French Drug Trial:1 Coma & 5 Critically ill



Paris: One person is in a coma and five others are in critical condition after participating in a drug trial in France, the country’s health ministry announced Friday. In a statement, the health ministry said a “serious accident” occurred at a private laboratory in the city of Rennes, and that all trials of the drug have been suspended there. French prosecutors have opened an investigation.

The ministry did not name the drug or the company that produced it, saying only that it was “a drug taken orally being developed by a European laboratory.” French media outlet iTélé reports that the trial involved a cannabis-based painkiller that was being tested by Biotrial, a laboratory based in Rennes. Biotrial’s website includes a call for volunteers to participate in trials at Rennes and Newark, NJ, but the link to the Rennes volunteer is currently broken.

According to the health ministry, all six volunteers were in good health prior to taking the oral medication at their homes. The lab has informed that government that it is in the process of recalling other volunteers, though it is not yet clear how many people were involved in the trial. In its statement, the health ministry said the trial aimed to evaluate the safety, tolerance, and pharmacological profile of the new drug. The ministry was first notified of the situation last night.

A Biotrial representative declined to comment on the reported accident when reached by phone, saying only that the health ministry will hold a press conference in Rennes Friday afternoon and that the company will be participating in it.