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Tuesday, November 16, 2004

It's time to bring evidence-based drug testing back.

The New York Times Book Review (November 14, 2004) reviews two books that savage the current process used to bring drugs to market: The Truth about the Drug Companies by Marcis Angell, and Powerful Medicines by Jerry Avorn. We've all sat in the doctor's office, waiting while expertly coiffed drug salespersons deliver their free drug samples and sales pitch to our physicians. Unfortunately the information and samples they provide are most likely not the result of adequate testing. We're beginning to see the results as drugs are being pulled off the market for unrecognized harmful side-effects and several lawsuits have been settled or are pending against pharmaceutical companies for fraud, price gouging, or withholding information about deleterious drug effects.

Industry expenses for marketing have been estimated at about $54 billion, just about twice what they spend on research and development. It's unfortunate that much of it goes to getting a penis to stand up rather than better flu vaccine, but perhaps that reveals our own priorities.

Only 133 of the 415 new drugs approved by the F.D.A from 1998 to 2002 were actually "new molecular entities" and of those only 14 percent were considered by the agency to be "a significant improvement" over existing drugs. The other problem lies in the way drugs are tested. Ideally, evidence-based medicine would use randomized clinical trials to determine which drugs are safe and effective. Instead the marketplace has been used to judge the value of pharmaceuticals. One recommendation has been to create an independent national institute to test drugs and judge their worth. Given the drug companies' power, I suspect Hell would freeze over first.


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