Perspectives on Psychedelic Research, Clinical Trials, and Continuing To Connect From The Heart

Dr. Manish Agrawal, MD 12:50

So, you know, when I was wandering all those times I thought I was just going from one thing to the next, but now I can look back those were sort of, that was the crumbs I was following. We just work sort of brings together all of those interests. Yeah,

Dr. Sandy Newes 13:05

I love that. So let me just also highlight you’re like, oh, yeah, you know, we just, like, wrote a study, got over your Bluebird, he raised money built out of space. Like, as if those are, like, simple things, like, I love that. You just kind of toss that out. Like, yeah. How long did that take you from like, the beginning of the writing of the proposal to the actual kind of launching of the first study in the new space. I’m curious. I’m just curious.

Dr. Manish Agrawal, MD 13:30

Yeah, it was a really interesting time. You know, study probably took about a year to write, and then the whole story is kind of funny. I mean, it’s like hard to believe, but like we there’s an open shell. And I said, I want to do this work. And I talked to this man who’s incredible guy whose wife had died of ovarian cancer. And I didn’t say it in these words, but in essence, I said, this is to help treat broken hearts. And he said, what’s what I wanted to do? And so he said, Fine, silhouette. I said, psilocybin. So he never heard of this, and he wrote a check for us to get architectural drawings. So I got drawings and and there’s like this, it was going to cost, I don’t know, 1.2 million or something, to build it. December. We did this fundraiser, December of 19, oh. Then COVID hit, yeah. And we raised some money, but we started construction. And the people, like, nobody starts construction with all the money, but we just did. And then the month just trickled in, and, I don’t know. We the fundraiser in December, and we had it built by July, August. I mean, I should say the person that’s not on this podcast is Kim Roddy, yeah, and she really built the space out. She’s like the operational genius behind all of this, and she’s oversaw the project built. It out. Did all the stuff, you know, I, I do the hand waving. She does the work.

Dr. Sandy Newes 15:06

Well, having had the honor to spend some time with Kim, I can certainly appreciate her contribution. And, yeah, appreciate you recognizing that. So you two are a good team. Yeah, that’s, I mean, that’s pretty fast,

Dr. Manish Agrawal, MD 15:19

like it is strange. COVID actually worked for us in that time. It’s like, because so much construction shut down, but it was continued medical settings, and so people are able to work here and do it. And, yeah, I mean, it was a strange time, like we were the county was going to close and not give permits out, and so a developer we knew got the permits on the weekend before all these things sort of interesting is like it was, it was like some we were possessed. Thing was possessed. It just sort of happened right

Dr. Sandy Newes 15:56

if one, if one believed in following the signs, one might have thought that that seemed like a very clear sign that you were on the right path.

Dr. Manish Agrawal, MD 16:02

We never believed that. We just stepped in through one door, and if a door opened, we just kept going. But we didn’t play out.

Dr. Sandy Newes 16:10

Yeah? Well, so then, so has research always been a piece of it for you? Like, has it been kind of, you know, it sounds like you wrote the proposal and then the clinic came. Most people think about doing it the other way. So I’m just kind of, you know, you’ve got a clinic, and then you try to do some research so well, I

Dr. Manish Agrawal, MD 16:28

mean, so I’ve been doing research for my whole time. So, I mean, I was went to the NIH and have a master’s in research from Duke, and was on faculty there. And so I sort of got bored, honestly, with oncology research. And then I so I didn’t finish it, so I actually joined my resident at Georgetown. I took a year off and got a master’s in philosophy and the ethics. So I was doing research in ethics as well at the NIH, and I got a little bored with that. It was like, but So research, yes, in the terms of asking questions and but at the time and currently still, because psychedelics are schedule one, the only way you can study them is through research. But this allowed me to ask questions that I really cared about, like, how do people face death, you know what? When you lose meaning? And so there is a part of me that is genuinely interested. And so a research question was important, practically, to be able to do anything and to study and do this work. You can’t just go out and give psilocybin, but I also was interested in the evidence, like, what does this really work? So that’s always been a part of who I am, yeah,

Dr. Sandy Newes 17:41

well, so I’m sorry if I derailed the kind of, you know, how did you get there piece? I realized that I did. And, you know, I’m hearing, as you’re talking about it, this weaving together, of like, you know, engineering, and then ethics, you know, philosophy, and then medical, like, so I can see how all of those things weave together for you. And I mean, did that ultimately lead you to cancer? Kind of, because bringing those things together,

Dr. Manish Agrawal, MD 18:05

yeah, cancer, because I think it’s a hard to really enjoy meaningful conversations with people. And so cancer sort of cuts to the chase like nothing does. And so people get very real, and you’re talking about what matters and and so I really enjoyed that. And then I enjoyed the technical aspects of it at the time of, how do you really manage a complex disease with multi specialties, and whether it’s chemo, radiation and surgery and different nuances, and how do you guide someone through that piece, as well as the psychological aspect of it? And so, so cancer really called a lot from me to do that.

Dr. Sandy Newes 18:45

Well, so kind of and then so bridging that with psychedelics. Does it feel like a natural progression of that, or is there other things about that that really just excite you about being in the field or interest you about being in that field?

Dr. Manish Agrawal, MD 19:00

Yeah, for sure, there’s a natural bridge, because basically, I have even deeper conversations, and have dropped the chemo and the radiation and the surgery, and so now we just talk about really deep things. And so yes, I think you can have incredibly meaningful conversations with people about, you know, things that they don’t even understand, or you don’t even understand about themselves. So that part of it for sure, it’s been a natural extension. And then, you know, I guess all these things sort of make sense as I look back, I’ve always been a pretty pragmatic person, and so I liked philosophy and those things in like real life, like, what does it really matter to you as a person? And when I got my master’s, I realized I didn’t want to get a PhD, because it got really academic and ethereal and like you’re sort of solving questions in your head, but they’re not like practical ones. And so in a way, this is like the best lab for those kind of questions, because you get to see humanity sort of. Of naked, right, unbridled, yeah, yeah.

Dr. Sandy Newes 20:04

I love that, right, which we certainly do see in psychedelic land. We do. I mean,

Dr. Manish Agrawal, MD 20:11

you see it everywhere, but we see it really in your face in psychedelic land,

Dr. Sandy Newes 20:15

yeah, yeah. Well, so what are kind of you know, so, right? You run a clinic that does clinical work and also does research. So you know, what are some of the interesting things about that for you?

Dr. Manish Agrawal, MD 20:32

Well, I think it’s interesting is, I’m continually learning, like you never, sort of come to the bottom of this and and so I think my first fora into it was, Wow, this is really powerful. These people know all this stuff, and then now that done it and treated a lot of people like, well, they knew some stuff, but they were wrong about a lot of things, and there’s a lot more to learn than and lot more to unlearn. And so that’s been sort of interesting to me. And the other thing that I’m really interested in philosophy, and just in general, is, like, sort of philosophy of mind, you know, sort of like this intersection between you call it psycho spirit. Like, what is mind? What is conscious? Like, we have words for it, but, like, what is it really and, you know, how do we make sense of it? And so seeing that continually butt heads and like people have this experience that can’t quite fit into this framework of right medicine or biology or philosophy or religion, it’s just sort of like it defines quite any, quite any paradigm perfectly. And so I love how it continually knocks me off my feet. Of like, I think I understand something, and I don’t, and I think I understand this, and I don’t

Dr. Sandy Newes 21:46

interesting. One of the things I find fascinating, kind of, along those lines, is with psychedelic work. You know, I do a lot of ketamine assisted psych therapy, specializing, really, in complex trauma. And is, it’s non linear, like the idea that there’s, like, a linear story that emerges, just goes out the window,

Dr. Manish Agrawal, MD 22:04

like, or that you’re or that there’s your depth isn’t so much that you can plummet and get to know it fully, like, somehow you’re gonna get into the human mind and solve it like a puzzle, and it’ll be just this black and white linear thing. And so, so, yeah, saying another way. It’s, like, non linear, because it’s not right.

Dr. Sandy Newes 22:23

I try to scare people away, both clients and trainees, from like, we’re not searching for the aha moment. Like, that’s not what this is. You’re not gonna, like, suddenly be like, Oh, I get it. Like, it’s all about this thing, and now I’m better. Like,

Dr. Manish Agrawal, MD 22:38

yeah, that I’m gonna fix myself and I’m gonna get some problem to solve. It’s a very hard thing to unwind, both in the patient and in the clinician, honestly. Mm, hmm,

Dr. Sandy Newes 22:49

yeah, well, and that’s a really interesting question. You said, you know, if people having to unlearn things, and, you know, I mean, I’m aware of, you know, kind of research methodology. And maybe this seems like a bit of a leap, but kind of weaving those things together like, you know, you have done a bunch of psychedelic research, and, you know, you all have very much influenced the field in terms of kind of moving that forward, for people who don’t know, I mean, the MDMA Research and psilocybin research is that accurate? Yeah. And so, you know, I’m really kind of curious, like, what, what do you see, as you know, really exciting about what you have all done with the research, but then, you know, what are the limitations? And, of course, there’s methodology, but then there’s also this piece about kind of that you’re talking about, like philosophy of mind, and are we really encapsulating the experience, and is it similar or different when people are in psychedelics? And that’s obviously a huge opening to really speaking at whatever place that you want about that. But those are some really interesting weaving together.

Dr. Manish Agrawal, MD 23:52

You know, not being a psychiatrist at first of that was a disadvantage, but now people have pointed out, and I really feel like it is an advantage, because I wasn’t stuck with necessarily these paradigms of of what was going on, and so I was able to, like, see the limitations of the tools and the message we have. And that’s not to say you throw them out, but you know, at a very basic level, you’re describing something inside of you that you put words on, like I’m experiencing grief or sadness or anger, but that’s just sort of sort of capturing it. And then you read something, and you call it depression, we call it trauma, and then I’m interpreting that and putting my label on it. But really, there’s a lot more unknown than us easily that is recognized. And so people quickly go to a diagnosis, oh, I have depression. I have people that come in to do I have depression, I have trauma. I said, I don’t know. He said, I have the doctors tell me both things and and they feel like they’re the problem. And I say, actually, it’s not you. All you know is you don’t feel. Right, yeah. And then you are describing it, and then you’ve read somewhere or somebody’s label that, and then you start telling yourself that thing, but it’s actually, can we have beginner’s mind and really get down to, like, not put a label on it, but figure out what it is that you’re feeling and what’s happening, and then build on that. And so, so I’ve really been able to see some of the limits of we do standardized testing, like the Mini or the skit to make a diagnosis, and then we use validated scales like mad Ross or PCL, which are fine, but they’re tools. They don’t and so I see very often in the field, certainly with sponsors, but even CRA s or somehow, like it’s black and white, that if you fill out this thing, then you either got 20 or above, you got depression. If you don’t, then you don’t, or you don’t, have trauma in this. It’s but the human mind is way more complicated than that, and so I think I’m really seeing the limits of what we have, and like this is pushing us beyond sort of what what we think and, and there’s real repercussions. You know, I just was talking to somebody yesterday, and he’s like, he’s been diagnosed with PTSD, and then he got treatment. He got some better and then somebody told him he had OCD, and then he went back to a different hospital, somebody told me had bipolar. And and says, confusing for people. So if that answers sort of what we’re going down to, but I

Dr. Sandy Newes 26:32

what you saying is, you know that we’re trying tell me if I’ve got this, if you know that you’re kind of, we’re trying to sort of, what is the right word, you know, break down into measurable components, you know, some elements of the human experience that might not fit into standardized testing, and then, depending on what the lens of whatever professional is doing the evaluation and whatever knowledge base they’re coming from. And now I’m branching into my own experience. I used to do assessment for like, years, and so I’ve lived this on multiple levels, you know, and then somebody tells you one thing, and then that that also as a patient or a client, that also then informs your experience, okay, also going to inform the way in which you’re going to present yourself to the next professional. And then we go into this rabbit hole of trying to take, you know, really, you know, experiential phenomena, like lived experience and encapsulated right, which has really, like, been, been, you know, really the the core dilemma of psychotherapy, outcome research all along, like, how do we measure it? What are we measuring? How do we affect change? What are we looking at?

Dr. Manish Agrawal, MD 27:36

Yeah, and it’s, and it actually is an interesting thing of shorting your cat, you know, like the observation is affected by the observer. You can’t have an, you know, in physics and so, and that’s okay. I think where we do arrive potentially is, if you like, don’t realize that’s going on. You know, it’s like I describe it as a flat, flat Earth problem. So, like, if you know, like, you have this paradigm that the earth is flat, but you’re not. But there’s people that are saying, Is it round and flat? And there’s a whole debate about it, but you got to work pragmatic, like, it’s flat, it’s fine, but if you forget that, that’s what you’re working out of, and you don’t realize there’s a question, then it can lead out to some rabbit

Dr. Sandy Newes 28:20

holes, right? I mean, it’s super interesting, right? Because, like, CBT used to be the gold standard in, you know, psychotherapy and very easily measured, easily encapsulated, we can, like, eat more easily, measure change, and now that’s kind of out of vogue. And yet, there’s a reason why it existed, and it’s not like those methodologies just went away.

Dr. Manish Agrawal, MD 28:43

But because, because I’m not in that field like I am in it, but I’m not, yeah, I always think, like these three letter acronyms, they’re gonna

Dr. Sandy Newes 28:51

this is the new big thing,

Dr. Manish Agrawal, MD 28:54

three letter thing, and this is it. And it’s just like, and, no, I see therapists struggle with that because they get it attached to that, and then when the person doesn’t fit exactly into that, they can’t quite ram them in, and they get frustrated with it, and then it’s like, the patient becomes the problem, or the it’s like, but, you know, the human psyche can’t fit into a three letter acronym.

Dr. Sandy Newes 29:17

That’s so funny. I just told Signi today in our morning we were that. I was like, maybe we need to come up with an acronym. We both just laughed.

Dr. Manish Agrawal, MD 29:26

I would love for there to be an acronym, right,

Dr. Sandy Newes 29:28

right, right. Maybe we can, you know, come up with one well. So, you know, this is kind of talking about, you know, just bringing some of the challenges in the research, and then that kind of, you know, brings the question of, you know, bringing psychedelic assisted psychotherapy into the mainstream like we’re obviously not there. We are there with Ken mean, and I’m happy to talk about that, because that really is psychedelic assisted psychotherapy, and people often don’t think of it as such. But, you know, we’ve got. Got these sort of boxes at the human psyche. We’ve got the research, and it’s has its limitations, and it can only carry us so far. Then we’ve got the human pieces about, how do we create safety and who can do that? You know, those are some things. And so as you’ve been instrumental in moving, you know, this ball down this field, kind of ideally headed towards, you know, some kind of way in which it opens up and expands access more. What do you see, kind of the challenges that we’re all facing here, and how can providers interested in the field kind of take some of that to heart? 

Dr. Manish Agrawal, MD 30:37

I think ketamine is a good example, in terms of, you see it playing out in ketamine, right? So you practice ketamine a certain way, but most of the people that come to our clinic that have been through ketamine, they went to an office, somebody gave them ketamine, and they checked on them, like somewhere in between, or they didn’t, and then they finished and went home. And that’s, that’s what most people think ketamine therapy is. And so it’s not like the medical or the field has decided this is how you do ketamine therapy. Like, there’s people that don’t believe that you need to therapy, or don’t do therapy, and then obviously you’re in the camp that think that’s almost criminal, that you wouldn’t do it any other way.

Dr. Sandy Newes 31:16

Of course you would do therapy. And here’s a good idea, you actually sit with them. Like, what sit with them? That’s crazy.

Dr. Manish Agrawal, MD 31:22

I think that’s some of the challenges in the field that we’re seeing playing out and and so medicine, there’s no paradigm for therapy plus medicine, and the FDA itself said that we don’t regulate therapy, and yet, no one feels comfortable to give somebody high dos psilocybin in a room by themselves, right? And so the person is in that room, and then you hear, I’m called all different things, therapist, a mentor to support. You call the thing being done all different things, like therapy or support, or psychological mentoring or guiding. And so I think really coming to grapple with that this is some new thing that doesn’t quite fit into the old box, and even therapists struggle with it a little bit because they think it’s just therapy. But there is a real medical component to this. I mean, sure, there is a strong physiologic thing that happens, like people’s blood pressures go up, they can and most therapies can’t quite lead you into this deep space, and there’s a real, physical thing that happens, you know? And so, so I think that’s where I say people want easy answers, like it fits into this medical bucket or just this therapy bucket, but it’s like, what if it’s a new bucket that we haven’t yet fully does, don’t know yet, and we need to do more studies, or to look at it and have a more of a humble approach to it, to say we got to figure this out. This is really interesting. It’s really exciting. It’s potentially can help people deeply, but we don’t know everything, and so let’s ask more, rather than come to this is the way to do it. And so I think that’s one of the challenges when something new is coming out, is people want a solution that you’re going to roll out right here, that it’s not quite worked out yet.

Dr. Sandy Newes 33:11

So how do we do it? Like, how do we, those of us who are interested in the field and people who want to get in the field and participate in that, like, how do we create a new bucket. Like, you know, I mean, you’re living this first hand, right? Like, you know, meeting with FDA people and living policy and doing research, and you know, that piece is of critical importance. And how do the others of us in the field, like support that? And, you know, kind of, like, I love that, right? It’s the integration, and that’s one of the things you know, for people who you know, maybe don’t know, but that we hit with MDMA, that the FDA was applying drug research methodology and overlooking some core tenants of psychotherapy outcome research methodology. And there is no third bucket where those two things coexist that is scientifically validated, right? So on previous methodologies,

Dr. Manish Agrawal, MD 34:02

that’s right. If the framework doesn’t work, rather than keep trying to cram in the same framework, maybe you need a new framework. It was the answer question. I don’t know if I have the answer to that, but what we’ve done, where we’ve learned, is to treat a lot of people and really pay attention and learn and talk about what we happens, and then we write studies to answer that. So, you know, we’ve done a group study and learned a lot about group versus individual. We’ve done couples work, and that’s very different than individual. We’ve treated with, you know, a lot of different medicines, from psilocybin to MDMA to LSD to five Meo to meth alone. And just new drug re, 104, and different disease states like depression and trauma and and having that allows us to sort of see like, what’s underneath going on there. And so it’s created a space for us to learn and to be able to write and publish and talk about so that’s how. We’ve done it. But I guess I would say, like I think that we need this, this field more than any is going to need more disciplines, not less. And that, as a physician, I can say, if it’s good, Relevate it to the medical world, it will not solve it. We need therapists. We need social workers. We need people in other specialties. And acupuncturist was to work with who’s brilliant has brought in a lot of insight. And so because other paradigms may have views in that are going to be inherently helpful, so we have to figure out how to get those voices heard, and and, and, and have that insight as we as things emerge that’s

Dr. Sandy Newes 35:48

interesting. Like, even we were having a discussion in our training the other night about the role of, like, blood pressure monitoring. If you’re not a medical professional and you’re doing, you know, lozenge work in your office, like, can you or can’t you, you know, take somebody’s blood pressure. Can you or can’t you take a pulse ox? Whereas, if I’ve got a pulse ox on somebody, and, you know, their pulse rate goes up dramatically, and it stays up, that’s telling me something about their psychological distress, as well as something that may be an adverse outcome on a physiological level. So, you know, that’s a very simple example of how that plays itself out. And if we try to put it in the two separate silos, then that’s a big problem.

Dr. Manish Agrawal, MD 36:25

Yeah, and things have happened both ways, like people have gotten, we have not had that fortunately, but people have gotten chest pain, and people like, oh, that’s psychological. And it was actually a heart attack, and that happened during an MDMA session. And conversely, people are having truly heart pain and not cardiac pain, and then they have EKGs done that’s sort of disruptive to their thing. So, like, it does take a real nuance to sort out, well, what is happening with this person, right?

Dr. Sandy Newes 36:54

And it’s interesting, because, you know those adverse outcomes pieces, like, I’m not saying that I have an answer to this, but you know that balance of like, you know, okay, so we have some lived experience of not only statistically, but actually seeing this, where somebody’s having a heart attack, and you know, we can witness some adverse outcomes, and we’ve seen how they’ve been handled well and not handled well. And then we also have data to suggest that there are positive benefits for a clinically significant number of people, and in fact, they may be quite positive outcomes. Like, how to what are your thoughts on balancing that? Like, how do we balance the possibility of adverse outcomes with the fact that we also are treating, you know, adverse outcomes, or, you know, suffering in that I don’t,

Dr. Manish Agrawal, MD 37:41

I don’t struggle with that much, because in medicine, there’s nothing without risk. And so as an oncologist, I gave lots of drugs to lots of people with very serious side effects, but it helped them treat their cancer. And so, I mean, that’s just part of practicing medicine. It’s, there’s no there’s not a single intervention in medicine, not a single pill, anything that you give or take that doesn’t have a risk to it. And so you just have to weigh the risks versus the benefit. And so, in fact, I found that interesting somewhat. I’ve written editorial around this that I’ve not yet published, but that, you know, in oncology, a lot of times, drugs have gotten approved, or we think like we use drugs that are quite toxic with one to 5% benefit, and we think that makes sense, and patients want it, and doctors want it, and the society is okay with it. And then people with trauma, which I find to be as debilitating as cancer, people lose meaning they lose connection to the relationships. They’re not able to work. There’s a lot of similarities, and yet the tolerance for some of the risk is much lower. And I think it’s not as well understood how debilitating trauma and mental health can be always and so I think that there is real risk, and we need to continue to study it and really do a better job of screening who people are that’s not appropriate for because it’s not right for everyone. It’s not a magic bullet. But at the same time, we don’t need to be scared of risk. We don’t need to we just need to say it’s this, it’s 5% it’s 3% whatever it is. And that’s, you know, get anesthesia, when you get a colonoscopy, when you get surgery, when you get when you take an antibiotic, you know, you can cause Achilles tendinitis. I mean, it’s like, yeah, totally, yeah.

Dr. Sandy Newes 39:35

So we’re almost out of time. So just, you know, and, you know, a minute and 30 seconds I’m kidding, but or less, you know, I could ask you about training, or I could ask you any things, but really, you know, if you were a practitioner, assuming that you are, you know, already have, you know, experience as a therapist or a medical person, you know, what is your recommendation to people who are interested in getting involved in this field? What is. Do they need to look for, what should they be doing? How

Dr. Manish Agrawal, MD 40:02

do they get involved? Getting involved as a therapist, you mean doing their medical, more medical

Dr. Sandy Newes 40:07

person, like assuming that base level, that we’re already operating from that perspective, and somebody’s interested in making the jump into psychedelics. You know, are their thoughts on, like, training, or where the field is going, and ways for them to kind of jump in?

Dr. Manish Agrawal, MD 40:22

Yeah. I mean, the field is certainly growing and evolving, and I think that training is going to be a big part of it. And there’s been an emphasis on didactic, and there’s been a lot of courses, you know, our approach is very much supervision and hands on. I think that you have to get your hands dirty, be humble and learn, because it is a new thing, and that’s what I would recommend, if you’re a therapist, go to a place where there’s experience and learn with someone that’s done it, because there’s a lot of nuances that you are not going to learn in the classroom or in a book, and you really need a community of people that are learning. So our therapist, you know, we meet weekly, but we also go over other things. There’s other monthly supervision, and that’s where you’re going to improve a lot. And so, yeah, so I think training is going to be important and and I guess just to see easy to say, but it’s hard for all of us, is to, like you learn a certain approach, and it’s really valuable, but also be open to the limits of that approach when you’re coming to this, and not try to make this fit into that approach. But don’t throw it out. It’s helpful. You gotta. You gotta stand somewhere. It’s just a stance. I love that,

Dr. Sandy Newes 41:41

like, take a kind of scientific evaluative approach, be open to the fact that what you’re doing isn’t working, but also be open to the fact that what you’re doing is working. And I

Dr. Manish Agrawal, MD 41:52

would say this, this is challenging because it can’t but stir your own biases and your own and so in order to really do this work and be in the trenches with people, it will require a lot of you, and you’ll have to continue to be self aware. Otherwise, I think it can be detrimental for people, for sure.

Dr. Sandy Newes 42:14

Well, I really appreciate your time. Anything else you’d like to add?

Dr. Manish Agrawal, MD 42:18

No enjoyed the conversations. Thanks for your questions.

Dr. Sandy Newes 42:22

I very much enjoyed the conversation as well, and I really appreciate it. And our listeners, this will come out in several weeks. Please watch for it and check out our other episodes as well. And thank you again. Thank you so so much. I’m really honored for having the opportunity to talk with you in this way. Thank you.

Dr. Manish Agrawal, MD 42:40

Thanks. All right.

Outro 42:43

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