Breakthroughs Blog: NIH

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.

In this guest post, Rachel Cohen—regional executive director of the Drugs for Neglected Diseases initiative (DNDi) North America—writes about the need for research to develop new health products for neglected tropical diseases (NTDs). This post originally appeared on the US Agency for International Development’s (USAID) Impact blog . The United States government and its country partners should be commended for the tremendous achievements in the fight against neglected tropical diseases (NTDs) as part of the USAID NTD Program. When it comes to research, the US government also plays a major role in NTDs: the National Institutes of Health is by far the largest funder of basic research for NTDs. The commitment to NTD implementation programs and research has spanned several presidential administrations, receiving widespread bipartisan support from both sides of the congressional aisle. However, not all NTD research is created equal. Beyond basic research, much more research and development (R&D), including late-stage product development, for new drugs, vaccines, and diagnostics is urgently needed for those NTDs where adequate tools do not exist. Without such new tools, disease control and elimination will not be possible for certain NTDs—greater investments in research are urgently needed. For example, when it comes to the filarial parasitic-worm diseases of river blindness (onchocerciasis) and elephantiasis (lymphatic filariasis), which together infect over 150 million people, the standard treatment of ivermectin, alone or in combination with albendazole, can lead to brain damage or death in people co-infected with loiasis (Loa loa, also called African eye worm). Also, current drugs kill only juvenile and not adult worms, which continue to infect, requiring repeated mass drug administrations. The Drugs for Neglected Diseases initiative (DNDi)—a nonprofit R&D organization—is looking to develop a new macrofilaricide (a drug targeting adult worms) to address this gap in NTD treatment. Of the 17 NTDs defined by the World Health Organization, DNDi focuses most of its attention on the three with the highest case fatality rates—African sleeping sickness, Chagas disease, and kala azar (visceral leishmaniasis, or black fever). These diseases are not yet included in the USAID NTD Program. Although cases of African sleeping sickness (human African trypanosomiasis) have dropped over recent years, this fatal disease continues to infect people in remote, conflict-ridden pockets of the Democratic Republic of Congo, among other hotspots. Diagnostic tools are inadequate—painful lumbar punctures must be performed—and the current treatment requires hospitalization and intravenous infusions, which are difficult in unstable, resource-poor settings. DNDi is therefore aiming to develop an easy-to-take oral pill for sleeping sickness, which can treat both stages of the disease and do away with the need for painful lumbar punctures. This would go a long way in helping eliminate the disease once and for all. While continuing to provide existing medicines for NTDs, greater commitment to developing new NTD treatments and other tools is sorely needed if disease control or elimination is to be achieved. Patients infected now with these neglected afflictions are anxiously waiting.

Since our last update on the latest budget action on the Hill, two significant events happened late last week in Congress and at the White House. First, the White House’s Office of Management and Budget (OMB) released a report on the potential impact of sequestration on federal agencies. Sequestration would require a reduction in government spending of $109 billion per year for nine years, beginning in January 2013. According to the report, most defense programs relevant to global health—including global health research and development (R&D) programs at the Department of Defense—would receive a 9.4 percent cut under sequestration. Non-defense programs—including most programs at the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the US Food and Drug Administration (FDA), the State Department, and the US Agency for International Development (USAID)—that are not exempt from cuts would receive an 8.2 percent cut. It’s important to note that some parts of these programs’ funds are exempt from cuts. For instance, out of a total budget of $34.249 billion for the NIH in fiscal year (FY) 2013, the sequestration applies to $30.861 billion. The rest is exempt. As for the primary agencies that fund global health and R&D programming, the report finds that: The total cut to NIH would equal $2.529 billion. This would put NIH’s total funding for FY 2013 at $31.720 billion. At USAID, the Global Health Programs account—the account responsible for all of USAID’s global health R&D work—would be cut by $670 million, leaving the final global health program’s funding level at $7.498 billion. The FDA, which plays a key role in regulating global health products, would see a cut of $318 million, with a final funding level of $3.624 billion (not including funding from user fees). The CDC would see a cut of $470 million from its overall funding, with $464 million coming from non-defense activities funding. This leaves CDC with a final funding level of $6.861 billion. These predictions are based on current FY 2012 funding levels. Many of these agency programs are already dealing with looming cuts to their funding levels for next year under various congressional budget proposals. If FY 2013 appropriations bills in Congress reduce agencies’ funding even further, the sequestration cuts would be even steeper than what’s outlined in the OMB report. Second, the House of Representatives late last week approved a Continuing Resolution (CR) for FY 2013, in order to keep the government running through the end of March 2013. The House approved the measure by a vote of 329-91, with 70 Republicans and 21 Democrats in opposition. The bill now moves to the Senate and is expected to pass this week. The CR funds the government at $1.047 trillion, consistent with the Budget Control Act. It also includes a slight 0.6 percent increase across the board for all federal programs, essentially maintaining spending at current levels. The CR provides a total of $55.2 billion for International Affairs, slightly higher than the $54.9 billion current level and higher than either the House or Senate FY 2013 appropriations recommendations. House Appropriations Committee Chair Hal Rogers (R-KY) said that lawmakers will aim to finalize appropriations bills when they return to work after the November elections. “We intend to use the lame-duck session to the fullest extent,” he said, adding, “Just because this CR will last until March 27 of next year, we will not rest on our laurels until that time.”