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France Clinical Trial: 90 Given Drug, One Man Brain-Dead

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http://www.bbc.co.uk/news/world-europe-35320895

One man is brain-dead and another five people are in hospital after an experimental drug was administered to 90 people in a French clinical trial.

There is no known antidote to the drug, the chief neuroscientist at the hospital in Rennes said.

Of the five men in hospital, three could have permanent brain damage, Gilles Edan added.

Reports that the drug is a cannabis-based painkiller have been denied by the health ministry.

The trial, which involved taking the drug orally and has now been suspended, was conducted by a private laboratory in Rennes.

The experimental drug was manufactured by the Portuguese company Bial.

All those who volunteered for the trial have been recalled and the Paris prosecutor's office has opened an investigation.

Before it's given to humans how do they calculate the risk of it having a fatal effect?

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Do people get money for this?

The cannabis angle is interesting.

Depending on the trial you could be "well paid", although I would only consider it well paid if nothing goes wrong, however it going wrong could take decades. I think one of my colleagues partners used to take part in trials I'm sure for some trails it was a 4 figure sum.

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I took part in some research once. I was invited to take part in some tests while undergoing n MRI scan.

They had this massive scanner several floors underground below an 18th century house near Russell Square.

All I got at the end was a crap T-shirt and a picture of my brain.

At least I have done my bit for medical science though.

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I took part in some research once. I was invited to take part in some tests while undergoing n MRI scan.

They had this massive scanner several floors underground below an 18th century house near Russell Square.

All I got at the end was a crap T-shirt and a picture of my brain.

At least I have done my bit for medical science though.

AND, most importantly, you have a picture off your brain. ? More than most of us have.

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I work in this industry and typically before the first in human trial the compound will have gone through animal testing to estimate a 'no observed adverse effect level' (NOAEL). First in human design tends to be single ascending dose (SAD) so start first cohort of around 6 subjects on the lowest dose and assess safety before escalating dose for next cohort. As an additional safety measure first subject to be dosed is often followed up for safety before dosing the rest of the cohort.

My guesses as to what may have gone wrong:

Human metabolism of drug very different to animals tested so NOAEL estimate wrong and starting dose too high/ no dose safe for humans.

Dosing error during drug preparation.

Delayed adverse effects.

It will be interesting to see what the cause of this is. I always feel nervous about first in human due to this type of rare but devastating potential outcome. I hope the poor people recover and that more ways to prevent this risk are found.

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Information so far, seems to be that 6 people in the maximum dose group were taken ill, 3 with likely irreversible neurological injury.

MRI showed haemorrhagic necrosis of the brain tissue

Drug was first tested in chimps in July 2015

The drug, BIA 10-2474 is said to be a FAAH inhibitor, which works on the body's internal cannabinoid system (it prevents the natural cannabinoids from being neutralised after use, so makes them more potent). The idea is that this might be useful for neurodegnerative conditions which can be associated with mood disorders or anxiety.

Dosing protocol was daily dosage over a 2 week period - not yet clear how far into the trial things got before people started becoming ill.

The last similar event was in London with the drug TGN-1412, with a number of people taken ill. In that case, it was due to a dosing error - the administered dose had been calculated using an incorrect animal model. This did not take into account different immune system operation in humans, as a result, the dose given was about 1000x the anticipated dose. The drug apparently did what it was supposed do, so there is a pharma company interested in resurrecting it at 1/1000 of the dose.

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The cannabis angle is interesting.

Only big pharma knows how to take a perfectly safe natural drug and then modify/synthesize it to the point of making it deadly... :rolleyes:

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The cannabis angle is interesting.

The Eagle, on 15 Jan 2016 - 10:19 PM, said:

Only big pharma knows how to take a perfectly safe natural drug and then modify/synthesize it to the point of making it deadly... :rolleyes:

If only there were a form of cannabis that we knew would be safe to consume...

It was not cannabis based ,whether it was a synthesized drug trying emulate cannabinoids i have not got a clue

The BBC were reporting it to be cannabis based due to the fact that it targets endocannabinoid receptors ,they seen cannabinoids and put two and two together and got five

Edit to replace MSM with BBC ...why do i not find that surprising

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If it is dosing error, then the risk of dosing error hasn't been properly assessed. With an off the shelf medicine, the magnitudes are already pre-set- You take one tablet per day in most cases.

However the difference between 10mg and 100mg can be catastrophic.

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http://www.bbc.co.uk/news/world-europe-35320895

Before it's given to humans how do they calculate the risk of it having a fatal effect?

In-vitro experimentation on human cells to evaluate the toxicokenetics of the substance.

Very small doses to large numbers of Mice - look for sides. (Mice are apparently a relatively good proxy for humans). Don't know if they still use primates - costly with ethical issues.

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The rhetoric is to investigate what went wrong but depending on your perspective I imagine the system as a whole is unforgiving and could actually be said to have worked. We'll see.

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Just heard on the news that this particular company was paying £3500 for people to take part in trials.

Apparently payment of up to £4000 is not uncommon and some students take part in these trials.

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The rhetoric is to investigate what went wrong but depending on your perspective I imagine the system as a whole is unforgiving and could actually be said to have worked. We'll see.

Quite possibly, that was the thrust of my last post in this thread. There's still the possibility of screwup though.

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Perhaps the courts need a new sentence?

Instead of just life imprisonment, add a life imprisonment with clinical trials, for people who might have been hung in the past.

Then if something goes wrong it doesn't matter as much and it could act as a deterrent against crime. It's win win?

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Perhaps the courts need a new sentence?

Instead of just life imprisonment, add a life imprisonment with clinical trials, for people who might have been hung in the past.

Then if something goes wrong it doesn't matter as much and it could act as a deterrent against crime. It's win win?

Yeah - let's experiment on criminals - how wonderful

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Guest eight

I took part in some research once. I was invited to take part in some tests while undergoing n MRI scan.

They had this massive scanner several floors underground below an 18th century house near Russell Square.

All I got at the end was a crap T-shirt and a picture of my brain.

At least I have done my bit for medical science though.

This explains very, very much.

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