One dead after Phase 1 drug trial in France
A phase 1 drug trial is under scrutiny after one person has died and 5 others are in critical condition following ingestion of the drug. The private laboratory in France, Biotrial, has been testing a pain and mood disorder medication for Bial a Portuguese pharmaceutical company. The drug was a FAAH inhibitor and was supposed to act on the body’s pain, enocannabinoid, system. It had been tested on chimpanzees and just moved to the human phase earlier this month.
A multitude of media outlets have been reporting on the incident and additional details are becoming available to the public. There are now reports of French prosecutors launching a manslaughter investigation into the unusual case, which shined a spotlight on the practice of testing drugs on paid, healthy human volunteers.
Bial is cooperating with an investigation into the drug procedures due to the unforeseen outcome for the 6 patients who have suffered. French health authorities have said three of the hospitalized volunteers face possible brain damage.
Drug trials have four phases, phase one focuses on safety, phases two and three include trials to evaluate the drug’s effectiveness, and stage four works off the market data when the product is used. Various trials are held throughout the year on different types of drugs and it is very rare for these outcomes to come across. The testing is critical in getting new products to the market for life science companies.
These unfortunate events serve as a reminder of the low frequency but high severity nature of human clinical trial testing. France’s public body ONIAM, which is responsible for compensating the victims of medical accidents, said it had in its files only around 10 cases of accidents during drugs trials over the past 15 years, and “with consequences infinitely less serious” than the case in Rennes.
Life science companies have complex risk needs when it comes to clinical trials. Following the outcome to this trial, it will be interesting to see if there are changes made to the requirements facing Phase 1 trials in France. After the Parexel/Tegenero case in 2006, the UK instituted stricter regulations for Phase 1 trials, which might prompt France to follow suit. Because the sponsor for the drug company is in Portugal, Bial might not have the excess/DIC coverage needed to face this claim.
There are various stages that need to be accounted for and it is essential that the right risk needs be assessed and in place before these trials begin. When something such happen like the outcome Bial is seeing, it is critical for the company to have a plan in place to assure they are protected. Gallagher is experienced in this process and can help ensure risk mitigation for your life science needs.
About the Author
Ceiry A. Fox is an Area Vice President at Gallagher WGA and a member of the Property and Casualty Group. Ceiry’s main focus is working with high profile Risk Management clients in the life sciences and technology sector.