What Was The Drug In The French Trial That Left A Man Brain Dead? Biotrial Insists It Followed International Regulations
On Friday, France's health minister announced that six men were hospitalized after participating in a drug trial, and that one of them was brain dead. The French Ministry of Social Affairs, Health, and Women's Rights said in a statement that there was a "serious accident" in the first phase of a clinical trial for a drug taken orally, and the sick volunteers were admitted to the Centre Hospitalier Universitaire de Rennes in Brittany. After hearing the tragic news, many are wondering what the drug in the French trial was intended to do.
The trial was conducted by drug-evaluation company Biotrial based in Rennes, which released a statement saying there were "serious adverse events related to the test drug." The statement also insisted that the trial followed international regulations, as well as Biotrial's procedures, at every stage, and the company is in close contact with French health authorities. "The priority at Biotrial remains the safety of our subjects," the statement read.
The French minister of social affairs, health and women's rights, Marisol Touraine, said during a news conference in Rennes that the drug was being developed by Portuguese drug manufacturer Bial. According to Touraine, the medicine had previously been tested on chimpanzees and was given to 90 people for the clinical trial. It was intended to act on the body’s endocannabinoid system, which deals with pain, The Guardian reported. Contrary to some reports, Touraine clarified that it wasn't a cannabis-based painkiller, but the name of the medicine has not been released.
The six men hospitalized received the drug more than once, and began experiencing adverse symptoms on Sunday, when the first was taken to the hospital. Pierre-Gilles Edan, head of neurology at the Rennes hospital treating the men, told The Guardian's Angelique Chrisafis that aside from the patient who was brain-dead, three others were suffering a "handicap that could be irreversible."
The trial was meant to test for potential side effects of the unnamed drug, and Touriane explained that a Phase 1 trial, like this one, is conducted to "evaluate the safety of its use, tolerance, and pharmacological profile of the molecule." Typically, Phase 2 trials verify that the drug actually works, and Phase 3 compares it to existing medicines after the drug passes the first two tests, both in the United States and Europe.
Thousands of people participate in clinical trials each year, usually to make a few extra bucks. Touraine called the horrible incident "unprecedented," and death or serious illness from the beginning phase of a clinical trial is pretty rare. The last serious mishap occurred in 2006, when young men spent weeks in a London hospital with damage to their immune systems following a Phase 1 trial for TGN1412, an an immune-system stimulant that was intended to treat multiple sclerosis, leukemia, and rheumatoid arthritis.