French drug trial disaster: one man brain dead, five in hospital

One person is brain dead and five others are in a serious condition in France after a clinical trial went terribly wrong, the French health minister said on Friday (Jan. 15).

The drug was developed by a Portuguese company, Bial, and was being tested in humans for the first time. The trial took place at a private facility near the western city of Rennes.

Health Minister Marisol Touraine said the drug was designed to treat mood disorders, and did not contain any cannabis as media initially reported. She said the drug was meant to act on the body’s endocannabinoid system, which deals with pain and is also responsible for the human response to cannabis.

“The families are devastated. We will do everything we can to shed light on what happened,” Touraine told reporters.

The minister said the trial disaster was unprecedented in France, but urged caution as investigations get underway.
Volunteers called for checkups

The six volunteers who ended up in hospital are all men, aged between 28 and 49, and were the ones who had been given the highest dose of the drug, she said.

The trial has now been suspended, and all of the 90 people who took part in it are being called in for medical checkups.

Both the drugmaker Bial and the research company that carried out the study, Biotrial said they were in full compliance with international guidelines and regulations.

-- (c) Copyright Euronews 2016-01-16

Such are the risks of drug testing, if everything else has been done in compliance with standards.

Wow! France was the world leader in protecting animals in cosmetics industry! Now I understand why animals were and still are used in testing unknown chemicals.

...they initially tried to pretend cannabis had something to do with it.....

...shameful......

...scare people off of natural foods, herbs and remedies.....

...sell them artificial concoctions that cost them a fortune...and their lives......

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Drug companies trying to make synthetic marijuana so they can patent it and overcharge for it.

The real thing works, is safe but doesn't make drug companies a ton of cash...

...they initially tried to pretend cannabis had something to do with it.....

...shameful......

...scare people off of natural foods, herbs and remedies.....

...sell them artificial concoctions that cost them a fortune...and their lives......

I believe the drug under trial was designed to act on the body's endo-cannabinoid system.

Edited January 16, 201610 yr by Loeilad

The absolute hilarious bit of this article is their strong denial of their 'disaster' drug containing cannabis. The cannabis would work better alone than this drug ever would at treating mood disorders!! Medical cannabis is wonderful at relieving pain and can also help in alleviating the symptoms of numerous other ailments.

Oh Yes ,Why would anyone want to participate in a drug test with an OUT OF COUNTRY medical company that has a questionable reputation ?

Wow! France was the world leader in protecting animals in cosmetics industry! Now I understand why animals were and still are used in testing unknown chemicals.

These drugs would have already gone through animal testing... it's no guarantee of safety in humans (though better than going straight to human subjects).

http://scienceblogs.com/insolence/2015/09/28/gcmaf-and-an-unscrupulous-quack-profiled-by-the-bbc/

There is a never-ending supply of snake oil merchants in this internet world......

You're Welcome!!

Both the drugmaker Bial and the research company that carried out the study, Biotrial said they were in full compliance with international guidelines and regulations.

...and so now they can sleep like babies...they have done nothing wrong.

Many moons ago I was traveling with a group of backpackers and often times were tough so finding short periods of work was a big part of the culture and quite often several would disappear to do drug trials but I never could, not to say I never dabbled in them but I knew what they where but being used as a guinea pig freaked me out even if the money was good

...they initially tried to pretend cannabis had something to do with it.....

...shameful......

...scare people off of natural foods, herbs and remedies.....

...sell them artificial concoctions that cost them a fortune...and their lives......

What about tobacco, it´s also a natural but the biggest killer.

Numerous off-topic posts and replies removed.

"luck11"

Please Google Steve Jobs greatest regret. You can do/say whatever you want, we shall agree to disagree

Wow! France was the world leader in protecting animals in cosmetics industry! Now I understand why animals were and still are used in testing unknown chemicals.

Wow! France was the world leader in protecting animals in cosmetics industry!

Probably why they chose to use human subjects instead.

All pharmaceutical drugs are toxic, it just varies in how much and how long till the side effects kick in.

Which is why they are ok for acute or short term use, long term use is not a good idea, however that is where the big profits lie.

Also the FDA just takes the companies word that drugs (and GMs) are safe, they don't test things themselves. Manufacturers and regulators have a too cosy a relationship.

This is one that went bad in a first world country where the story will actually come out.

Seems a bit odd to have 90 people participating in a clinical trial where dosage has not yet been determined. Usually dosage is worked out in Phase I trials with only a few participants who are under close watch.

All pharmaceutical drugs are toxic, it just varies in how much and how long till the side effects kick in.

Which is why they are ok for acute or short term use, long term use is not a good idea, however that is where the big profits lie.

Also the FDA just takes the companies word that drugs (and GMs) are safe, they don't test things themselves. Manufacturers and regulators have a too cosy a relationship.

This is one that went bad in a first world country where the story will actually come out.

There is no indication that the FDA was involved in this drug trial.

Please stay on topic.

Many moons ago I was traveling with a group of backpackers and often times were tough so finding short periods of work was a big part of the culture and quite often several would disappear to do drug trials but I never could, not to say I never dabbled in them but I knew what they where but being used as a guinea pig freaked me out even if the money was good

Stick to sperm donor banks.... Much better

Drug companies trying to make synthetic marijuana so they can patent it and overcharge for it.

The real thing works, is safe but doesn't make drug companies a ton of cash...

Some people trying to say cannabis is OK,

I have seen too many "brain dead" drug abusers, and cannabis is not OK...

Edited January 16, 201610 yr by Basil B

Drug companies trying to make synthetic marijuana so they can patent it and overcharge for it.

The real thing works, is safe but doesn't make drug companies a ton of cash...

Some people trying to say cannabis is OK,

I have seen too many "brain dead" drug abusers, and cannabis is not OK...

You've not seen anyone brain dead from cannabis use.

And I'm not talking about having a bong every 5 minutes. I'm talking about medical use of marijuana.

I had a friend who used to shake uncontrollably with MS and his mother had to go out and buy weed illegally as it was the only thing that stopped the shakes. He wasn't getting horizontally stoned, he was having enough to make life livable.

I think he had that right as a fellow human.

Wow! France was the world leader in protecting animals in cosmetics industry! Now I understand why animals were and still are used in testing unknown chemicals.

These drugs would have already gone through animal testing... it's no guarantee of safety in humans (though better than going straight to human subjects).

An article on Deutsche Welle said the drug had been tested earlier on chimpanzees, the closest primates to Humans. Presumably nothing unusual was seen.

Drug companies trying to make synthetic marijuana so they can patent it and overcharge for it.

The real thing works, is safe but doesn't make drug companies a ton of cash...

Some people trying to say cannabis is OK,

I have seen too many "brain dead" drug abusers, and cannabis is not OK...

No recreational drugs are good for you. Some are worse than others.

In 20+ years in AA, I have met thousands of people whose lives would have been better had they been legally allowed to choose weed over booze.

Not to say weed is good for you, but the legal alternative is much worse.

Edited January 16, 201610 yr by impulse

Drug companies trying to make synthetic marijuana so they can patent it and overcharge for it.

The real thing works, is safe but doesn't make drug companies a ton of cash...

Some people trying to say cannabis is OK,

I have seen too many "brain dead" drug abusers, and cannabis is not OK...

That's so classic! Thanks for the laugh! I needed that.....

The drug was designed to target the same receptors but there is no Cannabis or THC involved in this trial.