Tuesday, November 01, 2005

FDA DTC Hearings: Snippets from Day 1

I am in Washington, DC attending the FDA public hearing on DTC. I will try to summarize a few of the more interesting presentations here. Later, I will cover the proceedings in more detail in the Pharma Marketing News newsletter.

People are polite in Washington, DC. They don’t rush and knock you down in the Metro (subway) like people do in NYC. Similarly, FDA people and presenters at today’s public hearing on DTC were very polite too. The nice FDA people asked nice questions and the nice presenters, for the most part, didn’t blast the FDA for not doing anything to reign in DTC.

[There was one exception: Lisa Van Syckel from drugawareness.org made an impassioned presentation that claimed drugs like Paxil and Prozac were responsible for the deaths of many adolescents. The video she presented was very disturbing and it suggested that the FDA rejected evidence and refused to do anything about these drugs.]

I rated each presenter as to whether they supported DTC or were against it. By my estimate, the presenters were evenly divided: 50% for and 50% against. Good balance FDA!

Anyway, the first panel, for the most part presented results from cognitive and linguistic studies. These studies measured readability, etc. and were designed to quantify “fair balance” in ads; i.e., presentation of risk and side effect information commensurate with benefit information. Most confirmed the obvious like: risk information in print DTC requires a reading level two grades higher than that required for the benefit information.

A study reported by Ruth Day of Duke University, discovered that the bee in the Nasonex TV commercial 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. Pretty neat, eh?

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 had a clue!

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.” There’s a sound bite for you!

Lewis Glinert of Dartmouth was a very witty and droll presenter on the linguistic merits of DTC advertising. He stated, for example, “consumers should not expect to find any logic in ads.” He also claimed that DTC ads have many touches of “postmodernist irony.” He didn’t explain what that meant nor did he offer any examples. Too bad.

Gilbert threw out some linguistic terms like “fragmatics” and cited the phrase “ask your doctor” as an example. It all depends on what you mean by the word “ask,” which according to Gilbert has a “web of meanings.” Who knew drug advertisers had such a depth of linguistic knowledge? Anyway, the FDA promised to look into this.

A few panelists presented convincing data that showed that DTC was effective in people to seek medical care. One study presented by Andrew Kleit of Penn State also claimed to show that DTC was “efficient,” meaning that it drove the right people – those who would benefit the most from the advertised treatment – to seek help better than those who were not the best candidates.

On the other hand, Micelle Spence of Kaiser Permanente cited her organization did that showed patients who saw a COX 2 ad and asked their docs about the drug were significantly more likely to be prescribed the drug even though clinical guidelines recommended other NSAIDs for these patients. Of course, the guidelines were based on cost-effectiveness rather than clinical data. Spence concluded that many new drugs promoted by DTC demonstrate a “small benefit for a large fee.”

A couple of other interesting tidbits before I call it quits for the night:
Celebrities in advertising: Abby Mehta of Gallup and Robinson did a study of Celebrities in DTC Advertising financed by Pfizer. She found that although ads featuring celebrities were more effective at “breaking through the clutter” and were more “likeable” by consumers, the ads generally were not more informative or believable and may or may not motivate consumers to seek treatment (it depends on the condition).

Power of images: Diana Zuckerman of the National Research Center for Women & Families suggested that the power of DTC is in the images, not the words. The positive benefit images are so powerful, she contended, that the images defeat any attempt at fair balance. This left the FDA wondering how it would regulate images to achieve fair balance – how could they measure the effect? Zuckerman suggested that the only way to guarantee fair balance is to do away with images in ads. Yeah, that could happen.

Don’t ask me what the likely outcome of this hearing will be viz-a-viz possible new regulations from the FDA. All I can point to is the tenor of the questions that the FDA asked as a hint to where they may be going.

Clearly fair balance and better presentation of risk information is of great interest to the FDA. With so many nuances like the use of certain words and phrases, images, font size, placement, etc. that affect fair balance, it would require a great deal of micromanaging the creative process to regulate DTC ads under a new regulatory regime focused on balancing benefits and risks. It may be easier to place a moratorium on DTC advertising of new drugs until doctors and the public become more familiar with side effects. After all, many presenters – especially representatives of drug companies – are careful to point out that DTC is only one source of information about drugs and not even the top source. A few months without DTC, therefore, would not limit consumers’ knowledge of available treatments nor adversely affect their motivation to seek treatment.

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