Coalition Seeks Better Way to Push Pills

WASHINGTON Just how many prescription drug ads featuring a doctor discussing a pill's risks and benefits will viewers tolerate before growing bored and tuning out? A coalition of medical marketing agencies fears that a combination of current federal rules governing direct-to-consumer ads, safety concerns over drugs like Vioxx and increased scrutiny of the ads by the CEOs of drug companies following last year's adoption of voluntary principles from the drug industry's trade group are stifling the ability of agencies to deliver effective messages to consumers.The Coalition for Healthcare Communication—which includes the American Association of Advertising Agencies, American Advertising Federation, Association of National Advertisers and Public Relations Society of America, among others—asked the Food and Drug Administration on March 31 to develop new rules to make the ads clearer and simpler. It also wants the FDA to create an advisory committee to recommend the best way to communicate drug information in DTC ads.What concerns the coalition is the current FDA rules, which originated in the 1960s, when drugs were marketed to doctors, not consumers. It argues that what doctors need to know—like who should take a drug and what all of the side effects are—is different from what a consumer should learn from an ad."We want the FDA to create rules that focus on the information needs of consumers," said John Kamp, the coalition's executive director. "The DTC rules are based on information a doctor needs to know. But that is not what the patient needs to know."Kamp thinks a "zenith" has been reached in the number of drug ads where doctors appear discussing risks and benefits. Creatives adopted this strategy to comply with both the FDA rules and the voluntary principles adopted by the Pharmaceutical Research and Manufacturers of America last August. "The drug companies have become much more conservative in their advertising, and frankly, that is a good thing," Kamp said. "But there has to be more creative approaches than white-coat doctors. The creative folks have been challenged."Anne Devereux, evp at BBDO, New York, and a member of the committee that prepared the petition, puts it this way: "There are a whole bunch of DTC ads that use doctors in white coats explaining diseases. As soon as you start doing that, consumers stop listening," Devereux said. "The state of DTC ads over the last few months in response to the new [PhRMA] guidelines has been much more conservative execution and messaging."One AstraZeneca ad for Toprol-XL featured a doctor who kept popping up to discuss risks and benefits with patients. The new Pfizer Lipitor campaign uses Dr. Robert Jarvik, the inventor of the artificial heart, to discuss the drug.The FDA, which is currently reviewing its rules on DTC ads following a public hearing on the issue last November, declined comment. The FDA regulates DTC ads using "fair balance" rules, which require a balanced representation of a drug's risks and benefits in each ad. U.S. drug companies, which spent $4.2 billion advertising prescription drugs last year, are the only U.S. companies required to disclose negative information about a product.Some drug companies disagreed with the notion that the ads have become too conservative. "To say we are creatively constrained is a cop-out," said Don Apruzzese, senior director of consumer marketing at AstraZeneca. "You can be extremely creative and still adhere to the principles."What's more, the drug industry trade group PhRMA did not exactly welcome the petition. "We are puzzled by it," said PhRMA svp Ken Johnson. "Our member companies are very serious about striking a careful balance between benefit and risk, and from all indications, they are doing a very good job of that in their new campaigns."PhRMA later issued a statement saying the FDA rules have been "extremely effective" and it "does not believe there is any need for major revisions." However, the group did say it would support "carefully targeted revisions designed to help improve the communication and understanding of benefit and risk information."Associating itself with any attempt to change the rules is tricky for PhRMA, which does not want to appear like it is asking for a relaxing of the rules to raise drug profits.That, however, is exactly what consumer groups think the petition is all about. "They want to play up the emotive imagery and hide the bad news," said Gary Ruskin, executive director of Commercial Alert, a nonprofit that seeks to reduce the amount of commercialization in American life. "This is helping to obfuscate and hide all the bad news about side effects and contraindications to make people forget that even when used properly, prescription drugs can cause death or serious illness."Peter Lurie, deputy director of the Public Citizen's Health Research Group, also thinks the petition is an attempt to scuttle the fair balance rules. "What they mean by clear, simple language are very brief explanations of the dangers," Lurie said.But Kamp denies that his group is asking the FDA to remove the risk disclosures. "Nobody wants the risk warnings taken off DTC ads," Kamp said. "It's not good for the FDA, consumers, [nor] drug makers."Even AstraZeneca's Apruzzese thinks the FDA rules could be improved. "Both the FDA and the drug manufacturers have the same goal in mind of a fully informed patient," he said. "What we have not found the solution to is, 'How do we get there in an effective way?'"

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Coalition Seeks Better Way to Push Pills

Wendy Melillo

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