Thomas Nesi - Poison pills; The untold story of the Vioxx drug scandal

who suffer from chronic pain and arthritis, Vioxx seemed like a miracle. One of the most widely promoted and prescribed pain medications in the worldused by more than twenty million peopleit was endorsed by the medical establishment and celebrities such as Olympic champion figure skater Dorothy Hamill. With annual sales of $2.5 billion, Vioxx became a pharmaceutical bonanza before being abruptly taken off the market in September 2004, after it was revealed that it led to an increased risk of heart-related disease and death.

Drawing on internal documents, video footage, court testimony, and exclusive interviews, as well as three decades of experience inside the medical industry, Tom Nesi tells the dramatic story of what the drugs manufacturer, Merck, knew and when. It is a compelling narrative of business and medical science run amok, with a cast of characters ranging from those at the highest levels of the multibillion-dollar pharmaceutical industry to research scientists, marketers, and drug company sales reps. Here also are accounts from physicians, lawyers, financial analysts, and patients and their families whose lives have been forever altered by Vioxx.

Set against a fascinating history of the origins of the modern pharmaceutical industry, Poison Pills is a shocking tale that involves the breakdown of the United States

The Untold Story of the Vioxx Drug Scandal

Tom Nesi

St. Martin s Press New York

THOMAS DUNNE BOOKS.

An imprint of St. Martins Press.

All rights reserved. Printed in the United States of America. For information, address St. Martins Press, 175 Fifth Avenue, New York, N.Y. 10010.

www.thomasdunnebooks.com

www.stmartins.com

Library of Congress Cataloging-in-Publication Data

Nesi, Thomas J.

Poison pills : the untold story of the Vioxx drug scandal / Tom Nesi. 1st ed. p. cm.
Includes bibliographical references and index.
ISBN-13: 978-0-312-36959-0 (alk. paper)
ISBN-10: 0-312-36959-X (alk. paper)
1. RofecoxibSide effects. 2. Merck & Co. I. Title.
RA1242.R64N4 2008 362.17'82dc22
2008019633

Today... [we] are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world. We are talking about a catastrophe that I strongly believe could haveshould havebeen largely or completely avoided. But it wasnt, and over 100,000 Americans have paid dearly for the failure.

David J. Graham, M.D., MPH, Associate Director for Science, Office of Drug Safety, U.S. Food and Drug Administration, testifying before the U.S. Senate Finance Committee, November 18, 2004, on the harm caused by Vioxx

The very essence of civil liberty certainly consists in the right of every individual to claim the protection of the laws, whenever he receives an injury. One of the first duties of government is to afford that protection. The government of the United States has been emphatically termed a government of laws, and not of men. It will certainly cease to deserve this high appellation, if the laws furnish no remedy for the violation of a vested legal right.

William Marbury v. James Madison, Secretary of State of the United States , Supreme Court of the United States, 5 U.S. 137, February 1803 Term, opinion of the court delivered by Chief Justice Marshall

Carol Ernst remembers with vivid clarity the death of her husband, Bob, on May 6, 2001. After a sentimental dinner at the Olive Garden restaurant in Keene, Texas, the same spot where the two had gone on their first date, the couple returned home and went to bed. The meal had been healthy as usual because Bob was a triathlete, and though he was fifty-nine, was in better condition than most people half his age. The only health problem he suffered from was pain in his hand that was being treated by a new drug called Vioxx. The pill seemed to work welland had few side effectsor so it appeared.

When Carol Ernst tells the story of her husbands death, her eyes are sad, voice soft, words pensive. She still blames herself for Bobs fatal heart attack. I feel very guilty at times. I feel like if Bob had never met me, he might still be alive because I was the one who told him to ask about the Vioxx.1

This was the second marriage for both Bob and Carol. Ms. Ernst had been alone for fifteen years after her first marriage had ended, and considered herself blessed that she had met and fallen in love with this tall, well

built man who could bike-ride sixty-two miles in the Fort Worth, Texas, heat, barely breaking a sweat. He worked at the local Wal-Mart and led a fitness class called Young at Heart.