Breakthroughs Blog: PEPFAR

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.

From the development of new drugs for malaria and tuberculosis to the mapping of debilitating but preventable diseases, research and development (R&D) can be a catalytic force for scaling up impact. Many of USAID’s [US Agency for International Development] global health successes in preventing child and maternal deaths, controlling the HIV and AIDS epidemic, and combating infectious diseases can be partially attributed to breakthrough research and development that altered the course of an illness or accelerated diagnostics and treatment through breakthrough innovation and ingenuity. This year’s report to Congress coincides with our new five-year strategy, which focuses on three interrelated goals. Our first goal is to accelerate the development, introduction, scale-up, and sustained use of new technologies, health tools, and approaches; secondly, we want to influence the adoption of priority life-saving health and development interventions; and finally, we want to strengthen the capacity of people, systems, and partnerships to conduct research and utilize results to improve health outcomes.Photo caption and credits: A lab technician in Rwanda. Riccardo Gangale for USAID/ Courtesy of Photoshare  Although R&D can take years to come to fruition, when it does, it can save lives and be a total game changer. Take malaria for instance. One of the most notable areas of R&D investments for USAID is the development of new vaccines, medicines, and insecticides for malaria prevention and control, as well as research to improve malaria programs. Many lives have been saved since the launch of the U.S. President’s Malaria Initiative (PMI) in 2005, but continued success depends on strategic R&D investments.Last year, the sustained efforts of many partners paid off and led to the development of three new classes of malaria drugs, including the drug Tafenoquine which, if approved, could be the first new medicine to treat relapsing malaria in more than 60 years. In Cambodia, research on the safety and tolerability of single, low-dose Primaquine, a drug used for reducing malaria transmission, has been recommended for adoption in areas moving toward malaria elimination.Another health challenge with the potential for high returns on investment in terms of R&D is multidrug-resistant tuberculosis (MDR-TB). USAID knows from experience that this is a very complex and expensive disease to treat because of its severity and long-term treatment plan, which is why the agency has been supporting several clinical studies evaluating the efficacy of shorter drug regimens.For treatment that can last for as long as two years, medicine adherence has been a huge challenge in combating MDR-TB. Shorter and simpler to administer regimens may help increase adherence and acceptability, while decreasing side-effects and transmission. Interim results from STREAM Stage-1, one of the USAID-supported studies of shorter MDR-TB regimens, have potential to inform global guidelines and improve the lives of millions of people.Along with high-quality research, USAID has continued to invest in ground-breaking tools and innovations that have been deployed in countries around the world. These cost-effective tools have not only saved lives, but millions of taxpayers’ dollars. They have also contributed to strengthening our national security by enabling countries to mitigate impact and contain the spread of infectious diseases.During the 2015-2016 Zika outbreak in Central and Latin America, for instance, USAID supported 26 innovations to combat Zika and future threats through the Combating Zika and Future Threats Grand Challenge. Innovations range from mosquitoes infected with Wolbachia, a naturally-occurring bacteria that prevents the transmission of diseases to humans, to a disease surveillance digital platform that could protect vulnerable communities from becoming hot spots not only for Zika but also for malaria, dengue, chikungunya, and other infectious diseases, including currently known and unknown threats.School students in Paris, Colombia participate in growing and releasing their own Wolbachia mosquitoes as part of a science project. Photo Credit: World Mosquito Program Colombia.The Grand Challenges enable us to adopt an open-source model that empowers more people from all walks of life to offer solutions to global health problems. Research and partnerships spur innovation, which in turn harnesses the ingenuity and expertise of an increasingly diverse global development community. USAID facilitates this process and opens the door for new ideas. Supporting innovative research approaches in disease mapping is another way for USAID to maximize global health impact. Knowing where diseases are most prevalent can shed light on their root causes, strengthen programs and more effectively target interventions.Lymphatic filariasis or LF, for instance, is a parasitic disease spread by mosquitoes and one of seven neglected tropical diseases that USAID prioritizes. Last year, USAID supported the expanded roll-out of a new survey protocol to assess the LF in low prevalence settings. In Ethiopia, the study mapped the disease in 45 districts, and results showed that only three of them warranted treatment. This finding saved millions of dollars that may have otherwise been spent to provide treatment in areas where the disease was not endemic. The World Health Organization has endorsed the new survey protocol to be used in other areas of uncertain disease prevalence, including Vietnam and Cameroon.These handful of tools and research projects are only a small fraction of the global health R&D portfolio that USAID has supported around the world. Despite the fact that USAID investments in health R&D are often working behind the scenes, their contribution to saving and improving lives is significant. These types of strategic investments continue to change the way communities think about what is possible in disease prevention and health promotion. You can download a copy of USAID’s latest global health-related R&D report here.This blog originally appeared on USAID’s website and has been cross-posted to Breakthoughs with USAID’s permission.  

On Tuesday, the Trump Administration released its full fiscal year 2018 (FY18) budget proposal, “A New Foundation for American Greatness.” As foretold by the “skinny budget” proposal released in March, this budget proposes dramatic increases in defense spending and border security, offset by cuts to discretionary spending—including significant cuts to programs that support global health and medical research at the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the US Agency for International Development (USAID). Dramatic cuts to global health programs at the State Department & USAID At a high-level, President Trump proposed roughly a 25 percent cut to global health programs at the State Department and USAID, when compared to final fiscal year 2017 (FY17) funding levels. Looking just at USAID global health programs, funding levels were reduced over 50 percent from FY17 levels, from US$3.05 billion to $1.5 billion. The Administration also used the budget proposal to advance goals of streamlining USAID and State Department operations to find cost savings and efficiencies. Despite strong bipartisan support for the United States’ flagship global HIV and AIDS program, the President’s Emergency Plan for AIDS Relief (PEPFAR), HIV and AIDS programs across State and USAID were targeted for cuts and consolidation. Direct funding for PEPFAR through the State Department received a $477 million cut, dropping to $3.85 billion from $4.32 billion, and USAID funding for complementary HIV and AIDS programs was zeroed—reflecting a funding cut of $330 million. The zeroing of HIV and AIDS programs at USAID also means associated research and development (R&D) funding for HIV vaccines and microbicides was eliminated. Man and woman standing in front of a sign that reads "USAID." (PATH/Felix Masi)Other funding cuts include a $62 million cut to global tuberculosis (TB) programs—including cuts to the TB drug facility and multidrug-resistant TB financing—a $65 million cut to maternal and child health programs, a $47 million cut to nutrition programs, and a $25 million cut to programs for neglected tropical diseases. USAID malaria programs (the President’s Malaria Initiative) received an $81 million cut, after factoring in a proposed $250 million transfer of remaining Ebola funds. USAID family planning programs were eliminated.Slashed funding for medical research at NIH and public health protection at CDC Biomedical research also saw significant cuts, with a proposed $7 billion or 21 percent cut to NIH. Of particular importance to global health R&D, the Administration proposed a $1.1 billion cut to the National Institute for Allergy and Infectious Diseases—which leads research in infectious diseases like HIV and AIDS, Ebola, and Zika—and elimination of the $70 million Fogarty International Center, which builds partnerships and trains researchers around the world. Instead, the Administration allocated $25 million to the Office of the NIH Director to coordinate global health research. At the CDC—our lead agency for preventing, detecting, and responding to public health threats at home and abroad—overall budgets were cut by $1.3 billion, over 15 percent. This included a $70 million cut to CDC’s National Center for Emerging and Zoonotic Infectious Diseases and an $85 million cut to the Center for Global Health.What happens next for global health R&D?These broad and wide-ranging cuts proposed for global health and medical research programs are deeply concerning, and threaten to reverse gains achieved through our landmark global health programs, stall progress in promising research, and ultimately jeopardize lives at home and abroad. They also are in stark contrast to stated goals of the Trump Administration to honor our commitments to global health, bolster global health security, and support high-priority biomedical science.Fortunately, Congress has ultimate control over government spending, and leadership on both sides of the aisle has asserted that dramatic cuts to foreign aid, global health, and medical research will not pass muster. As FY18 negotiations continue in Congress, GHTC will continue to stress the importance of global health R&D programs across the US government and highlight the critical role US-supported research plays in saving lives at home and around the world.

Office of Management and BudgetLast Thursday, the Trump Administration released an outline of its budget proposal for fiscal year (FY) 2018, proposing dramatic cuts to US agencies involved in global health research and development (R&D) including the State Department (State) and US Agency for International Development (USAID) and the Department of Health and Human Services (HHS), including the National Institutes of Health (NIH). If enacted, these cuts would have significant impact on programs that advance global health innovation and protect the world and Americans from global disease threats. As an introduction to the Trump Administration’s budget priorities, this short and “skinny” budget outline lays out only high-level issues and proposes spending levels for top-line accounts. A more detailed funding proposal is expected in May that will include funding levels for individual agencies and programs. Still, while short on detail, the proposal is clear on targets for proposed reductions: the budget calls for nearly a one-third reduction in funding to State and USAID (cuts of $10.1 billion) and an 18 percent reduction in overall funding for HHS (cuts of $15.1 billion). Within HHS, a one-fifth reduction in funding (cuts of $5.8 billion) is proposed for NIH. The only US agency involved in global health R&D to receive a proposed increase in funding is the Department of Defense (DoD)—which is proposed to receive a 9 percent ($54 billion) boost. It remains unclear whether any of this increased funding would be directed to medical and infectious disease research. Reading between the lines, the President’s “skinny” budget foretells a challenging funding climate for global health R&D at State, USAID, and HHS: State Department and US Agency for International DevelopmentFunding for State and USAID was among the hardest hit in the President’s proposed budget. The blueprint calls for a 28 percent cut to State and USAID base funding, which grows to 30 percent when reductions to overseas contingency funds are included. USAID is a critical component of the US government’s support for global health R&D: In 2015, USAID provided nearly US$80 million in funding to support global health R&D. Cuts to USAID funding could stall promising innovations under development and halt efforts to roll out new technologies in USAID programs. While the President’s proposal does express support for US global health initiatives including the President’s Emergency Plan for AIDS Relief (PEFPAR); the Global Fund for AIDS, Tuberculosis and Malaria; Gavi, the Vaccine Alliance; and US malaria programs; the level of support proposed for these programs remains unclear. Language in the blueprint does not indicate if these programs would continue robust or expanded activities, or indicate whether these programs would be supported at current funding levels. It is also important to note that not all global health programs were called out in the budget, leaving uncertainties about how critical programs supporting maternal and child health, nutrition, tuberculosis, and neglected tropical diseases will be prioritized by the Administration. The budget also articulates a dramatic overall shift in America’s approach to diplomacy and development assistance with specific proposals calling for consolidation of State and USAID activities, linking aid and assistance to strategic interests, and reducing funding for the United Nations and affiliated agencies. It will be important to continue to monitor the impact of these proposals. Department of Health and Human Services The Administration’s budget proposes an 18 percent reduction to HHS funding across the board—cuts that if enacted would bring HHS to its lowest level of funding in nearly two decades. This would significantly reduce funding for HHS agencies engaged in global health R&D, including NIH, the US Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Biomedical Advanced Research and Development Authority. Not only would cuts of this level have real impact on ongoing and future research needs, they could also undermine America’s leadership in global health R&D and diminish our ability to prevent, detect, and respond to emerging health threats. A full picture of the President’s proposal for HHS is not yet available, but limited details follow below: National Institutes of Health The President’s budget proposes a 19 percent cut to the NIH budget. NIH leads the world in financial support and technical expertise for global health R&D—so cuts of this magnitude would have a detrimental and lasting global impact on ongoing and future research projects. The budget also proposes a reorganization of NIH Institutes and Centers and calls for the elimination of the Fogarty International Center. Fogarty plays an important role in global health R&D. Its programs build partnerships between US and international researchers and strengthen the capacity of scientists in low-income countries to address critical global threats like HIV and AIDS, Ebola, and other emerging infectious diseases. Calls to eliminate this center are concerning. Cutting the Fogarty Center—a small center with a $70 million budget—would save little in the overall federal budget, while increasing our vulnerability to global disease threats. The President’s blueprint also calls for a “rebalance” of federal contributions to NIH research funding, which warrants careful consideration and further monitoring. If NIH research priorities are shifted to align only with disease burden in the United States—as is sometimes proposed—important research on neglected diseases and conditions will be jeopardized, ceding US leadership in this arena and potentially leaving Americans more vulnerable to infectious and emerging disease threats. Centers for Disease Control and Prevention and health preparedness The President’s budget proposal does not include overall funding levels for CDC, nor does it call out specific CDC programs for support or reductions. However, given the magnitude of cuts in the overall HHS budget, it is clear CDC funding is also at risk. The only CDC mention in the blueprint is a proposal to shift $500 million in CDC funding to block grants to be administered by the states. While details on this proposal are scarce, it’s likely these funds would be repurposed from within CDC’s budget, rather than represent new funding. CDC leads the United States’ public health defense system against infectious diseases, so robust funding for the agency is a global health and national security imperative. The agency plays a unique and important role in global health R&D by developing new tools and techniques for disease surveillance, training researchers and health workers overseas, and developing new health tools to advance disease detection, prevention, and response efforts. The budget also proposes the creation of a new Federal Emergency Respond Fund to enable rapid response to public health threats like Zika or Ebola. Such a dedicated fund has been championed by many public health leaders, including former CDC Director Tom Frieden. However, in the President’s request, there are few details regarding the fund’s approach or operations. It remains unclear how large the fund would be, whether it would support preventative R&D, or whether funding for the program would come at the expense of current US government emergency response and preparedness initiatives. As the budget proposal also call for reforms to “key public health, emergency preparedness, and prevention programs” under HHS—which could include CDC and other global health security programs—there remains more questions than answers. Food and Drug Administration The FDA also plays an important role in global health R&D by facilitating the review of new global health products to ensure they are safe and effective before entering the market. While the President acknowledged the need to direct more funding to the FDA, the budget blueprint does not propose increased government support for the agency, but rather calls for doubling user fees paid by healthcare companies for the regulatory review of their products—from $1 billion to $2 billion. Noting the constrained budget environment, the proposal says that companies benefiting from FDA approval “can and should pay for their share.” In addition to user fee increases, the Administration also proposes to take new, unspecified actions to speed the development and approval process for drugs and other medical products. Patient advocate groups and the private sector alike have stressed their belief that current review procedures appropriately balance thorough review of safety and efficacy with efforts to expedite products through the review process. Department of Defense The Presidential budget proposes a 9 percent ($54 billion) increase to discretionary funding for DoD. DoD plays a critical role in R&D for infectious diseases; however, the budget blueprint does not address DoD’s medical research activities and provides little information about what increased defense funding may be targeted. Congressional response and next steps The President’s budget proposal is the first official declaration of policy and spending priorities for the Administration and marks the beginning of months of discussions within Congress and the Administration on how best to allocate funds. Congress ultimately controls government spending, and many members on both sides of the aisle have expressed skepticism or criticism about the Administration’s budget blueprint, including its proposed cuts to foreign assistance and medical research. While there are calls in Congress to reduce government spending, and we may see cuts to US agencies engaged in global health R&D, the spending bills passed by Congress will likely look much different than the President’s proposal. GHTC will continue to monitor the FY18 budget and appropriations process and advocate for robust funding for all programs that support global health R&D.