Breakthroughs Blog: Guest post

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?”

Tiffany Moy is the Global Health Research & Development Advocacy Intern at Research!America (R!A). R!A is the nation's largest not-for-profit public education and advocacy alliance committed to making research to improve health a higher national priority. R!A, in partnership with Aeras, the International AIDS Vaccine Initiative, the International Partnership for Microbicides and OneWorld Health, hosted a Capitol Hill briefing Nov. 15 on the role of product development partnerships (PDPs) in global health R&D. The event was co-sponsored by Reps. Brian Bilbray (R-CA) and Chris Van Hollen (D-MD). During the event, Bilbray acknowledged that the health challenges ahead of us will require sustained investment in the R&D process from both the public and private sectors, and he called for bipartisan support for both funding streams. “We can’t spend time patting ourselves on the backs,” Bilbray said. “[While we can’t] forget to celebrate our successes, we must continue to look at the challenges.” He declared the public and private collaborative network essential, saying without the basic research—or what he called the “sea plankton”—there would be no venture capital or opportunity to invest in the “krill.” Rep. Brian Bilbray (R-CA) speaks at Research!America's event on product development partnerships at the Rayburn House Office Building in Washington, DC, on Tuesday. “We must create the opportunity for people to invest their funds,” he said, “not just for the next iPhone for but the next breakthrough cancer treatment. Otherwise we just have good intentions without good solutions.” Mary Woolley, president and CEO of Research!America, moderated the discussion between panelists Ann Ginsberg, MD, PhD, vice president of Scientific Affairs at Aeras; Brid Devlin, PhD, executive vice president of Product Development at the International Partnership for Microbicides (IPM); Eugenio de Hostos, PhD, MBA, director of Research and Pre-Clinical Development at OneWorld Health; and Steve Fling, PhD, site director of the International AIDS Vaccine Initiative (IAVI) Neutralizing Antibodies Center at The Scripps Research Institute. Woolley’s opening remarks emphasized the role of health research as a major driver of the American economy and a key factor in our country’s global leadership. The panelists discussed how the non-profit PDP model speeds medical progress on diseases like HIV and AIDS, tuberculosis (TB), malaria and diarrheal diseases. PDPs play a vital role in accelerating the research and development of critical health technologies like vaccines, drugs, and diagnostics. The model allows risk sharing but also the sharing of technical resources and scientific expertise. Fling expressed pride in IAVI’s breakthroughs in the field of HIV and AIDS, as well as in its partnership with Seattle-based biotech Theraclone, which has led to additional partnerships with Pfizer and other drug companies. Devlin noted that IPM’s microbicide ring, designed to give women greater control over protecting themselves from HIV, is the first such product to come so far in the R&D pipeline. “HIV is the leading cause of death for women ages 15 to 44 worldwide,” she noted. The ring will enter late-stage clinical trials in early 2012. OneWorld’s de Hostos added that “this is not just about bringing technologies to bear on these diseases but it’s also about capturing the intellectual capital we have here.” Of solving one of the world’s greatest health challenges through the PDP model, Ginsberg said, “Using business practices, we are combining the public health need and expertise wherever we can find it. Ten years ago, there were no candidates and now there are 12 TB vaccine candidates in the R&D pipeline. [This is] the first time in history that so many TB vaccines have gotten so far” in the development process. A new, more effective TB vaccine could reach the market as early as 2020 and has the potential to greatly reduce the 1.4 million lives lost to TB each year. “This,” Ginsberg said, “could not have happened without the PDP model.” To learn more about how global health R&D is impacting the health and economies of other states, click here.

Mitchell Warren, the executive director of AVAC and a founding member of GHTC, wrote the following op-ed in reaction to Secretary of State Hillary Clinton’s speech at the National Institutes of Health and her announcement to prioritize achieving an AIDS-free generation. This op-ed originally appeared in The Hill’s “Congress Blog” this week. Last week at the National Institutes of Health (NIH), Secretary of State Hillary Clinton laid out an ambitious vision to end the HIV and AIDS pandemic. In a statement that no US leader has made before, Clinton said that it is possible to achieve an AIDS-free generation. The goal Secretary Clinton lays out is indeed possible, and we welcome her announcement of an additional $60 million for implementation of a combination of prevention strategies in four sub-Saharan African countries and evaluation of their impact. But this funding can only be viewed as a down payment on the work that needs to be done. In order to get there, the Obama administration, along with developed and developing country governments around the world, need to add specific commitments, milestones, and strategies to the vision. And they need to commit to the long haul. It is 16 days to World AIDS Day, and we expect to hear additional commitments and see leadership from President Obama, with an eye to both the international and domestic epidemics. The good news is that, as Secretary Clinton emphasized, there is a strong foundation on which to build. Thanks in large part to prior US support for HIV research and implementation, particularly via the NIH, we have today three key tools to help end the epidemic: voluntary medical male circumcision, effective treatment for people living with HIV, and prevention of mother-to-child transmission. If taken to scale, the number of new infections will plummet. But Secretary Clinton also noted the need to continue developing new tools for tomorrow. The commitment to both research and implementation must be unwavering. There are three critical research priorities that require long-term investment to truly close the door on AIDS. First, we need real-world research to understand how best to use additional HIV prevention tools that were recently found effective in clinical trials, including topical microbicides and pre-exposure prophylaxis, or PrEP. Second, we need to sustain the search for a vaccine to prevent HIV, especially now that the vaccine field is being re-energized by promising new scientific advances. Third, we need to pursue the increasingly real possibility of developing a functional cure for HIV infection. It is critical to sustain investments in research and development for additional powerful prevention tools. On World AIDS Day, we will be listening for a strong, specific commitment to scaling up the tools we have at our disposal immediately, with a focus on combination prevention and an emphasis on HIV testing and counseling, which is the gateway to male circumcision, prevention of mother-to-child transmission, and treatment and care for HIV positive people. Now is the best possible moment to invest in research, when the possibilities for long-term success are greater than ever before. This is when we should double down on some of the amazing successes we’ve seen in the past few years. As Secretary Clinton said in her speech, it is possible to create an AIDS-free generation. Research has made this goal possible, and we must stay focused on the future. We cannot turn back now. Not when there is a potential end to this epidemic finally in sight.