Consumers are just as skeptical about the FDA-approved patient labeling on the back of DTC ads as they are about the ads themselves. Regardless of how accurate and authoritative the information is, many consumers suspect that companies may be more interested in promoting their products than in helping individuals make informed decisions about whether to use them.
Can anyone really blame people for that attitude? For years, the media have published articles about the soaring costs of pharmaceuticals and the price disparity between brand-name products and their generic versions. Experts have repeatedly informed consumers that generics are cheaper, implying there is no need to request brand-name products. Reports of newly discovered adverse effects that resulted in injury and death have compounded that distrust.
Those factors have produced an underlying suspicion regarding the advertising of brand-name products. Consumers ask, “What are you trying to sell me now?” Ironically, many are unaware that some companies have developed readable and consumer-friendly Patient Package Inserts (PPIs) to replace the unreadable, technical Brief Summary that appears on the back of DTC ads.
Consumers fail to realize that PPIs are not advertising. Reviewed and approved by FDA, a PPI must include a balanced presentation of both risks and benefits. But because that information appears on the back of the ad, many consumers assume it is promotional in nature. They either ignore the information or treat it skeptically.
Surfing into Trouble
Consumers have put more and more faith in medical information provided by what they assume are “objective” sources. Such sources include the thousands of Internet sites providing that type of information.
Despite the trust many consumers have in Internet sites to be accurate and objective sources of information, the quality of the information is coming under attack. News reports recently noted that Internet sites may be “a quick link to bad health information.” The reports were based on a study by the University of Michigan Health System and published in the journal Cancer. The authors found that although Internet sites may be fast and convenient sources of information, their advice is far too often inaccurate, misleading, and unproven.
Of the material the researchers located for one disease, web site operators failed to have the content reviewed for medical accuracy or provide source attribution for 40 percent of the information. The researchers concluded that health professionals must improve the quality of the content available and must help patients find it.
Those findings only reinforce the fact that consumers need a way to know which information sources they can trust. As they try to become more informed, they increasingly ask which sources are objective. And even when the source may be legitimate, it often fails to provide the information in language a consumer can understand.
The new drkoop.com site provides an example. It attracts ten of thousands of visitors a day and provides an immense amount of information. However, the site operators obviously have geared the content to the most highly educated consumers. The majority of Americans, who read at the grade 6-8 grade level, will learn little from that content–and worse, may become unsettled or frightened.
Public Health Protection
Many consumers are unaware the FDA does not review or approve Internet site content, health material appearing in books and magazines, or the medication information that some hospitals, pharmacists, and physicians develop. That gives pharmaceutical companies an opportunity to take their DTC advertising one step further–and regain consumer trust–by providing purchasers with the authoritative, accurate information they seek. The challenge to the DTC strategy is getting consumers to recognize that the patient information in the ad is accurate and objective and meets FDA’s stringent fair balance requirements. In other words, the FDA-approved PPI should be the document that consumers know they can trust the most.
Although FDA is unlikely to put its “seal of approval” on DTC and PPIs in today’s political climate, there must be a way to inform consumers that they can trust PPIs. Given the recent, widely reported news about bad Internet health information, pharmaceutical companies could hardly find a more suitable time to take action that increases consumer awareness of the PPI.
Indeed, FDA must also be very concerned about the University of Michigan study linking inaccurate health information to the Internet. Because FDA seeks to protect the public health, it seems reasonable that consumers receive some urgently needed help in finding high-quality information.
So, what’s the next step? Get the message to consumers that DTC ads contain trust-worthy information. Consumers will learn that they can turn to pharmaceutical companies for accurate and objective information on prescription products.
Dr. Dorothy L. Smith is a consumer education expert and president of Consumer Health Information Corporation. The full-service company specializes in patient labeling, program development, and strategic planning for DTC campaigns.
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Published in Pharmaceutical Executive, September 1999. Copyrighted material; All rights reserved.