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Can Faster Drug Trials Be Any Safer?

Last year, I warned you about the "fast track" status of some experimental cancer drugs, quickly pushed to market, even though none of them helped patients live any longer. Some researchers are cautiously optimistic about a new process called surrogate markers, what amounts to tests or patient milestones researchers use as stand-ins to predict longer-term patient survival rates, among other things.

The key word here is predict not confirm side effects. These surrogate markers were developed to predict with reliability whether a drug will provide "a survival benefit or not," according to one researcher. And because the FDA is all over this one -- claiming improved efficiency of product development and improved safety -- you know there's probably trouble here...

Can we trust the FDA and their partners -- the mega-drug companies -- to make the right call on new drugs, much less safety, when the existing process is already so fatally flawed?

Just ask the families of patients who died during a recent drug trial for Aricept.

Yahoo News March 29, 2006

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