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In this guest post, Dr. Mary Moran—executive director—and Dr. Penny Farrell—analyst—from Policy Cures shares key findings from the recently released G-FINDER survey. Nine million people still die each year from infectious diseases with lacking or insufficient treatments. The need for research and development (R&D) for new products has never been more urgent. But R&D costs money. The annual G-FINDER survey collects data about funding for neglected disease R&D from over two hundred organizations, including all major public, private, and philanthropic funders. The 2013 G-FINDER report shows that overall funding for neglected disease R&D was $3.2 billion, about half a billion dollars higher than in 2007, with the public sector providing two-thirds of this funding—around $2 billion. But beware—beneath this calm surface figure, there are some dangerous currents, and their direction is changing rapidly. 1. New trends in public funding revealed The headline public finding figure of around $2 billion has been maintained in 2012, but this figure masks marked new funding trends… Public funding for neglected disease R&D with and without the US. Click to enlarge chart. If we focus on the 2011-2012 section of this graph, it’s clear that US funding is rising, but non-US funding has ebbed. In other words, US funding is keeping neglected disease R&D afloat. In 2012, US funding increased by $86 million (up 6.4 percent)—the first increase seen by the US government since 2009. US investment has almost returned to its 2009 peak, when there was a large infusion of funds under the American Recovery and Reinvestment Act, created in response to the global financial crisis (GFC). But between 2009 and 2012, non-US high-income country government funding has decreased by 20 percent. That’s over $90 million lost. Some of this is cyclical. For example the United Kingdom’s Department for International Development disburses funds in generous 3-5 year cycles. But this does not explain all of this worrying trend, and without the United States, public funding for neglected disease R&D would be spiraling downwards. 2. Public funding for R&D needs to change tack 2007-2012 percent change in funding to basic research and product development. Click to enlarge graph. Another dangerous funding current is the post-GFC shift away from product development. Saving lives means not only doing basic laboratory research, but also ensuring that this research is translated into new medicines, vaccines, and tests that will save many of the 9 million lives lost each year to neglected diseases. But, post the GFC, governments have been redirecting their funding away from product development, which is often done abroad, in order to support basic research that can be done, and funded, in academic institutes at home. In the six years prior to 2012, there was a 27 percent increase in public sector funding for traditional basic research, but public funding for urgently needed product development over the same period shrank by nearly 2 percent. For diseases that mainly rely on public funding, such as HIV and AIDS, the result is a skewing of investment away from product development. 3. Funding for product development partnerships (PDPs) took its biggest blow yet in 2012 PDP funding 2007-2012. Click to enlarge graph. PDPs are a not-for-profit funding model that started around the year 2000. PDPs bring public and private organizations together to make products for diseases where there’s a market failure. To date, they have been the most productive product development sector—we have them to thank for nearly three quarters of the 18 new drugs and vaccines created for neglected diseases since 2000. In 2009, PDPs received $530 million—but since then their funding has plummeted by nearly one-third, and 2012 saw the biggest decrease yet. In early 2012, PDPs had at least 91 products for neglected diseases in clinical development. If this funding pattern continues, we will be forced to ask which projects to drop—will it be one working on more reliable treatments for tuberculosis, one developing a cure for African sleeping sickness, or one making a vaccine for malaria? The 6th annual G-FINDER report was launched in London on Dec. 11, 2013, and is available at http://policycures.org/gfinder.html. Conducted by Policy Cures and funded by the Bill & Melinda Gates Foundation, G-FINDER reports on global funding of R&D for new products for neglected diseases.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The recently released annual G-FINDER survey found that total global funding for neglected disease research in 2012 amounted to $3.2 billion, which included an increase of $92.1 million—or 3.2 percent—over 2011 levels. Unfortunately, non-US government funding fell by 12.4 percent in 2012, with 11 governments either cutting or freezing funding. This drop was offset by an increase in US government funding by 6.4 percent from 2011. After returning from the 8th International Summit of Heads of Medicines Regulatory Agencies in Amsterdam, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg wrote in FDA Voice about the increasing need for international regulatory agencies to work together. The FDA has granted GHTC member Medicines for Malaria Venture and pharmaceutical company GlaxoSmithKline Breakthrough Therapy designation for tafenoquine, an investigational medicine for the treatment and relapse prevention of Plasmodium vivax malaria. The Bill & Melinda Gates Foundation has named Susan Desmond-Hellmann, chancellor of the University of California, San Francisco, as its new CEO. A new article on SciDev.net examines how science is now more influential within the US Agency for International Development than it has been for the last two decades. Civil society groups are reacting to a set of demonstration projects recently selected by a World Health Organization expert panel to find new ways to fund health research for neglected diseases.

The US Agency for International Development (USAID) is the nation’s lead foreign assistance agency. Throughout its 50-year history, USAID has worked with other government agencies, the private sector, and nongovernmental organizations to support the development and introduction of affordable health products appropriate for addressing the diseases and health issues in developing countries. The GHTC has launched a new blog series to highlight the impact of USAID’s commitment to global health research and development (R&D). The series will showcase stories from individuals who have benefited from the agency’s support and investment in R&D—as well as people whose lives would vastly improve if USAID were to expand its support for health R&D into new areas. Our second post is by Natalie Nelson, a tuberculosis (TB) survivor from Tennessee who believes that if USAID expanded its support for health R&D to include TB vaccine research, the agency could help change the lives of TB patients like her worldwide. Q: Many people think of TB as a disease of the past—or a disease that only impacts people in developing countries. But your experience with TB demonstrates that the disease impacts Americans, too. How did you contract TB, and how has the disease impacted your life in the US? A: I was working as a volunteer physical therapist in a small healthcare facility in South Africa when I contracted TB. I assisted patients infected with TB and HIV. After I came home to the US, I started getting sick. It took an entire year to be correctly diagnosed—and after finding out I had multi-drug resistant TB (MDR-TB), my life drastically changed. TB forced me to quit my job as a physical therapist. I received a 2-year treatment program, a mask, an isolation sentence, and with that, a new stigma. My life and my desire to return to South Africa were both placed on hold as I accepted a new lifestyle: swallowing drugs as I was directly observed by a health care provider each morning and afternoon and a drug infusion for 2 hours, 5 days a week for the first 6 months, then 3 days a week for the next year and a half. Natalie Nelson is a TB survivor from Tennessee who believes that if USAID expanded its support for health R&D to include TB vaccine research, the agency could help change the lives of TB patients like her worldwide. Credit: Aeras. Although the treatment was completely exhausting both physically and mentally, having TB brought an awareness that I never would have experienced otherwise. I feel blessed to have the care that I received, and now I can fight for and speak up for those who do not have the same options. Q: Your story also demonstrates the growing issue of resistance to currently available TB treatment options, which makes the disease much more difficult and expensive to treat. What was that experience like for you, in terms of undergoing TB treatment, its side effects, and its costs? A: Having TB was extremely scary. So many things were uncertain, and the questions were endless. Was the medicine working? Would I eventually need surgery? Would I even survive? No one could tell me definite answers. I just had to keep pressing forward and swallowing the pills, as there was no alternative. There were numerous side effects from the medication—it seemed like a new one would surface each week. First, I was terribly weak and frail. I lost over 20 pounds and my iron levels bottomed out, so I was tired all the time. Then, I developed excruciating kidney stones in both kidneys. Every afternoon around 3:00 my face would flush, my temperature spiked, and I had to lie down. At times, my fingers went numb, and I dropped things constantly. Though all of this was terrible, the worst side effect was short term memory loss from Cycloserine—the drug I was taking to treat my TB. I forgot what I was saying mid-sentence, and constantly repeated myself. I got lost driving and forgot to show up to appointments. I became socially awkward and utterly undependable during this time. This was really difficult and embarrassing. The costs were astronomical. TB cost me my job, my energy, years of my life, special moments with friends and family, my health—and at times—my sanity. I am unsure of the exact dollar amount because there are some losses that can't be calculated, but the cost was easily over half a million dollars. Q: Currently, there is only one vaccine to prevent TB—the Bacille Calmette-Guérin (BCG) vaccine. While BCG is the most widely used vaccine in the world, it has not successfully eliminated the disease due to its limited efficacy. Based on your personal experience with TB, how would new and improved vaccines—as well as treatment options—help in the fight against TB worldwide? A: We can never truly eradicate TB without a vaccine, better diagnostics, and treatment options. I passionately believe that prevention is key and that new vaccines and treatments could mean billions of dollars saved every year. It would mean that TB would not be a plane ride away. It would mean the college student on spring break traveling to Africa for mission work wouldn't have to worry about his safety. Currently, it would mean that the person who dies every 30 seconds of every day of TB would not. Q: As you know, USAID currently does not support research to develop new TB vaccines. How would support from USAID for TB vaccine research help patients like you in the US and around the world? A: Support from USAID to develop new vaccines will mean moments and years and lives saved around the world. A vaccination before my trip to South Africa might have changed everything. The truth is I will never know what could have been. But what IF I had received an improved TB vaccine before traveling? Maybe I would have returned home and never lost my job as a physical therapist. Maybe I would have stood next to my friend Laural as she said her vows, rather than lying in bed on isolation. Maybe I would have been more present in my friends’ and family's lives during those three years. Maybe I would have gone back to South Africa. For countless others around the world, a better TB vaccine would be life-changing. Maybe a mother will not worry about passing the disease to her children. Maybe a doctor will save millions of lives. TB does not discriminate. It does not matter who you are—if you breathe, you are at risk. This is why support for research of new vaccines is absolutely imperative. USAID should absolutely choose to be a part of this global fight. After all, who would willingly choose to NOT be a part of claiming lives were SAVED, lives were LIVED, and dreams were PURSUED? I hope we can all confidently say we were a part of this solution.

In this guest post, Kari Stoever—vice president of External Affairs at Aeras—writes about European support for new vaccines against tuberculosis (TB). TB is a disease most often associated with countries in the developing world, particularly in Asia and Africa. While India and China had the largest number of cases in 2012, Europe is not immune. Europe accounts for almost 18 percent of global cases of multidrug-resistant and extensively drug-resistant TB, with the highest burden in Eastern Europe. TB is estimated to cost the European Union around €6 billion (US$8 billion) each year. New vaccines to prevent TB will be the most cost-effective and long-term approach to saving lives and money, so it makes sense that Europe leads the world in the research and development (R&D) of TB vaccines. Europe is a major contributor to the development of vaccines globally, with as much as 75 percent of the global TB vaccine portfolio either originating in Europe or being developed in partnership with European public or private organizations. Of the five major donors contributing to TB vaccine R&D, three of them are European. Since 2000, the European Commission (EC) has invested more than €34 million (over US$46 million) in research for new TB vaccines. Along with European Union Member States, the EC has also invested more than €42 million towards clinical trial site preparedness, capacity building, and support in Africa through the European and Developing Countries Clinical Trials Partnership (EDCTP). Recently the EC announced a €25 million (approximately US$34 million) call for proposals to accelerate the development of new TB vaccines. Europe is a major contributor to the development of vaccines globally, with as much as 75 percent of the global TB vaccine portfolio either originating in Europe or being developed in partnership with European public or private organizations. Credit: PATH. The announcement comes as an important new collaboration between European funders and a global network of researchers is forming. The new initiative, the Global TB Vaccine Partnership (GTBVP), aims to channel finances to TB vaccine R&D to establish a robust and diversified global portfolio of clinical and preclinical candidates. One of the top priorities for the GTBVP will be to strengthen and diversify the preclinical and clinical portfolio to facilitate a more rational, cost-effective, and accelerated vaccine development process through the sharing of technical, financial, and market risks. The GTBVP’s role will be to foster greater alignment among researchers and funders’ objectives, and implement an effective mechanism for collaboration, information-sharing, and decision-making. Aeras, the Netherlands-based TuBerculosis Vaccine Initiative (TBVI), the EC, the European Investment Bank (EIB), the Bill & Melinda Gates Foundation, and the EDCTP are spearheading the development of the GTBVP. The evolution of the collaboration The push for a new financing mechanism and governance structure began in March 2012 when the EC, with support of the EIB, expanded its engagement with TBVI and Aeras to develop a Business Case for Investment. The document provides evidence of a viable market incentive for new TB vaccines, opening the door for more expensive later stage trials to be financed through cost-sharing arrangements with industry and the use of other risk-sharing financial instruments. Public sector grant funding for early stage research would act as a catalyst for this private sector investment, providing significant leverage to donors. By working with researchers around the world, it is envisioned that the GTBVP will play a crucial role in ensuring that research into life-saving TB vaccines continues to progress in the most efficient way possible. Europe’s leadership has been critical to the formation of the partnership, and the EC is to be commended for its excellent commitment to much-needed health interventions, especially a vaccine that would drastically reduce the number of TB cases. TB is a global threat requiring global action, and through the new partnership there is a historic opportunity for donors, disease-endemic countries, researchers, and other stakeholders to work together and achieve the goal of having new, more effective TB vaccines available globally.