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  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 guest post, S. Patrick Kachur, MD, MPH, FACPM—chief of the Malaria Branch in the Division of Parasitic Diseases and Malaria at the Center for Disease Control and Prevention’s (CDC) 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 about the emerging global security threat of anti-malaria drug resistance and CDC’s efforts to prevent, detect, and respond to this growing threat. Emerging resistance to antimalarial drugs is of growing concern to the CDC. Photo: CDC Malaria starts with a small bite from a mosquito and can quickly turn into a life threatening illness. The President’s Malaria Initiative (PMI), Global Fund to Fight AIDS, Tuberculosis, and Malaria, and other global efforts have made remarkable progress to help control malaria, saving an estimated 3.3 million lives since 2000 according to the World Health Organization’s (WHO) 2013 World Malaria Report. Key interventions that contributed to this success include insecticide treated bed nets (ITNs), indoor residual spraying (IRS), rapid diagnosis and treatment with artemisinin-containing combination therapies (ACTs), and intermittent preventative treatment during pregnancy (IPTp). However, to sustain momentum and move toward elimination of malaria, new tools and technologies will be required. While ITNs remain a highly effective tool and should continue to be used, we must acknowledge that ITNs are not perfect given the challenges of adequate coverage, personal use, durability, daytime biting, and insecticide resistance. Of additional concern, there is evidence in Southeast Asia that the malaria parasite may be developing resistance to artemisinin drugs—the last remaining class of antimalarial drugs and the basis for treatment around the world. Reasons for this resistance are multifactorial, including poor treatment practices, inadequate patient adherence to treatment, and widespread availability of monotherapies, counterfeits, and substandard forms of the drug. Given the mobility of human populations, this resistance could easily spread. We have witnessed the spread of resistance to antimalarial drugs (chloroquine) before, beginning in Southeast Asia and then quickly spreading globally; it would be a devastating setback for child survival and a threat to global health security if artemisinin drug resistance followed this same pattern and reached Africa, where most malaria occurs. Understanding this resistance phenomenon, containing its current focus of transmission, and remaining vigilant for resistance in other parts of the world align well with the Global Health Security Agenda to prevent, detect, and respond to potential threats. Prevent Limiting inappropriate use of antimalarial drugs is important to preventing resistance. New rapid diagnostic tests help. Photo: PATH/Gena Morgan One way to actively prevent or mitigate resistance is to limit the inappropriate use of antimalarial drugs. For generations, health workers and consumers used malaria drugs without confirming the diagnosis of malaria. In the last decade, new rapid diagnostic tests made it possible to detect the parasites before giving treatment. Used consistently, this approach could reduce the unnecessary use of antimalarial drugs and improve the detection and treatment of other illnesses. Another approach to prevent drug resistance relies on identifying and removing counterfeit and substandard antimalarials from the market. These medications, similar to substandard doses of antibiotics, can contribute to increased resistance. The US government—CDC, the Food and Drug Administration, the US Agency for International Development, and PMI—are using novel technologies to easily detect counterfeit and substandard drugs with the touch of a button, outside of a specially equipped laboratory. Additional efforts will be needed to ensure these medications are removed from the market. Another way to help prevent resistance from worsening is to ensure a wide spectrum of tools exist to prevent and control malaria, especially where drug-resistant parasites are present. CDC, as part of PMI, is working with partners to develop and evaluate newer interventions and approaches such as durable wall linings or spatial repellants to aid in mosquito control, and promising vaccines which have been shown to reduce the number of malaria cases in vaccinated children and young infants. Detect Enhanced surveillance is critical to track how, where, and how fast the resistance is spreading. Through PMI, the US government supports and provides financial and technical assistance to countries for antimalarial drug resistance monitoring. Furthermore, rapid and accurate detection of resistant malaria parasites are critical for the prevention, treatment, and containment or elimination of infections, and will drive reduction of unnecessary antimicrobial use. As part of its efforts to monitor malaria domestically, CDC is working to characterize the drug resistance profile of malaria infections diagnosed in the U.S. This provides an early warning of spreading resistance and helps to monitor the situation more accurately. The use of genetic sequencing can also help quickly determine when a person is infected with drug resistant malaria parasites, so that clinicians can provide the best treatment. This information also guides CDC’s recommendation for medications taken for malaria prevention for people traveling to an area where resistance is detected. Respond Containment efforts are underway in all areas with suspected or confirmed artemisinin resistance in affected countries. PMI supports containment of artemisinin-resistant malaria in the Greater Mekong sub-region in Southeast Asia. In higher transmission areas, efforts focus on limiting the risk of spread by lowering the malaria burden through intensified malaria control, by increasing access to diagnosis and appropriate treatment, and by scaling up provision of health care services to migrant and mobile populations. In addition to containment efforts, CDC and partners actively contribute to global policy discussions on antimalarial drug resistance, helping provide recommendations for action that are based on the best available data. The ability to respond quickly and accurately also requires building global capacity and developing a cadre of trained and experienced staff. The call under the Global Health Security Agenda is to create and strengthen real-time networks of information systems to detect outbreaks and up-to-date rapid diagnostic tests enabling in-country laboratories to conduct at least five of 10 core tests for high-risk and high-priority diseases—malaria being one of them. The public health investments made through the Global Health Security Agenda will not just benefit a few target diseases. Instead, the increased capacity to prevent, detect, and respond through current and newly developed evidence based interventions, improved surveillance systems, accurate real-time rapid diagnostic testing, and an available cadre of trained people will benefit all known and emerging infectious disease threats, including resistant malaria parasites.

Last week, we reported on exciting policy language included in the Senate Department of Defense appropriations legislation, and earlier this summer, the House and Senate State and Foreign Operations bills also included recognition of the role that new technologies could play in advancing global health. Today we have even more good news to report: The Senate Appropriations Labor and Health and Human Services (LHHS) Subcommittee released its own fiscal year (FY) 2015 appropriations legislation, after a lengthy internal debate on domestic health concerns. Senate supports global health R&D in LHHS appropriations bill. Photo: NIAID Senate calls for increase in NIH funding; still lags behind need The legislation covers funding and policy issues for several key global health research programs at the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Office of Global Affairs at the Department of Health and Human Services (HHS). At GHTC we’ve voiced concern that funding for NIH has lagged behind both inflation and the research program needs of the agency. Last week, we learned that the Senate LHHS appropriations subcommittee has appropriated $30.6 billion for NIH—which represents an increase of $606 million over FY 2014. This is a welcome increase; however, as the subcommittee noted in its report introduction, NIH’s funding is still unacceptably low, even with this improvement. Report language supports global health programming at NIH Within NIH, several key research centers were funded at reasonable levels, including the National Center for Advancing Translational Sciences (NCATS) and the National Institute for Allergy and Infectious Disease. The committee expressed its support for continued funding for neglected tropical diseases (NTDs), microbicides, and antibiotic research, as well as government-wide research collaboration, among other priorities. In an exciting move, the committee also included NCATS report language requesting that NCATS include a report in its FY 2016 budget justification “on initiatives targeted at neglected diseases and global health conditions, with specific focus on global health technologies and devices.” Global health is an essential part of NCATS’s mandate, and this language will ensure that it is prioritized within the program. CDC global health programming receives increased funding in bill The legislation also provides strong support for research at the CDC’s global health programs. Under the bill, the National Center for Emerging Zoonotic and Infectious Diseases (NCEZID) would receive an increase over FY 2014 funding levels. In addition, the subcommittee’s report mentions the Chikungunya outbreak in the Caribbean and the United States and encourages coordination between NCEZID and the CDC’s Center for Global Health on global health security efforts. Speaking of the Center for Global Health, this program received a rare increase in the Senate bill over even the President’s FY 2015 budget request. This is likely a result of support for the new Global Health Security Agenda. Most notable was the inclusion of a new line item in the Center’s budget for “Global Health Protection.” The bill also included positive language on CDC’s work on malaria and NTDs and provided continued funding for the National Public Health Institutes—an epidemiology and research capacity-building program in select countries. House LHHS bill has not been released; continuing resolution likely The House Appropriations LHHS Subcommittee has not released a bill for FY 2015 and may not do so at all. As it looks more likely that a continuing resolution will be necessary to continue uninterrupted government funding for NIH, HHS, and CDC global health R&D programs, Congress should work to come to an agreement that robustly supports funding and smart policy improvements for these programs. Ashley Bennett is GHTC’s policy officer.