Clinical trials, media, reciprocity, open science: Founder of The Trip Report, Zach Haigney

​

Zach Haigney: [00:00:00] This is a really challenging space. It's really nuanced. It's really complex. It's unlike anything else because of the non-ordinary states of consciousness, the amount of historical and cultural use and baggage there is. The really exciting utility as therapeutics. So let's just, let's do this right.

[00:00:27] Greg Kubin: [00:00:27] Welcome to Business Trip. A podcast about psychedelic entrepreneurship. Psychedelic medicine is transforming mental, physical, and spiritual health, and entrepreneurship will be key to expanding access. Business Trip explores the business models and origin stories of the most interesting companies in psychedelics.

[00:00:49] I'm your host, Greg Kubin. This week's guest is Zach Haigney, author of The Trip Report, which is a newsletter about psychedelics, policy and business. In 2019, Zach started writing The Trip Report and quickly grew his readership by analyzing psychedelic news headlines from every angle. For example, during Oregon's ballot measure in 2020 to approve psilocybin therapy.

[00:01:12] Zach wrote extensively about the content of the bill. He gathered views from different constituencies and explored the implications for therapists, patients, and the industry. Zach is able to distinguish the signal from the noise and reports with a sense of fairness. In this episode, we discuss Zach's path to get involved in the space.

[00:01:32] Why some of the existing clinical trials will likely fail. And the trade-offs between open science and incentivizing more scientists to start companies. We'll also talk about companies bringing in perspectives from indigenous communities. And now to the episode.

[00:01:51] So Zach, very excited to have you on the pod. 

[00:01:54] Zach Haigney: [00:01:54] Thanks man. Excited to be here. 

[00:01:55] Greg Kubin: [00:01:55] I first met you mid-2020. I think I had received my fourth issue of The Trip Report and I was like, wow, I like the way this guy writes. And I liked the way that he thinks. So I replied to your email and I said, Hey, cool, newsletter.

[00:02:13] And you replied and we hopped on a Zoom and we chatted. And since then you and I chat basically every Friday and we catch up on what's what. In the world of psychedelics. 

[00:02:26] Zach Haigney: [00:02:26] It's the highlight of my week, man. 

[00:02:28] Greg Kubin: [00:02:28] Wow. The feeling is mutual and one day we'll meet in person. So Zach, let's talk about Trip Report, and really what brought you into the space?

[00:02:39] What's your interest of psychedelic medicine and how did that then lead you to start the newsletter?

[00:02:44]Zach Haigney: [00:02:44] I remember a very specific moment where like the idea crystallized in my mind of newsletter, commentary, analysis, insight. The name of the trip report, because a trip report is a recounting of one's psychedelic experience.

[00:03:01] Right? Terrence McKenna trip reports are sort of noteworthy, Aldous Huxley. There's a, it's a thing. And I thought it was a cool pun or play on words like the trip report as like a, a news outlet. And so this simultaneous, like the name, the ethos, the vibe, the early inklings of their product kind of crystallized in one moment.

[00:03:20] And I remember exactly where I was and I thought, Oh, that's it. Because up until then I was thinking, this is really cool. And I had been following the science from MAPS and Johns Hopkins. I had my own personal experiences. I recognized that this was going to be a thing COMPASS Pathways had had been around for at least a year and a half or so at that point, Usona had been progressing through there.

[00:03:44] So this was in May of 2019 and in the months and maybe year and a half or so leading up to that, I was just really thinking to myself, man, I wish I was in this. I wish I was a scientist or a physician or something that could get involved in it. And I was spending all my time reading about the science and the things that are happening.

[00:04:02] And I was just like, I'm going to start writing about it because that's. I'm going to, I'm going to figure out how to create an opportunity for myself and do that. So that's the origin story of The Trip Report. And I'm not a journalist, I'm not a scientist. I'm not trained in that capacity, but I felt like I have a unique background to the point where I, I know enough to be dangerous.

[00:04:20] And I say that somewhat facetiously, but my first job out of college was to - one of my first jobs was a clinical research coordinator. And so I was managing phase two clinical trials for new HIV drugs. And so this is. Know,, the phase that COMPASS Pathways and Usona are in right now, phase two of the FDA trial process. I worked on, on, on those types of trials, but for HIV medications.

[00:04:42] And so I saw how the sausage was made and I had a, I had an inkling into how this world works and then the yin to that yang or Yung is that I'm also an acupuncturist. And I spent the last eight years as a practicing acupuncture in Chinese medicine, which I think we'll get into a little bit because I think there's a lot of overlap and there's a lot of

[00:05:01] ways that, that the culture or the adoption of acupuncture and Chinese medicine and perhaps alternative medicine in large can inform, I think the future of therapists training, set and setting clinical operations, that kind of thing. So anyway, I was just, I've been taken with this domain for a while.

[00:05:19] Couldn't stop reading about it and stop thinking about it and had to do something, and so started a newsletter.

[00:05:28] And frankly like the collection of sub-domains, if we will, that are coming together in what we're calling like the psychedelic ecosystem- things like neuroscience, spirituality, self-actualization healthcare, delivery of healthcare, payment of healthcare, indigenous wisdom, traditional medicines, the opportunities, the challenges, the trade-offs like it's like really, to me, it's the most interesting

[00:05:52] thing ever. And so I think there's an endless sort of array of topics to really dig into. 

[00:05:58] Greg Kubin: [00:05:58] Yep. Definitely. It definitely attracts the curious mind. So you've worked in phase two clinical trials. So you've probably seen trials fail and it will be very interesting to see how many trials actually succeed, how much, how many need to start over.

[00:06:15] Do you have any gut instincts around that beyond just MDMA like when you learn about a new company that is initiating a trial? Are you like, they're probably not going to succeed. And if so, like what are any heuristics that 

[00:06:28] you use? 

[00:06:28] Zach Haigney: [00:06:28] I think that there is, it cost a lot of money. To improve requires a lot of money to take a drug through the FDA approval process.

[00:06:38] Even like announcements made six, nine, 10 months ago, 12 months ago. I think if you like are looking at clinicaltrials.gov, they're still not there. You know what I mean? Like it there's a lot of friction. Let's say there's a lot of, I don't, I'm not trying to use the word bureaucracy, but it's a slow and it's a methodical and it's applauding and it's a, it's a high, like expertise that is not common.

[00:07:03] And it cost a lot to, to hire that level of expertise. And then it cost a lot of money to organize a trial and to get it set up and to push it through the various phases. So with that caveat, I wonder like the guys over at Psilocybin Alpha have a great resource, of kind of tracking all of the clinical trials that are ongoing.

[00:07:25] And I was surprised it's quite a lot of sponsored commercial trials. I don't know, maybe 30, or let's say it's 30 give or take, but most of them are like, in phase one, if not earlier. And that is like maybe on average, a five to seven year time horizon. It's not that there's any like product or project or something.

[00:07:47] That's like, Oh, I question it's just like, this is for as much excitement and fanfare and enthusiasm that I have that I think is palpable. It's still a long way away. 

[00:07:57] Greg Kubin: [00:07:57] I think one last point there is, I feel like the trials will actually become political as they progress because once they becomes more and more likely to succeed, I think other constituencies that may be completely not FDA related, maybe it's DEA, maybe it's even on a congressional or presidential level.

[00:08:17] I mean, on that topic, what are some other challenges, complexities and nuances of the space that you're thinking about?

[00:08:24] Zach Haigney: [00:08:24] Well, thing that I've been thinking about 

[00:08:25] lately is the, so I think it was in 2007, then Bob Jesse, and the Council for Spiritual Practices, at least I'm not sure if he wrote the statement on open science and open practice, but I think of it in that way.

[00:08:38] I think it's because it's on their website. But open science is this idea that, um, it's actually kind of complex because it depends on like the domain that you're talking about and the level of research and, and what kind of research that's being done. But it's essentially like data sharing. Like a field can progress a lot quicker if like the data that researchers generate can be distributed and shared and not protected by either like, you know, the whole academic publishing world is like a weird

[00:09:06] kind of some people call it like a Ponzi scheme or just an industry with perverse incentives, but that's one sort of way that sort of open sciences is trying to change the landscape. But another way is like in opposition or at least a more thoughtful consideration of how we think about like intellectual property and patents.

[00:09:24] And so there's a large number of people who have signed on to the open science, open practice statement. And there's a handful there's maybe four or five different bullet points. It's kind of like the Northstar pledge in that it presents this, not even an ideal, but there was a, there was an article from symposia that used the phrase, like a plea for decency.

[00:09:42] So I suppose it's like, This is a really challenging space. It's really nuanced. It's really complex. It's unlike anything else because of the non-ordinary States of consciousness, the amount of historical and cultural use and / baggage there is. The really exciting utility as therapeutics. So let's just, let's do this

[00:10:03] right. And usually it's deemed as taken as like this, like patents are bad kind of thing. And with that understanding, like I'm putting myself into the position of like a like a, a, like a researcher, let's say like at one of the psychedelic science centers or elsewhere that had, has gone through a PhD, has gone through a post-bac.

[00:10:21] They studied neuroscience or 5-HT2A or serotonin system in some capacities so they're primed to be to do really interesting work in this space. I don't know what, like deciding that and adhering to it, like take them out of a position to make a living. You know what I mean? Or to capture the value that they create, if they're starting on to like, not advise companies or work for companies or take equity or to develop a drug for companies.

[00:10:52] Because like I said, it costs a lot of money to take a drug through the FDA approval process and MAPS has been at it for a really long time. And they have somebody like Rick Doblin, who is, he's a genius when it comes to advocating for the project and raising money. And it's not clear to me that other nonprofit sort of routes will

[00:11:15] will be able to have the success that MAPS has had. You know what I mean? So it'll be interesting to see how that unfolds. So that's one sort of, kind of area I think about. I am. I just saw just before we got on the call, I saw a tweet from Paul Austin that was sort of soliciting recommendations or ideas about how technology is going to interface with this whole thing.

[00:11:35] And this is just not, this is like across the board. To towards digital therapeutics and the various tools and technology and tracking and biometrics and digital phenotyping that has had some resistance maybe in, in terms of being adopted in healthcare. But I think COVID, and sort of the constraints that, that has placed on healthcare delivery are changing that.

[00:11:57] And so the use of technology, man, that's really interesting and fascinating, and obviously has its upsides and downsides. And so that's another area that's really cool and interesting that I'm thinking a lot about what are you thinking about? 

[00:12:13] Greg Kubin: [00:12:13] What am 

[00:12:14] I thinking about? I'm thinking about diversity and inclusion and reciprocity.

[00:12:21] And how there's an opportunity today for companies in the space to figure out ways to bring diverse voices into their companies, and basically make sure that the way in which they're developing their protocols and making decisions is really informed by the knowledge base that has existed. And it frankly was developed by indigenous communities.

[00:12:46] Um, thinking a lot about that because there are not that many companies in the space yet that are super proactive about incorporating those kinds of ethos. And so I think that there's a window of time when that norm could really be set. I think that window is open still. I think at a certain point, that window will be closed.

[00:13:07] And so I've been thinking a lot about how to solve for that, how to make it so that it's not something you force on a company to do, but something that you incentivize or see that as a important component of building their business. 

[00:13:18] Zach Haigney: [00:13:18] So it's 

[00:13:19] almost like I'm kind of just winging this as a, as it's coming up, because I think about this a lot and I don't have a good understanding of how companies can be informed by traditional

[00:13:30] systems, can employ the wisdom holders, can capture some of the value that's being created, because those are the things that I think a lot of us are like thinking about and concerned about. And yeah, I wonder if there's like this kind of meeting of East and West or old and new framework that that can be leveraged 

[00:13:47] here.

[00:13:48] Greg Kubin: [00:13:48] On that point. How can we bring in diverse voices, both within companies, can we bring in perspectives from indigenous communities? Uh, how can we create systems so that the companies themselves are bringing in those communities as stakeholders in their businesses, and really not just colonizing, you 

[00:14:07] know?

[00:14:08] Zach Haigney: [00:14:08] Yeah. Journey Colab is doing some interesting stuff in that area. I don't know the specifics of it, but when I talked to them months ago, that was important to them. And it's good to see that. And I think there's a lot of people that are like looking at them and trying to learn from what they're doing. It feels like they're set in to set the tone in that regard.

[00:14:27] Greg Kubin: [00:14:27] No, totally. 

[00:14:28] They're assuming leadership in that way. And they are using an analog of Mescaline, which is comes from peyote and they're using it to treat alcohol use disorder in a group setting. They're pioneering on a bunch of levels like with their reciprocity, everything from, uh, allocating 35% of the company equity to these communities that they're working with.

[00:14:50] They are bringing in people from a governance standpoint to advise on the actual decisions of the company. They are following certain protocols, there's one called the Nagoya Protocol and other one, the Free, Prior and Informed Consent, um, that basically include these communities in the decisions that they're making.

[00:15:09] So more of that, but I think the reality is even obvious as we're talking about it, there needs to be more education in and granted it's on us to do the education. And I guess most people haven't spent the necessary time going in and doing the research themselves to figure out what they could be implementing.

[00:15:26] What I have heard some companies talk about though, is the idea of bringing, like bringing up the idea of, for example, giving equity to, um, indigenous communities and investors not being cool with that, or wanting to give a certain amount of their profit of their business, to the, these communities and investors not being cool with that.

[00:15:44] And like that's where it becomes really tricky and complicated because maybe some investors aren't cool with that, but I guarantee you, a lot of investors are. Are there any companies that you think should exist that are not here yet? 

[00:15:59] Zach Haigney: [00:15:59] Yeah. So, a few months ago. Over the summer, I heard about this idea about pragmatic clinical trials and

[00:16:07] to step back and say the clinical trials that we most commonly talk about are sponsored clinical trials are intended to prove efficacy and safety for that a drug kind of satisfies a certain criteria and can be then marketed and approved. And so what they need to do is really restrict the population that is taking the drug throughout.

[00:16:27] So there's, what's called inclusion and exclusion criteria. The type of people that can be in a trial have to match like a very sort of narrow criteria. That's very like different from the real world, right? Like where people have comorbidities are on other medications, they have this, that, or the other thing.

[00:16:45] And so a way to combine like data capture and making psychedelic sort of medicine accessible sooner, while also accounting for and capturing data, is this idea of pragmatic clinical trial. So there's less scrutinized inclusion-exclusion criteria. They're there. They still might be managed in, in, in academic settings or go through the same sort of protocol.

[00:17:07] But anyway, it's like a way of enabling research that enables access before approval. And this would be done at a higher, a greater scale than what's currently being done. I'm really excited about that. The next sort of step to that is enabling the administration of psychedelics in a research setting to be done at home.

[00:17:29] And there is a growing sort of field that is in the clinical trial space. That's goes by decentralized clinical trials for remote clinical trials. And it leans heavily on like biometric data, digital phenotyping, like proof of dosage, proof of experience, proof of safety, proof of perhaps like a trip sitter or something.

[00:17:52] And I just think, like, I don't know if COVID's going away anytime soon. I'm not as optimistic about the vaccine as I think maybe other people are, um, there's going to be, this kind of growing sort of nascent space of decentralized clinical trials, we're going to have a whole bunch of trained psychedelic therapists

[00:18:07] that are not going to have an opportunity to practice except for ketamine clinics. So is there a way of combining all of these things in the form of a company that it's like a CRO it's like a clinical research organization that, that enables at home administration in a research context? Is that a completely batshit, crazy idea?

[00:18:27] I don't know but it's something that I think has legs and could be, it would be really cool. It would have been able more malleability and mobility and adaptability of the clinical trials. So they get done faster and showing the work that like, if accounted for appropriately, like one somebody's home can be a safe place.

[00:18:49] Greg Kubin: [00:18:49] Yeah, I think a lot of people want to take it at home. And that is like a setting that people are actually most comfortable in versus going into a clinic or a center that isn't, that they're not as familiar with. Um, any, any last words, Zach, anything else you'd like to share to our 

[00:19:05] listeners? 

[00:19:06] Zach Haigney: [00:19:06] I would say I really,

[00:19:07] I have, I started The Trip Report in May of 2019, has a couple of thousand readers, had a couple of hundred paid subscribers. The reality of people that thought the work that I was doing was at a high enough level to compensate for me, it was like the greatest feeling in the world. It was also like a greatest responsibility and I am so grateful to my readers.

[00:19:46] Greg Kubin: [00:19:46] The psychedelic medicine industry is moving quickly. You've got new companies raising millions of dollars to develop therapies and protocols using a range of psychedelics. And while Zach cares about the growth and success of the industry's businesses, he also cares deeply about the integrity of the space.

[00:20:03] The complexity is real. The stakes are high. So we need voices like Zach and The Trip Report to make sense of it all. You can subscribe to The Trip Report at thetripreport.substack.com. This is Business Trip, a podcast about psychedelic entrepreneurship. If you like this episode, you can help us by subscribing to the podcast and leaving us a review.

[00:20:25] You can tweet at us or find us on the gram at businesstripfm. And if you're building a company in psychedelics or you're looking to get more involved in the space, email me at greg@businesstrip.fm. I'm your host, Greg Kubin. Business Trip is created by me and Matias Serebrinsky. Producer and editor is Jonathan Davis. Sound design and engineering came from Zack Frank.

[00:20:49] Our theme music is by Dorian Love and additional music credits are in the show notes. This is Business Trip. Thanks for tripping with us. We'll see you next time.

[00:21:07] We're going to do a meditation. Once the tabs are closed for 20 seconds. 

[00:21:11] Zach Haigney: [00:21:11] Yes.

[00:21:12]Greg Kubin: [00:21:12] Maybe 20 

[00:21:13] minutes.

[00:21:14]Zach Haigney: [00:21:14] Maybe a lifetime. 

[00:21:15] Greg Kubin: [00:21:15] Maybe 20 lifetimes. 

[00:21:17] Zach Haigney: [00:21:17] Now we're getting weird.