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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 House Appropriations Committee easily approved the State and Foreign Operations Subcommittee’s (SFOPS) appropriations bill. Both chambers have also released their accompanying reports which provide policy language that gives further clarity on the policymakers’ thinking and intent. The US Food and Drug Administration (FDA) has released a guidance to assist sponsors in drug development for the treatment and prevention of neglected tropical diseases (NTDs) for low- and middle-income countries. The guidance is intended to represented the FDA’s current thinking regarding drug development for NTDs, including clinical trial designs and internal review standards to support approval of drugs. UK Prime Minister David Cameron has called for a global action plan to effectively treat drug-resistant superbugs. Prime Minister Cameron appointed ex-Goldman Sachs Chief Economist Jim O’Neill to lead the analysis on the issue and identify why few new antibiotics are being developed. The O’Neill Commission will also develop a plan for “encouraging and accelerating antibiotic development,” as well as explore incentive mechanisms for drug makers to produce antibiotics even if they are rarely used. Global Health Council (GHC) Executive Director Christine Sow recently wrote about the top ten trends shaping today’s global health outlook. Sow—who was made executive director of the GHC last November—went on a “listening tour” over the last three months to get a better sense of the global health community’s priorities and needs. The All-Party Parliamentary Group on global tuberculosis (TB) in the United Kingdom has released a new report on research and development for global health. The report seeks to explain why diseases that kill so many are neglected in research efforts, and provides a wide range of views and ideas on how to solve the problem.

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.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Last week, US policymakers and global health advocates came together to talk about progress made on preventing maternal and child deaths. The US Agency for International Development (USAID) hosted 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. The National Institutes of Health has awarded Boston Medical Center $861,000 to train Ugandans basic research for tuberculosis and emerging diseases. Boston Medical Center is one of five institutions to receive similar funding to enhance infectious disease research in low- and middle-income countries. Sabin Vaccine Institute’s Peter Hotez writes in the Huffington Post about the latest developments in hookworm vaccine development and the efforts of HOOKVAC—a global consortium uniting academic, medical, and research partners to find a vaccine to prevent neglected tropical disease hookworm, which currently more than 400 million people suffer from. ASPIRE—one of two late-stage clinical trials for a microbicide to protect women from HIV—has completed enrollment of trial participants, with 2,629 women from 15 trial sites in Malawi, South Africa, Uganda, and Zimbabwe. Now that enrollment is complete, we could potentially find out results from this pivotal trial by late 2015, early 2016. GHTC member Jhpiego has been awarded the US government’s largest project to end preventable maternal and child deaths. The Maternal and Child Survival Program, a 5-year, $500 million agreement supported by the USAID, will accelerate the rapid expansion of innovative, high-impact health approaches in 24 priority countries in order to save the lives of every woman and child in need. At an event last week launching the Pediatric HIV Treatment Initiative, panelists discussed the need for “the right medicines for pediatric HIV”—including the need for simplified treatments, and developing, producing, and distributing these medicines to children in low- and middle-income countries.

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.