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Out- T~atio~al interests are inevitably linked to tire Stealth of people throughout tire wotlcI. Healths, like eclucatio~, is an investment in human capital fiat can Whelp breath cycles of poverty ant! political instability contTibutillg to national alar! global economic development and is of funcIamental importance in shaping the stability and well-being of a Elation or r egion. Tire tragecly of HIV/AIDS ifs Africa leas cleeply scarrec! large regions of the continent, ant! it threatens to undermine economic progress, institutional strengths, ant! tire survival of family unfits. Although less visible titan the AIDS epidemic, the Truman toll of economic hardship acid social instability in Russia leas resulted ilk a 10-year decrease in life expectancy for men, ant! an over 40 percent decrease in births rate from tire n~id-80s to tire mid-9Os, far loweT titan tire replacement rate neeclec! to sustain population levels, the economy, Alice current sta'~ciarcIs of liv- ing. These aide only two examples of global healths events that conic! Create peace, prosperity, amuck international relatioT1SilipS in tire aecacles to come. Tire global reacts of emerging infectious cliseases cart be more immediate. Within days of tire issuance of Microl~ial Threats to Health E'nerge`?ce, Detection, and Response (2003), the SARS epidemic burst alto WoTidVieW, TemilldiTlg US that a pan- demic can emerge witty astonishing speed and spread globally in a matter of weeks. Shortly ti~ereafteT; bovine spongiform encephalopatI~y (Mad Cow Disease) and monkeypox emerged for tire first time in tire Americas. He~' lil(e eduCatiOn' is an inveStnlent In Iluman .} ~) Lit T a:

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]~RMI.~ I1~< ]~tj~r~_~x 6~rRt i55~s i~ u~-At7~ The IOM contributes to improver! global health trough studies bleat advise on how to reduce the burdens of disease and disability in developing countries, that illuminate emerging threats to international anc! global health, and that emphasize infectious diseases tile most truly global threats to i~ealtl~. ~ ~ . .. I-- wIsEAst I. .. I. . '1fectious diseases toc/ny ignore geographic nils] political boundaries, airy t1~`s constitute c' global threat tight places every nations acid every persons at risk. Foot! prO4tfCtS, livestock, exotic pets, and material goods acid the 'microbes they carry are excha'~gec! as cultt~resfro~n every regions oftI~e world are explo~-ecI. --Microbial Threats to Health, 2003 Infectious diseases continue to burclen populations around tire world. Hotly naturally occurring acid intentionally introduced biological threats lyric! increasing potential to cause clisease, disability, ant! Neatly. Through botch committee studies and convening activities, tire IOM assesses emerging threats, the capacity of national and international systems to respond to tI~ose threats, and tire research and artier investments neces- sary to molest an adequate response. Microbial Threats to Heat: Emergence, Detection, ant! Response (2003) conclucles treat tire public health and mecca communities in tire United States aloe inadequately prepa~-ec] to clear effectively wield infectious dis- eases. Tire report extends and expands upon a 1992 IOM report, Emerging Infections: Microbial TI'reats to Hen/th in tire United States, which brought taxis issue to national attention and stimulated research efforts and policy actions. Tire new report describes scientific, social, and political tresses that leave influenced infection acid clisease emergence arid control over the past decade. New or pre- viously unrecognized! diseases Such as SARS) leave emerged and known diseases that were tI10UgI1t to be virtually eradicated in tire U.S. (such as measles and per- tussis) have reappeared, occasionally in epidemic propor- tions. The r eport reviews the current state of knowledge on how infectious diseases emerge and identifies opportunities for public health actions, Motif domestic and worldwide, to strengthen capabilities for detecting and responding to microbial threats and preventing tire

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3 t~x spread of infectious diseases. It calls on tire United States to make sig`~ifi- cant efforts to enhance the global capacity for responding to microbial threats, focusing in particular on threats in the developing wapiti. This will require providing technical ant! financial assistance, expanding research acid surveillance, ant! shearing I`nowledge ant! best public health practices across national boundaries. Among othe' ~ecommencIations, tire report stresses tile need for federal, state, anti local governments to rebuilt! and sustains the infiast~uctu~^e of the U.S. public health system, which leas suf- fered From years of neglect. Aft effective surveillance system is critical to detect and monitor infec- tious disease, boric within the U.S. amuck globally. ill 19967 able Executive Office of else President, acting on advice Cons its National Science acid Technology Committee, issued a directive Rectal ing that U.S. citizens were clot being adequately protected fiom emerging infectious diseases. The directive (NSTC-7) stated tI1at national and international capabilities for monitoring, respot~ciit~g to, and preventing infectious diseases were insuf- ficient, ant! it caller! for a more robust national policy to improve Otiose capabilities. Among actions taken in response, the Department of Defense in 1997 established tile Global Emerging Infections SurveilIa~ce ant! Response System (GEIS). After several years of operations, massagers of tire GEIS asI OCR for page 23
[N,~N,!~ 7~--~< /~)~ CKI116~AL ~~.~S Or HEAL11-I toward achieving its goals in protecting tile heat of U.S. military and civil- ian populations, as well as global health interests. Tire r effort recommenci- ec! some refinementssuch as increasing tire number of personnel who leave applied epiclemiological expertise, expanding training pi ograms, and broadening communications efforts to include public Stealth partners- and called for tire government to inc' ease financial support fo' the systen~ to help ensure its lo~g-te~~m success Unlike viruses and microorganismstl~e agents of most known infec- tious cliseases priors are act anally sl~apec! forest of a normal n~a~n- malian protein. Identified in 1982, pinions appear to be associated wield a group of uniformly fatal '~euroclegenerative diseases called transmissible spongiform encepl~alopatI~ies (TSEs), which include "Mad Cow Disease." Conventional metI~- octs useful to cliagnose most infectious diseases fad! to cletect TSEs. Timbre is no cure, prophylaxis or fail-safe a~temortem diagnostic test for TSEs. A decacle's worthy of attempts to clevelop effec- tive prior-detection tests Slave largely failecI. Consequently, tire lJ.S. Department of Defense launched tire National Priors Research Program in 2002 with $42.5 million and requester! tire assis- tance of tire IOM to review scientific I<~owlecige about TSEs ant! to recom- menc! the highest-priority research for funding. Advancing Prion Science: Guidance for the Nations! Priors Research Programs? (2003J concludes that .~-~5 dPi't~ t~ ~ aSSOCiatet! wait ~ Up of Ally fatal neurt,4~ g0~ti~3 ji50350~8 catle] ~ * o ," ranSmIsS' Ule Spongl'l'0~m encenf'alonat-hies (TSEs) whith fin cIude~ 'Mad Cow ~ iSeaSe.' progress il1 developing an antel11ol tem diagnostic test to detect priOllS Will be slow unless fundamental questions are answered about tire n~olecular biology of potions and tire normal prion protein from WI1iCl~ it is derived. TIle committee stressed treat tire infiastructure capability for research on TSEs in tire U.S. is limited due to constraints in funding, lab facilities, and Umber of investigators trained ilk taxis Idly specialized area. International collaboration offers opportunities to expand treat capacity. A'~`malar'al~s Malaria remains else leading killer of children in Africa and a significant cause of morbidity among adults and children in Africa, Asia, and focally, in ouster parts of tire world. Resistance to inexpensive antimalarial drugs is widespread, and few effective drugs even expensive ones - exist to fill tire current need, which is growing. An upcomin`, IOM report will examine evolving patterns of malaria (including drug resistance) and tire options for

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~~Ri\L ~<,4~ AND liNrFT(~?~S ~~45E controlling it, witty the aim of cleveloping policy strategies, particularly financing strategies, that couic! leac! to tire greatest goof! for those accost affected, as well as for tire larger popt'lation at r isI<. The potential for incre- n~ental in~proven~ent of existing, new antimalarials through pl~ar~naceuti- cal technology also will be explored. The cages poser! by infectious diseases clen~anc} concerted and coordinates! efforts along a number of fronts, from treating inclividual patients and preventing tire spread of clisease within comn~u~ities to sI~ap- ing public policies in tire United States anti worIc~wicle. Tile lOM's Forum on Microbial Threats, creates! in 1996, fosters wicle-ra~gi~g discussions among tire various parties who square a stake in improving the prevention, detection, and management of these diseases. Forum workshops provide timely opportunities for representatives from academia, industry, profes- sional ant! interest groups, amuck government to cliscuss, in a neutral setting, critical and sometimes contentious issues. Such cross-sector dialogue leas helped in establishing priorities for research and public i~ealtl~ policy, iden- tifying areas in need of greater attention, and illuminating opportunities for more effective collaboration I'etween else private and public sectors. Recent wo~13 mu.. Ail- ~ ~ {t?YOf ~ ~ ~ \ n'0t,9 `~%, ~ s A. : ,\ `~ \ off is n a ', t{ ~ ~ ~1~ t t} I : ~ E. Call O j5' ...:: A A(~:~N 1 '22-"' RcSt~] :'" ~ ~Dt19UC. t1~t'`~Sic tore t I'. ~ ~ R^~< -I Emerging and Re-emerging Infectious Diseases, 1996-1997. SOURCE: Emerging Infectious Diseases from the Globa/ to the Local Perspective: Workshop Summary, 2~)01, page 3.

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|~IN(i I~E i. brig iR3~ CRI11~AL a... I,\ IDEALS where tizzy account for I~alf of all cleatl~s. Belt no region is free from con- cern, and every inI~abitecl continent regularly experiences large outbreaks of some type of infectious clisease. The lOM report concludes that fighting tire global spread of infectious diseases will talce political resolve and suf- ficient financial] resources. The workshop brought together key representa- tives fi one tire Americas, Afi ice, Asia and the Pacific, and Euro ope. Wiley sur- veyec! such issues as the factors that contribute to the emergence of infec- tious diseases, efforts to coordinate surveillance activities and responses witl~in ant! across borders, and remaining needs for research and resources. In the report, participants stressed treat the world community must work toward a set of common goals. Among finest goals are strengti~- e~ing disease surveillance of l~u~nans and clomestic animals Wick can pass diseases to humans, fostering good public health practices, expand- ing training programs, conducting collaborative research in a number of targetec! areas, a'~c! accelerating vaccine development Alice distribution. The Emergence of Zoonotic Diseases: Unclerstancling the Impact on Animal airy Suntan Health (2002~. Diseases passed to Pumas frown animals- zoonoses are leaching causes of illness ant! cleated in many nations, ant! they negatively affect commerce, travel, acid economies woridwicle. Many factors influence the emergence and spreac! of zoonoses, ranging frown molecular interactions in microbes to forces that trigger tire growths and movement of populations ancI changes in the environment. There also is concern about tire potential use of zoonotic agents as "bioweapons" by terrorists. The IOM report explores tire forces that drive zoonotic diseases and offers some broacl-based strategies treat will help tire United States arch tire world in preventing ant! controlling talent. Participants cited a Bleed to expanc! research in a varied of areas, including tire patI~o- genesis of zoonotic agents and tire development of vaccines; to entrance national ant! international laboratory capabilities; to strengthen surveil- lance systems titan can provide early waving for emerging zoo~oses; acid to mount education programs to increase public awareness of tire prob- lems and minimize undue fears. Perhaps tire most funcian~ental neec! is for improved collaboration and cooperation among government agencies at all levels, as well as among members of tile Unman health, veterinary, wildlife healths communities. There also is co'3~n abot~t thg potently! use of zoo noliC a~s aS Lb Jo_ weapo'~' by te`~;~.. Considerations for Viral Disease Eradication: Lessons Learned clue! Future Strategies (2002~. Tile success in using vaccines to eradicate smallpox sug- gests tire possibility of eradicating many officer viral diseases tight once

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GLOBAL ~~-ALl~''l.~:) Me- D~-,4~r were consiclerec! beyond slope. IncleecI, the eradication of several diseases, including polio and measles, is on tire horizon. This prospect raises tire importance of aciciressing early on a range of issues likely to surround tire cessation of immunization and otI~er prevention activities. Tile IOM report examines the biological challenges, medical interventions, and operational considerations to be faced and I~igl~ligl~ts efforts titan may facilitate wise clecision-maki~g in the post-eraclication era. Participants pal ticularly empl~asizect titan eradication must not beget con~placency. Reemergence of a virus or its intentional reintroduction will remain a threat, especially as immunity wanes and tire populations at large grows snore susceptible to infection. Enough vaccine sl~oulc! be stockpiler! (or provision made foil emergency replenisI~ment) to cope witty any outbreaks treat might arise, and surveillance sixfold continue to quickly iclentify local outbreaks before Riley can spread. Among other actions, it is vital to continue research on viral biology arm! vaccine tecI~ology, and to make sure tight remaining viral stocks if it is deemed necessary to maintain such stocksbe secure- ly contained. In else wake of September 11 and r ecent anthrax events, our nation's bioterrorism response capability leas become an imminent priority for pol- icymakers, researches, public Dealt officials, acac'ae~nia and the private sector: In a tI~ree-day workshop treat was cap- turec! in a workshop sun nary titieci Biological Threats to Terrorism: Assessing the Science a',`/ Response Ca,vabilities (2002), experts from each of these communities came together to identify, clarify, and prioritize tire next steps that need to be tableau in order to prepare and strength bioterrorism response capabilities. Fron1 the ctis- cussions, it became clear treat of utmost urgency is tire neec] to cast tire issue of a response in an appropriate fi-ameworI; to attract the attention of Congress ant! the public in order to garner suffi- cient and sustainable support for such initiatives. No matter flow tire issue is framed, numerous workshop participants agreed that there are many gaps in tile public healths infrastructure anc'a counter~neastare capabilities that must be prioritizes! and acIdressec' in order to assure a rapid and effec- tive response to anotilel big-terrorist attack. R .~ ~ mini 0~] ~ ~ i ()i ~ (~0 (' ~ t~ respons`~ capab;lillty has become ~Ln in~minent priors fly for p`-~cymakers' re~, public Huh officials, acaden~ia and the priV`~-~e Sector. The Resistance Phenomenon in Microbes amuck Infectious Disease Vectors: Implications for Suntan Henith O!?4 Strategies for Containment (20031. Resistance in bacteria, viruses, al protozoa to therapeutic agents is an increasing challenge. More microbes are becoming resistant to name ~9

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|~,~,~~,~,~~r(~ If ]~3~ CKI]~%AL [.~IfE-S /~ l~ drugs, thereby reducing able power of drugs for combating infectious clis- eases. Tire IOM report discusses tire causes ant! consequences of drug resistance in microbes ant] examines current and potential strategies for mitigating its impact on unman health. Participants stressed treat the emer- gence of resistance must be recognized as an integral partnot an aberrant partof mica obial life. Developing a fuller understa'~cling of flow 'microbes evolve where facet! with drugs Nay leac! to innovative ways to bring tavern under control. Additionally, tire revolt examines tire influence of pesticide ant! i~secticicle resistant infectious clisease vectors on control measures for diseases sucks as malaria. Oliver suggestions for action i~clucle fully implementing national and international programs being developer! to contains microbial resistance, expanding surveillance efforts to ensure early detection of problems, supporting scientific and epicle~niological studies in targeted areas, strengthening professional education and train- i~g, and conducting economic studies to both inform policy making amuck suggest incentives for encouraging individuals ant] institutions to adopt practices tight will Whelp limit tire spread of antimicrobial resistance. 1 ~ RE IN .. DEvEtOPlNG Woken Brain clisorclers now affect at least 250 million people in tire clevelop- ng wapiti, amuck taxis number is expected to increase as snore people live to old age. Brain disorders encompass a wide range of clisabling conditions, including epilepsy, stroke, schizophrenia, unipolar depression, bipolar clisorde'; mental retardation, cere- bral palsy, and autism. Yet public acid private health sys- tems in cleveloping countries have paid relatively little attention to brain clisorciers, concentrating instead on tire major communicable diseases. Neurological, Psychiatric, and Develoyn1e'~tal Disorders: Meeting the Challenge in tile Developing World (2001) concludes that titers are effective amuck affordable ways to treat or even prevent many brain disorders in developing countries, and it presents a comprehensive plan designed to Whelp these countries help their citizens who have or are at risk of developing epilepsy, schizophrenia, clepression, or other such disorclers. Tire report outlines strategies that can be implementer! i~nmecliately in developing countries, such as increasing public and professional awareness and unclerstanding of brain clisorclers, extending ant! strengthening sys- tems of primary care to cleliver health services for brain disorders, and 30

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GLOI3AL ~~-AL7W ,4..~D i.~( ~~?~ ~~-,] SE making cost-effective interventions available to patients who will benefit. It also proposes strategies for creating better options for tire future. Actions inclucle assessing the cost-effectiveness of specific treatments ant! health services ill local settings and monitoring tire incicler~ce, prevalence, anct burden of brain ctisorciers in cleveloping countries; creating national centers in developing, countries to carry out to aini'~g acid ~ essay Cal on be ain diso~-cie~s, ant! li~ki~g these centers with institutions in I~igh-income coun- t~ies; ant! crafting anal funding global programs devoted to improving understanding of brain disorclers in tire developing world. Tire Neatly of a motley; fetus, or newborns is tragic wherever it occurs. WI~ile relatively r are in tile inclustrializec! world, Rinse Teals are consicier- ably more common in cleveloping countries, accounting for tile vast major- ity of the 515 000 maternal Beatles; 4 million late fetal cheaters; and 4 mil- lion ~~eo~atal Beatles conservatively estimated to occur Tacit year. Most of these deaths occur between late pregnancy and tire enc! of the first week of a cluing s life. Each yeas; snore than 4 nonillion children are born with bi~-tl~ defects one of the major causes of death in newborns. A set of companion reports, Improving Filth Outcomes: Meeting the Chal/enges in the Deve/opi'~g WON// (2003) ant! Reducing the Impact of Birth Defects: Meeting t/~e Cha//e`?ges in the Developing World (2003) review tile eviclence on interventions treat can improve birth outcomes ant! reduce birth clefects. Tire Outcomes report recognizes tire important role of women s education social and econon~- ic status on birth outcomes. It also reviews the available statistics on n~ajor causes of 'maternal and neonatal mortality acid morbidity and of fetal loss summarizes cur r ent knowledge ant! practice with regarc! to a heartily preg- nancy anal identifies cost-effective opportunities for in~provi'~g births out- comes. Three adverse births outcomes are addressed in more cletail: low birtI~weigI,t; births clefects; and perinatal t~ans~nissio'~ of HIV/AIDS. Tile report concludes treat a sI OCR for page 23
Selected' Recommendations for Health Sciences Research The Role of Large-Scale Science: NIH and other federal funding agencies that sup- port ~arge-sca~e biomedical science should develop a more open and systematic Inethoc] for assessing important new research opportunities emerging from Else sci- entific community in which a ~arge-scale approach is likely to achieve the scientific goals more effectively or efficiently than tracl itional research efforts (Large-Sea/e Biomedical Science: Exploring Strategies for Future Research, 2003) Protecting Research Participants: Feclera~ regulations Aloud be extended to include every research project that involves human participants regardless of the source of funding or the setting. The Institutional Review Board (IRB) as the principal representative of tine interests of potential research participants should focus on tire ethical aspects of protecting participants with other organizational units taking responsibility for risk management and regulatory compliance. The informed consent process should be an ongoing interactive clia~ogue between research stain acid research participants that inclucles an assessment of participants unJerstancling of the discussion. (Responsible Research: A Systems Approach to Protecting Research Participants, 2002) Focus on Integrity in Research: Funding agencies should] establish research grant programs to identify measure ant] assess those factors that influence integrity in research. Also each research institution should develop anc3 implement a compre- hensive program designee] to promote integrity in research using multiple approaches adapted to the specific environments within each institution. Institutions should implement effective educational programs that enhance the responsible COIldUCt of research. (integrity in Scientific Research, 2002) Expanding Research on the Role of Sex in Human Health: Promote research on sex at tile cellular level; study sex differences over a ~ifetin1e; and examine genetic variability disorclers of sex differentiation reproductive status and environmental influences to better unclerstand human health. Alsoj expand research on sex cliffer- ences in brain organization and function. Monitor sex differences and similarities for all human diseases that affect both sexes. (Exploring the Biological Contributions to Hun1an Health: Does Sex Matter.?, 2001 ~