• Federal regulation: Drug withdrawal Federal regulation: Drug withdrawal By the St. Louis Post-Dispatch – October 4, 2004 When pharmaceutical giant Merck unexpectedly recalled its blockbuster arthritis drug Vioxx last week, its stock took a beating. It dropped nearly 27
• Federal regulation: Drug withdrawal
Federal regulation: Drug withdrawal
By the St. Louis Post-Dispatch – October 4, 2004
When pharmaceutical giant Merck unexpectedly recalled its blockbuster arthritis drug Vioxx last week, its stock took a beating. It dropped nearly 27 percent before the end of business.
But the organization whose stock is really in free fall is the U.S. Food and Drug Administration. It was once among the world’s most respected regulatory agencies. No longer.
Last week’s Vioxx recall is yet another in an embarrassing series of missteps in which the FDA had failed to protect consumers. The agency knew about the problems, but it failed to act decisively.
Four years ago, Merck gave federal regulators a study showing higher rates of heart problems in people taking Vioxx. A year later, a doctor at the Cleveland Clinic conducted a review of all published studies on the drug. Patients who took it had a five-fold increase in heart attacks and stroke, he concluded.
That was in 2001. The following year, the FDA required that a warning be added to the drug’s labels. But except for an initial flurry of publicity, most patients taking Vioxx and similar drugs never heard about those problems.
Instead, they heard hundreds of millions of dollars in so-called direct-to-consumer advertising. Those ads touted Vioxx and Celebrex, a similar drug made by Pfizer, as breakthrough medicines for arthritis. In fact, those drugs are no more effective than over-the-counter remedies at relieving pain, yet they cost substantially more. Their advantage is that they’re believed to reduce the risk of ulcers and serious stomach problems. But as many as three-quarters of those taking Vioxx and Celebrex are not at risk for those problems.
Thanks to the ads, those drugs became blockbusters; Vioxx alone brought in $2.5 billion during 2003. It is estimated that 2 million people around the world were taking it at the time it was recalled, 1.3 million of them in the United States. Celebrex has not been shown to have problems, although further study is warranted.
The Vioxx recall comes just weeks after congressional hearings on antidepressants and young people. During those hearings, the FDA was forced to admit that it squelched a staff recommendation to warn patients about an increased risk of suicide in young people and adolescents.
In an effort to speed lifesaving drugs to the market, former President Bill Clinton urged the FDA to be less adversarial and more of a “partner” with drug companies. But in a little more than 10 years, safety concerns have caused at least nine drugs to be withdrawn from the American market.
If that’s not enough to trigger a full-scale congressional review of the FDA, consider what preceded the decision to take Vioxx off the market.
It wasn’t pressure from federal watchdogs; there was none. Merck acted only after being hit with a class-action lawsuit.
