possible the referral centers, standardized protocol should be used in
each VA facility.
· The timeliness of data received from the VA Medical Centers (VAMC) to
be entered into He PG Health Registry database needs to be improved.
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APPENDIXA
57
Finding 2
No single comprehensive data system exists that enables researchers to
track the health of Persian Gulf War veterans both while on active duty and after
separation. As a result, it is not possible to conduct research and determine He
morbidity and mortality experience of this population. Although both the VA
and the DoD have medical records systems in place, Hey are inadequate and
unlinked. This lack of a single data system is a hindrance to research concerning
delayed health effects, both for Persian Gulf veterans and for those serving in
future encounters.
Recommendation
· The Vice President of the United States should chair a committee
composed of representatives from HHS, DoD, and the VA to devise a plan to
link data systems on health outcomes with the development of standardized
heals forms, the ability to access information rapidly, and an organized system
of records for rapid entry into the data system.
Finding 3
The characteristics of the population at risk are critical to any definitive
studies of Gulf War health effects. The DoD has taken the proper steps to
enumerate and describe this population that will be part of the planned, but yet
incomplete, Army Geographical Information System model.
Recommendations
· The DoD registry needs to be completed as quickly and accurately as
possible.
· The secretaries of DoD and VA should develop a single service-
connected health record for each present active duty and former service
member. All health data entries should be recorded in this single record for the
individual.
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ADEQUACY OF THE VA PERSIAN GULF REGISTRY AND UCAP
COORDINATION/PROCESS
Finding 4
The committee has noted with interest and some concern the wide variety of
disciplines and expertise among persons who have considered possible causes of a
mystery illness. It has appeared to the committee that some of these persons and
organizations are simply not qualified to draw reasoned scientific conclusions, or
to implement those conclusions by means of specific medical intervention. There
may be substantial risk from inappropriate interventions because of adverse
reactions to drugs, development of resistant strains of microorganisms, or
especially the diversion of attention away from more orthodox diagnoses and
treatments that hold some promise of relief from symptoms of a "mystery illness."
Recommendation
· Decisions to provide funding, to refer patients, or to change usual operating
procedures for providing financial support should be based on more solid scientific
bases than has sometimes been evident in prior resource allocation. Funding
should be subject to external peer review and approval.
Finding 5
There are dozens of studies of POW health effects under way now, and many
others are being initiated. Several efforts appear to be redundant, yet there are
clearly gaps where research efforts are necessary. In its final report, the IOM
Committee will recommend some additional specific research projects.
Presently, the total number of undiagnosed conditions is unknown because the
data either are insufficiently understood or unavailable. Data Hat are available are
fragmented, managed by different methods in different agencies, and based on a
wide variety of unconnected rationales, from both military and civilian institutions.
Many research efforts should, but do not, rely on a common set of data resources.
Because so many unanswered questions remain concerning multi-system
etiologies that have been proposed to explain undiagnosed signs and symptoms, all
future as well as current evaluations must ensure that findings can be reconciled
across studies.
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APPENDIXA
59
Recommendations
· The Persian Gulf Veterans Coordinating Board (chaired by the secretaries
of VA, DoD, HHS) should actively coordinate all studies developed from any
new initiatives that receive federal funding, to prevent unnecessary duplication
and to assure that high priority recommended studies be conducted. These
studies should undergo appropriate external peer review before, during, and
after data collection and analysis.
· More staff should be assigned by the Persian Gulf Veterans Coordinating
Board in order to monitor, collect, assemble, and make accessible when
appropriate all relevant requested emerging data from studies now underway,
and make periodic reports to the appropriate federal oversight authority.
· Each new initiative should be evaluated in the context of what it can
contribute. That is, each new study should add something of value to the
information already being obtained or accumulated.
CONSIDERATIONS OF STUDY DESIGN NEEDS
Finding 6
To date, most studies of POW veterans have been piecemeal-one military
unit here, one collection of volunteers with some problem there, etc. But, some of
these studies have several fundamental problems. They are necessarily incomplete,
they usually lack proper controls, they are hard to generalize, they are subject to
grave statistical problems because of post-hoc hypotheses and multiple
comparisons, and where an effect truly exists they tend to have low statistical
power to detect a difference. Thus, bits and pieces are not likely to answer any
critical questions. The committee recognizes that an initial effort to survey a
sample of veterans is underway, but more is needed.
Overall, there has been a broad and serious lack of adequate attention to the
design of individual studies, and even more seriously, the scope and organization
of an appropriate collection of studies, each focused on the resolution of a specific
question. The committee regards this as a grave, though understandable, failure.
Experts in research design can and should work shoulder to shoulder with experts
in the subject matter of each individual study; this is particularly true for work in
epidemiology. A broader view of the whole collection of studies, including input
Tom experts in subject matter and in research methods, persons knowledgeable
about data sources and medical care systems, and those win general appreciation
of public concerns and public policy, has been conspicuously lacking. We believe
that good studies could be done, but Hat Hey will require substantial input from
experts in epidemiological methods.
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ADEQUACYOF THE VA PERSIAN GULFREGlSTRYAND UCAP
Recommendations
· The VA and DoD should determine the specific research questions that
need to be answered. Epidemiologic studies should be designed with the objective
of answering these questions given the input of experts in epidemiologic research
methods and data analysis, along with the input of experts in the subject matter
areas to be investigated.
· To obtain data on symptom prevalence, health status, and diagnosed
disease, the secretaries of DoD and VA should collaborate to conduct a
population-based survey of persons who served in the PG, and of PG-era service
personnel. The study should be designed to allow for adequate comparisons of
outcome by sex, service branch, and rank, with oversampling among certain
subgroups to allow for analysis. The IOM committee is willing to comment on and
assist in the study design. An evaluation of the feasibility and need for a
longitudinal study should take place coincident with this national survey.
Finding 7
Initial characterizations of smoke and unburned contaminants from the oil
well fires and other sources are not adequate, nor have the data available been
reduced to a format usable for drawing conclusions or conducting health studies.
Considerable data exist from a wide number of sources, but they have not been
compiled or analyzed in any organized or efficient way. For example, lead levels
that would cause acute toxicity have been reported; however, questions about the
validity of these reports have not been adequately addressed.
Recommendations
· DoD should assemble and organize these data from all sources for
evaluation by the IOM committee.
· DoD should conduct a study that simulates exposure in tents heated by
diesel fuel, with composition similar to that used in the PG. Fuels and conditions
should simulate as closely as possible the conditions that existed in the PG.
Exposure to lead and its possible effects should be explored further. The
committee reviewed work done indicating that some personnel in the Gulf had
lead levels consistent win acute intoxication. Thus in investigating lead exposure,
special attention should be given to any history of abdominal pain or mental
disorders.
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APPENDLYA
61
Finding 8
As acknowledged by the investigator, the VA study of mortality in the PG
veteran population is of insufficient duration to observe a higher rate of death than
would be expected from chronic disease outcomes.
Recommendation
· The VA should plan and provide support for its mortality study to continue
in the fixture in order to permit the detection and investigation of long-term
mortality from chronic disease.
Finding 9
Although infertility, unrecognized and recognized pregnancy loss, premature
delivery, fetal grown retardation, birth defects, and abnormal development are all
components of reproductive health, studies and surveillance efforts to date have
focused primarily on birth defects, fetal and neonatal deaths, and low birth weight.
Adverse reproductive effects can be mediated through males as well as females, so
it is important to study exposures of both parents. Information on infertility and
miscarriage has not been included in the VA Health Registry efforts Moreover,
data on outcomes are available only from a single cluster study in Mississippi and
the Army Surgeon General's preliminary data evaluation. DoD recently launched a
study of reproductive health, and the VA and DoD clinical evaluation protocols
provide some surveillance of infertility, miscarriage, birth defects, and infant
deaths.
The design of scientific studies to address reproductive risk associated with
environmental exposures is complex. A variety of endpoints may occur throughout
the continuum beginning with fertility, through intrauterine, peripartum, and
neonatal development, and continuing with effects manifested only later in
childhood. Additionally, sophisticated expertise is required to document
environmental exposures as the etiology for adverse pregnancy experience. There
are research groups in some academic and federal settings that could, if deemed
appropriate, conduct such complex research.
Recommendations
· VA and DoD should include reproductive outcomes among the array of
health endpoints in surveillance programs based on medical records and individual
questionnaires. Medical records, such as those to be included in the Seabees
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ADEQUACY OF THE VA PERSIAN GULFREGISTRY AND UCAP
reproductive study and the DoD reproductive health study, would be suitable to
ascertain stillbirth, low birth weight, preterm delivery, and major birth defects.
Questionnaires such as those administered for the VA health registry exam could,
in addition, address questions of infertility and clinically recognized miscarriage.
· The Persian Gulf Veterans Coordinating Board should consider specific
exposures that are most likely to adversely affect reproductive health of women,
men, or both, distinguishing between agents that would affect reproductive health
only if exposure occurred at or around the time of critical periods during
pregnancy versus those that might have effects that would persist after the
cessation of exposure. As specific hypotheses linking exposure and reproductive
outcomes are identified, studies that are suitable to providing more conclusive
results for those associations should be designed.
· The Persian Gulf Veterans Coordinating Board should remain alert but
skeptical about cluster studies such as those underway in Mississippi. Studies of
this kind may be valuable in suggesting etiologic hypotheses; however, they have
little promise for resolving questions about links between experiences in the
Persian Gulf and reproductive health. Population-based studies of reproductive
health outcomes are essential to resolve questions of effects of Persian Gulf War
service.
Finding 10
Women who did not realize that they were pregnant at the time were deployed
to the Gulf; others became pregnant during their service in the Gulf. These groups
of women may have been exposed to substances potentially hazardous to
themselves and to their unborn babies. A study would permit comparisons of birth
outcomes and potential adverse health effects on women exposed at different times
in their pregnancies.
Recommendation
· The Persian Gulf Veterans Coordinating Board should conduct a study to
compare women deployed to the PG who were or who became pregnant at any
time during the Persian Gulf War with an appropriate group of other women who
were pregnant, but did not serve in the POW, to evaluate potential adverse health
outcomes to the mother or child. This study should only be done if a sufficient
number of women can be identified. Efforts should be made to gather
exposure information relevant to service at potentially high-risk times during
gestation.
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APPENDIX A
63
Finding 11
The committee has become aware that rosters exist that contain the names
of persons vaccinated with anthrax and botulinum toxoid.
Recommendation
· DoD should maintain its lists of those receiving anthrax and botulinum
vaccines for the purpose of conducting follow-up studies on these cohorts.
Finding 12
Troops were given packets of pyridostigmine bromide (PB) pills to be taken
as a prophylactic to the threat of nerve agent exposure, at the direction of their
commanding officer. PB by itself, in recommended doses, is a safe drug.
Additionally, DEET (N,N-diethyl-m-toluamide) and pennethrin were used by
the troops to prevent insect bites. There is some information about the possible
long-term toxicity to humans of DEET absorbed through the skin; however
there appears to be little or no information about dermal absorption of
permethrin from residues left on clothing, bedding, or elsewhere. Although
permethrin is generally not applied to skin, animal studies have shown that
permethrin is transferred from cloth to skin, and subsequently absorbed (NRC,
1994~. There is little information about how PB, DEET, and pennethrin might
interact; interactions among these compounds are possible and are inadequately
studied.
Recommendation
· Studies are needed to resolve uncertainties about whether PB, DEET, and
permethrin have additive or synergistic effects. Unsubstantiated suggestions that
they may have chronic neurotoxic effects need to be tested in carefully controlled
studies in appropriate animal models. Appropriate laboratory animal studies of
interactions between DEET, PB, and permethrin should be conducted.
Finding 13
Reported symptoms suggestive of visceral leishmanial infections include
fever, chronic fatigue, malaise, cough, intermittent diarrhea, abdominal pain,
weight loss, anemia, lymphadenopathy, and splenomegaly. The committee has
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ADEQUACY OF THE VA PERSIAN GULF REGISTRYAND UCAP
considered two aspects of exposure to L. tropica and resulting infection with
leishmania: the occurrence of either cutaneous or visceral leishmaniasis; and the
possibility that some component of the poorly defined illness referred to as "Gulf
War Syndrome" may result from leishmania infection.
Leishmaniasis (L. tropical in PGW veterans has been evaluated in some very
limited clinical studies, but not in epidemiological studies. The clinical studies
suggest that the complex of symptoms in the PGW veterans diagnosed with
leishmaniasis differs from what has been described in the literature for other forms
of leishmaniasis. A major limitation to further investigation and diagnosis of
leishmaniasis is the lack of an informative serologic test or other easy to use
screening tests.
Recommendations
· The DoD Joint Technology Coordination Group II has research
responsibilities for infectious diseases of military importance and should give high
priority to the development of a screening approach' to be used under field
conditions expected in deployment, and a useful diagnostic test for L. tropics The
board also should review the status of leishmania research, with a view toward
either drafting a request for proposals for test development, or the structured
coordination of existing activities.
· All physicians should be notified to look for symptoms that are consistent
with both leishmania infection and those reported as "Gulf War Syndrome." Clear
instructions for folIow-up actions should be widely communicated throughout the
physician community. Veterans of Desert Storm should be notified that if they
have symptoms that may suggest viscerotropic leishmaniasis they should bring this
possibility to the attention of the staff at any facility where they obtain any health
care, whether it is in the VA system or not. The latter may be particularly
important due to the potential for long-term survival of leishmania in the host.
· When it becomes feasible, VA, DoD, or both should conduct an
epidemiologic and seroepidemiologic study of leishmaniasis in PGW veterans
presenting symptoms or conditions and appropriate controls. Special attention
should center on a possible relation between leishmaniasis and the "Gulf War
Syndrome."
Finding 14
The ecology and epidemiology of L. tropics are insufficiently studied.
Many important questions remain unanswered conceiving host species, vectors,
and means of transmission to military personnel. The possible role of dogs as
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65
rcse~oirs of disease Ed the existence of vectors other Man sand Dies me
questions ~ have been raged.
Recommendedons
~ DoD should closely monitor aN anion reg~d~g ecological Ed
clinical Adds of a. ~- berg conducted ~ He U.S. Ed ~road.
~ Intem~iona1 Ed U.S. rese~cbers should be queried conceding say
advances ~ diagnostic 1ec~iques far idea ~ ~
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Representative terms from entire chapter:
gulf war
