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2 Scale Up Existing Interventions to Achieve Significant Health Gains The global health community has reached a critical juncture. Knowledge, innovative technologies, and proven tools to help millions of people are within reach. Yet despite demonstrated success in tackling certain health issues, the gap continues to grow between what can be done with existing knowledge, and what is actually being done in disadvantaged communities. Existing interventions are not widely used even though many are inexpensive and easy to administer (Bryce et al., 2003; Jamison, 2006). In the area of child mortality, for example, the tremendous gains made in child survival over the past half-century—due to interventions such as vaccinations and dietary supplementation strategies—have actually slowed or been reversed since the mid-1990s (Ahmad et al., 2000). At the same time, chronic diseases such as diabetes and heart disease have joined the list of infectious diseases traditionally found in low- and middle- income countries, in an extraordinary global epidemiologic transition (Abegunde et al., 2007; Jamison, 2006; Laxminarayan et al., 2006; Omran, 1971). Steps are thus required to address this double burden of disease, as well as to com - bat emerging infectious threats such as pandemic flu. If the global community neglects its responsibilities at this critical moment, health outcomes for the most vulnerable populations will remain static or decline, progress achieved in poverty reduction thus far will be threatened, and the poorest countries will continue to be left behind. ACHIEVE THE MILLENNIUM DEVELOPMENT GOALS BY 2015 The globally recognized Millennium Development Goals (MDGs) were adopted by Member States of the United Nations (UN) in 2000 to achieve demon- 

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0 THE U.S. COMMITMENT TO GLOBAL HEALTH strable reductions in poverty and improve specific health outcomes by 2015. Three of the eight goals pertain directly to health (Goals 4, 5, and 6); the other five, indirectly (see Box 2-1). Although progress has been made, as discussed below, the MDG targets remain a distant goal for many countries, particularly in sub-Saharan Africa and parts of South Asia (UNICEF, 2008). MDG 4: Reducing Child Mortality Global child mortality rates have dropped steadily over the last 50 years. Between 1960 and 1990, the rates of decline in worldwide child mortality aver- aged 2.5 percent per year. By contrast, from 1990 to 2001, the rates of decline averaged 1.1 percent per year. Although this deceleration might be expected in regions that had already achieved low mortality rates, such slowing has also occurred in high-rate regions (Black et al., 2003; Sepúlveda et al., 2006). Between 1990 and 2006, about 27 countries—the large majority in sub- Saharan Africa—made little or no progress in reducing childhood deaths (see Figure 2-1) (UN, 2008b). In 2005, only 7 of the 60 countries that account for more than 94 percent of child deaths in the world were on track to reach MDG 4 (Bryce et al., 2006). While progress has been made in important areas—for example, deaths from measles fell by two-thirds between 2000 and 2006 due to dramatically improved vaccination programs covering 80 percent of children in BOX 2-1 United Nations Millennium Development Goals Goal 1 Eradicate Extreme Hunger and Poverty Goal 2 Achieve Universal Primary Education Goal 3 Promote Gender Equality and Empower Women Goal 4 Reduce Child Mortality • arget 1: Reduce by two-thirds the under-5 mortality rate T Goal 5 Improve Maternal Health • arget 1: Reduce by three-quarters the maternal mortality ratio T • arget 2: Achieve by 2015 universal access to reproductive health T Goal 6 Combat HIV/AIDS, Malaria, and Other Diseases • arget 1: Halt and begin to reverse the spread of HIV/AIDS T • arget 2: Achieve, by 2010, universal access to treatment for HIV/ T AIDS for all those who need it • arget 3: Halt and begin to reverse the incidence of malaria and other T major diseases Goal 7 Ensure Environmental Sustainability Goal 8 Develop a Global Partnership for Development SOURCE: UN, 2008a.

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 SCALE UP EXISTING INTERVENTIONS CIS, Europe 27 17 45 Eastern Asia 24 Latin America and 55 the Caribbean 27 82 Northern Africa 1990 2006 Target 35 77 South-Eastern Asia 35 69 Western Asia 40 79 CIS, Asia 47 85 Oceania 66 120 Southern Asia 81 184 Sub-Saharan Africa 157 0 20 40 60 80 100 120 140 160 180 200 Rate per 1,000 FIGURE 2-1 MDG 4: Deaths of children under 5 per 1,000 live births (1990, 2006, and 2015 target). Now 2xa.eps SOURCE: UN, 2008b. low- and middle-income countries (UN, 2008b)—the lack of well-functioning health systems in these countries severely constrains the delivery of many essen - tial health interventions (Bryce et al., 2003). As a result, despite substantial atten- tion from global health agencies, mortality of children less than 5 is projected to decline by only 27 percent between 1990 and 2015, substantially less than the MDG target of 67 percent (Murray et al., 2007). While the causes of child death differ substantially from one country to another and therefore require a greater understanding of the epidemiology of child health at the country level (Black et al., 2003; Jones et al., 2003; Lawn et al., 2004), six causes account for 73 percent of the yearly deaths of children younger than 5: pneumonia (19 percent), diarrhea (18 percent), malaria (8 per- cent), neonatal pneumonia or sepsis (10 percent), preterm delivery (10 percent), and asphyxia at birth (8 percent); undernutrition is an underlying cause of more than half of all child deaths (Bryce et al., 2005). Diarrhea and pneumonia alone

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 THE U.S. COMMITMENT TO GLOBAL HEALTH account for 4 million child deaths each year, while an additional 11 million to 20 million children are hospitalized annually for pneumonia (Rudan et al., 2004). At least one effective intervention is available for preventing or treating each main cause of death among children younger than 5 (apart from birth asphyxia) (Jones et al., 2003), and about 20 proven interventions available today are fea- sible for implementation in low-income countries at high levels of population coverage (Bhutta et al., 2008; Bryce et al., 2006; Darmstadt et al., 2005; Jones et al., 2003). Overall, existing health interventions could reduce child mortality by as much as 63 percent if they could reach those in need—children in the 42 countries that accounted for 90 percent of all childhood deaths in 2000 (Jones et al., 2003). These simple and cost-effective measures include promotion and support for breastfeeding; the management of diarrhea with low-osmolarity oral rehydration salts and zinc; the prevention of pneumonia and meningitis with Haemophilus influenzae type b (Hib) vaccine; the use of insecticide-treated bed nets; and supplementation with vitamin A, among others. Achieving MDG 4 does not require a wait for new vaccines, drugs, or technology—although these should remain on the agenda in order to improve efficiency and effectiveness in the future; the requisite interventions are avail- able now. MDG 5: Improving Maternal Health Outreach services can achieve impressive results when providing interven- tions such as vaccinations, but they offer little assistance in other medical cases such as childbirth or pregnancy complications, which require a functioning health service. Although maternal deaths represent only 1 percent of global mortality, 500,000 such deaths every year constitute a serious indictment of public health systems (Beaglehole and Bonita, 2008). Maternal death rates are the largest inequity in health and vary enormously across countries, ranging from as low as 4 per 100,000 live births in Australia to 2,100 per 100,000 in Sierra Leone—a greater than five hundredfold difference (Beaglehole and Bonita, 2008; Gwatkin, 2004). Ninety-nine percent of maternal deaths occur in low- and middle-income countries (see Figure 2-2). Progress has been slower for this MDG than for the others, especially in sub- Saharan Africa, suggesting that this issue is not yet firmly on the global agenda despite decades of effort (Shiffman and Smith, 2007). Only 47 percent of births in sub-Saharan Africa and 40 percent in South Asia are attended by a skilled professional. Meanwhile, progress in North Africa and Southeast Asia has been remarkable, demonstrating that substantial improvements are possible even in low- and middle-income countries (UN, 2008b). Increasing the coverage of key maternal health provisions, including access to family planning services, skilled birth attendance, and obstetric services, would go a long way toward achieving MDG 5 (Ronsmans and Graham, 2006;

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 SCALE UP EXISTING INTERVENTIONS 95 Eastern Asia 50 58 CIS 51 180 Latin America and the Caribbean 13 0 1990 2005 Target 250 Northern Africa 16 0 19 0 Western Asia 16 0 450 South-Eastern Asia 30 0 550 Oceania 430 620 Southern Asia 49 0 920 Sub-Saharan Africa 90 0 0 100 200 300 40 0 500 600 700 800 900 10 00 Deaths per 10 0,000 live births FIGURE 2-2 MDG 5: Maternal deaths per 100,000 live births (1990, 2005, and 2015 target). Now 2xb.eps SOURCE: UN, 2008b. UN, 2008a). In low- and middle-income countries, about one-fourth of pregnan - cies are unintended (Haub and Herstad, 2002), highlighting the need for ways of avoiding them. Ensuring access to family planning and reproductive health for all women could help avoid up to 35 percent of maternal deaths (Belhadj and Touré, 2008). A commitment is also required to establish countrywide systems of quali - fied and adequately equipped personnel, along with an effective infrastructure that allows women to be referred and transported for emergency obstetrical care (Campbell and Graham, 2006; Ronsmans and Graham, 2006). Without these, one in six women living in the world’s poorest settings will continue to die from treatable or preventable complications in pregnancy and childbirth (Ronsmans and Graham, 2006).

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 THE U.S. COMMITMENT TO GLOBAL HEALTH MDG 6: Combating HIV/AIDS, Malaria, and Other Diseases Recently, HIV/AIDS, malaria, and tuberculosis (TB)—often termed “the big three” because of their significant disease burden—have benefited from increased political commitments from the U.S. government’s bilateral program PEPFAR (President’s Emergency Plan for AIDS Relief); the international financing insti - tution, the Global Fund to Fight AIDS, Tuberculosis, and Malaria (the Global Fund); and the World Bank’s Multi-Country HIV/AIDS Program for Africa, among others. A growing recognition of the enormous global impact of these three diseases has also led to an increase in research efforts, with philanthropies (such as the Bill & Melinda Gates Foundation) and U.S. government agencies (including the Centers for Disease Control and Prevention, the National Insti - tutes of Health, and the U.S. Agency for International Development) galvanizing research that specifically targets the needs of populations in the world’s poorest settings. HIV/AIDS Epidemic Continues to Be a Leading Cause of Death Worldwide AIDS continues to be the leading cause of death in Africa and the sixth- largest killer worldwide (WHO, 2008b). Recent expansion of antiretroviral treat - ment for HIV-infected individuals through PEPFAR and the Global Fund, among others, has succeeded in reversing the direction of AIDS mortality; between 2005 and 2007, the number of people who died annually from AIDS declined from 2.2 million to 2 million (UNDP, 2008). However, in 2007, 2.7 million people were newly infected with HIV, signaling a failure to prevent the spread of the disease (UN, 2008b). Despite the knowledge of successful, cost-effective strategies to prevent the transmission of HIV—condom use, reduction in the number of sexual partners, male circumcision, the prevention of mother-to-child transmission, and protec - tion of the blood, organ, and tissue supply—the disease continues to spread at an alarming rate, especially among women in low- and middle-income countries (UNAIDS, 2008). Continued efforts to disseminate messages that motivate peo- ple to adopt these effective risk-reducing behaviors and interventions are critical (Coates et al., 2008; Potts et al., 2008; Wilson and Halperin, 2008). New tools and strategies to prevent HIV infection through sexual transmis- sion are also essential for halting the spread of the disease. Although condom effectiveness in preventing HIV transmission ranges from 80 percent (Weller and Davis-Beaty, 2002) to 94 percent (Hearst and Chen, 2004; Pinkerton and Abramson, 1997; Rutherford, 2008), sexual intercourse and condom use dur- ing the sex act are not always controlled by women. The development of HIV prevention products that do not require the cooperation or consent of one’s partner is thus critical (WHO, 2009c). Two experimental biomedical products that would greatly empower women (and men) to protect themselves and their

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 SCALE UP EXISTING INTERVENTIONS partners are microbicides—a compound that can be applied inside the vagina or rectum to protect against sexually transmitted infections, including HIV—and pre-exposure prophylaxis—a single drug, or a combination of drugs, to prevent infection (Lagakos and Gable, 2008). A vaccine to protect against HIV infection, while possibly decades away, would fundamentally alter the global response to the epidemic. Malaria Results in One Million Deaths Every Year Globally, more than 2 billion people are at risk of malaria each year (Snow et al., 2005). Despite dramatic reductions in malaria incidence and mortality in many parts of the world in recent years, approximately 500 million people still contract the disease, resulting in 1 million deaths annually (Greenwood et al., 2008). The threat of malaria has declined in many countries with high rates of infection due to the increased availability and accessibility of artemisinin- containing antimalarial drugs, and antimosquito measures such as long-lasting insecticide-treated nets (LLINs) and indoor residual spraying. A 2008 World Health Organization (WHO) report on the impact of LLINs and artemisinin-based combination therapies (ACTs) in four African countries found “strong initial evi - dence” in Rwanda and Ethiopia that the mass distribution of LLINs to children under 5 years of age, in combination with the distribution of ACTs nationwide, resulted in a dramatic decline of more than 50 percent in both in-patient malaria cases and malaria deaths (WHO, 2008d). Nevertheless, new infections and re-infection continue, making a malaria vaccine of utmost importance. The vaccine candidate RTS,S has been found to reduce malaria incidence among children by more than 50 percent in two Phase II field trials.1 This vaccine, which can be administered safely with other child - hood immunizations, functions by halting malaria parasite replication in the liver (Abdulla et al., 2008; Bejon et al., 2008). Should the upcoming large-scale Phase III trials be successful, the RTS,S vaccine could be licensed by 2011 and avail - able by 2012, providing a powerful tool in conjunction with additional malaria interventions (Engel, 2008). Tuberculosis Demands Improved Prevention, Diagnostic, and Treatment Options Despite the slow global decline in TB incidence per capita (less than 1 percent each year), the disease still kills 1.7 million people annually (WHO, 2008c). Between 1990 and 2003, the incidence of TB remained stable in all regions except Africa and the former Soviet republics and even rapidly declined 1 The RTS,S vaccine was developed in 1987 by the Walter Reed Army Institute of Research and GlaxoSmithKline (Basu, 2007) and later received support from the PATH Malaria Vaccine Initiative and the Bill & Melinda Gates Foundation.

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 THE U.S. COMMITMENT TO GLOBAL HEALTH in emerging market economies such as Latin America and Central Europe (Dye et al., 2005; WHO, 2008c). Rates in Africa increased in part due to co-infection with HIV (Corbett et al., 2003), and in Eastern Europe due to economic decline and the general failure of health services (Dye and Floyd, 2006). Since 2003, the number of new tuberculosis cases per capita has continued to fall worldwide. This decline can partly be attributed to the successful imple- mentation of drug treatment programs (Dye et al., 2005). PEPFAR supported TB treatment for more than 395,400 HIV-infected patients through September 2008 (PEPFAR, 2009), while the Global Fund provided 4.6 million people with effective TB treatment through December 2008 (Global Fund, 2009). How- ever, if global targets for tuberculosis control are to be met, Africa, China, and India—which collectively account for more than two-thirds of undetected TB cases—will have to improve both the extent and the timeliness of diagnosis of active TB and increase the rate of successful treatment (UN, 2008b). Successful diagnosis remains a major challenge in the control of tuberculosis; for example, the number of multidrug-resistant TB cases successfully diagnosed and notified in 2006 represented less than 5 percent of the nearly half million cases estimated to exist worldwide (WHO, 2008c). The current class of TB drugs—the most recent of which was introduced in the 1960s—imposes a long and complex regimen on those burdened with the disease. Although effective, the treatment regimen itself is one of the greatest obstacles to controlling the disease. Because of the length of treatment and its negative side effects, patient compliance is often poor, ultimately resulting in drug resistance. A factor that vastly complicates diagnosis and treatment is the extremely drug-resistant form of tuberculosis, XDR-TB, which leaves patients (including many with HIV) virtually untreatable with currently available drugs (WHO, 2006c). TB treatment also involves considerable health system costs in terms of direct patient observation, amounting to more than $4 billion a year worldwide. This further handicaps TB control programs, fueling drug resistance and preventing the systematic treatment of latent TB infection—the reservoir for the epidemic (see Box 2-2). Neglected Diseases of Poverty Exacerbate the Burden of the Poor AIDS, TB, and malaria are familiar names, but few U.S. citizens are acquainted with the other infectious diseases that commonly plague poor families in low- and middle-income countries. Often termed the neglected diseases of poverty, these scourges have afflicted the world’s poorest since ancient times and continue to be common among the estimated 2.7 billion people living on less than $2 a day. These conditions frequently result in long-term disability and poverty (Hotez et al., 2007) and carry disease burdens that are grossly underestimated and may be comparable to those of HIV, malaria, and TB (Hotez et al., 2006a, 2006b; Savioli et al., 2006).

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 SCALE UP EXISTING INTERVENTIONS BOX 2-2 Drugs and Vaccines for Tuberculosis Research In 1995, the directly observed treatment, short-course (DOTS) control strategy for TB was launched (WHO, 2008f). DOTS is an inexpensive and highly effective means of treating patients already infected with TB, while preventing new infec- tions and the development of drug resistance. In many low-income countries, DOTS costs only $3 to $7 for every healthy year of life gained (World Bank, 2003). The DOTS strategy provides diagnosis, patient registration, and a six-month multidrug treatment regimen, where the patient’s compliance with treatment is “directly observed” even as he or she is free to work, go to school, and be with family. By combining individual patient outcome evaluation to ensure cure and cohort evaluation to monitor overall program performance, DOTS forms the core of the WHO’s Stop TB Strategy (Floyd and Pantoja, 2008). A shorter or otherwise simpler treatment regimen would greatly help to improve patient compliance and to lower toxic side effects, thereby increasing cure rates. A shorter treatment would also reduce the costs of TB treatment, both for patients and for health systems. New and faster-acting drugs could radically transform the fight against tuberculosis by accelerating DOTS, treating multidrug-resistant TB (MDR-TB), improving the treatment of latent infection, and reducing TB transmis- sion. Effective treatment of latent TB is particularly important for patients co- infected with HIV (Bornemann et al., 2002). The Global Alliance for TB Drug Development, a public-private product develop- ment partnership, has the primary goal of developing within a decade new anti-TB drugs that shorten and/or simplify treatment, are effective against MDR-TB, and address both active and latent forms of the disease. A central stipulation for any new drug is that it be accessible and affordable for all who need it (Bornemann et al., 2002). No vaccine yet exists that is truly effective against adult pulmonary tuberculo- sis, the strain that accounts for most of the disease burden worldwide (Stop TB Partnership, 2009). The bacille Calmette-Guérin (BCG) vaccine, created in 1921, is currently the only available vaccine against TB. The vaccine is effective against severe forms of pediatric TB, but is unreliable against adult pulmonary TB. BCG is the most widely administered vaccine in the world, yet more than one-third of the world’s population carries the disease (WHO, 2007b). A modern, safe, and effective vaccine is therefore urgently needed to prevent all forms of TB, including drug-resistant strains, in all age groups and particularly among people with HIV. In recent years, a number of new vaccine candidates for tuberculosis have been developed and shown promising results when tested in animals. Aeras TB, a nonprofit biotechnology company, has recently entered a new vaccine candidate human safety trial in South Africa (Aeras, 2009). Two common groupings of these neglected infectious diseases are helminth infections and kinetoplastid infections (Hotez et al., 2008; Stuart et al., 2008). Helminth infections, caused by parasitic worms, are the most common clinical conditions among the “bottom billion”—the world’s poorest people living on

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 THE U.S. COMMITMENT TO GLOBAL HEALTH less than $1 per day (Collier, 2007)—and include parasites such as roundworm, hookworm, onchocerciasis, and schistosomiasis. Children and adolescents suffer the highest burden of worm diseases, experiencing growth and developmental delays that result in deficits in intelligence and cognition. Hookworm and schis - tosomiasis are common infections that cause anemia among women in their reproductive years. Because of their pronounced impact on maternal and child health, the disease burden caused by helminths is exceedingly high (Collier, 2007; Hotez et al., 2006b). Kinetoplastid infections are caused by related parasites and include three diseases: trypanosomiasis, Chagas disease, and leishmaniasis. These infections are less common, but being vector-borne, they could increase as a consequence of climate change and other environmental influences (IOM, 2008b). Neglected infectious diseases are often treated on a mass scale with vari - ous drugs; for example, mass administration of diethylcarbamazine and selec - tive treatment or administration of diethylcarbamazine-medicated salt have succeeded in interrupting the transmission of lymphatic filariasis in the Pacific region (Ichimori et al., 2007). Vector control, followed by mass treatment with ivermectin, led to the control of onchocerciasis in 10 west African countries (Amazigo et al., 2006). Azithromycin treatment and the SAFE (surgery, antibiot - ics, face cleanliness, and environmental improvement) strategy have eliminated blindness-causing trachoma in Morocco (Cook, 2008), and multidrug treatment has eliminated leprosy as a public health problem in more than 93 countries (Molyneux, 2008). The efficacy of mass treatment was confirmed in a systematic review of ran- domized controlled trials (Reddy et al., 2007). Because the major multinational pharmaceutical companies provide many of the drugs used for mass treatment free of charge, this approach is one of the most cost-effective global public health control measures (Hotez et al., 2007). The efficiency and effectiveness of mass treatment could be increased through the integration of several vertical disease control programs (Brady et al., 2006; Hotez et al., 2006b, 2007; Molyneux, 2008) since integration provides cost savings of almost 50 percent (Brady et al., 2006). In 2005-2006, a low-cost rapid-effect package of four drugs was developed to simultaneously target the seven major neglected tropical diseases (Hotez et al., 2006b, 2007). To launch an integrated global assault with the rapid-effect pack- age, about $2 billion to $3 billion will be needed over the next five to seven years, or roughly 40 to 50 cents per person per year (Hotez et al., 2007, 2009). New technologies and interventions developed for diseases that are found overwhelmingly or exclusively in low- and middle-income countries are usually serendipitous, as when a veterinary medicine developed by Merck (ivermectin) proved to be effective in the control of African river blindness (onchocerciasis) in humans (Campbell, 2005). Similarly, eflornithine—originally intended as a cancer treatment and also known to be highly effective against a strain of African sleeping sickness (trypanosomiasis)—was initially abandoned by drug manu -

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 SCALE UP EXISTING INTERVENTIONS facturers until it was discovered to be effective in preventing unwanted facial hair (see Box 2-3). Yet for many of these infections, genomes for the parasites and vectors have been completed; increased investment in the mining of these genomes could result in breakthrough discoveries of new diagnostic, drug, and BOX 2-3 Human African Trypansomiasis: Diagnosis and Treatment Human African trypanosomiasis, or sleeping sickness, is spread by infected tsetse flies (Glossina genus). Although sleeping sickness is not fatal, it can be grossly debilitating by affecting the central nervous system, causing changes in personality, and creating difficulty in walking and talking. WHO estimates that there are currently 50,000 to 70,000 cases of African sleeping sickness, responsible for an estimated 1,525,000 disability-adjusted life-years (DALYs) (DNDi, 2008; WHO, 2006a). Case detection requires major human, technical, and material resources, such as blood samples and spinal tap. Diagnosis becomes even more difficult because the disease primarily affects poor rural populations with little access to health facilities. New, accurate, and simple diagnostic tests that could determine the stage of disease are required, along with drugs that could be administered orally (CIPIH, 2006). Currently there is no vaccine or drug available to prevent infection. While drugs to treat the disease are available, they are old, difficult to administer under poor conditions, and not always successful. Pentamidine is the first-stage treatment for the Trypanosoma brucei (T.b.) gambiense strain of African trypanosomiasis, and although it has a few side effects, it is generally well tolerated by patients (WHO, 2006a). Eflornithine is a highly effective treatment for the T.b. gambiense strain of Af- rican trypanosomiasis, particularly in the late-stage disease. It is safer and more effective than other treatments, such as melarsoprol, but the dosing regimen is strict and the drug is expensive. It was originally intended as a cancer treatment, but was registered for African trypanosomiasis in 1989. Highly expensive, eflorni- thine was largely abandoned by drug manufacturers until it was discovered to be an effective treatment against unwanted facial hair. Due to extensive lobbying by Medicins Sans Frontieres in 2001, Sanofi-Aventis (formerly Aventis), the patent holder, agreed to provide $12.5 million worth of the drug to WHO over five years. Now that this five-year period is over, Sanofi-Aventis has agreed to transfer the technology and assist other manufacturers that are willing to develop eflornithine; the Indian Institute of Chemical Technology (Hyderabad, India) and ILEX Oncol- ogy (Texas, USA) are both working on cheaper ways to produce the drug (CIPIH, 2006). Targeted research on human African trypanosomiasis has revealed new and more promising treatments. A Phase III study—made possible by a public-private partnership—confirmed that eflornithine in combination with nifurtimox is a safe, effective treatment for stage 2 patients with the disease, and even more practical than eflornithine alone. This combination drug was added to the WHO Essential Medicines List in May 2009.

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