The FDA will be coming to a mall near you…again!

You previously may have seen FDA interviewers following a “mall-intercept” protocol, interrupting the shopping of about 1,800 “self-identified, moderately overweight” shoppers at malls to survey them on the content and format of the brief summary in direct-to-consumer (DTC) print ads (see “FDA Coming to a Mall Near You?“).

Now, the FDA plans to do a new study: “consumer evaluations of variations in in communicating risk information in direct-to-consumer (DTC) prescription drug broadcast advertisements.” (See notice here.)

The FDA is trying to determine whether the use of competing, “compelling” visual information about potential drug benefits interferes with the viewers’ processing and comprehension of risk information about drugs in DTC advertising or with their cognitive representations of the drugs.

Take the Nasonex, anti-allergy TV ads, for example. You know, the one with the talking, French bee.

A study reported by Ruth Daly of Duke University, and summarized at an FDA hearing in November, 2005 (see “FDA DTC Hearings: Snippets from Day 1“), discovered that the bee beat its wings furiously when risk information was being presented but was still when benefit information was presented. Day claimed that the beating wings divert viewers’ attention from the risk information.

How devious DTC advertisers are! I never thought they were clever enough to employ such nefarious devices to subvert the fair balance guidelines of the FDA, which never dreamt of looking at such visual devices! Until now, that is.

Notwithstanding the credibility of her studies, Day’s main point was this: In TV and print DTC ads “risk information is physically present but functionally absent.”

The proposed FDA study seems designed to determine if there is any merit to Day’s accusation.

Since the FDA is seeking comments on the methodology of the proposed study, I will offer my comments.

The protocol calls for FDA screeners to look for consumers over the age of 40 — which shouldn’t be too hard to find in malls — as long as they speak English, but don’t read Chinese.


What’s reading Chinese have to do with DTC TV ads? Do these ads include subliminal Chinese characters with coded messaging for the Chinese-reading citizens of this country?

Turns out that the protocol will use the latest cognitive science technique called Affect Misattribution Procedure (AMP), in which participants are asked not to judge the TV ads’ imagery directly, but to judge whether or not a Chinese character shown to them afterward is positive or negative. (See “A Misattribution Approach to Implicit Attitudes“).

Attention K-Mart Shoppers (aka, FDA mall-intercept study participants):

“We will be showing you pairs of pictures flashed one after the other. The first picture is a photograph. You should do nothing with the photograph; it is simply a warning signal that the second image is about to appear. The second image is a Chinese character. Your job is to judge the pleasantness of each Chinese character.”

Here’s an example of how this might work:

Now I understand why the FDA does not want Chinese people as participants in this study.

They might read the character following Bush’s image and understand that it says “One who tries to deny health insurance for children” whereas the character following the Nasonex bee might translate as “Nice pet to have around the house while you do household chores.” [I understand that Chinese characters pack a lot of meaning!]

Are Chinese Characters Neutral These Days?
But these days — what with lead paint in toys imported from China, tainted toothpaste made in China, and counterfeit drugs manufactured in China — ALL Chinese characters might elicit “unpleasant” feelings in most English-speaking Americans over 40!

I suggest, therefore, that the Chinese characters be replaced with Mayan hieroglyphics! Here’s some the FDA can use:
After all, how many Mayans are likely to be found in malls? Like, zero! Of course, you’ll have to eliminate the glyphs that show penises or hearts been ripped out of teenage girls!

How About Measuring Saccadic Eye Motion?
I can’t help wonder what Lee Weinblatt, Founder and Chief Executive Officer of the PreTesting Company, thinks of AMP.

What PreTesting measures is Saccadic Eye Motion. You cannot see without this motion. Humans and other animals do not look at a scene in a steady way. Instead, the eyes move around, locating interesting parts of the scene and building up a mental ‘map’ corresponding to the scene.

“After years of debate,” reports the Newark Star Ledger (see “Measuring Drug-ad Interest: The Eyes have It!“), “some researchers now think saccadic eye motion provides a kind of window into subliminal thoughts. Passive eye monitoring, Weinblatt said, is a more accurate way of gauging a subject’s response than diaries or focus groups, which depend on the honesty of participants or their willingness to push buttons.”

I interviewed Weinblatt in a Pharma Marketing Talk podcast back in July (see details here; listen to an audio archive here; read the article here). He’s a very interesting and lively person. You’ll be entertained and more knowledgeable about measuring DTC ad effectiveness after hearing what Lee has to say!