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Drug Trial Failure in France Leaves Six Hospitalized — One Brain-Dead, Biotrial Under Investigation

By Janice Malcolm
Published on: 03:37 PST, Jan 15, 2016

On Friday, the Health Minister of France announced that a drug trial had gone horribly wrong after six of the volunteers ended up being hospitalized, with reports that one participant was brain-dead. The other five persons who were injured due to the drug trial are all in critical condition and some news outlets are proposing that the trial was cannabis related.

The drug trial was for an oral test medication, taking place at a private lab in western city of Rennes, France that belonged to a company by the name of Biotrial. Thus far, the exact nature of the drug that was being tested is being withheld from the public; however, the health ministry has continued to deny the suspicions and reports that the drug was cannabis related. The public has also been informed that the trial has been suspended and that the company will be recalling all of their volunteers. The exact number of persons who were involved in the drug trial is still not clear. BBC reported that according to the ministry of health, the drug trial accident occurred on Thursday.

Marisol Touraine, the French minister for social affairs, health and women’s rights, released a statement that called the hospitalization of the six Biotrial volunteers a “tragic accident” and issued a pledge that she would get to the bottom of exactly what went wrong in the drug trial. The Paris prosecutor’s office had also been said to have opened an investigation into the trial. Minister Touraine is expected to travel to Rennes on Friday and visit the Centre Hospitalier Universitaire de Rennes, where the brain-dead volunteer and the others in critical neurological condition are admitted. She is also expected to speak at a news conference.

“Marisol Touraine wishes to share with the families of the patients her solidarity and her deep determination to shed light on this tragic accident and establish who was responsible.”

The French-based Biotrial has a world-renowned reputation and specializes in drug trials. It has carried out thousands of trials since it was originally established in 1989. The current study was one that was only in Phase I of the clinical trial when the six Biotrial volunteers became drastically ill. During this phase the main concern is safety and under careful supervision a number of volunteers, either healthy or with a medical condition, are given a small dose of the drug in order to verify if there will be any side effects not to actually test to see if the drug works.

According to The New York Times accidents during Phase I trials like this one are rare but not unheard of. Persons who have the specific medical condition, for which the drug is being developed, are introduced to the drug during Phase II to see if it can actually help. Phase III trials are only for those medicines or devices that have passed the first two stages. During Phase III, current treatments are compared with the developing ones and often lasts for a year or more and involves thousands of patients.

Considering the rarity of such outcomes, it is doubtful that this accident leaving six persons critically injured will adversely affect clinical trials as a whole. Clinical trials are a key component to obtaining necessary data and volunteers taking part in the trials help companies continue to develop new treatments for serious diseases such as cancer, multiple sclerosis and arthritis. Thousands of persons take part in clinical trials every year and most are not negatively affected.

Nonetheless, by May new EU regulations designed to help streamline testing procedures and result in speedier clinical drug trials across the 28-nation bloc are due to take effect.

[Photo by David Vincent/ AP Images]

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