FDA in More Hot Water as It Excessively Relaxed Drug Approvals

With all the news I post here about the porous state of drug safety in America, I bet you're wondering why concoctions like Ketek ever manage to get approved by the FDA, even though they have demonstrable and harmful side effects (liver damage).

The FDA's justification for the way it approves the drugs it does is clearly not in your best interests, that is unless you are a major shareholder in one of the drug companies. According to a fascinating Wall Street Journal piece, antibiotics, unlike other drugs, adhere to a greatly diminished standard. A drugmaker need only demonstrate that its product works "about as well" as older drugs, and not necessarily better than existing ones.

Referred to as noninferiority trials, these procedures provide results that, unlike conventional placebo-driven testing, are less clear-cut. In fact, noninferiority trials have been used to judge the value of antibiotics for some 60 years.

Even worse, such trials are being used by the mega-drugmakers to justify the use of medications for less serious problems -- think ear infections -- that can be better treated without them.

Questions about this approach -- many of them from Sen. Charles Grassley (R-Iowa) who chairs the Senate Finance Committee -- have prompted the FDA to re-evaluate its approach, but expect great pushback from the powers that be.

Pittsburgh Post-Gazette.com June 13, 2006

Wall Street Journal June 13, 2006 Subscription Required

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