Breakthroughs Blog: NIH

In the past, the United States has contributed to important breakthroughs in global health—from the eradication of smallpox to a 74 percent drop in measles deaths worldwide. Because of longstanding US leadership and support for global health research and development (R&D), Americans and millions around the world no longer live in fear of diseases like polio and measles, and many more are on treatment for diseases like HIV and AIDS and malaria. In fact, the US government is the largest supporter of global health R&D in the world, supporting the development and delivery of vaccines, drugs, diagnostics, microbicides, and devices. However, as we sit at a very important moment in global health product development, the political and economic environment in the United States is causing some to worry. Budget constraints have put funding at risk at many of the federal agencies involvement in global health R&D. Because of longstanding US leadership and support for global health research and development (R&D), Americans and millions around the world no longer live in fear of diseases like polio and measles, and many more are on treatment for diseases like HIV and AIDS and malaria. Photo: PATH/Evelyn Hockstein Today, the GHTC launches a new fact sheet outlining the important contributions the US government has made to global health R&D and why it’s critical the United States continues to robustly support the global health research pipeline. There are currently more global health products in the pipeline than ever before—with more than 365 new tools under development as of April 2012. Contributing to the success of many of these products is the US government’s partnerships with nonprofit product developers. These organizations partner with the public and private sectors to maximize resources and create tools for patients in low- and middle-income countries. Increased investments in global health research by the United States have the potential to increase the amount of tools combating global diseases. Just some of the products currently in the research pipeline include: The RTS,S malaria vaccine candidate, which is currently being tested and a policy recommendation for its use could be issued as early as 2015. Such a vaccine could reduce the burden of sickness and death from malaria. A new oral drug for sleeping sickness, fexinidazole, which recently entered late-stage clinical trials in patients in the Democratic Republic of the Congo. As a simple, short-course oral pill, fexinidazole could transform care for African sleeping sickness, which is fatal without treatment, and could potentially reduce its incidence among the most afflicted populations and accelerate elimination of the disease. Cost-effective diagnostics that are under development for malaria, tuberculosis, and neglected tropical diseases. These diagnostics could be administered in a variety of health care settings and could rapidly and accurately identify sick patients. An antiretroviral‐based microbicide which offers hope for women’s HIV prevention. Though more testing is needed following promising results from a 2010 advanced clinical trial, a microbicide could give women the power to protect themselves with or without their partners’ cooperation. In sub-Saharan Africa, where the epidemic has hit hardest, women 15 to 24 years old are at least twice as likely to be infected with HIV as young men.   In the research pipeline for global health products, 200 of the 365 products under development have some sort of US government support. With so much investment from the United States, there is even more at risk if funding is cut. Over the past several years, the US Congress has not been able to agree on a long-term budget for the federal government. Policymakers have allowed sequestration, or widespread automatic budget cuts, to affect all federal programs. These constraints have the potential to push back or halt promising research supported by several federal agencies involved in global health R&D—including the Centers for Disease Control and Prevention, the Department of Defense (DoD), the US Food and Drug Administration, the National Institutes of Health (NIH), and the US Agency for International Development (USAID). Due to sequestration: DoD is expected to receive budget cuts between 8 and 10 percent in fiscal year (FY) 2013. The DoD has been instrumental in the development of several global health technologies, many of which are used to protect Americans soldiers serving abroad. These cuts could affect the Walter Reed Army Institute of Research, the Naval Medical Research Center, and the Military HIV Research Program. NIH, the largest funder of global health R&D in the world, was forced to cut $1.7 billion from its budget by the end of FY 2013. NIH conducts nearly half the early-stage global health research, and supports thousands of domestic jobs all around the United States. USAID—with a presence in more than 100 countries—is best suited to support the clinical trials in low- and middle-income countries that ensure basic research is translated into appropriate health products. USAID is the largest supporter of HIV vaccine and microbicide development—both of which will be essential to achieve an AIDS-free generation. For many of the products currently in the global health research pipeline, continuous US support is essential. Without it, much of the breakthrough research that pushed these products to later-stage development will be lost—sometimes forever. US leaders should seize upon the recent successes in global health R&D and pass a long-term budget that ensures America’s legacy as a leader in innovation and science is not forgotten.

  As we discussed yesterday, lawmakers in the House and Senate have been busy with several pieces of legislation that would fund global health and research efforts across the federal government. Our first post yesterday detailed implications for global health research and development (R&D) activities at the US Department of State and US Agency for International Development. Today, we provide highlights for other key agencies involved in global health R&D. Labor-HHS The Senate Appropriations Committee has approved legislation to fund the Labor, Health, and Human Services (HHS) account, which includes support for the National Institutes of Health (NIH) and the US Centers for Disease Control and Prevention (CDC). Currently, there is no House version of this bill—a hearing scheduled for last week was canceled—so while we don’t have those figures to compare funding levels with, we do know that the House allocation for this account is drastically lower than the Senate version. Lawmakers in the House and Senate have been busy with several pieces of legislation that would fund global health and research efforts across the federal government. including the DoD, CDC, FDA, and NIH. The Senate bill would fund the NIH at $30.9 billion, which is a welcome but small increase of $307 million over FY 2013. Many key institutes and centers—including the National Institute of Allergy and Infectious Diseases, the National Institute of Child Health and Human Development, and the Fogarty International Center—were funded at levels higher than the final FY 2013 allocations but lower than the levels President Obama requested for FY 2014. One exception is the National Center for Advancing Translational Science, which received a total of $662.4 million under the bill—a boost in funding of $87 million over FY 2013. This includes a total of $50 million for the Cures Acceleration Network. The legislation would fund CDC at $6.9 billion, an increase of $681 million over FY 2013 and $300 million over the President’s request. This funding includes $391 million for the Center for Global Health, a significant increase of $46 million over FY 2013. The National Public Health Institutes received a $10 million allocation under the bill, which also included a large bump for polio eradication: $146 million versus the $131 million the President requested and the $116 million from FY 2013. The National Center for Emerging Zoonotic and Infectious Diseases was funded at $335 million, an increase of $44 million over FY 2013. FDA The House recently passed its appropriations legislation to fund the US Food and Drug Administration (FDA), providing the agency with $2.485 billion (not including income from user fees). This is roughly $20 million more than the agency received in FY 2013 and $40 million more than the President requested. Language was included in the bill that would ensure the FDA can review products for all neglected diseases, encourage the agency to “build stronger partnerships with global regulatory stakeholders, and strengthen its internal capacity to review products for neglected diseases.” Similar language was included in the Senate version of the legislation, which funds FDA at a higher level of $2.562 billion, or roughly $77 million more than the House version. Defense The full House passed a Department of Defense funding bill, in which the entire agency was provided with $513 billion. The bill would also provide $9.6 million for malaria vaccine development efforts, and welcome language is included in the bill report regarding the need for such a vaccine. The Senate Appropriations Defense subcommittee voted on its version of Defense funding yesterday, July 30th. We’re still waiting for the release of the accompanying bill report to determine any implications for global health R&D. As we pointed out yesterday, it’s clear that many global health R&D programs are being flat-funded year after year. If Congress is unable to reach a long-term budget deal, sequestration cuts will take effect again, further hampering efforts to develop urgently needed new technologies. Congressional policymakers could still reverse this trend by fully funding global health and health research programs through the FY 2014 budget conference later this year, as well as through negotiations around the impending debate on the US debt ceiling. However, with the difficult political climate, it’s unclear whether they will take advantage of this important opportunity. Links to other helpful analyses: American Association for the Advancement of Science Alliance for a Stronger FDA

Today, the Senate appropriations committee approved a fiscal year (FY) 2014 appropriations bill that outlines funding levels for the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). The Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) Appropriations Bill would take the positive step of restoring sequestration cuts to CDC and NIH, although there is mixed news for global health programs at the agencies. NIH The bill would fund the NIH at a total of $30.9 billion in FY 2014, restoring this year’s five percent sequestration cut and providing a small increase over last year’s budget. Science Insider reports that the NIH had “strong support” from Senate Appropriations Committee Chair Barbara Mikulski (D-MD), who recently said that she is determined to reverse "reckless cuts to American biomedical research." In her opening remarks earlier today, Sen. Mikulski said, “Because of the investments we have made in NIH over the past decades, … HIV and AIDS is no longer a death sentence, and polio and small pox are essentially eradicated in this country. These medical breakthroughs didn’t just happen, they occurred because this Committee supported NIH, and the NIH supported dedicated scientists who sought knowledge and medical breakthroughs. We must keep up this support.” The bill includes $50 million, five times the FY 2013 level, for NIH’s Cures Acceleration Network, which aims to speed the translation of medical research discoveries in the laboratory that have not advanced far enough to attract significant investments from the private sector. According to Nature, in order to approve a new NIH budget—as opposed to passing yet another continuing resolution for FY 2014—the House and Senate must agree on a common figure for the agency. As a comparison, the House FY 2014 Labor-HHS bill would provide $8 million less for NIH compared with the Senate version. The Senate Labor-HHS appropriations bill for FY2014 would fund the NIH at $30.9 billion and the CDC at $7.022 billion. Credit: PATH/Evelyn Hockstein CDC The Senate bill would provide CDC with $7.022 billion in funding for FY 2014. The bill would restore the $800 million cut from CDC’s budget by sequestration and add a $22 million funding increase. The bill would provide $391.9 million for CDC’s Center for Global Health. This would include $116.9 million for CDC’s Global AIDS Program, which is equivalent to the FY 2013 level, but $15 million below President Obama’s FY 2014 request. The bill would provide $19.3 million for CDC’s Parasitic Diseases and Malaria program, which is comparable to FY 2013 levels, but less than the $22.2 million requested by Obama. CDC’s Division of Tuberculosis Elimination would receive flat funding at the FY 2013 funding level of $140 million. No additional funding for the division’s research programs was allocated. Finally, the bill also contains a total of $19.2 million for Global Public Health Capacity Development. These funds are for a new initiative to support public health capacity building in at least five developing countries over a two-year period to be overseen by CDC. The fate of the Labor-HHS appropriations bill is unclear from this point on. There is a $91 billion funding gap between the House and Senate overall budgets for FY 2014. And while the House Labor-HHS subcommittee has its overall budget, the subcommittee has not announced a date for consideration of a bill. Whatever happens, both the House and Senate must work to protect funding levels at the NIH, CDC, and all federal agencies that support global health and research programs.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The National Institutes of Health has released a fact sheet on the impact of sequestration. The fact sheet states that, due to budget cuts, approximately 700 fewer research project grants will be awarded this year compared to fiscal year 2012. New statistics show that the vaccine MenAfriVac™—developed through a partnership between the World Health Organization and PATH—has significantly reduced the number of cases of meningitis A in Africa. The most recent meningitis season marks the lowest number of cases in ten years. Scientists at Virginia Tech and the University of Florida are making progress in developing a new species-specific insecticide that would be lethal only to insects that carry malaria. Though they have seen positive results, the scientists still think it will be four to five years before they are ready to submit the compound for federal approval. Drugmakers in Japan have agreed to release data on experimental compounds for possible use to create drugs to combat malaria, tuberculosis, and neglected tropical diseases. The pharmaceutical companies are part of a five-year partnership called the Global Health Innovative Technology Fund.