'Serious accident' at clinical trial in France leaves one 'brain-dead' and several hospitalized
French clinical trial goes wrong and hospitalizes test subjects
One man has been left brain dead and three others face permanent brain damage after taking part in clinical trials for a new drug, the worst such accident in France’s medical history.
Ninety people from the Brittany area in western France took part in the trial, taking some dosage of the drug aimed at reducing pain and anxiety.
Six men aged between 28 and 49 started taking repeated doses at higher levels than other participants on January 7. By Sunday, one member of the group was rushed to hospital, with a brain condition that was so bad doctors thought he was suffering from a stroke. Four others have since been hospitalised.
Six men aged between 28 and 49 started taking repeated doses at higher levels than other participants on January 7. By Sunday, one member of the group was rushed to hospital, with a brain condition that was so bad doctors thought he was suffering from a stroke. Four others have since been hospitalised.
"What has happened is unprecedented in France," said Marisol Touraine, the health minister, on Friday. The Paris prosecutor's office said an investigation had been opened.
One of the six men appeared to be unaffected, but “among the remaining four, there are three whose condition is sufficiently severe to fear a handicap that could be irreversible in the best of worlds,” said Pierre-Gilles Edan, head of neurosciences at Rennes hospital.
He said that he feared their condition would deteriorate and that there was “no known antidote” to their “brain lesions”.
The remaining participants in the trial have been contacted to undergo brain scans.
Based on a compound similar to the active ingredient in marijuana, the drug was developed by Portuguese pharmaceutical company Bial.
The oral trial, which has now been suspended, was conducted by Biotrial, a private French-based company with a solid track record and offices in London and America.
In a message on its website, the company said that "serious adverse events related to the test drug" had occurred. The company insisted that "international regulations and Biotrial's procedures were followed at every stage".
A spokesman for the London branch of Biotrial said that it did not conduct trials in the UK.
Britain saw an equally horrific accident in 2006 when six men were hospitalised in Northwick Park Hospital in London after a clinical trial where they were given a drug intended to fight autoimmune disease and leukaemia. One was described as looking like "the elephant man" after his head ballooned.
Up to 300,000 clinical tests for medical drugs take place every year and serious mishaps are extremely rare, according to doctors.
“The shock is all the greater as these people undergoing the clinical trials are healthy, they are not ill and don’t expect such an accident,” said Ms Touraine.
Dr Ben Whalley, a neuropharmacology professor at the University of Reading, said that while such incidents were incredibly rare, "there is an inherent risk in exposing people to any new compound".
New EU regulations to speed up clinical drug trials and streamline testing procedures across the 28-nation bloc are due to take effect in May.
He said that he feared their condition would deteriorate and that there was “no known antidote” to their “brain lesions”.
The remaining participants in the trial have been contacted to undergo brain scans.
Based on a compound similar to the active ingredient in marijuana, the drug was developed by Portuguese pharmaceutical company Bial.
The oral trial, which has now been suspended, was conducted by Biotrial, a private French-based company with a solid track record and offices in London and America.
In a message on its website, the company said that "serious adverse events related to the test drug" had occurred. The company insisted that "international regulations and Biotrial's procedures were followed at every stage".
A spokesman for the London branch of Biotrial said that it did not conduct trials in the UK.
Britain saw an equally horrific accident in 2006 when six men were hospitalised in Northwick Park Hospital in London after a clinical trial where they were given a drug intended to fight autoimmune disease and leukaemia. One was described as looking like "the elephant man" after his head ballooned.
Up to 300,000 clinical tests for medical drugs take place every year and serious mishaps are extremely rare, according to doctors.
“The shock is all the greater as these people undergoing the clinical trials are healthy, they are not ill and don’t expect such an accident,” said Ms Touraine.
Dr Ben Whalley, a neuropharmacology professor at the University of Reading, said that while such incidents were incredibly rare, "there is an inherent risk in exposing people to any new compound".
New EU regulations to speed up clinical drug trials and streamline testing procedures across the 28-nation bloc are due to take effect in May.
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