Kim Lufkin

  “I’d be careful not to break something that would be hard to put back together,” Alan Magill—director of Malaria at the Bill & Melinda Gates Foundation—said this week at the GHTC’s annual congressional briefing. Sequestration, just days away, was a primary concern for Magill and others at the event, which focused on how US policymakers can protect the nation’s investments in global health research in upcoming budget discussions. As Magill and others stressed, sequestration and federal budget cuts would severely hamper research taking place across the US government to develop new vaccines, drugs, and other tools for global public health. According to moderator Lisa Cohen, executive director of the Washington Global Health Alliance, more than 350 health innovations are in the research pipeline. She added that 200 of these are supported by the US government through agencies such as the Centers for Disease Control and Prevention (CDC), the Department of Defense (DoD), the US Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the US Agency for International Development (USAID). (from right to left) Lee Hall from the National Institute of Allergy and Infectious Diseases, Caroline Ryan from the President's Emergency Plan for AIDS Relief, and Alan Magill from the Bill & Melinda Gates Foundation. Photo credit: PATH. Widespread budget cuts would stop scientific progress in its tracks—progress that cannot be seamlessly picked up again if funding were to resume in the future. “Many biomedical studies cannot survive cuts in funding in the middle of their work. It would be an irreversible mistake to halt these ongoing global health research efforts,” Cohen said, adding, “Halting funding would mean that the world may never benefit from these tools that are so close to development and delivery.” As the panelists stressed, there are several compelling humanitarian reasons to protect US investments in global health research. “Scientific advancements have brought us to a tipping point in the fight against HIV and AIDS,” Caroline Ryan, deputy coordinator for Technical Leadership at the President’s Emergency Plan for AIDS Relief (PEPFAR) said. She added that “science has set us on a new path—a path to achieving an HIV-free generation.” Lee Hall, chief of the Parasitology and International Programs Branch at the National Institute of Allergy and Infectious Diseases, said that the NIH is supporting research for an array of new, lifesaving health tools—including drugs, diagnostics, and vaccines for malaria, Chagas disease, and tuberculosis. “We’re standing at a very promising moment,” Hall said. “Looking at what’s on the horizon, it’s clear that a lot will come out of our support for global health research. We need new tools if we are to realize the benefits of US support for global health.” Speakers also emphasized that there are countless domestic benefits that come with US investments in global health research. “We live in a globalized world, whether we like it or not,” Magill said. “This presents us with the choice to exert America’s leadership role and shape the world how we’d like to see it—or let someone else do it for us.” Magill added that with the ease and speed of airline travel, “what’s happening in the middle of Africa today could be happening at Dulles tomorrow.” Hall also highlighted that many areas in the United States are vulnerable to tropical infections, and that diseases like Chagas are appearing throughout some Southwestern states. Lee Hall (left) and Alan Magill (right) at the GHTC's annual congressional briefing. Throughout the event, all three panelists underscored the importance of partnerships to advancing research and science for new health tools. According to Ryan, PEPFAR “gets more bang for our buck” by working in partnerships with other US agencies, such as the NIH and FDA, as well as philanthropic groups like the Gates Foundation. As an example, Ryan cited that PEPFAR and USAID are supporting the development of microbicides with a research infrastructure established by the NIH. Hall also cited NIH’s numerous partnerships with US academic institutions, nonprofit groups, and other federal agencies like the CDC and DoD. Magill stressed that from the Gates Foundation’s perspective, the US government is a critical partner in global health. “The Bill & Melinda Gates Foundation can only provide a small fraction of what the US can bring to the table,” he said, adding that investments in global health research should not only be seen as humanitarian aid—they are investments in science that provide “a lot bang for a little buck. We should save programs that are investments in the future.”

We have long known that Washington is operating under a remarkably unorthodox budgetary process. Sequestration threatens to reduce funding for most federal programs by at least five percent. More than halfway through the current fiscal year, policymakers still haven’t completed work on the 2013 budget. They will likely be finishing budget negotiations for this year as they start the process all over again for 2014. These tense and uncertain budgetary circumstances in Washington are placing enormous constraints on research and development (R&D) efforts to develop new and improved vaccines, drugs, and other tools for global public health. In the midst of these critical federal budget decisions, the Global Health Technologies Coalition (GHTC) is releasing our fourth annual policy report. We believe that sequestration and the federal budget present the United States with the opportunity to take two decidedly different paths. Policymakers can renew the nation’s longstanding role as a leader in supporting global health R&D by preventing sequestration and protecting research funding in the federal budget. Alternatively, policymakers can place this leadership role at risk by allowing sequestration to take place and reducing investments in global health R&D in the federal budget. The fourth annual GHTC policy report provides actionable steps that US policymakers can take to protect global health R&D in the upcoming budget negotiations. Congress and the Obama administration are not in an enviable position—they are facing incredibly challenging decisions regarding the budget. They must set priorities for the country and provide funding for them. In these times of fiscal constraint, policymakers need to be even more discerning and invest in essential activities that not only save lives and improve health worldwide, but also provide jobs and reap other rewards at home. Our policy report proves that global health R&D unquestionably meets all of these goals. Previous US investments in research to develop new vaccines, drugs, diagnostics, microbicides, devices, insecticides, and other tools have led to some of the greatest advances in global health to date, saving countless lives and resulting in billions of dollars in cost savings. With increased investment and support from the US government, further gains are within reach for HIV and AIDS, malaria, tuberculosis, neglected tropical diseases, maternal and reproductive health, and childhood survival. Global health research also drives US job creation and economic growth, while protecting the health of American citizens who are increasingly at risk of global infectious diseases. For instance, 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. Supporting research to develop new vaccines and drugs will help fight these diseases both at home and abroad. Our report provides actionable steps that Congress and the administration can take to protect global health R&D in the upcoming budget negotiations. The report also provides clear recommendationsfor how the US government can increasingly coordinate its global health research activities—which stretch across multiple agencies, branches, and departments—around a cohesive strategy. In the coming months, policymakers have the opportunity to set a course for renewal by ensuring that the nation’s fiscal policies and international development programs support research and innovation for global health. The reasons are clear, and there is too much to lose by pulling back now. The GHTC’s fourth annual policy report can be found online. The report will be released today at a Capitol Hill briefing.  

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.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Mozambique has completed its first HIV vaccine trial and is set to begin a second, demonstrating the country’s increased research capacity. The Global Alliance for TB Drug Development and UNITAID are calling for more action against childhood tuberculosis (TB), including research to create new and improved pediatric treatments. Officials with the Walter Reed Army Institute of Research say that sequestration will affect further testing of a potentially cutting-edge malaria vaccine. New trials are being plannedfollowing news that a toddler in Mississippi has been functionally cured of HIV. The US Agency for International Development has announced that its contractors could see current or future funding reduced as a result of sequestration.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Brazil recently registered a new test for leprosy, developed by the Infectious Disease Research Institute. The test is offering hope that cases of the disease can be found and cured before permanent disability or disfigurement develops. Francis Collins, head of the National Institutes of Health (NIH), has said that although each of the 27 institutes and centers at NIH would have to cut 5.1 percent under sequestration, the directors of each center could decide how to apportion the funding cuts. The White House Office of Science and Technology Policy has released a proposed policy aimed at maximizing the benefits of life sciences research while minimizing the odds that the results of such research will be misused. The proposed policy was developed collaboratively by several federal agencies and is now open for public comment for 60 days. Sequestration would force the State Department to cut $200 million from humanitarian assistance accounts and $400 million from global health funding, Secretary of State John Kerry wrote in a letter to Congress this week. Sen. Ben Cardin (D-MD) writes in a new opinion piece that sequestration “could have a profoundly destructive effect on research into important medical and scientific advances.” The Institute of Medicine has released a new report on the President’s Emergency Plan for AIDS Relief(PEPFAR). The report recommends, among other measures, that PEPFAR increase its emphasis on HIV prevention.