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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 _ ~

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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

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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

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\'~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' OCR for page 113
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

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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.

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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.

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[~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 OCR for page 113
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 OCR for page 113
[~.~.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

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MILl I`'\~N' ~~)N.~\'EL AM) t)~ OCR for page 113