Questions on the $3.8 Billion Drug Ad Business

When Emily Martin was hospitalized for emergency gallbladder surgery last summer, her doctors found that she also had acid reflux, causing erosion of her esophagus.

"My stomach was very unsettled,'' said Ms. Martin, a 26-year-old mother in Oradell, N.J. So she asked her doctor for Nexium, the "purple pill" that is the nation's most widely advertised prescription drug. "I saw the commercial and they showed people talking about immediate and miracle relief,'' she said.

It has worked, without side effects, said Ms. Martin, who pays only a $30 monthly insurance co-payment for Nexium, which can cost $200 a month or more.

Patients like Ms. Fleming are why the pharmaceutical company AstraZeneca spent nearly $260 million on television and other mass-media advertising aimed at Nexium users last year.

Approved by the Food and Drug Administration in 2001 as a treatment for severe acid reflux disease, Nexium is now so commonly prescribed for heartburn and indigestion symptoms that it has become one of the nation's best-selling drugs, with United States sales last year of $3.1 billion - even though many medical experts say that for most patients, cheaper over-the-counter heartburn remedies may work just as well.

The issue of drug advertising directly aimed at consumers was thrust into the news recently when Merck withdrew its arthritis painkiller Vioxx from the market, citing studies indicating a risk of heart attacks or strokes. Critics noted the role that advertising and marketing played in the drug's being widely prescribed to patients who might have done just as well with ibuprofen or other inexpensive over-the-counter remedies.

Vioxx, whatever its safety risks, was hardly unique as a prescription drug that became a best seller on the strength of advertising aimed directly at consumers. In the seven years since the F.D.A. lifted longstanding strictures against such ads, prescription drug advertising has grown into a $3.8-billion-a-year business. And the F.D.A. says that, despite the controversy accompanying the withdrawal of Vioxx, it has no plans to place new curbs on such ads.

Nexium is typical of the brand-building trend. No one is arguing that the drug poses serious health risks, beyond a slight chance of side effects like headaches and flatulence. Despite clear beneficiaries like Emily Martin, though, many medical experts say most patients would do just as well with various cheaper over-the-counter remedies for indigestion and heartburn, including AstraZeneca's own Prilosec - a chemically similar predecessor that no longer requires a prescription and sells for $40 a month or less.

"Nexium is no more effective than Prilosec," said Dr. Sharon Levine, an executive with Kaiser Permanente, the nation's largest health maintenance organization. "I'm surprised anyone has ever written a prescription for Nexium."

Read more at nytimes.com


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