Appendix A
Authored Papers

IMPLICATIONS OF RESTRICTIONS ON FOREIGN STUDENTS AND SCIENTISTS FOR INFECTIOUS DISEASE RESEARCH

Ronald M. Atlas, Ph.D.

Graduate Dean and Professor of Biology and Public Health Codirector, Center for Deterrence of Biowarfare and Bioterrorism

University of Louisville

Louisville, KY


It is clear that after September 11, 2001, we live in a new era, an era of fear—fear of foreigners who could be terrorists and fear of scientific information that could be misused by terrorists. The consequence is that we in the scientific and academic communities are now subject to new levels of public scrutiny that are manifest in the regulations governing visas for foreign students and visiting scientists and in the security clearance requirements for those with access to microorganisms and toxins (select agents) that are considered high-risk biothreats that might be used by terrorists. As graduate dean at the University of Louisville, dealing with foreign graduate students and visa issues being implemented under a post-9/11 regulatory framework, as a scientist involved in biodefense, and as a past president of the American Society for Microbiology (ASM), which has certainly been on the forefront of the debate on the select agent rules and the legislation that was passed after the anthrax attacks of Fall 2001 to reduce the threat of



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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century Appendix A Authored Papers IMPLICATIONS OF RESTRICTIONS ON FOREIGN STUDENTS AND SCIENTISTS FOR INFECTIOUS DISEASE RESEARCH Ronald M. Atlas, Ph.D. Graduate Dean and Professor of Biology and Public Health Codirector, Center for Deterrence of Biowarfare and Bioterrorism University of Louisville Louisville, KY It is clear that after September 11, 2001, we live in a new era, an era of fear—fear of foreigners who could be terrorists and fear of scientific information that could be misused by terrorists. The consequence is that we in the scientific and academic communities are now subject to new levels of public scrutiny that are manifest in the regulations governing visas for foreign students and visiting scientists and in the security clearance requirements for those with access to microorganisms and toxins (select agents) that are considered high-risk biothreats that might be used by terrorists. As graduate dean at the University of Louisville, dealing with foreign graduate students and visa issues being implemented under a post-9/11 regulatory framework, as a scientist involved in biodefense, and as a past president of the American Society for Microbiology (ASM), which has certainly been on the forefront of the debate on the select agent rules and the legislation that was passed after the anthrax attacks of Fall 2001 to reduce the threat of

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century bioterrorism, I have found myself balancing divergent norms of science and society and communicating across boundaries of national security, science, policy, and public concerns—trading the world of a laboratory scientist for a bully pulpit before journalists to reach the public, congressional hearing rooms to reach policy makers, and forums like this to reach fellow scientists. We in the scientific community have an obligation to provide an educational forum that reaches far and wide, within the scientific community about the new legislation and regulations, and about how we need to comply to be good citizens of the world. Additionally, we need to educate the broader public as to the importance of international exchange in the scientific arena so as to ensure that regulations are constructed in ways that permit the advancement of biomedical research. We have a need to explain to the public and policy makers that the best defense against the threat of bioterrorism is to advance the research agenda against infectious diseases so that we have the vaccines, therapeutics, and diagnostics needed to combat emerging and reemerging infectious diseases as well as “plagues” that may be introduced by terrorists. We need to make clear that biomedical research is an international endeavor and that the battle against infectious diseases must be global. We also have an obligation to engage in a dialog with the national security community so that we understand the threats and vulnerabilities of our new world and can engage in activities—some of which will involve constraint and adherence to the new regulatory mandates—that will reduce the threat of the misuse of the life sciences by terrorists. When the USA Patriot Act was first proposed, it would have banned all foreigners from entering a U.S. laboratory where a select agent was present. The ASM explained to the Congress that biomedical research is international in nature. We brought a clear message to the debate: infectious disease is a global health issue that requires international exchange and cooperation. Half of the manuscripts submitted to ASM journals come from outside the United States. If we curtail international collaborations, then we put the health of this and other nations at risk. If we cannot combat infectious diseases regardless of where they occur in the world, we put U.S. national security at risk as well. The Congress listened. When the Patriot Act was passed, such proposed global restrictions on foreigners were removed. Having said that, we in the scientific community also made compromises concerning who could have access to select agents and the regulatory system overseeing possession of those agents. In my view, the compromises were critical for demonstrating that the scientific community was responsive to public concerns about bioterrorism and for achieving public support for biomedical research needed to advance biodefense capabilities. I recognize that some people would accuse me of having entered into a Faustian deal for having agreed that we should restrict certain individuals

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century from having access to select agents within U.S. laboratories, namely, aliens from countries that the United States designates as supporting terrorism and those individuals who are not permitted to purchase handguns. When the ASM looked at the impact of restricting individuals from the few nations that are designated by the United States as supporting terrorism, and only restricting them in the laboratories where a limited number of select agents were present, we found that there were very few scientists and very few exchanges that were being affected in the United States. We agreed to accept that provision, which became a restriction in the Patriot Act and which was subsequently incorporated into the Biopreparedness Act, and thus, into the regulatory scheme of the Centers for Disease Control and Prevention and the U.S. Department of Agriculture oversight of select agents. George Poste, who has been very outspoken about the hubris of the scientific community placing the United States in danger by not fully recognizing the potential for misuse of science, had made the claim that the Patriot Act and the implementation of the select agent rule are major impediments to industry that is multinational, and that the biotech industry would not fare well under the Patriot Act. The restriction imposed by the Patriot Act and subsequently incorporated into the Biopreparedness Act stated that individuals from nations that support terrorism may not have access to select agents in U.S. laboratories. Thus, it should have minimal impact on multinational corporations. It is true that implementation of the select agent rules involves a site-specific registration and clearance process. An individual cleared to work with certain agents in one laboratory who goes to work in another laboratory requires a new clearance. Additionally, the owners of each private laboratory in possession of select agents must be cleared. Potentially that can impact the ability to collaborate and to move personnel from laboratory to laboratory. We are still in the early phases of implementing the new select agent possession regulations and need to wait and watch carefully for real impacts. If we detect negative impacts, then we need to bring them to the attention of the relevant departments and agencies and insist that they be responsive. We also need to recognize that we have new responsibilities in the era of terrorism. Unfortunately, the days of a graduate student working alone in a laboratory with dangerous pathogens in the middle of the night are probably gone. But maybe this is for the good of all, as appropriate biosecurity measures should enhance biosafety. Perhaps the greatest challenge for the scientific community will be developing a working relationship with the national security and law enforcement communities. The Biopreparedness Act requires that the Department of Justice clear individuals who have access to select agents. This responsibility has been given to the Federal Bureau of Investigation (FBI). This is a new system, and there is legitimate concern over how it will work. Can it provide appropriate security oversight without interfering with the

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century legitimate pursuit of science, especially as the magnitude of biodefense research increases exponentially? At this point, we do not have any data that suggest that the system is not going to work—but there is considerable concern. Beyond the regulations and clearances imposed by the Biopreparedness Act, there is concern that some government laboratories, for example, Department of Defense laboratories, Department of Agriculture laboratories, and potentially other laboratories within the Department of Health and Human Services, will further restrict foreign nationals from entering those laboratories. The select agent regulations do not provide for such broad restrictions of international scientists. While there may be some areas where classified research is conducted and where restricted access for foreign nationals may be appropriate, it is important for the scientific and biomedical communities to highlight the value of international scientific exchanges for global health and national security. Turning to the issue of visas for students and visiting scientists, the implementation of new regulations aimed at reducing the risk of terrorism is raising concerns in the academic and scientific communities. Resources are needed to ensure appropriate implementation of the new tracking and interview systems. Within the academic and scientific communities, we need to gather systemic data to document problems. The major educational organizations, including the American Association of Universities and the Council of Graduate Schools, requested that the requirement for interviews to obtain visas be implemented only if there were sufficient resources to prevent undue delays that would interrupt the flow of foreign students into the United States. The State Department promised to be responsive and quickly instructed the consular services to give preference to students for interviews so that educational exchanges are not inhibited. The ASM asked the State Department to develop procedures and allocate resources necessary to assure prompt and appropriate action on visa requests for students and researchers seeking to study within the United States. The ASM pointed out that educational exchanges and training of students, researchers, and clinicians in microbiology and other scientific disciplines from countries around the world are critical for the advancement of biomedical science and public health. If we limit our ability to exchange scientific information and train scientists, then we will severely limit our ability to fight infectious diseases—and infectious diseases do not respect any political borders. The ASM therefore urged the State Department to eliminate the adverse impact of visa policies on the continued education and training of foreign students in the United States. Given that the ASM has supported appropriate measures to reduce the risk of terrorism, it did not urge laxness in processing visas. Rather, the ASM urged that screening processes be undertaken with a minimum of disruption of educational and

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century research endeavors, urging observance of the following principles in designing and implementing screening procedures: Screening procedures must be developed, planned, and implemented in a manner and on a schedule that ensures that interviews or other processes do not interfere with legitimate scientific training. The United States must devote the necessary resources to ensure that prudent procedures do not fail as a result of a lack of adequately trained personnel to implement the procedures in a timely manner. Microbiology and other sciences must not be singled out as an area of concern or in a manner that admission of students for science education and training is impeded. In light of inevitable limitations upon resources, procedures must be developed that expedite, on the basis of objective criteria, the processing of visas least likely to pose a threat so the overall system permits the timely admission of all qualified individuals legitimately interested in advancing their education or advisory role to U.S. governmental agencies. The process for reentry of trainees who have been granted visas for training in the United States should be simplified, eliminating the requirement for reentry interviews for students who have been out of the United States only for a brief period. In response, the State Department reiterated its commitment to protect international exchanges of students and researchers. Thus, in many ways we are at a critical crossroads. We face a new regulatory environment—one crafted out of fear of terrorism. We face a critical need to advance biomedical science to combat the threat of bioterrorism as well as the emergence and reemergence of deadly infectious diseases. We must find the right balance between openness and security—between restrictions and free exchange impacting foreign students, visiting scientists, and international collaboration. This will require continuing dialogue among the scientific community, the national security community, policy makers, and the public. We must be ready to confront the challenges of infectious diseases in this new era of regulatory oversight of research and educational exchange.

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century TRAINING AND SUSTAINING THE PUBLIC HEALTH LABORATORY WORKFORCE—OUR FIRST LINE OF DEFENSE AGAINST INFECTIOUS DISEASE Scott J. Becker, M.S. Association of Public Health Laboratories Washington, D.C. Public health laboratories play a lead role in the detection and response to infectious disease. That role cannot be performed without a sound laboratory infrastructure—including highly trained staff and linkages with private-sector laboratorians—that must be in place well in advance of a crisis. However, an ongoing shortage of skilled laboratorians compromises the nation’s laboratory system and reduces our vigilance for infectious microbes. To remedy this situation and avert the consequences of more dire workforce deficiencies, public and private employers, trade groups, and relevant government agencies must find new ways to attract and retain the nation’s next generation of laboratory technicians and scientists. Public Health Laboratories and Microbial Threats to Health As vividly demonstrated by efforts to contain West Nile virus in 1999, anthrax in 2001, and severe acute respiratory syndrome (SARS) in winter 2003, public health laboratories play a crucial role in identifying and analyzing infectious organisms in support of public health disease investigations. Infectious disease testing is, in fact, one of the core functions of public health laboratories and encompasses a range of vital activities (CDC, 2002). These activities include: Isolating and identifying causative agents—including emerging or reemerging pathogens—that are present in clinical specimens (e.g., blood, urine, saliva) or in unusual specimen matrices such as food and environmental samples. Determining the source of infections by identifying human carriers and environmental sources of disease. Providing specialized tests for low-incidence, high-risk diseases, such as tuberculosis (TB), rabies, botulism, and plague. Confirming atypical laboratory test results and providing reference diagnostic testing to private-sector laboratories that may not have the ability to fully identify disease agents of public health significance. In addition to hands-on testing to characterize infectious agents, public health laboratories perform a number of services to support and improve

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century testing programs and to manage laboratory data for effective disease surveillance (CDC, 2002). These services include: Conducting research to develop and validate diagnostic tests for emerging infectious diseases and to improve existing infectious disease tests (for example, by developing rapid test methods). Providing advice to private-sector laboratories regarding newly marketed tests. Developing and overseeing quality assurance programs for private clinical laboratories through training, consultation, certification, and proficiency testing to assure the reliability of laboratory data used for communicable disease control. Ensuring the ability to accumulate, synthesize, and communicate test results and other laboratory information essential for public health analysis and decision-making. Providing a statewide disease reporting network. Participating in national database systems for surveillance of diseases of national and global concern. State public health laboratories are the critical link between the nation’s many private-sector clinical laboratories—which, by virtue of their primary diagnostic function, are often the first to report unusual laboratory results—and the public health establishment. They maintain strong ties with national laboratories at the Centers for Disease Control and Prevention (CDC) and other federal agencies, and with state health officers, state epidemiologists, and directors of state programs in sexually transmitted disease, tuberculosis control, maternal and child health, and environmental health. It is easy to recognize that infectious disease outbreak investigations and disease prevention and control efforts depend on sound and timely laboratory data. It is similarly clear that all of these activities will be adversely affected by deficiencies in either public health laboratory capabilities (specific services performed) or capacity (volume of services that can be performed within a defined time period). Workforce limitations affect both. Public Health Laboratory Workforce Shortage The current shortage of skilled public health laboratorians is not a sudden phenomenon. Rather, it has been ongoing for some years. Public health laboratories, like other parts of the public health system, have suffered chronic underfunding. An October 2000 report concludes that long-term reductions in public health laboratory staffing and training have impaired the ability of state and local authorities to identify biological agents

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century (Smithson and Levy, 2000). More recently, a 2002 Institute of Medicine (IOM) report refers to the nation’s “antiquated laboratory capacity” that leaves Americans vulnerable to exotic infectious organisms as well as more mundane microbes (Committee on Assuring the Health of the Public in the 21st Century, 2003). Unpublished data from a “straw poll” conducted in spring 2003 by the Association of Public Health Laboratories (APHL) show an average vacancy rate for state laboratory testing personnel of 8.6 percent. These data are comparable to data from the American Society of Clinical Pathologists’ (ASCP) 2002 wage and vacancy survey, which found that the average vacancy rate for staff-level medical technologists ranged from 6 to 10.2 percent, depending on geographic region (Ward-Cook et al., 2003). But some states greatly exceed the average. Tennessee is one. The state public health laboratory has been struggling since late 2001 to fill fully a third of its clinical microbiology positions (personal communication, J. Gibson, Director of Microbiology Laboratory, Laboratory Services, Tennessee Department of Health, August 11, 2003). However, although these figures represent significant understaffing, they may be deceptively low. The number of staff positions authorized by states generally does not keep pace with the laboratory workload. That is, any vacancies likely represent a true reduction in laboratory capacity. In Kentucky, for example, the state laboratory is recruiting for two positions in 2003, including the laboratory director’s post, which had been vacant since December 2002. However, the state completely eliminated ten laboratory positions due to budget constraints, and these positions do not get counted as vacancies (Isaacs, 2003). There also is evidence that public health laboratories and other employers have increased the use of temporary staff and broadened the selection criteria for permanent positions, thereby filling vacancies with less qualified individuals (a medical laboratory technician in place of a medical technologist, for example) (ASCP, 2003). The lack of adequate laboratory capacity was driven home during the bioterrorism incident that occurred in fall 2001, when many public health laboratories required overtime hours and halted much routine work because key personnel were diverted to testing for B. anthracis or to related support activities, such as sample log-in and screening. The Connecticut state lab brought in a team of volunteer microbiologists and the New York City lab arranged to borrow staff from the city’s private clinical labs to augment beleaguered public health laboratory workers (APHL, 2002; APHL, 2003a). Even the relatively mild SARS outbreak in the United States in winter 2003 strained laboratory capacity (APHL, 2003b). If two moderate infectious disease outbreaks were to coincide, the nation’s public health laboratories would be overwhelmed.

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century Where Have All the Lab Workers Gone? The growing shortage of laboratory workers stems from three root causes: the ongoing retirement of a significant cohort of senior staff, including laboratory leaders; government hiring practices; and a shrinking pool of future laboratory professionals that impacts both the public and private infectious disease workforce. In many cases, public health laboratories are losing their most skilled personnel before they have a chance to recruit and train replacements. One northeastern state saw 20 percent of its laboratory staff—19 individuals—retire in June 2003. Ohio’s state laboratory director writes in Focus magazine, “What laboratory can replace the knowledge (and value) that a senior technologist with 29 years experience immersed in molds and fungi brings with them to work every day? How about trying to replace your senior chemists, bacteriologists, virologists, or immunologists?” (Becker, 2003). Of particular concern, an APHL study anticipates an average of 13 vacancies in state public health laboratory director positions by 2006, with a candidate pool that more than two-thirds of current directors describe as either “not adequate” or “only marginally adequate” in size to meet future needs (Schoenfeld et al., 2002). In addition to scientific and technical expertise, public health laboratory directors must have management, public policy, and communication skills, making this position especially difficult to fill, but also especially important, since it is the directors who provide leadership in times of crisis and who advocate for the needs of the laboratories. From one vantage point, the public health laboratory workforce shortage can be seen as part of an overall shortage of state government employees—one that is likely to get worse. According to a 2002 report by the Council of State Governments (CSG) and the National Association of State Personnel Executives (NASPE), both the pending retirement of current state employees (whose average age is 44.5 years) and mandatory state hiring freezes or other hiring limitations (in effect in 27 states) contribute to the declining number of state workers (Carroll and Moss, 2002). On average, the current vacancy rate of state government positions is just over 11 percent, but more than half of states report vacancy rates above the national average, including Alaska at 21.6 percent. The CSG/NASPE report predicts that state governments could lose more than 30 percent of their workforce by 2006 due to the twin problems of an aging workforce and continuing state budget shortfalls (Carroll and Moss, 2002). From a second vantage point, the public health laboratory workforce shortage can be seen as part of a serious labor problem plaguing public health and private clinical laboratories throughout the nation. The U.S. Bureau of Labor Statistics projects that 122,000 new medical technologists and medical laboratory technicians will be needed between 2000 and

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century 2010—or roughly 12,200 new clinical laboratorians each year—to replace retiring workers and meet the rising demand for laboratory tests (Hecker, 2001). Yet in recent years, on average fewer than 5,000 individuals have graduated from accredited training programs annually (U.S. Department of Labor, 2002; Painter, 2000). In 1999, the ASCP certified fewer medical technologists than it did in 1959 (2,216 and 2,349, respectively) (Painter, 2000). A drop in the number of students interested in laboratory science has led to the closure of hundreds of training programs approved by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS), a fact that does not bode well for the future. There were about 1,000 NAACLS-approved programs in 1970, compared to about 500 today (Painter, 2000; NAACLS, 2003). California, the most populous state, had only eight clinical laboratory science programs in the 2003–2004 academic year, with a combined class capacity of just 89 students (AMA, 2003). And not all programs are necessarily filled to capacity. Lack of knowledge about professional laboratory careers (a byproduct of low recognition for current workers) and higher-paying job options in the science and allied health fields are the chief reasons cited for declining enrollments (Beckering and Brunner, 2003; CHP 2001). In fact, public health laboratories are suffering from the combined effects of government workforce problems and adverse trends within the field of laboratory science. Recruitment Issues Recruiting laboratory scientists for any position is difficult in the current job market since qualified workers are scarce. But there are additional challenges. The field of laboratory science is evolving much more rapidly than ever before, and new entrants to the field must be prepared to constantly update their skills. Yet, despite the degree of technical expertise required, laboratorians receive little recognition for work that is largely unseen by the public. Moreover, many laboratory positions are in rural areas and inner cities—locations that tend to be less desirable. Potential public health laboratory recruits also face government hiring constraints, limited career mobility, and generally lower salaries and greater on-the-job learning curves than in the private sector. The 2001 terror attacks and recent SARS outbreak afforded laboratorians some measure of public appreciation for their work, but also raised fears of extraordinary biosafety risks for all infectious disease laboratorians. In addition, the terror attacks spawned new federal legislation that complicates the hiring process for some laboratories, including all state public health laboratories and many university-based research facilities.

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century Challenges to recruitment include: Rapidly Changing Technology Ten years ago, infectious disease laboratorians were expected to be proficient in classic methodologies to identify infectious organisms: microscopy, culture techniques, and serology. Those methods are still used. But today they exist alongside an ever-changing and increasingly complex set of newer methods that staff members in more advanced laboratories must know or be prepared to learn quickly: commercial nucleic acid amplification tests (used for tuberculosis and sexually transmitted diseases), conventional polymerase chain reaction (PCR), real-time PCR (used for emerging infectious diseases and agents of bioterrorism), pulse field gel electrophoresis (a molecular “fingerprinting” technique used for outbreak investigations), and the latest methods—spoligotyping and variable number tandem repeat analysis. In addition to mastering these techniques, laboratorians must also possess above-average computer software skills to track specimens, analyze data, and communicate test results to relevant parties (e.g., specimen submitters, state health officials, national disease databases). Unique Public Health Skill Sets In order to work in a public health setting, a laboratory scientist must have an added skill set above and beyond the technical expertise described above. The average university-trained molecular microbiologist, for example, lacks a working knowledge of infectious disease outbreak management, quality control practices, the principles of population-based disease surveillance, Biosafety Level 3 work practices, and the role of the state epidemiologist and other state and national health officials with whom the laboratory must interface on a regular basis. Ultimately, to work well within a public health laboratory, technical staff must understand the public health relevance of clinical testing. Whereas a private-sector laboratorian will test a sputum sample to determine whether a specific patient is positive for tuberculosis, public health laboratorians will sometimes process the same sample, but to other ends. The public health scientist wants to identify the exact strain of TB infecting the patient and to compare it to TB isolates from other individuals. Is the same strain responsible for multiple TB cases within the state? Do current cases represent the leading edge of a larger infectious disease outbreak? The public health laboratorian may also conduct susceptibility testing to gauge the pathogen’s resistance to a host of antimicrobial agents and work with epidemiologists to forward this information to infection control practitioners and clinical laboratories throughout the state.

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century Introduction Malaria and dengue remain as major health burdens and as obstacles to economic development throughout much of the world’s tropics, while Lyme disease and West Nile fever continue to emerge in many temperate regions. The growing level of annoyance caused by many diverse insects and ticks, of course, adds to the need for effective entomological interventions. The research activities that are appropriate for dealing with these problems focus primarily on vector ecology, but they also include epidemiology and population genetics, as well as aspects of insect physiology. Vector transgenics may, in the future, provide useful modalities. The research interests of the faculty serving in U.S. universities largely determine the characteristics of our scientific workforce, and the discussion that follows is designed to identify the forces that influence hiring practices for faculty engaged in public health entomology. Discussion Source of U.S. Research Funding In teaching institutions in the United States, health-related positions for junior faculty are allocated largely on the basis of external funding. Such “soft” funding less critically defines faculty profiles in universities whose appointees receive their salaries from the various states. During the second half of the 20th century, therefore, the administrations of schools of public health and of medicine increasingly designed their faculties around the “investigator-initiated” system of research grants awarded by the National Institutes of Health, and the “RO1” system of grants served largely as the engine of faculty growth. Today, job descriptions continue to be composed mainly around this perception. Before 1982, proposals relating to vector-associated disease were reviewed by the members of the Tropical Medicine and Parasitology Study Section of the National Institute of Allergy and Infectious Disease (NIAID). The entire gamut of relevant disciplines was considered by this group of experts in entomology, microbiology, vaccinology, and other disciplines. Developments Following the Woods Hole Conference of 1978 Entomological review was separated from the regular TMP Study Section in 1982, in the wake of the development of the first hormonomimetic insecticides and the landmark meeting of this committee in 1978 in Woods Hole, MA. The meeting was inspired by the research accomplishments of the noted insect physiologist Carroll Williams, who spoke of the “third

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century generation of insecticides” that was then being developed. The sense of this meeting held that although funding for insect physiology had previously derived largely from the National Science Foundation, any research effort pertaining to the physiology of insects should now be considered relevant to tropical medicine or parasitology. The NIAID accepted this recommendation and agreed to consider such proposals. Many proposals subsequently were submitted, and they were reviewed by the TMP Study Section as a whole. Some of the proposals in insect physiology were funded, and this encouraged additional submissions, which, in turn, required the assignment of reviewers who specialized in insect physiology. Within 4 years, so many basic physiological proposals were submitted that a new ad hoc committee was formed to evaluate all proposals requiring entomological attention. Epidemiological and parasitological applications of entomology, as well as certain arbovirological proposals, were thereupon separated from the health-related sciences and placed in a context that included basic insect physiology. The composition of this standing committee thereafter evolved to match the proposals that were submitted, a situation that would necessarily tend to favor subjects familiar to the members of the committee. By 1994, the effect of this separation of entomology from health was such that the community of public health entomologists in the United States became alarmed. Led by George Craig, the various societies that were most directly concerned with tropical health addressed resolutions to the NIH director, requesting corrective action. These societies included the American Society of Tropical Medicine and Hygiene, the Entomological Society of America, the Society of Vector Ecology, and the American Mosquito Control Association. The societies pointed out that 93 percent of the 56 grants in vector biology that were funded in 1993 dealt with fundamental insect physiology or molecular genetics, and that their principle investigators mainly were associated with experimental research rather than with tropical medicine or medical entomology. Within a decade after this ad hoc study section became a separate unit, virtually all NIAID-funded work on vector-associated disease would then have been conducted entirely at the bench. No analysis of previous funding patterns was provided. Developments Following the Keystone Conference of 1998 American scientists concerned with vector-associated infections began to employ molecular techniques during the late 1980s; the first symposium on that subject was held at the annual meeting of the American Society of Tropical Medicine and Hygiene in 1986. It examined the idea that the pathogen competence of a vector population might be reduced by releasing transposon-favored, transgenically incompetent mosquitoes. None of the speakers were, themselves, engaged in work on vector arthropods. That

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century situation soon changed. Numerous vector-related projects soon focused largely on molecular genetics. Indeed, 22 of the 53 titles that comprised the 1998 Keystone Symposium on transgenesis, titled “Toward the Genetic Manipulation of Insects,” dealt with mosquitoes or kissing bugs (James et al., 1998). The expertise of three of the five conference organizers derived largely from their research accomplishments with mosquitoes. This influential symposium was the second in a continuing series of such events that were funded by the John D. and Catherine T. MacArthur Foundation and attended by members of various granting agencies. The sequencing of the genomes of Plasmodium falciparum (Gardner et al., 2002) and Anopheles gambiae (Holt et al., 2002) and the ongoing NIAID-funded effort to sequence that of Aedes aegypti have greatly facilitated such work. The creation of an insect that might be released in nature and that would transmit particular useful genes to a disproportionate fraction of its offspring became the goal of many research efforts. The self-generating dynamic that followed the acceptance of insect physiology by the TMP Study Section in 1978 operated once again in 1998. The many proposals relating to molecular genetics that were submitted to the ad hoc medical entomology panel, soon designated as an “Ad Hoc Special Emphasis Panel,” required appropriate reviewers’ expertise. Members of a review panel would naturally tend to favor proposals in their own discipline. Such a shift in membership encouraged the submission of more proposals of this nature, and the more molecular proposals that were submitted and funded, the more the membership shifted. In a session held in 2002, for example, 17 of the 20 members were themselves engaged exclusively in experimental research performed in the laboratory. This process accelerated into 2003 when the Ad Hoc Special Emphasis Panel was divided, much as the original Tropical Medicine and Parasitology Study Section was divided in 1982. All entomological proposals that included a field component were thereupon removed to an epidemiological study section, then operating within the NIAID. Sources of Research Funding The NIAID program of investigator-initiated grants in tropical medicine and parasitology was augmented in 1980 by a system of tropical disease research units that originally was designed to support overseas work on the five parasitoses selected by the World Health Organization (WHO) and expanded in 1995. These “program grants” include several discrete “projects,” and they generally are based in a tropical site. Although few in number, these university-based programs continue to provide first-rate employment and training opportunities for people engaged in research on vector-borne infections.

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century Supplemental funding opportunities have been provided since 1982 by the Small Business Innovation Research Program (SBIR), which is designed to encourage small U.S. businesses to develop innovative products in conjunction with the academic scientific community. Various governmental agencies contributed more than $1 billion during 2002 to this program. A complementary program, known as the Small Business Technology Transfer Program (STTR), expanded support for these academic–entrepreneurial links, and contributed nearly $100 million more during 2002. Although health expenditures would have comprised only a fraction of these totals, the financial incentives would be considerable. Except for efforts devoted to bioterrorism, it seems unlikely that these programs would be sufficiently reliable to serve as stimuli for the creation of academic appointments. The NIH’s system of training grants has long provided crucial support to many generations of students interested in vector-associated disease. The NIAID program is designated mainly for U.S. nationals, and the program conducted by the Fogarty International Institute is mainly for foreign scientists. Although both programs support students, neither provides faculty salaries. The federal Centers for Disease Control and Prevention (CDC) recently initiated a system of training grant awards in public health entomology, and it now awards research contracts in response to particular emerging infections. These training programs and occasional research efforts do little to stimulate faculty hiring. The United States military was an important source of extramural funding for research in vector-associated disease during the 1970s. The military-funded, investigator-initiated proposals, much as those considered under NIH’s RO1 system, supplied funds according to the opinions of an Ad Hoc Study Group on Medical Entomology of the Walter Reed Army Institute of Research. This panel operated in the pattern of an NIH study section. That program, however, was too small to influence staffing patterns in the U.S. university system, and it ended during the middle 1980s. Particular projects on such vector-borne “select agents” as those responsible for tularemia and eastern equine encephalitis have been funded by the Defense Advanced Research Projects Agency. But this source of funding, too, is small and potentially short-lived and may not influence university hiring practices. The various Naval Medical Research Units also maintain overseas laboratories that conduct research projects devoted to vector-borne infection. Grants from the National Oceanic and Atmospheric Administration support faculty engaged in research on the distribution of these infections. The U.S. Agency for International Development (USAID) became a major granting agency in 1963, in the wake of the failure of the worldwide effort to eradicate malaria. Although malariological research was discouraged during the eradication effort, 5 percent of all operational funds were designated for research after the effort was abandoned. An audit of the

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century program, conducted in 1983, described a $125 million general research fund that had been awarded since 1963 (GAO, 1982). Of this, the $26.5 million that had been spent was devoted mainly to academic research on drug and vaccine development. Robert Desowitz’s book Malaria Capers (1993), however, described the sadly disappointing nature of this research effort. USAID’s subsequent program of “environmental impact evaluation” provided opportunity for numerous university faculty to gain important experience in the epidemiology of infectious disease, but provided little salary support. Such “nonacademic” units as Harvard University’s Institute for International Development once devoted important resources to the central administration of that institution, but generated few new teaching faculty. The personnel were recently transferred to Boston University. The National Science Foundation also awards relevant funds. Although certain of the non-health-related U.S. governmental agencies provide some support for university faculty, their impact on university hiring practices seems slight. Funds from the U.S. Department of Agriculture (USDA) largely shape the faculties of U.S. land-grant institutions. Faculty at these state universities draw their salaries as a line item in each state’s budget, and many of them also acquire research funding from federal “Hatch” funds. Until recently, these universities produced many of the medical entomologists employed by public health agencies and universities. The entomological orientation of the land-grant programs has been uniquely strong, and the departments of entomology in the United States tend to be located in such institutions. This element of financial permanence largely insulates the faculties of land-grant colleges from peer-generated pressures on their faculty profiles. Although NIAID funding supplements their basic agriculture-oriented sources, the faculty profiles of the land-grant schools tend to respond less directly to public health requirements than do those of schools of medicine or of public health. Various foundations have long played an important part in funding research efforts relevant to vector-borne infection. The Rockefeller Foundation, of course, contributed much fundamental knowledge during the early part of the 20th century. The MacArthur Foundation’s program has focused narrowly on molecular biology, as has the program of the Burroughs Wellcome Fund. The Bill & Melinda Gates Foundation has entered this field of endeavor with a system of unusually large donations. A multimillion-dollar gift to the London School of Tropical Medicine has permitted that institution to transform its malaria activities with a multifaceted program of research. An even larger gift to the Johns Hopkins Bloomberg School of Public Health, from another anonymous source, permitted that school to expand its malaria program. New faculty members appear to have been recruited in response to both of these gifts. The Gates Foundation has

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century recently requested suggestions for a grand malariological challenge, and we await the result. This effort, too, seems likely to increase the number of scientists engaged in research on vector-borne infection. Although foundation support now tends to be directed toward narrow “cutting-edge” goals, such funds have been sufficiently generous and sustained since the early 1990s to influence faculty hiring patterns. Antimalaria interventions recommended by the Roll Back Malaria program of the WHO and its partner agencies seek to halve the burden of malaria during the first decade of the millennium, and to halve it once again by 2015, by “scaling up” the application of these techniques. Only limited operational research is conducted, and progress has not yet been reported. The United Nations recently launched a Millennium Development Goals program for reducing poverty in the developing world, and one component of this program is concerned with developing antimalaria strategies. The role of research in this developing strategic formulation is yet to be defined. Changes in Vector-Related Activities in U.S. Universities A comprehensive review of the status of training and research in public health entomology was conducted in 1982 as part of the Coolfont Symposium, which was organized by the National Research Council and included participants from various universities, diverse laboratories, the military, federal and multilateral granting agencies, and various foundations. Questionnaires were submitted to 28 schools of medicine, schools of public health, departments of biology, and departments of entomology that were identified as potential sources of training in disciplines that pertained to the transmission of vector-associated disease. The 24 institutions that responded listed 63 relevant faculty, and about half of the respondents had only 1 faculty member. Of those responding, 17 had teaching programs that included some field-related component; but only 7 had overseas components. Characteristics of the different programs that were identified are instructive. Because faculty in the seven land-grant institutions draw their salaries from their state coffers, they tend to design their research and teaching programs around local needs. The training programs of these institutions focused on the biology of the vectors themselves, and none included course work in epidemiology or pathogenesis. A few programs included virological components. Conversely, the seven health-oriented institutions emphasized course work pertinent to the burden of human disease while downplaying entomological subjects. The salaries of these health-related faculty were then, as now, notoriously soft, deriving mainly from external sources, a fact that induces the faculty to cast a broad net in their search for grant support. Overseas activities play a large part in their endeavors. The three responding departments of biology were housed in pri-

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century vate institutions. Their programs and research orientation differed. One department, at Notre Dame University, trained a large fraction of the medical entomologists of the time and focused on the biology and genetics of mosquitoes. Some seven doctoral-level vector biologists had been graduating from these diverse U.S. institutions each year. In general, the respondents suggested that the growth of their programs was less dynamic than in the recent past. A smaller but comparable survey of U.S. training opportunities in public health entomology was conducted in 2002 by Walter Tabachnick at the request of the American Mosquito Control Association (personal communication). He found that 12 universities had active doctoral-level programs in the subject and that they employed 33 relevant faculty. These instructors had been producing some nine doctoral graduates in vector biology per year since 1998. A simple comparison of the Coolfont and Tabachnick surveys suggests that nearly half of the relevant programs may have been discontinued during the past 2 decades, and that the extant programs employed only half as many faculty as in 1982. Surprisingly, no diminution in doctoral graduates was evident. Transgenesis came to dominate vector-oriented studies beginning in 1993, when a series of notable research findings was published (Aldhous, 1993). As practiced, these research efforts generally include no field component. The Special Program for Research and Training in Tropical Diseases (jointly supported by the United Nations and several other international organizations), the MacArthur Foundation, and the Burroughs Wellcome Fund, modified their funding policies in 1993 such that future grants in this discipline would be devoted to attempts to create transgenic vector insects. Although the public health usefulness of such a mosquito was then controversial (Spielman, 1994) and still remains in doubt, an aura of excitement has increasingly come to surround vector transgenesis. The proportion of the faculty that Tabachnick surveyed who were engaged in this narrowly focused aspect of the study of vector-associated disease may be quite large. In general, then, fewer university faculty in the United States appear to be prepared to investigate the transmission of vector-borne pathogens than in the recent past. The magnitude of the investment in research in vector transgenics will affect this trend. Conclusions A panel recently convened by the Institute of Medicine recognized that the United States now lacks the capacity to confront the health threats posed by vector-borne pathogens (Institute of Medicine, 2003). The panel concluded that the Centers for Disease Control and Prevention, the Department of Defense (DOD), the National Institutes of Health, and the

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century Department of Agriculture “should work with academia, private organizations, and foundations to support efforts at rebuilding the human resource capacity at both academic centers and public health agencies in the relevant sciences—such as medical entomology, vector and reservoir biology, vector and reservoir ecology, and zoonoses—necessary to control vector-borne and zoonotic diseases.” These diverse federal agencies differ in their faculty-enhancing policies. In the past, only the NIH had sufficient resources and a commitment to investigator-initiated research to affect staffing decisions at health-related and private U.S. institutions. The influence of the USDA mainly affects land-grant institutions, and staffing decisions there respond largely to the interests of their respective state legislatures. The departments of entomology in these institutions, therefore, tend to be shaped by local interests. Funding by the CDC and the DOD has been much lower than that of the NIH, and their funds have been directed toward narrowly defined goals that have changed as the perceived need has changed. The National Science Foundation, which was not included in the IOM recommendation, at least until recently, has tended to fund basic rather than health-related research. The CDC, the DOD, and the USDA employ vector-related health scientists, but without stimulating the faculty appointments that result in their production. Therefore, the human resource capacity at U.S. universities that might be capable of dealing with vector-related issues in health would depend largely on the system of generous investigator-initiated research that resides at the NIH. The IOM recommendation cited above omits reference to the contribution of private foundations to the human resource capacity of U.S. academe. The Gates Foundation and the Burroughs Wellcome Fund seem likely to play an important role in this dynamic. The funding policies that they pursue in the immediate future may encourage faculty to engage in insect transgenesis, insect physiology, or research relating to transmission of pathogens. Changes in the NIH system of proposal review may impose novel constraints on health-related research on vectors conducted by the faculty of U.S. universities in the immediate future. Investigator-initiated proposals might be evaluated at the NIH in an epidemiological context in place of the biological milieu that pertained in the recent past, and the research tradition of at least some of the authors of these proposals will differ fundamentally from that of their reviewers. Faculty working in land-grant institutions, in particular, may not readily be able to address reviewers whose research tradition focuses on numerical rather than experimental applications. In addition, many of the reviewers of proposals dealing with vector transgenics will, themselves, be practitioners of that discipline. Authors of research proposals that pursue aspects of insect physiology may also find

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century themselves at a disadvantage. These developments seem likely to increase the numbers of funded research proposals that approach vector biology from the tradition of molecular biology. The administrators of U.S. schools of public health and of medicine, therefore, would feel constrained to plan their staffing policies accordingly. A cohort of scientists is required who can usefully produce the next generation of public health entomologists and whose research activities will promote that goal. Their programs will strike some balance between the three entomological interests that have vied for support during the past half century—vector biology, insect physiology, and molecular biology—and their work should incorporate strong epidemiological features. Because faculty-hiring priorities are determined so strongly by the NIH system of investigator-initiated grants, a major responsibility in this regard falls on that federal agency. Participation by foundations and private donors may contribute powerfully to the outcome of this process. The characteristics of the evolving discipline of public health entomology remain to be defined. References Aldhous P. 1993. Malaria: Focus on mosquito genes. Science 30:605–608. Desowitz RS. 1993. Malaria Capers: Tales of Parasites and People. New York: W.W. Norton & Company, Inc. GAO (General Accounting Office). 1982. Malaria Control in Developing Countries: Where Does it Stand? What is the U.S. Role? Report to the Administrator for International Development, Agency for International Development, 26 April 1982. ID-82-27. Washington, DC: General Accounting Office. Gardner MJ, Hall N, Fung E, White O, Berriman M, Hyman RW, Carlton JM, Pain A, Nelson KE, Bowman S, Paulsen IT, James K, Eisen JA, Rutherford K, Salzberg SL, Craig A, Kyes S, Chan MS, Nene V, Shallom SJ, Suh B, Peterson J, Angiuoli S, Pertea M, Allen J, Selengut J, Haft D, Mather MW, Vaidya AB, Martin DM, Fairlamb AH, Fraunholz MJ, Roos DS, Ralph SA, McFadden GI, Cummings LM, Subramanian GM, Mungall C, Venter JC, Carucci DJ, Hoffman SL, Newbold C, Davis RW, Fraser CM, and Barrell B. 2002. Genome sequence of the human malaria parasite Plasmodium falciparum. Nature 419:498–511. Holt RA, Subramanian GM, Halpern A, Sutton GG, Charlab R, Nusskern DR, Wincker P, Clark AG, Ribeiro JM, Wides R, Salzberg SL, Loftus B, Yandell M, Majoros WH, Rusch DB, Lai Z, Kraft CL, Abril JF, Anthouard V, Arensburger P, Atkinson PW, Baden H, de Berardinis V, Baldwin D, Benes V, Biedler J, Blass C, Bolanos R, Boscus D, Barnstead M, Cai S, Center A, Chaturverdi K, Christohides GK, Chrystal MA, Clamp M, Cravchik A, Curwen V, Dana A, Delcher A, Dew I, Evans CA, Flanigan M, Grundschober-Freimoser A, Friedli L, Gu Z, Guan P, Guigo R, Hillenmeyer ME, Hladun SL, Hogan JR, Hong YS, Hoover J, Jaillon O, Ke Z, Kodira C, Kokoza E, Koutsos A, Letunic I, Levitsky A, Liang Y, Lin JJ, Lobo NF, Lopez JR, Malek JA, McIntosh TC, Meister S, Miller J, Mobarry C, Mogin E, Murphy SD, O’Brochta DA, Pfannkoch C, Qi R, Regier MA, Remington K, Shao H, Sharakhova MV, Sitter CD, Shetty J, Smith TJ, Strong R, Sun J, Thomasova D, Ton LQ, Topalis P, Tu Z, Unger MF, Walenz B, Wang A, Wang J, Wang M, Wang X, Woodford KJ, Wortman JR, Wu M, Yao A, Zdobnov EM, Zhang H, Zhao Q, Zhao X, Zhu SC, Zhimulev I, Coluzzi M, della Torre A, Roth CW, Louis C,

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Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century Kalush F, Mural RJ, Myers EW, Adams MD, Smith HO, Broder S, Gardner MJ, Fraser CM, Birney E, Bork P, Brey PT, Venter JC, Weissenbach J, Kafatos FC, Collins FH, and Hoffman SL. 2002. The genome sequence of the malaria mosquito Anopheles gambiae. Science 298:129–149. Institute of Medicine. 2003. Microbial Threats to Health: Emergence, Detection, and Response. The National Academies Press: Washington, DC. James AA, Beckage NE, Christensen B, Ffrench-Constant R, and Raikhel AS. 1998. Toward the Genetic Manipulation of Insects. Taos, New Mexico. Keystone Symposium, Sponsored by The John D. and Catherine T. MacArthur Foundation. Spielman A. 1994. Why entomological antimalaria research should not focus on transgenic mosquitoes. Parasitol Today 10:374–376. Spielman A. 2003. Research approaches in the development of interventions against vector-borne infection. J Exp Biol 206:3727–3734.

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