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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.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. In a bit of good news, the fiscal year (FY) 2015 defense appropriations bill—which was approved by the Appropriations Committee last Thursday—includes a $7 million increase for peer-reviewed medical research—from $200 million in FY 2014 to $207 million this year—despite a reduction in overall Department of Defense (DoD) funding from FY 2014 levels. In addition, in the accompanying report, the Appropriations Committee included very strong language recognizing DoD’s substantial contributions to global health research and development (R&D) and the need to support sustained US investments in this area. FHI 360 sat down with International Partnership for Microbicides CEO Zeda Rosenberg to discuss last week’s 20th International AIDS Conference. In this short video, Rosenberg highlights the need to focus on key populations—such as young women in sub-Saharan Africa—and the importance of women-initiated products like microbicides as a HIV prevention tool. Nearly 40 years after the discovery of the Ebola virus, no licensed treatments or prevention options are currently available. With the largest outbreak ever of the virus currently underway in West Africa, some are arguing that scientists should begin to develop new drugs and vaccines to combat this deadly disease. According to CNN, it’s likely too late for a vaccine to have enough of a preventative impact now, but using this time to test experimental vaccines—such as one developed by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health—could help when Ebola emerges again in the future. Last week, the United Nation (UN) General Assembly’s Open Working Group on Sustainable Development Goals released its proposal for a set of goals to succeed the UN Millennium Development Goals which come to an end in 2015. These proposed goals—referred to as the Sustainable Development Goals—will define the post-2015 development agenda. Of the 17 proposed goals put forward by the group, two contain targets related to R&D of new health technologies. Chagas disease—a neglected tropical disease (NTD) transmitted from the kissing bug and affecting millions of people in Latin America—is now on the rise in northern Virginia. Some doctors in the United States are not familiar with the disease and therefore do not test their patients regularly, which poses a risk to the general population in the United States. Many of the 8 million people with Chagas disease around the world never show signs of the disease, but about a third develop heart disease or megacolon and—when untreated—appear to die from sudden heart attacks. Chagas disease is just one example of NTDs affecting more and more people in the United States.

  Senate supports global health R&D in defense appropriations bill and report. Photo: Ken Kistler Earlier this month, we reported that both the House and Senate Appropriations Committees included language supporting global health research and development (R&D) in their reports concerning funding for the Department of State, foreign operations and related programs. Last week, we heard even more good news for global health R&D out of the Senate Appropriations Committee—this time related to the Department of Defense (DoD). The fiscal year (FY) 2015 defense appropriations bill—which was approved by the Committee last Thursday—includes a $7 million increase for peer-reviewed medical research—from $200 million in FY 2014 to $207 million this year—despite reducing overall DoD funding from FY 2014 levels. In addition, in the accompanying report, the Appropriations Committee includes very strong language recognizing DoD’s substantial contributions to global health R&D and the need to support sustained US investments in this area. The committee report includes language submitted by GHTC recognizing “the critical contribution that the department’s [R&D] portfolio makes in protecting our troops from infectious and neglected diseases they may encounter on missions around the world” and noting “the need to sustain and support US investment in this area by fully funding those R&D programs that carry out this work.” Committee recognizes role of infectious disease research in improving US security The committee report also recognizes the threat that neglected infectious diseases—such as malaria, dengue fever, and Chikungunya—pose to the effectiveness of US forces deployed overseas and expresses concern over reductions in research funding for these disease areas. In the report, the committee notes that it is “concerned with the department’s decisions over recent years to precipitously decrease funding for malaria research” and that it “encourages the department to address diseases of military importance and invest in research for chemoprophylaxis, surveillance, and other countermeasures.” Photo: PATH/Gabe Bienczycki Report calls for DoD to improve coordination across R&D programming The committee report also includes language—submitted by GHTC—which directs each DoD program involved in infectious disease research to submit a report of its R&D activities to the House and Senate Defense Committees outlining the program’s funding and accomplishments from FY 2011 through 2014. As well, the committee urges DoD to partner with other organizations involved in infectious diseases research—including other federal agencies—to mitigate the duplication of research efforts and maximize the use of DoD resources. It is GHTC’s hope that these reports and activities will lead to improved coordination across DoD global health R&D programs, as well as improved coordination across all US agencies involved in global health R&D, which will in turn help fill current gaps in research programming and assure US investments are used most effectively. GHTC is glad to see the Senate recognizing DoD’s critical role in global health R&D, as well as advocating for sustained funding and improved coordination for global health R&D programming at DoD. We are hopeful that the language included in the Senate defense appropriations report will be included in whatever final legislation is passed.