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France: Drug involved in French clinical trial disaster wasn't cannabis-based

Emily Gray Brosious

Sun Times Extract

Friday 15 Jan 2016

Experimental drug in botched clinical trial didn’t contain cannabis, French health officials say.

The trial medication that left one person brain dead and five seriously ill was not a cannabis-based painkiller as earlier reports indicated, according to French health minister Marisol Touraine.

Per the Guardian:

Touraine said the drug was a so-called FAAH inhibitor meant to act on the body’s endocannabinoid system, which deals with pain. Earlier reports suggested that the drug contained cannabinoids, an active ingredient found in cannabis plants, but the minister said it did not contain the drug or any derivatives of it.

Officials said 90 volunteer participants had taken some dosage of the drug. The six patients who became ill were males between the ages of 28 and 49, and had been in good health before taking the experimental oral medication, as reported by Reuters.

All trials have been suspended on this medication, which is made by the Portuguese drug company Bial.

French ‘cannabis’ drug trial disaster leaves 1 brain dead, 5 in critical condition

*Update: The drug involved in this clinical trial disaster is not cannabis-based, as earlier reports indicated.

Botched drug trial in France leaves six people in the hospital.

According to the French Health Ministry, one person is brain dead and five are critically ill after participating in a clinical drug trial for an unidentified pharmaceutical firm at a clinic in northwest France, as reported by the Guardian.

The ministry hasn’t revealed what the medication was intended to be used for, but a source told Reuters that the drug is a cannabis-based painkiller.

The six volunteers were in good health prior to taking the oral medication, which was done in a private lab that “specialized in carrying out clinical trials,” as reported by Reuters.

It is not yet clear if this trial drug was a synthetic or natural cannabis-based medication. It is also unknown whether or not the cannabis component of the drug is what caused the accident.

The drug was in phase one of clinical testing, the period when volunteer participants take a medication to evaluate its safety and potential side effects.

Per the Guardian:

Medical trials typically have three phases to assess a new drug or device for safety and effectiveness. Phase one entails a small group of volunteers, and focuses only on safety. Phase two and three are progressively larger trials to assess the drug’s effectiveness, although safety remains paramount.

All trials on this drug have now been suspended.

http://extract.suntimes.com/information-resources/10/153/12379/medical-cannabis-fibromyalgia-treatment/

 

 

 

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