Timeless fears

Anxiety over hypothetical safety risks that could emerge decades in the future led an FDA advisory committee last week to apparently mutually exclusive conclusions. How the agency will square that circle could provide some insight into its current thinking on how to weigh risk versus benefit in drug approvals.

The Arthritis Drugs Advisory Committee voted 8-7 with one abstention that Pfizer Inc. had not demonstrated the safety of Celebrex celecoxib to treat juvenile rheumatoid arthritis, but then voted 15-1 that it should be approved for the indication because the benefits outweigh the risks.

The committee also voted unanimously that PFE (New York, N.Y.) had demonstrated efficacy in juvenile RA through a single 26-week study that showed non-inferiority to naproxen within a 13% margin.

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