Man dies after taking part in French drug trial

In the United States in June 2001 a healthy young volunteer who had taken part in a study into the causes of asthma died.

The French health ministry said it immediately sent agents to the medical facility to determine if all the rules had been followed in the testing and if the facility where the patients were staying during the trial maintained sanitary conditions. By targeting the body’s endocannabinoid system, the FAAH inhibitor is aimed at tackling mood and anxiety issues, as well as consequences of neurological complications such as movement coordination disorders.

French TV channel iTele said the trial was for a painkiller containing cannabis, but this was denied by the health ministry.

Six volunteers are seriously ill in hospital after a medical trial at a private clinic in France.

Health Minister Marisol Touraine says all the men were healthy before they volunteered for the drug trial.

Three of those in hospital could have been left with permanent brain damage, according to doctors in Rennes, where the men are being treated.

All six men in hospital were aged between 28 and 49 and were healthy when the trial began on 7 January, she said.

“Toxicity deaths in Phase 1 trials are rare”, said Daniel P. Carpenter, a professor of government at Harvard and an authority on the U.S. Food and Drug Administration.

In France, adults volunteering for Biotrial tests can earn between €100 and €4,500 (£76 to £3,400).

The case has been referred to the health branch of the Paris prosecutor’s office. In the Phase II and Phase II trials, drugs are tested to evaluate their safety and effectiveness before going to the final stage of approval for sale.

That prompted a review of procedures and resulted in the United Kingdom regulatory agency imposing new testing standards, including recommendations to use the lowest possible dose and to test new drugs only on one person at a time.

Clinical trials typically have three phases to assess a new drug after preliminary tests on animals and human cells in petri dishes.

The six men in Britain now apparently have a higher risk of cancer and autoimmune diseases tied to their exposure to the experimental drug.

“This type of incident is tragic but very rare in the world of clinical trials”, said Professor Jayne Lawrence, chief scientist with Britain’s Royal Pharmaceutical Society.

“However, like any safeguard, these minimise risk rather than abolish it”, Dr Whalley said.