French Health Minister Marisol Touraine, left, and Professor Gilles Edan, the chief neuroscientist at Rennes Hospital, address the media during a press conference held in Reenes, Western France, Friday, Jan. 15.
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The French health minister, Marisol Touraine, said: “The shock is all the greater because these were healthy people, not sick in any way, who had no reason to fear such an accident”.
While it’s not entirely known what caused such an adverse reaction in the volunteers, the trial was meant to test the side-effects and safety of the new drug – however, all tests have been suspended and the other 90 volunteers have been recalled.
Six men aged between 28 and 49 started taking repeated doses at higher levels than other participants on Jan 7.
The company conducting the testing said on its website the trial was administered “in full compliance with the global regulations and Biotrial’s procedures were followed at every stage throughout the trial”.
She said there were very strict regulatory standards in the European Union for such trials and “those in charge of the trial would have had to have shown they had done everything they could to protect patient safety before the trial was allowed to go ahead”.
The French government promised to investigate the “tragic circumstances” of what it called an unprecedented and exceptionally serious accident which has sent shockwaves through the pharmaceutical industry. The six men who were hospitalized were taking the drug “regularly”. Three of the other five victims had probably suffered “irreversible” brain damage, Professor Edan said.
The company’s officials say that their main concern is monitoring the trial’s participants, especially those who are being hospitalized. She said she was “overwhelmed by the distress” of the drug trial victims, whose “lives have been brutally turned upside down”.
In 2006 in the United Kingdom, six previously healthy men were treated for organ failure only hours after being given an experimental drug targeting the immune system.
Clinical trials are the key to getting that data – and without volunteers to take part in the trials, there would be no new treatments for serious diseases such as cancer, multiple sclerosis and arthritis. “The shock is even greater given the fact that the people taking part in clinical trials are healthy”.
Biotrial did not give any further details on the drug in testing or other trial volunteers.
That said, drug companies typically don’t initiate Phase I trials (there are three phases in the clinical trial process) unless they’re reasonably certain the drug is safe, usually after prior testing on animal models.
Medicines then go into larger Phase II and Phase III trials to assess their effectiveness and safety before they are finally approved for sale.
Biotrial, with headquarters in Rennes and offices in London and Newark, New Jersey, said it had over 25 years of experience in clinical trials and uses “state-of-the-art facilities”.
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Dr Whalley said: “However, like any safeguard, these minimise risk rather than abolish it. There is an inherent risk in exposing people to any new compound”.
