Breakthroughs Blog: Microbicides

In this guest post, Emily Donaldson—program coordinator at AVAC—and Tom Harmon—senior policy analyst at the International AIDS Vaccine Initiative (IAVI)—write about the state of HIV prevention research funding as the first-ever conference devoted solely to HIV prevention research and development (R&D) takes place in Cape Town, South Africa, this week. Progress toward new tools to prevent HIV infection—including vaccines, microbicides, the use of antiretroviral treatment as HIV prevention, pre-exposure prophylaxis (PrEP), and a host of other options—is being presented and discussed at the inaugural HIV Research for Prevention Conference (HIVR4P) in Cape Town this week. While much progress has been made over the last few years, a four percent decline in funding between 2012 and 2013 speaks to the uncertain nature of the global environment in which that research is taking place. Such cuts hinder the ability of the researchers in Cape Town and across the globe to continue their work and could delay progress toward efficacy trials and eventual rollout of new prevention options. Investment data for almost every technology being discussed in Cape Town can be found in HIV Prevention Research & Development Investment in 2013: In a changing global development, economic, and human rights landscape—the most recent annual report by the HIV Vaccines and Microbicides Resource Tracking Working Group. The data show that the US government continued to fund more than 70 percent of HIV prevention R&D efforts in 2013. The combination of recent funding cuts across all US government budgets and declines in European investment in HIV prevention R&D led to the overall decline in funding from the previous year. Relying on such a small number of very committed donors is problematic when one or more of those donors is forced to reduce their support.The report also highlights funding declines in nearly every category of HIV prevention R&D, underscoring an urgent need to sustain and diversify funding sources through partnerships between governments, philanthropies, and the biopharmaceutical industry. The 2013 data provoke a concern that HIV prevention R&D is increasingly becoming a lower priority for public agencies funding international development, as portfolios and priorities within those agencies shift. Global health and development negotiations such as those around developing successors to the United Nations’ Millennium Development Goals take place far from the context of most HIV prevention clinical trials, but such international commitment at the highest levels can keep HIV and AIDS a priority for development agencies that can bolster support for science, technology, and innovation in endemic countries to end the epidemic. The report also compiles the number of volunteers taking part in HIV prevention R&D trials, which totaled almost 670,000 people in 2013. Most of these individuals are based in sub-Saharan Africa where the epidemic has its most profound impact and where several large-scale treatment-as-prevention and voluntary medical male circumcision trials and projects are underway. However, that balance doesn’t cut across all new prevention technologies—80 percent of volunteers in vaccine and PrEP trials reside in the United States and Europe. Ensuring that new HIV prevention options are appropriate and acceptable means testing them in partnership with those regions and those communities that need them most. Such communities are represented here at HIVR4P, and we’re excited by the opportunity to see them mingling with the experts working tirelessly to improve the state of HIV prevention R&D science and in turn hasten an end to the AIDS epidemic. However, they can’t do it without a diverse, committed investment base. Funding data show signals of vulnerability in support for HIV prevention R&D and support the need for policymakers and advocates to ensure that the state of the field remains a healthy one. The HIV Vaccines and Microbicides Resource Tracking Working Group consists of AVAC, IAVI, and the Joint United Nations Programme on HIV and AIDS. The report and summary materials are available at www.hivresourcetracking.org.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. In a bit of good news, the fiscal year (FY) 2015 defense appropriations bill—which was approved by the Appropriations Committee last Thursday—includes a $7 million increase for peer-reviewed medical research—from $200 million in FY 2014 to $207 million this year—despite a reduction in overall Department of Defense (DoD) funding from FY 2014 levels. In addition, in the accompanying report, the Appropriations Committee included very strong language recognizing DoD’s substantial contributions to global health research and development (R&D) and the need to support sustained US investments in this area. FHI 360 sat down with International Partnership for Microbicides CEO Zeda Rosenberg to discuss last week’s 20th International AIDS Conference. In this short video, Rosenberg highlights the need to focus on key populations—such as young women in sub-Saharan Africa—and the importance of women-initiated products like microbicides as a HIV prevention tool. Nearly 40 years after the discovery of the Ebola virus, no licensed treatments or prevention options are currently available. With the largest outbreak ever of the virus currently underway in West Africa, some are arguing that scientists should begin to develop new drugs and vaccines to combat this deadly disease. According to CNN, it’s likely too late for a vaccine to have enough of a preventative impact now, but using this time to test experimental vaccines—such as one developed by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health—could help when Ebola emerges again in the future. Last week, the United Nation (UN) General Assembly’s Open Working Group on Sustainable Development Goals released its proposal for a set of goals to succeed the UN Millennium Development Goals which come to an end in 2015. These proposed goals—referred to as the Sustainable Development Goals—will define the post-2015 development agenda. Of the 17 proposed goals put forward by the group, two contain targets related to R&D of new health technologies. Chagas disease—a neglected tropical disease (NTD) transmitted from the kissing bug and affecting millions of people in Latin America—is now on the rise in northern Virginia. Some doctors in the United States are not familiar with the disease and therefore do not test their patients regularly, which poses a risk to the general population in the United States. Many of the 8 million people with Chagas disease around the world never show signs of the disease, but about a third develop heart disease or megacolon and—when untreated—appear to die from sudden heart attacks. Chagas disease is just one example of NTDs affecting more and more people in the United States.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. During the past year, leaders from the US Global Leadership Coalition (USGLC)—an advocacy organization promoting diplomacy and development—have traveled across America seeking out innovators and innovations that best demonstrate how strategic US investments in global development can enhance America’s foreign policy and security interests—an approach USGLC calls “smart power” diplomacy. USGLC’s report—Innovations in Smart Power—featured PATH’s Vaccine Vial Monitor and the Public Health Institute’s Global Health Fellows Program II. Dr. Francis Collins—director of the National Institutes of Health (NIH)—announced on the NIH Director’s blog that NIH will, through its various institutes and centers, begin piloting the idea of awarding longer grants that offer more sustained support for investigators in the hopes it will allow them greater freedom to innovate. Currently, most NIH-funded grants are “project-based”—meaning applicants have very clear research aims for what they will accomplish in a defined period of time, typically between 3-5 years. Policy Cures released a report—titled Tuberculosis: The Last Mile—which explains why current treatments to tuberculosis (TB) control aren’t working; provides a snapshot of the major funders in TB research and development (R&D); and outlines what new products are in the TB pipeline, and how these products could change the future for patients with TB. Last month, the Bill & Melinda Gates Foundation awarded exploratory grants—as part of its Grand Challenges in Global Health program—to three projects aimed on improving the design of the female condom to make it easier to use and more pleasurable. Currently, female condoms represent only a small part of the overall commercial market and are not as widely used as a prevention tool by the global health community. “Female condoms give women a choice to say: ‘Okay, if you don’t want to wear one, I will,’” said Debby Herbenick, one of the grant recipients. GHTC members AVAC and the International AIDS Vaccine Initiative, as part of the HIV Vaccines & Microbicides Resource Tracking Working Group, released a new report tracking funding for HIV prevention R&D in 2013. The report found funding was down by US$ 50 million—or four percent—when compared to 2012. The 2013 decrease can be attributed largely to diminished US investment in all areas of HIV prevention research, as well as significantly reduced investment in some European countries.

Tomorrow US policymakers and global health advocates will come together to talk progress made on preventing maternal and child deaths. During the day, the US Agency for International Development (USAID) will host a high-level forum called Acting on the Call: Ending Preventable Child and Maternal Deaths to both celebrate progress and assess the challenges that remain. That evening, the 5th Birthday and Beyond coalition will celebrate America’s leadership and investments worldwide to help children reach their fifth birthday. US investment in R&D has led to new innovations that are saving the lives of mothers and children. Photo: PATH/Teresa Guillien While you’ll probably hear a lot of different facts and figures, one message will be clear—the world has made remarkable progress in preventing the deaths of millions of women and children. In fact, maternal and child deaths have been cut in half in just over two decades. That means that every day this year, 17,000 more children will live and 700 more mothers will survive childbirth than did two decades ago. Central to this progress has been US investment in research and development (R&D) that has led to new medicines and innovative health products that are saving the lives of mothers and children. Globally new vaccines, drugs, diagnostics, and other health innovations have led to 4.2 million fewer child deaths in 2013 compared to 1990, according to a report by the Institute for Health Metrics and Evaluation. Innovations like the polio vaccine, oral rehydration solution to treat diarrhea, and antiretroviral therapies that prevent maternal to child HIV transfer, and others treatments have resulted in incredible gains for maternal and child health.   No country has done more than the United States to help save the lives of the world’s poorest mothers and children. A critical part of the US approach has been our world-leading investment in global health R&D. In fact, the US government is the largest funder of global heath R&D in the world—contributing over 45 percent of total investment. US government investment in global health R&D has led to breakthroughs that have transformed or are poised to transform efforts to reduce maternal and child mortality. Some examples include: The Oxytocin-Uniject™ This is a device filled with oxytocin that helps contract the uterus to reduce post-partum hemorrhage—or excessive bleeding—the leading cause of maternal death worldwide. It is easy to inject and requires little training to administer, so it’s made a dramatic difference in the ability of health workers to administer oxytocin in emergencies or in remote locations outside of traditional hospital facilities. USAID played a crucial role in funding research towards the development of this product. RTS,S malaria vaccine candidate RTS,S is the most clinically-advanced vaccine candidate for malaria—a disease which kills a child every 40 seconds. A recent study showed that infants who receive the RTS, S vaccine had one third fewer cases of both clinical and severe malaria. A vaccine could be an important tool in reducing child sickness and death from malaria. The Department of Defense provided critical funding for the early development and clinical testing of RTS,S. Rotavirus vaccines Rotavirus-induced diarrheal disease kills roughly 435,000 children younger than five each year. Two currently available rotavirus vaccines were introduced in the past two decades, with other vaccines under development showing tremendous progress. The National Institutes of Health developed the first available rotavirus vaccine and has been a financial partner in the development of subsequent vaccines. In addition, the Centers for Disease Control and Prevention also monitors efficacy and safety, and supports clinical trials of rotavirus vaccines. New contraceptive technologies Family planning technologies allow women to space their pregnancies—making it more likely for both the mother and child to survive childbirth. An analysis of 172 countries found that family planning prevented 272,000 maternal deaths in just one year. However, the contraceptive options that exist today don’t always meet the needs of women in developing countries. New vaginal rings are being developed that will be long-lasting and easy for the user to insert and remove without a doctor’s assistance, while new multipurpose prevention technologies combine the delivery of contraceptives with microbicides which reduce the transmission of HIV and other sexually transmitted infections. USAID provides funding towards the development of many of these new contraceptive technologies. While tremendous progress has been made in decreasing maternal and child deaths worldwide thanks in part to new health innovations, each year 6.6 million children still die before their first birthday and 289,000 women still die from pregnancy-related causes. That translates to 18,000 children under the age of five and 800 pregnant women or women in childbirth dying every single day. The United States can and must do more. While the United States should increase access to proven and existing drugs, vaccines, and other health tools for maternal and child health, it is just as critical to develop the next generation of tools to prevent and treat existing and emerging diseases. Sustained and continued investment by the US government in global health R&D is critical to ending maternal and child deaths.