Building a better drug ad: Direct-to-consumer marketing

High cholesterol. Erectile dysfunction. Insomnia. Depression. Such conditions are just a few examples of the many health complaints now on consumers' radar. They also are the subject of direct-to-consumer advertising of prescription drugs and devices either via TV and radio or news pages.

With DTC's proliferation -- the drug industry spent $4 billion on it in 2004 -- the serious questions about the phenomenon have taken on escalating importance.

Is DTC advertising educational? Does it maintain a fair balance in communicating a drug's or device's benefits and risks? What impact do DTC ads have on the doctor-patient relationship? How do the ads affect health care costs?

These matters were among the issues explored by the AMA in a beefed-up guidance issued last month at its Annual Meeting. The guidance, part of a Board of Trustees report, acknowledges that these ads are likely here to stay. Therefore, the goal is to make them better. By seeking to ensure that DTC ads are educational and not misleading, the AMA's recommendations are a step forward.

For instance, the Association urges that advertisements responsibly inform consumers about the drug or device and the disease it is meant to treat and provide objective, easily understood information about the medication's benefits and risks. The Pharmaceutical Researchers and Manufacturers of America advanced a similar set of principles last year. But the AMA report also offers specific insights regarding the subtle challenges involved in achieving them. It asserts that simply providing equal amounts of benefit and risk information is not enough.

Many physicians, the document notes, believe that DTC ads cause patients to overestimate a treatment's benefits or trigger confusion about the relative risks involved. The AMA cites a body of scientific research supporting this view, including recent psychological research that studies DTC ads' cognitive accessibility -- or the ease at which people can find, understand, remember and use drug information. Some findings:

• TV drug ads often place risk information in the middle or just past it. Such placement can make drug risks difficult to process and retain.
• The word "you" commonly is used in presenting benefits but rarely is used regarding risks, thereby personalizing the potential positives.

Thus, the AMA views consumer confusion as an important point of focus. The new recommendations urge that ads reflect the drug's or device's true efficacy based on the clinical trials that led to its approval. And not only should the amount of time or space devoted to benefit and risk messages be comparable, but the cognitive accessibility of this information also should be, too.

But the AMA guideposts do not stop here. Ads also should discourage self-diagnosis and encourage consumers to consult their physicians. The portrayal of doctors by actors should be avoided because it could be misleading. In cases where an actor is cast in such a role, the spot should include a prominent disclaimer. Similarly, physicians -- retired or active -- should shy away from appearing in DTC promotions. The AMA also calls on the industry to place print, broadcast and other forms of DTC advertising in a way that avoids exposure by audiences that are not age-appropriate for their messages.

Finally, the Food and Drug Administration should review ads before they appear. The AMA also specifically calls for increased agency funding to support this activity. And physicians should be educated about a new product or updated therapeutic indication before a campaign begins.

But even as the guidelines evolve, fundamental DTC advertising concerns persist about the ads' impact on the physician-patient relationship and drug utilization and costs.

To find answers, the AMA will urge the FDA, other federal agencies and the pharmaceutical industry to do research. If harm is determined, increased legislation should be considered.

DTC advertising has long been a concern for physicians. Now, the AMA's updated guidelines represent an effort that can help move these ads in a positive direction, one where they can be used as educational tools to help patients, physicians and the practice of medicine.