Breakthroughs Blog: Malaria

While lawmakers battled it out on the field last week during the annual Congressional Baseball Game (Democrats won for the sixth year in a row!), they found something they could join together on as the House Appropriations Committee easily approved the State and Foreign Operations Subcommittee’s (SFOPS) appropriations bill on Tuesday afternoon. Since GHTC reported two weeks ago on initial funding levels between the bills, both chambers have also released their accompanying reports which provide policy language that gives further clarity on the policymakers’ thinking and intent. What’s new? House and Senate appropriation reports included language supporting global health R&D. Photo: PATH/Patrick McKern We think the House Committee hit a home run in their inclusion of language submitted by the GHTC on the need for coordination across the US government on global health research and development (R&D). The language in the report directs the US Agency for International Development (USAID) to coordinate across the government with the other agencies involved in global health R&D. As it currently stands, there is no cross-US government global health R&D strategy, which leads to gaps in research, inefficiencies, and missed opportunities. This is a no-cost fix which will help leverage taxpayer dollars, fill gaps, and ensure that the ball is not dropped when valuable research needs to be shared across agencies. We’re glad to see policymakers are recognizing the need for improved coordination, and we are hopeful this language will be included in whatever final legislation is passed—whether in a continuing resolution, conference, or omnibus bill.   New to this year’s Senate report was the inclusion of a ‘Research and Development’ line within the Global Health section of the report which noted “the Committee supports investments in new global health technologies to address ongoing global health challenges.” This is another score for R&D advocates and one we hope will be included in final law. Also new for both chambers’ reports was the inclusion of language supporting the Global Development Lab. Both versions express support for the lab, as well as instructions to keep Congress informed on its progress. Continued support for R&D Similar to last year’s report, the House included language encouraging USAID to continue supporting research around the need for new drugs to address neglected tropical diseases (NTDs). Also like last year, the Senate language was a bit more enigmatic—noting the contributions of the private sector in R&D for NTDs, but not specifically mentioning USAID’s role in the process. Again, we’re hoping the House language will be included in the final bill. Similarly, the House provides strong language around continued support for microbicide development. R&D for malaria continued to have strong support, particularly from the Senate bill, which, similar to previous years, included language about the need for new insecticides, diagnostic, and vector control tools, alternatives to arteminisin combination therapies and counter resistance, and pediatric formulations. While this isn’t new, it’s encouraging to see this remains a priority for policymakers. As in previous years, the Senate bill provides strong support for the acceleration of research for contraceptives that are “effective, affordable, and easier to deliver.” Both reports included language about efforts to develop a malaria vaccine and language around the need for continued research for a vaccine to combat AIDS. Next steps Now that both chambers’ appropriations committees have approved their respective SFOPS bills, it will be up to policymakers to work out the differences, both in funding levels and policy. We’re hoping lawmakers can figure out a way to keep the ball rolling, but whatever happens, we’ll be watching the situation closely.

Tomorrow US policymakers and global health advocates will come together to talk progress made on preventing maternal and child deaths. During the day, the US Agency for International Development (USAID) will host a high-level forum called Acting on the Call: Ending Preventable Child and Maternal Deaths to both celebrate progress and assess the challenges that remain. That evening, the 5th Birthday and Beyond coalition will celebrate America’s leadership and investments worldwide to help children reach their fifth birthday. US investment in R&D has led to new innovations that are saving the lives of mothers and children. Photo: PATH/Teresa Guillien While you’ll probably hear a lot of different facts and figures, one message will be clear—the world has made remarkable progress in preventing the deaths of millions of women and children. In fact, maternal and child deaths have been cut in half in just over two decades. That means that every day this year, 17,000 more children will live and 700 more mothers will survive childbirth than did two decades ago. Central to this progress has been US investment in research and development (R&D) that has led to new medicines and innovative health products that are saving the lives of mothers and children. Globally new vaccines, drugs, diagnostics, and other health innovations have led to 4.2 million fewer child deaths in 2013 compared to 1990, according to a report by the Institute for Health Metrics and Evaluation. Innovations like the polio vaccine, oral rehydration solution to treat diarrhea, and antiretroviral therapies that prevent maternal to child HIV transfer, and others treatments have resulted in incredible gains for maternal and child health.   No country has done more than the United States to help save the lives of the world’s poorest mothers and children. A critical part of the US approach has been our world-leading investment in global health R&D. In fact, the US government is the largest funder of global heath R&D in the world—contributing over 45 percent of total investment. US government investment in global health R&D has led to breakthroughs that have transformed or are poised to transform efforts to reduce maternal and child mortality. Some examples include: The Oxytocin-Uniject™ This is a device filled with oxytocin that helps contract the uterus to reduce post-partum hemorrhage—or excessive bleeding—the leading cause of maternal death worldwide. It is easy to inject and requires little training to administer, so it’s made a dramatic difference in the ability of health workers to administer oxytocin in emergencies or in remote locations outside of traditional hospital facilities. USAID played a crucial role in funding research towards the development of this product. RTS,S malaria vaccine candidate RTS,S is the most clinically-advanced vaccine candidate for malaria—a disease which kills a child every 40 seconds. A recent study showed that infants who receive the RTS, S vaccine had one third fewer cases of both clinical and severe malaria. A vaccine could be an important tool in reducing child sickness and death from malaria. The Department of Defense provided critical funding for the early development and clinical testing of RTS,S. Rotavirus vaccines Rotavirus-induced diarrheal disease kills roughly 435,000 children younger than five each year. Two currently available rotavirus vaccines were introduced in the past two decades, with other vaccines under development showing tremendous progress. The National Institutes of Health developed the first available rotavirus vaccine and has been a financial partner in the development of subsequent vaccines. In addition, the Centers for Disease Control and Prevention also monitors efficacy and safety, and supports clinical trials of rotavirus vaccines. New contraceptive technologies Family planning technologies allow women to space their pregnancies—making it more likely for both the mother and child to survive childbirth. An analysis of 172 countries found that family planning prevented 272,000 maternal deaths in just one year. However, the contraceptive options that exist today don’t always meet the needs of women in developing countries. New vaginal rings are being developed that will be long-lasting and easy for the user to insert and remove without a doctor’s assistance, while new multipurpose prevention technologies combine the delivery of contraceptives with microbicides which reduce the transmission of HIV and other sexually transmitted infections. USAID provides funding towards the development of many of these new contraceptive technologies. While tremendous progress has been made in decreasing maternal and child deaths worldwide thanks in part to new health innovations, each year 6.6 million children still die before their first birthday and 289,000 women still die from pregnancy-related causes. That translates to 18,000 children under the age of five and 800 pregnant women or women in childbirth dying every single day. The United States can and must do more. While the United States should increase access to proven and existing drugs, vaccines, and other health tools for maternal and child health, it is just as critical to develop the next generation of tools to prevent and treat existing and emerging diseases. Sustained and continued investment by the US government in global health R&D is critical to ending maternal and child deaths.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Last week, the Center for Strategic and International Studies hosted a panel on the occasion of the release of its summary report, Strategic US Leadership—Essential to Address the Global Tuberculosis Pandemic, which examines US approaches to tackling tuberculosis (TB) both in the United States and abroad. The report concludes that the United States needs to better lead, coordinate, and prioritize its TB efforts, as well as create robust, long-term research partnerships with key institutions in select emerging economies to promote the discovery and development of new TB tools. GHTC member PATH has been awarded a three-year, US$15.6 million grant from the Bill & Melinda Gates Foundation to develop effective treatments for severe acute secretory diarrhea (ASD). The new grant will support a portfolio approach to drug development in an effort to maximize the chances of successful drug candidates to treat ASD, as well as support new engagement with the public and private sectors. Last week, the US House of Representatives introduced the End Neglected Tropical Diseases Act in an effort to turn the tide in the fight against neglected tropical diseases. The bill was introduced by Rep. Chris Smith (R-NJ) and already has bipartisan support from Reps. Matt Salmon (R-AZ), Hank Johnson (D-GA), and Greg Meeks (D-NY).   Osman Sankoh, executive director of INDEPTH, emphasized the important role of research and innovation for development in low- and middle-income countries (LMICs) in The Lancet Global Health Blog. Sankoh writes that “stronger international commitment to investing in research, development, and innovation in LMICs” is crucial in the post-2015 development agenda. He added that “research into health threats not only saves lives—it also helps governments and donors to save money.” Scientists at Imperial College London have created genetically-modified mosquitoes that produce 95 percent male offspring with the goal of helping control malaria. They believe introducing these mosquitoes into the normal mosquito population could lead to a shortage of females and a crash in overall population, thus reducing malaria incidences. GHTC member Aeras has released a new film exploring the TB crisis in the mines of South Africa. The film—called Undermined—looks at “the river of TB flowing out from the mines, and why a vaccine is critical to the global fight against this disease.”

In this guest post, Renate Baehr—executive director of Deutsche Stiftung Weltbevoelkerung—writes about the next rendition of the European & Developing Countries Clinical Trials Partnership (EDCTP) and how its expansion will impact more lives in low- and middle-income countries. April 2014 was an important month for European support for global health research and development (R&D). Already the world’s leading contributor of development assistance (as measured by Official Development Assistance), and at the forefront of R&D in the health and pharmaceutical sectors, the European Union (EU) has agreed to significantly increase its budgetary support for global health R&D to tackle poverty-related and neglected diseases. Last month, the European Parliament and EU Member States reached an agreement on the successor to EDCTP —imaginatively entitled—EDCTP2. The EDCTP was established in 2003 and is a partnership of 16 European countries—among which 14 are members of the EU—and 48 sub-Saharan African countries, funded through the EU’s multiannual R&D budget, Horizon 2020. Its original objective when founded was to address the critical need for new and innovative medical products to prevent, diagnose, and treat HIV and AIDS, malaria, and tuberculosis (TB). Following its successful first cycle, both the scope and the budget of EDCTP have now been expanded. With a budget of €683 million, EDCTP2 will spearhead collaborative efforts to support the clinical development of new or improved diagnostics, drugs, vaccines, and microbicides against HIV and AIDS, TB, and malaria. The scope of EDCTP will also expand to include neglected tropical diseases (NTDs) prevalent in sub-Saharan Africa (excluding Chagas disease). Additionally, at a meeting in The Hague at the beginning of this month, the program welcomed eight African countries to join EDCTP. This is the first time in the program’s history that African countries will formally participate, a move which will for the first time enable their full participation in the EDCTP’s governance and decision-making structures through the EDCTP General Assembly. Why is this important? Because poverty-related neglected diseases—namely HIV and AIDS, malaria, TB, and the 17 NTDs listed by the World Health Organization here—affect more than one billion people across the globe. To respond to this challenge, EDCTP2 is directed towards supporting and developing much-needed, affordable, innovative, and quality health products to prevent, diagnose, and treat neglected infectious diseases. Not only is it targeted at having new products developed for market release by the end of the program, but in order to ensure that the successes of the program are sustained, EDCTP2 will also focus on increasing transnational research and developing research capacities in sub-Saharan Africa where they are needed on the ground. Breakthroughs achieved by EDCTP2 over the next 10-years have the potential to transform the lives of millions of people living with the devastating effects of TB, HIV and AIDS, and malaria. Global health R&D can have a direct impact on the health of people living in low- and middle-income countries, lifting a burden of diseases that stifles economic growth and prevents young men and women from reaching their full potential, socially and economically. EDCTP2 is one contribution to ending this, and we call on EU Member States to take this example and follow suit by ramping up their own funding for innovative ways to fight these diseases and advance global health. We look forward with interest as to how it will progress in the coming years. For more information on our work and what we are doing on global health R&D, check out our blog!