bad bugs need drugs

BAD BUGS, NEED DRUGS Why Antibiotics Deserve Congress Attention and Immediate Action Infectious Diseases Society of America Willard N. Sears Purple Heart, WWII Cynthia L. Sears, M.D. Professor of Medicine & Oncology Johns Hopkins

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  1. BAD BUGS, NEED DRUGS Why Antibiotics Deserve Congress’ Attention and Immediate Action Infectious Diseases Society of America Willard N. Sears Purple Heart, WWII Cynthia L. Sears, M.D. Professor of Medicine & Oncology Johns Hopkins University School of Medicine IDSA Treasurer

  2. Physician Perspective The Power of Effective Antibiotics: 1943 & today 4 y.o. girl in excellent health suddenly developed facial skin infection, high fever. The infection spread leading to swelling that prevented swallowing or breathing. On arrival to the hospital After 14 days penicillin Herrell ’43 Proc Staff Meetings Mayo Clinic 18:65-76

  3. Physician Perspective The Collective Power of Effective Antibiotics Antibiotics caused US deaths to decline by ~220 per 100,000 in 15 years US Infection Death Rate per Sulfa 300 300 100,000 population Penicillin All other medical technologies reduced deaths by ~ 20 per 100,000 over the next 45 years 100 100 Armstrong, G. L. et al. JAMA 1999;281:61-66.

  4. Physician Perspective The Tragedy of Ineffective Antibiotics: The Crisis is Now Life-altering Disability Premature Death Mariana Bridi da Costa Tom Dukes Rebecca Lohsen (22 yr)--Dead colostomy, lost 8” colon (17 yr)--Dead Addie Rerecich, 11yo Double lung transplant Carlos Don Ricky Lannetti Stroke, nearly blind (12 yr)--Dead (21 yr)--Dead $6 million hospital bill

  5. The Crisis in Antibacterial Resistance Geographical distribution of extreme-drug resistant Klebsiella bacteria Nov, 2006 Nov, 2006 Current

  6. Extreme-drug resistant Acineto bacter Common Cause of Combat Wound Infections in US Soldiers Percent Extreme-drug Resistant Acinetobacter has risen dramatically 70% 60% 50% 40% 30% 20% 10% 0% 1999 2001 2003 2005 2007 2009 Hoffman et al ’10 ICHE 31:196 - 7; Higgins ’10 JAC 65:233 -8; Lautenbach ’09 ICHE ’09 30:1186 -92; Rosenthal ’10 Am J Infect Control 38:95 -104; Hidron ‘ICHE ’08 29:996 -1011; Dizbay ’10 Scand J Infect Dis; Kallen ’10 ICHE 31:528-31; NY Times

  7. Lives Devastated/Lost Due to Antibiotic-Resistant Bacteria While precise numbers are unknown (& the CDC works to update the impact of antibiotic resistance): One resistant bacterium (MRSA) kills more Americans (~19,000) annually than emphysema, HIV/AIDS, Parkinson’s and homicide combined. CDC reports: 2 million HAIs/90,000 deaths annually in U.S. The majority due to antibiotic-resistant bacteria Boucher HW, Bad Bugs, No Drugs, No ESKAPE CID 2009; 48:1-12 Klevens RM et al, JAMA. 2007;298:1763-1771

  8. Additional Costs/Length of Stay Associated with Antibiotic-Resistant Bacteria When antibiotic resistant bacterial infections are compared to antibiotic sensitive bacterial infections: Annual cost to the US healthcare system: $21-34 billion dollars Additional hospital days: 8 million additional days RR Roberts, CID 2009:49, 1175-1184; PD Maudlin, AAC 2010:54, 109-115

  9. Antibiotic Development IDSA’s Motivation/Perspective (systemic drugs) 16 Total # New Antibacterial Agents 14 12 Our patients need new antibiotics 10 8 6 to stay healthy and alive! 4 2 0 '83-'87 '88-'92 '93-'97 '98-'02 '03-'07 '08-'12 1980 2012 Administration Primary Professional Activity 7% 2% 2% 5% 5% 7% Basic 4% 4% IDSA Membership Research 3% 3% Clinical 8% 8% 10,000 strong Microbiology Majority physicians Clinical Research providing clinical care, 14% 14% Hospital contributing to clinical care Epidemiology Patient Care 54% 54% 3% 3% Public Hlth

  10. Policy Initiatives 2004 BAD BUGS, NO DRUGS 2010 BAD BUGS, NEED DRUGS The 10 x ‘20 initiative 2011 IDSA PUBLIC POLICY CID 52 (Suppl 5):S397, 2011

  11. recommends: CID 52 (Suppl 5):S397, 2011 1. Adoption of Economic Incentives and Collaborative Mechanisms to Address the Market Failure of Antibiotics 2. New Regulatory Approaches to Facilitate Antimicrobial Development & Approval 3. Greater Coordination of Relevant Federal Agencies’ Efforts 4. Enhancement of Antimicrobial Resistance Surveillance Systems 5. Strengthening Activities to Prevent and Control Antimicrobial Resistance 6. Significant Investments in Antimicrobial-Focused Research 7. Greater Investment in Rapid Diagnostics R&D and Integration into Clinical Practice 8. Eliminating Non-Judicious Antibiotic Use in Animals, Plants & Marine Environments

  12. Key Steps Congress can take to Address Antimicrobial Resistance STAAR Act S trategies t o A ddress A ntimicrobial R esistance Awaiting Introduction/Enactment Will strengthen federal coordination, accountability, leadership as well as support antimicrobial stewardship efforts in health care facilities Strengthen the antimicrobial pipeline 2012: G enerating A ntibiotics I ncentives N ow ( GAIN , exclusivity) Enacted. 2013??: Still needed additional economic incentives (e.g., R&D tax credits) plus a new FDA regulatory pathway (limited population — LPAD) Increase funding for CDC & NIH Antimicrobial resistance surveillance, advanced detection methods, data collection and research Ban antibiotic use to fatten agricultural animals (cows, pigs, chickens)

  13. The Disheartening Current Status of the 10 x ‘20 Initiative

  14. Our Goal: Your Goal Protect This Global Treasure Prior generations gave us the gift of antibiotics. Today, we have a moral obligation to ensure this global treasure is available for our children and future generations.

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