WASHINGTON — The Food and Drug Administration wants to figure out just how well older Americans are able to comprehend the prescription drug ads they see on TV.
In an upcoming study, described in a notice posted publicly late last week, the agency will test whether Americans 60 and older understand some of the more complex information presented in the commercials they see between network news and NFL football games. They want to test whether people understand more complex ads as well as they did simpler ads — or if it is too much information for people to process.
Americans 60 and older will participate in the studies, the agency said, because they are more likely to be interested in the drug being studied and therefore more motivated to pay attention. The FDA noted that older people use more prescription drugs and watch more television than younger people.
The research is getting underway at a time when the American Medical Association is advocating for a ban on prescription drug ads, the American public is infuriated over high drug prices, and pharmaceutical companies are increasingly advertising treatments for more serious conditions than had been seen on the airwaves before.
The new study is part of an entire field of study by the FDA. In 2012, the agency published a report that found simple information in drug ads (a comparison to a placebo, for example) presented in certain ways helped people better understand how well the drug worked.
Julie Donohue, a University of Pittsburgh professor who has researched direct-to-consumer drug advertising, characterized the FDA’s new study as an attempt to determine “how much can we throw at people and expect them to retain?”
Participants will be shown TV ads twice for a fictional medication for cataracts. They will then take a survey gauging how well they understood the information in the ad, how well they retained the information, and how they ultimately perceived the drug’s risks and benefits.
The ads will vary. Some will describe side effects more simply, for example, occurring in “10 percent or less” of patients; others will be much more specific — say, 6 percent to 10 percent. Some ads will give only a single outcome for taking the drug (52 percent improved their vision); others will offer an additional outcome (52 percent improved their vision and people were able to see on average 85 out of 100 letters in an eye chart test).
In a related study, the agency will also examine whether different visuals — one that accurately represents the drug’s benefits, another that overstates them, or no image at all — affect how people perceive the information in the ads. The FDA has also undertaken a separate project researching whether cartoons in drug ads distort how viewers perceive the drug’s risks and benefits.
The question of what information in drug ads is useful to consumers dates back at least to a 2004 study published in Health Affairs by Drs. Steven Woloshin and Lisa Schwartz of Dartmouth University. They found that a “benefit box” helped lower people’s perception of how well a drug worked — people tend to be overly optimistic about how well advertised medications work without information being put in context, experts say.
A 2011 study published in the Journal of Health Communication focused specifically on the elderly and found that their ability to understand drug ads was dependent on how well they were able to understand other kinds of medical information. If they were less literate in medical information, they were less able to understand the ads — a finding that “alerts us to the inadequate informational values of (direct-to-consumer) ads for consumers who truly need such information in order to be more educated and empowered,” the authors wrote.
Meredith Rosenthal, a Harvard University professor who has studied drug advertising, said she wasn’t sure how much progress can be made in improving comprehension of TV drug ads. Some research suggests that drug ads mostly serve as a motivator to get people to go see their doctor, and so it’s not clear how much their content actually matters.
“I’m not sure how critical it is that consumers understand those risks,” she said. “I think what’s critical is that physicians understand that.”
She added, though, that she saw the FDA study as “a completely legitimate question to ask and potentially important pursuit.”
And even if the net effect of most drug ads is driving people to the doctor’s office, Donohue thought more detailed information in those ads could still change people’s behavior.
“I think this information could have an effect on whether patients actually ask for medications,” she said. “If it changes the perception of efficacy and safety … then it will change the behavior.”