Table Of Contentt h e r i s k s o f p r e s c r i p t i o n d r u g s D O N A L D w. L I G h T
The Risks of Prescription Drugs tackles critical questions about the pharmaceuti-
cal industry and the privatization of risk. To what extent does the FDA protect the
public from serious side efects and disasters? What is the efect of giving the
private sector and markets a greater role and reducing public oversight? This vol-
ume considers whether current rules and incentives put patients’ health at greater
risk, the efect of the expansion of disease categories, the industry’s justifcation
of high U.S. prices, and the underlying shifts in the burden of risk borne by indi-
viduals in the world of pharmaceuticals.
“Although many are aware that pharmaceutical industry lobbyists infuence policy
decisions, few know the full consequences. This book is enlightening.”
J ILL QuADAGNO, author of The Transformation of Old Age Security
“Clear, concise, and unfinching, this book provides consumers with tools for
self-defense and concerned citizens with a road map for rebalancing American
medicine.”
JOhN ABRAMSON, author of Overdosed America: The Broken Promise of
American Medicine
“This book introduces important debates on pharmaceutical promotion and market-
ing, needed drug evaluation and regulation, professional conficts of interest, and
increased medicalization of behavior. It explores important trends and policy ques-
tions that all engaged citizens should consider.”
DAvID MEChANIC , author of The Truth About Health Care: Why Reform Is Not
Working in America
DONALD w. L IGhT is professor of social medicine and comparative health care at the University of
Medicine and Dentistry of New Jersey and a senior visiting researcher at Princeton University.
AdditionAl ColumbiA/SSRC bookS on the pRivAtizAtion of RiSk And itS
impliCAtionS foR AmeRiCAnS:
Bailouts: Public Money, Private Proft
E d i t E d b y r o b E r t E . w r i g h t
Disaster and the Politics of Intervention
E d i t E d b y a n d r E w l a k o f f
Health at Risk: America’s Ailing Health System—and How to Heal It The Risks of
Edi t Ed b y j ac o b s . h ac k E r
Laid Of, Laid Low: Political and Economic Consequences of Employment Insecurity
E d i t E d b y k at h E r i n E s . n E w m a n
PRescRiPTion DRugs
Pensions, Social Security, and the Privatization of Risk
E d i t E d b y m i t c h E l l a . o r E n s t E i n
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L IGhT T hE R ISKS OF PRESC R I PT IO N DRuGS c o l u m b i a
a c o l u m b i a | s s r c b o o k
p r i vat i z at i o n o f r i s k s e r i e s
the risks of prescription drugs
The Columbia University Press and Social Science Research Council
Series on the Privatization of Risk
the columbia university press and
social science research council
series on the privatization of risk
Edited by Craig Calhoun and Jacob S. Hacker
The early twenty-frst century is witnessing a concerted e¤ort to privatize risk — to
shift responsibility for the management or mitigation of key risks onto private-sector
organizations or directly onto individuals. This series uses social science research to
analyze this issue in depth. Each volume presents a concise review of a particular
topic from the perspective of the public and private allocation of risk and responsibility
and o¤ers analysis and empirical, evidence-based opinion from leading scholars in the
felds of economics, political science, sociology, anthropology, and law. Support for the
series comes from the John D. and Catherine T. MacArthur Foundation.
Jacob S. Hacker, ed., Health at Risk: America’s Ailing Health System — and How to Heal It
Andrew Lako¤, ed., Disaster and the Politics of Intervention
Katherine S. Newman, ed., Laid O¤, Laid Low: Political and Economic Consequences
of Employment Insecurity
Mitchell A. Orenstein, ed., Pensions, Social Security, and the Privatization of Risk
Robert E. Wright, ed., Bailouts: Public Money, Private Proft
The Risks of
Prescription Drugs
edited by donald w. light
columbia university press | new york
a columbia/ssrc book
columbia university press
Publishers Since 1893
New York Chichester, West Sussex
Copyright © 2010 The Social Science Research Council
All rights reserved
Library of Congress Cataloging-in-Publication Data
The risks of prescription drugs / edited by
Donald W. Light.
p. cm. — (The Columbia University Press
and Social Science Research Council series on the
privatization of risk) (Columbia/SSRC book)
Includes bibliographical references and index.
isbn 978-0-231-14692-0 (cloth : alk. paper) —
isbn 978-0-231-14693-7 (pbk. : alk. paper) —
isbn 978-0-231-51926-7 (ebook)
1. Pharmaceutical policy — United States.
2. Pharmaceutical industry — Risk management.
3. Drugs — Risk factors. 4. United States. Food and Drug
Administration. I. Light, Donald, 1942– II. Series:
Columbia University Press and Social Science Research
Council series on the privatization of risk. III. Series:
Columbia/SSRC book.
[dnlm: 1. Drug Industry — standards — United
States. 2. Prescription Drugs—standards — United
States. 3. Drug Toxicity — United States. 4. Medication
Errors — prevention & control — United States. 5. Risk
Assessment — United States. qv 736 r5955 2010]
ra401.a3r57 2010
338.4'76151 — dc22
2010009014
Columbia University Press books are printed
on permanent and durable acid-free paper. This
book is printed on paper with recycled content.
Printed in the United States of America
c 10 9 8 7 6 5 4 3 2 1
p 10 9 8 7 6 5 4 3 2 1
References to Internet Web sites (URLs) were
accurate at the time of writing. Neither the editor
nor Columbia University Press is responsible
for URLs that may have expired or changed since
the manuscript was prepared.
Design by Julie Fry
Cover by Vin Dang
contents
c hapter one
Bearing the Risks of Prescription Drugs 1
donald w. light
chapter two
The Food and Drug Administration:
Inadequate Protection from Serious Risks 40
donald w. light
chapter three
The Commercialization of Medical Decisions:
Physicians and Patients at Risk 70
howard brody
chapter four
Pharmaceuticals and the Medicalization of Social Life 92
allan v. horwitz
chapter five
Medicalization and Risk Scares:
The Case of Menopause and HRT 116
cheryl stults and peter conrad
epilogue
Toward Safer Prescribing and Better Drugs 140
donald w. light
List of Contributors 166
Something is very wrong with a system that leads patients to demand,
and doctors to prescribe, a drug that provides no better relief and causes
signifcantly more serious side effects . . . How have we gotten to a place
where expensive new drugs could become “blockbusters” when there
was little scientifc evidence to justify their routine use?
— John Abramson, MD, 2004
the risks of prescription drugs