Head Inside Mental Health
Todd Weatherly, Therapeutic Consultant and mental health professional hosts #Head-Inside Mental Health featuring conversations about mental health and substance use treatment with experts from across the country sharing their thoughts and insights on the world of behavioral health care.
Head Inside Mental Health
From Drug Development to Patient Lives with Dr. David Pickar
What if a single medication could revolutionize the treatment of thought disorder and psychosis? Join us as we invite Dr. David Pickar and the team he supports at Help in the Home back to the show to explore the potential of a new anti-psychotic medication approved by the FDA, Cobenfy. Setting itself apart by targeting the brain's cholinergic system and M1 and M4 receptors, Cobenfy sets a promising a new pathway for reduced side effects in antipsychotic treatment. We also discuss the FDA's pivotal move to relax restrictions on Clozapine, a decision that could reshape its role in mental health care and the med management challenges it has faced in the past.
From this springboard we dive into the sophisticated world of pharmaceutical innovation, focusing on the unique mechanisms behind anti-psychotics. We also shed light on the historical and financial intricacies of drug development, from the Hatch-Waxman Act to the current dynamics between pharmaceutical companies and the generic market. With the global antipsychotic market on the brink of expansion, we explore the delicate balance between groundbreaking medication R&D and the lived experience of those using these medications often for most of their adult lives. Join us for this enlightening episode that offers a candid look at the evolving landscape of mental health care.
Hello folks, thanks for joining us on Head Inside Mental Health, featuring conversations about mental health and substance use treatment, with experts from across the country sharing their thoughts and insights on the world of behavioral health care, broadcasting on WPVM 1037, the voice of Asheville independent commercial-free radio. I'm Todd Weatherly, your host, therapeutic consultant, behavioral health expert, returning to the show with us today, himself and several guests, but Dr David Picard. Dr Picard is adjunct professor of psychiatry at Johns Hopkins Medical School and the Uniformed Services University of the Health Sciences. He received his medical degree from Yale University School of Medicine, completed his residency in psychiatry there. Dr Picard has served on the National Institute of Mental Health as a USPHS commissioned officer and captain and chief of the experimental therapeutics branch, dedicated to the studying of schizophrenia and psychosis. He also served on the psychiatry drug advisory committee for the FDA. He is fellow emeritus of the American College of Neuropsychopharmacology and is distinguished life fellow of the American Psychiatric Association. That's a mouthful in by itself.
Speaker 1:Dr Picard participates in neuropsychiatric drug development with emerging biotechnology companies and has served as a psychiatric consultant to the US Special Prosecutor. He is also the founder and president of Gabriel Sciences, a company whose mission is advancing the development of novel treatment for schizophrenia. Dr Pekar has received numerous honors and awards in the course of his career, has co-authored or co-authored over 400 publications and over 27,000 citations in the field of psychiatry and medication research. He is also the producer of documentary film the Realities of Serious Mental Illness. Dr Picard practices psychiatry in Chevy Chase, maryland, with emphasis on the care of patients suffering from serious mental illness, including clients served by MobileMed, a nonprofit provider of care for some of the most vulnerable individuals in the area, and our friends of the show Help in the Home provided supported independent living services. There in Rockville, maryland. Founders Rayette and Michael Stacey Derrick, as well as their clinical outreach Shannon Harris, are joining us as well today. Everybody Dr Picard, welcome back to the show.
Speaker 2:Thank you, todd, for having me. You know I can't wait. I enjoyed the last time so much and I'm thrilled to be here with Rayette St Stacy and Shannon the folks from Help in the Home who provide a pretty unique opportunity to help families and patients who are seriously ill.
Speaker 1:Yeah, well, you know we talked a little bit about this last time, but it's, you know, being able to provide care, residential treatment and hospital treatment is what it is and it's got its place. But the rubber meets the road out there, where people try to live independently again and receive the services of folks like Help in the Home and being able to just maintain, you know, these kind of fulfilling and supported living lives is really important, and if they don't have that, they end up stumbling and repeating cycles through the hospital and everything else. But one of the biggest pieces to that, of course, you know, for me it's very important where the stumbling blocks have a tendency to happen, we end up getting involved because somebody is going through residential treatment again or whatever is med management, and some of med management is people who are resistant to meds, or maybe they get to a place and they stop taking them because they don't want them. But another one is also finding the right med. We've got a lot of medications out there antipsychotics and medications that serve individuals suffering from psychotic disorders or suffering schizophrenia or schizoaffective disorder and one of the meds that we want to talk about today is Cobenify.
Speaker 1:No, no, I see I'm saying it wrong again. Cobenify, is that right? Tell me, you're gonna go there, we there, we go see I can I can speak to them and change it if you'd like okay, yes, you know, just just for me, because my accent, but you know from ashville, you call on anything you want in Asheville.
Speaker 1:That's right. We don't even care if it's right. See Well, Cobenfi, tell us a little bit about this medication, Dr Picard, and how we got here, your experience with it, your thoughts about it. Just give us the lay of the land.
Speaker 2:I'm glad to, and putting it into the context, that seriously mentally ill patients and patients who have psychosis in general and that could be manic patients, even depressed patients, brief psychotic episodes need antipsychotic medication.
Speaker 2:Yeah, and you know the first wonder drug and I think pardon me for backtracking a little because I'm a bit old, you know but the original antipsychotics fell in the category of wonder drugs, the way antibiotics did it. It may not appreciate it, but up until then there was nothing and these drugs were effective in reducing psychosis. They don't take away the disease and they could get better, and they've gotten better over the years. But there's been quite a bit of time before there's been an introduction of a new anti-psychotic and that's what CoBENF is, and it was approved. But let me go just to give our listeners, our friends here, a little perspective. When I was at the NIH I did an outside consultation for Eli Lilly Company on a drug, tiny little pharmaceutical firm, right, you know, yeah, a small one, a small one, right, right mom and pop shop.
Speaker 2:Okay, okay, um and uh. Yeah, you got it and they asked me to look at this answer. I'm talking about 30 years ago, 25 years ago, and they asked me to look at this compound they had developed and they had done quite a few clinical trials and it did appear to be an antipsychotic and that drug was xenomaline, and xenomaline is the name of the drug, that's co-benthine.
Speaker 1:Oh.
Speaker 2:Okay, and this is 30 years ago. It was ready to go.
Speaker 1:Right.
Speaker 2:But there was a problem, and I'm going to circle back. Everybody tell you more about how we use Cobenfi and why people got excited and so forth, but it produced an array of side effects that the company felt were prohibitive at that point to moving the drug forward. And the drug was taken over by an old colleague of mine, Steve Paul, and he used to be one of the most senior people at Lilly, but he brought it to his own company and what they did was they added another drug to the mix. So when you get co-benthly it's two drugs and the second drug takes away a lot of the side effects that were a problem as opposed to having to find another med which handles all the side effects.
Speaker 2:That's right.
Speaker 2:It's exactly right, todd. And the problem with that? Because it's true with a lot of antipsychotics that you need anticholinergics, cogentin and so forth, to help with side effects. The side effects were so pronounced. Certainly the company. I can't speak, I'm not speaking for Eli, but my observations were that the company just didn't feel this was going to work. You're going to turn off too many people. And when they added this other drug I'm going to come back to it it's very nicely handled. It's nicely handled in the sense that clinically it's a very comfortable drug, maybe more than other antipsychotics. That's right.
Speaker 2:Another step to the side, if not quite back, the development of antipsychotic drugs. The first ones were in the 50s, 60s. It changed the world of mental illness, blah, blah, blah, blah, blah, blah. And there are a lot of excellent ones. The best one is still clozapine, which is developed, believe it or not, in the 70s but requires blood tests. And I can certainly speak a lot about clozapine, but the field has not produced a drug that's a little different in mechanism in forever. And Copenfi comes along and there was an enormous enthusiasm, as there should be, by people who care for patients or families or patients themselves, because it is a little different mechanism which I'm going to talk about in a second. So this was approved by the FDA. I don't have the date in front of me, but I'm going to say with the last six months and I think you can get it in most pharmacies now, but it's just getting out there, okay.
Speaker 1:I've got a quick question for you.
Speaker 2:Yeah, interrupt me please.
Speaker 1:Well, there was a recent FDA. There was a case with Clozapine and the FDA and they were trying to change some of the restrictions with Clozapine and the FDA and they were trying to change some of the restrictions. It didn't make it, or the case was continued or they're coming back to court about it, but basically people didn't get the result that they wanted and we're still facing a lot of what ultimately are a pain in the butt in terms of getting it managed for a person, blood tests and certified psychiatrists to be able to prescribe it and all those things. It makes it difficult, especially for people who are resistant to taking medications. Was there and do you know or do you think, that CoBENFI was making its way down the line and they didn't want Clozapine to make any new developments or get greater on the scene before they were able to introduce this new bed? Was there any politics there? I?
Speaker 2:love you, todd, you're from North. Carolina I can tell it. You think there's some kind of conspiracy going on there too Right.
Speaker 2:Who came in there with the guns blazing? In fact, you're giving them more credit than they deserve. Fair, but the point is well taken. Let me go back to a couple of things. Clozapine, to this day, is the most effective antipsychotic. It had a risk for losing white blood cells this goes way, way back in my residency days and as a result, the FDA, food and Drug Administration, requires blood tests that are a pain in the tuchus. That's Yiddish for butt. It's a pain in the butt and it has, I believe, has limited the utility of clozapine. One thing you're not right about it went through. They're taking away the REMs.
Speaker 1:So they are yes.
Speaker 2:Oh well, that's great actually, yeah it's great and the reason it's fascinating. A granulocytosis is the loss of white blood cells, which is life-threatening. When they first did trials of clozapine back in the 70s, one country had a large number of A-granulocytosis and that country was Finland. Now I think it's because many Finnish people are not that outgoing, but I could be wrong on that but I've never seen it anywhere else. But it has been an unfortunate side of the clozapine story and now, with this change, you're going to see more of it. Now, one of the things that made everybody excited about Copenphi because there have been other new drugs introduced, but they've basically been I don't want to use the term knockoffs, that's not fair but very similar mechanisms and effectiveness. Okay Right.
Speaker 1:It's not far off. The mod, the, the original molecule, essentially one step better.
Speaker 2:There was a second generation that started clozapine as a whole thing unto itself, but risperidone, uh uh uh, alanzapine okay, yeah, those drugs were considered the early second generation drugs, had less in the way of the motor side effects and more effective, but they weren't the same as clozapine and far from perfect. Okay Right, this thing, this darn thing, is a very interesting drug because it has a different mechanism. I love them. I spent a lot of my life looking at mechanisms and developing drugs and so forth. So let me take a half a step back. It works through the cholinergic system. Now hang on a second. These are neurotransmitters. Anybody out there does the term neurotransmitter mean anything? If it bothers you, don't worry about it, I'll get by it, you know.
Speaker 2:But these are the molecules that enable one neuron, that's a nerve cell, to talk to another neuron. And frigging neurons live together by social, economic status? No, but they run together, they do group, they do group, they run together and create systems of the brain that have different mechanisms related to the brain and the dopaminergic systems, meaning systems where the neuron, principal neurons of dopamine uh, is a neurotransmitter have been the critical ones for us in schizophrenia. And they and why? And I'm looking at everybody listening out there, I'm looking at todd's face and he's saying, hey, wait a minute, we're not talking about clozapine, we're talking about co-bemphi. Get on the story.
Speaker 1:Well, I'm here, jack I mean I di I'm sorry yeah it was your mistake. It was you know.
Speaker 2:No, I'm teasing you because it's relevant, so bear with it. All known antipsychotic drugs work through either blocking dopamine receptors or somehow, in the case of clozapine, through a variety of mechanisms, modify it. Now I used to say there's a famous Einstein quote that God is subtle but not malicious. Okay, if dopamine has nothing to do with schizophrenia, your highness, that's malicious, all right. So there's no question in my mind that it's involved. In what way is it involved, and do you need to deal with it directly to produce antipsychotic effect? Well, maybe not. So here's this drug, invented 20 odd years, 30 years ago, whatever that hits acetylcholine neurons or cholinergic neurons, and they have their own systems in the brain and they have their own mechanisms, including the parasympathetic autonomic nervous system. I'm sorry, but things that control heart rate and things in your internal organs.
Speaker 1:Things you don't have to think about.
Speaker 2:Right, all right. So okay, good. How is that an antipsychotic? Well, there are different cholinergic receptors. They hit the M1, that's the way they call it, and the M4. Okay, in the cortex. Good, cortex is your high part of the brain. We think psychosis comes from dopamine dysregulation in some of the deeper lower parts and the cortex may sit on that and quiet it down. Just like in real life, your conscious thoughts sometimes sit on your unconscious thoughts in case you noticed, uh, the cortex.
Speaker 2:The old psychoanalysts talked about super ego, your sense of conscious and your conscious sense of self, and it would modulate it, which was your emotional self. Well, guess what? The cerebral cortex, the prefrontal cortex, modulates deep subcortical systems like dopamine. And so the analysts, in a funny way, were not that wrong. And so it's the cortical systems that help to keep dopamine systems in check, and when they're out of check with the illness, you improve it any way you can. And by God, co-benthy, which they're bragging about being muscarinic or cholinergic is the term turns out to work by quieting down dopamine systems, just by a different pathway. So it's cholinergic onto dopamine, and it does it without bonding to dopamine receptors or causing some of the side effects.
Speaker 2:Now, is it as good as the great drugs like Clozapine? We don't know yet, but there's no question it's an antipsychotic. I'm going to tell you something else Most antipsychotics virtual are not pleasant. I mean I when I say that. I mean it's not that you can't give them away at a cocktail party, but you have motor side effects that people feel them.
Speaker 1:Now they have tremendously long-term.
Speaker 2:Yeah, you know people don't like them and sometimes as a psychiatrist, and you have somebody who's lost touch with reality. Now he's back in reality and wants to go off his meds. Sometimes out of reality feels more appealing than to reality. To some of these folks who've been ill, you know their lives is not what it was. Quote, quote intended to be struggling Hell with it. I'm stopping medicine At least they're my own head.
Speaker 2:Happens a lot, a lot, not a little, a lot, okay. And the fact that these traditional antipsychotics, they make you feel a little funny. That's why we often give extra drugs to help side effects.
Speaker 2:Well, one of the things that struck me most about Combenfi is that, relatively speaking, it's very well tolerated. It's not principally a dopaminergic drug. It works on dopamine indirectly. You with me. It does acetylcholine things and guess what? They're in the cortex, frontal cortex, and they drop down to quiet dopamine indirectly and it's a much more pleasant sensation in the body. So one of the things I like about CoBed-3, that I like a lot is that it's better tolerated.
Speaker 2:Now, having said that, the cholinergic systems have some bad side effects and I told you early on when they were developing the drug. So the drug Cobenfi is the active drug, zonomaline and trospium, which is anticholinergic, to help the side effects. So in one pill they have a drug to help the side effects and the active drug. And in fact, when people take Cobenfi, my experience and when you read from the controlled data because that's all we've had for a long time is from the drug trials is that the patients find it much more tolerable. I love that. I love that. Now I, as an old scientist, clinical scientist, I have a million questions I'd love to answer. Unfortunately I retired from running that thing at the NIH, but it's an interesting drug so it's very well tolerated.
Speaker 2:A little bit of a different mechanism. It indirectly hits dopamine. Okay, I like that. Would it be helpful if you added it to other antipsychotics in patients who are not fully doing? Well? Don't know the answer, but I'll bet it will. I think you're it to anti, other anti-psychotics and patients who are not fully doing well, don't know the answer, but I'll bet it will. Right, I think you're going to see in a lot of different directions but a lot of people who are medication resistant might experience benefits that.
Speaker 2:That is the traditional uh todd.
Speaker 2:That's your traditional indication for clozapine right and if it were in my hand right now? I know the company, I know these guys. This is not a knock on the pharmaceutical industry, but just a knock on the pharmaceutical industry. They are I can't use that word. They're nervous Nellies. How about that? For a benign term, okay, and they don't like to. If they, they have something good, don't fool with it. Um, but this drug should be used in a lot of different ways until we fully understand its benefit yeah, but they're being they're being driven by r&d saying we need a new product, we want something new.
Speaker 1:You know, like they have to find the difference between those. Those two uh influences, don't they?
Speaker 2:you got it and I was gonna. I, I think people this but the anti-psychotic drug, the pharmaceutical drug business, is a big business. Among the drugs, the anti-psychotics are among their highest revenue driven drugs. In its peak, the drug Risperidone probably earned about $5 billion a year billion a year.
Speaker 1:Well, I mean, you know, it's no secret that pharmaceutical companies really like it when you get on a medication you have to take for the rest of your life.
Speaker 2:You got it and the only thing you know, the only things the pharmaceutical industry does not like, as you may know, is the fact that there's a patent law and once it goes off patent, other people can do generics they can do generics, they can do generics, yeah, they can take it away I don't know, I mean dad, I don't know how familiar I with drug development, but it's a fascinating thing.
Speaker 2:It's a it's called hatch waxman law that did that. Hatch was orrin, hatch good republican, and waxman was a congressman he was a senator orrin and waxman was a congressman from that jewish congressman from mass, and they created a law. They both had things they wanted and so they let the pharmaceutical industry get some more protection on certain things. That was a hatch and Waxman insisted that once the drug is off patent, all the information on that drug can go to generic manufacturers. Off patent, all the information on that drug can go to generic manufacturers so that once it's done I can take everything from the FDA and now make the drug myself.
Speaker 1:Before that you have to do all that stuff yourself. A little anti-monopolization kind of stuff.
Speaker 2:Correct. That's right, todd, and that created the generic business. Generic was not a business before that. How about that? You know, I'm sorry, I'm rambling, you stopped me.
Speaker 1:No, I the I want you rambling is makes great show.
Speaker 2:I'm just sorry that I can't speak to the audience and hear what they'd like to say. I like that.
Speaker 1:Maybe someday we'll me give you We'll get a live show going at some point in time. No, go ahead what you got here you go, todd.
Speaker 2:The worldwide anti-psychotic drug market is expected to grow from about $14.5 billion right now to $26 billion by 2032. So this is a big market and it's now a large generic market too. So the pharmaceutical industry is very sensitive to not fooling around with what they had, I know in my working in drug development. But this one sort of snuck through got out and has given a lot of enthusiasm and positive vibe to our community.
Speaker 1:Like you say, but it's got. You know you're talking. We're talking about a new med that's already got 25 years worth of development on it, which is, you know, it's mind boggling a little bit, but it is.
Speaker 2:When it came out, todd, I was away from that for a bit. I was taken back when I saw I hadn't realized my old buddies were developing it again and I smiled to myself. And by God, it's a good antipsychotic. They added this other drug to it so the side effects were less and they did a nice job. Steve. Paul did a nice job on it, but you're right and there's got to be more Me I'm always thinking, but I like the mechanism of indirectly softening or modulating dopamine transmission and I didn't think of it that way. The people literally weren't smart enough, but that's what it does and that's what it does and I love it.
Speaker 1:No, I'd love to. I've got a theory that I would, that you, we, I've got a crew here that is very qualified to tell me that I'm 100% wrong or I might be onto something or I need to give up my career in behavioral health care and so possibly Stacy Rayetta or Shannon want to pitch in. But I work with families pretty regularly. I ended up giving some. The family was faced with an individual. He was suffering from psychotic features. It was new to him. He was in that kind of first episode category. Families also don't know anything about this. All of a sudden they're faced with a family member who's got psychosis in their profile, etc, etc. The whole thing. They're just trying to get as much information. I ended up having to call with them. I actually we did a record of the call. I went back to the script that it. You know the notes that get taken, and I made a blog out of it. Like, look for the you know, for the layperson, the person out there who's really trying to figure this out.
Speaker 1:There are a couple of different ways that psychosis occurs for a person. Diagnosis aside, you've got a person who suffers from thought disorder, it's got psychotic features, and they may be experiencing psychosis as a result of drug use. But the chances are good it was latent and they're going to suffer from psychosis for the rest of their life and they need an antipsychotic. You've got people who are living in this category and we're finding them these days that suffer from a psychotic episode as a result of drug use and if you take the drugs away they don't have psychosis anymore. And we're seeing these folks. They're out there but they've got to be really careful about what they put in their body. And then you've got people who suffer from pretty serious mood disorder, bipolar disorder or even psychotic depression and those kinds of things. And the meds differentiate a lot of times in these two kinds of categories.
Speaker 1:Because a person who suffers from mood disorder let's say it's mania, let's say it's depressive or maybe they experience both at high levels but if they go over a threshold on the mood whether manic's depressive or maybe they experience both at high levels but if they go over a threshold on the mood, whether manic or depressive, once they go past that threshold they start to have thought disorder and they can even have a psychotic break.
Speaker 1:Sometimes you can give one of these people, a person who's suffering from a condition like this a mood stabilizer without an antipsychotic and so long as they've got a pretty decent diet, they're taking care of themselves and they're getting sleep and they're on a mood regulator, they never pop over the threshold and experience psychosis, whether it's high or low, and they may be able to get away with not having an antipsychotic on board. And it basically makes three categories of people suffering from psychosis and the various ways they get treated. That's a dumbed-down way of explaining it to folks who are faced with this for the first time, but it was approachable. Would you add anything to that? Am I completely off and what would you add?
Speaker 2:Todd, I would never say you're completely off you'd be among the first dr the words we use in jersey. I can't say you understand what I'm saying. I do, okay, I don't. I don't know if anybody out there can hear my jersey accent. I haven't lived there since since I graduated from college. I'd just like to call it home. I'm teasing you. I'm teasing you. Psychosis means loss of touch with reality, often shown by delusions. Delusion is a false belief, todd, and I know many of your people out there know that. But just for clarity, so a false belief might say the FBI is after me, but it's not true. Or that person over there means me harm. Those are paranoid kind of things. They're not bizarre because it's possible the fbi is after me, they're just not there's.
Speaker 1:Because you're paranoid doesn't mean they're not after you. Yeah okay.
Speaker 2:But then there's what's called bizarre delusions. So when I talk about aliens controlling or reading your mind or you putting thoughts in my head, that can't happen and those are mostly characteristic of patients who have schizophrenia, okay, and bizarre delusions. And some folks are required not just delusions, but bizarre delusions, now losing touch with reality. Ie, psychosis occurs in a lot of different disorders, including depression, the depressive psychosis, just what you were talking about usually have a globality about how depressed you are or about how it's awful for your children that I'm staying alive, and it doesn't mean just schizophrenia. I was just reviewing a case I'm writing about in my book for a patient who had severe postpartum psychosis.
Speaker 2:One of the strangest psychosis, most deadly psychosis, are psychosis that typically occur the postpartum blues or sadness having given birth pretty common after the first two or three weeks, but a month later, when people start getting depressed and they get globally depressed. And this particular woman cut herself all over her body with a one-month-old child at home and you read them. We all hear about these. People kill infants and so forth and that's psychosis in a postpartum state. Which is pretty, which is bad? No question bipolar, a bipolar psychosis. You want to see grandiosity. So not only am I dealing not with reality, I want you to know okay that Julius.
Speaker 1:Beezer is nothing compared to me Right, I'm the greatest rapper that ever lived.
Speaker 2:You got it, you got it, and that's how I say I'm a doctor. No, that's not, it's a joke. It's a joke. I don't just play one on TV, I'm a real guy. All kidding aside, it's interesting, todd, that you mentioned it. When I was training and then, when I started becoming a scientist, I came to the United States. I always loved psychosis and it sounds funky because I don't know why I liked sick people when I did internal medicine for a year after medical school and the psychosis is a characteristic of our more ill people. Now, the people who have schizophrenia have psychosis, but they gosh darn it, todd. They also have flatness of affect. They don't express themselves well um.
Speaker 1:They pick up on social cues.
Speaker 2:Well, they look like they've got on the spectrum and they have and and they have, uh, executive function difficulties. You know it's a tough one. So if there's any folks out there listening to us who have family members who have schizophrenia, you know these things, the so-called negative symptoms. You know these things, the so-called negative symptoms, things they don't have, and the so-called positive things that they have that shouldn't be there voices and so forth and so on. And I've been around medicine and psychiatry a long time, but that illness, to this day I think about it and how hard it is for the families. And I don't know if there's any families out there listening to us today who are working with kids who have the illness.
Speaker 1:For certain.
Speaker 2:Yeah, and let me say something parenthetically on that. When I meet a new family and so forth, one of the things I like to do when I get to know them, todd, is if they have a, a sibling, I like to bring in the sibling and chat with, not to find oh, I'm going to find secret information. No, no, no, no. The siblings have a very tough time and they, in other words, they got a brother or sister who's very ill. It takes a tremendous amount of your mom and dad's time. There's just so much oxygen in the room you can, at one level, resent that you're not getting the attention and then you say, holy mackerel, I can't resent that. My, my sister's so sick the serious illness right yeah, you know I don't.
Speaker 2:That's not me, of course they should, but they feel it and when I bring guys in and gals, I like to tell them thank you and I say to them thank you, that's cool I always do it because I said you know you're doing what you're doing to be a good sibling and caring about him.
Speaker 2:But I know it's hard, and it's hard maybe hard for your parents to step aside and take themselves away from your ill brother. But let me tell you, thank you, because I know by being yourself, by caring about the family and going on with your life productively is a huge thing, and it's made difficult because you have a sibling, not as bad as him or her, but it's tough. And so I'm just pulling you aside to let you know, as a shrink, I know what you go through, not specifically, but I know it's hard and thank you, you're doing it for your brother and your whole family.
Speaker 1:Well, and it's not just hard for that moment, it's hard for a lifetime, you know, for for so many, which is why you know we're pretty helpful. We're super grateful for the work that you know helping the home and you're doing with these folks to help them find kind of long-term care solutions. I'm curious yeah about. I'm curious about um, if you're, you know, just to circle it back around, are you seeing the results of CoBENFI in the populations that you serve right now?
Speaker 2:It's just getting Todd, it's just getting out. So when we can reconvene this session a few months from now, I'll have a better feel for it.
Speaker 1:Yeah, let's see. You know, we should pick it up next year and figure out what you're seeing there it's interesting.
Speaker 2:Okay now. So the drug was from lily. Sorry, sorry to talk like this is the market week. Okay, so the drug was from lily. They let it sit there. The former most senior medical person at lily formed a small company that licensed it out. That was my, my buddy.
Speaker 1:Oh wow, and fixed it up.
Speaker 2:Steve Paul, and Steve is very sharp and he likes to invent new blah, blah, blah, blah blah. So they licensed it. Then what they did? They made sure they had the addition of this other drug to fight the side effects and then they just sold it to Bristol Myers about a month ago, two months ago. Bristol Myers is one of the large pharmaceuticals, or we used to call it Big Pharma, and sometimes when I say Big Pharma, people are listening and they say did you say Pig Pharma? No, no, big Pharma.
Speaker 1:Though they've been interchanged, I'm sure.
Speaker 2:I've had many people say what does Pig Pharma have to do with it? I say no, it's Big Pharma.
Speaker 1:Now it's controlled by Bristol Myers, which hasn't had a good psychiatric drug in a bit and they'll do a nice job marketing it Now it's-. I bet Eli Lilly is very happy about the fact that Bristol Myers got it.
Speaker 2:I haven't had the opportunity to look at the contract, but you know they're participating in some of the benefits. Yeah, sure, the way it's done done, but it's an interesting, complex business, so we'll see where come benfi does. I I'm after those guys a little bit to do these other things about it that I'd like to see done, but that's another. That's another uh question. I'm going to call steve one of these days and have a chat with him on that.
Speaker 1:So one thing I'll ask about cobenfi that I I think it is is I'm curious about to see if it's an effect. I don't know if you have a thoughts about this but, um, when you see people who are suffered from long-term psychosis, uh, and you know, maybe they've, they've done, they've done the med gauntlet, they've been on everything under the sun and you know they may not have what we would call a full psychotic break, but they have persistent delusions. My parents I've got a client right now. This individual, he attacked his parents which is for people who know about psychosis and schizophrenia attacking a family member is pretty common, unfortunately but attack his parents because they were aliens, right, and despite the fact that he's been in care for quite a while now and actually doing pretty well, still maintains this persistent delusion.
Speaker 1:His parents are aliens and they still can't have a conversation with one another. And they still can't have a conversation with one another. Will you think that this drug or this complement of drugs in one pill will have any better impact on these persistent delusional features that accompany individuals suffering from psychosis, especially if they have schizophrenia? Do you think it's going to have a little better reach into some of the symptomology?
Speaker 2:Todd, that's a great question at many levels. I can circle around and do that.
Speaker 1:You know, I like to ask a good question, you know.
Speaker 2:Yeah, I was. No, no, it's an interesting one, one that I've had more than a little experience with, because sometimes, when they don't believe their parents are angry, they also go feel that way about their doctor, which is me right. He was obvi, and we'll come back to the violence associated with this illness and the dangers of it, and it's real. Next, do I think co-benthy would help with those people? Now you're asking me as a scientist. See, I would love to see a clinical trial and I'd like to see it alone, with these folks and in combination with another anti-psychotic, to address that question. Now let me tell you something industry doesn't love those kind of studies, do you know why? Because if something goes wrong or it's negative, they don't want to hear it. Okay, I?
Speaker 2:want to know the money yeah, I want to know the answer. So if it's negative, okay, we look at it this way. Negatives are important, always are. So it's slow to get going to do it Now. With the current situation that we all know in terms of the attitude towards government and government funding, with the current administration, how much money there's going to be to do trials like that, supported by the government. I truly don't know. I have no idea. In the past you would see some, but it's a great question. You know, todd, you would have loved being with us for 20 odd years.
Speaker 2:I was at the NIH for 23 years and we were in what was called the Intramural Research Program. So the National Institutes of Health and National Institute of Mental Health, which is one of those institutes, has what's called an intramural and an extramural program. Extramural are all the universities where I give grants to them or trials I'm setting up and I want people to participate in, and that's the largest amount of money these days that's spent. The original part of the program was the intramural program, which is what I was part of and what has made the NIH famous, and the intramural program is where you have scientists on board right here I'm pointing to the clinical center about three miles from where I'm pointing and the clinical center on the NIH campus, and that's where we would run these things and you would have funded research, not grants. You'd have a certain funding for a year and they would review your work every few years very aggressively.
Speaker 2:But I didn't have to have things approved. They trusted me as a scientist and there were scientific reviews, all sorts of things like that, but it gave you the freedom to do your own. The most famous discoveries from the NIH broadly come from the intramural program and I'll give you one, just not to derail too much. But I've been thinking about the intramural program because it was my home for quite a few years. And, of course of now, what's happening in government. And I give the example of the National Cancer Institute, which is one of the institutes. It's part of the NIH but actually has a direct funding right from Congress.
Speaker 2:It's huge Now, when I was there all those years, one of the things I respected and liked about the NCI National Cancer Institute they always had patients real life even though they did a lot of lab work and I was fascinated my years because the drugs they were using were not dissimilar to what I used in medical school in my internship and nothing new had come. And then about, I don't know, 15, 12 years ago 15 years ago, time fast Steve Rosenberg, whom I knew, developed the first drug for melanoma and that was a monoclonal antibody type approach, and it was enormously successful. Melanoma was not a death sentence, but it was wholly different.
Speaker 1:It was bad yeah.
Speaker 2:Bad and that one finding has rocketed anti-cancer treatments using some of those same mechanisms enormously. Now I mention it for the following reason I'm going to bring it home to us who care about mentally ill people. At the present time there are no patients with schizophrenia. In the NIH Clinical Center I ran a ward that had 10, 12 patients who were there for months at a time, drug-free. We managed them and St Elizabeth's had a research arm that would run from NIH. There are none of them. No patients, none, zero. And that's another conversation and it's about genomics and it's about science and it's about trouble for us In psychiatry. We care for men. Do we need more trouble? Now this came along so I have no idea what's going on. Now I'm not going to say no wise-ass cracks, but it's interesting. It's a fascinating time to live through. But the clinical center and the intramural research program was the hallmark of most Parkinson's disease and the use of dopaminergic agonists came from that came from there. It goes on and on and on.
Speaker 1:One of the biggest treatment modalities we've got for Parkinson's right.
Speaker 2:Yeah, right, so I'm just saying that it was a unique setting. Universities wanted their money. Everybody there wanted their money. Musk and Trump doesn't like them giving out money, but the universities, they have their own congressmen, and so it started in mental health. It was genomics are going to tell us everything we need to know. We don't need patients and it's been one of the saddest developments, but that's a conversation for another time.
Speaker 1:Todd, yeah, studying humans through chemistry labs yeah, it's an interesting kind of proposal.
Speaker 2:Yeah, Genomics is a tool to help study people To them. People are a tool to help study people to them. People are a tool to help study genomics. Capisce.
Speaker 1:Yeah.
Speaker 2:And that's what the story. If I had to say it in one sentence, that's it.
Speaker 1:I'm not saying I'm not excited about the study of genomics, like I think it's fascinating stuff and I think it's got real potential, but you're going to need human beings.
Speaker 2:And that's the purpose of it. And that's the purpose of it. And that's the purpose of it is to help people right, and they lost that track. I'm telling you, they want to help people in a theoretical way, and then yeah, they lost their arms length way yeah, they lost their, but it came at the expense of patients and that's the.
Speaker 2:That's the thing. When that first came and I got a kick out of it, I felt like I was in in putting a dunce cap on. In China they make all academics put you're dumb. If you were an academic, well, if you were interested directly in patient science, they'd put a figurative dunce cap on you. You're not smart, you should be in genomics in the lab, and it was a very strange change that occurred during my last some years at the NIH. I've been out for quite a while. I still get calls from reporters because those meetings were all documented. And when one of these drugs that we were talking about then is now having trouble in the real world because it got approved. And then they look at the reporting. You always see Dave Picard saying something funny. So I get calls. I'm not sure the senior FDA people love me as much as I deserved, but anyway, that's another story. We can put that on another topic. It's part of the drug development situation.
Speaker 1:Well, it seems like we've got several topics, including Cabin Fee, to follow up on a little later on to see where it's going to see what new developments happen and what's happened on the national level with funding for mental health care and those kinds of things. I'll be excited. Dr Picard, you're always welcome to the show. It's just a blast to have you on. Stacey Rayetta Shannon, I know you know Dr Picard. He has a lot to say, so I appreciate you joining us. Just the same. We'll talk a little bit more about how it lands on the road out there with helping the home, but this has been Head Inside Mental Health on WPBM 1037, the voice of Asheville, Todd Weatherly, your host, dr Picard. Stacey Rayada Shannon, thank you for being on the show again.
Speaker 2:Thank you, man.