WHAT MAKES A DRUG TOO RISKY?

Few people are caught more tightly in the vortex of
the controversy swirling over drug safety than Debby
Demaree and her family. Her three teenage children
take Adderall, the attention-deficit drug Canadian
regulators banned from the market there. Her son also
takes Accutane, an effective acne medicine that
infamously causes birth defects. A decade ago, at age
seven, one of her daughters took the antidepressant
Prozac, whose rivals have recently been implicated
for increasing suicide risk. Meantime, her husband
was taking Vioxx for intermittent back pain last fall
when Merck & Co. yanked that pill from the market
over heart concerns. Now he's taking Celebrex, which
has since come under a similar cloud of its own. Ms.
Demaree is troubled by the possible hazards these
drugs pose, but that's not what she's really worried
about. For her family, "the side effects of not
having those drugs," she says, "are much more serious
than the risks of taking the medications." As an FDA
advisory panel opens three days of hearings on the
safety of painkillers - some of which have been on
the market for decades - Ms. Demaree's concerns
underscore the challenge that regulators, drug
companies and doctors alike face as they confront
troubling evidence of potentially serious risks of
medicines that have provided benefits to millions of
patients.

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