6 fall ill in France after participating in clinical trial

The ministry said the six volunteers in Rennes, in western France, had been in good health until taking the oral medication, developed by “a European laboratory”.

The French Agency for the Safety of Health Products, the General Inspectorate of Social Affairs, and even the health branch of the Paris prosecutor’s office have made a decision to investigate the matter seriously.

One person has been left brain-dead and three others face irreversible brain damage, Touraine said. “We will do everything we can to shed light on what happened”, Touraine told reporters.

Calling the incident “unprecedented” at an afternoon news conference in Rennes, Touraine said: “I have no knowledge of a comparable event”.

The company said five people, rather than six, had been hospitalized, including one left brain dead, without explaining the discrepancy with the official French figures.

The worst of those affected is brain dead, it said, while the other five are described as being in a critical neurological condition.

The trial, which involved taking the drug orally and has now been suspended, was conducted by a private laboratory in Rennes. “It acts on the endocannabinoid system”.

The clinical trial was testing a painkiller based on a natural brain compound similar to the active ingredient in marijuana.

The drug being tested didn’t contain cannabis or any substance that was derived from cannabis either. A message on the company’s website stated that they are working with health authorities to understand the cause of the accident, while extending thoughts to the patients and their families. It is not derived from cannabis. She urged calm, saying that no drug now on the market was implicated in the failed trial. Approximately 90 people had taken the drug while about 30 others received a placebo.

The drug, administered to men between the ages of 28 and 49, was meant to treat mood disorders such as anxiety.

In France, adults volunteering for Biotrial tests can earn up to £3,400.

“Undertaking Phase 1 studies is highly specialist work”, said Daniel Hawcutt, a lecturer in clinical pharmacology at Britain’s University of Liverpool. Researchers generally start with the lowest possible dose for humans after extensive drug tests in animals.

Each year thousands of volunteers participate in clinical drugs trials and experts point out that tragic results are rare.

The six men who became ill in England now apparently have a higher risk of developing cancer and auto-immune diseases tied to their exposure to the experimental drug.

“The trial has been conducted in full compliance with the global regulations and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital”.