Television viewers who have seen the advertisement for Relenza, a new flu medication, know that it ends with a woman who has taken the drug sitting in her kitchen while her husband fixes chicken soup and the flu, personified by an actor, mills about.
What they may not notice is that the ending is a new one: the Food and drug Administration forced the drug’s manufacturer, Glaxo Wellcome, to pull an earlier version.
In November, the agency cited the company for false and misleading advertising. The original advertisement, which ran nationwide for a little more than a week, ended with the woman ushering the flu, played by Wayne Knight, the actor who was the irritating mailman on the “Seinfeld” television series, out the door.
The difference may seem slight, but agency officials said the first commercial exaggerated the effectiveness of this drug,” said Dr. Tracy Acker, an official in the division of drug marketing, advertising and communications at the agency.
In an interview, Dr. Acker said agency officials worried that the original commercial might “encourage people to use the drug thinking it’s this miracle cure when it has this very marginal effectiveness.”
While it is not unheard of, the action is highly unusual. Thought the agency sends about 200 letters a year to drug makers questioning their advertising or promotion, only in a few does it demand that television advertisements be altered or removed.
The action was expected to fuel a debate over the advertising of prescription drugs directly to patients, which some experts fear may encourage patients to demand, and doctors to prescribe, medicines that may not be appropriate.
Relenza and another new flu drug, Tamiflu by Hoffman-LaRoche, have been heavily advertised, and on Wednesday, agency officials issued a health advisory saying that doctors appeared to be relying too much on the new drugs. The agency said some patients might have died because they did not get other, more aggressive, treatment.
Officials said the warning had been prompted, in part, by concerns over heavy television advertising, but they did not say they had already forced Glaxo Wellcome to pull an advertisement. On Tuesday, the agency had posted its violation notice to the company on its Web site. The notice was dated Nov. 23.
The 60-second advertisement is the centerpiece of Glaxo Wellcome’s national campaign for Relenza, said Julie Dean, a spokeswoman for the company. She said the original commercials, produced by the advertising agency Saatchi & Saatchi, began appearing on Nov. 15 and was withdrawn as quickly as possible after the F.D.A.’s letter on Nov. 23. The new version was first broadcast on Dec. 4, Ms. Dean said.
“We felt that what we put together in the first ad was a reasonable representation of Relenza’s activity,” she said, “but the F.D.A. was concerned and we addressed that concern. We worked with the F.D.A. to make sure that we are sending responsible and good messages to the consumers.
Other than the ending, the advertisements were alike,” Ms. Dean said. They begin with Mr. Knight, personifying the flu, knocking at a woman’s door. He pushes his way inside and within moments, the woman has a blanket around her shoulders and a thermometer in her mouth. He muscles his way onto the couch, between her and her husband, and takes up residence. He awakens her at 2:30 in the morning by playing the bagpipes. Finally, she takes a dose of Relenza, an inhalant, and tries to throw him out. There the versions diverge. In the original, she succeeds; in the revision he is still hanging around, laughing at the thought that chicken soup could help the patient.
About 300,000 prescriptions for Relenza have been written since it came on the market last fall, and hundreds of thousands have been written for Tamiflu. With the flu season in full swing, there have been a number of stories about the illness, although some experts have wondered if the advertising about the new drugs, as opposed to the flu outbreak itself, is driving the media atten6tion.
Such advertising has been proliferating since August 1997, when the agency relaxed its restrictions.
Dr. Raymond Woosley, chairman of the pharmacology department at Georgetown University, questions the benefit to consumers.
“I’ve got serious concerns,” Dr. Woosley said. “The advertising may attempt to get information out to patients. That’s very important, and that’s the goal. It wasn’t the goal of the advertising to let they hype the drugs.”
Sheryl Gay Stolberg, January 14, 2000, The New York Times
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