A botched clinical trial in France has left one man brain dead and five others hospitalized in a serious condition. According to the New York Times, the news about the botched clinical trial has been confirmed by Marisol Touraine, the French minister for social affairs, health and women’s rights.
In a statement issued on her behalf, the French ministry confirmed that a “serious accident” had taken place and that the six men who were all aged between 28 and 49 were hospitalized at the Centre Hospitalier Universitaire de Rennes, in eastern Brittany. The minister also described the incident as being “unprecedented” while adding that she has never heard of any other comparable event. She also paid a visit to the hospital where they were undergoing treatment and met the family members.
“I was deeply moved by their suffering,” Ms. Touraine said after the visit.
While one of the men has already been declared brain dead, at least three others seem to have suffered some sort of irreversible brain damage following the botched clinical trial. The true extent of brain damage can only be evaluated after the patients show some signs of recovery. Initial diagnosis using magnetic resonance imaging scan did show signs of irreversible brain damage.
The clinical trial on the men were carried out by Biotrial on behalf of drug maker Bial. Biotrial is based out of Rennes, while Bial is a Portuguese company. The clinical trial involved more than 128 participants out of which 90 individuals were given the drug. The others were given another drug but were told that they were given the same drug as others as part of a placebo.
According to USA Today, the drug undergoing the clinical trial was developed to help people overcome mood, anxiety, and related issues. It was also designed to treat the effects caused due to neurodegenerative diseases. The drug reportedly acted on the brain’s endocannabinoid system, a set of brain receptors.
According to Carl Elliott, a bioethicist at the University of Minnesota, many of the phase 1 trial volunteers tend to be poor and unemployed people who are ready to give consent to clinical trials like this for money. He adds that these people are generally exploited. The details of the six men who have been hospitalized following the botched clinical trial remains under wraps.
That said, several other experts say that incidents of this nature are extremely rare and that companies undertaking phase 1 trials should investigate and cover all possible ill effects before going ahead.
Biotrial claims that they followed all regulations before the botched clinical trial and said it would cooperate with all kinds of investigations. The statement read,
“The trial has been conducted in full compliance with the international regulations, and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital. We are in close and regular contact with the health authorities and ministry in France.”
A similar claim is also being made by Bial, the manufacturer of the drug. Bial says it has also followed all guidelines mandated for conducting clinical trials.
Here is an excerpt from the statement issued by Bial following the incident.
“Bial is strongly committed to ensuring, first of all, the well-being of the participants in this trial and to determine thoroughly and exhaustively the causes which are at the origin of this situation.”
The application for this particular clinical trial was submitted by Biotrial on April 30, 2015. French drug regulator The French Agency for the Safety of Health Products approved the trial on June 26. The actual clinical trial started on July 9. However, it wasn’t until January 4, 2015, that people were actually administered the drug. Shortly after the drug was given, one man quickly fell ill. He was followed by five others after which the trial was stopped.
(Images: AP Photo/David Vincent)