• Business Week, Thursday, December 7, 2006 11:46 AM

Once the Food & Drug Administration has approved a drug for its specified treatment, doctors may prescribe it for any ailment. A study by Dr. Randall Stafford, a Stanford University medical professor, found that 21% of all prescriptions are for unapproved treatments. These so-called off-label uses can mean mega-money to drug producers.

Lidoderm--the pain patch from Endo Pharmaceuticals Holdings Inc.--is projected to generate $300 million in sales this year as a treatment for all kinds of aches and pains. But it was approved for just one thing: alleviating pain from shingles.

The FDA formally bars drug company reps from talking up off-label treatments. But drug reps often encourage doctors to test an approved drug in novel settings by handing out studies showing how their drugs performed in various clinical trials when doctors request such data.

They also give away samples as a favor to patients. Doctors and patients then pass stories of successful off-label treatments to one another, boosting demand for the medications.

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