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FDA Says Some Drug-Ad Images May Be Misleading to Consumers

By CHRIS ADAMS and ANN GRIMES
Staff Reporters of THE WALL STREET JOURNAL
 

Nothing beats pictures to drive home a message, but some drug companies find their visuals are raising the ire of federal drug-ad watchers.

Last week, the Food and Drug Administration sent a critical letter to eight makers of drugs used for treatment of HIV, the virus that causes AIDS. That letter singled out the strapping subjects used in many ads -- the "robust individuals engaged in strenuous physical activity" and other "healthy-looking individuals." The FDA told companies they had until May 18 to identify which promotional materials will be revised, and that changes needed to be made within 90 days.

The letter didn't single out specific ads but was addressed to the companies making HIV drugs. It came after a public controversy, centered in San Francisco, about whether such images were affecting gay men's decisions about practicing safe sex. "Advertising is more than just words, and the FDA is focusing on the fact that the power of advertising comes from the images, the audio and the use of music," says Michael Shaw, executive director of EthicAd, an Atlanta nonprofit organization developing standards for so-called direct-to-consumer drug ads. Such ads, targeted at patients, not their doctors, have increased rapidly in recent years, despite persistent criticisms that they are costly and misleading.

"The advertisers have been pressing the boundaries, shall we say, in terms of how far they can take it on the visuals, thinking the FDA would focus more on the content, the substance, the written word," Dr. Shaw says. For example, a recent television ad for Celebrex, the arthritis drug co-marketed by Pharmacia, Peapack, N.J., and Pfizer, New York, was cited by the FDA as "misleading because the totality of the images, the music and the audio statements ... overstate the efficacy." The co-marketers of Celebrex modified the ad in light of the FDA's concerns.

The FDA says it has for years monitored such ad images, both direct-to-consumer and those in traditional medical journals. But drug-ad experts say the agency is getting increasingly vigilant about doing so. Washington lawyer Marc Scheineson, a former FDA official and a partner at Reed Smith LLP, who represents the industry and EthicAd, sees the recent FDA action involving HIV drugs as a "warning shot across the bow." He says it is designed to "stake out its territory" on what is appropriate and what isn't. Eventually, Mr. Scheineson suggests, drug makers will go along with the FDA enforcement to avoid a public spat with the agency.

Prescription-drug advertising has risen sharply since 1997, when the FDA issued guidance to companies about how to structure direct-to-consumer broadcast ads. Since then, the agency has been in a battle to keep up with the thousands of drug-ad images on TV, in newspapers and magazines, on the Web and in other media. Some of those ads present images in a way standard medical journal ads never did.

The FDA, in its letter last week, noted that "images that are not generally representative of patients with HIV" are "misleading because they imply greater efficacy" than the evidence suggests. Thomas Abrams, who heads the FDA's Division of Drug Marketing, Advertising and Communications, says his division gets 32,000 marketing submissions a year. To respond to concerns from the public, the division decided to review the whole class of drug ads at once, rather than ad by ad, as is normally the case.

In San Francisco, some objected to ads that depicted "men who were very sexy, shirtless and muscular," says Jeff Klausner, director of Sexually Transmitted Disease Prevention and Control Services at the San Francisco Department of Public Health. The ads "falsely portrayed the lack of seriousness of HIV and make it seem more manageable."

Dr. Klausner says he and many other doctors "have been somewhat annoyed at the tone of these ads for years." But a rise in new HIV infections prompted him last fall to contact the industry, starting with Merck, whose ad for its anti-HIV drug Crixivan depicted healthy-looking young people hiking on a rocky mountain. In November, Dr. Klausner wrote the company a letter saying that "in my 15 years in taking care of HIV patients, even with the new treatments, no one has been mountain climbing."

Merck, Whitehouse Station, N.J., responded by acknowledging his concerns but saying it felt the ads were fair and honest, and that they didn't contribute to risky behavior. Dr. Klausner said the company reported that one HIV-positive member of a focus group had told them he was able to go mountain climbing after taking the company's drug. Patients on Crixivan report feeling energized and able to go back to work, says Merck spokeswoman Kyra Lindemann. "They feel like their life is renewed." Merck wouldn't comment on its plans for the mountain-climbing ad.

Write to Chris Adams at chris.adams@wsj.com¹ and Ann Grimes at ann.grimes@wsj.com²

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