The Food and Drug Administration (FDA) plans to conduct research into direct-to-consumer (DTC) pharmaceutical drug ads by measuring 1,500 participants’ understanding of side effects' risks after viewing TV ads. The focus of the new study will be on what is known as the "major statement" — that endless list of side effect warnings, generally read in a lowered voice at an abnormally rapid pace.

“There is concern that as currently implemented in DTC ads, the major statement is often too long, which may result in reduced  consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects,” the agency said in a statement issued last week. “At the same time, there is concern that DTC TV ads do not include adequate risk information or leave out important information.”

To test its hypothesis that limited disclosure is better, the FDA will recruit consumers who identify as having been diagnosed with one of three possible medical conditions. The test will take place over the Internet and require about 30 minutes. People employed in either health care or marketing will be excluded. According to the FDA, each year drug companies spend $25 billion promoting their prescription products in the U.S. and about one-fifth of that money is spent on DTC marketing campaigns. So what exactly is all the fuss about?

The Ads Speak For Themselves

A mash-up of a few of these ads (courtesy of lapsus 5, YouTube) speaks volumes. Who wouldn’t think twice about taking a medication after listening to side effects that include a long list of relatively mild (dizziness, nausea, dry mouth), moderate (constipation, fainting upon standing) and downright serious (unusual changes in behavior, thoughts of suicide, stroke)? If you agree with the general premise that every drug has some side effects yet some conditions require medical treatment, then these commercials may potentially be doing a disservice by confusing or scaring off those who truly need a medication.

In other cases, prescription drug ads are criticized as much for their imagery as their major statement. In the following ad (courtesy of howsthepeepingtommy, YouTube), some see the blue robe as belittling a serious mental health condition.

 

Worldwide, only the U.S. and New Zealand legally permit direct-to-consumer advertising of prescription drugs. Presumably, most other countries consider it a bad idea. Those who dislike the practice, according to ProCon.org, might argue that the money spent on advertising is passed on to consumers. Ads cause people to pick medicines based on the effectiveness of the ad rather than the effectiveness of the medication, and ads cause patients to desire and request medications from their doctors that may be unnecessary, thus leading to an over-medicated and unhealthy society. Those in favor of these ads argue that consumers should be informed about medical conditions and therapies, and the ads even help to de-stigmatize certain conditions. The ads might even be said to help demystify medical treatment and doctors themselves, who should not be seen in such a powerful, almost godly light. Arguments for and against aside, what matters most in the end about any advertisement is its truthfulness.

A recent study conducted by researchers at Dartmouth University and the University of Wisconsin found that “potentially misleading claims are prevalent throughout consumer-targeted prescription and nonprescription drug advertising on television.”  Specifically, the study found that 33 percent of the most emphasized claims in prescription and over-the-counter drug ads were objectively true, 57 percent were potentially misleading, and 10 percent were false. Overall, prescription drug ads presented more objective truth (43 percent) and fewer blatantly false claims (just two percent) than nonprescription drug ads.

 

Source: Faerber AE, Kreling DH. Content Analysis of False and Misleading Claims in Television Advertising for Prescription and Nonprescription Drugs. Journal of General Internal Medicine. 2014.