Clinical trial in France leaves 6 ill, 1 brain-dead
PARIS – Six medical volunteers have been hospitalized – one in a state of brain death – after taking part in a botched drug test at a clinic in western France, the Health Ministry said Friday.
The prosecutor’s office has opened an investigation into what the ministry called a “serious accident during a clinical test” in Rennes. It did not name the clinic.
Health Minister Marisol Touraine went to Rennes on Friday after ordering an investigation into the organization and how it conducts clinical tests. She was holding a news conference later and the Rennes-based lab Biotrial said its CEO, Jean-Marc Gandon, would join her.
The ministry statement said those who fell ill had taken an oral medication in the first phase of testing, which studies safe usage, tolerance and other measures on healthy volunteers. It was not immediately clear whether the six were among a larger group of volunteers involved in the tests or what dose they had been given. The statement did not name the type of medication being tested.
Biotrial, with headquarters in Rennes and offices in London and Newark, New Jersey, says on its website 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).
It is 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.
But there was a similar incident in Britain in 2006, 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.
© 2016 The Associated Press