French Volunteer for Bial Drug Testing Dies
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A French volunteer who was left brain dead after the drug trial conducted by Bial, a Portuguese pharmaceutical company, died on Sunday according to Rennes Hospital, where the man was being treated.
The victim was one of the 90 paid healthy people to go through the drug trial. He was the first one to feel discomfort and was admitted after taking the drug for three consecutive days. Then, five other men were hospitalized after him. The hospital where the patients were being treated said the other five patients were already in their stable condition, Reuters reported.
The Guardian has revealed that the man who died and the other five who were admitted to the hospital were among those given the highest dosage of the drug being tested.
All trials involving the drug has been suspended and all volunteers have already been contacted to monitor them. Ten out of the 84 more volunteers were already tested. Fortunately, none of them showed any of the anomalies experienced by those who were admitted.
The reports indicate that the drug being tested is a Cannabis-based medication being developed to treat anxiety and other mental problems, and to fight against cancer, chronic pain, high blood pressure, multiple sclerosis and even obesity.
It was a Phase 1 clinical trial. It has been carried out to determine how safe the drug is if it is administered by single doses by mouth. Unfortunately, it ended to be the most tragic clinical trial that took place in France.
The people who participated in the trial joined at their will in exchange for 1,900 euros. They were given that amount to take drug given to them from Jan. 4 to 18. After what happened, the trials conducted by Bial for this medication have all been postponed.
It is normal for pharmaceutical companies to hold trials. It is always mandatory for companies developing medications to go through three phases of trials. These trials will be used to assess whether the drug is safe and effective.
According to BBC, the first phase of every trial should only involve a small number of participants. The participants vary. There are some who are healthy while there are some who are already diagnosed with a medical condition. This phase should not be aimed to check if the drug actually works. It should only be a test to determine whether there are side effects of using the drug.