Prof Edan said four of the other men have “neurological problems”, of whom three could have “irreversible” brain damage.
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Health Minister Marisol Touraine described the horrific bungle as “an accident of exceptional gravity…without precedence” in France.
All trials of the drug are now suspended, and volunteers participating in the study have been called back.
France’s national drug safety body (ANSM) confirmed it was the worst-ever incident to have taken place in a drug trial in the country.
The group of volunteers were given the drug on Thursday January 7th. She said the six men hospitalized had taken the drug regularly, in high doses. Doctors initially thought he had been the victim of a stroke given how suddenly he had fallen ill.
In a tweet on Friday Biotrial said: “Our thoughts go out to the volunteers and their families” adding that they thanked the medical teams involved for their support.
“What we are seeing today is without precedent”, Touraine told reporters.
All six volunteers had been in good health prior to beginning the trial for the unidentified orally-consumed drug. “I have no knowledge of any similar event”. They took the same dosage of the drug.
Their conditions vary in terms of seriousness although none of them are in a coma. The three men feared to suffer from permanent brain damage were hospitalized a few days later. But before any new drug can be given to patients, it must first undergo extensive testing for both safety and effectiveness.
On Friday, the Health Minister of France announced that a drug trial had gone horribly wrong after six of the volunteers ended up being hospitalized, with reports that one participant was brain-dead. Its French headquarters are in Rennes, and the trial began in July 2015.
The drug had been tested on chimps, but not on humans.
The drug being tested didn’t contain cannabis or any substance that was derived from cannabis either.
“This is unprecedented”, French Health Minister Marisol Touraine said on Friday. There’s no known antidote for the treatment, which acts on systems in the body that respond to pain, Touraine said.
Who was leading the trial?
According to the French newspaper Ouest France, Biotrial a major actor in the medical research, carried out the test. The clinical trial company with 200 of its 300 staff is based in Rennes.
“Undertaking Phase 1 studies is highly specialist work”, commented Daniel Hawcutt, who is a lecturer in clinical pharmacology at Britain’s University of Liverpool.
CORRECTION: An earlier headline said one patient lost his life in the experiment. The Paris’ prosecutor’s office has started an investigation into the case involving the testing of the new painkiller compound.
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The French ministry statement said those who fell ill had taken an oral medication in the first phase of testing.
