Breakthroughs Blog: NIH

Did you know that Americans spend more money on ice cream in three weeks than the US Government spends on global health research and development (R&D) in a year? And despite this relatively modest investment in the creation of new global health tools, the United States is the worldwide leader in R&D for neglected diseases. When we at the GHTC tell US policymakers the story of how global health R&D has revolutionized people’s lives around the world, we highlight the prominent role that the US Government plays in funding and supporting the development of new global health tools. We’ve always believed that US leads the world in investment in global health R&D, and that this comparatively small investment has paid off many times over in lives and dollars saved. We’ve seen the effectiveness of US-funded technologies like the polio vaccine, oral rehydration solution, and HIV and AIDS drugs. We’ve known that tools in the pipeline would have similar game-changing effects. And now we have the evidence to prove it. A new report, released today by the GHTC and Policy Cures, provides important confirmation that the US is the largest global health R&D funder in the world, investing $12.7 billion over the last decade. A new report, released today by the GHTC and Policy Cures, provides important confirmation that the US is the largest global health R&D funder in the world, investing $12.7 billion over the last decade. In fact, the US government in the last decade more than doubled its annual commitment to developing new global health products, from $685 million in 2000 to $1.4 billion in 2010. These investments represent just 0.01 percent of US gross domestic product. Our report confirms the strong leadership role the US has played in the global health R&D landscape, and also includes new information on spending and support by key US federal agencies—the Centers for Disease Control and Prevention, Department of Defense, US Food and Drug Administration, National Institutes of Health, and US Agency for International Development. New information also details the public health impact of products already on the market, and new health and economic projections detail the possible impact for health tools still in development. There is an exciting pipeline of 365 new vaccines, drugs, diagnostic, and other products for global health, and the US Government is supporting 200 of them. These are just a few examples of the immense impact of global health R&D, and the incredible benefits it will continue to have if robust support continues. The US is not alone in this effort—many governments around the globe, philanthropic foundations, and private industry partners provide large amounts of funding, technical expertise, and key intellectual property to develop new global health tools. The global health R&D landscape would not be the same without these important allies. While the success of US investment in global health R&D is exceptional, the report makes clear that sustained and increased US support is essential to ensuring that the potential of global health research is not lost. The report provides recommendations for how the US Government can maximize its investments in new global health products. The recommendations are: The US Government should maintain its funding for global health R&D, and increase this funding where possible. The US Government needs to have a greater focus on the later stages of research and product development to fully leverage its global health R&D investments. The US Government should increase funding to partnering mechanisms that are focused on translation of global health research. With all of the amazing results of global health R&D we have seen—and with this new evidence that global health R&D is a worthwhile, cost-effective investment—it would be a shame to retreat now. With the US leadership role comes the responsibility to continue pushing the boundaries of science and leading the world in combating global health diseases.

In this guest post, Dick Walker—director of the Enteric Vaccine Initiative at PATH’s Vaccine Development Program—writes about how the double-mutant heat-labile toxin is a potential booster for much-needed new vaccines against diarrhea. The leading bacterial causes of diarrhea are enterotoxigenic Escherichia coli (ETEC) and Shigella, and vaccines against these pathogens could save the lives of up to a half-million children each year. PATH’s enteric vaccine project is working to accelerate the development of several promising vaccine candidates. We are also looking at innovative ways to make these vaccines as effective, practical, and affordable as possible so they can be easily implemented in the developing world. Adjuvants, ingredients that may enhance the effectiveness of some vaccines, are one important area of focus. PATH is currently involved in research on a highly promising new adjuvant, the double-mutant heat-labile toxin (dmLT), which could open more doors to achieving immunity in the intestine. The dmLT is actually an ETEC antigen (a substance that causes the immune system to produce antibodies against it), so it may offer protection against both diarrhea and intestinal infection when used in conjunction with vaccines that are targeted to mucosal surfaces like the intestine. We aren’t exactly sure why, but children in resource-poor countries often have a lower response rate to mucosal vaccines. A wide range of factors may contribute to this issue, such as the influence of breastfeeding and maternal antibodies, poor nutrition, or increased exposure to intestinal pathogens. An adjuvant like the dmLT may help to bridge this gap in effectiveness. Dick Walker with children in Cambodia. Promising vaccine technologies can help expand and improve the arsenal of tools to use in the fight against diarrhea among children. Right now, we’re working with the National Institutes of Health’s (NIH) Division of Microbiology and Infectious Diseases on a Phase 1 clinical trial using oral doses of dmLT (not in conjunction with a vaccine) in healthy adults. We will have complete results later this year, but the preliminary data are quite promising. Meanwhile, we are about to launch our first Phase 1 trial of the dmLT combined with one of our oral ETEC vaccine candidates. In addition, we plan to start another Phase 1 trial to test the dmLT intradermally (through the skin), and we would also like to study its use sublingually (under the tongue), to see if these alternative delivery routes can achieve an immune response in the intestine. If preclinical studies accurately predict what will be seen in humans, delivering dmLT in these ways could open up a whole range of possibilities for developing more effective and practical vaccines. This type of innovative research is critical to moving forward the field of vaccines to address diarrheal disease, and support from the NIH and other partners is critical to this effort. As the dmLT and other promising vaccine technologies progress in their development, we know we are getting ever closer to expanding and improving the arsenal of tools to use in the fight against this major killer of children.

Research!America, a GHTC member, recently hosted an event on global health research and development (R&D) in New York. In this guest post, Mandy Goldberg, MPH, shares highlights from the event. Research!America, in partnership with the AIDS Vaccine Advocacy Coalition (AVAC), Drugs for Neglected Diseases initiative North America (DNDi), Global Alliance for TB Drug Development (TB Alliance), International AIDS Vaccine Initiative (IAVI), SUNY Downstate Medical Center, and Treatment Action Group (TAG), hosted a forum, Global Health Research and Development in New York: Fueling Innovation and Saving Lives, on Monday, April 9, at the New York Academy of Sciences. Mary Woolley, president and CEO of Research!America, opened the forum by acknowledging the remarkable progress made in the growing field of global health research in New York in the past decade. She also released the results of a new state poll commissioned by Research!America that shows that 64 percent of New Yorkers are concerned about global health, and 63 percent believe that global health research is important to New York’s economy. Congresswoman Nita Lowey (D-NY-18) then took the stage and explained the significance of global health R&D as an economic driver that creates jobs for New Yorkers. She stated that “despite the critical importance and significant economic impact of these programs, funding for global health is threatened again this year” in regard to the proposed fiscal year (FY) 2013 budget, and pledged to continue fighting for “robust funding for all our global health programs, including critical research and development.” Renowned global health commentator Laurie Garrett, senior fellow for global health at the Council on Foreign Relations, moderated a discussion between panelists Rachel Cohen, regional executive director, DNDi North America; Jack DeHovitz, MD, MPH, distinguished service professor and director, SUNY Downstate AIDS International Training and Research Program; Margaret McGlynn, president and CEO, IAVI; Mel Spigelman, MD, president and CEO, TB Alliance; and Pol Vandenbroucke, MD, vice president of development, emerging markets, Pfizer. In her opening remarks, Garrett emphasized the importance of the US commitment to global health funding, especially after the 2008 financial crisis, when “the United States stepped up to the plate” after the community saw “a huge number of players disappear” from the field. She stated that “if we cannot protect the US commitment to global heath spending, every single program in global health is going to have to chop, chop, chop its budget.” Laurie Garrett moderated a panel including Mel Spigelman, Pol Vanderbroucke, Rachel Cohen, Margaret McGlynn, and Jack DeHovitz. Panelists then discussed how innovative partnerships among public, private, and academic sectors are transforming the way that research is conducted and yielding promising developments for the future of global health. Spigelman highlighted that the TB Alliance is “on the verge” of technological breakthroughs, which require an increased commitment to research due to the costly final stages of testing and clinical trials. Partnerships in global health R&D are cost-effective, he argued, citing the TB Alliance’s NC-002 clinical trial conducted in partnership with the US Agency for International Development, Bayer, and Novartis. This trial has the potential to produce a drug regimen that could reduce the TB treatment to 4 months, potentially saving as much as 90 percent of current costs. Vandenbroucke emphasized that the private sector has unique resources and capabilities to contribute to partnerships that are essential for the development of health technologies. He stated that cuts to the federal budget would affect the work of the pharmaceutical industry “in the long term, as less funds are available to do the basic groundwork to study diseases” that Pfizer then applies during its advanced drug development process. Cohen expressed concern over the fact that neglected tropical diseases (NTDs) received the single largest percentage funding cut of the global health programs in the President’s FY 2013 budget request and the impact this would have on DNDi’s work. She noted that there is currently no federal funding available for late-stage product development for NTDs, and the current FY 2013 budget request “totally eviscerates the possibility of future investments, at least for the coming 2 years,” if passed, which threatens the continued progress of DNDi’s efforts. McGlynn spoke about the evolution of IAVI from an advocacy organization to a product development partnership, with the support of Mayor Bloomberg and New York City. IAVI’s Vaccine Design and Development Laboratory, established in Brooklyn in 2006, plays a pivotal role in the Mayor’s New York City Bioscience Initiative and is a key component of IAVI’s global AIDS vaccine R&D network. McGlynn stressed that the scientific expertise of New York City’s “globally educated and raised” workforce has been essential to IAVI’s work, and to the growth of global health R&D in the area. DeHovitz reinforced that multisectoral collaborations have yielded major advancements in the field of HIV and AIDS. He cited the federal contribution to international HIV and AIDS through the work of the Fogarty International Center at the National Institutes of Health, which funds advanced research training in public health at five New York City universities. He also spoke of “the huge upsurge of interest among our health care students in global health,” stating that 45 percent of medical school entrants are interested in global health and 30 percent of medical school graduates have had a global health experience in school. “They’re committed, they’re interested and they want to help,” he said, noting the potential impact of this group to the future of global health. New York—home to seven of the top 50 US research universities, the largest bioscience workforce and second-largest life sciences workforce of any US city, and three global health product development partnerships (PDPs)—is clearly a world leader in global health R&D, and this growing industry is a promising economic engine for the state. There was a general consensus in the room that the community needs to work together to ensure that global health R&D remains a priority. Great progress has been made in the development of new technologies to fight TB, HIV and AIDS, and NTDs, and increased funding is needed to sustain this momentum and build upon previous successes. Spigelman noted that the current “slash and burn” Congress could have a devastating effect on global health efforts, and argued that the US will get “the most bang for that buck” by investing in global health technologies that will reduce the foreign aid budget in the long term. Woolley concluded the forum with a call to action, asking the global health community to share with others, including their members of Congress, the importance of the work that they do. A video of the event is available here. For more information on global health R&D in New York, check out the New York edition of Research!America’s economic impact state fact sheet and public opinion poll series.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) has released its final report. The report offers recommendations to close the funding gap in global health research and development. The Fogarty International Center and other programs at the National Institutes of Health are awarding about $20.3 million over the next five years to train the next generation of global health researchers and scientists. The US Agency for International Development (USAID) has released a new policy that aims to ensure the quality and integrity of the agency's scientific activities. The report recognizes that USAID is the US Government’s “lead international development agency, for which science and technology are critical means for improving the quality of peoples’ lives around the world.” A new study offers insight into promising new targets for future HIV vaccine efforts.