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The prospect of deep cuts in the federal budget threatens to reverse the dramatic progress of a bipartisan US commitment to defeat neglected diseases in developing countries, according to a new report released today by the Global Health Technologies Coalition (GHTC). Federal investments in global health research and development (R&D) programs that span multiple agencies have helped nurture an array of new vaccines, medicines, diagnostics, and other health products needed to combat diseases like HIV/AIDS, malaria, tuberculosis (TB), and childhood killers like pneumonia and diarrheal diseases. Despite these advances, President Obama's budget request for 2013 calls for several decreases for global health when compared with last year's levels. Several global health R&D programs at US agencies also saw drastic funding cuts. There are widespread concerns that cuts to global health R&D programs, which support critical efforts to develop the next generation of lifesaving health products, could grow even larger, given the pressure to reduce the US budget deficit. "[T]he budget climate in the United States continues to be severe, and US policymakers are beginning to implement austerity measures that could impact funding for global health R&D," the GHTC report stated. "Indeed, the continuing fiscal situation undoubtedly puts these programs at risk in the future, when global health R&D programs could see even more severe funding cuts than have already occurred." According to the GHTC report, global health R&D projects are among the best investments US policymakers can make, which would make funding cuts even more devastating. Last year alone produced multiple research breakthroughs, including results from a trial showing that early antiretroviral treatment can prevent HIV transmission to uninfected partners and results from a Phase III malaria vaccine trial showing that the vaccine candidate known as RTS,S can provide young African children with significant protection against clinical and severe malaria. "It would be ironic if widespread and unprecedented cuts in global health R&D were to take place just as past investments begin to bear fruit," said Kaitlin Christenson, MPH, GHTC's director. "US commitment was instrumental in eradicating smallpox and conquering polio and is now helping achieve unprecedented reductions in deaths from malaria and diarrheal diseases. Equally dramatic breakthroughs can be expected for a variety of other diseases if we continue to invest in research for new lifesaving health products." GHTC, which represents 40 nonprofit organizations focused on developing new vaccines, drugs, and other disease-fighting tools for the developing world, warns that the future could look far different from the progress being made today. Its report, Sustaining Progress: Creating US policies to spur global health innovation, found that while the US commitment to global health R&D has bridged deep political divides in Congress and garnered particularly strong support from the last two presidential administrations, it is now confronting a major test. The report notes that in the 2012 budget process, some individual global health R&D programs experienced reductions, alongside cuts to what are known as product development partnerships (PDPs)--relatively new and innovative types of public-private partnerships focused on developing drugs, vaccines, diagnostics, and other products specifically for patients in low-income countries. In addition, the report found that overall investments in global health R&D remained far short of what is actually needed. Global health R&D is spread throughout the US government and includes research and product development efforts supported through a variety of programs at the US Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Department of Defense (DoD), and the US Agency for International Development (USAID). The GHTC report points out that the US is not alone in trying to balance the need to address fiscal constraints with maintaining a commitment to reducing global health disparities. The report cites the recent "Global Funding of Innovation for Neglected Diseases" survey, which found that in 2010, investments in R&D from all sources worldwide, public and private, fell by 3.5 percent. Public sector investments declined the most, dropping by 6 percent. According to the GHTC report, "The rest of the world is struggling with the same global financial crisis that is challenging the United States." Further, "other major donors could be inclined to maintain their commitments if the United States persists." GHTC also recommends an increased emphasis on health-related R&D in major international development programs, such as the President's Emergency Plan for AIDS Relief (PEPFAR). According to the report, "US investments in global health research can produce real results, and the nation must persist in our efforts to develop the next generation of lifesaving health products. US leaders have the opportunity to seize on this bipartisan legacy and recent scientific advancements and stay focused on the end goal--saving lives around the world. The United States cannot give up now."

A new report finds that the United States government is the largest funder of global health research and development (R&D) in the world, investing $12.7 billion over the past 10 years in the creation of new vaccines, drugs, diagnostics, and other products for neglected diseases of the developing world. That funding, according to the report, helped lead to the development of more than half of the 45 new health products in the last decade that have been used to save lives around the world. The report, which will be released by the Global Health Technologies Coalition (GHTC) and Policy Cures on Friday at a briefing in Washington, finds that the US government each year provides around 45 percent of the total global investment and 70 percent of all government investment worldwide in global health R&D. In the last decade, the US government more than doubled its yearly financial commitment to developing new global health products, from $685 million in 2000 to $1.4 billion in 2010. These investments represent just 0.01 percent of US gross domestic product (GDP). The report, Saving lives and creating impact: Why investing in global health research works, finds that five federal agencies—the National Institutes of Health (NIH), US Agency for International Development (USAID), Department of Defense (DoD), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA)—provide significant contributions each year to global health R&D. This commitment from the US Government and its federal agencies has led to a remarkable increase in global health products. Forty-five new health tools were registered between 2000 and 2010, and the US Government was involved in 24, or 53 percent, of these new global health products in the last decade. “This report provides critical new evidence for policymakers in the United States,” GHTC Director Kaitlin Christenson, MPH, said. “We always believed that the United States was a leader in global health R&D, and that US investments were making a huge difference in the global public health landscape. And we now have clear evidence that support these beliefs and shows the critical importance of US support for these lifesaving health tools.” Many of these new products are on course to save millions of lives and dollars around the world. The report looks at two global health technologies developed with US Government support—a new meningitis vaccine and a new test to diagnose tuberculosis (TB)—and finds that US investments have led to hundreds of millions of dollars in savings. For example: Estimates predict that the new meningitis vaccine MenAfriVac™ will prevent approximately 437,000 cases of meningitis over the next 10 years, saving around 43,500 lives and averting around 105,000 disabilities. In all, the introduction of MenAfriVac™ is estimated to save about $570 million in the next decade. The Xpert ® MTB/RIF test is expected to triple the number of patients diagnosed with drug-resistant TB, curbing the spread of drug resistance and enabling patients to be prescribed the correct treatment immediately. In addition, the report highlighted two global health products now under development that could have a major impact in reducing deaths and illnesses. They include: Several HIV vaccines currently under development. New modeling indicates that a vaccine with even 50 percent efficacy provided to just 30 percent of the population could reduce the number of new HIV infections in the developing world by 25 percent over 15 years—preventing 5.6 million new infections. Shorter TB treatment regimens currently under development could reduce transmission of TB by 10 percent, resulting in fewer infections and fewer people requiring treatment for the disease. The United States and its partners are now supporting the largest pipeline ever of new global health products, the report said. Federal agencies are working with partners in the nonprofit, academic, private, and philanthropic sectors to support development of 200 of the 365 products in the pipeline, many of which will become the next generation of lifesaving vaccines, drugs, and other tools. “Our report also shows that a sustained and even increased commitment to global health R&D from the United States is needed now, especially as several promising research projects are moving toward later-stage clinical trials—the final steps to ensure that the products are effective and safe,” Christenson said. This next generation of global health products promises to deliver even greater health and economic gains, both at home and abroad. For instance, the report finds that funding for global health R&D not only benefits the developing world—it also boosts the US economy. Around 64 cents in every dollar spent by the US government on global health R&D goes directly to US-based researchers. “After years of neglect, the global health R&D landscape for new products has been transformed in the last decade, driven by sustained investment from the US government and increasing support from industry, other public funders, and philanthropic agencies like the Bill & Melinda Gates Foundation,” the report says. The report finds that the health and economic benefits, both domestically and internationally, provide clear reasons for the United States to continue its support for global health R&D. It also offers recommendations for how the US Government can generate an even greater impact from its investments in new global health products. These include maintaining funding levels for global health R&D and increasing these levels where possible; and bolstering its partnerships with industry, nonprofit groups, and the philanthropic sector to translate promising research into new successful health products. The report also noted that US support for global health R&D has been heavily tilted toward basic science research and increased support for the later stages of research will be needed as more products move into the final stages. “We now have proof that the US government has made a lasting impact on health around the world through its support of research for new health tools,” Christenson said. “As the United States and its partners work to push the next generation of lifesaving products over the research finish line and into the hands of people in need worldwide, this report provides a way forward for making US investments in global health R&D even more effective.”

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The US Agency for International Development announced the launch of its second request for applications for its ‘Saving Lives at Birth: A Grand Challenge for Development’ program, which calls for innovation prevention and treatment approaches for pregnant woman and children in developing countries. The Centers for Disease Control and Prevention discusses its role in global HIV and tuberculosis research and development (R&D) with Science Speaks. Medicines for Malaria Venture announced more than 100 million child-friendly malaria treatments have been delivered to 30 malaria-endemic countries since 2009. The announcement represents a key success story in global health R&D OneWorld Health’s treatment for leishmaniasis is now registered for use in Nepal.