The setting: A comfortable living room in a family home. Two women are chatting, when the younger one spots a bottle of Aleve (naproxen) on a counter.
"Hey Mom," she asks, sounding concerned. "Are you still taking Aleve for your arthritis pain. . . . What about all the news lately?"
"Oh honey, I checked with my doctor," her mother answers; she says he told her it is "fine" for her to keep taking Aleve as long as she "follow[s] the directions on the label."
This is a scene from a television commercial intended to reassure the public that Aleve is safe. The ad is running more than a month after the National Institutes of Health (NIH) halted a major drug trial, citing health risks tied to naproxen. A spokesman for Aleve maker Bayer HealthCare last week refused to say exactly when or why the company launched the ad campaign, or if more television or print spots are planned.
National sales for Aleve in 2003, the most recent year tallied, totaled $151.2 million, excluding sales at Walmart and club stores, according to Brandweek magazine. Market research groups say it is too soon to tell if sales of the popular over-the-counter drug have dipped since NIH stopped the trial.
This is not the first time in recent months a drug manufacturer has sought to control damage through advertising. In November, a few days after Food and Drug Administration (FDA) scientist David J. Graham publicly called into question the safety of cholesterol drug Crestor, manufacturer AstraZeneca placed print ads in major newspapers -- including The Washington Post, the New York Times and USA Today -- asserting that the FDA had "confidence in the safety and efficacy" of the product. In December, following a complaint from health advocacy group Public Citizen, the FDA ordered the drug company to stop running the ads, calling their claims "false or misleading."
Sidney Wolfe, director of Public Citizen's Health Research Group, said last week the Aleve ad did not misrepresent facts as the Crestor ad did. But he complained that the Aleve ad does not mention a heightened risk for gastrointestinal side effects associated with the use of nonsteroidal anti-inflammatory drugs -- the drug class that contains Aleve.
Aleve's label advises people ages 12 to 64 not to exceed two pills every eight to 12 hours or three pills a day; those over age 65 shouldn't exceed one pill every 12 hours without a doctor's okay. In addition to arthritis, the drug is commonly used for backaches, muscular aches, headaches and menstrual pain.
-- January W. Payne
