Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat

354 Pages·2005·1.892 MB·English

by  Fran Hawthorne

ffirs_hawthorne.qxd 1/4/05 3:28 PM Page i
INSIDE
THE FDA
The Business and Politics Behind the
Drugs We Take and the Food We Eat
Fran Hawthorne
John Wiley & Sons, Inc.
ffirs_hawthorne.qxd 1/4/05 3:28 PM Page ii
Copyright © 2005 by Fran Hawthorne. All rights reserved.
Published by John Wiley & Sons, Inc., Hoboken, New Jersey
Published simultaneously in Canada
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, scanning, or otherwise, except as permitted under Section 107 or 108 of
the 1976 United States Copyright Act, without either the prior written permission
of the Publisher, or authorization through payment of the appropriate per-copy fee
to the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923,
978-750-8400, fax [phone], or on the web at www.copyright.com. Requests
to the Publisher for permission should be addressed to the Permissions Department,
John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, 201-748-6011,
fax [phone].
Limit of Liability/Disclaimer of Warranty: While the publisher and author have
used their best efforts in preparing this book, they make no representations or
warranties with respect to the accuracy or completeness of the contents of this
book and specifically disclaim any implied warranties of merchantability or fitness
for a particular purpose. No warranty may be created or extended by sales
representatives or written sales materials. The advice and strategies contained
herein may not be suitable for your situation. You should consult with a professional
where appropriate. Neither the publisher nor author shall be liable for any loss of
profit or any other commercial damages, including but not limited to special,
incidental, consequential, or other damages.
For general information on our other products and services, or technical support,
please contact our Customer Care Department within the United States at
800-762-2974, outside the United States at 317-572-3993 or fax [phone].
Wiley also publishes its books in a variety of electronic formats. Some content that
appears in print may not be available in electronic books. For more information
about Wiley products, visit our Web site at www.wiley.com.
Library of Congress Cataloging-in-Publication Data
Hawthorne, Fran.
Inside the FDA : the business and politics behind the drugs we take and the
food we eat / Fran Hawthorne.
p. cm.
Includes bibliographical references.
ISBN 0-471-61091-7 (cloth)
1. United States. Food and Drug Administration. 2. Pharmaceutical policy—
United States. 3. Food adulteration and inspection—United States. I. Title.
RA401.A3H39 2005
353.9′98′0973—dc22
2004022067
Printed in the United States of America
10 9 8 7 6 5 4 3 2 1
ffirs_hawthorne.qxd 1/4/05 3:28 PM Page iii
To the generations:
my parents,
Lillian and Edward Hawthorne,
and my children,
Mallory and Joey
toc_hawthorne.qxd 1/4/05 3:31 PM Page iv
Contents
Introduction v
Chapter 1: Case Study: Chasing Cancer 1
Chapter 2: Beyond Science 23
Chapter 3: The First 100 Years 35
Chapter 4: “You Don’t Know Which Agency Is in Charge” 65
Chapter 5: Truckloads of Paper 79
Chapter 6: Case Study: The Return of Thalidomide 109
Chapter 7: How Picky Is the FDA? 123
Chapter 8: How Powerful Is Industry? 143
Chapter 9: Case Study: The Death of Monica George 179
Chapter 10: When Consumers Get Angry 191
Chapter 11: A Political Pawn 209
Chapter 12: FDA and DNA 233
Chapter 13: The FDA Meets Madison Avenue 253
Chapter 14: Frivolous Drugs? 273
Chapter 15: The Next 100 Years 285
Acknowledgments 309
Notes 311
Bibliography 329
Index 333
iv
flast_hawthorne.qxd 1/4/05 3:30 PM Page v
Introduction
The Holiday Inn in Bethesda, Maryland, is an unassuming stucco
building tucked sideways off a slow commercial street, across from a
Pizza Hut, a gas station, and a mini-mart. You enter from the side drive-
way and climb up a wide, curving staircase to reach the Versailles II ball-
room on the second floor.
On a sunny February morning in 2004, as week-old snow lingered in
piles at the edge of the sidewalk, it was standing room only in that ball-
room. Some three hundred people had come—parents, grandparents, sib-
lings, and friends, bearing posters and white satin ribbons—to talk to the
United States Food and Drug Administration about the medicine that
had killed someone they loved.
The long room was decorated in shades of beige and blue, with tex-
tured beige wallpaper, beige-and-brown carpeting in a fleur-de-lis motif,
and a turquoise ceiling studded with 16 crystal chandeliers. At one end,
three tables had been arranged in a large “U” for the two panels of 36 out-
side experts who had been summoned to advise the FDA, along with a few
agency staffers. Facing them were rows of burgundy-and-purple brocade
chairs, a battery of TV cameras, and a microphone for the audience.
They came from Rhode Island and California, from Texas and Col-
orado, Arizona and Pennsylvania. Most of them were middle-aged, the men
in business suits, the women in nice slacks. One mother quoted the Book
of Revelations; another wore a button supporting Democratic Senator
John Edwards for president. A 10-year-old girl read an Archie comic
book, while a boy of about six played with his GameBoy. In the hall
outside the ballroom, one blonde woman asked another, “Was your daugh-
ter suicidal?”
They came with tales of the anguish and horror that they and their
families had lived through after a teenage son, daughter, grandchild, or
friend had started taking an antidepressant medication legally prescribed
by their doctor and approved by the FDA. While on the medication, the
teenagers had killed themselves, or someone else, or tried to. The fami-
v
flast_hawthorne.qxd 1/4/05 3:30 PM Page vi
vi INTRODUCTION
lies blamed the drugs, and they wanted the FDA to do something to pre-
vent more horror stories.
Tom and Kathy Woodward. Their 17-year-old daughter Julie had
hung herself in the garage six months earlier, after seven days on Zoloft.
Terri Williams. Her 14-year-old son Jacob had hung himself in the
attic with a belt while taking Prozac. A friend held up a picture of Jacob
in his football uniform.
Corey Baadsgaard with his father, Jay. Corey had used first Paxil, then
Effexor. Then he woke up in a juvenile detention center one morning.
Apparently, he had carried a hunting rifle to school and held his class
hostage, but he didn’t remember any of that. “These drugs are hell. Look
what they’ve done to my son!” Jay Baadsgaard shouted, his voice hoarse.
He strode out of the ballroom, slamming the door behind him.
Glenn McIntosh. His daughter Caitlin hung herself in the girls’
bathroom in her middle school when she was 12; she had been using
Paxil and Zoloft. She had been a straight-A student and had hoped to be
a veterinarian.
Eileen and Todd Shivak. Their 11-year-old son Michael had taken
Paxil. He was still alive. But he had tried to slash his wrists in class, had
run in front of a moving car, and was now afraid of doctors, teachers, and
police. “His peers think of him as a freak,” the Shivaks said.
One after another, more than 60 people spoke.
The medications had all been approved by the FDA years ago, starting
in 1988, for adults. Millions of people said the pills had saved them from
unbearable depression, anxiety, compulsive behavior, panic attacks, and stom-
achpains. Yet the medicines had been controversial almost from the start,
because of their ability to alter people’s moods and personality so power-
fully. Almost 13 years earlier the FDA had convened a similar meeting of
outside experts to discuss whether these pills led to suicidal tendencies in
adults; some of the same people now in the audience at the Holiday Inn
had been there, too. Back then, emotions had been so intense that the
chairman of the advisory panel had worn a bulletproof vest. The Church
of Scientology had condemned Prozac. A small study by two Harvard
researchers had seemed to show that people on Prozac were prone to
suicidal thoughts, and patients and their families had sued Eli Lilly and
Company, the manufacturer of the drug. In 1989 a Kentucky printing
press operator named Joseph Wesbecker had killed eight co-workers plus
himself with an assault rifle and wounded a dozen others a few weeks
flast_hawthorne.qxd 1/4/05 3:30 PM Page vii
INTRODUCTION vii
after he started taking Prozac. The FDA panel back then recommended
further research. Still, the FDA had decided that the drugs were beneficial
and safe for most people, based on the weight of scientific studies, and
should stay on the market.
For patients under 18, there was the added concern about how these
powerful chemicals might affect brains that were still developing. Chil-
dren’s brain chemistry is different from that of adults. So even if the drugs
were completely safe for adults and helped ease their depression, that did
not mean they were necessarily safe or helpful for children. Only Prozac
had ever been officially authorized as an antidepressant for this age group.
Studies on the other drugs (most of them belonging to a class known as
selective serotonin reuptake inhibitors, or SSRIs) had not clearly shown
that they worked significantly better than a placebo, or fake drug.
Nevertheless, doctors could legally prescribe any of the medications
for any age, and they did: The usage rate for children under 18 jumped
more than threefold from the early 1990s to 2001, according to a study
by Washington State University; the FDA reported that almost 11 mil-
lion prescriptions for that age group were written in 2002.
If there was no sure proof that the SSRIs were effective for youths, nei-
ther had any clinical trials on patients clearly and definitively demon-
strated that the medications increased the risk of suicide—or at least, that
was what the medical community believed. The companies that produced
the drugs, anxious not to lose this rich market, insisted that the families’
stories were only anecdotal—though heartbreaking—aberrations. What
made things even more difficult to sort out was that the patients taking
the pills were unhappy to begin with, by definition, and might have
tended toward suicide with or without the medications. It was also hard
to define what to consider a “suicide attempt.” Slapping yourself on the
head? Stabbing yourself with a pencil during an exam? For that matter,
even as the use of the antidepressants had been rising, the overall rate of
teenage suicide in the United States had dropped in the late 1990s. So
maybe the pills were actually helping to reduce the number of suicides.
The FDA had issued a warning specifically about Paxil in June 2003 after
the drug’s manufacturer, GlaxoSmithKline, submitted studies that showed a
higher level of what might be suicidal thoughts and incidents among adoles-
cents and younger children taking that drug, compared with patients taking
a placebo. (Most of the data about Paxil was not made public, and the New
York state attorney general, Eliot Spitzer, sued GlaxoSmithKline a year later
flast_hawthorne.qxd 1/4/05 3:30 PM Page viii
viii INTRODUCTION
for withholding the trial results.) In October came a stronger FDA warning
about the whole group of antidepressants. The warnings did not forbid doc-
tors from using these medicines, however. There still seemed to be no defin-
itive proof, either that the drugs led to an increased risk of suicide, or that any
drug but Prozac worked in youngsters. The FDA commissioned Columbia
University to conduct yet another study. Meanwhile, in December, the
British equivalent of the FDA took a stronger step, warning doctors in the
United Kingdom to shun all antidepressants but Prozac for children.
Most of the speakers at the Holiday Inn called for stricter labels on the
drugs, and some urged that only trained specialists, not generalists or
pediatricians, should be allowed to prescribe them. Some demanded an
outright ban. They wanted the FDA to protect their children. Yet many
of them were skeptical that the regulators would.
Dawn Rider exuded an air of competence and confidence; she was a tall
woman with a bright red jacket and long, thick, dark hair. Her 14-year-
old son had died after taking Prozac. Then her husband was given Paxil
to help him cope with the death, and his attempt to withdraw from that
drug destroyed their marriage, she told the crowd in the ballroom.
During the lunch break, I asked her what she hoped the FDA would do.
“I don’t have a lot of faith in the FDA,” she replied. “There’s too much
sway from the pharmaceutical industry.” She pointed particularly to the fact
that Mitchell E. Daniels Jr., a former Lilly executive, had been the White
House budget director and was running for the Republican nomination
for governor of Indiana. (He would later be elected.) And somehow it was
only Lilly’s drug Prozac that had been approved for children. “I was sitting
there, watching them [on the FDA panel] today. I almost noticed bored
expressions.”
“It’s clear that the FDA is a political entity,” Tom Woodward told the
three dozen panelists. “Under the Bush administration, the FDA is put-
ting the drug industry over the interests of the public.”
The FDA?
The Food and Drug Administration, the agency that was created in
1906 to make sure that Americans were never again poisoned en masse
the way Upton Sinclair described in his novel The Jungle? That poll after
poll has always shown is one of the most trusted arms of the entire
government?
For almost a century, the FDA has been the Good Housekeeping seal of
approval, the Nobel Prize, and Ivory soap (99 and 44⁄ percent pure) com-
100