Appendix F
Report to Congress: Health-Related Research and Development Activities at USAID

June 2005

EXECUTIVE SUMMARY

Congress requested that the U.S. Agency for International Development (USAID) provide a report describing its role in the research, development, and application cycle and its efforts to coordinate research and development activities with other agencies. This report responds to this request and provides details on the amounts spent on research by health issue or disease, recipient, and stage of research or development funded.

From 2002 to 2004, USAID invested between 6 and 7 percent of its total health-related budget in research and development. In 2004, this percentage represented $155 million. That year, the largest amount of research funds was spent on HIV/AIDS related research, followed in descending order by research on family planning and reproductive health, research on infectious diseases, and research on child survival and maternal health, including polio and micronutrients. The results of USAID-supported research have had significant public health impacts, starting with Oral Rehydration Salts (ORS), now used in about 85% of child diarrhea cases in almost half the world’s children under 5. The results of vitamin A research now save approximately 1 million pre-school aged children a year.

And, the impact of zinc, another USAID research product, on decreasing child mortality could be as or more significant than vitamin A. By 2004, 2.5 billion autodisable syringes and 900 million vaccine vial monitors, both results of USAID-supported research, had been sold or distributed worldwide. USAID-funded research has resulted in food fortification programs, making fortified



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The Fundamental Role of Science and Technology in International Development: An Imperative for the U.S. Agency for International Development Appendix F Report to Congress: Health-Related Research and Development Activities at USAID June 2005 EXECUTIVE SUMMARY Congress requested that the U.S. Agency for International Development (USAID) provide a report describing its role in the research, development, and application cycle and its efforts to coordinate research and development activities with other agencies. This report responds to this request and provides details on the amounts spent on research by health issue or disease, recipient, and stage of research or development funded. From 2002 to 2004, USAID invested between 6 and 7 percent of its total health-related budget in research and development. In 2004, this percentage represented $155 million. That year, the largest amount of research funds was spent on HIV/AIDS related research, followed in descending order by research on family planning and reproductive health, research on infectious diseases, and research on child survival and maternal health, including polio and micronutrients. The results of USAID-supported research have had significant public health impacts, starting with Oral Rehydration Salts (ORS), now used in about 85% of child diarrhea cases in almost half the world’s children under 5. The results of vitamin A research now save approximately 1 million pre-school aged children a year. And, the impact of zinc, another USAID research product, on decreasing child mortality could be as or more significant than vitamin A. By 2004, 2.5 billion autodisable syringes and 900 million vaccine vial monitors, both results of USAID-supported research, had been sold or distributed worldwide. USAID-funded research has resulted in food fortification programs, making fortified

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The Fundamental Role of Science and Technology in International Development: An Imperative for the U.S. Agency for International Development sugar, cooking oil and flours available to the majorities of the population of many countries. More recently, USAID research on natural family planning has resulted in the development of two new methods, both of which have shown to be very effective when used correctly. USAID supported large-scale efficacy trials of insecticide treated nets (ITNs) across Africa, which provided definitive data on the highly effective impact of ITNs for preventing malaria among the most vulnerable populations of women and children. This report further details the impact of research in many other areas. USAID invests in research to identify and assess key health problems affecting populations in developing countries and to develop and introduce new vaccines, tools, and approaches to help resolve these problems. The objective of almost half of USAID research activities is to find ways to “introduce” and make life-saving interventions accessible to those most in need—children under 5, mothers, people living with or at risk of HIV/AIDS and TB, and women and men of reproductive age. The other objectives of USAID research activities are to identify or assess major public health problems and develop a new tool or approach to help resolve these problems. Other partners complement the different roles that USAID plays in the cycle from research to implementation. In some cases, for example research to develop a malaria vaccine, the objective of U.S. Government partners is different from that of USAID—a short-term vaccine to protect troops versus a long-term vaccine to protect vulnerable women and children. In the case of Oral Rehydration Salts and Vitamin A, USAID’s role began with the identification of the problem and the development of the intervention, right up to wide scale introduction, working with WHO and UNICEF. USAID’s research role in yet other cases is to provide information necessary to the private sector to carry out large scale commercialization of new products such as fortified foods and long-lasting insecticide treated bed nets. USAID’s role in the development of microbicides, for example, is to focus research and development on safe, effective and acceptable microbicides to prevent HIV infection that have the appropriate cost and product characteristics for use in developing countries and, in some cases, offer dual-protection as a family planning method. USAID collaborates with NIH, CDC, and FDA to develop the U.S. Government’s Strategic Plan for Microbicides. This report details research that USAID has supported and its results. In some of the newer areas of research the report also looks at ongoing studies. One example of these is a soon-to-be commissioned review by Brian Sharp, Medical Research Council, Durban, South Africa, and Christian Lengeler, Swiss Tropical Institute, Basel, Switzerland, to compare indoor residual spraying (IRS) and ITNs across a range of malaria transmission settings in sub-Saharan Africa in terms of cost-effectiveness, impact on health measures, and operational constraints. The report, expected in early 2006, should provide clear, evidence-based guidance to

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The Fundamental Role of Science and Technology in International Development: An Imperative for the U.S. Agency for International Development National Malaria Control Programs and USAID missions on key factors to consider when selecting vector control interventions to ensure maximum public health effectiveness for money spent. Another example is the ongoing research on simple low-cost community care packages (warming, delayed bathing) that could reduce neonatal deaths by an average of 40 percent in low resource settings. Section I The six research areas included in Section I account for the majority of USAID health-related research and results over the past two decades. Section I describes each area and explains how it was identified. It also describes the role of USAID, its coordination with U.S. government agencies and other partners, and the main results of the research investment to date. The six research areas are: Vaccine development Maternal, newborn, and child health interventions Microbicides Contraceptive technologies Malaria Tuberculosis 1. VACCINE DEVELOPMENT Malaria Vaccine: USAID’s research role is to speed the development of malaria vaccines to protect children and pregnant women from death and serious disease in malaria-endemic areas. USAID has had a critical catalytic role in moving the current set of vaccine candidates through the research process to field trials. As a result of USAID’s investments over the years, two vaccine candidates are currently undergoing safety or efficacy trials in the field. USAID works with DOD partners such as the Walter Reed Army Institute of Research and the Naval Medical Research Center; HHS partners such as the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration; and the Malaria Vaccine Initiative, a Bill & Melinda Gates Foundation funded program. HIV/AIDS Vaccine: USAID’s research role accelerates the development and introduction of new vaccine candidates and technologies and helps link vaccine designers with manufacturers and developing-country sites suitable for testing promising HIV vaccine candidates. USAID supports HIV vaccine research as well as policy analysis and other work to pave the way for introducing vaccines when they become available. USAID works with the

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The Fundamental Role of Science and Technology in International Development: An Imperative for the U.S. Agency for International Development International AIDS Vaccine Initiative and the Partnership for AIDS Vaccine Evaluation (the U.S. government HIV vaccine coordination group) and would like to be involved with the Global HIV/AIDS Vaccine Enterprise as it unfolds. Childhood Vaccines—Rotavirus and Pneumococcal Conjugate Vaccines: USAID’s research role is to catalyze and coordinate clinical trials of refined rotavirus vaccine and a large-scale clinical trial of pneumococcal conjugate vaccine. USAID works with the World Health Organization (WHO), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), the British Medical Research Council, the London School of Hygiene and Tropical Medicine, the Program for Appropriate Technology in Health (PATH), and vaccine manufacturers. USAID’s participation and investment in the Global Alliance for Vaccines and Immunization (GAVI) supported the selection of these two vaccines for a new approach to accelerated vaccine development and introduction in developing countries. Vaccine- and Injection-Related Technologies: USAID anticipated the need for technologies that could prevent syringe and needle reuse and supported the development and introduction of the devices now known as auto-disable (AD) syringes and vaccine vial monitors (VVMs) to ensure that only potent vaccine is used. USAID works with WHO; the United Nations Children’s Fund (UNICEF); PATH; Becton, Dickinson and Company; Pfizer Inc.; and GAVI. To date, 2.5 billion AD syringes and 904 million VVMs have been sold or distributed worldwide. 2. MATERNAL, NEWBORN, AND CHILD HEALTH INTERVENTIONS Maternal and Neonatal Health: Since the launch of the Safe Motherhood Initiative in 1987, USAID has supported the development and testing of new technologies and community and facility approaches as well as meta-analyses to improve and transform maternal and neonatal interventions. USAID coordinates with WHO; host governments; U.S. and developing-country researchers; NGOs/PVOs and universities in Nepal, Bangladesh, Egypt, Tanzania, Thailand, Pakistan, India, Peru, and Malawi; the World Bank; and the American College of Nurse Midwives. Some USAID-supported technologies and approaches—the home-based maternal record, for example—now are used in countries around the world, while others are still in the development and introduction stages. Oral Rehydration Salts, Oral Rehydration Therapy: USAID supported research to develop and introduce oral rehydration salts (ORS) and oral rehydration therapy (ORT) to treat dehydration caused by diarrhea, especially

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The Fundamental Role of Science and Technology in International Development: An Imperative for the U.S. Agency for International Development the early development research undertaken by the International Centre for Diarrheal Disease Research, Bangladesh (ICDDR,B). With support from USAID and other donors, ORS became the cornerstone of the WHO/UNICEF Program on Control of Diarrheal Diseases. In 33 countries containing almost half the world’s children under age 5, use of ORS/ORT increased from about 33 percent of cases in 1990 to 85 percent by mid-decade. USAID recently supported WHO and other research partners in refining the ORS formulation. The new formulation, called reduced-osmolarity ORS, further reduces the need for intravenous therapy and is safe for treating both children and adults. UNICEF and WHO have adopted the new formulation as the global standard. Micronutrients—Zinc: USAID-supported research built the evidence base that led to WHO and UNICEF signing a 2004 agreement revising the protocol for using zinc supplements to treat diarrhea. USAID is supporting work to introduce zinc into programs and is working with host governments to accelerate the adoption of the new recommendations for diarrhea treatment. USAID also supports product supply, guideline development, program planning, and marketing. USAID has supported the development of zinc formulations by manufacturers in a way that ensures thermostability in hot weather environments and under poor storage conditions. USAID works with WHO, the Johns Hopkins University Bloomberg School of Public Health, ICDDR,B, local universities, and international NGOs. Micronutrients—Vitamin A: USAID supported the research that established the base of evidence for the discovery that two cents worth of vitamin A given to children every six months could reduce child mortality by 34 percent and fatality from measles by more than 50 percent, as well as reduce the severity of diarrhea and malaria. USAID continues to support research on the effects of vitamin A on maternal health and pregnancy risk. UNICEF, with procurement largely funded by the Canadian International Development Agency, now delivers 600 million to 800 million vitamin A supplements each year, saving the lives of approximately 1 million preschool children every year. More than 60 countries around the world have implemented vitamin A supplementation. Food Fortification: USAID supported assessment research on vitamin A deficiency and anemia prevalence and the development and introduction research necessary for large-scale food fortification programs. This research has included stability and acceptability tests, technology trials, and stability trials and has resulted in food fortification programs that have made fortified sugar, cooking oils, and/or flours available to the majority of the populations of Bangladesh, Nicaragua, Philippines, Zambia, Uganda, Eritrea, Morocco, West Bank/Gaza, and Ghana. USAID works with health, industry, and food

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The Fundamental Role of Science and Technology in International Development: An Imperative for the U.S. Agency for International Development ministries; bureaus of standards; the World Food Program; national associations of food producers, millers, growers, etc.; UNICEF, the Pan American Health Organization; the Micronutrient Initiative; and local universities. 3. MICROBICIDES USAID supports research for the development of safe, effective, and acceptable microbicides that have the appropriate cost and product characteristics for use by women in developing countries to prevent HIV infection. This research program is coordinated through collaborations with other U.S. government agencies, including NIH, CDC, and FDA, as well as other bilateral and multilateral donors, and both national and international organizations that are supporting or conducting activities related to microbicide research and development. These collaborations maximize efficiency and progress through the coordination of scientific plans, joint priority setting, sharing of resources, and learning through new data and experience. About three quarters of USAID funding supports essential phase III clinical studies that are currently underway. The remaining quarter supports developing capacity at sites for future clinical studies, research on selected second-generation microbicide candidates, and product introduction issues. 4. CONTRACEPTIVE TECHNOLOGIES USAID supports development research to improve existing and develop new contraceptive technologies and to identify and test innovative approaches to improving the effectiveness and efficiency of family planning (and related reproductive health) service delivery. USAID also supports introduction research to expand the variety of effective contraceptive methods available in USAID-supported family planning programs worldwide. USAID works with the Eastern Virginia Medical School; Family Health International; the Population Council; Georgetown University; PATH; WHO; CDC; NIH; FDA; the United Nations Population Fund; the U.K. Department for International Development; the Bill & Melinda Gates Foundation; the Hewlett Packard, Rockefeller, and Buffet foundations; Pfizer Inc.; Wyeth; Ortho-McNeil Pharmaceutical; Schering AG; and Organon. USAID-supported research has resulted in the availability of a wider variety of new contraceptives and improvements in the understanding of existing technology. 5. MALARIA In addition to malaria vaccine development, USAID supports research to assess the feasibility, acceptability, safety, and impact of malaria

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The Fundamental Role of Science and Technology in International Development: An Imperative for the U.S. Agency for International Development prevention and treatment technologies and to monitor the spread of drug-resistant malaria. USAID also supports research to develop new drugs for treating both uncomplicated and severe malaria and new technologies for improved home management of malaria. In the 1990s, USAID supported early clinical trials of artemisinin-based combination therapy (ACT) in children in Africa. ACT is now the WHO-recommended treatment for malaria and is being rolled out throughout Africa. USAID is now funding operations research to evaluate the introduction of new ACT treatments in sub-Saharan Africa. USAID also supported groundbreaking trials of insecticide-treated mosquito nets (ITNs) that demonstrated they can reduce under-5 mortality from all causes by about 20 percent and reduce clinical cases of malaria by 40 percent to 50 percent. ITNs are now being scaled up and used throughout Africa. Malaria research is carried out through a variety of organizations, including WHO, CDC, the Medicines for Malaria Venture, the Kenan Institute of Asia, and U.S. Pharmacopeia. 6. TUBERCULOSIS USAID supports research in areas critical for accelerating the introduction and global expansion of the DOTS (directly observed treatment, short course) strategy and improving DOTS program performance. USAID focuses on the development, evaluation, and introduction of new diagnostics, drug regimens, and approaches that will improve the DOTS strategy and are appropriate for use in low-resource countries, including effective approaches to TB-HIV co-infection. USAID’s early support of the “ProTest” approaches to TB-HIV co-infection resulted in workable models for addressing co-infection that are now being scaled up in multiple countries in Africa and are also included in the WHO and Stop TB Partnership guidance on TB-HIV. USAID also supported clinical trials on TB drug regimens of the International Union Against Tuberculosis and Lung Disease (the Union). The study’s results, published in October 2004, confirmed that a six-month course of treatment with a specific set of drugs was more effective than an alternate eight-month course with other drugs. These results are now included in the International Standards of Care for TB Treatment. USAID is currently supporting the development of new drugs in partnership with the Global Alliance for TB Drug Development. USAID’s TB research partners include WHO; CDC; the Union; the TB Diagnostics Initiative at the Special Program for Research and Training in Tropical Diseases (a WHO/UNICEF/World Bank program); Johns Hopkins University; the University of Alabama, Birmingham; and the Global Alliance.

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The Fundamental Role of Science and Technology in International Development: An Imperative for the U.S. Agency for International Development Section II Fast Facts and Trends, 2002-2004 USAID invests 6 to 7 percent of its total health-related budget in research and development. This percentage represented approximately $112 million in 2002, $123 million in 2003, and $155 million in 2004 (Table II.1). The proportion of funding obligated to research ranges from around 5 percent for child survival and maternal health (CS/MH),1 to between 5 and 10 percent for HIV/AIDS and family planning and reproductive health (FP/RH), to between 10 and 15 percent for infectious diseases (ID) From 2002 to 2004, the total amount of funding for research grew from $112 million to $155 million. The health issue or disease with the largest single share of that funding for all three years was HIV/AIDS (37%, 37%, 46%), followed in descending order by Family Planning/Reproductive Health (29%, 32%, 24%), Child Survival, Maternal Health, including Polio and Micronutrients (14%, 15%, 14%), Malaria (7%, 7%, 7%), TB (6%, 5%, 5%), and AMR, Surveillance and Other ID (7%, 4%, 3%). While USAID/Washington centrally manages the largest number of research activities, the proportion of research managed by USAID missions increased from 15 percent of activities in 2002 to 21 percent in 2004 Introduction research is the largest share of research activities (45 percent); assessment and development research are at about the same level, around 27 to 28 percent (Figure II.8). USAID missions originate the majority of assessment research activities (60 percent missions, 40 percent USAID/Washington) (Figure II.8). USAID/Washington originates the majority of development research activities (75 percent USAID/Washington, 25 percent USAID missions) and introduction research activities (65 percent USAID/Washington, 35 percent USAID missions). The recipients of USAID’s research investments include collaborating agencies and partners such as grantees and contractors; universities; NGOs/PVOs; host governments; the Centers for Disease Control and Prevention; the National Institutes of Health; and the Department of Defense. 1   This percentage is lowered by the GAVI funds included in this overall account (between $55 and $65 million)

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The Fundamental Role of Science and Technology in International Development: An Imperative for the U.S. Agency for International Development Amount/Percent of Health or Disease Area Funding Used for Research, FY 2002-2004 Health or Disease Area 2002 2003 2004 $ Mil Percent of Total Funding $ Mil Percent of Total Funding $ Mil Percent of Total Funding HIV/AIDS $41 8% $46 7% $72 6% Family Planning/Reproductive Health $33 7% $40 9% $38 9% Infectious Diseases (inclusive of AMR/other ID, malaria, TB) $23 12% $20 11% $23 11% Child Survival/Maternal Health (inclusive of polio and micronutrients) $16 4% $18 5% $22 5% Vulnerable Children $0 0.06%   0% $1 7% Total Obligation on Research $112 7% $123 6% $155 7% Distribution of Total USAID Health-Related Research Funding by Each Major Health or Disease Area Health or Disease Area 2002 2003 2004 HIV/AIDS 37% 37% 46% Family Planning/Reproductive Health 29% 32% 24% Infectious Diseases (inclusive of AMR/other ID, malaria, TB) 20% 16% 15% Child Survival/Maternal Health (inclusive of polio and micronutrients) 14% 15% 14% Vulnerable Children 0.02% 0% 0% Total 100% 100% 100%

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