The Goldilocks test

April 17, 2005

THE FOOD and Drug Administration is having trouble finding the Goldilocks formula for determining which pharmaceuticals should be approved for commercial use.

During the outcry last fall after the pain reliever Vioxx was pulled off the market by its manufacturer, critics complained that FDA regulators failed to do the job themselves because they were too lax. In the wake of the FDA's decision this month to withdraw approval of a Vioxx competitor, Bextra -- and order stricter safety warnings on some over-the-counter pain relievers -- came complaints that the FDA was overcompensating the other way.

It seems unlikely the embattled agency will be able to instill confidence that its judgment is "just right" until Congress changes a structure that encourages FDA officials to get too cozy with the drugmakers they regulate. In fact, the agency's recent vigilance is seen in some quarters as a gesture to convince Congress that such an overhaul isn't necessary.

The lawmakers shouldn't fall for it.

The FDA's decision to yank Bextra may well have been just right. Like Vioxx, the pain reliever has been linked in studies to increased risk of heart attacks, strokes and a potentially fatal skin disease. The agency reasoned that the pain-relieving benefits did not justify ignoring those risks because patients can take a similar drug, Celebrex.

But the appearance of a wildly swinging pendulum in response to public clamor -- enhanced by an advisory panel's split decision last week on silicone breast implants -- isn't reassuring. Creating an independent office within the FDA to review the safety of drugs already approved for market by a different team of regulators would help restore the perception of balance.

Tinkering with science to produce a desired result is a widespread practice by regulatory agencies under the Bush administration's control. The president received strong political and financial backing from most industries in anticipation that he would cut the red tape that impedes their business. Stakes at the FDA are particularly high, though, and personal to every American because medicine plays a huge role in maintaining health and quality of life.

Doubts about the agency's judgment are heightened by signs that it is rife with internal turmoil. That impression was reinforced last week by an anonymous note to a Senate committee containing allegations of personal impropriety against acting director Dr. Lester M. Crawford, whom Mr. Bush nominated to officially take over the top job.

Meanwhile, the dietary supplement industry has been emboldened by a federal court decision overturning the FDA's ban on the herbal stimulant ephedra, blamed for the deaths of young athletes. Further challenges to the agency's authority are likely.

All drugs and perhaps many dietary supplements pose some risk. The FDA can't and shouldn't pretend that it can provide absolute protection. But the agency must convince a wary public that it seeks a balance between benefit and risk according to scientific, rather than political, considerations.

Putting distance between regulators who approve products and those who monitor the safety record thereafter would do much to bolster public confidence.

Baltimore Sun Articles
Please note the green-lined linked article text has been applied commercially without any involvement from our newsroom editors, reporters or any other editorial staff.