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Keep Our Families Safe: Consumer News For Families
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Safer Drugs Now

[Column 331, April 4, 2005] | Archived Columns

By Todd A. Smith*

On Sept. 25, 2004, Monty Huggins of east Tennessee lost his otherwise healthy 39-year-old wife, Janet, when she died suddenly of a heart attack. Janet had been prescribed Vioxx for help with her rheumatoid arthritis and had been taking it for only a month when she died.

It turns out that Vioxx was more dangerous than its manufacturer, Merck, let on. In fact, the company knew as early as November 1996 that there was an increased risk of stroke associated with its blockbuster drug.

But instead of informing doctors, the company trained its field staff to "dodge" doctors' concerns about the cardiovascular risks of Vioxx, according to an internal document titled "Vioxx Dodge Ball." Merck eventually withdrew Vioxx from the market. Monty Huggins remembers hearing about it on the news the morning he was getting ready for Janet's funeral. By then, say FDA scientists, Vioxx may have caused as many as 140,000 Americans to develop serious heart disease.

So what went wrong?

A look at real, internal documents from the company—documents like "Vioxx Dodge Ball"—shows that Merck consistently encouraged deceptive marketing of its blockbuster drug. And the company is by no means the first in the pharmaceutical industry to hide dangerous side effects from the public and the FDA.

In the now-infamous case of Fen-Phen, diet drug manufacturers aggressively marketed the drug combination to millions of consumers despite knowing the deadly risks. The manufacturer, Wyeth, had successfully used deceptive labeling to silence critics for over two years before the FDA took action in 1997.

It's the same story with PPA, an ingredient used in over-the-counter cold medicines like Triaminic. The ingredient was said to cause strokes in young women in the 1970s, but pharmaceutical executives waited more than 20 years to substitute another ingredient because of costs and, even then, they didn't act until the FDA "requested" that they do so.

Thanks to a handful of public interest attorneys, you can now see for yourself the "smoking gun" documents from the pharmaceutical industry that show what these companies knew and when they knew it about the risks of their products.

A new web site, www.saferdrugsnow.org, outlines for consumers the series of company cover-ups and regulatory failures that took place well before the belated recalls of drugs like Vioxx, anti-depressants, PPA, and Fen-Phen.

The Dog that Didn't Bark

These internal documents show a disturbing pattern of deceptive marketing tactics and ineffective regulation. It is the mission of U.S. Food and Drug Administration (FDA) watchdogs to make noise when the drug companies put profits before people. But in the case of Vioxx, the watchdog simply didn't bark. One concern is that many of the scientists that review drugs for the FDA have conflicts of interest. For example, almost a third of the FDA panel members who voted in February 2005 to let Vioxx stay on the market recently consulted for the pharmaceutical industry, according to a New York Times investigation.

Efforts to Eliminate the Last Line of Defense

It is difficult to understand, given what we know now about the marketing practices of the pharmaceutical industry, why anyone would attempt to make it harder for injured patients to hold companies like Merck accountable for their actions. But one bill gaining steam in Congress would almost completely immunize the manufacturers of dangerous and deadly drugs from being punished in the courts-the so-called medical malpractice bill.

So what's a patient to do?

Ask questions. Before taking a new drug, don't hesitate to ask your doctor tough questions about the risks and side effects. Ask him or her about the benefits and risks of newer drugs as opposed to older ones. The FDA now says many of the patients put at risk from Vioxx would have been better off on plain-old over-the-counter painkillers.

Be an informed consumer. See for yourself how the drug industry has manipulated doctors and the public at www.saferdrugsnow.org.

And finally speak up. Be sure to let your elected officials know that Americans deserve safe and effective drugs. Let Congress know that justice for the Huggins family and for all the victims of medical errors and dangerous drugs means corporations that deceive the public and put all of us at risk must be held accountable.

For more health and safety information and tips, please visit AAJ's "Keep Our Families Safe" Web site at http://www.justice.org/private/kofs/index.aspx.