Drug trial goes terribly wrong

by Will Ashworth18 Jan 2016

What started out as a simple clinical trial of a cannabis-based painkiller has tragically turned into a life threatening situation where four people are seriously ill and receiving treatment in a French hospital while a fifth person is said to be brain dead.

The painkiller in question is produced by Portuguese lab Bial and was being tested by UK research company Biotrial. A total of 90 people took the drug for the trial while others were given a placebo.

"A serious accident took place during a therapeutic trial near Rennes,” said French Health Minister Marisol Touraine adding that the trial has been halted.

The drug was in Phase 1 testing where healthy volunteers are given the drug in order to determine if it is safe for consumers to ingest. It’s often in this phase where issues of drug safety often bubble to the surface.

"Undertaking Phase 1 studies is highly specialist work," said Daniel Hawcutt, a lecturer in clinical pharmacology at the University of Liverpool.

The research company conducting the trial is experienced in these undertakings suggesting all the normal protocols were followed and adhered to.

"During (...) a study which was being conducted for a sponsor, serious adverse events related to the test drug have occurred in some subjects. The trial has been conducted in full compliance with the international 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,” Biotrial’s press release stated. "We are in close and regular contact with the Health Authorities and Ministry in France. The priority at Biotrial remains the safety of our subjects.”

At this time it’s unknown what part cannabis played in the illnesses that beset the five volunteers but it’s once again put the legalization of marijuana in the spotlight – and not in a good way.

COMMENTS

  • by Diane 2016-01-18 3:43:12 PM

    very sad , my heart goes out to all involved.