FDA requires drugmakers to include both major and minor side effects in advertisements, but a study suggests that the information could be overwhelming and interfere with a consumer's understanding of a drug's true risk.
FDA in 1997 mandated that drugmakers allot equal space in in direct-to-consumer (DTC) print and broadcast ads to a drug's benefits and risks to ensure consumers have a balanced understanding of the drug's risk-benefit profile.
For the study, published in Nature, researchers sought to examine how U.S. consumers respond to drug-related ads. To do so, they conducted six experiments involving more than 3,000 participants and DTC advertisements for the drugs Lunesta and Cymbalta. The researchers had participants watch two versions of the ads: one that listed both major and minor potential side effects of the drugs and one that only listed major potential side effects of the drugs.
Overall, the researchers found DTC ads that contained both the major and minor potential side effects of a drug diluted the value and importance of each piece of information in the ad.
Specifically, the researchers found that consumers who saw DTC ads that listed two major potential side effects and two potential minor side effects considered Lunesta and Cymbalta to be safer than consumers who viewed DTC ads that listed only the drugs' major potential side effects. The researchers also found consumers who viewed the drugs as safer had a higher preference for the drugs and a greater willingness to pay more for the drugs.
However, the researchers found consumers appeared to remember a drug's major side effects when print ads listed the side effects in bold text, even in cases when the ads also included the minor side effects in regular text.
Study authors Niro Sivanathan, associate professor of organizational behavior at the London Business School, and Hemant Kakkar, a fourth-year doctoral candidate in organizational behavior at the London Business School in Scientific American wrote that the study's findings "add to the chorus for the redrafting of policies surrounding the communication of risk of pharmaceutical drugs."
They explained, "These findings raise the ethical and practical dilemma of achieving transparency with the consumers by sharing all potential side effects, while safe-guarding them against" so-called "argument dilution bias," which occurs when an individual's "conclusions" about something "are roughly based on averaging both the relevant and non-relevant information, instead of ignoring the non-relevant information." They explained, "In other words, the non-relevant information dilutes the value and importance of the relevant information."
The researchers added that the study also could have implications for risk communication beyond DTC drug ads, including "physicians who have to communicate varying risks of an experimental procedure" and "public service advertisements that attempt to highlight the risk associated with life choices" (Paavola, Becker's Hospital Review, 2/21; Sivanathan/Kakkar, Scientific American, 2/20; Baker, "Vitals," Axios, 2/21).
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