Man dies after taking part in botched French clinical trial

The ministry said the six volunteers in Rennes, Brittany, had been in good health until taking the oral medication, which was developed by “a European laboratory”. The company said five people, rather than six, had been hospitalised, including one left brain dead, without explaining the discrepancy with the official French figures.

The pharmaceutical company producing the drug, Bial, said it was cooperating with the investigation and followed “international best practice” when developing the drug.

The trial, which involved taking the drug orally and has now been suspended, was conducted by a private laboratory in Rennes.

Touraine added that the trial was being conducted for a painkiller drug that was based on a brain compound with similar properties as the active ingredient in cannabis.

A man who was left brain-dead during a drugs trial in France has died, while five others remain in hospital with grave fears for their recovery. Dr. Edan also said that one of the six volunteers did not show any symptoms of this problem, but is still being supervised carefully.

The CEO of Bial, Antonio Portela, has issued a statement via the Portuguese news service LUSA that they are working with authorities in France to understand what caused the accident and death of the unidentified volunteer. Early media reports say that the test drug may be the compound BIA-10-2474, something BIAL said is designed for treating “neurological and psychiatric pathologies”. The testing has been stopped, Health Minister Marisol Touraine said in a news conference Friday, and health authorities have been reaching out to the rest of the volunteers to let them know about these adverse effects.

Reportedly, French prosecutors have launched a manslaughter investigation into the case.

A research company called Biotrial had been testing the drug manufactured by a Portuguese company, which is meant to help with anxiety and other mood disorders. A statement revealed that the other 84 patients who took the drug where contacted.

“This type of incident is tragic but very rare in the world of clinical trials”, said Professor Jayne Lawrence, chief scientist with Britain’s Royal Pharmaceutical Society.

Medicines then go into larger Phase II and Phase III trials to assess their effectiveness and safety before they are finally approved for sale. Last Sunday, one member of the group was rushed to hospital, with a brain condition that was so bad doctors thought he was suffering from a stroke.

The men now apparently have a higher risk of cancer and autoimmune diseases tied to their exposure to the experimental drug.