Experimental Drug Trial Gone Wrong

In an unfortunate and tragic accident involving the clinical trial of an experimental drug manufactured by Portuguese pharmaceutical company Bial, one person was left dead and five others critically ill in a clinic in north-west France. The trial was being conducted by the French company Biotral on behalf of Bial. One hundred and twenty eight healthy volunteers between the ages of 18 and 55 were recruited for this study, having been paid 1,900 euros each. Ninety of these volunteers were administered with different doses of the drug, while the rest were given a placebo.

The drug in question, known as BIA 10-2474, was designed to act as a painkiller to treat anxiety and motor disorders associated with Parkinson’s disease. Early reports claimed that the drug was a compound related to cannabis; these claims were however dismissed by the French Health Minister. The hospitalized volunteers were the first to receive multiple doses of the drug, which resulted in severe symptoms including bleeding brain tissues.

Since news of the incident broke, several scientists have raised concerns regarding the protocol used for the trial. Particularly, questions have been raised regarding the interval of time between the dosing of successive volunteers. Certain reports claim that Biotral began giving the six volunteers doses of the drug simultaneously, which would be a mistake since the standard protocol calls for a delay between doses for different volunteers.

Speculations are also being made with regards to the actual chemical structure of the drug, and how it could have resulted in the symptoms that were observed. According to an unconfirmed clinical trial report obtained by a French newspaper, the drug has a pyridine oxide structure, and is meant to inhibit fatty acid amide hydrolase enzymes, preventing the breakdown of cannabinoids in the brain.

The last major incident involving the failure of a clinical trial took place in London in 2006, resulting in six men suffering permanent organ damage and the loss of fingers from severe immune reactions during the testing of an arthritis and cancer drug candidate. As more information regarding the current incident is gathered, it is hoped that the knowledge gained can be used to prevent such catastrophes in the future.