Pain

Lessons from the deadly French trial

Thursday, 2 Jun 2016


An official review into the French trial of the experimental compound BIA-10-2474 highlights three main errors of judgement that led to the death of one volunteer.

The review commissioned by the French Health Ministry run by Biotrial said the company failed to seek information fast enough about study volunteer Guillaume Molinet who died.

It also did not tell other volunteers what happened to Molinet or notify the french drug agency, the Agence Nationale de Sécurité du Médicament (ANSM), quickly enough.

The report also noted that the ANSM should have asked for more details about the escalation of doses described in the protocol.

The Office of Public Prosecutions has also started a preliminary investigation into the trial.

BIA 10-2474 is a Fatty acid amide hydrolase (FAAH) inhibitor that breaks down endogenous compounds that act as neurotransmitters via the cannabinoid receptors.

According to Professor Sir Munir Pirmohamed, a pharmacologist and Vice President of the British Pharmacological Society, the idea behind the development of FAAH inhibitors is to preserve the analgesic effects without having the negative effects of cannabinoids.

However in an editorial in the BMJ Nicholas Moore a professor of pharmacology at the University of Bordeaux in France said one of the main lessons learned was to not test drugs in humans that do not have clear therapeutic potential.

“This was a not unusual phase 1 study of a new wannabe drug and included four substudies: single ascending doses, multiple ascending doses, a food interaction study, and some pharmacodynamic testing looking for potential indications” he wrote.

He suggested that perhaps the use of high doses was a “fishing expedition” to try to find some activity where previous drugs sharing the same purported mechanism of action had failed.

“This raises the issue of the moral responsibility of the pharmaceutical company that decided to develop an apparently useless drug.”

The legal actions have begun, and the truth and guilt, if any, will eventually be established.

“Meanwhile, as all drugs are dangerous, even if some of them are useful, shouldn’t we ensure at least some potential usefulness of a drug before we expose people to its dangers?” he asked.

 

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