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One reason for the boom is the government's clarification of the rules of this advertising. The Food and Drug Administration rules on drug advertising date back to 1969, explains Nancy Ostrove, branch chief in the division of drug marketing, advertising and communications. Those early regulations said if a drug manufacturer wants to tell people what its drug does, it also has to give the possible side effects. Because manufacturers didn't really want to give the downside, they were getting around those regulations by just mentioning the name of the drug or talking about a malady that could be helped without mentioning the name of a drug.

Also Today Diapers and drugs A new study shows a three-fold increase in mind-altering drugs being given to preschoolers. By Arthur Allen

"That was causing a lot of confusion," Ostrove says. "Consumers and patients were going to the doctor asking for things that were totally inappropriate for them."

So in 1997 the FDA updated the regulations. They now say that prescription drug ads have to give the whole story -- the benefits and the possible side effects. For example, an ad for Tamiflu shows a young woman in pajamas in her bedroom, obviously down and out with the flu. She reaches for a glass of orange juice. In a very soothing voice, an announcer says there is more help for her -- Tamiflu. That calm slow voice continues and, after all of the wonderful possibilities for the drug's effectiveness are explained, the announcer says, a bit more quickly, "One in 10 may experience mild nausea or vomiting."

In addition, the ads have to give consumers a way to find out more about the drugs. They should include an 800 number, a Web site and reference to a print ad about the drug, and they must advise people to talk to their doctors.

"For the most part what we're seeing is reasonable since the 1997 regs," Ostrove says. Drug manufacturers are required to send the FDA copies of all their promotional materials for review, she says, and so far they haven't seen any adverse effects from the ads. Ostrove said the biggest risk she sees from this type of advertising is the possibility of "trivializing prescription drugs."

"There's the risk of patients now believing that their doctors aren't necessary to make the decisions about whether to take a drug," Ostrove says. "There's a belief that perhaps it will affect the patient-physician relationship."

Dr. Edward Benz, chairman of medicine at Johns Hopkins University in Baltimore, sees a potential danger in that a little knowledge of these drugs could be dangerous. "An ad is a sound bite and a sight bite that's on for 30, 40, maybe 60 seconds tops," Benz says. "For something as important and complicated as a potent medication, I don't think that's enough time for people to be forming judgments."

Some consumer groups agree. "The only reason behind this advertising is to create demand for product," says Larry D. Sasich, a pharmicist at Health Research Group, a unit of Public Citizen in Washington, D.C. Sasich points to an article in Medical Marketing and Media, an industry trade journal. "That piece said that over the years the purpose of these ads is to drive consumers into doctors' offices to ask for brand-name drugs."

Industry spokespeople say the aim is to educate. "We believe that a well-informed patient is more apt to obtain appropriate and effective treatment," says Schering's Robinson. "That's the reason why we've implemented a patient information program."
salon.com | Feb. 23, 2000

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