FDA should consider the impact of images on consumer behavior as part of its evaluation of direct-to-consumer advertisements, the National Research Center for Women & Families suggested.

"The image is so powerful that it should be regulated," NRC for Women & Families President Diana Zuckerman said at an FDA public hearing on DTC advertising Nov. 1-2.

FDA's efforts to ensure that DTC ads adequately inform consumers about the risks of a drug are rendered ineffective by the ads' persuasive imagery, Zuckerman said.

"When you have an image that's powerful, who are we kidding when we say this is an educational ad?" she said, citing two magazine ads for Merck's Vioxx . One ad featured an older woman kneeling in front of a child, and the other showed an elderly woman pushing a wheelbarrow in a garden.

Right now, "medical products are being sold just like any other product," she said.

"Instead of really giving us information about risks and benefits," the goal of DTC ads is to make consumers seek out the drug, Zuckerman added. "They're effective, but they're not educating us."

Consumer behavior is being directed by such imagery and not just by the risk and benefit information in DTC advertisements, Zuckerman said. "If you want to change people's attitudes and if you want to change people's behavior, you don't just talk to them about facts, you give them an image."

Zuckerman suggested that studies be performed to evaluate the power and effectiveness of advertising images on consumers.

"In the same way that manufacturers are required to provide data on the effectiveness and safety of their products, they could be required to provide some kind of data...on the impact of their ads."

"There should be limits on how powerful these images can be," she added.

One type of image that may be so powerful that it should not be used, is that of celebrities, Public Citizen Health Research Group Deputy Director Peter Lurie suggested.

Gallup & Robinson Research Director Abby Mehta said that celebrity DTC ads may be perceived more favorably than non-celebrity ads but are not necessarily more persuasive.

Mehta presented results of a study, commissioned by Pfizer, on the impact of using a celebrity spokesperson in DTC advertising.

"Celebrity spokespersons in ads were consistently rated more significantly favorably than non-celebrity spokespersons for a variety of attributes, such as likeability and credibility," although they were "not perceived as providing more important messages, or being more informative, or even more believable overall" compared to non-celebrity ads, Mehta added.

"In terms of persuasion...there were no differences across all celebrity and non-celebrity ads."

In addition to employing persuasive images to convey a positive message to consumers, magazine ads are designed to highlight the benefit information, Zuckerman said.

Magazine ads typically feature "large lettering about the benefits" on the front, while "most of the risk information is in tiny fonts on the back that many people never even look at, but even if they do it's actually impossible to read."

"At a minimum you would want risk information to be put in a font that's as large as the benefit information," and "it shouldn't be on the back....it should be next to [the benefit material] and it should be incorporated in the ad," Zuckerman said.

The arrangement of risk and benefit information within DTC ads has an adverse impact on consumers' understanding of drug risks, participants maintained at the hearing.

Ruth Day (Duke University) asserted that although the risk and benefit content in DTC ads may technically be balanced, consumer comprehension of such information is not.

"There is currently a clear, unfair balance in cognitive accessibility of benefits versus risks in ads, weighted toward the benefits side," Day said.

One cause of the inferior risk information uptake is the way "chunking" - an information arrangement technique that improves retention - is used in ads, she noted.

"Chunking is partly the clustering of like information, not sprinkling it around in different places...and then separating it from the surrounding information," she explained. In DTC ads, chunking is employed prior to the presentation of risk information, "but once the side effects are uttered there is no chunking."

After the side effects message, "more information just keeps coming, which makes it hard to mentally digest" the risk details, Day observed. An expert in the psychology of language, Day is a former member of FDA's Drug Safety & Risk Management Advisory Committee.

Another structural characteristic of DTC ads which limits consumer understanding of risk information is the serial positioning of the side effects message. "When we see or hear a list of items and then have to report them, we do better at the beginning and the end of the list and have trouble in the middle," Day noted.

Side effects in broadcast DTC ads are typically disclosed between 60%-85% of elapsed time, Day said. "Clearly unfavorable location is being used to place the side effects."

In addition to its inferior positioning within the ad, risk information usually is presented more quickly and requires a higher reading ability to understand, Day said.

"Risk information is there. It is physically present, but it is functionally absent," Day said. "Is this fair balance?" she asked. "No."

Research shows that there is an unfair balance of benefits versus risks in terms of the information that consumers take away from DTC ads, "but it can be improved," Day said.

FDA apparently agrees. Several warning letters issued by the Division of Drug Marketing, Advertising & Communications since July have cited ads' lack of balance of risk information and efficacy claims (¹ Also see "FDA Ad Division Letter Surge Shows Focus On Prominence Of Risk Information" - Pink Sheet, 1 August, 2005., p. 7).

The agency also plans to release a draft guidance on "Achieving Fair Balance in Print and Broadcast Advertisements" this year (² Also see "Patient-Reported Outcomes Promos Need “Substantial Evidence,” FDA Says" - Pink Sheet, 7 February, 2005., p. 29).

The National Consumers League suggested consumer understanding of drug effectiveness could be improved through the use of a "facts box."

"For DTC ads to truly educate and benefit consumers, they should not only contain understandable risk information but also information on the drug's benefits," NCL Health Policy Director Rebecca Burkholder said.

NCL believes "that a standardized information panel such as an Rx facts box - much like the successful format that is now being used for nutrition facts, [dietary] supplement facts and OTC drug facts - would be a better way to communicate risk and benefits to consumers."

"Many ads use vague qualitative terms to describe the benefits; for example, 'lower your number for cholesterol drugs.' The absence of actual benefit data may lead consumers to believe that a drug works better than it actually does," Burkholder said.

"A benefit box of published data on the chance of various outcomes with and without the drug should be considered for inclusion in DTC ads," Burkholder added. "Consumer perception of drug effectiveness could be improved with this type of information."

Studies have shown that consumers are less likely to have an exaggerated impression of a drug's efficacy if a benefits box is included in DTC advertising, American Medical Association Director-Science, Research & Technology Joseph Cranston said.

Office of Medical Policy Director Robert Temple asked whether adding specific benefit information to DTC ads would cause more confusion among consumers.

"I agree it is a tricky issue" but "I think...that it is possible for certain drugs to do that," Burkholder said. "We would like to see more studies on this issue."

Several participants at the hearing also favored delaying DTC ads following approval until post-marketing data are obtained and analyzed (³ Also see "DTC Ad Delay Pending Collection Of Post-Marketing Data Endorsed By ASHP" - Pink Sheet, 7 November, 2005., p. 9).

Is A Picture Worth A Thousand Words? – FDA Evaluation Of DTC Images Urged

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