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Simpler Rx Warnings Urged For Ads

Saying "less is more," a coalition of advertising and public relations groups wants to strip most of the warnings from prescription drug ads aimed at consumers.

Current direct-to-consumer advertisements "over-warn and under-inform," according to a petition submitted Friday by the Coalition for Healthcare Communication to the Food and Drug Administration. "The result is more confusion than communication."

"Our goal is simpler, clearer messages that communicate both the risks and benefits of prescription medicines, more informed doctor-patient dialogue and improved patient compliance," said John Kamp, executive director of the coalition. The organization represents trade associations specialized in medical advertising, communications, marketing and publishing. It also receives some financial support from the drug industry.

A consumer advocate countered that prescription drug ads should contain clearer, not less, language.

"To pull away or remove those fine details, we are against that. I guess we are saying, 'more is better,"' said Bill Vaughan, a senior policy analyst at Consumers Union. "Have the key facts up front, but some of us would like to read to the end to be aware of the consequences and be sensitive to some of the things we might want to report to our doctors."

The Coalition for Healthcare Communication suggests in its petition that consumers would be better served by skimpier ads that still relay enough information to prompt them — without scaring or confusing them — to discuss with their doctors an advertised drug's risk and benefits. The ads would simply carry a boilerplate warning that all prescription drugs have potential risks and benefits, it said.

"While some may think it desirable to tell consumers about all side effects and contraindications, no matter how clearly this information is communicated to consumers, a significant number will lack the education or background to comprehend or act on it," the petition, signed by Kamp, reads in part.

The FDA has six months to respond to the petition, the latest of several filed since the late 1980s that seek to alter how the agency regulates drug ads aimed directly at consumers. An agency spokeswoman did not immediately return messages left to seek comment.

The agency held two days of hearings in November in response to those other petitions, which sought, variously, to either ban direct-to-consumer drug ads or exempt them from federal regulation.

The withdrawal of the Merck & Co. pain reliever Vioxx in September 2004 invigorated the debate over consumer ads, as the drug had been heavily promoted, including in ads featuring Olympic skating gold medalist Dorothy Hamill. The drug was withdrawn after long-term use was associated with potentially lethal side effects.

The Coalition for Healthcare Communication's members include the American Association of Advertising Agencies, Healthcare Marketing and Communications Council and Public Relations Society of America.

Representatives of the Pharmaceutical Research and Manufacturers of America did not immediately respond to messages left seeking comment. The organization's own guidelines stress that drugs ads should include "a balanced presentation of the benefits and risks associated with the advertised prescription medicine."

By Andrew Bridges

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