DDMAC study: Serious risks in brief summary don't scare off readers

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The presence of information on serious side effects in the brief summaries of print DTC drug ads seems to have little effect on reader behavior, preliminary results of an FDA study show. The age and health literacy of readers, on the other hand, had a measurable impact.

FDA's Division of Drug Marketing, Advertising and Communications is trying to determine whether there's a better way to present the brief summary, and has completed the first part of a three-phase study on the question. DDMAC asked participants, recruited at shopping malls, to examine ads for a make-believe product called Oncazil, variously presented as a treatment for asthma, high cholesterol or excess weight. In some ads, both the full page and brief summary warned of a serious side effect. “In rare cases, Oncazil may cause serious heart valve problems that begin with a noticeable change in heart rhythm,” the copy read. Others contained no such warning.

Participants were monitored to gauge the amount of time spent on the promotion page and brief summary, in milliseconds. They were then asked to fill out a questionnaire assessing perceived risk, comprehension, topic selection and intent to ask their doctor about the drug.

“Some people have suggested in the past that adding a serious risk on the front page might, in fact, scare people away, and maybe they would not read the brief summary or pursue asking their doctor about that,” said Amie O'Donoghue, social science analyst at DDMAC. “We did not find that. We also did not find that the risk information caused people to report that they would go to their doctors frequently, so it didn't seem to have an effect either way.”  

Older participants spent more time reading the promotion and brief summary, had better comprehension and selected more topics, while participants with low health literacy lagged behind.

The second phase of the study will look at different ways of presenting facts – for instance, whether more precise statements of risks and benefits (“This drug worked for x% of patients”) improves comprehension – and the third phase will test several different formats for the brief summary, including a Q&A format, the traditional three-column format, one similar to the OTC “fact box” and one pulling highlights from the PI. DDMAC hopes to have data for all three phases available by summer, said O'Donoghue.  

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