In the face of the COVID-19 pandemic, as scientists and researchers work to manufacture vaccinations and treatments as quickly as possible, the documentary The Human Trial follows the search for a cure for the global diabetes epidemic, and why it’s taking so long.
“It’s become a joke in the community that the cure is always five years away. Stay strong, the cure is on the horizon,” Lisa Hepner, who was diagnosed with Type 1 diabetes more than 30 years ago, and produced and directed the film with her husband Guy Mossman, says in The Human Trial. “But each year more than five million people die from diabetes waiting for that cure.”
In 2014, the filmmakers landed the story of a small biotech company, ViaCyte, rethinking how to cure diabetes using embryonic stem cells, but they had no idea that on their second day of shooting the U.S. Food and Drug Administration (FDA) would give the company the green light for their clinical trial.
In The Human Trial, Hepner and Mossman give us a unique view of ViaCyte's clinical trial, developing a bioartificial pancreas for the sixth-ever embryonic stem cell trial in the world, which could potentially cure Type 1 diabetes. Earlier this year, ViaCyte was acquired by Vertex, another biotech company that has been working on its own stem-cell treatment.
“It all starts with the pancreas, the ugliest organ in the body,” Hepner explains as a voiceover in the film. “In Type 1 diabetes, the body attacks itself and destroys the cells that produce insulin, and when you don’t have insulin, sugar builds up in the blood and it can’t get into the cells. It’s as vital to the body as oxygen.”
She goes on to highlight that too much sugar in your blood is toxic and can lead to blindness and strokes, to just name a couple risks. When people with Type 1 diabetes have low blood sugars, they can become unconscious or die.
“I’m constantly injecting insulin to control the amount of sugar in my blood,” Hepner says in the film. “Normal blood sugars are flat with the odd spike, my blood sugars look like the Himalayas.”
What’s particularly fascinating and unique about The Human Trial is how it shows the “firewall” or barrier that exists between the two worlds of clinical trials, the patients and the researchers.
“When we started to make this film, we didn't know what this clinical trial was going to be like for the patients,…I don't think the patients really knew either, I don't think the biotech company knew either,” Lisa Hepner told Yahoo Canada.
There were seven trial sites in the U.S. and Canada, and in The Human Trial we meet Maren Badger and Greg Romero, through the site at the University of Minnesota.
Badger is patient number one, the “pioneer” of the trial. She was diagnosed with Type 1 diabetes at the age of two and had her first seizure when she gave birth to her first biological child, another when giving birth to her second child, which led her and her husband to adopt four children.
Romero was diagnosed at 11 and his father also had diabetes, and went completely blind. In The Human Trial, we see the patient losing his eyesight as well. Romero admits he spent years not taking care of his disease, sometimes not being able to afford the insulin and medication needed to do so, but now he doesn’t want to “abandon” his daughter.
Throughout the film we see Badger, in particular, wondering if she’s actually seeing positive results from the trial, or if any improvements are a result of some other contributing factor, or if it’s just a placebo effect.
Of course, the filmmakers had to gain the trust of ViaCtye that they would not film or divulge anything that could compromise the trial, including interactions with patients that could put their entire study at risk. But the film raises an important question about what that “firewall” between the researchers and patients really needs to look like.
“Standard operating procedure for any clinical trial is to have the firewall to give the integrity of the study, we understand that's important," Lisa Hepner said. “But does that firewall have to be as thick as it is? Does it have to be impenetrable? Can we not make the patient experience a better one?"
"It was really important to us to show that, to show what these patients were going through, because too often we read a headline, ‘COVID vaccine shots in arms,’ but why did that happen? That happened because people volunteered for these studies, they volunteered to put that vaccine into their arms when they didn't know if it was going to work… So without the people, clinical trial participants sacrificing for us, we wouldn't be living a normal life right now.”
What’s not often displayed in science-based documentaries is the physical and emotional toll of actually being a clinical trial participant, with their desperation for the trial to be successful very evident. But The Human Trial does that honestly, particularly with a Type 1 diabetic leading us through the story.
“I think that it was hard for Lisa as well, as you can see in the film, seeing the patients kind of agonize in this way and not being able to help them, it speaks to a lot of discipline, at least as a storyteller, as a journalist to sort of not cross that line with them,” Guy Mossman said. “I think this is really an exceptional situation and can only be made by a filmmaker who was personally afflicted by the condition, where we would have stuck it out the way we did with so many unknowns, I think anyone else would have pulled out.”
“I think because I have Type 1, my motivation was more authentic and genuine,” Lisa Hepner added. “Other people could certainly have told it, I don't know if they would have stuck it out, while I was like a dog with a chew toy, we weren't going to let it go because we didn't know where the science was headed.”
“People do truly want to see things tied up in a neat bow and I think that science and a story about science really kind of grates against that. We’re looking for a happy ending, we're looking for an ending where we have a conclusive ending. I think that the film shows that science is a lot more complicated.”
As someone with Type 1 diabetes, Hepner stresses that the momentum that has built up for international research communities to find a cure and treatment for COVID-19 should be the model for finding a cure for the diabetes epidemic. We were capable of innovating quickly for COVID-19, we should be doing the same for a diabetes cure.
“Am I tired of having diabetes not taken seriously? Absolutely… It is a serious disease, the fact that people think it's benign, just eat better, just take your shot of insulin and shut up, it's not like that,” Hepner said. “It's not only a financial drain, it's a mental drain, it's a physical disease that is debilitating, either in the short term or the long term, this disease needs to be cured.”
“My message is to have tangible hope that is based in knowledge and science, and if you follow the science and talk to the researchers, there is realistic hope for a functional cure in five years. We need to continue to make a lot of noise to make sure the funding continues… Some people in the diabetes community who have money and the access to the treatments, will say, ‘Oh, this is manageable disease,’ but…it's not for most of the world… Don't turn your eye to most of the people who are suffering in a massive way.”
The Canadian premiere for The Human Trial will be held in Toronto on Oct. 24. The film will be available on Amazon, Apple TV, Google Play and other digital platforms on Nov. 11.
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