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FIC FY2005 Congressional JustificationTable of Contents
- Combating AIDS and Emerging Infectious Diseases - Promotion of Maternal and Child Health - FIC Story of Discovery - Addressing the Global Disease Burden of Trauma and Injury - The Global Culture of Science Authorizing Legislation: Section 301 and 307 and Title IV of the Public Health Service Act, as amended. Reauthorizing legislation will be submitted. Budget Authority:
This document provides justification for the Fiscal Year 2005 activities of the John E. Fogarty International Center (FIC), including HIV/AIDS activities. A more detailed description of NIH-wide Fiscal Year 2005 activities can be found in the NIH section entitled "Office of AIDS Research (OAR)." INTRODUCTION"Science knows no country because it is the light that Louis Pasteur "Science for global health," the mission of the Fogarty International Center , has never been more important than it is today. In an increasingly interdependent world, the United States and nations around the globe not only share the risk of diseases but also the burden they inflict on healthy people. There is a growing recognition that overcoming these challenges requires medical research partnerships among scientists in developed and developing countries. The Fogarty International Center (FIC) research and capacity building initiatives target health disparities between developed and developing countries, and support joint efforts to "jumpstart" the journey to better health for most of the world's poor. It is now commonplace knowledge that improving health in Latin America , Africa and Asia benefits the health of the American people. When it comes to disease, we are truly one world. Several years ago, West Nile virus arrived from the eastern Mediterranean to the United States , probably on an airplane. The same can be said for the transmission of SARS from China to Canada and to the United States . What befalls Brazil , Kenya and India , befalls us also, and what benefits them, benefits us. To achieve its aims, Fogarty has developed innovative research and training programs for young scientists from the U.S. and developing countries. The Center fosters collaborative medical research between U.S. scientists and those from developing countries on problems of worldwide importance such as HIV/AIDS, malaria and tuberculosis, as well as acquired abnormalities of the brain, tobacco-caused illness, and other chronic diseases. When SARS first appeared in China in the winter and spring of 2002-03, there was a rapid global response to this dangerous "killer." Through an international effort involving many countries and the World Health Organization (WHO), by June 2003 the epidemic had been halted. When SARS first appeared, it was a mystery. However as Miguel de Cervantes writes in Don Quixote, "The beginning of health is to know the disease." Collaborative international science provided the answer within a few months. This is a tribute both to modern advances in virology in the last fifty years and international science, largely funded by the NIH. One major purpose of Fogarty has been to train a large cadre of foreign scientists in the latest methods of medical science so that when the unexpected appears in any place on the globe they are ready to apply their talents and experience. We must have "excellence at the end of the line" if we are to meet the challenges of emerging and re-emerging diseases of the future, as well as continue to prevent and treat diseases which still afflict so much of the world. At a May 2003 symposium marking 35 years since the establishment of FIC, scientific leaders from developed and developing countries gathered to commend Fogarty for its achievement and commitment to improving health and reducing health disparities everywhere, and to refocus on the unfinished agenda. Speaking at the symposium, "Global Health: A Challenge to Scientists," Dr. Jean Pape, a long-standing FIC grantee and Director of the foremost HIV/AIDS program in Haiti, noted: "Fogarty-trained personnel have enabled us to be successful in receiving support from the Global Fund for AIDS, TB and Malaria (Global Fund), and to expand interventions, including antiretroviral treatment, to 25 centers. Our new Fogarty project will allow us to introduce young Haitians at an early stage in their careers to public health challenges and the research needed to resolve them. The project will help us retain the brightest stars where they are most needed - here in Haiti ." This is surely science for global health in action. SCIENCE ADVANCESFogarty now supports over two dozen collaborative international medical research and training networks, each designed to meet a particular need and contribute to the improvement of global health. The scientists in these diverse networks are also working together. For example, those working on AIDS collaborate with those working on other emerging infections, and on research ethics. Such unions are building the foundation for "centers of research excellence" in the developing world. Following are illustrative examples of scientific successes supported by FIC. Combating AIDS and Emerging Infectious DiseasesNewly emerging and re-emerging infectious diseases pose daunting challenges to the U.S. and to the global community. The recent outbreaks and detection of the coronavirus causing SARS demonstrates the need for strong research and surveillance resources around the world, and the ability to work collaboratively, and share information, techniques, and samples. Only international scientific partnerships can facilitate such endeavors. Thus, Fogarty-supported training for infectious disease researchers in low- and middle-income nations ensures that a robust research enterprise and established collaborations are in place when and where they are needed most. At the same time, foreign trained scientists can contribute to vital medical research programs on shared challenges faced by the U.S. and our partners abroad. The Fogarty AIDS International Research and Training Program (AITRP), now in its 16th year of operation, has been a major source of support for training a cadre of foreign medical scientists from developing countries necessary to combat the global HIV/AIDS pandemic. Working through U.S. universities, Fogarty has supported Masters level, Ph.D., and post-doctoral training for young scientists in the hardest hit countries. These scientists are needed to test AIDS vaccines abroad, to develop effective public health strategies to reduce the transmission of AIDS in Uganda , Haiti , Thailand , South Africa and elsewhere, and to provide the knowledge base to introduce treatment for those already infected. Over time, nearly 2,000 researchers from over 100 countries have been trained in the U.S. , many at senior levels, and over 50,000 through in-country workshops and courses. Significantly, in a study of five AITRP programs, 80% of trainees return to their home countries. Among the leaders who have received training under this program are the current or former ministers of health in Senegal , Rwanda , Uganda and Malawi . This large international cadre of trained scientists facilitated the successful implementation of other new programs such as the Pediatric AIDS Foundation Call-To-Action, and the President's initiative on prevention of maternal-to-infant transmission of HIV. In addition, health scientists trained under the program have played vital roles in helping approximately 20 countries receive awards from the Global Fund, for example, in Nigeria , South Africa , the Republic of Georgia , Haiti , Russia and China . FIC-trained scientists form the foundation of numerous international HIV/AIDS research programs supported by other NIH components. Preliminary data show that over 50 independent awards supported by other NIH institutes depend significantly on foreign scientific collaborators trained under the FIC AITRP. In addition, virtually all of the Vaccine Trials Networks (over a dozen clinical trials networks that are preparing for the eventual wide scale testing of HIV vaccines) depend significantly on foreign scientific collaborators trained under AITRP. The same holds true for the NIH Prevention Trials Networks, which test interventions on a wide scale basis to reduce HIV transmission. At least five of the six Popular Opinion Leader sites, which identify community leaders who will act as change agents to reduce the spread of HIV and mitigate its impact, involve former AITRP trainees in significant ways. NIAID's Comprehensive International Program for Research on AIDS, based in China , Senegal and South Africa , involves a range of former FIC AITRP trainees. The Fogarty Global Infectious Disease Research Training Program similarly enhances the ability of developing country scientists and health professionals to understand, detect, identify, and ultimately control and prevent outbreaks of emerging infectious diseases other than HIV/AIDS, and as varied as drug-resistant pneumococcal infection, West Nile virus and dengue hemorrhagic fever. This is achieved through collaborative research and training with U.S. scientists. Given the global need to mobilize quickly to identify, contain, and control an emerging infection, the research and training network established under this program can generate, disseminate and apply new knowledge to reduce the risk of disease through new rapid, reliable, and inexpensive diagnostic tests, new and improved means of treatment and prevention, and better understanding of the environmental and ecological breeding ground for emerging infectious problems. FIC recently made 10 new awards in this program to support research training in Brazil , Columbia , Mexico , Peru , Kenya and Malawi . This raises the total number of countries participating in the FIC non-AIDS infectious disease training programs to nearly 20. Scientists trained under this and predecessor programs have become leaders in their countries in helping to identify emerging infectious diseases, laying the groundwork to better prevent, identify and treat diseases such as SARS and other infectious diseases that may arise in the future. One example of how Fogarty programs simultaneously advance U.S. and global health interests is demonstrated by recent studies on the epidemiology of Hemophilus influenzae type b (Hib) pediatric meningitis. An effective vaccine against this organism is routinely given in the U.S., but not yet in most developing countries. Where widely employed, Hib vaccine dramatically reduces the number of meningitis cases. Recently, Fogarty-supported research collaborators from the University of California at Berkeley, Cornell University, the Federal University of Bahia, Brazil, and the Brazilian Ministry of Health studied the effects of implementing Hib immunization in Brazil. Before widespread Hib vaccination began, 97 percent of meningitis due to H. influenzae were caused by type b. After the 1999 introduction of Hib vaccination of children under two years old in Bahia , Brazil , type b meningitis decreased by 69 percent as expected. However, an increase in the incidence of H. influenzae type a meningitis was noted. This observation has raised a new concern that such new strain(s) may emerge to replace H. influenzae b. It demonstrates there is no ground for complacency, and additional research on the epidemiology of H. influenzae meningitis is needed, with attention given to the development of an effective vaccine for whatever additional strain(s) may emerge in the U.S. and other countries. Promotion of Maternal and Child HealthWhile overall maternal and infant morbidity and mortality rates are low in the United States , in many countries and even in some communities in the United States , these rates remain unacceptably high. Risk factors include the lack of access to prenatal care, poor nutrition and frequent pregnancies, leading to high rates of stillborn and low birth-weight babies and high maternal and perinatal mortality. Birth defects remain a major cause of infant deaths, and are responsible for significant mental and physical abnormalities among the survivors that live into adulthood. To improve maternal and infant health, FIC, in collaboration with the National Institute of Child Health and Human Development, supports the International Maternal and Child Health Research and Training program. Developing country research trainees within this collaborative program, and other FIC programs, are studying a broad range of diseases in pregnancy and infancy, with the goal of preventing complications of pregnancy and protecting infants from infectious diseases and perinatal transmission of HIV/AIDS. For example, scientists at the University of North Carolina and the University of Malawi have identified a new and effective means to minimize mother-to-child transmission of HIV after birth. This is important because low-income women in sub-Saharan Africa typically do not obtain medical attention during pregnancy and are usually uninformed of their HIV status until delivery. Research has shown that prepartum or intrapartum medical intervention to prevent mother-to-child transmission of HIV is effective. Still, for many mothers the only chance to intervene is post-partum. Two relatively inexpensive regimens of post-partum protection for newborns - zidovudine plus nevirapine or nevirapine alone - have recently been compared for efficacy by FIC supported researchers. Close to one thousand babies of Malawian women with HIV whose first prenatal visit was within two hours of expected delivery were entered into a clinical trial to compare the two forms of preventive treatment. HIV tests were conducted on cord blood samples and blood collected at one week and subsequent intervals within a year of delivery. The data showed that the addition of zidovudine provided more protection than using a single drug. For example, the overall rate of mother-to-child transmission at 6-8 weeks was 15.3 percent in 484 babies who received nevirapine and zidovudine and 20.9 percent in 468 babies who received nevirapine only. Implementation of the two-drug regimen will mean that more newborn infants will have a chance to grow to be healthy adults, even where the lack of resources and other obstacles to extending medical care and awareness to women limits prenatal care and interventions. NIH ROADMAPFogarty is working to support the objectives of the NIH Roadmap Initiative through several strategic programs. First, the Center is supporting the Roadmap theme of Re-engineering the Clinical Research Enterprise through its International Clinical, Operational and Health Services Research and Training Award program on AIDS and TB (ICOHRTA AIDS/TB). The ICOHRTA AIDS/TB program supports the training of physicians, nurses, medical sociologists, mental health and other health services researchers in a team effort to devise new strategies to administer, in a cost effective fashion, new AIDS and TB drugs into the health care systems in resource poor nations. This FIC-led effort will fill a critical gap by building a cadre of professionals with skills in the design and conduct of clinical trials, as well as in operational and health services research essential to insure the rapid translation of clinical information to policies that extend implementation of treatment from the bedside to the clinics and to communities. Second, FIC supports a unique NIH interdisciplinary effort relevant to the Roadmap theme on Building Research Teams of the Future. Through an in-house research program, Fogarty staff health scientists and mathematicians who analyze complex research questions are working with clinicians, economists and medical scientists to "model" the spread (slow or fast, for example) of new emerging infectious diseases. At its best this is a predictive science (as was employed for SARS) that not only identifies effective and cost-effective intervention points and models the economic benefits of large-scale vaccine and other intervention programs, but it also helps to identify the questions that must be asked as epidemics evolve. Just as the general of an army utilizes the weather predictions of a meteorologist in planning a military campaign, those who make health policy must consider the predictions of a mathematical "modeler" on the future course of an emerging epidemic in developing the most effective strategies to confront it. FIC Story of DiscoveryFogarty International Center 's AIDS International Training and Research Program: Building International Leadership in HIV/AIDS
FIC NEW INITIATIVESAddressing the Global Disease Burden of Trauma and InjuryThe global burden of death and disease due to trauma and injury will rise sharply in the coming decades.[1] The numbers and the burden are startling: more than 1.2 million people are killed in traffic accidents annually, and millions more are injured or disabled. Deaths from all types of injuries, including war and domestic violence, are projected to rise from 5.1 million in 1990 to 8.4 million in 2020, with road traffic injuries as a major cause for this increase. Economic costs of road traffic injuries alone around the world are estimated at $518 billion per year, while the economic burden from violence and related disability will account for up to 5 percent of GDP in some countries (WHO). To gain insight into the opportunities for research on trauma and injury in developing countries, FIC met with U.S. and international experts in June 2003 to discuss priorities for research, training and the development of new technologies to reduce the impact of trauma and injuries in developing countries. The major topics were: research gaps and training in the developing world; basic and applied science gaps in the diagnosis and treatment of injury, wound care, wound healing, spinal cord and brain injury, rehabilitation and orthopedics; and short and long-term mental health consequences of violence, trauma and injury. Fogarty will initiate a new research and training program to address the growing burden of morbidity and mortality due to trauma and injury. Among the features of the program will be training across the range of basic to applied science, the epidemiology of risk factors, acute care and survival, rehabilitation, and the long-term mental health consequences. Possible research areas will include development of low-cost synthetic blood products and diagnostic imaging tools, identification of behavioral intervention strategies that are effective, particularly in youth and other high-risk groups, and health services research to determine cost-effective measures for emergency care in low-income settings. Benefits of this program will accrue not only to developing countries but, as low-cost and effective strategies are identified, to communities around the world. The Global Culture of ScienceFogarty will continue its commitment to fostering and enhancing a global culture of science. This will include efforts to ensure full participation of the "best and brightest" around the world in the excitement and promise of the biomedical research enterprise, to promote the ethical conduct of research, to improve the quality of professional journals in the developing world, to enhance the media's ability to convey reliable scientific and health advances in resource-poor settings, and to engage communities in poor countries to the greatest extent possible in the medical research endeavor. Career Path Issues for Women in Health SciencesAs Fogarty supports research to address critical global health challenges, many of which affect women and children disproportionately, the Center is committed to ensuring that career paths in science are fully open to women. At an October 2003 colloquium on career path issues facing women in the life sciences, including women in the developing world, Fogarty and its co-sponsors, the NIH Office of Research on Women's Health and the National Institute of Environmental Health Sciences (NIEHS), heard from a community of scientists, administrators and science funding agencies about opportunities in advancing career issues for women in the life sciences. To follow up on the recommendations, FIC and partners will: collect data on developing country women in science and their career paths; support workshops to develop skill sets for women scientists in the developing world that would better enable them to take on leadership roles within health research and/or policy settings; and develop and implement strategies to effectively utilize the Internet and other information technologies to network, to mentor and otherwise support women in the life sciences internationally. Developing the Next Generation of U.S. Leaders in Global HealthWhile Fogarty works to build capacity and train young scientists in the developing world, critical steps have been taken to ensure that U.S. junior scientists and clinicians have opportunities to engage in international research projects at a formative stage in their careers. The Center will continue, enhance and expand two programs to bring the next generation of U.S. scientists more fully into the global culture of science. The International Research Scientist Development Award (IRSDA) program provides post-doctoral training for four years, two of which must be conducting research in a developing country. To build international research faculty in U.S. institutions, an additional competitive supplementary award is available to IRSDA trainees beginning a tenure track faculty appointment at a U.S. research institution. Nearly 20 U.S. scientists are now being supported as IRSDA trainees. Addressing an earlier step in the career path, FIC has recently teamed with the Ellison Medical Foundation, the Association of American Medical Colleges, and the Association of Schools of Public Health to create a new pre-doctoral clinical research training program for U.S. medical and public health students. Under this program, students will spend a year in a developing country conducting NIH-sponsored clinical research under the mentorship of an experienced foreign investigator and a collaborating research team. The first students to be selected will begin the program in the summer of 2004. As sensitivity to global health issues increases in medical and public health schools across the U.S. , this interest in clinical research training abroad will continue to grow. Combined, these two initiatives will develop future U.S. researchers who have a commitment to confront the challenges of global health, who will understand the realities of conducting research in resource-limited settings, and who will make long lasting friendships for the U.S. in critical places around the world. Disseminating the Best Health and Science InformationScientific progress is dependent on full access to the information published in high-quality scientific and clinical journals. For a number of reasons, the journals published in developing countries do not contain the best science, and yet for researchers from those countries, these journals may be the most widely available sources of information. Following Fogarty-sponsored consultations (in collaboration with the National Library of Medicine) with journal editors from both developed and developing countries, it is clear that many medical and health journals in the developing world do not meet the needs of their physicians and scientists. This is due to a number of factors including part-time or voluntary staff, inadequate funding, small circulation, infrequent and irregular publication dates, a limited number of submissions, and lack of vigorous peer-review and editorial expertise. As a pilot project, Fogarty, together with the National Library of Medicine and the National Institute of Environmental Health Sciences, has initiated plans to build editorial expertise and strengthen medical and scientific journals in the developing world. In September 2003, the three partners sponsored a workshop involving the Editors of the Journal of the American Medical Association, American Journal of Public Health, Environmental Health Perspectives, British Medical Journal, and Lancet and four Editors from Sub-Saharan African journals (Malawi Medical Journal, Ghana Medical Journal, Mali Medicine, African Health Sciences-Uganda). The intent is to twin journals from the North and South for training and quality improvement. A common set of goals emerged, including professionalization of editors, development of journal business and marketing plans, author training in science writing, access to qualified reviewers, translation where appropriate, networking, and better technology and instrumentation. The potential for publishing the same paper in a U.S. or British Journal and one from Africa was also examined. The twinning initiative will commence in FY 2004 and continue in FY 2005. The news media, through print, radio and television, is the major source of health information for the general public around the world. Where access to the Internet is limited, the news media is an even more important source of information about health. This is true as well in the U.S. , for example for the Latino community. Following several consultations with journalists, Fogarty together with the National Cancer Institute, sponsored a workshop in October 2003 for 25 health reporters and medical broadcasters from Latin America and the Caribbean as well as from Latino media outlets in the U.S. The meeting focused on three areas of medical importance: HIV/AIDS, tobacco, and environmental health and cancer. The meeting presented new science and health information, explored strategies for obtaining reliable information, and helped to establish networks among the journalists from the countries involved to promote comprehensive coverage and inform quality reporting of health-related news stories. The participants were also provided information on how to access recent advances by NIH scientists. Based on lessons learned from this first effort, further workshops are planned in FY 2005 in Latin America as well as in Africa and Asia . Global Health at the Community LevelFor health research to be truly successful it must ultimately benefit the health of people. New research findings on specific diseases, whether heart disease or AIDS, must be known, understood and utilized by those who are afflicted. Within the range of Fogarty-sponsored research and training programs, additional efforts will be made to include the community in the formulation of the research and the dissemination of results. The goal is to understand the social, economic, and/or cultural conditions that affect health. For example, community involvement can help to identify the most pressing health needs and concerns, develop measurement instruments of outcomes that are culturally appropriate, establish mechanisms to both inform the research subjects and maximize participation, and utilize research findings to improve health. Because Fogarty's research and training programs consist of a global network of researchers and research sites, the Center is uniquely positioned to provide a forum to explore how to best to integrate principles of community-based participation into research in a global context. Lessons learned will be valuable to Fogarty and the NIH community as best practices are identified and emulated. CONCLUSIONBiomedical science in the 21st century requires new approaches to solving public health problems. This is especially true in the context of today's urgent global health needs. Individual researchers working alone are no longer the only means to generate scientific advances. Indeed, it will be research teams that will propel medical research forward in the coming decades. Fogarty's unique mission to invest in human capital and build scientific capacity in the developing world with an emphasis on generating useful and practical health interventions for local populations is strengthened by its cutting-edge strategy of investing in critical research and its promotion of international research collaborations. Investments in specific disciplines, disease areas and cross-cutting NIH initiatives (such as bioethics) effectively linked together create an integrated package, allowing Fogarty initiatives to simultaneously maximize the benefits of all NIH investments in international research. BUDGET POLICYThe Fiscal Year 2005 budget request for the FIC is $67,182,000, including AIDS, an increase of $1,838,000 and 2.8 percent over the FY 2004 Final Conference Level. Also included in the FY 2005 request is FIC's support for the trans-NIH Roadmap initiatives, estimated at 0.63% of the FY 2005 budget request. The Roadmap funding is distributed through the mechanisms of support, consistent with the anticipated funding for the Roadmap initiatives. A full description of this trans-NIH program may be found in the NIH Overview. A five year history of FTEs and Funding Levels for FIC are shown in the graphs below. Note that Fiscal Year 2001 FTEs is not comparable to the figures in the succeeding years due to NIH's consolidation of its Human Resources function in FY 2003 and the transfer of FIC's International Services Branch. NIH's highest priority is the funding of medical research through Research Project Grants (RPGs). Support for RPGs allows NIH to sustain the scientific momentum of investigator-initiated research while providing new research opportunities. The FY 2005 NIH request provides for an aggregate 1.3 percent increase in average cost for Research Project Grants, consistent with the Gross Domestic Product deflator. The FIC is providing an average cost increase of 1.9 percent for direct recurring costs in non-competing continuation awards. Competing RPGs are based on an average cost increase of 1 percent. The Fiscal Year 2005 request includes funding for 164 Other Research Grants. Research Management and Support receive an increase of 2.7% over FY 2004. The mechanism distribution by dollars and percent change are displayed below. [1] The Global Burden of Disease: A Comprehensive Assessment of Mortality and Disability from Diseases, Injuries, and Risk Factors in 1990 and Projected to 2020, Global Burden of Disease and Injury Series Vol I, Sec. 6.2 (Christopher J.L. Murray and Alan D. Lopez, eds.), Harvard University Press (1996). Graphs1. FTEs by Fiscal Year
2. Funding Levels by Fiscal Year(Dollars in Millions)
3. FY 2005 Estimate Percent Change from FY 2004 Mechanism
4. FY 2005 Busget Mechanism(Dollars in Thousands)
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