By Zach Haigney, Aug. 24
Below is an excerpt only:
The world is absurd.
That is not a value judgment. Absurd can be positive or negative. In discussing the challenges of developing psychedelic medicines with Will Sacks on his Evolving Earth Podcast (episode to be released in a few weeks) one topic we focused in on is the absurdity of the following premise:
An organism grows out of the ground.
Humans have been ingesting this organism for a long time.
There are documented transient psychological effects from ingesting this organism (scientifically and culturally documented) that aid in therapeutic/spiritual development under appropriate circumstances.
Yet, because of federal laws, it requires millions of dollars to legally:
2. Confirm safety and efficacy
3. Deliver one active ingredient from this naturally occurring organism
Some estimate that the price tag for the end-user/insurer will be in the $35,000 range.
We can all recognize the absurdity of this situation.
To be fair, the rage against this absurdity should be lessened upon learning about thalidomide and society’s demands that have to lead to current drug development protocols.
So these constraints have a purpose even if they can be significantly improved.
Creating psychedelic medicines under the constraints of current legal, scientific, and business landscape requires figuring out how to novelly and reproducibly:
1. Get psilocybin out of mushrooms (or create it by other means)
2. Get psilocybin into people.
The drug approval process (and subsequent use in ‘the real world’) and the scientific method demands that each dose is precisely the same.
There are two trends we’re seeing addressing these two issues:
1. Companies developing biomass cultivation, isolation, and extraction of psilocybin from mushrooms
2. Development of sublingual/oral dissolvable technology for psilocybin delivery
Recent Biomass Cultivation Plans
At least three companies have made their intentions to produce psilocybin from natural products known, highlighting the lower costs and the superiority of naturally-derived psilocybin.
One expert I have spoken with stresses that this is not cannabis— the amount of psilocybin in a mushroom, is small when compared to the amount of THC/CBD in cannabis.
“I predict that isolating and purifying psilocybin from brown goo (the primary extract) is going to prove quite complicated and labour and cost intensive. It’s not at all like extracting and isolating cannabinoids from cannabis, which is what I suspect many people think they can emulate with fungal biomass.”
Furthermore, the isolation and extraction technology is primitive, and these “natural” products are likely extracted via flash chromatography, a process that relies heavily on “unnatural” solvents making aGMP grade guarantee very challenging.
“Also important to realize: standardization of natural products is going to be a challenge compared to synthetic substances. GMP synthetic psilocybin can be purified to >99.9% relatively easily, and this avoids the regulatory requirement to characterize any impurities above 0.1% in materials intended for human use. It’ll be very interesting to see if the biomass folks (there are numerous companies claiming to be working on extracted psilocybin) manage to pull this off. I predict they’re going to find this to be very challenging, and much more expensive than they think.”
In other words, there is much daylight between the claims we’re seeing and current state of the art.
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