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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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PRINTED FROM UNIVERSITY OF NORTH CAROLINA PRESS SCHOLARSHIP ONLINE (www.northcarolina.universitypressscholarship.com). (c) Copyright University of North Carolina Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in NCSO for personal use.date: 01 December 2021

Blockbusters and Bombs

Blockbusters and Bombs

Pressures on the Pharmaceutical Industry

(p.140) Chapter Seven Blockbusters and Bombs
Prescription for Change

Michael Kinch

University of North Carolina Press

The first indications of future trouble are identified. For most of history, new medicines arise from nature but this approach came into question as evidenced by the development of the cancer drug Taxol. As understanding of biology and chemistry incraesed, a degree of over-confidence arose as researchers assumed that new technologies would allow them to predict the most effective medicines. These changes were a response to an environment confronting twin pressures in the form of rising generic medicines coupled with ever more costly research and development activities needed to develop new products to replace those devastated by generic competition. These issues were exacerbated by a rising dependence upon “blockbuster” products, which conveyed short-term revenues but inevitably needed to be replaced by even more profitable products once generic competition intervened. Dependence on blockbusters was exemplified by the story of ulcer medicines, which was disrupted by an audacious study by an investigator who used himself as a Guinea pig to make his point. As such risks increased, the industry became more cautious and the race was on to make incremental improvements upon competitors’ products. All the while the cost of developing new medicines continued to escalate.

Keywords:   Taxol, Blockbuster drugs, Generic medicines, Gastric Ulcer

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