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Drug trial in France leaves one brain dead and five critically ill

anewfaceinhell

anewfaceinhell

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Jun 1, 2011
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A "serious accident" in a French clinical test has left a person "brain dead" after a French drug trial went wrong, according to reports.

The test concerned a "cannabis-based painkiller"

Several people are in critical condition, with one in a coma, the BBC reported.

Health Minister Marisol Touraine has said the test subjects were taking an oral medication during a trial in Rennes.

"A serious accident took place," she said.

A statement issued by the French health ministry confirmed that one of the test subjects is 'en état de mort cérébrale', or "brain dead."

According to the French newspaper Ouest France the trial was being carried out by Biotrial, a major clinical trial company with 200 of its 300 staff based in the country.

The company based in Rennes, Brittany but which also has offices in London, Brussels and the US.

The trial has been called off and who volunteers who took the medication are being recalled, she said.

It is unclear how many people have taken part in the trial.

The Paris prosecutors office told AFP news agency it has launched an investigation.

Biotrial says it is to hold a press conference with the health ministry at 1.30pm at Rennes CHU hospital.

Taking part in clinical trials can be highly lucrative and is popular among students seeking to earn a little extra money.

Mishaps are rare, but in 2006 six men were hospitalized in London after a clinical trial where they were given a drug intended to fight auto-immune disease and leukemia.

Source: http://www.telegraph.co.uk/news/wor...ves-one-brain-dead-and-five-hospitalised.html
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It seems that Biotrial was testing this drug for a Portuguese company named Bial, according to French newspapers.
We don't know yet what compounds compose this drug and their dosages.
 
its says on the bbc text news that its not know if it was a cannabis based drug
 
foolsgold said:
its says on the bbc text news that its not know if it was a cannabis based drug
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I just discovered Bial had an interest in FAAH inhibitors, and clamed a couple of patents on those (see https://www.google.com/search?hl=en&tbm=pts&q=inassignee:"Bial"+cannabinoid)
I never heard of FAAH before, but it seems the role of that protein is to somehow break down anandamine, which act on CB1 and CB2 receptors.

So I guess one of those FAAH inhibitors might be implicated in this incident.

EDIT : It seems the drug is called BIA 10-2474 (http://www.breizh-info.com/2016/01/15/rennes-biotrial-bialessai-therapeutique/) and isn't based on cannabis.
 
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consumer said:
Trust the pharma companies to actually make cannabis deadly..
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On the one hand, I agree with your sentiment. Natural cannabis is an amazing medicine without messing with it. And the pharma companies are not to be trusted.

On the other hand, if we (they) mess with it, we could create multiple medicines, for different ailments, based on compounds that are easy to measure and therefore doses can be precise. This could be extremely beneficial to people with severe illnesses, for example.
 
I'm of the opinion that pure substances are safer and better than "natural" medicines of the same kind. Take cannabis for example. We're positive that it contains certain substances that are beneficial to (ill) people, but it is also very likely that the unprocessed plant contains some substances that may be somewhat harmful (not in a serious way in the case of cannabis, but more negative than positive) as with anything natural - because they all contain an immense number of different substances. So if we can separate the definitely good-for-health substances from the neutral/negative ones, we will improve the medicine. Of course, that requires thorough knowledge about the plant, its constituents, their effects and possible synergies and antagonism between compounds.
 
It's not a cannabis based drug - it's a trial of a fatty acid amide hydrolase inhibitor (FAAH). The compound is totally synthetic and this is presumably the first time it has been trialed in man.
Derek Lowe says sources state that there's at least one person brain dead, possibly up to three more, after deep cerebral hemorrhage.

Trust the media to use this as an opportunity to drum up FUD around the issue, man!

This just goes to show that anyone experimenting with these new cannabinoid agonists or like compounds must be very, very careful... this drug in question has been trialed in chimpanzee etc without any problems.
 
I'm under the impression that the endocannabinoid system is much less understood than the monoaminergic, and much more complicated. We've only very recently started to formally work with it regarding any medicinal quality, and for a long time only synthetic THC was available, which safety was already proved many times over.

That's pretty scary that chimps were fine when given it, but that it caused someone to basically die.

Yeah, sounds like we should be diverting a significant portion of research funds toward other neurotransmitter types/systems from understanding chemicals with primary action on the monamines.
 
sekio said:
It's not a cannabis based drug - it's a trial of a fatty acid amide hydrolase inhibitor (FAAH). The compound is totally synthetic and this is presumably the first time it has been trialed in man.
Derek Lowe says sources state that there's at least one person brain dead, possibly up to three more, after deep cerebral hemorrhage.

Trust the media to use this as an opportunity to drum up FUD around the issue, man!

This just goes to show that anyone experimenting with these new cannabinoid agonists or like compounds must be very, very careful... this drug in question has been trialed in chimpanzee etc without any problems.
Click to expand...

Great article and website the comments where especially helpful in me understanding wth was going on.
 
Shit is terrifying... I did a suboxone trial once so it was no big deal and I k ew it was a drug I'd had experience with. But some anxiety drug that's a painkiller and a canabinoid? Did I read that right?

How the hell could that happen?
 
I've read contradictory reports claiming on one hand that it's a cannabinoid, and on the other that it's an opioid painkiller. The effects they're describing definitely sound a lot more like an opioid overdose than anything you're likely to get from a cannabinoid, though.
 
^
Opiods increase intra-cranial pressure , brain hemorhaging is not a typical effect of opiate OD though...
 
No those that read a bit further on this or the updated wikipedia will see it is not a cannabinoid or an opoid, but a FAAH inhibitor that works on the endocannabinoid system. Tragic case as earlier trials on FAAH didn't produce such effects, they even tested in chimps.
 
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