Breakthroughs Blog: HHS

In this guest post, Beth P. Bell—director of the National Center for Emerging and Zoonotic Infectious Diseases—and Tom Kenyon—director of the Center for Disease Control and Prevention’s (CDC) Center for Global Heath—write about a new initiative from the US government to address global health security. The US government’s recent commitment to global health security recognizes that health security is an essential part of every nation’s national security. As both Department of Health and Human Services Secretary Kathleen Sebelius and CDC Director Tom Frieden have said, “A health threat anywhere is a health threat everywhere.” These threats may come from naturally occurring disease outbreaks, the emergence of drug-resistance, or by the intentional or accidental release of dangerous pathogens. They may occur anywhere on the planet at any time. Mitigation of such threats is greatly enhanced when the nations in which they may arise are able to detect them early, respond rapidly, and prevent them from happening again—or better still, from happening in the first place. In February, the United States joined with 28 other countries, the World Health Organization (WHO), and 3 other international organizations to launch the Global Health Security Agenda. At the launch, the United States made a commitment to working with 30 countries over the next 5 years to establish and strengthen their abilities to prevent, detect, and respond to infectious disease threats. In fiscal year (FY) 2014, a group of 12 nations will accelerate engagement in these global health security strengthening partnerships with US agencies. Pending additional resources, more countries will be added in FY 2015 and beyond. Global health security is embodied in a comprehensive set of specific targets to prevent, detect, and respond to infectious disease threats. These objectives are based in part on the WHO’s revised International Health Regulations (IHR (2005)) which established core requirements for monitoring public health threats globally and responding rapidly and effectively to contain them. Although adopted by nearly every nation on earth, fewer than 20 percent of Member States who signed on to the IHR (2005) are in full compliance. One of the major objectives of the US government’s global health security effort is to greatly increase IHR compliance. Partner countries will develop systems, policies, and procedures to prevent or mitigate outbreaks. Prevention priorities include: Monitoring and slowing antimicrobial resistance (AR), the ability of bacterial and viral pathogens to acquire resistance to antimicrobial drugs. Nations should have at least one reference laboratory able to identify—and to report—at least three of the seven WHO priority AR pathogens using standardized detection assays. Practices and policies to prevent animal diseases from spilling over into human populations. Immunization of at least 90 percent of each nation’s 1-year-olds with at least one dose of measles vaccine (or a combination vaccine including measles). Having this capacity means a nation is able to adequately carry out other immunization and health-care efforts. The United States will also work with countries to create and strengthen real-time networks of information systems to detect outbreaks, and up-to-date rapid diagnostic tests to enable their laboratories to conduct at least five of 10 core tests for high-risk and high-priority diseases. Six of these core tests are for diseases that are among the WHO Top 10 Causes of Death in low-income countries: influenza virus, poliovirus, HIV, tuberculosis, malaria, and typhoid fever. The remaining four tests will be selected by the partner country based on national public health concerns. Other priorities will strengthen countries’ abilities to detect global disease threats including: Surveillance for potential public health emergencies. Interconnected electronic reporting systems. Training for doctors, veterinarians, biostaticians, lab scientists, and field epidemiologists. The United States will also assist partner countries to develop skills and build systems to mount effective responses to health threats. These include establishing emergency operation centers (EOCs) with rapid-response teams and linkage to a network of labs that monitor for disease outbreaks. The goal is for an EOC to be able to activate a coordinated response within two hours of detecting a public health emergency. Nobody knows where the next health threat will arise. In a world linked by international travel and commerce, no nation is more than a plane flight away from any other. Global health security is a key element of every country’s national health security. For more information, please visit CDC’s global health security website at http://www.cdc.gov/globalhealth/security/.

In this guest post, Heather Ignatius, senior policy and advocacy officer at PATH, writes about the important role US agencies play in advancing global health technologies. In the field of global health, partnerships are often a primary key to success. The complexities of health, policy, and product development are technically nuanced, but together with the US government, PATH and others are making great advances to adapt, develop, and introduce breakthrough technologies across the health spectrum. To demonstrate how essential US government’s contributions have been—and will continue to be—in improving global health through the development and introduction of lifesaving technologies, we recently released three publications highlighting PATH’s work with the US Agency for International Development (USAID), the US Department of Defense (DoD), and the US Department of Health and Human Services (HHS). These collaborations complement the many other global health product development and introduction efforts spearheaded by other private- and public-sector partners. Together, these contributions to improving global health will not only benefit people in developing countries, but also US military personnel and US citizens traveling abroad. We hope that these examples inspire continued investment by the US government in global health research and development. PATH partners with the US government to develop and adapt innovative global health technologies—including thermostable vaccines, injection devices, and medicines—that safeguard the health of mothers and children, like these in Kenya. Credit: PATH/Evelyn Hockstein. Developing innovative technologies in partnership with USAID For more than 25 years, PATH has worked through the HealthTech program at USAID to identify health needs and then adapt, design, develop, and advance appropriate and affordable health technology solutions. Through the HealthTech program, PATH has invented, designed, developed, or co-developed 85 technologies that are tailored to low-resource settings and can be manufactured locally. Examples include diagnostic tests for infectious diseases, portable scales that help health workers screen newborns for low-birthweight status, the Uniject® injection system, and the SILCS diaphragm. HealthTech technologies are in use throughout the world through partnerships with the World Health Organization, the United Nations Children’s Fund, and commercial collaborators. Adapting and introducing diagnostic technologies for low-resource settings with HHS With funding from the National Institutes of Health, PATH is advancing effective, low-cost, and easy-to-use diagnostic tools that can be used in low-resource settings to identify HIV and AIDS, tuberculosis, malaria, and other diseases. These diagnostics improve people’s chances for a healthy recovery while enabling health care workers to better track outbreaks of diseases. Together, PATH and HHS have also worked to increase the availability, accessibility, and affordability of essential point-of-care diagnostic tests by assessing critical clinical needs, identifying innovative technologies, supporting clinical testing, and creating training programs. Developing new vaccine technologies with DoD In collaboration with the US Naval Medical Research Center (NMRC) and the Walter Reed Army Institute of Research (WRAIR), PATH is developing and testing new approaches for vaccines against enterotoxigenic Escherichia coli and Shigella—two of the leading bacterial causes of diarrheal disease worldwide. PATH, WRAIR, and NMRC are collaborating on preclinical and clinical studies as well as manufacturing activities related to vaccine development. Additionally, PATH is working with NMRC, among other partners, to assess potential markets for low-cost and effective vaccines and to demonstrate the opportunity for industry investment in developing these vaccines. With funding from the Defense Threat Reduction Agency, PATH is developing temperature-stable vaccine formulations to support DoD product development efforts. These thermostable formulations will extend the shelf life of vaccines, making them ideal for storing and allowing them to be safely transported and stored for extended periods of time outside of the “cold chain” of proper refrigeration. Thermostable vaccines are especially important for remote areas of the world where limited or no electricity for temperature control makes it challenging to maintain vaccines’ potency.

In this feature on Breakthroughs, we provide an update on what’s currently happening with global health in Congress and an outlook for future legislative activity. Following the August recess and Labor Day Holiday, Congress is now back for a very brief time before it takes another break to focus intensely on campaigning ahead of the November elections. We don’t expect much action on legislation specific to global health or research programs. Instead, Congress will focus on passing a Continuing Resolution (CR) for fiscal year 2013 in order to keep the government running through the end of March 2013, as members juggle the remaining legislative tasks on their plate. The CR actually includes a tiny 0.6 percent increase across the board for all federal programs, including those that fund global health research. However, the resolution will expire long after the looming budget sequestration goes into effect in January 2013 and will also run into the fiscal year 2014 budget process, effectively creating a budgeting perfect storm. Advocates for a wide range of federal programs are in high gear to convince Congress to delay sequestration or to pass a balanced budget in its place. Some of those advocates have found congressional allies willing to take on their cause. Also this week, we’re looking for a report from the Obama Administration on the potential impact of sequestration on federal agencies. As we outlined in our last update, sequestration could result in cuts ranging from 8.5 percent to 14 percent to most federal programs, depending on the outcome of the budget negotiations in Congress and the November elections. Sequestration would undoubtedly have a significant impact on global health and research programs at agencies like the Centers for Disease Control and Prevention, the Department of Defense, the US Food and Drug Administration, the National Institutes of Health, and the US Agency for International Development. We’re eager to see this report and learn more about how sequestration might impact efforts supported by these agencies to develop new lifesaving global health tools. Global health research and development (R&D) programs span the breadth of the US budget. Congress needs to work to protect these essential R&D programs from disproportionate cuts and ensure that funding is sustained—and increased if possible—for the coming years. Although the elections may be on the top of everyone’s to-do list for now, temporary budget fixes that leave these activities vulnerable to indiscriminate cuts and similar actions will not work forever. We need a plan that protects global health R&D and other key programs for the long-term, and right now, that job starts with Congress.

Last week, HHS released its first-ever global health strategy at an event that convened leaders from several US agencies involved in global health, as well as representatives from non-governmental organizations. Releasing the strategy, which highlights many priorities for global health research and development (R&D), is an important move for HHS, as it encompasses agencies such as the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA), all of which play crucial parts in global health R&D. HHS Secretary Dr. Kathleen Sebelius, who spoke at the event, stated that “we can no longer separate global health from America’s health … our only chance to keep Americans safe is if our systems for preventing, detecting, and containing disease stretch across the globe too.” She also noted that “every day, Americans benefit from efforts in global health, whether they know it or not.” Sebelius emphasized that the HHS global health strategy should not be an extra, isolated add-on to other programs, but must be an extension of HHS domestic programs and its already-existing programs in global health, with the following goals: To focus on areas where HHS can engage globally in work that benefits and improves the health and well-being of Americans. This will include promoting research partnerships that help develop new treatments to support this goal. To provide leadership in areas where HHS has unique technical expertise, “starting with the world’s leading researchers at the NIH, its leading epidemiologists at the CDC, and its leading regulators at the FDA.” To work with other US agencies and the Administration to advance US interests in global health and support the President’s Global Health Initiative. Sebelius' opening remarks were followed by a panel discussion moderated by KFF Executive Vice President Diane Rowland. Panelists included Nils Daulaire, director of the Office of Global Affairs at HHS; Ariel Pablos-Méndez, assistant administrator for Global Health at the US Agency for International Development; Kerri-Ann Jones, assistant secretary of state for Oceans and International Environmental and Scientific Affairs; Helene Gayle, president and CEO of CARE USA; Harvey Fineberg, president of the Institute of Medicine; and Jen Kates, vice president and director of Global Health and HIV Policy at KFF. While Sebelius’ speech emphasized the role of the strategy in meeting the health needs of the American population and US diplomatic goals, the panel discussion did the reverse—it examined how US agencies could be more engaged in global health work, and where they are strategically a best fit. The panel had several insights for the use of the HHS strategy and the future of HHS engagement in global health work abroad, including partnerships with HHS agencies not traditionally known as global health leaders—such the Centers for Medicare and Medicaid Services, which could help to strengthen health system capacity around the world. The new strategy includes many major objectives that seek to spur global health R&D in order to develop new tools and interventions to help improve health and save lives around the world. These objectives include: Preventing infectious diseases and other health threats, including through measures such as vaccine development, boosting manufacturing capacity, and improving vector control. Increasing investments in regulatory science and partnerships worldwide. Strengthening multilateral efforts to promote science-based standards and guidelines for global health. Amplifying research and innovation to promote the development of new tools and approaches to help prevent, diagnose, and control disease. Overall, the strategy represents a great step forward in global health R&D at the HHS agencies, and a recognition of how essential their programs are, both to the US and populations around the world.