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In this guest post, Emily Donaldson—program coordinator atAVAC: Global Advocacy for HIV Prevention—writes about an upcoming congressional briefing on November 18 that will highlight the latest in HIV and AIDS research and development. The world has made enormous strides in beginning to end the AIDS epidemic. Yet, there were still 2.3 million people newly infected with HIV in 2012. In order to continue to bring down new infections, it is essential to achieve high coverage rates of treatment and prevention methods, including voluntary medical male circumcision, male and female condoms, and harm reduction. In the long-term, new prevention tools, especially an effective preventive HIV vaccine, are critical for achieving maximum impact and ending the AIDS pandemic. Research to develop new prevention tools is critical for achieving maximum impact and ending the AIDS pandemic. Credit: PATH/Evelyn Hockstein. Since the Military HIV Research Program’s (MHRP) landmark RV144 trial first showed that an HIV vaccine was possible, MHRP, the National Institutes of Health (NIH), and partners have worked to build on those results. Additionally, US government-supported research in a range of new vaccine candidate strategies are moving forward in trials and in basic research for future clinical testing. At the same time, NIH and the US Agency for International Development (USAID) are developing new antiretroviral-based prevention options, such as treatment-as-prevention, pre-exposure prophylaxis, and microbicides. Through research programs like those at the MHRP, NIH, and USAID, the US can dramatically advance science and play a critical role in stopping the spread of the epidemic. Join us at a congressional briefing, Monday, November 18, as we call on Congress to invest in HIV prevention research. amfAR, The Foundation for AIDS Research AVAC: Global Advocacy for HIV Prevention Center for Global Health Policy International AIDS Vaccine Initiative In cooperation with Congresswoman Barbara Lee invite you to a Congressional Briefing The Role of HIV Research in Ending AIDS: New Developments in HIV Vaccine and Prevention Science Monday, November 18, 2013 12:00-1:30 p.m. Capitol Visitor Center, South Congressional Meeting Room Lunch will be provided Speakers include: Carl Dieffenbach, director of the National Institute of Allergy and Infectious Diseases’ Division of AIDS Margaret McGlynn, president and chief executive officer, International AIDS Vaccine Initiative Fredrick Sawe, associate director International Clinical Research, MHRP Christina Polyak, research physician, MHRP, Walter Reed Army Institute of Research Christine Lubinski, vice president for Global Health, Infectious Disease Society of America Kevin Fisher, policy director, AVAC: Global Advocacy for HIV Prevention, moderator For more information or to RSVP, please contact Emily Donaldson at AVAC at edonaldson@avac.org or 646-369-1476.

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 this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The World Medical Association has adopted and published a revised version of the Declaration of Helsinki, which sets standards regarding medical research involving human subjects. The changes reflect a call to increase protection for people taking part in medical research. GHTC member Aeras and the Statens Serum Institut have initiated a new clinical studyfor a candidate tuberculosis (TB) vaccine. In related news, GHTC member the Global Health Innovation and Technology (GHIT) Fund announced that it will invest $720,000 for early work on a novel vaccine candidate against TB being co-developed by Japan’s Create Vaccine Co., Ltd. and Aeras. The Kaiser Family Foundation released a new public opinion survey on the US role in global health. The survey finds that Americans’ basic level of support for current levels of US spending on efforts to improve health for people in developing countries has held relatively steady in recent years. GHTC member the International AIDS Vaccine Initiative (IAVI) has released its 2012 annual progress report, which details IAVI’s progress, accomplishments, and key partnerships over the past year. The White House's Office of Management and Budget (OMB) recently confirmed that sequestration has drained about $85 million in user fees from the US Food and Drug Administration. The cuts are expected to continue, according to an OMB response to Rep. Anna Eshoo (D-CA), which she released this week. GHTC member TB Alliance has entered into a collaboration with Svizera Europe, one of the leading global supply and distribution companies for TB treatments. The partnership aims to create and enable access to new medicines for childhood TB.

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.