FDA Weighing Risks, Benefits of Drug Ads

WASHINGTON - Twenty-nine million Americans mentioned an undiagnosed health condition to doctors after seeing a drug advertisement, an executive from Pfizer Inc., the world's largest drug company, told federal officials Tuesday.

But an insurance company representative countered that such ads also made patients more likely to ask for inappropriate prescriptions for Celebrex and Vioxx, new-generation painkillers introduced through campaigns totalling $239 million. The differing views were part of wide-ranging testimony by 19 speakers during the first of two daylong meetings about drug advertising scheduled by the Food and Drug Administration.

Such advertising has exploded since 1997, when the agency relaxed rules, allowing prescription products to be promoted on television. Drug makers now spend about $4 billion annually ads.

J. Patrick Kelly, president of Pfizer US Pharmaceuticals, said 43 percent of patients who asked their doctors for advertised drugs suffered from such "high priority" diseases as asthma, diabetes and high blood pressure that, left untreated, exact a high toll on public health.

Dr. Robert Temple, director of the FDA's Office of Medical Policy, agreed.

He said patients who stop taking medications to lower high cholesterol represent "a public health disaster," and asked whether Pfizer could better tailor its health messages to help address the problem.

There was also much disagreement in testimony heard by the 11-member FDA panel.

John Kamp, of the Coalition for Healthcare Communication, cautioned the agency about micromanaging drug ads.

But Gail Javitt, of Johns Hopkins University, urged the FDA to more aggressively regulate advertising claims for "highly dubious" genetic tests sold over the Internet, like a test that misinformed expectant parents of a fetus' gender.

Drug maker AstraZeneca, in written testimony, called for mandatory FDA review of ads before they run. "We think this is a logical next step," Tony Zook, the company's senior vice president of commercial operations, said in an interview. Forty FDA staffers reviewed 52,800 drug promotional items submitted by drug makers voluntarily last year, including 586 TV and radio ads, according to the agency.

Dr. Marlene Tandy, a Johnson & Johnson senior counsel who appeared representing AdvaMed, the world's largest trade association for medical device manufacturers, opposed AstraZeneca's position.

"It's an option. We don't think it should be mandatory," Tandy said.

Drug advertising proponents and opponents did agree that the advertising quality could be improved.

Diana Zuckerman, of the National Research Center for Women and Families, flipped through print drug ads that featured idyllic photos of patients.

She was peppered with questions about one showing a smiling mother and playful child in an advertisement for Adderall XR, a Shire Pharmaceuticals Inc. treatment for attention deficit/hyperactivity disorder.

"The image is so powerful, it should be regulated," Zuckerman said. She said such ads are designed to sell drugs as blithely as cars or toys by overstating benefits while detailing their risks in tiny type.

Many television spots make it difficult for consumers to understand drug risks by employing such tactics as fast-paced narration and visuals that distract from side-effect information, said Ruth Day, a Duke University researcher who tests how consumers comprehend ads. After seeing an ad, Day said, as few as 20 percent of consumers understand a drug's risks, but 80 percent remember benefits.

Day played for the panel a clip of a Nasonex ad for an allergy nasal spray that showed a hovering cartoon honeybee. "Watch his wings," she said.

They flapped rapidly during the segment devoted to side effects, but disappeared when the drug's benefits were discussed by a narrator.

A change as simple as placing risk details earlier in television ads, as researchers did for a fake flu-remedy spot, increased consumer understanding of side effects.

Gary Stein, of the American Society of Health-System Pharmacists, suggested that "rapid-fire" delivery of information about drug risks be slowed and that on-screen text be added to make it easier for viewers to follow.

Diedtra Henderson can be reached at dhendersonglobe.com.