Lisa Hepner takes us through what it’s like to be a human rodent in a high stakes trial. The pressure is hot. This particular test trial is the first one using humans after a success on mice, but only180 days are left of Viacyte’s funding. Everyone wants the scientific experiment to work, especially two patients, both parents, whose lives are on the line.
The hope is that this new strategy, introducing stem cells harvested from IVF (in vitro fertilization) will grow and increase in the body to create insulin and cure diabetes in its hosts. But in order to know if the cells are growing and increasing, the patients must undergo surgery every few weeks to remove the stem cell packs and then insert new ones in multiple locations.
Maren Badger and Greg Romero, both in the Minneapolis area, readily volunteered. Maren, a mother with six children, has such wildly fluctuating blood sugar levels that she is periodically in danger of collapse and death.
Greg has had at least 10 experiences in the last 12 months that caused him to become incapacitated. In addition, his eyesight is deteriorating so badly from bleeding in his eyes that he is in danger of losing his sight altogether.
These people have diabetes. When they have high blood sugar they are at risk of losing a limb or blindness and if they have low blood sugar it can result in death. The WHO (World Health Organization) reports that each year more than 1.5 million Americans die from diabetes. In 2017, it cost $237 billion for direct medical costs to treat them (American Diabetes Association).
Viacyte, the company tracked in this film, has been working on research that involves programming stem cells from IVF to produce insulin. After success in tests with mice, the FDA gave its approval to use human subjects. Since it takes 10-20 years to develop a new drug, research and development of new drugs can be excessively expensive and time-consuming.
Viacyte’s financial clock is ticking. Part of the film tracks the lives of the researchers pitching to pharmaceutical companies for funding. They travel to Saudi Arabia and Japan, hoping their highly populations will be a factor influencing investment.
In the meantime, we get to know Maren and Greg and their bodies’ responses to each explant and implant surgery.
This is an extraordinarily well made, suspenseful film that tracks the human research project through six years of human trials. Susan Metzger, editor extraordinaire, gets high marks.
“The Human Trial” helps explain high pharmaceutical costs and the challenges inherent in the research and development of new drugs. But most importantly, it reveals the sacrifices of our fellow humans who allow themselves to be part of the required process.
Rating: 10/10
Credits
Director, Producer and Writer: Lisa Hepner
Director of Photography: Guy Mossman
Producers: Jonathan Formica, p.g.a., Lesko, p.g.a., and Scott Stevenson, ACE
Editor: Susan Metzger
Composer: Miriam Cutler | COMPOSER
Executive Producers: Amy Rapp, Marla Oringer and Greer Wylder
Release: 2022
Website: https://www.thehumantrial.com/
How to watch on multiple platforms: https://www.thehumantrial.com/watch
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