The Challenges of the MDMA Research Studies: Annie and Michael Mithoefer Part Two

Dr. Sandy Newes 15:31

To do. I mean, I’m a trauma therapist. Like some people get worse before they get better. Usually have to learn to experience. You have to learn to like, be in the present moment, to be able to be in your body, to be able to feel your emotions, to be able to go through either events or just be in relationship with others. Like that’s what recovery is, right?

Annie Mithoefer 15:52

Yes.

Dr. Sandy Newes 15:53

And there isn’t a world in which you can’t have some upset during trauma.

Michael Mithoefer 15:57

Therapists can tell you that, right?

Annie Mithoefer 15:59

Yeah.

Dr. Sandy Newes 16:00

Yeah. So I want to just mention one other piece, and then we’ll move into the therapeutic model, because there was another piece too about like expectancy effects and selection bias. And again I just want to just note like that is again endemic in psychotherapy outcome research.

Michael Mithoefer 16:14

Can I say something more about the positive thing. Yeah please. Because I think they do have a point, you know, even though we didn’t report it that way. Yeah, I get what they’re saying in a way, because, you know, we had that one very egregious situation with the phase two study in Canada.

Annie Mithoefer 16:31

For those who.

Dr. Sandy Newes 16:32

Don’t know, that was where there was sexual abuse of a participant.

Michael Mithoefer 16:36

Right? Not during the MDMA session, but while the person was still enrolled in the study. It was terrible. The therapist and his wife was the co therapist. You know, that was terrible. And, you know, it happened once, so I don’t want to make light of that at all. And the fear that I understand is that people start feeling really good, and then they’re more vulnerable to being manipulated by the therapists. Right. And I think the other thing that can happen is the therapist can get ego inflation because this amazing healing is happening in front of them. The therapist is the patient. The participant is projecting it onto the therapist. As such, a great therapist and the therapist should take that on and suddenly they’re going down the wrong path. So it’s a serious problem. And we need to we obviously need to be careful of that. And that would be the reason for looking more rigorously into the positive emotions and whether, you know, what are the risks of that. So that’s I love that. I just want to say that’s fair enough to reject to that.

Dr. Sandy Newes 17:41

To me, when you say it that way especially, it seems like a solvable problem. Like, you know, train, train, educate, train, educate, train and track really, really carefully. And you know, we have ethics boards and we have review boards and this stuff happens. Therapists have sex with patients. It’s like the most common thing brought up in front of the ethics boards. We don’t want that.

Michael Mithoefer 18:03

Definitely not.

Annie Mithoefer 18:04

Obviously.

Dr. Sandy Newes 18:05

But it does happen. And it’s unfortunate that it happened in this one occasion. And it’s useful, as you say, to look at it. And it’s a solvable problem.

Michael Mithoefer 18:14

Yeah. And we hear that some other people have said they’ve been harmed. The public comment commentators said that we, you know, the company has made not real. I don’t work for the company, but I’m a consultant. But they’ve made a lot of efforts to make it easier to report because we want to know. Everybody wants to know if somebody had a problem. Sure. So there’s a hotline and all that. We haven’t been able to find out any details about the other people, except we know that some people have said the harm was they had such a deep experience with these therapists in such a short period of time, and then it was over. So I get that too. That makes there. Ethical questions about how long can we should we keep doing blinded, controlled trials with these medicines? Once we’ve got enough data to reassure us enough, we need to figure out another way to study it in more depth. Right. Like adaptive real world trials or something, you know, there are.

Dr. Sandy Newes 19:18

A patient can continue with the therapist.

Annie Mithoefer 19:20

Yeah.

Dr. Sandy Newes 19:21

And that would be a real world application. There’s a real world therapist I’m not.

Annie Mithoefer 19:24

Going to be I’m not going to say and done. Yeah. Right, right, right.

Dr. Sandy Newes 19:28

And you know, how we get that paid for is, you know, continues to be a question. But yeah, I just wouldn’t do that.

Michael Mithoefer 19:32

So ironically, these are artifacts of the research design more than there are problems with MDMA. Right. Some of these things.

Dr. Sandy Newes 19:41

So we got about ten minutes max. So just to kind of move into, you know, the development of the therapeutic model. Another one of the, you know, kind of criticisms has been like, this isn’t really therapy like. And it is I mean, it really like as, again, as a trauma therapist, like I can see the different elements of that. And obviously a great deal of intention was put into that. And the study design is that you’ve got independent raters actually checking that you’re doing particular things that are elements of the model.

Annie Mithoefer 20:11

Inherent traders adherence ratings. Yeah.

Dr. Sandy Newes 20:13

And again, that is what, you know, Manualized treatment looks like in a flexible protocol, which is real world application.

Michael Mithoefer 20:22

Yeah. One person on the advisory committee said, well I don’t know. The therapy apparently is just the therapist doing whatever they want that doesn’t really fit with the fact that we have all these highly trained adherence raters who have to show that they have inter-rater reliability very frequently, and they’re able to rate according to the manual, whether people are following or not. It’s not just a random activity, right?

Dr. Sandy Newes 20:50

Have to be able to know you’re seeing a particular intervention. You have to have.

Annie Mithoefer 20:53

Adherence measures for each type of session, for the prep, for the MDMA and for the integration session. Yeah. And so they’re looking at the videos and then giving that information to the supervisors who are supervising that therapist. Yeah. With that participant.

Yeah.

Michael Mithoefer 21:12

So people had all the therapists had not only the adherence trainers, but supervision from us or other experienced, more experienced people. Based on watching the videos of the sessions, we saw what they were doing and we gave them feedback. So it was a very rigorous process. Yeah. And, you know, when it went the way it developed is we we never discussed with anybody how we were going to actually do the therapy.

Dr. Sandy Newes 21:39

That we wanted to take that up. Well, so there is that. Trauma therapist, though, right?

Michael Mithoefer 21:48

There was no one else involved that knew anything about therapy.

Dr. Sandy Newes 21:52

Well, you’re but you’re also not going to do CBT for eight hours. Like, it’s like giving you you know, that context of a long session is a piece of that as well.

Michael Mithoefer 22:02

But, you know, we had the model that we’d learned from Stan and we kind of combined it with our own experience working with Trauma. And later we had internal family systems training and stuff. But, you know, we started out we just did it. And the I had written an appendix describing the approach about the inner healing intelligence. It was not very long and it had one reference, Stanislav Grof LSD psychotherapy page, whatever, where he talks about the inner healing intelligence. That was it. So we did the first study and it worked. So we realized we got to replicate this, see if we can replicate it and see if others can replicate it. Therefore, we need a manual. And at first we said, you know, we don’t really like manuals. And this is very flexible and intuitive. How can you have a manual? But then we kept coming back to the reality. We had to have a manual. And then we realized actually, you know, you can have a manual with flexibility. Right. And so we thought, well, let’s try to write a manual. And so what we did was that required June May Roos, a psychologist who’s a friend now to watch where we had audio and then some video of our sessions, sessions for the first study. She watched them all and took notes. So her goal was to see if we were doing what we said we were doing and to give examples if we were, and then discuss it if we weren’t. So she did that, and then we spent two different week long periods, one at our house, one at her house with her, like marathons, 12 hours a day, watching a video or listening and talking about it and refining the manual to describe what we’ve been doing. Yeah. And because what we realize is, yeah, it’s there’s a lot of flexibility, but it’s not random. And we can describe the important principles of what we do.

Dr. Sandy Newes 24:03

Right. And I mean, again, in my training, you know, back in the 50s or whenever people first started to try to research psychotherapy, it was the same thing like, oh, we can’t manualized we can’t manualized the magic. Right. You know, people think that they’re doing something unique, but you have to, you know, and out of that comes theoretical development, and out of that comes efficacy and being able to look at different elements of the treatment. And, you know, that’s where that can all go.

Michael Mithoefer 24:29

I wish we’d met you 25 years ago. You know a lot about psychotherapy.

Dr. Sandy Newes 24:40

I mean, I really did. So well, so I mean, there’s a lot that we could go into on that. So certainly what I’m hearing is there was a great deal of intention put to the model that you took, what you had been doing, but you’d already been doing trauma work for a really long time and had been doing it effectively, that you had already blended non-ordinary states of consciousness with trauma work. So that informed what you were doing, and then you went back and then you manualized it. You looked at. And then made an adherence manual. Right? Yeah. And you studied other emerging things. Like. Experiencing.

And things like hakomi And all of those different things that are informing.

Annie Mithoefer 25:19

It. Yeah, there’s certainly a psycho dynamic framework.

Michael Mithoefer 25:22

How powerful. What a powerful addition learning about IFS has been from, you know, Dick Schwartz has developed such a powerful model of that. And it is a really good synergy.

Annie Mithoefer 25:33

Totally.

Dr. Sandy Newes 25:33

Well, and so, you know, paying attention over the years to what’s emerging and then adding in what you think, you know, working. I mean.

Annie Mithoefer 25:41

That sure is.

Dr. Sandy Newes 25:42

The scientific method right

Dr. Sandy Newes 25:44

And so I just once again, just really, really honor that. What I see as just like an incredible attention to psychotherapy outcome research methodology. I don’t know anything about drug research methodology, but I know some I know something about the scientific method.

Annie Mithoefer 26:01

Yeah.

Dr. Sandy Newes 26:01

And so, you know, I see that as being every step of the way. So.

Michael Mithoefer 26:06

Well, thanks. Can I and I just I’d like to say one more thing about the therapy is for any shuts me up.

Annie Mithoefer 26:12

No, I’m not going to shut you up. Because you have one more thing.

Michael Mithoefer 26:19

You know, we’re not saying the way we describe this in the manual is what everyone should always do from now on at all. We’re not asking that people only use this method with MDMA if it’s approved, right? Where, you know, people are going to innovate and there might be there probably are better ways and there certainly are different ways.

Annie Mithoefer 26:41

Yeah.

Michael Mithoefer 26:41

What we’re saying is these are some foundational principles that other others have learned before us. And we’ve learned many people have learned about using this kind of medicine or this kind of approach to shifting consciousness. People have learned some very important things about that over many years. Stan Grof has told us when he first gave people LSD in Prague. He had his white coat on and his stethoscope and the clock, and they were sitting at a desk. You know, they didn’t know. There you go. He was going to be here for a minute. He was a Freudian and biological psychiatrist.

Annie Mithoefer 27:19

Right.

Michael Mithoefer 27:19

He paid attention to what was happening and adjusted accordingly. So what we want to throw out all of that, you know, these very intelligent, highly trained scientists and and psychiatrists and psychologists, the things they’ve learned over decades about important principles of working with this kind of state. No, we don’t want to throw that out. We’ve learned a lot from them. We’ve added some to it. We want people to have a grounding in this foundational understanding of the potential of these medicines, and the potential for something unexpected to happen.

Dr. Sandy Newes 27:57

Well, and the fact that isn’t it. It’s 40 some percent improvement in the placebo group. Correct? So the therapy itself is having a significant clinically significant effect on the on the placebo group.

Michael Mithoefer 28:12

Absolutely. Among people who in most of the studies, most of the people had had lots of treatment with therapy and medications and had PTSD for years. And as you said, there’s something about an eight hour session.

Annie Mithoefer 28:28

Yeah.

Michael Mithoefer 28:29

I think that was a big part of the time. People would really and and something about respecting the inner healing intelligence and the relationship. But yeah.

Annie Mithoefer 28:38

Yeah, Yeah.

Dr. Sandy Newes 28:39

So what else would you like to share? We’ve covered research methodology. We’ve covered your origin stories. We’ve covered some of the journey here. We’ve covered some of the methodology pieces. We’ve got the final approval meeting I don’t know what you know. It was the final final or what that is. But there’s another meeting coming up with the FDA in August.

Michael Mithoefer 29:01

Well, that’s their deadline.

Annie Mithoefer 29:02

Okay. Well, what I one thing I would like to say is that, you know, if if we do get approval it, we also want to be careful. Yeah. We’ve always been really worried about the importance of training and making sure people get trained to do this and then supervision or consultation and mentoring. I mean, I didn’t know how to work with us when I first did it.

I knew something about being with people in Non-ordinary states, but each participant is different. And so knowing, having an ongoing relationship with your mentor or supervisor for, you know, unexpected things. I think that’s got to be part of it, right. And, you know, the people that say you don’t need much therapy, like with psilocybin and, you know, I don’t I don’t want it to go that way. Yeah. Yeah. Yeah.

Dr. Sandy Newes 30:00

Well, and that’s such an important piece is like, you know, as we I agree like that we need absolute careful attention as a person who does training and who also does psychedelic therapy with ketamine. I’m better than I used to be. Yeah. Working with ketamine. After 20 some years of having done psychotherapy, like I’ve learned a lot, there is a lot.

Annie Mithoefer 30:20

Well, that’s just like any doctor, any nurse, anybody. Yeah. You learn from experience. Yeah.

Michael Mithoefer 30:27

And we’ve we’ve learned over the years we’ve done lots of trainings with several thousand therapists. And we’ve noticed that it’s much easier to train an experienced trauma therapist how to work with MDMA than to train someone who’s familiar with Non-ordinary states but doesn’t have much experience with trauma. So it just points to how important the therapy is, right? It’s not different from supporting people with trauma the way every experienced trauma therapists already has experience in without MDMA. It’s not that different from that, right?

Dr. Sandy Newes 31:09

So the emphasis on being careful, like I heard, you know, embedded in the discussion like that, there were some important points about like tracking the positive effects and what are we concerned about. And you know, that there were some points raised and that you’d like to see some follow up on that, I love that. Yeah. All right. And so maybe there can be some good coming of that that we can know how to be even more careful.

Annie Mithoefer 31:30

Sure. Yeah. Yeah.

Michael Mithoefer 31:32

So, yeah, we don’t want to blow off the concerns at all. Yeah.

Annie Mithoefer 31:35

And and it’s exciting. It would be, you know, really wonderful for people for for patients out there.

Dr. Sandy Newes 31:44

Well, and I’m hearing on, you know, on social media like, you know, veterans there’s an outcry like, don’t keep this from us.

Annie Mithoefer 31:50

Well, they’re very they’ve already taken it into their own hands. Yeah. You know. Right.

Dr. Sandy Newes 31:54

And that’s the danger.

Annie Mithoefer 31:55

Yeah. Yeah.

Dr. Sandy Newes 31:57

As luminaries in the field, as some of the most influential people, like, within this whole domain. And we’re taking into account the need for training and supervision and, you know, careful rollout and tracking it really carefully. What advice would you have for, really, for me, as a person who actually runs a training program and would like to be involved in this, and really for others like who are involved in that training and supervision effort. Like what kind of advice do you have for people like me or others?

Michael Mithoefer 32:29

We need you. That’s not advice, but yeah. Yeah. I think I Well, you’re already doing it, you know. You’re doing ketamine trainings, and if MDMA is approved, you’ll be capable of doing MDMA training. So I think for those people who in your position who have a lot of experience, my advice would be figure out how to develop a local or regional center where people can not only get training, they can get ongoing supervision, mentorship, community.

Annie Mithoefer 33:07

Community.

Michael Mithoefer 33:08

And an ongoing relationship with the center. Yeah. Is I think that’s the best way to ensure safety. You know, if there’s a community of therapists and their mentors, if somebody starts to go off the rails, there’s more chance someone can help them with their problem before it becomes a disaster.

Annie Mithoefer 33:28

So yeah. And maybe part of that community, too, would be having a program where people who couldn’t afford, who don’t have insurance because we don’t know what’s going to happen with the cost, the access. We don’t know about the insurance. We know that there’s a code. Yeah, but having some kind of a patient access, right.

Dr. Sandy Newes 33:48

Some kind of fund that increases a wide range of.

Michael Mithoefer 33:51

Yeah, that’s a whole huge problem.

Annie Mithoefer 33:53

But people need like a community after they have these experiences.

Dr. Sandy Newes 33:57

Oh for. Sure. So that they, you know, have people they can talk to. Sure. Integration circles and therapists too. Like, I mean, it’s a it’s a thing, right? When you’re like, working with Non-ordinary states, even when you’re not on the medicine, like you’re in a non-ordinary state, just if you’re meeting with a client and you’re a tomb. Yeah. You know, that in and of itself is its own thing.

Annie Mithoefer 34:17

Yeah.

Michael Mithoefer 34:18

And, you know, there is the risks that people get too attached to the medicine and don’t understand what you’re saying is often more happens during the integration period than during the MDMA session. It’s just so important for. That’s one of the messages Is that I’m advising you to carry forward. Yeah. Is making sure people don’t forget how much is not happening in the MDMA session itself, but is happening as it continues to unfold.

Dr. Sandy Newes 34:47

Center could offer ways to integrate meditation, breathwork, different types. I see that with ketamine, it’s like people are just like, oh, give me that medicine. I’m like, no, no, no. Like, yeah, you know, preparation, medicine, integration. That’s the process. We can’t shortchange any of those. Yeah.

Annie Mithoefer 35:07

Right.

Michael Mithoefer 35:07

So I think can I say one other.

Annie Mithoefer 35:09

Thing, please?

Michael Mithoefer 35:11

I mean, this this probably this might sound grandiose and ridiculous, but, you know, I think we all know that the mental health system, psychiatry and psychology need needs radical change. Yeah, it’s we got a pretty pathetic situation going on with how we’re doing with treating people that are suffering with mental health. Yeah. And it hasn’t been getting better very fast at all. In fact, the numbers are getting worse, right? So the big change is needed. This is a not just another drug. This is a totally different approach to healing. Not that we’ve come up with, but we’re bringing forward. Right. That that’s where, you know, that’s where the real lesson is. Yeah. We need to shift the whole system toward serving and supporting people’s inner healing capacity, rather than just handing out drugs to them or telling them what they need. And that’s a huge lift. So I think in a way we’re at a point. Approval is going to come sometime, whether it’s August or not. We don’t know. We hope so. Right. It’ll come for psilocybin soon too, I’m pretty sure, and others to follow. But the crossroads is going to be how the system likes to not change and likes to suck everything into the way it’s already operating. Yeah. And there’s, you know, you can already see it, right? People wanting to kind of minimize the therapy or get rid of the psychedelic effects, or how can we have eight hour sessions? How can this fit into what we’re doing? Well, what you’re doing is not working very well. And this is different. So you’re going to have to do it differently if you want to do it right. And so that’s I think we’re at a battle for middle earth. As I think of it.

It feels. Like to me. That which way is it going to go, how much. And I’m sure it’s going to be mixed. But to me that’s that’s where I hope you next generation can make sure that this changes the system rather than the system distorts. The potential of these medicines. Yeah.

Dr. Sandy Newes 37:23

Well, and it’s so interesting because it’s like there’s like symptom reduction. And then this is like enhanced consciousness, the ability to deepen into meaningful relationship, the capacity to experience joy and well-being of which symptom reduction becomes a part of it. But when we begin to look at growing the good and enhanced quality of life and that that is a multi-modal multi factor piece, which this is just one piece, right. You know like I see what you’re saying. It’s a systemic change.

 Yeah.

Michael Mithoefer 37:57

And some people don’t want that. Some people would rather just have a pill. But many people would be willing to go through the effort and the pain that it can take to take this other route to really develop. So people should have the right to choose between those two approaches.

Dr. Sandy Newes 38:13

Any last thoughts, future directions, things you’d like to see?

Annie Mithoefer 38:19

No. This has been great, Sandy. You all are just. Yeah, such a joy. Thank you so much.

Michael Mithoefer 38:26

Thanks for your thoughtful. Yeah. Questions and ideas.

Dr. Sandy Newes 38:29

I mean, I’m just deeply humbled. deeply honored and so grateful of all that you all have done for the field. And that’s brought us to this moment and the way that’s impacted my life personally and professionally. So thank.

Annie Mithoefer 38:41

You. Thank you.

Michael Mithoefer 38:42

That’s touches me.

Dr. Signi Goldman 38:51

Thanks for joining us at Living Medicine. Be sure to check out our upcoming episode with Dick Schwartz, the founder of IFS, where he talks about unusual experiences encountered in the altered state. See you soon. 

Outro 39:14

Thanks for listening to Living Medicine. We’ll see you again next time.