The man left brain-dead in a clinical drug trial has died Monday, the University Hospital in Rennes, France, reported.
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French authorities launched 3 investigations Saturday, January 16, at a research laboratory in the northwestern city of Rennes into a drug trial that left one person brain-dead and three others facing potentially irreversible brain damage.
“A serious accident took place during a therapeutic trial near Rennes”, French Health Minister Marisol Touraine said.
They were declared in good health before they started taking the drug on January 7 at a private Biotrial testing facility in Rennes. However, Health Minister Marisol Touraine said that the new drug is not marijuana based.
The other five remain in a stable condition, with four showing “neurological problems“, the hospital said in statement.
Medicines then go into larger Phase II and Phase III trials to assess their effectiveness and safety before they are finally approved for sale. The hospital is arranging to test all those involved in the drug trial, which was in its first phase.
It is a high price to pay, but thousands of people do safely take part in similar trials each year. Bial has yet to confirm the drug that was being tested. All trials on the drug have now been suspended and all volunteers who have taken part in the trial are being called back, the health ministry added.
During phase one testing, the dose of an experimental drug is slowly increased over time, which might explain why the participants did not get sick immediately.
The six patients that fell in where amongst 90 testing the drug, and a further 18 patients were testing the placebo version of the medication.
Dr. Ben Whalley, a neuropharmacology professor at Britain’s University of Reading, said standardized regulations for clinical trials are “largely the same” across Europe. After the incident, all the volunteers who took the drug was traced and contacted – being followed by the trial’s suspension.
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The men were admitted to intensive care, where some of their heads swelled up – giving the incident its nickname, “the elephant man” trial – after 19 Century Englishman Joseph Carey Merrick, whose severe deformities led to him being exhibited as a human curiosity. “However, like any safeguard, these minimise risk rather than abolish it”, Whalley said.
