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Yesterday, at an event hosted by ONE and (RED) to commemorate World AIDS Day, President Obama declared the beginning of the end of AIDS: “Today is a remarkable day. Today, we come together, as a global community, across continents, faiths and cultures, to renew our commitment to ending the AIDS pandemic –once and for all.” I was honored to join a group of distinguished guests to witness the President’s World AIDS Day address and to hear comments from former Presidents George W. Bush and Bill Clinton; the current President of Tanzania; and a powerful panel that included a few superstars—Bono and Alicia Keys—members of Congress, business leaders, and activists. The powerful panel that included a few superstars—Bono and Alicia Keys—members of Congress, business leaders, and activists.For thirty years, the US government has led the fight against HIV and AIDS, and has played an important role in advancing science to better understand HIV and how to prevent, treat, and diagnose infection. Over the last three decades, we’ve witnessed the fruits of that leadership and the longstanding investment US policymakers have pledged to research on HIV and AIDS: from the first AIDS treatment drugs, to this year’s news that medicines to treat HIV infection could actually help prevent it, too.Yesterday’s speakers reinforced the notion that our commitment to fighting AIDS must not waiver. President Bush declared that when budget constraints exist, we need to set priorities and focus on what works. He added that there is no greater priority than living out the mandate of “to whom much is given, of him much shall be required.” His perspective was reinforced by Alicia Keys, who said, “We have the opportunity to be a global community that leaves the legacy of an AIDS-free generation. If we have the power to, then we must.”Recent research results show that we have many of the tools we need to forever change the trajectory of the epidemic. But, as Obama said, now is not the time to be complacent. We still lack a vaccine, a microbicide gel, and other tools that could help us win the war against AIDS.I’m encouraged to see the continued commitment by the Obama Administration to fighting this disease coupled with bipartisan support from congressional leaders like Congresswoman Barbara Lee and Senator Marco Rubio. My hope is that this commitment translates to continued support for research that will lead us to the next generation of tools to fight HIV and AIDS. As Sanjay Gupta, moderator of the event, said, eradicating AIDS is a goal that “allows us to stand at that most perfect union of audacity and achievability.” Will our government rise to the challenge?

Roger I. Glass, M.D., Ph.D., is director of the Fogarty International Center at the National Institutes of Health (NIH), where he oversees research and research training programs for U.S. and foreign scientists working to improve health in the developing world. Over the last four decades, about 5,000 scientists worldwide have received significant training through Fogarty programs. In addition, Dr. Glass serves as Associate Director for Global Health to the NIH Director, providing guidance on global health, facilitating international research collaborations and convening the world’s best scientific minds to address the most pressing health research questions. As we commemorate World AIDS Day 2011, I am both encouraged by the recent discoveries that are improving and prolonging lives and reminded of the challenges that remain in our battle to defeat this terrible disease. I was heartened to gather earlier this year with many of Africa’s premier infectious disease scientists and medical educators as we—together with PEPFAR—launched our Medical Education Partnership Initiative. Through this effort, we hope to make an enduring impact on the quality and availability of health care workers and researchers throughout the continent. This is vital to our goal to establish true country ownership and enable Africans to set their own research agendas, based on the most pressing local needs. Peruvian scientist Dr. Isaac Alva, of Universidad Peruana Cayetano Heredia, has conducted extensive field work studying HIV and AIDS and other diseases among indigenous communities in Peru. He is currently earning his master’s in public health through Fogarty’s AIDS International Training and Research Program. (Photo by David Snyder for Fogarty/NIH) I was also fortunate to see firsthand many of the researchers funded by the National Institutes of Health who are working on the front lines. During this year—the 30th anniversary of the beginning of this epidemic—it is appropriate we acknowledge the advances made against this and other infectious diseases by the National Institute of Allergy and Infectious Diseases (NIAID) and its director, Dr. Anthony S. Fauci, and by the many scientists around the world supported by NIAID and other institutes and centers of the NIH. But if the great advances have been made standing on the shoulders of giants, in Isaac Newton's phrase, I think Fogarty has a hand—or a shoulder, perhaps—in a number of the research breakthroughs. Trainees supported through Fogarty-funded grants have helped contribute to the work that led to this progress. We're pleased to see our 20-year investment in some of these developing country sites paying off with trainees who are well qualified to move forward the research funded by NIAID and others. A singular breakthrough in the news is the study known as HPTN 052, which revealed that men and women infected with HIV reduced the risk of transmitting the virus to their sexual partners through early initiation of oral antiretroviral therapy (ART). Fogarty grantee Dr. Myron "Mike" Cohen, who runs the global health institute at the University of North Carolina, is the principal investigator of the study, funded mainly by NIAID with additional funding from other institutes. Dr. Roger I. Glass, director of Fogarty International Center at the National Institutes of Health, visited Africa to see firsthand the health improvements HIV and AIDS advances have brought to the continent. (Photo courtesy of Fogarty/NIH) This is the first randomized trial to definitively indicate that an HIV-infected individual can reduce sexual transmission of HIV to an uninfected partner by beginning ART sooner. This adds very strong scientific evidence that you can use treatment of HIV as an effective prevention modality by decreasing the possibility that a person who is infected would transmit HIV to their sexual partner. More than 30 Fogarty-supported trainees in Malawi, India, Botswana and Thailand worked on the study. Very recently, the conclusions of this discordant couples trial were buttressed by results from a pre-exposure prophylaxis, or PrEP, trial that showed that heterosexual participants who took a daily Truvada pill had a significantly lower chance of being infected. Fogarty trainees are also at the forefront of the studies to determine the effectiveness of an antiretroviral microbicide (tenofovir gel) in preventing sexually transmitted HIV infection in women. The training was supported by a grant under Fogarty's AIDS International Training and Research Program (AITRP). Dr. Quarraisha Abdol Karim of Columbia University, who directed the CAPRISA-004 study, is the director of the Fogarty training grant and has mentored many trainees continuing this work. Moreover, Fogarty Scholar Dr. Kogie Naidoo has reported a randomized clinical trial conducted at Durban demonstrated that antiretroviral treatment should begin at the same time as TB treatment. This result has caused the WHO to change its guidelines for TB treatment. Finally, Dr. Sten Vermund of Vanderbilt University has directed a multi-country study, funded partly by NIAID with some Fogarty trainees participating, demonstrating the effectiveness of ART therapies in stopping mother-to-child transmission of the HIV virus. Sten's program has trained 64 individuals in degree programs, nearly all of whom have returned to their home countries. There remains much to be done in the effort to achieve "a world without AIDS," in Dr. Fauci's phrase. As we mark World AIDS Day and the 30th anniversary of that effort, Fogarty is pleased to have played a significant role in training many of the researchers who are positioned to lead the battle.

Nelson L. Michael, M.D., Ph.D is the Director of the U.S. Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research (WRAIR), an international HIV vaccine research program that successfully integrates HIV and AIDS prevention, care and treatment. In this post, Col. Michael reflects on the progress being made in HIV prevention science. December 1 marks the commemoration of World AIDS Day—a day to reflect on an epidemic that has affected millions of lives worldwide for three decades now and how far we’ve come towards an end. This year’s focus and theme is a right on target: “Leading with Science, United for Action.” Recent scientific achievements have brought us closer to eliminating AIDS than we have ever been. Results from the landmark RV144 trial, an international collaboration that involved more than 16,000 Thai volunteers, were announced in 2009. While it took a quarter of the century from the discovery of HIV to show that a vaccine is possible, the results of RV144—which showed the first scientific evidence of vaccine efficacy—have propelled the HIV vaccine research field forward. Earlier this year, we announced the results of extensive follow-up laboratory studies that provide new clues about the types of immune responses that may have played a role in the protection seen in RV144. These new advances were the result of nearly two years of work by more than 100 researchers at 25 institutions worldwide. We now have a better understanding of how the vaccine may have prevented infection and a renewed scientific direction to help guide future vaccine development. We are united in our efforts to end AIDS; no one organization can do it alone. As we move forward, MHRP’s collaborators are leading a tremendous effort to identify correlates of protection. Additionally, a new collaboration—a public-private partnership called P5 that comprises MHRP, the Division of AIDS/NIAID, the Bill and Melinda Gates Foundation, Sanofi Pasteur, Novartis, and the HIV Vaccine Trials Network—is planning the next set of Phase IIb trials to build on the results of RV144 and bring us closer to a vaccine product with a public health impact. MHRP’s commitment to ending AIDS extends beyond developing an efficacious vaccine to creating innovative programs to prevent and treat HIV through the President’s Emergency Plan for AIDS Relief (PEPFAR). In 2011, our site in Uganda, the Makerere University Walter Reed Program launched the first ever mobile circumcision clinic with the ambitious goal to circumcise 6,000 men by year’s end, Kenya has become a leader in the prevention of mother-to-child transmission (PMTCT) due in large part to the efforts of the Walter Reed Project, and the number of patients currently receiving antiretroviral therapy at all of MHRP’s African sites—Kenya, Nigeria, Tanzania and Uganda—exceeded 100,000. A world without AIDS seems more achievable now than any other time in history. However, one prevention strategy alone will not be the end all to this pandemic. We must maintain the momentum and commitment to both scaling up currently available and evidence-based prevention strategies and finding a long-term solution to eliminate AIDS. In the meantime, MHRP is uniquely positioned to move HIV vaccine science forward and to inform HIV prevention, care and treatment with scientific data to develop best practices and to ensure the best, most efficient practices are provided around the globe.

Aarthi Rao is a senior program associate at the Center for Global Health R&D Policy Assessment of the Results for Development Institute. The Center analyzes a range of policy and financing ideas to accelerate the development of drugs, vaccines, and diagnostics for diseases of the poor. Ms. Rao works across many of its initiatives, including the assessment of tax credits for global health R&D and a study of the innovation system in India. This post shares some of the main findings of the Center's recent report, "R&D Tax Credits: A Tool to Advance Global Health Technologies?" As policymakers scramble to assemble measures that strengthen the US economy, tax credits are often proposed as tools to support domestic industry, spur job growth and encourage innovation with minimal intervention. In a political climate where the global health community worries about shrinking budgets and delivering “value for money,” tax credits to US companies to develop drugs, vaccines, and diagnostics for diseases of the poor seem even more appealing. While most policymakers agree that well-designed, tax credits are a good broad-based measure to support commercial R&D, making them work for global health is more complicated. Government support for R&D is often justified on grounds that the knowledge that R&D creates is a public good—by increasing overall knowledge, because innovation leads to improvements in general well-being. Nevertheless, firms would pursue a certain amount R&D on commercial grounds alone in order to earn profits from their innovations. But because R&D is high risk and costly, policymakers use tools, such as tax credits, to stimulate commercial innovation by lowering the costs and risks. The tricky part for the government is setting the right level for a tax credit—ideally, the government should offer credits that are high enough to encourage new innovation without paying for too much R&D that would have happened anyway. For biotechs and pharmaceutical companies doing global health work, tax credits may help offset some of their expenses, but the resulting technologies are unlikely to be profitable in the absence of other incentives since poor patients and countries have limited buying power. A reduction in losses can certainly help companies who are conducting global health R&D out of goodwill, but it will not likely catalyze much new research on its own. The UK, for instance, tried subsidizing research for HIV and AIDS, tuberculosis (TB) and malaria through a 20%-40% tax credit, but the private sector response was underwhelming. One solution is to increase the level of the credit and see if more firms respond, but this risks paying for a large amount of undefined work, much of which will fail in the early stages. However, there may be other ways to position a tax credit so that it does help to accelerate the development of new neglected disease technologies by US firms. There are new tax credit proposals on the table that challenge us to think past single mechanisms to packages of support that foster innovation. The Innovate America Act not only broadens the research tax credit, but it also suggests creating a pilot program to fund the commercialization of technologies developed through the National Science Foundation and mandates the development of a virtual platform for product developers to connect with public researchers. The Qualifying Therapeutic Discovery Project Tax Credit Extension Act reinforces the program’s focus on grants to emerging biotechs. These bills underscore that tax credits alone are not enough, and bring renewed attention to the challenge of commercialization. A tax credit for global health might encourage companies to do more early stage work, but they are unlikely to take on the full late stage development costs (think of the price tags for phase I-III clinical trials) for promising discoveries. Rather than pushing tax credit rates past 100%, a “package” approach could bring the most cost effective mechanisms for particular stages of R&D together. The ideas in the new tax credit legislation might not be quite right for global health R&D, but it is important that the global health community comes together to identify the ones that are. Discussions around product development for global health often focus on the role of product development partnerships (PDPs), or philanthropy on the part of industry and international donors—all of these are critical to global health—but there may be a way to make R&D for some diseases of the poor fit into the business models of US companies. Truly neglected diseases with almost no markets are unlikely to interest firms, but there are some neglected diseases that affect more than just the poor. Type II diseases, which have both donor and modest private sector markets, offer a good testing ground for incentive packages. For example, could a tax credit coupled with a purchase commitment shift the cost and risk equation far enough that firms could dedicate some of their brightest scientists to fighting diseases like dengue and TB? The tax credit could help offset upfront costs, whereas the purchase commitment helps ensure that a technology does in fact get fully developed by guaranteeing a certain level of market demand. This combination is just one possibility, but opens up a range of questions about what diseases have modest markets and what incentives suit particular stages of R&D. If these questions can be systematically laid out in relation to the preferences and strengths of US firms, then putting forward a well-designed package of targeted policies and incentives could be one way that global health advocates can advance the neglected disease pipeline by channeling bipartisan enthusiasm for supporting innovation in the US. To learn more about tax credits for global health R&D, read “R&D Tax Credits: A tool to Advance Global Health Technologies?”