Kim Lufkin

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. In a continuation of the US Agency for International Development’s (USAID) focus on global health science and technology, GHTC members PATH and Research!America write about the health and economic benefits of US investments in product development. In related news, USAID has released new figures detailing how over the past decade, the agency has been involved in more than 1,600 public-private partnerships with more than 3,000 individual entities The National Institutes of Health published figures detailing how sequestration will impact its 2013 budget. According to the figures, available funds will drop by $1.55 billion from last year. Aeras received at $2.9 million grant from the Bill & Melinda Gates Foundation to work in collaboration with the University of Oxford and biopharmaceutical company Okairos to support the development of vaccines against tuberculosis, HIV, and malaria. PATH has launched a clinical trial in Bangladesh to test a new formulation of oral rehydration solution, a therapy to combat severe dehydration resulting from diarrheal disease.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The US Agency for International Development is celebrating the role of science and innovation in improving global health from May 1-10. The Drugs for Neglected Diseases initiative (DNDi) was selected as one of two finalists for the Rockefeller Foundation's "Next Century Innovators Award." DNDi was chosen from among 1,000 nominations for its innovative approach to research and development to address the urgent health needs of the world's most neglected and vulnerable people. The National Institute of Allergy and Infectious Diseases has announced that a clinical trial, called HVTN 505, evaluating a two-part HIV vaccine candidate has been halted. The GHTC recently released the Global Health Regulatory Requirements Database, a unique resource designed to help researchers and regulatory professionals access needed information to secure approval to conduct clinical trials and market products. Rep. Gerry Connolly (D-VA) has introduced the Global Partnerships Act of 2013, which would overhaul the Foreign Assistance Act of 1961 and make US foreign assistance more efficient and effective.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The US Centers for Disease Control and Prevention (CDC) has released a new global health strategy for 2012 to 2015. The strategy includes four broad goals the agency would like to achieve in that timeframe, and it also includes a focus on global health research and capacity building in developing countries. The CDC “aspires to create a world where people live healthier, safer, and longer lives,” the strategy says, adding, “The agency will draw upon innovation and research to meet these combined challenges and assure even greater health impact in the future.” A recent CNN interview with Dr. Peter Hotez, dean of the National School of Tropical Medicine and president of the Sabin Vaccine Institute, highlights the growing emergence of neglected tropical diseases in US populations. Citing poverty as the overriding factor, Dr. Hotez explained that neglected tropical diseases such as Chagas disease, cisticercosis, toxocariasis, and dengue fever are contributing greatly to the burden of disease in the US. President Obama has signed the Food and Drug Administration Safety and Innovation Act into law. The bipartisan bill reauthorizes both the Prescription Drug User Fee Act and Medical Device User Fee Act, and adds health technologies for rare diseases to the list of product categories that may qualify for accelerated FDA review. The US Agency for International Development and the National Institutes of Health have launched a new grant program that promotes research to help end preventable child deaths and promote child survival in developing countries. Called the Partnerships for Enhanced Engagement in Research Health, the program will provide up to $450,000 over three years to each awardee to support collaborations that address research-to-practice barriers in child survival. At last week’s London Summit on Family Planning, the Bill & Melinda Gates Foundation announced that it will spend more than $1 billion over the next eight years to increase access to contraceptives in the developing world and to support research for new methods of birth control. Additionally, public-private partnerships at the summit made announcements regarding increased access to and research for contraceptives in sub-Saharan Africa and South Asia.

“I can’t think of a reason why academic scientists should not engage in global health research,” Dr. Dennis Kyle, distinguished university health professor at the University of South Florida, said last week at the Consortium of Universities for Global Health (CUGH) annual conference. Kyle was speaking at a panel hosted by the GHTC, which focused on current fiscal and policy realities in the United States that will impact global health research and development (R&D) in the coming year and beyond. Kyle and other panelists stressed the importance of partnerships across a range of sectors to advance global health R&D and develop promising new global health tools. “Academic partners can be incredibly successful in product development,” Kyle said, adding that the university scientists are “great sources of innovation.” Dr. Dennis Schmatz—board chair and president of Medicines for Malaria Venture (MMV) North America—echoed that product development partnerships like MMV rely on collaborations with universities and other sectors, such as governments, pharmaceutical companies, and philanthropic donors. “Product development partnerships are a powerful model that brings together academia, the pharmaceutical industry, and many other sectors to focus on a single mission: developing lifesaving new health products,” he said. As an example of how successful such partnerships can be, Schmatz cited that to date, MMV has helped register or prequalify four new malaria medicines, with seven promising new treatments currently in development. The panel also focused on how sequestration and budget cuts could impact their work in global health R&D. “We know that the academic community has so much to offer,” Dr. Ticora Jones, Higher Education Solutions Network (HESN) manager at the US Agency for International Development (USAID) said. She added that USAID is “moving forward, building partnerships in spite of sequestration. USAID wholeheartedly supports harnessing science and technology to solve development challenges.” Jones cited HESN—which aims to create hubs for innovation at US colleges and universities—as an example of how USAID will continue to build partnerships for global health and other development issues. She also stressed that USAID frequently collaborates with other US federal agencies, such as the National Institutes of Health and NASA, on international development challenges. Karen Goraleski, executive director of the American Society for Tropical Medicine and Hygiene, emphasized that sequestration and other budget cuts have forever changed how global health researchers should advocate for continued support for their work. In addition to the humanitarian and lifesaving benefits of global health R&D, Goraleski stressed that researchers should discuss the domestic benefits of US government support, such as job creation and diplomacy. “Research is a good bet, and will always be a good bet, for creating jobs at home and forging diplomatic ties abroad,” she said, adding, “Researchers and scientists often develop long-lasting and hugely beneficial relationships with universities and communities overseas.” Kyle also argued that global health research creates economic benefits for US universities and state academic institutions. For instance, the Kyle Lab at the University of South Florida provides jobs for 90 people at the university. “Those are real dollars and real jobs,” he said. Kyle added that US support for global health research helps train the next generation of health scientists. If US support for global health R&D is severely cut due to sequestration, “we’d lose the next generation of scientists. We can’t just train these people and then have it turn into a situation where there’s no avenue for them to continue their work,” he said. Finally, all panelists highlighted that investments in global health research and product development are needed over the long-term, given the timeframe needed to create successful new products. “Innovation takes time,” Schmatz said, adding, “We need to keep vigilant, as new threats like drug resistance always create the need for new and better products. You can’t stop or you’ll lose all the ground you’ve gained.”

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Congresswoman Barbara Lee (D-CA) has released the Ending the HIV and AIDS Epidemic Act of 2012, a bill that outlines a policy and financing framework to achieve an AIDS-free generation in the United States and globally. The bill was introduced in advance of the XIX International AIDS Conference next week. The Drugs for Neglected Diseases initiative, in collaboration with Indian drug manufacturer Cipla, has announced plans to develop and produce an improved first-line antiretroviral combination therapy specifically adapted to meet the treatment needs of infants and toddlers living with HIV and AIDS. A recent blog post on AIDS.gov by Col. Nelson Michael, director of the US Military HIV Research Program at the Walter Reed Army Institute of Research, discusses efforts to develop an HIV vaccine through an ongoing public-private partnership. The first-ever global scientific strategy to develop an HIV and AIDS cure was launched ahead of the XIX International AIDS Conference. The strategy identifies seven important priority areas for basic, translational, and clinical research. It also maps a path for future research collaboration and funding opportunities. The European Commission has announced plans to open access to scientific research results to foster increased innovation. The commission hopes that the new policy will allow broader and quicker access to scientific papers, as well as make it easier for researchers and businesses to build on the findings of publicly funded research.

Although we’re several days into sequestration, details about the full impact of funding cuts are still hazy. On Friday, the Office of Management and Budget (OMB) released a report to Congress, which details funding cuts required to offset $85 billion in the fiscal year (FY) 2013 budget. In order to reach this goal, the OMB report indicates that global health research and development (R&D) programs will be subjected to cuts of either 5 percent or 7.8 percent. But because the cuts must take place over a seven month period (instead of a full year) to fit within the fiscal year, OMB calculates that these cuts could actually be at a rate of 9 percent and 13 percent with the remaining funding for this year. OMB’s report provides some specific details on how the cuts are calculated. It also provides illustrative examples of what the sequestration cuts might look like if applied equally within federal agency budgets. However, because agency heads will have discretion over how specific cuts affect their agencies, the exact implications of sequestration will be determined in the coming weeks. Estimates are emerging regarding the widespread impact of sequestration on the agencies that support global health R&D. Photo credit: PATH While waiting for these details to come out, we are starting to see some estimates emerge regarding the impact of sequestration on the agencies that support global health R&D. For example: The National Institutes of Health’s discretionary budget will be reduced from $30,899,000 to $29,321,000 for FY13, a cut of over $1.5 billion. The sequester would equate to a $2.6 billion reduction to the State Department and US Agency for International Development (USAID) FY13 budget, translating to a $1.7 billion cut to foreign assistance programs. In particular, sequestration will cut over $400 million from global health initiatives at the State Department and USAID, including R&D initiatives. Global health programs at the Centers for Disease Control and Prevention are likely to be reduced by taking 5 percent from HIV and AIDS initiatives and then taking 5 percent from the remainder of the account. Discretionary spending for the Department of Defense (DoD) is subject to a 7.8 percent reduction, which would include any global health R&D initiatives embedded in DoD programs. Some reports indicate that the US Food and Drug Administration will lose about 9 percent of its budget for FY13. The Obama Administration is urging Congress to allow the agency to spend $41 billion-worth of user fees. In the meantime, the government is currently running on a Continuing Resolution, which expires on March 27. Congressional leaders and President Obama have expressed hopes about successfully negotiating a new spending bill by March 27, in order to avoid a government shut-down. These negotiations may also provide an opportunity to reverse the sequester, before the full impact of the cuts are felt across the government. The President’s budget request for FY14 is also on the horizon, with reports indicating that it might be released on March 25. The House and Senate will begin to take up FY14 budget resolutions, which each Chamber must pass by April 15. It’s becoming increasingly clear that sequestration is the wrong way to reduce the nation’s debt, especially when the impact would set back innovation and devastate global public health. Policymakers should use the upcoming budget negotiations as an opportunity to reverse sequestration and develop a long-term budget solution that protects and—where possible—increases funding for global health product development. Slashing funding will interrupt scientific progress and leave us without the urgent tools we need to address health needs now and in the future.