Marissa Chmiola

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. In the spirit of the Thanksgiving holiday, GHTC’s communications officer Marissa Chmiola put together a list of ten global health advancements she’s thankful for this holiday season. The list includes advancements toward polio eradication, new Ebola treatments, vaccine candidates against hookworm, dengue fever, malaria, and much more. The Bill & Melinda Gates Foundation announced a new policy that will require all research it funds to be published in a manner that is free for the public to access. Vox gives the lowdown on how this new policy could impact researchers. Since this Gates Foundation policy is in conflict with the practice of top scientific journals who charge access fees for their articles, Gates-funded scientists could have to stop publishing their articles in these top journals. On the other hand, it’s also possible that since the Gates Foundation funds so much research—spending US$900 million each year—these journals may have to change their policies or lose out on publishing potentially important research. The New Yorker takes an in-depth look at how the growing global vaccine market is spurring companies to pursue development of an Ebola vaccine. According to the author, companies have realized that while vaccines can be more difficult to develop than prescription drugs, that difficulty can also be an asset because it is then harder for generic companies to produce copycat versions. While an Ebola vaccine likely won’t become a big money maker for pharmaceutical companies, with government and aid agencies offsetting some of the development costs, companies could break even on their investments and gain some positive publicity in the process. This past week saw lots of great articles for World AIDS Day discussing progress on fighting HIV and AIDS. The International Partnership for Microbicides’ Chief Executive Officer Dr. Zeda Rosenberg discusses the need for new products such as microbicides which will help women protect themselves from HIV. AVAC’s Executive Director Mitchell Warren argues that more precision is needed in setting the prevention targets to meet UNAIDS five-year goal of reducing HIV infections by 500,000, including research into new prevention and treatment options.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Last week we learned just how much pharmaceutical companies think a fast track review by the Food and Drug Administration (FDA) could be worth. Gilead Sciences paid US$125 million via auction to purchase a priority review voucher from Knight Therapeutics. This voucher will allow Gilead to shave four months off of the FDA review time for a drug of its choice. The priority review voucher system was created in 2007 to incentivize development of drugs for neglected diseases. Bloomberg reports on a recent study out of the Tufts Center for the Study of Drug Development which found it costs pharmaceutical companies on average $2.56 billion to bring a new drug to market. This is more than twice the cost it took 11 years ago. According to the study’s author, this higher cost results from larger and more complex clinical trials, as well as the number of drugs that fail in development. The Bill & Melinda Gates Foundation last week pledged $5.7 million to test potential treatments for Ebola. The research being funded will examine the effectiveness of using blood plasma taken from Ebola survivors to treat those infected, as well the effectiveness of an experimental antiviral drug called brincidofovir. While it has been common practice for decades for doctors to use blood donations from Ebola survivors as a form of treatment, there has not yet been rigorous studies conducted to examine the effectiveness of this practice until now. The US Department of Health and Human Services last Wednesday unveiled new proposed reporting requirements or clinical researchers registering and submitting results to ClinicalTrials.gov. The most significant proposed change is that companies will be required to submit summary results from trials even if the product has not been approved or licensed for use in the United States.

We have many reasons to be thankful. Photo: Satya Murthy As global health advocates, our work often requires us to focus on unmet needs—such as the number of people worldwide who still die from preventable diseases each year, or the lack of adequate resources and investment to tackle these diseases. Yet with Thanksgiving just around the corner, there is much for which we, as global health advocates, can be grateful in terms of advancements achieved in the development and deployment of lifesaving global health technologies. In the spirit of the holiday, here is my list of ten global health advancements I’m thankful for this Thanksgiving: After years of slow progress in the development of drugs, vaccines, and diagnostic tools to fight Ebola, efforts are now moving at hyper speed. Several experimental treatments and vaccines are now being tested in clinical trials in Ebola-endemic countries. Thanks to the development and widespread implementation of effective vaccines, this year the world moved one step closer to the eradication of polio. Scientists from the US Centers for Disease Control and Prevention believe that the second of three forms of poliovirus has successfully been eradicated. The first vaccine against hookworm has been shown to be safe in early-stage clinical trials. An effective vaccine could protect the more than 600 million people infected with this dangerous parasite worldwide. Widespread access to and use of antiretroviral therapy (ART) is fueling incredible progress in the fight against HIV and AIDS. According to the UNAIDS 2014 report, 2013 saw the lowest level of new HIV infections this century and the lowest number of AIDS-related deaths since 2005. As of this summer, nearly 14 million people are accessing ART. The world could soon have an important new tool in the first against dengue fever. Results from the second Phase III trial of the first vaccine candidate against dengue fever showed the vaccine to decrease incidences of dengue fever by nearly 60 percent. Within a few years, women could have new, user-friendly options to protect themselves against HIV. Several new antimicrobial vaginal gels and antiretroviral-releasing contraceptive vaginal rings are currently undergoing clinical trials. Significant progress has been achieved this year towards the development of new tools to fight malaria. After receiving expedited regulatory approval from the US Food and Drug Administration last year, new malaria drug treatment candidate tafenoquine entered Phase III trials this year. Additionally, the malaria vaccine candidate RTS,S is now under regulatory review by the European Medicines Agency. New pediatric drug formulations to treat tuberculosis (TB) could be available as early as late next year, according to developers. This advancement is critical as there is currently no appropriately dosed, child-friendly TB treatment available. New vaccines, drugs, diagnostics, and other health innovations have led to 4.2 million fewer child deaths globally last year compared to 1990. There are 365 global health products in the research pipeline that have the potential to fuel incredible gains in health for people around the world. With so much accomplished in 2014 and so many promising tools on the cusp of development and delivery, we have much to be thankful for this Thanksgiving. This Thursday, enjoy your Turkey and fixings with family and friends and give thanks for the incredible progress we’ve achieved this year. And then next week, when our turkey hangovers pass, we’ll get back to work.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Last week, East Asia Summit members signed a regional commitment to eradicate malaria from the Asia-Pacific region by 2030. This communique, which came out of the 9th East Asia Summit, includes support for the research and development of new drugs and diagnostic tools to fight malaria. As the international community races to develop a vaccine against the Ebola virus, a World Health Organization official said the World Bank may establish a mechanism to help indemnify Ebola vaccine makers in case liabilities arise once a vaccine is widely administered. In some cases, rare adverse reactions to a drug are not always identified through the clinical trial process, so a mechanism that protects manufacturers from liability could reduce the financial risk of bringing an Ebola vaccine to market. The New York Times Magazine took an in-depth look at why there are so few blockbuster drugs invented today. Scientists expected that once the human genome was sequenced, it would usher in a golden era of drug development and profits for the pharmaceutical industry. While there have been breakthroughs, it’s since been discovered that most diseases affecting large numbers of individuals are caused by a handful of interacting mutations, which makes them tougher to treat and prevent. The article looks at this and other factors impacting drug development. A team of Chinese scientists claim to have eradicated malaria in Comoros—a small island nation off the east coast of Africa—by administering a new Chinese-made drug to all 700,000 people on the island as part of a massive medical experiment supported by the Comoran government. The scientists say that by administering repeated doses of medicine to everyone in the country for three months, they removed the malaria parasite from the bloodstream of the entire population, thereby halting the life cycle

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. GHTC’s Senior Policy and Advocacy Associate Jenny Howell assesses how tomorrow’s congressional election results could impact global health research and development (R&D). With Republicans expected to gain seats in the House and take control of the Senate, shifts in the makeup and leadership of key committees with oversight over global health R&D are expected. Senators Tom Harkin (D-IA) and Lamar Alexander (R-TN) announced their intention to introduce a new bill to accelerate the development of treatments and vaccines for Ebola. The bill would add Ebola to the list of qualifying tropical diseases for the Food and Drug Administration’s priority review voucher program—which is designed to incentivize the development of drugs, vaccines, and other health tools for neglected tropical diseases. Emily Donaldson, program coordinator at AVAC, and Tom Harmon, senior policy analyst at the International AIDS Vaccine Initiative (IAVI), discussed the state of HIV prevention research funding while the first-ever conference devoted solely to HIV prevention R&D took place last week in Cape Town, South Africa. During his speech at the annual meeting of the American Society of Tropical Medicine and Hygiene, Bill Gates said he believes it is possible to eradicate malaria within a generation. To reach that goal, Gates pledged that the Bill & Melinda Gates Foundation would increase its malaria program budget by 30 percent—to more than $200 million per year. A group of European universities and medical groups plan to give experimental drugs to Ebola patients in West Africa without assigning any trial participants to a placebo group. These groups say it would be unethical to withhold potentially lifesaving treatment, but US officials argue that without a control group, it is impossible to assess whether the drugs are effective. The Wall Street Journal takes a deeper look at this debate.

Photo: © 2011, Charlotte Raymond Photography for International AIDS Vaccine Initiative (IAVI) With the 69th session of the United Nations (UN) General Assembly opening this week in New York and the global community debating how best to refine the post-2015 development agenda, over 150 organizations and individuals signed a petition to UN Secretary General Ban Ki-moon and Member States urging the UN to keep the research, development, and delivery of new and improved health tools at the heart of the post-2015 development agenda. Specifically, the petition—which was circulated by GHTC, the Council on Health Research for Development, and the International AIDS Vaccine Initiative—requests that the “UN fully supports in the post-2015 Sustainable Development Goals [(SDGs)]-Framework the research, development, and delivery of new and improved medicines, vaccines, and other health tools for the diseases and health conditions that predominantly affect low- and middle-income countries as well as marginalized, vulnerable populations globally.” The signing organizations and individuals represent a diverse group of research and academic institutions, private sector entities, and nongovernmental organizations from all regions of the globe: Africa, Asia, Europe, Oceania, and North and South America. GHTC is pleased to see such broad and substantial support for the inclusion of health R&D components in the post-2015 agenda, and hopes that the Member States and officials who are shaping the agenda will take note. Below is the full text of the petition and list of signatories: Excellency, Secretary General Ban Ki-moon, Member States of the UN, We, the below signatory organizations request that the UN fully supports in the post-2015 SDG-Framework the research, development, and delivery of new and improved medicines, vaccines, and other health tools for the diseases and health conditions that predominantly affect low- and middle-income countries as well as marginalized, vulnerable populations globally.  Thanks to the leadership of the UN and investments by Member States, the current Millennium Development Goals have made major contributions to improving the health and lives of millions of people around the world. A sustained focus on some of the greatest global health challenges has led to enormous progress in many areas, including significant improvements in the development and delivery of health tools such as drugs to treat HIV and AIDS, tuberculosis (TB) and malaria. Efforts to tackle diseases have also helped underpin progress in other important areas, such as gender equality, child mortality, and maternal health. Millions of lives have been saved. However, major challenges remain, and the health burden imposed by poverty remains far too high. In this context, it is essential that the post-2015 development agenda retains a strong focus on eliminating poverty-related diseases and conditions. The post-2015 agenda must build on previous achievements to ensure that healthy lives and access to health services can be achieved in an equitable and sustainable way, leaving no one behind. This means ensuring universal access to proven health interventions. But it also means developing and delivering new health technologies which can help address the shortcomings of existing interventions and sustainably reduce morbidity and mortality over the longer term. This will require continued support for the research, development, and delivery of new tools to the combat major epidemics like HIV and AIDS, TB, and malaria, as well as other poverty-related diseases and conditions ranging from neglected tropical diseases to reproductive, maternal, and child health. Continuous investment of human and financial resources in science, technology, and innovation is essential to achieve both economic and social development for all. We are encouraged by the current inclusion of the need to support the development of new medicines and vaccines for diseases particularly affecting developing countries in the Zero Draft document of the SDGs. Concern remains, however, about the omission of medical devices and diagnostics which also contribute to improving health outcomes, the lack of clarity on how this effort will be funded, and how supporting policies, incentives, capacity building, collaboration, and knowledge and technology sharing will be defined and implemented. As organizations working to save lives and improve health, we urge you to commit explicit and full support to health research and related policies and capacity building as a core component of a new, post-2015 agenda for equitable health and sustainable development for all. We ask that you press Member States to offer similar support, and to formally assess how to measure progress towards this goal, and how to fully and sustainably finance and enable the research, development, and delivery of essential new and improved health tools. Sincerely, ACTION Aeras African Services Committee AIDS-Fondet Amsterdam Medical Centre, University of Amsterdam American Society of Tropical Medicine and Hygiene Asociacion Gestion Salud Poblacion Association of Commonwealth Universities AVAC Bishkek Feminist Collective SQ Boston University Canadian Coalition for Global Health Research Canadian HIV and AIDS Legal Network Caribbean Public Health Agency Caribbean Vulnerable Communities Ciflorpan, University of Panamá COHRED Comité Nacional Cubano de Bioética Community Health Evangelism Programme Commonwealth Human Rights Initiative Department of Epidemiology, University Hospital F Hached, Tunisia Department of Psychiatry, Chiang Mai University Dept of Paediatrics, IrruaTeaching Hospital Edo State Nigeria Deutsche Stiftung Weltbevoelkerung Development of People's Foundation Drug Discovery Unit, University of Dundee Drugs for Neglected Diseasesinitiative Duke University ECOM - Eurasian Coalition on Male Health Egerton University Estonian Network PLWHIV European Investment Bank European Public Health Association Euvadis Facultad de Quimica, Universidad de la Republica, Uruguay Faculty of Tropical Medicine Federal Teaching Hospital Abakaliki, Ebonyi State, Nigeria FIND FIOCRUZ Fiocruz Minas Friends Africa (Friends of the Global Fund Africa) GAT George Institute GESPAM GlaxoSmithKline Global Alliance for TB Drug Development Global Health Advocates Global Health Consulting Global Health Council Global Health Technologies Coalition Global HIV Vaccine Enterprise Government of Kenya gTt-VIH (Spain) Hanoi School of Public Health Health Reform Foundation of Nigeria Edo State Chapter, HKMU Hospital Nelson Piccolo Hospital Sionsberg Hubert Kairuki Memorial University icddr,b IHCAI Foundation INDEPTH Network Institute of Human Nutrition and Food Institute of Tropical Medicine Institute Tropical Medicine Antwerp Instituto de Investigaciones Epidemiologicas, Academia Nacional de Medicina, Buenos Aires Instituto de Observação da Terra Instituto de Salud Carlos III Instituut voor Tropische Geneeskunde Interagency Coalition on AIDS and Development International AIDS Vaccine Initiative International Consortium on Anti-Virals International Organization for Chemical Sciences in Development International Partnership for Microbicides International Vaccine Institute Johns Hopkins Bloomberg School of Public Health Kairuki Memorial University Kapkatet medical training Centre Kenya National Bureau of Statistics Koningklijk Instituut voor de Tropen Kyrgyz Indigo La Gazette Law Office of Laurel G. Yancey, P.C. Medical Research Council of Zimbabwe Medicines for Malaria Venture menZDRAV Foundation Micro Insurance Academy Ministry of Education and Sports, Philippines Ministry of Health and Social Welfare, Tanzania Ministry of Health, Barbados National AIDS Research Institute National Institute of Health Research & Development NEPAD Science, Technology and Innovation Hub Netherlands Health Research Organization Nige Academy of Science North Eastern Council, Health Adviser One child-one world One Family Health Oswaldo Cruz Institute Parviflora Research Organization PATH People’s Health Movement Philippine Council for Health Research and Development Philippine Department of Health Policy Cures Population Council Public Health Institute Public Private Partnership Health Society RALSA Foundation Research Department, National Hospital Rosales Research into Cultura and Reproductive Health For Sustainable Human Development (RECARDEV) RESULTS UK Royal Tropical Institute, Netherlands Rural Community Health Research SA Medical Research Council Sabin Vaccine Institute School of Population Health, University of Queensland Section of Infectious Diseases, Dept of Medicine, St Luke's Medical Center, QC, Philippines Sensoa South Africa-Department of Health South African Research Ethics Training Initiative STOP AIDS Swiss Tropical & Public Health Institute The Africa Centre for Health and Population Studies The Environment Ameliorators The University of Western Australia Tools To Work Treatment Action Group Uhamka University Unidad de Investigacion Cientifica, Facultad de Ciencias Medicas, UNAH Universidad del Valle Universidad Nacional Autonoma de Mexico Universidade de Sao Paulo University of Bergen University of Birmingham University of Brasilia University of Cagliari University of California, Irvine University of Cape Coast University of Edinburgh University of Health and Allied Sciences, Ho. Ghana University of KwaZulu-Natal University of Melbourne University of Nigeria, Nsukka University of Oslo University of the Witwatersrand Washington Global Health Alliance Y+ Network Individuals: Alix Beith Francesca Coloni Franko Family Wanjiku Kabiru Malcolm McNeil Ophelia Mendoza Ellene Mocria