European health group releases 'roadmap' to address antibiotic resistance
The European Public Health Alliance's Stakeholder Network on Antimicrobial Resistance (AMR) has released a roadmap outlining the path European leaders should take in their efforts to fight drug-resistant infections.
Emphasizing the need for a multidisciplinary, "One Health" approach, the roadmap calls for European Union (EU) member states and institutions to pursue five strategies against AMR:
- Set targets and performance indicators for progress in reducing antibiotic use and antibiotic-resistance in human and veterinary medicine
- Help countries mobilize resources for better implementation of national AMR policies
- Close the collaboration gap between civil society and EU policy makers
- Focus EU policy-making on infection control and prevention and antibiotic stewardship programs
- Tackle the environmental dimension of AMR in the framework of the European green deal
The strategies are aimed at what the Stakeholder Network on AMR sees as some of the current gaps in the EU's response to rising antibiotic resistance. To date, according to the group, the European Commission has not set any targets or performance indicators for antibiotic use, several EU countries have no national action plan in place, and civil society groups have not been formally brought into the policy-making process.
"For Europe to become a global leader and best practice region on AMR the EU must demonstrate ambition, leadership and policy coherence between all AMR-related areas, ensuring that political and policy priorities are translated into action and have a lasting impact," the roadmap signatories write.
Nov 18 AMR Stakeholder Network roadmap
EU regulators approve new rapid diagnostic test for clinical use
European regulators today granted CE-mark certification for the T2 Resistance Panel, a rapid diagnostic test that can detect antibiotic resistance genes associated with sepsis-causing pathogens from whole-blood samples.
Developed by T2 Biosystems of Lexington, Massachusetts, with support from CARB-X (the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator), the T2 Resistance Panel can detect 13 of the most serious antibiotic-resistance genes identified by the Centers for Disease Control and Prevention, directly from blood and within 3 to 5 hours. It's the first diagnostic test that can detect all of these resistance markers from blood samples, and the first to graduate from the CARB-X portfolio.
"This represents a huge step forward for patients, and a critical milestone for CARB-X," Kevin Outterson, JD, executive director of CARB-X, said in a CARB-X press release. "Rapid diagnosis of drug-resistant infections is essential to improve appropriate treatment for patients, and to save lives."
The CE-mark indicates conformity with the health, safety, and environmental protection standards that govern products sold within European Economic Activity countries, and is legally required to place a medical device on the market in Europe. The certification means that the test can now be used on patients in Europe.
The T2 Resistance Panel was granted Breakthrough Device designation by the US Food and Drug Administration earlier this year, but is not yet available for clinical use in US hospitals.
Nov 20 CARB-X press release
Paper calls for short-term, long-term strategies on antibiotic development
A new paper in The Lancet Infectious Diseases calls for a two-pronged strategy to address the weakness of the antibiotic research and development (R&D) pipeline.
In their assessment of current efforts to stimulate antibiotic R&D, researchers from the United Kingdom note that a combination of push incentives from public-private partnerships like CARB-X and the Global Antibiotic Research and Development Partnership (GARDP) and pull incentives, such as the antibiotic subscription model recently announced by the UK National Health Service, are currently keeping the antibiotic pipeline from completely running dry.
But just barely, they argue. Even with these efforts, a combination of high development costs, low public investment, and low profit margin for new antibiotics is causing many pharmaceutical companies to abandon the market. And companies that do produce new antibiotics are facing financial difficulties.
In the short term, the authors of the paper argue, this model needs to be maintained, because the pharmaceutical industry is still the best equipped to undertake antibiotic innovation. Therefore, strengthening current push and pull incentives and creating new ones, like market-entry rewards, is the best course of action for the immediate future. But because the long-term viability of the for-profit antibiotic development model is unclear and antibiotics are a global resource that needs to be distributed equitably, the authors propose the creation of an international, publicly funded, non-profit antibiotic R&D institute to transform how new antibiotics are discovered and developed.
"The formation of such an institute would create a permanent, integrated, open, and transparent home for the two key resources produced during pharmaceutical R&D: knowledge and skill," the authors write. "Novel antibiotics would be a public commodity that could be developed according to a prioritisation process determined by greatest need rather than greatest profit, and disseminated according to a principle of what could be termed shared burden."
The authors suggest the institute could be financed through a variety of mechanisms, including government funding, taxation, antibiotic usage fees, insurance payments, and contributions from the pharmaceutical industry.
Nov 18 Lancet Infect Dis paper
FAO manual helps guide prudent antibiotic use for pigs, poultry
Yesterday the United Nations Food and Agriculture Organization (FAO) and the Swedish University of Agricultural Sciences (abbreviated SLU) launched a manual on the prudent use of antibiotics in pigs and poultry targeted especially to farmers, pharmacists, and veterinarians in non-EU Eastern European and Balkan countries, the Caucasus, and central Asia.
"The manual is about how to reduce the use of antibiotics in livestock through disease prevention. We have focused on poultry and pig breeding since it is where most antibiotics are used globally," Ulf Magnusson, DVM, PhD, SLU professor and lead author of the manual, said in an SLU news release. SLU experts wrote the manual with a working group of international experts, including additional Swedish scientists. Sweden is a world leader in keeping food animals healthy while using minimal antibiotics, according to the release.
The manual covers the prevention of infectious diseases without antibiotics, how to use the drugs prudently and effectively, and practical recommendations on combining prudent use with preventive measures for good productivity. Non-drug measures to prevent disease include good animal husbandry and welfare, effective external and internal farm biosecurity, and appropriate vaccine use.
The authors detail how to phase out the use of antibiotics for growth promotion, avoid the use of highest-priority antibiotics that are critical for human medicine, use antibiotics only after a veterinarian has diagnosed a disease, strive for individual treatment of animals, and dispose of unused antibiotics, among other stewardship steps.
The authors write, "The recommendations are highly relevant for those who have larger, more commercial and professional production systems. However, the principles for disease prevention and use of antibiotics may be applied by all categories of farmers." The FAO also notes that, although the manual focuses on a specific geographical region, its principles may be applied elsewhere, as well.
Nov 19 FAO/SLU report
Nov 19 SLU news release