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Deadline drugs often fail
A new study questions some FDA practices.
WASHINGTON - Vioxx, Bextra, Rezulin, Baycol. Looking at drugs yanked off the market, Harvard University researchers found a disturbing pattern: Medicines approved right on deadline by the Food and Drug Administration are more likely to cause safety problems later on than those cleared with more time to spare.
Congress set strict deadlines for the FDA to speed the arrival of new medications, but critics have long complained the ticking clock spurred a dangerous rush to judgment.
The Harvard analysis of decades of drug approvals, published in today's New England Journal of Medicine, provides the first scientific evidence supporting some of those complaints.
The FDA challenged the findings with its own statistics. Still, the study sparked calls to reexamine the balance of speed vs. safety.
"The article is a wake-up call," said Steven Nissen, the Cleveland Clinic's influential cardiology chief who helped sound the alarm on the risks of some of those ultimately doomed drugs.
"It puts the FDA in a very difficult situation when they're trying to make complex decisions under these very, very tight deadlines," he added. "We've got to reevaluate now whether that's good public policy."
