Manish Agrawal MD and Paul Thambi MD are oncologists who have spent decades caring for patients with cancer. They realized early in their careers that chemotherapy could treat the cancer—but what about the emotional, psychological and spiritual impact of facing mortality?
When they learned about the potential for medications like MDMA and psilocybin to help people gain access to parts of their minds they didn’t know existed—and to address the human experience of suffering—they quit their day jobs as practicing cancer doctors to found Sunstone Therapies, the sole psychedelic-assisted therapy research and treatment center in the Washington, D.C. area.
The data are increasingly clear: these non-addictive substances hold the power to expand consciousness and improve quality of life.
When guided by a trained therapist in the appropriate setting, even one experience with a psychedelic medication can help people unlock closed doors in their minds and to feel safe enough to explore its contents. They can be the catalyst for patients’ ability re-route well-worn pathways of negative and maladaptive thoughts, feelings and behaviors.
It turns out that science and spirituality aren’t mutually exclusive.
On this episode of Beyond the Prescription, Drs. McBride, Agrawal and Thambi discuss the inseparability of physical and mental health; the promise of psychedelic therapy to treat the psychological impact of cancer and other diseases such as PTSD, anxiety, and depression; and their shared excitement about the potential for these drugs to fundamentally expand the standard of care in medicine.
Manish Agrawal, MD
Manish brings an extensive background and experience that spans medicine, engineering, philosophy, and ethics to his role as CEO of Sunstone Therapies. Driven by a deep interest in healing, Manish is particularly passionate about whole person healing and the transformative potential of psychedelic therapies. Manish previously held the position of Co-Director of Clinical Research at Maryland Oncology Hematology, where he dedicated 15 years to the care of cancer patients. He completed a fellowship at the National Cancer Institute, National Institutes of Health, and his residency at Georgetown University Medical Center.
Paul Thambi, MD
Paul brings deep experience in oncology care and clinical trial design to his role as Chief Medical Officer at Sunstone. He is a proponent of strong organizational culture and strives to create a compassionate, open and accepting workplace to advance whole person healing in medicine. As a medical oncologist, Paul developed important and meaningful relationships with patients, witnessessing their emotional and physical distress upon diagnosis and throughout treatment, leading him to explore psychedelic therapies to improve the emotional and mental health of patients fighting cancer. Paul completed his oncology fellowship at the National Cancer Institute and, prior to pursuing medicine, he began his professional career in engineering and consulting.
Join Dr. McBride every Monday for a new episode of Beyond the Prescription.
Please be sure to like, rate, and review the show!
The transcript of the show is here!
[00:00:00] Dr. Lucy McBride: Hello, and welcome to my office. I'm Dr. Lucy McBride, and this is Beyond the Prescription, the show where I talk with my guests like I do my patients, pulling the curtain back on what it means to be healthy, health as more than the absence of disease. As a primary care doctor, I've realized that patients are more than their cholesterol and their weight. We are the integrated sum of complex parts. Our stories live in our bodies. I'm here to help people tell their story, and for you to imagine and potentially get healthier from the inside out. You can subscribe to my free weekly newsletter at lucymcbride.substack.com and to the show on Apple Podcasts, Spotify, or wherever you get your podcasts. So let's get into it and go Beyond The Brescription.
[00:01:03] Buckle your seatbelt. Today we are going to talk about one of my favorite subjects, the re emerging field of psychedelic medicine. I truly believe it is going to change the landscape of modern mental health care in this country. I cannot wait to introduce you to my guests today, Dr. Manish Agarwal and Dr. Paul Thambi. They are oncologists who have spent decades caring for patients with cancer. They realized early in their careers that chemotherapy could treat the cancer, but what about the whole person? What about the emotional, psychological, and spiritual impact of facing a hard diagnosis and mortality? When they learned about the potential for psychedelic medicines like MDMA and psilocybin to address patients’ whole health, to offer some acceptance and insight and access to the patient's interiority in ways that they had never seen before, Paul and Manish left their day jobs as practicing cancer doctors to found Sunstone Therapies.
[00:02:13] This is where I am now sending some of my patients, not just to face cancer diagnoses, but also for anxiety, depression, and PTSD. Sunstone Therapies is the sole psychedelic assisted therapy research and treatment center in the Washington, D. C. area. The goal of Sunstone is to better treat the emotional and psychological impact of cancer and other disorders. Paul and Manish are contributing to the fundamental expansion of the standard of care in medicine and it is a wonderful thing to be part of and to watch. Paul and Manish, thank you so much for joining me today on the podcast.
[00:02:53] Dr. Paul Thambi: It's a pleasure to be here. Thanks for having us.
[00:02:55] Dr. Manish Agarwal: Yeah, it's great having you. Thank you.
[00:02:57] LM: The two of you together have backgrounds in medicine, engineering, philosophy, data science, and research, yet you landed in the field of psychedelics for a reason. Tell me why that is. What is so exciting about this field to you?
[00:03:15] MA: Paul and I both have been practicing oncologists for almost 20 years, and over time we got really good at taking care of cancer patients, their physical symptoms, but their quality of life was not always directly proportional to how they physically felt. And over time it really starts eating away at you, that you're not able to take care of the emotional health of cancer patients.
[00:03:35] When we saw this emerging field and started looking at the data, We visited and learned about it and then got training and explored to see is this real. And that's what sort of led us down this path is, for me personally I've always been into philosophy, that's why I have my masters in philosophy.
[00:03:54] I've been interested in the human side of medicine not just the science side. Both have fascinated me and this really brought both of them together. The reason that Paul and I both went into medicine is to treat people and to make them feel better. And really, for the cancer patient, for any patient, you have to take care of everything, not just the physical symptoms.
[00:04:14] PT: Everything that Manish said is echoed in my life and how I was drawn to this. And I think there were a few patients that really suffered emotionally that really hit home for me. And I carried that pain from what they went through with me. And when Manish showed me the data on psychedelic assistive therapy, it wasn't really the data, it was really more these YouTube videos where we saw how there were a couple of patients on the NYU trial and the Hopkins trial, and how they were before they went on that treatment and after. And there was a palpable change that you could feel through the video even, and it was just something that I wanted to be able to see if we can bring to our patients.
[00:05:00] LM: Can you give me an example of a patient who has been served by this treatment, maybe a cancer patient? I'd love to hear an anecdote.
[00:05:08] MA: There's a young patient with kids and a serious cancer, and had struggled with depression, didn't know anything about psychedelics, but really applied. And to see the change in his life, he's changed the relationship with his mother, who had a hard time with her son having cancer. And he was able to have a conversation with her afterwards, saying, I want my mom back.
[00:05:29] And then he was bleeding, when he went home for something else, he got a cut. And his young boy sat up and said, “Dad, are you dying?” And he was able to sit and have a conversation with him. He said, I would never be able to do those things before. And he was able to really sense into that. And then the other group that's really, I've sort of been really blown away by is the military that we've been treating recently.
[00:05:51] They have such complex things that they've seen, such complex trauma. And they've tried everything. I mean everything. For a military person to come and seek this care is not easy because the entire institution, it can affect their career if they talk about mental health. So they're desperate and to see the lives that are turned around, I literally wouldn't believe it if I didn't see it.
[00:06:15] And it's been powerful to see them going from, thinking about suicide regularly, to really no meaning, to a sense of despair, to not where everything is great and perfect, but they're having a fundamental change, and they want to live, and they want to reconnect, and they're building their lives back together.
[00:06:33] LM: I mean, that says everything that you need to know about why this is important. Acceptance, hope, peace, which isn't possible every day of the week, nor is it mutually exclusive with ongoing pain, as humans experience a myriad emotions on a day to day basis. But to think that there's something out there that could give people more agency and acceptance is pretty extraordinary given that we've had pretty poor tools to help people with emotional health and mental health. And so I guess my question to you is then, how do you see the psychedelics changing the way we think about mental health?
[00:07:19] PT: One of the things that can help to do is just to shine a light on this is a part of our health that we need to focus on. There is now these tools that are being talked about that can be helpful, perhaps more helpful than the existing tools and that allows people to start talking about their emotional health more to their doctors, to their family.
[00:07:44] And in terms of how these medicines can help, I think it's not just the medicine. I just want to talk a little bit more about that because the medicine does some things and would act on some of the same receptors that SSRIs act, but there's more to it than the medicine. You talked about it being an experience and it is that, and it's not always that it finds stories that are hidden, sometimes those stories are there and people feel them all the time, but they turn away from them. And what you need to do, what we're starting to learn with this is that you need to create an environment, a container as it's called in this space, that feels safe, that allows people to trust and be vulnerable in that space.
[00:08:32] So that when they experience those fears, and some of those stories may be hidden, some of them may be ones that they've lived with their whole lives, but now they can look at those. They can be with that story that they've felt, and face it. Because they feel a sense of trust, and they're with therapists or people who care about them.
[00:08:53] Who created a relationship with them that allow them to go deep into that story and find the pieces of that story that serve them and the, and the pieces of the story that don't and talk about that, integrate that into their lives, integrate that into their conversations with their families. It's that that does the healing more so than the medicine or as much as the medicine.
[00:09:17] LM: It's such an important point because I see patients Who I will kind of raise this idea to—people who have complex PTSD or who are facing terminal diagnosis. And sometimes they'll say to me, well, I tried mushrooms in college and [it] didn't do much then. And I just had a bad experience. I remind them that that set and setting matters so much.
[00:09:40] And I think it's such a good point that it's not just the medicine.It's the ability to feel vulnerable and safe, which is sort of this mystical aspect of the medications and then to face some things that you already did know you had and that weren't hidden. I think that's a great point.
[00:09:57] MA: Yeah, I mean, I think it's actually pretty nuanced in all of that, because one thing I tell people is, I think psychedelics allow you to access psychic material like no other thing that I know of. But they're not a magic bullet. And if MDMA cured PTSD, I tell people that anyone that goes to a rave wouldn't have PTSD anymore.
[00:10:22] But lots of people go to raves and still have PTSD. And so it must be more than the medicine. So it's not to take away from it, because I think you have access, but it is again, the context or, or how it's received. And so, it's like any medicine, the wrong dosage in the wrong context can be harmful or beneficial.
[00:10:37] And what you talked about, I think, is really nuanced, and I think it's important. We actually call it sometimes therapy assisted by psychedelics. Because a relationship allows you to really trust, and to trust yourself, and to go deep. And if you have that sense of trust, you're able to access material that you may not otherwise be able to.
[00:10:56] And a lot of times, sometimes injury or things occurred in a relationship and to have another wiring of your brain in a healthy relationship, to be witnessed when you were in pain or just to be held or to be supported is a different experience now than it might have been the time that it happened. And you're able to almost nurture that younger part of yourself.
[00:11:18] And so that's, it's really, it is quite cutting edge and that's one of the things that fascinated us because it's not… people want medicine therapy. It's like, it's really this combination of the two and, and so you can emphasize one, emphasize the other, but without the two and done in concert and the right setting, it just is not as effective.
[00:11:37] And so, you know, for us the therapists and the medicine are super important, but so is everything else. So the way the room is set up, the furniture, the music. The person that answers the phone, the way you're received, the way the follow up is. Because if you think about it, we all are sort of on alert, and you get a sense in your gut, can I trust this place? Can I trust this institution? Can I trust this store? We have relationships with people and institutions, and you start… some part of your psyche that's assessing for danger knows, how deep can I go? And so, you really have to build a place that tries to reassure even the unconscious part that it's okay to go deep here.
[00:12:18] LM: I think it's such a good point. And because I was going to ask you how much… let's take psilocybin, for example, which is the active ingredient in mushrooms, how much of that feeling of safety and trust is the chemical itself, and how much is the therapist, the experience of, you know, calling the front desk, scheduling, seeing the lighting, seeing the room, because I have patients who are in therapy for 30 years, even, who trust their therapist, who feel safe, they have a comfortable experience, but they aren't actually making the kind of progress that you sometimes see in patients who have three experiences with psychedelics in the right setting.
[00:13:08] MA: I don't think it's medicine that causes the trust. I think it's the environment. I think the medicine brings to the surface the issues that are there, and without the trust, you are not able to process them. And so, yeah, if they have a trusting relationship with their therapist, that's probably a really important piece, but then it's also deeper than that.
[00:13:29] Can the therapist handle whatever material comes up? Are they able to be with that? Do they know how to navigate that? And so, if there's distress or anxiety or fear, what they don't necessarily need is reassurance or minimizing of it, and it's how to navigate those waters that's a different skill set than traditional therapy. I don't think the medicine in itself causes trust, it just amplifies what's there, but in a therapeutic relationship trust can be built, and trust is an intrinsic part of each one of us, but it's to rediscover that.
[00:13:58] LM: Such a great point.
[00:14:00] PT: I echo all of that. I think also, what the medicine does is when you feel that trust, the medicine is a catalyst for you to go into those crevices that you talked about within the story. It may be a story that you know about, but now there's going to be chapters of that story that were hidden to you. And if you feel the trust, it allows you to do that in a way that I think is hard to do on your own. So there is that catalyst that you get from the medicine around that.
[00:14:30] LM: It's so gratifying to hear you talk about these sort of mystical and, and visible elements of the human experience because, again, I think that's what's missing in modern medicine, at least in the United States. We don't think about the 364 days a year you're not sitting with your doctor as health.
[00:14:52] We don't think about the way we feel in our bodies, the way we think, our self perception, the way we approach stress or vulnerabilities as health. When actually there are direct physical impacts of chronic stress on our bodies. There's direct physical impact of what you described as a vigilance.
[00:15:16] In fact, so many patients I see have been diagnosed with anxiety. And we'll use the word anxiety kind of casually, because it's so commonly used, people know the word, but, but actually when you dig deeper with a lot of these patients who have “anxiety” it's not necessarily that they worry excessively, or that they feel even anxious, they don't even often identify with that word, but that's the code in their charts: F41.9, but a more nuanced description of the way they feel, I think, is this vigilance, this sort of emotional, behavioral, and then sometimes medical reaction to feeling threatened that stems from an experience or set of experiences in their childhood. And we talk about adverse childhood experiences having physical and emotional mental health manifestations later in life.
[00:16:06] But I see patients all the time who have been diagnosed with anxiety, but whose symptoms stem directly from some adverse childhood set of experiences or experience. And then they have hypertension, binge eating, cardiovascular disorder, cardiovascular disease, racing thoughts, sort of like a twitchiness physically and emotionally when they are faced with stress. And I think that those are the people, as far as I understand it, who have had PTSD who are being studied first and foremost with psychedelics. Is that right?
[00:16:41] PT: Yeah, that's right. Right now, that's the indication that has shown the most benefit with MDMA.
[00:16:45] MA: Yeah, and to piggyback on, I mean, you've made a couple of points, I guess, and we should probably just touch on them. I think just working backwards… the last point, I think that if people do have these feelings of anxiety or depression, and I think when, um, a disservice we've done is pathologize them, that somehow that's the problem.
[00:17:05] And it actually is a sign of health because they're having a normal reaction to abnormal situations. And so, what trauma can sometimes be is that when you're very young you have a situation that was very difficult. But you responded normally, you would feel anxious or you'd feel depressed or sad. But then you didn't have support in that situation and so it got stuck.
[00:17:27] And then, now you react when things arise, your body, your psyche has a visceral memory of that, of that lack of safety or that issue that occurred. And so, it's not that the person is a problem, it's not a pathology. They had a normal response to an abnormal situation, whether it was an abusive family member or neglect or abandonment, whatever it was.
[00:17:50] It's just that, that situation isn't occurring now. And they need support to be able to work out of that. And what they do, what I've seen sometimes, is that actually becomes their superpower. So they get really sensitive. If you had power issues and somebody that powered over you wasn't, you get really sensitive to that.
[00:18:07] And you know in your body when something might be happening even before your mind does. And so, it's turning that story to say it's not a problem as much as how you can move on with it. And then the only other comment I was going to make is on the first part you were saying around, medicine, not looking at these other aspects of our emotional health and I think it's a historical time, really. I think for much of history, the shamans were the physicians and there was a connection between the mind, body, and spirit. And then to great progress, we developed a great scientific understanding of the body and develop antibiotics and other things that help us live a lot longer.
[00:18:47] And that's helped us, but then because your blood pressure is good and because your coronaries are clean and you don't have cancer, it doesn't mean you're happy. Now I think things are turning again, that the human is not just a biological entity, but it's also a spiritual, emotional, psychological… whatever you want to call it.
[00:19:06] And until you have all of that together. You're just not going to feel fully human. And so before there was this science versus religion or science versus woo woo or whatever it is. But I think more and more you'll see really respected neurobiology labs that are starting to, to talk about that. And you're doing MRIs of monks of brains and you're seeing that meditation causes certain changes.
[00:19:27] And then when we do MRIs of patients on psychedelics, going back to your point on vigilance, there is something called the default mode network. And that part of the brain is always looking for problems. It's the default mode. It's being vigilant. And that's the part that quiets down, other parts of the brain wake up, and they're able to start connecting.
[00:19:49] And so science now is backing up what's happening. And so there's not so much this tension there, and people are wanting to both be physically and emotionally whole.
[00:19:58] LM: It makes so much sense. I've heard Roland Griffiths talk about the experience that long term meditators can have as being the closest to the experience or benefits of psychedelic. Is that something you agree with?
[00:20:18] PT: Yeah, I think that, that makes sense. I mean, I think deep meditation allows you to see or feel things that you're feeling with a little bit of removal from that. And that allows you to have a different perspective. So, there is a correlation that can be made.
[00:20:36] LM: So, when people look at the New York Times and they see an article about psychedelic medicine, I think they automatically, in many cases, go to two thoughts. One, aren't these recreational drugs that are just for people in rock concerts in the 1960s? And two, that doesn't apply to me. This is for people who are really far gone. And so I'd love for you to speak to the sort of stigma around psychedelic medicine, where that comes from.
[00:21:08] PT: Yeah, and Michael Pollan talks a lot about this in, in his book How to Change Your Mind and how there was social and maybe political pressure around creating stigma. So I think that's some of what happened and then also you get into the 1980s where, you know, this is your brain on drugs, those commercials that would come out that really heightened my sensitivity as a child growing up in the 80s around that.
[00:21:34] And I think those are things that are hard to release. And now that we're starting to understand, and this is coming up again, psychedelics, realizing that these have been around for millennia. And they've been used by cultures as rites of passage for ways to solve the problems of a community. And I think now that those stories are coming back up and also the scientific data which provides people with a level of comfort, especially those people that have this fear of addiction and drugs and all of those things that I had when I was a kid, knowing that this is coming up in the medical institution. Along with the stories from the past are allowing for people to see this in a different way and to accept it more… I think one of the reasons that people feel safe doing this is that, especially like in the environments that we have at Sunstone, where it is in a sort of a medical environment, where our office, where we treat people, is on the campus of a hospital, and they can see the hospital out the window.
[00:22:36] And we're clinicians that have treated patients before as doctors, and it's in a research setting. That allows them to overcome that stigma, to feel safe as they embark on this thing they were told never to do in the past.
[00:22:51] LM: And so what do you make of this kind of... Emerging industry where people are taking the medicines off label with various healers and going on retreats in Costa Rica, because I worry, I don't know if you worry that if the set and setting are not appropriate, if the person who is supposed to be the guide isn't trained or perhaps worse, if the recipient of the therapeutic isn't aware of the potential risks and isn't guided in an appropriate way, then, then we might end up losing all the ground and getting these medications approved through the appropriate medical channels. Do you have that concern?
[00:23:32] MA: For sure, to some degree I do. I mean, I think there are probably great practitioners around some of those settings, but there's just no way to filter through that. And what I worry about, and I get more worried about, is the longer we're doing this, because we're treating complex PTSD patients, they're complicated. And things that come up, if you're not trained and equipped to do that well, it actually... it causes more harm. In fact, I was speaking with a senior psychedelic therapist who's worked for MAPS in Colorado, and she does only things legally, but she does a lot of integration work, and it's integration work for people that did psychedelics underground.
[00:24:17] And the biggest thing that she sees... As people got re-traumatized because they would have an experience and it was severe and the therapist wasn't able to be there. So then again, it felt like what I'm feeling is not okay, which is a feeling that they had the first time. And so she's having to rework through that.
[00:24:35] So in that way there's legitimate concern. And the other thing that I worry about is, we've seen this, that you talk to people, they seem fine, or you have one assessment of their mental condition, but it gets more complex and even they're not aware of it fully. And so you have to be really prepared for that.
[00:24:56] And the other point I was going to make is what you said, what you asked initially about the underground. But then you also said, people said, I'm not as sick, or how about that stigma? So I think there's a real stigma around mental health. There's a stigma around psychedelics and there's a stigma around mental health.
[00:25:13] And so this is both. What it still surprises me time and time again is that people just under report their symptoms, but they still seek it out. So there's sort of this dance. They're like kind of… I'm really kind of okay because it's how they dealt with it. It's like we don't have an environment where you're able to be sad or anxious and there's not something wrong with you and so people play it down and… this is totally anecdotal, but I swear it's worse with men. We'll see, they'll come in, and they're like, I'm fine, I'm fine, and then you, well I drink a lot, and then, yeah, I guess I have feelings of sadness, and then you do the scale, and it's like, wow.
[00:25:53] I think it's even harder for men to admit their emotional struggles and that's just a generality, but overall I think there's a collusion of denial around our emotional state and somehow you just have to be, present a certain way, and there's something wrong with you if you're struggling.
[00:26:07] LM: I mean, I have a couple of thoughts about that. One is thank you for saying out loud that men are more walled off than women to a woman. No, I'm kidding. I think you're generalizing, but yes, let's just acknowledge that we are very self aware species, women, that is. Secondly, I think we all have a level of denial.
[00:26:22] I think denial serves us sometimes, right. Denial is a way of partitioning off pain so that we can cope and function. But then when denial takes on a life of its own and the stuff that is in the denial closet is sort of seeping through the edges and like running out of the bottom of the closet and informing our health, that's when denial is no longer serving us. It's when it's actually in the driver's seat. So it strikes me that the experience, in an appropriate setting with a psychedelic, could help people pull that wall down or open that closet and, and take a look inside and maybe rethink how they approach that thing they didn't think they could approach.
[00:27:08] And then secondly, yeah, mental health still has a bad rap when, as you both know, we all have mental health. It's not a feature you can kind of opt out of as like the human without the mental health. And as you said earlier as well, we tend to medicalize and pathologize mental health.
[00:27:30] So in a way that's good because we are acknowledging that these have medical consequences, that an anxiety disorder is a medical condition, as opposed to just a personality flaw, which was what some people think of it as. But we also tend to label and sort and diagnose conditions that are just normal.
[00:27:50] Like, of course, when someone has been raised by an alcoholic parent and they have been conditioned to sort of be a certain way, sort of invisible or good or not a problem, that is going to have an impact on their health such that when they get into a therapist's office or a doctor's office in their forties and their maybe that's not depression.
[00:28:13] Maybe you had a response to an experience and sure the symptoms are that of depression, but it's actually something more complex, more nuanced. And so I'm not really asking you a question. I'm just making an observation that we're up against a lot as we market these medicines and therapeutics to people because of the stigma around mental health because of the stigma around drugs But I think if it's done well—which is why Sunstone and other research institutions exist—if it's done well, and we can actually help people understand that their interior lives their past their stories have relevance to their health. And that yes, having clean coronary arteries and nice blood pressure is great, but it's not sufficient for health, then it really, I do think is going to change the way we think about health.
[00:29:04] It’s already changed it for me. It's just that it's not legal yet in DC. And I haven't tried psychedelic medicine. I want to, it has changed the way I think about emotional health. I mean, I've been thinking about mental health and health in this way, my whole career, but I don't think modern medicine has given doctors really permission to do that.
[00:29:20] And so I wonder what you think is in the pipeline. Are these things going to be FDA approved in the next five years, ten years? Are people going to be able to access these therapeutics? Are there going to be enough guides to appropriately shepherd people through the process? What are we looking at in the next year or five years.
[00:29:41] MA: I just want to comment a little bit on what you said around the denial piece. I think that denial actually is quite healthy. And on where your neurological system was, when you experienced something, it might've been, it probably was overwhelming and the proper and healthy response would have been denial and to put it into a box.
[00:30:00] It's just that now it's not necessary and it's not integrating back into your life. And so I'm very wary of pathologizing any of these things because they're usually healthy. It's just in the context now. And so I just make that one point and the other one around the mental health issue that, it's good that we're talking about it, but I think that we wouldn't want a life without emotions, right?
[00:30:23] If you push down your anxiety and your fear, you also push down your joy and happiness and love, the things that we humans live for. And so they sort of go both hand in hand and you can't have both of those.
[00:30:38] LM: Yeah, sort of like when we talk about alcohol when we're sort of self medicating, right? It blunts distress, but also blunts joy, libido, life. So you can't selectively numb. You also can't selectively be the human without an emotional life because that wouldn't be good. Then we'd all be like chat GPT or AI, right?
[00:31:00] PT: Yeah, yeah, and it just, I'm just going to piggyback on that denial part of things too, because I think one of the things that's important to remember is that people have built up these ways of denial, of sort of pushing things away. Psychedelics, like we mentioned before, can be a catalyst to break through that denial.
[00:31:17] That can be, you can lose your balance when that happens. So I just want to highlight again how important it is to have that integration and that container afterwards because you can't feel that way afterwards. You have to be with people that help you find that centeredness again.
[00:31:35] And in terms of access and what's happening, we talked about how MDMA has been studied in PTSD for some time now. And there are two phase three trials. They're showing significantly positive results. And that might be the first medication that gets approved as a psychedelic for PTSD outside of esketamine, which has been approved for depression. And that might happen in the next year or two and we will hope for that.
[00:32:01] And psilocybin is behind that in terms of how it's being used in various types of depression, and more and more information is coming out around that looks good, and perhaps if it continues to look good, that could be the next medication that gets approved. We'll see. So I think those are the things that are happening in terms of access and how we get this to people if they are approved, if they do show that they are effective, You're right, I don't think our healthcare system is built for this right now and there aren't enough therapists that are trained in this to treat everyone that has PTSD or even a half the people that have PTSD that might qualify for MDMA or for psilocybin in some sort of depression. And that's what we're thinking a lot about.
[00:32:48] We have investigated how to do this in a group setting, with group preparation, taking the medicine as a group, and having integration as a group. We find it is not only a way that introduces efficiencies, but we also see therapeutic healing with that approach, too. To be able to be connected with another group of people that have something similar to what you have or what you're going through, whether that be cancer or PTSD or depression, and to develop this bond during the sessions that you have with each other around preparation and integration, we think that's probably going to be therapeutic, too.
[00:33:29] That model also allows for more people to be trained on this. So, we're trying to think about how to do that from a group setting. We're trying to think about how digital tools can be used to improve or to give us efficiencies in this setting, but also remembering that there's compassion that's needed with this, so not to overuse digital processes. We're thinking about that as well. How do you do scheduling and other things? So, I think there's a number of problems to be solved around access, but they're solvable.
[00:34:00] LM: And so if you're listening to this and you're thinking to yourself, wow, I've been in therapy for 10 years. I'm on Prozac, but I still feel anxious. I'm sure there's some parts of me I haven't really discovered. This sounds really interesting. Or if you're just listening and want to try psychedelics, where would you go?
[00:34:18] Would you have to enroll in a clinical trial? Would you call Sunstone? Would you wait until MDMA is approved? What would you do if you were curious and wanted to participate in the research or the therapeutic elements here?
[00:34:31] MA: I think the first thing you would do is look for a clinical trial. And so, there are many, many places now that are doing research throughout the country and internationally. And certainly at Sunstone, we have five studies open now, and we will have another three more open this year. We have them in depression and anxiety and PTSD and cancer and family members of cancer patients and so there's other places that have that. So I think that's sort of the most rigorous way to get that. And I do think that some medicines, as Paul said, will be approved next year. I think that, I cannot underemphasize the importance of the context and the safety. What you don't want is to do something and get worse and so you want to make sure that you have safety if you're not good on that road.
[00:35:16] And I think we've talked a lot about the upsides of psychedelics and we're talking about that because so much of mental health right now, we don't have great treatments for, but we're still really in early days and we still have a lot to learn. Who's most going to benefit? Which people are completely contraindicated for?
[00:35:36] How do you get people ready? And so I understand the hype because people are desperate. And at the same time, I want to be cautious in that I think we're still learning about how to use these powerful medicines.
[00:35:50] LM: Yeah, I mean, I think one thing I am concerned about in particular, and I know this is out there in the public, is the potential risk for someone, particularly in their 20s who may be predisposed to schizophrenia. Is there a link between the use of psychedelic drugs and either the awakening or the schizophrenia or mental illness?
[00:36:09] Plus, as you've already talked about, this idea of not having the right set and setting not having the appropriately trained guide or the feeling on the patient side of of safety and trust such that people get worse. So what are the absolute contraindications right now in your mind?
[00:36:28] PT: Some of them are around people who have a tendency towards manic episodes. Like bipolar disorder with mania because that has been described where people had manic episodes after having a psychedelic experience, so I think that's one firm contraindication right now, at least in research trials.
[00:36:49] The others are—there are some cardiac effects that people worry about with some of the psychedelic medicines, so if there's a history of abnormal heart rhythms or a potential tendency to have an abnormal heart rhythm, that's another contraindication. Some of them like MDMA have sympathomimetic effects, which means they can cause the heart rate to go up and the blood pressure to go up. So if someone doesn't have controlled high blood pressure, or if they have underlying heart disease, they may need to get evaluated with a stress test and things like that to show that things would be safe if those conditions happen.
[00:37:27] LM: And what about, so many Americans are on SSRIs, so is there a contraindication? For people who are on SSRIs or who are on any other medications at all?
[00:37:38] MA: In terms of the SSRIs, right now we taper people off of them, and it's less about safety as much as efficacy, that we think it might blunt the depth of the response of a psychedelic. Although there are ongoing studies that are bringing some of that into question, and so they probably do work maybe at a higher dose, and so it's not an absolute contraindication, it's certainly not a contraindication for safety, it's just a, you might limit its efficacy.
[00:38:02] LM: Interesting.
[00:38:03] MA: And some of the drugs that can prolong the QTC, there's some concern around that, and so we certainly do EKGs on all the patients.
[00:38:11] LM: What is so great about the way you're describing the research is that you have a healthy level of respect for these medications. You have enthusiasm, but it is tempered with appropriate caution. So thank you guys for joining me. It's been so fun learning about Sunstone. I've been grateful to you guys for taking some of my patients into your clinical trials, and I can't wait to see what's next.
[00:38:37] PT: Thanks for having us, Lucy.
[00:38:39] MA: Yeah, it's just been great getting to know you.
[00:39:03] LM: Thank you all for listening to Beyond the Prescription. Please don't forget to subscribe, like, download, and share the show on Apple Podcasts, Spotify, or wherever you catch your podcasts. be thrilled if you liked this episode to rate and review it. And if you have a comment or question, please drop us a line at firstname.lastname@example.org. The views expressed on this show are entirely my own and do not constitute medical advice for individuals. That should be obtained from your personal physician.