Healthy Skepticism Library item: 14387

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Keenan T.
Insider's new book chronicles drug Vioxx's fall from grace
Canwest News Service 2008 Sep 19
http://www.canada.com/victoriatimescolonist/news/life/story.html?id=466b7144-7389-4989-a310-74cb9c186421

Abstract:

How ‘super Aspirin’ became a drug safety catastrophe

Full text:

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fortunes rose and fell on its superstar Vioxx, which had reached $2.5 billion in annual sales before being voluntarily withdrawn from the market on Sept. 30, 2004.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.
Nesi’s carefully researched chronicle of the Vioxx saga, called Poison Pills: The Untold Story of the Vioxx Drug Scandal, was 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 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 an issue for some people but still concludes, after three years of poring over research, 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 baths, massage and physical therapy.
The Vioxx saga has moved into the hands of lawyers and with a vengeance. In a personal injury and wrongful death case in Texas, the widow of Robert Ernst was 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.”
“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.