What Ails The FDA? Payola

LET'S FACE it. The FDA is doing a poor job of ensuring that prescription drugs are safe and effective. It approves drugs that offer only minimal benefit, and then sometimes leaves them on the market long after they've been shown to be dangerous. Take Vioxx, the hugely popular arthritis drug that was taken off the market in September and now might return if an FDA advisory panel has its way. This is one of a class of drugs called COX-2 inhibitors (Celebrex and Bextra are the others) that are supposedly easier on the stomach than over-the-counter remedies like Advil or Aleve. It was rushed to market in 1999 even though it was never shown to be any better for relieving pain than the older drugs. The FDA then let it stay on the market for four years after a clinical trial showed it was probably more likely to cause heart attacks or strokes than to prevent stomach ulcers. It could have insisted that the manufacturer, Merck, immediately conduct a large-scale study to better define the risks and that the company add a warning in its direct-to-consumer ads that made Vioxx sound like a miracle drug (think Dorothy Hamill skating effortlessly to ''It's a Beautiful Morning"). The FDA is now implying it doesn't have that authority, but it does. Why is the nation's most important regulatory agency appeasing the pharmaceutical industry instead of protecting the public? One answer is that it is on the industry's payroll. Literally. Since 1992, by an act of Congress, drug companies pay the FDA ''user fees," which are earmarked almost entirely for speeding up drug approvals. Consequently, the agency now behaves as though that were its main job, not ensuring safety and effectiveness.