Breakthroughs Blog: Maternal health

  Breastfeeding has served as the primary method for a mother to feed her infant since the dawn of humanity, but could it also be a way for her to administer life-saving medicines to her baby? The answer is yes—if a group of researchers from the United States and United Kingdom have their way. The JustMilk nipple shield contains a rapidly dispersible tablet containing drugs or nutrients that are delivered to the infant during breastfeeding. Photo: JustMilk The researchers—who have formed the nonprofit JustMilk—are developing a nipple shield device that allows a breastfeeding mother to administer drugs or nutrients to her infant through her breast milk. The device is easy to use—a mother would simply place the shield—which contains a rapidly dispersible tablet potentially containing antimalarials, antiretrovirals, antibiotics, or micronutrients—on her breast while feeding her child. As the milk passes through the device, it breaks down the tablet and delivers the medicines or nutrients to the infant. The “eureka moment” According to JustMilk’s cofounder Dr. Stephen Gerrard, PhD, the idea for the device emerged out of a design challenge—how to prevent HIV transmission during breastfeeding in developing countries—that his team was issued at the 2008 International Development Design Summit. The team had an idea to create a wearable device that deposits HIV-inactivating compounds into breast milk. After discovering the existence of both potential compounds and a wearable device—a nipple shield—the team realized it was on to something. “The eureka moment was that we could combine the two, and then you have a way of depositing antimicrobial compounds into milk,” said Gerrard. “The second point straight after that was—hang on—this could be a general drug and nutrient delivery device for infants.” Since then, the JustMilk team has focused on the broader potential of the device as a drug or nutrient delivery system. “Over 4.8 million infants under the age of one die each year from conditions like pneumonia, malaria, diarrhea, and HIV,” said Gerrard. “And an overwhelming majority of those conditions can be treated, and the deaths can be avoided by appropriate administration of agents to the infant….We’re trying to tackle those big issues, and we’re looking to make a major impact.” Overcoming the challenges of drug delivery in low-resource settings Gerrard believes JustMilk’s device offers advantages over conventional methods for administering drugs to infants, which often create challenges in low-resource settings. Liquid drug formulations can have a limited shelf life and require refrigeration; while powdered or dry formulations require reconstitution with potable water and can create accurate dosing issues. Gerrard believes a prefilled, disposable version of the JustMilk nipple shield could address many of these challenges, as well as empower a mother by allowing her to personally administrator medicine to her baby in a natural context. A work in progress: Putting users first JustMilk co-founders Geoff Galgon (left) and Dr. Stephen Gerrard, PhD (right) at the Saving Lives at Birth Challenge. Photo: JustMilk JustMilk, which received a grant last year from the Saving Lives at Birth Challenge, is still in the early stages of product development and is currently conducting research to inform the design, marketing, and eventual delivery of the device. In the next two months, JustMilk will begin user acceptability studies with mothers at the University of Venda in South Africa to answer questions like: should the device be disposable or prefilled with medicines, how should it be packaged, and would its use generate stigma for users—and if so—how can that be prevented? JustMilk also plans to conduct a study examining how infants react to intermittent use of the nipple shield to determine if the breastfeeding process is impacted by the infant using the shield once or twice a day. Gerrard sees that these studies are vital to the development process. “You have to have your end user right there from the beginning of the design process,” he said. “You have to get all these things right in the first place; otherwise, if you’re going through the clinical trial approval process and you’ve got something wrong, you’re going to have to go back again.” Gerrard acknowledges that the next six months will be a critical time period for the organization as it seeks to establish the viability of the product, mitigate any risks during its development, and potentially attract the involvement of medical device manufacturers. He explained, “Our goal with this device is to establish feasibility, demonstrate that it can confer a health benefit to infants, and hope the market reacts.” Marissa Chmiola is GHTC’s communications officer. JustMilk received a funding grant in 2013 from the Saving Lives at Birth Challenge—which is supported by the US Agency for International Development, the Bill & Melinda Gates Foundation, the Norwegian Ministry of Foreign Affairs, Grand Challenges Canada, and the UK Department for International Development. JustMilk has also received support from the Clinton Global Initiative, public health charity FHI 360, the University of Cambridge, and the National Collegiate Inventors and Innovators Alliance.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The Senate Appropriations Labor and Health and Human Services (LHHS) Subcommittee released its fiscal year 2015 appropriations legislation, after a lengthy internal debate on domestic health concerns. The legislation is—for the most part—good news for funding levels and policy issues for several key global health research programs at the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), and the Office of Global Affairs at the Department of Health and Human Services. Since its discovery nearly 40 years ago, we have learned a lot about Ebola. Yet there are still no effective treatments or vaccines to protect people against this deadly disease. According to an article in Vox, this is not because of “a lack of human ingenuity or scientific capacity,” but rather due to a global innovation system that does not prioritize the health research needs of world’s poorest populations. Drs. S. Patrick Kachur, MD, MPH, FACPM—chief of the Malaria Branch in the Division of Parasitic Diseases and Malaria at CDC’s Center for Global Health—and Larry Slutsker, MD, MPH—director of the Division of Parasitic Diseases and Malaria at CDC’s Center for Global Health— write in Breakthroughs about the emerging global security threat of anti-malaria drug resistance and CDC’s efforts to prevent, detect, and respond to this growing threat. They write: “…to sustain momentum and move toward elimination of malaria, new tools and technologies will be required.” Despite progress made to prevent maternal and child deaths by the United Nations’ Millennium Development Goals (MDGs), still too many mothers and children are compromised or killed by preventable diseases. PATH President and CEO Steve Davis writes for Devex about the need to take advantage of the progress made thus far by the MDGs and accelerate innovation to meet the health needs of millions of people in low- and middle-income countries. It’s World Breastfeeding Week (August 1-7) and as breastfeeding has served as the primary method for a mother to feed her infant since the dawn of humanity, we wonder if this could be a way for a mother to administer life-saving medicines to her baby? According to a group of researchers in the United States and United Kingdom, the answer is yes. Two recent promising developments in the fight against malaria were announced last week. Malaria is one of the leading killers of women and children in the world, and in sub-Saharan Africa particularly—where 90 percent of the more than 620,000 annual malaria deaths occur—new tools to fight the disease are desperately needed.

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.