A clinical drug trial in France has been suspended after hospitalizing six men, one of whom is now brain dead and in a coma. Three of the other hospitalized men may end up with permanent brain damage.
The French prosecutor’s office has now opened an investigation into the botched drug trial, and all current trials of the drug have been suspended.
The drug was an experimental painkiller that targeted the same areas of the brain and nervous system that are affected by cannabis. The drug was made by a Portuguese pharmaceutical company called Bial, with the trial taking place at a private clinical lab in the French city of Rennes.
Ninety different volunteers were involved in the trial and took some dosage of the drug. They are now being called back to undergo monitoring.
The six men hospitalized were all between the ages of 28 and 49-years-old and were otherwise healthy. They began taking the painkiller on January 7. Three days later, one man reported feeling sick, followed shortly by the others.
Now, one of the men is brain-dead and in a coma, while a neuroscientist is warning that three of the other men may have permanent brain damage.
Of the remaining two hospitalized volunteers, one is suffering from neurological problems while the other is in less serious condition.
French Health Minister Marisol Touraine advised people to remain calm, as there are no similar drugs currently available to the public.
She also cleared up mistaken reports in the media that the drug contained—or was based on cannabis—when it really just targets areas of the body that are also affected by cannabis.
Toruaine vowed that the government would get to the bottom of what she called an “accident of exceptional gravity.”
“I was overwhelmed by their distress” Touraine said. “Their lives have been brutally turned upside down”.
In France, clinical drug trials typically pay volunteers roughly anywhere from $100 to $5,000. Drug trials only begin after extensive testing on animals.
While serious incidents like this one are rare, they have occurred before. In 2006, a trial for an experimental drug in London ended up sending six healthy men to the hospital. The men suffered organ failure, with one man’s head ballooning in size and another man losing his toes and fingertips. All of the men were left with an increased risk of cancer and other diseases.
All drug trials in Europe must adhere to strict regulations, but medical professionals and researchers admit that there is some risk always present.
Clinical drug trials are also routinely done in the U.S. and can pay varying amounts of money to volunteers. Medical professionals recommend taking careful consideration before taking part as well as researching the specifics of the drug, clinical trial, and pharmaceutical company.
Sources for Today’s Article:
“6 hospitalized in France after ‘serious accident’ in clinical trial,” CBC web site, January 15, 2015; http://www.cbc.ca/news/health/drug-trial-france-1.3405247?cmp=rss.
“France clinical trial: 90 given drug, one man brain-dead,” BBC web site, January 15, 2016; http://www.bbc.com/news/world-europe-35320895.
“French drug trial disaster leaves one brain dead, five injured,” Reuters web site, January 15, 2015; http://www.reuters.com/article/us-france-health-test-idUSKCN0UT131.