All trials of the drug, which is intended to treat mood and anxiety issues as well as movement coordination disorders linked to neurological issues, have since been suspended.

The victims were given the experimental drug made by Portugal’s Bial in an initial phase 1 stage 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 patient fell ill.

Touraine said the five people 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 social affairs inspectorate (IGAS) found that the company did not properly inform volunteers and had implemented a flawed testing protocol.

Biotrial contested the IGAS findings in a statement on Sunday evening, complaining of “carefully orchestrated leaks”.

Bial was not immediately reachable for comment on Monday.

Touraine gave Biotrial a month to present a comprehensive action plan to ensure accidents would not happen again.

France will liaise 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 inquiry.

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.

 

(Editing by Gareth Jones)

Source: Reuters Health

http://www.reuters.com/article/us-france-health-tests-idUSKCN0YE132