A clinical study of Sainte-Justine Hospital was suspended after Health Canada detected significant ethical violations. The “DEC GEN” study was aimed at children with cancer who did not respond to standard treatments.
The DEC GEN clinical study was launched in 2015. Six young patients took part. She was suspended a year after its launch. At the time of suspension, five of the six participants had already died. The sixth is dead after.
Health Canada’s report identifies 76 violations of the Food and Drugs Act, 23 of which are critical, posing an undue risk to the rights, health and safety of patients.
The hemato-oncology unit of Sainte-Justine Hospital defends its practices.
Sainte-Justine maintained that there was a lot of misunderstanding on the part of Health Canada and that the problems in the study were administrative in nature.
“In no case, from our point of view, has the clinical trial endangered the lives of children,” says Jacques L. Michaud, director of the Sainte-Justine research center.
Almost two years after the study was suspended, Health Canada agrees that the side effects were consistent with the protocol, and that all six deaths were caused by the disease.
Marie Bram started working for Spruce Tribune in 2017. Marie grew up in a small town in northern Manitoba. But moved to Ontario for university. Before joining Spruce Tribune, Marie briefly worked as a freelance journalist for CBC News. She covers politics and the economy.