After taking part in a clinical trial for a new painkiller - conducted by private research company Biotrial - one man has died, while five more have been hospitalized.
Image credit: Biotrial.
The men were admitted to the Rennes University Hospital in western France last week. One man was said to be brain-dead as a result of the experimental drug, and yesterday, the hospital released a statement announcing his passing.
The other five men are believed to be in a stable condition, though French health authorities have warned that three of them may be left with permanent brain damage.
French prosecutors say they have now expanded their investigations into the clinical trial to include possible manslaughter charges.
The phase 1 clinical trial - conducted by private research company Biotrial - began on January 7th this year, enrolling 90 healthy participants to test a new molecule described as a fatty-acid amide hydrolase (FAAH) enzyme inhibitor.
FAAH is an enzyme that can break down endogenous cannabinoids (endocannabinoids) in the brain. Researchers have previously suggested that blocking this enzyme could be an effective strategy for treating chronic pain.
Is BIA 10-2474 the culprit?
French news site Breizh-info.com have published a document - believed to have been provided by an individual who applied to be part of the trial but who was rejected - that they say demonstrates how this latest phase 1 clinical trial was being conducted.
The document states that the FAAH inhibitor being tested was BIA 10-2474. While this drug is listed as being in phase 1 testing - which assesses a drug's safety - on BIAL's Pipeline list, the pharmaceutical company and Biotrial have not confirmed this to be true.
The document also states that 128 healthy volunteers aged 18-55 took part in the trial, 90 of whom were given BIA 10-2474 at different doses, while the remaining participants were given a placebo.
According to BIAL, the development of the FAAH enzyme inhibitor "has been conducted since the beginning in accordance with all the good international practices guidelines, with the completion of tests and pre-clinical trials, particularly in the area of toxicology."
They add that the drug had already been administered to 108 patients "without any moderate or serious adverse reaction."
While it is currently unclear what caused the adverse reactions in six of the clinical trial participants, BIAL claims they are "strongly committed" to finding out and are working with all the relevant authorities to do so.
"Our thoughts go out to the volunteers and their families. We are working hand in hand with the Health Authorities to understand the cause of this accident," added Biotrial in a statement.
The clinical trial was terminated as soon as reports emerged of severe reactions to the drug, and the remaining 84 volunteers were contacted, 10 of whom underwent medical examination, though Rennes University Hospital say no "anomalies" among these individuals have been identified.
A further five trial participants will undergo medical examination.
Incident may raise questions about clinical trial procedures
This is not the first time an early-stage clinical trial has led to adverse outcomes.
In 2006, a phase 1 clinical trial conducted in London, UK - dubbed the "Elephant Man trial" - led to six young men being treated for multiple organ failure within hours of taking a drug called TGN1412, developed to combat autoimmune disease and leukemia.
Manufactured by pharmaceutical company TeGenero Immuno Therapeutics, the drug led to one man losing his fingers and toes, while all men were told they would likely develop cancers or autoimmune diseases in the future due to their exposure to the drug.
It should be noted, however, that such severities in early-stage drug trials are rare, though this latest incident is likely to raise questions about the safety of such trials and whether there should be more stringent procedural strategies in place.
Our Knowledge Center article "How do clinical trials work?" provides further information on the procedures involved in testing new treatments on humans.