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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.

READ ALSO: How does drug approval work?

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

Germany should make cannabis available at pharmacies not ‘coffee shops’, says FDP boss

Germany's possible new government could well relax the country's strict cannabis laws. But FDP leader Christian Lindner says he doesn't want to go down the Netherlands route.

A demonstrator smokes a joint at the pro-cannabis Hanfparade in Berlin in August 2021.
A demonstrator smokes a joint at the pro-cannabis Hanfparade in Berlin in August 2021. Photo: picture alliance/dpa | Annette Riedl

The Social Democrats (SPD), Greens and the pro-business Free Democrats (FDP) are set to engage in coalition talks in a bid to become the next German government.  And the future of cannabis will likely be one of the topics to be thrashed out.

In drug policy, the three parties are not too far apart in their positions. So it’s possible that the drug could be decriminalised.

However, nothing is set in stone and the parties still haven’t come to a common line on the question of where and to what extent cannabis could be accessed. 

The leader of the Liberal FDP, Christian Lindner, has now come out in favour of allowing cannabis products such as hashish to be sold in a controlled manner. 

Consumers should be allowed “to purchase a quantity for their own use, for example, in a pharmacy after health education,” Lindner told a live broadcast on German daily Bild on Sunday.

Lindner said he was sceptical about the sale in “coffee shops” according to the Dutch model. “I am in favour of controlled distribution, and therefore health education must be able to take place,” he said.

READ MORE: Patients in Germany still face hurdles accessing medical marijuana

People in the Netherlands can access cannabis products in coffee shops under the country’s tolerant drugs policy. However coffee shops have to follow certain strict conditions. For instance they are not allowed to sell large quantities to an individual. 

Lindner said his main aims were about “crime and health prevention” and not with “legalising a right to intoxication”.

It’s not clear if Lindner advocates for prescription-only cannabis for medical use, or an over-the-counter model. 

The FDP previously said that they they are in favour of the creation of licensed shops. Their manifesto highlights the health benefits, tax windfalls and reallocation of police resources that legalisation would create.

The Green party also want licensed shops, as well as a whole new approach to drug control starting with the controlled legalisation of marijuana. The Greens state that “strict youth and user protection” would be the centre point of their legislation and hope to “pull the rug from under the black market”.

The SPD also want a reform of Germany’s prohibition stance – but are more cautious than the smaller parties on the legalisation aspect. They would like to initially set up pilot projects. 

READ ALSO: Why Germany could be on the brink of legalising cannabis

Controversial topic

So far, the sale of cannabis is officially banned in Germany. Possession of cannabis is also currently illegal across the entire country. Those caught carrying the substance can face anything from a fine to five years in jail.

However, the justice system generally looks away if you are caught carry small quantities for personal use unless you have a previous conviction.

The definition of personal use differs from state to state, with Berlin having the most liberal rules and Bavaria the tightest.

It is estimated that around four million people regularly use cannabis in Germany.

Representatives of police unions in Germany have warned against legalisation. They argue that cannabis is an often trivialised drug that can lead to considerable health problems and social conflicts, especially among young people.

Oliver Malchow, from the GdP police union, said that “it doesn’t make any sense to legalise another dangerous drug on top of alcohol”.

The current Ministry of Health also continues to oppose the legalisation of cannabis, a spokesperson for Minister Jens Spahn (CDU) made clear. Cannabis is a dangerous substance and therefore legalisation is not advisable, the spokesman said. 

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