Ketamine Insights

MDMA and Post Traumatic Stress Disorder: The Fight for Psychedelic Therapy

• Cristina Pearse • Season 2 • Episode 9

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We hear a powerful story about the power of MDMA to help heal PTSD.

An FDA advisory committee recently voted against approval of MDMA as a treatment for Post Traumatic Stress Disorder (PTSD), despite extremely promising results from clinical trials. So, in this episode, Molly speaks with Cristina Pearse, founder and CEO of the Protea Foundation, who received MDMA treatment as part of the recent trials. Cristina describes the impact of her childhood trauma as a powerful tsunami. With the help of MDMA-assisted therapy, she says, it became just a puddle at her feet. 

Together, we discuss the potential of this medicine, the FDA study design, the recent vote, and the role of advocacy in securing access to this life saving medicine.

If you enjoy Ketamine Insights, please share it with a friend and rate or review it on your favorite podcast platform. Online engagement  (ie. ratings and reviews) helps us reach a larger audience.

A New York Times article about the FDA vote on MDMA, which took place on June 4, 2024: https://www.nytimes.com/2024/06/04/health/fda-mdma-therapy-ptsd.html

You can read (MDMA applicant) Lykos' response to the vote here: https://news.lykospbc.com/2024-06-13-Lykos-Therapeutics-Statement-on-FDA-Advisory-Committee-Meeting

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Theme Song: [00:00:00] She's sometimes sad, she's sometimes happy. She's doing things to make her life less crappy. Trying a treatment that's new on the scene. Let's sit back and talk about ketamine. 


Molly: Welcome to Ketamine Insights, a podcast about psychedelic medicine and mental health. We are not trained experts and nothing in this podcast should be taken as medical advice.


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All right, so today's episode is a little different because we're talking about a very recent event. On Tuesday, June 4th, we got some very bad news out of the FDA. Their advisory committee voted [00:01:00] overwhelmingly against approving MDMA as a treatment for post traumatic stress disorder. Now, this isn't the final decision from the FDA. But from what I'm hearing, it's unlikely that the FDA will go against its own advisory board.


The final decision is scheduled to come in early August. Before this, there had been every indication that the FDA would approve the treatment. They even fast tracked the approval process based on the extremely promising results from the phase 3 trials. Just real quick, those results, 86. 5 percent of the people within the group that received the MDMA treatment had clinically meaningful improvement 18 weeks after the treatment.


So that's 86. 5 percent with clinically meaningful improvement and 71% Did not meet the criteria for PTSD diagnosis anymore. By the end of the study, these are really, really promising results. Really hopeful. This is the first time a psychedelic has come [00:02:00] anywhere near this close to approval in the U S as old listeners of the podcast will know, ketamine is not approved [for mental health].


It's being used off label, which is why it's not covered by insurance. And the effort to earn FDA approval for MDMA started decades ago. Let me summarize what happened to this effort to get MDMA approved. In general, the FDA usually measures the efficacy of a drug against a placebo. That means that in any given study, half of the participants don't receive the medicine.


Instead, they receive a placebo. In order to eliminate placebo bias, both the patients and the doctors are kept ignorant of which patients are receiving the placebo and which patients are receiving the medicine. The FDA does this in order to understand the placebo effect of the drug and a drug has to perform better than a placebo in order to be approved.


The structure of this MDMA study was that they divided the patient into two arms, two groups, [00:03:00] and one MDMA group received three sessions of MDMA along with therapy. And then the placebo group received three sessions of placebo along with therapy. The severity of the PTSD in each patient was measured before, during, and after the treatment.


As is usually the case, the applicant designed the study and the FDA approved the study design before the study began. So then here's what happened. The advisory committee had several concerns and I'm going to go through the three biggest ones here. One, the difficulty of maintaining blindness. It's no surprise to anyone that most patients were able to tell whether they were tripping on MDMA.


This is pretty unavoidable when the medicine causes an actual experience. The FDA panel was worried that this introduced bias on the part of the patients and the therapists in the room. The second concern was that there was no standardization with respect to the therapy the patients received.


Instead, the [00:04:00] therapy was tailored to the patient's needs. Finally, during one of the roughly 500 sessions involved in the study, there was a case of unprofessional behavior on the part of a healthcare worker. I don't know what this was about. I think either a therapist came on to the patient or inappropriately touched a patient while the patient was on MDMA.


The investigation for this one is ongoing. So the advisory panel was worried about the safety of patients while under the influence of MDMA. So if you zoom out, the advisory committee had two major concerns about the study design and one concern about a patient's safety during an MDMA session. I'm just going to say for myself, as someone living with PTSD, I've been watching this process with a lot of hope since 2019.


The trials were interrupted by COVID, and since the trials restarted, I've literally been counting the months until I might have access to this new treatment. So when I watched the hearing online last Tuesday, it was deeply disappointing. The panel [00:05:00] voted 9 to 2 against the question of whether MDMA assisted therapy is effective.


And they voted 10 to 1 against the benefits being worth the risks. So that was a heavy result. I was reading about this and trying to collect all I could. And came across a quote by Christina Pierce. And I've invited her on the show. To talk about all this with me. She graciously agreed. She's the founder and CEO of the Protea Foundation, which focuses on improving the lives of women living with PTSD.


So Christina, thank you so much for being here. 


Cristina: Hi, Molly. It's great to be here. Thank you. 


Molly: Can we start just with you telling us a little bit about yourself? Where are you from? How did you come to start the Protea Foundation? 


Cristina: Sure. I'm originally from Hawaii. As I mentioned in the FDA comments section, I had less than ideal upbringing and so I had a very you know, high ACE [00:06:00] score.


I have been challenged with that through my life, but didn't realize or, or understand my diagnosis of PTSD until I was in my mid forties. So, I went through our healthcare system being diagnosed and, and misdiagnosed. As having a whole host of other things, you know, the things we're all so used to, right?


Depression and anxiety bipolar disorder. But of course, along with all of those things, then came the progression of the medications that we, you know, apply to this, looking at this through the lens of it being a disease model. So when I was in my mid forties, finally got the diagnosis. Went back to research what other things could be done because I was shocked that the doctors turned around and prescribed the exact same medications that I had been prescribed already.


And one in particular was very devastating and actually caused a [00:07:00] suicidality. I actually attempted suicide on the medication. So, you know, I became very drug averse at that point and just said, okay, I am going to try to live a life of healthy, you know, diet and exercise. I became a competitive triathlete.


You know, I was, I was very, I'm dedicated to maintaining a very healthy lifestyle, but as we all know from any experience with PTSD. Over time, the effects still come in through the doors of the house and they come, you know, through an increasing number from different kinds of triggers. It doesn't even have to be related to the original trigger.


It's like, once the structure is weakened and that resilience is worn down. You know, that the triggers start to impact you more and more. And so unfortunately, I just, I wasn't losing the suicidality. I wasn't losing the ability to sort of self arrest when I was in high stress [00:08:00] situations. And so I continued to seek treatment.


After realizing that the same exact medications were the only thing that were still available to me, I researched things like ketamine therapy and other, you know, novel therapies. And I happened upon the clinical trial, which was going on with the MAPS clinical trial, that was happening in our backyard in Boulder.


So that was sort of a You know, wonderful blessing to have happen and realized at that point that that this might be a possibility, you know, for me to pursue this kind of therapy. So that's how I discovered it. When I went through the therapy, I originally received placebo and so I consider myself one of the fortunate people that got to go through it twice.


And. With a real sense of contrast, you know, how did it differ between being an actual talk therapy [00:09:00] modality versus it being the dual having the actual medicine? And then I should say that along the way just having gone through the trial on placebo, I really appreciated the therapy, the strength of the therapy, and the confidence of my therapists in the room.


That, that really inspired me to look toward, gee, what could I do to create more awareness around getting the proper diagnosis much earlier in life. Because I was a very early childhood sexual trauma survivor. And I had this high ACEs score because of all these adverse childhood events. There was a lot, you know, untangle.


And it's no wonder to me having gone through this therapy alone versus having the, the reset or the boost of the medicine, The experience between going through the medicated trial was absolutely life changing because in that [00:10:00] very first medicated session, and I got three by the way, three medicated sessions.


But even in that very first medicated session, I had such a shift in perception that I was able to push the, the fire alarm, the bells and everything else that keep you on that fight flight response to everything completely to the side to be able to process and really start to have time more than anything around unraveling why I couldn't resolve, you know, these early traumas.


And there are some amazing insights that I had in that, 


that it happened so quickly because I realized that what I had been experiencing as extreme shame around the sexual trauma in


Emma, I had completely turned that knife toward myself in judgment, in self criticism. Instead of ever being able to connect the [00:11:00] dots of, gee, that child, I mean, Very young child sitting in that room, going through the kind of traumatic experiences that I lived through. Didn't know how to cope with any of this.


Didn't have the emotional capability. Didn't, did the best she could to basically survive through those circumstances. And and maybe that shame didn't really belong with me. Maybe being told that I needed to be quiet and not to tell anybody, you know, wasn't my responsibility. But the profound difference for me as a, as a sexual trauma survivor was also recognizing that as horrific as the sexual traumas were in and of themselves, the really truly offending trauma was that I did tell someone and she denied it, told me that I was imagining it and actually shamed me for it by saying, don't you get enough attention as it is.


And so. You know, in hindsight, [00:12:00] when you're able to push the fight flight to the side and really examine all of the circumstances around it with this added self compassion that I've probably never had in my life that really helped me turn the corner and unwind a lot of it. Then I had something to work on with my therapists, right?


I had something for them to actually be able to help me unwind instead of me sitting there in sessions going, I don't want to be perceived as a victim. I don't know why this bothers me so much. It happens and I'm over it. It's terrible. It happens to a lot of people and trying to, you know, rationalize my way through it Having that space to really feel it on so many levels and hold that compassion and understand this wasn't about thinking my way through.


So that in a nutshell, I think is one of the real reasons why I am such a strong advocate now for this therapy. And my frustration at the FDA, I [00:13:00] feel like I entered a room and I entered the wrong room. I couldn't even. Get my head around why they were discussing the kinds of issues and the granular details that they were hung up on versus the bigger picture.


You know, I've, I've thought about this quote and it's like, you know, people say you can't worry about the bees when the bears are chasing you, it's like tens of thousands of people each year die from this. And we're sitting there having discussion and quarrel over whether or not a piece of data, you know, was, was sufficient in this particular, you know, one instance or whatnot.


You know, I, I absolutely am a proponent of safety and efficacy, but I think on both counts, that was absolutely, and continues to be proven. This will save lives. I hope that our, this advisory committee doesn't lose sight of that. Although again, I want to say that this is sort of like [00:14:00] being invited to the Olympics and them not having a sport for us.


Right. This is a championship, absolutely high performing form of therapy. And then to have a committee that isn't equipped to be able to judge it properly shouldn't be, it shouldn't penalize the competitor. And that's what this is all feeling like right now.


Molly: I couldn't agree more. It feels like the, I mean, first of all, thank you for your story.


It's very powerful and I appreciate you sharing it with us. I think the, the thing that occurred to me, I used to work in Washington, DC in the Senate and in the bureaucracy a little bit. And. The thing that occurred to me is just that the FD, you know, throughout the hearing on Tuesday, everybody was bemoaning that there hasn't been a breakthrough in PTSD treatments in, they said in, you know, 20 years, but it's been much longer than that.


They're talking about the last drug that was approved, which as you say, it's the same drugs for [00:15:00] depression and the efficacy is not very high. So they're bemoaning the lack of progress that we've made. And then this new Drug comes with this new paradigm with this sort of breakthrough treatment where, you know, almost 86 percent of people are responding.


And it just felt like the FDA didn't have the imagination, you know, they sort of threw up their hands and said, well, it doesn't fit into our paradigm. We don't regulate therapy. It doesn't. And it's like, no, that's the point. It doesn't fit into the paradigm. That's not working. It's a different paradigm.


Come with us. You know, 


Cristina: that's right. It felt like it was a situation where the audience is going, wait, wait, you're not, you're not understanding it, but the MDMA itself is so well characterized. We know exactly what it does in the human body. We also know exactly what trauma does. To the human body. I attended the international Trauma conference that Bessel van der Kolk [00:16:00] hosts, you know in in Boston and I sat through four or five days of well researched Neurobiology experts neuroscientists, you know behavioral.


I mean you name it One after the other presenting all of this data showing not only do we understand the efficacy of the psychedelics, although we don't understand the exact, precise mechanism that makes it work, we can see this, this window that opens up, right? That we're able to sort of relearn and retrain in this neuroplasticity that happens.


We understand that. We know what the effect is on the HPA, you know, functions in the body. We know the adrenal response. We know what the, you know, what, what the, what the body does when it responds to trauma and stressors. And so to me, it's like understanding the drug, understanding what the body does and reaction to it.


And then we get hung up on this [00:17:00] therapy wrapper around it. Which is so subjective because that's the challenge of therapy, right? Individuals respond differently to different kinds of therapy. Otherwise, we'd have one kind of therapy available and You know, I don't know that we mentioned this today, but you know, I'm also in school Studying and I'm in graduate school as a mental health counselor clinical mental health program at Wake Forest And so again, you have this layer of, you know, this understanding of the context of therapy coming in hundreds of flavors and yes, some are more evidence based than others, but it still has, it still resides with the therapeutic alliance, right?


It was hard. It was so hard to watch this one woman in particular, who I know has been brought up, you know, multiple times because the therapeutic alliance and the modality of the therapy for [00:18:00] her didn't work. And then on top of it, her therapists were absolutely in the wrong to then cross, you know, ethical, moral, legal boundaries, you know, after the trial.


But now we're holding that so far out of perspective. That this is now holding up, you know, tens of thousands of lives. I just, I feel like that is such an important message for us to understand and say, yes, the therapeutic wrapper, we can do more research around that and saying which form of therapy is the most effective.


Molly, just yesterday I did an interview with the Atlantic Journal constitution because they're doing a trial at Emory university. And there it's a single medicated session. But it's using prolonged exposure therapy. In a person centered approach and trying to see what that does right through their clinical trial population, I believe it's about 40 patients who have been selected for this trial.[00:19:00] 


And so again, I think, of course, there are ways to improve upon the efficacy, but we are improving from 87%. That is one heck of a baseline right to fine tune a medication. Name any other medication, any other drug in our arsenal where we have the risk profile of MDMA with guardrails of having therapists in the room while it is being administered, right?


And let's hold that in perspective for a moment instead of paying attention to the one spinning top that veers off and then allow fear to really You know bind us. I think that's the biggest tragedy out of that that process that we all, when you're 


Molly: referring to, there was one instance that they were, that they talked about at the hearing the other day where out of about 100 patients, there was one.


Where there was malfeasance, they didn't really go into what [00:20:00] exactly happened, but there was one incidence of the therapists acting out of turn and that that is one of the things that has derailed this investigation, it looks like, the investigation into MDMA. 


Cristina: Yeah. Yeah. Yeah. It's, you know, because again, you're going to have a bad actor in a system wide process, no matter what.


But again, you can't throw everything out, right? The baby with the bathwater you know, certainly comes to mind, but but I do know after watching that, that, that advisory committee and particularly trying to understand the makeup and who the members are on the committee and why their opinions would hold so much weight and sway.


with the FDA, keeping in mind that the FDA themselves have been working with maps on this trial, on the design for decades. And they're the ones who signed off on saying, yes, this is novel. It is going to be a [00:21:00] big challenge in anything that has any sort of mind you know, perceptive shift, altering component to it, to blind that kind of a study.


And their solution was to have a third party rather than judge whether or not they could tell if the patient right had had the medication afterwards, which seems like a pretty good solution. But then to have that exact trial design be criticized at the hearing itself then was very, it was very difficult.


You having a DC background would appreciate. I think this, I love this quote, but it's always, you know, there, there are things you don't want to be, you don't want to see being made and that's laws and sausages. And I'm going to add FDA advisory committees, you know, approving drugs to that list. Yeah.


Because that was, that was just a, that was a mess.


Molly: It was known, of course. So it's difficult to do blinding when [00:22:00] the pill is not an inert white pill that you take and you don't know if it's doing anything to you. The, the medicine is an experience. Yeah. And so, of course, it's going to be difficult to do a double blind study, but like you said, they knew that that was a risk, they knew that was a problem, they planned around it, and the FDA agreed to the study design, and then the, the same, the advisory committee turned around and criticized that very design that had been worked FDA and MAPS.


So that was one of the huge disappointments that it just between that and the FDA putting it on fast track and then the committee putting the brakes on so completely it felt like they're really just not on the same page as each other and and I was wondering the same thing as you like how Who is this committee made up of that they're so, they have such a different kind of like almost different philosophical approach to what therapy can [00:23:00] work for PTSD and illnesses like it.


Cristina: And imagine the culture clash between the psychedelic sciences, right, and traditional clinical medicine. And then, you know, legislators, regulation, and, you know, people who are, you know, very risk averse, right? So, you know, you, you have, we had a lot in the room. And the biggest thing is, though, this should have accounted for that.


Because we know, we can anticipate that there is going to be very different schools of thought coming at this. But it, it's, it, again, we can't lose perspective of, Real lives hang in the balance here. And so cultural issues or sort of paradigm shifting that needs to occur you know, to, to really, truly sort of, I want to say accurately perceive any sense of, of risk with this [00:24:00] medication.


I just, I really, truly believe that if they, you know, they need a second committee meeting, they need to reconvene and, and run this through again and, or I really strongly believe that the committee that actually makes the decision, this needs to be one of those historic moments when they don't stand by the recommendation, they need to go through their own assessment.


I'm fully confident that Lycos is going to give them the data that they need. and that they will, you know, in fact, I'm, I'm very optimistic they're still going to pass this. So, you know, I'm going to be in that minority right now and say, yeah, they completely messed that up in that, in that AdCom meeting.


But but I think there's still very strong indications for hope because I think the data really, really. 


Molly: That's interesting. Cause I was, I had heard that maybe Lycos, which is the applicant the company spun out of maps that created the application for MDMA. That they might withdraw their application and redo the phase three trial and sort of.[00:25:00] 


Not do a full reapplication, but kind of start over from phase three and go forward again. But I don't know if that's even allowed or if that's how it's done. It certainly would set us back years. If that was the next step, 


Cristina: it would certainly set us back years. 


I think even, and so again, this is, this is at what cost, like I asked at the, at the original hearing, right? A lot of people are still waiting for this. And I want to say if the differences between individuals feeling like they're at their wits end, and this is something that they just can't live with anymore, and they're contemplating suicide.


whether or not there are some side effects or whether or not they have therapy and need to change therapists midstream just really seems like a manageable risk. So again, I go back to the MDMA as well, characterized the therapy rapper needs to be well formed, but this committee was not the one to make that judgment.


I just really hope there's some other [00:26:00] way to address this. I you know, intervention. You know, I don't know if you have any sense of what kinds of other alternatives there would be to having to reapply. 


Molly: I don't, this wasn't the area that I focused on when I worked in the Senate, but I, I, I did focus on medical research and I don't know of any way for Congress even to intervene without, I mean, all they can do really is give money to the NIH, the, the, even the department of defense now has money to do this kind of research, which is a great step forward.


But as far as like actually getting approval for the drugs, I don't, I don't know myself of any way that they could help and that, as, as slow moving as they are these days, it might not be faster, unfortunately. But I think you're right that there was just such a real lack of, like, liaison work.


It feels like, as you said, they were speaking different languages. And the idea that they don't regulate therapy, and therapy was part [00:27:00] of the intervention, and that they, that they always rely on blinding, and blinding is a lot more complicated here, if not completely impossible. Just put up this wall that they couldn't and the consequences are suffered by the people with PTSD all over the country at home trying to figure out what to do without a lot of help from the medical system. 


Cristina: That's right. And on top of that, again, another component of raising awareness around this issue is the number of people that are yet to be diagnosed with PTSD.


So many people, particularly what we know now about You know, particularly with, with sexual assault victims and realizing how many of those go on to develop PTSD. You know, the rates are so phenomenally high, higher than veterans, higher than, you know, any other category. And so, for so many of those, because it is a, a crime of [00:28:00] shame on the part of the victim instead of on the perpetrator, right?


It never gets reported. It gets put under the rug, never to see the light of day. And so you never connect the dots that that's the reason why you are Suffering from so many other things because you continue to look at it as why can't I get over this or even though I'm over this, why is it still impacting my life?


And so, to me, I'm really worried about the number of, of victims out there you know, on the full gender spectrum that aren't even in this headcount. And and could really be helped by this therapy. And this delay is impacting all of them as well and their communities and their families and their loved ones.


And, you know, it just ripples. 


Molly: Yeah. It's a great point. And I think having a successful treatment would possibly bring people into the diagnosis and if there's hope for the diagnosis instead of, you know, I'm one of them who [00:29:00] sort of wallowed in this world of treatment resistant depression for a decade without, and you know, a big reason for quote unquote treatment resistance.


is trauma and you're not going to get better in a lot of cases without addressing the underlying trauma that's causing the depression and you can treat it with all the SSRIs that you want but without the insight that you mentioned earlier it's you're not going to get very far in a lot of cases and I'm one of those cases 


Cristina: The current medications, from my perspective, all mask who we are in our experience. And so you're trying to suppress symptoms. You're trying to reduce, you know, when you're feeling sad. And so you're, you become less yourself, right? So you're even further away from sort of uncovering your trauma. And so again, one of the things that I just really appreciated about this.


Therapy is that you absolutely [00:30:00] you get to the abscess that is in this disease and you dig that out and then you can finally heal. 


Molly: so every, every drug therapy that's out there right now is pulling us away from that, right?


Cristina: It's pulling us away from really feeling and experiencing that trauma by just masking it and numbing it and dulling those symptoms. Instead of recognizing that those symptoms are there for a very reason. Those symptoms are sort of ways of our body telling us that, you know, that there is an issue and that we do need to resolve something.


And so rather than trying to suppress those little fires, right, we need to be addressing them. And so by going in and addressing that abscess, it, you can really. Truly heal from this trauma and again move forward and and have your resilience restored I know that was another big question that came up is okay Well now we have this big fear that you know, all these people are [00:31:00] going to be addicted to MDMA like they are You know these opioids and you know, whatnot.


And I'm sitting there saying, you don't understand the opposite's going to happen. The efficacy of this is going to get out. It's going to continue to spread. There's going to be a groundswell of people wanting this. They're going to turn to the street for their supply. Then we're going to have bad drugs, right?


Some people are going to get those. 


Molly: Right. And people turn to drugs like opioids when they're suffering from PTSD. It's not, it's not the MDMA that's the danger as much as the lack of treatment for PTSD. But you know, but 


Cristina: even if people are saying, okay, well, let's just, let's go, you know, find. Therapists and let's go out and do MDMA ourselves and, you know, and, and make our own therapy, you know, that's high risk because you don't know where you're getting your drugs from and, and so now we're going to create that kind of a crisis.


So I think to me, the bigger risk is when you have this, this groundswell of people saying, well, if this works, I need to do it because I'm [00:32:00] desperate. But then we have a bad supply. We have, you know, all these other issues, you know, does the FDA get to wipe their hands, wash their hands of it at that point?


I mean, to me, I feel like that's a, that's a much higher risk. And that would absolutely be on them. 


Molly: Yeah. 


Cristina: Yeah, 


Molly: absolutely. And the, the, it's a real false the idea that if you do nothing, you haven't made a choice. And nothing, none of the consequences can be your fault. It's just not true.


Doing nothing is a choice in this case. And I think I just want to go back to something you said earlier about, you know, the idea of sort of suppressing the symptoms and suppressing the body's attempts to raise the red flag and say something's wrong here. Really, we talk about that a lot at Ketamine Insights that like, trusting the body as a healer and trusting your self to know how to heal itself if given the right sort of [00:33:00] soil to to work in to grow in and and that's a very different paradigm from the medical paradigm that sees itself going to battle with cancer for example going to battle with the bad parts of yourself sort of breaking down the barriers and listening to the the inner voice that's saying like 


This is what I need. This is the comfort that, that I need is just a very different paradigm from the, take a pill and you'll be better tomorrow. 


Cristina: As I went through my sessions, Molly boy, do I understand the challenge of trying to convey how the trauma was resolved in clinical terms, because you're literally having a sensation of your brain restoration.


Like for me, what what came up was literally having You know, you look to the plant kingdom, it's having a parasitic vine lifted off of your, your structure as a, as a tree in the forest, right? So now you can get [00:34:00] nutrients and you can thrive because you're no longer coded in this, you know, in this disease.


It's another sense of literally having what used to be a fight flight superhighway open up into a very broad pathway with side streets and rivers and streams and, you know, walkways and bridges and, you know, And all these options, right? So it's discernment around how you're going to react to something.


And then on top of all of that, this sense of in your own voice, in your own language, someone telling you what you need to shift your perspective. So I alluded to it in the hearing, but for me, it came in the form of realizing that any time in the past when I had been overwhelmed, I was experiencing almost a tsunami.


It was really, you know violent water filled with all this debris. And, you know, it was very scary and [00:35:00] overwhelming. And to suddenly have in my own voice, sort of a tap on the shoulder that says, Christina. Stand up and then to realize that you're merely in a puddle at your feet and that you are bigger than this and that quite possibly your little five year old, six year old, seven year old self has been stuck thinking that all these things are looming so large.


When, when you've overcome it, you are resilient. You are still alive and, and you're not still stuck back there, right? So how do you explain that in clinical terms and, and have people embrace and understand that this is medically valuable you know, and, and that this individual journey, if you will, is something that we just need to trust that it's going to happen for people.


But it is. It is happening. It is the unway. It's unfolding for people. People are finding their own inner healer, just like I did. That, that [00:36:00] voice that, that tells myself what I need to do to meet the therapist on the outside so that we know what we have to work on. And no amount of unidirectional therapists telling me what I need to do would ever resolve that, right?


But you don't know what you don't know until you get that assisted therapy, that assisted drug boost, or reset button, if you will, to heal the cognitive ability, right? To heal perception, to heal, you know, your, your Your biological response to stress to then be able to unravel future stress. and and trauma.


Molly: Yeah, to, to sort of turn down the, the volume, as you said, the tsunami of consequences and just have a moment to actually listen to yourself and be able to hear hear the truth, [00:37:00] really hear the fact that it is just a puddle at your feet and that you're, that's such a powerful image that you're, you know, You know, overcome and then you realize, no, no, it's not the ocean.


It's just a puddle. 


Cristina: It's perspective and to just truly be able to connect the dots. And again, I go back to, like, for me, having that revelation that it wasn't the index trauma, so to speak, that was the, the harmful trauma. You know sort of a barrier to healing. It was the peripheral stuff around it. You know, for me, there was also a little bit of sort of survivors guilt built into this as well in this realization that, you know, potentially, you know, A predator was very dangerous.


Why didn't I do more to stop him? You know, why didn't anybody listen to me? I should have done more, you know, all of those things that happen. And, but those are, are feelings of, of just shared in humanity. It doesn't [00:38:00] matter what the trauma is. These are all the same kinds of You know, feelings that we have.


It's, it's like soldiers in war feeling like, why couldn't they save their friends or, you know people in natural disasters, why weren't they able to, hold up a wall or, do some, mega task, you know, miraculous thing. Exactly. Superhuman thing. These are all very common themes and, and yet to have something that helps you get out of your own way to unravel it.


Is just, is, is so difficult to explain in medical terms but we, but we see it, we know it, we can prove it, right? People are really truly resolving their trauma through this therapy. So, so it's a challenge, I think, to, to try to figure out how to put this in terms that, the medical community, as they have defined this, are going to feel comfortable with.


But I think we can do it 


Molly: right. And it was to the extent that it was codified, you know, [00:39:00] it was able to show meaningful progress on the different scales that people use to report their distress and the, you really can't ask for better results that's not the drugs that we use today.


It's a success if it's a 30%, you know, in mental health, especially As someone who's tried more than 12 or 15 different antidepressants, the idea of an 86. 5, I mean, it just makes you want to cry, to be honest. And without side effects. Right, 


Cristina: and without having to take it repeatedly for the rest of your life.


For the rest of your life. I mean, there's just, to me, again, I want to go, did I walk in the wrong room? Like, I just can't understand. Having the lived experience of being medicated is weird. By so many of these SSRIs. I mean, I was even prescribed anticonvulsants and, you know, you name it because of bipolar.


Exactly. And so, my gosh, just going through that, right? That, that, that is [00:40:00] another trauma. 


Molly: Yeah, the physical toll on your body. It is another trauma and being told, Oh, no, All these years you've been on this, that probably wasn't helping. Maybe it's bipolar that you have. Let's try this whole other class of drugs.


And maybe we were wrong and just going through it over and over again. And yeah, the everything, the weight gain, sexual side effects, the, you know, suicidal ideation that every there's so many life changing side effects. And. MDMA's side effects seems to be insight and 


Cristina: empathy and positivity and, you know, and can do ism.


It's self acceptance. Exactly. I mean, to be restored on, on this level, to, to, to rejoin the human race as a productive member, instead of feeling, That you are somehow flawed and that there's something biologically, neurologically, fundamentally wrong with your character instead of like I [00:41:00] have the insight now where I'm like, Oh my gosh, like, you know, I don't want to say I'm amazing, but I'm pretty amazing for still being alive for what I've come through.


And so we should celebrate that resilience on the part of people that suffer through trauma. And why aren't we doing that? Why aren't we shifting that entirely where we're saying, you know what, you're still here, that proves your resilience. Now let's get you back to that full resilient person again so that you can keep marching forward.


I mean, that's the shift that needs to 


Molly: occur. And talk about the ripples, you know, we talked about the negative ripples, but the positive ripples of somebody being restored in that way to their whole family to their community is really, it's really meaningful. It's really important. Absolutely. 


Cristina: And I see the shift already even personally within, you know, my circles and within my sphere of influence, and more importantly, it breaks the cycle, right, of it happening.


Absolutely. [00:42:00] intergenerationally. So especially with my son, when I see our family's generational trauma and the cycles, and I start to connect the dots through all of that, it's, it's astounding how the wrong dots are connected. Come to light, right? Just today, I posted on, on Proteo Foundation's Facebook an exercise.


It's an illusion where you look at it and your eyes, you know, can't discern between squares and circles. And I sort of likened that to what happens to people who suffer from PTSD is over time, you can no longer see both shapes. You start to only be able to see, you know, one particular component. And I think it's important because having people restored to resilience.


to where they can see not only more accurate reality around their history, and [00:43:00] they can see the right dots and both shapes, and they can connect the right dots, I think really helps people shift their narrative. It helps them understand that they aren't the terrible people they think they are. You know, and, and really truly be able to turn the corner and say, you know, yay, yay, me yay resilience.


And, and, and now I have. 


My cup is overflowing and I have more to give. So, you know, so, so what's that? What's that worth? 


Molly: Right, and to think of the, the, you know, the partner, the child being raised by a person who's not clouded by shame and convinced that they have done something terrible and that it's their fault and that, you know, it's a different parent.


It's a different partner after recovery. 


Cristina: Yeah. Who shows up and just not having that, the default switch in the wrong position. Right. [00:44:00] Where you're now able to see the positive in things and you're, you're able to, to pause and say, Oh, that felt like a criticism. Was that a criticism? You know, did that, is that what I'm feeling?


Is that what you meant? Like, can we explore this? Yeah. Did you mean it that way? That space


and hopefully, you know, organizations like yours and doing the patient advocacy work and maybe podcasts like this, who knows, are able to kind of.


Molly: raise awareness and make it not so scary. Put the drug war behind us. I wanna give you a chance to talk about any plans you have with the Pro Teya Foundation, 


Cristina: I, I, I would love to Thank you. I, I think the biggest thing right now, and I, I fully agree with you, this is, this is a mere delay. You know, more than anything else, but but what we are doing as a foundation, even even if MDMA assisted therapy doesn't become available to our population that we would love to help because that is one of our missions, right?


Is to is to create more access. To people who wouldn't otherwise [00:45:00] have it, but is to focus then on the other two tiers of our mission. The first one is that community based trauma education. It's connecting the dots between ACEs and childhood experience to trauma in the present time and making sure that people are even having a dialogue around trauma and PTSD and able to then find resources to get to trauma informed therapists.


Because I think shifting away from blame and the disease model is so critical. So that's work we can be doing in the interim and then training therapists on the modality of psychedelic therapy. So even though we can't be, you know, providing the actual MDMA or, you know, or, or that we can still obviously be building up a much larger therapeutic base of people who are competent in this area.


It's really important to me that we don't have. You know, people who aren't [00:46:00] qualified in the space providing the therapy in the space. They do need to be aware of all the different, you know, points of inflection, right? Have we really resolved suicidality in this patient? Are we at risk of this person, you know, maybe becoming worse through the therapy because they're getting closer and closer to unraveling their root cause, but it can be very painful to get there.


And very scary. And so it's really making sure that there's, there's a level of competence you know, to that. 


Molly: Yeah, and enough, enough of those professionals to serve the demand once we're able to, 


Cristina: once 


Molly: we're able 


Cristina: But you know, we'll see. We'll see what happens in August. I'm doing everything I can in the interim. I'm, you know, approaching Congress.


I'm trying to be the activist. I am trying to learn how to be that voice in the room that is saying, this is not okay and it needs to be loud. You know, so I really [00:47:00] appreciate the opportunity to have like this platform truly, because I don't know, I'm so new to trying to be an advocate for something like this, but I believe in it so wholeheartedly that this will save so many people.


And this is, you know, I have suffered from PTSD for 47 years, and I don't want anybody to walk a single step. In that journey, so anything I and the people who join our community can do. To even shorten that by a day, but more importantly to instill that there is something good coming down the pike, right?


We do have an effective therapy and we just need to get there. Hope I think is the biggest thing we can instill on people who suffer from this. And, and that's our work right now. That's the first step we're, we're taking. And and I hope that we have a,bigger job to do in August.


It would be a nice, a nice issue to tackle is getting [00:48:00] everybody through that pipeline. 


Molly: That's right. Well, I just want to thank you so much for the work that you're doing and the voice that you, I mean, I, I was just reading that New York Times article on Wednesday morning. So disappointed and got to your portion of the article down at the bottom and I thought, you know.


These voices should be at the top of the article. You know, this is the, this is the problem. The problem isn't a bureaucratic one. The problem is a human one. And we're, given this opportunity to alleviate so much suffering. And it really is powerful. 


it's so powerful the way that we advocate for ourselves, but also for each other. When we have that common. Experience. So anyway, I just want to thank you so much for being one of those people because it's really important. 


Cristina: The honor is mine. Truly. I feel so incredibly. lucky, really, that I had the opportunity to participate in this trial.


I mean, those odds were [00:49:00] extraordinary to, you know, to have that opportunity. So it's also a felt sense of responsibility. I was given a gift and it's time now to turn around and, and really do everything I can to share that. It is, it is absolutely unfair to me that this isn't something that is available now, today to anyone who suffers.


This is, this is so exciting and so amazing and it, it needs to be shared. So yeah, I, I love that people get really motivated to help each other through things like this. It's almost like trauma is so pervasive that people don't really want to believe that it is something that impacts all of us and yet we know this, you know, you look at the root cause of so many of our social issues and it is mental health related.


And so, again, this impacts us on such a [00:50:00] fundamental level. And so, from my perspective, it's like if I were looking at the best place to invest a dollar. It would absolutely be in a root cause solution instead of band aids. You know, I just, I really think this has that potential to really cure a lot of, a lot of what ails us as a society.


So thank you, Molly.


Molly:  Really appreciate being able to talk about this. so much for taking the time and sharing your story and joining us today. I really, really appreciate it and hopefully we, maybe we'll have another call in August with good news. 


Cristina: Stay in touch and let me know how it goes. If I can ever be of any assistance, you, you let me know.


Molly: Okay. Thank you. Thanks for listening to this episode. If you liked it, please share it with someone who might find it helpful. And if you want to help keep the podcast going, you can support us by subscribing through Patreon or Substack. Just go to [00:51:00] those platforms and search for Ketamine Insights. This episode was hosted and produced by me, Molly Dunn, and our theme song is by Solid State Symphony.


See you next time. And in the meantime, take care. Remember to advocate for yourself and never ration your joy.