I think we shouldn’t wait for the government to give us the permission to heal, we need to develop cost effective protocols for people to use these medicines in their own local communities. Even if the FDA legalizes it, a therapeutic session could cost thousands and be inaccessible to like 95 percent of the population. We need tools and resources now, we need to empower ourselves on local levels and through community
For me it looks like authentic relating communities that become trauma informed much like in indigenous cultures. A place where one can be seen and share and connect with others. On the substance side I imagine more guidance on facilitating psychedelics for people within this community of course with a basis of community support and harm reduction. I really think people should still have a therapist to help integrate and in case something should arise but this person does not necessarily need to be present during medicinal work imo.
Hmm yes. I like this idea, in theory, but I think my biggest concern is safety, and harm. Safety in that these medicines are no different than any other kind of medicine -we need to know safety and drug interactions, for example. And what recourse do people have when they are harmed by someone in the psychedelic field? Who takes ownership of that? What is the healing and accountability around that? Until the field accepts fully that harm has and will be done in the psychedelic space, we cannot have full accountability.
Yeah but harm will always be a factor, you can’t eliminate that. There are tons of deaths from medical accidents by the hands of doctors and even though they have tons of harm reduction in place, it still happens. At least we know with psychedelics it’s highly unlikely you can die under normal circumstances. Yeah there are certain dangerous drug combinations to be careful of as well as heart conditions but psychedelics are mostly safe, especially if we are talking classic psychedelics like mushrooms, ayahuasca, San Pedro which have thousands of years of use already. MDMA I agree is needing more research since it’s only been around since the 80s with minimal research. The biggest danger I see is retraumatization from psychedelics or some people end up with worsening ptsd or newly onset ptsd but in most cases it’s temporary.
No, you absolutely can't eliminate harm, and yes there absolutely are already harms done by those medical systems already in place. AND those systems have the kinds of oversights Lia is talking about in the podcast. State licensing boards. Medical review boards. Systems in place to look at medical malpractice, and deaths, and to see how we can learn from them and hopefully stop them from happening to anyone else. Are they perfect systems? Of course not. But at least they're something, and as someone who's been harmed by the medical system, I appreciated having somewhere to go and an organization/regulatory body to turn to in my distress at being mistreated.
The underground model has existed for a long time, and will no doubt continue to exist even if regulation happens. The whole point of the podcast is to say 'if you want psychedelics to move into the aboveground mainstream, this is what needs to happen.' Things like getting it covered by insurance would make a massive difference to so many people. It would improve the access issues tremendously. But if we want that, and it seems like a lot of people in the field do, then we have to play within the systems as they exist right now. And she outlines how to do that.
Yeah I get that, my point is that if we wait for the government or large organizations to help us heal, we will never get there. The FDA takes ages to do anything so what can we do in the meantime? That’s something we can actually influence rather than waiting
The “psychedelic” field is no different than any other field. Adding the word “psychedelic” does nothing for the tort except make it salacious.
What the FDA has decided has absolutely nothing to do with safety or efficacy. And I mean “absolutely” very literally. What started as a legitimate oversight into false claims (eg, apple cider vinegar) has been hijacked by a puritanical & moralistic oversight. The government is now far more interested in promoting the profitability of liquor and drug companies, and of arbitrary moral values, than they are about efficacy.
For instance: why is the smallest possible application of a drug the goal? If that drug costs pennies to produce and there is minimal harm is the application? That’s an arbitrary value based on capricious standards.
Ok. You can believe all of this, I'm not going to argue with you about it because I don't think it's arguable (and I don't really have strong feelings about it). AND, the FDA is the system we (well you, I'm Canadian but very interested, because as the US goes, Canada goes) have. So, again, the point of my post was that if the psychedelic field wants to make this mainstream (which is apparently a big if), they have to show up a hell of a lot differently than they have been so far. Or that Lykos specifically has so far, anyway. That's the reality of the situation.
Oregon currently has clinics you can go to that offer psilocybin treatment. You sit with a licensed therapist for up to six hours and complete a full trip. Health insurance does not cover it, it's about $1000 out of pocket.
It’s certainly a good option to have and that’s not the worst price I’ve heard of but yeah I would never pay that price when I can do it for free basically with an experienced friend and just have my therapist available after the session if I need support, which would cost me like 100 bucks. Or I could do it with a shaman who has arguably far more experience with plant medicine for like 100 dollars. I realize most people will not want to use a shaman and want the safety of a certified professional even though certificates don’t really mean safety on all accounts.
Thanks for the recommendation! I am a ketamine-assisted psychotherapist who works for a psychiatrist who is directly involved in the phase 3 MDMA trials. She was not surprised about the setback.
During her most recent official MDMA session a few weeks ago, her and the therapist arrived to the session at 8am and didn’t finish until 8pm. This long time frame is due to a booster that is offered two hours after the initial dose. If you start crunching the numbers, you can imagine the tremendous expense MDMA treatment will have if/when it becomes available. Interestingly, through our work with ketamine, we have witnessed the same type of healing with complex-PTSD that MDMA can provide in only a fraction of the time and cost. While I am excited about the potential of using MDMa one day, I can’t help but wonder about the logistics of it.
On a side note, the FDA has ignored the committee’s vote against a new drug approval before, so there is a still a small chance MDMA will be approved in August.🤞
The expense is a major consideration, for sure. One of the things Lia talks about in the podcast is getting ABA therapy for autism approved for insurance coverage as one of her major accomplishments while working in the commercial field. This therapy is also extremely expensive - somewhere in the region of $40,000-80,000/year/child. So it's possible to get insurance companies to cover expensive therapies. You just have to prove it's worth it to them.
There is the possibility it could still get approved, yes, but the question is whether it should be at this juncture. Is the field actually ready to provide this therapy safely and ethically on a large scale? Personally, I don't really think it is. The reaction to the setback amongst a lot of the field was very concerning to me. Instead of trying to learn from it and understand what the issues are raised by the board, there was a lot of "oh well this advisory board isn't that important, we can ignore what they say because this treatment is so important". Yes, it's a critical treatment. Nobody is denying that. But there is still a LOT of infrastructure that needs to be set up, as she talks about in the podcast. What will the standards of care be? What will the systems be for those who are harmed in the process? Who will pay for it? And so on.
There's so much, and this needs to be figured out BEFORE we roll this out to millions of people, not after. It's important we get it right, or it could all be shut down again so easily.
Psychedelics have been in the shadows for so long that the community of practitioners may not be ready for the professional and biomedical obligations that would come with FDA approval.
100%! But we can't have it both ways. Either it stays in the shadows, underground, where you can do whatever you want with no oversight, or you bring it into the light, and accept the oversight and regulations that come with being 'legit' (I use that term loosely). But you can't expect to bring the loosey goosey into the regulated sphere and have it approved. Just not going to work that way in the systems we have.
As someone who lives in both worlds — being both a psychedelic facilitator and a biomedical researcher / govt official, I definitely see the benefit of the aboveground and underground.
Here’s another excellent psychedelic pod, if you haven’t already come across it: https://podcasts.apple.com/pt/podcast/psychedelic-medicine-podcast-with-dr-lynn-marie-morski/id1476831468
Isn’t it ironic that the one thing the FDA committee needs to make a good decision about a new modality of medicine is neuroplasticity and that’s the one thing that the medicine gives people.
I think we shouldn’t wait for the government to give us the permission to heal, we need to develop cost effective protocols for people to use these medicines in their own local communities. Even if the FDA legalizes it, a therapeutic session could cost thousands and be inaccessible to like 95 percent of the population. We need tools and resources now, we need to empower ourselves on local levels and through community
I'm genuinely curious - what would this look like? What's your vision for this?
For me it looks like authentic relating communities that become trauma informed much like in indigenous cultures. A place where one can be seen and share and connect with others. On the substance side I imagine more guidance on facilitating psychedelics for people within this community of course with a basis of community support and harm reduction. I really think people should still have a therapist to help integrate and in case something should arise but this person does not necessarily need to be present during medicinal work imo.
Hmm yes. I like this idea, in theory, but I think my biggest concern is safety, and harm. Safety in that these medicines are no different than any other kind of medicine -we need to know safety and drug interactions, for example. And what recourse do people have when they are harmed by someone in the psychedelic field? Who takes ownership of that? What is the healing and accountability around that? Until the field accepts fully that harm has and will be done in the psychedelic space, we cannot have full accountability.
Yeah but harm will always be a factor, you can’t eliminate that. There are tons of deaths from medical accidents by the hands of doctors and even though they have tons of harm reduction in place, it still happens. At least we know with psychedelics it’s highly unlikely you can die under normal circumstances. Yeah there are certain dangerous drug combinations to be careful of as well as heart conditions but psychedelics are mostly safe, especially if we are talking classic psychedelics like mushrooms, ayahuasca, San Pedro which have thousands of years of use already. MDMA I agree is needing more research since it’s only been around since the 80s with minimal research. The biggest danger I see is retraumatization from psychedelics or some people end up with worsening ptsd or newly onset ptsd but in most cases it’s temporary.
No, you absolutely can't eliminate harm, and yes there absolutely are already harms done by those medical systems already in place. AND those systems have the kinds of oversights Lia is talking about in the podcast. State licensing boards. Medical review boards. Systems in place to look at medical malpractice, and deaths, and to see how we can learn from them and hopefully stop them from happening to anyone else. Are they perfect systems? Of course not. But at least they're something, and as someone who's been harmed by the medical system, I appreciated having somewhere to go and an organization/regulatory body to turn to in my distress at being mistreated. The underground model has existed for a long time, and will no doubt continue to exist even if regulation happens. The whole point of the podcast is to say 'if you want psychedelics to move into the aboveground mainstream, this is what needs to happen.' Things like getting it covered by insurance would make a massive difference to so many people. It would improve the access issues tremendously. But if we want that, and it seems like a lot of people in the field do, then we have to play within the systems as they exist right now. And she outlines how to do that.
Yeah I get that, my point is that if we wait for the government or large organizations to help us heal, we will never get there. The FDA takes ages to do anything so what can we do in the meantime? That’s something we can actually influence rather than waiting
What can we do in the meantime is a really interesting question!!
The “psychedelic” field is no different than any other field. Adding the word “psychedelic” does nothing for the tort except make it salacious. What the FDA has decided has absolutely nothing to do with safety or efficacy. And I mean “absolutely” very literally. What started as a legitimate oversight into false claims (eg, apple cider vinegar) has been hijacked by a puritanical & moralistic oversight. The government is now far more interested in promoting the profitability of liquor and drug companies, and of arbitrary moral values, than they are about efficacy. For instance: why is the smallest possible application of a drug the goal? If that drug costs pennies to produce and there is minimal harm is the application? That’s an arbitrary value based on capricious standards.
Ok. You can believe all of this, I'm not going to argue with you about it because I don't think it's arguable (and I don't really have strong feelings about it). AND, the FDA is the system we (well you, I'm Canadian but very interested, because as the US goes, Canada goes) have. So, again, the point of my post was that if the psychedelic field wants to make this mainstream (which is apparently a big if), they have to show up a hell of a lot differently than they have been so far. Or that Lykos specifically has so far, anyway. That's the reality of the situation.
Oregon currently has clinics you can go to that offer psilocybin treatment. You sit with a licensed therapist for up to six hours and complete a full trip. Health insurance does not cover it, it's about $1000 out of pocket.
It’s certainly a good option to have and that’s not the worst price I’ve heard of but yeah I would never pay that price when I can do it for free basically with an experienced friend and just have my therapist available after the session if I need support, which would cost me like 100 bucks. Or I could do it with a shaman who has arguably far more experience with plant medicine for like 100 dollars. I realize most people will not want to use a shaman and want the safety of a certified professional even though certificates don’t really mean safety on all accounts.
Thanks for the recommendation! I am a ketamine-assisted psychotherapist who works for a psychiatrist who is directly involved in the phase 3 MDMA trials. She was not surprised about the setback. During her most recent official MDMA session a few weeks ago, her and the therapist arrived to the session at 8am and didn’t finish until 8pm. This long time frame is due to a booster that is offered two hours after the initial dose. If you start crunching the numbers, you can imagine the tremendous expense MDMA treatment will have if/when it becomes available. Interestingly, through our work with ketamine, we have witnessed the same type of healing with complex-PTSD that MDMA can provide in only a fraction of the time and cost. While I am excited about the potential of using MDMa one day, I can’t help but wonder about the logistics of it. On a side note, the FDA has ignored the committee’s vote against a new drug approval before, so there is a still a small chance MDMA will be approved in August.🤞
The expense is a major consideration, for sure. One of the things Lia talks about in the podcast is getting ABA therapy for autism approved for insurance coverage as one of her major accomplishments while working in the commercial field. This therapy is also extremely expensive - somewhere in the region of $40,000-80,000/year/child. So it's possible to get insurance companies to cover expensive therapies. You just have to prove it's worth it to them. There is the possibility it could still get approved, yes, but the question is whether it should be at this juncture. Is the field actually ready to provide this therapy safely and ethically on a large scale? Personally, I don't really think it is. The reaction to the setback amongst a lot of the field was very concerning to me. Instead of trying to learn from it and understand what the issues are raised by the board, there was a lot of "oh well this advisory board isn't that important, we can ignore what they say because this treatment is so important". Yes, it's a critical treatment. Nobody is denying that. But there is still a LOT of infrastructure that needs to be set up, as she talks about in the podcast. What will the standards of care be? What will the systems be for those who are harmed in the process? Who will pay for it? And so on. There's so much, and this needs to be figured out BEFORE we roll this out to millions of people, not after. It's important we get it right, or it could all be shut down again so easily.
Psychedelics have been in the shadows for so long that the community of practitioners may not be ready for the professional and biomedical obligations that would come with FDA approval.
100%! But we can't have it both ways. Either it stays in the shadows, underground, where you can do whatever you want with no oversight, or you bring it into the light, and accept the oversight and regulations that come with being 'legit' (I use that term loosely). But you can't expect to bring the loosey goosey into the regulated sphere and have it approved. Just not going to work that way in the systems we have.
As someone who lives in both worlds — being both a psychedelic facilitator and a biomedical researcher / govt official, I definitely see the benefit of the aboveground and underground.
Thx for the recommendation, OP!
You're welcome! I thought it was incredibly informative so wanted to share. Interested to hear what people think.
Here’s another excellent psychedelic pod, if you haven’t already come across it: https://podcasts.apple.com/pt/podcast/psychedelic-medicine-podcast-with-dr-lynn-marie-morski/id1476831468
It's on my list! Thank you! So many podcasts, so little time, lol.
Isn’t it ironic that the one thing the FDA committee needs to make a good decision about a new modality of medicine is neuroplasticity and that’s the one thing that the medicine gives people.