Hot Docs Review: ‘Off Label’ Shows You The Reality Of Human Pharmaceutical Test Subjects

By  · Published on May 3rd, 2012

by Lauren Flanagan

Off Label, the new documentary from Michael Palmieri and Donal Mosher (October Country), investigates the epidemic of skyrocketing prescription drug use in America – more specifically, how medications are being tested, marketed, sold and used for purposes they weren’t originally intended for, and the toll it takes on human subjects. The film follows seven stories of people who serve as human test subjects – both willing and unwilling – by pharmaceutical companies. There’s a man who’s made his living as a human guinea pig and has just reached the age where he can no longer take part; the middle-aged bipolar woman who takes 18 pills a day with varying degrees of success; the mother of a boy who brutally killed himself when he was put on the wrong medications in a clinical study; and a young Iraq war vet with PTSD who was prescribed a cocktail of drugs instead of getting the treatment he needed. All of these stories are used to make an unapologetic case against the use of prescription drugs for off-label purposes.

Some of these stories are hugely compelling. Andrew Duffy, the traumatized war veteran, suffered unimaginable horrors (some of which are shown in graphic detail) while working as an Army medic in the notorious Abu Ghraib prison where he was forced to administer unnecessary and excruciating pain to prisoners. Understandably Duffy returned home in need of serious psychiatric help. What he found instead was doctors giving him handfulls of medications for various symptoms but no one who was willing to talk to him and help him deal with the trauma. Altering the chemicals in his brain wasn’t the answer, he said. His PTSD was not from an imbalance, but from an experience. “I don’t need medication,” he says in the film. “I need help.” Help he eventually found through an organization of war veterans against the war. Other subjects in the movie aren’t so lucky (lucky being a relative term…).

A mother whose son committed a grisly suicide while part of a clinical anti-psychotics drug study is the other immensely compelling character in this movie. She tried desperately to save her son and remove him from the trial, but because he was not a minor his personal consent to be put into a closed clinical study was irreversible by her. She could see that he was on a fast downward spiral but there was nothing she could do to remove him from the study. He killed himself in a most brutal way and there was nothing she could do to help him. She’s now fighting to have “Dan’s Law” (a law that prevents doctors from putting their patients into their own clinical trials) passed on a national level. It’s a heart-wrenching and horrifying story.

But here’s the problem with the movie. While some of these stories are terribly compelling, there’s also a large chunk of somewhat irrelevant information. There’s a young couple in Texas who fund their wedding with the money they’ve made through clinical drug trials. That’s it. There’s nothing said about any of the effects they’ve suffered through these trials or even why they chose this route instead of getting more conventional jobs. It seems as though the only reason they’re in the film is so that their friends can lament to the camera about how many drugs they’ve been prescribed. It’s a lot, sure, but without having any background there’s no way of knowing why they were prescribed these drugs or what effects they had on any of them.

There’s also a man who was incarcerated in the 1960s for selling marijuana and put into clinical trials he was told were safe. He ended up suffering from side effects including prostate cancer, rheumatoid arthritis, and deformation of his hands. He alludes to the doctor who knowingly put people at risk and used prisoners as human guinea pigs, but spent most of his time discussing his faith and the healing powers of Islam. It would have been far more interesting and beneficial to the movie to go into more depth about the studies.

The movie is all over the map, looking at stories of various people who take various medications for various reasons. It would have been great to take a closer look at how and why these meds were prescribed. The movie alludes to a loss of humanity in the search for the most effective mix of drugs to alleviate human suffering, and it seems like an opportunity to explore this appalling industry was lost. The movie is more about examining the human cost of these attempts, and while it makes for a sad and at times horrific story, it feels like there’s something missing.

The Upside: A powerful look inside the practice of using drugs for purposes they weren’t originally intended for and the toll it takes on the human subjects.

The Downside: Some very interesting stories felt cut short to make room for those that seemed far less relevant.

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