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Psychedelic-Assisted Therapy: Healthcare Policies and Ethical Practices

Learn about the ethics and healthcare policies involved in psychedelic-assisted therapy. Jordanna Davis and Jacqueline Lampert join to discuss the implications.



Episode Summary

Welcome to the first episode in our three-part series where we explore the world of psychedelic therapy. In this episode, health policy experts Jordanna Davis and Jacqueline Lampert join to discuss the experiences of psychedelic-assisted therapy and its profound social implications. This series aims to uncover the complexities and potential of psychedelic mental health treatment options.


Key Takeaways

  • Controversial medical debate on whether psychedelic therapy practitioners should have personal psychedelic experiences

  • Concerns around cultural appropriation in psychedelic therapies and the need for respectful acknowledgment of indigenous practices

  • The complexity of patient-clinician dynamics if a patient prefers a provider who has personal experience of their condition

  • Significance of professional practice guidelines that ensure ethical and culturally sensitive approaches in guided psychedelic therapy

  • The future of psychedelics in therapy and its potential to revolutionize mental health care


Enjoy this insightful first episode as we unravel psychedelics and mental health with Jordanna Davis and Jacqueline Lampert. Tune in for the next two episodes of this exciting series dedicated to exploring psychedelic therapy research.


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Guest Bios

Jordanna Davis is the President of Rockingstone Group, a New York-based health policy consulting firm serving a diverse clientele including hospitals, health plans, and tech companies. Prior to founding Rockingstone in 2016, she was integral to the operations at Sachs Policy Group, advising New York's major health systems. Jordanna's extensive experience in Washington, D.C., includes roles as a Health Care Fellow for Senator Russ Feingold and a Legislative Assistant for Senator Sheldon Whitehouse, contributing significantly to the Affordable Care Act. She also brings experience from the Georgetown Health Policy Institute and the Greater New York Hospital Association. Jordanna is a board member of the New York eHealth Collaborative and holds a BA from Yale University and an MPP from Georgetown University. She resides in New York with her family.


Jacqueline Lampert is a Principal at Rockingstone Group, specializing in health consulting that combines policy expertise with experience in various healthcare sectors. She played a pivotal role as a health policy advisor for the U.S. Senate Democratic Policy Committee, contributing to the Affordable Care Act under Senate Majority Leader Harry Reid. Her career also includes legislative work for Senator Tim Johnson and roles at UPMC and New York Life Insurance Company. Jacqueline holds a Master of Public Policy from Georgetown University and a Bachelor's in Communication from Northwestern University. She resides in Ohio with her family.


Transcript

Georgie Kovacs:

Join us as we delve deeper with Jordana and Jacqueline into how this evolving landscape is reshaping the future of mental health care.


Georgie Kovacs:

Thank you so much for joining the Fempower Health podcast. It's so interesting how this psychedelic series has come about. I've been thinking about it for a really long time and I wasn't really sure how to approach it. I had read Michael Pollan's history and I knew about his book, but I was like, I don't know if that's the know expert to have on the podcast. And I was talking to a dear friend of mine who is also a healthcare consultant, and she told me that I should speak with Jordana. So, Jordana, you and I had a call, and I thought this was going to be a very simple conversation. We'd do an episode and then we'd be done talking psychedelics. And you educated me on all these things that I didn't even realize we needed to discuss.


Georgie Kovacs:

And so I really appreciate you educating me on that. And we're going to talk about that today because it's inspired a three part series, and I'm actually doing series now on lots of health topics because I do think a lot of them warrant more than one episode. And so thank you for helping get the ball rolling on that. So, without further ado, before we dive into the topic, why don't we do some introductions and we can take it from there? So, Jordana, since I brought up your name, why don't you go ahead and start?


Jordanna Davis:

Thanks, Georgie. We're so excited to be here. I'm Jordana Davis. I'm the president of the Rockingstone Group. We're a health policy consulting firm in New York. My background is in the federal government. So I worked for two senators during the drafting and passage of the Affordable Care act. And we've been working on the policy side of psychedelic medicine for about three years.


Jacqueline Lampert:

And Jacqueline, I'll just echo Jordana's. Thanks, Georgie. It's so exciting to be with you today to talk about this exciting work. My name is Jacqueline Lampert. I'm a principal with the Rockingstone Group. Jordana is based in New York. I'm based in Ohio, and I also have a background in the federal government. I worked for also two different senators, including Senate leadership, during drafting and passage of the Affordable Care act.


Jacqueline Lampert:

And then once I left the Senate, I worked a payer in a health insurer and also a provider, and have been consulting for a number of years. We consult with a range of different healthcare organizations, providers, payers, advocacy organizations, health tech companies, all looking at healthcare from a public policy lens.


Georgie Kovacs:

For those who've listened to the Fempower Health podcast in many episodes, maybe like, hold on a second. You usually have either patients who are going through a health issue or a doctor or someone who's researching and. Hold on a second. What are consultants doing on this podcast? So I just want to address what could be the elephant in the room? Who knows? But one, I think as this podcast has evolved, women's health has evolved. Like, in the beginning, it was all about what are these conditions? And now with social media, there's so much happening with foundational education. But now we're in this place of so many things, in all of healthcare is evolving. So what is the landscape and how does that impact us, whether we are a clinician? Because I know a lot of clinicians now listen to the podcast, and even as a patient. And so that's really why we're doing this.


Georgie Kovacs:

Know, I alluded to Michael Pollan's book, and since that's been published, and probably for many other reasons, the discussion on psychedelics has exploded. And Jordana, when we first started talking, you had educated me that there's really a few areas that we need to look at. It's not as simple as are psychedelics good or bad. It's much more than that. And you laid out this landscape, which is, again, why it's a series. So why don't you start with helping us understand the broader piece of how we need to look at it? Because it does have an impact on so many other aspects for clinicians, patients, researchers, the whole industry.


Jordanna Davis:

I think that's a really wonderful place to start. You can get really confused about psychedelics out there, reading news in the world. So let's make it really clear. We think of psychedelics in four buckets. We call these access pathways. So the first one is the medical model. This is the area in which we work. What do we mean? We mean pharmaceutical companies studying a particular compound through a clinical trial, looking to make measurable improvement on a particular diagnosis, the same way you'd undergo any other medical treatment or specific diagnosis that was causing you suffering.


Jordanna Davis:

So we have two pharmaceutical companies that are working towards an NDA, a new drug application to the FDA. That's compass pathways. They're studying psilocybin for treatment resistant depression. And then we have maps and they're studying MDMA for PTSD. Okay, so that's number one. Number two, wellness models. If you've heard about Colorado, you've heard about Oregon. This is what we mean.


Jordanna Davis:

These are states that have legalized a particular psychedelic for use within certain regulatory boundaries. So you have to be at a specific location, you have to be using a specific guide. Some important notes on Colorado and Oregon. You don't need a particular diagnosis to use these drugs in these states, you generally have to use a guide. That guide has done some level of state training, but actually specifically in Oregon, if you have medical training, you can't use it in your work under that program. So it's really not a medical model. It's important for people to know that. But of course, without fail, any article you read about Colorado or Oregon will mention a clinical study.


Jordanna Davis:

And so consumers have a right to be confused about that. The third is decriminalization. This is advocates looking for use of these recreational drugs without criminalization. And the fourth is spiritual and religious use. So we have federal law that protects certain pathways for folks to use these for religious and spiritual purposes. It's easy to be confused. Our focus is on a medical model. And even honestly, some of the pharmaceutical companies can be unclear about their work.


Jordanna Davis:

In the same breath, they'll talk about culture, well being, medical, and it's quite confusing for anybody.


Georgie Kovacs:

The wellness legalized. I just want to touch on this one. I almost like paused when you said that Oregon is not sorry. The way you mentioned it, I'm like, wait, I don't understand. It didn't even make sense that I can't even repeat what you said because it was so confusing to me.


Jordanna Davis:

So Oregon has created a structure in which there can be legalized use of particular psychedelics within certain regulatory structures. So if you're in a certain location, if you're with a guide, those are appropriate uses under the state law. If you are a guide in Oregon, there's some state training that you need to do, but you're actually, from a statutory perspective, prohibited from using your medical training in your work as a guide. So this is very specifically not a medical model.


Jacqueline Lampert:

I think it does get confusing. So, for example, if you are a mental health practitioner and you want to be a guide in Oregon, you can take the state training to be a guide, but you sort of have to take your mental health practitioner hat off while you're performing services as a guide in the Oregon wellness model. And I think it can get a little bit murky because a lot of times when these initiatives are placed before voters, the messaging will talk about the mental health benefits of psychedelic assisted therapy. But this isn't a mental health treatment. It's not psychedelic assisted therapy. It's really wellness access to a psychedelic drug.


Georgie Kovacs:

Thank you very much. That makes a lot more sense. Thank you. And then for Colorado, it's, again, more the wellness approval, so to speak. Okay, so let's talk about the medical piece of this in this series. I'm going to be interviewing a researcher who's going to talk about where we are with the data, and his name is Andrew Penn. I'm so excited to connect with him and what else we still need to be researching. I'll also be interviewing Lynn Marie, who runs psychedelic Medicine association, and she'll help us understand the nuances of working with clinicians and patients, because I know there's like all sorts of rumors on how all these patients hurt their doctors and therefore psychedelics are evil.


Georgie Kovacs:

We should never use them again. Mixed messages out in the media. So she has a lot of perspectives. Now let's talk about from your expertise, what do you think within this framework are the potential social implications? Because it's one thing to have certain things legalized versus not, and we can make all the arguments on what that should be. But what are some implications that we should consider around this widespread use of psychedelics?


Jacqueline Lampert:

That's such a great question, and I think it's important to think about the implications maybe in a couple of different ways. When we think about the implications of more widespread recreational use or wellness use, those may be a little bit different than the implications of widespread medical use. And our work, as I think Jordana said, has been really focused on the medical model, and we really bring, given our backgrounds, a public policy lens to that. And so sort of given all of that, I would say, thinking about the medical model, the results from these trials are quite promising. I think we look at some of the trials for post traumatic stress disorder, and many of these patients don't have PTSD after they go through psychedelic assisted therapy. Many people have their depression symptoms substantially reduced. So I think if psychedelic assisted therapy performed in the same way, once it's available outside a clinical trial to a broader population, as we're seeing it perform inside a clinical trial, we can be incredibly hopeful about the social implications for reduced suffering from these targeted mental health conditions. I think it's important to remember at the same time that all clinical trials, including these trials for psychedelic assisted therapy, have limitations that can make it difficult to predict how they will be received and how effective they'll be in a broader population.


Jacqueline Lampert:

So when we think about psychedelics, there have been a relatively small number of fairly racially homogeneous research subjects, although the more recent clinical trials have become more diverse. And like all clinical trials, these studies are conducted on a very carefully screened population. And the people in the trials typically don't have other mental health or physical health conditions because we're trying to target how does this treatment affect this condition? But that's not really the way people exist in the real world. We know from other research data that people with mental health diagnoses have other physical and mental health challenges. They don't typically present with just one diagnosis. So I think that we will really still have a lot to learn once these treatments become available outside of a clinical trial and how hopeful we can be about their impact on a broader population.


Georgie Kovacs:

It's really going to be exciting to see what happens with our technology, the mandates that are happening. So it's even broader than for psychedelics because it is scary that clinical trials are very controlled and we haven't had the technology we do now to truly monitor real world evidence for a lot of different medications that are on the market. And with psychedelics, I don't know. Would you say that it's a greater risk even with psychedelics, that the homogeneity, I think I said that, right, the homogeneity of these trials and being so specific in how they're running them, meaning it's not necessarily the real world. Do you see that it's a greater risk with psychedelics?


Jordanna Davis:

I don't know if it's a greater risk. This is true of every trial. Unfortunately, it's why the federal government is making such a broad initiative to try to improve it. Psychedelics generally actually have showed a fairly positive safety profile relative to some of the other drugs that we use in mental health. So I think it's probably just no different than anything else.


Georgie Kovacs:

And again, this is why I wanted to do this episode series, because I will say I haven't fully understood, and there's a lot of things that we can try to research, but we can't always realize what all in this world we need to dig further into. And with psychedelics, I think on the surface people probably misunderstand how they work and can help people. So maybe we can talk about that piece because you are saying the safety profile isn't as bad as people think, but I'm not sure if the general public fully feels that way.


Jordanna Davis:

The medical model looks like other medical models. We've got a psychedelic medication paired with specialized psychotherapeutic support, and we're looking to promote healing of a specific condition. Today, of course, it's only available within clinical trials, but we're talking about broader access. So generally when we talk about the medical model, and we call it psychedelic assisted therapy, we have five parts. The first part is patient screening. A clinician interviews a patient, determines whether a psychedelic medication could be appropriate and indicated for treatment. Second piece is medication management. Some patients are on other medications and they may require dose adjustment, temporary discontinuation of other medications to avoid some undesirable interactions that can be true of a lot of medications that folks take.


Jordanna Davis:

The third is called preparatory psychotherapy. So this is where a patient meets with the clinician, builds therapeutic rapport, trust the clinician educates the patient about what the psychedelic experience is going to be, and then, of course, explaining logistics, where should you go when you're going to show up, what should you wear, and any potential risks that are there as well. And then also, which is really important, providing approaches for emotional self regulation. During the medication administration session, many emotions may arise that a person has not dealt with before. They can be bigger and stronger than anything you felt before. And then you go to the medication administration session today. That's a six to eight hour session. Remember that everything that we're talking about is based on the clinical trials that have gone on.


Jordanna Davis:

We're not talking about any innovation that might happen in the future. Today, these are six to eight hour sessions. They're typically under the supervision of two healthcare practitioners, one generally a therapist, maybe a second therapist, or another staff member. And the care team, of course, remains with the patient through the session until the effects of the drug have worn off. And again, the healthcare team might provide psychotherapy during the session. They might provide other therapeutic interventions. And needless to say, they're monitoring the patient for signs of any physiological psychological distress, offering support as needed. The last piece is the one that clinicians tell us is absolutely the most important, and it's called integration.


Jordanna Davis:

It is usually three or more psychotherapy sessions. They're typically conducted in the days and weeks after the medication administration session. Of course, this therapy can go on for the rest of your life. Many people in therapy for the rest of their lives. The provider helps the patient assimilate potential insights that were gained during the medication administration session, process the experience, incorporate the insights into your life, and that's the broad scope of the medical model.


Georgie Kovacs:

So, a question for you then. So this is how the clinical trials are run. And I see such a connection with medical and wellness. I'm actually curious if we're going to see a lot of blurred lines around this, because when I think medical, the historical way that our society works is I'm sick, I go to doctor. That's where I think medical. And I feel like wellness just from a general perspective. When I think wellness, I think proactive, not necessarily going to an MD, just having other ways of looking at my health. But when you're in the medical world, it's highly regulated, and in the wellness, it's less regulated.


Georgie Kovacs:

And so if you don't mind, I'd love to just do a quick comparison here of potential risks. Are all of these steps needed for psychedelics to be safe?


Jacqueline Lampert:

A lot of the work that we're doing is really trying to clarify these different pathways and the different risks and benefits of each so that a consumer can make an informed decision. And I think this gets a little bit to your question earlier about kind of the fear or uncertainty surrounding some of these new treatments. Some of that, I think, is just related to stigma, both stigma about mental health care and seeking mental health care in general, and then stigma about these drugs, which are schedule one substances and are not legally available in the United States right now. But I think the other part of it is there are thoughtful risk benefit analysis that needs to take place if you have some of these conditions that are contraindicated for psychedelics. And so if you go to a wellness model, it is unlikely that that access pathway would provide the same steps that Jordana just laid out for the medical model. So you likely wouldn't have the rigorous screening to ensure that you don't have these contraindications. And then, because at least in Oregon, the guides cannot use their mental health training. There is no psychotherapy because you need mental health training to provide psychotherapy.


Jacqueline Lampert:

There's really just staying with the person who's taking the drug and ensuring their physical safety during the time that they're under the effects of the medication. So the pathways are very different and there are definite and clear risks and benefits to each.


Jordanna Davis:

I would add, when we talk about the medical model, we're talking about compounds being approved for specific diagnoses, which means that folks in the US who would be eligible need those diagnoses. And of course, we know 40% of medication use in the US is off label, but I think folks would be quite careful and they would obviously be rems, which are sort of rules that the FDA puts out for drugs that have sort of some sort of a risk profile. And we wouldn't be talking about, probably early on, broad, broad access to these drugs through the medical model.


Georgie Kovacs:

Right. It's not like we're having to necessarily create new drugs because the drugs already exist. It's more the trial of how we use them. Is that correct?


Jacqueline Lampert:

That's right. These compounds have existed for millennia, and some of the pharmaceutical companies are taking that approach, that the compounds have existed for millennia. They're not applying for patents, and they're just to use these compounds in a targeted way for a particular condition. Other pharmaceutical companies are taking the compounds that are sort of naturally occurring and making minor adjustments to them so that they can apply for a patent, and then it would be just that compound that they're applying in clinical trials to a particular condition. So that does make this field pretty unique, that some of the compounds that are in clinical trials and will be placed before the FDA for approval are not new, necessarily, because they've existed since potentially the beginning of time.


Georgie Kovacs:

I don't even know how I asked this question, so I'll just go with it and ask it in the very blunt way from what you understand, because people will want to know this. Are there legitimate nuances from these companies who are trying to patent the actual product for the consumer? How would all this work? And how do you access the different medications once they would be on the market for the ones separating out ones that are researched and patented, versus the on