Breakthroughs Blog: Contraceptives

In the past, the United States has contributed to important breakthroughs in global health—from the eradication of smallpox to a 74 percent drop in measles deaths worldwide. Because of longstanding US leadership and support for global health research and development (R&D), Americans and millions around the world no longer live in fear of diseases like polio and measles, and many more are on treatment for diseases like HIV and AIDS and malaria. In fact, the US government is the largest supporter of global health R&D in the world, supporting the development and delivery of vaccines, drugs, diagnostics, microbicides, and devices. However, as we sit at a very important moment in global health product development, the political and economic environment in the United States is causing some to worry. Budget constraints have put funding at risk at many of the federal agencies involvement in global health R&D. Because of longstanding US leadership and support for global health research and development (R&D), Americans and millions around the world no longer live in fear of diseases like polio and measles, and many more are on treatment for diseases like HIV and AIDS and malaria. Photo: PATH/Evelyn Hockstein Today, the GHTC launches a new fact sheet outlining the important contributions the US government has made to global health R&D and why it’s critical the United States continues to robustly support the global health research pipeline. There are currently more global health products in the pipeline than ever before—with more than 365 new tools under development as of April 2012. Contributing to the success of many of these products is the US government’s partnerships with nonprofit product developers. These organizations partner with the public and private sectors to maximize resources and create tools for patients in low- and middle-income countries. Increased investments in global health research by the United States have the potential to increase the amount of tools combating global diseases. Just some of the products currently in the research pipeline include: The RTS,S malaria vaccine candidate, which is currently being tested and a policy recommendation for its use could be issued as early as 2015. Such a vaccine could reduce the burden of sickness and death from malaria. A new oral drug for sleeping sickness, fexinidazole, which recently entered late-stage clinical trials in patients in the Democratic Republic of the Congo. As a simple, short-course oral pill, fexinidazole could transform care for African sleeping sickness, which is fatal without treatment, and could potentially reduce its incidence among the most afflicted populations and accelerate elimination of the disease. Cost-effective diagnostics that are under development for malaria, tuberculosis, and neglected tropical diseases. These diagnostics could be administered in a variety of health care settings and could rapidly and accurately identify sick patients. An antiretroviral‐based microbicide which offers hope for women’s HIV prevention. Though more testing is needed following promising results from a 2010 advanced clinical trial, a microbicide could give women the power to protect themselves with or without their partners’ cooperation. In sub-Saharan Africa, where the epidemic has hit hardest, women 15 to 24 years old are at least twice as likely to be infected with HIV as young men.   In the research pipeline for global health products, 200 of the 365 products under development have some sort of US government support. With so much investment from the United States, there is even more at risk if funding is cut. Over the past several years, the US Congress has not been able to agree on a long-term budget for the federal government. Policymakers have allowed sequestration, or widespread automatic budget cuts, to affect all federal programs. These constraints have the potential to push back or halt promising research supported by several federal agencies involved in global health R&D—including the Centers for Disease Control and Prevention, the Department of Defense (DoD), the US Food and Drug Administration, the National Institutes of Health (NIH), and the US Agency for International Development (USAID). Due to sequestration: DoD is expected to receive budget cuts between 8 and 10 percent in fiscal year (FY) 2013. The DoD has been instrumental in the development of several global health technologies, many of which are used to protect Americans soldiers serving abroad. These cuts could affect the Walter Reed Army Institute of Research, the Naval Medical Research Center, and the Military HIV Research Program. NIH, the largest funder of global health R&D in the world, was forced to cut $1.7 billion from its budget by the end of FY 2013. NIH conducts nearly half the early-stage global health research, and supports thousands of domestic jobs all around the United States. USAID—with a presence in more than 100 countries—is best suited to support the clinical trials in low- and middle-income countries that ensure basic research is translated into appropriate health products. USAID is the largest supporter of HIV vaccine and microbicide development—both of which will be essential to achieve an AIDS-free generation. For many of the products currently in the global health research pipeline, continuous US support is essential. Without it, much of the breakthrough research that pushed these products to later-stage development will be lost—sometimes forever. US leaders should seize upon the recent successes in global health R&D and pass a long-term budget that ensures America’s legacy as a leader in innovation and science is not forgotten.

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.