Making its world debut at the 2012 Tribeca Film Festival, Off Label is the second feature length documentary from the team of Michael Palmieri and Donal Mosher of October Country fame. Currently available on VOD and digital platform, Off Label reveals the toll that prescription drugs take on a wide array of Americans—ranging from volunteers for human testing, a war veteran suffering PTSD, a mother who lost her son to clinic drug trials and beyond.

Palmieri and Mosher, in this “call to reflect” film, make abundantly clear that nearly every American is affected by the pharmaceutical industry in some way. Off Label is not an exposé. It offers the chance for real people to share their stories of horror, regret, hope, and loss in the face of Big Pharma. We spoke to the duo about their films, their storytelling process and what they think about new filmmaking tools like Vine and Instagram Video.

Tribeca: Off Label celebrated its world premiere at TFF 2012. What was the road after the Festival like?

Michael Palmieri: After Tribeca, we went with the film to festivals like Hot Docs, LA, Sheffield, and all over place. Interestingly enough, we actually used the festival screenings as a mode of fine-tuning the film. There were a number of things we learned halfway through the festival, such as, having to remove a particular piece of music because we couldn’t get the rights to it. We had to switch out the song that we had originally wanted to start the film and that really changed the beginning of our movie.

Because of the Festival circuit, we were able to observe how audiences responded to the film, so we ended up doing a lot of re-chewing and reshuffling scenes around.  That process really started with our trying to address the music concern, but along the way, we listened to how audiences were responding and tried to dial the film in a little better. We think we ended up with a much better film.

Tribeca: How did you decide to go with a distributor like Oscilloscope?

MP: We still think there’s a kind of brick and mortar approach that works really well because when you put a film out theatrically, you garner the sorts of reviews you need to have the film continue on in its digital space. We certainly understand that the majority of people who are going to see this film will most likely be seeing it in some digital form. With Oscilloscope, the plan was to release the film both theatrically and digitally at the same time to take advantage of the press and insure that the film will have a long life digitally.

Tribeca: Your first collaboration, October Country, focused on Donal’s family and their story. What made you choose the subject of off-label medical test subjects and the repercussions of these tests?

MP: Our Off Label producers, Anish Savjani and Vincent Savio of Film Science, initially approached us right after a rough cut rooftop screening of October Country. They asked us if we were interested in making a film about human guinea pigs. We thought we were certainly interested, so we did some research, got back to them and decided to give it a shot.

We started filming with the express intention of focusing on guinea pigs in the medical industry, but the further we got into the subject; we felt we needed to broaden the scope. The subject naturally extended into the way some of these drugs are marketed after they’re tested and ratified. We also followed the process to the end usage of the drugs by people in the culture. However, our focus always remained on the people on the margins of society. It’s those people who actually do the drug testing because often times they don’t have the means to get any other job. It’s a well-paying occupation, although it obviously has its dangers.  

It’s like Vine and Instagram Video are bringing filmmaking back to the era of Super 8 and 8mm.

Tribeca: Were you at all daunted by the subject?

MP: The whole thing is daunting. The subject is so enormous that we felt that the best we could do was to leave the viewer asking more questions. This is a very complicated subject to which there is no clear specific answer.

Tribeca: How did you settle on the people that you interviewed?

Donal Mosher:  Consistent with our work in general, we tried to focus on people who are a little outside mainstream society. That was definitely one of our criteria for choosing the characters who made it into Off Label. We also didn’t want experts or people who were sitting back and thinking about the problem. We wanted people who, in some way, have made marketing or consuming pharmaceuticals an active part of their lives.

Tribeca: What does Off Label say about America and its citizens and Big Pharma? Are you using this documentary as a wakeup call for public?

DM: As filmmakers, we’re more interested in life inside the issue than the way the issues play out in a broader “wake up call” sort of manner. I think a hardcore fact-based film about the pharmaceutical industry should be made and needs to be made, but I think what we hope to do with Off Label is show that there are other implications. There are facts and figures and medical analysis, but we wanted to show the emotional toll.

MP: In one way, we wanted to look at the human dimension of the problem as opposed to examining a specific data set that sets out the problem on a piece of paper.

I actually like to watch films that work in that exposé manner, but it is very hard for me to consider making a film like that because when you enter into subject matter as big as pharmaceutical medicine is in this country, you come up against a lot of contradictory information. The topic quickly becomes very gray, much more complex than you think it is.

It’s very easy to assume that the pharmaceutical companies are bad, and it’s very easy to say drug testing is wrong and that the test subjects are victims and possibly heroes. In reality, however, everyone involved is implicated in some manner. So rather than this film being this call to action, it is more of a call to reflect on what’s going on in the culture at large on the multiple levels.

Tribeca: Were any of medical test subjects and their families reluctant to come forward and share their stories? Were they worried about the possible repercussions of their statements, especially Andy Duffy, the former Army Medic?

MP: Andy is a very outspoken individual. He’s active in Veterans against the War. He’s very outspoken and well-spoken about his views, so he was in no way concerned about what he was saying in the film. He’s also been discharged already so there was no real problem. I think he raises some really interesting topics around the VA. Certainly, we didn’t intend to portray the VA as doing damaging things to vets on purpose. It’s more that they don’t have the money or the personnel to deal with the numbers of people who really need a combination of drugs and talk therapy.

Tribeca: Donal, is it true that you volunteered to use your own arm for the shot of the 14-guage-needle going into the vein?

DM: That’s my arm, yeah.

MP: Well, I certainly wasn’t about to do it [laughs] because I’m scared of needles.

Tribeca: How important was it for you to experience that moment with Andy Duffy?

DM:  I’m not really frightened of needles or that amount of pain, but doing that did change my relationship to Andy’s ordeal. We talked about it for a while before—whether it was appropriate, whether he wanted to re-experience what he had previously felt overseas—just for the sake of the camera. It became a much more sober experience mentally than it was physically.

MP: It’s a dramatic re-enactment moment, and since the subject here is large corporations putting things inside of our bodies, the more physically tactile we could make the film, the better.

Tribeca: You two were featured in a New York Times article focusing on the  rise of the writing credits in documentary films. Can you discuss your writing process? How does it factor into the editing stage of filmmaking?

MP: You obviously have to do a lot of research, but we kind of work in a fashion of information gathering. I guess it’s more in the verite style, I guess. For us the writing process really happens during the edit. You have so much material that you’re really shaving down in an editorial fashion. We don’t write scenes out or try to make things happen specifically ahead of time because it just doesn’t launch.

DM: After we get to know our footage, we do, however, make outlines of potential scenes.  We want to enter the edit room with some idea or outline of what might work and then execute it.

MP: When you’re gathering the material as you go, you’re assessing possible scenes in the film. That informs the next set of interviews that you end up doing or the next set of images you focus on. So our filming process is part of our writing process. When we sit down to edit scenes, we spend a lot of time trying to refine a scene to make it as good as it can possibly be, to make sure that it is actually working. We may just restart it because often times is interesting is the transition between scenes.

Much of what’s happening in Off Label I think is happening much in the juxtaposition points between the stories. That made for a very, very difficult edit, but we don’t want to step on top of what people actually do or say. We’re still writers but it’s just a different process of writing.

Consistent with our work in general, we tried to focus on people who are a little outside mainstream society.

Tribeca: Have you have you been exposed to new video technology like Vine or Instagram Video?

MP: I love it. I completely resisted Vine at first, and then somebody forced me to start using it and I love it so much. With Instagram video, you now have 15 seconds to play with, which is great. It’s perfect for capturing an immediate portraiture of something, of environment or whatever. I use it all the time. However, I don’t know how we would ever expand upon or use that in a really heavy documentary fashion, other than giving an impression of a moment.  It’s hard to do anything in 15 seconds.

DM: I like them both; I think they’re both really different. It’s like Vine and Instagram Video are bringing filmmaking back to the era of Super 8 and 8mm. They allow you to go back to the basics, using these small cameras to produce a lot of really beautiful ephemeral experimental work, like in the old days. Some of my favorite images and films have come off both video platforms.  I like the way Vine makes you think in terms of capturing reality as a living moment.

Tribeca: Do you have any advice that you would give for budding documentarians?

MP & DM: Get a day job! [both laugh]

MP: I don’t know if it would be considered advice, but I would love to see filmmakers exploring ideas in the spirit of asking questions.  I guess the advice would be to always remain open and curious as to what’s going on because if you go into a subject with your mind set, you will be limited.  When you enter into situations with your mind open to possibilities, you will make a more interesting film. 

Off Label is currently available on VOD and digital platforms. If you're in NYC, you can catch this riveting doc at Cinema Village.