Friday, May 27, 2016

1 Brain Dead, 5 Others Hospitalized As Casualties Take Place In French Drug Test

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.

No comments:

Post a Comment