Industry vs. FDA Regarding DTC Animation Study

Transcription

1 December 2016 Vol. 15, No. 5 Pharma Marketing Network Industry vs. FDA Regarding DTC Animation Study It s Unnecessary & Unscientific Author: John Mack Published by: Pharma Marketing Network PMN

2 Vol. 15, No. 5: December 2016 PMN On February 23, 2016, FDA announced that it proposed to study Animation in Direct-to- Consumer Advertising (Docket No. FDA N-0538; It is important to examine whether animation in drug ads inflates efficacy perceptions, minimizes risk, or otherwise hinders comprehension of drug risks and benefits, said FDA in its Federal Register announcement. For more details regarding the particulars of this study, read Cute & Creepy DTC Drug Ad Mascots ; AbbVie, Astrazeneca, Eli Lilly, GSK, Merck, Regeneron Pharmaceuticals and other industry stakeholders have submitted comments to the FDA regarding this study. This article summarizes several of these comments and FDA s responses to them. Why Now? Perhaps the bad publicity surrounding certain DTC ads that ran during the 2016 Super Bowl influenced the FDA to propose this study. Valeant, for example, ran an ad for Xifaxan for the treatment of irritable bowel syndrome with diarrhea (IBS-D). The ad featured the animated character nicknamed variously Gut Guy, Bubble Guts, or Bubble Guy. Some people consider the character disturbing and creepy. No Practical Utility Merck was not impressed by the study: While the proposed collection of information may be interesting to learn, it may not have practical utility for the general public and may be unnecessary for the proper performance of FDA's functions. Regeneron expressed a similar concern; i.e., the results from this study should not be used to guide or influence FDA's current thinking on the use of animation in DTC ads. But FDA pushed back: On the contrary, said FDA, this particular study has the potential to directly influence policy in an area that we have no prior research on. Although one research study cannot answer all questions, we believe we have designed the study in such a way that we will be able to provide information on the issue of animation in DTC ads. Because there is no previous research of this kind, this will be an informative study that will help FDA develop guidance and policy in the future, should the research reveal a need to. Animation is Protected Speech Meanwhile, The Advertising Coalition, representing national trade associations whose members prepare and deliver advertising through television, newspapers, magazines, and the Internet, whipped out its 1st Amendment gun: [T]his study must be viewed through the lens of two Supreme Court rulings that explicitly protect commercial speech, including advertising. In particular, the FDA must be mindful of the Supreme Court's ruling in Zauderer v. Office of Disciplinary Counsel, which held a state regulation of an advertising illustration unconstitutional and subject to strict scrutiny. Eeriness of Certain Types of Animation Perhaps the most interesting comments had to do with measuring the eeriness of certain animations. Both Astrazeneca and Eli Lilly objected to study Question 26, which asks test subjects to rate the eeriness of ads using rotoscoped characters. In 2007, a Pfizer Celebrex TV ad used this animation technique (see Figure 1, below). Figure 1. A Rotoscoped Image in a Celebrex TV Ad We feel that question 26 should be deleted because it is a leading question, said Astrazeneca (AZ). If not deleted, change eerie to strange. Lilly contended the question is leading because it directs participants to respond only negatively about their perceptions of the character. The Uncanny Valley Theory FDA s response to AZ referred to the uncanny valley theory concerning rotoscoped images as cited in this publication: Clayton, R.B. and G. Lesher, The Uncanny Valley: The Effects of Rotoscope Animation on Motivational Processing of Depression Drug Messages. Journal of Broadcasting and Electronic Media. 2015;59(1):

3 Vol. 15, No. 5: December 2016 PMN Given the uncanny valley theory concerning rotoscoped images, said FDA, we feel it is crucial to maintain this specific question [26] about the eeriness of the character. Further, in response to Lilly, FDA said: We agree that this is an unusual question and may seem off putting without context. However, previous research has compared live action and rotoscoped action in advertisements and has determined that people feel uncomfortable with rotoscoping because it is very similar to what we expect from live renditions, but not exactly. This theory is called the uncanny valley theory. Question 26 comes directly from this previous research and we feel strongly that we need the question as it is to ground our comparison of live action and rotoscoping in the prior literature. According to the authors of the research cited by FDA, The Uncanny Valley Theory, proposed by Mori (1970), provides a theoretical explanation as to why viewing animated images or messages may evoke a strange viewing experience. Originally linked to Freud s 1919 concept entitled The Uncanny ( Das Unheimliche ), the uncanny valley theory assumes that mismatches among human and nonhuman features strike discords among the observer, and the overall effect is eerie. This dip in the observer s affinity for the object is called the uncanny valley. Figure 2: The Uncanny Valley Theory In the case of viewing rotoscoped-animated characters in depression drug commercials, the uncanny valley theory would predict that viewers would reject animated characters once they begin feeling eerie or begin to experience unpleasant emotions due to the uncanny human realism of the animated characters. That is, when human features look and move almost, but not exactly, like natural human beings, it evokes a negative, or repulsive response. Mori theorized that such an effect, or revulsion, is similar to viewing an animated corpse (Mori, 1970/2012). Animated corpse is an apt description of the Pristiq wind-up doll. Pfizer, which did not submit comments to the FDA regarding this study, is responsible for this definitely uncanny human realism of an animated character in its Pristiq ad. The eerie doll represents how it feels to be depressed; i.e., like a walking corpse! At the end of the ad, the doll transforms into a happy, although perhaps still eerie, doll. What s Animation Good For? GSK, which also discounts the usefulness of the study, made some comments about animation in drug ads that are worth repeating here: In addition to animation being used to grab attention, increase ad memorability, and enhance persuasion, there are other important reasons a sponsor might choose to use animation in DTC advertising: Animation can be a very effective way of educating consumers about complex conditions in simple ways. Animation can be used to help consumers quickly identify that an ad is relevant to them/ their condition. Animation is a tool that can de-personalize an ad to help make it more relevant to more people with the medical condition. 2

4 Vol. 15, No. 5: December 2016 PMN Is The Study Unscientific? FDA seemed a little perturbed by comments suggesting that it's research is unscientific and should not be used to inform its guidelines. In its comment to Regeneron, FDA said: Although this is the first study to directly examine animation in DTC ads the way we have proposed here, the research we have designed is robust and well controlled. As trained research psychologists, we adhere to the highest standards in terms of rigorous control, prespecified hypotheses, appro- priate statistical analyses, and reasonable and responsible interpretations. Our research undergoes many internal and external reviews before and after data collection, including a stringent OMB review (of which public comment is a part), multiple levels of internal clearance, and peer review at well-respected academic journals in relevant fields. Although FDA never exclusively uses the findings of one scientific study to make policy decisions, the quantitative research we conduct is one part of the calculus that FDA uses to inform policy decisions. Further Reading Gallery of FDA Studies of DTC Advertising; #Pharma Cites 1st Amendment to Oppose FDA's Study of Animated "Mascots" in Drug Ads; #FDA Needs to Do a Better Job Communicating DTC Research Results, Says Expert; TV DTC Advertising Is Not Dead Yet!; Addendum: Another FDA Study: Character-Space-Limited Online Prescription Drug Communications FDA is planning to study whether substantive risk information in the character-space-limited communications is effective in communicating risks when benefit claims are made, or whether a link to the risk information is sufficient, according the Federal Register announcement (FDA-2016-N ; Regardless of character space constraints that may be present on certain Internet/social media platforms, notes the FDA, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication. The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product. FDA will study a character-space-limited communication about a fictional weight loss drug, embedded in a Google search page about weight loss. In other words, FDA will use a standard Google Adword format and specifically will NOT be studying ad formats in Twitter or other character-limited social media channels. However, the results will no doubt influence any guidance regarding social media promotions. We hypothesize that participants who see substantive risk information in the character-space-limited communication, compared with link-only participants, will have greater retention of the risk included in the communication and higher perceived risk. We will explore whether including substantive risk information in the character-space-limited communication affects the likelihood that participants notice the communication or click the link to the risk information. We hypothesize that participants with a search goal, compared with a browse goal, will have greater retention of the benefit and risk information and higher perceived risk because they will be more likely to notice the character-space-limited communication and to click the link to the risk information. 3

5 Vol. 15, No. 5: December 2016 PMN Another FDA Study (continued) This study has the potential to convince the FDA to approve the one-click rule in future guidance. Recall that the so-called one-click rule states that as long as risk information is one click away, then FDA s regulatory concerns have been met (read Overcoming Space Limitations in Social Media ; However, in the past, FDA has sent out letters that cited this practice as violative (see Death of the One-Click 'Rule' or 'Received Precedent' or Whatever! ; If the research is conducted and convinces that public health is protected, that patient safety is honored, and it does prove effective in getting patients the safety information they need, the one-click rule would be an absolute game changer for the industry," Michael Spitz, VP of digital strategy and business development at Klick Health (read Will We Soon See the FDA Approve the One-Click Rule in Official Guidance? ; Further Reading 4