Breakthroughs Blog: NIH

In this guest post, Jaclyn Schiff—American Society of Tropical Medicine and Hygiene (ASTMH) Director of Communications—highlights news in global health research presented during the recent ASTMH Annual Meeting. Just two week ago, more than 3,700 attendees gathered in Washington, DC, to announce, share, and discuss the latest research findings on a broad range of global health issues, including neglected tropical diseases, surgery in the developing world, and malaria. Just two week ago, more than 3,700 attendees gathered in Washington, DC, to announce, share, and discuss the latest research findings on a broad range of global health issues at the ASTMH Annual Meeting. Credit: ASTMH. Though the meeting attracted one of the largest crowds ever, the absence—due to federal travel budget cuts—of key researchers from the Centers for Disease Control and Prevention, National Institutes of Health, the Army, and Navy was noticeable. This also significantly affected the Annual Meeting last year, and the cuts persist with no sign of letting up. One unfortunate consequence is that scientific collaboration suffers at the Annual Meeting and at countless other research-focused gatherings. When science is stifled, we all lose out. But our colleagues who were able to make it, got on with it, and the media reported extensively on their findings. News coming out of the Annual Meeting covered a lot of ground—from gender bias in global health science to plague surveillance involving traditional healers in Uganda. So just in case you weren’t able to take it all in, here are three critical pieces of research from this year’s meeting: Potential danger from the Plasmodium vivax parasite: The malaria vector may be rapidly evolving to overcome the natural resistance conferred by a blood type found in millions of Africans. Science Now reported on the findings: To enter human blood cells, the parasite usually uses the so-called Duffy blood group protein, a protein on the surface of red blood cells. But because up to 95 percent of the population across sub-Saharan Africa lacks the protein—a genetic trait called “Duffy negative”—they have long been thought to be protected from infection. Yet reports have emerged in recent years of Duffy-negative people who are nevertheless infected with vivax malaria. “If vivax can establish itself in Africa, it can really undo a lot of the malaria progress we’ve made,” study co-author Peter Zimmerman, PhD, of Case Western Reserve University told the New York Times . Moving towards improved hookworm treatments: Researchers presented findings showing that they had completely cured lab animals of parasitic hookworm. To achieve the results, scientists used a modified version of a common human dietary supplement. The findings represent an “important development in our effort to find a safe, affordable and effective way to confront a major global health problem,” the study’s lead researcher said. In its report on the research, Xinhua  notedthat “the only drugs available to treat hookworms in humans were originally developed to combat parasites that infect farm animals.” The study researchers say that current treatments are not effective enough and that drug- resistance is rising. Strange dengue patterns in the United States: As dengue fever continues to spread from Key West north into the Florida mainland, it remains a mystery as to why this dangerous mosquito-borne illness is not yet common around Tucson, Arizona—even though outbreaks routinely occur in nearby Mexico and mosquitoes that can carry dengue are now common in the state. As The Verge reports, researchers think human or biological factors somehow explain why dengue hasn’t spread in Tucson. "It may be that the temperatures in Tucson are so hot," Mary Hayden, a scientist at the National Center for Atmospheric Research, told the BBC . She added “the relative humidity is so low that the mosquitoes may not be able to survive in that climate long enough for the virus to cycle within them.” Additional highlights, original news stories, and interviews are available on the #TropMed2013 Tumblr.

After two-and-a-half weeks in limbo, government employees were able to return to work on October 17th—when Congress finally reached a temporary agreement to re-open the government. As we’ve highlighted previously, many federal employees involved in the day-to-day work of global health research programs were furloughed during the government shutdown, leading to lost research and delayed studies. While government employees have been catching up on email and trying to recover work that was slowed or halted by the shutdown, policymakers have been taking tentative steps toward negotiating a longer-term budget deal. While we have more answers now than we did a week ago, things are still murky—and long-term answers about the budget are still unknown. Policymakers have been taking tentative steps toward negotiating a long-term budget deal that will impact global health and research programs. October budget deal The congressional deal reached on October 17th contained short-term fixes to three major issues: It extended current spending levels through January 15, 2014. It extended the debt ceiling through February 7, 2014. It created a new committee tasked with developing and approving a long-term plan to fund the government by December 13, 2013. Spending levels for federal research programs The deal extended current fiscal year (FY) 2013 post-sequester spending levels through January 15, 2014. While FY 2013 levels for global health initiatives, including research programs, at the State Department and US Agency for International Development have fared relatively well when compared with other foreign aid accounts, we saw drastic cuts at agencies such as the National Institutes of Health, the Centers for Disease Control and Prevention, and the Department of Defense—all of which support vital global health research and product development efforts. These funding cuts will remain in the budget deal reached last month. It’s detrimental to scientific progress when increasingly reduced research budgets become the norm. Coupled with the lack of a compromise on the debt ceiling level, such actions hurt US financial credibility and the nation’s leadership in research for new technologies to aid in the fight against disease. Budget Conference Committee As part of the shutdown deal, Congress established a Budget Conference Committee, tasked with coming to agreement that both chambers can agree upon to fund the government past January 15, 2014. Leading the Budget Committee is House Budget Chair Paul Ryan (R-WI) and Senate Budget Chair Patty Murray (D-WA). The conference is a bi-partisan, bi-cameral group made up of 29 Members. While the committee has several options, a major focus will be replacing the sequester. A second round of sequestration cuts will automatically kick in on January 15, 2014, if Congress doesn’t pass a budget solution that includes targeted, smart cuts. Both Republicans and Democrats have expressed an eagerness to reach a deal, but ideas for how to do so continue to appear miles apart, with no sign of moving toward a compromise. It is more likely that if the Budget Conference Committee comes to an agreement, it will address the final FY 2014 budget—including the upcoming January 15, 2014, sequester cuts—but go no further. This approach is really nothing new, since it essentially replaces the normal order of appropriations for FY 2014. The Budget Conference Committee held its first meeting on October 30th, and its next public meeting is scheduled for November 13th. Opposition to the continued budget purgatory seems universal. Several advocacy groups, including InterAction and the Business Roundtable, have sent letters to members of the committee urging them to come to an agreement quickly. We agree with these pleas for a long-term budget solution. As we saw earlier this year, debating budgets for two different fiscal years simultaneously is not productive and is a poor way to set programmatic priorities. While it may seem usual business these days to have concurrent debates on the traditional budget, the sequester cuts, and the debt ceiling, we’re hopeful that this budget conference committee will act boldly to reset the process by rapidly agreeing on final FY 2014 funding levels and a long-term debt ceiling compromise. Congress and the Administration should then be able to move on to the myriad of other priorities they have on their plates.

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