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Antibiotic Resistance: Opinion Leader Forum, 2002


Description: The subject of this report is the management of antibiotic resistant organisms in the US prepared primarily through in-depth interviews with: - clinical and academic authorities - managed-care medical and disease management executives and - pharmaceutical and diagnostics industry executives. This has produced an audit of the current opinions and attitudes of the thought leaders in the user segments of the pharmaceutical and diagnostic marketplace.


Contents: Antibiotic Resistance Opinion Leader Forum
Experts’ Views: Diagnosis, Treatment, Products and Closing the Need Gap

Table of Contents

Disclaimer .................................................................................................................................................................... i
Therapeutic Overview ............................................................................................................................................... v
I. General Issues in the Management of Infectious Diseases ....................................................................... 1
1. Introduction ................................................................................................................................................. 1
1.1 Scope of the problem ..................................................................................................................................... 1
1.2 What is an infectious disease? ........................................................................................................................ 2
1.3 Nature of infectious diseases .......................................................................................................................... 3
1.4 Microbes: the cause of infectious diseases ..................................................................................................... 3
1.4.1 Occurrence of infectious diseases ........................................................................................................ 5
1.4.2 Role of research in prevention ............................................................................................................. 6
1.5 Host defenses against infectious diseases ....................................................................................................... 6
1.6 Public health measures to prevent infectious diseases.................................................................................... 8
1.7 Treatment of infectious diseases..................................................................................................................... 9
1.7.1 Treatment of bacterial diseases ............................................................................................................ 9
1.7.2 Treatment of viral diseases .................................................................................................................. 9
1.7.3 Treatment of fungal and parasitic diseases ........................................................................................ 10
1.7.4 Resistance to antimicrobial agents ..................................................................................................... 10
1.8 Emerging and re-emerging infectious diseases............................................................................................. 11
1.9 Antibiotics ................................................................................................................................................... 14
1.9.1 Introduction to antibiotics .................................................................................................................. 14
1.9.1.1 Mechanisms of antibiotic action ................................................................................................................14
1.9.1.2 Inhibition of cell wall synthesis .................................................................................................................14
1.9.1.3 Disruption of cell membrane structure.......................................................................................................14
1.9.1.4 Inhibition of protein synthesis ...................................................................................................................14
1.9.1.5 Inhibition of DNA transcription.................................................................................................................15
1.10 Classes of antibiotics................................................................................................................................ 15
1.10.1 Penicillins, cephalosporins, and other β-lactams ............................................................................... 15
1.10.1.1 Overview ..................................................................................................................................................15
1.10.1.2 Utility........................................................................................................................................................15
1.10.1.3 Strengths and weaknesses.........................................................................................................................16
1.10.2 Aminoglycosides............................................................................................................................... 16
1.10.2.1 Overview ..................................................................................................................................................16
1.10.2.2 Utility........................................................................................................................................................16
1.10.2.3 Strengths and weaknesses.........................................................................................................................16
1.10.3 Tetracyclines ..................................................................................................................................... 17
1.10.3.1 Overview ..................................................................................................................................................17
1.10.3.2 Utility........................................................................................................................................................17
1.10.3.3 Strengths and weaknesses.........................................................................................................................17
1.10.4 Macrolides ........................................................................................................................................ 17
1.10.4.1 Overview ..................................................................................................................................................17
1.10.4.2 Utility........................................................................................................................................................18
1.10.4.3 Strengths and weaknesses.........................................................................................................................18
1.10.5 Streptogramins .................................................................................................................................. 18
1.10.5.1 Overview ..................................................................................................................................................18
1.10.5.2 Utility........................................................................................................................................................18
1.10.5.3 Strengths and weaknesses.........................................................................................................................19
1.10.6 Rifamycins ........................................................................................................................................ 19
1.10.6.1 Overview ..................................................................................................................................................19
1.10.6.2 Utility........................................................................................................................................................19
1.10.6.3 Strengths and weaknesses.........................................................................................................................19
1.10.7 Glycopeptides and other peptide antibiotics ...................................................................................... 19
1.10.7.1 Overview ..................................................................................................................................................19
1.10.7.2 Utility........................................................................................................................................................20
1.10.7.3 Strengths and weaknesses.........................................................................................................................20
1.10.8 Quinolones ........................................................................................................................................ 20
1.10.8.1 Overview ..................................................................................................................................................20
1.10.8.2 Utility........................................................................................................................................................20
1.10.8.3 Strengths and weaknesses.........................................................................................................................21
1.10.9 Oxazolidinones ................................................................................................................................. 21
1.10.10 Other antibiotics................................................................................................................................ 22
1.10.10.1 Overview ..................................................................................................................................................22
1.10.10.2 Utility........................................................................................................................................................22
1.10.10.3 Strengths and weaknesses.........................................................................................................................22
1.11 Mechanisms of antibiotic resistance ......................................................................................................... 22
1.11.1 Antibiotic inactivation....................................................................................................................... 23
1.11.2 Antibiotic entry and efflux................................................................................................................. 23
1.11.3 Mutation of the antibiotic target site .................................................................................................. 23
1.11.4 Alternative metabolic pathways......................................................................................................... 23
II. Issues in the Management of Antibiotic Resistance ................................................................................. 25
1. The challenge of antibiotic resistance ....................................................................................................... 25
1.1 Are microbes ‘smarter’ than we are?............................................................................................................ 30
1.2 What’s a physician to do? Some say treat empirically ................................................................................. 32
1.3 When patients demand an antibiotic ............................................................................................................. 35
1.4 Why are hospital-acquired infections different? ........................................................................................... 36
1.5 Education is part of the solution to antibiotic resistance............................................................................... 38
1.6 The Centers for Disease Control and Prevention (CDCP) initiative to control antibiotic usage in the
community setting.................................................................................................................................... 38
1.6.1 Tackling antibiotic resistance............................................................................................................. 38
1.6.2 CDCP’s national campaign................................................................................................................ 38
1.6.3 Medical school curriculum................................................................................................................. 39
1.6.4 National media campaign................................................................................................................... 39
1.6.5 HEDIS measures............................................................................................................................... 40
1.7 The CDCP initiative to control antibiotic usage in the healthcare setting .................................................... 40
1.7.1 Overview of the campaign ................................................................................................................. 40
1.7.2 Twelve steps to prevent AR among hospitalized adults..................................................................... 41
1.8 Minnesota Antibiotic Resistance Collaborative (MARC) ............................................................................ 45
1.9 Selected experts’ comments regarding educational efforts to better manage antibiotic usage .................... 46
1.10 From farm to fork...antibiotic use in agriculture ....................................................................................... 46
1.11 Selected experts’ comments on the use of antibiotics in agriculture......................................................... 49
III. Issues in Current Pharmaceutical Approaches to Managing Antibiotic Resistance ............................ 51
1. Zyvox and Synercid ................................................................................................................................... 52
1.1 Inside Zyvox ................................................................................................................................................ 52
1.2 Other experts’ comments related to Zyvox and Synercid ............................................................................. 54
2. Paratek Pharmaceuticals: the Tetracycline Resistance Project (TET) and the Multiple Antibiotic
Resistance Project (MAR).......................................................................................................................... 55
2.1 The TET....................................................................................................................................................... 55
2.2 The MAR project......................................................................................................................................... 56
3. Microbia, Inc. – conquering biofilms ........................................................................................................ 58
4. Structural GenomiX (SGX) – hunting the protein target ....................................................................... 60
5. Antex........................................................................................................................................................... 64
5.1 ART platform .............................................................................................................................................. 64
5.2 NST platform............................................................................................................................................... 65
5.3 VEP platform............................................................................................................................................... 65
5.4 Vaccine pipeline .......................................................................................................................................... 66
5.4.1 Helivax.............................................................................................................................................. 66
5.4.2 Campyvax ......................................................................................................................................... 67
5.4.3 Activax.............................................................................................................................................. 68
5.4.4 Tracvax ............................................................................................................................................. 68
5.4.5 Twarvax ............................................................................................................................................ 69
5.4.6 Gonovax............................................................................................................................................ 69
5.5 Antex Partnerships....................................................................................................................................... 69
5.5.1 Aventis .............................................................................................................................................. 69
5.5.2 GlaxoSmithKline (GSK).................................................................................................................... 69
5.6 Inside Antex................................................................................................................................................. 70
6. Sequella, Inc – a focus on TB..................................................................................................................... 71
6.1 The challenge of TB .................................................................................................................................... 72
6.2 Inside Sequella............................................................................................................................................. 72
7. Versicor, Inc. .............................................................................................................................................. 76
7.1 Anidulafungin – a novel antifungal .............................................................................................................. 76
7.2 Dalbavancin – completes phase II recruitment in May 2002........................................................................ 76
7.3 Inside Versicor............................................................................................................................................. 77
8. Cubist Pharmaceuticals............................................................................................................................. 77
8.1 Cubist Corporate Partnerships ...................................................................................................................... 78
8.2 Inside Cubist ................................................................................................................................................ 78
IV. Need Gaps in the Management of Antimicrobial Resistance................................................................. 81
1. Need gaps in the management of antimicrobial resistance from a public health perspective.............. 81
1.1 Surveillance ................................................................................................................................................. 81
1.2 Prevention and control................................................................................................................................. 82
1.3 Research....................................................................................................................................................... 83
1.4 Product development ................................................................................................................................... 83
2. Top priority action items to combat antimicrobial resistance ................................................................ 84
2.1 Surveillance ................................................................................................................................................. 84
2.2 Prevention and control................................................................................................................................. 84
2.3 Research....................................................................................................................................................... 85
2.4 Product development ................................................................................................................................... 85
3. Experts’ perceptions of the need gaps in the management of antimicrobial resistance ....................... 85
3.1 Educational need gaps in the management of antimicrobial resistance ........................................................ 85
3.2 Product development need gaps in the management of antimicrobial resistance ......................................... 87
3.3 Need gaps in genetic approaches to managing antibiotic resistance............................................................. 89
3.4 Vaccine need gaps in the management of antibacterial resistance................................................................ 91
Appendix I The Battle Against Antimicrobial Resistance..................................................................................... 93
Appendix II Company Profiles of Innovative Firms in Antibacterial Therapy ............................................... 115
Appendix III CDCP Interim Guidelines for Prevention and Control of Staphylococcal Infection Associated
with Reduced Susceptibility to Vancomycin (1998)............................................................................... 129
Appendix IV Recommendations for Preventing the Spread of Vancomycin Resistance Recommendations of
the Hospital Infection Control Practices Advisory Committee (HICPAC) (1998).............................. 133
Appendix V Recent developments in antibiotic therapy ..................................................................................... 141
Appendix VI Antibiotic drug development programs ......................................................................................... 157
Glossary of Infectious Disease Terms.................................................................................................................... 161
Commonly used acronyms .................................................................................................................................... 163


List of Tables

Table 1.1 Examples of emerging infectious diseases.................................................................................................. 12
Table 1.2 Examples of re-emerging infectious diseases ............................................................................................. 13


Summary: The subject of this report is the management of antibiotic resistance in the US. More specifically, however, the subject of antibiotic resistance has been approached primarily through in-depth interviews (a forum) with clinical and academic authorities, pharmaceutical industry and pharmacy benefit manager executives, and other experts in the field of antibiotic resistance management.

The objective of the report is to produce a close-in snapshot of the current opinions and attitudes of the thought leaders in the user segments of the pharmaceutical, medical, and pharmacy benefit management marketplace as it relates to the management of antibiotic resistance.




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