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OCR for page 113
l'~formatio'~ gainedirom the 'numerous studies of veterans of specific
conflicts has given rise to broacler questions regarding tile co'~seque`?ces
of service in any major military engagement. Concer/? now is beingfocused
on questio!?s of war-related illnesses aI?4 postbeploymet~t health issues.
)h4~, ~ EAllM ANI.) ~MPRt)\fIN(' ~~:)RMANCE
Infectious cliseases pose a substantial thereat to tire nation's military
forces, Troops bottle at Illume anti abroad face risk frown exposure to natural
pathogens of; as recent events Ilave grapl~ically clemonstrated, from tire
intentional use of weapo'~ized infectious agents.
Vaccines often are flee best way to provide p~-o-
tection against sucks infections. Else U.S. Andy
Meclical Research and Materiel Command asleep!
tire IOM to preview tire process by wl~icI~ tire
Department of Defense acquires vaccines ant!
maintains their availability. Protecting Our Forces:
n?provi!?g Vaccine Acquisitions and Avai/ability in the
U.S. Military (2002) conclucles bleat tire DoD's acquisition process is overly
complex, fragmentecl, and thwarts effective coordination with tire vaccine
industry. P~-oble~ns exist at all stages, from identifying disease risks
tough laboratory research, product development, clinical trials, vaccine
licensure, and ensuring that manufacturers comply with regulatory
requirements. Indeed, poorly alignec! acquisitions processes and an inacle-
Trot>~s both at home a'id
abroad face~ risk from export
Sure to natural pathogens
(-~] the intellli(-~!
use~ olf weaponized infect
liouS agentS~
a
z
z
_ ~
OCR for page 114
Or 1~E Fly CRI11~AL [~.S IN -Aft
quote commitment of financial resources rather Plan unclearec! scientific
or technological hurdles contribute to else unavailability of some vaccines.
The report outlines a number of ways by which the DoD can strengthen the
process, begin'~i~g witty combining all vaccine acquisition responsibilities
fancier a single authority and provicling funding com~nensu~^ate with the
tasI<. Otl~e~ ~-ecommendatio~s include adopting program goals that ensure
greatest strength and continuity in the science anc! technology base across
tire full spectrum of infectious disease threats, anti developing manufactur-
ing arrangements that ensure consistent vaccine availability by acI`iressing
such issues as lo'~g-te~n~ co~nn~it~nent, predictable volumes amuck prices,
i~dem~ification, and intellectual property rights.
Military personnel must often be alert for extencled periods. Providing
tire opportunity for adequate sleep wouic! be ideal but is often impracti-
cal. Motif scientific research anti everyday experience leave demonstrated
that caffeine can increase alertness measurably. The U.S. Army asleep the
IOM to assess whetI~er ant! flow caffeine can be used to help alleviate th
various impairments that sleep deprivation can produce in military situa-
tions. Caffeinefor the Sustainment of Mental Task Perforn~a'~ce: Forn~lationsfo`-
Military Operations (2001) concludes treat caffeine in amounts of 100 to 600
milligrams per clay can effectively maintain cognitive performance in such
areas as reaction speec] and visual ant! auclitory vigilance.
(For comparison a five-ou~ce cup of coffee contains
roughly 100 nag of caffeine.) A similar amount 200 to 600
mg per day can dance physical endurance in a variety
of activities ant! may be especially useful in restoring
decreases in performance that occur at high altitudes.
Moreover sustaine(l use of caffeine at tI,ese levels clues
not appear to pose any serious acute or chronic health
risks. Tire best way to give caffeine to military personnel
would be via a delivery system such as caffeinated cI~ew-
ing gum or caffeine-supplementect food bars that pro-
vides it in 100-milligram increments. Total dosage sI~ouict
not exceec! 600 mg per day. The report also recommencis fiat the military
conduct further research on tire drug modafini! which may be even more
effective than caffeine while lacking some of its less clesirable traits such
as appetite suppression.
During warfare troops can lee exposed to a variety of infectious
agents toxic chemicals and other conditions titan can cause clisease both
OCR for page 115
MA Pro it'~.~£t Aide t)7~Mi\S
immediately and over the longer term. The lOM's Medical Follow-up
Agency, establisl~ed shortly after World War 11, monitors tire health and
well-being of military personnel following timer terns of service. In its
early years, else program consisted preclon~i~antly of clinical follow-up
stuclies in wl~ich veterans were examined for aftereffects of injuries and
diseases. Tire program flow conducts a variety of epidemiological ~ meal clot
studies, collaborates with r esearchers from
diverse backgrounds to obtain and analyze
records clata, amuck manages traditional delibera-
tive studies using parcels of expert volunteers.
Ogle outgoing project is the Meclical Follow-up
Agency Cohort Catalog. Tile catalog describes a
collection of study populations of former mili-
tary personnel, witty tire cohorts being assem-
blec! as part of completed or p~-oposecl research
projects dating to the 1940s. A dynamic work in
progress, else catalog currently contains su~nma-
ry information on 48 different populations.
These contorts, as compiled, do not exist anywhere else. Tire cohorts ravage
in size front small, sulk as a group of 1,500 soldiers who fought in the
lkorean War amuck developed I~emo~-rI~agic fever; to large, such as a group
with all individuals admitted to military l~ospitals during World War 11. The
catalog was cievelopeci to matte outside researchers and organizations
aware of the wealthy of ciata rescue ces available and ultimately to stin~ulate
totem to conduct collaborative ~esea~~cI~ with tire agency.
iT-~e Mt>~' Fop
Agency Cohort Cc' talog
I ~ c<~-~tion t:~f
study ply of ror~
'~` ~~ I-
with the co1~ts befog
assembled as part of con,
pleted or proposed re~
search pro~^~s `]IaLting to
the 1940~.
tOM's Medical Follow-up Agency also conducts a program treat adciress-
es healtI~-relatect questions ranging far beyond the specific effects of par-
ticipating in warfare. For more titan a century, studies of Truman twins leave
provicled a unique way to gauge the relative effects of genetics anti envi-
ro'~nent Ott health. Witty Ellis in mincI, tire agency in 1958 began clevelop-
ing wheat leas come to be called tile National Acaciemy of Sciences-National
Research Council WWII Veteran Twin Registry. The registry includes
detailed information on clearly 16,000 sets of twins Also had jointly
entered n~ilitary service during World War 11. Tire fact treat members of tire
registry are veterans is not, per se, a material factor in tidbit I~ealtI~, but
their status does provide a number of practical advantages for researchers.
Indeecl, the registry represents one of the most valuable longitudinal
cohorts of aging men available. Over tire years, researchers have published
more than 200 journal articles that drew on data frown tire registry. The
variety of Rinse studies illustrates tire registry's wicie-ranging usefulness,
~ ~ ~5
OCR for page 116
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Representative terms from entire chapter:
anthrax vaccine
\'~PMIY(t 1~] F()YI-~M CPI11~AL I~ IN HI-,4~7YT-!
with the topics acldressec! inclucling l~eart disease, AlzI~eimer's disease,
scl~izophre~ia, alcoholism and tobacco-relatecl diseases, suicide, and
clecli~es in cognitive functioning. The registry operates uncier a set of prin-
ciples clesignect to maintain its value as a resource for research as well as
to protect tire twins' privacy against unwarranted intrusion.
Else U.S. military currently leas only a limited '~umber of licensed meci-
ical countermeasures to use in protecting service personnel against more
titan a dozen clifferent bacteria, viruses, and toxins tint have beers ide~ti-
fied as possible biological warfare agents. Tire Department of Defense, as
part of its Chemical acid Biological Defense Program, is conducting ~ broad
research and clevelopment program aimed at adding new clru:,s, vaccines,
antitoxins, and other protective agents to this
repertoire. At the request of Congress, the IOM
currently is reviewing these efforts. Accelerating
the Research, Deve/op'~ent, anc! Acquisition of
Medical Countermeasures Against Biological
Watfare Ageists: littering Report (2003) provides a
description of the study's approach. The final
report, slates! for publication in late 2003, will
icle'~tify obstacles to tire clevelop'~ent and licen-
sure of new products and malice recommenda-
t~o~s for flow tire acquisition processes can be accelerated while ensuring
that new countermeasures will be effective and safe.
The U*So nlilitdiay Hi
has Fly ~ I'mited number
t't i't~3~] medical coun~
terI~s tO uSe in
protecting service pa..
ne] against more than a
do'en Miff k~-~ria'
Nc`~'all(] tOxinS*~.
Arms Ram C:
From 19G2 to 1971. U.S. forces soraved several types of he'
MILl1''\~Y PERS()N.~L Al\D i)~2,~J\5
· Veterans apace Ageist Orange: Update 2000. This report reaffirms most of
tire findings of tire initial report ant! tire first two updates. In one excep-
tion, it concludes tight there is "limited or suggestive" evidence of an asso-
ciation between exposure amuck an increased risk of acute myelogenous
leukemia (AML) in the cl~ilciren of veterans. AML is a cancer of tire bone
mat ~ ow cells bleat pi oduce sever a] forms of blood cells. PI evious r efforts
had found that the eviclence was "inadequate or insufficient" to determine
wetly a link existed between I~e~bicide exposure and AML of Oliver can-
ce~s in veterans' cl~ildren. The update also concludes that there is limiter!
or suggestive evidence of an association witty type 2 (adult offsets diabetes.
This kiosk was riot found in previous updates, although an IOM report
focuses! Ott diabetes acid issued in 20001,act suggested sucks a connection.
· Veterans a''d Agent Orange: He' bicide/Dioxin Exposure and Acute
Mye/oge'~ous Leukemic ill the C1~ilciren of Vietnam Veterans (2002) Upon exam-
ining al] available evidence regarding a potential linI; between exposure
and AML, this report clowngrades the level of risk that was expressed in the
2000 update on Agent Orange. The update founder! its conclusions, in part,
on the suggestive results of a stucly by the Australian Institute of Health
and Welfare but that study was later found to contain a miscalculation that
lecI to an incorrect assessment of riser There also is new eviclence from
German and Norwegian studies of AML in tire offspring of parents Silo bead
been exposed on their jobs to pesticides Fiat are polemically similar to tire
I~erbicicles used in Vietnam, wield neither study finding a significantly
increased level of risk. The report concludes treat current evidence is inacl-
equate or insufficient to determine whetI~er titers is an
association between veterans' he~bicicle exposure ant!
AML in their cI~ilciren.
.
Veterans and Agent Orange: Update 2002. Beyond
affirming previous reports, taxis update finds sufficient
evidence to conclude that thieve is an association
between exposure and an increaser] risI; of developing
chronic lym,~ocytic leukemia. Taxis is a specific form of
leukemia that squares many traits with Hodgkin's disease
and non-Hocigkin's lympl~oma, botI1 of which are known
to be positively associated witty herbicide exposure.
Previous updates bead considered all forms of leukemia
collectively, and flack fount! tire combined evidence to be
inadequate or insufficient to support a generalized association witty I~erbi-
cicle exposure. For taxis update, however; tire Department of Veterans
Affairs (VA) asked tire IOM to consider chronic lymphocytic leukemia on its
117
I\~Nr(~ 1~-~<' FI~f~f-~- CKI/1C-%AL [~)'ES IN ~~
own. Regarding other forms of leukemia, tl~e available eviclence remains
inadequate or insufficient to establish whether there is an association witty
herbicide exposure. Tile report makes recommendations for research to
resolve taxis and other continuing scientific uncertainties about tire health
effects of flee herbicides user! in Vietnam.
· Characterizing Exposure of Vete'ans to Ageist Orange ant/ Other Herbicides
Usec! in Vietnam: Uteri Findings and Reco~n'~e'~datio`?s (2003J. In studying
tire effects of l~erbicides on tire health of veterans, a 'major problem leas
always been the lack of detailed information on the actual exposures of
individual veterans. Tire lOM's initial report Ott Agent Orange offered a
number of recommendations for low to obtain better data, ant! tire
Department of Veterans Affairs asleep tile IOM to oversee tire development
ant] evaluation of improver! exposure models. In 1998, an inciepencaent
group of researchers was commissioned to clevelop and test models of I~er-
bicicie exposure. This report reviews the progress to ciate, concluding treat
the ciraft moclel is a valid means of assessing tire wartime exposure of vet-
e~ans to I~erbicicies. When completecI, this mocael-
ing system acid tire expanded database that it
sllouIc] produce, increases tire potential values of
research into tire stealth effects of tire I~erbicicles
sprayer! in Vietnam. Towarc! taxis encI, tile report
recon~mencis that tile NlA and Artier government
agencies facilitate acIclitional epiclemiological stuct-
ies of veterans by nongovea~a~'ne~tal organizations
and inclepencaent researchers.
Regarding ofI~r forms of
leukemia' the availal'le
evidence In; Anodes
quate or insufficient t(3
establish whether there is
an association with
hel*hiCIde ~\p05~O
Tile next update in tire Veterans a''d Ageist Orange series is in progress.
Taxis review will build on information gathered for previous reports, but
will focus to a large degree on more receipt scientific studies and Oliver
information developed since their release. In adclition, the IOM is concluct-
ing a review al evaluation of tire evidence regarding tile time period
between exposure to dioxin, tire toxic contaminant often present in Agent
Orange, and tile occurrence of respiratory cancer.
F1~l Effects Or tnt Cam EVER
Almost 700,000 U.S. troops, including many members of reserve units,
participates! in tile 1991 war il1 tire Persian Gulf. WitIlil1 a relatively sI1ort
time of returning home, a number of reservists and active-duty personnel
reported health problems tight tizzy believer! to be service connected.
MILl1''lkil PERSONNEL AND L)rI1~\
As mancIatecl by Congress, the IOM leas conclucted several studies to assess
tile potential health effects of a variety of biological a'~c! chemical ageists
to whicI~ military personnel may leave been exposer] cluring tire was:
Gulf War amuck Health, Volume 11: Insecticides and Solvents (2003) confirms
l~nown associations ant] conclucles that there is sufficient evidence to sup-
port a causal ~elationsI~ip between the solvent benzene and two kinds of
clisorcters, acute leukemia and aplastic anemia, baser! on flee current bocly
of pee~-~eviewec! literature. There also is sufficient evidence of act associa-
tio~ between benzene and aclult leukemia, between solvents and acute
leukemia, acid between propylene ,Iyco! and allergic contact dern~atitis.
For a variety of otl~er chemicals there is limited off suggestive evidence of
act association witty a ravage of cancers, neurobel~avioral problems, arid
officer health effects. For tire majority of agents, however; tire evidence is
inadequate or insufficient to determine whether there is a link between
Demographic Characteristics of U.S. Gulf War Troops
Characteristics
Sex
Male
Female
Age (mean) in 1 991 (years)
Race or Eth'~icity
Non-Hispanic/White
Black
Hispanic
Other
Rank
Entistecl
Officer
Military Branch
Army
Navy
. . .
marines
Air Force
Military Status
Active Duty
Reserves or National Guarcl
Percentage of Troops
93
7
27
70
23
5
2
90
10
50
~3
15
12
1 7
SOURCE: Gulf War and Health, Vol. 11: Insecticides and Solvents,
20()3, page 575.
[~Yt'~cr I~~--~E Ft;~-~. CRIl1~%AL Is~s IN ~~-AIlY}
exposure and adverse stealth effects. The eviclence is insufficient to rule out
any stealth effects associated with cI~e~nicals.
The theirs volume in tl~e IOM series Ott i~ealtl~ effects sten~n~i~g front
the Gulf War is in progress. It is focused on a variety of environmental par-
ticulates, pollutants, and synthetic conical co~npou~ds believed to leave
been present in the region. Among the agents uncler review are hydrogen
sulfide, fumes fi oils diesel Pleaters, gasoline, jet fuels, by-pro~iucts fiom of!
fires, I~ycirazine, amuck nitric acid. As with Else previous reports, tire
Department of Vexes ens Affairs will consider the ~ esults in developing, com-
pensation programs for veterans alto leave developed l~ealtl~ problems as
a result of ted wartime service.
More titan a decade after the enc! of tire Gulf Was; concerns remain
about whether military personnel Silo were deployer! to tire region are
now receiving effective treatment for any health problems brought about
by their service Gwif War Veterans: Treating Syn?pton~s and Syndromes (20013
identifies a variety of problems 1
1~11 PER\~)N..~! A,\D VE7~MN.S
bacteria that cause the clisease. These events lent urgency to an IOM study
already uncler way on tire vaccine currently being used to protect against
anthrax. The Department of Defense in 1997 hac! announced a plan for the
n~ancIatory vaccination of all military personnel against tire disease. To be
pleaser! in gradually, the program began in 1998 with personnel scl~eclulec!
for deployment to i~igI~-risk areas. However, some service members and sci-
entists expresser! concern about the vaccine's efficacy and safety, ant! the
DoD, at tire r equest of Congress, asker] the IOM to study Vilest issues. The
Anthrax Vaccine: Is It Safe? Does It Work? (2002) ~~ ~~£h~;~
answers biotic questions in tire aff~r'~ative. But
tire vaccine does leave certain drawbacks' includ-
ing reliance on a six-dose vaccination schedule
over 18 months, anti improvements are needed.
The report calls for efforts in several main areas:
improving tire way else vaccine is used, expand-
ing surveillance efforts to detect side effects
dlocs have c32~1:ain drttw-
l33cks, ;~1~g reliance
On ~ SiX -I ~~3Lti0~
schedule over ~ ~ months,
and imprOvelne`~S are~
from its use, ant! developing a better vaccine. A new vaccine si~ouIci clot
cause any severe local reactions, si~ouIc! require only two or three injec-
tions tight provide protection for at least a yeas; ant! should remain potent
for a long period so titan it can be stockpiled to ensure treat ample sullies
are available widen neeclecI.
--r r
After tire Department of Defense launched its plan for tire manclato~y
vaccination of all military personnel against anthrax, Congress clirected tile
Centers for Disease Co~tro! Alice Prevention (CDC) to develop a research
program to aciciress concerns about tire vaccine's safety and efficacy. Tire
CDC, in turn, asI
[~.~.T 7~--~]'- /< t) ~ ~ ~~< Call ]~( ~t /,\~5'[)~5 Afar ~~A~
Studies Proposed by CDC for the Anthrax Vaccine Safety
and Efficacy Research Program
Efficacy
· Anthrax Vaccine Absorbed: Human Teactogenicity and Immt~nogenicity
Trial to address change in route of administration and dose reduction
· Nonhuman primate vaccine close ranging immunogenicity and
challenge trial
:
- ~ c,
Immune Correlates of Protection (ICP) against inhalationa~ anthrax
Safety
Anthrax Vaccine Adsorbed: Human Reactogenicity and Immunogenicity
Trial to address change in route of administration and dose reduction
~ Fo~Iow-up study of textile mill workers vaccinated against anthrax
· Studies based in the vaccine health care center network
· Effects of change of route of administration on local adverse events fo~ow-
ing AVA vaccination
· Effect of AVA vacci nation on hea~ti~-related q unity of life
· Effect of hormonal phase in the female population on the occurrence
of adverse events following immunization with AVA
· Enhancecl signal detection and hypothesis testing for adverse events fo~low-
ing anthrax vaccination
· Possible role of aluminum hydroxide adjuvant in AVA-associatecl
adverse events
Acceptability
· Survey of knowledge attitucJes acid beliefs regardir~gthe anthrax vaccine
among military personnel
· Survey of civilian and military Stealth care providers regarding the anthrax
vaccine and the reporting of possible vaccine-associatec] adverse events
SOURCE: An Assessment of the CDC Anthrax Vaccine Safety anc! Efficacy
Research Program, 2002 page 3.
and for tire establishment of a committee of external scientific experts to
assist in planning ant! setting priorities for incliviclual studies and for the
progran~ as a whole
~~ I: ~~ CHEMICAL ^~0 8~t
In the wake of potential exposures of U.S. troops to the chemical war-
fare agent satin during tire 1991 Gulf War; as well as civilians exposures to
Ill 22
MILl I`'\~N' ~~)N.~\'EL AM) t)~
