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DRUGS

Volunteer left brain-dead as French drug trial goes wrong

France's Minister of Health admitted on Friday that there was a "serious accident" during a drugs trial with one of the healthy volunteers left brain-dead and five others fighting for their lives.

Volunteer left brain-dead as French drug trial goes wrong
Photo: AFP
 
An investigation has been launched after the drugs trial being carried out in the western city of Rennes went tragically wrong.

Some media reports in France claimed the drug was a cannabis-based painkiller and AFP quoted a source “close to the case” who said the drug contained cannabinoids – an ingredient found in cannabis plants.

However a spokesperson for France's health ministry has told The Local this information is false.

“This medication did not contain cannabis and was not a cannabis-based drug,” said Health Minister Marisol Touraine.

According to France's Minister of Health Marisol Touraine the trial has been called off after one person was left brain-dead and five others hospitalised after taking the drugs.

However some reports suggest the victim has been left in a coma, which would mean the brain damage may not be permanent. 

It is believed eight people were taking part in the trial, but of two of them had been given a placebo.

“A serious accident took place,” the minister said, adding the study had been halted and all volunteers taking part recalled.

“This trial was performed in a licensed private institution specializing in the conduct of clinical trials (…) in healthy volunteers. This accident caused the hospitalization of six of the volunteers at the University Hospital of Rennes. One of them in intensive care, is brain dead,” said the minister in a statement.

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French drug trial goes wrong: How does drug approval work?

The Paris prosecutor's office said an investigation had been opened by police as well as health authorities.

Touraine, who was informed of the accident on Thursday evening, was on her way to Rennes on Friday morning, where she is expected to hold a press conference along with a representative from the company Biotrial which was leading the trial.

The study was a phase one clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”, the minister added in a statement.

Touraine gave no further details on the type of drug being trialed or what it would eventually be used for.

She simply said it was a medication “taken orally and in the process of being developed by a European laboratory”.

Medical trials typically have three phases to assess a new drug or device for safety and effectiveness.

Phase I entails a small group of volunteers, and focuses only on safety.

Phase II and Phase III are progressively larger trials to assess the drug's effectiveness, although safety remains paramount.

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

The trial was being carried out by the private laboratory named Biotrial, that was accredited and approved by the Ministry of Health. 

The firm released a statement via Twitter in which it insisted that all the necessary rules were followed.

Biotrial is a French company that employs 300 people worldwide, including 200 in France. It also has labs in Paris and in London and New Jersey, from where it carries out “a large variety of early clinical studies,” according to its website.

On its website Biotrial boasts of having 25 years experience in clinical drug trials. 

Every year thousands of volunteers, often students looking to make extra money, take part in such clinical trials which are seen as safe.

 

 

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DRUGS

French minister calls for Eurovision winner to be disqualified if singer fails drug test

France's Europe minister on Monday called for "total transparency" over speculation that one of Italy's victorious Eurovision contestants used cocaine during the song contest, saying it should be grounds for disqualification if confirmed.

French minister calls for Eurovision winner to be disqualified if singer fails drug test
France's entry, Barbara Pravi, said she didn't care whether Måneskin had used drugs or not. Photo: Kenzo Tribouillard/AFP

Damiano David, the outlandish vocalist for Italian rockers Måneskin, has agreed to take a drug test after video footage appeared to show him snorting something from a table backstage during Saturday’s contest.

“I think there needs to be no doubt here, and total transparency,” Europe Minister Clement Beaune, who attended the show in Rotterdam, told RMC radio. “If there is a problem, there are penalties… Provisions are made for sanctioning measures, including potential disqualification in case of problems.” 

French hopes had been riding high on singer Barbara Pravi, who was a bookmakers’ favourite to end France’s 44-year Eurovision drought with her
moody ballad “Voila.”

But she was edged out at the last minute by a surge in public votes for Måneskin, with a final tally of 524 to Pravi’s 499.

“I don’t want to be a sore loser,” Beaune said, but “in terms of image, we can’t let people think that such competitions can result in such behaviour.”

The president of France’s public broadcasting group, however, said Monday that France would not contest its second-place finish, no matter the speculation over David’s backstage antics.

“France has absolutely no intention to lodge an appeal,” France Televisions chief Delphine Ernotte told the Parisien newspaper. “The vote was quite clearly in Italy’s favour — it didn’t steal its
victory and that’s what matters,” she said.

Pravi herself said she was not interested in the speculation.

“What’s true is that they were chosen by both the public and the jury. Afterwards, if they use drugs or they put their underwear on backwards or whatever… it’s not my problem,” she told France 2 television on Sunday.

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