Calculating risk

December 22, 2004

FIRST IT was Vioxx, then Celebrex, now Aleve. What a pain - literally. Battered athletes and arthritic boomers fear they are running out of options for maintaining their quality of life.

When pain relievers heavily promoted for years are suddenly found to be dangerous, there's bound to be alarm. But the latest news from the pharmaceutical front must be kept in perspective.

All drugs pose some risks, which vary widely among patients. Their use should always be weighed on a case-by-case basis.

Yet disturbing questions about popular and frequently prescribed medicines underscore the need for far more rigorous monitoring of pharmaceuticals by the Food and Drug Administration - even after they have been approved for the U.S. market.

FDA whistleblower Dr. David J. Graham warned the Senate Finance Committee last month that the agency is too sympathetic to the industry it regulates to perform its watchdog role in the rigorous manner Americans expect. An internal FDA survey made public last week found that two-thirds of agency scientists queried by federal investigators in 2002 shared Dr. Graham's concerns. One-sixth of nearly 400 scientists said they had been pressured to approve drugs despite doubts about safety, effectiveness or quality.

That is not to say that Aleve, also known as naproxen, is necessarily in the same league with Vioxx, the prescription drug estimated to have caused fatal heart attacks in 55,000 patients. Findings from one study - the first in naproxen's 30-year history to link it to cardiovascular ailments - showed the rate of heart attack or stroke was 50 percent higher among patients taking Aleve than among those taking Celebrex or a placebo. A separate study indicated Celebrex posed an increase risk of heart ailments, but that finding was not confirmed in the study including naproxen.

Vioxx was pulled off the market in September by its manufacturer. Celebrex and Aleve remain available.

So the primary task for patients is to determine what medicine works best for them and whether its benefits outweigh the risks. Short-term, moderate use of any of these products appears to pose very little danger. Daily use may be another matter.

For Congress, the job is to quickly approve legislation to implement reforms suggested by Dr. Graham, including separating the office that monitors each drug's safety from the staff that grants its original approval, to remove the conflict of interest.

President Bush can help by endorsing that effort and by filling the post of FDA commissioner, which has been vacant since February. The embattled agency is too important to leave in the hands of an acting administrator who lacks the portfolio to give it a strong, new direction.

Pharmaceuticals are increasingly vital to health care, often prolonging lives and sparing patients from surgery. But Americans must be as informed as possible about their options, including alternative therapies.

One such therapy is acupuncture, the ancient Chinese needle treatment that University of Maryland researchers reported this week can relieve pain and improve function of arthritic knees.

Not as convenient as a pill, but maybe worth a try.

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