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Across-the-board cuts to US R&D programs could have a devastating impact on efforts to develop new drugs for tuberculosis (TB) and HIV/AIDS, the world's first malaria vaccine, and other vital global health products in development, according to a new report from a coalition of nonprofit groups focused on advancing innovation to save lives. "We know that policymakers are currently facing difficult budget decisions. But any reductions in funds could eliminate essential support for the development of global health tools and slow or halt the progress made against addressing a number of deadly diseases," said Kaitlin Christenson, MPH, director of the Global Health Technologies Coalition (GHTC). The report from the GHTC, Renewing US leadership: Policies to advance global health research, comes as Washington is bracing for a "budget sequestration" process that, according to some estimates, could cut 5.2 percent from programs across government, including initiatives that have put hundreds of new drugs, vaccines, diagnostics and other disease-fighting tools into the product pipeline and established the US as the world's leader in developing life-saving global health technology. The analysis finds the cuts to global health R&D "would barely make a dent in reducing the US federal deficit but would have a crippling impact on people's health and lives around the world." "There is much to lose by pulling back now," the report states. Some estimates predict that under sequestration, global health initiatives at the State Department and US Agency for International Development (USAID) could lose $482 million, money that supports, among other things, the development of new drugs to quell an alarming resurgence in deadly TB and new tools to escalate the fight against HIV/AIDS. Meanwhile, the National Institutes of Health (NIH), which is supporting a new dengue vaccine candidate, new HIV prevention methods, and potential new treatments for TB, could lose nearly $2 billion. In addition, the sequestration process would result in steep losses for R&D programs funded by the US Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Department of Defense (DoD). Taken together, the cuts throughout the government could jeopardize any number of the 200 global health products that have advanced in the research pipeline thanks to US support. Conversely, the GHTC finds that "continued and consistent US investment in R&D...will provide the momentum needed to push promising new tools over the finish line." These tools include: a new microbicide that could give women the power to protect themselves from contracting HIV with or without their partners' cooperation; new insecticides that could help control insects that spread deadly diseases like dengue fever, Chagas, filariasis, and leishmaniasis; new drugs and vaccines to help fight back against the alarming spread worldwide of drug resistant TB; modern reproductive technology that could greatly lower maternal mortality rates by giving women worldwide the ability to plan for the birth of their next child; and a new oral drug for African sleeping sickness, which is fatal without treatment. "Today, all across the US government we see solutions emerging to global health problems we've been fighting for decades, or, in some cases, centuries," said Steve Davis, President and CEO of PATH. "The DoD is helping advance a promising AIDS vaccine candidate. The FDA is spurring the development of new drugs and vaccines for TB. NIH is helping to put us ever closer to a malaria vaccine. The CDC is coming up with a new test for detecting dengue virus, which is critical to monitoring its rapid spread. And USAID is providing essential support for new reproductive health technologies." "US taxpayers are rightly demanding results from federal expenditures," Davis added, "and the wise investments our government has made in global health R&D are clearly providing excellent returns." The GHTC report notes that US investments in global health R&D have helped deliver "some of the greatest advances" the field has ever experienced. Recent achievements include a new, highly effective Africa-specific vaccine for meningitis A; a new rapid test for detecting TB; and the world's first malaria drug for children. The GHTC also finds that global health expenditures, which include support for product development partnerships (PDPs) with the private sector, are helping boost the nation's economic performance. The report cites evidence that "64 cents of every dollar spent by the US government on global health R&D goes directly to US-based researchers and product developers." Moreover, the drugs, vaccines and diagnostics so crucial to saving lives in countries with high burdens of infectious diseases are increasingly needed to protect public health on the home front. For example, just this past summer, Florida experienced its largest TB outbreak in 20 years. Dengue fever has now persisted on the US mainland long enough that it may have developed its own unique US strain. And Chagas, a disease carried by so-called "kissing bugs" that can cause serious heart and digestive problems, is now migrating northward from Latin America. Up to one million cases have been found in the US, with the disease burden believed to be particularly high along the Gulf Coast. The GHTC report observes that "there are an estimated five million impoverished Americans who live with neglected tropical diseases--including a previously hidden burden of neglected diseases among the poor in the southern United States." The GHTC asserts that, ultimately, if "the damaging effects of sequestration do take place, agencies must do their best to protect product development priorities within their budgets." "Even in these difficult fiscal times, US policymakers must persist in their support for global health research," the report states. US Legacy and Leadership at Risk The GHTC report finds that the threat of cuts via sequestration is part of a broader and troubling trend that has seen US support for global health decline over the past few years. For example, the latest Global Funding of Innovation for Neglected Diseases (G-FINDER) survey documented a $30 million drop in 2011 in US support for global health-related research and product development. GHTC worries that the US is drifting in a way that could "put the nation's legacy as a scientific and humanitarian leader at risk." The report points out that the sequestration debate is occurring at the same time lawmakers are debating funding levels for the rest of this year and for 2014--a separate discussion, but one that also has significant implications for global health research. GHTC views the 2013 and 2014 appropriations process as an opportunity for the US decision makers to step back and re-examine budget priorities and "reverse the trend of decreased global health and R&D funding seen in recent years." According to the GHTC, "There could not be a better time for the United States to renew its global health R&D legacy." Also, given that budget pressures will demand better performance from government-funded endeavors, the GHTC is calling for a new "five-year strategy" that coordinates global health research and product development across the federal government. The GHTC envisions a strategy that, among other things, clarifies priorities and provides "metrics to measure success." The GHTC believes work should begin now with the goal of completing the strategy by December 2014.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The Senate has passed a fiscal year (FY) 2014 budget resolution that would provide $45.6 billion for the international affairs budget. The House has also passed an FY2014 budget resolution that would provide $38.7 billion in funding for international affairs. A system developed by the National Institutes of Health tracks biomedical research funded by agency worldwide. A group of global experts write in The Lancet Infectious Diseases about the need for strong global leadership to tackle tuberculosis (TB) worldwide. In related news, more than 250 scientists, researchers, and TB advocates gathered in Cape Town, South Africa, at the Third Global Forum on TB Vaccines to examine the future of TB vaccine research and development. A team of researchers at the Scripps Research Institute and the International AIDS Vaccine Initiative report in the current issue of Science a novel strategy to aid the design of vaccines that can elicit broadly neutralizing antibodies against HIV.

During last week’s State of the Union address, President Obama called on policymakers to find a solution to the federal budget debate before sequestration—or widespread and indiscriminate cuts to all federal programs—takes place next month. “These sudden, harsh, arbitrary cuts would jeopardize our military readiness. They’d devastate priorities like education, and energy, and medical research,” he said, adding, “They would certainly slow our recovery, and cost us hundreds of thousands of jobs. That’s why Democrats, Republicans, business leaders, and economists have already said that these cuts, known here in Washington as the sequester, are a really bad idea.” The GHTC and others in the global health and research communities have long stressed the importance of preventing sequestration in order to stop the devastating cuts it would have on US programs that—among other lifesaving activities—are helping to develop and deliver innovative vaccines, drugs, diagnostics, and other tools to benefit global public health. US policymakers must prevent sequestration in order to stop the devastating cuts it would have on US programs that—among other lifesaving activities—are helping to develop and deliver innovative vaccines, drugs, diagnostics, and other tools to benefit global public health. Photo credit: PATH Sequestration would not only hinder efforts to save lives and improve health around the world. As President Obama emphasized last week, US investments in research also contribute to a wide range of domestic benefits—such as job creation and economic growth—that would be diminished by sequestration. “Now is not the time to gut these job-creating investments in science and innovation,” Obama said during his address. “Now is the time to reach a level of research and development not seen since the height of the Space Race. We need to make those investments.” Also last week, several federal agencies released new details about the impact of sequestration on their budgets and programs. For instance, in a letter to Senate Appropriations Chair Barbara Mikulski (D-MD), Health and Human Services (HHS) Secretary Kathleen Sebelius outlined the harmful effects of sequestration on agencies within HHS that “protect the health and enhance the well-being of all Americans.” As just one example, medical research at the National Institutes of Health (NIH)—the largest supporter of global health research in the world—would be severely hindered by sequestration. Cuts to the NIH would delay progress on the treatment and prevention of debilitating conditions that affect people both at home and abroad. “In general, NIH grant funding within states … will likely be reduced due to both reductions to existing grants and fewer new grants,” Sebelius wrote. “We expect that some existing research projects could be difficult to pursue at reduced levels and some new research could be postponed as NIH would make hundreds fewer awards. … With each research award supporting up to seven research positions, several thousand research positions across the nation could be eliminated.” Congress also came out with its own estimates on the level of federal budget cuts that would result from sequestration. Democratic members of the House Appropriations Committee released a report that finds sequestration would have far-reaching consequences for domestic growth and employment. Sequestration could slow US economic growth by half in 2013 and cut more than 2.14 million domestic jobs. Additionally, the report outlines the potential effects of sequestration on agencies that fund global health and research programs. “A sequester would force cuts to global health and development funding of over $432 million, severely hindering the United States government from taking advantage of opportunities to dramatically change the face of disease and, in some cases, permanently reduce suffering,” the report claims. It adds that sequestration would cut the US Agency for International Development’s (USAID) global health budget by $139 million. Cuts to USAID’s global health programs would hinder progress in the development of game-changing new technologies, such as research to develop an HIV and AIDS vaccine. The report also finds that the Centers for Disease Control and Prevention and the Food and Drug Administration would be cut by $350 million and $120 million, respectively. The NIH would be cut by $1.6 billion under sequestration. Last week saw a chorus of voices from across the US government, demanding that policymakers do everything they can to ensure that sequestration does not take place. Such widespread cuts would severely hinder US programs that are finding more effective tools to prevent and treat disease worldwide. These programs are also creating jobs and spurring the economy at home. It’s critical that policymakers come up with a federal budget plan that not only prevents sequestration, but also protects US investments in global health research and other successful programs.