To the millions of Americans who suffer from chronic pain and arthritis, Vioxx seemed like a miracle. One of the most widely promoted and prescribed pain medications in the world -- used by more than twenty million people -- it 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 drug's 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 medical system, the failures of the Food and Drug Administration, and enormous profits made by a large pharmaceutical corporation at the potential cost of thousands of lives.
|Publisher:||St. Martin's Publishing Group|
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About the Author
Tom Nesi has been a pharmaceutical executive and medical industry insider for thirty years. He lives in Princeton, New Jersey.
TOM NESI has been a pharmaceutical executive and medical industry insider for thirty years. He lives in Princeton, New Jersey.
Read an Excerpt
Prelude: The Widow
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 59, 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 well -- and had few side-effects -- or so it appeared.
When Carol Ernst tells the story of her husband’s death, her eyes are sad, voice soft, words pensive. She still blames herself for Bob’s 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.”
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 62 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.”
An hour after the couple sank into bed, that May 6th night, Carol was awakened by Bob’s labored breathing. “At first I thought I heard him snoring,” Carol says, but her experience working in medical offices warned her otherwise. “When I woke up more, I realized it wasn’t snoring. It’s what’s called agonal breathing, those last few breaths.”
Paramedics arrived minutes later. They started vigorous cardiac pulmonary resuscitation. No response. Twenty minutes later, Bob Ernst was dead from cardiac arrest, brought on by an irregular beating of his heart.
Carol’s daughter, Shawna Sherrill was with her mother later that night when the 56-year-old woman broke down. When an Emergency Room doctor said her husband was dead, Ernst said she was devastated. “How can this be?” Carol cried. She thought her husband was the image of health. It was a question she asked over and over, to everyone from her doctor to the pathologist who performed an autopsy on her husband.
Carol found information on the Internet about the potential of the pill Vioxx to cause heart disease and contacted an attorney who agreed to take the case. The lawyer, Mark Lanier, a top trial attorney as well as a part-time Baptist minister with a down-home folksy style, finally put Carol on the witness stand in August 2005. Her calm, sincere and convincing story of her marriage and Bob’s death deeply struck the jurors. They also expressed deep anger at the secret memos about Merck’s knowledge of Vioxx and heart disease revealed during the trial.
Less than a week later, the twelve men and women delivered a stunning verdict that sent shock waves through the drug industry. Vioxx, the pharmaceutical giant Merck’s most popular pill, which the company had pulled off the market a year earlier because of a study linking it to heart disease, was responsible for the death of Carol Ernst’s husband.
The still grieving widow thought she had won the case. In fact, her fight and that of tens of thousands of others had only begun. Merck immediately appealed the verdict and said it would fight each case one by one.
* * *
The future and safety of medicine will be determined, not only by laboratory work and drug safety testing, but by the results of jury trials, legislation regarding drug company liability, and other complex judicial and regulatory decisions. The 2004 removal of the bestselling and highly touted pain pill, Vioxx, by Merck Corporation, and the resulting litigation, has involved at least 27,000 patients, and countless state and federal fraud probes. These investigations have generated controversy, made headlines, changed physician prescribing habits and caused anyone who has ever thought of taking a pill to question whether it is free from causing disastrous harm. The clashes will continue for years, if not decades, as the most critical issues in medicine flare in public.
Even the Supreme Court is now involved and justices are staking out their positions for one of the most important medical opinions of the new century. In a related case, Justice Stephen Breyer asked who should make the decisions that will determine whether a drug is on balance going to save people or, on balance, going to hurt people. “An expert agency on the one hand or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt and don’t see those who need the drug to cure them?”
The Vioxx legal battles involve the collision of two titanic forces. On the one side is the pharmaceutical giant Merck, which has spent close to two billion dollars on legal fees to try cases and limit financial losses. On the other side, patients, their lawyers, and grand juries are still pouring through millions of secret corporate documents and listening to testimony, attempting to decipher the odd and tumultuous events surrounding the development of Vioxx and other pills in a similar class of drugs.
Despite proposed legal settlements with injured parties of $4.85 billion and Merck's agreement to pay the government $671 million to settle claims it overcharged and bribed doctors for a number of medications, the Vioxx story continues with just as much passion and zeal as ever, with many astonishing new revelations yet to come.
"Merck still has Vioxx lawsuits coming from all directions including Canada -- from patients in 18 foreign countries, from health providers and consumers who paid for Vioxx and want their money back, and from stockholders looking to recoup losses," reports Linda Johnson of the Associated Press.
Furthermore, thousands of former Vioxx users who claim other injuries -- dangerous chest pain, abnormal heart rhythms, and similar conditions -- are excluded from the settlement and many of their cases continue.
Scientists and attorneys are also looking into the frightening possibility that Merck never fully revealed the dangers of Vioxx with regard to patients with memory loss (cognitive impairment) and mild Alzheimer's disease.
Predicting what will happen next in the serpentine tale of Vioxx is impossible. The story of this drug, which began in laboratories in the early 1990s, has all the earmarks of a medical Godfather story -- a virtual war between the largest drug companies in the world, threats to investigators, manipulated research disputed by the very medical journals that published them, “incomprehensible” press releases, and endless lawsuits -- one involving an attempt by Merck to censor a Spanish medical bulletin. Careers rose and fell and billions of dollars hung on the words of investigators worldwide.
Dr. Jerry Avorn, professor of medicine at Harvard Medical School, who has studied the deceptions and dangers of the pharmaceutical industry for years, was surprised by Merck's secret e-mails and memos presented at the Ernst trial. "Even as a seasoned observer of drug company affairs, I have been surprised by the way Merck handled the emerging evidence about cardiac risk," Dr. Avorn said.
Nonetheless, Carol Ernst's lawyer, Mark Lanier, was blasted by everyone from physicians to newspaper columnists for winning the trial by twisting the facts and relying on nothing but "an ignorant jury of hicks," despite the fact that his witnesses included some of the best known physicians and scientists in the world. Even as the Texas jury was deliberating, Merck's lead attorney, Gerry Lowry, said, "If he [Lanier] had any evidence Vioxx causes arrhythmia, this case would have been over three weeks ago."
A few months after the trial verdict, CNBC broadcast a debate between Lanier and Richard Epstein, the James Parker Hall distinguished service professor of law at the University of Chicago and a senior fellow at the Hoover Institute. The professor had written an op-ed piece for The Wall Street Journal and said that “physicians lamented” the fact that they could no longer use the drug.
Many leading newspapers, including The Washington Post, also mocked the Ernst trial. In an editorial entitled "The Vioxx Hex," the Post wrote that the "Texas jury awarded $253.4 million to the widow of a man who died of a heart attack triggered by arrhythmia, which is not a condition Vioxx has been proven to cause." The Post said the jury was confused about the medical evidence.
On September 12, 2006, a year after the trial, The Journal of the American Medical Association issued a public health bulletin and published a study from the Harvard School of Public Health, Brigham and Women's Hospital, and Harvard Medical School clearly demonstrating that Vioxx "increased risks of kidney [kidney] events and arrhythmia events [heart rhythm disorders]." Eric Ding, a coauthor of the study, noted that the evidence of kidney damage was evident by the year 2000, one year before Bob Ernst died. The Harvard study further showed a link between Vioxx and arrhythmia by the year 2004. This evidence had been verified one year before the campaign by many connected with the Ernst trial as peddlers to “junk science.”
Eric Ding says the evidence about the Vioxx/arrhythmia association "should have been disclosed much sooner . . . because publication is very slow.” The study authors stated that Vioxx use was associated with increased risk of arrhythmia and damage to the kidneys. Higher doses and longer duration of Vioxx treatment contributed to the adverse effects. Among Lanier's expert witnesses were Dr. Benedict Luchessi, M.D., Ph.D., inventor of the heart pacemaker and one of the world's best known authorities in cardiovascular pharmacology and professor at the University of Michigan Medical School. Luchessi actually helped train some of the Merck researchers working on Vioxx. Also among the experts for Carol Ernst was Dr. Isaac Wiener, cardiologist and co-director of the Cardiac Arrhythmia Center at UCLA Medical Center in Los Angeles.
The way many media reports came out, Carol Ernst was not a victorious widow; instead, she and the jury that heard her were portrayed as menaces to pharmaceutical innovation and the scientific method itself.
Wrote Professor Epstein, "[I'm] a scared citizen who is steamed that those ‘good people’ have imperiled [my] own health and that of [my] family and friends. Nobody of you have ever done a single blessed thing to help relieve anybody's pain and suffering. Just do the math to grasp the harm you've done . . . Your verdict says you think that the American public is really better off with just hot-water bottles and leftover aspirin tablets."
Americans have hardly returned to hot water bottles, and it seems odd that one of the nation's leading attorneys would be frightened by a 60-year-old widow and a handful of Texas citizens. But Merck was just beginning to fight and had in its employ some of the largest law firms in the world, and a war chest of over a billion dollars. The company's tactics in the trial and subsequent statements made it clear Merck was playing "hard-ball" and would fight each case brought against it, one by one. Nor did the pharmaceutical company ever concede any wrong doing.
Contradicting Dr. Avorn and others, Merck argued that it gave adequate notice of the heart risks of Vioxx in the drug’s label or product description that accompanies the drug. Somehow, the warning never made it into any of the thousands of television commercials for Vioxx that blanketed the United States. Since these advertisements are monitored by the Food and Drug Administration, it should cause great concern about giving so much power to this federal agency, as Justice Breyer suggests.
Senator Charles Grassley, (R) Iowa, former chairman of the Senate Finance Committee, who conducted the hearings on Merck, summarized: “The FDA was also negligent in the Vioxx case . . . those running the nation’s public safety agency repeated dismissed the concerns of their own scientists and seemed to do everything possible to keep the public in the dark about the emerging problems with Vioxx.”
Despite Merck’s power and finances, many lawyers and physicians still press on, perhaps inspired by the sentiment of Carol Ernst after her trial victory. She felt the fight was not just for her, but that every man and woman deserved a right to know what a medication could do to them. Her husband, Bob, would never have touched Vioxx if he had known about its true risks.
Copyright © 2008 by Tom Nesi. All rights reserved.