A clinical trial of a drug in France has left one person in a coma and five others critically ill. In response, the French health ministry has put a halt to the trials in what it describes as "a serious accident". Yesterday in a statement, the French Ministry of Social Affairs, Health, and Women's Rights announced that a serious incident had occurred as part of a Phase 1 clinical trial on an oral drug being developed by a European lab. The trial was being conducted in a licensed private institution to evaluate the safety and tolerability of a particular molecule in health volunteers. The accident resulted in the hospitalisation of six volunteers at the University Hospital of Rennes. One of the volunteers is in intensive care, apparently "brain dead".
The experimental drug was administered to 90 people, and no antidote to the drug exists. Five men are in critical condition in hospital, one of them potentially facing permanent brain damage. The adverse effects happened only yesterday, on January 14 in France.
The ministry has suspended the trial, and the firm is recalling all volunteers. The name of the private company was not initially disclosed by the ministry, but French media outlet iTELE claimed that the drug, a pain reliever containing cannabis, was being developed by Biotrial. Also, The Verge pointed out that Biotrial's website contains a call for volunteers to participate in drug trials at Rennes and Newark, New Jersey.
The French health ministry is denying reports that the drug is a cannabis-based analgesic, but the experimental drug is being developed by Portuguese company Bial. The firm conducting the tests, Biotrial, admitted on its website that "serious adverse events related to the test drug" had occurred, but that "international regulations and Biotrial's procedures were followed at every stage."
French Minister Marisol Touraine was in quoted in the BBC as saying her government will "get to the bottom… of this tragic accident." The Paris prosecutor's office has now launched an investigation.
Clinical trials are standard practice before new medicines can be administered to patients. By performing these tests, drug developers can collect information about the safety and efficacy of unproven medicines. Without volunteers, it would be exceptionally difficult, if not impossible, to bring new drugs to market. That said, drug companies typically don't initiate Phase I trials (there are three phases in the clinical trial process) unless they're reasonably certain the drug is safe, usually after prior testing on animal models.
As for this breaking story, it will be interesting to see what kind of due diligence was performed by the company prior to launching the clinical trials.
Top image: Biotrial Lab via ALU Vennais