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Summary and Assessment Joshua Lederberg, Ph.D. Nobel Laureate and Sackler Foundation' Scholar, The Rockefeller University Emerging infections are clinically distinct conditions whose incidence in humans has been shown to be increasing (IOM, 1992~. These diseases continue to disrupt the health care system, and successful detection and treatment of these diseases is becoming increasingly complicated. The public health system also is continually challenged by unexpected disease outbreaks, whether an influenza epidemic or an act of bioterrorism. To be prepared and responsive to these in- fections and outbreaks, the public health infrastructure requires attention and resources. Periodic infectious disease outbreaks serve to remind the public of the im- portance of the public health system. That outbreaks and epidemics of infectious diseases have been successfully prevented or controlled leads to the common misconception that the public health system is more than sufficient. Such mis- conceptions, however, belie the true risks to public health, and reinforce the public's expectations in the face of increasingly complex emerging infections and the changing health care environment. Disease investigations are now more complex in nature than they were in the past because of a variety of new pathogens and risk factors, outbreaks, and bioterrorist activities that cross state and national boundaries often raising po- litical and economic concerns. The ability to quickly recognize and respond to widely dispersed disease outbreaks is a challenge to the public health system, particularly in an era of increasing global population mobility and the wide dis- tribution of centrally produced foods.

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2 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS To further complicate matters, emerging infectious diseases are competing with other types of diseases and with other health care priorities. The practice of public health is moving away from the traditional focus on communicable dis- ease control and into new arenas, such as chronic disease and injury prevention. Simultaneously, public health programs have been dramatically underfunded, with less than 1 percent of the $1 trillion investment allocated to health care going to support public health functions (Margaret Hamburg, Assistant Secre- tary for Planning and Evaluation, U.S. Department of Health and Human Serv- ices, personal communication, November 19984. In the mid 1980s to early 1990s, the relative percentage was actually declining, despite a renewed atten- tion to and appreciation of the critical role of public health, and the expanding demands on public health systems. For example, in 1992 the United States spent only approximately $74.5 million for all infectious disease surveillance through the public health system (Michael Osterholm, state epidemiologist and chief, Minnesota Department of Health, personal communication, November 1998~. Another challenge facing the public health system is its fragmentation and dependency on categorical funding systems at the national, state, and local lev- els. Dependence on the one-time investments that states and localities choose to make to support surveillance activities and dependence on the leadership that may emerge by chance in the state or local public health department compro- mise the sustained efforts needed to support the public health system. A renewed commitment to a national approach to infectious disease surveillance is needed both to support new requests for funding and to sustain the full range of activi- ties related to infectious diseases that confront public health today. To help inform the debate about the capability of the public health system to respond to and control emerging infections, the Forum on Emerging Infections convened a workshopthe subject of this workshop summary to identify, clarify, and solidify some of the current and potential best practices in the public health arena to combat the threat of emerging infectious diseases. The workshop focused on four major areas of importance to public health systems that both shape and are shaped by the nature of emerging infections: (1) epidemiological investigations, (2) disease surveillance, (3) communication, coordination, and education and outreach, and (4) strategic planning, resource allocation, and eco- nomic support (see Appendix B. Workshop Agenda). At the workshop, participants described the components of the current sys- tem at the national, state, and local levels. In the ensuing discussions, partici- pants debated many of the challenges that must be overcome and identified pos- sible opportunities for addressing the obstacles. These discussions emphasized three cross-sectoral thematic areas in which carefully placed investments could make a positive contribution toward improving the capability of public health systems to respond to emerging infections: (1) integration of public health sys- tems, (2) investment in human capital, and (3) improved collaborations between the private and public sectors.

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SUMMARYAND ASSESSMENT 3 This summary highlights the workshop presentations and analysis of the discussions. The first section, Assessing the Capability, is a summary of the presentations and discussions surrounding the four major topics of the work- shop. The subsequent section, Strengthening the Capability, is an analysis of the three thematic areas and the challenges and opportunities that the public health system faces in each. The final section presents some concluding remarks. The views and opinions discussed in this workshop summary, as well as the chal- lenges and opportunities, do not necessarily represent the views of the Forum on Emerging Infections or the Institute of Medicine. ASSESSING THE CAPABILITY Epidemiologic al Investigations Because emerging infections continue to disrupt the health care system and their detection and treatment are becoming increasingly complicated, it is essen- tial that public health agencies frequently and methodically make every effort to collect, assemble, analyze, and make available health information about the community. This not only entails the provision of health status statistics and community health needs but also requires epidemiological studies of health problems. Diagnosis and investigation of health hazards within a community can be performed by health departments at the federal, state, and local levels if they have the appropriate levels of resources, adequately trained personnel, and es- tablished systems of reporting and communication. Although each sector faces some common and unique challenges, each component may also require coordi- nation at several levels, from the local to the state to the federal level. Federal resources, through the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Food Safety and In- spection Service (FSIS), are available to assist in infectious disease investiga- tions, but they can do so only if state and local public health agencies have the infrastructures in place to detect and report unusual disease occurrences. Inves- tigators at the federal level, largely through CDC, have better investigational tools, such as computerized databases, computational technology, and electronic mail, which has allowed individuals and federal agencies to recognize and report incidents that might not otherwise have been detected. An additional important service of the CDC is assistance with outbreak notification to other federal agencies and jurisdictions. Finally, the CDC can assist with the implementation of control measures. Two other federal agencies also play a vital role in many foodborne illness- related outbreak investigations because of their regulatory mandates. The U.S. Food and Drug Administration, a sister agency to CDC in the Department of Health and Human Services, has regulatory oversight over food products except meat, poultry, and egg products, which is the purview of the Food Safety and

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4 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS Inspection Service, the public health agency of the Department of Agriculture (USDA). In recent years, FDA has tried to improve its coordination of multi-state outbreaks with CDC and other federal agencies. Because foodborne outbreaks frequently involve low-level, sporadic contamination of widely distributed food, often food from other countries, FDA must interact with multiple federal agen- cies and jurisdictions. The FDA Division of Federal-State Relations aims to conduct outreach and coordinate such efforts. In 1997, FSIS' Office of Public Health and Science created the Epidemiology and Risk Assessment Division that includes eight field epidemiologists who assist states, local jurisdictions, and CDC with trace-back efforts during outbreaks where FSIS-regulated prod- ucts have been implicated. Additionally, at the level of the Assistant Secretary for Food Safety of USDA, the Foodborne Emergency Response and Rapid Evaluation Team (FERRET) has been created to facilitate a prompt, effective, and coordinated response to food emergencies by the many USDA agencies. State health departments are often at the front line of outbreak investiga- tions and receive news about an illness from many sources, such as the medical care system, the public, the disease surveillance systems of other public health institutions, or the news media. Once the cause of an outbreak is determined, control and prevention measures must be implemented. These may include edu- cating the population at risk, providing direct medical intervention (e.g., pro- phylaxis with antibiotics), or ensuring withdrawal of a product from the market. Documentation that details the process of the investigation, the findings, and the recommendations is often required at the state level. In general, epidemiological investigations and surveillance efforts at the state level are challenged by a variety of factors, such as changes in the health care system. In addition, many states are still using paper-based disease re- porting systems. A number of states do not have a state epidemiologist, and the responsibility of daily disease surveillance is often sporadic and inadequate. Better computational resources could improve the system and accelerate dis- ease reporting. Local health departments face the strains of an insufficient infrastructure. At a bare minimum, local health officials need basic investigational skills, such as how to design appropriate questionnaires and improve interviewing techniques. They also need to learn proper methods for the collection of environmental and clinical specimens, as well as advanced computer and communications skills, including skills that permit them to better interact with the media. Importantly, they need to extend these skills beyond food-borne outbreak investigations, which are the most common types of investigations at the local level, to investi- gations of respiratory illnesses in school systems, occupational exposures, and nosocomial infections. Local public health departments, however, are often plagued with a high rate of staff turnover, poor pay, intermittent calls for indi-

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SUMMARYAND ASSESSMENT 5 viduals with unique skills, and inadequate financial support, thus making main- tenance and continuity of skills difficult and training essential. Historically, clinicians have played a central role in outbreak investigations and disease surveillance. Long before the causative agents of infectious diseases were known, the observations of medical practitioners served to alert the com- munity to unusual medical occurrences. Even after the etiologies of infectious diseases were unraveled and laboratory tests made available, clinicians still played an essential role in providing patients for study and assisting in some epidemiological investigations. Today, however, many physicians often are not sure when or where to report suspicious cases of infection, are unaware of the need to collect and forward clinical specimens for laboratory analysis, and may not be educated regarding the criteria used to launch a public health investiga- tion. Moreover, there is often a lack of communication among public health agencies and community physicians. Academic institutions must assume a primary role in keeping practicing health professionals informed about the new knowledge, practices, and tech- nologies that can be used to respond to emerging infections. Academic health centers must capitalize on new technologies in continuing education, distance learning, and executive training that make use of the Internet, wide-area com- puter networks, and satellite-based communications capabilities. To be effective, these activities must be conducted in close partnership with national, state, and local public health organizations. Cultural and conceptual gaps exist across the various disciplines and levels that are involved in integrated and effective public health research and practice. The key elements that comprise an integrated public health system include solid capabilities in basic laboratory, epidemiological, clinical, behavioral, and health care services, and policy research, as well as effective education and public out- reach. The gaps among these elements include those that have historically ex- isted between academic public health institutions and academic medical institu- tions and between academic public health institutions and the larger health care sector. The historical disconnect that exists between academic public health and the larger health care sector, particularly as it pertains to private health care de- livery systems and diagnostic laboratories, must be repaired to maintain ade- quate responses to emerging diseases. Surveillance Surveillance is an early-warning system for diseases and must be the first link in the chain of public health action, as it is an essential element for any dis- ease control or eradication effort. It is a daily responsibility that at present is somewhat sporadic and mostly inadequate in its current capability to anticipate and detect early emerging disease trends in the United States. Surveillance is a science and a tool, and is typically foreign to the traditional academic medical

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6 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS curriculum in the United States. Although a tremendous amount of surveillance is accomplished, much of it is disease-specific, resulting in disjointed programs and unsustainable systems supported by categorical funding. Traditional public health surveillance involves concurrent epidemiological investigations, laboratory analysis, and health care delivery as well as the fol- lowing activities: (1) identification of unusual clusters of disease and their geo- graphic and demographic spread, (2) estimation of the magnitude of an outbreak and a description of its natural history, (3) determination of the factors responsi- ble for the emergence of a disease, (4) laboratory and epidemiological research, and (5) successful specific intervention efforts. To accomplish this, public health surveillance relies on the ongoing and systematic collection, analysis, and inter- pretation of data that are reported to a central agency in a timely manner. Public health surveillance systems can vary in their objectives, work scopes, and methods, and in terms of whether they are either privately or publicly sup- ported or operated. They can range from complex international networks to small, community-based programs. Monitoring measures within these systems are either passive or active. The characteristics that are vital to one system may be less important to another. Moreover, efforts to improve the quality of one system may impair the functioning of another system. A public health surveillance network needs to have a balance of character- istics from each system from the national, state, and local levels and from both the public and the private sectors. One area of focus that can achieve that bal- ance should be population-based strategies, which provide the foundation upon which disease incidence and prevalence are enumerated and from which all sub- sequent response activities originate. Population-based surveillance provides the means to differentiate between anecdotal or temporal reports of cases and actual outbreaks of infection. An emphasis on population-based disease surveillance also necessitates the development of a set of standards for epidemiological in- vestigations, laboratory analyses, case reporting across geographical and juris- dictional boundaries, and personnel qualifications. The public health capacity for population-based disease surveillance, how- ever, is highly variable among states and varies even more widely among county and local health departments. Disease surveillance systems at the national, state, and local levels have developed independently in response to various health cri- ses and needs, recent legislation, and available resources. Accordingly, there is a need to integrate existing public health surveillance systems. For example, 50 to 60 different infectious disease surveillance systems exist nationwide. The re- gionalization of surveillance systems and laboratory capacity is one means of integration, but this issue requires further discussion. The Emerging Infection Program (EIP) network, sponsored by CDC, is one program that emphasizes the importance of population-based disease surveil- lance and the dimensions and texture of surveillance information. The EIP net- work has formed the basis of a surveillance system that needs continued and

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SUMMARYAND ASSESSMENT 7 increased support. This large, national effort has helped public health laborato- ries to contend with the challenges of multiple jurisdictions and their reporting requirements. This type of a network between the private and public sectors, however, requires a certain level of data standardization, a goal that has not been fully met. A thorough review of the public health infrastructure is warranted to create a new, comprehensive national plan to develop and apply established standards for the public health infrastructure (laboratory, epidemiological, communica- tions, and personnel standards) within and across the public and private sectors. A national commitment is therefore necessary to maintain a network and its readiness through standardization and proficiency testing. A national surveil- lance plan should take into account the diverse surveillance uses of data, ap- proaches, and emphases at different levels of government, as well as anticipated capacity needs and scope of testing. Routine collection of surveillance data will be an invaluable resource in retrospective analyses for surveillance purposes. In addition, the results obtained from evaluations of these disease surveillance data must be freely shared among federal, state, and local agencies, as well as be- tween the public and the private sectors, for infectious disease surveillance to be effective. Withholding of surveillance data on disease prevalence and incidence for marketing and economic reasons can be detrimental to disease surveillance activities. Improving the infectious disease surveillance infrastructure requires coordi- nation and collaboration, not the fragmentation and duplication of laboratory services. A lack of standardization of the data elements to be reported can impair the ability of the private sector to report back to the state epidemiology officer and challenges the reporting systems of the state health laboratory. In addition, disjointed programs as a result of categorical funding do not allow some states to be able to monitor disease trends. For example, many states cannot afford to monitor trends in the numbers of rodents with hantavirus infection, or assist border communities in Mexico with monitoring efforts that may provide a win- dow on the emergence of diseases such as dengue fever or cholera. In the area of laboratory services, there is a particular need for adherence to standard laboratory analysis practices, in part because of the unique role of the public health laboratory. For example, the molecular characterization of patho- gens is not a clinically relevant test and is typically not supported in the private sector. Moreover, these tests can be costly because of the equipment, specialized reagents, and skilled technical staff that are required. Yet these tests are a critical weapon in the public health armamentarium as a means of combating emerging infectious disease outbreaks because modern epidemiological investigations rely on the modern laboratory tools of molecular biology for outbreak investigations. Coordination and collaboration between public and private laboratory services and the use of specialized diagnostic tests need to be encouraged and adequately supported financially and politically. This collaboration extends to regulatory

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8 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS agency laboratories which feed into PulseNet and similar team efforts, and work to identify sources of foodborne outbreaks. Coordination and communication will become increasingly important as new partnerships are created and old partnerships are renewed. This will espe- cially be the case if a national commitment to maintaining a disease surveillance network and ensuring its readiness through standardization, proficiency testing, and support of a staff of trained health care professionals is upheld. It is in the areas of coordination and communications where a future role for public-private partnerships that have not existed previously may be found. Partnership of pub- lic and private entities will likely create new opportunities in infection control and fiscal support for public health activities. A strong commitment to the de- velopment of a national surveillance network and the strengthening of partner- ships between the public and private sectors needs to be made. Communication, Coordination, and Education and Outreach Clear communication is an essential function for effective coordination across the public health sector to prevent and respond to disease outbreaks. It is also a key element in the fight for sustained financial support of public health activities. The components of public health and the core capabilities required to maintain public health at multiple levels need to be understood by policy mak- ers, regulators, and public health professionals. A uniform process for commu- nication of the elements of public health can provide guidance as to the best means to leverage opportunities among the public, academic, and private sec- tors, especially by professional organizations. Although such communication and uniform processes exist between federal and state public health systems, timely coordination and implementation within states needs strengthening. Barriers to effective and timely coordination and communication have their roots not only in inadequate information technology but also in underqualified and transient personnel. Continuing education and training programs developed from an advocacy group perspective and targeted to the promotion of public health surveillance within states may generate the intellectual and financial commitments needed to strengthen the public health infrastructure. In this case, opportunities exist for the private sector to participate in the direct support of the infection control infrastructure. For public health surveillance to be effective, there must be a free flow of information among federal, state, and local agencies, as well as between the public and the private sectors. Competition among and within the sectors is not necessarily desirable and, in fact, can be detrimental to public health surveil- lance activities. Agencies charged with conducting disease surveillance and re- sponding to the surveillance findings need to have well-established communica- tions systems that can facilitate the timely collection of surveillance data and

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SUMMARY AND ASSESSMENT 9 transmission of alerts about emerging infections across the country. The systems must also be able to share rapidly the information with those who need to know. These communications systems are hampered by the need to transmit informa- tion across state lines, to federal agencies, and to a variety of local and intrastate groups, including health departments, other state agencies, laboratories, emer- gency departments, hospitals, physicians, the public, and the media. Too often, however, communications systems at the state and local levels are outdated, situational, and low budget. Few assessments of their sufficiencies have been conducted, and no standards or guidance for the development of such systems exist. In addition, many state governments are further hampered because they have little information on technology capability and are discouraged from de- veloping it because of downsizing. Opportunities are available, however, to improve communications channels between the scientific and policy-making communities, among all levels of gov- ernment, among professional health care organizations, and between public health officials and the public. This requires intellectual, political, and financial commitments. It requires resources dedicated to the training of individuals who deliver public health services. Effective sharing of information obtained from population-based surveillance and control efforts also needs the same commit- ment. The education of clinicians who must report the data and care for patients must not be neglected. Likewise, the development of more streamlined, accu- rate, and standardized medical record keeping is needed within and between the public and private sectors. Strategic Planning, Resource Allocation, and Economic Support Many improvements in the health of Americans have been achieved through public health efforts. Vaccination programs, safe food and drinking water, and responses to disease outbreaks are among the advances in public health that prevent untold morbidity and mortality and improve the quality of life. The American people value public health, and many see the core functions of public health as essential services that are provided by federal, state, and local governments. However, when the public health system is functioning well, it is invisible to the public and is taken for granted. The U.S. Congress is generally supportive of public health activities that in- volve emerging infectious diseases. The general message received by Congress is that research is good for everybody and that research will make people healthier and will save Medicare dollars. There is, however, competition for research funds. Policy makers and the public identify with diseases. The most successful groups receiving research funding are those that are disease-specific, such as groups advocating funding for cancer or diabetes research.

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10 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS The various components of the public health system are difficult to explain and promote to the public and to those who appropriate funds. Furthermore, infectious diseases are not seen as a health threat to Americans but, instead, are seen as a problem primarily faced by people in other counties. It is thus difficult to communicate the urgency and importance of maintaining current infectious disease prevention and health promotion programs to meet future infectious dis- ease threats, especially when the public does not perceive infectious diseases to be important. Consequently, public health is poorly understood by the public and by pol- icy makers and decision makers. Despite a renewed attention and appreciation of the critical role of public health and the expanding demands of public health, public health programs have been dramatically underfunded, with less than 1 percent of the $1 trillion investment from health care going to support public health functions. For fiscal year 1999, the Senate Appropriations Committee is able to devote a $3.2 billion increase for the agencies of the Public Health Serv- ice, translating into a 14.5 percent increase from previous fiscal year (Jack Chow, Labor, Health, and Human Services Subcommittee, Senate Appropria- tions Committee, personal communication, November 1998~. Public health's fiscal survival depends on categorical funding streams that may vary at the state and local levels and on unique investments that states and localities choose to make in supporting surveillance activities. Its fiscal survival is also affected by the chance that leadership may change in the state or local health department. Because the public health system is highly fragmented, a renewed commit- ment to a national approach to public health and infectious disease surveillance with well-defined roles for state and local governments is in order. This is needed to support both new requests for funding and the full range of infectious disease issues that confront public health today. If the public health system is to care for the public's health, the focus cannot be solely on health care delivery systems. It is important that the public and policy makers are aware of the range of often unique services that public health can provide to promote health and prevent diseases. Advocating for public health is often difficult, especially if those people and organizations that are best suited to be advocates are understaffed, have inade- quate resources, may have real or perceived limitations on their ability to lobby, and are not experienced in the art of advocacy and communication. Yet, mem- bers of the U.S. Congress, state legislators, and managed care organizations must be educated about the needs of the public health system, particularly the public health infrastructure and its role in combating emerging infections. Emerging infectious diseases are but one concern of the public health sys- tem. In addition, the issues that surround emerging infections are different from those of other public health concerns. Until public health laboratories and clini- cal departments have the resources and infrastructures necessary to meet the

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SUMMARYAND ASSESSMENT 11 challenges of emerging infectious diseases, planning will remain reactive rather than strategic. A common language targeted toward policy makers and patients would be a first step to communicating effectively the challenges that the public health community faces in its struggle to build and sustain the necessary infrastructure to combat emerging infections. Short, succinct, nontechnical dialogue with the public and decision makers is needed when advocating for greater core support at the local, state, and national levels. STRENGTHENING THE CAPABILITY The workshop presentations and subsequent discussions converged on the overriding need to strengthen and support the core capability of the public health systems for infectious disease surveillance, response, prevention, and control. Variations in the capabilities of public health departments to detect and respond to disease outbreaks point to the need for public health departments at all levels to define their core capacities for epidemiological investigations, particularly as those capabilities relate to the activities of the public health laboratory. For ex- ample, surge capacity in response to an outbreak is one area in which the public health laboratory can begin to define its core capability and standards. Improved communication and collaboration between the private and public sectors may enhance the core capability and bridge the gap between clinicians and public health practitioners. The need for collaboration among disciplines and the need to bring in new partners from commercial laboratories in particular and nongov- ernmental organizations in general, emphasize the fact that additional resources will be needed to implement new mechanisms to provide for the public's health. Opportunities are available, however, to improve communications channels between the scientific and policy-making communities, between the local and state levels and the national level, among professional organizations, and among public health officials and the public. This requires intellectual, political, and financial commitments. It requires resources dedicated to the scientific training of individuals involved in the delivery of public health services, to effective sharing of information from population-based surveillance and control efforts, to the education of clinicians who must report the data and care for patients, and to the development of more streamlined, accurate, and standardized medical record keeping. The discussions at the workshop emphasized three cross-sectoral thematic areas in which carefully placed investments could make a positive contribution toward improving the core capability of public health systems to respond to emerging infections. These areas are assessed below.

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SUMMARYAND ASSESSMENT 13 Although there are common uses of surveillance data at the local, state, and national levels, the emphasis on these data varies. For example, investigation of individual cases is critical at the local and state levels but less so at the federal level (unless a disease outbreak occurs across state boundaries). On the other hand, evaluation of larger-scale prevention and control measures (for example, the impacts of new vaccines) is a high priority at the federal level. A national surveillance system should take into account this diversity in the uses of data, approaches, and emphases at the different levels of government. Along with these benefits of Internet-based information systems, however, patient confiden- tiality must be carefully considered. Modern infectious disease surveillance needs to move beyond traditional paradigms of disease surveillance and reporting. A nationwide infectious disease surveillance network will involve a unified strategy for epidemiological investi- gations in which the infection control community, the media, and informed pub- lic work more effectively at the state and local levels. It will need to better in- corporate research results and new technologies as they become available from a wide array of sources. It will require an integrated public health system that collectively helps evaluate the public health implications of a disease uncovered during an outbreak investigation while data are still being gathered. These new data can provide impartial advice for timely and appropriate prevention and regulatory actions. Specific considerations promoting the integration of public health systems toward the development of a nationwide infectious diseases surveillance system are discussed, as follows: . Increase the use of novel surveillance systems and modeling tech- niques to help predict, detect, or monitor disease trends, environmental and climatic conditions, or genetic shifts that suggest disease outbreaks and fa- cilitate epidemiological investigations. Improved methods are needed to iden- tify the risk factors associated with disease outbreaks. Better understanding of the root causes and determinants of outbreaks can then be used to initiate pre- vention programs and mitigate the impact and spread of an infectious agent. However, to protect the public from emerging infections, it is not sufficient to culture only contaminated specimens, determine the nucleotide sequence of a pathogen or its isolate, and identify a new pathogen from an infected individual; rather, surveillance activities should examine the continuum of disease. Surveillance is becoming increasingly complex owing to a number of factors, including the change and loss of habitats worldwide, the interaction of humans with animals and disease vectors, and increased global travel. Although some intermediaries of disease are monitored (e.g., chickens and encephalitis), most are not. Although the monitoring of vectors (e.g., the tiger mosquito) is inadequate, it can serve as an early-warning system for human disease. Ideally, surveillance should have the capacity and scientific capability to monitor human

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14 PUBLICHEALTHSYSTEMSAND EMERGING INFECTIONS health in light of pathogen mutagenicity and changing environmental factors. Likewise, the utilities of biological, ecological, environmental, climatic, and behavioral factors need to be validated for the development of new algorithms and other analytical methods that can be used to forecast disease outbreaks. . Protect the confidentiality of medical records and preserve the mis- sion of public health. The need to enhance the disease surveillance capacity of public health systems and the need to communicate this information is con- founded by the need to protect patient privacy. Public unhappiness with man- aged care and concerns about the confidentiality of medical records have re- cently focused attention on the need to develop better means to protect patient medical records and medical information. However, quality disease surveil- lance often requires the use of a name-based data system to track individual cases of disease. A means of ensuring the ability to conduct quality surveillance and, at the same time, the appropriate protection of patient and consumer in- formation is needed. The impact of systems and legislation designed to protect patient confidentiality in association with infectious disease surveillance re- mains to be determined. . Define the minimum communications capacities and technologies needed to respond to infectious disease epidemics and pandemics, whether they occur naturally or are purposefully induced. The establishment of a system that assesses and responds to the health needs of a population cannot simply focus on health care delivery systems. Responses to new disease threats, ranging from naturally occurring outbreaks to bioterrorist activities, will require unique services that the public health system can provide to promote health and prevent disease. Defining these mechanisms to build a fundamental, integrated capacity for infectious disease surveillance and communication will lay the foundation for a first line of detection and response to potential bioterrorism incidents or the threat of influenza pandemics. . Develop intrastate and interstate integrated communications systems as part of a nationwide infectious disease surveillance system. Frequently, communications systems at the state and local levels are outdated because of funding, technological, or situational constraints. For example, funding limita- tions in some health departments currently rely on surface postal delivery and direct oral communications as the standard means of communication at the in- trastate level for all messages except those that are most urgent. Conversely, interstate and national communications rely on video- and teleconferencing to relay high-quality information. Moreover, few standards or little guidance have been established for the creation of uniform criteria for effective disease report- sing, and communication systems. On the technical side of communications, public health systems need to be fully integrated with modern computer information systems. Internet-based communications systems have the promise of linking local and state health de- partments, hospitals, managed care organizations, and federal agencies respon-

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SUMMARYAND ASSESSMENT 15 sible for infectious disease surveillance and response. The rapid exchange of information through the Internet could be the mechanism needed to strengthen the infrastructure in infectious disease surveillance and data collection in real time. Along with the benefits of Internet-based information systems, however, the issues surrounding patient confidentiality must also be carefully considered. The opportunities of computerization in the context of a failing public health system should not allow one to be seduced into a sense of accomplish- ment, however. The Internet is still limited as a communications tool within states and many health care professionals and institutions do not have access to it. Except for academic health centers, most health care providers, emergency departments, and hospitals do not have Internet access, much less a centralized e-mail system. Further consideration must be given to the validity of the information shared. Rapid linkage of public health departments and laboratories with other health care providers, managed care organizations, and national centers is only as valuable as the quality of the data collected and the capacities of the epidemi- ological and laboratory surveillance systems. The establishment of standardized and integrated disease surveillance databases is one of the first steps that will require intellectual, political, and financial commitments to develop the art of a nationwide surveillance system. Already there are a variety of disease surveil- lance databases found nationally, within health departments, among hospitals, and across the managed care systems. Rapid communication combined with common algorithms for pathogen and disease identification, adherence to safety protocols, and recognition of an outbreak highlight the growing complexity of and difficulties with the integration of public health databases for disease sur- veillance purposes. Given the current trends of downsizing within state and local health departments, it is unlikely that intrastate communications will improve unless there is increased political will and financial commitment. . Determine CDC's capacity to review additional data, assess new situations, and determine appropriate responses if CDC investigators have already been diverted to other disease outbreaks at domestic or interna- tional sites. Previously unrecognized diseases are appearing with alarming fre- quency, both domestically and internationally. Placed against a background prevalence of known diseases, outbreaks of unknown origin place a severe strain on any public health agency. This is particularly the case given that there is a nationwide dearth of well-trained and experienced health care professionals ca- pable of investigating exotic pathogens. Because of the impacts of disease out- breaks on health, economies, trade, transportation, and national security, the capacity of CDC to respond to multiple disease outbreaks needs to be evaluated. Similarly, an assessment is needed on how to achieve better coordination among CDC, state health departments, and regulatory agency (FDA and FSIS) field investigative teams.

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16 PUBLIC HEALTH SYSTEMS ANrD EMERGING INFECTIONS . Develop communication systems to facilitate the ability of large commercial laboratories to rapidly share data with multiple jurisdictions. Each public health laboratory resides in a fairly unique health care and public health system, and each operates a fairly unique information system. Problems of further fragmentation of a system of laboratory networks are evident as labo- ratories whether they are local, commercial, or public conduct increasingly smaller numbers of routine tests for the diagnosis of infectious diseases. The need to communicate or share data with collaborating or other laboratories therefore becomes less frequent. Thus, the traditional system of communica- tions and maintenance of the collegial relationships that fostered the exchange of information and disease reporting are similarly breaking down. Electronic linkages with large commercial laboratories and health care providers in the community, with the national centers and reference laboratories, and within a health department and across jurisdictions will be key to effective infectious disease surveillance. Investment in Human Capital Without a clear commitment to invest in human capital, the entire fabric of the public health system is ineffective. One cannot object to the need for sus- tainable systems, interconnectivity, communication, capacity, advocacy, and planning; however, a dearth of public health professionals trained in epide- miology and surveillance is presently a concern. Some of the factors that con- tribute to this shortage include inadequate salaries, staff development, re- sources, and academic partners and a lack of an appropriate curriculum, as well as a lack of a multiyear grant or budget cycle that has the potential to create an incentive for state and local health departments to invest in personnel. It is therefore vital that programs that teach population-based science to trained health professionals in epidemiology and surveillance be developed along with programs that retain these professionals in state and local health departments. The following items were identified as providing a possible framework for ac- complish these objectives. . Develop targeted public health training programs. Building the public health workforce requires two interrelated actions: (1) development of the future workforce, and (2) retention of the workforce once it is trained for a career in public health. Historical distinctions between public health and medicine have resulted in the marginalization of public health by medical students and new physicians. Adequate exposure of medical students to public health activities so that they may consider the possibility of a career in public health, greater famili- arity with the tools of public health, and promotion of an awareness of the role of the practitioner in the public health system all need further development. Academic institutions and professional organizations are uniquely positioned to engage more directly with public- and private-sector organizations in designing

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SUMMARYAND ASSESSMENT 1 7 tailored training programs for their workforces. Training programs targeted to the public health and commercial laboratory workforce need to be strengthened. Aca- demic health centers are also the intellectual hub for training public health profes- sionals. Here there is an opportunity for increased investment in education and outreach for all health professionals in the area of emerging infections and, in par- ticular, the area of antimicrobial resistanceconditions that are population-based. Multidisciplinary approaches are needed to educate medical and public health professionals on the pathobiology of infectious diseases. Additionally, there is a lack of public health professionals trained in epide- miology, which undermines the capabilities of public health. Surveillance sys- tems must be in place to ensure that state-level responses to outbreaks are ade- quate, appropriate, timely, and efficient. To respond to and investigate these outbreaks, adequate resources are necessary at the local, state, national, and in- ternational levels. Resources include not only computers, laboratory equipment, and environmental monitors but also adequate numbers of trained epidemiolo- gists. Investments must be made in the training of new public health profession- als and in the retention of experienced professionals. The need to better communicate public health matters to the public and policy makers is clear. However, one of the problems facing the public health system is a sense of continuity and leadership reflected by a continuation of in- dividuals in public health roles. Reports from the Association of State and Ter- ritorial Health Officials reveal that the average time of service for a commis- sioner of health is less than 2 years. Many of these positions are filled by political appointees who have some experience in healthoften in health care delivery or disease care delivery, but not in public health. The leadership pro- vided by a public health commissioner affects the role of public health depart- ments in the changing picture of the health care system. . Promote linkages among academia, the medical community and the public health sector. Efforts that support linkages between academic public health institutions and professional organizations could help encourage the practice of public health as a chosen academic profession. Currently, population- based sciences such as epidemiology and concepts of surveillance are not main- stays in health professional training. However, academia is equipped to provide continuing education in these areas. Collaborative research between academia and public health departments needs to be more strongly encouraged and funded. Because practicing physicians require greater awareness of issues re- lated to emerging infections, disease reporting, and population-based health, it is essential that creative and innovative continuing education programs be devel- oped by public health, organized medicine, and academic communities. Aca- demic institutions must engage more directly with public- and private-sector organizations in designing training programs tailored for their workforces. Changes in the health care system are causing concerns about the traditional way in which disease surveillance is conducted. Traditional patterns of reporting

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18 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS are lost as the source of health care delivery shifts from the inpatient to the out- patient setting. Lost is the dedicated epidemiological reporting system found within the inpatient setting. Cost-containment factors, increased patient loads, and new demands in the outpatient setting are placing increased pressures on providers' time and expertise. The resulting trend of the greater use of empiric treatment, which helps to alleviate some of those pressures, may actually be decreasing the level of reporting of information on infectious diseases. A critical issue then becomes the role of the physician in public health and infectious dis- ease surveillance. Efforts to increase the linkages between the medical and pub- lic health communities are needed early in the physician's training and through- out his or her career. Cultural and conceptual gaps exist across the various disciplines that need to be more allied in effective public health practice and research. Key elements for an integrated public health system include basic laboratory research, epide- miological research, clinical research, behavioral research, health care services and health care policy research, and education and public outreach. The histori- cal disconnect between academic public health and the larger health care sector must be repaired so that the responses to emerging diseases are more effective, particularly as this disconnect pertains to private health care delivery systems and diagnostic laboratories. . Funding sustainable careers. Efforts need to be made to reconsider yearly line items in budgets for investments in personnel. One-year grant cycles do not encourage investments in recurring costs, such as personnel. A more creative approach to grants and grant cycles needs to be considered to give states and local health departments an incentive to invest in human capital. In addition, steps must be taken to encourage revamping the 1-year grant cycles to invest in personnel. One-year grant cycles do not reinforce investments in recurring costs, such as personnel. Sustainable careers are also dependent upon the development of regional capabilities for training, interpretation, problem solving, and improvement of information technologies, as well as regional approaches to planning, as a prac- tical solution to limited resources and disparate state and local laboratory capa- bilities. It is difficult to develop the kinds of career ladders within public health that are important to the retention of good people. Support of regional capabili- ties for ongoing training in continuing medical education is needed to promote careers in public health and create meaningful career ladders and opportunities for professional development. Additionally, regional approaches to planning should be encouraged as a practical solution to limited resources and disparate state and local laboratory capabilities. There is also a need to expand CDC's Epidemiologic Intelligence Service (EIS) program at the state and local levels to train public health professionals in epidemiology and surveillance. In the area of foodborne-illness investigations

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SUMMARYAND ASSESSMENT 19 outbreak-related field activities included should be for the EIS officer with FDA and FSIS as part of the EIS training experience. Finally, even though the PulseNet program has experienced many suc- cesses, it is stretched in its ability to subtype every isolate and to follow up with appropriate epidemiological investigations because of a lack of trained person- nel resulting from inadequate funding. As such, more support is needed for this program in order for it to successfully reach it's ability to conduct timely sharing of information that can facilitate the recognition of an outbreak. Improved Collaborations Between the Public and Private Sectors A disconnect exists between the needs and abilities of the public and private sectors when it comes to disease surveillance. Although commercial interests have unique capabilities to conduct the type of testing required by the public sector, they do not have the incentives or resources. On the other hand, detailed epidemiological follow-up studies are most suitable for the public health sector. Both sectors have necessary roles. Public-sector laboratories play an important role because of the unwilling- ness of private laboratories to voluntarily perform activities that will not make profits and because of the more direct accountability of public-sector laborato- ries to elected officials and the public. Despite these factors, public sector na- tional laboratories need ample opportunities to collaborate with academic and private-sector facilities to help standardize databases and evaluate reagents and techniques. Such collaborations will be particularly important in response to changes in the ways in which health care is administered and as the need for cost containment continues to grow. For example, one area of collaboration is re- ferred to as "split sampling" whereby partnerships are formed between public and private laboratories. Split sampling can be defined as follows. As the com- plexity of disease investigation increases, the complexity of laboratory testing increases and some necessary tests will remain relatively rare, expensive, and very scientifically precise. Therefore, to verify results, many specimens ana- lyzed in a public laboratory may need to be split, with half of the sample sent to commercial laboratories for rapid analysis or for analysis with arcane, costly, and unusual rare reagents. Although split sampling is expensive and is an ac- cepted standard for samples whose results will require legal or regulatory action, it is not reimbursed by traditional health plans. Nevertheless, isolates and speci- mens examined by split sampling, an essential procedure to confirm the pres- ence of a specific pathogen, come from various health care settings. Specific opportunities to promote public-private sector collaborations include: . Leverage the potential advantages of working with managed care. The transformation of the health care system has created an adversarial relationship

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20 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS among public health officials, managed care organizations, and state legislators. For example, an overemphasis on economic efficiency and cost containment cre- ates disincentives for disease reporting and isolate submission. In addition, con- tracts with large national commercial laboratories may create barriers to com- plying with state and local disease reporting requirements. Yet, a common issue underlying these negative effects of managed care is the lack of adequate funding for support of the public health infrastructure. Managed care plans have inte- grated databases that could be used by public health systems to track infectious diseases among the plans' populations. Likewise, there is a potential for seamless communication between public and commercial laboratories, managed care or- ganizations, and public health officials. The development of partnerships with managed care organizations may be one way in which public health laboratories could share databases and contain infrastructure costs. Additionally, standardized contract language could be developed to bind public health laboratories and man- aged care to foster partnerships. . Define the unique and complementary roles of the public- and pri- vate-sector laboratories and identify their core capabilities. States and large local jurisdictions must have the expertise and experience needed to rapidly mount laboratory investigations in response to disease outbreaks. Additionally, federal agencies with outbreak-related laboratory missions, including CDC, FDA, FSIS, and DoD, need to have an adequate level of expertise to rapidly identify new threats which emerge. Public health laboratory expertise is one function that should not be fully privatized because the role of government in protecting the nation's health will inevitably determine laboratory investments. However, the competitive environment of managed care, the growth of inde- pendent laboratories, and the consolidation of hospital laboratories influence some of the important shifts in the capacities of public health laboratories. A means of fostering closer partnerships between public and private laboratories is needed to help develop compatible surveillance and reporting systems. For ex- ample, public health departments could receive data on disease incidence from the private sector. These data would then be integrated into a larger national public health surveillance system. Special emphasis could also be placed on hospital emergency departments, which are frequently vital sources in the re- porting of disease outbreaks. Coordination of these capabilities will become a key element to determine where the locus of activity should lie for a given dis- ease or outbreak situation. . Regionalization of state public health laboratories. The functions of the public health system are highly fragmented across national, state, and local lev- els, as well as between the public and private sectors. Use of strategies such as cost subsidization for certain routine tests and for more specialized kinds of services is one way in which public health laboratories are trying to remain eco- nomically viable and yet sustain their responsibility for infectious disease sur- veillance. Some public health laboratories are also focusing some of their efforts

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SUMMARYAND ASSESSMENT 21 on various activities that have importance for government functions. This has created dilemmas for state and local public health laboratories in terms of where they should set their priorities. It may be time to consider the regionalization of state public health laboratories. Areas of focus for such regionalized public health laboratories would be the use of certain kinds of expertise and specialized ca- pacities that have limited commercial value but that have enormous consequences for public health and safety. A renewed commitment by the public and private sectors to a coordinated national approach to public health and infectious disease surveillance is needed to support new requests for funding and to sustain the full range of infectious disease-related activities that confront public health today. . Systems to evaluate diagnostic reagents and techniques. Comprehen- sive infectious disease surveillance is beyond the capacity of any one laboratory, whether it is public or commercial. For example, adequate evaluation of diag- nostic reagents and methodologies and ensuring that the techniques used are the most appropriate for the assumptions of the test are labor- and resource- intensive. Yet, laboratory results, results of data analyses, and interpretations vary if standardized techniques are not followed. Specialized techniques in modern biology and the skilled personnel needed to perform those tests are usu- ally too costly for most laboratories but could be obtained through the use of a regional system and private-public partnership. A unified system of sharing materials and methods would be an invaluable tool for rapid communication, pathogen and disease identification, establishment of protocols for safety, and enhancement of the ability to detect multijurisdictional outbreaks. . Educate members of the U.S. Congress, state legislators, and gover- nors about public health activities and indicate to these individuals that mere additions to, or extensions of, existing categorical funding are insuffi- cient to meet the public health system's needs. The U.S. Congress has come to appreciate the value of basic research and could similarly come to appreciate the need for an adequate public health infrastructure and nationwide system for infectious disease surveillance. Issues related to emerging infectious diseases, including bioterrorism, food safety, antimicrobial resistance, and vaccination programs, could be used to promote the need to build the fundamental capacity for integrated infectious disease surveillance as an important first line of action in detecting and responding to infectious diseases. This is an opportunity for the public health community to create partnerships with patient advocacy groups. . Expand private sector investments in public health research so that public health services, applications, and prevention research are funded at sufficient levels to accommodate discoveries derived from basic research. The driving force behind advances in disease surveillance, prevention, and re- sponse is a vigorous and multidisciplinary basic and targeted research enterprise. Public, policy makers, and public health practitioners need to stay informed about recent research results and applications of discoveries related to under- standing of diseases. The timely analysis and dissemination of surveillance data

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22 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS gathered through public-private sector collaborations could promote better pa- tient care. Physicians could be better informed with the latest medical informa- tion and better able to provide their patients with the most appropriate care and, at the same time, reduce the risk that an infectious disease is spread to the larger community. CONCLUDING REMARKS The changing face of health care poses new challenges for the detection, treatment, and prevention of infectious diseases. Historically, public health de- partments, hospitals, and clinics have been the main sources for the detection and treatment of infectious disease outbreak. State and federal laboratories have been the driving force behind surveillance. The function of the public health system is diffuse, with managed care organizations and industry playing new roles. All of this comes at a time when the communications potential is en- hanced by the existence of the Internet and large, accessible databases. These combined forces simultaneously place new pressures on and offer new opportu- nities to the public health system. Yet, the basic infrastructure of the public health system, particularly at the state and local levels, is eroding. With that de- terioration comes a diminished capacity to predict, detect, and respond to an emerging infectious disease. An adequate public health system is made up of various components. A1- though the list presented below is not comprehensive, it nevertheless provides a good representation of the components that should be considered. The changing demographics and environmental conditions that the United States and countries around the world are experiencing have important influences on public health and include global travel; immigration and migration; movement of products, includ- ing food and other potential vectors of disease; population growth; urbanization and crowding; changing socioeconomic conditions, particularly the worsening poverty observed in so many areas of this country and other parts of the world; and significant ecological changes such as deforestation, reforestation, irrigation, and changing patterns of agricultural and pesticide use. These changes are dy- namic and contribute to the complexities of emerging infectious disease outbreaks. Because of such events, the need for the development and implementation of a fundamental capability for infectious disease surveillance at the community, state, and national levels cannot be overemphasized. Uniformity needs to be established in the currently fragmented public health systems, particularly in the public health laboratories that exist throughout the country. If the United States is to have a robust public health system, ongoing training and the creation of meaningful career ladders and opportunities for professional development within the practice of public health need to be established and considered priorities. Additionally, public health systems must be completely integrated into the computer age. The current standard for laboratory reporting in most state health

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SUMMARY AND ASSESSMENT 23 departments is still surface mail, with a measured 10- to 14-day lag time in some states. To speed up the reporting process, public health systems need to seriously consider application of computer and electronic communications technologies to their laboratory reporting systems. It is also critical for health departments to have electronic linkages with other health care providers in their communities and with national centers such as CDC, as well as to explore the issue of data integration and data comparability both across systems within a health depart- ment and across the various levels of the public health systems. Public health systems also need to enhance their capability to communicate critical information, particularly information about the risk of an infectious dis- ease outbreak. Intrastate communications systems are often underdeveloped, lack standardization, and are rate-limiting steps in some forms of communica- tions. The development of laboratory listservers would increase real-time con- nections and therefore enhance the communications capabilities to detect, as- sess, and respond to emerging infections and outbreaks. Public health systems also need to further explore and have the capacity to have Internet-based bulletin boards for the reporting of information on emerging infections. The electronic and computer media are also especially important for clinical laboratories since this would enable clinical data to be manipulated into a form in which it could be sufficiently standardized and shared among institutions and organizations. This process could begin to facilitate everything from public health surveillance activities to clinical trials that require cross-institutional coordination and coop- eration. These actions would promote the development of a much-needed na- tional disease surveillance system. Public health systems must also embrace the human component. They need to attract and maintain a cadre of public health professionals who are well edu- cated and knowledgeable about technologies. Training opportunities must be made available to these professionals to keep them up-to-date on pertinent issues that would increase their knowledge and capabilities on public health issues, including surveillance and epidemiological investigation issues. Additionally, to attract and retain these professionals, public health systems must be willing to compensate them adequately. Salaries need to be competitive not only for public health professionals (including epidemiologists and laboratorians) but also for the information technology personnel who work in the public health arena. For example, many hospitals cannot compete in the current technology marketplace for the best networking and computer experts because high-technology compa- nies can provide them with much more competitive salaries. Lastly, the public health infrastructure should contain a number of qualita- tive features. Not only does it need to be sustainable but it should be adaptable and capable of anticipating future problems. An adequate public health system should also have an infrastructure that can quickly adjust to a given portfolio of problems and that should be resilient, transfo~ative, and able to be revised when necessary.