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Prescription for ChangeThe Looming Crisis in Drug Development$
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Michael Kinch

Print publication date: 2016

Print ISBN-13: 9781469630625

Published to North Carolina Scholarship Online: May 2017

DOI: 10.5149/northcarolina/9781469630625.001.0001

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Trials and Tribulations

Trials and Tribulations

(p.35) Chapter Two Trials and Tribulations
Prescription for Change

Michael Kinch

University of North Carolina Press

The testing of new medicines is a complex, labor- and cost-intensive practice that has evolved over the past 200 years. This chapter explains some of the jargon used by medical practioners and industry scientists to explain how the cure for scurvy by a promising young British Navy captain gave rise to the naming of Royal Navy sailors as “limeys.” More than a century later, the Nazi atrocities of the Second World War likewise contributed to the rise of modern ethical practices and examples of how these have been implemented include the approval of breakthrough cancer medicines. In doing so, we discuss the different “phases” of clinical trials and relate the lessons learned from a tragic 2006 clinical trial in London that caused one volunteer's head to swell so large that he was referred to as “the Elephant Man.” By understanding how the size and intensity of clinical trials has grown over time, one begins to appreciate the parallel escalation of drug costs. Finally, we discuss the thalidomide crisis and how the bravery and persistance of a new female FDA employee overrode a multi-national conglomerate to prevent America from falling victim to the severe birth defects experienced by many other countries.

Keywords:   Clinical trial, Thalidomide, Scurvy, Angiogenesis

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