"The thalidomide tragedy of the early 1960s led to important reforms in the regulatory authority of the Food and Drug Administration (FDA), including giving it the power to require that a manufacturer demonstrate efficacy before a new drug can be marketed.
We take this expectation for granted today, but it was seen as revolutionary, and bitterly opposed by many, at that time.
The delayed "discovery" of the dangers of rofecoxib and other high-profile drugs should indeed cause us to ask what additional lessons can be learned from our current debacles and prompt a thorough review of how drug risks are detected.
Unfortunately, many of the lessons drawn from such case studies by regulators, clinicians, companies, and the public, including the proposal rightly condemned by Roth-Cline, have led to the wrong conclusions. "
Evaluating Drug Effects in the Post-Vioxx World
There Must Be a Better Way
Jerry Avorn, MD
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