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Thought Leadership

Psychedelics and End of Life Care: Understanding the Legal Landscape

 
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There has been a lot of buzz around psychedelics, and particularly their potential usefulness in treating existential suffering at the end of life. Husch Blackwell was the first law firm in the country to establish a Psychedelics & Emerging Therapies practice group devoted to helping clinicians, researchers, and investors navigate the complex and difficult legal and regulatory issues involved in developing new therapies in this space.

In this episode, host Meg Pekarske is joined by the leaders of Husch Blackwell’s Psychedelics & Emerging Therapies practice group, Kimberly Chew, Karen Luong, and Natasha Sumner, who provide an overview of what psychedelics are, their legal status under federal and state laws, and liability considerations for clinicians. We also discuss the recent amicus brief they filed on behalf of nearly 30 end of life and palliative care providers in a case before the U.S. Court of Appeals for the Ninth Circuit. While there is a lot to digest here, we hope it is a helpful starting point for learning about this complex and evolving area.

Read the Transcript

This transcript has been auto generated

00;00;05;01 - 00;00;35;02

Meg Pekarske

Hello and welcome to Hospice Insights: The Law and Beyond where we connect you to what matters in the ever changing world of hospice and palliative care. Psychedelics and End of Life Care: Understanding the Legal Landscape. Wow, this is an exciting topic. And so Karen, Natasha, Kimberly, thank you so much for joining me. And you're the leads on our psychedelic practice here at the firm, so it's a real honor to have you.

00;00;35;02 - 00;01;01;13

Meg Pekarske

And this is such a cutting edge area. I know nothing about. So I'm just here to ask inquisitive questions that hopefully our listeners want to hear the answers to as well. Because I know I'm dying to learn more about this area. So given that many of our listeners probably don't even know what what psychedelics, you know, from a legal standpoint, what it is and what it isn't.

00;01;01;13 - 00;01;31;05

Meg Pekarske

And so can you, Kimberly, talk a little bit about what psychedelics are like, what fits in that bucket, and who who defines what is what is a psychedelic for purpose, for drug purposes? Yeah.

Kimberly Chew

Thanks so much, Meg. Certainly. First of all, I want to thank thank you for having us on your podcast. So psychedelics is really a loose term for substances that have psychoactive properties.

00;01;31;05 - 00;02;02;24

Kimberly Chew

It doesn't really have a legal term per say other than legally allow the psychedelics, in which case we're talking about things like MDMA, LSD, psilocybin, Dante, ayahuasca, ibogaine are on the schedule one. And there's one substance that is not that is considered psychedelic. We kind of grouped under this terminology because it does have psychoactive properties, but it's a different schedule under the Controlled Substances Act, and that is ketamine.

00;02;02;24 - 00;02;40;22

Kimberly Chew

So ketamine is a schedule three and was approved by the FDA for use as a anesthetic. And it has been gaining popularity for off label use for the treatment of anxiety and depression. But it's really just a loose term. So basically, if a psychedelic substance is part of the schedule one under the control under the Federal Controlled Substances Act, then it's basically found to not have any approved medical use considered to be highly addictive and have a safety profile issue, generally speaking, by neuroscientists.

00;02;40;22 - 00;03;09;15

Meg Pekarske

So I'm taking that for you. You jump that down first. So thank you for doing that. I'm a scientist and a lawyer, so super smart. So Natasha, so most of the substance, things that are not approved for any medical reason, but there's all of these trials I think you can, you know, read in the newspaper. I mean, it's becoming commonplace in public media.

00;03;09;15 - 00;03;33;09

Meg Pekarske

I know as a recording in this session, The New York Times just had an article on the use of psychedelic and end of life care. And so I think it's in popular media. So we have all you hear about these federal trials going on and then we say, Oh, Oregon is allows certain clinics in Colorado. And so it seems like there's federal and state issues and there's these trials.

00;03;33;09 - 00;03;47;00

Meg Pekarske

Tell us a little bit more about what's going on in terms of trials and how does that work if these substances aren't approved medically for and they're illegal substance substances?

00;03;47;07 - 00;04;16;15

Natasha Sumner

Yeah, that yes. Yeah, yeah. It is confusing and it's confusing to to a lot of people and I think it's confusing, especially because there's so much out there in the media. That's exactly right. It's kind of you know, people use the term it a there's a renaissance going on, you know, with psychedelics right now. Um, so, so as Kim said, almost all of these drugs are on schedule one, which means that there is no medically approved use.

00;04;16;15 - 00;04;41;23

Natasha Sumner

So the only way that anyone can, quote, use these drugs are in clinical trials. So and there are very specific ways that anybody who is a researcher can legally, you know, get get these drugs. So you have to go through and get DEA licenses and all these things. It's it's a pretty, you know, complicated and long process to do that.

00;04;42;04 - 00;05;12;00

Natasha Sumner

Um, and so, yes, there are lots of trials going on. Many people are familiar with MDMA and the new drug application that unfortunately was not approved by the FDA fairly recently. So that will continue on and they'll probably be some more, you know, phase three trials going on and then, you know, that will be another new drug application that will then be hopefully approved at some point.

00;05;12;00 - 00;05;21;12

Natasha Sumner

And MDMA will then hopefully be approved at some point. Psilocybin trials are going on, um, you know, LSD and yeah.

00;05;21;12 - 00;05;45;18

Meg Pekarske

And maybe can I, if I can pause me there for a second. So trials are essentially to test the medical efficacy of these drugs to do something which you need to then file a drug application with the FDA to say, I, this can legally be used and prescribed by providers to treat various medical symptoms, which, you know, in end of life care

00;05;45;18 - 00;05;54;27

Meg Pekarske

there's just a lot of existential angst around that. And so that's what the the sort of nuts and bolts of these trials are. Got it.

00;05;55;09 - 00;06;19;20

Natasha Sumner

That's it. That is exactly right. And, um, you know, it's that's exactly right. So so what, you know, most of these are studying one very particular use. So use for anxiety or use for post-traumatic stress disorder. So this isn't just kind of a general like, you know, throw it against the wall and hope it sticks kind of idea.

00;06;19;25 - 00;06;44;02

Natasha Sumner

And this isn't okay. So we're going to, you know, study this drug and then suddenly MDMA is going to be moved from schedule one to schedule for. That's not what's most likely going to happen. Okay. So you asked the question, you know, state and federal. So at the federal level, it is illegal except for research. So we also have, as you mentioned, Oregon.

00;06;44;02 - 00;07;14;26

Natasha Sumner

The Oregon has this program, the state program and out just for your listeners. I am not in Oregon, you know, lawyer. And so but Oregon does have this program. It's approved, it's a state run program. And um, basically there's, um, psilocybin, um, approved facilitators that can run the psilocybin, um, that can facilitate psilocybin sessions for PTSD, anxiety, whatever it is.

00;07;14;27 - 00;07;39;25

Natasha Sumner

Okay, so that's at the state level. And then Colorado also has some program and I don't know all of the details, specifics of that. Um, the sort of rub is that, you know, this is, they call it like federalism, but basically federal law in anything really trumps state law. So federally all of this is illegal except for, you know, for research.

00;07;39;25 - 00;07;51;14

Natasha Sumner

But you have at the state level, you have the state run program, especially in Oregon. And so it's sort of like, well, is this legal and what's going to happen? And quite frankly, nobody knows.

00;07;52;03 - 00;07;52;09

Meg Pekarske

Yeah.

00;07;52;21 - 00;08;13;09

Natasha Sumner

But it's very confusing to a lot of people. And so we get a lot of questions. You know, people will call us and say, hey, I want to, you know, open up this psilocybin, you know, microdosing, blah, blah, blah. And we have to explain to them, well, it's not legal. It's not legal even in, you know, Oregon or, you know, other than at the state run program or whatever.

00;08;13;09 - 00;08;28;21

Natasha Sumner

And it is very confusing to folks. And so we do a lot of explaining of the difference between federal and and state and how that works. And it is disappointing to people. I know, but but hopefully we do a good job of explaining that.

00;08;28;21 - 00;08;51;06

Meg Pekarske

Yeah. Yeah well and it sounds like in because I think we were probably the first law firm the country to have this psychedelics practice group so is a lot of what you all do in the practice group about helping people with clinical trials related to these? I know, Karen, you're going to tell us a little bit about the litigation we are involved in.

00;08;51;06 - 00;09;01;09

Meg Pekarske

But but is that sense? It's not currently legal. Is that mostly what the legal work is that there is to do during this period of time?

00;09;01;19 - 00;09;04;02

Natasha Sumner

Yeah, that's exactly right. So clinical research.

00;09;04;02 - 00;09;04;13

Meg Pekarske

Work.

00;09;04;18 - 00;09;28;24

Natasha Sumner

And then as Kim mentioned, there is also ketamine. So because ketamine is a schedule three drug, it can be used legally off label. And so we have assisted quite a few folks with setting up ketamine clinics, helping them with their sort of corporate piece and then understanding how to get the kind of clinic itself up and running the brick and mortar and that sort of thing.

00;09;29;12 - 00;09;49;22

Natasha Sumner

So we've done that quite, quite, quite often. And many of these folks are wanting to get the ketamine clinic up and running with the hope that MDMA psilocybin will once will be legal at some point, and they will already have everything kind of set up, and they can then just move into the next phase.

00;09;50;00 - 00;10;18;03

Meg Pekarske

So, yeah, one more question before we get to litigation with Karen is like just throwing this at, you know, the road to the legalization of marijuana that like that. Is there anything that can be learned through sort of that trajectory there? I mean, I think we're talking about very different substances that probably have different concerns related to them.

00;10;18;03 - 00;10;39;06

Meg Pekarske

But like, what do we learn? Because we also we're one of the first law firms in the country to have a, you know, medical marijuana practice and so what do we have given all of our deep knowledge in that area? Is any of that helpful to say how long is this going to take? What's going to be required?

00;10;39;06 - 00;10;41;11

Meg Pekarske

Like any insight from that?

00;10;41;24 - 00;11;01;25

Natasha Sumner

Yeah. I mean, I think Karen actually is probably a better person to answer that because she actually did practice some cannabis law. And and I'm not a cannabis person, but I will say that they are very different practices because cannabis really did go more of kind of the business sort of end of things and really didn't go on the medical side.

00;11;01;25 - 00;11;26;26

Natasha Sumner

There was not a lot of research that happened on them. And and so the research is really happening now. And so it is very different. And people ask that question all the time, which it does make sense. Right. Are they you know, they're both schedule one. There are medicinal or, you know, you know, properties for both cannabis as well as all of these other schedule one, not all of but many of these Schedule one drugs.

00;11;26;26 - 00;11;52;28

Natasha Sumner

So it makes sense. But they are very different. And I think the trajectory that we see for, um, for these drug that we're talking about is, you know, I don't know if MDMA is going to be first. I think it just depends on what happens with the sort of psilocybin. That's up next. Because psilocybin there are drugs, psilocybin that are in the schedule that are in phase three trials.

00;11;53;06 - 00;12;17;07

Natasha Sumner

So if those eight, there's a new drug application that gets filed with the FDA coming up fairly soon. That may happen before the sort of phase three B, three, C, whatever's next for the MDMA. If those don't complete, then I think we might see psilocybin next. Um, but I think it's going to be MDMA psilocybin. Those are going to be kind of what's next.

00;12;17;07 - 00;12;33;00

Natasha Sumner

And I anticipate that in the next couple of years. But I don't know that anybody real other than the folks that are doing the research really know kind of what you know. But that's what I think we're going to see. You know, cannabis is a little bit different, but I think Karen might be able to talk a little bit about that.

00;12;33;13 - 00;12;35;15

Meg Pekarske

Yeah. Karen, what are your thoughts on that?

00;12;35;23 - 00;13;08;10

Karen Luong

Well, you know, this is, I think one, you know, it's a sort of different perspective on this is cannabis, I think is a really good example along, you know, along with psilocybin about how they're how the current regulations or FDA or Controlled Substances Act ignores the fact that there are ton lot well, there are many schedule one substances that are currently in Schedule one that have accepted medical use because medical marijuana has been an accepted thing for decades now, right?

00;13;08;11 - 00;13;08;20

Meg Pekarske

Yeah.

00;13;10;09 - 00;13;20;15

Karen Luong

But it's sort of still in schedule one. Well, under the controlled substances Act, the definition of a Schedule one substance is that there is no accepted medical use.

00;13;20;24 - 00;13;22;29

Karen Luong

So I think one

00;13;22;29 - 00;13;43;17

Karen Luong

of the definitions, but it's pretty much the main definition of, you know, is that there is absolutely no medical use. And that's why this is schedule one marijuana. It clearly under like nobody thinks marijuana fits into that category, but it's still in schedule one. So it's sort of a disconnect here. Yeah. And that's actually, you know, we're we're going to move and talk talk about litigation next.

00;13;43;17 - 00;14;00;07

Karen Luong

And that's exactly what these series of cases that add up the firm has been helping out on is about. And there are is a really interesting series in cases that are called Ames versus DEA, and they are in the Ninth Circuit Court of Appeals and there are three of.

00;14;00;08 - 00;14;02;10

Meg Pekarske

Them that's in California. Right. Karen.

00;14;02;21 - 00;14;21;23

Karen Luong

I forget, is California and Arizona. And okay, I should probably know all the states that are in there, but it's you know, it's several states and all each of these cases are called end versus DEA. So it's a little bit confusing. And then people who are like we who work on these cases refer to them as one, two and three.

00;14;21;23 - 00;14;50;14

Karen Luong

But basically, I want to talk about two kind of aspects of it. Like one, one aspect of it. One case was a direct petition and this is very similar like a to a, you know how cannabis is a schedule one drug, right? One of the ends versus DEA cases was a direct petition by the petitioner to reschedule psilocybin from schedule one to schedule two based on the argument that there is accepted medical use.

00;14;51;11 - 00;15;04;03

Karen Luong

And so they know. So a little background on this. Dr. Sunil Aggarwal, who is the head doctor in the Ames Institute. Ames stands for Advanced Integrated Medical Science Institute, and it's a Seattle.

00;15;04;03 - 00;15;05;03

Meg Pekarske

Book.

00;15;05;03 - 00;15;34;07

Karen Luong

Medical Research Organization. And Dr. Sunil Aggarwal is a doctor who practices in in Seattle, and he's a palliative care doctor who wanted to provide psilocybin therapy to his end of life patients, but he didn't want to risk losing his medical license for unapproved use of this substance. So what Dr. Agarwal did was he wrote the DEA and asked, ask, can you accommodate the use of psilocybin under the right to try act?

00;15;34;07 - 00;16;07;23

Karen Luong

And I'll talk about that in just a second. But the DEA refused and they sued. And so so Ames Institute sued the DEA and they argued that the DEA sort of improperly, summarily denied their request to reschedule psilocybin, even though there is definitely accepted medical use for psilocybin, it has been granted breakthrough therapy status. There are definitely clinical trials going on and and they quoted scientific articles about this.

00;16;07;23 - 00;16;33;17

Karen Luong

But I think backing it up to the more, you know, sort of practical aspect of what like non-scientists would would find interesting about this is that the use of psilocybin for end of life, for end of life care, the point of it is like right now, I think in hospice care and, you know, in a lot of a lot of end of life patients, but there isn't a lot that we do for these patients other than give them painkillers.

00;16;34;21 - 00;17;02;26

Karen Luong

As psilocybin therapy has been proven to directly and profoundly help end of life, patients deal with their impending death on an existential matter, like a natural level, you know, and really just come to peace with that, with that. And that is, you know, arguably just as important as making them physically comfortable. It makes them it helps them be at peace with the fact that they're going to be passing.

00;17;02;26 - 00;17;19;05

Karen Luong

So it's a sort of different focus on palliative care and a sort of shift towards, you know, maybe we should recognize that that was also an important thing for people who are dying, not just to, you know, mitigate their pain, but to help them, you know, ease their transition.

00;17;19;05 - 00;17;41;27

Meg Pekarske

And and what you're saying makes so much sense, Karen, when you think about the structure of the Medicare hospice benefit, I mean, it's dealing with the different quadrants of your being. I mean, it's like, okay, we have a physician and a nurse dealing with your medical symptoms, but then we have a social worker that's helping you with the psychosocial issues.

00;17;42;06 - 00;18;06;06

Meg Pekarske

Then we have a chaplain who's part of your care team that is helping with, you know, the spiritual aspects because this is not dying, is not a medical event. It is like whole full body event. And so I think what you're saying really resonates a lot with there is a lot more than just the physical symptoms of dying that we need to palliate.

00;18;06;06 - 00;18;23;20

Meg Pekarske

I guess so. So anyway, it's it's very interesting. So this this case that we I understand the firm our firm and and you in particular did this amicus brief. So friend of the court brief in one of these Ames cases then.

00;18;24;02 - 00;18;43;16

Karen Luong

Yes. So we represented a cohort of almost 30 doctors and some of the most prominent names in there in this field who urged the DEA to reopen or actually to open a rulemaking proceedings so they could be heard on their experience with end of life patients. Because what the DEA did was they summarily denied the petition to reschedule psilocybin.

00;18;43;27 - 00;19;01;14

Karen Luong

And our amicus brief was on behalf of the doctors who said, Hey, you should listen to us. I mean, like why these doctors directly deal with end of life patients? And they are their voice should be heard because there is an accepted medical use and who is making the termination and of whether there is an accepted medical use.

00;19;01;14 - 00;19;26;14

Karen Luong

Maybe you should talk to the doctors and have them make the determination and not the DEA who is the enforcer. That's what that's what our amicus brief was about. And just, you know, I mean, psilocybin is twice the designated a breakthrough therapy by the FDA. Just it it clearly has medical use and doesn't belong in schedule one. So that was that was one of the Ames cases.

00;19;26;14 - 00;19;46;05

Karen Luong

Oral arguments happened over a year ago and the court actually granted the petition and ordered the DEA basically to come back and explain themselves. And yeah, you know, unfortunately, they remanded it back to the DEA. So so it was like sort of and then ordered the DEA. You need to give a better explanation. I mean, it's well over a year.

00;19;46;05 - 00;20;05;20

Karen Luong

It's been I think a year or two months now. The DEA has done absolutely nothing. They're completely dragging their feet on this, you know, so so hopefully, hopefully something does happen soon. The DEA actually listens to the court's order and explains themselves about why they summarily denied this rescheduling. But that's not the only strategy that that Ames is taking here.

00;20;05;20 - 00;20;31;24

Karen Luong

And there was another Ames case, which is a petition to allow psilocybin under the right to try out. And so I, I think it's 31 states maybe be more now and the federal government have enacted right to try statutes and the federal right to try act was enacted in 2018 and it allows patients with life threatening conditions to access experimental treatments that had not yet been approved by the FDA.

00;20;32;17 - 00;21;00;25

Karen Luong

And all the proponents argue that psilocybin should be available under this framework given its potential therapeutic benefits. So that was that is a separate tact talked to it is not it's a different argument than basically psilocybin doesn't even fit into schedule one. But this this argument is still the same and should be allowed under right to try. And in order to to be allowed under right to try you, it has to be an eligible investigational drug.

00;21;01;14 - 00;21;10;15

Karen Luong

So we have passed phase one clinical trials for safety. I think both I think there are two psilocybin drugs right now that are that are past phase one clinical trials.

00;21;10;22 - 00;21;11;10

Meg Pekarske

Oh, really?

00;21;11;10 - 00;21;29;25

Karen Luong

Are there are drug candidates. You know the into so this therapy is available and and the argument is that the DEA should allow it there's no reason why it shouldn't be allowed under right to try. These are needy patients who who are at the end of their life and don't don't have time to waste and wait around for FDA approval.

00;21;30;02 - 00;21;47;07

Karen Luong

They might hope they might pass away before by by the time that happens. Oral arguments happened on that a several months ago. We went up to San Francisco and listened and listened to them in there. And yeah, no, there's not been a determination by the court yet. So we're going to have to watch for that.

00;21;48;02 - 00;21;48;29

Meg Pekarske

Interesting.

00;21;49;08 - 00;22;15;04

Karen Luong

Yeah. And it is going to have a lot of far ranging implications. It's it's you know, the outcome for the DEA would set could set legal precedent about what about, you know, on sulfide and other psychedelics. It can it'll affect medical research and access and it could change the regular regulatory framework. So there's a lot of interesting stuff in the works and Emre and I on this.

00;22;15;18 - 00;22;54;02

Meg Pekarske

Yeah, it's like truly trail blazing. I mean, this is the incredible work you guys are involved in. Very exciting times. So I guess maybe we bring it and there's clearly like a part two, part three, part four, like dot, dot, dot. I did this podcast, but I guess for today's episode maybe we, we conclude with you, Kimberly talking about because I know you talked with clinicians before about what are your legal and liability considerations as it relates to these issues.

00;22;54;11 - 00;23;26;08

Meg Pekarske

Because if you're doing end of life care, palliative care or, you know, working with patients that might benefit like and people are like, can I do this? What are that? My risks to my license and personally like what are some sort of high level issues that you go through with people on that?

Kimberly Chew

Yeah, sure. We actually do counsel a number of clinicians that worry about how to protect themselves from Malpractise claims when discussing, you know, psychedelic therapeutics.

00;23;26;08 - 00;23;51;28

Kimberly Chew

And I'm just going to back up a little bit because that just, you know, if you're just going to wonder where is where is the risk? The legal risk extends back to the Controlled Substances Act and accomplice liability that attaches. So basically to accomplice liability. Is is it kind of any activity that's deemed to like, quote, aid and abet the furtherance of the these prohibited activities under the course of this act?

00;23;52;08 - 00;24;27;27

Kimberly Chew

So, you know, lots of physicians or prescribers may be worried about referral to a psychedelic treatment outside of a research context or even referral to research, you know, how is that how is that done? And would would liability attach, you know, that that sort of thing. So, I mean, in the United States, I'm just going to focus on ketamine because on federal level, I mean, we're I'm going to just like kind of map Oregon and Colorado out of South Asia for now that that really we're kind of only really talking about ketamine as a psychedelic treatment.

00;24;28;04 - 00;24;52;24

Kimberly Chew

So a physician or a prescriber may be thinking, well, what are the risks involved with kind of recommending or discussing with my patient a ketamine as a therapy like low dose ketamine as a therapy for the treatment of anxiety or depression, which would be off label use, off label use. As many physicians and practitioners know, is kind of practice all the time with all kinds of drugs.

00;24;53;06 - 00;25;14;18

Kimberly Chew

And so in that case, we would basically, you know, like what we like to say is like, yeah, off label use is legal and that's on a state that you have to go into your state and more local guidance as to your practice and the best way to manage your practice. But the promotion of off label use is really not helpful.

00;25;14;25 - 00;25;39;26

Kimberly Chew

So if you're promoting that is yeah, you should use as a first line of treatment for anxiety. You're recommending that the off label use of ketamine, we don't recommend that as the best practice. There are other therapies available for treatment of anxiety and depression that is probably best practice to follow through first in order before resorting to off label use of a substance like ketamine.

00;25;40;08 - 00;26;22;10

Kimberly Chew

And that's I know that might that might drop some controversy, but that really is just the safest practice to your practice. You know, the safest way to power this. And then we also recommend that clinicians provide medical monitoring that not everyone because ketamine is off label, there's kind of all the across the gamut kind of use that we've seen all the way from at home use to, you know, or which would choke bars or pills or something like that or going into a clinic for an injection, intramuscular injection or going to a clinic for an intra venous ID, a slower infusion of ketamine.

00;26;23;15 - 00;26;58;23

Kimberly Chew

And for clinicians, we recommend that they provide medical monitoring and advise that they stay under the care of a qualified primary care physician or mental health provider as they're undergoing academy treatment. The typical typically what we've been hearing from practitioners is that this is not a it's not one and done so it's different than a lot of other psychedelics like so the psilocybin has been said to have life changing events even with sometimes a single treatment.

00;26;58;23 - 00;27;20;11

Kimberly Chew

That too. Yeah, yeah, yeah. But ketamine is not known to have these kind of durable effects. It's more of something. It's not worked out since off label, but I mean, more frequent like monthly, etc., that, that sort of thing. And then you have to undergo it a couple of times at least. And so some people do not respond.

00;27;20;29 - 00;27;48;00

Kimberly Chew

I mean, there's some some I've heard from researchers that sometimes people don't respond until 12 sessions later, which is really long, but some people respond right away. So kind of run the whole the whole gamut. And so we we do recommend, you know, just good communication with their patients that include a statement that, oh, you know, it's not recommended by the FDA per se.

00;27;48;00 - 00;28;30;06

Kimberly Chew

It's not approved the FDA approved for anesthetic, but low dose is not approved by the FDA. So it would be good to disclose that as part of your practice, in addition to other informed consent things that you should be disclosing as well. So if you if a clinician is thinking about referring to like a psychedelic clinical trial, some of the things we advise them to do is to when discussing with our patient about this possibility, is to explain to them that clinical trial, because not everyone understands, I mean, it's experimental in nature and that there is control group participation and that they there will be inclusion criteria associated with the clinical trial, in which case

00;28;30;06 - 00;28;54;09

Kimberly Chew

they may not qualify for such inclusion and therefore may not be part of the treatment. So there's just no guarantee of a treatment and that, you know, they will be signing informed consent before participation. It will have its own medical risks associated with that clinical trial. And that's just something that, you know, even though the clinical trial is legal, you know, if it's all it's all done legally, if a physician is referring out that that's just something to mention, right?

00;28;54;09 - 00;29;21;13

Kimberly Chew

As a best practice to their patients, you know, that is just. Yeah, that there's discomfort, there's no guarantee. Other considerations that a physician should consider are things like, you know, the physician patient privilege, which, you know, a number I'm sure lots of physicians are aware of this, that just protects that privilege, will protect confidentiality of communications between the doctor and and, you know, the caregiver and the patient.

00;29;21;23 - 00;30;00;09

Kimberly Chew

But that doesn't exist under federal law. So that's something. Yeah, that's just something that we like to point out for when they're talking about a substance that's currently on the schedule one, it's considered it's illegal. If you just don't want to be a liability to attach to your practice, it's best to be aware of all of these risks that these things that they're talking about, unless it's part of a clinical trial in the United States and their US physician, that they're better off sticking, you know, and not having a corpus liability attach from Controlled Substances Act, sticking with all the legal avenues, which is research or ketamine at this point.

00;30;00;20 - 00;30;26;08

Kimberly Chew

So yeah, it's generally unlawful to talk about illegal substances that they can under certain frameworks are just is hard stuff bad. Well this is why I'm so glad that that you're here and can answer these questions because I think a lot of people are very curious about this. And obviously most of our listeners are all end of life and palliative care providers.

00;30;26;08 - 00;30;55;18

Meg Pekarske

So I think, you know, first in line of who this could, you know, patients could benefit from this. But also as this is in the public media, I think being very aware as a hospice physician, what you are talking about, I mean, we've dealt with this a little bit about, you know, cannabis and because that's still illegal from a federal perspective.

00;30;55;18 - 00;31;24;15

Meg Pekarske

And so Medicare dollars can't be used to pay for that. And, you know, some of these issues but are somewhat familiar to hospices. But so it's just, I think, wonderful to have you all as a resource as people navigate this because this is feels like it's prone with a lot of challenges, but it's also a really exciting time.

00;31;24;15 - 00;31;47;00

Meg Pekarske

And as someone who, you know, is at a dead end in terms of how can they help their patients, you know, this is there's a reason why it's been studied and how many clinical trials right now that there's hopefully a lot of potential for helping people here. But. Well, this is fascinating. Thank you so much, the three of you, for your time today.

00;31;47;00 - 00;32;18;15

Meg Pekarske

This is wonderful. And I just know that we're going to be talking again. So I have people that are waiting to listen to this podcast. I have someone like you said, you're doing the psychedelics podcast. I don't see it coming out. So we have people that are just like just waiting every time we release our podcast. So we're going to be releasing this, we're recording this here at the end of 2024, but it's going to be, I think, released here in the early part of 2025.

00;32;18;15 - 00;32;33;07

Meg Pekarske

And hopefully the law hasn't changed dramatically, but I'm going to bet that it hasn’t by 2025, right by January 2025, with everything we said is still going to be relevant because we know government moves very, very slowly.

00;32;33;12 - 00;32;57;29

Natasha Sumner

I don't know. One thing we might see, though, is with Kennedy coming in in the new administration and he’s pretty pro psychedelic, so we may see some pretty quick changes, but not not by January 2025, but fairly soon after, we might see some which is is a good thing, because this is the kind of thing that we do want to see for your listeners and the physicians and their clients for sure.

00;32;58;03 - 00;33;27;13

Meg Pekarske

Yeah, well, wonderful. Thank you so much for your time. And I can't wait to hear how how all of this develops, so. Thanks again and we'll talk soon.

 Thank you. Yeah. Thanks so much, Meg.

 Well, that's it for today's episode of Hospice Insights: The Law and Beyond. Thank you for joining the conversation. To subscribe to our podcast, visit our website at huschblackwell.com or sign up wherever you get your podcasts.

00;33;27;24 - 00;33;31;28

Meg Pekarske

Until next time, may the wind be at your back.

Professionals:

Kimberly I. Chew

Senior Counsel

Karen Luong

Partner

Natasha V. Sumner

Senior Counsel