Put Side Effects in Perspective

Imagine you are a consumer reading a DTC ad for a certain medicine. The ad says the medicine will help 9 out of 10 people taking it. The ad also says that 2 percent of patients taking it could have serious side effects, such as blood clots, strokes, and decreased vision.

Naturally you start wondering if you would be part of that unlucky 2 percent; it is just human nature to be more concerned about the risks than the benefits. Consumers do not know what “2 percent” means as a statistic and really don’t care. They want to know what it means for them. Unfortunately, there is nothing in the ad that puts the risk in perspective.

The result? The DTC message has instilled doubts about the risks of taking the medicine instead of confidence in its benefits.

Fair Balance?

Too many pharmaceutical companies communicate product “risk” information in DTC ads in a “risky” manner. Perhaps companies don’t know how to select the particular side effects consumers need to know about. Or maybe they don’t know how to describe side effects so consumers can make informed decisions about the risks and benefits.

When companies take the path of least resistance and simply reprint the technical language from the professional labeling, they may meet minimum requirements, but they do themselves and consumers a disservice. Consumers need to know the most common side effects and what to do if side effects occur. Companies must give consumers practical and adequate information on benefits and risks.

It sounds like common sense, but look at what DTC ads in magazines are saying. Ask yourself if the fine print is going to alarm you or build your trust in the product.

Claritin (Schering Corporation):

The front of the ad says the medicine “has a low occurrence of side effects, which occurred about as often as they did with placebo (sugar pill). Most common were headache, occurring with 12 percent of people; drowsiness, 8 percent; fatigue, 4 percent; and dry mouth, 3 percent.”

Does 12 percent mean there is a high chance or a low chance of getting a headache? The other side effects are apparently less common, but nothing here tells the reader how to interpret the statistics.

When I turn the page to learn more, I am faced with a page of technical information packed with more statistics and tables comparing Claritan with placebo and two other medicines. That does not help a bit.

I do not care that “in an 18-month carcinogenicity study in mice and a two-year study in rats, loratidine was administered in the diet at doses up to 40mg/kg (mice) and 25 mg/kg (rats).” I do not understand any of the section about “AUC data,” “significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas),” and “mutagenicity studies.” I just know the word “tumor” and decide this drug is too risky. Now contrast that example with a DTC ad that puts the side effects in perspective for consumers.

Viagra (Pfizer, Inc.):

This product carries serious risk if taken with medicines that contain nitrates. You could have a heart attack or stroke! However, the language of the warning clearly presents the risk without overly frightening people.

For example, it states that “VIAGRA must never be used by men who are taking any medicines that contain nitrates…If you have taken VIAGRA with any nitrate medicine or illicit drug containing nitrates, your blood pressure could suddenly drop to an unsafe level. You could get dizzy, faint, or even have a heart attack or stroke.” The ad mentions prescription and illicit drugs that contain nitrates and directs readers to consult a physician for more information

The manufacturer has carefully selected, ordered, and discussed the side effects so the consumer understands the early warning signs. This ad avoids using terms like “myocardial infarction” or “cerebrovascular accident.” It clearly describes them as heart attack or stroke.

The Patient Package Insert also cautions that “During sex, your heart works harder. Before you start any treatment for erectile dysfunction, ask your doctor if your heart is healthy enough to handle the extra strain of having sex.” Every man reading this now knows that the risk of heart problems could be due to just having sex and that not every side effect is due to taking the drug. That puts the side effects into proper perspective.

Pfizer also adds some practical advice: “If you take VIAGRA after a high-fat meal (such as a cheeseburger and french fries), the medicine may take a little longer to start working.” The company went the extra mile to inform people how to take the drug correctly and explain why they should avoid taking VIAGRA after a high-fat meal.

A Matter of Trust

When DTC ads ignore the benefits and focus on the risks, they are less effective than they could be. Why deliver a message in terms only a doctor or a pharmacist understands? Those professionals do not bear all the risks when taking a medicine–in fact, they are paid to prescribe and dispense it.

Consumers need to get product information in a straightforward manner. Unless companies explain the risks clearly and simply, we will continue to distrust the information that pharmaceutical companies disseminate.

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, March 1999. Copyrighted material; All rights reserved.