Dr. David A. Kessler, the former commissioner of the US Food and Drug Administration, told drug and advertising executives yesterday that he was wrong in his seven-year effort to prevent the pharmaceutical industry from promoting drugs directly to consumers, an indicator of how completely the once-forbidden ads have won over some critics.
Kessler, now the dean of Yale University School of Medicine, opposed prescription drug advertisements during his tenure at the FDA from 1990 to 1997, fearing they would create a flood of misinformation and confusion.
''I think I was wrong,'' he said, speaking at a conference on direct-to-consumer advertising - or DTC in the jargon of the industry - at the Marriott Copley Place Hotel in Boston. ''I think you've done a pretty good job.''
Kessler's remarks capped a celebratory day for people in the business of promoting prescription drugs. A video played for the conventioneers caught the mood, featuring the song by Huey Lewis and the News, ''I Want a New Drug,'' and ending with the promise ''DTC. It's here. For good.''
Amid the pie charts and videos, there was a palpable sense of relief. Direct advertising appears to have turned a corner in public acceptance, growing from a $791 million in 1996 to $2.5 billion in 2000. Once a controversial marketing practice, ads with smiling Viagra-using couples, athletic elderly arthritics, and lengthy side effect descriptions have now become a staple of pop culture.
''On the whole, I think there is a lot of educational benefit,'' said Kessler, citing a 2001 Kaiser Family Foundation study showing that direct advertising has increased consumer understanding about drugs, their side effects, and the conditions they treat.
Critics still contend that the ads prompt some patients to make unreasonable demands for certain drugs. The critics also say that the ads underplay side effects, cruelly tantalize seniors without drug coverage, and contribute to drug price inflation by their cost.
One week after Kessler left the FDA in 1997, the agency removed most of the regulatory barriers that had prevented such advertising. Advocates considered the move a grant of independence, and companies began pouring money into ads that unabashedly targeted consumers.
When researchers studied the effects of the ads, they found mostly positive results for direct advertising, most importantly a 1999 FDA study that found consumers liked the ads. A new version of that study is scheduled to be released at the conference tomorrow, with data indicating that direct advertising is effective: One-quarter of patients requested a specific brand of drug during visits to the doctor, and 69 percent had the requested drug prescribed.
Direct advertising accounts for 16 percent of drug promotion; efforts aimed at doctors take up more than 80 percent of promotion budgets.
Critics of direct advertising contend that only doctors can rationally consider the costs and benefits of prescription drugs and that the ads exploit patient desires to be cured of afflictions.
A congressional hearing last July raised the possibility of stricter regulation of ad content, though no legislative push has developed.
Yesterday's conference opened with a defiant retort to these critics.
Critics have ''blustered and tried to blow our house down, but they haven't,'' said Robert Ehrlich, chief executive of RxInsight Inc., the largest direct advertising consulting firm in the United States and host of the conference.
Ehrlich spent most of his address defending direct advertising. Many in the field consider him a sort of founding father, because he designed the ad campaign for the cholesterol-fighting drug Lipitor while an executive at the drug firm Parke-Davis.
Though surveys show that doctors think direct advertising has little impact on their prescribing practices, much of the grumbling has come from doctors' groups that say the ads will create overly demanding patients.
But Ehrlich said physicians would have to get used to the ads. ''Once you tell people there's a cure for something, the more likely they are to pressure doctors to prescribe it,'' he said.
But one statistic that did concern yesterday's gathering was a survey, sponsored in part by Ehrlich's firm, that found that 66 percent of the public believes that direct advertising is partly responsible for increasing drug costs.
''It goes beyond the Ralph Naders; there are reasonable people attacking DTC,'' said Ehrlich, drawing nervous laughter.
He said that consumer marketing costs are 2 percent of overall pharmaceutical sales and therefore have little impact on price.
Kessler, after acknowledging his reversal on direct advertising, also warned that the advertising will probably get caught up in future debate over drug costs.
''DTC has put the pharmaceutical industry in the cross hairs of the public,'' Kessler said.
Raja Mishra, Boston Globe. April 17, 2002
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