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FDA to push firms to make ads clearer about drug risks

WASHINGTON -- In response to criticism from doctors and consumer groups, the Food and Drug Administration will ask drug companies to do a better job of explaining medical risks in their increasingly imaginative commercial spots, while allowing yellow toenail-fungus monsters and traffic cops who "gotta go" to continue appearing on American airwaves. The FDA yesterday opened two days of hearings on the subject of consumer advertising, for the first time publicly presenting survey data that shows prescription advertising is generating widespread skepticism among doctors.

Fully 70 percent of general practitioners said they believe the advertising "confuses relative risks and benefits," while 75 percent said it causes patients "to think drugs work better than they really do," the FDA's survey said.

Despite those findings, there is little chance of a reversal in the way drugs are being marketed in the United States. American pharmaceutical companies, which got the green light for prescription ad campaigns in 1997, spend nearly $3 billion a year on consumer advertising, pushing greater limits of creativity with every season. The FDA survey also found an explosion in interest among medical consumers on the Internet, with 38 percent of patients reporting the Internet as a source of information, up from 18 percent five years ago.

"The genie is now fully out of the bottle," said Dr. Janet Woodcock, the FDA's director of drug evaluation and research. "What had been unthinkable in the 1950s, such as the discussion of medical conditions openly on television, has become commonplace now."

Trying to keep pace, the FDA is developing guidelines to refine the presentation of medicine advertising, which will be issued by the end of the year. FDA officials said a main goal will be to present risk information in plain, consumer-friendly English, instead of physician-speak and legalese. Too often, the risk information is tacked on a rapid-fire monologue that is incomprehensible, or buried in fine print in magazine and newspaper ads, say critics.

"If the language is more consumer friendly, it will make it easier to take valuable information away from the advertising," said Thomas Abrams, the director of the agency's division of drug marketing, advertising, and communication.

Many health professionals agree drug advertising does encourage more discussions between doctors and patients about serious health concerns. The ads are seen as especially helpful in breaking down societal barriers about depression and urinary incontinence, the subject of the catchy "gotta go" ads aired by Pfizer for its prescription drug, Detrol LA.

But even on those positive notes, there are signs the public is taking a more jaundiced view of these commercials, which began flooding the airwaves in 1997.

The FDA survey found that 32 percent of patients questioned in 2002 agreed that advertisements for prescription drugs helped them make better decisions about their health. That represented a sharp decline from 1999, when 47 percent of patients thought the advertisements were helpful.

"As we get more and more drugs advertised," said Linda Golodner of the National Consumers League, which has also surveyed patient sentiment, "more people will recognize it as: Just as a car dealer wants to sell a car, pharmaceutical companies want to sell medication."

Yesterday's hearing was scheduled as the FDA has come under fire for a decline in the number of advertising-related warning letters it sends to drug companies. And a gap in enforcement was highlighted last year by the General Accounting Office: There is no requirement that the agency review advertisements before they are placed in glossy magazines or broadcast on television. So even when the FDA does act to curb claims in an advertisement, it is often too late.

That was the case this year with Lamisil, a drug manufactured by Novartis AG that is approved for the treatment of toenail fungus. Novartis hired cartoonists to draw "Digger," a character who is supposed to represent toenail fungus shown lifting a toenail and diving in. By the end of the 60-second TV commercial, Digger has been squashed by a giant Lamisil tablet and the toenail has been returned to a uniform, healthy pink.

The advertisement began airing in April. After four months, the FDA's division of drug marketing, advertising, and communication told Novartis the commercial spots were "misleading" because they exaggerated the drug's effectiveness. The agency also accused Novartis of minimizing the risks. The "compelling and attention-grabbing visuals," it said, distracted from the voiceover describing risks.

Novartis, which pulled Digger off the airwaves after receiving the letter, said it stands by the concept for the spot.

"Novartis is working diligently to revise the campaign moving forward so that the FDA's comments are appropriately addressed," the company said in a written statement provided to The Boston Globe.

Abrams, the head of the FDA ad monitoring division, said the FDA could not require presubmittal of ads without a change in the law. The Lamisil warning letter and several other recent cases of promotion enforcement coincided with a recent escalation of the advertising issue by FDA Commissioner Mark McClellan, who has given speeches before trade groups warning that misleading advertisements will not be tolerated.

Meanwhile, at least one drug company, Pfizer Inc., is getting proactive about public relations problems associated with consumer advertising. The drug company was alone this week at the FDA hearings in providing its perspective. Citing a publishing industry survey by Prevention Magazine in 2002, it planned to point out today that 61 million consumers talked with a doctor as a result of seeing a prescription drug ad. Pfizer also is actively working to bring more plain language side-effects warnings into its spots.

"Consumers do recognize that it is advertising, and valuable information nonetheless," Dorothy Wetzel, Pfizer's vice president for consumer healthcare, said in a telephone interview. Pfizer points out that, according to one survey last year, 66 percent of adults agree that consumer ads increase awareness of new treatment options.

But critics say the blizzard of consumer and doctor surveys presented in Washington this week carry little validity.

"Those data are totally unreliable," said Dr. Arnold Relman, a professor emeritus at Harvard Medical School who has been critical of the drug industry. "If they want to say that direct-to-consumer ads have a certain effect on the behavior of people who see them, they have to compare it to people who don't see the ads. And the fact is, that there isn't anybody in the United States who is alive who doesn't see them."

Christopher Rowland can be reached at crowland@globe.com.

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