November 29, 2004

Drug Safety Concerns

A STAMP of approval by the Food and Drug Administration used to instill the highest confidence.

If the FDA ratified use of a medicine, the public assumed it was safe - and the health benefits from taking the drug outweighed any risks.

But recent drug recalls and warnings have shaken trust in this federal regulatory agency.

In just the last few months, the public has learned that popular antidepressants for adolescents can trigger suicidal behavior and that the painkiller Vioxx doubles the risk of heart attacks and strokes when taken for longer than 18 months.

Another top-selling drug, the cholesterol-lowering Baycol, was pulled from shelves a few years ago after it was linked to a sometimes fatal muscle paralysis.

In all these cases, the FDA has come under fire for its apparent slowness in responding to problems with drugs once they're on the market.

One of its own drug-safety reviewers skewered his employer recently before Congress. "The FDA as currently configured is incapable of protecting America" from unsafe drugs, Dr. David Graham said.

Such criticism is right: Having the FDA monitor possible problems with drugs after it has already approved them puts the agency in conflict with itself. The concern is that FDA officials might be less aggressive than necessary in tracking potential dangers from drugs because their own agency approved them.

Just as troubling are charges that the drug industry exerts undue influence over FDA decisions - that the relationship between manufacturers and the regulator is "too cozy," as Sen. Charles Grassley, R-Iowa, puts it.

The highly respected Journal of the American Medical Association suggests a reason for that coziness. In an editorial in the Dec. 1 issue, the editors note the effects of a 1992 law that responded to pressure from patient advocates and the drug industry to speed up the drug-approval process. The law requires pharmaceutical firms to pay "user fees" to allow the FDA to increase its drug-review staff. Between 1993 and 2001, the industry paid $825 million in such fees to the agency, the editorial notes.

JAMA editors suggest the payments may compromise the FDA's oversight ability. Since the user fees began, average time for FDA approval of new standard drugs has been cut nearly in half, the editorial notes, and "as an inevitable consequence of faster approvals," the percentage of drugs recalled has shot up.

When one of the nation's most prestigious medical journals and a leading drug-safety expert both publicly question the FDA's ability to quickly take dangerous drugs off the market, it's time to pay attention.

Congress should follow the recommendation of JAMA editors and create a board independent of both the FDA and the pharmaceutical industry to monitor the safety of drugs after they are approved. That's the only way to restore confidence in the FDA and to safeguard the public's health.