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Man dies in drug test Previously, dogs were already dead
Active ingredient promised a variety of applications
Just a few weeks earlier, France had a serious incident in a clinical trial. One volunteer died after taking an experimental drug and four more were seriously injured. According to the then statements of the French Minister of Health Marisol Touraine, the victims were men who had taken the drug several times. The active ingredient BIA 10-2474 previously appeared extremely promising, as it should help inter alia against anxiety disorders, Parkinson's, chronic pain and cancer. A total of 90 volunteers had received the substance, which was developed by the Portuguese pharmaceutical manufacturer Bial. The company Biotrial carried out the test in Rennes (Brittany).
First the dogs died and then a test person. Picture: sudok1 - fotolia Backgrounds still unclear
However, the circumstances surrounding the serious incident have not yet been clarified, so the pressure on the French authorities and the pharmaceutical manufacturer Bial is growing. According to the news agency "dpa", Biotrial boss François Peaucelle told French radio station RTL that the four injured men are back home. These had contributed to the tests neurological disorders and would continue to receive medical care and regularly examined. Some, according to François Peaucelle, would be in rehab, but predictions about possible long-term consequences could not yet be made. Another participant had shown no symptoms, but had been taken to the hospital as a precaution, the report went on.
Tiny tissue injuries in the brain
According to a statement by a scientific committee of the ANSM, the brain lesions in the affected persons have caused tiny tissue injuries, reports the "dpa". These would be "at the base of the skull", according to the head of the administration Dominique Martin opposite the newspaper "Le Figaro" - everything else, according to Martin, however, the medical confidentiality. But how could such violent consequences occur? Since the quality of the product, according to the ANSM committee, met the requirements, contamination apparently did not come into consideration.
Problems only in the high-dose group
On the other hand, a so-called "threshold effect" is suspected, which could have led to the side effects occurring only after a certain dosage. Because 84 people had previously taken the enzyme inhibitor BIA 10-2474, without any difficulties afterwards. Nearly 50 of them received the drug once in a dose of up to 100 milligrams. The participants were then given a daily dose of the drug in groups for ten days. While the group with 20mg a day had no problems, it came with the group with 50 milligrams finally to the massive consequences, the information of the committee.
Gross negligence on the part of the laboratory
Therefore, the experts would have two hypotheses in the room. First, the effect of the substance could possibly go beyond the pure inhibition of the enzyme FAAH (Fatty Acid Amide Hydrolase). In addition, a degradation product (metabolite) of the active substance may be responsible for the severe consequences. However, further investigations should follow, the results of which were announced at the end of March. From the point of view of the French authorities, the Labor Biotrials had several major omissions. For example, those responsible would have not sufficiently informed about the progress of the state of health of the first person who was admitted to the clinic on the fifth day of the trial. As a result, the remaining volunteers had received another dose the next day. The experiment was finally stopped by the afternoon.
Also, Biotrial did not inform the other subjects about the incident and gave late notification to the authorities, the news agency continued. According to Biotrial boss Peaucelle compared to the "time" stated that the condition of the first subject was initially not alarming. "Until Tuesday (the day after the break), we were not in a crisis mood. That changed abruptly on Wednesday morning when we learned about the symptoms of other patients, "Peaucelle is quoted as saying.
Several dogs previously died in animal experiments
There is also criticism because certain documents are not given to the investigation to the public. As reported by the ANSM, two more documents were supposed to go online, but the manufacturer Bial did not agree. "We gave all the information we could give. There is now commercial property, "says ANSM boss Martin. Particularly piquant is that the said documents apparently also contain information on previous animal experiments with the active ingredient. But even so, more and more information is coming to light, it is now also known that several dogs died in the animal experiments. According to the ANSM, however, this is "not unusual", as very high doses were deliberately used to check tolerance limits in these tests. As the "dpa" further reports, Bial had told the Portuguese weekly "Expresso" that the animals had died "due to lung injuries", so "any direct link" with the problems could be ruled out.
Sufferers still suffer from dizziness and blurred vision after weeks
Now it remains to be clarified, whereby it actually came to the serious incident. In addition, considering the events from an expert's point of view, the handling of data after an accident should generally be considered. "Business secrets are a valid principle, but they are detrimental to the general interest," said Stephen Senn, head of a working group of the Royal Statistical Society on clinical trials against Figaro. "It is necessary that the data can be discussed by all," the expert is further cited by the "dpa".
A victim also spoke up and told the regional newspaper "Le Maine Libre" about his life after the experiment. "I still have dizziness and discomfort when I stand for more than ten minutes. I keep seeing twice, "said the 42-year-old. His doctors would hope for improvement later in the year, but "they are not safe," the man continues. (No)