Ashley Bennett

In this feature on Breakthroughs, we provide an update on what’s currently happening with global health in Congress and an outlook for future legislative activity. Foremost on Congress’ plate this week was, of course, the appropriations process. Last week, House Budget Committee Chair Paul Ryan (R-Wisconsin) released his fiscal year (FY) 2013 budget resolution, which the House Budget Committee has now approved by a 19-18 vote. The full House passed the resolution yesterday 228-191, making the appropriations process even more complicated, as the legislation conflicts with much of the Budget Control Act (BCA) signed into law last year. In the resolution, international affairs funding in the approved resolution totals $49.1 billion. This is a reduction of $7.1 billion, or 12.6 percent, compared with President Obama’s FY 2013 requested funding levels. A report accompanying the resolution outlines some potential cuts that could help achieve this $7.1 billion cut. The section that covers the State and Foreign Operations account does not mention any global health-specific policy changes, so it is unclear at this stage how global health, as well as research and development for new health tools, would fare under Ryan’s resolution. Regardless of the House’s approval, the resolution will be dead on arrival in the Senate. House Democrats introduced their own budget alternative, authored by Maryland Democrat Chris Van Hollen. Their approach follows what President Obama requested fairly closely, but both this alternative as well as a more conservative resolution—supported by the Republican Study Committee—did not garner the votes needed to pass. Also this week, the National Institutes of Health (NIH) Director Francis Collins testified before the Senate Appropriations Committee. When he spoke at a similar House hearing recently, the new National Center for Advancing Translational Sciences (NCATS)—which Collins stated has the potential to support the development of new tools for rare and neglected diseases—was a hot topic, and the same was true with the Senate. Collins was questioned on plans for future projects at NCATS, and whether they would affect the NIH basic research budget. The effect of across-the-board federal budget cuts on the NIH was discussed during the Senate hearing, with Collins stating that there would be hundreds of great research projects that would not be funded if these widespread cuts take place. You can read testimony from Collins—as well as National Institute of Allergy and Infectious Diseases Director Anthony Fauci and other NIH leaders—here. Now that most of the hearings have been completed on the President’s budget request, appropriations committees in both the House and Senate will soon move to approve legislation for all accounts in the federal budget. It’s likely that the House subcommittee will start to approve funding legislation in May, with the Senate following suit shortly after. The process is moving along normally—for now. With growing anxiety about whether Congress will alter the required across-the-board budget cuts, and the Presidential election drawing closer, we may still see a replay of previous years’ deadlock.

As people across the globe celebrate World TB Day this week, several groups are highlighting the fact that the current tools to prevent, test, and treat tuberculosis (TB) are greatly outdated. The world has been “beyond antiquated in our approach” to developing new TB tools. That is how Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health, described a not-so-bygone era in the history of TB research and development (R&D). Fauci was speaking at a briefing organized by the Critical Path to TB Drug Regimensin partnership with the Global Alliance for TB Drug Development (TB Alliance), US Agency for International Development (USAID), NIAID, and the US Food and Drug Administration (FDA). During the event, representatives from key US government agencies made the case for the urgent need for new technologies in the TB toolkit. “It can’t take 40 years for us to get our next TB drug,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research stated, highlighting one of the lesser known facts about TB—that the newest drug was approved over 40 years ago. “We need to capitalize on the momentum we have,” she added. Many current TB drugs are toxic and have serious interactions with other medicines, and most regimens take over six months to complete. The disease kills 1.4 million people and infects 8.8 million each year. As people across the globe celebrate World TB Day this week, several groups are highlighting the fact that the current tools to prevent, test, and treat TB are greatly outdated. Photo credit: PATH Joining Fauci and Woodcock were Robert Clay, deputy assistant administrator for Global Health at USAID; Mel Spigelman, CEO of the TB Alliance; and Christine Lubinski, vice-president for Global Health at the Infectious Diseases Society of America (IDSA). All speakers stressed the urgent need to conduct R&D for new and improved TB prevention and treatment options. They also lauded the use of partnerships between non-profit organizations, private pharmaceutical companies, and US Government agencies in the development of new drugs and other technologies. Fortunately, the TB Alliance, a GHTC member and product development partnership (PDP), announced the launch of a new combination drug trial that could pave the way for the next generation in TB treatment approaches. The group has launched stage II trials for NC-002—a novel drug regimen combining a well-known generic TB drug with two new drug candidates. The trials will take place in South Africa, Tanzania, and Brazil, and results will be known in roughly a year. This trial is also the very first of its kind. It will test both patients with ‘drug sensitive’ TB, who do respond to current treatments, along with patients with multi-drug resistant TB (MDR-TB), who do not respond well to currently available treatment, to determine differences in the groups’ response to the new drug regimen. As Spigelman outlined, the potential impact of this trial is immense—it could reduce the costs of treating MDR-TB by 90 percent, as well as decrease treatment time by over 80 percent. This exciting news in TB drug development follows closely on the heels of new funding for new prevention tools. Last week, GHTC member Aeras announced that it received a grantfrom the Bill & Melinda Gates Foundation of up to $220 million over five years to conduct R&D for new TB vaccines. Aeras stressed that it is developing new TB vaccines against the backdrop of a significant increase in drug-resistant strains of the disease worldwide. Additionally, today Aeras—along with the TuBerculosis Vaccine Initiative and the STOP TB Partnership—also announced a new blueprint for TB vaccine development. "To develop a new TB vaccine that will be fully effective, researchers, donors, and other partners will need to collaborate and coordinate their efforts as they address tough research questions," said Dr. Lucica Ditiu, executive secretary of the Stop TB Partnership. "We cannot allow ourselves to be overwhelmed by either the costs or the obstacles. It is time to be bold and dare to do more in TB, especially in supporting the development of a new vaccine." As we recognize World TB Day, the need for new and better prevention, diagnostic, and treatment options for the disease is clearer than ever before. And it’s encouraging that GHTC members like Aeras and the TB Alliance—along with many other partners—are at the forefront of R&D efforts to create these desperately needed health tools.

On Monday, President Obama released his Administration’s much-anticipated FY 2013 budget request to mixed reviews. In his introduction to the overall budget request, Obama emphasized that research and development (R&D) programs are essential to the US economy and the country’s future. He even highlighted the work of the National Institutes for Health (NIH) and the Food and Drug Administration (FDA) in this area. When looking at the budget numbers for global health, Obama’s emphasis on R&D in his introduction played out in various ways, with some good and bad news. Overall, the President’s request was in line with the rumors that preceded its release. Global health numbers faced nearly across-the-board decreases when compared with FY 2012 levels, although the broader State and Foreign Operations account did receive an increase. Under the State and Foreign Operations account: The Global Fund To Fight AIDS, Tuberculosis and Malaria and the GAVI Alliance received major increases. The President’s Emergency Plan for AIDS Relief (PEPFAR) saw funding cuts. Most global health line items in the budget for the US Agency for International Development (USAID)—aside from family planning and reproductive health—received reductions in funding, some by as much as 25 percent. These funding cuts could drastically affect USAID’s ability to support global health R&D projects. Global health R&D funding under the Department of Health and Human Services (HHS) account saw additional inconsistent results, with some good and bad news. The FDA received an $11 million increase. However, this increase relies on the collection of user fees, which has some constraints. Overall NIH funding remained at FY 2012 levels, with essential programs at National Institute of Allergy and Infectious Diseases and the Fogarty International Center receiving small, but welcome, increases. The Office of AIDS Research stayed the same as last year, as did the new National Center for Advancing Translational Science (NCATS). More flat-funding was seen at the Centers for Disease Control and Prevention (CDC). HIV and AIDS and polio stayed essentially the same as FY 2012, with malaria receiving a small increase. Otherwise, global health programs at CDC were requested at last year’s levels. Further drastic cuts at crucial Department of Defense research programs on malaria, HIV and AIDS, and neglected diseases add to the concerning budget slashing. It is important to note that the President’s Budget Request is not the last word on global health R&D funding. Congress has the authority to change the funding levels as it sees fit. However, it could be difficult to justify spending above what the Administration views as appropriate, especially given the current fiscal crisis and the shortened election-year appropriations process. Although some of the proposed reductions may appear to be minor, given the larger picture of the federal budget, they will certainly have serious effects on R&D projects—both for those now on the cusp of groundbreaking results, and for those in the future. The Administration has tried to soften the blow of these budget reductions by pointing out that cost-savings can be found in global health scientific advances like newer HIV drugs, inexpensive diagnostics, and streamlined vaccine delivery devices. It’s absolutely true that these new tools can save dollars while they save lives. The question is, if we cut US global health R&D funding now, will we have these urgently-needed advances to rely on five or ten years down the road? More information on the President’s budget request can be found at the following links: Kaiser Family Foundation Budget Tracker White House Office of Management and Budget Website and blog post

Ashley Bennett, senior policy associate at the GHTC, writes about the new programs announced at a White House event on Wednesday to promote innovation in global development. Earlier this week, senior Obama Administration officials announced several exciting new programs to support and highlight the power of innovation in global development, including global health research and development (R&D) for new products. United States Agency for International Development (USAID) Administrator Rajiv Shah announced a partnership, entitled the Higher Education Solutions Network, designed to promote new solutions to global development obstacles. The partnership will create hubs for innovation at US colleges and universities to “create and leverage a virtual network of leading experts who will help USAID solve distinct global development challenges” through ramped up engagement with students and faculty. Next, Dr. David Kappos, director of the US Patent and Trademark Office (USPTO), unveiled the Patents for Humanity pilot prize competition through Challenge.gov. Patent applicants whose product benefits “humanitarian needs”—including medical technologies—will be eligible to win a certificate good for expedited patent review for an additional product that they would like to submit. The program operates in a fashion somewhat similar to the Priority Review Voucher program at the Food and Drug Administration. An important distinction, though, is that for the USPTO pilot program, the certificates are non-transferrable. This program should help private businesses pursue product R&D for areas of need that they may not necessarily find commercially attractive, which may have applications for global health diseases that predominantly affect populations in developing countries. “By harnessing the power of science and technology with research and development, Patents for Humanity plays a key role in advancing President Obama’s global development agenda. By collaborating with parts of the world in ways unimaginable just a few years ago, and by unleashing broader prosperity in emerging economies, this important new USPTO initiative demonstrates that the power to innovate is the power to lead, by design, and by solution,” Kappos wrote in a blot post about the program. Finally, the National Institutes of Health (NIH) launched a new model licensing agreement to accelerate licenses for nonprofit organizations that are engaged in neglected tropical disease (NTD) product development to use certain inventions and compounds from NIH and the FDA laboratories. The scope of the program includes vaccines, drugs, therapeutics, and diagnostics for NTDs as defined by the World Health Organization. The wealth of technology available from these sources has the potential to drastically impact global health product development by expanding the material resources scientists need for their studies. During the launch event, the story of MenAfriVac™, a product developed by GHTC member PATH, was used to demonstrate the power technology transfer has on research for neglected diseases. “We‘d like to see more of those transactions occur and more non-profits take up our technologies to bring them to the people that most need them in low-income areas of the world,” said Mark Rohrbaugh, director of the NIH Office of Technology Transfer. In addition to these initiatives for global health research and development, new programs for mobile technology, clean energy, and hybrid seed production were also announced. All of these new programs align with the Administrations overall global development policy, including President Obama’s Presidential Policy Directive (PPD) for development, as well as with the innovation theme outlined in the recent State of the Union address. “A core part of my global development strategy is harnessing the creativity and innovation of all sectors of our society to make progress that none of us can achieve alone,” President Obama said. President Obama is right. Using the power of innovation from all partners—from the US agencies to academic institutions, not-for-profit groups, and the private sector—can have significant impacts on longstanding global health and development challenges. It’s critical that US policymakers continue this spirit of innovation. You can find more information on this White House fact sheet and also on the Science Speaks blog.

On Tuesday night, President Obama gave his annual State of the Union address to Congress. While the President was not as focused on using science to help the United States out-innovate the rest of the world as he was during last year’s State of the Union address, he did re-commit his administration to harnessing the strength of innovation to create an “America built to last.” Obama stressed the importance of basic research in the development of new health tools. He also urged Congress not to cut parts of the budget that will hurt the promise of science and technology: “Innovation also demands basic research. Today, the discoveries taking place in our federally-financed labs and universities could lead to new treatments that kill cancer cells but leave healthy ones untouched. New lightweight vests for cops and soldiers that can stop any bullet. Don’t gut these investments in our budget. Don’t let other countries win the race for the future. Support the same kind of research and innovation that led to the computer chip and the Internet; to new American jobs and new American industries.” President Obama called on Congress to support the work of entrepreneurs and researchers—through tax breaks and other financial incentives, in addition to funding. Much of the speech targeted improvements to domestic priorities such as American job creation, immigration policy reform, and finance industry management. However, it was clear that the President is seeking a renewal of American leadership around the world through engagement on international human rights and international business. Leadership in global health research and innovation will be a critical part of this effort. Recent global health R&D news–from the exciting preliminary results of a malaria vaccine to the startling news of a completely drug resistant TB strain–demonstrates the that the US should not halt or slow its support for R&D in the fight against global health challenges. President Obama stressed the importance of basic research in the development of new health tools during his State of the Union address on Tuesday evening. Photo: Evelyn Hockstein/PATH. This year is a pivotal one for US support of global health R&D for several reasons. These include changes at the Global Fund, the International AIDS Conference in Washington, DC, this summer, the roll-out of the new National Center for Advancing Translational Science at the National Institutes of Health, and additional research results from a number of important studies. All of these are mixed with looming budget sequestration cuts and a presidential election. President Obama’s speech made it clear that he will support the R&D programs that lead to cost-effective tools that can save lives. It is yet to be seen if Congress will follow suit. You can find a video of the speech, with accompanying charts here: http://www.whitehouse.gov/state-of-the-union-2012

Last week, HHS released its first-ever global health strategy at an event that convened leaders from several US agencies involved in global health, as well as representatives from non-governmental organizations. Releasing the strategy, which highlights many priorities for global health research and development (R&D), is an important move for HHS, as it encompasses agencies such as the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA), all of which play crucial parts in global health R&D. HHS Secretary Dr. Kathleen Sebelius, who spoke at the event, stated that “we can no longer separate global health from America’s health … our only chance to keep Americans safe is if our systems for preventing, detecting, and containing disease stretch across the globe too.” She also noted that “every day, Americans benefit from efforts in global health, whether they know it or not.” Sebelius emphasized that the HHS global health strategy should not be an extra, isolated add-on to other programs, but must be an extension of HHS domestic programs and its already-existing programs in global health, with the following goals: To focus on areas where HHS can engage globally in work that benefits and improves the health and well-being of Americans. This will include promoting research partnerships that help develop new treatments to support this goal. To provide leadership in areas where HHS has unique technical expertise, “starting with the world’s leading researchers at the NIH, its leading epidemiologists at the CDC, and its leading regulators at the FDA.” To work with other US agencies and the Administration to advance US interests in global health and support the President’s Global Health Initiative. Sebelius' opening remarks were followed by a panel discussion moderated by KFF Executive Vice President Diane Rowland. Panelists included Nils Daulaire, director of the Office of Global Affairs at HHS; Ariel Pablos-Méndez, assistant administrator for Global Health at the US Agency for International Development; Kerri-Ann Jones, assistant secretary of state for Oceans and International Environmental and Scientific Affairs; Helene Gayle, president and CEO of CARE USA; Harvey Fineberg, president of the Institute of Medicine; and Jen Kates, vice president and director of Global Health and HIV Policy at KFF. While Sebelius’ speech emphasized the role of the strategy in meeting the health needs of the American population and US diplomatic goals, the panel discussion did the reverse—it examined how US agencies could be more engaged in global health work, and where they are strategically a best fit. The panel had several insights for the use of the HHS strategy and the future of HHS engagement in global health work abroad, including partnerships with HHS agencies not traditionally known as global health leaders—such the Centers for Medicare and Medicaid Services, which could help to strengthen health system capacity around the world. The new strategy includes many major objectives that seek to spur global health R&D in order to develop new tools and interventions to help improve health and save lives around the world. These objectives include: Preventing infectious diseases and other health threats, including through measures such as vaccine development, boosting manufacturing capacity, and improving vector control. Increasing investments in regulatory science and partnerships worldwide. Strengthening multilateral efforts to promote science-based standards and guidelines for global health. Amplifying research and innovation to promote the development of new tools and approaches to help prevent, diagnose, and control disease. Overall, the strategy represents a great step forward in global health R&D at the HHS agencies, and a recognition of how essential their programs are, both to the US and populations around the world.