Waubonsee Community College

Antibiotics, the perfect storm, David M. Shlaes

eng

Includes bibliographical references and index

portraitsillustrations

index present

non fiction

Antibiotics

bibliography

620364836

David M. Shlaes

the perfect storm

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