In 2016, Guillaume Molinet lost his life. Neither in a road accident, nor after a long illness. But during a clinical trial.
While he had volunteered to test a molecule in the Biotrial laboratory in Rennes, the father died suddenly. A question then arises: how could such a tragedy occur despite the rigor of the protocols governing clinical trials in France? Dr Gérald Kierzek, medical director of True Medical, gives us some answers.
3 days after the start of the trial, the father dies of a brain injury
Guillaume Molinet leads a very ordinary life. Breton artist and father of a family, he is in good health and attentive to his lifestyle. Like many French people, this forty-year-old agrees to participate in a clinical trial to make some money. First registered as a “replacement”, he finally joined a study organized by the Biotrial laboratory.
The 49-year-old man then receives a first administration of the product (a new molecule supposed to relieve certain neuropathic and chronic pain and certain symptoms of Parkinson’s disease, according to data from France Info). But during a second injection, on the third day of the trial, his condition suddenly deteriorated. He is in a coma.
“He begins to have vision and balance problems… He reports this and is transferred to the emergency room in the evening,” his brother confided to our colleagues.
On January 17, 2016, Guillaume died suddenly. A brain injury will be diagnosed. At the same time, several other volunteers from the same study are hospitalized. They will survive, but will have after-effects. And if the trial is immediately interrupted, the shock is immense for the loved ones. How can we imagine that a healthy volunteer could lose his life during a clinical trial… even though it is renowned for its highly regulated protocols?
If the Portuguese laboratory Bial and the person responsible for the tests have since this affair been “indicted“, and that “inaccuracies” were noted in the expert report, it would seem that the doses injected into Guillaume Molinet were… far too high.
A large dose would have been injected
According to the Molinet family’s lawyer, Jean-Christophe Coubris, a much too large dose of the product was administered to the victim.
“For a reason that we are completely unaware of today, the decision that was taken by the laboratory was to go for doses significantly higher than the desired effect”confirms the expert to France Info.
He also regrets the lack of caution among researchers at the time (only tests had been carried out on animals): “Even though we have done all the tests on animals, as we are in completely different designs from the tests which were carried out on these animals, ultimately we do not know the risk taken by healthy volunteers by injecting them with a molecule with such a large dose. he specifies.
For Dr Gérald Kierzek, medical director of True Medical and emergency doctor, this decision is part of poorly controlled therapeutic risk-taking:
“LThe choice of doses “significantly higher than the desired effect” (change from 20 mg to 50 mg without sufficient recent data) was probably aimed at exploring effectiveness despite an unpromising molecule, leading to non-targeted inhibition of brain enzymes and unforeseen toxicity (hippocampal damage)”, he explains to us. “Experts from the General Inspectorate of Social Affairs (IGAS) and theThe National Agency for the Safety of Medicines and Health Products (ANSM) also described this protocol as “insufficiently precautionary”, with too rapid progression of doses despite the absence of initial side effects, without the regulations being formally violated at the time.
What do we think of the current level of safety of clinical trials in France?
If the story of Guillaume Molinet reminds us that, despite strict rules, zero risk does not exist, should we still doubt each clinical trial? No, believes Dr Gérald Kierzek, who recalls that these tests “are essential for research“.
“Phase 1 clinical trials – that is to say the first administration of a drug in humans – are strictly regulated: they require authorization from the ANSM and a favorable opinion from the CPP (Committee for the Protection of Persons, including association representatives)”, he relates.
Any healthy adult can therefore volunteer, whether via platforms like Covireivac or through hospitals.
“Participants receive complete information on the risks, benefit from compensation limited to constraints (up to €6,000 per year maximum) and are placed under continuous medical surveillance. The trial is immediately interrupted in the event of a serious effect,” calls back the doctor.
“After the accident in Rennes, the rules of caution were reinforced, in particular on the escalation of doses and the selection of volunteers, confirming that this tragedy constituted an unprecedented accident “rather than a persistent systemic dysfunction”, concludes Dr Gérald Kierzek.