Botched French drug trial leaves 1 brain dead, 5 in hospital
Botched French drug trial leaves 1 brain dead, 5 in hospital
(35 minutes later)
PARIS — Six previously healthy medical volunteers have been hospitalized — including one man who is now brain dead — after taking part in a botched drug test at a private clinic in western France, the French Health Ministry said Friday.
PARIS — Rennes chief neurosurgeon Gilles Edan says three of the 6 men hospitalized over a botched clinical drug trial in France could have “irreversible” brain damage.
The prosecutor’s office has opened an investigation into what the French Health Minister Marisol Touraine called “an accident of exceptional gravity ... without precedence” in France at the Biotrial lab in Rennes.
Speaking Friday at a press conference in the western French city of Rennes, Edan said one man is brain dead and four others have “neurological problems” — of which three could have permanent damage. Another man is being kept in the hospital, but is in a less critical condition.
The drug trial, which was testing a new painkiller compound, involved 90 healthy volunteers who were given the experimental drug in varying doses, she told reporters Friday at a news conference in Rennes. All six hospitalized men were between 28 and 49 and were healthy when the trial began on Jan. 7, she said, adding that one man now classified as brain dead was admitted to the Rennes hospital on Sunday.
Health Minister Marisol Touraine says all the men were healthy before they volunteered for the drug trial. She urged calm and said no drug currently on the market was implicated in the failed trial.
The chief neuroscientist at the hospital in Rennes, Professor Gilles Edan, said Friday there’s no known antidote to the experimental drug that Biotrial was testing.
It’s rare for volunteers to fall seriously ill when testing new drugs. Researchers generally start with the lowest possible dose for humans after extensive drug tests in animals.
The French ministry statement said those who fell ill had taken an oral medication in the first phase of testing, which was studying safe usage, tolerance and other measures on healthy volunteers.
Biotrial, with headquarters in Rennes and offices in London and Newark, New Jersey, says it has over 25 years of experience in clinical trials and uses “state-of-the-art facilities.” In France, adults volunteering for Biotrial tests can earn between 100 euros and 4,500 euros ($110 to $4,922).
In 2006, Britain saw a similar incident, when six previously healthy men were treated for organ failure only hours after being given an experimental drug targeting the immune system. That prompted a review of procedures and resulted in the U.K. regulatory agency imposing new testing standards, including recommendations to use the lowest possible dose and to test new drugs only in one person at a time.
The six men in Britain now apparently have a higher risk of cancer and autoimmune diseases tied to their exposure to the experimental drug.
Dr. Ben Whalley, a neuropharmacology professor at Britain’s University of Reading, said standardized regulations for clinical trials are “largely the same” throughout Europe.
“However, like any safeguard, these minimize risk rather than abolish it,” Whalley said in a statement. “There is an inherent risk in exposing people to any new compound.”
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Elaine Ganley in Paris and medical writer Maria Cheng contributed from London.
Copyright 2016 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Copyright 2016 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
