One man is brain dead and four others are likely to suffer “irreversible handicaps” after participating in a drug trial for a French company that specialises in testing new medicines for pharmaceutical firms.
The men began taking the drug orally on January 7th. Tests had begun last July 9th, but at much lower dose levels. The 108 people in the Rennes area who have taken it are all being contacted. The dosages administered from January 7th until tests were suspended on January 11th were the highest to date.
On January 10th, the first victim, who is now brain dead, was hospitalised. His condition deteriorated very rapidly, said Gilles Edan, chief neuroscientist at Rennes Hospital.
Five other men were subsequently taken into care, suffering from side effects. In four cases, “one fears irreversible handicaps”, Dr Edan said.
No antidote
There is no known antidote to the drug, he added.
The men had volunteered for Phase I tests of an experimental drug called BIA 10-2474 which was intended to treat “mood swings and anxiety and motor difficulties linked to neuro-degenerative diseases”, such as Parkinsons.
Contrary to press reports, the drug does not contain cannabis.
The men, aged between 28 and 49, were in good health, as required for Phase I tests. In Phase I tests, doses are gradually increased. They are first tested in animals.
In Phase II, drugs are tried on patients who have medical conditions. Phase III trials, which often last for more than a year, compare drugs to existing treatments or placebos.
Thousands of volunteers test new medicines every year before they are put on the market. They are often students eager to pick up extra money.
Without such tests there would be no new treatments for diseases including cancer, multiple sclerosis and arthritis. Volunteers are always warned of the risk, but such accidents are extremely rare.
‘Unprecedented’
The French health minister
Marisol Touraine
, who rushed to Rennes to assess what she called an “unprecedented” event, promised to “get to the bottom of this tragic accident”. She said she was “overwhelmed by the distress” of the drug trial victims, whose “lives have been brutally turned upside down”.
The drug is manufactured by Bial, a Portuguese pharmaceutical company. Tests were conducted by Biotrial, a French company founded in 1989, with branches in London and Brussels.
Biotrial has been approved by the French health ministry. Every test must first obtain authorisation from the National Agency for the Security of Medicines. The agency authorised the tests last June 26th.
Ms Touraine said Biotrial had planned to test the drug on 128 healthy volunteers, men or women, aged between 18 and 55. All tests were stopped on Monday January 11th.
“Serious adverse events related to the test drug” had occurred, Biotrial announced on its website. It insisted that “international regulations and Biotrial’s procedures were followed at every stage”.
Biotrial is “a well-known laboratory, known for the seriousness of the studies it undertakes”, Ms Touraine said.
Biotrial earned €35 million in 2014. Two-thirds of its 300 employees are located in Rennes. It purchased the Canadian company Warnex in 2012.
The director of Biotrial told the Breton newspaper Ouest France in 2014 that he wanted to triple turnover and that "it would go much more quickly if France would authorise clinical trials more rapidly".
The Rennes judiciary police and the Oclaesp, a section of the gendarmerie specialising in health matters, are investigating the case on behalf of the health section of the Paris prosecutor’s office.
