Can consumers really understand what clinical trials have to say about comparative risk and benefit? And what are the rammifications?
The FDA is studying whether/how to add comparative and numeric information describing benefit and risk data to the brief summary in direct-to-consumer print advertising.
The agency is looking at various presentations of quantitative and qualitative information in a boxed format and determine how consumers perceive drug efficacy and risk as well as measure their understanding of the benefit and risk information.
FDA's summary of the study proposal notes that evidence indicates formatting can impact consumer comprehension of information, and using bullet points or section headings can make the information more readable.
"It is not known whether simply adding efficacy rate information to a consumer-friendly brief summary would be sufficient to enable consumers to understand a product's efficacy, or whether qualitative summations are necessary as well," the agency said in the Federal Register.
Well – duh. No news there. All of this is pursuant to the media-friendly (but poorly designed) Dartmouth University study.
One thing that requires no additional study is, shall we politely say, the relative user-unfriendly nature of the current brief summary. The joke inside the FDA (if a joke it can be called) is that the brief summary is like the Holy Roman Empire – neither brief nor a summary.
Nor of tremendous utility.
According to the FDA’s 2002 study, 65 percent of doctors believed that the DTC ads their patients saw confused them about the relative risks and benefits of prescription drugs—and that is a problem. In a 1999 FDA study, 56 percent of patients who saw a DTC print ad said that they read the brief summary “not at all” or “a little.” In the 2002 study that number jumped to 73 percent—an increase of seventeen percentage points. During that same three-year span, those saying they read “almost all” or “all” fell from 26 percent to 16 percent— these ten percentage points are not decimal dust by any stretch of the imagination.
In the “decimal dust” category, consider this: In 1999, 3 percent said that they weren’t aware that the brief summary even existed. In 2002 that dropped a full decimal place to 0.3 percent. In other words, more people knew that the brief summary was there, but fewer people were reading it.
For more on why the current long format brief summary doesn’t work see this article from Health Affairs.
As to the idea of a risk “window” – it’s already part of the FDA lexicon (see the January 2004 draft guidance on alternative presentations of the brief summary).
For more on that topic (as well as the variable nature of consumer comprehension and alternate solutions) see this paper from the Drug Information Journal.
