What Side Effects?

"We contend that the [U.S.] Food and Drug Administration [FDA] -- in regulating direct-to-consumer advertisements to list side effects that range from the serious, such as stroke and thoughts of suicide, to those less serious, such as dry mouth and headache -- have diluted consumers' judgements of the overall severity of the drugs' side effects."
Researchers, new DTC study

"For professional advertisers, the idea that long disclosures will work is ridiculous."
"Good advertising has short, simple messages that people can understand and act on. These long messages we've seen in DTC [direct-to-consumer] is a broken regulation that needs to be fixed quickly."
John Kamp, head, Coalition for Healthcare Communication

"All drugs, whether prescription or over-the-counter, can have side effects. Side effects can range from headaches and upset stomach to those more serious such as liver or kidney injury, heart problems, or even death. Some side effects can be predicted in some people based on what occurred during the drug’s testing, but some rare events occur unexpectedly when many more people take the drug after it is approved."
U.S. Food & Drug Administration

Well-intentioned it may have been for the U.S. FDA to require the pharmaceutical industry to list all the potential side-effects that might be encountered as a by-product of a particular drug's use, but it seems that unintentionally their inclusion in television advertising might have a lulling effect in the minds of viewers. Too much detail, too much content may lead the potential consumer to the belief that divulging all in this manner provides some kind of assurance that there is nothing to be concerned about.

In other countries such as Canada, DTC advertising is not permissible by law, although the law is rarely enforced through Health Canada. Still, if prescription products are advertised they are done so in a manner that fails to link the drugs with the cause of their use, as a means of getting around the prohibition. DTC advertising in Canada is a muted affair, barely noticeable, in comparison to the loud and garish prominence of DTC pharmaceutical advertising commonly seen in the United States.

The FDA doubtless felt it was aiding the consuming public in requiring pharmaceutical companies to list all possible side-effects of drugs. Their purpose was to alert consumers to all and any potential risks in drug use. Unfortunately, it seems people have no wish to be alerted. Research has indicated that people have a tendency to pay little attention to the most serious side effects and instead they focus on the purported benefits of the drug, a newly-published study points out.

Researchers must have felt incredulous at their own results; instead of creating a cautionary atmosphere with the revelations of possible side-effects in drug use, the drugs have become a more marketable commodity, with increased sales resulting from the situation, according to researchers whose study was published in Nature Human Behaviour. Six experiments were operated by the researchers with over 3,000 participants in the United States.

The purpose of the study was to test whether the provision of this information highlighting major and minor side effects reached its purpose to increase awareness; instead it was found to reduce overall perception of the severity of side effects. The United States represents one of two countries permitting this type of prescription drugs promotion [along with New Zealand]. Critics point out that all too often advertisements promote new, higher-priced medicines, encouraging consumers to seek unecessary prescriptions.

The American Medical Association unsuccessfully campaigned to ban direct-to-consumer advertising two years ago. Three years ago the FDA launched a study of its own in hopes of determining whether the long list of potential risks could lower consumer understanding, minimize important risk data, and cause some people to potentially skip medicines, fearing side effects. The pharmaceutical industry had its own concerns over advertising requirements feeling consumers could react unfavourably to drugs listing side effects.

They now doubtless feel relief that the new research posits that some consumers may tune out these warnings in large part. Whatever the Food and Drug Inspection Agency determined from its own study has not been released to the public, however.

"If FDA is keen that all side effects are listed, especially if certain ones impact a subsample of the population, then one route is to categorize the seriousness of these side effects by increasing the attention people afford to those side effects, such as 'heart attack and stroke' versus side effects such as 'headache and nausea'."
"We show that simply highlighting and providing larger red font to the more serious side effects, while keeping to normal black font to the less severe side effects, helps mitigate the problem."
Niro Sivanathan, lead author, associate professor of organizational behavior, London Business School