Breakthroughs Blog: United Nations

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The release of antibiotics into the environment is a significant environmental threat, according to a new United Nations Environment Programme report. The presence of antibiotics have been found in soil deposits, lake and river sediment, and wastewater facilities around the world, suggesting industrial, human, and pharmaceutical disposal leads to traceable amounts of antibiotic compounds in the environment. This issue alarms experts because even minimal traces of antibiotics may lead to the continued evolution of antimicrobial resistant bacteria. While more research is needed on the consequences of antibiotics in the environment, experts suggest various strategies to help mitigate the problem including deploying improved methods to treat wastewater, treating animal waste before using it as fertilizer, and improving antimicrobial stewardship. An Army-developed Zika vaccine candidate (ZPIV) performed well across three Phase 1 clinical trials, according to new findings published in The Lancet. The three studies were designed to elicit information on background immunity, vaccine dosage, and vaccine schedule in adult populations. A total of 67 participants received two injections four weeks apart, and researchers found more than 90 percent of participants who received the ZPIV vaccine had an immune response to the virus. The Army developed the vaccine candidate in response to the 2015 outbreak, noting the need for a Zika vaccine not only to advance global health, but also to protect US service members and their families. Countries are restricting use of the world’s only dengue vaccine—Dengvaxia— following an announcement by developer Sanofi Pasteur raising safety concerns. The company discovered, from data analysis, that the vaccine could raise the risk of a deadly form of dengue for people who had not been exposed to the virus prior to vaccination. In response, the Philippines ceased an ongoing, mass immunization campaign, and Brazil tightened restrictions on the vaccine. While Sanofi stressed there were no reported deaths related to the dengue vaccine, they believe more severe cases of dengue may occur if an immunized individual, who was not previously infected before receiving the vaccine, is then subsequently infected with dengue. This rare complication leaves children at a higher risk of contracting the severe form of dengue, as they are less likely to have been exposed to infection before receiving the vaccine. Dengue sickens hundreds of millions of people and kills more than 20,000 every year, underscoring the need for a safe, effective, vaccine.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The US Centers for Disease Control and Prevention (CDC) reported that they expect rates of multidrug resistant tuberculosis (MDR-TB) in Russia, India, South Africa, and the Philippines to rise significantly in the next 25 years. These four countries carry the heaviest burdens of resistant (both drug-resistant and MDR) TB, accounting for 230,000 cases in 2015—nearly 40 percent of cases worldwide. It is predicted that one third of all TB cases in Russia will be drug resistant by the 25-year mark. The CDC suggests that efforts should be taken to prevent the airborne transmission of TB. In addition, CDC notes the need to expand diagnostic capabilities in low- and middle-income countries and access to rapid diagnostics and effective treatments. Zoonotic diseases, or diseases passed from animal to humans, such as Ebola, HIV and AIDS, swine flu, Spanish Influenza, malaria, and the bubonic plague, have been around for hundreds of years. With increased disease surveillance efforts globally, PREDICT, a global surveillance network financed by the US Agency for International Development and other partners, has recognized something important: healthy ecosystems and wildlife leads to less disease, which lowers disease burdens and makes humans safer. In tracking outbreaks like Ebola and swine flu, PREDICT has taken samples from over 55,000 wild animals and have tracked down 815 novel viruses. When ecosystems are damaged and the animals living in those systems are displaced, disease rates are higher. This research suggests that climate conservation can also help prevent pandemics. The United Nations Environment Agency and partners launched a new surveillance platform called the Global Mosquito Alert designed to survey mosquito patterns. Leveraging a global network of scientists and volunteers, the platform will track mosquito populations and disease patterns around the world. The global alert will provide real-time open access data via cloud computing networks, allowing the general population to engage and contribute to documenting and observing the patterns of mosquitoes.  

2016 was a year that ushered in significant shifts in the global health landscape. We witnessed the waning of the Ebola epidemic and the waxing of the Zika outbreak; important leadership changes among the biggest institutional players in global health; and the development and introduction of new innovations that could turn the tide against leading infectious disease killers. As the year comes to an end, GHTC is reflecting on the top stories in global health innovation that made news in 2016. Here are seven of those top moments: 1. Scientists mobilize against Zika A vial of the National Institute of Allergy and Infectious Diseases (NIAID) Zika Virus Investigational DNA Vaccine (Photo: NIAID).Once considered an obscure virus responsible for a mild illness, Zika took the world by storm in 2016. As the virus gained a foothold in more than 60 countries, its association with devastating birth defects and neurological conditions was firmly established. Prior to Zika’s emergence in the Americas, only 25 research papers had been published on the virus. As the epidemic grew, scientists around the world joined the fight against Zika, often sharing their data and research in real time to speed progress. Thanks to the efforts of these researchers, over the past year our scientific understanding of Zika has grown exponentially, and we have advanced a robust pipeline of new tools to prevent, detect, and treat Zika. Today, there are more than 35 Zika vaccine candidates under development; 13 Zika diagnostics have been authorized for use by the US Food and Drug Administration; and researchers are screening novel compounds and evaluating existing drugs to advance treatments for the disease. 2. The world commits to the fight against antimicrobial resistance United Nations General Assembly (Photo: GHTC/Matthew Robinson). 2016 marked the year the world finally got serious about tackling antimicrobial resistance. On the heels of several major analyses examining the potentially devastating health and economic impact of antimicrobial resistance, the United Nations (UN) General Assembly convened global leaders for a high-level summit on antimicrobial resistance—the fourth time such a meeting has been held on a health-related topic during the UN’s 71-year history. At the close of the summit, UN member states unanimously endorsed and adopted a political declaration committing to developing action plans and policies; mobilizing resources; and supporting public awareness, surveillance, and R&D efforts to combat antimicrobial resistance. It is our hope that 2017 will mark the year political commitment translates to concrete action to advance the development of new antibiotics. 3. New strategies deployed to stymie mosquito-borne diseases Mosquito-borne diseases remain an age-old scourge, but 2016 saw the advancement of several novel strategies to combat these tiny foes. Efforts to combat mosquito-borne diseases with the transmission blocking–bacteria Wolbachia took an important leap forward this year. Past studies have shown that when the Wolbachia bacteria is introduced to Aedes aegypti mosquitos—which carry viruses like Zika and yellow fever—it prevents the viruses from replicating and blocks further transmission. Because the bacteria can be passed from one generation of mosquitoes to the next, the bacteria offers hope for eliminating a virus’s presence within a local mosquito population. After several years of conducting small-scale tests of this method, the Eliminate Dengue Program announced in 2016 it would begin conducting two large-scale trials in South America to determine whether this approach is effective in halting the spread of mosquito-borne diseases in large urban settings. This year the biotech company Oxitec also advanced efforts to test the use of genetically modified mosquitoes to reduce mosquito populations and disease transmission. The company has engineered mosquitoes that mate with A. aegypti mosquitoes, producing offspring that are unable to mature to adulthood. Early last year, Oxitec introduced the mosquitoes into the Brazilian city of Piracicaba, resulting in an 82 percent decrease in the population of A. aegypti mosquitoes in just nine months. Now, Oxitec has expanded the trial to a larger geographical area and is also initiating trials in the Florida Keys and the Cayman Islands. 4. World’s first kid-friendly TB medicine launches Children who receive tuberculosis (TB) medicines require a different dose than adults, yet until this year, there were no TB medicines designed specifically for children, so parents were forced to split or crush adult pills in an attempt to administer the right dose to their child. This year, that all changed with the launch of the world’s first kid-friendly TB medication. Developed by TB Alliance, the medicine is designed with the unique needs of children in mind: It is fruit-flavored, dissolvable in water, easy to administer, and appropriately-dosed. Already, more than 30 countries have adopted the new medicines, and enough orders have been placed to treat half of childhood TB cases worldwide. 5. Unique HIV prevention option for women reaches important development milestone Image captionMonthly vaginal dapivirine ring helps protect women against HIV (Photo: International Partnership for Microbicides). Women may soon have a powerful new tool at their disposal to prevent HIV infection. Earlier this year, the International Partnership for Microbicides (IPM) announced the results of two large phase 3 clinical trials demonstrating that a monthly vaginal ring containing the antiretroviral drug dapivirine can help protect women from HIV. While initial results indicated that the dapivirine ring reduced HIV risk by approximately 30 percent, further analysis revealed that the ring reduced infection rates by 75 percent in women who used the ring consistently. Now, IPM is seeking regulatory approval for the dapivirine ring and is conducting open-label studies, enabling trial participants to continue using the ring as IPM collects additional data. The dapivirine ring is the only long-acting, female-initiated HIV prevention tool to have proven successful in phase 3 clinical trials. Young women in sub-Saharan Africa are more than twice as likely to be infected with HIV than their male counterparts, and thus female-centered prevention tools are needed stem the epidemic. 6. Roll out begins of world’s first malaria vaccine candidate After decades of development and testing, the world’s first malaria vaccine candidate will soon be introduced in several communities in sub-Saharan Africa. The vaccine—RTS,S—was developed by PATH and GlaxoSmithKline and received a positive opinion from the European Medicines Agency last year following completion of phase 3 clinical trials. In November, the World Health Organization (WHO) announced it would pilot and evaluate the vaccine in real-life settings, thanks to funding from The Global Fund; UNITAID; and Gavi, the Vaccine Alliance. Pending results of these pilot tests, WHO will determine whether to deploy the vaccine on a wider scale. 7. New global health technologies advance through the pipeline PATH launches an easy-to-use, rapid diagnostic for onchocerciasis (Photo: PATH/Dunia Faulx) Over the past year, several other promising new health innovations have moved through the development pipeline and one step closer to reaching the hands of patients: Two important health tools—a novel, affordable oral cholera vaccine developed by the International Vaccine Institute, and the Woman’s Condom developed by PATH and partners—received WHO prequalification this year, paving the way for their procurement by UN agencies and other international procurement organizations. Two new rapid diagnostic tests for the neglected tropical diseases onchocerciasis (river blindness) and lymphatic filariasis were launched this year. Developed by PATH, these tests provide results in just 30 minutes and can be stored at a wide range of temperatures. Development has begun for an affordable therapy for hepatitis C. In 2013, the world’s first cures for hepatitis C hit the US market, however, treatment remains out of reach for many patients due to the high price tag. This year, the Drugs for Neglected Diseases initiative announced it would begin testing an alternative therapy in phase 2 and 3 clinical trials, with a guarantee from the manufacturer that, if successful, the entire regimen will be sold for no more than US$294.  As 2016 draws to a close and 2017 begins, it is time for the global health community to redouble our efforts to make sure this vital progress in global health innovation continues to ensure that people around the world will have access to lifesaving and life-improving health technologies.

As always at this time of year, the international diplomatic community is dealing with the adrenaline letdown following the conclusion of two weeks of mayhem in midtown for the United Nations General Assembly (UNGA). Attendees left with renewed inspiration, a few new political commitments, and for many, a nasty sinus infection that spread all too easily given the diplomatic necessity of copious hand-shaking. In our hyper-connected world where a single international event can spark a global outbreak of something far more deadly, it was apropos that two global health R&D topics received significant attention at this year’s assembly. Antimicrobial ResistanceAs GHTC has previously discussed, the assembly included a special High-Level Meeting on Antimicrobial Resistance (AMR), which was marked by an unusual level of agreement and commitment among member states and United Nations (UN) agencies on what actions are needed to address this challenge. The meeting concluded with the adoption of a political declaration, which among other priorities, acknowledges the importance of catalyzing R&D for the new diagnostics, vaccines, and antibiotics needed to combat AMR.The declaration specifically addresses R&D at three levels: National: Countries should include resources and policies to support R&D in their national AMR plans. Regional: Regional groups should develop regional AMR plans that leverage innovative partnership and incentive mechanisms to support R&D. Global: The UN system should include in its global AMR strategy sufficient policies to encourage global R&D efforts; the entire multilateral system (including development banks) should provide resources to support the above AMR plans, including for R&D; and the UN Secretary-General should establish an oversight group to ensure that all of these efforts are coordinated. We were pleased to see a dedicated call for all stakeholders in global health to ensure that R&D is a key part of addressing AMR and that sufficient resources are allocated to incentive mechanisms. Yet as one panelist rightly noted during the summit, “If I have three key points, they are implementation, implementation, implementation!” As the global community has seen far too frequently in the past, normative agreements reached at the UN require programming to translate them into progress on the ground. It will take civil society pressuring national governments to keep their commitments to this very progressive framework for it to have the impact it can and should. Access to Medicines TB medicines. Photo credit: PATH/Matthew DakinLess than one week before UNGA, the UN Secretary-General’s High-Level Panel on Access to Medicines (HLP) released its long-anticipated final report, which outlines dozens of recommendations from the panel in response to its mandate “to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”Both the mandate and the process of developing the report was controversial, as evidenced by the dissenting commentaries contained in an annex to the report. As outlined in the HLP cochairs’ letter to the Secretary-General, the dozens of agreed recommendations fall into four broad categories: Governments must urgently increase their current levels of investment in health technology innovation to meet unmet needs and should enter into negotiations for a binding global R&D treaty that delinks the costs of innovation from the end prices of health technologies in order to address issues that existing innovation mechanisms have failed to adequately remedy. There must be much greater transparency to ensure that the costs of R&D, production, marketing, and distribution, as well as the end prices of health technologies are clear to consumers and governments. Governments and the private sector must refrain from explicit or implicit threats, tactics, or strategies that undermine the right of World Trade Organization (WTO) members to use flexibilities as reaffirmed in the Doha Declaration on TRIPS [WTO Agreement on Trade-Related Aspects of Intellectual Property] and Public Health. WTO members must register complaints against undue political and economic pressure, and take punitive measures against offending members. The Secretary-General should establish an independent review body tasked with assessing progress on health technology innovation and access, and a High-Level meeting on Health Technology Innovation and Access should be convened by 2018.  In this environment, given the timing of the release of the report, the UN Development Programme convened at the last minute an invite-only panel discussion on the final day of UNGA. The session featured forceful remarks from the panelists and advocates, in addition to a lone dissenting statement from a member state government reiterating their concerns over the mandate of the panel.Ultimately, however, the takeaway from the event was the same as from the AMR meeting earlier in the week: the panelists unanimously agreed that the HLP’s work is done and that the Secretary-General now holds responsibility for moving the agenda forward. As a group convened without a member state mandate, the HLP had no binding authority to enact or enforce its recommendations and can only advise on what possible solutions might be. Advocates in the room noted that civil society activism can help hold governments to account and drive forward the recommendations to implementation.Overall, UNGA 2016 showed both the strength and the weakness of our multilateral governance structures. The UN can dream big, convene the world’s most senior leaders, and get them to agree to normative statements. However, implementing those norms requires the full support of its member states. This is not to minimize the importance of such a convening role; we would not have made the progress we have against HIV and AIDS, for example, without the UN’s forceful leadership. What remains to be seen, however, is whether the is a similar confluence of civil society, member state government, and multilateral organization support to move forward the AMR and access agendas over the coming years.