Serious and actionable risks, plus disclosure: Investigating an alternative approach for presenting risk information in prescription drug television advertisements

Abstract

Background

Broadcast direct-to-consumer (DTC) prescription drug ads that present product claims are required to also present the product's major risks. Debate exists regarding how much information should be included in these major risk statements. Some argue that such statements expose people to unnecessary amounts of information, while others argue that they leave out important information.

Objectives

Examine the impact of type of risk statement (unedited versus serious and actionable risks only) and a disclosure indicating that not all risks are presented on consumers' ability to remember the important risks and benefits of a drug following exposure to a DTC television advertisement (ad). Risk and benefit perceptions, ad-prompted actions, recognition of the disclosure statement, and evaluations of both the disclosure and risk statement were also examined.

Methods

A web-based experiment was conducted in which US adults who self-reported as having depression (N = 500), insomnia (N = 500), or high cholesterol (N = 500) were randomly assigned to view one of four versions of the television ad, and then complete a questionnaire.

Results

The type of risk statement had a significant effect on risk recall and recognition, benefit recognition, perceived risk severity (depression condition only), and perceived benefit magnitude (high cholesterol condition only). Disclosure recognition (using bias-corrected scores) ranged from 63% to 70% across the three illness samples.

Conclusions

The revised risk statement improved overall processing of the television ad, as evidenced by improved risk recall and recognition and improved benefit recognition. Further, the presence of the disclosure did not adversely affect consumers' processing of drug risk and benefit information. Therefore, limiting the risks presented in DTC television ads and including a disclosure alerting consumers that not all risks are presented may be an effective strategy for communicating product risks.

Introduction

Prescription drug advertising regulations (21 CFR 202.1) require that broadcast (television, telephone, or radio) advertisements (ads) that present product claims also present the product's major side effects and contraindications in either the audio or audio and visual parts of the ad. This requirement ensures that consumers are provided with a fair balance of information about product benefits and risks which both serve to inform consumer judgment and decision making about the advertised product. The statement of major side effects and contraindications is often referred to as the major statement or major risk statement. Typically, the amount of side effect or risk information in drug labeling is greater than the amount of benefit information, a characteristic which is similarly reflected in the ad. Including such information requires the use of time and space in the ad, which means that a requirement for a major statement necessarily constrains the inclusion of other types of content in an ad. Such risk information may affect consumer perceptions and decision-making, although available research does not yet offer unequivocal conclusions in that vein, as Frosch and colleagues have noted.1, 2 The major statement is mandated, yet there are various views as to the optimal form for such a statement. Many stakeholders have contributed to the debate regarding the design of major statements, including legislators, physicians, consumers, the pharmaceutical industry, and researchers.

Arguments in favor of maximizing the amount of information to be included in a major risk statement can draw support from both social science research on informed decision-making and available work on consumer preferences. Numerous scholars have argued that direct-to-consumer (DTC) television ads historically have not included adequate risk information and that some leave out important risk information necessary for informed decision-making.1, 3 Moreover, consumer research also suggests that consumers would prefer ads to contain more information about drug risks than they currently do. Consider, for example, studies finding that a majority of consumers agree that ads do not provide enough information about risks.3, 4, 5 Such consumer preferences are particularly important to note in light of the premise that the effectiveness of communication increases when messages reflect consumer preferences for format.6, 7, 8 In addition, consumers often do not seek information beyond DTC prescription drug ads. Friedman and Gould,³ for example, reported that only a small minority (roughly 17%) of study respondents said they would seek out additional information after seeing a DTC ad. Although it can be debated whether this number represents a positive or negative outcome, it indicates that by not seeking additional information or visiting a health care provider, DTC ads are the main, and perhaps only, source of drug information for some individuals. As a result, DTC television ads arguably offer a prime opportunity for risk information presentation, so limiting major risk statements might represent a missed opportunity.

Is more necessarily better in the case of risk information, however? Some researchers have noted that consumer preferences may not necessarily relate to their actual ability to recall or understand risk information (e.g., Aikin, O'Donoghue, Swasy, and Sullivan⁹; Barnes et al.¹⁰; Hamstra et al.¹¹), which means researchers should look to evidence beyond expressed preferences. Moreover, as noted earlier, typical broadcast ads have distinct time limits that require trade-offs. Given the typical length of a DTC commercial at 30–120 s, the inclusion of complex or lengthy risk information in that time frame may reduce consumer resources to process important parts of an ad. Extensive major risk statements conceivably could expose people to an overwhelming amount of information, which could lead to an overall reduction in comprehension due to cognitive overload or strategic avoidance. Even if consumers engage and process a thorough presentation of risk information, they may not be able to interpret and use the information because of constraints on working memory or information processing style.12, 13 In this way, the additional risk information would be physically present but functionally absent.

Earlier studies have reported mixed results regarding the potential influence of risk information amount and type on consumer recall and recognition of pertinent facts. For example, research by Morris and colleagues in the 1980s failed to find a consistent pattern of effects. One study¹⁴ found no difference in recall and knowledge when four versus two risks were presented, yet two follow-up studies found that ads with four¹⁵ or six¹⁶ risks actually produced greater risk recall than when two or three risks were presented, respectively. In another study, Hoek et al.¹⁷ tested the recall of information in a standard DTC ad versus one with limited information. The unedited version mentioned two side effects and two contraindications and recommended that patients consult their doctor to determine if the medication is suitable for them. The limited information, or edited version, contained the same two side effects but did not contain the precaution or contraindications. Contrary to predictions, the study failed to find any significant difference in the recall of the drug's indication, risks, or benefits between conditions. In a more recent study, Kavadas et al.¹⁸ found that highly involved consumers recalled fewer ad claims when exposed to a high ratio of risk-to-benefit information (e.g., 6 risk and 2 benefit claims) than those exposed to an ad with a low risk-to-benefit ratio (e.g., 6 benefit and 2 risk claims). This outcome suggests that listing a large number of additional risks could hinder memory for ad concepts beside risks.

Although valuable in their contribution to the literature, the studies summarized here are limited in terms of the small number of risks presented across conditions. Anecdotally, recent DTC television ads are seen as including a very long list of risks.¹⁹ Whether consumers can adequately process a large number of risks remains an open question and one that is critical to address given the potential implications for informed consumer judgment and decision-making.

Limitations to working memory may also affect decision-making.20, 21, 22, 23, 24 People may be better able to make decisions based on an abridged and well-curated set of risks than under the circumstances of more complete information presentation. As just one example, Kahn and Kupor²¹ demonstrated that a medical product may be perceived as less threatening when nonserious risks (congestion, fatigue) are presented alongside serious risks (seizures) compared with presentation of serious risks only. Inclusion of more nonserious risks promoted less accurate judgments about risk in this case. Similarly, Mayer and Moreno²³ argue that a cognitive load-reducing technique (what they call “weeding”) that eliminates interesting but extraneous material could help prime consumers to engage only in essential processing of the critical information presented. If risk information were restricted to only the most critical drug facts, then consumers conceivably would have more working memory available for information processing and improved decision-making.

The notion of an abbreviated risk statement has invited concerns and critiques. Limiting the amount of presented risk information requires in many cases omitting some specific risks or attributes of risks that, in turn, could reduce consumers' opportunity to learn various drug facts and limit informed decisions about whether to seek out those treatments (e.g., Davis²⁵). One approach to enhance consumer comprehension while simultaneously reducing the amount of risk information presented is to focus only on the risks that are serious and actionable. Examples of serious and actionable risks include suicidal thoughts or behavior and allergic reactions, whereas unpleasant taste and morning drowsiness, while actionable, might be considered insufficiently serious to warrant inclusion in the face of more serious risks. Limiting the risks to those that are serious and actionable serves a dual purpose. First, it may reduce the cognitive burden that may result from having to process a large amount of information. Second, serious and actionable risks may be perceived as more relevant, thus improving attention and comprehension of the risk statement. Such an approach addresses concerns raised by some that DTC ads often do not sufficiently distinguish between clinically important and unimportant problems.26, 27, 28 Relatedly, certain signaling techniques might also facilitate the success of a relatively brief major risk statement, for example, by providing a cue to identify the risks as serious or important at the start of the risk statement29, 30 (although also see O'Donoghue, Sullivan, Aikin, and Betts³¹ for negative findings on this topic). Adding such a cue necessarily adds some length to the major statement, but it may also convey important information about the degree of risk entailed by the risks that follow.

Another complementary option to counter concerns is to disclose to the consumer that the presented risk information has been restricted. Advertisers could include a disclosure statement indicating that the risks presented are not a full list and directing consumers to seek additional information, for example, by consulting one's doctor or consulting patient labeling, if available. Such a strategy may help address the concern that simply omitting risk information might lead consumers to believe there are no other risks beyond those mentioned in the ad. Whether consumers would notice such disclosure is not yet settled, however. Earlier research cited by Morgan and Stoltman³² found low levels of recall for warnings and disclosures for a variety of products.33, 34, 35, 36 Special steps should be taken, then, to ensure that such a disclosure would be noticed and processed. For example, presenting information using both visual and audio modalities has been shown to result in better processing outcomes than single-modality presentations (see, for example, Aikin, O'Donoghue, Squire, Sullivan, and Betts³⁷ and Brasel and Gips³⁸). Still, investigation within the specific context of prescription drug television advertising is needed.

Assuming consumers attend to the disclosure statement, research is also needed to examine whether the presence of this statement aids or hinders overall consumer understanding of statements in the ad. No studies to date have explored the impact of this specific type of disclosure, but initial research on the use of other contextual statements in television ads, including prescription drug ads, suggests there may be little impact on consumers' information processing, recall, and understanding. For example, a study that investigated the impact of adding a toll-free statement to DTC television ads found that although the statement was well recognized, processing of other ad elements was not significantly affected.³⁷ Similarly, another study presented a disclosure (in text form in the lower portion of the screen for a limited time), and although participants reported feeling competent in their ability to recall the disclosure statement, the actual recognition of it was significantly lower compared with other ad content.³² More broadly, at least some previous research has found that government-mandated disclosures can have unintended effects on consumer behavior (e.g., Green and Armstrong³⁹) and understanding.⁴⁰ Further research is needed to explore whether including a disclosure about risks specifically has a detrimental, beneficial, or neutral effect on consumer recall, perceptions of a product's risks and benefits, and other ad-prompted actions.

The goal of this study was to experimentally test the effects of two actions on consumer perceptions: (1) limiting the risks in the major statement to those that fall into the categories of serious or severe, such as boxed warnings, and those that are actionable, such as those a patient would be able to recognize and do something to mitigate or avoid, and (2) including a disclosure to alert consumers that other product risks are not included in the ad. The project team also sought to replicate the study across three unique contexts and with three illness populations: consumers who self-reported as having depression, insomnia, or high cholesterol. These medical conditions were chosen because they represented medical conditions with low, medium, or high prevalence, they affected both men and women, they represented a mix of chronic and asymptotic versus symptomatic conditions, and they were all advertised to consumers. Of note, because the ads for each medical condition vary in ways not accounted for by our experimental manipulations, we do not aggregate findings across medical conditions; rather, we replicated the design in this manner to learn about the generalizability of our findings across ads targeted at different medical conditions. Outcomes of interest comprised memory of the disclosure as well as the risk and benefit statements, perceived product risk and benefit, information seeking and other ad-prompted actions, and perceived clarity of the risk and disclosure statements. Based on the issues and literature summarized above, key research questions are presented below.

Research Question 1. Does limiting the risks presented in DTC prescription drug television ads (and including a signal about the severity of the risks to follow) improve retention of the drug's serious and actionable risks and benefits?

Research Question 2. Does limiting the risks presented in DTC prescription drug television ads (and signaling the risks as serious) affect consumers' perception of the drug's risks and benefits?

Research Question 3. Does limiting the risks presented in DTC prescription drug television ads (and signaling the risks as serious) affect intentions to seek more information about the drug?

Research Question 4. Do people have more positive evaluations of the revised versus unedited risk statement?

Research Question 5a. What percentage of people notice an advertisement disclosure regarding limits of included risk information?

Research Question 5b. Do people have positive evaluations of the disclosure?

Research Question 6. Does including a disclosure alerting consumers that there are other risks not disclosed in the ad improve retention of the drug's serious and actionable risks and benefits?

Research Question 7. Does including a disclosure alerting consumers that there are other risks not disclosed in the ad affect consumers' perception of the drug's risks and benefits?

Research Question 8. Does including a disclosure alerting consumers that there are other risks not disclosed in the ad affect consumers' intentions to seek more information about the drug?

Research Question 9. Does including a disclosure moderate the relationship between limiting risks and recall and recognition of serious and actionable risks, risk perceptions, and ad-prompted actions?