Thursday, June 16, 2005

FDA to Eli Lilly: You better knock that shit off, that's some cheezy ass, fake bullshit

The FDA sent Eli Lilly a letter regarding a direct-to-consumer (DTC) advertisement for Strattera. The commercial features a person living in a video game (kind of like that Chappelle Show skit, I suppose), losing points for doing thing like forgetting to put the cover sheet on the TPS reports. PharmaLive has the text of the actual letter. It seems Strattera was actually approved for ADHD, and marketing it for ADD is inappropriate. This is actually not totally clear, and part of the letter more or less admits it's not entirely clear what exactly ADHD is, or who has it:

The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.

Lilly is also taken to task for downplaying the risks associated with Strattera (potential liver damage, discussed here and elsewhere.

The bottom line:

DDMAC requests that Lilly immediately cease the dissemination of promotional materials for Strattera the same as or similar to those described above. Please submit a written response to this letter on or before June 28, 2005 describing your intent to comply with this request, listing all promotional materials for Levitra the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to me at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD-42, Rm. 8B-45, 5600 Fishers Lane, Rockville, Maryland 20857, facsimile at (301) 594-6771.

It's not clear what Levitra (a drug for Erectile Dysfunction, made popular by former Senator Bob Dole, although Dole did commercials for Viagra) has to do with all this. This reminds me of a similar situation at work recently, where I was reviewing a statement of work, and all of a sudden there was a mention of a representative from Best Buy being involved in the project. We aren't Best Buy. The contractor is not Best Buy. Somebody cut-n-pasted without noticing this detail - whip out the Strattera, and take mine away because I actually read the thing.

Part of the FDA's problem seems to be the barrage of visual stimuli presented in the commercial. Some of us grew up on MTV and have seen Jerry Bruckheimer's movies, we can deal with it.

The TV ad fails to clearly communicate the indication for Strattera because of competing visuals, graphics, and music that are presented at the same time as the information described above relating to the indication. As stated above, the images that are presented relating to the product’s indication are portrayed as seen through the screen of a videogame. The viewpoint of the screen changes periodically, from seeing the world through the eyes of the actor playing the main character, to seeing the character himself and back again. During the presentation of the various situations the character is engaged in, a box with the words “SCORE” (including a running tally of numbers) and “LEVEL 1” is shown in the upper right-hand corner of the screen and another box with superimposed text is shown in the middle of the right of the screen. The text scrolls and flashes. The text, graphics, and voice-over are also accompanied by eerie sound effects. All of this distracts from the viewer’s ability to process the visual information related to the product’s indication.

Ah, now if only somebody would get after Hollywood for using special effects and technology to distract people from their ability to discern if movies are crap.

Eli Lilly spokeshole Jennifer Bunselmeyer said the company has stopped the nationwide advertisement at the FDA's request, but the company didn't believe the ad was misleading, according to an article in The Kansas City Star.

And remember, cut-n-paste makes waste.


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