French Authorties Blame Both Biotrial and Bial Over Fatal Drug Trial
May 24, 2016
By Alex Keown, BioSpace.com Breaking News Staff
PARIS – A French health ministry ruling faulted both Portugal-based Bial-Portela and the French laboratory Biotrial for a failed drug trial that left one patient dead and five others hospitalized earlier this year.
Marisol Touraine, France’s health minister, said that although neither company violated health legislation in France, both share responsibility over the dosage of the medication given to patients as well as criticism over the time it took to seek medical assistance after the first patient became ill, Reuters reported Monday. The ministry criticized what appeared to be a breakdown of responsibility between Biotrial, the contract research organization conducting the trial, and Bial, the developer of the drug. In its report, investigators from the France's IGAS social affairs inspectorate said Biotrial “had not properly informed volunteers and had followed a flawed testing protocol,” according to Reuters. During a Monday press conference Touraine said Biotrial had been given one month to put into place a plan of action that would prevent future trial failures such as the January incident, Reuters added.
Biotrial sharply criticized that statement, saying it complied with the law and noted the drug was one developed by Bial and not them. The company also criticized the French ministry for not allowing it to provide any input into the report regarding actions it had taken in the wake of the tragedy in January.
“Biotrial deplores this situation, especially since it has always strictly respected the test protocol validated by the ANSM, and that it has been shown that it is the Portuguese Laboratory Bial’s compound, by it unexpected and unpredictable toxicity, which is at fault for the accident,” according to a statement on Biotrial’s website.
Additionally, Biotrial said several months ago it had put in place a plan of action following exchanges with the French National Agency for the Safety of Medicines and Health Products (ANSM).
Bial-Portela told StatNews there had been no signs during the trial that indicated those patients would have such a negative reaction to the drug.
“Until the date of the accident, no previous signs that could have prevented what happened were detected, nor did any comparable toxicity occur in the pre-clinical trials in animals,” Bial said, according to the StatNews report.
Earlier this year, the French ministry criticized the lab for the slow reaction time of staff. In February, Touraine released initial findings of its investigation, which said the lab should have halted trials after the first patient was hospitalized. However, the ministry said the drug was administered to five more patients the next day. The French ministry investigation followed the failure of a Phase I clinical trial studying an experimental fatty acid amide hydrolase inhibitor being developed by Portugal-based Bial-Portela at a Biotrial facility.
FAAH inhibitors are designed to break down endocannabinoids, including anandamide, in the brain and are also being investigated for use in the treatment of chronic pain. Bial’s BIA 10-2474, the drug tested in the French facility, is designed to inhibit FAAH, and thus slow the breakdown of endogenous cannabinoids, which might help fight pain. The drug was administered to 108 patients, but only those six were negatively affected.
FAAH inhibitors are being studied by other pharmaceutical companies. Janssen, a division of Johnson & Johnson , was developing a FAAH inhibitor for social anxiety disorder until the French tragedy occurred, then it suspended its program. Merck and Pfizer are developing FAAH inhibitors for treatment of osteoarthritis pain, insomnia, Tourette syndrome, and cannabis withdrawal.