Date: Fri, 5 Jan 2001 12:13:59 -0800

To: Recipient List Suppressed:;

Fraud study concludes that self regulation has failed.

Can We Trust FDA Advisers?

December 18, 2000

Umpires must be impartial. If they aren't completely objective, no one could trust their critical calls.

Just imagine the chaos if a referee called a crucial play fair that should have been foul.

If that decision tipped the balance to one team and later people learned that the official had received gifts or money from that team, a major scandal would result.

In the world of pharmaceuticals, the Food and Drug Administration serves as the umpire. The agency determines which drugs get approved and which are rejected. Its decisions affect the lives of millions of people every day.

How well does the FDA do its job? Can you trust its objectivity?

Such questions have become more pressing as high-profile medications have been pulled off the market due to safety concerns. The diet pill Redux, the diabetes medicine Rezulin and most recently the irritable bowel drug Lotronex all caused unacceptable complications.

The federal bureaucracy is governed by extremely strict rules... But there is a loophole in this seemingly safe system. Because the FDA is faced with so many complex decisions, it frequently calls on outside experts to help it sift through the evidence. When these advisory panels make recommendations to the FDA about new drugs, their advice is usually followed.

Too often these advisers have financial ties to drug companies.