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French Drug Trial Goes Horribly Wrong, Leaves Man Brain Dead
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A drug trial in France has been suspended indefinitely after one person has been rendered brain dead and another five were left seriously ill.
All six men were admitted to a local hospital at the beginning of the week. French health minister Marisol Touraine has since made her way to the town of Rennes, where the trial for Portuguese pharmaceutical firm Bial was taking place. The trial was intended to test for side effects of a new painkiller and was in a stage one phase, where the medication was being consumed by volunteers to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule.”
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Original reports stated that the drug being tested was cannabis-based, but Touraine later refuted the claim.
Touraine confirmed at a news conference on Friday that the six male volunteers ranged from ages 28 to 49. They started taking the drug on January 7 and one person reported feeling ill three days later, with the other five reporting the same shortly after. They were part of a group of 90 individuals who took part in the trial, although only about half took the drug and the other half were given a placebo.
Although it hasn’t been confirmed what the medication was intended to be used for, it’s been stated that might have been a potential painkiller since it acts on the body’s endocannabinoid system, which deals with pain.
It’s also unclear whether the families of any of the participants will sue Bial. But for volunteers who participate in such trials stateside, there is little recourse for them when things go wrong. Researchers aren’t required by federal law to compensate volunteers who are harmed in such trials, but simply need to state whether compensation will be available in the consent forms that volunteers fill out for trials that involve more than a minimal risk.
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