March 31, 2017
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Newsletter of the Antibiotic Resistance Coalition (ARC)

Table of Contents (click on links to jump to sections)

Policy Updates on AMR

OIEOn March 17th, the WHO Director-General Margaret Chan and UN Deputy Secretary-General Amina Mohammed announced the official composition of the Interagency Coordination Group on AMR for which they will serve as co-chairs. This announcement came as a result of the mandate within the Political Declaration on AMR adopted by the 71st Session of the United Nations General Assembly in September 2016. The Political Declaration came in recognition of the severity of this global challenge, and “consensus about the actions needed to prevent a post-antibiotic era”. The Interagency Coordination Group so far consists of 15 expert representatives (8 female and 7 male) from around the world, including Martin Khor of South Centre and Professor Otto Cars of ReAct-Action on Antibiotic Resistance. Officials from select UN agencies including the World Trade Organization, UN International Children's Emergency Fund, UN Environmental Programme and others will also be named to the group. The objective of the group will be to “provide practical guidance for approaches needed to ensure sustained effective global action to address antimicrobial resistance, including options to improve coordination, taking into account the Global Action Plan on Antimicrobial Resistance.” Members of this group will be meeting within the next few weeks to determine the group’s terms of references and work towards producing a report for the 73rd session of the United Nations General Assembly in September 2018.
Recording of Announcement on Establishment and Composition of UN Interagency Coordination Group on AMR
Antimicrobial Resistance Diagnostic Challenge - Dr. Robert W. Eisinger
For the first phase of the Antimicrobial Resistance Diagnostic Challenge, ten semifinalists have been chosen among 74 concept submissions. The Antimicrobial Resistance Diagnostic Change is a U.S. federal prize competition led by the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) that would award up to $20 million in prizes for innovative, rapid, point-of-care diagnostic tests to address drug-resistant bacterial pathogens. Each semifinalist will receive $50,000 to further develop their concepts into prototypes. For the second phase of the challenge, all participants are eligible to compete for an award up to $100,000. The prototypes will be due by September 2018 with finalists chosen in December 2018 - those selected can receive up to $100,000 before undergoing a performance evaluation. In July 2020, three final winners will ultimately be chosen to share an amount up to $20 million.
On March 30th, CARB-X announced its first round of recipients of 11 biotechnology companies and researchers in the United States and United Kingdom that would receive financial and technical assistance towards accelerating and developing novel antimicrobials and diagnostics for drug-resistant infections. With this announcement will be an upfront investment of $24 million as well as another $24 million in milestone payments over a three-year period. Eight of the teams are based in the United States, while the other three are in the United Kingdom. The initial round of recipients includes three potential novel classes of antibiotic drugs and seven new bacterial targets with all candidates focused on Gram-negative bacterial pathogens prioritized by both the U.S. Center for Disease Control and Prevention and WHO. CARB-X, a public-private partnership launched by the U.S. Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) plans to invest up to $450 million over five years for accelerating global antibacterial innovation, including drugs, diagnostics, vaccines, and devices. The investment will be focused on preclinical discovery and development of a minimum of 20 new antibiotic technology candidates. Within the five year period, CARB-X will also aim to advance at least two new products into human clinical trials. Candidates found to be successful and promising will b supported through early clinical development before being positioned for private investors to bring to market.
The U.S. Government Accountability Office (GAO) has identified a number of oversight gaps related to the use of medically important drugs in farm animals. While acknowledging the increased veterinary oversight of antibiotics and data collection on antibiotic use in food animals and resistance in bacteria, the GAO has pointed out that, for example, long-term and open-ended use of antibiotics for disease prevention has not been addressed by changes to drug labels and gaps in farm-specific data on antibiotic use and resistance remain. Furthermore, “FDA and USDA’s Animal and Plant Health Inspection Service (APHIS) do not have metrics to assess the impact of actions they have taken” without which they “cannot assess the effects of actions taken to manage the use of antibiotics.” While the Netherlands, Canada and the EU have taken various actions to manage the use of antibiotics in food animals, similar steps have not been taken by US federal agencies. The Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) have not yet begun to conduct on-farm investigations during foodborne illness outbreaks. According to GAO, developing a framework to help the USDA “identify factors that contribute to or cause foodborne illness outbreaks, including those from antibiotic-resistant bacteria in animal products” should be considered a priority.
India has issued new national guidelines on the use of antibiotics as part of their strategy to fight drug-resistant superbugs. As the world’s largest consumers of antibiotics, it is estimated that drug-resistant neonatal infections kill 60,000 newborn babies each year. The new guidelines, issued by the Indian Council of Medical Research (ICMR), are intended alter the way antibiotics are prescribed across the country. “Doctors’ education on antibiotic use has so far been limited to what medical representatives of pharmaceutical companies told them,” according to ICMR’s deputy director Kamini Walia, “Some hospitals have prescription guidelines, but most don’t.” The Economic Times reports that Indian hospitals have begun to report resistance to last-line carbapenems and colistin antibiotics in their intensive care units, prompting authorities to issue public warnings against taking antibiotics without a prescription on state-run radio stations. Warnings have also been issued to pharmacies after an American woman died in the United States after contracting a rare superbug while in India.
Dr. Manica Balasegaram, Executive Director of the Global Antibiotic Research and Development Partnership (GARDP) delivered an intervention at the 21st Meeting of the WHO Expert Committee on the Selection and Use of Essential Medicines. GARDP was launched in May 2016, incubated by the Drugs for Neglected Diseases initiative (DNDi) in collaboration with the World Health Organization (WHO) in support of the Global Action Plan for AMR, aiming to develop new treatments for bacterial infections where drug resistance is present or emerging, or for which only inadequate treatment exists. Within the intervention, GARDP highlights pediatrics as an area with major gaps, urging for more robust studies and trials for children. With regards to sexually transmitted diseases, they call for definitions be harmonized with those used by the WHO Department of Reproductive Health and Research. Dr. Balasegaram also requested more clarity in the comparative analysis of azithromycin and doxycycline. He concludes GARDP’s statement by saying that they “strongly support the review being used in alignment with other key WHO activities, specifically the Global Development and Stewardship Framework, the Priority Pathogens List, and the antibiotic pipeline review; specifically to help determine gaps and priorities for R&D in the areas where GARDP will be working. He added that GARDP “will be embarking on R&D programmes to develop new treatments for neonates, children, and for STIs” based on this existing work.
In late February, the WHO published a list of the 12 priority pathogens which they believe pose the greatest threat to human health and for which new antimicrobials are most urgently needed. The list included multidrug-resistant Gram-negative bacteria occurring in hospitals such as Acinetobacter baumannii and Pseudomonas aeruginosa, but omitted the world’s top infectious disease threat, tuberculosis, responsible for nearly a third of all AMR-caused deaths. Although the WHO published a separate statement recognizing its importance, its omission from the global priority list was noted by tuberculosis patients, researchers, and advocacy groups across the world. “Failing to include TB on its list was a dramatic departure from the data, and it undermines efforts to find the new and better treatments that patients desperately need. This is particularly critical for those countries where drug-resistant TB is epidemic,” said José Luis Castro, Executive Director of the International Union Against Tuberculosis and Lung Disease. In response, WHO Assistant Director-General Dr. Marie-Paule Kieny addressed this omission of TB, stating that “there is already consensus that tuberculosis is the most important priority for research and development of new antibiotics.” An editorial published in The Lancet Infectious Diseases also notes the omission of Clostridium difficile from the list as this pathogen contributes to a high burden of disease requiring novel narrow-spectrum drugs.
On World Tuberculosis (TB) Day, the Medicines Patent Pool (MPP) and TB Alliance announced an agreement to license the clinical development of sutezolid, a promising candidate for drug-resistant TB. This recently announced sublicense would allow for the development of sutezolid in combination with other TB drugs. In late January, Sutezolid was licensed to the MPP from Johns Hopkins University following advocacy efforts from ARC members including Universities Allied for Essential Medicines and Public Citizen as well as other allies. This license from Johns Hopkins marked the first TB drug in the MPP’s portfolio. Upon announcement of this new sublicense, Greg Perry, Executive Director of the MPP remarked, “We are grateful to the civil society coalition that pushed for the clinical development of sutezolid. If further studies are successful, this product could be a game-changer in improving options for patients.” 

FEATURE: The Trans-Atlantic Consumer Dialogue Hosts Side Meeting on "Consumer Health, Consumer Action, and Antimicrobial Resistance"

On March 22nd, the Trans-Atlantic Consumer Dialogue (TACD) hosted a side meeting on “Consumer Health, Consumer Action, and Antimicrobial Resistance” in Washington, DC. This side meeting brought together leading consumer organizations including ARC members as well as academics, and government officials for a half-day to discuss key policy issues across the Atlantic and globally on antimicrobial resistance in food animal production. Co-chaired by Steve Suppan of the Institute for Agricultural and Trade Policy, the meeting outlined ongoing efforts by consumer advocacy organizations to raise public awareness and accelerate around national and global initiatives to prevent the onset of “the post-antibiotic era.” The TACD is a forum launched in September 1998 of over 80 EU and US consumer organizations with the aim of providing concerted input to European and United States governments and also, as a way of strengthening the voice of consumers at the global level. The full agenda for the side meeting can be found here.

The meeting comprised of three panels and discussion among participants. The first panel on “Human antibiotic resistance and human health: One Health initiatives” moderated by Professor Anthony So of the ReAct Strategic Policy Program included perspectives from Professor Lance Price of the Antibiotic Resistance Action Center at George Washington and Nina Renshaw, Executive Director of the European Public Health Alliance. Here, Dr. Price discussed the evidence linking the use of antimicrobials in food animal production to emerging resistance in humans, necessitating public health action. Ms. Renshaw complemented this presentation with insights on the European policy pipeline on AMR and the need for these efforts to be urgently scaled as countries within the region are already at the front lines of a “post-antibiotic era.” Speakers on the second panel on “Antimicrobials in Animals Raised for Food: Monitoring Use and Preventing their Abuse” outlined the design and implementations of national, regional, and global programs aiming to monitor and minimize antimicrobial use in food animal production. The panel moderated by Dr. William Flynn, Deputy Director for Science Policy in the U.S. Food and Drug Administration included perspectives from government officials and civil society. Agnieszka Jarmula of the Health, Food Safety, and Consumer Affairs European Delegation to the United States and Anna de Klauman of the Ministry of Food and Agriculture of the Embassy of Denmark noted the progress achieved in reducing antimicrobial use as well as the proposed action plans to curb antimicrobial use that might be emulated across the Atlantic. Also on this panel was Cameron Harsh of the Center for Food Safety who outlined the U.S. policy landscape on data collection and regulation on antibiotic use and the necessary next steps to address this issue. Michael Hansen of Consumers Union complemented this presentation highlighting current negotiations establishing a Codex Alimentarius Physical Working Group on Antimicrobial Resistance that would update global guidelines on antimicrobial use in food animals.

The final panel featured voices from civil society organizations on “What can governments/non-governmental organizations/private sector do?” Here, speakers spoke of current initiatives to enable cooperation and coordination among different stakeholders on AMR and the challenges faced in doing so. Steve Roach of Food Animal Concern Trust spoke on what the U.S. and European governments can learn from each other in addressing AMR and the role of civil society in highlighting those lessons learned. Mae Wu of Natural Resources Defense Council highlighted efforts to legally challenge the FDA’s  and other agencies’ lack of action on curbing antibiotic use. She also noted state legislative efforts she has been involved in towards introducing antibiotic use and resistance data collection and regulations in California and Maryland and their status. Shifting towards consumer engagement, Jean Halloran of Consumers Union described the impetus for the Chain Reaction reports and campaigns targeting food retail outfits to raise public awareness to shift consumer demand and ultimately, the supply chain for food animals. Finally, Reshma Ramachandran of ReAct-Action on Antibiotic Resistance spoke on the origins of the Antibiotic Resistance Coalition and their engagement across national and global policy fora on AMR. She also emphasized the increasingly important role of civil society in holding various stakeholders accountable in upholding commitments within the UN Political Declaration on AMR and ensuring effective action.  

Throughout the convening, there was robust discussion on how consumer advocates and other stakeholders in the U.S. and Europe could work together to further raise awareness and push for effective policies to curb AMR.

From the Research Bench

Cepheid, Rutgers New Jersey Medical School and Foundation for Innovative New Diagnostics (FIND) have announced a new version of the Xpert MTB/RIF test for the diagnosis of tuberculosis (TB) as well as rifampicin resistance, the Xpert® MTB/RIF Ultra or Ultra on World TB Day (March 24th). In 2015, TB killed 1.8 million people in 2015 while 580,000 TB patients (of 10.4 million infected people) were resistant to the critical first-line drug rifampicin. However, only 25% of drug-resistant cases and 70% of new TB cases were diagnosed or treated in 2015, leaving significant gaps in our understanding of the disease and its impacts. A WHO expert evaluation concluded that the new test was better able to detect TB in difficult to diagnose and vulnerable populations. According to Dr. Catharina Boehme, CEO of FIND, the test is believed to have “immediate impact for children, HIV/TB co-infected patients and other difficult-to-diagnose groups by enabling rapid TB diagnosis.
Dundee University has received almost £1 million (approximately $1.25 million) from Innovate UK to combat antimicrobial resistance. The grant will be used to source new antibiotics through the construction of a medical chemistry laboratory and for the creation of the Antibacterial Drug Discovery Accelerator, which will be used to find new drugs. “This award will help us address one of the fundamental needs in tackling antimicrobial resistance – the creation of new antibacterial drugs,” says Regius professor of Life Sciences at Dundee University, Mike Ferguson. “A crucial gap in the drug discovery process is in the early phase, translating discovery science innovation into `drug-leads’ that can then be developed for clinical trials and delivery to patients. We have considerable infrastructure and expertise in drug discovery at Dundee. This award will enable us to build on that and significantly boost our work on bacterial diseases, where drug-resistant infections are threatening all countries and adversely impacting the clinical management of patients.” 
In a study published in The Lancet, the National Institute for Health and Care Excellence (NICE) and National Institute for Health Research Horizon Scanning Research and Intelligence Centre (NIHR HSRIC) of the United Kingdom have examined the future antibiotic pipeline to determine what agents could potentially receive marketing authorization over the next 5 years. While they identified 28 such agents, most were next-generation agents derived from existing classes of agents, and of the 11 agents with novel mechanisms, five were not active against high-risk systemic, urinary tract, or respiratory infections. Their conclude that while they support the current accelerated development of new antimicrobials to combat antimicrobial resistance, it is necessary to identify key gaps and prioritize these areas for research and development. 
On February 14th, Elon Musk’s SpaceX launched the antibiotic-resistant ‘superbug’ Methicillin-resistant Staphylococcus aureus (MRSA) into space. It will join the International Space Station, where it will be living in microgravity. The purpose is to accelerate MRSA’s mutations, speeding up its life cycle. According to lead research Anita Goel, this will be “[leveraging] the microgravity environment on the ISS to accelerate the Precision Medicine revolution here on Earth.” The hope is that this will allow scientists to understand how MRSA evolves and changes at a faster rate than its progression on Earth. This knowledge could be used to find ways of combating MRSA before the changes occur on Earth as well as for this information to be extrapolated to other bacteria.
An interdisciplinary study from the University of Leicester published in Environmental Microbiology, has revealed that two bacteria causing respiratory infections – Streptococcus pneumoniae and Staphylococcus aureus – are directly affected by air pollution. One of the main components of air pollution, black carbon, was found to cause significant structural, compositional, and functional changes in bacterial biofilms, which are key to bacterial colonization and survival. Alarmingly, it affected the tolerance of both S. pneumoniae and S. aureus to multiple antibiotics, including increasing the resistance of S. pneumoniae to penicillin and enabling it to spread from the nose to the lower respiratory tract. According to Dr. Julie Morrissey, Associate Professor of Microbial Genetics in the University of Leicester’s Department of Genetics and lead author of the paper, “This work increases our understanding of how air pollution affects human health. It shows that the bacteria which cause respiratory infections are affected by air pollution, possibly increasing the risk of infection and the effectiveness of antibiotic treatment of these illnesses.” Air pollution is believed to be responsible for approximately one-eighth of all deaths worldwide, about seven million per year.
A comprehensive literature review found that high rates of resistance to WHO-recommended first-line treatment options for neonates and children have been identified in bloodstream infections across India. 1179 studies were screened and 82 papers selected to determine patterns of antimicrobial resistance in isolates of bloodstream infection among hospitalized children in India. Of a total of 50,545 reported blood cultures, 29.1% were positive. The authors conclude that there is “an urgent need to both enhance antibiotic stewardship and infection prevention and control measures and consider urgently how to repurpose older antibiotics back into routine care in India.” 

To subscribe to the monthly ARC Newsletter, please sign up here. Visit the ARC website at abrdeclaration.org to view the Newsletter and get other updates on ARC.

Note: The ARC Newsletter will periodically capture key meetings and developments, as well as news and resources, on antibiotic resistance for Coalition members and partners. This newsletter is prepared and published through ReAct North America/Strategic Policy Program at Johns Hopkins Bloomberg School of Public Health. The ARC Declaration on Antibiotic Resistance can be found here. Please share items for consideration for inclusion in future newsletters by writing to Reshma Ramachandran at rramach9@jhu.edu.







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