Dr. Jeannie Fontana - Charting the Future of Safe and Accessible Psychedelic Therapies

Welcome to the Radical responsibility podcast. I'm Dr. Fleet Mola and I'm excited to guide you on a journey of authentic transformation. In each episode, I'll bring you insights from leading experts to explore trauma recovery, mindfulness practices, positive psychology, and innovative breakthroughs in health, wellness and life optimization. This is a space for real conversations that inspire meaningful change, helping you find alignment with the person you were always meant to be. Let's get started.

What if the key to unlocking the future of mental health care isn't just the therapies themselves, but the way we choose to fund and structure them? I'm joined today by Dr. Jean Fontana, who brings a powerful vision for how psychedelic assisted therapies could follow the same path that transformed stem cell research in California. Together, we'll explore how the TREAT initiative, T R E A T treatments, research, education, access and therapies could shape a future where psychedelic medicine is safe, ethical and available to all. Let's dive in.

My name is Dr. Fleet Maul, your co host for this session, and I'm really thrilled to be here today with Dr. Jeanne Fontana. Welcome, Dr. Fontana.

Thank you. Delighted to be here.

Oh, we're thrilled to have you. I've been looking forward to this conversation. I'm sure we're going to learn a lot. So Treat humanity and your Treat California initiative is really positioned to play a key role in advancing research into psychedelic assisted therapies. And I wonder if you could share just the inspiration behind this and just in reading your bio about your work in establishing the ALS center for Excellence there at Cedars Sinai. I mean, really large scale economics involved and potentially large scale change. So I know that your Treat California project is about creating a significantly sized fund for this research. So maybe you could just talk about how that evolved and how you think that might meet some of the current gaps in funding for the ongoing research and development of this field.

Well, thank you. So I'll start when I finished all my training and my mother was diagnosed with als. And at the time it was a disease that wasn't talked about as often as it is now. And there are no known treatments, there's no known cost still, and the life expectancy is just awful. So I was of course driven to try to find a therapy to help my mother and then those who suffered from als. So how did I do that? Having a background in medical science research, I wanted to build research programs and there was no funding in ALS at the time. And simultaneously, the embryonic human embryonic stem cells were just discovered in the late 1990s. And so I happen to be working with a world renowned medical research institute down in San Diego now, the Burnham is Burnham Institute. And there was a remarkable stem cell scientist there, as well as other incredible scientists. And we explored using stem cells to derive a model in a dish. You can't take human brain tissues to create a model. And frankly, I was tired of curing mice and rats. I think they play an important role, but infrequently translate to human therapeutics. So we were exploring developing a model of ALS in a dish. Funding from the federal government and George Bush in 2002, for political reasons, put a moratorium on embryonic stem cell research. We are still confronted today with the pro choice issues, the political lightning rods. And it had a direct impact on me and my drive to help find a therapy to treat my mother and others who were suffering from als. And so policy impacted research, and that really bothered me. Fortunately, there was a force of nature here in California whose son was diagnosed with diabetes. And he was working with scientists up at Stanford and they shared with him that in fact, embryonic stem cells could potentially be a therapy for diabetes. And E2 came across, well, where do you get the funding to do the basic research? Federal government stopped it. In fact, it was so extreme that that if you were doing research in a lab that was funded, leaving the light bulb was funded by the NIH and you were doing embryonic stem cell research, your institution could be threatened with losing its NIH funding in its entirety. So it was a very effective way of enforcing a policy. But this force of nature said, let's figure out a way to create a funding agency and get around this federal restriction. And so he pushed what's called a citizen driven ballot initiative. It's a mechanism by which Citize can come together and say, hey, we want our government, in this case the California government, to respond to our needs. And so we went and campaigned for this in the early 2000s. And in 2004, the stem cell initiative was passed and created the first of its kind in the world and the largest in the world. A $3 billion funding agency dedicated to basic research in stem cells, but the focus of expediting the development of therapies. And so we weren't just going to just fund basic researchers. We wanted to get therapies into patients safely, securely, as quickly as possible. And so we were charged with building what is now the infrastructure for the regenerative medicine space. And that was a wonderful, like in the trenches experience that I shared for nearly a decade working with all the thought leaders and academic institutions leaders to develop an expeditious funding mechanism. And I think by all accounts we were quite successful. The money ran out in 15 years and there were two FDA approved therapeutics and nine breakthrough and fast track therapeutics, and importantly about 60 compounds, what we call in the pipeline that were deserving of funding. We also created jobs, about 50,000 new jobs in California. And the country went about to 80,000. We created in excess of $10 billion of revenue to the state of California. So the same force of nature went back to the voters in 2020, during the height of the pandemic, qualified for the ballot, which is a big challenge. And in 2020, the voters of California approved an additional $5.5 billion. And so what you see today is that we created an independent state funding agency whose grant goal was to expedite research to get therapies into patients. We were able to deliver on that promise and that the voters of California liked what we accomplished and continued funding that. So I go into detail with this model to share with you that this is the model that I think would be an effective pathway to take to create funding, then very necessary funding to bring psychedelic assisted therapies to the public in a safe, responsible and ethical manner. Most people aren't aware of this pathway because in California we were the first of its kind. We still are the largest in the world. And there's been one other state that has copied us, that is in Texas, and they created a funding agency for cancer research. I want to fast forward and get into the psychedelic space with my work with als. And I trained also at the va. I had fondness for our veteran community. I believe it's important that we take better care of our vets. And some science papers were brought to my attention about the treatment of treatment resistance, persistent PTSD using psychedelic assisted therapy. It caught my eye for a number of reasons. One was these studies were coming out of our top academic institutions. They were large clinical trials and importantly, they were showing dramatic improvement. Up to 70% of the patients that underwent the psychedelic assisted therapy had dramatic improvement in their PTSD. These are people that have been suffering for over 20 years who have failed conventional therapy. They tried all the therapies that are available, including SSRIs and talk therapy and exposure therapy and all kinds of things. And they don't work for those people. So that caught my attention. And then as I had the luxury during COVID to really do what I call a deep dive, I do due diligence before I get involved in a program and then started attending some conferences. It became very clear to me that this paradigm offers a new tool in the toolbox of healthcare providers to meet an unmet need. And I just want to close by saying this is part of it. I believe these medicines are not for everybody, that they need to be treated with great respect, that there needs to be proper infrastructure, support the safety, use of these medicines and the beginning of the rest of the person's life in their healing process. So I understand all the political hangover from the 70s, 80s and 90s actually, and that there are some real concerns, I think for the public. But I believe that through good research, good safety, risk identification, education and transparency that we can actually bring these much needed therapies to those are millions and millions and millions of people that are suffering from a variety of issues.

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Wow. Well, it's an incredible work and there's lots of followed up on there. Yeah, actually it was my own tracking of the research with vets that really inspired me to develop our first Psychedelic Assisted Therapy Global Summit in 2022 and I started following the work a number of years prior to that and I have my own background with psychedelics in the 60s. I'm a baby boomer and was a an enthusiastic participant in the counterculture of that time. But I had been away from it for a long time but I really started seeing this research. Oh this is really significant. Although I'm Just curious. The work you were doing at the Burnham Institute, is that the correct name? Is that any similarity to the approach, the work that Rudy Tanzi and his team have done at Harvard and that team that's discovered some of the precursor genetic markers of Alzheimer's?

Yes, and yes. And actually through the funding of the California Institute of Regenerative Medicine, we had collaborative funding so with them. So the idea of bringing scientists together from their various institutions to help address this problem is. Yes, we do that.

The therapies that came out of that initial funding round with the agency that you established were these stem cell therapies.

In particular with the California Institute of Regenerative Medicine? Yes, it was. It's all funding for stem cell therapies and it's still focused on stem cell therapies, but also modifications. You know, I think that there are really exciting combination of technologies including CRISPR with stem cells. I think it's okay to start considering we're going to cure many diseases with the stem cell CRISPR combination. And then I think it's also equally reasonable to talk about we can cure some what we're called mental health issues with psychedelic assisted therapy done properly.

Yeah, I mean there are so many really fascinating advances in developing a medicine and, and the idea that they would be slowed down by politics is kind of disheartening. But your ability to speed up the process and support the process with these citizen ballot initiatives, I mean California is pretty well known for these ballot initiatives. Some have been around taxes and other things. Probably some helpful people would fall on either side of some of those arguments. But it is an interesting approach to getting things done and interesting that I was thinking, you know, other large states might follow suit. So it makes sense that Texas would follow suit. And Sarah, as you're envisioning this initiative that would create a funding agency, similar funding agencies, both psychedelic research. And I understand it's not just about the research but also envisioning how to build the infrastructure.

Absolutely, it is about building the infrastructure. You know, TREAT is an acronym that stands for treatments, Research, Education, access and therapies for Psychedelic Assisted therapy and other novel therapeutics to address mental health, addiction and pain. So in addition to running clinical trials, we already know there's good preliminary data and I want to highlight that most of the psych true psychedelics and we can talk about them. The psilocybin, mescaline, ibogaine, DMT and lsd. The four out of those five are, are plant based or fungal based medicines that are not patentable. They've been around mankind for decades, if not tens of thousands of years. And so pharmaceutical companies haven't gotten involved because the financial incentive is not there. And also political restrictions made it challenging. So in creating this funding agency, we can actually look at these therapies that are not patentable and look at how best to use them, which patients are more amenable to which type of psychedelic and explore, you know, whether they should have one on one therapy or whether group therapy or there's some combination of such in their healing process. So that's kind of the research and there was a whole like, you know, universe on how to look at the different applications of these medicines. Equally important, I think, is the training of the therapist. So thus far we know we're not quite sure whether you can just take a psychedelic without having any kind of support around you and you can have insights. My gut tells me that's not the case, but I want to let the data drive those decisions. But right now it seems like we have to have good therapists or facilitators who can educate the person as they're going through the process, be there with them while they're undergoing the medicine for these insights. And then importantly, I think is what you do with the information afterwards. And that requires training therapists to understand how to assist the person on their learning process. I talk about you are empowering a person to take agency over their well being. Well, as an athlete I was taught how to play a sport and I had a coach who said I was also on the team. Move over here. Watch this or watch that. When we're shown how to do things, we I think can incorporate things easier. In addition to educating and even academically in the school systems about mental health issues, it's educating the public. It's time to change the narrative around how really to deal with anxiety, depression, addiction, other than our generation, which was, you know, you don't talk about it. And there was a bias against people who, you know, couldn't overcome their problems. What's wrong with them? Are they not tough enough or they're spoiled or whatever, you know, sort of a blame game. And then of course there's been, you know, the elucidation that there is some genetic predisposition to certain things. And so then it also takes away, I believe, responsibility for the person to have accountability for their sense of well being. We live in a society, if you will, that sort of keeps us in a victimhood type mentality. You go to a doctor, they give you a medicine, you know, it's A medicine, you take it and you take something every day. This paradigm is very different. It's for a short period of time and then it's for the rest of the person's life. So education, both the academic way, the training of the therapist and then importantly the public, and then lastly developing a better access to care model is equally significant. I mean we can come up with a great therapy, but if only the rich people can get it, I mean, that's a start. But we all know that, you know, the underserved communities are hardest hit with many of these issues. And I just scratch my head and I say, you know, we can't afford not to come up with some novel therapeutics and bring it to the public in a safe, responsible and accessible way.

We still don't know that much about the actual healing mechanisms of these psychedelic medicines. There's a lot of speculation and we do know some things. Robert Harhart Harris has his entropic brain theory. There does seem to be some contribution to neuroplasticity. And then you know, there's some suppression of the default mode network. We'll let the brain reorganize to have other types of experiences which can be healing and transformative. So there's a lot of speculation. And you also talked about the pharmaceutical companies not taking such interest in these classic psychedelics because they most of them derive from plants and that's not patentable. I know there are some pharmaceutical companies looking to see if they can create non psychedelic versions of these which the ideas would support. Neuroplasticity, maybe have some similar effects to SSRIs but not have the psychiatrist. Of course a lot of people feel, well the real magic is in those transformative experiences. But all that remains to be seen. I tend to kind of fall on the other side, but I'm open go where the data goes. But another, I know there's one pharmaceutical company that's actually trying to work with psilocybin, create a version of psilocybin that would be shorter in duration and have fewer side effects, which would mean that you wouldn't have to have the expense of the very long guided 6 to 8 to 10 hour journey, maybe something sorted at 2, 3, 4 hours and fewer side effects, which means you could have higher doses possibly. So there are some things going on like that. So I'm curious about where we feel we are with the research and what's needed. And also in light of the fact that the FDA elected not to reschedule MDMA currently on the advice of its Advisory committee, which a lot of us are questioning the composition of that advisory committee and some of it seems nonsensical. But of course, you know, the request for better research is always a good request. But anyway, so let's spend a little time with the research. Where do you think we are? What do we need to do? How do we move the ball down the field with the research?

Funding, funding, funding. I mean the research doesn't happen unless you have funding. So that's why I want to create this, I believe state funding agency to provide the funding necessary to ask those questions. There are great scientists in this space who are doing wonderful work and there could be more if there was funding available. Very similar to the same thing I experienced with stem cells and trying to come up with treatment for als. It all comes down to funding. So I'm a big supporter of using data to drive policy and we just don't know enough yet. But we certainly have some strong indications of what's going on. And to me it just means we need to do more funding. These medicines have been in man for tens of thousands of years. And I think we can say these circumstances, these plant based medicines mostly except Melissa and the fungus based, they have a strong contribution to human civilization and society and they've had over a long time. So let's like look at the data, come up with ways to safely administer them to people. I don't, again, I don't think everybody is amenable to this. And we have to decide, we have to data to decide which people are amenable and which people aren't and then start running these trials on larger scale, collecting information, tracking information over time. Not the old paradigm where you're just in a clinical trial for a short period of time and then you lose track of them. You know, we can take advantage of all the technological advances that we have, including wearable devices and apps that can keep patients engaged and we can, we can keep this information in a large bioinformatic database that we will make open to the public and safe in a secure way so that there could be researchers anywhere around the world that could just site look at, well, maybe you know, what happens to these type of people under these circumstances and come up with some novel way of administering these medicines. Again, it's so promising, it's so promising that we have to do this. I mean economically it just makes no sense to me to keep on doing the same, same, same and that the billions of dollars we're spending on depression, anxiety and addiction and pain, I mean we can go on and on and on. So yes, research is essential to move it forward safely.

So I had the pleasure of Dr. Rick Strassman for this. Strassman, I should say. And I'm finally reading his book Spirit Monocle that I wanted to read for a long time. It's a great narrative and story about his journey through funding and research and the FDA and all the rest of it. And so curious, and this little points of my ignorance around this particular element, but, you know, there are things going on at the state level that have moved things forward, even though the federal government's not ready to go there for medical marijuana, recreational marijuana in various states, the decriminalization of plant medicines in Colorado and Oregon, and there's a ballot initiative coming up where I live in Massachusetts. So I'm curious, in California, is there a sort of state level of the fda and would research be able to move forward in California even without the FDA sort of putting their imprimatur on it, or is California willing to do that? I mean, you know, this whole state federal relationship and how that impacts funding and research and policy, these are great questions.

And again, I'm going to say I've got beginner's luck because I was involved with the Serum is the acronym for the California Institute of Regenerative Medicine. Embryonic stem cell research was federally prohibited, yet we were as a state agency able to work with the federal government on promoting research and bringing these medicines. We got FDA approval on two of them. So there are ways to do it. You know, again, my experience is showing a comprehensive program and working with the federal government addressing concerns that we actually can bring new therapies to the marketplace now. Yes, I would like to bypass a lot of the bureaucracy and the political polarization. Believe me, I would. However, because it's a reality we need to work. I believe we work within the system. Let me just share with you one of the concerns I have going state by state following the cannabis pathway. And I appreciate each of us come to the world using our experience to best to go forward. And there are many who have used the cannabis model successfully. It's taken decades to bring these medicine, cannabis to certain states and it's still federally illegal. As you know, follow that pathway. With psychedelics, I have a concern. My concern is that psychedelics, as you're probably well aware, are much more powerful and needed, I believe, to be treated with great respect. I have concern. When I was on my listening tour in California, I was with Governor Todd down in San Diego and we had to traipse over the homeless people down. Before we got into city hall and I was talking about the importance of bringing psychedelics safely to the public, he goes, look out my window. He goes, you see all those homeless, they're high, they're drunk, and now you want them to be on lsd? And I was like, no. And I don't. And so I do feel that these medicines need to be in a supervised setting. I personally have five kids. I didn't want my kids to be able to go into my medicine cabinet if that was it, and grab an LSD pill like they can ketamine or opioids. I'm not suggesting that there's not hypocrisy here, but I think because of the political history, the polarizing political history of these medicines, I have a sense that how powerful that they are, that they do need to be treated with respect. And so while I don't believe anybody should be in jail for drug use or abuse, honestly, I think they need to be in treatment program. I do hesitate about making these medicines legal and decriminalized state by state without having the infrastructure there for safety. We saw in Oregon what happened, the amount of drug abuse that was happening there and overdose. You know, you could argue, and I think reasonably argue, that it's common dominant with the fentanyl lacing and the pandemic spurred, you know, worsening mental decline. I get it. But look at the backlash the state. And I think it could be a real problem again, I've also worked with this group of mothers whose children were experimenting with various psychedelics and for terrible reasons ended up dying. They were not supervised. And what I admire about these moms is they're not saying, don't ever let anybody touch a psychedelic because their kids are going to die. Rather, they're saying, how do we do this so that it can be done safely? And then lastly, when you go state by state, it means that the people in our country, the other people in our country don't have access to it. And I believe this is such an unmet need and so many of us are suffering that we have to make this available for everybody in our country.

Yeah, you bring up some really important distinctions there. And you know, what has happened with the world of medical marijuana, medical cannabis, and then now recreational in many states, there's been a kind of a natural blending of those movements and the commercialization and so forth. Maybe it works there because cannabis for whatever some people think is much more benevolent or at least lower risk than at least if it's not mixed with other things, lower risk than the psychedelic medicines. Now having said that, psychedelic medicines are very powerful medicines and yet apart from ketamine, which is not a true psychedelic, they're not considered addictive. But then of course they can be mixed with other things and it can get into this, this whole milieu. So obviously it needs to be treated very carefully. So maybe we could move into the world of training a little bit. And I'm curious about what your initiative, how you would be supporting that. So there are existing training programs for mostly for clinicians, licensed clinicians and some for guides. Fluence as a training organization, very involved. The California Institute of Interval Studies as a graduate level professional training program. They're open university where I got my master's degree, has a similar program, I think the University of Arizona under Dr. Wiles, developing one for physicians. So there is an existing infrastructure of training programs developing. And I'm curious about how your initiative, if it goes through and you have this funding, would work with those and try to enlarge the landscape of that training.

Yeah, so a couple of things I want to just finish up on, you know, legalization and decrim. I want to share that while I think it's important that more research is done in building safety predict, it doesn't mean that we're going to go slowly. It doesn't mean it's going to go slowly. Okay. So part of the element, part of the important element of psychedelic assistance therapy is having good facilitators. And as you just mentioned, there are various programs that are training people to handle it, which I think is great. I think there needs to be some consistency and quality control so that in this space I do think it is different than my other experiences of the therapy because there is this, I call it non sexual intimacy. There's a non sexual intimacy that I've not experienced in any other paradigm that I have. And I think that that lends to part of the healing process. But it also can lead to inappropriate sexual relationships, transference of emotions that are very strong. And I think it takes some real awareness on the therapist's part and the training of that to make that in the forefront. And how we do that exactly is something that needs to be discussed. Let me share with you the model again, with which I'm basing how we would build treat. Each of the divisions, treatments, research, education, access and therapies would have their own leader, a CEO of that division, if you will, that would pull together thought leaders in the space. We don't need to reinvent a lot of stuff. But what we do need is pull people together and go, okay, we already know that this type of therapy works well and what are the concerns and how do we have quality control and scale it? These are public forum meetings where you come together and then you come up with a plan and then you start executing on the plan. And what I am demanding to be the case in this agency is that we have a plan that is easy to modify with input, that we get information that we get. So in other words, I don't want to be going down this path just because it went down there. And then we find out that, oh, something has come up in this, this part of the training process does not work well, that we need to modify it, that we have to have the program in place that we can modify. So when you look at the therapists that are available right now and the idea of getting FDA approval of these therapies to start so that they're available to all, I think we have to go on a more relied method until we can get more information on how we can branch out. So what does that mean? It means starting with already trained professionals, psychiatrists, psychologists, LFTs, MFTs, and then and so on and so forth to start with that. And then as we show that these medicines are safe and effective, that we want to build it out more. There is a paucity of therapists now in our country for mental health care. So part of what our funding would do would be to pay for training. We anticipate creating about 200,000 new jobs for therapists. I mean, that's the minimum. That's what's needed in our country. I think an untapped potential source is, are the nurses. I'm aware that the nurses, certainly in California, are so dissatisfied with their working conditions that they choose not to work as nurses anymore. And it's not that they don't want to be healthcare providers who just can't stand the system that's asked of them. And I thought, what a wonderful way to bring them back into the fold to be good facilitators. So these are some of the initial ideas that we're sharing about how we would build the necessary training and certification and oversight needed for the psychedelic assisted therapist.

This is such a really important issue. And the idea that, you know, you want to create funding to be able to do that scale is very exciting because a couple of things in terms of the economics of going to scale, some people talk about non clinical guides being, you know, at least part of the equation. And that may be possible, but then there's also the emerging kind of, you know, the, or the existing psychiatric so called psychiatric renaissance and all that's kind of happening below ground and above ground and somewhere in the middle. And so there's a lot of non clinical people, you know, and there's even training programs out there for non clinical people who are, you know, supporting people as coaches and really outside of the medical model, outside of the clinical model. And my concerns with that, and I voiced this in a number of conferences and so forth, is that these non clinical folks have not had the kind of clinical training that teaches you about transference and countertransference and all the other potential for ethical violations and just problematic things which happens in the world of psychotherapy frequently enough now. We would hope it never happens, but even with all the training, it still happens because these are very intimate relationships. And you know, I was, I think, disappointing that the FDA advisory committee decided to focus in on that one incident that happened six years ago in the clinical trials, because actually this happens much more frequently that in the world of psychotherapy. Now psychiatric medicines do exacerbate or elevate that intimacy. So maybe the risk is higher. But even in the medical model there are a lot of clinical psychologists and psychiatrists who have not had much therapy training, quite frankly, and yet they would be, you know, so it may often be the master's level therapists, the LMFPs and others who've actually had more real therapeutic training. You know, it's on universal, but I mean there's some elements of that. So I think it's really important how to think about doing that. And certainly within clinical work on psychedelic assisted therapy, we're not talking about the broader exploratory use of psychedelics by the population, but within this world it is really going to take a big effort and funding to train, as you said, a couple hundred thousand well trained therapists, clinically trained therapists that are needed to do this safely and to not create the kind of backlash that could happen.

Yeah, so yes, and I have met some incredible facilitators in quote, unquote underground and have great respect, great respect for those who have dedicated their lives to help. Unfortunately, there are many, I mean, in la, everybody calls themselves a shaman. So there are those two. And so my concern is, how do you, I call them the wisdom keepers? They're true wisdom keepers. How do you bring them and have them at the table advising and informing as we build this, the therapy or facilitator portion of this. I think it would be stupid of us not to bring the Wisdom Keepers to the table and take advantage of the depth and breadth of what they know.

We try to bring Wisdom Keepers, indigenous people with genuine deep shamanic training and so and definitely not talking about that world. And in the world in the Americas and Africa and other places where there are shamanic traditions working with plant medicines. By the time they're in that role, they've been through a lifelong process of training.

That's right. Generation sometimes.

And they may have, I think, have a lot to teach us in the clinical world of the west. And there can be great communications there. At the same time, there's this whole. And there are some, there's even psychotherapists who have decided to let go of their licensure and work underground because they are impatient. They want to do the work with people and they're probably doing really great work. But there's also a bit of a Wild west out there and there's a lot of who take on the shaman label, as you said, and they may or may not have actually trained with indigenous shamans outside the country or wherever. And yet they're already training other people and under that kind of guise and imprimatur, you know, so I think it's. How do we really honor the depth of training that is in the indigenous world and with a relation of sacred reciprocity and mutual respect, pull together the best marriage of that in our clinical training. And you know, we can't really address, it's hard to address what's going on in the underground. But we certainly, as we roll this out above ground and try to reach people, we want to do the best we can with it.

Absolutely. And I see it in steps or stages. You know, we could make the analogy of climbing Mount Everest. You don't just race up Mount Everest. I mean, you prepare for months and months. You go to, you know, stage one, two, three, four before you summit. So I can see many ways of progressing with this medicine and bringing it again safely and excessively to those in need. It's pretty clear to me that in order to do that we have to do more traditional pathway. So psychiatrists, psychologists, mfts, people and give them extra training in this space to start. We will also, I want to share run studies because we have research dollars to look at the non traditional facilitators, the under the Wisdom Keepers and look at that more ritualistic approach to healing. And really, you know, you could make an analogy, and I don't think it's far fetched at all is, you know, religion has done that for society. We come to church, we pray as community, something beyond ourselves, bigger and beyond ourselves. Well, in many my experiences, in many ways, that's what the underground facilitators do. They help us stay in touch with that spiritual energy. Some call it God, some call it spirit, force, love, whatever, but it's important. And how do we explore which people are more responsive to this approach and others? And so I like to think about when you go to a restaurant and you have a menu and you may not like anything with cheese in it, and I do, and I want to be able to order my dish with cheese and you want your dish without cheese. And so this is part of changing the paradigm with which we deliver mental health care. What resonates best for you? So in order to get there, we need to do the studies and it does not have to be long term, but it's tracking these outcomes and it's following what happens with these people under various circumstances, with time, over time, and then how to have a safety net for those people if they start crashing again, if you will. So I very much embrace the spiritual side of this healing process. And spiritual perspectives are different from different people. And I think all of us should be able to come together and use whatever resonates most deeply with me as an individual and you as an individual. How to do that safely, though, in the beginning is going to require more standardized care.

Well, it's very exciting to hear that your initiative would put real research dollars and support into exploring the indigenous plant medicine traditions as well and how to bring these together. It's very exciting. And I want to talk before we run out of time here, I want to be sure to talk about public education and also delivery systems and accessibility. But just one thing that occurred to me as you were speaking there, there might be something I've been involved in, in a VLAD care hospice and chaplaincy a good part of my professional life. And there might be something to learn from the world of clinical chaplaincy. You know, although most chaplains are trained to meet people where they are and work with anybody from any religious tradition, but we're not telling the chaplain what their theology should be, but at the same time, they are getting trained in basic clinical skills as well. Right. So there might be something to learn from that existing infrastructure.

Absolutely. You know, again, I think when we have money and then bring together thought leaders to say, hey, let's look at this, look at the route, and then we can do that. And you absolutely bring up a great point. So, you know, again, just need the opportunity to have funding so we can actually address these programs. And then I focus on how to do it cost effectively and efficiently. I'm not interested in bureaucracy 20 years later. LA la la. No, let's go now.

Yeah, great. It's interesting coming out of the medical world and the research world, you seem to have a strong entrepreneurial spirit, which I think is what it's going to take to get the job done. So I do want to talk about potential delivery systems, issues of accessibility and diversity and so forth, but in terms of public education, I think it's important in terms of psychedelic assisted therapies, in terms of shifting, you know, removing stigmas, not just about psychedelics, but also mental health altogether. That longer term, bigger project of removing the stigmas around mental health, but the public education around changing, you know, being more informed and changing uninformed attitudes around all that. But then also in terms of the fact that there is this psychiatric renaissance going on and there is inevitably going to be people exploring these who are ostensibly, well, people exploring them for their own spiritual evolution, psychological evolution, personal growth and so forth, it seems to me that we need to take ownership of this and create good public education so these citizens can do that in a well informed way. They can be educated and you know, a little bit the buyer beware thing, you know, that we do. And I love what you said before, I mean, you know, I felt like you were singing my song earlier when you talked about the ownership and how to shift out of a system that tends to put us all in the victim position. Name of my book is Radical Responsibility. So I'm very much into how do you marry both individual and collective responsibility effectively. So those of us in this movement, we need to somehow take responsibility for educating the public so people, whether it's in a clinical setting or not, can make informed decisions.

Absolutely. Come join my team and efforts because this is exactly, you know, what we need. We come together and we come up with ways to effectively accomplish what you just mentioned. And so I think using the social media platforms that seem to sway public perception right now are critical. These are new skills. I mean, our generation is learning how to use this where the younger generation know how to use it. Well, I'm very hopeful. I'm hearing I have a gen zer. Their emotional lexicon, their terminology of dealing with emotions, self regulating is so beyond our generation, I marvel. I mean, if we were given those tools when we were younger and that they're doing it, you know, they learn on a TikTok or you know, whatever Instagram and they're picking up these little pearls I think is wonderful. My challenge has been how to reduce all that I'm sharing with you in like a 15 second like moment. I mean that's my biggest. You've heard me talk. I mean, I can't even talk, you know, and how to get it into a hashtagable, you know, message where this, you know, audience right now is all about add. You know, if your attention is not there, that's gone. So. But there are ways it's engaging the younger community just inherently know how to use these platforms better. You know, having funding to do that again through Treat so that we can actually develop great content because there's people are so just randomly going on their own and putting up stuff because they think it's helpful and you know, it's. A lot of it is, but a lot of it's not. So having some kind of stamp of approval or that I think is important.

Absolutely. Let's talk about delivery systems and equitable access and diversity and so forth. You know, there's been a lot of discussion from Maps and others talking about the need we need to train this huge number of therapists, as you mentioned as well. But there's also ideas of experimenting with group therapy models. Whether it was the actual sessions would be group or at least the integration would be integration groups. The clinical trials, the way they're done is not scalable as we know and would be incredibly expensive. And we don't want this to be a type of healing that's only available to an elite. Maybe is currently the situation to a degree. So I'm curious about initial ideas you have about scalability and delivery systems as well as how your initiative would fund about figuring this out. Figuring out there may be ideas on the horizon that we haven't even thought of yet to make all this work.

Work. That's right. So yes to all of the above and I. It's easy for me to go back into the research part. So we mentioned earlier we would have money to explore how a person does through group therapy versus one on one therapy. And maybe it's a combination. Maybe a person needs to come to this medicine space and they are more comfortable with one on one therapy and they evolve and grow and then they become in a group therapy or even ceremonial therapy and. Or maybe they need to go back to one on one depending upon the evolution of their emotional journey, if you will, of healing. We know that it's usually not just one issue. I mean people. Depression is not usually one thing. Or you know, complex ptsd, it's not one trauma. Addiction is not usually one thing. There are multiple things that we as I think empowering the person to have agency over one's well being the rest of their lives. So we have to have a system that can support that, that how to do that. Okay, yet to be determined. Right. Because this is a new paradigm that we're introducing. I have a strong inkling, these are all inklings, is that community is important. So a person will come with an issue. Let's just say depression, suicidality, and you know, undergoes psychedelic assisted therapy and has dramatic improvement. And within that short period of time, call it three months, it's like wow, wow, wow. And now they're kind of on their path, right. And these medicines for them, that might be the one and done or it might be they need a booster of six months or a year every five years. Yet to be determined. We have to have infrastructure in place to support the person. So how to scale that, how to scale that and scale it cost effectively are important questions. One approach that is not taken is the cost of not doing anything. Okay, let's take the example of opioid use disorder in California. These numbers are hard to pinpoint, but on average it was about $98 billion. And if we can treat 10% of those people, just 10% would save $9 billion. Okay, how would these monies be allocated? So the monies, instead of spending 98 billion on treatment paradigms that aren't as effective, we could spend a quarter of that or half of that on paradigms that are including community outreach programs where going into the different communities. Because each community has its own specific need, we go to those community leaders and help build programs around those specific needs. This is not reinventing the will. There are programs that have done that. But what we would do is pull the best of these programs together, discuss the pros and cons of them and how to execute on them, start executing on them to decide this program is working or it's not working and why, using that information to modify. So these are some ideas. It's like we're building something that we don't know what it is yet. I have no, no sense that we know exactly what to do. I mean we don't. We can't possibly. But what I do have confidence in is if our goal is to treat people, improve their outcomes, make it cost effective and accessible to all, and we focus on that trifecta that we can solve whatever problems come up. Only caveat that I'm concerned about is this. There is sometimes a societal backlash to if there's change. It means you're take. You may be perceived as you're taking something away from somebody to give it to somebody else. And that strikes a very primitive response in humans. We see it today in our political system. And so how to navigate those perceptions, I think is probably the most difficult and challenging aspect of bringing this to the public. It safely and responsibly.

Well, as well as the public and cultural attitudes and societal attitudes and so forth. If you're talking about $98 billion and starting to ship those resources, there's economic interest involved there.

So I want to just point out as a female leader to come and lead as a strong feminine leader who now I'm not trying to act like a man. I've got, you know, guys are great. But to lead with inclusivity, with aspirations and focusing on helping and serving each other. And I don't just mean idealistic pie in the sky. I mean this is our reality. And I would love the opportunity to bring together change makers and roll out a novel way of delivering mental health care. And if we start first in California and then it rolls out to the rest of the country, this is a paradigm shift and this is putting the accountability towards as a gift to the individual to take ownership and it's empowering for that person and providing the support systems and safety nets that are needed to do so.

Well, California certainly has led the way in many fields and standards and regulatory and many different fields. There's often the California standard. Right. It's referenced in so many different field. So I'm curious, just a couple more questions. One is, I'm wondering, is there anything we can learn from. I don't know what's going on in California. I think it's pretty uniform nationally, I think. But with ketamine assisted therapy, ketamine is used legally off label for, in combination with psychotherapy. And I think there's been a proliferation of ketamine assisted therapy clinics and individual practitioners. And then there's also the infusion clinics where people are not getting the therapy and they are benefiting. Some people are benefiting, it's lowering depression. People have different views about that. But anyway, we have this infrastructure out there. Let's, you know, maybe leave the infusion clinics aside for a moment. But the proliferation of ketamine assisted therapy clinics and so forth. And I wonder how that is in California, whether there's anything to build on there or and so forth.

I have to disclose my bias. I have a bias against this model. I am aware of patients who have benefited from ketamine and so I support that. But this financial model where a patient come in, they spend anywhere, at least in Los angeles, you know, 500 to $1,000, they go in, they get some, you know, the medicine, there's no therapy during it, and then they leave. While I appreciate the world of business structured around finances and financial incentives, I struggle with the motivation of this. So. And then, you know, the bad outcomes get amplified. So. And then it pushes everything back. And again, I like people to have choice and I like people to be aware and have safety. But I think there needs to be more infrastructure in place to support the safety of this. I do want to add my other biases. I think ketamine will be dramatically impactful with acute suicidality. Right now, a patient comes in with suicidal ideation and plan and they put on a 72 hour hold, put on SSRIs, it's going to take two to six weeks. And you know where some of the studies that I've read about ketamine in these circumstances can be life altering. So I'd like to see that used more rigorously as well as perhaps even with first responders as they come in with people who are traumatized and just take the edge off for them a little bit.

So I agree with you around. I mean, my bias is similar to yours in terms of the infusion clinics and even worsers, there also has been a proliferation of psychotherapy, ketamine assisted psychotherapy practices in clinics. So that's why I was really asking about whether something within that existing field of professionals, licensed clinicians who are delivering ketamine assisted psychotherapy, whether there's anything we can learn there and build on there.

Sure. And it's new, but there's no centralized way of collecting information. So. But yes, people getting help and if that is an effective way to do it, absolutely.

So where does your initiative stand? When will this go on the ballot? And so where does all this stand?

Okay, so we launched our initiative in 2022 in California, unfortunately. So a citizen driven ballot initiative is, other than it cost anywhere from 20 to 30 million dollars to qualify for the ballot, which is not chump change for a lot of people. So we started and we started raising some money and it was pretty great. And when we received, we ran out of funding. Long and short is we ran out of funding. Part of the process is we submit the legislation to The Attorney General's office. The Attorney General's office then has supposedly no influence from any other people and writes the language that the voters will see on the ballot. And in our particular case, our language was, I thought, put in the most negative light, terrible. It started off with constitutional amendment to create funded by bonds to create psychedelic research agency. And then the first sentence was using lsd, you know, ketamine, and nothing about the unmet need and the cost that we can, could potentially save. So when we polled that language, we found that the voters still approved, strongly approved funding to go for research and to safely bring these medicines out to the citizens. What they did not support was they didn't believe a government agency could spend the money wisely. And so while I agreed, I mean, that's why I'm doing this, because I agree that the government's not spending our money wisely. They're not aware that this is actually an independent state agency. And we will be with boards of entrepreneur people, problem solving people. And so rightly, you know, the citizens didn't want to spend additional $5 billion on yet another healthcare program. But it doesn't seem to be changing anything. And the homelessness we see around California is just staggering. So we withdrew from the campaign, but I have not stopped and I continue to explore different strategies to create a funding agency. And depending upon the election outcome, what would be ideal is if I could go to the federal government and establish an independent agency through the federal government, not dissimilar to what we would do on the state level. Of course, depending upon who wins the election may be more amenable to this than not. And if there continues to be support that I'm getting, I will probably run another citizen driven ballot initiative in 2026.

In raising the funds to do those kinds of ballot initiatives which many people were aware of, there's been many of them in California. Do you do grassroots fundraising to raise that kind of money?

Yes, I did. You know, the way I've been successful in life is I usually find stakeholders that have some significant wealth that. And then they make some phone calls with their friends and say, hey, I think this is something meaningful and is somebody who's been touched, touched personally by either suicide or addiction or depression or end pain, somebody who's had a personal connection or they support the military that come in and be some lead donors and then we fill in with the public's support. So that's still my approach. But I'm open if any of your listeners have any ideas for me on how Best to approach it. I'm all ears.

Absolutely. Well, that personal connection is so important. I helped start the first hospice program in a federal prison. After submitting proposal after proposal, it was finally when a new associate warden over programs came into that institution who recently had an experience with his own family in hospice. And because of that personal thing, he said, let's get this a prior. I'm also remembering being at the psychiatric science conference in Denver and last year and listening to Governor Rick Perry, former governor of Texas, who probably conservative Republican governor, but so passionate about veterans and supporting veterans in their health and willing to follow the science and the data that he ended up becoming a supporter of this research.

And I use that example a lot. Not only a supporter, but he went to his legislation and created $100 million fund to continue research for psychedelics and the treatment of PTSD in the military. So, yes, and so, you know, the work that you're doing here, bringing it to people's awareness is so important. I found that on my sort of campaign listening trail, I ran into two types of people, one that were aware of psychedelics and most that were not. And so I had to spend quite a bit of time explaining about, you know, the good science about this, that, no, I'm not, you know, the Timothy Leary take, you know, tune in, drop out, all that. And so there's a lot of education to share with people in our country. And the last thing I want to do, share that in the last five years, the shift of awareness of certainly psilocybin has been dramatic. There was a poll that was done in 2017 nationwide, and 20% of people supported research in psychedelics. And that in 2023, 2022, end of 2022, went up to 80%. And that was both Republicans and Democrats. One of my biggest donors, my first donor, was a very conservative Republican from Florida. That was really very uplifting for me to think that I got a conservative Republican from Florida to be one of my first lead donors. So.

Well, it's very. It's wonderful when some of these very human issues can bring people together across political divides. I've been very involved in criminal justice reform, and there has been criminal justice reform issues that have brought people together from both sides, both from the humanitarian angle, but also from just the economics of what we're doing as a work. Right. And so these absolutely come together. Absolutely.

Yeah, absolutely. Support. I support that. And, you know, I feel that addressing the mental health issue sort of the foundation of it. I mean, you can talk about, you know, somebody has some trauma in their lives, they don't know how to deal with it. They become an addict and then they have to steal and they crazy and then they're in jail. There's so many different pathways you can go down to, but I think if we can address the underlying cause, which is oftentimes how one deals with their emotional trauma in life. And I don't just mean rape or assault, but, you know, I don't feel loved. I don't feel like I fit in or these things that end up dictating how we act in the world.

So Dr. Fontana, just been incredibly illuminating. I really applaud your work and wish you all the best with your work and I hope you get momentum. This initiative again, it just makes so much sense and so needed and we hope, I mean everything you're talking about is the educational part is very much the mission of this summit. So thank you for being and I really wish you all the best.

Well, thank you. I really enjoyed myself and congratulations to you and all the good work you're doing.

Thank you.

You too. Thank you for joining me on the Radical Responsibility podcast. Remember, real change happens when we commit to our growth, face our challenges with compassion, and stay open to transformation. If you found this episode helpful, I encourage you to subscribe and help us spread the message of healing and personal empowerment. Stay grounded, stay present, and stay true to you. Take care.

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