Botched French Drug Trial Leaves Patients Critically Ill

French Medical Study Mishap
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The big question in France:  what went terribly wrong?   This, after a botched drug trial lands 6 men in this hospital, some critically ill.  Authorities have suspended the trial, in which 90 volunteers were given the medication.
 
French health officials say the men -- between 28 and 49 -- were all healthy before they began taking an experimental drug.  Made by a Portuguese company, they say,  the oral medication was designed to treat mood and anxiety disorders and neurodegenerative diseases.

Brain scans show four volunteers may have suffered serious neurological damage, and the hospital says there is no treatment to reverse their side effects.

French authorities say one man in comatose, classified as "brain dead." Three others may have suffered irreversible neurological damage.  A fifth volunteer has had no symptoms, but is being carefully monitored.

In the trial, run by the private research company Biotrial, the 6 men starting taking the investigational drug Jan. 7, in varying doses. Four days later, the most severely injured man was hospitalized followed by the others.

Biotrial, which has more than 25 years experience in clinical trials, says it followed all of the safety regulations and procedures.

The trial, now suspended, was an early stage Phase I trial. This was the first time the drug was tested in humans after being tested in animals.

Most Phase 1 trials are small and carefully monitored.  The focus is finding whether the drug is safe and what the best dose may be for patients.

Complications in Phase 1 trials are rare, experts say, and researchers follow strict safety protocols.   But the French study is not unprecedented.

In 2006, a British drug trial was halted after 6 volunteers were hospitalized in intensive care after taking an experimental medication as part of a drug trial.  

But at this point, it's not yet known whether the medication, or the dosage, or something else  is to blame for causing so much damage.

 French health officials say the men -- between 28 and 49 -- were all healthy before they began taking an experimental drug.  Made by a Portuguese company, they say,  the oral medication was designed to treat mood and anxiety disorders and neurodegenerative diseases.

Brain scans show 4 volunteers may have suffered serious neurological damage, and the hospital says there is no treatment to reverse their side effects.

French authorities say 1 man in comatose, classified as "brain dead." Three others may have suffered irreversible neurological damage.  A fifth volunteer has had no symptoms, but is being carefully monitored.

In the trial, run by the private research company Biotrial, the 6 men starting taking the investigational drug Jan. 7th, in varying doses. Four days later, the most severely injured man was hospitalized followed by the others.

Biotrial, which has more than 25 years experience in clinical trials, says it followed all of the safety regulations and procedures.

The trial, now suspended, was an early stage Phase I trial.  This was the first time the drug was tested in humans after being tested in animals.

Most Phase 1 trials are small and carefully monitored.  The focus is finding whether the drug is safe and what the best dose may be for patients.

Complications in Phase 1 trials are rare, experts say, and researchers follow strict safety protocols.   But the French study is not unprecedented.

In 2006, a British drug trial was halted after 6 volunteers were hospitalized in intensive care after taking an experimental medication as part of a drug trial.  

But at this point, it's not yet known whether the medication, or the dosage, or something else  is to blame for causing so much damage.


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