December 30, 2016
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Newsletter of the Antibiotic Resistance Coalition (ARC)

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

A Look Back at ARC Milestones in 2016

Quick Hit Policy Updates on AMR

Recently released data from the Animal Drug User Fee Act shows that antimicrobial use in food animal production is rising despite increasing concern over drug resistance. In 2015, almost 10 million kilograms of antibiotics were used in food animals - 2% more than the year prior. Between 2009 and 2015, domestic antimicrobial sales and distribution approved for use in food animal production also increased almost by one-quarter. In 2015, medically-important drug sales and distribution in the United States accounted for 62% of domestic sales of all antimicrobials approved for use in food animals. In 2017, voluntary guidance from the U.S. Food and Drug Administration will go into effect in which antibiotic manufacturers would remove labels from the drugs to indicate that they can be used for growth promotion and instead would be labeling these drugs to only be used with veterinary oversight. Many of these drugs approved for weight gain, however, are also used for routine disease prevention. The blurry line between these indications has raised concerns that the voluntary withdrawal of these drugs’ use for growth promotion will just be replaced by a relabeling of indicated use for routine disease prevention, without any real change in antibiotic use in food animal production. In the next year, it will be seen whether this voluntary guidance will curb this rise in antibiotic use and ensure veterinary oversight as between 2009 and 2015, the percentage of medically important antimicrobials approved for use in food animals approved for dispensing over-the-counter decreased only slightly from 98% to 97%.
In late November, the European Food Safety Authority (EFSA) and European Medicines Agency (EMA) released new data on antibiotic use and resistance in agriculture. Although the European Union has taken measures to restrict the use of antibiotics for growth promotion in food animal production, the data shows that the region still struggles to control the use of colistin, a last-line antibiotic in human medicine rarely used due to its significant toxicity. Prior data noted that colistin is the fifth most-widely sold antibiotic in food animal production across the region. The European Food Safety Agency found colistin resistance in a relatively low number of bacteria collected from livestock- roughly 1% of E. coli from broiler chickens and 7% from turkeys. Although the EU has taken steps to ban the use of antibiotics, continued use of these antibiotics for prevention is still allowed - a loophole that is thought to have contributed to these rates of resistance. As Dr. Marta Hugas of the EFSA says, these findings raises “an alarm for global action and that “one country cannot do it alone.”
OIEOn December 2015, the United Nations (UN) General Assembly passed a resolution calling for a first-ever High-level Meeting on the fight against tuberculosis (TB) in 2018. This follows recently released figures from the World Health Organization (WHO) showing that TB is the world’s leading infectious killer, with 10.4 million new cases in 2015 and 1.8 million deaths. Despite this dramatic increase in deaths, TB has remained low on the global agenda -- in fact, TB is the only disease of the three most deadly never to have been discussed at a high-level discussion. According to the resolution, the WHO will work alongside the UN Secretary-General in consultation with Member States “to propose options and modalities for the conduct of such a meeting, including potential deliverables, building on existing efforts in this regard.”

The United Nations General Assembly also adopted without vote another resolution entitled “Global health and foreign policy: health employment and economic growth” with multiple parts of the document focused on innovation and access to medicines. The resolution calls for global health partnerships to support Member States, particularly low-income countries, in achieving universal health coverage including equal access to “essential, safe, affordable, effective, and quality medicines.” The General Assembly also committed to supporting technology transfer agreements “with the objective of increasing the availability and affordability of medicines and related health technologies” and to also “encourage the utilization of the multi-stakeholder forum on science, technology and innovation for the Sustainable Development Goals, created as a component of the Technology Facilitation Mechanism, to identify and examine technology needs and gaps.” The resolution also called upon the Secretary-General, keeping in mind relevant reports such as that of the UN High-Level Panel on Access to Medicines, to encourage discussion among Member States and other relevant stakeholders on “appropriate policy options to promote access to medicines, innovation, and health technologies.

The resolution also welcomed the recently adopted Political Declaration on AMR during the UN General Assembly earlier this year. It also recognized the principles and commitments outlined in the Political Declaration including the need for a multisectoral “One Health” approach and the request to the Secretary-General “to update Member States on the creation and work of the ad hoc inter-agency coordination group, bearing in mind that its recommendations are to be submitted to the Assembly by its seventy-third session.”
OIEAccording to an investigative piece published in Bloomberg Businessweek, the introduction of antibiotics into China’s food animal production system has huge ramifications on its aquaculture industry, the largest in the world, posing a threat to global public health. Chinese agriculture has historically depended on the recycling of nutrients that promote the growth of house and other livestock to feed fish through runoff into the waterways. As up to 90 percent of antibiotics administered to swine can pass undegraded through urine and feces, this can directly impact farmed fish and seafood. Coupled with the emergence of colistin resistance in November 2015 linked to antibiotic use in animal husbandry, food animals including seafood has become an increasingly alarmingly source of drug resistance. The ramifications of such use is also global as China supplies the majority of aquaculture trade and is the largest exporter of seafood. Due to vague distribution networks, these products often end up in ports in the United States, which has prompted American seafood producers to call for intensified scrutiny of imported seafood. The FDA has since halted Malaysian shrimp exports because much of Chinese shrimp producers were transshipping through Malaysia, but dirty shrimp may now be routed through alternative countries, including Peru, and most recently, Ecuador.
On November 9, the Duke-Margolis Center for Health Policy held a public workshop on “Designing Economic Incentives for Antimicrobials: Implementation in the U.S. Context” in Washington, D.C. The workshop brought together stakeholders from the pharmaceutical industry, infectious disease physicians, federal agencies such as BARDA and the U.S. Food and Drug Administration and payors to discuss the costs of antimicrobial development, the challenges to ensuring return on investments for new antimicrobials, and various proposed economic incentives to promote continuous development of live-saving drugs. Sessions included the application of transferable exclusivity vouchers to the antimicrobial market, market entry rewards for high priority antimicrobial drugs, and a sustainable path to value-based reimbursement. The Duke-Margolis Center also released a report on the issue, “Tracking the Progress of Economic Incentives for Antimicrobial Drug Development in the U.S. and Across the Globe”, which outlines a series of push and pull economic incentives towards the development of novel and effective antimicrobials. According to the report, this work was supported by external funding from Merck & Co.
The Association of Public Health Laboratories is currently accepting applications for the 2017-2018 cohort of fellows. In conjunction with the US Centers for Disease Control and Prevention, APHL is offering the APHL-CDC Antimicrobial Resistance (AR) Fellowship Program, which provides master’s- and doctoral-level graduates with the opportunity of a collaborative 12-month fellowship, working on a range of antimicrobial resistance issues. There are two tracks, the Antibiotic Resistance Laboratory Network Track where fellows will work in one of the seven public health laboratories across the US following a two-week rotation at the CDC, and the Drug-Resistant Tuberculosis Track where fellows will work with public health leaders to perform and apply molecular methods to identify and control drug-resistant TB outbreaks. 

FEATURE: The ReAct network follows up on the 7th Meeting of the WHO-STAG on AMR

In follow-up to the 7th Meeting of the WHO Strategic and Technical Advisory Group (STAG) on AMR held on November 2-3, ReAct-Action on Antibiotic Resistance sent a letter to the WHO AMR Secretariat to recapitulate several points for the organization along with its partners, including the FAO and OIE, to take into consideration moving forward. The main objectives and expected outcomes from the recent STAG meeting were: 
  • to make recommendations on the global action plan on antimicrobial resistance implementation post the high level meeting on AMR held at the United Nations General Assembly held on September 21, 2016;
  • to advise on options for a stewardship framework in response to operative paragraph 4(7) of resolution WHA68.7 that endorsed the global action plan on antimicrobial resistance;
  • to discuss the monitoring framework for the global action plan and advise on next steps; and
  • to start the renewal process of the STAG and determine the duration of membership for each STAG member.
The ReAct network was among the participants of this meeting including ARC members and other civil society organizations, academia, foundations, country missions, and industry. A complete summary of the meeting by Dr. Anthony D. So, head of the ReAct Strategic Policy Program can be found here

In the follow-up communication, ReAct coordinators urged the WHO and its partners to ensure that the financial and technical resources being mobilized follow the principles outlined in the UN Political Declaration, adopted by the General Assembly at the first High-level Meeting on AMR. They write, “Such funding should be needs-driven and evidence-based and considered a shared responsibility while explicitly ensuring affordability, effectiveness and efficiency and equity as well as delinkage of return of investment from volume-based sales of novel drugs.” Additionally, in recruiting technical resources to support the implementation of National Action Plans along the lines of the global development and stewardship framework, ReAct also recommended the creation of a pool of global and local experts to provide such technical inputs. 

ReAct also called upon the WHO to provide further support for the development of National Action Plans through:
  • a decision framework tool that would support priority setting across components of the national action plan, a context-specific system map that affords guidance to where a country might derive the most yield from investment;
  • a community of practice among those working in-country on AMR, especially across country champions and those who might benefit from peer-to-peer opportunities to share lessons of how to work on AMR; and
  • within the strategic planning process, targets of opportunity and measures that might serve as triggers to advance the policy agenda of responding to AMR. Regarding the draft monitoring and evaluation framework developed by the WHO for National Action Plan development, ReAct also requested that the organization allow for other perspectives to be shared alongside the requested country responses. This would help ensure greater accountability and engage a broader range of stakeholders. ReAct also applauded the release of the global guidelines on the prevention of surgical site infections, which outlines 29 recommendations for doing so. To help disseminate the message of these global guidelines, the network suggested that the WHO consider developing a campaign approach, enlisting civil society and setting measurable targets.

    On innovation, ReAct emphasized the need for the WHO along with other key stakeholders and funders offer clearer guidance towards the coordination and financing of other areas of other areas innovation. For instance to truly achieve a One Health approach, innovation of new technologies for human health are not only needed but also of new technologies for agriculture through improved diagnostics and new vaccines. Beyond innovation of technologies, the network also noted the need for innovation of practice “both to ensure improved stewardship of antibiotics in healthcare delivery and more sustainable agricultural practice.”

    ReAct concluded the communication by reiterating the ask for WHO, in co-chairing the UN Inter-Agency Coordination Group, to commit this process “to principles of public transparency and conflict of interest review to safeguard [its] integrity.” They also encouraged the WHO and UN “to continue dialogue and exchange with civil society” noting the work of the Antibiotic Resistance Coalition. In the new year, ReAct will be meeting with WHO to discuss the inputs outlined in this communication further.

FEATURE: Access to Medicines: A Fight for the Right to Health

(Translated from a post by ReAct Latin America)
Representatives from a coalition of 25 civil society organizations convened for a meeting focused on access to medicines in the Latin American and Caribbean region on December 6th in Panama City. This meeting followed the 159th session of the Inter - American Commission on Human Rights (IACHR) and included representatives from the LAC Alliance for Access to Medicines, International Action for Health in Latin America and the Caribbean, Caritas Latin America and the Caribbean, Latin American Episcopal Council, Mission Health - Colombia, Latin American Network for Access to Medicines, as well as other organizations from Brazil, Colombia, Peru, the United States and Argentina.

The meeting explored the lack of access to medicines necessary for health and life in Latin America and the Caribbean, specific causes to this lack of access, and proposals aimed at overcoming disease, suffering and disability suffered by millions of people in the region.

According to Priest Francisco Hernández, Regional Coordinator of Caritas Latin America, this situation disproportionately affects the developing world, where, according to the World Health Organization, 80% of the world's population lives and where over 10 million people die each year. Juan Carlos Raxach, a member of the Brazilian Association for the Fight Against Cancer (ABIA), noted that the problem is also manifested in the government’s role in establishing their health policies. In the Brazilian case, the current health system reform is putting at risk the largest public health system in the world, an achievement of the people guaranteeing coverage and equal access. On the other hand, the problem is aggravated by the fact that pharmaceutical companies undermine the health budget by charging very high prices for medicines.

José María di Bello, Coordinator of the HIV program in Argentina, stressed that governments have an obligation to consider medicines as social goods and not as merchandise. "In my country, in the development of these policies, strict criteria was established in 2012 for the analysis of patent applications for drug products, which has closed the way to several illegitimate patents that sought to increase the cost of medicines, increase generics in the market and reducing the prices of these drugs. To allow the subordination of the right to health, to the right to property, is to condemn humanity to genocide," he concluded.What about the situation with antibiotics in Latin America?

As Luz Marina Umbasía and Francisco Rossi of the IFARMA Foundation - Colombia stated, "One of the topics most discussed about antibiotics is the issue of innovation, which is the most emblematic problem of the crisis linked to intellectual property issues and patents, because these medicines are not a good business and there is no investment to develop new antibiotics, because the current logic of pharmaceutical companies is not to invest in medicines that really cure or whose treatments are very short. In addition, there is a particularly sensitive debate on this issue, because in the hypothetical case a new antibiotic effective for resistant infections is developed, these should be conserved, which is against the interest of any drug developer -- another fundamental reason why the innovation and development of new antibiotics is stagnant. This reality has also promoted the debate on access to medicines and has been very much linked to how to confront the current industry that took ownership of the innovation model, but does not intend to give any response to this issue.”

An alternative that could be developed, according to Rossi, is to have generic antibiotic options. Colombia and other Latin American countries have had great difficulties with this option as pharmaceutical companies have carried out smear campaigns, with pseudo-scientific publications suggesting that generic drugs could induce greater resistance in colonies of bacteria that they are tested against during development. Many patients today do not have access to the branded versions of these drugs because their prices are high, which also violates their right to health. He also noted, that "The most paradigmatic case is the one that has to do with antibiotics to treat resistant tuberculosis, because in several countries in Latin America, civil society organizations have denounced how inaccessible the combined treatments of antibiotics are due to their high prices.”
 
What is the proposal of this coalition?

Faced with the problem of lack of access to medicines, Dr. Germán Holguín, Director of Health Mission and Coordinator of the Alliance for Access to Medicines, said that it is urgent to support the design of incentives for pharmaceutical innovation and overcome patents and high monopoly prices in order to effectively alleviate diseases that disproportionately affect low- and middle-income countries. Similarly, it is necessary to abolish pharmaceutical patents in these countries for medicines necessary for health and life because the damage that pharmaceutical patents have caused by setting scandalous prices and blocking competing drugs with affordable prices is manifested in high morbidity and mortality rates.

Another proposal put forward by Holguín is to ensure the full exercise of the right of governments to grant compulsory licenses for the production of medicines and to promote the legal classification of the blockade of affordable generic medicines as “crimes against humanity.”

For ReAct Latin America, this convening was of paramount importance for the region, as these discussions helped to further unveil the causes behind diseases and promote solutions starting with commitments between institutions, government agencies, academia, civil society organizations, and the community.

From the Research Bench

Researchers published results from a randomized, open-label equivalence trial in The Lancet Global Health on the use of simplified antibiotic regimens for young infants seen in the outpatient setting in Pakistan. The study found for infants aged 0-59 days who presented with signs of severe clinical infection, two simplified antibiotic regimens with fewer injections are equivalent to the reference treatment. As injectable antibiotics for young infants may not accessible or available in countries with high neonatal mortality, such a simplified regimen in the outpatient setting could increase access to treatment and save lives. 
A study published in the New England Journal of Medicine found in children aged 6 to 23 months with acute otitis media (middle ear infections), a reduced duration of antimicrobial treatment showed higher clinical failure rates compared to children who received the standard duration of treatment. Clinical failure was characterized by worsening symptoms, otoscopic signs of infection, or failure to achieve resolution of symptoms and signs. Over 500 children with acute otitis media either received amoxicillin-clavulanate for a standard duration of 10 days or for a shorter duration of 5 days followed by a placebo for another 5 days. Researchers measured symptom scores, rates of clinical response, recurrence, and nasopharyngeal colonization. Although clinical failure rates differed between the two groups, they found no significant differences between the rate of adverse events or rate of emergent antimicrobial resistance between the two regimens. For a quick take video on the research findings, visit this link here.
The Centers for Disease Control and Prevention (CDC) released results from a Bayesian hierarchical model to improve estimates of drug resistance incidence and help further overcome issues related to missing or limited data. Looking at nontyphoidal Salmonella data from 2004 to 2012 from the National Antimicrobial Resistance Monitoring System and Laboratory-based Enteric Disease Surveillance, researchers used this modeling approach to address issues related to the high variation in reporting of such infections by year and state, likely associated with testing in certain states, underreporting, incomplete serotyping, and of small numbers of pathogenic isolates. By statistically “borrowing strength” from previous years or neighboring states, they were able to address this variability. In the United States, Salmonella infections are a major cause of illness accounting for an estimated 1.2 million infections, 23,000 hospitalizations, and 450 deaths. The authors conclude that these estimates could “help define the magnitude of the resistance problem, target prevention efforts, and assess whether control measures are working” and also these methods could be used to “assess progress from control measures.”
New research from two different groups of scientists has led to the development of candidate vaccines that could protect against bacterial infection by slowing down a specific mechanism of action that pathogens use to survive. In order to reproduce, bacteria use special chemicals to rob cells of iron. One of the research groups from the University of Michigan designed their vaccine to target the specific iron-stealing molecules, or siderophores, of E. coli urinary tract infections. The other group from the Massachusetts Institute of Technology and University of California Irvine, targeted a Salmonella strain. Both groups immunized mice and later infected the animals with bacteria. Results showed dramatically fewer bacteria in the bodies of the immunized mice; however, these vaccinated mice still developed infections. In the E. coli study, vaccinated mice had at least one tenth of the bacteria in their urine and kidneys, while in the Salmonella studies, vaccinated mice had bacterial numbers that were 20,000-fold lower than unvaccinated mice. The fact that similar results were produced by multiple groups provides an important proof of concept to move forward with these vaccines as a possible alternative to antibiotics. 

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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