Antibiotics (eBook)

Contents 6
1 The Perfect Storm 8
2 The Miracle 15
3 Resistance 20
The Basics 20
Antibiotics for Animals and Crops Lead to Resistance for People 21
In Our Hospitals, Things Are Getting Critical 25
Antibiotic Resistance Plus Toxin Production Equals Death 28
Our Communities are Not Spared 30
Resistance Summing Up 32
4 The FDA 34
We Need Them, but They Have Become Part of the Problem 34
The FDA Increases Clinical Trial Design Stringency and Costs. Companies Abandon Antibiotic Research 37
Mild Infections Require Placebo-Controlled Trials Industry Balks 40
New Antibiotics for Mild Infections Are Forced from the Market While Generic Antibiotics Are Still Approved in the Absence of Placebo-Controlled Trials 43
The Ketek Scandal 43
Pneumonia The New Frontier. New Trial Requirements for Pneumonia Will Make Approval Much More Difficult and Costly and Sometimes Simply Infeasible 46
The FDA Can Change Its Requirements After Completion of a Trial and then Require New Trials for Approval 49
The FDA is Regulating Itself Out of the Antibiotics Business 51
We Need Balance and Perspective from the FDA 52
The FDA Makes It Difficult for Them to Obtain Good Advice 53
5 Europe 55
6 The Industry 61
Antibiotics Form a Cornerstone of the Pharmaceutical Industry 61
Resistance Should Create Opportunities 64
Industry Consolidation Reduces the Effort in Antibiotics 65
Antibiotics Are Not Financially Attractive in the Consolidated Industry 67
Industry Takes a Risk-Averse Approach to Its Clinical Trials, but Deprives Us of the Most Important Information 69
Discovery of New Antibiotics Is Becoming Harder 70
The US Market Share is Stagnant or Shrinking. Will the Industry be Able to Prioritize Ex-US Territories? 71
Research and Development Costs Increase, but Approvals Are Down 72
Some Good News for Everyone 73
Antibiotic RD in Biotech Is Stymied by Late Stage Clinical Trial Costs 75
Biotech Is Still a High-Risk Proposition 77
7 Modest Proposals 80
The Role of Government 80
Government Loves a Task Force 80
Government Can Play Several Important Roles 82
The Transatlantic Taskforce on Antimicrobial Resistance 84
Government-Sponsored Research and Research Tools Are Required 84
Industry Incentives Will Probably Also Be Required. Europe Is Leading the Way in Thinking Here 85
The FDA (and EMEA) 87
The FDA and EMEA Both Must Adapt a More Balanced Approach to Antibiotics. Required Trial Designs Must Be Feasible 87
Do We Want New Antibiotics for Mild Infections? Is Bacterial Bronchitis in the Setting of Chronic Lung Disease a Mild Infection? 87
The FDA Must Modify Its Guidelines for Clinical Trials in Community Acquired Bacterial Pneumonia 88
The FDA Has to Stop Moving the Goal Posts in Mid-Stream 90
The FDA Has to Level the Playing Field with Generic Antibiotics 91
Congress Needs to Step Back from the FDA Especially Where Science Is Concerned 91
Our Government Needs Access to the Best Advice it Can Get 92
How About a Totally New Approach to Drug Development? 92
Communication Between the Industry and Physicians Is Required, but is Becoming More and More Restricted 94
What Should the Industry Be Doing? 95
The Current Large PhRMA Model Is not Viable. These Giants Need to Divide Themselves into Bite-Size Portions to Survive 96
8 Conclusions 100
Bibliography 103
Index 106