Last December, the U.S. Food and Drug Administration warned doctors that a drug widely prescribed to children for attention deficit hyperactivity disorder carried with it "the potential for severe liver injury." The FDA demanded that the manufacturer, Eli Lilly, relabel the product with a new bold-letter warning. Since the drug was introduced in 2002, some two million people have taken it. The FDA discovered that two of these patients had suffered subsequent liver problems.

So far, so good. Perhaps a little overzealous. But the FDA had been less vigilant about more serious safety concerns related to the pain relievers Vioxx, Bextra, and Celebrex. An FDA whistleblower told the U.S. Congress that tens of thousands of patients may have died needlessly because of the FDA's misjudgments about Vioxx alone. Perhaps the whistleblower overstated the influence of drug manufacturers on the FDA's hesitation to warn the public about these drugs. Nevertheless, a thorough examination is in order.