Requests for potentially dangerous drugs by people who have seen the medications advertised on TV are leading the Food and Drug Administration to re-examine the way pharmaceutical companies advertise their drugs on TV.

Last month, the FDA said it plans to study how consumers respond to TV ads, including whether the positive visual images override in consumers' minds the discussion of risks and possible side effects.

Critics of drug company marketing say that the TV ads' positive visual images — such as the fun-loving group of middle-aged buddies singing the praises of Viagra, or the woman who no longer feels like the whole world knows she has a bladder control problem — trump the discussion of risks and side effects, which are usually limited to a quick voice-over at the commercial's end.

The FDA already requires that the ads offer a balanced portrayal of risks and benefits.

Pharmaceutical companies spent $4.23 billion on direct-to-consumer advertising in 2005, according to IMS Health, a health care information company — a 400 percent increase from 1996.

While that figure includes all forms of advertising aimed at consumers — such as in newspapers and magazines, TV ads accounted for most of the money spent.

"They wouldn't spend billions of dollars a year if they didn't work," says Dr. Sidney Wolfe, director of Public Citizen Health Research Group and a frequent critic of the pharmaceutical industry.

BAN NOT OPTION

Experts say the FDA study won't lead to an outright TV ad ban. The courts would probably strike down such a ban as an unconstitutional restriction on the First Amendment-protected commercial speech, Wolfe says.

Francis Palumbo, executive director of the University of Maryland School of Pharmacy's Center on Drugs and Public Policy, agrees there won't be a return to the pre-1997 days, when a change in FDA guidelines opened the floodgates to a torrent of TV advertising.

"It's like the camel with its nose under the tent," says Palumbo, who has written about direct-to-consumer advertising. "Once they let the nose in, the rest of the camel came with it."

In the late 1990s, the FDA told drug companies they no longer had to list every risk and side effect in their TV ads, a requirement that had limited the number of TV ads.

Instead, drug makers could highlight a drug's most serious risks and side effects and refer patients to another source, such as a Web site or toll-free telephone number, for more information.

SERVING PURPOSE

Depending on the outcome of the FDA's study, the agency could require changes in the content of drug ads, such as making the major statement more prominent, or requiring that it take up a certain percentage of the ad's length, Palumbo said.

While critics say TV ads lead to overuse of prescription drugs and boost healthcare costs unnecessarily, the pharmaceutical industry counters that the ads educate consumers and prompt an important dialogue between patients and physicians.

Dr. Nicholas Biasotto, a family practice doctor in Stanton, Del., says the proliferation of TV ads doesn't bother him.

"I'm not forced to use a drug that's on TV," he says.

The ads serve a purpose, he said. "They at least get the patient in the office and questioning me. It starts a conversation."

In a 2001 Kaiser Family Foundation survey, 30 percent of patients said they asked their physician about a drug they saw advertised on television, and in 44 percent of those cases, patients were prescribed the drug they asked about.

A Kaiser Family Foundation study released two years later found that each dollar spent on direct-to-consumer advertising resulted in an added $4.20 in sales.

Drug industry critics say the FDA needs to do more to tighten advertising aimed at consumers, including adding more staffers to review ads. Ad campaigns often run their course before the agency gets around to its review, critics say.

The FDA can require a company to change or pull ads it feels are misleading.