French drug trial gone horribly wrong
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French drug trial gone horribly wrong

16 Jan 2016 | By Anupa

French drug trial gone wrong, Minister rushes to Rennes

A French clinical trial left 1 man brain-dead, 5 critically ill (out of the total 90 volunteers).

The French Health Minister will be travelling to Rennes to monitor incident.

Medical experts are stating that Phase 1 trial-damages are isolated as they involve healthy subjects.

This trial stands rare, which is why the involved companies and the experts are being put under the radar.

Timeline

15 Jan 2016: French drug trial leaves 5 casualties, one brain-dead

French-based Biotrial on behalf of the medicine manufacturer Bial held a drug trial performed at the University Hospital of Rennes.

This Phase-1 trial tests the safety and side-effects of the freshly made drugs on healthy volunteers.

Volunteers were on the drug since 4th January and the first after-effect was noticed last week after which the five casualties and one brain-dead patient was taken.

Fact: Bial and Biotrial

Bial is a Portuguese pharmaceutical company producing antibiotics, anti-allergens and drugs treating problems related to the nervous system and cardiovascular health. Biotrial is a French laboratory that facilitates pharmaceutical drug trials like the one in question.

15 Jan 2016: Questions raised on the composition of the drug

Questions raised on the composition of the drug

Initial reports suggested that the drug was a cannabis-based painkiller but later, a source stated that it contained cannabinoids, which is an active ingredient found in cannabis plants.

French Health Minister, during the press conference, promised to take all responsibility for the incident.

Bial, the drug manufacturer, said that they were following the legislation and cooperating with the investigation.

Fact: What is cannabinoids?

Cannabinoids are found in marijuana flowers that provide relief for symptoms including migraines and muscle cramps. Overuse of cannabinoid leads to Cannabinoid hyperemesis syndrome, which is characterized by recurrent nausea, vomiting and abdominal pain.

15 Jan 2016: Doctors admit no cure for drug trial victims

According to medical experts, the medical condition of the three irreversible brain disorder casualties and the brain dead casualty was a rare situation.

The other two casualties are suffering from less risky neurological illness.

A top doctor declared that there was no known antidote for the affected volunteers.

The Health Minister expressed her grievances over the incapacity to provide antidotes to the victims.

15 Jan 2016: Prosecutors investigation leads to drug discovery

Prosecutors investigation leads to drug discovery

According to the French Health Minister, reports had found that the drug was not a cannabis painkiller.

Bial identified the drug as an inhibitor of an enzyme known as FAAH, or fatty acid amide hydrolase.

It was reported that FAAH when paired with other drugs, is usually harmless, but it was not always compatible in different compositions as happened in this case.

16 Jan 2016: French drug trial gone wrong, Minister rushes to Rennes