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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.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. At the annual Grand Challenges meeting in Brazil this month, the Bill & Melinda Gates Foundation announced a new partnership with pharmaceutical companies to accelerate vaccine research and development (R&D). For the first project, the Gates Foundation will partner with GlaxoSmithKline on early-stage research for vaccine thermostability. According to studies published in Nature, a potential new HIV treatment has a "profound and unprecedented" impact on the virus. The trials were performed by Harvard Medical School and the National Institute of Allergy and Infectious Diseases. GHTC member Treatment Action Group released a new report on tuberculosis (TB) research funding. The report finds that after seven years of slow and unsteady increases in funding, TB R&D investors reported a drop in spending in 2012 that threatens to undermine the tenuous gains made since 2005. The Centers of Disease Control and Prevention released a report stating that the number of malaria cases in the United States is at the highest level in forty years. Nearly all the cases were Americans or foreign travelers bringing it into the country. About two-thirds were infected in Africa, where malaria is common. A new analysis published in The Lancet Global Health found that only 37—or four percent—of the 850 drugs and vaccines registered from 2000 to 2011 were for neglected diseases. The study also found that just 1 percent of existing clinical trials are for the development of tools for neglected diseases.

In this guest post, Mike Frick—project officer at the Treatment Action Group (TAG)—writes about the organization’s new report on funding for tuberculosis (TB) product development. Each year since 2006, TAG has tracked spending on research and development (R&D) for new diagnostics, drugs, and vaccines to improve TB treatment and prevention. The 2013 Report on Tuberculosis Research Funding Trends: 2005–2012 presents eight years of funding data. It also compares current spending in six research areas to the corresponding R&D funding targets outlined in the Stop TB Partnership’s Global Plan to Stop TB, 2011–2015. For the first time, TAG also analyzed investments in pediatric TB R&D. The report finds that after seven years of slow and unsteady increases in funding, TB R&D investors reported a drop in spending in 2012 that threatens to undermine the tenuous gains made since 2005. How much did funding decline? Funding for TB R&D fell by $30.4 million from 2011 to 2012. The $627.4 million spent on TB R&D in 2012 represents just 31.4 percent of the $2 billion annual investment called for by the 2011-2015 Global Plan and leaves a shortfall of $1.39 billion. At $10.3 million, investments in pediatric TB R&D comprised less than 2 percent of total 2012 spending and declined by 12 percent compared with 2011 levels. Where did funding fall the most? Compared to 2011, spending on TB R&D fell in four research categories: Funding for diagnostics fell by 23.4 percent from $55.4 million in 2011 to $42.4 million in 2012, leaving 87.5 percent of the $340 million annual target unfunded. Drug research spending dropped by 6.7 percent from $254.8 million in 2011 to $237.8 million in 2012. This leaves 67.9 percent of the $740 million annual target unfunded. Investments in vaccines declined by 9.3 percent from $95.4 million in 2011 to $86.6 million in 2012, leaving 77.2 percent of the $380 million annual target unfunded. After exceeding the annualtarget in 2011, funding for operational research dropped back below this target amount, declining by 9.8 percent from $85.5 in 2011 to $77.1 million in 2012. Funding for TB R&D fell by $30.4 million from 2011 to 2012. The $627.4 million spent on TB R&D in 2012 represents just 31.4 percent of the $2 billion annual investment called for by the 2011-2015 Global Plan and leaves a shortfall of $1.39 billion. Source: TAG/Hollander Snow Studio Who supports TB R&D? Public sector donors gave 61 percent of the global total, followed by the philanthropic sectorwith 20 percent and the private sector with 18 percent. Multilateral institutions contributed just 1 percent of total spending. The top ten donors disbursed 78 percent of total TB R&D investments in 2012. Two organizations – the National Institute for Allergy and Infectious Diseases (NIAID) and the Bill & Melinda Gates Foundation – each spent over $100 million and together comprise 45 percent of the global total. Public and philanthropic institutions in the United States and United Kingdom continue to underwrite the bulk of TB R&D. The BRICS countries (Brazil, Russia, India, China, and South Africa) remain conspicuously absent from the top 10 list. Top 10 TB R&D Funders in 2012 Including 2012 amount and increase (↑)/decrease (↓) /flat-funding (→) compared with 2011 level 1. NIAID ($169.1 million) ↑ 2. The Bill & Melinda Gates Foundation ($111.6 million) → 3. Otsuka Pharmaceuticals ($60 million) ↓ 4. Other National Institutes of Health (NIH) Institutes and Centers ($36.6 million) ↓ 5. The European Commission ($27.3 million) ↓ 6. Anonymous pharmaceutical company ($22.8 million) ↓ 7. The US Centers for Disease Control and Prevention (CDC) ($18.8 million) ↑ 8. The UK Department for International Development ($16.9 million) ↓ 9. The UK Medical Research Council ($14.8 million) ↓ 10. The Wellcome Trust ($13.4 million) ↑ Will funding continue to fall? The $30.4 million decline may intensify in coming years. This drop does not reflect the impact of sequestration-related funding cuts in the US, which forced the NIH to cut 5 percent ($1.55 billion) of its fiscal year 2013 budget. Sequestration led the CDC to cut support for the Tuberculosis Trials Consortium (TBTC), one of the world’s leading TB drug research networks, by 13 percent. In response, the TBTC closed three clinical trials sites. In a field that has struggled to attract scientific attention and talent for decades, sequestration-related cuts could eliminate critical opportunities for young investigators to build their scientific careers in TB R&D. Will the private sector close this gap? Private sector companies could play a much larger role in TB R&D. Yet, for the first time since 2005, private sector spending declined, dropping by 22.1 percent in 2012 compared with 2011. Pfizer, which contributed $6.3 million to TB drug research in 2011, recently announced the closure of its anti-infectives research division. Other drug companies decreased their investments, including Otsuka, whose TB drug delamanid will soon complete a Phase III trial. Wavering commitments to TB R&D from the private sector will place greater pressure on public institutions just as they begin to face unprecedented budgetary drawbacks. Philanthropic support also remained relatively flat, increasing by just 3.1 percent over 2011. What is the impact of this decline? Decreased funding today will delay the development, approval, and implementation of faster diagnostic tests, better drug regimens, and more broadly protective vaccines that are urgently needed to fight TB, which causes 8.7 million people to fall sick and kills 1.4 million people each year. Donors from all sectors in high-, middle-, and low-income countries must recommit to meeting the funding levels required to accelerate TB R&D and end the global TB epidemic.