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.
Related to this episode:
Resources for Mental Health
Learn more about the Rockingstone Group
Connect with Jordanna Davis and Jacqueline Lampert
Article on first NDA for psychedelics
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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 ones that have been on the market?
Jordanna Davis:
At the core of your very important question is that the cost of drugs in this country are absolutely out of control, and they make treatments unattainable for the large majority of Americans. So what is a huge hurdle that the medical model of psychedelic assisted therapy has to overcome. We can talk about some of them. We talked about one, which is FDA approval. We can talk about another, which is DEA scheduling. And the third one that is hugely important is insurance coverage. It is the path towards equitable access. And we have the Medicare program, the largest insurer in the country covers maybe 18 - 19% of people.
Jordanna Davis:
They're a thought leader. When Medicare says they're going to cover something, private insurance companies very often follow. They create something called an NCD or a national coverage determination. It would be extraordinarily important if drugs that got FDA approval were able to get an NCD from Medicare. We don't know if that would happen. It's also really important that Medicaid programs, which are state run health insurance programs that cover another 18 19% of people, make decisions to cover these drugs if they had FDA approval. The third issue is private insurance. Everybody who doesn't have Medicare or Medicaid, aside from a small percentage of people who are uninsured in this country, we've done a good job in the last couple of years to get that much higher.
Jordanna Davis:
They're on private insurance. It's really important that private insurance companies cover these drugs. The clinical trials that are running now, we've seen estimates that it can cost up to $30,000 to run to do a single course of the medical model which we described earlier. So it's really important that coverage is comprehensive and available to people so that they can have access to these drugs. Needless to say, the mental health system is rife with people not taking insurance. Right. Just taking cash. It won't work.
Jordanna Davis:
You won't have access to these drugs if people aren't covered with insurance.
Georgie Kovacs:
And is it $30,000 for the whole trial or per person?
Jordanna Davis:
Per person going through one of those treatment patterns that we discussed, and I.
Jacqueline Lampert:
Would just add a little bit about how the applications that will come before the FDA for this treatment are a little different than what the FDA typically sees. So the FDA is generally in the business of determining whether, let's just take a drug or maybe a device is safe and effective for use in a certain population. The interesting thing about these psychedelic applications is that we have some indications that the pharmaceutical companies will be applying for an approval of psychedelic assisted therapy. Now the FDA is not in the business of regulating what it calls the practice of medicine. This is why we see many off label uses of FDA approved drugs, because the FDA says, we've said it's safe and that you can use it and you prescriber are responsible for the practice of medicine, and you can prescribe it to whatever patients you think would benefit. So if the companies are applying for approval of psychedelic assisted therapy, it's not just the drug, right. It's the whole therapeutic container, it's called. That goes with it.
Jacqueline Lampert:
And that's a different question for the FDA to consider that it doesn't typically consider. And then that could impact how patients can access the full course of the treatment.
Jacqueline Lampert:
If the treatment is not just taking the drug, but having the entire therapeutic experience that goes with it. That's a little bit of a different access question than just, should I just get this drug wherever I can find it. I think the other thing I would say about patent versus non patent, we know that for any of these sort of naturally occurring compounds, there is a lot of variation in their potency and dosing. And so it can be a challenge sometimes to know what you're taking and how much of it and that sort of thing. And so I think maybe that could be a way that manufacturers are trying to, I mean, obviously make money, because as you pointed out, this is a capitalistic system, but also to get to.
Georgie Kovacs:
Patient safety, it's so unbelievably complex, and I'd rather just address the elephant in the room with the best way we can possibly answer the question. So I really appreciate that. One question that's also looming is, if we get this right with psychedelics, and even when I was listening at the conference to all these experts talk about various aspects of psychedelics, do we see this future where we could possibly have a system where it's one time dosage or however often, and how we use these medications could be completely transformed? Like, are we really possibly getting to that point?
Jacqueline Lampert:
I think that we can be hopeful of a future like that. I don't know that we know for sure for a number of reasons, including the limitations that I described earlier, but we are seeing patients who go through, and in some of these clinical trials, they may have three doses, which is a lot different than chronically taking medications and participating in therapy in a lifelong way. But after three doses, there are some patients that don't have PTSD anymore or have such substantial reductions in their depression symptoms that their life is radically transformed. And I think that when you have a therapy that can deliver that kind of healing, it is really an ethical responsibility to investigate it further and to see which patients can benefit from this and how they can benefit and then to make sure that they can access it. But I do think psychedelics are showing a lot of promise. There's also so much hype in this field. So I think it's really important to be responsible in the way that we're investigating how these treatments are working in these trials and then being very clear about which patients we think can benefit from them once they're approved.
Georgie Kovacs:
Back to equitable access, then. So we talked about the pathway for how Medicaid and Medicare are really leading the mean. Have there been discussions with them yet on approval and access, or have we not even gotten there yet? Like, what's their stance today?
Jordanna Davis:
I think generally, the federal process is an NDA, a new drug application to the FDA, FDA consideration of risks and benefits, approval or rejection, and then it moves to a consideration by Medicare, a consideration of scheduling for the DEA and so forth. So I can't speak to whether or not there have been sort of internal conversations at the Department of Health and Human Services about it, but that
would generally be the, like, there's some people.
Georgie Kovacs:
Who say, we already know this works. Why can't this just happen? Right? And then we need the trials to prove it. But I guess I'd never really thought about it until you explained it the way you did. So are we to now understand that we do need, is it only pharma companies or is it other to go through these trials to be able to have the evidence so that Medicare and Medicaid is comfortable with the coverage?
Jordanna Davis:
Yeah, that's exactly right. And we mentioned earlier that there are two pharmaceutical companies that are actually fairly close that we're getting to the end of this year. But it seems like certainly next year will be applying for new drug applications. And again, that's compass pathways. They're using psilocybin for the treatment of treatment resistant depression, and then maps with the use of MDMA for PTSD. And right behind that, we have another company that's looking at major depressive disorder.
Georgie Kovacs:
Let's say the trials come out and we are now in the Zen place. Medicare and Medicaid have said thumbs up. We have access. How does this impact the overall healthcare system? Because, like, for example, right now, because of the women's health focus, I see all these femtech companies who are doing telehealth, and they all need the Obgyns and the nurses and whatnot, but there's a projected shortage. So I'm like, how is it that with the number of companies trying to do telehealth, trying to have all these obgyns that are soon going to potentially not exist run this, I think, now to psychedelics? So right now, the way mental health works is you have the telehealth provider, you have your traditional. I've got my 45 minutes or hour appointment. This is a completely different model. This is, I go to someone for an entire day, but there's a lot of steps that happen in between.
Georgie Kovacs:
Have there been models done? I don't know if you guys have done it where it's like, okay, in order to achieve this, on the one hand, if people only need one to three to five doses, they're in and out of the system. But then you have people who have to go every week, once a month to their therapist to get so like, it's completely like lopsided with how we work today. Correct.
Jordanna Davis:
Jacqueline mentioned something really important earlier about mental health care, and we'll talk about in a minute. There are so many challenges here that reflect the rest of the healthcare system as well. So where do you go in the healthcare system and just sit in a room for six to 8 hours? Where does one do that? It's a very real question. Are there enough providers? There aren't even enough providers to do therapy. So now we're adding another service into the system. And these are really very real structural questions. There are a couple of models. We would bore your listeners to tears if we went through a couple of other healthcare models that might be sort of mirrors for this, but I think we don't really have something that looks like this.
Jordanna Davis:
And this is a very real question.
Jacqueline Lampert:
I think it's a really smart point to get to the infrastructure investments that need to happen in mental health care generally. But certainly for this particular model, which is so practitioner heavy. Right? Like we've got several sessions of psychotherapy where we have two practitioners that are potentially spending an entire day with one patient. We don't have a model for that.
Jacqueline Lampert:
Maybe in a surgical setting, but we really don't have a model for that in a mental health setting. So this really does require just a lot of practitioner time, effort, investment upfront. But when I think about sort of the long term or sort of healthcare arc of a patient, we know that patients that have these types of mental health conditions also have higher spending on physical health and other mental health conditions. And so we would expect to see that if we can help or resolve some of these mental health conditions, that then we would see savings. On the physical health side, we might see fewer visits to the emergency room because of mental health conditions. There are other things like cardiovascular disease or diabetes that are associated with some of the mental health conditions that are being studied in these trials. And so if we can affect the mental health side, then perhaps we would see a health improvement on these physical health challenges. And so the spending on a patient over the arc of their life may even out or maybe even be reduced because we're getting them the right care at the right time.
Jordanna Davis:
I really agree with that. And I would add a reminder that we're basing everything on the model of care that's being used today in the clinical trials. Is it possible that you can do this work in groups? Maybe you do a whole bunch of people at once with a smaller number of practitioners. Is it possible that there's a shorter acting substance that becomes available that's maybe a two hour drug instead of a six to eight hour drug? Those would really change these logistical questions.
Georgie Kovacs:
As you're talking about this, I'm thinking today, based on what we have, I could see a few things happening. One for probably how one can access psychedelics today and possibly in the near future, until we figure out the model, it's probably going to be people who have the money, the cash to pay for it. And yet this can impact so many others. And even for the near term, could Medicaid and Medicare pause this because they wouldn't know how to handle the infrastructure? So I feel like the infrastructure piece could impact access, but then also I could see people being impatient with this whole process and possibly risk going to people who may not be as properly trained because of the limits in access. I just feel like there's this wonky access for people who don't have the money, but also for those who do, maybe going to the wrong places because we're trying to figure all this out.
Jordanna Davis:
People can't get services in the places where the quality and the value can be demonstrated, and they go elsewhere.
Jacqueline Lampert:
I think, too, we do a lot of things right in the US when it comes to healthcare, but know a big ship and it moves, it turns slowly. And so sometimes when we see these new developments or exciting new treatments come forward, we don't get access to them as quickly as we want to. I think we've seen that with a number of new drugs that have come on the market that the demand really spikes at the beginning, and we may have drug shortages or provider shortages as everything gets evened out. So I think there will be bumps along the way. And I do think to your equity question, that's been a focus of our work for our whole careers before we started working on psychedelics, is really expanding first access to health insurance because we know that people without health insurance really struggle to get the care that they need, and secondly, to ensure that that health insurance is meaningful. And when we're talking about psychedelics, it means that we have to see not just Medicare and Medicaid, but private insurers, the VA, all providing coverage of this treatment again, once it is FDA approved so that people can access it. So it is really a key question. I think there's also other nuances of that coverage, like what kind of a rate is it going to pay? It has to pay a rate to a provider to make it worth their time to provide this coverage.
Jacqueline Lampert:
So these issues won't be sorted out the day that the treatment is approved by the FDA. But I do think the field is grappling with these challenges and thinking through them and working to prepare for that day.
Georgie Kovacs:
So today, if I say I want to try psychedelics, I can. What's the pathway to access?
Jordanna Davis:
Now, if you were interested in being a part of the medical model, you'd need to be part of a clinical trial. And you could go to clinicaltrials.gov, and you can look by your location and see if there's a clinical trial near you that you could be a part of.
Georgie Kovacs:
Otherwise, it's the wellness model. Correct.
Jordanna Davis:
If you live in a state where there is legalization under certain regulatory structures, then you could have access through those states. I guess.
Georgie Kovacs:
What has had you both interested in? I know you do public policy on so many different aspects, but what has had you most interested in psychedelics specifically? I mean, perhaps the answer is obvious with the conversation we had, because this is just fascinating, like so complex and innovative and new, and it's like, how do you answer this question? I think it's so cool. So if I were in your job, that's what my answer would be. But I'd love to hear from you both.
Jacqueline Lampert:
I think for me that is a huge part of it, Georgie, is we've worked on healthcare policy issues for so long, it sort of kind of naturally bleeds into these sort of operational issues. And this field presents a lot of unique challenges and really interesting questions to think through because it is so unique and it's brand new and it could be potentially transformative. I think that makes it an exciting field to work in. And I think generally, for me, mental health is just a very compelling area of work, in part because of the incredible suffering that we see from mental illness. This obviously increased over the pandemic, but it was certainly an epidemic before 2020. And we do have treatments, but they don't work for everyone. And innovation in this field has been pretty limited. And so I think I became engaged and stay engaged because the studies of this treatment show such promise for some populations.
Jacqueline Lampert:
And I think I said before, when things show promise, I think we have an ethical responsibility to study them without stigma attached. We need to kind of scientifically look at is this working? Who is it working for? How is it working? And I think there can be a lot of hype around psychedelics, but these studies do show promise. And when we have an opportunity to reduce suffering from mental illness, even if it is for just a certain population, that makes this work really important.
Jordanna Davis:
I was just going to add that of know Jacqueline and I are so motivated by our work on the Affordable Care act and to expand access. But the work has put us in communication with people who feel quite disenfranchised from the US healthcare system. Some of them looked at us, looked at our past work on the ACA, saw us as total defenders of the healthcare system. And that was really a challenging conflict to work through. It gave us a chance to say, we don't think this is a perfect system. We've argued we can help people more, though, by working in the system than outside of it. We don't need to burn it all down. But it was absolutely a challenging space for us to navigate.
Georgie Kovacs:
What do you see as the future here? We can make guesses, which is these drugs get approved and there could be challenges ahead with how do we get this system to work? Because the care model is so different for me. I feel like this bright spot, and maybe I'm just being too excited about it, is could we completely transform the mental health of the world if we can figure this out?
Jacqueline Lampert:
I think a lot of people do approach this work with sort of an almost religious fervor about the transformational power of these medicines. And I'm not sure I'm quite there in terms of changing the world. However, I do think that there are patients for whom these drugs will completely transform their experience of the world, and that makes it in itself useful. I don't know that these are for everyone, but I do believe that there are some patients for whom these treatments will be transformational.
Jordanna Davis:
I would remember that we've had years, decades of a lack of innovation and mental health, and that even incremental changes are really important changes. This doesn't have to change the world to be important. And I think we lose ourselves to some degree. We lose the value of the work when we try to make it that big. It's really important, even if it changes thousands of people's lives and not millions of people's lives. These are terrible, terrible diseases that these drugs are looking to treat.
Georgie Kovacs:
Yeah, no, absolutely. Those are fair statements. And is there any advice? And I know you're not clinicians, and so we'll get to the researchers and clinicians in the next episodes. But just if you were to give advice to either a clinician or a patient today, based on what you know from your expertise comfort zone, what would you say we need to know today? And then we'll hear from the doctors and researchers after and see what they have to say.
Jordanna Davis:
If I were a patient or if I were a family member of a patient that had suffered from one of the diseases that are in the most advanced stages of clinical trials, I would wait and look for FDA approval and then seek out licensed clinicians who can do that work and give me a real chance of hope for me or my family members.
Jacqueline Lampert:
I agree with that. I think that the field is working to establish the foundation of establishing and measuring quality of care in this space. One of the projects that we have done was leading a group of experts in writing professional practice guidelines for the field. We need clinical practice guidelines for this field. I think outside of a clinical trial environment, I would want those pieces, those foundational pieces that signal high quality care to be in place for someone who is seeking treatment for one of these conditions through psychedelic assisted therapy.
Georgie Kovacs:
No, that's fair. And I'm glad I asked the question because I will say, just given everything I've been through and the health care system, fertility treatments, et cetera, I kind of have started to go on the side of I don't really care anymore. I'm just going to do whatever, and as long as it's within the realm of safe, I will try most things I will say, this episode has helped me say even I would pause and wait for the trial. And I really appreciate how you've educated us on the thought that is going behind this and why we do need these trials to just clarify how we use them.
Jordanna Davis:
About a year ago, Jacqueline and I started working with a tremendous group of clinician scientists to write professional practice guidelines for the field. These set standards for the way that practitioners should behave in the work of psychedelic assisted therapy. There are really wonderful, smart, thoughtful people that are working in this field, and I have no doubt that they're going to make progress in improving people's lives. We have to trust that those folks are doing the science and they're going to get it through all of our regulatory structures, and this will be a mainstream part of mental health care at some point.
Georgie Kovacs:
Ladies, I am so honored that you made this time, and I'm thrilled with the work that you're doing. You're clearly incredibly talented and doing the right thing, and I'm so excited to see what happens, and I'm excited to hear what the other experts have to say as well. So thank you. Thank you. Thank you. This was so much fun.
Disclaimer
The information shared by Fempower Health is not medical advice but for informational purposes to enable you to have more effective conversations with your doctor. Always talk to your doctor before making health-related decisions. Additionally, the views expressed by the Fempower Health podcast guests are their own and their appearance on the program does not imply an endorsement of them or any entity they represent.
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