Breakthroughs Blog: NIH

  “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.”

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.

President Obama officially began his second term in office this week, and will have a host of new faces to work with in Congress and his own administration. Below, we provide a roundup of some of the most critical leadership changes that could affect funding and policies for global health and international development programs. Secretary of State: The Senate Foreign Relations Committee will hold a hearing on the nomination of Sen. John Kerry (D-MA) to be the next secretary of state today. Sen. Bob Menendez (D-NJ) will oversee the hearing, as Kerry is the current chair of the Foreign Relations Committee. The Rethinking Foreign Assistance blog offers four questions to look for during Kerry’s confirmation hearing, including how he would work to ensure that the US Agency for International Development (USAID) is the premier development agency in the world, and what the new Office of Global Health Diplomacy would focus on during his tenure. President Obama officially began his second term in office this week, and will have a host of new faces to work with in Congress and his own administration. House Foreign Affairs Committee: Rep. Ed Royce (R-CA) is the new chair of the House Foreign Affairs Committee, and Rep. Eliot Engel (D-NY) is the new ranking member. The committee oversees legislation that impacts international development and global health efforts, including bills that affect funding and policy priorities at USAID. According to Science Speaks, Engel is a “global health champion” who succeeds former ranking member Howard Berman (D-CA), who lost his re-election bid in November. Royce “brings a mixed record on global health support to the post, having voted yes to the original Leadership Act that authorized the $15 billion President’s Emergency Plan for AIDS Relief (PEPFAR) in 2003, but then voting against reauthorization of PEPFAR in 2008, as the global AIDS response prepared for a transition from emergency to sustainable humanitarian response.” Following a closed-door meeting last week, Engel said, "The Democratic members of the Foreign Affairs Committee represent a wide range of views and experiences, and we will work together to help ensure that US foreign policy best serves our national interests." Other Democrats new to the committee include Rep. Karen Bass (D-CA) for the subcommittee on Africa, global health, global human rights, and international organizations; Rep. William Keating (D-MA) for the subcommittee on Europe, Eurasia, and emerging threats; Rep. Eni F.H. Faleomavaega (D-Samoa) for the subcommittee on Asia and the Pacific; and Rep. Albio Sires (D-NJ) for the subcommittee on the Western Hemisphere. Senate Appropriations and Budget Committees: Several new leaders have joined the Senate Appropriations Committee and the Senate Budget Committee, which are tasked with overseeing a “likely dwindling pool of federal dollars” across the US government. According to Science Speaks, both committees are now chaired by senators who hail “from two states that serve as headquarters to global health agenda setters.” Sen. Barbara Mikulski (D-MD) is the first woman to head the Senate Appropriations Committee. She represents Maryland, the home to the National Institutes of Health, and has been “lauded for her strong support for medical research and public health.” Sen. Richard Shelby (R- AL) is the new lead Republican on the committee. Shelby was one of eight senators to vote against the “fiscal cliff” deal, but has steadily supported PEPFAR. Sen. Patty Murray (D-WA)—whose state is home to global health groups such as the Bill & Melinda Gates Foundation, the Global Alliance to Prevent Prematurity and Stillbirth, the Infectious Disease Research Institute, PATH, Seattle BioMed, and the Washington Global Health Alliance—now heads the Senate Budget Committee. She has been recognized for her support of issues that include health and women’s equity. As co-chair of the Joint Select Committee on Deficit Reduction, Murray called on organizations to submit letters in support of the International Affairs budget.

In this guest post, Kirsten Thompson, MPH, and J. Joseph Speidel, MD, MPH, of the University of California, San Francisco, write about the need for new and improved contraceptive options worldwide. Today marks World Contraception Day, and there is much to celebrate about the successes of modern family planning. Women all over the world are having smaller, healthier, and more prosperous families, thanks in part to increased access to safe and effective contraception. As Melinda Gates points out, there is no controversy in empowering women to decide if and when to have a child. But the contraceptive revolution is far from finished. An estimated 222 million women in developing countries want to delay their next child or limit the size of their family, but are not using a contraceptive. As we near the deadlines for the Millennium Development Goals and the Every Woman, Every Child campaign, improving contraceptive access is one of the most cost effective solutions to reduce maternal and infant mortality, and prevent mother-to-child transmission of HIV. Voluntary use of contraceptives already prevents 218 million accidental pregnancies, 118,000 maternal deaths, and 1.8 million infant deaths each year—we could prevent millions more accidental pregnancies, and maternal and infant deaths with expanded access. Voluntary use of contraceptives already prevents 218 million accidental pregnancies, 118,000 maternal deaths, and 1.8 million infant deaths each year—we could prevent millions more with expanded access and increased R&D. Photo credit: PATH. Global leaders have committed to help expand access to family planning services, particularly in nations with underdeveloped health systems. While expanding access is critical to reaching global health and development goals, we also need to reinvigorate contraceptive research and development (R&D). Do we need new contraceptives? We’ve learned a lot about how women and men use family planning over the last 50 years, including what they like and don’t like about various contraceptives. In developing countries, the most common reasons for not using contraception—cited by 20 percent to 50 percent of married women at risk of an accidental pregnancy—were side effects, health concerns, and inconvenience. Up to half of women had stopped using a method because they experienced or feared side effects. It’s clear that some women find hormonal side effects unacceptable. We’ve also learned that humans find it almost universally difficult to take daily medication. Over half of people taking daily medicine regularly fail to take it, whether it’s a birth control pill, a medicine to treat high blood pressure, or an antibiotic to prevent a transplanted organ from being rejected. Taking any medication inconsistently means is doesn’t work as well. So in reality, we have only two highly effective and reversible contraceptives: the implant and the intrauterine device (IUD). Both of these require highly skilled healthcare providers for placement and removal, and for some women, they are prohibitively expensive. So we need to focus our efforts on creating, safe, effective, and innovative methods of family planning that can be used in low-resource settings. Research shows that there is demand for methods that don’t yet exist, such as: User-controlled methods that do not require daily action for effectiveness. Methods that prevent transmission of HIV and pregnancy simultaneously. Methods for women that do not require a male partner’s participation or knowledge. Methods that could be used once to prevent pregnancy around the time a woman has sex. Non-surgical methods of sterilization. No one contraceptive method works for everyone, and we know that offering a wide range of methods increases satisfaction with family planning services and increases the number of couples using contraception. Public funding for contraceptive R&D is critical and effective Of the contraceptives now available in the United States, the majority were developed with public funding at universities and nonprofit organizations, or with philanthropic support. The original birth control pill became available after support from philanthropists, and a new IUD under development by Medicines360 will follow suit. The Mirena and ParaGard IUDs, Ella emergency contraception, and the contraceptive vaginal ring were all developed with US public funding. The first implantable contraceptive Norplant, the female condom, and the new SILCS diaphragm were all developed with philanthropic and public funding. The injectable contraceptive Depo Provera was developed with private funding, but the studies that allowed it to be marketed in the US were carried out with public funding. The public sector—including the US Agency for International Development, the National Institutes of Health, and the World Health Organization—has a great track record for contraceptive R&D. The public sector is also able to conduct R&D at approximately one-tenth the cost of private pharmaceutical companies. With mergers and new management at large pharmaceutical companies in the last decade, none of these companies have active contraceptive R&D programs. The US public sector has been a global leader in past contraceptive R&D, but funding for this work has steadily declined in the last 30 years. The time is right for the US government to reinvigorate its commitment to leadership in this field, and reap the benefits in maternal and child health globally.