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Who Do You Trust: FDA, Drugs, Doctors?

Posted on: Wednesday, 9 March 2005, 09:00 CST

Some people were surprised last month when a panel of Food and Drug Administration advisers recommended that the pain medications Celebrex, Bextra and Vioxx be kept on the market. Although there are risks associated with the drugs, the experts said, they don't outweigh the benefits.

The vote margin was wide for Celebrex, narrow for Bextra and very narrow for Vioxx. The controversy about the class of drugs known as Cox-2 inhibitors began last year when Vioxx was shown to cause heart problems in some patients.

The advisory panel found Celebrex to be safe in small doses, was critical of the limited research on Bextra, and concluded that even Vioxx has its place.

The advisers said the drugs should carry prominent label warnings. Patients should try to control pain with more established medicines before turning to Cox-2 drugs. And studies designed to gauge risk should be ongoing. (Previous studies were aimed primarily at developing new uses for the drugs rather than at risk.)

Critics have expressed doubt about the independence of the commission members, noting that some of them are too close for comfort to drug companies. Even if that is the case, there is some value in their advice. It could help doctors make good choices about which patients could be harmed or helped by the drugs.

Doctors sometimes complain of being pressured by patients on the one hand and persuaded by sample-toting drug salesmen on the other. It apparently can be hard for doctors to resist the pleadings of patients who've been won over by commercials for prescription drugs - - especially if all the doctors know about the drugs is what the manufacturers have told them.

The FDA should take seriously the recommendation of its panel regarding labeling and continuing risk trials. We do not believe advertising of drugs should be curtailed, although it should be carefully monitored to make sure the messages conveyed are accurate.

As the agency considers the advice it has received, another panel is forming: an independent oversight board to monitor real-world experience with FDA-approved medicines.

This shift toward long-term study and continuous review could prevent scenarios in which deadly side-effects go undiscovered for years.

Like the panel that issued the Cox-2 report, the FDA's new drug safety board should routinely make its findings public. For too long, the FDA has seemed too cozy with drug companies and not forthcoming enough with the public. That needs to change.

Source: South Bend Tribune

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