One
person is brain dead and five others are seriously ill after taking part in a
drug trial for Portuguese pharmaceutical firm Bial at a clinic in north-west
France.
The
French health ministry said the six male patients aged 28 to 49 had been in
good health until taking the oral medication. They started taking the drug on 7
January. One person started feeling ill on Sunday and the other five afterwards.
The brain dead volunteer was admitted to hospital in Rennes on Monday. Other
patients went in on Wednesday and Thursday.
Pierre-Gilles
Edan, head of the hospital’s neurology department, said one man was brain dead,
three others were suffering a “handicap that could be irreversible” and another
had neurological problems. The sixth volunteer had no symptoms but was being
monitored.
The
French health minister, Marisol Touraine, said 90 people in total had taken
part in the trial and received some dosage of the drug; others had taken a
placebo. All trials on the drug have been suspended and all volunteers who have
taken part in the trial are being called back.
The
ministry said the test was carried out by the Bio-trial clinic for Bial, which
“specialized in carrying out clinical trials”.
The
trial was intended to test for side-effects of the new drug but all trials at
the clinic have been suspended and the French state prosecutor has opened an
inquiry.
Touraine
said the drug was a so-called FAAH inhibitor meant to act on the body’s
endocannabinoid system, which deals with pain. Earlier reports suggested that
the drug contained cannabinoids, an active ingredient found in cannabis plants,
but the minister said it did not contain the drug or any derivatives of it.
Touraine
said 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”.
Medical
trials typically have three phases to assess a new drug or device for safety
and effectiveness. Phase one entails a small group of volunteers and focuses
only on safety. Phase two and three are progressively larger trials to assess
the drug’s effectiveness, although safety remains paramount.
Testing
had already been carried out on animals, including chimpanzees, starting in
July, Touraine said.
Bial
said it was committed to ensuring the well-being of test participants and was
working with authorities to discover the cause of the injuries, adding that the
clinical trial had been approved by French regulators.
Every
year, thousands of volunteers, often students looking to make extra money, take
part in such trials. Mishaps are relatively rare, but in 2006 six men were
treated for organ failure in London after taking part in a clinical trial into
a drug developed to fight auto-immune disease and leukemia.
culled from stelladimokokorkus
culled from stelladimokokorkus
