Phase I Clinical Trial Disaster

[Sprout]

The first human trials by Bial of a novel drug has resulted in catastrophe.
Six participants have been hospitalised - one is clinically brain dead, four have major neurological damage and one is asymptomatic but under observation.
The drug being tested was BIA 10-2474, an inhibitor of Fatty Acid Amide Hydrolase which is the enzyme responsible for metabolism of endocannabinoids.

The direct cause of the "deep, necrotic and hemorrhagic lesions" is not known.

Article
Statement from Bial

 

[consumer]

I had friends that participated in drug trials when they were going through university. The money was ok but i didn't think it was worth the risks. They emerged unscathed but events like this certainly provide food for thought.

 

[Don Luigi]

Aye I've been reading about that for the past couple of days. Many people think that volunteering for these clinical trials is easy money. However, every now and again things go very wrong. People accept the risks but I feel many don't fully appreciate the risks. The last one I remember is the Paraxel trials a few years ago where the heads were swelling to a few times their normal size.

It is tempting and has some element of altruism to it, though that is mostly negated by the potential financial gain. No amount of money would be worth the risk of taking part in clinical trials for me.

 

[Sadie]

Something like this happened about 10 or so years ago. I've just spent 15 minutes of my time trying to find the article and I'm giving up. It was a major headline at the time. Pretty much all the participants were in critical condition. A scary thought.

 

[F.U.B.A.R.]

Makes you appreciate the risks we take with RCs when even the big boys can fuck up like this. For this stuff to have reached human trials it will have undergone years of research already - much more than most RCs will ever get, yet we take brand new unresearched chemicals knocked up by Chinese laboratories with no quality control.

 

[consumer]

Yeah i have to agree there. A lot of these RC's have no history of human use. It's been a miracle that nothing like this has happened, well at least to my knowledge it hasn't.

 

[Si Dread]

personally, I find the idea of relinquishing control of my body &/or brain to some enormous, souless drugs company considerably riskier than RC research but maybe that's just me...

Grim story though. BBC reported that this was due to a Cannabinoid painkiller trial but I think the drug in question simply worked on the endocanabnoind system. Which suggests to me that using cannabis for your endocannabinoid deficiencies is probably the safer route...

 

[Ceres]

Makes you appreciate the risks we take with RCs when even the big boys can fuck up like this. For this stuff to have reached human trials it will have undergone years of research already - much more than most RCs will ever get, yet we take brand new unresearched chemicals knocked up by Chinese laboratories with no quality control.

Quite. It's the same thing except people taking RC's are paying to trial the drugs on themselves, with none of the safeguards in place that come from clinical trial protocols.

 

[Ceres]

Yeah i have to agree there. A lot of these RC's have no history of human use. It's been a miracle that nothing like this has happened, well at least to my knowledge it hasn't.

There was one on the market for a while that was subsequently found to trigger rapid growth of multiple tumours in people taking it. Something related to stereoids / hormones though rather than a recreational drug. Forgot the name of it now.

 

[SmokingAces]

personally, I find the idea of relinquishing control of my body &/or brain to some enormous, souless drugs company considerably riskier than RC research but maybe that's just me...

Grim story though. BBC reported that this was due to a Cannabinoid painkiller trial but I think the drug in question simply worked on the endocanabnoind system. Which suggests to me that using cannabis for your endocannabinoid deficiencies is probably the safer route...

Couldn't agree more with this post. For no amount of money would I play guinnea pig for any kind of drug company. Although I sometimes think users here experimenting with some of the more obscure RC's are doing exactly that, without being paid

 

[Sprout]

personally, I find the idea of relinquishing control of my body &/or brain to some enormous, souless drugs company considerably riskier than RC research but maybe that's just me...

Grim story though. BBC reported that this was due to a Cannabinoid painkiller trial but I think the drug in question simply worked on the endocanabnoind system. Which suggests to me that using cannabis for your endocannabinoid deficiencies is probably the safer route...

When it to comes disastrous medical trials the BBC really ought to just fuck off jumping on sensationalism buzz words before they can even be bothered to spend 2 minutes checking the bullshit and misinformation they're spreading on a subject where bullshit and misinformation is absolutely fucking stupid.

FAAHi's are Cannabinoid painkillers as much as MAOi's are Amphetamine stimulants.
Fucking shit for brains journalists. 8)

Not to mention it was indicated for Neuropsychiatric pathologies and not analgesia.

 

[consumer]

personally, I find the idea of relinquishing control of my body &/or brain to some enormous, souless drugs company considerably riskier than RC research but maybe that's just me...

Grim story though. BBC reported that this was due to a Cannabinoid painkiller trial but I think the drug in question simply worked on the endocanabnoind system. Which suggests to me that using cannabis for your endocannabinoid deficiencies is probably the safer route...

I dont see how taking drugs (oh i'm sorry.."researching" drugs lol) from a RC company that have never been trialed on humans is any safer than participating in clinical trials for a pharmaceutical company. Personally I would not do either.

 

[BecomingJulie]

Anyone else think this could be a false-flag operation designed to stir up anti-cannabis sentiment?

 

[consumer]

I don't think it's any big conspiracy. They just fucked up big time.

 

[Tangerine Dream]

Yeah i have to agree there. A lot of these RC's have no history of human use. It's been a miracle that nothing like this has happened, well at least to my knowledge it hasn't.

A RC opiate gave people Parkinson's, effectively, a while ago...

 

[consumer]

A RC opiate gave people Parkinson's, effectively, a while ago...

There you go then. I don't see using RC drugs as any safer than participating in clinical trials...if anything it's riskier due to the lack of research into these substances.

 

[Don Luigi]

I dont see how taking drugs (oh i'm sorry.."researching" drugs lol) from a RC company that have never been trialed on humans is any safer than participating in clinical trials for a pharmaceutical company.

I completely agree. Although I, hypocritically, don't pay enough credence to the logic, I think it's a delusional self-comfort to think otherwise. The only thing I don't have much concern about is lysergamides, due to their relatively high safety profile. However, I'm not organic chemist or pharmacologist. Furthermore, all it takes is a dodgy synth or a particularly greedy vendor to pass off a product that isn't genuine.

 

[Si Dread]

The chemists & pharmacologists are the ones who make sure that whatever I am testing is already safe & likely to have a particular effect. I think it's much riskier "using" RC's regularly or on nights out that it is to research lysergamides correctly but again, that's just my opinion.

I dont see how taking drugs (oh i'm sorry.."researching" drugs lol) from a RC company that have never been trialed on humans is any safer than participating in clinical trials for a pharmaceutical company. Personally I would not do either.

Fair enough, we clearly differ.

I think of "taking" drugs as something to do for fun. Like having a beer in the evening over a curry or necking half a pill to enjoy bouncing at a gig.

When I get given a brand new psychedelic to test, I am not taking it for fun. I am taking it to make notes of the onset, effects & duration, any physical effects such as on blood pressure & heart rate, breathing etc. The experiment is done is the same environment every time, usually my home & a nearby, quiet local park & always during a sunny day. Repeating experiments under the same conditions aids differentiation of effects with often extremely similar com pounds. Socialising & having "fun" is out of the question. Sometimes it's challenging enough making the notes themsleves! lol

I'm not inclined to use RC's for fun anymore because I decided it was too dangerous after poisoning my brain on the still popular 5-mapb. You don't need to preach to me about the dangers of RC's, I am personally experienced. Which is why I focus my interest in novel psychedelics.

Sasha Shulgin spent decades inventing, synthesising & assying personally new materials & he died of natural causes.

Nonetheless, this sort of work is not for the slightly dim or faint hearted.

 

[Ceres]

Yep, RC's nearly killed me until I got some higher education in pharmacology and molecular biology along with some chemistry. So even someone treading carefully armed with knowledge can make a mistake and end up dead, it is all about EDUCATION EDUCATION EDUCATION and informed risk taking. There are drugs I simply will not touch because out of experience I know they aren't good for me mentally or physically, and absolutely will not be anyones guinea pig.

 

[Sadie]

Must admit, even sham could confirm. I've had bad reactions to RC's. I've still not got feeling in my right foot and I don't even take substances. I happen to be on holiday. For the most part I'm a "good girl" I don't partake normally and I kinda got fucked over.