Marketing Drugs to Unsuitable Patients

Published: January 28, 2005

Even as expert advisers to the Food and Drug Administration prepare to take a closer look at a potentially risky class of painkillers, the COX-2 inhibitors, disturbing new evidence has emerged that these drugs have been prescribed primarily to patients who do not need them. If an analysis just published in The Archives of Internal Medicine holds up under further scrutiny, it will provide a telling example of how an avalanche of marketing can propel the use of new drugs far beyond reason, posing needless risks to patients they are unlikely to help.

Clinical studies show that COX-2 inhibitors, like Vioxx and Celebrex, are no more effective as pain relievers than many older nonprescription drugs. Their presumed advantage is that they are thought to pose less risk of such severe gastrointestinal side effects as ulcers or bleeding, which kill thousands of people each year. Unfortunately, the drugs can also pose a cardiovascular risk. Vioxx has been shown to cause a small increase in heart attacks or strokes with prolonged use, causing the manufacturer to pull it from the market. The whole class of COX-2 drugs is now under review.

The COX-2 drugs were initially hailed as potential lifesavers for a small minority of patients at real risk of fatal gastrointestinal effects. But according to researchers at the University of Chicago and Stanford, almost two-thirds of the COX-2 drugs prescribed from 1999 to 2002 went to patients with a low or very low risk of gastrointestinal complications. They were not appropriate candidates, under professional treatment guidelines, for the drugs.

The research did not show why COX-2 usage expanded indiscriminately, but there seems little doubt that intense advertising and promotional campaigns inevitably snared many patients who should not have taken them. Indeed, the growth in COX-2 use over time was primarily among patients least likely to benefit.

Two advisory panels to the Food and Drug Administration will meet in mid-February to consider an array of studies on the safety and benefits of the remaining COX-2 drugs. Some consumer advocates want a ban on all drugs in the class, while other experts suggest that not all of them pose the same cardiovascular risk. Should the F.D.A. choose to allow some COX-2 drugs on the market, it will need to find ways to limit their use to those who truly need them.