Risk vs. Benefits: The Consumer Holds the Trump Card

DTC advertising has added an entirely new dimension to the role of consumers in making decisions about prescription medications. Consumers are now on the cutting edge-they are very concerned about the risks vs. benefits of a medication because they are the ones who are going to have to live with any consequences of the drug therapy.

I was recently invited to speak at a Drug Information Association (DIA) meeting in Manhattan, where I joined a panel of FDA experts and representatives of a major advertising agency and public relations firm to explore the topic, "New Ways To Promote ... Marketing of Pharmaceuticals: How To Be Aggressive and In Compliance." I was asked to evaluate DTC ads and patient education materials from the consumer's perspective.

In our discussion, I noted that when a person's health is at stake, they will do all they can to protect it. Each consumer will decide if the benefits of a medication are greater than the risks they are personally willing to take. But in order to make an informed decision, patients need to be able to understand both the benefits and the risks. The information given to them in the Patient Package Insert (PPI), patient compliance materials, and DTC ad (both the front and the back of the ad) and collateral materials must make sense to them. On the other hand, if the symptoms are presented in a way that patients can't recognize from their own experience, the warnings will be meaningless.

In this example taken from an actual DTC ad, put yourself in the place of the consumer. Would you be able to recognize the early warning signs of any of these "possible side effects" so you could take appropriate action that would allow you to continue taking the drug?

What are the possible side effects of [PRODUCT]?

Eye: Cataracts, conjunctivitis/conjunctival infection, dry eyes, ocular itchings, severe vision loss, subconjunctival, sub retinal or vitreous hemorrhage.
Heart: atrial fibrillation, peripheral vascular disorder, hypertension, varicose veins.
Metabolic/nutritional: Albuminuria, creatinine increased. Urogenital: Prostatic disorder.

I guarantee that the average consumer won't understand these terms. My concern is that this listing of medical terms will work against the effectiveness of the DTC ad as well as lead to decreased patient retention.

Symptoms of adverse events must be presented in terms that patients can recognize and understand. If you must inform patients that your product could cause liver dysfunction such as hepatitis, go the extra step and tell the patient the warning signs of hepatitis in practical language. For example, "Call your doctor if you become unusually tired; lose your appetite; or develop nausea and/or vomiting, a yellow color to your skin or eyes, or dark-colored urine or pale stools."

Consumer Health Information Corporation's Expertise
in Patient Communications

Developing messages for consumers and patients on medications requires a very specialized blending of medical information, regulatory requirements, marketing techniques, health literacy principles, patient compliance strategies, and behavior modification techniques... then translating everything into language the average consumer can understand ... and reinforcing it with an effective "patient-friendly" design.

Even though a DTC campaign or a patient information program has met all the requirements of the company's clinical, marketing, legal and regulatory teams as well as the FDA regulations, it can NEVER be maximally effective if the consumer does not understand the information.

Consumer Health Information Corporation's experts in patient compliance and consumer behavior know how to develop "consumer-friendly" materials that motivate patients to take the medication correctly. Only then can the product fulfill its potential.

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