Combating Antimicrobial Resistance: The Way Forward - Dr. James Hughes, Professor of Medicine and Public Health with Joint Appointments in the School of Medicine and the Rollins School of Public Health at Emory University, from the 2014 NIAA Symposium on Antibiotics Use and Resistance: Moving Forward Through Shared Stewardship, November 12-14, 2014, Atlanta, Georgia, USA.
More presentations at http://www.swinecast.com/2014-niaa-antibiotics-moving-forward-through-shared-stewardship
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Dr. James Hughes - Combating Antimicrobial Resistance: The Way Forward
1. 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
3. OUTLINE
The Problem
The Challenges
The Opportunities
4. 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
5. 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
Human susceptibility to
behavior
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.
6. The Washington Post
March 16, 1993
“In 2002, out of
89 new drugs, no
new antibiotics
were approved.”
7.
8. The Challenges
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.
9. Resistance
World Health Day
April 7, 2011
Market Failure Innovation Gap
ESKAPE Bugs
Bad Bugs / No Drugs
“10 x ‘20”
“No Action Today,
No Cure Tomorrow”
BMJ 2010;340:1115-18
%
Drug Approvals
#
Combating Antimicrobial Resistance:
Policy Recommendations to Save Lives
10. 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/
11. WHO AR Priorities
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
http://www.who.int/drugresistance/documents/surveillancereport/en/
12. “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
13. IOM Forum on Microbial Threats
2010 2012
Antibiotics as a Global Public Good
15. 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
16. 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
18. Core Elements
• Leadership commitment
• Accountability (single
leader)
• Drug expertise
(pharmacist)
• Action (recommendation
implementation)
• Surveillance (usage and
resistance
• Education (prescribers)
• Data sharing
19. Game Changers
Culture Independent Diagnostic Testing
Whole Genome Sequencing
Bioinformatics
Healthcare Reform
Electronic Health Records
Social Media
One Health
21. 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
22. 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
23. 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
24. 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
25. 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
26. 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
27. 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
28. 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
29. 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
30. 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
31. 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