EthicAd Council offers marketers seal of approval

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A non-profit organization devoted to developing ethical standards for direct-to-consumer pharmaceutical advertising hopes to serve as a mediator between the competing interests of federal regulators, physicians, pharmaceutical manufacturers and advertising agencies.

At the same time, the Atlanta-based EthicAd Council, largely made up of medical professors, wants to protect consumers from misleading information by setting guidelines for the content of broadcast and print ads.

The organization hopes to use those guidelines to function as a Good Housekeeping Institute for DTC, giving marketers the chance to submit their ads and earn an "EthicAd Seal of Approval."

"DTC is a privilege, not a right," said Michael Shaw, the group's executive director and a one-time internist. "Healthcare companies have a responsibility to provide honest, reliable information."

While the group's primary function is to serve as a consumer advocate, it also sees its role as a supporter of pharmaceutical companies and their marketing efforts. Dr. Shaw said he believes once guidelines are developed that all the disparate groups endorse, pharmaceutical companies will be able to more effectively market their drugs.

UNTYING MARKETERS' HANDS

"To a large extent, pharmaceutical companies have had their hands tied," Dr. Shaw said.

Broadcast DTC advertising has mushroomed since the U.S. Food & Drug Administration loosened its guidelines in 1997, altering its more stringent regulations on how marketers had to report potentially harmful side effects. Yet some drug marketers feel the FDA remains too restrictive. The FDA counters that it tries to ensure consumers receive information that is balanced and doesn't overtly raise expectations.

Some consumer advocates support the idea that DTC ads provide more information that empowers people, but many also want to ensure that information is presented in the proper light.

While some have softened their opinions of DTC ads, many physicians remain skeptical, believing DTC messages overly influence patients and interfere with physicians' role as prescribers.

"There's a lot of resentment out there in the medical community," said Dr. Shaw, who ran medical education agency Health Science Media, which was sold to True North Communications in 1996. While there, he worked on launch programs for Pfizer's blockbuster erectile dysfunction drug Viagra and Warner-Lambert's promising diabetes drug Rezulin, which recently was pulled off the market following negative reactions in patients.

ALL THINGS TO ALL PARTIES

The EthicAd Council believes there is a way to provide useful, thorough and relevant information to consumers in a manner that is well marketed; in other words, in ways to satisfy all parties in the booming DTC arena. Skeptics, however, said that may be too ambitious a goal.

"For 30 years, I have been searching for voluntary guidelines that have been followed by any group, particularly when they involve a public health issue," said Larry Sasich, a pharmacist with consumer advocacy group Public Citizen. Private companies, he added, don't have much incentive to follow restrictions unless they are regulated by law. "That's the nature of business . . . If a company is battling for market share in a competitive market, they'll do what it takes."

Beth Miller, senior VP-director of CME Health, Minneapolis, a unit of Campbell Mithun Esty, questioned whether consumers might respect an ad with an EthicAd Seal of Approval.

USEFULNESS QUESTIONED

"In the age of the empowered consumer, these `seals of approval' may not carry the same weight as they used to," she said. "I think that may be particularly true in regard to healthcare."

The FDA, with its strict adherence to the law, may be the hardest of the parties to satisfy.

"They don't have a regulatory role," said Nancy Ostrove, chief of the FDA's Division of Drug Marketing, Advertising & Communications. "There is a law and there are regulations."

EthicAd hopes to issue a draft of possible standards by fall. Dr. Shaw said he would like to see the guidelines encourage marketers to offer understandable, complete and balanced information, and include in their ads some alternatives to the drugs being advertised.

Before the ad guidelines are issued, the non-profit this summer will set out guidelines for accepting contributions to fund its work. Dr. Shaw said funds from drug companies and ad agencies will be accepted, though rules will be set to ensure the group's independence. The group would function similarly to national consumer advocacy organizations for certain diseases, which accept drug company sponsorship but try to function independently.

Besides corporate contributions, another possible funding source could be user fees for the vetting process to obtain an EthicAd seal. So far, the group's funding has come largely from Dr. Shaw himself.

The group last week mailed out information packets to 50 of the largest healthcare ad agencies, seeking their participation as it works to develop its guidelines.

ADVISORY BOARD

The group's National Advisory Board is made up of medical academics, including faculty members from Harvard Medical School and Johns Hopkins University School of Medicine. Though their input will be sought, no members of the pharmaceutical industry will serve on the council's board. EthicAd Council's chairman is Donna Hill Howes, director of health education for Time Inc. Health; Time Inc. itself has an interest in promoting DTC in order to boost ad pages.

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