One person is brain dead while
five others have fall sick in a clinical drug trial taking place in Rennes of
western France. All are undergoing treatment in the hospital with possibility
for permanent brain damages in case of three patients.
One injured has been suffering
from neurological problems while the other one is in less critical condition.
All of them have been volunteering in the drug trial comprising around 90
participants.
Biotrial private facility,
specialized in clinical trails, has organized trial of a research level drug developed
by Portuguese drug company, Bial. The volunteers under trial have been provided
the drug in different dosage. All other volunteers are being contacted butt no
further casualties have been reported. Meanwhile, the Paris prosecutor's office
has started probing the casualties and compelled Biotrial suspending all trials
of the drug.
The trial has been aimed at
tackling mood and anxiety related disorders. Neurons controlling the movement
coordination of the subjects under trial have been monitored; informs French
Health Minister Marisol Touraine while addressing a press conference.
Trial of the drug over the six
injured has begun on January 7 and halted on the following day after one
subject has reportedly fall sick. All the six subjects from age range of 28 to
49 have been diagnosed containing sound health before taking the oral dose of
the pain killer medicine.
The painkiller under trial exerts
similar compound effects over human brain as marijuana does. Testing of the
research level drug on human has been initiated since June last year. Prior to
this incident, no moderate or severe adverse effects have been reported from
108 patients who have volunteered in the trial, inform a Bial statement.
Bial states the number of injured
as five including one brain dead without providing details for the discrepancy
with the French health authority. However, the Portuguese drug manufacturer has
committed doing everything to ensure the well-being of the trial participants.
Meanwhile it has been assisting
the authority to unearth the reason for injuries. The drug manufacturer through
its statement claims to have due approval from the French regulator to conduct
the drug trial.
Volunteering in pain and anxiety
drug trials has become a popular mean of earning some extra quick bucks for
the French people. Biotrial spends in between €100 to €400 ($110 to $4,920) for
each adult, volunteering in Biotrial tests, claims the drug testing authority.
Phase 1 trials (like that under
discussion) studies safe usage, side effects and other measures on healthy
volunteers instead of drug effectiveness. Such trials are conducted to
determine the effective dosage for different stages of sickness.
Falling sick seriously for the volunteers, while
undergoing such trial, is a rare event, as informed by the industry insiders
since the drug under trial gets tested over other mammals before testing over
humans. Researchers usually start with the lowest possible dose in humans after
extensive tests in animals. Prior to humans, the Bial developed painkilling
drug has also been tested on chimpanzees and other animals.
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