Tuesday, May 24, 2016
Portuguese drugmaker Bial and French laboratory Biotrial are at fault "on several counts" for a failed drug trial that left one person dead and five others hospitalized in January, French Health Minister Marisol Touraine said on Monday.
All trials of the drug, designed to treat mood and anxiety issues as well as coordination disorders linked to neurological issues, have since been suspended.
The victims were given the experimental drug made by Bial during a phase one trial at a private facility in Rennes, Brittany, run by France's Biotrial.
"A final investigation report confirms that the conditions under which the test was approved did not breach existing legislation," Touraine told journalists.
"Inspectors consider, however, that Bial and Biotrial are responsible on several counts; regarding the dosage prescribed (...) and the time taken to alert authorities," she said.
An initial inquiry in February had already established that Biotrial had been too slow to react when the first subject became sick.
Touraine said the five patients who had fallen ill after the trial were out of danger and no longer in hospital, but she criticized the way Biotrial had managed the crisis.
In their final report, inspectors from France's IGAS social affairs inspectorate found that the company had not properly informed volunteers and had followed a flawed testing protocol.
Biotrial has contested the IGAS findings, complaining of "carefully orchestrated leaks".
Bial said it was "profoundly saddened" by the outcome of the Rennes trial but added there had been no data to suggest it should not proceed with the progressive dose increases approved by authorities beforehand.
Touraine said on Monday that Biotrial had been given a month to outline measures it planned to take in order to avoid any repeat of the accident.
France will work with the European Commission and the European Medicines Agency to improve trial practices at an international level, she said.
In addition to the IGAS investigation, the affair is the subject of a separate judicial enquiry.
Cases of early-stage clinical trials going badly wrong are rare but not unheard of. In 2006, six healthy volunteers given an experimental drug in London ended up in intensive care.
On Jan. 21, U.S. company Johnson & Johnson said it had suspended international trials of a drug similar to the one experimented by Bial.
Source : reuters.com
