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News & Reviews
The first book to appear on Vioxx - the biggest pharmaceutical scandal of our time.
Poison Pills:
The Untold Story of the Vioxx Drug Scandal
by Tom Nesi
Veteran pharmaceutical executive and medical industry insider Tom Nesi paints a frightening portrait of high-stakes medical Russian roulette with his explosive examination of one of the greatest medical scandals of all time, the Merck & Co. Vioxx fiasco. In his new book, Poison Pills: The Untold Story of the Vioxx Drug Scandal – the first work to appear on the Vioxx uproar – Nesi goes behind the scenes to probe what many consider the greatest drug safety catastrophe in history. He has poured through thousands of pages of secret internal documents that were subpoenaed in court cases, video footage, and court testimony. Nesi also conducted extensive and exclusive interviews with the myriad scientists, marketers and physicians who had special knowledge of what was the fastest growing and most popular pill in the world: Vioxx.
Poison Pills tells the spell-binding story of what Vioxx’s manufacturer, Merck & Co, knew and when concerning the pill’s potentially dangerous and lethal side effects. Nesi’s engrossing and thoroughly researched book also delves into the inner workings of the Food and Drug Administration, as well as certain universities and laboratories across the world, many of which were at the epicenter of the research and development of Vioxx. In many cases, these institutions would have been in the position to know early on of the possible dangers linked to taking the drug. Nesi also intersperses amusing historical and contemporary stories about the pharmaceutical business to help the reader put the story into perspective. In all, though, the reader will come away shocked at what the public was told about Vioxx, and will certainly be angered to see how this sordid "Big Pharma" story all played out.
Nesi’s inspiration for this book stemmed from a tragic personal loss: his wife Susan died after a battle with brain cancer in 2002. His consternation regarding her treatment by the "medical establishment" caused him to reflect on his own life and career, a career that included himself as part of that "medical establishment." The loss of his wife gave Nesi time to reflect on all aspects of his life and career. The more he looked into them, the more his views, goals, and dreams changed forever.
In re-examining his profession, and coming across the news that started to break about Vioxx’s possible harmful side effects, Nesi believed he had found the perfect story.
With his insider connections and personal experience working in the world of "Big Pharma," he had the opportunity to tell people about the insidious workings of companies who put profits way out in front of the health and well-being of those they have promised to help.
His experiences writing the book both astonished and angered him. He encamped daily at the National Library of Medicine and the Princeton University Firestone Library coursing through historical documents. Research documents, including some from Merck’s own archives, opened his eyes to many of the myths surrounding the development of modern medicine. He was most surprised to find that many of the popular "exposes" about pharmaceutical companies had serious errors, misconceptions or conflicts of interest. He wanted to write something completely new about the industry, as only someone who actually worked in it would be able.
With his painstaking work on Poison Pills now finished, the reader will understand how millions of Americans who suffered from chronic pain and arthritis viewed this new medicine, Vioxx, as a miracle. No drug before or after was as widely promoted and prescribed. It quickly became the number one pain medication in the world – used by twenty million Americans alone – and soon was endorsed by not only the medical establishment but by prominent celebrities in the sports world. With annual sales of $2.5 billion it was the fastest selling drug in pharmaceutical history. But when it was all over, after the revelations, lawsuits, and Congressional investigations, the pain and suffering and possible loss of life due to its powerful and potentially deadly side effects, Merck & Co agreed to settle some 50,000 law suits to the tune of $4.85 billion, and hundreds of millions of dollars more in government fines for deceptive marketing practices. The hope for miracle was anything but.
No book will make the reader reexamine the pharmaceutical industry like Poison Pills. And no reader will – or should – ever be as accepting of the promotion of a wonder pill without a healthy dose of skepticism.
ABOUT THE AUTHOR
Tom Nesi is a “patient advocate” for the FDA. He has been a pharmaceutical executive and medial industry insider for thirty years, and was a consultant for Merck for nearly ten years. He lives in Princeton, New Jersey.
Poison Pills: The Untold Story of the Vioxx Drug Scandal
By Tom Nesi
Publication Date: September 16, 2008
Price: $25.95, Cloth
Pages: 304
ISBN # 0-312-36959-X
We Would Appreciate Receiving Two Tear Sheets Of Any Reviews Or Mentions.
A Thomas Dunne Book
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New book documents Vioxx's fall from grace
Tom Keenan, For The Calgary Herald
Published: Thursday, September 04, 2008
If medications had personalities, Vioxx would be that macho guy in a Hummer who just took your parking space (and the one next to it), who then gets out, smiling and talking on his cellphone.
Touted as a "super aspirin," Vioxx was, for a time, the No. 1 pain medication in the world, backed by aggressive marketing to physicians and the public.
How it got to be "the single greatest drug safety catastrophe in the history of the world," in the words of a U.S. Food and Drug Administration official, is a fascinating story that's about to be told for the first time in a new book.
Its author, Tom Nesi, is a medical industry insider, having been director of public affairs of the Squibb Corp., not far from the New Jersey headquarters of Merck & Co. Inc.
Merck's fortunes rose and fell on its superstar Vioxx, which had reached $2.5 billion in annual sales before being voluntarily withdrawn from the worldwide market on Sept. 30, 2004.
That day, Dr. Peter Kim, then president of Merck Research Laboratories, announced that data from clinical trials "suggested an increased risk of confirmed cardiovascular events beginning after 18 months of continuous therapy."
In other words, the drug that was treating your arthritis pain might give you a fatal heart attack.
Imagine the scene when a food product, like tainted meat or spinach, is pulled off the shelves, except in this case there are pharmacists yanking bottles of pills, patients fretting about what they're ingesting and doctors worrying about having done more harm than good by prescribing what was supposed to be a miracle drug with minimal side-effects.
Nesi's carefully researched chronicle of the Vioxx saga, called Poison Pills: The Untold Story of the Vioxx Drug Scandal, has just been published by New York-based St. Martin's Press.
In a phone interview from his New Jersey home, the former pharmaceutical executive is surprisingly opposed to taking drugs for pain. He says that men, in particular, need to "listen to our bodies."
He even reports that "pain is good. Vioxx researchers are now saying that pain is an important indicator of what your body is sensing and that dulling it isn't a great idea."
What about that tension headache or those aching muscles?
"No harm in taking an aspirin after a tough workout to make you feel better," Nesi says. "But taking a painkiller like Vioxx every day because you are in pain is not a good thing."
He acknowledges that pain is a legitimate issue for some people but still concludes, after three years of poring over research documents, including some from Merck's own archives, that "anyone with a chronic pain related condition, including athletes, should develop methods to control pain that do not involve medication."
He recommends warm baths, massage and physical therapy.
The Vioxx saga has moved into the hands of lawyers and with a vengeance. A personal injury and wrongful death case in Texas saw the widow of Robert Ernst awarded $253.4 million.
Nesi uses that family's tragic story to open his book. He reports that when Carol Ernst speaks of her late husband, who was a healthy 59-year old triathlete, "her eyes are sad, voice soft, words pensive."
"She still blames herself for Bob's fatal heart attack," writes Nesi, because she "was the one who told him to ask about Vioxx."
Merck fought that case, and all Vioxx suits, as if the future of the company depended on it, which Nesi says it does. In May, a court in Texas reversed the Ernst decision, finding "the evidence (against Vioxx) to be legally insufficient on the issue of causation," and ruling that "the appellee (Carol Ernst) takes nothing."
Still, Merck is offering to settle some 50,000 outstanding lawsuits for $4.85 billion, plus hundreds of millions of dollars in fines for deceptive marketing practices.
In Canada, a class action has been certified in Ontario and a national team of law firms is soliciting people who may have been hurt by Vioxx (see vioxxnationalclassaction.com).
Merck's lawyers are fighting the certification of the class in Canada, arguing in a press release that "heart attacks are unfortunately common in the population and caused by many different risk factors."
The whole Vioxx mess changed the way many people, including Nesi, think about the pharmaceutical industry.
"Vioxx is a cautionary tale," he says. "The drug wound up potentially killing tens of thousands.
"Drug companies spend hundreds of millions of dollars in ads and marketing to convince doctors and lay people of the efficacy and safety of their products.
"But wait. Ask your doctor to give you older, more proven pills, before spending big bucks on new ones. Don't be fooled by 'free' samples. These are the most expensive drugs you are likely to take."
Even if they win every single Vioxx case, Merck's problems may not be over.
Just as unexpected heart attacks darkened the future of Vioxx, a new report suggests a possible link between Merck's much-hyped cholesterol-lowering drug Vytorin and prostate, gastrointestinal and skin cancers.
While the data is still inconclusive, a just-published editorial in the prestigious New England Journal of Medicine calls for caution, noting that the increased rate of cancer "should not be assumed to be a chance finding until further data are in."
It also admits that "physicians face uncertainty about how to act on the information."
If the experts are baffled, what's an ordinary patient to do?
"I would certainly not take a new drug until at least two years on the market," advises Nesi, "unless it is very, very necessary. Many new drugs are no better than older ones and are more expensive."
And, like thalidomide, which caused birth defects back in the 1950s, bad side-effects may take years to be discovered.
Still we seem to want our "miracle drugs" on the market as quickly as possible.
"Take two Aspirins and call me in the morning" may be history as medical advice, but "get a sports massage, exercise more and eat a healthier diet" may come into vogue as the smartest, and certainly the safest, thing a doctor can tell a patient.
Tom Keenan, I.S.P., is an award-winning science writer, professional speaker and professor at the University of Calgary.
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Dramatis Personae
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David Anstice
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President, Human Health – The Americas; member
of the Management Committee, Merck & Co (now formerly President)
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Francesca Catella-Lawson, MD
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Assistant Professor, Department of Medicine,
University of Pennsylvania (left U. of Penn to take
the position of Associate Director, Clinical
Research Gastrointestinal Group, Clinical Sciences,
Merck research Laboratories)
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Garret A. FitzGerald, MD
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Robinette Foundation Professor of Cardiovascular
Medicine, Department of Medicine, University of
Pennsylvania; Chairman, Department of
Pharmacology, University of Pennsylvania
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James Fries, MD
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Professor of Medicine, Stanford University
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Kenneth C. Frazier
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Senior Vice President and General Counsel;
member of the Management Committee, Merck &
Co. (now formerly Senior Vice President and
General Counsel; member of the Management Committee, Merck and Co., was promoted to Executive Vice President and President, Global Human Health, Merck & Co
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Raymond V. Gilmartin
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Chariman of the Board, President, and Chief
Executive Officer; member of Management
Committee, Merck & Co. (later resigned as
Chariman of the Board, President, and Chief
Executive Officer; and member of Management
Committee, Merck & Co.)
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David J. Graham, MD MPH
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Associate Director for Science, Office of Drug
Safety, U.S. Food and Drug Administration
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Peter S. Kim, MD
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President, Merck Research Laboratories, member of Management Committee, Merck & Co.
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Philip Needleman, Ph. D.
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President, Searle Research and Development, Monsanto Company
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Bruce Psaty
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Professor of Medicine & Epidemology, University of Washington
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Alise Reicin, MD
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Senior Director, Pulmonary-Immunology Group, Merck Research Laboratories, Merck & Co. (later promoted from Senior Director, Pulmonary-Immunology Group, Merck Research Laboratories, to Vice President of Clinical Research at Merck & Co.)
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Edward M. Scolnick, MD
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President, Merck Research Laboratories; member of Board of Directors; member of Management Committee, Merck & Co. (later retired from his position as President, Merck research Laboratories; member of Merck’s Board of Directors; and member of Management Committee)
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Deborah Shapiro, MPH
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Director, Biostatistics and Research Division Sciences, Merck Research Laboratories, Merck & Co.
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Eve E. Slater, MD
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Assistant Secretary of Health, U.S. Department of Health and Human Services (2001-2003); Senior Vice President, Corporate Public Relations and Regulatory Liaison, Merck & Co. (left the Department of Health an d Human Services one year after taking the position. She is now Vice President of World Wide Policy, Pfizer Corp)
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Eric Topol, MD
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Chairman of Cardiovascular Medicine, Cleveland Clinic Foundation
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John L. Wallace, Ph. D.
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Professor of Pharmacology and Therapeutics, University of Calgary, Alberta, Canada
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Frank A. Wolheim, MD
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Editor, Rheuma 21; former Chairman of the Department of Rheumatology, University of Lund, Sweden
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Lester Crawford
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Given the title of FDA Commissioner and confirmed by the Senate. He resigned three months later and a year later was indicted on criminal charges of conflict of interest
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