Breakthroughs Blog: NIH

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. During the past year, leaders from the US Global Leadership Coalition (USGLC)—an advocacy organization promoting diplomacy and development—have traveled across America seeking out innovators and innovations that best demonstrate how strategic US investments in global development can enhance America’s foreign policy and security interests—an approach USGLC calls “smart power” diplomacy. USGLC’s report—Innovations in Smart Power—featured PATH’s Vaccine Vial Monitor and the Public Health Institute’s Global Health Fellows Program II. Dr. Francis Collins—director of the National Institutes of Health (NIH)—announced on the NIH Director’s blog that NIH will, through its various institutes and centers, begin piloting the idea of awarding longer grants that offer more sustained support for investigators in the hopes it will allow them greater freedom to innovate. Currently, most NIH-funded grants are “project-based”—meaning applicants have very clear research aims for what they will accomplish in a defined period of time, typically between 3-5 years. Policy Cures released a report—titled Tuberculosis: The Last Mile—which explains why current treatments to tuberculosis (TB) control aren’t working; provides a snapshot of the major funders in TB research and development (R&D); and outlines what new products are in the TB pipeline, and how these products could change the future for patients with TB. Last month, the Bill & Melinda Gates Foundation awarded exploratory grants—as part of its Grand Challenges in Global Health program—to three projects aimed on improving the design of the female condom to make it easier to use and more pleasurable. Currently, female condoms represent only a small part of the overall commercial market and are not as widely used as a prevention tool by the global health community. “Female condoms give women a choice to say: ‘Okay, if you don’t want to wear one, I will,’” said Debby Herbenick, one of the grant recipients. GHTC members AVAC and the International AIDS Vaccine Initiative, as part of the HIV Vaccines & Microbicides Resource Tracking Working Group, released a new report tracking funding for HIV prevention R&D in 2013. The report found funding was down by US$ 50 million—or four percent—when compared to 2012. The 2013 decrease can be attributed largely to diminished US investment in all areas of HIV prevention research, as well as significantly reduced investment in some European countries.

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.

As the DC summer kicks into full swing, Congress has had a busy month moving forward fiscal year (FY) 2015 funding legislation for a variety of government programs including global health research and development (R&D). Global health R&D at USAID: Yesterday, both the House and Senate State and Foreign Operations (SFOPs) appropriations subcommittees held mark-ups of their draft bills. The House draft provides only topline spending numbers, with the addition of family planning/reproductive health, polio, the President’s Emergency Plan for AIDS Relief (PEPFAR), and the Global Fund funding levels. The House funded the overall account above the White House request, but below what was appropriated in FY 2014. Including the State Department and the US Agency for International Development (USAID) numbers, funding was $132 million below the numbers Congress appropriated in FY 2014, but a welcome $257 million more than what the White House had requested. For a quick comparison of numbers, check out the Kaiser Family Foundation’s SFOPs policy analysis. The other accounts called out in the House bill were $59 million for polio (the same as FY 2014, but 18 percent higher than the President’s request) and family planning at $461 million. Funding for family planning was a significant but not unexpected cut from both the FY 2014 number (24 percent cut) and the White House request (28 percent cut). As the full House appropriations committee has not yet marked up the bill (and it’s not clear that they will), details on the contents of the bill report’s priorities and other policy riders are not yet known. We do know the House bill reinstates the Mexico City Policy—which prevents nongovernmental organizations who receive federal dollars from promoting abortion services as part of family planning­—or prohibits any funding to the United Nations Population Fund (UNFPA). The full committee may take the bill up for consideration sometime next week. The Senate summary provides considerably more specific account figures for global health than the House bill. The Senate bill flat-funds the Global Fund and PEPFAR compared with FY 2014 and is even with the White House request—it’s interesting to note that for this overall account, the House bill appears to provide a higher funding level, even though we don’t yet know the exact funding distribution. Most other accounts were funded at levels either matching or slightly above FY 2014 funding. One exception is the tuberculosis (TB) account, which faces an $11 million cut from FY 2014 levels, although it is not as dire as the proposed White House funding level, which would have cut an additional $23 million. There is better news to be found for family planning and reproductive health, neglected tropical diseases, polio, and vaccine access. There’s no explicit word in either the House or Senate bills regarding the overall Maternal and Child Health account. NIH, CDC, and FDA Last week the Senate held its Labor, Health, and Human Services (LHHS) subcommittee mark-up and released a summary of their draft bill. A full Senate committee mark-up has yet to be scheduled, and the House has yet to move forward with its own draft bill. This account remains one of the most contentious, both because of ongoing efforts to alter the health care reform programs and because of a Senate plan to use the Overseas Contingency Operations account as a complicated and likely unsustainable mechanism to boost up funding for domestic priorities. The committee requested $30.459 billion for the National Institutes of Health (NIH), an increase to both the White House and FY 2014 levels by $324.0 million and $605.7 million, respectively, but still far less than the $32 billion needed. Global health programs within both NIH and the Centers for Disease Control and Prevention (CDC) also did quite well in the Senate bill—the CDC’s Centers for Global Health and Emerging Zoonotic and Infectious Diseases, the NIH’s National Institute of Allergies and Infectious Diseases (NIAID), and the Fogarty International Centers were nearly all funded at levels above both FY 2014 and the White House request. Both the House and Senate have also marked-up their legislation to fund the Food and Drug Administration (FDA). The House bill funds the FDA at $2.583 billion (this number represents budget authority and does not include user fees), which is a $23 million increase over FY 2014 and is about level with the White House request. The Senate bill funds the FDA at $2.588 billion, an increase of $36 million over FY 2014. The Senate is taking up this bill as part of a “minibus” along with the bills from the Commerce, Justice, and Science subcommittee, the Transportation subcommittee, and the Housing and Urban Development subcommittees. The Senate version of the bill also included some interesting report language around FDA’s international leadership to combat threats to global health and the global drug supply chain.  Defense The House Appropriations Committee approved their FY 2015 bill which essentially flat funds Department of Defense (DoD) R&D—which includes all research at DoD, not just neglected disease R&D—from FY 2014 levels. The American Association for the Advancement of Science provides a helpful summary of R&D funding within the draft bill which can be found here. The Senate Appropriations Committee has yet to mark-up a bill. In both the House and Senate, we see policymakers diverging from the priorities emphasized by the White House in its original budget request: there is little mention of any implementation of the infamous Opportunity, Growth, and Security account suggestions for global health or health research, although the Senate Appropriations Committee has developed its own plan for handling the declining budget caps while still supporting accounts they view as important to US health research programs. While the progress we’ve seen so far is commendable, Congress must speed its efforts to enact smart, evidence-based appropriations for global health R&D programs and their overarching accounts. As the end of the current fiscal year looms closer, policymakers must work together to avoid the stalemate that caused the government shutdown of the fall of 2013 and should support strong funding levels for global health R&D.