July 5, 2021

Similar Interests, Different Parties, and the Scientific Process of New Medicines

The psychedelics industry is booming. Everyone wants a piece of it — between the startup companies, the regulatory bodies, the university medical schools, and ultimately, the people in need of these products and services. As Chief Medical Officer at MINDCURE, Dr. Joel Raskin provides deep insight into the interactions between these institutions as well as his robust knowledge of the scientific process.

Similar Interests, Different Parties, and the Scientific Process of New Medicines

Sherry Walling - 0:00:09
Psychedelics may be the future of Psychiatry. If you think I'm overreaching, look around at the number of new university or medical school-based research programs that are becoming centers of excellence or some other kind of psychedelic-related hub. Look at the number of new startups related to psychedelics, popping up on the market. It seems like on a weekly basis. Recently, I've been curious about how all of these different components work together, how startups interact with government regulatory bodies, interact with University Medical schools, interact with maybe Big Pharma.

Sherry Walling - 0:00:42
What's the process of taking an idea all the way through to a medicine? What's the connection between these big structures? These big research entities and the individuals on the other side who are in need of some help or alleviation of their pain? To get at this conversation and from a different perspective, I decided to sit down with the Chief Medical Officer of MINDCURE, Dr. Joel Raskin, and ask him more about how research happens and how different systems work together to make new compounds a possibility. Dr. Raskin holds an MD from the University of Toronto and he's had a long and amazing career working all over the world on lots of different kinds of problems, but he has specific expertise in the development of psychiatric medications.

Sherry Walling - 0:01:29
Dr. Raskin came out of retirement to join the team at MINDCURE and he brings deep expertise and a unique perspective that I'm grateful to be able to share with you today. Welcome to the MIND CURIOUS podcasts, a place where we explore both the promise and challenges of psychedelic compounds. Our conversations often bring us to the intersection of science, spirituality, medicine, law, and human consciousness. Please keep in mind that the contents of this conversation are not intended to be specific medical advice. Welcome to the conversation and let's dive in.

Sherry Walling - 0:02:01
It is wonderful to have the opportunity to talk with you and hear a little bit about what you're working on and what you're excited about when it comes to your new position in Mind Cure Health.

Dr. Joel Raskin - 0:02:22
Well thanks, Sherry. I am very excited about joining Mind Cure Health for really several reasons. As a psychiatrist, I was a part of what I thought was really an exciting time. The SSRIs revolutionized the treatment of depression. The second-generation antipsychotics really revolutionized the treatment of people with schizophrenia. But also I saw that things were not good enough. These treatments didn't work for everybody.

Dr. Joel Raskin - 0:02:51
A lot of people were intolerant to them and we needed other options, and I always thought that the psychedelics were an option that should be studied because people were taking them for various illnesses or problems, and I always felt that they should be studied. And so most recently, there's been this explosion of interest in the psychedelics, after really a period of inactivity in mental health as far as new drugs, and so I was very excited to join because MINDCURE seems to be really taking a very holistic view to people with various mental illnesses and issues in the sense that we're looking at digital health. We're looking at psychological ways to help people as well as the medications, and as I said, that holistic view is what people really need.

Sherry Walling - 0:03:50
Well, you're singing my song as a psychologist, so sometimes when psychiatrists and psychologists get together, we see the individual patient a little bit differently. But I think the thing that you're talking about that MINDCURE is so excellent at is really seeing the whole person and thinking about those biochemical medical interventions as well as how to really support people integrating new experiences and new treatments into their life on a day-to-day basis.

Dr. Joel Raskin - 0:04:18
Well, Sherry, you are correct that psychiatrists and psychologists don't always get along. But it's not necessarily because we don't agree with each other. I had so many people that I had to see that I couldn't give people the time for therapy, and I know that they wanted it, and I knew they needed it, and it was often hard to find a psychologist who they could see. And realistically, I think studies have shown not everyone needs medication. Not everyone needs therapy, but most people if they need medication, benefit from the psychotherapy as well, and studies have shown that. That two is better than one and so I am a big supporter of the psychological piece to it.

Dr. Joel Raskin - 0:05:03
Medications are generally not enough for most people.

Sherry Walling - 0:05:12
What was your early exposure to the work that was being done around psychedelics? So you mentioned there's been this recent explosion and interest in the research community around some of the benefits that psychedelics might have for treating mental health conditions, but that predates the last 5-10 years, right? That's a longer history and I'm just curious how you first encountered that work.

Dr. Joel Raskin - 0:05:39
Well, my first encounter actually was a long time ago, and it's going to make me feel very old, but when I was in my training actually, one of the oncologists that I was working with wanted to study the effects of marijuana to see if it could help people with cancer pain. It wasn't cannabis back then. Actually, we got permission for our patients to smoke in the bathroom and we were looking at the effects of the marijuana on could it reduce their cancer pain, anxiety, some of these things. I can tell you that sitting in the bathroom, interviewing these generally younger people with cancer as I sat in this locked room with them smoking, I think I gained about 20 pounds during that process. But it always got me interested, and I've always been interested in let's say the nonconventional or nontraditional medication options because people need options, and so it always had interested me.

Dr. Joel Raskin - 0:06:40
But the scientific community was not really excited about it and really dissuaded people from studying psychedelics and the nonconventional options. More recently, there's been this real interest again. It's very exciting that they're taking a scientific approach to it and I think that's really critical. The psychedelics are now being studied as potential medicines, and are going through the rigor that every medicine goes through, and I actually really support that.

Sherry Walling - 0:07:17
When you talk about that rigor, what does that look like? I mean, what does it look like, just for a layperson to understand, to take a medicine through the process of proving that it's helpful? What does it look like to take it all the way through to be something that's widely implemented?

Dr. Joel Raskin - 0:07:37
So taking something through from an idea to a medicine is really a very long process and regulated as well by the government via health authorities like the FDA or Health Canada. And there are rules around what's required to actually bring a medicine forward. There has to be a lot of safety data from animals first before we actually bring it into people. And then in human studies, there are three phases that we go through. And logically, they're called Phase One, Two, and Three, which is great.

Dr. Joel Raskin - 0:08:10
So Phase One is a bit of the safety and trying to understand the dosing. So that's Phase One, and that establishes is the drug safe in healthy people. Phase Two becomes what we call the proof of concept. Does the drug work in the disease state we're interested in, and if it works, and if it's safe and well tolerated, you generally try to pick the dose from that and move into Phase Three, which are the large efficacy trials. And regulators, they want to-- they want to be sure that the drug works.

Dr. Joel Raskin - 0:08:46
They want two positive trials and they also want long-term exposure to show that it's safe because in a short-term study, if someone takes a medicine for a year or for life, we need to study it and with that package of the efficacy trials and the safety, that's when you would go to the regulator to submit your drug. My job is to make sure that people are safe. Patient safety is the number one thing that we have to be aware of and make sure that we're dealing with throughout the development process.

Sherry Walling - 0:09:26
And what happens if there is an adverse event somewhere in that process?

Dr. Joel Raskin - 0:09:31
Well, adverse events is something we watch very, very closely in clinical trials, and what we see in clinical trials is that adverse events happen, but they also happen with placebo and that's one of the reasons why we have to have placebo 'cause we need to know what is the actual contribution of the drug and we report the adverse events to the regulatory agencies. However, there is special attention paid to what we call the more serious adverse events. These are adverse events that are unexpected that might cause someone to have to go into hospital. And we have often in clinical trials under development, we have what we call a data management board or a Safety Board who are not affiliated with the company and they help us assess the safety and give us feedback as well. But there's this very, very rigorous attention to the safety to adverse events reporting and its regulated reports to the health authorities.

Sherry Walling - 0:10:38
I mean you have such deep experience in science and in bringing drugs through-- medications through this process and making sure, as you say, that the part of your job is to make sure that people are safe. I guess I'm curious with psychedelics because they have in some cases this history of being used in ceremonial ways and being used as sort of sacred plant medicines, they have a history and a life outside of science. Does that enter the conversation for you? You know, I know sometimes people feel uneasy about these sacred traditional medicines being now kind of co-opted by Western scientists in ways that maybe aren't helpful or dishonor them.

Dr. Joel Raskin - 0:11:25
I believe that we can learn a lot from traditional cultures and societies have been using herbal remedies, natural things for ceremonial purposes, for health purposes. You know, one of the most common heart drugs, digoxin is from a plant. I mean-- and it was learned to be used from observations and learning from these cultures. So first off, I believe we can learn a lot. I don't think that we're necessarily co-opting or doing evil by studying them as medications.

Dr. Joel Raskin - 0:11:55
I think we're actually honoring the tradition by saying, "You know, there's value here." Not everything is developed from a a test tube. The challenge I think sometimes with the history of the psychedelics is that especially among the research community and physicians, they're seen as something used by, you know, other people. They're not medicine. They scare physicians and you know, physicians like myself, we are control freaks.

Sherry Walling - 0:12:29
Thanks for calling it out.

Dr. Joel Raskin - 0:12:31
We are, I can't hide it, you know.

Sherry Walling - 0:12:34
You know, we need you to be. The public needs you to be, right? Careful and in charge, and conscientious and all of those things, but yes.

Dr. Joel Raskin - 0:12:44
Sure, but that's one of the reasons why a lot of physicians are frightened of the psychedelics and don't really understand them or have said, "That's not my area," you know. And I think that's contributed to them not having been studied for so long. And yes, there are risks. But like I said, everything has side effects. I think in the current time and world we live in, there's a good chance that Tylenol might not have been approved if we brought it forward today because there are safety issues if you take too much.

Dr. Joel Raskin - 0:13:11
So for me, I think in taking the psychedelics forward, credibility is key because we're going to have to prove to physicians and the research community and to people out there who maybe aren't users of psychedelics or see them as the evil thing for young people. It really behooves us to actually be more careful.

Sherry Walling - 0:13:42
To go above and beyond.

Dr. Joel Raskin - 0:13:44
Yes, so we can prove that the credibility is there and that these can be used appropriately, safely, and effectively.

Sherry Walling - 0:13:52
Has it been strange for you to connect with your doctor friends and to talk about this new position that you've taken in a psychedelic company? Has it raised some eyebrows?

Dr. Joel Raskin - 0:14:02
So, I have never had more responses to a LinkedIn announcement than I have since I joined MINDCURE and most of my physician friends are actually really excited, and I think some of it is that you kind of-- to them taking this step into the unknown, and they're all sort of saying like, "Good for you," like, "This is really fantastic," you know. I don't know if they're saying that because they wouldn't do it. You know, it's so, "Okay, you know, he's crazy enough to do it." But a lot of them have said, you know, "Good for you because people need options." You know, those of us who have been treating patients for years, yes, the treatments are way better than they used to be, but we still know that they don't address the needs of so many people, and it's terrible to feel sometimes sitting across from someone and they're telling you, "This hasn't worked" or "I can't take it because of the side effects." "I feel better but I can't tolerate it." And you sit there and it's agonizing because you want to help people, and so most of my friends have been incredibly excited and curious. And I told them, "No samples though," that I-- you know, I'm not (laughing)

Sherry Walling - 0:15:21
There is not a lab, not a lab that they get invited to (laughing). Yeah, it's a good thing to have a sense of humor about. I think, you know, similarly, as I've been doing this work and doing this podcast, it certainly raised a lot of eyebrows among people that I grew up going to church with, and people that I have had different interactions with at different times, and I think it's just fun to be able to say I'm really curious about this as a scientific process and as something that provides hope and help to people.

Dr. Joel Raskin - 0:15:52
You are exactly right, Sherry. I look at it as no different than any other sort of drug development other than these have been around for a while, and there is a stigma to them, both positive and negative, and I don't know if it's going to work. Some will, some won't. I think, like any development, we're going to have some challenges, and hopefully we're going to have some successes, but I look at it that my job is to study these like I would anything and hopefully bring options to people. And it's not going to replace conventional medications, it's another option.

Sherry Walling - 0:16:35
Well, let me ask you this question. How does it feel different to work for a startup, right? A psychedelic startup that's moving quickly as opposed to maybe some of the other positions that you had with Eli Lilly or with medical schools that have I would imagine set a sort of different culture of doing science and a different dynamic? What's it like to be in startup land?

Dr. Joel Raskin - 0:16:58
So working in a startup land is very different than working in academia or with a big pharma company. The biggest difference, I think, is sometimes the speed. When I work in other areas, there are so many layers of approvals and processes that I have to go through. Now in startup, there are still processes, we're not-- not doing the things that we have to do, but I find now is that I have to do them. It's that I don't have 10 people that I could assign things to. It really falls on me a lot.

Dr. Joel Raskin - 0:17:35
The other piece is that everyone is in the same boat though, so everyone is hands-on and showing initiative in the startups, and I find that really refreshing 'cause everyone has the authority in a lot of ways to make decisions and move forward. So, things go faster. I think the other thing is that the people who are in startups are also sometimes a little different in that they have to want to have that kind of initiative, authority, decision making. So, it's fun, like it's-- I mean I love my other work and I don't mean to say it wasn't fun. And I've had the benefit since I retired two years ago and started doing other things to work with several small companies, and they're all incredibly refreshing and a lot of the people believe they can change the world.

Dr. Joel Raskin - 0:18:27
My approach isn't to change the world. I don't take that approach because I think that's pretty tough. But what I do want to change is the life of the person in front of me.

Sherry Walling - 0:18:46
Yeah, I've spent a lot of the last few years of my career in the startup space, after having spent a lot of time in VA hospitals, large government hospitals and medical schools, and so that sense of sort of the audacious goal that I want to change the world, the big, mission driven, ambitious, moving fast, a little scrappy is a different feeling. And as you say, there are really brilliant, well intentioned, hardworking helpers in all of those different contexts. But it's just a little bit of a different flavor of pudding to be in the startup space. Thinking about those different-- sort of that shared goal of let's make this better, let's just talk about let's make this better in the mental health world. What are some of the challenges and/or hopes that you have around how those different systems can work together?

Sherry Walling - 0:19:39
So you've got regulatory government systems, you've got traditional drug development companies and medical schools, you've got startups, you have all these different pockets of people who, let's just assume have very similar overall goals. How do we integrate those pieces in a way that is effective for the patient who's on the other end of the story?

Dr. Joel Raskin - 0:20:08
That is a really good question and I was always told that you should never say to someone that's a really good question because it implies that the other ones were not so good. But you've really hit the crux of one of the issues is that everyone works somewhat independently in these companies and in the ideal world, it would be more collaborative. That's difficult because we live in a capitalist society and people want a return on their investment and such. And there's intellectual property and all these different things that get in the way of true collaboration. But science has a way of being transparent and publishing data, we learn from each other.

Dr. Joel Raskin - 0:20:45
And I think we do need to talk to each other. And again, I think if we take the focus that-- and I'll say the patient 'cause we're talking about people with potentially with mental illness as an example, and they are people-- they are people with an illness, and that's really important. I remember in the days when we used to talk about someone as a schizophrenic and that's terrible 'cause they're not a schizophrenic. They're a person with schizophrenia. We don't look at someone and say, "Oh, there's a hypertensive." We say, "No, it's a person with high blood pressure" or a person with cancer and we've been really fortunate with in psychiatry that with the newer medications, we have switched to talking about people with schizophrenia or people with major depression, but we still have challenges around taking a real holistic view.

Dr. Joel Raskin - 0:21:39
You know, when companies try to think that they want the whole pie. That's the wrong way to think. There are lots of pieces and it's a big pie. Unfortunately, there's a lot of people suffering. There's a lot of need.

Dr. Joel Raskin - 0:21:57
And so, what we really need to do is try to develop treatments that are customized to the person and so we need to develop treatments, psychological, medical, psychedelic. You know, it may not be for everybody and so we need to study it in a subgroup and say, you know, "We think this is the right one. Let's study that. Let's not go after the whole pie. Let's go after the pieces and that way, we'll end up treating the whole pie."

Sherry Walling - 0:22:31
And it strikes me that it's so helpful to have people like you in this conversation because you can speak these different languages, you're learning to speak startup, but you can speak medical school and regulatory bodies and you've been in these different environments that hopefully when the time comes will allow for the right kind of collaboration to say, "Hey, you know, we've got this little piece of pie over here, we can come and bring it to the picnic and share with the rest of you" and have some of that cross pollination in ways that honor the work that everyone is doing.

Dr. Joel Raskin - 0:23:07
Well, thank you. I mean, I've had a really fun career and I've had the opportunity to work all over the world with people, with illnesses, with the physicians, with governments. All over the world, you know, the takeaways are the same is that people are waiting for newer and better options and the opportunity now at this point of my career to study something old and yet new is really exciting, and if you'd asked me a year ago, would I be doing this? I would have said I haven't even thought about it, haven't even entered my mind. I knew it was out there, you know, and these things were being-- the psychedelics were being studied and I read it and followed it just like I follow conventional antidepressants and antipsychotic developments and other drug development. But the opportunity to join MINDCURE really was an exciting opportunity because of that holistic approach to the patient, looking at a variety of different medication and treatment, psychedelic options and the people, working with people who are excited about what they're doing, can't help but get me excited about what I'm doing as well.

Dr. Joel Raskin - 0:24:17
So it seems like a great opportunity to take all those learnings over the years and try something a little different and learn from, as you had talked about, the traditional things. I think the psychotherapies in addition to the psychedelics, I mean, that's that holistic patient approach, which I think is going to really, really help people in the future.

Sherry Walling - 0:24:54
Well, wonderful. We are so glad you're here and can't wait to see what you continue to work on and develop over the years to come.

Dr. Joel Raskin - 0:25:04
Oh, thanks, Sherry. I look forward to it too.

Sherry Walling - 0:25:11
Thank you so much for joining me. If you have more curiosities about all that MINDCURE is doing, follow us on the interwebs via all the social media channels and of course, our website, mindcure.com, and I would love to hear how you are finding this podcast. Is it helpful? Is it informative? What do you like? What would you like to hear more of?

Sherry Walling - 0:25:28
Feel free to leave that feedback in the form of a review or via comments on our social media channel. Thank you so much for listening.