Wednesday, 27 January, 2016

Patient declared brain dead after French drug trial dies

France drug trial leaves one man dead Health 3 0
Dillon Hess | 22 January, 2016, 14:34

Touraine said the experimental drug was not based on cannabis, as some media reports had claimed.

The six people had volunteered for the trial at a private hospital which specializes in clinical trials. The sheet describes a study of BIA 10-2474, a compound that Bial lists as being in Phase-I tests on its drug pipeline.

The accident was during a Phase I clinical trial at a lab in Rennes that specialises in them. However, several details suggest it is indeed the information provided to healthy volunteers who were considering participating in the study before it started.

The Portuguese drug agency said that the new drug "is not being used in ant clinical trials in Portugal". A small number of people, sometimes healthy, and sometimes with a medical condition, are given a tiny dose of the drug under careful supervision, not to test if the drug works, but in order to check for any side effects. A fifth man is suffering from neurological problems and a sixth man is being kept in the hospital but is in a less critical condition, he said.

As a result, one volunteer was admitted to the hospital after feeling sick after three days followed by five others who felt the same way in the succeeding days.

Biotrial was testing a drug that caused the death of one person and seriously injured five others

Weekend reports suggested the drug contained cannabinoids, an active ingredient found in cannabis plants, but Touraine said it did not contain the drug or any derivatives of it. However, the minister has since clarified that this is not the case.

In 2006, a British drug trial was halted after 6 volunteers were hospitalized in intensive care after taking an experimental medication as part of a drug trial.

One of the six is now in a coma, according to the French Ministry statement. The activity was held on a clinic in France headed by the research company Biotrial according to The Guardian. "Faced with such a serious situation, we would expect the laboratory to approach the health authorities more quickly", she said. Specifically, they will look for any missteps taken by the doctors who administered the trial. "There is an inherent risk in exposing people to any new compound". Serious incidents like these are rare in the testing of a drug.

Three separate investigations are under way to try and find out what went wrong. The men did survive, but with some permanent injuries.



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