Scientist: No known antidote for botched drug test in France

Scientist: No known antidote for botched drug test in France

The head of the neurology department of the hospital treating the volunteers told reporters that one man was brain dead; three others were suffering neurological problems as well as a "handicap that could be irreversible".

The French ministry statement said those who fell ill had taken an oral medication in the first phase of testing, which was studying safe usage, tolerance and other measures on healthy volunteers. The minister said the drug was meant to act on the body's endocannabinoid system.

A botched drug trial in northern France put six people in hospital, including one person who is brain-dead, the French government said on Friday.

The painkiller used in the trial was developed by Bial, a Portuguese pharmaceutical company.

Six male volunteers aged between 28 and 49 have since been taken to hospital, including one now classified as brain dead, she said.

Prosecutors have opened an investigation into the case.

Touraine said she was determined to "shed light on" what happened.

Touraine had earlier said that an IGAS inspection would begin Saturday.

As per National Institute of Health Clinical trials of new medicines or medical devices are done in phases.

The initial Phase I stage of clinical testing consists of a medication that is given to healthy volunteers to see the human's body response to it and to determine the appropriate dose that patients need.

In 2006, a volunteer turned into an "elephant-looking" man after a clinical trial in London sent six of its participants in intensive care.

The chief neuroscientist at the hospital in Rennes, Professor Gilles Edan, said Friday there's no known antidote to the experimental drug that Biotrial was testing.

A total of 90 volunteers were given the trial drug in various doses, but six have been hospitalized after being given "repeated" doses of the drug. It said 108 healthy volunteers had already participated in the tests without any moderate or serious adverse reactions becoming evident. Tests had begun last July 9th, but at much lower dose levels. Bial stopped its trial a day later. Phase two and three are progressively larger trials to assess the drug's effectiveness, although safety remains paramount. In a statement posted on its website, Biotrial reported that "the trial has been conducted in full compliance with the global regulations and Biotrial's procedures were followed at every stage throughout the trial". "It is very common for there to be side effects since all medicines (approved or in testing) exert both the desired effect and unwanted effects", said Dr Ben Whalley, a professor at Britain's Reading University.

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