A drug trial has gone very wrong leaving one person brain dead and five others in the hospital. Doctors fear that three of these male patients out of the five in the hospital may suffer irreversible brain damage. Six volunteer subjects out of the 90 who were given the experimental drug fell ill in a experimental drug trial taking place in France.
According to MSN News on January 17, the drug was created to treat mood and anxiety issues, along with treating neurological symptoms such as movement coordination. There are 128 volunteers in this drug trial between the ages of 18 and 55. Only 90 subjects were given some dosage of the drug. The remaining subjects were given a placebo.
“The medicine involved is a so-called FAAH inhibitor that works by targeting the body’s endocannabinoid system, which is also responsible for the human response to cannabis,” reports MSN.
Something went very wrong with the six men, ages 28 to 49, all of whom were in good heath until they started the drug trial. The Biotrial Clinic, which is a facility specializing in drug trials, is where this experimental drug research is taking place.
The six men started taking the drug for this trial on Jan. 7. The brain-dead volunteer was admitted to hospital on Monday, the French Health Minister Marisol Touraine said on Friday. Touraine met with the families of the six men in Rennes, western France on Friday then held a news conference.
According to CNN News, the drug trial has been stopped and the investigation is underway. The health department is reaching out to the remainder of the 90 participants, who were given some dosage of this drug, to inform them of these adverse reactions.
The medical staff is truly baffled as to what has happened. Touraine said at the news conference, “This is unprecedented. We’ll do everything to understand what happened.”
Before this drug trial used human subjects, it was tried on animals, including chimpanzees. All indications led the researchers to believe this would be a safe trial when going ahead with human patients. Experimental drug testing is done under tight guidelines and disasters such as what is happening today in France are rare, but they are not unheard of.
MSN reports that “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.”