Coming soon (August 8 or 9) to a theater that may be near you – if you live in Missoula, MT (or in a few other lesser or greater cities) – is the documentary Off Label, which asks the question: “What’s in your medicine cabinet?”

If your medicine cabinet contains psychotropic drugs such as Adderall, Ambien, Zoloft, and Prozac, you may want to see this movie. “Often these drugs are combined in polypharmacy cocktails or are given out for unapproved or untested indications, leading to abuse, dangerous side effects, and heavy dependence,” says the movie synopsis (here).

The movie premiered last year in East and West Coast International Film Festivals. Here’s an excerpt from a gushing review written by poet Dodie Bellamy (here):

“Not only is Off Label bearable, it’s a sensitive, poetic portrayal whose very existence sheds hope onto a pretty hopeless situation. The cinematography is gorgeous, punctuated with languorous shots of nature and of urban minutiae. For what seems like minutes, the camera seems to forget the interviewees as it drinks in the landscapes and interiors that frame them. The care and affection [directors] Mosher and Palmieri have for their subjects is evident in every scene. The subjects give themselves over to the camera with the uncomplicated trust of a child or lover. And the camera never betrays them. We see poor people, homeless people, damaged people, but they all look good, without being glamorized. People who are not beautiful in ordinary life look beautiful in this film.”

Sounds like Mosher and Palmieri should be directing direct-to-consumer (DTC) TV ads that feature real patients that “look good, without being glamorized.” I’m thinking about commercials such as those for Chantix produced by Pfizer. The people in these ads look good and are certainly not glamorized, however I would not say they “look beautiful.” But I think Dodie was taking some poetic license using that phrase. View the trailer below yourself and tell me how “beautiful” you think the people “look”:

In any case, what I call “Real Patient DTC” is all the rage in this era of social media where even the pharma industry aspires to have conversations with “real” patients. Of course, such conversations are made difficult due to concerns about how to handle such issues as “unsolicited off-label” questions and adverse event reports. Thankfully, the FDA has some guidance regarding the former (see here; Wow! Has it been over a year and a half since that bit of draft guidance was published? Which leads me to ask Where’s the final guidance?). FDA, however, does not have any guidance for handling adverse event reports received via social media.