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Photo: Neil Brandvold/DNDi Global Health Now took an in-depth look at the flesh-eating fungus mycetoma—which enters the body through cuts, and can result in swollen, deformed limbs—in a three-part series on this Untold Global Health Story of 2015. The final installation focuses on GHTC member Drugs for Neglected Diseases initiative (DNDi), a product development partnership that will be initiating a clinical trial in mid-2016 to assess the safety and efficacy of the antifungal Fosravuconazole against mycetoma. Fosravuconazole is currently under development by Japanese pharmaceutical company Eisai, where it has proven more successful at combatting mycetoma in petri dishes than currently used medicines. The leading treatment, itraconazole, is only curative for one in thirteen patients after a year of use. The article notes that DNDi’s entire budget for the study is under US$2 million, compared with the average $1 billion spent by pharmaceutical companies. Eisai has agreed to donate Fosravuconazole pills for the trial which will compare Fosravuconazole, itraconazole, and a placebo. Pharmaceutical company Gilead Sciences has been heavily criticized for “price gouging,” charging Americans $1,000 per pill for their drug sofosbuvir, which, for most patients, cures Hepatitis C in twelve weeks. However, in Egypt, where 10 percent of the population has chronic Hepatitis C—the highest rate worldwide—Gilead is selling them to the government for $10 per pill. The reduced price comes at a cost: to prevent the drugs from entering the black market and undermining Gilead’s sales, the Egyptian government has agreed to several restrictions that some advocates consider humiliating for patients and/or unethical. Not only are the drugs only sold at official government pharmacies, but patients must break the seal and take the first pill on-site to receive their first bottle and must return the original bottle to receive refills. The program has generated interest from other pharmaceutical companies, and the government has entered into similar deals with Bristol-Meyers Squibb and AbbVie, importing their medicines Viekira and Daklinza, respectively. Over the past year, more than 125,000 Egyptians have been treated, and the government hopes to treat another 300,000 each year starting in 2016, with the ultimate goal of reducing prevalence to 2 percent by 2025. Figure 1: Compounds included in the Pathogen Box, by disease (Photo: MMV) GHTC member Medicines for Malaria Venture (MMV) launched the Pathogen Box, a set of 400 compounds, each with proven activity (i.e., in test tubes) against neglected diseases, free for researchers and laboratories around the world. To create the Pathogen Box, MMV's team of chemists, as well as partners with expertise across neglected diseases, evaluated compounds in the European Bioinformatics Institute’s open access database, to determine those with the most potential. The team then acquired fresh samples of each compound to include in the boxes themselves. By expanding access to these samples, the Pathogen Box eliminates a major barrier to drug discovery for malaria, tuberculosis, schistosomiasis, Chagas, and other neglected diseases (See Figure 1).

Photo: PATH/Patrick McKernUpdate: The Global Health Technologies Coalition is excited to announce that the Global Health Innovation Act (H.R. 2241) passed the House of Representatives on December 18. Last month, Representatives Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) introduced a new piece of legislation—the Global Health Innovation Act (H.R. 2241)—that would strengthen global health research and development (R&D) programming at the US Agency for International Development (USAID).USAID plays an important role in advancing global health in low and middle-income countries and this legislation would ensure that the agency is taking appropriate steps to incorporate innovation for new global health technologies across its programming by requiring that the agency submit an annual report to Congress on the development and use of global health innovations in the agency’s programs, projects, and activities.The Global Health Innovation Act marks a key opportunity in advocacy for the need for innovation in global health. The GHTC dissects the bill below and highlights the key provisions.If passed, H.R. 2241 would: Make permanent and improve USAID’s annual report to Congress on health-related research and development activities. The act would require a comprehensive analysis of USAID’s activities to develop, advance, introduce, and scale up global health technologies. This allows policymakers and advocates to track and understand the full scope of health R&D activities taking place at USAID, identify best practices, and zero-in on gaps that may exist. Require USAID to articulate how it sets goals for health product development and measure progress toward these goals. The legislation would require USAID’s report to describe how it sets goals for health R&D in relation to its overall health objectives and mission, and how the agency measures progress towards these goals. This provides enhanced transparency into USAID’s decision-making and review processes. Require USAID to describe and demonstrate the impact of its investment in health innovations on global health outcomes. This includes analysis in the annual report of how the agency’s investments and activities in health innovation have advanced its goals to reduce the burden of HIV and AIDS, end preventable child and maternal deaths, and protect against infectious diseases. Such an impact analysis will help magnify the importance of investment in health R&D for achieving sustainable health solutions. Direct USAID to report on how it is working with partners, donors, and through public-private partnerships to leverage US investments to accelerate health innovation. This includes a description of the how the agency is working through partnerships to develop, introduce, and scale up affordable, available, and appropriate health products and close gaps in the health innovation development pipeline. This section of the report will acknowledge the diverse coalition of private sector, nonprofit, foundation, and academic institutions partnering with USAID on health innovations, and demonstrate the importance of a coordinated, cross-sector approach to health R&D. Encourage USAID to improve collaboration and coordination, both within USAID and between other US agencies, to fill critical R&D gaps. The act requires that USAID report on how it is coordinating R&D activities across its programs and how it is collaborating with other US agencies to support global health product development and ensure critical gaps are filled. This will help promote a whole-of-government approach to health R&D, which will better leverage investment, knowledge, and expertise. The legislation would make permanent and improve USAID annual report to Congress on its R&D activities. Credit: USAID The Global Health Innovation Act would not only ensure important information about USAID’s activities is made available to global health nongovernmental organizations, advocates, and policymakers in Congress, but it would also be an asset for USAID. In codifying the report on global health innovations, the bill will ensure that the agency continues to coordinate, streamline, and organize its use and development of global health technologies—a practice area that spans many departments and bureaus. It will also help the agency gauge performance, share best practices, and understand gaps in service to more efficiently and effectively serve its mission.The legislation draws upon the 21st Century Global Health Technology Act, legislation introduced in the 113th Congress, which sought to strengthen global health R&D programming at USAID by codifying programs supporting product development partnerships. The new legislation takes a more holistic approach, and directs USAID to analyze how it is using innovation to address global health challenges and the ways in which the agency can further accelerate the development and use of health technologies. It shifts away from endorsing specific programs and instead underscores the importance of USAID’s strong partnerships that leverage investments in R&D and advance global health innovation.Passing the Global Health Innovation Act will drive home the fact that health innovations are a critical piece of the global health agenda. GHTC and our members look forward to working with Congress to champion this important legislation.To read the full text of the Global Health Innovation Act, click here.

A child in Delhi holds new appropriate, child-friendly TB medicine in the correct doses. Photo: TB Alliance Early this month, GHTC member TB Alliance and its partners announced the creation of the first-ever appropriate, child-friendly tuberculosis (TB) medicine in the correct doses. These treatments, which will be available in early 2016, are simple to administer, affordable, and the first to meet childhood TB dosage treatment guidelines set by the World Health Organization (WHO) in 2010. GHTC’s Breakthroughs blog is joined by TB Alliance’s Cherise Scott, Director of the Pediatric Programs and Willo Brock, Senior Vice President, to learn more about this exciting development that could dramatically improve treatment for the one million children with TB each year. Q: Why do we need TB medicines designed specifically for children? And how are these new treatments more child-friendly than what’s in use today? Children need different dosing of their TB treatment than their parents. Until now, this meant that parents needed to split or crush pills to get to the right dosage, which is difficult. The current pills also taste bad, which can lead to children refusing to take their medicine and thus poor adherence and growth in drug resistance. The new formulations that are available are appropriately dosed, dissolvable, and fruit-flavored, which will improve adherence. This should simplify and improve treatment for children everywhere. For more information on what these medicines mean for children with TB and their families, see this video. Infographic: TB Alliance Q: According to WHO, 140,000 children die each year from TB. Given this tremendous need, why did it take so long for appropriately dosed, child-friendly TB medicines to be developed? Not only do 140,000 children die, at least one million children get sick every year from TB. However, children with TB have been neglected for too long. Children with TB often live in poverty, and companies therefore do not have a commercial incentive to invest in research and development for improved TB treatments. After WHO created specific dosage guidelines for children in 2010, TB Alliance, with WHO and a range of other partners, worked together with funding from UNITAID, the US Agency for International Development, and others to advance product development and introduce important medicines that fulfill this critical gap. Q: In product development we know that successfully developing a new product is only half the battle; it needs to actually reach patients to have an impact. What’s next for these treatments in terms of regulatory approval, introduction, and product roll-out? These new treatments for the one million people with TB each year. Photo: TB Alliance In early December 2015, TB Alliance announced the availability of the products under WHO’s “ERP” [Expert Review Panel] mechanism, which is an interim step to expedite access to lifesaving drugs. That means the products are now available for procurement through the Stop TB Partnership’s Global Drug Facility. Full WHO Prequalification is expected in 2016, which will enable even greater access. However, various countries require additional steps to register the treatments. We are asking everyone to help accelerate access to appropriate TB treatments for children by signing our call to action and asking governments to speed up approval and adoption of the new child-friendly treatment. Please sign it and spread the word!

In this guest post, Mike Frick, TB/HIV project officer at the Treatment Action Group (TAG), reflects on activist calls for greater investment in tuberculosis (TB) research and development (R&D) at the 46th Union World Conference on Lung Health and the stagnation of global TB R&D funding at a time of growing drug resistance. Activists march at the 46th Union World Conference on Lung Health in Capetown, South Africa to call for more funding for TB R&D. Photo: David Harrison One city, host to two TB conferences, opened by two marches, held eight years apart. In certain moments at the 46th Union World Conference on Lung Health in Cape Town, South Africa, the present echoed the past. On Friday, December 4, 1,000 people organized by Treatment Action Campaign (TAC) and SECTION 27 marched to the site of the conference to call on governments of the BRICS countries [Brazil, Russia, India, China, and South Africa] plus Indonesia to triple their funding for TB R&D. The sight of so many people demonstrating in support of TB R&D called to mind a moment at the 38th Union World Conference in 2007 when thousands took to the streets of Cape Town demanding greater global investments in TB research and programs. TAC march to demand more funding for research into & the treatment of TB. Photo: David Harrison Seasoned TB activists present at last week’s march likely experienced a feeling of déjà vu. Both marches pointed to the grave lack of investment in TB research. And each occurred at moments their participants described as emergencies. In 2006, an outbreak of extensively drug-resistant TB in Tugela Ferry, South Africa, captured headlines around the world and crystallized how decades of inattention had allowed TB to become more deadly. This year, marchers carried banners reading “We die of TB,” “Invest in TB research,” and “Invest so we can live” (see photos). According to the protest’s organizers, these messages were in response to ten years of data on global funding for TB research collected and analyzed by TAG in a report released on November 29. TAG’s tenth annual Report on Tuberculosis Research Funding Trends shows that after increasing modestly from 2005–2009, funding for TB research has stagnated in the five years since. Over this ten-year period, total funding for TB research has never exceeded more than US$700 million per year (see figure 1). In 2015, worldwide funding for TB R&D totaled $674 million, falling $1.3 billion short of the $2 billion experts estimate the world must spend on TB research each year to eliminate TB. Funding shortfalls have persisted in each category of research tracked by TAG—basic science, diagnostics, drugs, vaccines, and operational research—each of the last ten years, making the last decade one of missed targets and forestalled potential. Credit: TAG Members of TAC and those who marched with them understand that the pace of research to develop new drugs, diagnostics, and vaccines to fight TB is falling behind the spread of drug-resistant TB (DR-TB). The need for better ways to prevent, diagnose, and treat TB has never been greater. TB is now the leading cause of death from an infectious disease, responsible for more deaths each year than HIV and AIDS. In 2014, 400,000 people newly developed DR-TB. TAG’s research suggests that filling the funding gap and accelerating TB research will depend on increasing support from endemic country governments, which is why TAC directed the message of its march to the BRICS countries and Indonesia. Sixty-two percent of money spent on TB research comes from public institutions, a proportion that has grown in the wake of an exodus of pharmaceutical companies from TB research since 2012. Photo:David Harrison Throughout the week, activist voices compelling greater attention to TB research reverberated throughout the conference center. Speaking at the conference’s closing ceremony, Anele Yawa, TAC general secretary, pointed out that 40 percent of TB deaths occur in the BRICS countries, yet these nations give only 3.6 percent of the available funding for TB research. Calling out leaders of the BRICS countries by name, Anele urged them to triple their support for research to overcome a disease that kills so many of their people. “We can’t just tinker and settle for incremental change while our brothers and sisters are dying,” said Anele. “We demand a revolution in funding for TB research.” This call appears to be gaining traction in South Africa. At the end of the march, South Africa’s Minister of Health, Aaron Motsoaledi, accepted a memo endorsed by TAC, TAG, Médecins Sans Frontières, the Global TB Community Advisory Board, HIV i-base, TB Proof, SECTION 27, and the People’s Health Movement. The memo called on governments to declare TB and DR-TB public health emergencies and close the TB research funding gap. In some ways, Minister Motsoaledi’s very presence at the march was a sign of how things have changed since the first march for TB research in Cape Town eight years ago. In 2007, no parliamentarians or ministers of health received the protestors’ list of demands, and the stagnation of TB research funding in the years that followed suggests these earlier cries fell on deaf ears. Political will to support TB research is also gaining traction at the global level. A week before TAG released its report on TB R&D funding, the World Health Organization (WHO) launched the Global Action Framework for TB Research and announced the creation of a TB research focal point within the WHO’s Global TB Programme. Intensified research and innovation is the third pillar of the WHO’s End TB strategy, which aims to eliminate TB by 2035. Through the Action Framework, the WHO aims to advance TB research by building support for TB R&D at the country level, with a focus on low- and middle-income countries that bear the greatest burden of TB but that have traditionally given less than 5 percent of global funding for TB R&D. As part of this initiative, the WHO will work with a group of “pathfinder” countries to develop national strategic plans for TB research backed by concrete milestones over the next five to ten years. It is imperative that these plans are backed by financial commitments that increase TB R&D funding above its current level. Those who marched alongside TAC in Cape Town on December 4 took just the initial steps to build the public pressure and accountability that will be required to make the Action Framework a success and enable the research required to end the TB epidemic—in South Africa and across the world.