1 brain-dead, 5 in hospital after French drug trial goes wrong

A “serious accident” during a drugs trial in France has left one person brain-dead and five hospitalised, Health Minister Marisol Touraine said on Friday (Jan 15).

She said the six had been taking part in a “trial of an oral medication being developed by a European laboratory” in Rennes, northwest France.

Media reports said the drug was a cannabis-based painkiller, but this was denied by the health ministry.

The study had been halted and all volunteers taking part recalled, the minister said.

The study was a phase one clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”, the minister added in a statement.

Medical trials typically have three phases to assess a new drug or device for safety and effectiveness.

Small group

Phase I entails a small group of volunteers, and focuses only on safety.

Phase II and Phase III are progressively larger trials to assess the drug’s effectiveness, although safety remains paramount.

The Paris prosecutor’s office said an investigation had been opened.

Ms Touraine said she was determined to “shed light on” what happened.

Source: AFP

Francedrugsbrain-deadpainkillerUncategorisedMinistry of Health