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Deadly French drug trial: Lab had ‘major shortcomings’

An inquiry into the death of a man during a drug trial has found "three major shortcomings" at the French laboratory where he was being tested, the minister of health said Thursday.

Deadly French drug trial: Lab had 'major shortcomings'
Biotrial, the firm that led the fatal trial.Photo: AFP

Five other people were also hospitalised after taking part in a Phase I trial for a new pain and mood disorder medication at Biotrial, in western France, on behalf of Portuguese pharmaceutical company Bial.

France's social affairs inspectorate general, Igas, found “the laboratory did not stay sufficiently informed on the status of the first volunteer to be hospitalised”, minister Marisol Touraine told a news conference.

The lab gave the same drug to other volunteers on January 11, even after one had been hospitalised the day before.

Biotrial also did not “formally inform” the other volunteers of what had happened so they could make an informed choice on whether to continue with the trial, and also took too long to make authorities aware.

The exact causes of the accident have not yet been confirmed, however, Touraine said, adding that Igas did not think the accident meant the laboratory should be suspended from carrying out further tests.

Three separate probes have been launched to determine whether the incident was caused by a procedural error or by the substance being tested.

A total of 108 volunteers took part in the study at Biotrial, which has been carrying out drug trials since 1989. Ninety of them received the drug at varying doses, while the rest were given placebos.

Those hospitalised had received the highest dose. All have now returned home and will be given another health check up at the end of February, said Touraine.

The Igas report found Biotrial had “largely respected” the proper procedures when carrying out the trial, and had followed regulations.

The laboratory said it was “relieved” it was not held responsible for the volunteer's death, adding that “the supposed failings identified in Igas' preliminary report are in no way the cause of the serious undesirable effects witnessed”.

Bial also said it was satisfied the report had “confirmed that the protocols of the clinical trial complied with the law”.

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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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