1 man brain dead, 5 others hospitalized in French drug trial

Because Phase I trials are used to determine a drug’s toxic effects, they “are inherently risky, as unexpected events can – and do – occur”, Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, said in a statement.

France’s Health Ministry says one person is brain-dead and five other patients are in the hospital after something went wrong during a drug trial.

Two other men were admitted to the hospital; one suffered from neurological problems while the other was in a less serious condition but was told to stay for observation.

The Bia 10-2474 drug, produced by Portuguese company Bial, was being developed to tackle anxiety and motor disorders linked to neurodegenerative diseases such as Parkinsons.

“This test was carried out at a private facility specialized in carrying out clinical trials”, a ministry statement said.

The French Health Ministry have denied media claims that the volunteers were testing a substance containing cannabinoids, an active ingredient found in cannabis plants. The French Agency for the Safety of Health Products, the countrys drug regulator, authorized the trial on June 26, and it began on July 9. A fifth volunteer has had no symptoms, but is being carefully monitored. The clinical trial was the first one to test higher dosage.

Human participation in such trials and scrutiny by outside watchdogs are essential for obtaining market authorisation.

A spokesman for the London branch of Biotrial said that it did not conduct trials in the UK.

The head of Biotrial said yesterday that the laboratory was cooperating with investigators.

This particular drug being tested, was said to act similarly on the brain as cannabis. Although tetrahydrocannabinol (also known as THC, the main psychoactive compound in cannabis) is perhaps the most well-known cannabinoid, it is not a part of the drug that was being tested in Rennes.

A total of 90 people, aged 30 to 50, were given the drug in various doses, while others were given a placebo.

New EU regulations to speed up clinical drug trials and streamline testing procedures across the 28-nation bloc are due to take effect in May.

It’s rare for volunteers to fall seriously ill when testing new drugs. The men, in their 30s and 40s, started taking the drug on January 7 and started showing severe side-effects three days later.

Phase II and Phase III are progressively larger trials, typically involving hundreds or thousands of volunteers, to assess the drug’s effectiveness, although safety remains paramount. Phase one entails a small group of volunteers and focuses only on safety.

“However, like any safeguard, these minimize risk rather than abolish it”, Whalley said in a statement.