The clinical trial in Rennes, at a private clinic, involved 128 people (90 of whom were were given an experimental drug rather than a placebo.) Part way through the trial, eight people were seriously affected. One person died, and four have brain injuries.
The drug used was not named, although indications are it interacted with the nervous system and it was intended as a painkiller. The drug was manufactured by Bial, a Portuguese based pharmaceutical company. The drug was coded BIA 10-2474 and it is classed as “a fatty acid amide hydrolase (FAAH) enzyme inhibitor.” This class of drug can activate the endocannabinoid system, which affects pain sensation among other physiological processes. This particular drug was intended to treat anxiety and motor disorders associated with Parkinson’s disease, as well as chronic pain experienced by people with cancer and other serious health conditions.
At the time of the incident, Bial spokeswoman Susana Vasconcelos spoke with the magazine Nature. Here she stated that the trial had been conducted “in accordance with all the good international practices guidelines, with the completion of tests and preclinical trials.” She also noted that her company “is committed to determine thoroughly and exhaustively the causes which are at the origin of this situation.”
Following the incident, French Health Minister Marisol Touraine pledged to find out exactly what went wrong. Following this call, the French national drug safety agency (Agency for Medicines and Health Products Safety or ANSM) has issued a report containing the timeline of events for the Phase I clinical trial.
The timeline reveals those who were affected received the fifth of the highest dose escalation (50 mg) of the investigational drug at the same time. This was strictly against clinical trial guidelines, as issued by the European Medicines Agency (EMA) in 2007. Here the guidance calls for a set interval between doses. The guidelines were issued following some deaths in the U.K. at Northwick Park Hospital in 2006. In the U.K. incident, six men suffered major organ failure through an improperly convicted clinical trial.
Moreover, the report states that one evening a man became ill after receiving the drug and was hospitalized. The following morning, other patients received a further dose and then became ill. The trial was then discontinued.
A general concern with medics is that many clinical trials take place within a cloak of secrecy. The World Health Organization (WHO) is seeking to have all clinical trial material placed in freely accessible databases. This puts the health body at odds with some pharmaceutical companies who wish to protect propriety information.
