A Prescription for Change: The Looming Crisis in Drug Development

by Michael Kinch

Overview

The introduction of new medicines has dramatically improved the quantity and quality of individual and public health while contributing trillions of dollars to the global economy. In spite of these past successes—and indeed because of them—our ability to deliver new medicines may be quickly coming to an end. Moving from the beginning of the twentieth century to the present, A Prescription for Change reveals how changing business strategies combined with scientific hubris have altered the way new medicines are discovered, with dire implications for both health and the economy.

To explain how we have arrived at this pivotal moment, Michael Kinch recounts the history of pharmaceutical and biotechnological advances in the twentieth century. Kinch relates stories of the individuals and organizations that built the modern infrastructure that supports the development of innovative new medicines. He shows that an accelerating cycle of acquisition and downsizing is cannibalizing that infrastructure Kinch demonstrates the dismantling of the pharmaceutical and biotechnological research and development enterprises could also provide opportunities to innovate new models that sustain and expand the introduction of newer and better breakthrough medicines in the years to come.

Product Details

ISBN-13:	9781469647579
Publisher:	The University of North Carolina Press
Publication date:	03/01/2018
Series:	The Luther H. Hodges Jr. and Luther H. Hodges Sr. Series on Business, Entrepreneurship, and Public Policy
Edition description:	Reprint
Pages:	352
Product dimensions:	6.00(w) x 9.10(h) x 0.90(d)

About the Author

Michael Kinch is Associate Vice Chancellor and Director of the Center for Research Innovation in Biotechnology at Washington University in St. Louis.

What People are Saying About This

From the Publisher

This compelling and thoughtful book provides a unique perspective and critical analysis of the pharmaceutical industry and its mode of expansion.—Ronald Goldfarb, Sopherion Therapeutics



In this era of Valeant and congressional skepticism about the motivations of the leaders of the pharmaceutical industry and their investors, and as the fundamental processes of drug discovery and development become less effective and the costs of discovering new and useful scientific truths escalate, Michael Kinch asks, 'How did we reach this point?' A Prescription for Change lays out the fundamental facts and history of the industry to provide a brilliant, revealing, commonsense, and well-written answer to this timely and essential question.—Dr. Richard N. Foster, Chair, Presidents' Circle, National Academies of Science, Engineering, and Medicine

Editorial Reviews

Traces the history of the pharmaceutical and biotechnology industries and describes the evolution of the scientific, regulatory, social, and marketing forces that are compromising contemporary drug developments . . . . Well explained and illustrated with useful anecdotes.—Science Magazine



An informative and fascinating read for anyone with an interest in the drug discovery process, scientists, healthcare professionals, investors, regulators, or those who just want to see our economy flourish and public health to be improved for the global benefit to society or just to protect an individual 401K plan. . . . Highly recommend this well-written book as a must read for anyone with the slightest interest in how the drug discovery process impacts our economy and public health.—Doody's Reviews



Begins with the history of drug development from ancient times up to 2016. . . . Packs in detail, but keeps it readable.—Compression



A thorough review of the history of the development of every drug to receive FDA approval. . . . [Kinch] brings to this book many decades of research and harrowing personal experience with pharma.—EurekAlert!



A cogent and comprehensive view of where the drug industry is today and how it got there.—Health Affairs

From the Publisher

Reviewer: Thomas L. Pazdernik, PhD (University of Kansas Medical Center)
Description: Dr. Michael Kinch uses a personal journey through his career from academia to industry back to academia, including family experiences, as a platform to provide a fascinating story about the "good", the "bad", and the "ugly" of the drug discovery process. His book warns us that the failure to discover new cost-effective medicines could have catastrophic consequences on our economy and public health.
Purpose: His goal is to provide a unique perspective on how to learn from the past to incentivize and reinvigorate the drug discovery process. He provides a fabulous personal story on the reasons that changes in the drug discovery process must begin immediately.
Audience: This book is an informative and fascinating read for anyone with an interest in the drug discovery process, scientists, healthcare professionals, investors, regulators, or those who just want to see our economy flourish and public health to be improved for the global benefit to society or just to protect an individual 401K plan, since pharmaceutical and biotechnology companies are common investments in many retirement portfolios.
Features: The introductory chapter is a succinct background and overview of the author's personal journey leading to the publication of this fascinating book. The first chapter examines the history of the need to regulate medicines, while the second discusses the history and changes occurring over time in the clinical trials process required to document efficacy and safety of drugs. The next two chapters detail the birth of our modern pharmaceutical industry and provide an overview of the golden age of the pharmaceutical industry as well as some of the tragedies that led to changing tides in regulation oversight and overcorrections. Chapter 5 details the importance of modern research universities and how academic, governmental, and private sectors came together in the discovery of drugs that have saved millions of lives. The next two chapters describe the influence of the biotechnology industry on the drug discovery process and how a combination of the generic industry, blockbuster products, me-too drugs, and high profile failures created a lethal combination threatening the viability of the pharmaceutical industry. The subsequent two chapters identify how the successes and failures in the biotechnology industry now threaten the entire drug industry and focus on how the suburban Maryland area serves as a microcosm for the successes and failures in the biotechnology industry. Chapter 10 discusses how consolidation and growth of big pharma threaten the sustainability of future drug discovery and chapter 11 gives insight into how changes in the pharmaceutical industry have now created an impending state of crisis often referred to as the "valley of death." The final chapter ends the book more optimistically, noting how the ever widening "valley of death" could lead to unprecedented opportunities for entrepreneurial growth and public health improvements. Each of these chapters is told with anecdotes from the fascinating professional and family experiences of the author.
Assessment: I highly recommend this well-written book as a must read for anyone with the slightest interest in how the drug discovery process impacts our economy and public health.

Doody's Review Service