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Institute of Medicine (US) Committee on the US Commitment to Global Health. The US Commitment to Global Health: Recommendations for the Public and Private Sectors. Washington (DC): National Academies Press (US); 2009.

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The US Commitment to Global Health: Recommendations for the Public and Private Sectors.

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3Generate and Share Knowledge to Address Health Problems Endemic to the Global Poor

One of the greatest contributions the United States can offer to the global health campaign is to share America’s traditional strength—the creation of knowledge—for the benefit of the global poor. With its extensive expertise in science and research, the synergistic partnership between its public and nongovernmental sectors, and its strong financial commitments, the United States can do much to redress the imbalance in knowledge about high-income-country and low-income-country diseases, conditions, and health systems. The U.S. research community, in collaboration with its global partners, should leverage its scientific and technical capabilities to study health problems endemic to poor countries, more rigorously evaluate programmatic efforts to improve health, and promote global knowledge networks to enable low- and middle-income-country researchers to improve the health of their own populations.


As previously discussed, progress in global health over the last half-century has been remarkable and can mostly be attributed to the creation, dissemination, and adoption of novel interventions to improve health. In the public mind, scientific innovation to improve global health is often associated with the discovery of exciting medical tools such as vaccines or pharmaceuticals. In reality, however, such innovation also extends to activities that allow these tools to be utilized successfully. These include novel public health programs and healthcare delivery strategies, as well as population-based measures such as innovative epidemiological surveillance models to track disease within communities.

Indeed, most public health advances are the result of a comprehensive research strategy that incorporates a variety of tools and interventions spanning prevention, diagnosis, and treatment. The recent eradication of smallpox provides a concrete example of how such a comprehensive strategy dramatically altered disease burden (see Box 3-1). Without a series of research advances, coupled with the political will and financial commitments of national governments, donors, and intergovernmental agencies to invest in this research and its subsequent adoption, it is highly unlikely that smallpox eradication would have succeeded.

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BOX 3-1

Smallpox Eradication Made Possible by a Series of Research Discoveries. In 1967, when the World Health Organization (WHO) “launched an intensified plan to eradicate smallpox, the ancient scourge threatened 60 percent of the world’s population, (more...)

Today the world faces many enormous challenges in global health, including halting the spread of HIV, eradicating polio, controlling the use of tobacco products and the onset of chronic noncommunicable diseases, and bringing basic health provisions to the most disadvantaged populations. Like smallpox, today’s challenges will be met only by comprehensive research and delivery strategies that include the successful development and deployment of novel biomedical tools, new behavioral and public health programs, and impact evaluation to improve our understanding of what works and of how simple and cost-effective interventions can be delivered successfully in even the most resource-deprived settings.

Asymmetry in the Creation of Knowledge to Benefit the Global Poor

While the creation of knowledge through a comprehensive research strategy is critical for improving health in all countries, the capacity to undertake research varies sharply across countries. Representing only one-fifth of the world’s population, high-income countries are home to more than two-thirds of the world’s researchers, command three-quarters of the gross expenditure on research and development, and originate more than 90 percent of the patents granted in Europe, the United States, and Japan (UNESCO, 2005). High-income countries focus the majority of their research on conditions that affect people within their own borders. As a result, diseases or conditions that are overwhelmingly or exclusively incident in low- and middle-income countries are often neglected (WHO, 2001b), and little energy is devoted to research on how to improve healthcare systems to deliver interventions in these settings.

Health research in low- and middle-income countries, especially in the emerging market economies, has increased in recent years. Between 2000 and 2006, the average annual growth rate in the number of patent filings originating from China and India far outstripped that of all reported countries in Europe and North America (WIPO, 2008). Many countries, such as Brazil, Egypt, and South Africa, are now reaping the benefits of decades of investment in education, health research infrastructure, and manufacturing capacity. These countries are beginning to control endemic diseases and conditions by developing their own interventions, with only modest technical or financial assistance from high-income countries (Morel et al., 2005). For example, Brazil—which has the second-highest rate of leprosy in the world—contributed more than a quarter of the total funding for research on the disease (Moran et al., 2009).

Despite these developments, the U.S. research community—comprised of universities, U.S. government agencies, commercial entities, and nonprofit organizations—continues to play a prominent role in health research worldwide. The U.S. research community conducts 50 percent of all health research (Research!America, 2006) and generates almost twice as many scientific publications (32.7 percent of the world total) as low- and middle-income countries combined (17.6 percent) (UNESCO, 2005). Over the last decade, this commitment to health research has expanded its focus to include global health issues.

A significant portion of global health research is financed, managed, or conducted by American-based universities, public-private product development partnerships (PDPs), and U.S. government agencies that work in partnership with research institutions in low- and middle-income countries. Indeed, the emergence of university research consortiums and global PDPs dedicated to global health demonstrates the extraordinary interest and untapped potential within the U.S. research community to address the health needs of the global poor. By tapping more fully into this energy, the United States can further complement the expanded health research efforts of low- and middle-income countries and hasten the discovery and delivery of lifesaving knowledge.

Strengthen Knowledge on the Adoption and Dissemination of Existing Interventions

Attention is required to address the systemic bottlenecks in health systems and policy making in low- and middle-income countries that keep the full benefits of existing medical and public health knowledge and technologies from being completely realized. Surveys of deaths among children under 5 years of age in 42 low-income countries revealed that while improved technology could potentially avert 22 percent of deaths, improved utilization of existing methods could avert 63 percent of the deaths (Leroy et al., 2007).

Although most research focuses on interventions—97 percent of the grants awarded by the two largest research funders in recent years were for the development of new technologies (Leroy et al., 2007)—little is known, for example, about the characteristics of delivery strategies that could achieve and maintain high coverage for specific interventions in various epidemiological, health system, and cultural contexts. Systematic studies that help answer questions about how best to scale up and deliver existing interventions are urgently needed (Bryce et al., 2003; Mills, 2007; Walley et al., 2007). Unfortunately, few programs that deliver specific health interventions undergo the type of rigorous evaluation that improves our understanding of what works and where improvements should be sought.

Greater Attention to Health Systems Research

Health systems research is “the production and application of knowledge to improve how societies organize themselves to achieve health goals,” taking into account not only how activities are planned, managed, and financed, but also the roles, perspectives, and interests of different stakeholders. Health systems research is a continuum from rigorous and more generalizable scientific research on major issues facing policy makers, such as how to improve the effectiveness of human resource management, to operational or implementation research, which tends to be highly context-specific (Mills, 2008).

The Alliance for Health Policy and Systems Research conducted a biblio metric survey and found that over a period of 12 years (1991-2003), 1.8 million publications were indexed with at least one major subject heading in the field of health systems research, but only 5 percent of these were concerned with low-and middle-income countries, and an even smaller proportion were produced by low- and middle-income country researchers themselves (Alliance for Health Policy and Systems Research, 2004). While recent years have seen an increasing number of systematic reviews of particular areas of health systems research, in general, they have not yielded information that has dramatically influenced public policy. For example, although several studies have examined the effectiveness of working with private providers to improve equity in health for the poorest individuals, no robust conclusions to influence policy makers can be drawn without more extensive and higher-quality evidence (Patouillard et al., 2007).

Health systems research, when of high quality and when conducted through a number of comparative studies in different countries on a particular theme, is a particularly important method for identifying promising and generalizable interventions for health systems delivery (Mills, 2008). For example, health systems research has led to some influential practices, such as integrating the management of childhood illnesses (Arifeen et al., 2004; Armstrong Schellenberg et al., 2004) or rethinking the desirability of user fees (a nominal fee charged for health services) (Holla and Kremer, 2009) or charging for bed nets or other health goods (Ashraf et al., 2007; Hoffmann et al., 2009).

The Poverty Action Lab (PAL) at MIT tested the widely held belief that unless people pay for a product—in this case, for a bed net—they will neither value nor use it. One PAL study in Kenya tested this theory and found no evidence that paying for a bed net will increase its use (Cohen and Dupas, 2009; Dupas, 2009). Interestingly, another study in Uganda showed that if you charge for a bed net, it is more likely to be used by the highest-income earner; but if you give it away for free, it is more likely to be used by mothers and small children, who are most vulnerable to malaria (Hoffmann, 2007Hoffmann, 2008).

Health systems research is critically important for addressing pressing concerns such as human resource constraints and can offer approaches for delivering care in more efficient and creative ways (Bjorkman and Svensson, 2007). For example, in studies in India, giving a kilogram of lentils every time a child was immunized (and a set of plates with each additional dose) both increased immunization rates by 3 percent and reduced the cost per immunization. By placing a nurse—a limited resource and the greatest administrative expense—in one location with bags of lentils, people were willing to walk up to 6 miles to get the lentils (and their child immunized) (Banerjee et al., 2008).

Operational or implementation research tends to be more context-specific and focuses on promoting “the uptake and successful implementation of evidence-based interventions and polices that have … been identified through systematic reviews” (Sanders and Haines, 2006). Increased support for operational and implementation research would help to resolve many of the context- specific barriers to deploying existing interventions more routinely (Madon et al., 2007).

For example, strategies and drugs to prevent mother-to-child transmission of HIV, such as oral nevirapine prophylaxis, exist.1 Yet while the prevention of this mode of HIV transmission has proved highly efficacious in tightly controlled clinical trial settings, its effectiveness in real-world settings—and thus its use-fulness—is significantly diminished. Few women in low- and middle-income countries can access the required drug because the health systems in these countries lack the necessary components—human resources, physical infrastructure, laboratory capacity, procurement and supply systems, and fiscal management—to provide universal access to the drug (WHO, 2006). Operational research is urgently required for the uptake of this drug since vertical transmission of HIV/AIDS from parents to children continues to infect more than 400,000 children with the disease each year (UNICEF, 2008). Similarly, other simple interventions with proven benefits, such as the provision of potable water, polio vaccines, and bed nets, also await operational research that can allow their benefits to be widely available.

Operational and implementation research that includes cost-benefit analysis and acceptability studies will also be crucial before the scale-up of new interventions, such as the human papilloma virus vaccine to prevent infection and ensuing cervical cancer or male circumcision to reduce the likelihood of HIV infection. Policy makers in low- and middle-income countries will need to decide whether and how to add these interventions to their health programs, based on an array of factors including their cost-effectiveness and acceptability, but also larger issues such as disease burden and strain on the health system (Brooks et al., 2009; Saxenian, 2007).

The committee finds that too often, research efforts fail to address breakdowns in public health infrastructure and health systems delivery, such as poor surveillance systems, bottlenecks in drug supply pipelines, and chronic deficits in the health workforce. While additional research focused on cultural- and context-specific settings could allow the deployment of new interventions, it could also improve the deployment of several interventions already in use. The U.S. research community should support areas of study using operational, policy, and systems research to identify the desirable characteristics of interventions from the perspective of end users and to influence policy making, thus enabling innovations to be disseminated and used globally.

Measure Impact of Programmatic Investments in Health

Not only has research on healthcare systems been underutilized generally, but few programs that deliver specific health interventions undergo rigorous evaluation. This is a significant missed opportunity to understand how to improve programmatic efforts, for example, to understand why some households do not use newly installed water purification systems in spite of life-threatening disease or why children continue to fall ill to water-borne disease even after this service is provided. An assessment that only tracked the number of households that used water purification systems would not reveal that misuse of the water in the home perpetuated high rates of diseases.

The importance of knowing what works is critical if U.S. health efforts are to help countries achieve sustainable and far-reaching outcomes. Evaluation should thus form an essential component of U.S. global health programs. Yet with the exception of the Millennium Challenge Corporation, a U.S. government corporation established in 2004 to reduce global poverty through the promotion of sustainable economic growth, there has been little emphasis on evaluating impacts. Recent trends—including the reorganization of foreign assistance under the State Department and the implementation of the President’s Emergency Plan for AIDS Relief (PEPFAR)—have focused significant attention on creating indicators for recording and monitoring purposes, such as the number of health workers trained or the number of pregnant women receiving HIV testing and counseling (PEPFAR, 2007). Although such data on inputs (such as dollars spent) and outputs (such as vaccines delivered) are necessary for timely managerial decisions and accountability for the use of resources, they do not provide any useful information on the effect of U.S. interventions on saving lives and improving health.

As a result, the United States has lost the opportunity to learn what kinds of programs are most effective and should be disseminated to other settings and which ones are yielding fewer benefits than they could. For example, an Institute of Medicine (IOM) evaluation of PEPFAR found that some of the indicators collected did not provide appropriate information on the progress being made toward the ultimate goal of controlling the AIDS epidemic. In its early stages, most of the results reported were for targets that could be measured only in the short term and therefore revealed more about the process of implementation than the impact of the program (IOM, 2007). In response, the PEPFAR reauthorization calls for impact evaluation to examine the effect of PEPFAR programs on indicators such as incidence, prevalence, and mortality.

In addition to asking for measurement of inputs and outputs, Congress and other donors should require that program efforts be accompanied by rigorous country- and program-level evaluations to measure the effect of global health investments. Independent and rigorous evaluation, accompanied by careful study of the implementation process, is the recommended means of addressing policy questions of enduring importance. Beyond counting the number of vaccines administered or health workers trained, it is important to ask tough questions such as, Are we preventing HIV infections in adolescent women? Do our efforts lead to sustained reductions in child mortality? Critical questions like these should inform future U.S. investments by improving knowledge of what does or does not work. For example, such questions could help the authorizers of PEPFAR go beyond simply knowing the sheer number of individuals who undergo HIV counseling to understand whether or not the program is actually lowering the rate of HIV infection within a target population.

In order to arrive at this level of information, along with program-level evaluation, investments are needed for the expansion of country-based, reliable, transparent, and long-term systems for recording health information. These should include complete (as far as possible) registration of births and deaths, along with details on the causes of death, and focused surveillance systems for infectious diseases. Indeed, such systems form the backbone of any rapid global response to new diseases and pandemics, such as severe acute respiratory syndrome (SARS) and influenza, and will be needed to track sustained health gains in preventing infections such as HIV. Improved country-level tracking would also greatly enhance the success of partnerships with the Centers for Disease Control and Prevention, which has played a historically important role in surveillance (Levine, 2008b).

Recommendation 3-1. The U.S. research community should increase research and evaluation efforts to address the systemic bottlenecks in health systems in low- and middle-income countries that keep the full benefits of existing medical and public health knowledge and technologies from being completely realized.

  1. The U.S. research community should expand its research efforts through increased attention to health systems research (both for studies that can be generalized across countries and for operational and implementation studies that are culturally and contextually relevant).
  2. In addition to measuring inputs (such as dollars spent) and outputs (such as drugs delivered), Congress and other global health funders should require that efforts to deliver health interventions be accompanied by rigorous country- and program-level evaluations to measure the effect of global health programs on saving lives and improving health.

Continue Research to Develop Novel Health Technologies and Interventions

Global health would greatly benefit from the development and dissemination of a variety of novel behavioral and biomedical prevention strategies to combat infectious diseases. Antiquated diagnostics and treatments also need to be improved to achieve sustainable results in the management and control of disease and to reduce drug resistance that results from misdiagnosis or poor adherence to treatment regimens (Dowdy et al., 2008). These steps are especially important given that new vaccines against the three major infectious diseases seem unlikely to be deployed for another decade or more.

The research process involved in discovering, developing, and deploying a new biomedical technology is termed the “innovation cycle” by the World Health Organization (WHO) Commission on Intellectual Property Rights, Innovation and Public Health. It spans activities from basic science to translational studies; involves experts from multiple disciplines within and beyond the health and life sciences, such as behavioral scientists, chemists, engineers, and economists; and is conducted in partnership between local and global researchers, with the participation of the endemic communities. Its goal is to deliver good-quality interventions that are effective, culturally appropriate, accessibly priced, and made available in sufficient quantities (see Box 3-2) (CIPIH, 2006). While the innovation cycle runs quite smoothly in high-income countries, it often breaks down in low- and middle-income countries due to gaps and inefficiencies at each stage (discovery, development, and delivery). The U.S. research community should both conduct and fund research to help fill these gaps and should create norms for sharing that make it easier to access the information and tools necessary for research in low- and middle-income countries.

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BOX 3-2

Identifying Promising Interventions. The WHO Commission on Intellectual Property Rights, Innovation and Public Health identified an analytical framework laying out the four interrelated components that together define “the right to health interventions (more...)

Continue Support of Product Development Partnerships to Deliver New Technologies

One of the most promising approaches to bridge the enormous and widening gap in the availability of drugs, vaccines, and diagnostics to deal with the global disease burden is the creation of public-private product development partnerships. Tapping innovative philanthropic and government financing, PDPs combine cutting-edge technology with traditional product development to create new business models that address some of the world’s most devastating scourges (Matlin et al., 2008; McKerrow, 2005). PDPs have brought together participants from the public and private sectors, maximizing their skills and resources to tackle complex issues of drug, vaccine, and diagnostic development and distribution (Meredith and Ziemba, 2008). In many instances, PDPs are virtual pharmaceutical and biotechnology companies, made operational by the commitment to achieve an important aim that would not be possible for any one partner acting alone: the development of products for which there is little potential financial return on investment.

Although PDPs came into being only in the last 10 years, the global health field has already benefited enormously from their growth. One study found that the PDP approach, compared to when the commercial or public sectors act alone, was the most cost-efficient and delivered the best health outcomes for low- and middle-income country patients. PDP drug development trajectories matched or exceeded industry standards and were significantly faster than government drug development (Moran, 2005). The unique strengths of PDPs—their ability to galvanize sectors and research networks to identify the strongest selection of drug, vaccine, and diagnostic candidates; negotiate intellectual property, licensing, and pricing agreements early in the discovery process to ensure access and affordability for effective interventions; and react nimbly to opportunities within the research community—have laid the groundwork and provided lessons for future research endeavors across sectors and countries.

The committee finds that continued investment in PDPs is essential. Several PDPs are now moving promising products into large-scale clinical trials; additional and diverse funding will be needed to see these products through to development and to determine the best ways to deliver successful interventions. The U.S. government and private foundations should continue to support PDPs and other innovative research models that best address the unmet health needs of poor countries. The U.S. research community should continue to explore cross-sectoral collaboration to focus a diverse set of expertise on the discovery, development, and delivery of the new generation of cutting-edge biomedical advances that have the potential to revolutionize global health.

Study the Basic Mechanisms of Diseases That Disproportionately Affect the Global Poor

Most of the research being conducted on global health by the U.S. research community is biomedical research directed to just three diseases: AIDS, malaria, and tuberculosis (TB). This research is itself heavily biased toward vaccine and drug development and largely neglects diagnostic and platform technologies (technologies on which other technologies or processes are built) (Moran et al., 2009). However it is critical to develop and leverage both cutting-edge research tools and platform technologies because they facilitate innovation and attract the interest of leading research teams seeking breakthrough interventions, especially against the most neglected tropical diseases that have received little investment but place a high burden on low- and middle-income countries.

These technical research tools are immensely valuable at every step of the discovery process, for example, in developing suitable animal models, identifying biomarkers, and validating surrogate end points for treatment. Platform technologies such as proteomics, microarray, and high-throughput screening increase the efficiency of product development and allow researchers to make early decisions on whether or not to proceed with a promising lead. This is especially important given the high cost of biomedical research and the finite resources available for global health.

High-throughput screening—a search for chemicals that act on a particular molecule—is an example of a technology that enables drug developers to quickly test thousands of different compounds using robotic handling systems and automated analysis of results. Such screening, along with computer-based screening using molecular docking,2 is commonly used by industry and, more recently, by the academic community. Increasingly, these techniques are also being applied to neglected diseases, with compound libraries in the public and private sectors being queried for drugs against conditions such as African sleeping sickness, leishmaniasis, Chagas disease, and schistosomiasis (McKerrow, 2005; Renslo and McKerrow, 2006).

In one such example, the Sandler Center for Basic Research in Parasitic Diseases at the University of California, San Francisco (UCSF), established a consortium of core laboratories to develop new drugs for global parasitic diseases that have been ignored by the pharmaceutical industry. Initial work at the center focused on a drug lead for Chagas disease, which kills more people in Latin America than even malaria. A promising drug compound for Chagas was discovered by the UCSF team, with support from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH), and developed further by the Drugs for Neglected Diseases Institute (DNDi), a PDP, and the Institute for OneWorld Health, a nonprofit pharmaceutical company.

Several other new technologies also hold the promise to unlock the secrets of biological questions and dramatically impact the way we prevent, diagnose, and treat illness on a global scale. Virus chip technology, a tool using DNA sequences to quickly identify disease agents (Wang et al., 2002), played a critical role in identifying SARS in 2002 (Frankish, 2003). Nutrigenomics—the study of genenutrient interactions—indicates that “dietary imbalance” can increase the risk for noncommunicable diseases (Kaput and Rodriguez, 2004), showing the way to public health applications such as the response to chronic disease through dietary interventions. Genomics—the study of gene sequencing in living organisms—is expected to yield new preventive and therapeutic approaches to the treatment of global health diseases and to promote enduring food security in low- and middle-income countries. Genomics has already yielded an antimalarial drug that went into clinical trial in less than two years (Pang, 2002).

In addition to the work being done to identify new drug targets, state-of-the-art technologies such as reverse vaccinology are revolutionizing the vaccine field (Bambini and Rappuoli, 2009; Serruto et al., 2009). Researchers are now using reverse vaccinology to help identify a serotype-independent vaccine to address pneumococcal disease. The compelling need for this vaccine has prompted several governments and other donors to fund an “Advance Market Commitment” to further draw the commercial industry and nonprofit research institutes into apply ing the latest technological advances to develop a vaccine that would be conducive to fighting the disease in low- and middle-income countries (see Box 3-3).

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BOX 3-3

An Advance Market Commitment (AMC) for Pneumococcal Vaccine. Pneumococcal disease can cause severe infections and pneumonia; it kills close to 1 million children under 5 years of age worldwide every year (mostly in low- and middle-income countries) (CDC, (more...)

The application of cutting-edge science to the search for promising products to address neglected poor-country diseases is now occurring in labs at universities and research institutes across the United States. The committee finds that increased support for basic research, with heightened attention to using cutting-edge research tools and platform technologies, is possible, timely, and indispensable. Investments in basic research, particularly for diseases and conditions that disproportionately affect poor populations, will generate the knowledge upon which lifesaving medical interventions can be developed. Universities and research institutes undertaking such research should be strongly supported through grants from philanthropies and the U.S. government.

Adapt Existing Knowledge for Low- and Middle-Income Countries

While many areas require further research to identify novel technologies to address the health conditions of the global poor, additional attention is also required to adapt existing tools and interventions to better serve the global poor. Even when interventions for disease already exist, deploying them more widely and effectively in low- and middle-income countries and in distinct sociocultural settings can be very difficult, hampering global health progress (GFHR, 2004). Increasing utilization can often be achieved through adaptations to technologies and interventions—for example, by developing vaccines that do not require cold storage or modifying a behavior change program to adapt to the local context. Relatively minor adaptations can improve the effectiveness of certain interventions, such as combining drug regimes to improve clinical performance and combat drug resistance.

An example of such a modification can be seen in the treatment of malaria. At a time when malaria mortality and morbidity were on the rise due to widespread resistance to antimalarial drugs, a new combination of artesunate with another antimalarial drug was seen to confer significant clinical benefit (White et al., 1999). While such artemisinin-based combination therapies, or ACTs, are currently the most effective medicines for malaria, they are typically much more expensive than traditional malaria treatments (Garner, 2004; WHO, 2001a). In response, a variety of public-private initiatives have arisen to lower the barriers to producing ACTs and making them widely available. WHO entered into a special pricing agreement with Novartis (the manufacturer of the first ACT to be prequalified by WHO) to provide drugs at cost to governments in malaria-endemic countries; a pediatric, cherry-flavored tablet that dissolves in water or breast milk and tastes like fruit juice has now been devised to improve the drug’s acceptability (Novartis, 2009). Another combination therapy using two off-patent and thus cheap drugs, artesunate and mefloquine, was formulated under DNDi’s Fixed-dose Artesunate-based Combination Therapies project in collaboration with Brazil’s Farmanguinhos/Fiocruz to treat patients in Latin America and Southeast Asia (DNDi, 2008). To further ensure the widespread availability of ACTs, the Affordable Medicines Facility for Malaria was initiated in 2009. This partnership—originally suggested in the 2004 IOM report Saving Lives, Buying Time—aims to negotiate lower prices and provide copayments for ACTs to expand access to successful malaria treatment and reduce the drug resistance that can occur with less effective treatments (IOM, 2004).

Adapting vaccines to suit low- and middle-income countries would be another way to increase the use of an existing intervention. According to WHO, vaccine-preventable diseases such as measles, hepatitis B, and Haemophilus influenzae type b (Hib) disease cause an estimated 2.7 million deaths each year. However, vaccine delivery in low- and middle-income countries is hindered by the need to provide refrigerated transport and storage, multiple doses over the course of months or years, and the use of injections, which are unacceptable in some cultures. Improvements in vaccine delivery were identified as one of the Gates Grand Challenges (Grand Challenges in Global Health, 2008); scientists are exploring various alternatives to needle-based delivery of vaccines that are not dependent on refrigeration and that can be delivered in conjunction with other major vaccines (Juma and Yee-Cheong, 2005).

The need to adapt existing technologies for use in low- and middle-income countries goes well beyond the arena of infectious diseases and biomedical tools. Noncommunicable diseases such as heart disease and cancer have increased dramatically in low- and middle-income countries, but the pace at which proven therapies and preventive measures for these diseases are adapted and deployed there is not commensurate with the extent and public health impact of this epidemiological transition. Several lifesaving medicines are now available generically and can be produced cheaply, providing an opportunity to save lives in low- and middle-income countries.

Evidence suggests that a “polypill” combining three blood pressure lowering drugs (a statin, aspirin, and folic acid) in low doses could reduce cardiovascular events by more than 80 percent in healthy individuals (TIPS, 2009). The patients studied were middle-aged (45-80 years) Indian men and women without previous cardiac disease, but with at least one cardiovascular risk factor: high blood pressure, obesity, high cholesterol, diabetes, or smoking (Cannon, 2009). This polypill strategy may provide important insights into adapting and delivering existing therapies to tackle growing chronic diseases in settings where access to physicians and healthcare providers is sporadic or difficult (Cannon, 2009). The idea of prescribing a single pill without lifestyle changes (such as smoking cessation) to prevent cardiovascular diseases, however, is controversial. Opponents argue that it could it could lead to excessive medication and mask the major causes of cardiovascular mortality, such as those related to lifestyle or socioeconomic status (Costantino et al., 2007).

Behavioral interventions to combat noncommunicable diseases also need to be adapted to low- and middle-income-country settings, since several of the most prominent noncommunicable diseases—lung cancer, hypertension, and diabetes—can be mitigated by behavioral change. For example, smoking prevention and cessation programs have been tested extensively in high-income countries as strategies against lung cancer. The implications and extrapolation of these results to low- and middle-income countries are less understood and require appropriate behavioral trials in local settings (Buekens et al., 2004).

The committee finds the need to devote immediate attention to our continued inability to bring existing and future promising health interventions to the most disadvantaged populations. The U.S. research community has not yet fully capitalized on opportunities to adapt existing technologies and interventions to low- and middle-income countries.

Recommendation 3-2. The U.S. research community, in collaboration with global partners, should leverage its scientific and technical capabilities to conduct research using state-of-the-art technology and innovative strategies to address health problems endemic to low- and middle-income countries.

  1. The U.S. research community should continue to examine new interventions for the prevention and treatment of global infectious diseases.
  2. The U.S. research community should expand its research efforts in global health with heightened attention to two purposes: (1) to study the basic mechanisms of diseases that disproportionately affect the global poor, and (2) to identify means to control communicable and noncommunicable diseases by adapting existing knowledge for low- and middle-income countries.


Research on global health involves not only generating knowledge relevant to the context of low- and middle-income countries, but also effectively transferring such knowledge and technologies to these settings and ensuring that the intended beneficiaries can apply them on a sustained basis. All of this requires the involvement of researchers on the ground in low- and middle-income countries. With research increasingly conducted globally through virtual communities of geographically dispersed scientists, it is critically important that information be made available to in-country researchers through a global network to exchange ideas and scientific tools, promote sustainable cross-country research partnerships, and enable the timely dissemination of best practices for local problem solvers.

Opportunities for more productive collaboration have been made possible by novel technologies, especially those in the biological and medical sciences, with dramatic benefits in how medical research is conducted; how new information is published, stored, retrieved, and used; how scientists and clinicians communicate with each other; how diseases are monitored and tracked; and how medicine is practiced. However, these developments also present their own set of challenges. Several factors affect the sharing of knowledge, such as the nature of the knowledge and the norms for scientific exchange. For example, even as information technology has changed the speed and marginal cost of disseminating knowledge, intellectual property rights can make such knowledge costly to acquire. Even in the absence of patents, a technology that is new to low- and middle-income countries—such as conjugation technology for vaccine production—may not easily transfer without technical assistance. Norms related to the ownership of knowledge also influence the sharing of knowledge. These norms are rooted in statutes and regulations such as the Bayh-Dole Act, prevailing practices among research institutions and competing scientists, and guidance provided by funding agencies (So and Stewart, 2009).

Access to the Building Blocks for Research

In the path from bench to bedside (laboratory discoveries to medical treatments), the research continuum consists of inputs and outputs, each of which depends on the sharing of knowledge. Three stages in this continuum warrant closer scrutiny because decisions at these points significantly affect what knowledge can later be shared within the scientific community (So and Stewart, 2009). The three important elements relating to these stages are (1) access to scientific publications, (2) the norms for data and material sharing, and (3) patenting and licensing practices. Characterizing the obstacles to and opportunities for each can help point the way to paths that lower the barriers to sharing knowledge and improve the scientific community’s ability to respond to health challenges.

Access to Scientific Publications

One of the challenges to sharing knowledge through scientific publications is that the subscription price of journals is often unaffordable for researchers in low-and middle-income countries. Mailing hard copies of journals to these countries is also prohibitively expensive for research institutes in the advanced economies. Several strategies have been deployed to ensure greater access to such publications, such as tiered pricing or the pooling of published research in open access journals or repositories. With the advent of the Internet, much of this access can now be offered electronically, provided that health workers and researchers are equipped with computers and high-speed access to the Internet (see Box 3-4).

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BOX 3-4

Improving Connectivity in Low- and Middle-Income Countries. In an ideal world, everyone in the field of global health would have access to the digital tools needed to benefit from global research advances. In reality, of course, low- and middle-income (more...)

The WHO-led Health InterNetwork Access to Research Initiative (HINARI) is one example of a tiered-pricing approach for enabling online access to scientific publications. Launched in January 2002, HINARI seeks to provide tiered access to more than 6,200 major journals in biomedicine and related social sciences. In collaboration with participating publishers, HINARI divides low- and middle-income countries into two groups: (1) countries with a gross national income (GNI) per capita from $1,250 to $3,500 per year, whose institutions can receive access for $1,000 per year, and (2) countries below this GNI level whose institutions receive free access. HINARI has claimed that between 2002 and 2006, researchers in HINARI countries increased their rates of publication by 63 percent, while those in non-HINARI nations saw only a 38 percent increase (Nightingale, 2008).

The pooling of published research in open access journals or repositories is an alternative method of increasing access in low- and middle-income countries. Open access journals provide articles online without charging subscriber fees because they raise their revenue from other sources, such as upfront author fees. Several studies show that this free online access corresponded to higher mean citation rates in disciplines ranging from electrical engineering to mathematics (Antelman, 2004; Eysenbach, 2006; Hajjem et al., 2005; Lawrence, 2001). Notably, the impact of public access publication on citations in journals was twice as strong in low- and middle-income countries (Evans and Reimer, 2009).

Several health research funding agencies require investigators to make their publications accessible following publication. The NIH Public Access Policy requires investigators to submit final, peer-reviewed journal manuscripts arising from NIH funding to PubMed Central upon acceptance for publication. The Wellcome Trust requires submission of scientific publications resulting from its grants into UK PubMed Central within six months of the publication date, and even provides funding for the upfront fees associated with publishing in truly open access journals that make content freely available immediately upon publication (Wellcome Trust, 2007). Investigators in the Howard Hughes Medical Institute also face a similar requirement to deposit publications in PubMed within six months of publication (Howard Hughes Medical Foundation, 2007).

By retaining copyright and granting a nonexclusive license to journals, authors can also self-archive their work, oftentimes on their own websites or in a university repository. For example, in early 2008, the Faculty of Arts and Sciences at Harvard University adopted its own public access mandate whereby members submit electronic copies of all completed articles to an institutional repository that will eventually be accessible worldwide via the Internet (Guterman, 2008). This practice has spread: Harvard Law School and Harvard’s Kennedy School of Government recently adopted their own public access initiatives, as have the Stanford University School of Education, Boston University, and the Massachusetts Institute of Technology (Gavel, 2009; Jahnke and Ullian, 2009; Suber, 2008; Taylor, 2009).

Access to Research Data and Materials

The sharing of data and other research materials enables the scientific community to confirm study findings and also to build upon the work of others. Aggregating efforts thus lowers the transaction costs by sharing the building blocks of research. Unlike the electronic distribution of journal articles or data, the marginal cost of disseminating research materials may not be negligible, creating barriers to sharing. Competing public policy concerns can also sometimes set limits on their sharing; for example, some data may risk the personal privacy of human subjects or compromise the confidentiality of privileged proprietary information (So and Stewart, 2009). Dual-use technologies—developed for military purposes but adapted for industrial or consumer uses—have the potential both to advance scientific knowledge and to pose threats to public health or the environment; such research activities as well as resulting data and materials thus require government or institutional oversight (Davidson et al., 2007).

At the same time, emerging infectious diseases have highlighted the need for a more rapid and free exchange of information and materials. During the 2003 SARS outbreak, WHO’s Global Influenza Surveillance Network played a key role in linking the world’s leading laboratories and experts with real-time information (Heymann and Rodier, 2004). In the race to identify the coronavirus as the cause of SARS, 11 laboratories recruited by WHO regularly and voluntarily shared samples of the unknown virus and held conference calls to discuss their results (Surowiecki, 2004). Without this level of collaboration and sharing, the transmission of SARS might not have been halted within four months.

In times of public health crises, data sharing is crucial but can also lead to conflict over the ownership of information. To study the avian flu virus, researchers in high-income economies are dependent upon low- and middle-income countries to supply them with wild virus samples. However the patenting of avian flu wild virus samples sent to laboratories in the advanced economies and the likely high costs of any resulting vaccines recently created friction in the Global Influenza Surveillance Network. The refusal of Indonesia to share virus samples with WHO Collaborating Centers without an assurance of sharing in later benefits highlighted the importance of a bidirectional flow of benefits in the sharing of data and materials (Khor and Shashikant, 2008).

Advances in mobile phone and Internet technologies have an increasingly vital role in disease surveillance. Text (or SMS) messages can be used as an alert system for the public, and personal data assistant phones can help physicians improve critical response times (Park et al., 2008). Today, more than half of the disease outbreaks investigated by WHO have come to its attention from informal sources such as news media, press reports, chat rooms, and blogs (Heymann and Rodier, 2001). Automated systems such as HealthMap (see Figure 3-1) seek to expedite health surveillance strategies by integrating web-based information around the globe into one tracking system that reports disease outbreaks in real time (Freifeld, 2009).

FIGURE 3-1. All diseases reported to HealthMap from January 14 to February 12, 2009.


All diseases reported to HealthMap from January 14 to February 12, 2009. SOURCE: Freifeld, 2009.

Despite the significant challenges to creating repositories and sharing the knowledge from them, some promising developments can be seen in different but complementary approaches to broadening access to compound libraries used to find new treatments for neglected diseases. Tackling a range of neglected diseases, the Special Programme for Research and Training in Tropical Diseases (TDR) has launched a web portal, TDR Targets, to bring together data and annotation in a publicly accessible database on tropical disease pathogens. Users can undertake searches ranging from genomic or protein structural data to target drug ability on neglected diseases, or they can find information on diseases such as leprosy, filariasis, and Chagas disease. In the first 16 months since the launch of the database, the site has logged more than 10,000 visits, with more than 30 percent coming from low- and middle-income countries or regions where these neglected diseases are endemic (Agüero et al., 2008). This web-based initiative complements other efforts to bring together the partnerships and multidisciplinary networks needed for drug discovery for neglected diseases (Senior, 2007).

Funding agencies have again played an important role in setting norms for sharing data and materials. The U.S. Department of Health and Human Services has developed a clinical trial registry ( and data bank for the results of both federal and privately supported clinical trials conducted around the world. The Food and Drug Administration (FDA) Amendments of 2007 strengthened reporting requirements by requiring that clinical trial results completed before product approval be submitted to no later than 30 days after the drug or device has received FDA approval (United States Code, 2007). Building upon the momentum of these efforts, WHO has sought to provide a forum for developing best practices for clinical trial registration, and a number of countries now maintain prospective trial registries (WHO, 2009b).

Access to Patented Inventions

The patenting and licensing of inventions significantly influences the sharing of knowledge. The patenting of knowledge enhances its potential commercial value by rewarding the inventor with time-limited market exclusivity and can help mobilize needed private sector resources for further research and development. The approach to licensing the patent shapes the conditions of access and the sharing of knowledge (So and Stewart, 2009).

Tiering can be applied to patents and their licensing in the same way it applies to scientific publications, data, and material transfers. By setting limits of geography or use, licenses may offer royalty-free rates for the invention’s application in low- and middle-income countries. For example, in 2002, the TB Alliance signed an agreement with Chiron Corporation (now part of Novartis) for an anti-TB compound, PA-824. Chiron owned all the patents, know-how, and data for PA-824, as well as hundreds of its chemical analogues. The license agreement granted the TB Alliance exclusive worldwide rights for the development of TB drugs, and in an unprecedented move for a pharmaceutical or biotechnology company, Chiron agreed to take no royalty payments in low- and middle-income countries. Such licenses often promise little revenue return from these countries, but by reserving rights for application in the advanced economies, revenues from paying markets remain possible.

The role of academic licensing in global access visibly surfaced in 2001 at Yale University in the case of the AIDS drug Zerit. The compound d4t had been discovered by two Yale researchers with funding from NIH and Bristol Myers Squibb (BMS) in the early 1990s. In exchange for the funding, as is common practice in most U.S. academic institutions, BMS was granted an option to claim broad patent protection for the compound, which it subsequently exercised. In 2001, however, Doctors Without Borders requested a waiver of the South African patent. BMS rejected this request, leading to student protests on the Yale campus and increased public attention to the critical importance of the drug to thousands in South Africa. BMS then agreed not to assert its rights.

This led to an awakening on university campuses across the United States. Several universities have since taken measures to ensure that their research is accessible to researchers in low- and middle-income countries. For example, Boston University has made the decision to ask its faculty not to assert intellectual property rights on their patents when the intervention is used by global public health organizations, such as WHO or the United Nations Children’s Fund, to enable access in publicly funded programs in low- and middle-income countries (Stevens, 2009).

Funders have also sought to mitigate the concerns over exclusive licensing of inventions by establishing patent policies and requiring access provisions. Various foundations have issued guidance that encourages greater sharing of inventions resulting from their research, sometimes incorporating such conditions into their grant agreements. In funding point-of-care diagnostics for monitoring AIDS, the Doris Duke Charitable Foundation assessed how preexisting intellectual property affected the ability of its grantees to make good on the charitable objective of ensuring the technology’s availability at an affordable cost in low- and middle-income countries. The grant agreements also allowed the foundation to retain a nonexclusive, royalty-free license to any patents filed in these countries, giving it the ability to sublicense rights to make and distribute the product if the grantee failed to deliver on the charitable objective (Doris Duke Charitable Foundation, 2004).

Pooling patents can also help lower the transaction costs associated with assembling the tools needed to conduct research on a health technology. GlaxoSmithKline recently developed a patent pool, or an agreement among organization to share patents, through which it contributed more than 80 current and pending patent families (GlaxoSmithKline, 2009). This voluntary patent pool makes available the patented knowledge it uses to develop medicines for neglected diseases to other drugs companies, governments, and nongovernmental organizations. In order to enhance access to any drugs that are developed through the patent pool in low-income countries, GlaxoSmithKline has promised to cap the prices of these drugs at less than 25 percent of their potential price in high-income nations.

Recommendation 3-3. The U.S. research community should promote global knowledge networks and the open exchange of information and tools that enable local problem solvers to conduct research to improve the health of their own populations.

  1. Funders of global health research should require that all work supported by them will appear in public digital libraries, preferably at the time of publication and without constraints of copyright (through open access publishing), but no later than six months after publication in traditional subscription-based journals. Universities and other research institutions should foster compliance with such policies from funding agencies and supplement those policies with institution-based repositories of publications and databases.
  2. The U.S. government, universities, and other research institutions should develop new methods—such as simplified web-based procedures for executing agreements such as materials transfer and nondisclosure agreements—to expedite the sharing of information and research materials with researchers in low- and middle-income countries.
  3. Scientists, clinicians, advocates, and other personnel involved in defined areas of global health should develop trustworthy websites that aggregate published literature, incorporate unpublished databases or clinical trial information, promote digital collaboration, and disseminate news and other information about common interests.
  4. Universities and other research institutions that receive federal and philanthropic funding to conduct research should adopt patent policies and licensing practices that enable and encourage the development of technologies to create products for which traditional market forces are not sufficient, such as medicines, diagnostics, and therapeutics that primarily affect populations in low- and middle-income countries.


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A 1999 landmark randomized trial in Uganda testing the safety and efficacy of a single dose of oral nevirapine prophylaxis—given to mothers at the onset of labor and to infants within 72 hours of birth—showed a 50 percent reduction (compared to zidvudine) in perinatal HIV transmission in breast-fed infants, who were followed up to age 14-16 weeks (Guay et al., 1999). Subsequent studies following these babies up to age 18 months demonstrated the drug’s continued efficacy, with a 41 percent reduction in vertical transmission of HIV seropositivity (Jackson et al., 2003).


Molecular docking is a collective term that refers to theoretical methods and computational techniques to model or mimic the behavior of molecules.


In preparing this section of the report, the committee drew heavily on the background paper prepared by Dr. Anthony So and Mr. Evan Stewart (see Appendix F).

Copyright © 2009, National Academy of Sciences.
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