Impact of Risk Disclosures Through Direct-to-Consumer Advertising on Elderly Consumers' Behavioral Intent

The new FDA guidelines on Direct-to-Consumer Advertising (DTCA) of prescription drugs require the sponsor to present balanced benefit-risk information. However, data suggest frequent lack of compliance with these guidelines. Misinformation to consumers can have serious implications on health and safety. The study objective was to explore the impact of variations in risk disclosures through DTC print advertisements on consumer attitudes and behaviors. A 2 x 2 factorial design was implemented, where the risk statements in the advertisements varied in number and specificity. A convenience sample of 240 elderly (>=60 years) male and female participants was recruited. The participants were asked to read a print advertisement and then complete a questionnaire.Participants exposed to specific risk statements were less likely to look for additional information (p<0.01) and adopt the advertised drug (p<0.01). Additionally, they held less favorable attitudes toward the advertised drug (p<0.01) as compared to those presented with general risk statements. The number of risk statements presented had no significant effect on attitudes or behaviors. However, a two-way interaction effect of number and specificity of risk statements on likelihood of adoption was observed. This interaction demonstrates that when participants were exposed to two risk statements, they did not significantly differ in adoption rates as a function of specificity. However, when exposed to four risk statements, specificity had a significant impact on adoption of the advertised drug, such that participants receiving four specific risk statements were less likely to adopt the advertised drug. These findings have significant implications health policy. Presentation of highly specific risk information can adversely affect healthcare seeking behavior. Thus, drug manufacturers should aim at providing fair balance of benefit-risk information to lay consumers without compromising public health. There is also a need to re-evaluate and develop explicit FDA guidelines on fair balance of risk information presented in DTCA. Furthermore, the current research indicates that highly specific drug risk information can heighten perceived risk, which may result in reduced compliance.