PARIS – A clinical trial in France has left a man brain dead and five others have been hospitalized. The Portuguese drug company Bial has been testing an experimental drug called FAAH on 90 people, who have all taken the same dosage, French Health Minister Marisol Touraine said Friday. The Paris’ prosecutor’s office has started an investigation into the case involving the testing of the new painkiller compound.
Touraine said all trials on the drug have been cancelled and all volunteers are being called back. By targeting the body’s endocannabinoid system, the FAAH inhibitor is aimed at tackling mood and anxiety issues, as well as consequences of neurological complications such as movement coordination disorders.
Until taking the oral drug at the Biotral private facility, the six men in ages between 28 and 49 had been in good health, according to the health minister. All 90 test participants were given the drug in different doses at different times. She met volunteers and their families in the western city of Rennes before declaring at a news conference that the health authorities would do “everything to understand what happened” as they investigate what she described as “an accident of exceptional gravity”. Touraine said testing had been carried out on animals since July 2015.
The six volunteers affected began taking the drug on Jan. 7. After the brain-dead man was admitted to hospital on Monday, three of the five others went in between Wednesday and Thursday. Doctor Gilles Edan said they could possibly face irreversible handicap, Reuters reported. He added that one of the six men was being carefully monitored, though he had shown no symptoms.
In a statement, Bial said it was committed to warranting the wellbeing of test volunteers and was working with authorities to find out the cause of the accidents, remarking that the clinical trial had been authorized by French regulators. The Portuguese company declared five participants had been hospitalized and did not explain why the official French figures had said there were six volunteers being monitored at the hospital.
Such cases of early-stage drug tests going awry are rare but not unheard of. In London, a drug trial carried out in 2006 left six healthy test participants in intensive care. One of them lost his fingertips and toes, whereas another was described as “the elephant man” because his head ballooned. The company involved was TeGenero, a German firm developing a medication called TGN1412, which has since returned to tests for rheumatoid arthritis and is causing positive effects when given at a fraction of the original dose that led to six severe accidents about a decade ago.
“Undertaking Phase 1 studies is highly specialist work,” commented Daniel Hawcutt, who is a lecturer in clinical pharmacology at Britain’s University of Liverpool. “There is an inherent risk in exposing people to any new compound,” he added.
The initial Phase I stage of clinical testing consists of a medication that is given to healthy volunteers to see the human’s body response to it and to determine the appropriate dose that patients need. In the Phase II and Phase II trials, drugs are tested to evaluate their safety and effectiveness before going to the final stage of approval for sale.
Source: Reuters