A couple of years ago, Beacon Press published White Coat, Black Hat: Adventures on the Dark Side of Medicine, a book that Lauren Slater recommended as "required reading for anyone who has ever been a patient—in other words, for everyone." In WCBH, author Carl Elliott skewers drug-industry reps, exposes how Pharma companies ghost-write "scientific" research studies in support of their products, and introduces us to the world of human guinea pigging--a "career" path for those desperate enough to serve in drug study after drug study in exchange for mediocre pay and few benefits. 

Carl sent me an email this week to tell me he had just returned from the Tribeca Film Festival, where he had attended screenings of Off Label, a new film "for which my writing is given credit as the inspiration." He put me in touch with filmmakers Michael Palmieri and Donal Mosher, and I spoke with them via Skype as they were getting ready to leave New York. If you're familiar with WCBH and Carl's other writing in The New Yorker, Mother Jones, The Chronicle's Brainstorm blog, and elsewhere (including Beacon Broadside), you will certainly recognize the themes and people in the film. If you haven't read the book yet, get to it! And keep an eye out for screenings of Off Label. --Jessie Bennett, Blog Editor

Jessie Bennett: What is Off Label about?

Michael Palmieri: It's a film that examines the medicated margins of American society, and it does that initially through human guinea pigs. But it's personal stories of these people, so we're interested in the personal ramifications of the pharmaceutical culture that we live in, and how we're all sort of implicated in that process. 

JB: How did you come to make a film about human guinea pigging?

MP: We were showing a rough cut of our first film, October Country, at a film festival in late 2008, and these two producers--Anish Savjani and Vincent Savino, who we ended up working with--they saw the film and they followed up with us and said, "Hey, would you guys be interested in making a film about human guinea pigs? " And we said, "Yeah, sure, maybe. It sounds interesting..."

Donal Mosher: And they said they had money.

MP: Yeah, they said they had money, and we said, "Okay, sure!" They actually did have a budget to make it, and it was an intriguing subject, but we didn't know if it could become a whole film. It seemed to us initially like a 60 Minutes-length, investigative reporting piece more than what we're interested in doing, which is a broader view of a subject or a viewing from sort of left field. But the first articles they showed us were Josh McHugh from Wired magazine ["Drug Test Cowboys: The Secret World of Pharmaceutical Trial Subjects"] as well as Carl's article called "Guinea-Pigging" [The New Yorker], which we really latched on to. We really liked the way he wrote the piece. So we ended up contacting him and discussing what we were doing, and he gave us more leads, more information. We eventually ended up meeting him. It kind of developed organically from there. "Guinea pigs" was the initial interest, but then we expanded the idea once we understood on a deeper level what was going on that was somewhat suspect in the guinea pigging world. If the testing is messed up, then what's messed up about the marketing? And what are the end results?

DM: We also began to see how the issue didn't just lie in the zone of the issue itself, but it was pervasive. Every time we'd have a conversation with someone, they had a relative or they themselves were on pharmaceuticals. And the stories were multiplying in a way that made us think this is an issue that pervades many layers of culture far beyond medicine or taking medicine itself. So we wanted to start working those ideas into the film. 

JB: Who were some of the subjects that you spoke with? I recognized a few of the characters from Carl's writing. 

DM: Originally we spoke with Bob Helms [of Guinea Pig Zero]. A lot of the well-known names in the human guinea pig scene, the people who are testing the drugs. And then from there, we moved on to Mary Weiss, who is also in Carl's writing. 

MP: Robert Helms was in the original article that Carl wrote for the New Yorker. So we contacted him and spent time with him, and while we were in Philadelphia, Donal had initiated contact with a writer who had written a book called Acres of Skin, which gave us Eddie Anthony's story. He was an inmate in a prison at Holmesburg when it was actually legal to conduct medical testing on prisoners. And it really screwed up his life because some rough tests occurred when he was in there. We had initiated contact with Paul Clough through his website [Just Another Lab Rat]. Paul is based in Austin, but he has a website very much like what Robert Helms has with his fan zine Guinea Pig Zero, set up for people in the guinea pigging community to speak with one another and share. "Oh, this test actually pays good money." "These people have terrible food." It's kind of amazing, because these people are doing this for a living. 

JB: This is the thing that really shocked me about White Coat, Black Hat. "There's a human guinea pigging community?"

MP: And beyond that, it's a community of people who have no... there's no health plan for them. They're doing this because they don't have any other option. But for us, we could clearly understand that the testing is somewhat dubious on certain levels. I mean, obviously we need tests, there's a lot of positive, real things that come out of that testing. But people are lying to get into studies, and it's not exactly as clean of a population study as you would think it is. So the results are going to be skewed. Once we saw, "Okay, skewed results," we started moving more towards marketing, and we were introduced to [former pharmaceutical representative] Michael Oldani, through Carl. Again. Which is why, in a certain sense... how did we say it now? Not dedicated...

DM: "Inspired by."

MP: The film is truly inspired by Carl's writing. It's not just the characters that he led us towards, of which I think he led us toward five of the eight characters. But it's the endless numbers of hours spent with him in Minneapolis. At a coffee shop, where we would meet to discuss something, and we'd look at our watches and eight hours had passed. It's the types of conversations you dream to have all the time. We just got to know each other really well, and his style of writing is so expansive, and it moves from one idea to the next idea. He's such a big brain on a stick, you know what I mean? We wanted to try to do something like that with this film, that followed a line of reasoning as opposed to a specific plot. As a means to take in all of the complications of the issue that we were examining. But rather than having it point a finger at pharma and say, "This is the bad guy, and this is the problem." Which is the "call to action" documentary. We wanted to make a film that was a call to reflection, which is what Carl's writing is like, or the feeling at least that we got from it. 

JB: Mary Weiss, the mother of the test subject who died in Minnesota, who Carl writes about in WCBH, is featured in the film. Can you tell us about her story?

DM: In short, she attempted to get her son into a mental hospital. And when she couldn't, she found him space at the University of Minnesota. At first, he was assessed that he couldn't make any rational judgment about his own medication--that he wasn't sane enough. And then, within twenty-four hours, that was reversed. The full details of the story are in an article that Carl wrote for Mother Jones, but essentially it was a doctor who placed his own psychiatric patient in a very lucrative testing study. Not a study testing the efficacy of the drug that was prescribed for this young man, but a comparison marketing study where the dosage was fluctuating. The result was an incredibly sad and grisly suicide. From that point on, his mother has been fighting to change Minnesota laws, and to make those changes nationally. 

MP: And to clarify, this happened at the University of Minnesota, where Carl works. And the study that Dan Markingson was entered into was not only a marketing study, but it was a study that was conducted by the same doctor who was his attending physician. So the conflict of interest was so obvious in this case, but it was still legal. So Mary Weiss has helped pass the law to make that illegal. 

JB: You just finished up at the Tribeca Film Festival. How did it go?

MP: It went great. We showed the film four times. We finished yesterday, and the screenings were all pretty full. Carl was there for the first two screenings, with a couple of other people from the film. We are kind of thrilled with the response. It's gotten some fantastic reviews as well. So we're really happy. 

JB: How was the audience reaction to the film in Tribeca?

MP: I usually read it from the perspective of, "How many people left during the credits who didn't want to stick around for the Q&A?" An overwhelming number of people stuck around, which was a good sign to begin with, but the questions, they kept coming until they had to kick us out of the theater. So people are, I think, really engaged with the film. Everyone seems to be invested, so we're really happy. And if it causes people to pause and think about what medicine is going inside their bodies, I think we have succeeded, at least on that level, and it makes us very happy.

JB: And where are you headed next? 

MP: We're headed to HotDocs in Toronto, where the film is premiering internationally. The Toronto documentary crowd is insanity. We've already sold out most of our screenings, and they're gigantic places. We're looking forward to that. And we're hoping that there's a lot of European interest in screening the film.

JB: Well, it's an international issue. 

MP: But it's a very American film, so we're curious to how Europe responds.

DM: We're really curious to see, when there's an international audience, what stories they give us about the situation in whatever country the film might land. 

JB: And you have a screening in San Francisco as well?

MP: Yes, at the San Francisco International Film Festival. And we'll be doing more screenings in Europe and the US later in the year.

Find out more about the film at OffLabelFilm.com, follow them on Twitter, or like them on Facebook.