Congressional Justification FY2012

Reinvigorating the Biomedical Research Community.

Research advances will more likely occur when investigators study diseases onsite to develop health interventions that are responsive to local and international priorities. This requires trained, in-country scientists and robust institutions that understand local populations and collaborate with U.S. and other investigators. Fogarty responds to this need through support of long-term research and training partnerships between U.S. and low- and middle-income country (LMIC) research institutions, which has resulted in the training of more than 5,000 researchers many of whom contribute to major scientific advances. For example, the first results from a large clinical trial testing candidate microbicides that use anti-retrovirals (ARVs) found that the incorporation of an ARV into a vaginal gel was more than 50 percent protective against HIV infection when used as directed. This advance is a key step toward empowering women with a safe and effective HIV prevention tool. Notably, six of the study’s authors are current or former Fogarty-sponsored trainees. The lead scientists explicitly recognized Fogarty’s training support in making this trial possible.

Fogarty also supports the training of U.S. investigators to conduct global health research and actively engage in international scientific collaborations. These investments directly respond to the overwhelming demand for global health opportunities on university campuses across the U.S. In addition, these programs are helping to prepare early career scientists to participate in the global scientific marketplace, to build long-term relationships and to acquire skills that will help to ensure that the U.S. continues to be a global leader in health innovation.

Combating Global Disease.

In his “Focusing on Global Health” Theme, the NIH Director has highlighted infectious diseases, non-communicable diseases, and injuries. Fogarty’s Global Infectious Disease Research Training Program supports collaborations between U.S. and LMIC research institutions that are training early career investigators in infectious disease research and empowering the trainees to eventually become mentors and leaders of the next generation of scientists in their home countries. For example, Dr. Hector Garcia, a former Fogarty-supported trainee from the Universidad Peruana Cayetano Heredia (UCPH) in Peru, is now the recipient of NIH research funding to test treatments for epilepsy resulting from neurocysticercosis. Building on a twenty-year-old research and training collaboration between UCPH and the Johns Hopkins School of Public Health, Dr. Garcia is also the Principal Investigator on a Fogarty grant that is training students in infectious disease research, with an emphasis on diarrheal disease, cysticercosis, and tuberculosis. Notably, neurocysticercosis is the leading cause of epilepsy among U.S. immigrants from Central and South America. By extending the frontiers of science beyond our borders and investing in research where diseases are endemic, new interventions that are developed can help us better treat patient populations in the U.S.

Non-communicable diseases, such as heart disease, stroke, cancer, and diabetes, are the leading causes of worldwide mortality, accounting for 60 percent of all deaths. Eighty percent of this burden is in LMICs, where these diseases affect people disproportionately during their most economically productive years. Therefore, non-communicable diseases present a serious threat to economic development. Fogarty is addressing this challenge through its expanded program on Chronic, Non-Communicable Diseases and Disorders across the Lifespan, which supports training of in-country scientists to conduct research on these diseases. Given the high burden of non-communicable diseases in the U.S., knowledge gained from these research activities can inform domestic efforts to prevent and treat these diseases, particularly in low-resource settings.

Leveraging Resources through Innovative Partnerships.

It is imperative that we identify opportunities to leverage resources and expertise. Fogarty is administering a major new program called the Medical Education Partnership Initiative (MEPI) - a joint effort of the Office of the Global AIDS Coordinator, the Health Resources and Services Administration, the Department of Defense, USAID, CDC, and NIH. MEPI supports institutions in Sub-Saharan African countries and their U.S. partners to develop new models of medical education and to strengthen the ability of medical students and faculty to conduct research that responds to the health needs of their countries. As evidence of Fogarty’s successful investments in building research capacity, over half of the awardees in this highly competitive program have a history of ten or more years of Fogarty support.

Fogarty has also partnered with the Bill and Melinda Gates Foundation (Gates Foundation) and the Foundation for NIH (FNIH) on a study of Malnutrition and Enteric Diseases, which examines the relationship between malnutrition and intestinal infections and the consequences of these conditions on various aspects of child health and development. Investigators across multiple international research sites hope to facilitate the design of more targeted, cost-effective interventions that will reduce the burden of child morbidity and mortality from diarrheal diseases. Fogarty is providing scientific oversight and coordination of the research, FNIH is providing administrative and financial oversight, and the Gates Foundation is funding the study.

Deep regional expertise also enables Fogarty to facilitate scientific collaborations between countries. In the context of advancing science and health, Fogarty seeks opportunities to bridge differences between countries that might otherwise not engage and to build trust by encouraging scientists from around the world to work together to address shared health challenges. These partnerships promote goodwill, stability and peace, and effectively harness science for diplomacy. As the world continues to become more interdependent, international scientific partnerships will play a critical role in building bridges and in improving health for people worldwide. Fogarty’s unique programs will continue to enable scientists in the U.S. and abroad to work together to tackle the most pressing and complex health challenges of our time.

Overall Budget Policy:

The FY 2012 request for FIC is $71.3 million, an increase of $1.3 million, or 1.9 percent over the FY 2010 Enacted Level. FIC distributes its resources among many programs and mechanisms and is committed to funding the largest number of meritorious projects possible, while allowing the flexibility needed to support selected program priorities and to respond to emerging scientific opportunities. Funding decisions are based on the number of high-quality applications, the overall number of applications, and the availability of funds. FIC funds a large number of initiatives with collaborating funding partners that include other NIH Institutes/Centers, other government agencies, and non-government organizations. Funding decisions take into account program relevance and overall portfolio consideration.

Funds are included in R&D contracts to reflect FIC’s share of NIH-wide funding required to support several trans-NIH initiatives, such as the Therapies for Rare and Neglected Diseases program (TRND) and the Basic Behavioral and Social Sciences Opportunity Network (OppNet).

In FY 2012, FIC will support new investigators on R01 equivalent awards at success rates equivalent to those of established investigators submitting new R01 equivalent applications.

Research Capacity Strengthening

The development of appropriate and effective health interventions that address local needs and priorities requires a sustainable base of research sites and scientists in the U.S. and developing countries. Strong institutions that can conduct robust health research and train scientists in a wide range of disciplines are critical to finding solutions to global public health challenges, and to building the research workforce of the future. Fogarty is strengthening U.S. and low- and middle income country (LMIC) institutions by investing in multidisciplinary research, training and curriculum development related to global health, which will lead to more innovative and sustainable research environments.

Budget Policy

The FY 2012 request for this program is $38.4 million, an increase of $756 thousand or 2 percent over the FY 2010 Enacted Level. FIC’s new Strategic Plan 2009-2013 provides the pathway toward developing sustainable global health research and training programs where they are needed most. The plan’s first goal is to mobilize the scientific community to address the growing epidemic of chronic, non-communicable diseases related to increased longevity and changing lifestyles in the developing world. To accomplish this, FIC will invest in this area, while continuing to invest in the critical infectious diseases agenda. FIC’s Millenium Promise Awards in Non-Communicable Diseases Program plans to fund $1.5 million a year to support non-communicable diseases research training, with seven awards expected annually. In addition, FIC is working with other NIH components and private partners to develop further chronic disease initiatives.

Portrait of a Program: Framework Programs for Global Health

FY 2010 Level: $1.138 million
FY 2012 Level: $1.158 million

Interest in global health - both on the part of students and faculty - has soared on U.S. university campuses over the past several years. Furthermore, solving complex global health problems will require knowledge, imagination, and cooperation from experts in a wide variety of fields. Launched in 2005, the Framework Programs for Global Health (Framework) provide competitive grants to universities in the U.S. and in low- and middle-income countries to develop multidisciplinary curricula in global health and stimulate the participation of faculty and students from a wide range of disciplines in global health education and research. This has resulted in new undergraduate and graduate programs at 36 universities and partnering institutions, and has engaged university components representing numerous disciplines, such as medicine, public health, nursing, engineering, law, agriculture, business, and social sciences. For example, with support from Framework, the Harvard Program in Refugee Trauma at the Massachusetts General Hospital partnered with the University of Rome and the Istituto Superiore di Sanita to develop a new program for policymakers and healthcare practitioners focused on mental health interventions for traumatized populations. This program has trained 200 people from 60 countries, including doctors, psychologists, lawyers, occupational therapists, and journalists.

In 2010, the program was expanded using American Recovery and Reinvestment Act funds to include a problems-based multidisciplinary pilot training program - the Framework Programs for Global Health Signature Innovations Initiative. This initiative provides one-year support to U.S. universities and their partners to explore models for training postdoctoral investigators to carry out multidisciplinary research likely to produce innovative devices, practices or policies in global health. For example, one team will further develop, validate, and field test an inexpensive lens-free microscope that can be attached to a cell phone, allowing the user to send the image of a sample collected anywhere in the world to a distant computer for automated analysis and feedback. This can provide point-of-care surveillance and diagnosis of TB, malaria, HIV/AIDS, and water-borne diseases.

Fogarty will build on these programs in FY 2012 with a solicitation for an updated program that will combine the institutional capacity building approach of the original Frameworks program with the multidisciplinary problem-based training model of the Innovations initiative. The grants will allow institutions or consortia to develop new training models to address the most pressing issues in global health, while providing more opportunities for, and strengthening interactions between researchers from diverse disciplines across campuses

Budget Policy

The FY 2012 request for this program is $4.9 million, an increase of $63 thousand or 1.3 percent over the FY 2010 Enacted Level. FIC’s impact has historically been most significant in developing the pipeline of U.S. and foreign research talent. FIC intends to expand the number of overseas research experiences available for young U.S. scientists in order to encourage them to adopt careers in global health. FIC will also continue its research training partnerships between U.S. and foreign institutions and strive to enhance research opportunities for foreign scientists when they return home.

Portrait of a Program: Collaborative Trauma and Injury Research Training Program

FY 2010 Level: $1.176 million
FY 2012 Level: $1.197 million

Unintentional injuries (e.g., resulting from traffic accidents, drowning, poisoning, falls or burns) and intentional injuries (e.g., resulting from assault, self-inflicted violence or acts of war) kill more than five million people worldwide every year, accounting for nine percent of global mortality. [Note 4] Over 90% of these deaths occur in low- and middle-income countries (LMICs). [Note 4] A large proportion of those who survive their injuries deal with temporary or permanent disabilities. Notably, the Department of State has published data demonstrating that injury is the leading cause of death from non-natural causes in U.S. citizens traveling abroad. In response to this high burden of global mortality and morbidity, Fogarty established the Collaborative Trauma and Injury Research Training Program in 2004. The program supports research training partnerships between U.S. and LMIC research institutions related to clinical, translation, and implementation research on human trauma and injury. The ultimate goal of this investment is to facilitate the development of locally relevant and effective interventions to prevent or treat injuries in low-resource settings. Program partners include the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Neurological Disorders and Stroke, the U.S. Centers for Disease Control and Prevention, and the World Health Organization.

The program currently supports twelve grants that span the continents of Latin America, Eastern Europe, Asia and Africa. One grant involves a collaboration between the University of Maryland and various universities in Cairo, which is training leaders in emergency medicine with the goal of reducing traffic-related deaths in Egypt. A successful course on the assessment and management of trauma patients offered to 400 Egyptian professionals has now expanded to include Iraq. Training courses in public health preparedness and response have also been offered to the Kurdish Health Ministry to aid in the establishment of a formal medical emergency plan. Another grant is funding scientists at the University of California/Los Angeles and the University of the North in South Africa to train investigators to conduct research in trauma and injury prevention related to personal, interpersonal and community level violence and intentional injuries. Research activities specifically focus on minimizing mental health effects - specifically depression and post traumatic stress disorder. Grantees are partnering with local universities, research organizations, and traditional healers in their training activities. In an effort to build this capacity in a sustainable manner, the program will be presented to South African government officials to facilitate on-going training of researchers in universities and research centers across the country.

Budget Policy

The FY 2012 request for this program is $13.8 million, an increase of $140 thousand or 1 percent over the FY 2010 Enacted Level. This area encourages implementation science to address the “know-do” gap, and would expand research training opportunities for U.S. and foreign scientists, foster a sustainable research environment in LMICs, and build strategic partnerships to further global health. FIC plans to expand its International Clinical, Operational and Health Services Research Training Award program for AIDS and TB and has reinforced the initiative’s support for implementation research.

Portrait of a Program: : International Tobacco and Health Research and Capacity Building Program

FY 2010 Level: $1.781 million
FY 2012 Level: $1.813 million

Tobacco use is one of the gravest public health challenges our world has ever confronted. More than five million people die of tobacco-caused illness each year, and it accounts for 10% of adult mortality globally. Tobacco use is increasing in low- and middle-income countries (LMICs), which will bear the brunt of the tobacco epidemic in the 21st century. Without a significant shift in worldwide prevalence patterns, smoking is projected to cause roughly eight million deaths annually by 2030; notably, more than 80% of these deaths will occur in LMICs. [Note 5] Because tobacco-related disease strikes people in the prime of their working lives, it also negatively impacts economic development.

Successful implementation of tobacco control strategies is informed by scientific evidence; however, there is a lack of capacity for local surveillance, research, and evaluation of interventions in LMICs. Furthermore, globalization of the tobacco epidemic requires coordinated efforts and collaboration between researchers from high-income countries and their counterparts in LMICs. The International Tobacco and Health Research and Capacity Building Program addresses the critical role of research and local research capacity in reducing the global burden of tobacco consumption and the need to generate a solid evidence base that can inform effective local tobacco control strategies and policies. The program supports epidemiological and behavioral research, as well as prevention, treatment, communications, implementation, health services and policy research. Current NIH partners for this program include the National Institute for Drug Abuse and the National Cancer Institute; Fogarty anticipates the participation of additional NIH partners when this program recompetes in FY 2012.

Grantees supported by this program are developing evidence that can be useful to tobacco control efforts globally, including here in the U.S. For example, in Delhi, India, researchers aretesting the efficacy and cost-effectiveness of a comprehensive, community-based behavioral intervention for tobacco cessation among disadvantaged youth living in low-income communities. Such studies can inform efforts to curb adolescent smoking in the U.S - particularly in resource-poor settings. Researchers in California are working with Turkish scientists to design and evaluate the effectiveness of a text messaging-based smoking intervention that harnesses mobile technologies in Turkey. Given the widespread use of mobile phones globally, evidence from such studies can inform the design of cell phone-based health interventions in the United States and abroad.

Budget Policy

The FY 2012 budget estimate for RMS is $14.2 million, an increase of $376 thousand or 2.6 percent over the FY 2010 estimate. This increase in RMS reflects overall NIH policy for FY 2012 and will help to strengthen program management.

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