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Combating Antimicrobial
Resistance:
The Way Forward
James M. Hughes, MD Professor of Medicine and Public Health
Emory University Atlanta, GA
NIAA Antibiotic Symposium
November 14, 2014
Disclosure
No conflicts with this presentation
OUTLINE
The Problem
The Challenges
The Opportunities
IOM Definition of Emerging Infections
New, reemerging or drug-resistant infections whose incidence in humans has increased within the past two decades or whose incidence threatens to increase in the near future.
1992
The Problem
Table. Factors contributing to the emergence of infectious diseases according to IOM reports, 1992 and 2003
1992 IOM Report 2003 IOM Report
Human demographics and behavior
Human susceptibility to infection
Technology and industry Climate and weather
Economic development and land use
Changing ecosystems
International travel and commerce
Poverty and social inequality
Microbial adaptation and change
War and famine
Breakdown of public health measures
Lack of political will
Intent to harm
*Boldface indicates factors that contributed to the emergence and spread of antimicrobial resistance.
“In 2002, out of 89 new drugs, no new antibiotics were approved.”
The Washington Post March 16, 1993
Public Health Surveillance
Ongoing, systematic collection, analysis, and interpretation of outcome-specific data
Closely integrated with the timely dissemination of these data to those responsible for taking public health action to prevent and control disease or injury
Thacker SB. In: Principles and Practices of Public Health Surveillance. New York:
Oxford University Press, 2000.
The Challenges
ESKAPE Bugs
Bad Bugs / No Drugs
“10 x ‘20”
“No Action Today,
No Cure Tomorrow”
Market Failure Innovation Gap
BMJ 2010;340:1115-18
Resistance
%
Drug Approvals
#
Combating Antimicrobial Resistance:
Policy Recommendations to Save Lives
World Health Day
April 7, 2011
CDC AR Threats
Urgent Threats (3)
• C. difficile • CRE • Resistant N. gonorrhoeae
Serious Threats (12)
• MDR Acinetobacter • ESBLs • MDR P. aeruginosa • VRE • MRSA • Drug-resistant S. pneumoniae, NT
Salmonella, Campylobacter
Concerning Threats (3)
• VRSA • Erythro-res GAS • Clinda-res GBS
http://www.cdc.gov/drugresistance/threat-report-2013/
WHO AR Priorities
http://www.who.int/drugresistance/documents/surveillancereport/en/
Priority Pathogens
• E. coli res to 3rd gen cephalosporins & FQs
• K. pneumoniae res to 3rd gen cephalosporins & carbapenems
• MRSA
• Pcn-resistant S. pneumoniae
• FQ-resistant Salmonella
• FQ-resistant Shigella
• N. gonorrhoeae with decreased suscept to 3rd gen cephalosporins
“A robust public health system— in its science, capacity, practice, and through its collaborations with clinical and veterinary medicine, academia, industry and other public and private partners—is the best defense against any microbial threat.” 2003
2012 2010
IOM Forum on Microbial Threats
Antibiotics as a Global Public Good
Microbial Adaptation and Change
THE NEW YORKER, January 12, 1998 “10 x 20”
IDSA AR Priorities
Drug Development Pipeline
Bad Bugs, No Drugs
“10 by 20”
Increased Support for Basic and
Translational Research
Rapid Point of Case Diagnostics
Surveillance of Use & Resistance
Humans and Animals
Antimicrobial Stewardship
Regulatory Reform for Clinical Trial Design
and New Antibacterial Drug Approval
Combating Antimicrobial Resistance: Policy Recommendations to Save Lives
Economic Incentives
New Regulatory Approaches
Stronger Leadership and Improved Coordination of Federal Agencies
Enhanced Surveillance Systems
Strengthened Prevention & Control Programs
Funds for New Drug R & D
Rapid Diagnostics R & D
Elimination of Non-Judicious Use in Animals, Plants, & Marine Environments
IDSA Clin Inf Dis 2011;52(Suppl 5):S397-428
Preventing Antimicrobial Resistance in Healthcare Settings and the Community
• Leadership commitment
• Accountability (single
leader)
• Drug expertise
(pharmacist)
• Action (recommendation
implementation)
• Surveillance (usage and
resistance
• Education (prescribers)
• Data sharing
Core Elements
Game Changers
Culture Independent Diagnostic Testing
Whole Genome Sequencing
Bioinformatics
Healthcare Reform
Electronic Health Records
Social Media
One Health
“One Health”
Humans
Domestic Animals
Ecosystems
Wildlife
http://www.onehealthcommission.org/
The Opportunities
Common Ground for Medical and
Veterinary Communities
Antimicrobial resistance and usage
Avian, animal, and pandemic influenza
Other zoonotic diseases including those
associated with exotic pet and wildlife trade
Foodborne disease
Healthcare-associated infections
Blood, organ, tissue safety
Pathogen discovery / new diagnostics
Drug and vaccine development
Disease eradication
Biosafety / Biosecurity
Bioterrorism / Biodefense
President Obama Executive Order
Combating Antibiotic-Resistant Bacteria 9/18/14
National Security Priority
Interagency Task Force Co-chairs: Secretaries of HHS, USDA, DoD 5 year National Action Plan by 2/15/15
Presidential Advisory Council
Stewardship (humans & animals)
Surveillance (repositories, curated genomic databases)
Outbreak Response
New Drugs
Rapid Diagnostics
Increased International Cooperation
National Strategy on Combating Antibiotic-Resistant Bacteria
White House September 2014
Goals
• Slow emergence / prevent spread
• Strengthen “One Health” surveillance
• Develop rapid diagnostics*
• Accelerate basic and applied R&D • New antibiotics • Other therapeutics • Vaccines
• Improve international collaboration
*$20M prize for rapid PoC diagnostic for “highly resistant bacterial infections”, co-sponsored by BARDA & NIAID
http://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf
Report to The President on Combating Antibiotic-Resistant Bacteria
PCAST September 2014
Problem
• ~ 2M infections, 23K deaths • $55 – 70B in direct & indirect costs
Recommendations
• Strong federal leadership
• Effective surveillance & response • Genomics component
• Expanded fundamental research
• Robust clinical trial infrastructure & new regulatory pathways
• Economic incentives for drug development, stewardship programs, & rapid diagnostics
• Decreased use in animal agriculture
• Ensure international co-operation http://www.whitehouse.gov/sites/default/files/microsites/ostp/PCAST/pcast_carb_report_sept2014.pdf
Ways Forward For Shared Stewardship
• Replace the use of antibiotics when possible
– Human medicine
• Prevention—vaccination, infection control, preventive medicine
– Animal medicine and agriculture
• Vaccines, immunomodulators, farming practices
Ways Forward For Shared Stewardship
• Reduce the use of antibiotics when possible
– Human medicine
• Stewardship programs in healthcare—e.g., automatic stop orders
• Outpatient physician feedback and prescriber education—e.g., reduce prescribing for URT infections
– Animal medicine and agriculture
• Eliminate use of medically important antibiotics for growth promotion
Ways Forward For Shared Stewardship
• Refine the use of antibiotics
– Human medicine
• Right drug, right dose, right duration
• NHSN antibiotic use monitoring as a quality measure
– Animal medicine and agriculture
• Require veterinary oversight
• Decrease use of critically important antibiotics
• Monitor use in animal agriculture, including development of metrics
Needs for Moving Forward on Shared Stewardship
• Shared commitment
– Continuing dialogue, willingness to listen
• Better data on use for humans and animals
– Partnership between USDA, FDA and CDC (equivalent of NARMS for antibiotic usage) in collaboration with healthcare and food and pharmaceutical industries
Needs for Moving Forward on Shared Stewardship
• Communication • Adopting a One-Health approach • Developing a shared language for human and
veterinary medicine, industry, consumers, advocates
• Research • Better quantitation of the relationship between
agricultural use and resistance in human infections • Alternatives to antibiotic use in human and veterinary
medicine and agriculture1
• Better ways to implement stewardship in human medicine
1. PCAST report,
http://www.whitehouse.gov/sites/default/files/microsites/ostp/PCAST/pcast_carb_report_sept2014.pdf
Transatlantic Task Force on Antimicrobial Resistance
• Activity #18: Establish a joint working group of international subject matter experts to identify key knowledge gaps in understanding the transmission to man of antimicrobial resistance arising as a result of the use of antimicrobial drugs in animals and on the development of effective intervention measures to prevent this transmission, including the development of alternatives to antimicrobial drugs.
http://www.cdc.gov/drugresistance/pdf/TATFAR-Progress_report_2014.pdf page 17
Conclusions
Move beyond “the blame game”
Respond to and leverage Executive Order, CARB National Strategy, and PCAST recommendations
Identify priorities and develop metrics
Shared commitment to antimicrobial stewardship
Shared commitment to development of better data on usage and resistance in various settings
Development of a collaborative research agenda to improve evidence base
Shared commitment to communication and collaboration with professional societies public / private sector partners, and the public
Acknowledgements
Emory
Dianne Miller
Samantha Lammie
CDC
Steve Solomon
Rob Tauxe
Jeff Morelli
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