French Drug Trial: A Tragedy We Can All Learn From

Late this morning reports began to surface of a tragedy in France. A drug trial in Rennes had gone horribly wrong, leaving at least one person in a coma and others in critical condition. Some reports suggested one person had died. The drug in question remains unknown, as do pretty much all of the details of the incident, although a press conference has been scheduled for 16:30 local time.

Despite the lack of any solid evidence and the number of wildly differing claims swirling around the internet in the immediate aftermath of this story breaking, all of the mainstream media reports had one thing in common. They had all latched onto one apparently key factor – that the drug being trialled was a cannabis-based analgesic.

As it turned out, it wasn’t long before the French Health Ministry stepped in to debunk this claim. Unsurprisingly to anyone with even the most basic knowledge of cannabis and cannabinoids, whatever this drug was that had such disastrous effects, it wasn’t cannabis-based.

It’s not yet clear where or how this rumour started, but the speed with which it was picked up and presumed to be true was staggering. Especially when you start to dig a little deeper behind the headlines and translate the statement, given by the Ministry of Social Affairs, which brought the story to the media’s attention. Here it is in full:

“The minister responsible for social affairs, health and rights of women was informed last night of a serious accident during the carrying out of a phase one clinical trial of an orally administered medicine in the process of being developed by a European laboratory.

This trial had been carried out in an authorised private establishment which specialises in clinical trials, with the aim of evaluating the safe use, tolerance, and pharmacological profile of this substance on healthy volunteers.

This accident resulted in the hospitalisation of six of the volunteers at the University Hospital of Rennes. One of them is in intensive care, and is brain dead.

The company informed the Agence française de sécurité sanitaire des produits de santé (MSNA) of the interruption of the trial and currently is recalling all the volunteers who participated.

The MSNA has decided to conduct a technical inspection of the site of these clinical trials. As soon as she was informed, Marisol Touraine, Minister of Social Affairs, Health and Women’s Rights, took the General Inspectorate of Social Affairs (IGAS) to conduct an inspection of the organisation, means, and the conditions of intervention of this institution in the realisation of the clinical trial.

Marisol Touraine wants to share with the families of patients her solidarity and her deep determination to get to the bottom and establish all responsibilities in this tragic accident. She will travel to Rennes today; she will hold a press briefing.”

As you can clearly see, there is no mention of cannabis, and certainly not of the drug being cannabis-based. And yet the media, in the UK at least, seized on this unsubstantiated rumour and turned it into a headline that was soon being shared worldwide.

What can be learnt from this? Firstly, those responsible for such irresponsible headlines should take a long, hard look at themselves. Professional journalists should know better than to take rumours at face value. They should have reported the facts about the tragedy that was unfolding and left the speculation to those not in a position of influence.

In fairness to those media outlets and journalists, the references to cannabis in their articles were quickly discarded following the Health Ministry’s rebuttal. However, they should never have been there in the first place. Rather than turning this into yet another cannabis scare story, they should have focussed on the real questions raised by accidents such as this – Why do these appalling events occur? And what can be done to prevent them happening again? Ben Goldacre, ever a source of enviable clarity on these matters, spelt these issues out in a tweet referencing a passage from his book Bad Pharma.

What of the rest of us? What can we learn? Well, for one, we should also be heeding Dr. Goldacre’s words. Clinical trials are necessary, and whilst undeniably risky, those risks can and should be minimised. But perhaps just as importantly, if we are to take one thing away from this episode, it should be this: If the media are reporting on a breaking story, especially one that is science-related, it is never safe to presume that they’ve got it right. That goes for every media outlet. From the BBC, to the Guardian, to Russia Today and even Cannabusiness. We’re all fallible. We shouldn’t be, but we are.

We don’t yet have all of the facts in this case, but the eagerness with which certain sources leapt to implicate cannabis threatened to turn this story away from the human tragedy and scientific embarrassment that it is, and turn it into an anti-cannabis scare story with which to beat legalisation advocates.

Hopefully, now that the Health Ministry has refuted those cannabis-based claims, and with the full press conference scheduled for this afternoon, the memory of those headlines will fade and the serious ethical questions raised will be looked at in detail. Not just by the media, but by those in a position to make sure that such a tragedy doesn’t happen again. Our thoughts are with those for whom that international conversation may have come too late.