Doctors Ponder FDA Drug Controversy

Nov. 22, 2004 — -- Startling testimony by an FDA drug safety reviewer about five popular medications has the medical world buzzing about how tightly the agency should be regulating new medications.

In his Senate testimony last Thursday, FDA reviewer Dr. David Graham may have managed to scare thousands of unknowing patients as well.

Graham warned that Americans are "virtually defenseless" if other medications are deemed unsafe after having been approved by the Food and Drug Administration. He named five commonly prescribed medications already approved by the agency that he believes warrant re-evaluation.

These medications -- Accutane, an acne medication; Meridia, a weight-loss agent; Bextra, a pain reliever in the same class as Vioxx; Crestor, an anti-cholesterol medication; and Serevent, an asthma drug -- already passed rigorous clinical testing before being approved for use by the FDA.

Some in the medical world believe the agency needs to use the recent controversy over Vioxx, the arthritis drug that was found to increase risk of heart disease and was subsequently withdrawn by Merck, as a sign that it needs to become even more aggressive in the way it evaluates drug safety.

"With Vioxx in particular we've had a disaster of substantial proportions, and we still have important questions to answer on drugs that are still in the pipeline," said Thomas Moore, a health policy analyst for the George Washington University's Center for Health Services and Policy in Washington.

"The FDA absolutely must become strict with the way it handles medication safety," he said.

But others argue that there is more harm in tightening regulations than meets the eye.

"The far greater danger is if the Vioxx episode results in [the] FDA slowing down the approval of new therapies," said Sam Kazman, general counsel for the Competitive Enterprise Institute in Washington, D.C.