The hospital’s chief neuroscientist Gilles Edan said that of the five men hospitalized, three men could have permanent brain damage, Reuters reports.
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France’s public body ONIAM, which is responsible for compensating the victims of medical accidents, said it had in its files only around 10 cases of accidents during drugs trials over the past 15 years, and “with consequences infinitely less serious” than the case in Rennes. The health ministry announced all the participants were called back for testing, while the trial has been suspended.
One person is in a coma and five others have been hospitalized after participating in a clinical trial for a new drug in northwest France.
The drug, which was administered orally, was being tested for safety and potential side effects and was developed by a European pharmaceutical company, the ministry said. Ninety healthy volunteers were given the experimental drug in different doses at different times, said Touraine at a press conference.
French authorities launched three investigations yesterday at a research laboratory in Rennes after a drug trial conducted there left one person brain-dead and three others facing potentially irreversible brain damage.
It’s rare for volunteers to fall seriously ill when testing new drugs.
Phase III trials are only for medicines or devices that have already passed the first two stages, and involve them being compared to existing treatments or a placebo.
Six male volunteers between 28 and 49 years old have since been hospitalized, including one man now classified as brain dead, Touraine said, adding that the other 83 volunteers were being contacted. “The shock is even greater given the fact that the people taking part in clinical trials are healthy”. The brain-dead volunteer was admitted to hospital on Monday, the minister said. Four have “neurological problems” and one has no symptoms but is still being monitored.
Biotral said in a statement on Sunday that it is planning to work with the worldwide scientific community to develop “changes to the standards governing such trials”, without giving further details.
The experimental drug was manufactured by the Portuguese company Bial.
“The trial has been conducted in full compliance with the global regulations and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital”, the statement said.
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In 2006, six men in Britain were treated for organ failure hours after being given an experimental drug that targeted the immune system, AP reported.
