Clinical trial disaster: one man dead, five hospitalized in France

A doctor at the French hospital where a volunteer in an experimental drug test died says that the health of five others hospitalized last week is improving and one has returned home.

Under the trial, which started earlier this month, 90 healthy volunteers were given the drug in several doses at different times.

According to reports, the five other volunteers who were hostipalized remain in stable condition, however, the damage to their brains may be “irreversible”.

It is rare for volunteers to fall seriously ill during phase one trials, which study safe usage, side-effects and other measures on healthy volunteers, rather than drug effectiveness.

Brassier, head of Rennes University Hospital’s medical commission, announced that neither clinical nor radiological anomalies were found in 18 other volunteers checked so far.

The Biotrial laboratory in Rennes, western France, where a clinical trial of an oral medication left one person dead and hospitalised another five.

France’s public body ONIAM, which is responsible for compensating the victims of medical accidents, said it had in its files only around 10 cases of accidents during drugs trials over the past 15 years, and “with consequences infinitely less serious” than the case in Rennes.

As previously reported by the Inquisitr, six male patients between the ages of 28 and 49 were in good health prior to taking the drug on January 7.

The molecule was being developed to treat mood disorders and anxiety and movement disorders related to neurodegenerative diseases, and contrary to previous reports, the drug contains no cannabis, and is not a derivative of cannabis.

French health authorities have said three of the volunteers face possible brain damage. Instead, it causes “natural brain compounds act on specific receptors to exert their effects”.

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.

The company, which has been carrying out drug trials on behalf of pharmaceutical companies since 1989, said the situation is “even more upsetting given that there is as yet no explanation”.