Darshan
Hey everyone, welcome to the DarshanTalks podcast. I'm your host Darshan Kulkarni. It's my mission to help you trust the products you depend on. And today's conversation is going to be about products you depend on that you need to learn to trust. So as you may know, I'm an attorney. I'm a pharmacist, and I advise companies with FDA regulated products. So if you think about drugs, wonder about devices, obsess or pharmacy or ponder over psychedelics. This is the podcast for you. Just to be clear, both me and my guests are attorneys. Neither one of us are giving you political advice. Sorry, I give you legal advice. I'm a pharmacist, I'm not giving you clinical advice. And and this is just for educational reasons and for sort of a conversation and for entertainment. So I do these video podcasts because they're a lot of fun. And because I find myself learning something new each time. It'd be great, great enough someone's listening. So if you like what you hear, please like, leave a comment. Please subscribe. If you like what my guest is thing, feel free to contact him, maybe he can help you. Please share this conversation. If you think someone would help, wouldn't would enjoy the conversation. If you want to find me, you can reach out to me on twitter at DarshanTalks, or just go to our website at DarshanTalks, calm. today's podcast, this podcast is going to be about the gym, about psychedelics. And I'm really excited about this because this is a conversation that is that I've seen for a long time coming. But our guest today can talk about it. And he's been a guest with us before. But we hadn't we didn't have this conversation. So I'm really excited about it. So if you are in cannabis, and you're wondering what do we do products that are not cleanly regulated by the FDA? say and do if you are in pharma wondering how can you get into the psychedelic space and other concerns around it. If you're in the psychedelic space and trying to understand what that means? You're gonna have to have a great time in today's discussion. Our guest today is Ooh, hold on. Our guest today is Dr. Whitelaw. He's a consultant. He's a professor and he is a journal editor. And as as any good attorney will do, he has not named any any of the companies he works for, which is why we know he is a good attorney. And I know he doesn't work as an attorney. But But he he works as a consultant. So he works primarily in the risk management space, and we hopefully might get into that discussion a little bit as well. So I really recommend you you sort of listen and ask questions. Ladies and gentlemen, our guest for today. Seth Whitelaw Hey Sir. How are you?
Seth
I'm good Darshan, it's good to see you again.
Darshan
It's great to see you. It's different this time because you don't have a pipe in your mouth. And that it
Seth
I put it aside just for you.
Darshan
Having said that, I love your chair, which is very much a gamers chair. So I didn't beg you as a gamer. For all I know you are Are you a gamer.
Seth
I learned a game because I got into a little bit with my kids. But the main reason I have a gamers chair was I was looking for a really good, comfortable desk chair. And both of my boys who are avid gamers said yeah, yeah, games your dad?
Darshan
Really? Yeah, I would not have realized that I thought gaming chairs. I don't know, I don't know why I thought they'd be different and have different goals. I become obsessed by chairs recently, because I need to buy one. And I keep going down the Herman Miller path. And I don't want to pay I think last time I checked like 16 $100 for a Herman Miller chair. So
Seth
gamers gaming chairs tend to be a lot less expensive. But they're designed for people who are going to sit for hours at a time and be comfortable.
Darshan
Good to know. So that that's the cheaters way of getting a good chair without paying through the nose for it. So we're going to talk about psychedelics. And we're going to talk a little bit about how, and I probably should title this not just mushrooms, because that's what I think about when I think about psychedelics. So So first let's start by what you start a few set what you told me right before we got on, which is it's not just mushrooms.
Seth
So it's not just mushrooms. There are a lot of compounds in the psychedelic space from MDMA being as being a psychedelic to LSD to mushrooms. To You know, if you're going on a radical end of things, toads, there are all sorts of things that fall into iosa and they're Ibogaine. There are a lot of different psychedelic out there. A lot, a lot of them have been around and been used throughout the centuries by indigenous people. Some of them are manmade and newer, like MDMA, or LSD. But they run the gamut.
Darshan
So obviously, like you said, there's between the synthetic and the naturally occurring. They're all considered psychedelics. So what is it that commonly connects all of them?
Seth
Basically, they alter your mood, they alter your mind. In the case of MDMA, for example, it tends to relax people, it reduces their ability, their inhibitions. So if you're treating mental health, it's a way of kind of, to using it as a tool to break through barriers with people who have trauma and being able to process the trauma and allow them to be a bit more objective when they're trying to understand what's going on with them.
Darshan
So So it's interesting that you say that you're talking about the, for example, you talk about relaxation, which I think is really interesting, but thinking about what's in the news right now, from an FPS perspective. I know you follow it as much as I do. being someone who who have I believe you're a fellow of ft Li, weren't you?
Seth
Yes, I was a food and drug lords two fellow years ago.
Darshan
So So you are what most people would consider. I know, we aren't allowed to say words like this. So the equivalent of a expert or specialist and the reason I say that I think bar rules prevent us from calling each other that but to the extent, you know a lot about the space you you're very familiar with that space. From an intensity you intend to use perspective and tend to use perspective. When you're talking about a product, like mushrooms and LSD and MDMA. Why are these not regulated like drugs? And if so, why not?
Seth
For the most part, they're not well, they are regulated by drugs darsana, if you're going to use them for a clinical setting, a most of these products, though, are controlled one substances under the DEA. So DEA has determined like cannabis, that there are no medical benefits, no medical uses for these products. And as a result, although they're before they were classified into schedule one, there was research done, the research is essentially stopped since they've been classified. And so there isn't the research to support the fact that these products can in fact have medicinal purposes, and medicinal uses vine.
Darshan
So So you say that, but we both know that there are organizations that are starting to explore this, how are they exploring the space? In a world where possible?
Seth
Pardon me, the way they're exploring the space, quite frankly, darsan is most of these folks are exploring space from the standpoint of mental health. If you and I both know, the, when you look at pharmaceuticals intended for mental health, there aren't a lot of them. There aren't a lot of options out there, you've got a you've got the traditional antidepressants that we've seen seen, you've got some anti psychotic drugs that are out there. But by and large mental health is an area that people have not really delved into or touched on it because it is incredibly complicated. Because there's not only the, the component of the what the pharmaceutical can do, but there's also the component of needing to pair that with therapy. And how do you blend those two into a cohesive treatment plan for individual patients?
Darshan
You say that but how do you do that without access to the product and you can't you don't have access to the product because you can't do the research. You can do the research for this classifier you can't you
Seth
can't you can you just have to go You have to go get special permission from FDA and DEA to be able to do the research. And and you need to have a credible clinical trial plan and, and work from there. But again, one of the things that is Huck adeleke world unfortunately is trying to overcome is the fact that, you know, everybody remembers Timothy Leary. Everybody remembers the, you know, the Haight Ashbury days and so there there is a inborn prejudice that against allowing these products to move forward. And in the normal course of development. They all have risks they all have, they all have red, they all have risks of abuse, they all have risks associated with them. And there's a fair amount and like cannabis, there's a fair amount of baggage that goes along with them as well.
Darshan
Let's actually I don't know Timothy Leary, or Haight Ashbury, can you talk a little bit about what those are.
Seth
I'm taking you back to the 1960s, early 70s Larry was studying LSD for medicinal purposes at one point in time. Haight Ashbury, you know, was the flower children and you know, everybody can go use whatever they want and should have, you know, drugs should be decriminalized, and everybody should have a right to access whatever the heck they want from from from those days.
Darshan
And what happened? Why did why were those movements unsuccessful?
Seth
Well, for the most part, again, these things have risks, these things can hurt you. And so the sudden the science wasn't there to establish that they were unlike opioids, let's say the science wasn't there to prove that there was a medicinal value. So they got lumped into while they have a high, high risk of abuse, high in some cases, high risk of addiction. So there were concerns about that, so they lump them in it. The history is muddy, but it basically goes back to the 1970s in Nixon's war on drugs. So they all kind of put all this stuff into that bucket. So heroin, Cannabis, all this stuff got lumped into into one big bucket that we got we know a schedule one these days.
Darshan
So just gonna state the obvious I've never had heroin but is heroin. Does it have hallucinogenic slash?
Seth
heroin, heroin has pain related and addictive properties. Heroin, if you go back far enough, was actually invented by the bear company and we used as a cough suppressant years ago. Nokia? It's no, it's no, it's an opium derivative.
Darshan
I remembered that part. I did not know that. I didn't know what effect it had. But I appreciate you clarifying for those who didn't. The question I had is, if I mean cannabis is already being in the process of being some version of reclassified, what does that mean? And whatever impact is going to have if psychedelics go off back list, what's left on a schedule one list of that, but sounds like heroin,
Seth
but well, illegal fentanyl probably will be on a schedule one. But fentanyl obviously is a schedule two, because it does have some medicinal purposes, there's going to be very there, they're going to be a very few things left, ultimately, but which is why each one that comes off the list, they're gonna have to demonstrate a medical benefit for each one. So it's gonna take a while to shrink that list.
Darshan
Which is true, I guess, I guess the question I'm asking without asking it is, do you see and one of the reasons that there has been hesitancy in, in moving away from moving these these schedule one substances, and then regulating them is a administrative issue in terms of the DEA loses control over these products in the way that they have?
Seth
No, I don't think it's that I think it I think it's just a prejudice against the what people's some people view as the counterculture of the drug culture, you know, concerns that we're going to make the population into a bunch of attics that we're then going to have to deal with, I mean, the VA will still have control over this, for the most part, especially if they only allow these to become scheduled twos, because the only difference between schedule one and schedule two, honestly, is there's a medicine use.
Darshan
Right. So so you, you have interacted and, and or worked with companies that have this type of product as a end goal. My question for you is, what unique issues do you face? When when dealing with clients of this variety, if you will?
Seth
Well, I guess, first and foremost, is an understanding of the regulated environment, what is it? What is it going to take to prove the thesis that these actually work in a medicinal world? Now, what are adequate and well controlled studies look like? How do you define those endpoints? And what's also complicating that factor is, you know, are there adequate measures to define those endpoints? Because we're talking about mental health endpoints, we're not talking about just PK values or absorption rates or any of those things we're talking about? Having to pair these drugs as a tool with traditional mental health services to get the desired outcome in the end.
Darshan
So if that's true, why is it Why is the situation a different from any other startup in that Is it? Is it not easy to educate them on this stuff? Or are they read it?
Seth
No, it's not? No, it's not because a large number of folks are in again, it's changing. And it's changing rapidly because companies are beginning to realize this as an unmet medical need. It is in therapeutic area that has very few players in it. So it had mental health is obviously a big issue that's been not addressed for years. But I think when we talk about looking at this, from the standpoint of education, there are a large number of the folks who I work with or interact with, you know, there, there's also this well, we think everything should be decriminalized. Everybody should have access to it. We all understand there is a sort of a reaction to the government's regulation of it, big brother, there's all those kinds of inborn prejudices on the other side as well.
Darshan
So So you have these inborn prejudices? it, I found that when you're fighting that, you have to find the prejudice, you have to address the the trust issues before you can start educating them? What have you seen to be a a viable strategy in that education? Is it commiserate commiserating? Or sort of going look, I recognize you have these problems, but we have other problems to solve? And how do you sort of negotiate to help develop a compliance program for something that is, as you put it, a schedule one substance that's highly addictive, highly sought after?
Seth
I think I think what I try to use honestly, they're showing is try to walk them through the issues that we've seen in the opioid crisis, because the opioids, where the opioids come from, and what they do, and what's come about are is an excellent case study, it highlights what the government's concerns are going to be, and highlights how not to get yourself into those kinds of areas in trouble, a highlights the need to have, you know, really good data to support what you're trying to do and robust data around it. And to try to take out again, the challenge that I work with my clients is let's take out all of the policy stuff and set that aside, because we can argue policy all day long. Let's just argue the science. Do these things work? Do they not work? If they work? Who do they work for? What benefits do they provide? Are the benefits greater than the risks? Let's try to have the conversation around the science. And we'll worry about the policy stuff later. But let's for now just focus on the science and do you have the data to back it up?
Darshan
So I think I think you're 100% right, that you need to start from the data, you weren't going to convince most policymakers without the data in hand. Having said that, cannabis kind of did it. So it's not an impossible task. cannabis is still getting a lot of the data that they need, in terms of having the adequate well controlled trials that the FDA typically is expecting.
Seth
Yeah. But unfortunately for psychedelics, yes, there's a huge underground, illicit use of them. But unlike cannabis, we don't have a lot of that anecdotal data because people will talk about it. People are worried about enforcement. The government hasn't taken the same enforcement stance as they have the sort of hands off approach they've been taking with cannabis, at least at the state level. So cannabis has been fortunate at this point. Setting aside the data that's being generated for cannabis is good or bad, or robust from a FDA adequate and well controlled study point of view. The mass of data around cannabis says Hey guys, there's something here. Yeah, hey, regardless of how you you know, regardless of the fact you say we need additional studies to prove it, we need be able to use the FDA gold standard to prove it, etc, etc. It's hard to ignore the massive information that's out there. And the number of people who say look, I get a benefit from it.
Darshan
So how is this a different and I'm talking now cannabis and psychedelics. How is this different from say, the situation with hormones and wioth where literally I remember as a pharmacist, And again, I can say this because it's 20 years old and it's not hopefully implicating company in this moment. But the recollection then was every woman who was postmenopausal should be on Premarin. I remember when that study came out, saying turns up, it's not the greatest idea in the world. Every woman was on it. All the doctors agreed that that is the standard of care. And then this, this breakout study comes out and destroys everything we thought we knew. In that case, we had some data that suggested that this was a good idea. Cannabis psychedelics, do we do we struggle with individual case studies, clumping them together and saying there's something out here compared to, um, I think I think
Seth
you got to separates cannabis from psychedelics. And the reason, reason reason I said that is where psychedelic seemed to be beneficial, at least in the studies that are being done now has to do with mental health. And that area. As you all know, there's also that difficulty in talking about mental health in viewing mental health issues as being like pain, like any other disease state, it's something special, it's something different, we, we tend to bucket it differently. I remember years ago, hearing a talk given by Rosalyn Carter about you know, the prejudice around people with mental health issues. And, you know, arguing her argument was, I think the right one, which is why aren't we treating this just like any other disease state people? What is it's not special, it's, it's, they say, a biological system that somehow is not working the way it needs to work.
Darshan
I'm gonna play devil's advocate, I 100% agree with you that we need to go after and treat mental health a big difference. The big, the big question we have is that for most other disease states, we have objective measures we
Seth
can match. That's one of the problems there, Shawn is building those measurements. It's not right. They're not well established. Right? Yeah, there are there are scales there are you know, you name it. Scales? Yeah, that's, well, it's kind of like the subjective scales around pain. How do we quantify these things, because we're talking about feet, you know, in a way, human feelings. Human perceptions, it's hard to, it's hard to find objective ways to talk about it.
Darshan
So so we are talking about psychedelics, we're talking about schedule one substances. And again, just to clarify, and remind people, what is the schedule one substance,
Seth
schedule one substance, high risk of abuse or addiction, and no medical benefit,
Darshan
as opposed to schedule two, which is
Seth
high risk of abuse, I risk of addiction and some medical and a medical benefit.
Darshan
I'm a medical benefit, right? So the distinction is just that medical benefit as
Seth
a medical benefit distinction.
Darshan
So So if that's true, and you're developing a compliance program for a psychedelic product that may come to market in the future How do you begin to do sort of create that that compliance program
Seth
the same way complete any any compliance program or shine? It's not it's not any different? That's the thing. Although that is another thing that I worked with with my clients is that you know, the feeling that they're special, that what they're doing is special Well, yes, it is special because you're working in mental health and a lot of people don't work there. But as far as how the government views the company, how the government views your control mechanisms, how the government views how you do and conduct studies, You're no different you're not special. You're you you're just you in a way or just a I I hate to put it this way, but essentially you're just another pharmaceutical manufacturer, trying to get approval for the product.
Darshan
Yeah, I agree. And that's that's been hard when I talk to individuals who are coming into the space Yes, you're doing something unique, you're doing something that's special, but not for the reasons you think it is unique and special. It's unique and special because you're treating spaces that have commonly been ignored. And and I think it's important that that you draw that distinction now so now you've got clients are saying I'm special. What do they think they're special for? And and how do you how do you sort of address their concerns around it? Well,
Seth
the special ticks and ticks. I've seen take two forms. One is they're special because usually they're small. So there's the size argument that you've we've heard before in regular pharmaceuticals as well. Yes, true, the government may exercise some enforcement discretion based on size. But as we've seen from the recent cases, that distinction is a misnomer, and is certainly going away. There also the, there's also a sense that they're doing something for the public good, and somehow that's going to insulate them. Again, it's not, you know, if you're marketing something, even if it is for the public good, and it you don't have the data to back it up, and you're gonna be looked at the same way as any other company that doesn't have the data to back it up.
Darshan
Which is so interesting. Talk to me a little bit more about their their perception of they're doing this for the public good, isn't isn't everyone doing it for the public good. I mean, that's the entire basis on when someone's going to buy something that you think that they think it's going to benefit them.
Seth
Yeah, but I think for the most part, the folks that I work with, have a greater sense of trying to change the world, if I can put it that way. These these, these are folks who are committed to social justice, who are committed to racial diversity, who are committed to not being don't want to be a big for profit, pharmaceutical company, or at least behave in that fashion. Again, nothing wrong with being a big for profit pharmaceutical company. But we have seen certain, lots of egregious behavior from companies that don't want to be just motivated. But I guess the better way to put it is they just want to be motivated, just motivated by the profit line.
Darshan
Which is, which is great, but I feel like a lot of companies start out that way. And as they they spend billions towards developing their product, they realize that they cannot not charge. What is a pretty penny? Well, yeah, I
Seth
think I think these folks realize that like you're gonna have to there. But again, I think they're closer to the action around and the debate around when you say charge for a product, what is a reasonable price charge, it's not doing as grilling, and charging whatever the market will bear because you control the market, it's not about getting control. It's about helping people and making a reasonable return. that then allows you to go look at the next product and maybe help people there. There's a real the, I guess the way I could put it is there's a real sense of do gooder attitude. Yeah, and that's special because there are a lot of folks who don't have that but it doesn't insulate you or somehow give you a pass when it comes to enforcement.
Darshan
So so we can keep talking about this because it's such a fascinating area and emerging area of law and compliance so so thank you for coming and talking about it. As you know, we're going to be asking a few different questions for you to share with the audience. The first is just how can people reach you? And I think I'm sort of putting that up but for those people who are listening and not watching How can people reach you the
Seth
easiest way to reach me is through my email through my website why law comm white law compliance comm those are the value the fastest way to get get in touch
Darshan
with me. Very cool. My
Seth
timer you guys will check out my LinkedIn profile because it has my contact information there. I don't do what a lot of people do, which is just use their use a Gmail or a Hotmail account. It's actually my company, email and ways to get in touch with me.
Darshan
There you go. Um, my next question for you. Based on what we've discussed, what is a question like to ask the audience?
Seth
I think the question for the audience would be where do you see psychedelics going? Do you see psychedelics ever getting to the point where they can overcome the barrier and prejudice?
Darshan
So my answer would be, I think You're going to have to, so I usually try to answer first as you know, so my answer would be, I think what's probably going to happen is that cannabis is going to have to get make its way all the way to federal legalization. And you're going to need to have a couple years between federal legalization and sort of what does that actually mean. And then lawmakers will be more open to exploring psychedelics, I think I think psychedelics will happen. It's just a question of when,
Seth
okay, Darshan, I happen to agree with you on that, I think. Because we've we've also heard the arguments against cannabis about it's going to open up the world, and we're going to create a whole population of drug drug addicts or whatever else somebody wants to throw out there. And I think we are going to have to see that the world isn't going to come to an end when you legalize cannabis. Right. When we legalize re legalized alcohol.
Darshan
Exactly right. I think that's gonna be interesting as we continue, because people are gonna want to see that and, and then have their fears calm, then, then the government's gonna realize this is another source of revenue. I question whether it's psychedelics, or whether it's cannabis, whether the end goal will be medicinal use or actual recreational use. And the point is, you pointed out out the hall, I wonder if the future is they bypass or either bypass or sort of do an intermittent step with the eventual goal of recreational use, but we'll see how that plays itself out,
Seth
we'll see how that plays out. Although I tend to think that the way it's gonna go is a year, at least on the psychedelic front, as opposed to the cannabis front, I think you're gonna see because of the nature of what can happen without it being used in a controlled environment, and appropriately, I think you're gonna see it probably head toward the medicinal. Interesting, even though there's a lot of lot of people advocating and who want to see it, you be recreation alized. I think. I think in the end, the future, certainly in this successful future with the regulators is going to be going toward the medicinal side of things, I think you're more likely to prevail in that argument.
Darshan
I think people said the same thing around cannabis, though. Why do you think that will be different?
Seth
I think because we, because again, I think the risks are different. And the risk profile of cannabis is psychedelics versus cannabis is completely is very different.
Darshan
Okay, fair enough.
Seth
I, I think if you want, put it in quote, and putting it in quotes, misuse is different.
Darshan
Addiction potential patients,
Seth
the implications of misuse, are different.
Darshan
Yeah, the risks are higher is your point. So while there may be benefits, the risks are higher. So more control probably makes more sense as your point.
Seth
Yeah, and then especially when you're using it for money, you're not you know, you're using cannabis by and large correct me if I'm wrong, you're the more you're more of the expert. And I see as the biggest bucket out from a medicinal point of view is around pain management, and dealing with pain.
Darshan
Not quite, I mean, they're they're everything. I mean, you think about pain is obviously one big one without a doubt. But anxiety is a huge one, as you know.
Seth
But But yeah, but we're talking about when we're talking psychedelics, we're talking tend to be more serious types of mental conditions. Like PTSD, for example. Yeah. So we're talking about some some serious stuff that if not handled correctly connected with the again, these are all tools that have to be used in conjunction with other tools to get to the right result. And if they they have the potential to make those mental health conditions worse, if not used appropriately.
Darshan
Fair enough. Fair enough. So your next question, what is something you've learned in the last month that you think the audience might find interesting?
Seth
I've learned in the last month that this space is rapidly evolving. It used to be sort of the untalked about space and yet it seems to be getting a lot of attention, not just from entrepreneurs and venture capitalists who's see a potential market but also from the press as well. We are articles in the New York Times articles and you know, it's that well established media are mucking about it. So this is gone from being something that was sort of underground and in the dark to something that people were talking about saying, well wait a minute, maybe there really is benefit. What if this does help people with mental illness? What if this does become a treatment and I think COVID and being people being locked down and the resulting mental health challenges as a result of that, for all of us has kind of given psychedelics their time. It's the right time to have a start having these conversations.
Darshan
We're moving away from the moonshine version of psychedelics towards the Coors Light if you will so yeah otherwise or the
Seth
or the use of illicit drugs in the in you know, in the dark nightclub setting to more Kenny's things really help people can we really and we have limited tools so what we really need are more tools
Darshan
we should have a whole conversation on tools I think that'd be a fun conversation as well. Um,
Seth
I think there are a lot more tools and I think again, I think we're also getting I think the scientists are getting better at discussing how do you measure mental health improvements how do you how does it How does mental health work what is what else does it affect? What affects it? I think we're getting a better understanding of the biology the basic biology that we're getting a better understanding of how this all fits together you know the mind You know, we've we're, we've heard for decades the mind body connection, but I think we're starting to actually show of objectively the mind body connection and how that how that actually really works. I think we're getting smarter about it. We got a long way to go.
Darshan
Yeah, yeah. Um, last question. Um, what's something that made you happy in the last week?
Seth
Oh, made me happy last week. Yeah, honestly, Chase Yeah.
Darshan
Oh, that's very cool. Yeah. The one that was barking
Seth
Yeah, the one that was barking, the smallest one has the biggest mouth.
Darshan
They always do. I love it. Again, just remind everyone you can find set at s white law at White law compliance comm or go to his website at White law. compliance.com. Seth, thank you so much for coming on.
Seth
Oh, thank you for having me. Darshan. It's been a pleasure.
Seth
This is the DarshanTalks podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on twitter at DarshanTalks are the show's website at DarshanTalks.com