When good drugs turn bad

In late September, when the arthritis drug Vioxx was pulled from the shelves by Merck & Co., Garret FitzGerald, chairman of the Department of Pharmacology in the School of Medicine, thought it a wise move.

And it hardly surprised him.

As the researcher who led Merck and other drug company-funded studies of both Vioxx and a similar drug, Celebrex, in 1999 and 2001, FitzGerald had discovered that a substance in the drugs that alleviates gastrointestinal distress also blocks a mechanism that prevents cardiovascular problems. At the time, he warned that Vioxx—a painkiller for people suffering from arthritis—could elevate a patient’s risk of heart attack or stroke.

With Vioxx now gone from the market, FitzGerald still wonders if people who were at a high risk for heart disease should have been warned before taking the drug—a drug that, FitzGerald says, can be very beneficial to those not in the risk group. “This is a very useful class of drugs. They work,” he says. “Should there be some sort of warning for people at a high cardiovascular risk? … How do we define the parameters at which people can use?”

In the recent Merck-funded study that led directly to this fall’s medical surprise, Vioxx was tested in people with a low risk of heart attack and stroke against a placebo. While the results showed an increase in the risk of a heart attack and stroke—something that FitzGerald takes seriously—he adds that it affected only a small number of people in the study.

FitzGerald’s studies have suggested these problems may extend to drugs similar to Vioxx, even though, he says, the Food and Drug Administration claims to have found insufficient evidence of that. “What I’ve been rather stunned by is the silence of the FDA,” he says. “The FDA obviously has to be our guarantor of cautious behavior.” In late October, the European Medicines Agency, a pharmaceutical safety organization based in London, decided to examine similar class drugs on the market or in development as a precautionary measure.

FitzGerald praises Merck’s decision to pull Vioxx from the market, but blasts Pfizer for sitting on one of its own studies that suggests that Celebrex has side effects similar to Vioxx. “It’s important to recognize that all of us have legitimate interests that we have to serve,” he says. “Hopefully in the academic sector, the only interest that we’re paid to serve is to tell the truth as we see it.”

Originally published on November 4, 2004