Breakthroughs Blog: State Department

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. On Friday, February 15, President Trump signed into law a spending bill covering funding for State & Foreign Operations (SFOPs) for fiscal year (FY) 2019. The bill provides US$8.8 billion to the overall Global Health Programs account at the State Department and US Agency for International Development (USAID), which is a $150 million increase from the FY18 enacted level and $2.1 billion above the President’s FY19 request. Funding for all global health programs at the State Department and USAID either increased or remained flat compared to the FY18 enacted level and were also well above the President’s budget request. The World Health Organization (WHO) is working to contain an unprecedented outbreak of Lassa fever in West Africa, which has killed 59 people in recent weeks. This Ebola-like virus is transmitted to humans via exposure to contaminated rate urine and droppings, as well as from person-to-person. Although Lassa fever is endemic in parts of West Africa with outbreaks occurring yearly, health officials have confirmed at least 275 cases in Nigeria—the epicenter of the outbreak—since the beginning of the year. WHO has expressed concern regarding the high number of cases so early in the Lassa fever season, which is due to last another four months. Controlling Lassa fever is a challenge because its symptoms can be vague, such as headaches and chest pain, making the disease difficult to diagnose, and there is no licensed vaccine yet available. To contain the current outbreak, WHO is forming a regional coordination mechanism to share, process, and evaluate information regarding suspected cases and is also intensifying public awareness efforts about how to deter rats. In experimental studies conducted in mice, an antibiotic drug called AN12855 was shown to be more effective against tuberculosis (TB) than isoniazid, one of the standard treatments available. The new drug demonstrated both a much lower tendency to develop resistance, and it remained in the tissues where the bacteria that causes TB resides for longer, thus killing the bacteria more effectively. Further studies are required to determine if these outcomes will translate to improvements in treatments for humans. Current treatment for TB can range from six months to more than a year; thus, researchers are working to develop new drug regimens that shorten and simplify treatment.

On February 5, President Trump delivered his second State of the Union address. Among the long list of policy proposals and pledges in the speech was one of great interest to the global health research community—an announcement of a new whole-of-government plan to eliminate HIV transmission in the United States by 2030. Though just a few sentences long, this announcement hinted at a much-anticipated budget increase for HIV and AIDS efforts and linked the feasibility of this goal to “scientific breakthroughs”—many driven directly by US government investments in research for new tools to diagnose, treat, and prevent HIV and AIDS. As the President put it, “In recent years we have made remarkable progress in the fight against HIV and AIDS. Scientific breakthroughs have brought a once-distant dream within reach. My budget will ask Democrats and Republicans to make the needed commitment to eliminate the HIV epidemic in the United States within 10 years. We have made incredible strides. Incredible. Together, we will defeat AIDS in America. And beyond.”Though the announcement and the associated plan released shortly thereafter by the Department of Health and Human Services (HHS) is squarely focused on eliminating HIV transmission within the US, the wording of the statement and a subsequent editorial published in the Journal of the American Medical Association penned by key agency officials both connect to international efforts and reference advances in HIV research and product development supported by the US government.At this moment of excitement—a “once-in-a-generation opportunity,” as Alex Azar, HHS Secretary, put it in the release of the plan—it is worth noting how our “chance to end the HIV epidemic for the next generation” is based on decades of patient, bipartisan commitment by the US government to advancing our understanding of HIV and AIDS and our ability to diagnose, treat, and prevent it through the development of cutting-edge tools.As the AIDS crisis was growing in the 1980s, NIH research led to the development of the first screening tests to detect the virus in the blood supply and the first antiretroviral treatment, AZT. Later, NIH research led to strategies to prevent maternal-to-child transmission, improved combination therapies, and the discovery that antiretroviral therapies could be used to prevent and treat the disease—research that was foundational to the development of pre-exposure prophylaxis (PrEP). CDC research has expanded our understanding of the epidemiology of the disease, improved prevention and treatment programs, and supported the development of a novel diagnostic that can, for the first time, identify whether an infection is recent or longstanding to improve contact tracing.While many don’t associate the Defense Department with health research, the US Military HIV Research Program has been on the forefront of the battle against HIV to both protect US troops and reduce the global impact of the disease. The program supported a large-scale HIV and AIDS vaccine trial in Thailand that was the first to show that a safe and effective HIV vaccine is possible and continues to advance HIV vaccine research. The US Agency for International Development (USAID), in addition to funding the implementation of the President’s Emergency Plan for AIDS Relief (PEPFAR) programs in nearly 100 countries, has also supported HIV vaccine research, as well as the development of microbicides to reduce transmission among women—including a microbicide-based vaginal ring. The US Food and Drug Administration has also played a crucial role in ensuring the availability of HIV treatment and prevention tools for those in need globally. The agency operates a program to facilitate the “tentative approval” of antiretroviral drugs for purchase by PEFPAR programs and recently launched a pilot program with the World Health Organization (WHO) to expedite the review of HIV drug applications through WHO’s prequalification program.The progress we have achieved through sustained whole-of-government investment in HIV research is astounding, but a need for new and improved HIV and AIDS prevention and treatment tools, including a vaccine, remains. As President Trump said, we can end the HIV epidemic—through both the scale-up of existing interventions and continued investment in the development of new tools. Even a cursory glance at the history of HIV and AIDS shows that every new product developed for treatment or prevention has both increased our ambition to end the epidemic and fundamentally altered our approach. We cannot know for certain that the tools we have in hand today are the most effective we will ever have, so our continued commitment to discover the next game-changer must ramp up in tandem with our efforts to expand access to existing interventions.While the President’s pledge to end HIV and AIDS in the US and his acknowledgement of the importance of scientific breakthroughs is encouraging, his past actions have failed to match this rhetoric. In 2017 and 2018, the administration proposed the elimination of HIV and AIDS vaccine and microbicides funding at USAID and deep cuts to NIH and CDC programs that fund HIV research. As the President prepares to release his fiscal year 2020 budget request, we hope it will include the resources necessary to realize the goals of this welcome pledge, including strong funding for the programs which develop and deliver the tools needed to end AIDS domestically and globally. This is an area of historically bipartisan consensus that offers a rare but important chance at this moment of divided government for Congress and the administration to work together to achieve a bold vision: defeating AIDS in America—and beyond.

Last Friday, President Donald Trump signed into law a US$1.3 trillion spending bill to fund the US government through the rest of fiscal year (FY) 2018. Reluctantly signed by the President among a flurry of “will he, won’t he” tweets, the legislation represents a forceful rebuke by Congress of the Administration’s proposal to drastically slash funding for global health and medical research programs. Key US agencies and programs that advance global health research and development (R&D) not only saw their funding protected in the spending bill, but many also saw increases. This outcome demonstrates that our community’s appeals and messages have not fallen on deaf ears and that Congressional policymakers on both sides of the aisle want to see the United States continue its leadership in advancing innovation to improve the health of those in need around the world. Here are some of the key takeaways from the 2,000+-page bill: US Agency for International Development & State Department While the Trump Administration proposed slashing funding for global health programs at the US Agency for International Development (USAID) and the State Department by 25 percent, Congress stood firm in protecting these programs. The bill ultimately sustained overall funding for these programs at FY17 enacted levels. A few programs received increases including a boost of $15 million for GAVI, the Vaccine Alliance; $20 million for tuberculosis (TB); and $15 million for maternal and child health. Funding for USAID HIV and AIDS programming and family planning at State and USAID, which the President proposed eliminating fully, was protected at FY17 levels. Congress also directed $135 million from repurposed Ebola emergency supplemental funding to support USAID’s global health security programs.   USAID plays a leading role in developing health technologies for low-resource settings through its various global health programs, so it is critical that these programs receive adequate funding, so they can continue to prioritize R&D among their other activities. In light of the President’s proposal for deep cuts to these programs, a combination of level funding for some programs and increases for others is a positive sign in the midst of a challenging budget environment. National Institutes of Health   Strong bipartisan support for the National Institutes of Health (NIH) continued for FY18. While the President proposed a 21 percent cut to NIH funding, the final spending bill instead provided the agency with an increase of $3 billion—8.8 percent—over FY17 levels. This represents a historic funding high for NIH in actual dollars with increases spread across various NIH institutes and programs. Notably, the National Institute of Allergy and Infectious Diseases received a 7.2 percent increase—39 percent above the President’s FY17 request—while the Fogarty International Center, which was targeted by the Administration for elimination, received a boost of 5.2 percent compared to FY17.   NIH is the world’s leading funder of R&D for neglected diseases, providing approximately 40 percent of total global funding, so any changes to its funding produce a ripple effect felt by global health research institutes and people around the world. It is encouraging to see Congress continue its record of bipartisan support for NIH and take action to strengthen our nation’s leadership in medical research. Centers for Disease Control and Prevention   The US Centers for Disease Control and Prevention (CDC) also received a plus up in the FY18 omnibus. The agency saw its funding increased by $1.1 billion—nearly 15 percent—over FY17 levels. This was in sharp contrast to the 16 percent cuts proposed by the Administration. The CDC Center for Global Health (CGH) received a 12 percent increase, compared to a 21 percent proposed cut. This included a $1.5 million boost for parasitic disease and malaria and a substantial increase of $50 million for global health security programming, which supports implementation of the Global Health Security Agenda (GHSA). Funding for global immunization and AIDS programming within CGH remained level. The National Center for Emerging and Zoonotic Infectious Diseases also received a more modest 5 percent increase over FY17 funding.   CDC plays a critical role in advancing technologies and improving health systems to better detect, prevent, and respond to infectious disease threats worldwide. There was much concern surrounding the FY18 budget for CDC as the agency is facing a funding cliff. CDC and USAID received $1 billion from the Ebola emergency supplement to fund GHSA, but this money is set to run out in 2019. As a result, the agency has already announced plans to scale back its GHSA work in 39 of 49 countries. While more funding is still needed to sustain these programs, and the agency has yet to clarify how it will adjust programming in light of its FY18 appropriations; it is promising to see Congressional appropriators recognize the value of CDC’s engagement in improving global health security. Biomedical Advanced Research and Development Authority   The Biomedical Advanced Research and Development Authority (BARDA), which develops medical countermeasures against health threats including emerging infectious diseases and antimicrobial resistance (AMR), also received a boost in the FY18 spending bill. The agency saw its funding increased by $25 million—about 5 percent—over FY17 levels.   BARDA has played an increasing role in R&D for naturally occurring threats and emerging infectious diseases in response to the Ebola and Zika epidemics. With its focus on bridging the “valley of death” in product development and its ability to use unique contracting mechanisms to forge innovative and long-term private-sector partnerships, BARDA is well positioned to make an impact in this space. However, the agency has been constrained by a lack of dedicated funding for its emerging infectious disease portfolio. While it is promising to see appropriators increase the agency’s overall funding for FY18, GHTC will be pushing for more dedicated funding for emerging infectious diseases in FY19. Department of Defense   The Department of Defense’s (DoD) activities in infectious disease research also saw increases in the omnibus. DoD’s Peer Reviewed Medical Research Program—a program that conducts research on AMR, diarrheal diseases, emerging infectious diseases, malaria, TB, and vaccine development for infectious diseases—received $330 million in funding, which is an increase of $30 million over FY17 levels.   The FY18 spending bill is a big win for global health R&D stakeholders and advocates, but this victory may only be temporary. The legislation funds the government through the end of September, and the Trump Administration has once against proposed drastic cuts to global health and medical-research programs for FY19. So while the ink dries on this year’s spending bill and we take a moment to celebrate, GHTC is already gearing up for another difficult battle ahead on next year’s budget.

  2018 is shaping up to be another important year for US policy related to global health and medical research. As Congress returns for a busy work session and the White House continues to roll out policy reforms, here are the top five issues GHTC will be following in 2018: 1. US funding for global health R&D President Trump’s fiscal year 2018 (FY18) budget proposal called for dramatic cuts to global health, medical research, and public health accounts across the National Institutes of Health, US Centers for Disease Control and Prevention, US Agency for International Development (USAID), and the Department of State. While legislators pushed back sharply on these proposed cuts, Congress has not yet passed final FY18 spending bills. This means that we still do not have a final picture of what US government funding for global health and medical research will look like for this year. As Congress tries to navigate budget caps and other pressures that may constrain overall government spending, GHTC will continue to advocate for strong, stable public funding for critical global health and medical research programs. We’re also looking ahead to the fiscal year 2019 (FY19) budget and appropriations process, and bracing for a proposal from President Trump that may include even more significant spending cuts than those proposed in FY18. Despite verbal acknowledgement from the Trump Administration that US global health and medical research programs remain critically important, as the Administration continues plans to streamline government activities and reign-in spending, we do not expect to see prioritization of these issues reflected in Administration-driven spending proposals. GHTC will closely monitor FY19 proposals in the coming months and continue to engage with Congress, who ultimately sets government spending levels. 2. USAID and State Department reorganization As part of the Trump Administration’s plans to streamline and reshape the federal government, it has announced plans to reorganize the State Department and USAID. USAID plays an important role in global health research and development (R&D), supporting late-stage clinical research and implementation research as well as operating Grand Challenges to identify and advance promising health innovations from around the world. USAID and the State Department submitted reorganization plans to the White House Office of Management and Budget on September 15, 2017, but details of those plans have not yet been made public and further information remains scarce. GHTC will continue to monitor evolving plans and policy and strongly advocate for continued leadership of USAID in global health innovation. 3. BARDA reauthorization The Pandemic and All-Hazards Preparedness Act (PAHPA), which authorizes the Biomedical Advanced Research and Development Authority (BARDA), is due for reauthorization this year by Congress. In recent years, BARDA has played an increasingly important role in the advanced development of medical countermeasures for emerging infectious diseases, like Ebola and Zika, and antimicrobial resistance. Reauthorization presents a potential opportunity to bolster BARDA’s role in the global health R&D space. GHTC will monitor the PAHPA reauthorization process and work with Congress to support a strengthened role for BARDA in the emerging infectious disease space. 4. Global health security GHTC is also watching US efforts to promote global health security, including continued support for the Global Health Security Agenda (GHSA)—an international partnership launched in 2014 to help countries strengthen their ability to respond to health threats. The United States is now funding GHSA through the one-time emergency Ebola supplemental funding, which expires in FY19, so future financing for the program remains uncertain. Without renewed commitment and financial support for global health security activities, the United States will have to pull back critical disease detection, prevention, and response operations around the world. GHTC will also work to include R&D in global health security policy decision-making. During the two most recent global disease epidemics, Ebola and Zika, a lack of proactive, sustainable funding for R&D meant that United States and the world did not have the drugs, diagnostics, and other tools needed to contain these diseases. Despite this, GHSA in its current form lacks any prioritization or commitment to R&D to detect, prevent, and respond to global epidemics. As domestic and global discussions on global health security continue, GHTC will advocate for R&D as a critical component of epidemic preparedness and response. 5. US engagement with key multilateral bodies Multilateral organizations and partnerships are vital mechanisms to help advance a healthier and more secure world. In our modern and increasingly globalized world, new, emerging, or long-standing health challenges, which do not respect borders, cannot be tackled by individual countries alone. Strong US leadership and funding for organizations like the United Nations (UN), the World Health Organization, and the Global Fund to Fight AIDS, Tuberculosis and Malaria are key to advancing global health and ensuring that these organizations function effectively in support of US priorities. Despite several senior Trump Administration officials expressing support for strong multilateral engagement, the United States’ role in pushing for a recent $285 million cut to the UN’s overall budget appears more indicative of how the United States can be expected to engage in the near future. While it is currently unclear exactly how these cuts will be implemented across the various UN health-related programs, GHTC anticipates significant impact on the various UN technical agencies’ ability to support global health, including R&D. GHTC is committed to leading strong, coordinated action to advance US leadership in global health R&D in 2018 and beyond. The United States has long been a leader in global health, development, and medical research, and we look forward to sustaining and bolstering this legacy in the years ahead.