Drug risks raise doubt about ads

The millions of people using Vioxx, a pain reliever pulled from the market because of health concerns in September, "was a direct result of consumer advertising," Dr. Avorn says. "Direct-to-consumer advertising ensures that the greatest number of patients will be exposed to a drug at the very moment we know the least about it."

He and others say companies want to hype drugs right after they are approved for use by the FDA, while they still own the patent. Doctors are often pressured by patients to prescribe the drug, even threatening to go to another physician who will prescribe it.

By asking about advertised drugs, patients can see themselves as empowered and participating more in their own health care. But there's a downside to that. "At a time when the doctor-patient visit is increasing short, on average about 10 minutes," Avorn says, these discussions can "eat up several of those precious minutes" with patients saying "I think I need Drug X I saw on television last night." Doctors have little time with patients as it is, he says, and don't want to spend it "trying to talk patients out of taking drugs they don't need."

An in-depth discussion about changes in lifestyle - more exercise, quitting smoking, better diet, weight loss - is sacrificed for scribbling out a quick prescription. "They leap right to a pill," Dr. Wolfe says.

Drugmakers are under siege as they see clinical trials of their products halted, ads pulled for exaggerated or inaccurate claims, or drugs even taken off the market altogether. Vioxx was pulled off the market in September because of concerns that it increased the risk of heart attack and stroke. It was the biggest prescription drug recall in history: 20 million people were taking Vioxx, and worldwide sales had shot to $2.5 billion. Questions have now been raised about Bextra, and the National Cancer Institute stopped a clinical trial of Celebrex due to health concerns.

For its part, PhRMA, the drug industry lobby, defends the quality of drug advertisements. a"We have confidence in the regulation of direct-to-consumer advertising by the Food and Drug Administration," says spokesman Jeff Trewhitt. The FDA "aggressively monitors" the ads, he says, and in the case of more than 90 percent of the ads going on television, drug companies voluntarily submit them for advanced review by the FDA, he says.

Unlike other consumer ads, drug ads also must by law disclose side effects, Mr. Trewhitt notes. Sometimes those side effects "are rather gruesome, and that is part of the ad."

The US and New Zealand remain the only countries where drugs can be marketed directly to consumers, Wolfe says. He and other critics would like to see a stronger role by the FDA. Instead, he says, the reverse is happening: In 1998 the FDA asked that 157 drug ads be withdrawn; last year, that fell to just 23 requests.

From articles and ads aimed at doctors in medical journals to consumer ads, "Everywhere we turn for legitimate information the drug companies are having too much influence," Abramson says.

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