Communicating Risk Information in Direct-to-Consumer Prescription Drug Television Ads: A Content Analysis

Abstract

Direct-to-consumer (DTC) television ads for prescription drugs are required to disclose the product's major risks in the audio or audio and visual parts of the presentation (sometimes referred to as the "major statement"). The objective of this content analysis was to determine how the major statement of risks is presented in DTC television ads, including what risk information is presented, how easy or difficult it is to understand the risk information, and the audio and visual characteristics of the major statement. We identified 68 DTC television ads for branded prescription drugs, which included a unique major statement and that aired between July 2012 and August 2014. We used subjective and objective measures to code 50 ads randomly selected from the main sample. Major statements often presented numerous risks, usually in order of severity, with no quantitative information about the risks' severity or prevalence. The major statements required a high school reading level, and many included long and complex sentences. The major statements were often accompanied by competing non-risk information in the visual images, presented with moderately fast-paced music, and read at a faster pace than benefit information. Overall, we discovered several ways in which the communication of risk information could be improved.

Look, Puppies! A Visual Content Analysis of Required Risk Statements Embedded in Direct-to-Consumer Pharmaceutical Advertising

“…In particular, DTCA has come under criticism for violating the FDA fair balance guideline by using distraction during the major statement. Researchers have found that pharmaceutical companies frequently present incongruent, positive visual imagery during auditory disclosures of negative risk information (Avery, Eisenberg, and Simon 2012; Kaphingst et al 2004; Macias, Pashupati, and Lewis 2007) or pair incongruent visual images with moderately fast-paced music and faster narration (Sullivan, Aikin, and Poehlman 2019).…”

“…One concerning practice that frequently occurs during the major statement is the appearance of positively valenced imagery that is incongruent with the concurrent audio content discussing a drug’s risks (cf. Glinert 2005; Kaphingst et al 2004; Sullivan, Aikin, and Poehlman 2019; Sumpradit, Ascione, and Bagozzi 2004). Although FDA guidelines suggest that pharmaceutical advertisers should avoid presenting incongruous or distracting imagery during the auditory presentation of risk, little empirical research has considered whether such advertisers do in fact adhere to this standard.…”

The Effect of Including Quantitative Information on Multiple Endpoints in Direct-to-Consumer Prescription Drug Television Advertisements

“…8,9 There is a wide literature on how to present quantitative information to facilitate understanding. 10–14 Although content analyses have shown that few DTC television ads contain quantitative information about drug benefits and risks, 15–17 providing quantitative information in DTC advertising has been recommended, 18 and previous studies have shown it can help consumers better understand benefit and risk information in print ads 19–22 and television ads. 19…”

Aging and Direct-to-Consumer Prescription Drug Television Ads: The Effects of Individual Differences and Risk Presentation

“…For several products, this involves a substantial recitation of medical or technical terms. A recent content analysis (Sullivan, Aikin, & Poehlman, 2017) showed 96% of ads contained at least one medical term in the major statement, with an average of three terms per ad.…”

“…Second, DTC television ads vary in voiceover speed, which often increases when the major statement is read (Sullivan et al, 2017). Among adults over 60 with hearing loss, Jenstad and Souza (2007) found participants' speech recognition scores were lower in conditions of rapid speech versus normal speech.…”