Vioxx went mostly to patients who didn't need it, Stanford resea...( r high risk of GI bleeding-accounted fo...),Health

The researchers point to a couple of key factors behind the rapid growth of COX-2s. Prime among these is the heavy marketing of the medications. In 2000, for instance, Vioxx topped all direct-to-consumer drug advertising with expenditures of $161 million. The researchers also found that during the time period they studied, COX-2s eroded NSAID market share while increasing the total market demand for painkillers.

A second critical factor is the tendency among patients and physicians to believe that newer drugs are better than existing medications. "Drugs are approved on the basis of their superiority to placebo, not their superiority to existing drugs," Stafford said. "I think people misunderstand the nature of FDA approval and the criteria used to allow drugs to enter the market."

Stafford noted that nearly all drugs carry some risks, but physicians and patients are generally willing to use them if the likely benefits outweigh the harms. Many people, for instance, are allergic to antibiotics and yet physicians accept this inherent risk in patients who have significant bacterial illnesses because the benefits of treatment usually outweigh the risk of allergic reaction. For COX-2 inhibitors, however, the risks may outweigh the benefits, especially for patients at low risk for gastrointestinal bleeding, he said.

"It's too unsophisticated to brand any drug as being 'dangerous' or 'not dangerous'," Stafford said. "It depends on the setting in which the drug is used and the characteristics of the patient it's prescribed for."

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Contact: Susan Ipaktchian
650-725-5375
Stanford University Medical Center
21-Jan-2005