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Drug test in France: one brain dead, four people in mortal danger
Some participants in a drug study in France appear to be seriously ill from taking medication. One test subject even suffered brain death and is therefore clinically dead. The damage to the other test subjects may not be reparable. The reasons for the serious incident have not yet been clarified.
Serious incident during drug testing
"Looking for participants in a drug study" or "Earning good money as a test person" - you can always read such and similar calls in advertisements on the Internet. As a rule, it is pharmaceutical companies or universities that need healthy or sick test subjects for their research. In Germany alone, around 1,200 such studies are carried out annually, involving a total of around 10,000 test subjects. Both new drugs and new areas of application for already known drugs are being tested.
In France, such a study has now led to a serious incident: one subject is brain dead and four other people have suffered damage that may not be recoverable.
Participant in France is brain dead
According to a report by the APA news agency, a subject is brain dead in hospital after a severe drug test in France. Four other test subjects suffering from neurological complaints are also reported. Some of them fear irreversible damage. "Your need shook me," said French Minister of Health Marisol Touraine.
The country's authorities announced an investigation. According to the minister, 90 volunteers in different doses have already received the active ingredient, which was developed by the Portuguese pharmaceutical manufacturer Bial. The Biotrial company carried out the test in Rennes (Brittany). According to the information, the victims are men who have taken the drug several times. "At this point in time, we do not know what the exact reasons for the accident are," said Touraine.
Symptoms appeared after a few days
Contrary to initial media reports, the tested active ingredient does not contain cannabis. He aimed at mood swings and motor disorders in neurodegenerative diseases. According to Biotrial, the attempt was “carried out in full compliance with international regulations”, and all internal company procedures were also followed. Bial initially did not comment, but announced an opinion. Another test participant is said to have no symptoms, but is in the hospital for observation. On January 7, the six men, aged 28 to 49, started taking the drug, and on January 10, one of them began to experience symptoms. It was the man who is now in the intensive care unit and, according to the doctors, brain dead.
Drug previously tested on animals
According to the information, the laboratory stopped the test the next day. According to the APA, Professor Gilles Edan from the Rennes University Hospital said that at present no prediction of the condition of the injured can be made. The drug was reported to be in phase 1 of the clinical trial, which is a prerequisite for marketing approval. In this phase, drugs are tested for tolerance for the first time on healthy volunteers. According to Touraine, the drug had previously been tested on several animal species, including chimpanzees. Incidents or side effects must always be reported to the authorities immediately. The active substances are usually dosed very low in test phase 1. All of these tests always take place under medical supervision. "It is therefore an absolutely extraordinary event that a participant dies or comes to a hospital during such an early test phase," said Rolf Hömke from the Association of Researcher Pharmaceutical Manufacturers (VFA).
German company insolvent after incident
Hömke is only known of a similar incident in Great Britain in 2006, in which an active ingredient was tested against multiple sclerosis. At that time, six out of eight men had severe reactions five minutes after ingestion. Just a few hours later, doctors diagnosed multiple organ failure. The patients were in mortal danger for several days, one was in a coma for three weeks. The active ingredient came from the pharmaceutical company TeGenero from Würzburg.
The company had to file for bankruptcy a few months later. "After the TeGenero disaster, the rules for drug tests were tightened again, the dosage must now be much lower," says Hömke.
Western pharmaceutical companies carried out tests in the GDR
According to experts, Germany is in second place worldwide behind the USA in such tests. In recent years, such investigations have been discredited due to various scandals. For example, deaths have been reported in countries such as India and Nigeria. In Germany, the report about Western drug tests among GDR citizens caused a sensation. At that time, reports were made of sometimes fatal human experiments. According to this, Western pharmaceutical companies have commissioned over 600 drug studies in over 50 GDR clinics. Such tests have been carried out on sick people, premature babies and alcoholics, among others, some of which have been fatal. (ad)