Clinical trial in France goes wrong; 1 participant dies, 5 others hospitalized

In a tragic incident, a clinical trial of an experimental drug being conducted in France went wrong, causing the death of one participant and neurological complications in five others. Bial, a Portuguese pharmaceutical company that sponsored the trial, confirmed this in a press release. The doctor treating the patients has stated that some of them may suffer irreversible brain damage. The complete details of the trial drug – code named BIA 10-2474 – have not been made public. However, Biotrial, a well-known contract research firm that was conducting the trial, has revealed that the drug, based on a compound similar to cannabis, was developed to treat the anxiety disorders of Parkinson's disease, motor disorders, chronic pains, multiple sclerosis, hypertension, and obesity.

After successful animal trials, Bial’s experimental drug was in the Phase 1 trial to test its safety and efficacy in healthy humans. The clinical trials had begun in July 2015 and healthy participants on whom the drug was previously tested did not show any adverse effects. According to the details posted on the website of Biotrial, the affected participants aged between 28 and 49 years were enrolled for two weeks in which they were to be administered several doses of the drug for 10 days. However, the trial that began in January 2016 had to be discontinued abruptly after the patients reported deterioration of health.

Experts speculate that the drug may have been administered in a wrong dosage or may have become contaminated. They are also questioning the lack of information made available regarding the incident. Catherine Hill, a former member of the scientific advisory board of France’s National Agency for Medicines and Health Products Safety (ANSM), mentioned that, "The French authorities have not been very rapid nor transparent in their response.”

Although not revealing the structure of a molecule during the early phase of clinical trials is a commonly followed practice, many researchers have condemned it. Knowing about the drug’s molecular structure would enable experts to figure out whether the drug targeted other proteins than the ones intended and understand if the drug was toxic to some people. Bial spokeswoman Susana Vasconcelos stated that the trial adhered to all the guidelines followed internationally and the company "is committed to determine thoroughly and exhaustively the causes which are at the origin of this situation."

References:

Scientists in the dark after French clinical trial proves fatal (accessed January 19)

More details emerge on fateful French drug trial (accessed January 19)