The fact that they are using a synthetic version likely means they have constructed a molecule that’s patented or otherwise IP protected. I’m always torn about this, because it means that a cheap, globally available compound (psylocibin) which was what inspired this company to begin with when the founders used it on their son will remain medically inaccessible, possibly at Schedule I in the US, while this startup’s compound may end up being covered by insurance and rake in piles of cash.
I get that it takes a lot of money to prove the efficacy of drugs. But there should be a better way to open some of these chemicals up and acknowledge the community that has worked hard, often at great personal and reputational risk, to demonstrate that these well-known drugs offer powerful options to treat a range of psychiatric illnesses.
It's just psilocybin - the formulation is protected, but it's just magic mushrooms. They're studying doses of 1mg, 10mg, and 25mg. 25mg is roughly equivalent to a beginner dose of 2.5g. They should definitely do a followup of 25, 35, and 50mg, because the higher doses are most commonly associated with the most benefits across other studies that have been done.
It's never going to be a major moneymaker - you rarely encounter people who want to continue abusing it. 1 dose is sufficient for 6 or more months of mitigated symptoms, sometimes even allowing people to entirely escape negative thought patterns and depression. Psilocybin induces new synaptic pathways, helps balance out or suppress obsessive loops, so in combination with positive reinforcement in lifestyle patterns, habits, and changing environments, a single high dose psilocybin experience can radically alter someone's mental health and outlook for the better.
The literature is fascinating - one of the safest drugs known to science, yet one of the least exploited for medical or scientific purposes. There's a whole vast wealth of good data that will come from research like this, it's exciting.
> positive reinforcement in lifestyle patterns, habits, and changing environments ... can radically alter someone's mental health and outlook for the better.
Even without the lifestyle changes, you can get a 6+ month mitigation of symptoms, but without the lifestyle changes, the symptoms will return, and often it's an indicator of unhealthy lifestyle as opposed to a mental illness. Unfortunately, mental health and treatment with drugs ignores that all important bit. Maybe you are healthy, and are having a perfectly normal response to stressful, negative conditions, and don't need drugs. In the case of shrooms, it can suppress the obsessive loops and focus on being stuck for a long enough period that people can escape, but often that escape route has to be pointed out by a third party.
Unethical practices would be possible with psychedelics, still - don't provide the escape route, just keep people coming back for super expensive, slightly underdosed psychedelic trips every six months to mitigate symptoms.
It's a myth that you need a novel molecule to get a patent on a medicine.
A company can develop a formulation of generic, off-patent compounds and get FDA approval for that patented formulation.
Even old off-patent drugs are often brought back in new, on-patent formulations that can't be sold generically until the expiration of the patents on the formulation that was approved.
So even if they used psilocybin, they would get a patent on their formulation and get FDA approval for that formulation.
Devil's advocate suggests that a synthetic can be produced the same way every time where a cultured plant might have varying levels of the active compound in the plant. That makes it difficult to prescribe doses. As an example, suggesting a patient take 1 cap and 2 stems will be problematic for accurate dosing.
Conspirator's advocate says that bigPharma has synthesized and patented every active plant compound so that keeping the actual plants scheduled is to their benefit.
as if that's a guaranteed win. The low hanging fruit was to recreate what is already in nature. Creating something brand new never seen before would be a greenfield project that I'm sure most of bigPharma is not a fan of.
Pharma, sprang up from taking wondrous compounds found in nature and isolated them or refined them into new compounds that they could patent, market, and sell to consumers.
In what sense? Ibuprofen is a specific chemical compound, crude oil is anything but that - it's a mixture of a huge number of chemicals.
I don't think the pharma industry is a moral exemplar either. But this seems like a simple error that will just distract from your point. Others in the thread have given better examples.
Yet Ibuprofen is so easy to make that only 6 plants make it worldwide and when one goes offline the shortages are felt throughout the world.
Might be a bit more difficult than just crude oil
6 plants are allowed to make it. Everyone else thought the licensing fee was too high.
Unless you are referring to natural botanical plants, in which case, Pine Trees and turpentine is a good alternative found. IANAL but it would still need to find a way around the Ibuprofen compound patent.
> 6 plants are allowed to make it. Everyone else thought the licensing fee was too high
What licensing fee? It's an old, generic medicine. Anyone who wanted to set up an Ibuprofen manufacturing plant could do so relatively easily.
The reason more plants aren't coming online is that Ibuprofen is a couple pennies per pill at retail prices. There isn't money in making more ibuprofen.
What people get wrong is that you don't just trip balls and get cured. Re-integration therapy is vital for lasting effects. Grabbing some shrooms and digging in is recreation, which is perfectly fine, but don't fool yourself or anyone else by suggesting it's for treatment.
I think there's simply so much value in being able to see the same thing in so many different perspectives that you never have considered possible at all in your life before.
I believe there have been other studies that prove this for not just the synthetic. Yet we are all supposed to accept the "facts" that psilocybin (and cannabis) are considered schedule 1 illicit substances (high potential for abuse and no currently accepted medical use).
At that point it’s not "other studies", it’s more "tons of studies". It’s truly an exponential number of studies that had the same conclusions in the last 5-10 years.
And N=1 but I can say without any doubt that LSD (and a pretty low dose at that, 50ug at once plus some microdosing) played an immense role at recovering from burnout. It was like night and day even after such a low dose that I _knew_ I recovered.
Those are amazing and powerful but also potentially dangerous substances and it’s a crime that we don’t allow everyone to get the benefits by, if not freely legalize it, at least adding those in the medical toolbox.
"I believe with the advent of acid we discovered a new way to think, and it had to do with piecing together new thoughts in your mind. …
Why is it that people think it's so evil? What is it about it that—that is—scares people so deeply? Even the guy that invented it. What is it? Because they're afraid that there's more to reality than they have confronted. That there are doors that they're afraid to go in, and they don't want us to go in there either, because if we go in, we might learn somethin' that they don't know. And that makes us a little out of their control"
and the worse is (contemporany) research on these drugs being slowed down by the field getting the rare licenses to study something broad as "depression cure"... some types of pyschodelics are really effective to treat specific stuff like post-traumatic anxiety of unexpected events like the 9/11. with rates of prognosis improvement beyond 80%. Katherine MacLean has a nice critic on what are the politics/dynamics of this field
> and also completely legal to buy in certain locales
I'm not trying to be pedantic, but it's important to understand that according to federal law it's not actual legal to possess them regardless of which state you're in.
They're still illegal under federal law. A person could technically be prosecuted at the federal level even in a state that doesn't have state-level laws against it, though that's unlikely in practice.
> Yet we are all supposed to accept the "facts" that psilocybin (and cannabis) are considered schedule 1 illicit substances (high potential for abuse and no currently accepted medical use).
To be clear, this compound they're testing is also a Schedule 1 drug. COMP360 is their name for their psilocybin formulation. It's not a separate chemical, it is literally psilocybin.
Schedule 1 drugs can be used in clinical trials. Positive results in a clinical trial does not automatically remove the Schedule 1 designation. The medication is not approved yet and the clinical trial results are preliminary.
> "Researchers have called attention to the ways that the hype promoting psychedelics as miracle cures
replicates preceding claims about the efficacy of SSRIs and other antidepressants in prior decades.
As the drug historian David Herzberg articulated in conversation with UC Berkeley's The Microdose:
There’s been an enormous amount of money invested in psychedelics as people hope that they
can be the real Prozac in the same way that Prozac hoped it would be the real Valium and
Valium would be the real barbiturates, which would be the real morphine.
There’s a long history of hoping that maybe this time, it’s not so complicated;
maybe there is a simple switch to change people without having to change any [other] aspect of their [lives].
While others have noted similarities between the earlier SSRI hype and the ongoing hype for psychedelic medications,
the rhetoric of psychedelic hype is tinged with utopian and magico-religious aspirations that have no parallel
in the discourse surrounding SSRIs or other antidepressants. I argue that this utopian discourse provides insight
into the ways that global financial and tech elites are instrumentalizing psychedelics as one tool
in a broader world-building project that justifies increasing material inequality.
This elite project reveals how medicalized psychedelics can potentially undermine the very prosocial and
pro-environmental outcomes that the field's funders insist psychedelics will promote.
To understand the envisioned role of psychedelics within this elite project, this paper analyzes a different
parallel hype, revealing correspondences between the psychedelic industry hype and the concurrent
hype surrounding artificial intelligence (AI), including the Large Language Models (LLMs) that power ChatGPT.
The presence of these parallels is understandable when one considers their underlying affinities,
like two blooms from one plant: the same Silicon Valley and venture capital forces are investing
enormous amounts of capital to develop both as cultivars in their own image,
selecting for desired traits that further the existing socioeconomic order.
The fact that they are using a synthetic version likely means they have constructed a molecule that’s patented or otherwise IP protected. I’m always torn about this, because it means that a cheap, globally available compound (psylocibin) which was what inspired this company to begin with when the founders used it on their son will remain medically inaccessible, possibly at Schedule I in the US, while this startup’s compound may end up being covered by insurance and rake in piles of cash.
I get that it takes a lot of money to prove the efficacy of drugs. But there should be a better way to open some of these chemicals up and acknowledge the community that has worked hard, often at great personal and reputational risk, to demonstrate that these well-known drugs offer powerful options to treat a range of psychiatric illnesses.
It's just psilocybin - the formulation is protected, but it's just magic mushrooms. They're studying doses of 1mg, 10mg, and 25mg. 25mg is roughly equivalent to a beginner dose of 2.5g. They should definitely do a followup of 25, 35, and 50mg, because the higher doses are most commonly associated with the most benefits across other studies that have been done.
It's never going to be a major moneymaker - you rarely encounter people who want to continue abusing it. 1 dose is sufficient for 6 or more months of mitigated symptoms, sometimes even allowing people to entirely escape negative thought patterns and depression. Psilocybin induces new synaptic pathways, helps balance out or suppress obsessive loops, so in combination with positive reinforcement in lifestyle patterns, habits, and changing environments, a single high dose psilocybin experience can radically alter someone's mental health and outlook for the better.
The literature is fascinating - one of the safest drugs known to science, yet one of the least exploited for medical or scientific purposes. There's a whole vast wealth of good data that will come from research like this, it's exciting.
> positive reinforcement in lifestyle patterns, habits, and changing environments ... can radically alter someone's mental health and outlook for the better.
Edited out the least important step
Even without the lifestyle changes, you can get a 6+ month mitigation of symptoms, but without the lifestyle changes, the symptoms will return, and often it's an indicator of unhealthy lifestyle as opposed to a mental illness. Unfortunately, mental health and treatment with drugs ignores that all important bit. Maybe you are healthy, and are having a perfectly normal response to stressful, negative conditions, and don't need drugs. In the case of shrooms, it can suppress the obsessive loops and focus on being stuck for a long enough period that people can escape, but often that escape route has to be pointed out by a third party.
Unethical practices would be possible with psychedelics, still - don't provide the escape route, just keep people coming back for super expensive, slightly underdosed psychedelic trips every six months to mitigate symptoms.
Yes, they have a few patents on the unique formulation (a hydrated crystalline form of psilocybin). See also: https://psychedelicalpha.com/data/psilocybin-patent-tracker
It's a myth that you need a novel molecule to get a patent on a medicine.
A company can develop a formulation of generic, off-patent compounds and get FDA approval for that patented formulation.
Even old off-patent drugs are often brought back in new, on-patent formulations that can't be sold generically until the expiration of the patents on the formulation that was approved.
So even if they used psilocybin, they would get a patent on their formulation and get FDA approval for that formulation.
The same thing with Ketamine. As an i.v.-Medication dirt cheap, but the same drug in a nasal spray suddenly 500$(Spravato)
Devil's advocate suggests that a synthetic can be produced the same way every time where a cultured plant might have varying levels of the active compound in the plant. That makes it difficult to prescribe doses. As an example, suggesting a patient take 1 cap and 2 stems will be problematic for accurate dosing.
Conspirator's advocate says that bigPharma has synthesized and patented every active plant compound so that keeping the actual plants scheduled is to their benefit.
I'm fairly certain it's possible to extract psylocibin from the murshroom, giving the same advantages that the synthetic would have!
Edit0: for a more thorough look: https://www.mdpi.com/1424-8247/18/3/380
that's generally much more expensive
Than RnD for a brand new synthetic drug?
as if that's a guaranteed win. The low hanging fruit was to recreate what is already in nature. Creating something brand new never seen before would be a greenfield project that I'm sure most of bigPharma is not a fan of.
You just described 150 years of Big Pharma Law.
Pharma, sprang up from taking wondrous compounds found in nature and isolated them or refined them into new compounds that they could patent, market, and sell to consumers.
Ibuprofen, for example, is crude oil.
"Ibuprofen, for example, is crude oil."
In what sense? Ibuprofen is a specific chemical compound, crude oil is anything but that - it's a mixture of a huge number of chemicals.
I don't think the pharma industry is a moral exemplar either. But this seems like a simple error that will just distract from your point. Others in the thread have given better examples.
Yet Ibuprofen is so easy to make that only 6 plants make it worldwide and when one goes offline the shortages are felt throughout the world. Might be a bit more difficult than just crude oil
6 plants are allowed to make it. Everyone else thought the licensing fee was too high.
Unless you are referring to natural botanical plants, in which case, Pine Trees and turpentine is a good alternative found. IANAL but it would still need to find a way around the Ibuprofen compound patent.
> 6 plants are allowed to make it. Everyone else thought the licensing fee was too high
What licensing fee? It's an old, generic medicine. Anyone who wanted to set up an Ibuprofen manufacturing plant could do so relatively easily.
The reason more plants aren't coming online is that Ibuprofen is a couple pennies per pill at retail prices. There isn't money in making more ibuprofen.
If there wouldn't be money in it, they wouldn't have invested 200 Millions in a new plant in 2017
Then there must have been a market opportunity.
I bet there won't be much opportunity left after that plant comes online.
What licensing fee? There aren't any patent protections on Ibuprofen anymore. It's a generic for a very long time.
Also last time there was a shortage, one american BASF plant went down and they had trouble for almost a year before they could resume production
FWIW I at least am willing to pay someone else to make my Ibuprofen from the crude oil so I don’t have to. Sounds like it’d be messy.
What people get wrong is that you don't just trip balls and get cured. Re-integration therapy is vital for lasting effects. Grabbing some shrooms and digging in is recreation, which is perfectly fine, but don't fool yourself or anyone else by suggesting it's for treatment.
I think there's simply so much value in being able to see the same thing in so many different perspectives that you never have considered possible at all in your life before.
I believe there have been other studies that prove this for not just the synthetic. Yet we are all supposed to accept the "facts" that psilocybin (and cannabis) are considered schedule 1 illicit substances (high potential for abuse and no currently accepted medical use).
At that point it’s not "other studies", it’s more "tons of studies". It’s truly an exponential number of studies that had the same conclusions in the last 5-10 years.
And N=1 but I can say without any doubt that LSD (and a pretty low dose at that, 50ug at once plus some microdosing) played an immense role at recovering from burnout. It was like night and day even after such a low dose that I _knew_ I recovered.
Those are amazing and powerful but also potentially dangerous substances and it’s a crime that we don’t allow everyone to get the benefits by, if not freely legalize it, at least adding those in the medical toolbox.
"I believe with the advent of acid we discovered a new way to think, and it had to do with piecing together new thoughts in your mind. …
Why is it that people think it's so evil? What is it about it that—that is—scares people so deeply? Even the guy that invented it. What is it? Because they're afraid that there's more to reality than they have confronted. That there are doors that they're afraid to go in, and they don't want us to go in there either, because if we go in, we might learn somethin' that they don't know. And that makes us a little out of their control"
--Ken Kasey
and the worse is (contemporany) research on these drugs being slowed down by the field getting the rare licenses to study something broad as "depression cure"... some types of pyschodelics are really effective to treat specific stuff like post-traumatic anxiety of unexpected events like the 9/11. with rates of prognosis improvement beyond 80%. Katherine MacLean has a nice critic on what are the politics/dynamics of this field
It is outrageous that both cannabis and psilocybin are scheduled 1 drugs and also completely legal to buy in certain locales.
> and also completely legal to buy in certain locales
I'm not trying to be pedantic, but it's important to understand that according to federal law it's not actual legal to possess them regardless of which state you're in.
They're still illegal under federal law. A person could technically be prosecuted at the federal level even in a state that doesn't have state-level laws against it, though that's unlikely in practice.
while at the same time, Fentanyl is a schedule II drug.
> Yet we are all supposed to accept the "facts" that psilocybin (and cannabis) are considered schedule 1 illicit substances (high potential for abuse and no currently accepted medical use).
To be clear, this compound they're testing is also a Schedule 1 drug. COMP360 is their name for their psilocybin formulation. It's not a separate chemical, it is literally psilocybin.
Schedule 1 drugs can be used in clinical trials. Positive results in a clinical trial does not automatically remove the Schedule 1 designation. The medication is not approved yet and the clinical trial results are preliminary.
This paper is an incredible read: TESCREAL hallucinations: Psychedelic and AI hype as inequality engines
https://akjournals.com/view/journals/2054/7/S1/article-p22.x...
As someone who accidentally discovered the anti-depressive effects of psilocybin in my early 20s, I approve this message!
Does anyone know if it is just synthetic psilocybin or a psilocybin-like molecule?
Everything I've read from them indicates it's the same chemical, but in a specific formulation. It's described in detail in the patent (one of them: https://patents.google.com/patent/US20200199161A1/en)
From what I can tell from searching for "Comp360", it is simply synthetic psilocybin. See https://pmc.ncbi.nlm.nih.gov/articles/PMC10595939/
Obligatory mirror:
https://archive.ph/rIPvX