Breakthroughs Blog: USAID

Ahead of World AIDS Day, Secretary of State Hillary Rodham Clinton launched a new State Department blueprint to reach an “AIDS-free generation” within five years. “An AIDS-free generation will be within our sight,” Clinton said as she described the blueprint, which outlines key strategies the US will undertake to fight the HIV and AIDS pandemic. She also warned: “Now we have to deliver. … The history of global health is littered with grand plans that never panned out.” According to Clinton, an AIDS-free generation means that the world “can reach a point where virtually no children are born with the virus, and as these children become teenagers and adults, they are at a far lower risk of becoming infected than they are today. And if they do acquire HIV, they have access to treatment that helps prevent them from not only from developing AIDS, but from and passing the virus on to others.” The blueprint outlines several key actions to reach this goal, including: Scaling up the most effective prevention and treatment interventions. Targeting the populations at the greatest risk of contracting HIV, including people who inject drugs, sex workers, those trafficked into prostitution, and men who have sex with men. This also includes ensuring that HIV and AIDS programs recognize the particular needs of women and girls. Promoting sustainability, efficiency, and effectiveness. Promoting a global effort to achieve an AIDS-free generation. There have been several notable breakthroughs in HIV and AIDS science and research in recent years, and it’s critical that the US government prioritizes the development of new tools in any HIV and AIDS strategies and goals it creates. Photo credit: PATH. According to Clinton, science and research are key principles that must underlie each aspect of the AIDS-free generation blueprint. This includes US support for research to develop the next generation of “innovative technologies for prevention and treatment, such as microbicides and approaches that stave off opportunistic infections” like tuberculosis. It’s commendable that the US government is continuing its legacy as a leader in the fight against HIV and AIDS, as this blueprint indicates. It’s also encouraging that the blueprint focuses on developing new scientific breakthroughs in the fight against the disease. As Mitchell Warren from AVAC said in response to Clinton’s speech, “Powerful new HIV prevention options could together lead to dramatic reductions in HIV infections, but we don’t have all the information we need to scale them up in the right combinations for various communities. Urgent questions about the real-world use of new prevention tools in combination have been clear for months or even years, yet the work to answer them is barely under way. That’s as unconscionable as it is unnecessary.” There have been several notable breakthroughs in HIV and AIDS science and research in recent years, and it’s critical that the US government prioritizes the development of new tools in any HIV and AIDS strategies and goals it creates. But as Clinton stressed, it’s vital that the United States and its partners deliver on the promises outlined in the blueprint. According to the International AIDS Vaccine Initiative, the “realization of all this promise depends on sustained funding for HIV prevention research. Political will, too, must be sustained to secure the progress already made in the campaign against HIV. We must remember that any call to bring about the ‘end of AIDS’ will only be fulfilled if HIV prevention remains high on the list of global health priorities.” As the Obama Administration enters its second term in the new year, leaders across the Administration must ensure that the priorities outlined in this blueprint are fulfilled, particularly the US commitment to research and new HIV and AIDS tools. We cannot reach an AIDS-free generation otherwise.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The latest G-FINDER report finds that annual investment in neglected disease research and development (R&D) from donors worldwide has been in the decline in recent years. And while the report finds that the United States has maintained its position as the top funder of neglected disease R&D, US funding still decreased in 2011 by $30.6 million. A treatment for sleeping sickness has entered clinical trials in the Democratic Republic of the Congo, and trials will start soon in Central African Republic. The study was initiated by the Drugs for Neglected Diseases initiative (DNDi) and its partners. A new opinion piece argues that sequestration “would significantly delay new, life-saving medical treatments. But what many people don’t realize is that the massive cuts also would put a chokehold on the creation of high-tech jobs and threaten US global competitiveness.” The US Food and Drug Administration approved 35 new medicines in its fiscal year 2012, which ended in September, according to a new report. That number is one of the highest levels in years. Senators Patrick Leahy (D-VT) and Christopher Coons (D-DE) have introduced legislation that aims to bolster the US Patent and Trademark Office’s Patents for Humanity initiative by making certificates awarded through the program transferable to third parties.

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.