Man Dies After Being Left Brain Dead in French Drug Trial

A man who was left brain dead after an experimental drug trial in France has died, according to reports.

The drug trial for the six hospitalized men began on January 7 and was halted Monday, a day after the first volunteer fell ill.

One patient has been declared brain dead in Bial’s phase I drug trial at the University Hospital of Rennes in France. While this drug is listed as being in phase 1 testing – which assesses a drug’s safety – on BIAL’s Pipeline list, the pharmaceutical company and Biotrial have not confirmed this to be true. Biotrial was the drug evaluation company handling Phase 1 of the trial for the painkiller which was also expected to help patients with mood and anxiety problems and motor problems caused by neurodegenerative illnesses. 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. BIAL said it is committed to the well-being of test participants and is working with authorities to find out what caused the injuries.

Clinical trials are the key to getting that data – and without volunteers to take part in the trials, there would be no new treatments for serious diseases such as cancer, multiple sclerosis and arthritis.

The investigators and inspectors “are trying to understand… what could have happened and how it could have resulted in such a tragic situation”, he said.

French prosecutors have launched a manslaughter investigation into the unusual case, which shined a spotlight on the practice of testing drugs on paid, healthy human volunteers.

According to the statement, the trial was being performed in a lincensed private institution that conducts trials of drug safety, tolerability, and pharmacology, in healthy volunteers. Three of the men may have permanent brain damage, he noted.

In 2006, Britain saw a similar incident, when six previously healthy men were treated for organ failure only hours after being given an experimental drug targeting the immune system. Europe has strict regulations governing the conduct of clinical trials, with Phase I tests subject to particular scrutiny. “There is an inherent risk in exposing people to any new compound”. The drug has since gone back into tests for rheumatoid arthritis and is showing promise when given at a fraction of the original dose.