One person has been left brain-dead and five others are in serious condition after participating in a clinical trial in France of an experimental painkiller, Reuters reports. The new drug, made by a Portuguese company, works by targeting the body’s pain-controlling endocannabinoid system, which is also responsible for the human response to cannabis.
The French Health Ministry said the six volunteers in Rennes, in western France, had been in good health until taking the oral medication at a private facility that specializes in conducting clinical studies. The brain-dead volunteer was admitted to a hospital in Rennes on January 11, and the other subjects were admitted on January 13 and 14.
The volunteers were men aged 28 to 49, French Health Minister Marisol Touraine told a news conference. They started taking the drug on January 7 and started feeling ill shortly afterwards. A total of 90 subjects have taken part in the trial, with some receiving the experimental medication and others receiving placebo.
All trials of the drug have been suspended.
According to Reuters, cases of early-stage clinical studies going wrong are rare but not unheard of. In 2006, six healthy volunteers given an experimental drug in London ended up in intensive care. One was described as looking like “the elephant man” after his head ballooned. Another lost his fingertips and toes. This study led to the collapse of Germany’s TeGenero, the company developing a medication known as TGN1412. The drug has since gone back into tests for rheumatoid arthritis and is showing promise when given at a fraction of the original dose.
Source: Reuters; January 15, 2016.