Six medical volunteers have been hospitalized—including one who has been declared brain dead—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” at the Biotrial laboratory in Rennes. Biotrial’s CEO, Jean-Marc Gandon, was joining Health Minister Marisol Touraine at a news conference later Friday. The minister went to Rennes after ordering the investigation into how Biotrial conducts its clinical tests.
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 drugtests 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. 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.
Health care lawyer Philippe Courtois, speaking on i-Tele, called the botched drug test “a health care accident without precedence in France.”
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).
In 2006, Britain saw a similar incident, when six previously healthy men were treated for organ failure only hours after being given an experimental drugtargeting 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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Filed Under: Drug Discovery