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Brain death after drug test reasons puzzling, cannabis by no means responsible
Some participants in a drug study in France seem to be seriously ill due to taking the drug. A subject even suffered a brain dead and is thus clinically dead. The damage to the other subjects may not be made good again. The reasons for the serious incident are not yet clear.
Serious incident with drug test
"Participants wanted for drug study" or "Make good money as a subject" - such and similar calls can be read again and again in ads on the Internet. As a rule, it is pharmaceutical companies or universities that require healthy or even ill test persons for their research. In Germany alone, around 1,200 such studies are conducted each year, involving a total of about 10,000 subjects. Both new drugs and new applications for already known drugs are being tested.
Drug test failed. Image: Gina Sanders - fotolia In France, such a study has now become a serious incident: one subject is brain dead and four others have suffered damage that may be irreparable.
Participants in France are brain dead
According to a report by the news agency APA, a participant in a drug test in France is brain dead after severe side effects in hospital. There are also reports of four other subjects suffering from neurological complaints. For some of them, physicians may fear irreversible damage. "Your distress shook me," said French health minister Marisol Touraine.
The authorities of the country announced an investigation. According to the minister, 90 volunteers in various doses have already received the active ingredient developed by the Portuguese pharmaceutical manufacturer Bial. The company Biotrial carried out the test in Rennes (Brittany). According to the information, the victims were men who had taken the drug several times. "We do not know at this time what the exact cause of the accident is," Touraine said.
Symptoms occurred after a few days
Contrary to first media reports, the tested drug contained no cannabis. He aimed at mood swings and motor disorders in neurodegenerative diseases. According to Biotrial, the experiment was "carried out in full compliance with international regulations" and all internal procedures had been followed. Bial did not comment at first, but announced a statement. It is said that another participant has no symptoms, but is in the hospital for observation. On the seventh of January, the six men between the ages of 28 and 49 started taking the drug, and on the tenth of January, one of them had the first symptoms. This was the man who is now brain-dead in the intensive care unit and according to the doctors.
Drug previously tested on animals
According to the information, the laboratory broke off the test the day after. Professor Gilles Edan of the University of Rennes explained, according to APA, that at present no prognosis can be made regarding the condition of the injured. It has been reported that the active substance was in phase 1 of the clinical trial, which is a prerequisite for regulatory approval. For the first time ever, medications will be tested for tolerability in healthy volunteers. According to Touraine, the remedy has previously been tested on several animal species, including chimpanzees. Incidents or side effects must always be reported to the authorities immediately. Normally, the active ingredients in the test phase 1 are dosed very low. All these tests are always under medical supervision. "It is therefore an absolutely extraordinary event that at such an early test phase, a participant dies or comes to a hospital," said Rolf Hömke of the Association of Research-based drug manufacturers (VFA).
German company insolvent after incident
Hömke was only aware of a similar incident in the United Kingdom in 2006, in which an active ingredient against multiple sclerosis was tested. Six out of eight men had severe reactions five minutes after taking it. Only a few hours later, the 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 testing have been tightened again, the dosage must now be much lower," said Hömke.
Western pharmaceutical companies carried out tests in the GDR
According to experts, Germany ranks second only to the USA after such tests. In recent years, such investigations have fallen into disrepute because of various scandals more often. For example, deaths have been reported in countries such as India or Nigeria. In Germany, especially the report on western drug tests to GDR citizens caused a stir. Reported at that time was about partially deadly human experiments. Accordingly, Western pharmaceutical companies have commissioned more than 600 drug trials in more than 50 GDR hospitals. Such tests have been carried out among others on sick, preterm and alcoholics, some of them were fatal. (Ad)