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French Drug Trial Leaves One Brain Dead and Five Critically Ill (theguardian.com)
jones_supa writes: One person is brain dead and five others are seriously ill after taking part in a phase one drug trial for an unnamed pharmaceutical firm at the Biotrial clinic in France. In medicine, phase one entails a small group of volunteers, and focuses only on safety. Phase two and three are progressively larger trials to assess the drug's effectiveness, although safety remains paramount. The French health ministry said the six patients had been in good health until taking the oral medication. It did not say what the new medicine was intended to be used for, but a source close to the case told AFP that the drug was a painkiller containing cannabinoids, an active ingredient found in cannabis plants. Mishaps like this are relatively rare, but in 2006 six men fell ill in London after taking part in a clinical trial into a drug developed to fight auto-immune disease and leukaemia. All trials on the drug at the French clinic have been suspended and the state prosecutor has opened an inquiry.
The article clarifies:
Touraine said the drug was meant to act on the body’s endocannabinoid system, which deals with pain. Earlier reports had suggested that the drug contained cannabinoids, an active ingredient found in cannabis plants, but the minister said it did not contain the drug or any derivatives of it.
It appears to alter the subject's ability to spell simple words, even when the word is emboldened and all caps.
You know the other 2 are suddenly REALLY happy they got the placebo
Expect that in Phase 1 trials, no one is given a placebo. The purpose of Phase 1 trial is testing for safety, not efficacy, and is given to a very small number of healthy test subjects.
It has been reported in several media outlets that 6 were given the trial medication and 2 were given placebos in this particular round. In all around 90 people have participated in the Phase 1 trial so far, The article in the summary specifically states that some of the 90 were given placebos while the rest were given differing strengths of the drug. Everything I've read states that this particular round used the highest concentration of the drug and implies that with the other rounds the dosage increased with each round. So sounds like they were trying to find a maximum safe dosage. Basically they were looking for side effect or potential harm, in which case you certainly need a placebo group in each round to determine a baseline. And I would say they were wildly successful at determining the dosage at which the drug is unsafe.
The only thing necessary for evil to triumph is for it to be pitted against a slightly greater evil
Endocannabinoid system is modulated by more than just THC, CBD and the regular ol' cannabinoids in ganja. It's a rather complex system whose functional mappings and tructure-activity relationships are not very well understood.. yet. It offers incredible potential for modulation, far beyond what cannabis can do, and I for one welcome our Pharma Overlords to throw their resources at these problems.. provided that they don't botch things up like this, for fucks sake.
That happened at a homoeopathic clinic once. Instead of getting 0.0 of the active ingredient they got 000.0.
Confucius say, "Find worm in apple - bad. Find half a worm - worse."
Why not just let people consume the plant pretty much in its natural state?
Because that the endocannabinoid system can't be fully manipulated in all ways possible by just using naturally occurring stashes of THC.
The brain contains two primary receptors (CB1 and CB2) and a few minor G protein receptors as the trigger points of the endocannabinoid system.
The remainder of that system is the parts of the brain that generate THC to fill those receptors.
The system as a whole has a cascading effect on things in the brain everywhere from pain control to required memory forming processes to mood control.
Cannabis as found in plants is of forms not generated in the brain, and typically only stimulate one of the two major receptors, and rarely the G protein receptors at all.
From those that enjoy THC use recreationally, CB1 stimulation manifests as a "sleepy relaxed pain-killing high" where CB2 stimulation manifests as a "creativity and energy boost high"
But other than various amounts of receptor stimulation and thus various "how high" levels, you don't get much more out of it than that.
There are fully synthetic versions of chemicals designed specifically to stimulate both CB1 and CB2 (sometimes completely) as well as designed to hit the G protein receptors in various ways and by various methods.
These chemicals are usually called "THC equivalents" but the vast majority are anything but equivalent when looking at what they do and how they go about doing it in comparison to natural THC.
Did you know if you stimulate CB2 at 95%+, CB1 at anything over 50%, and block GPR18 uptake from the brains natural sources, you can induce a full sensory pathway failure for a few minutes?
The chemical JWH-210 was designed to do just this, and in effect causes a 10-15 minute "trapped in" coma with all the effects of sensory deprivation and decoupling the differentiation between sensory input and your memories of past sensory input.
The recreational crowd usually describes this as forced lucid dreaming.
The chemical AM-2232 stimulates CB1 partially and completely overloads CB2 beyond 100%, while also doing "something" to the Ki receptors previously thought unrelated to THC usage.
It has been described as "Imagine the highest high you have had, and multiply that by a hundred. Once you are high enough, keep going because it doesn't stop there"
The idea of AM was to provide pain control on the level of opiates, but without the dependency and withdraw issues opiates have. That part didn't quite work out in earlier versions of the chemical however (the withdraws were quite different from opiates, but there were still withdraws) and the chemical made a schedule 1 banned substance before further research could be done.
None of this is possible to obtain from THC in naturally growing plants.
The brain is much more complex than that, and can be "hacked" in many more ways and combinations using chemicals designed for that explicit purpose that have no naturally occurring equal.
If you'd like to kill a couple days with further reading, I submit to you the following research:
https://en.wikipedia.org/wiki/JWH-018
https://en.wikipedia.org/wiki/List_of_JWH_cannabinoids
https://en.wikipedia.org/wiki/List_of_AM_cannabinoids
The drug in question appears to be a FAAH inhibitor named BIA 10-2474.
Or Slashdot could step into the 21st century and provide an edit mechanism.
Even if is timed to a few minutes, it would be very helpful.
All my liberal friends think I'm a conservative, all my conservative friends think I'm a liberal.