Breakthroughs Blog: Maternal health

On February 15, President Trump signed into law a bipartisan spending bill—averting another partial government shutdown and ensuring full-year funding for the government for the remainder of fiscal year (FY) 2019. The move followed several days of speculation about whether discord between Congress and the President on funding for a border wall would imperil the spending measure passed by Congress to fund the remaining one-quarter of the federal government.The months-long saga ended with some great news for global health and research and development (R&D)—a roughly US$150 million funding increase for global health programs in the State and Foreign Operations (SFOPs) bill, as well as a significant boost to the Food and Drug Administration (FDA) under the Agriculture bill included in the package.The bill included some welcome increases to global health accounts which have been flat-funded for five years running, including a $50 million (1.16 percent) increase to the President’s Emergency Plan for AIDS Relief (PEPFAR) and a $2.5 million (2.5 percent) increase to the US Agency for International Development’s (USAID) Neglected Tropical Disease Program compared to FY 2018. Nutrition saw a $20 million (16 percent) increase and Maternal and Child Health got a $5.5 million (0.66 percent) boost. But perhaps the most notable win in the bill was a long-sought increase to USAID’s tuberculosis (TB) program. After TB was in the spotlight at the United Nations High-Level Meeting on TB in September, the United States backed up its pledge of additional support for the global fight against TB by including a $41 million (15.71 percent) increase to the program in the final spending package for FY 2019—the largest increase to the program in more than five years. All other global health accounts were level-funded compared to FY 2018, resulting in an overall increase of 3.23 percent for USAID Global Health—a stark difference from the 36 percent cut proposed in the President’s budget.While most accounts of relevance to global health R&D within the Department of Health and Human Services were funded for the entire fiscal year in a spending package passed in September, the FDA was one agency whose funding was still in limbo. The FDA’s unique funding structure—divided between budget authority, or discretionary funding (appropriated by Congress), and fees (paid by FDA users) —shielded the agency from some of the worst impacts of the partial government shutdown in December and January as it drew down on user fees to continue most operations. But the final FY 2019 funding package included a welcome $460 million (9 percent) increase for the agency, including a $269 million (9 percent) increase in budget authority.As the FY 2019 appropriations process lurched across the finish line, advocates were already gearing up for another budget battle for FY 2020. Check back for regular updates as appropriations hearings begin and GHTC continues monitoring the prospects for global health R&D accounts in the coming year.  For reference, the text of the Conference Report to accompany H.J. Res. 31, the Consolidated Appropriations Act, 2019, is available here, the text of the Joint Explanatory Statement is here (with the Global Health Program breakdown on page 454 of the PDF), and a division-by-division summary is available here.

For many mothers and babies around the world, the first 48 hours after birth are the most dangerous of their lives. For eight years, Saving Lives at Birth—spearheaded by USAID—has challenged problem solvers worldwide to create innovative solutions to make birth safer and save lives. Here are ten incredible innovations from this initiative: Many newborns struggle to breathe. While in developed countries, doctors use CPAP machines, these devices are too costly for most health facilities in low-resource nations. Fortunately, innovators at Rice University have developed a low-cost solution—the Pumani bCPAP. Delivering comparable treatment at 1/15th the cost, the Pumani has tripled the survival rate of babies with respiratory distress.   Blood pressure (BP) disorders like pre-eclampsia are a leading cause of maternal death. BP cuffs have been used to monitor BP since the early 1900s, but they can be hard to maintain and read by less-skilled health workers. A startup named Biospectal is reinventing this approach. It has developed the OptiBP, a cuff-less smartphone app that allows instant, accurate BP monitoring through a fingertip.   Affecting 60% of newborns, jaundice can cause brain damage or death if left untreated. In low-resource nations, doctors often don’t have access to costly lab equipment needed to diagnose the disorder. That’s where the BiliSpec comes in. Developed by Rice University, this handheld, battery-powered device can diagnose jaundice within two minutes using just a $0.05 paper strip and a drop of blood.   Even a small dip in a newborn’s temperature can put her life at risk. Continuous temperature monitoring is key to detecting issues early, but in overcrowded health facilitates, it can be hours between readings. To address this gap, Rice University developed the Neonatal Temperature Monitor—a simple, affordable tool to continuously monitor and display infant temperature, alerting staff of problems.   Malaria during pregnancy is dangerous for both mothers and their unborn babies. Researchers are studying whether a promising new malaria vaccine candidate—Sanaria’s PfSPZ vaccine—could offer a solution. The research team will test the vaccine in pregnant women and monitor the mothers and newborns post-birth. If successful, the project could radically change malaria management in pregnant women.   Poor water and sanitation in low-resource health facilities can expose moms and babies to infection at birth. Chlorine is a commonly used disinfectant, but supply chain issues make it hard for facilities to ensure a steady supply. PATH and MSR Global Health created an innovative, low-cost tool—the SafiStation Chlorine Generator—to produce chlorine on site using just water, salt, and electricity.     While stillbirths are common in poor regions, increasing evidence suggests that non-breathing newborns are often misidentified as stillborn when they have heart rates (HR) and could survive with resuscitation. To address this gap in care, researchers developed the NeoBeat, a low-cost, belt-like device that takes seconds to put on a baby and provides a continuous digital display of newborn HR.   Jaundice is common among newborns. Fortunately, if found and treated early it is also curable. To facilitate diagnosis and treatment in low-resource areas, innovators developed the Bilikit, a comprehensive package of low-cost tools to manage jaundice. The kit includes the Bilistick, a rapid, hand-held, portable diagnostic device, and the Bili-Hut, a portable, high-intensity phototherapy device.   Blood donation shortages in Africa can leave health workers with few options if a woman is hemorrhaging blood during childbirth. Attendants often resort to using a soup ladle and gauze to try to salvage and recycle a patient’s own blood. The Hemafuse pump by Sisu Global Health is a cost-effective, hygienic alternative. This tool sucks up blood, filters it, and transfers it to a bag for reuse.   Over 100,000 women die annually from postpartum hemorrhage (PPH) or excessive bleeding. PPH is treatable, but the tools widely used to control dosage are too costly or infrastructure intensive for low-income nations. That’s a problem Shift Labs hopes to solve with DripAssist—a low-cost, battery-powered tool that constantly monitors medicine flow via an IV drip, sounding an alarm if it fluctuates.   View as a video below: Photo credits: PATH/Doune Porter; Pumani bCPAP: 3rd Stone Design, GHTC; OptiBP: GHTC: Bilispec: Rice University, 3rd Stone Design; Neonatal Temperature Monitor: GHTC; PfSPZ vaccine: Leiden University Medical Center, GHTC; Safistation: PATH/Adam Drolet; Neobeat: Laerdal; Bilikit: GHTC, Bilimetrix srl Trieste, USAID, Little Sparrow Technologies; Hemafuse: Sisu Global Health; DripAssit: Medgadget, GHTC

There is no doubt that the past decade has brought transformative breakthroughs in global health innovation, from new medicines, to combatting leading child killers like malaria and tuberculosis (TB), to interventions that are making an AIDS-free generation possible. These game changers have saved millions of lives and helped unlock better health and opportunity for people around the world. The Global Health Technologies Coalition (GHTC) spent this past decade standing side-by-side in partnership with scientists and innovators, working to ensure they have the resources and supportive policies needed to advance innovation that truly drives impact. As we close out our tenth anniversary year and mark our first decade of advocacy, we wanted to take a moment to reflect on our shared progress and celebrate the headlines and moments that shaped global health research and development (R&D) over the past decade. Here are ten highlights: Could pills taken daily prevent HIV infection? That was a key question on researchers and activists minds in the early 2000s.By the end of the decade, the evidence pointed to yes. In 2012, the US Food and Drug Administration (FDA) approved the use of the antiretroviral drug Truvada as pre-exposure prophylaxis (PrEP) to prevent HIV infection. While it took several more years for PrEP to begin to be approved and introduced in low- and middle-income countries (LMICs), it has proved a powerful new tool in the global fight against HIV and AIDS. Revolutionary. Simple. Empowering. These are words that have been used to describe Sayana Press, an all-in-one injectable contraceptive developed by GHTC member PATH. Sayana Press combines a long-acting contraceptive with the easy-to-use Uniject injection system that involves minimal training, making it an especially suitable tool for low-resource settings and for women to self-administer. Since its introduction in 2014, more than 1 million doses of Sayana Press have been delivered to women worldwide, giving them greater power and autonomy over their reproductive health. Despite the fact that over 70 percent of all malaria deaths are children, before 2009 there was not a single high-quality malaria drug designed for kids. Instead, parents would crush adult tablets in what amounted to a daily struggle to provide an accurate dose as well as convince their kids to swallow these bitter tasting pills. This changed with the introduction of Coartem Dispersible, the first malaria medicine designed for children. Developed by GHTC member Medicines for Malaria Ventures, the medicine is affordable, easy-to-administer, sweet-tasting, and dosed for children. As of 2016, over 300 million treatments have been distributed worldwide, saving an estimated 750,000 lives. For more than a century, meningitis has ravaged a swath of the African continent known as the “meningitis belt,” killing one in ten people it sickened. But thanks to the efforts of a coalition of partners, including GHTC member PATH, we’ve stopped deadly meningitis A epidemics in their tracks. In 2010, MenAfriVac—a low-cost vaccine against mengingitis A—was introduced in Africa. Since then, more than 270 million people in 26 countries have been vaccinated, and thankfully, meningitis A is becoming a disease of the past. HIV and AIDS remains one of the greatest threats to women’s health globally, yet women and girls still lack the range of tools they need to protect themselves. Thanks to over a decade of effort by a unique partnership led by GHTC member the International Partnership for Microbicides, the future looks different. The partnership has advanced a new woman-center HIV prevention tool: a monthly, vaginal microbicide ring that deliver antiretroviral drugs. The groundbreaking new tool was found to reduce HIV risk in women in late-stage clinical trials in 2016, and it is now under regulatory review and poised for potential introduction worldwide. For parents with kids suffering from TB, getting their child to take multiple pills a day for months was a serious struggle, from trying to split up pills, to achieving the right dosage, to convincing children to swallow bitter tasting medicine. In 2016, this process became easier with the introduction of the first kid-friendly TB drugs. Developed by GHTC member TB Alliance, the drugs are appropriately dosed for children, dissolvable in water, and fruit-flavored to appeal to children. Already close to 80 countries, have adopted this improved treatment, with 700,000 courses ordered. Malaria has plagued humanity for tens of thousands of years. Fortunately, this past decade has brought a number of new and improved tools and approaches to tackle this age-old scourge, including the world’s first approved malaria vaccine, Mosquirix. In 2017, the World Health Organization announced plans to pilot the vaccine—developed by GHTC member PATH—in sub-Saharan Africa. While developing a high-efficacy vaccine against malaria has proved challenging due to the parasite’s complexity, Mosquirix, which reduced the rate of infection in children by 39 percent in clinical trials, is an important scientific breakthrough, and health officials hope it will prove a valuable addition in fighting malaria used alongside existing interventions. In 2014, the world’s deadliest Ebola outbreak caught the global community unaware and unprepared, devastating nations in Western Africa. While health workers went to work in the field to contain the immediate crisis, scientists went to work in their labs to develop a vaccine to prevent future epidemics. Thanks to research on Ebola vaccines that had been undertaken in the early 2000s, researchers were able to accelerate the leading Ebola vaccine candidate—RVSV-ZEBOV—from preclinical testing to phase III trials in less than two years. In 2016, it was announced that the vaccine was found nearly 100 percent effective in these trials. The vaccine could be approved by the FDA as early as 2019. More than two billion people worldwide suffer from hidden hunger—a condition characterized by deficiencies in micronutrients such as zinc, iron, and Vitamin A, which can cause stunted growth, blindness, and learning disabilities. In the 1990s, a young economist Howarth Bouis had a kernel of an idea: What if we could create better crops to provide better nutrition? His answer was biofortification, a process of naturally breeding sustenance crops so they are rich in micronutrients. After years of proof of concept research, in 2009, the nonprofit he founded—GHTC member HarvestPlus—introduced its first wave of crops in LMICs, providing nutrient-rich food for people in need. For decades, diagnosing multi-drug resistant TB (MDR-B) meant using older testing methods that took weeks to deliver results and required expensive laboratory equipment. In 2010, this began to change with the introduction of the Xpert MTB/RIF test, an automated diagnostic test developed by GHTC member FIND, which does not require microscopes or a laboratory, involves very little training to operate, and can deliver results in less than two hours, start to finish. FIND and partners will soon introduce a next-generation version—the Genexpert Omni—that is smaller, more portable, and battery-operated, which should further expand access to improved TB diagnosis. View a slideshow of more moments and milestones in global health R&D over the past decade. Here’s to ten more years of progress! At GHTC, we are proud to work with so many believers, innovators, and changemakers who are driving progress in global health. As we embark on 2018 and beyond, we recommit to continuing this momentum and look forward to another decade of advancing innovation to save lives.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past we. A quick and inexpensive test may make it easier to diagnose and distinguish betweenZika and dengue. Both viruses produce the same NS1 protein, making it is impossible for current NS1 protein-based diagnostic tests to discern between the two. To overcome this problem, scientists developed a set of antibodies produced from immune cells that can distinguish between an NS1 protein produced by the Zika virus and an NS1 protein produced by the dengue virus. In a study, the diagnostic test was able to discern between the two viruses, even when there was a lowNS1 protein count in the body. While further studies are required, this tool could become an essential diagnostic tool in areas of the world where both Zika and dengue are endemic. A series of papers exploring the impact of group B streptococcus (GBS) was published in Clinical Infectious Diseases. GBS is an infection a mother can pass to her fetus that can cause septicemia, meningitis, and even death. The papers argue that there are 410,000 cases of GBS every year with 147,000 associated stillbirths and infant deaths. There is also a major disparity of GBS cases between developed and developing countries: Many at-risk women in developed countries receive prophylactic antibiotics during labor, but those resources are often not available to women in developing countries. Scientists believe the solution to this problem is a GBS-specific vaccine, which could save over 100,000 infant lives.This vaccine may be critically important as scientists believe “immunizing expecting mothers is a potentially groundbreaking approach that could dramatically reduce the number of maternal and child deaths.”There is currently no GBS vaccine available, but there are candidates in development. The US Environmental Protection Agency approved the release of lab-reared “killer mosquitoes” to help reduce the population of disease-carrying mosquitoes in certain American states. A biotechnology start-up based in Kentucky—MosquitoMate—will rear these mosquitoes with a lethal bacterium that impedes reproduction and release the infected males into the wild. When the infected males mate with wild females, the offspring will not be viable due to malformed chromosomes. Over time, disease-carrying mosquito populations will dwindle. Other countries, including Brazil, have tried this method and found it successful, suggesting this could be a solution for countries severely affected by mosquito-borne illnesses. This method is also a “non-chemical way of dealing with mosquitoes,” so offers an alternative to pesticide-based vector control.