US FDA’s Rx Drug Promo Study Answers $798,000 Question
Executive Summary
Viewers spend more time on print ads that have more lengthy important safety information or a brief summary but impact on understanding is unclear, OPDP study finds. Another study finds exaggerated images of drug benefits in TV ads unsurprisingly can mislead consumers.
A US Food and Drug Administration study found that consumers viewing Rx drug print ads fixate for a longer period of time on those that have more lengthy important safety information or a brief summary.
Kathryn Aikin, senior social science analyst and research team lead in the FDA’s Office of Prescription Drug Promotion, presented the results of the study, “Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads,” at the Drug Information Association’s virtual advertising and promotion regulatory affairs conference on 9 March.
The study evaluated ads for two fictitious drugs that varied the length of the important safety information (ISI) and included or excluded a brief summary. It assessed attention to the ad and attention to the ISI, attention to the brief summary, and risk perceptions and retention.
Many of the study findings seem to confirm obvious or at least expected outcomes and it's unclear how they might impact policy.
Attention was measured in self reports and eye-tracking fixation. Fixation duration was recorded using glasses with an eye-tracking device that captures images of the eyeball multiple times per second. The fictious drugs were for overactive bladder and rheumatoid arthritis.
“We found that for attention, participants spent more time fixating on the ad when they saw either a long ISI or there was a brief summary,” she said. “They also spent more time fixating on the ISI when we had a long ISI although the fixations on the brief summary did not differ. However, self-reported attention did not vary by length of ISI or presence of the brief summary.”
Aikin said having a long ISI or a brief summary helped with recall but there was no clear evidence that ISI length or the presence of the brief summary affected perceived drug risks. In addition, she said correlations between self-reported and eye-tracking attention “were significant but generally weak.”
Aikin noted that the study had several limitations. She said participants’ behavior reflects the most attentive consumers. And although participants identified their medical condition there was no way to verify that through medical records. In addition, there was a low turnout for the study, which required OPDP to add a sixth data collection location.
The cost of the study was $798,027. It is one of the most expensive research projects, though there are several that cost more. (See chart of research projects in progress and pending publication at end of story). OPDP announced the research project in 2017, at which time the Pink Sheet provided cost information on studies then underway. (Also see "Rx Ad Studies Target Risk Info Location, Efficacy Framing, Oncology Products" - Pink Sheet, 9 Jul, 2017.) The researchers are currently writing up the results of the study for publication.
Exaggerated Images Of Drug Benefits Can Mislead Consumers
OPDP social science analyst Helen Sullivan presented the results of another study that found consumers have a less accurate understanding of drug benefits when they see exaggerated images of treatment effects in direct-to-consumer television advertisements.
Participants in the study were more likely to believe that a fictional drug eliminated a vision or skin problem if they viewed ads showing a blind spot or psoriasis plaque disappeared following treatment.
“These results provide evidence that exaggerated images of drug benefits in DTC television ads can mislead consumers,” Sullivan said.
The findings are part of the research project, “Quantitative Information in Direct-to-Consumer Television Advertisements,” which was first announced in October 2015.
The first part of the project, which looked at the effect of including quantitative information on multiple endpoints in DTC Rx drug TV ads, was published in 2019 in Medical Decision Making. The data presented at the DIA conference on visual images of Rx drug benefits is the second part, which is currently in press at the peer-reviewed journal Patient Education and Counseling. The entire project cost $1,206,651.
The second portion consisted of two studies, one involving an ad for a fictitious drug indicated to treat wet age-related macular degeneration (AMD) and the other for a fictitious drug to treat plaque psoriasis. The studies varied the images of drug benefit (no image, accurate image or exaggerated image of drug benefit) and included or excluded quantitative information. The ads presented before and after treatment images.
In the project’s wet AMD study, the accurate image showed blind spots shrank to a smaller spot with use of the drug and in the exaggerated image the spots disappeared. In the psoriasis plaque study, the ad showed a person with large plaque psoriasis on his arm, which was about 65% smaller after treatment in the accurate image and disappeared in the exaggerated image.
Participants, who were 60 years of age and older, were randomly assigned to view one TV ad. After viewing the ads twice, they were asked if the respective drugs eliminated vision problems caused by wet AMD and skin problems caused by plaque psoriasis.
Sullivan said in both studies, participants in the exaggerated condition were less likely to get the correct answer compared with participants in the accurate image condition. She said in the wet AMD study, participants in the no image condition were also less likely to get the answer right.
Participants were also asked to agree or disagree with the statement that vision or psoriasis would improve but not return to normal. In both studies, those viewing exaggerated images were less likely to give the correct answer compared with those viewing the accurate image.
Sullivan noted that the study participants were older internet panelists that may not represent the general population. In addition, while they were at risk for the medical conditions in the study, they did not actually have the conditions so might react differently than those who have the condition.
“We found consistency in the results using television ads for two different medical conditions with distinctive visual presentation,” she said. “So taking these results together, I believe that regulators and the pharmaceutical industry should try to ensure that DTC promotion is accurate and non-misleading, paying particular attention to images” presented in the ads.
FDA regulations require drug promotions to be accurate and non-misleading. Sullivan noted that OPDP has found from its content analyses of the marketplace that a lot of DTC TV ads do show some images of improvement of drug efficacy. The images in OPDP’s study showed complete elimination of symptoms, which she said is less common, but does happen.
She noted that in 2019, FDA issued an untitled letter for a television spot for a product that showed complete elimination of symptoms. FDA objected to Aclaris Therapeutics, Inc.’s video advertisement for Eskata (hydrogen peroxide) on ABC’s The View, in which a physician spokesperson said patients typically achieve complete clearance of seborrheic keratoses lesions. (Also see "Eskata Video Ad Broadcast On The View Gets Rebuke From US FDA" - Pink Sheet, 21 Jun, 2019.)
62 Research Projects
The finding that exaggerated images of treatment benefits can mislead consumers seems obvious or at least expected, as does the finding that viewers pay longer attention to ads with more lengthy risk information. And it does not appear that they will result in policy changes, or at least there is no indication of how such change might happen.
Several years ago, OPDP addressed questions about the impact its research projects have had since the first prescription drug TV commercial aired in 1983. It said its research has informed both sponsors and FDA of specific ways in which information can be communicated more clearly to the intended audience. (Also see "Have FDA Studies Changed Rx Drug Advertising?" - Pink Sheet, 29 Aug, 2017.)
The Pharmaceutical Research and Manufacturers of America at one point criticized FDA for the kind of research projects it was conducting on Rx drug advertisements, saying the agency had not explained how they furthered FDA’s goal of protecting the public health. (Also see "PhRMA Criticizes 'Exponential Pace' Of FDA Rx Drug Advertising Studies" - Pink Sheet, 13 Aug, 2018.)
The office has continued to launch new projects on direct-to-consumer and professional prescription drug promotion, including six last year. (Also see "US FDA Actions On Rx Drug Promos Covered New Territory Last Year" - Pink Sheet, 12 Jan, 2021.)
To date, OPDP has completed 38 research projects and has 10 pending peer review and publication and 13 in progress. The agency's most expensive project, with a price tag of $2m, was a study of online promotion that tested different ways of presenting prescription drug risk and benefit information on branded drug websites. (Also see "FDA’s Biggest DTC Advertising Study Eyes Online Promotion" - Pink Sheet, 8 Jul, 2013.)