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Ethics, the Medical Profession,

and the Pharmaceutical Industry

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HOOKED
 /&v Explorations in Bioethics and
W the Medical Humanities
Series Editor : James Lindemann Nelson

This series aims to include the most theoretically sophisticated, challenging, and
original work being produced in the areas of bioethics, literature and medicine,
law and medicine, philosophy of medicine, and history of medicine.
Explorations in Bioethics and
Medical Humanities also features authoritative
the
contributions to educational contexts and to public discourse on the meaning of
health and health care in contemporary culture and on the difficult questions
concerning the best directions for biomedicine to take in the future.

Editorial Board
Tod Chambers, Northwestern University
Alice Dreger, Michigan State University
Hilde Lindemann, Michigan State University
Martha Montello, University of Kansas
Jeremy Sugarman, Duke University

Dubious Equalities and Embodied Differences: Cultural Studies on

Cosmetic Surgery
by Kathy Davis

Hippocrates Maze : Ethical Explorations of the Medical Labyrinth

’

by James Lindemann Nelson

Healing the Self: Ethical Issues in Chronic Illness, Rehabilitation, and

Care
Palliative
by Bruce Jennings

Mass Hysteria: Medicine, Culture, and Mothers Bodies

’

by Rebecca Kukla

Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry

by Howard Brody
 HOOKED
Ethics, the Medical Profession,
and the Pharmaceutical Industry

Howard Brody

ROWMAN & LITTLEFIELD PUBLISHERS, INC.

Lanham • Boulder • New York • Toronto • Plymouth, UK
ROWMAN & LITTLEFIELD PUBLISHERS, INC.
Published in the United States of America
by Rowman & Littlefield Publishers, Inc.
A wholly owned subsidiary of The Rowman & Littlefield Publishing Group, Inc.
4501 Forbes Boulevard, Suite 200, Lanham, Maryland 20706
www.rowmanlittlefield.com

Estover Road
Plymouth PL6 7PY
United Kingdom

Copyright © 2007 by Rowman & Littlefield Publishers, Inc.

All rights reserved. No part of this publication may be reproduced, stored in a retrieval
system, or transmitted in any form or by any means, electronic, mechanical, photocopying,
recording, or otherwise, without the prior permission of the publisher.

British Library Cataloguing in Publication Information Available

Library of Congress Cataloging-in-Publication Data

Brody, Howard.
Hooked : ethics, the medical profession, and the pharmaceutical industry / Howard
Brody.
p. ;
cm. — (Explorations in bioethics and the medical humanities)
Includes index.
ISBN-13: 978-0-7425-5218-0 (cloth alk. paper) :

ISBN-10: 0-7425-5218-7 (cloth alk. paper) :

—
1. Medical ethics. 2. Pharmaceutical industry Moral and ethical aspects. 3.

—Professional
Physicians ethics. I. Title. II. Series.
[DNLM: Medical — United
1. Ethics, Conflict of States. 2. Interest — United States. 3.
Drug Industry— United Physicians — United
States. 4. States. 5. Public Policy— United
States. W
50 B8643h 2007]
R724.B76 2007
174.2’951 dc22 — 2006018423

Printed in the United States of America

@™ The paper used in this publication meets the minimum requirements of American
National Standard for Information Sciences — Permanence of Paper for Printed Library
Materials, ANSI/NISO Z39.48-1992.
If we put horse manure in a capsule, we could sell it

to 95 percent of these doctors.

— Harry Loynd, president of Parke,
Davis and Company, 1951-1967
 CONTENTS

Acknowledgments ix

Abbreviations xi

Introduction: The Tipping Point I

PART I OVERVIEW
1 The Good, the Bad, and the Ugly:

A Story ofTwo Medications 13

2 An Ethical Framework 23

PART II SPECIFIC ISSUES AND PROBLEMS

3 The Pharmaceutical Industry and the Free Market 53

4 Patents, Generic Drugs, and Academic Science 69

5 Research and Profits 86

6 Suppression of Research Data 97

7 The Quality of Pharmaceutical Research I 17

8 The Drug Rep: Historical Background I 39

9 The Drug Rep Today I 66

1 0 The Influence of Drug Reps: What the Data Show I 81

v i i i CONTENTS

I I Continuing Medical Education 200

1 2 Professional Organizations and Journal Advertising 2 1

1 3 The Industry and the Consumer . 230

1 4 The FDA: From Patent Medicines to AIDS Drugs 248

1 5 The FDA and the Industry, 1 99(^2004 268

PART III TOWARD SOLUTIONS

16 Solutions: The Management and Divestment Strategies 287

I 7 Solutions Requiring Enhanced Professionalism in Medicine 299

1 8 Solutions Requiring Regulatory Reform 3 1

Epilogue: Industry Woes and Professional Opportunities 339

Index 349

About the Author 369

 ACKNOWLEDGMENTS

A great many people have assisted me in the research and writing of this volume.
I have tried to note all of them in specific endnotes, and apologize to anyone I

have missed.
I turned at various times to Bob Goodman, Joel Lexchin, Peter Mansfield, Mike
Wilkes, Jeanne Lenzer, and John Abramson for advice and assistance. I especially
value the support and counsel of Rick Bukata and Jerry Hoffman. My involvement
with their “Primary Care Medical Abstracts” courses aided me in identifying litera-
ture and shaped my views on the deleterious impact of pharmaceutical funding on
physician education. Many colleagues in the Department of Family Practice and in
the Center for Ethics and Humanities in the Life Sciences, Michigan State Univer-
sity, supported and encouraged my research.
Anders Kelto served as my student research assistant and assisted me with the
initial stages of accumulating a computerized bibliography. Anders joined me and
my John Goddeeris and Andy Hogan in a research study of the
faculty colleagues
financial aspects of the medicine-pharmaceutical interface. While this project did
not lead to the hoped-for publication, I have made use of our findings at several

places in this volume.

Neill Bogan, Carl Elliott, and Jim Nelson read the manuscript and made helpful
suggestions.
My thanks to the Rowrnan and Littlefield staff: acquisitions editor Chris Anza-
lone, production editor Marian E. Haggard, and copyeditor Gary J.
Hamel.
A final note: The pharmaceutical industry and the medical profession represent
a moving target. Readers who are aware of the most recent breaking news often
wonder how to interpret what a book author says about a topic, not knowing how
X ACKNOWLEDGMENTS
long before the passage they are reading was actually written. So, for the record, I

would like to note that completed work on this manuscript in July 2005. I
I largely
continued to make small revisions into the early months of 2006; most of those
later revisions are so identified in the endnotes.

*\
 ABBREVIATIONS

AAFP American Academy of Family Physicians

AARP American Association of Retired Persons
ACCME Accreditation Council for Continuing Medical Education
ACT UP AIDS Coalition to Unleash Power
AG Attorney General
AIDS Acquired Immunodeficiency Syndrome
AMA American Medical Association
AWP average wholesale price
BAM Business for Affordable Medicine
CAUT Canadian Association of University Teachers
CCOHTA Canadian Coordinating Office for Health Technology Assessment
CDC Centers for Disease Control [currently, Centers for Disease Control
and Prevention]
CEO Chief Executive Officer
CLASS Celecoxib Long-Term Arthritis Safety Study
CMD Current Medical Directions
CME continuing medical education
CML chronic myelogenous leukemia
COX-2 cyclo-oxygenase-2 inhibitor drug
CRO contract-research organization
DHEW Department of Health, Education, and Welfare [currently, DHHS]
DHHS Department of Health and Human Services
DM district manager
DSM Diagnostic and Statistical Manual of Mental Disorders
DTC direct-to-consumer
DTCA direct-to-consumer advertising
 ABBREVIATIONS

EKG electrocardiogram
FDA Food and Drug Administration
FTC Federal Trade Commission
GIST gastrointestinal stromal tumor
GP general practitioner
HCFA Health Care Financing Administration [currently, Centers for Medi-
care and Medicaid Services (CMS)]
HHS [U.S. Department of] Health and Human Services
HIPAA Health Insurance Portability and Accountability Act
HIV human immunodeficiency virus
HMO health maintenance organization
HRG [Public Citizen] Health Research Group
IBS irritable bowel syndrome
ICU intensive care unit
IND new drug
investigational
MADD Mothers Against Drunk Drivers
MECC medical education and communications company
MIT Massachusetts Institute of Technology
NCI National Cancer Institute
NHLBI National Heart, Lung, and Blood Institute
NIH National Institutes of Health
NIPD National Institute of Pharmaceutical Development [hypothetical]
NSAID nonsteroidal anti-inflammatory drug
OIG Office of the Inspector General
PBM pharmacy benefit manager
PDA persona] digital assistant
PDUFA Prescription Drug User Fee Act
PhRMA Pharmaceutical Research and Manufacturers of America
R&D research and development
SLAPP strategic lawsuit against public participation
SMO site-management organization ^
SSRI selective serotonin re-uptake inhibitors
TRIPS trade-related intellectual property agreement
UCLA University of California at Los Angeles
UCSF University of California at San Francisco
USDA United States Department of Agriculture
VA Veterans Administration
VIGOR Vioxx Gastrointestinal Outcomes Research
WHO World Health Organization
WTO World Trade Organization
 Introduction

THETIPPING POINT

Tom and Ray Magliozzi, the Car Talk guys on National Public Radio, couldn’t
stop laughing as they described the poetic justice that once befell one of their ac-
The fellow was driving home from work during the wee hours of the
quaintances.
morning when he passed an unguarded construction site. Right next to the street
stood a pile of brand-new, four-by-eight-foot sheets of half-inch plywood exactly —
what he needed for a home remodeling project. He decided upon what the old
Army veterans used to call a “midnight requisition,” and piled a dozen sheets of
plywood on the top of his car. This being a spur-of-the-moment larceny, he had no
—
rope to tie down the load. But he reasoned that if he drove slowly he was only a
—
few blocks from his house nothing would happen. Hardly any other cars were on
the road that late. The pile of wood seemed to weigh a ton; it wouldn’t be going
anywhere.
Allwent well until the one other car on the road at that hour cut suddenly in
front ofhim at an intersection. He touched the brakes as gently as he could. As
the Magliozzi brothers described it between guffaws, he then saw events occur-
ring through his windshield as if in special-effects slow motion. Each sheet of
plywood slid forward, one at a time, and landed in the street in front of his car.
As each sheet slid forward, it took with it some portion of the automobile the —
grill, the headlights, the front fenders, the hood. Finally he contemplated a pile
of plywood and most of the front end of his car lying in the middle of the inter-
1.
section.
The plywood had reached what Malcolm Gladwell calls “the tipping point .” 2
The tipping point is a common feature of social change. Before one reaches the
tipping point, it appears that the social system is firmly stuck where it is. Perhaps
people have for years tried to reform or alter it, but its inertia has frustrated all

their efforts. Suddenly, once the tipping point is reached, the very inertia that
2 INTRODUCTION

previously frustrated change now pushes the change forward more rapidly, and
more powerfully, than anyone could have guessed.
Another feature of the tipping point is that it appears at first glance to be an
event of little consequence —
no different than all the other tiny shoves that people
have been applying to the stuck system for a long time without visible result. It
follows that at the moment one would hardly ever be correct in claiming
it occurs,
that the tipping point had been reached. (Any more than the Magliozzi brothers’
acquaintance could have been able to guess in advance what exactly was going to
happen when he put his foot on the brake.) Only in hindsight would one as a rule
be confident in identifying the tipping point.
What does all this have to do with the medical profession and the pharmaceuti-
cal industry?
A tipping point of sorts may have occurred in the spring of 2004. The event that
later history might pick out from all that happened was a legal action filed by the at-

torney general (AG) of the state of New York, on June 2. The AG

Eliot L. Spitzer,
accused the giant drug firm GlaxoSmithKline of fraud. Many lawsuits had been filed
in the previous several years by states’ attorneys general against major drug firms, all

claiming fraud. Those suits were mostly based on the allegation that the firms were
overcharging the state Medicaid systems for their drugs by manipulating the pricing
structure. The firms were supposed to charge Medicaid the lowest price they
charged any customer, but companies had found a variety of ways to hide the fact
that they had charged some favored buyers less than they were charging Medicaid.
But the New York fraud charges were quite different. Spitzer alleged that Glaxo-
SmithKline had deliberately concealed the results of four research studies of the
antidepressant drug Paxil when used in children and adolescents. These four studies
all showed that the drug either did not work well or that it caused harm. By contrast,
a fifth study was interpreted to show that Paxil was helpful in treating childhood de-
pression. 3 The firm rapidly published and then gave considerable publicity to the
fifth study, while doing its best to conceal from the medical community the contrary

results of the other four studies.

In 2003, British government regulators ruled that Paxil should^not be used in
the treatment of depression in children and adolescents because cases of suicide
were more frequent among younger patients using that and a few similar drugs.
On October 27, 2003, the U.S. Food and Drug Administration (FDA) also issued
4
an advisory to that effect.
The Wall Street Journal, whose editorial page tencjs to be a strong defender of
the pharmaceutical industry, took Spitzer to task for filing this lawsuit. The Journal
claimed that this was and publicity seeking, since
solely a matter of grandstanding
it was the FDA, not the state government of New York, that properly had jurisdic-

tion over the regulation of drugs in the United States. But the Journal’s editorial
missed part of the point. By filing a more or less unprecedented action on behalf
of the state, Spitzer was effectively making a claim about the FDA. He was accus-
ing the FDA of having been sufficiently captured by the pharmaceutical industry
so as no longer to be capable of protecting the citizens from potentially ineffective
or unsafe drugs. He was claiming that the citizens of New York had no recourse
other than to take matters into their own hands.
THE TIPPING POINT 3

At about the same time that Spitzer filed his lawsuit, journalist Shannon Brown-
Washington Monthly with the subtitle, “Why You Can’t
lee wrote an article for the
Trust Medical Journals Anymore.” Her target was less the pharmaceutical industry
that financed studies like the Paxil trials than the physician-investigators who con-
ducted the studies and then willingly did the bidding of the industry in the way
Brownlees choice of a subtitle
that they reported, or failed to report, the results.
carried with it an important message. In previous years, a vocal minority of physi-
cians and scientists had warned ominously (though to little practical effect) that
the medical literature was becoming seriously biased as a result of manipulation by
the industry. Brownlee may have been one of the first laypeople to grasp fully what
this meant for the public health — to fully understand the implications of the pub-
lic water hole of scientific information becoming polluted. 5
Brownlee also chose to frame her dismay in terms of trust. As a journalist, she
was familiar with the idea of professional ethics. If she wrote an article praising a
drug and did not disclose either to the editor or to the readers that she was in the
pay of the drug company, she expected certain consequences to follow that would
be deleterious to her future career. She could not understand how respected aca-
demic physicians could participate in what appeared to be the same sort of behav-
ior, yet be allowed to go on about their business as if nothing had happened. You

physicians, she seemed to be saying, were supposed to have taken an oath to pro-
tect our health. We trusted you. And now you have betrayed our trust.
In the wake of the New York lawsuit, a number of events occurred. Many major
U.S. newspapers wrote editorials strongly condemnatory of the pharmaceutical
industry, and calling for new legislation to require the publishing of research re-
6
sults in a centralized registry. At the time, most observers knew that a federal

clinical trials registry existed —

under the tutelage of the National Library of Medi-
cine —but assumed that the industry posted its clinical trials in that registry only
on a voluntary basis. Later it was revealed, to the surprise even of medical journal
editors, that the law required industry compliance. The FDA had issued in 2002
some guidelines to govern industry registration of their clinical trials, but had ap-
parently been either unable or unwilling to police the compliance. 7
GlaxoSmithKline announced soon after that it would immediately begin making
public information about all its ongoing clinical trials. 8 Merck and Eli Lilly quickly
9
followed The industry apparently smelled a public relations disaster looming.
suit.

By comparison, in 2001, Warner-Lambert had been accused by an investigative re-

porter for the Los Angeles Times of working with compliant FDA officials to keep its
diabetes drug, Rezulin, on the market despite mounting evidence that it was causing
deaths from liver failure. 10 No public outcry followed that revelation and no state
government filed suit against Warner-Lambert. The deaths of middle-aged people
with diabetes apparently did not have a strong grip on the public psyche. The allega-
and teenagers might commit suicide as a result of taking an antide-
tion that children
pressant medication was a different matter altogether. It seemed all too reminiscent
of the thalidomide scare of the early 1960s. A drug that caused babies to be bom
without arms or legs got ones attention. The realization of how close that drug came
to being sold in the United States caused sufficient public concern to move passage
in Congress of tough legislation tightening regulation of the drug industry.
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