Portuguese drug maker Bial and French laboratory Biotrial are at fault on many counts

Portuguese drug maker Bial and French laboratory Biotrial are at fault "on many counts" for a unsuccessful drug trial that left one person dead and 5 others hospitalized in Gregorian calendar month, French Health Minister Marisol Touraine said on Monday.  All trials of the drug, designed to treat mood and anxiety problems as well as coordination disorders coupled to medicine issues, have since been suspended. The victims were given the experimental drug made by Bial throughout a section one trial at a non-public facility in Rennes, Brittany, run by France's Biotrial. "A final investigation report confirms that the conditions under that the check was approved did not breach existing legislation," Touraine told journalists.

"Inspectors consider, however, that Bial and Biotrial are accountable on many counts; relating to the dose prescribed  and the time taken to alert authorities," she said. An initial inquiry in Gregorian calendar month had already established that Biotrial had been too slow to react once the 1st subject became sick.

Touraine said the 5 patients WHO had fallen sick when the trial were out of danger and no longer in hospital, but she criticized the approach Biotrial had managed the crisis. In their final report, inspectors from France's IGAS social affairs inspectorate found that the company had not properly up on volunteers and had followed a blemished testing protocol. Biotrial has contested the IGAS findings, complaining of "carefully musical group leaks".

Bial said it was "profoundly saddened" by the result of the Rennes trial however intercalary there had been no information to recommend it mustn't proceed with the progressive dose will increase approved by authorities beforehand. Touraine said on Monday that Biotrial had been given a month to define measures it planned to require so as to avoid any repeat of the accident. France will work with the European Commission and also the European Medicines Agency to enhance trial practices at a global 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 however not unhearable of. In 2006, six healthy volunteers given an experimental drug in London finished 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.