Wellness Unmasked: Psychedelic Therapy Breakthrough? Trump’s New Mental Health Order, PTSD Crisis & Big Pharma Limits
4/21/202627 mincomplete
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2:40Welcome to Wellness Unmasked. I'm Dr.
2:42Nicole Sapphire, and I have an interesting topic to talk to you about today.
2:45I'm not sure if you've caught the press conference over the weekend, but President Trump,
2:50straight from the Oval Office, was working on Saturday morning, and he had a lot
2:54of people behind him, including Secretary Kennedy, FTA Commissioner McCary, and he also had Joe
3:00Rogan behind him. Now, what were they all doing in the Oval Office on a
3:04beautiful Saturday? Well, it kind of felt like we were being transported back to the
3:081970s. Now, what do I mean by that?
3:11Well, because they were talking about psychedelic medications, and this executive order is aimed at
3:17accelerating research and access to medications like psilocybin, MDMA, LSD.
3:24I'm not sure if you knew that, but yeah, we have been studying these for
3:27decades in how that they may be able to help us with addiction and refractory
3:32cases of mental illness. Now, one that's specifically getting a lot of attention right now
3:37from the Oval Office is Ibogaine.
3:39Ibogaine is a little bit different than the others.
3:42While most psychedelics that have been studied, like psilocybin and MDMA, they primarily work through
3:49serotonin pathways, and they've been used for depression, PTSD, Ibogaine has a much broader pharmacologic
3:56profile. Not only does it interact with serotonin, but also opioid receptors and dopamine receptors.
4:03So, well, before we can jump into what this executive order even does, I want
4:09to take a step back for a minute, because when we talk about mental health
4:13and the potential treatments for it, we really are talking about chemistry.
4:17At the most basic level, I want to make sure that we all understand it.
4:21It's always a good refresher for me, and I want to make sure that you
4:23understand it too. So, again, at the most basic level, our mood, our behavior, and
4:28even how we process trauma, it's all influenced by a few key neurotransmitter systems.
4:35There are proteins, there are peptides, there are hormones, chemicals, all happening in our body
4:41and specifically in our brain.
4:43Serotonin, I know you've heard me talk about this.
4:46It helps regulate mood, anxiety, and just overall emotional stability.
4:51That's why so many antidepressant, anti -anxiety medications target serotonin.
4:57Dopamine is another one. Now, it's tied to our reward centers, motivation, reinforcements.
5:04When we find ourselves addicted to something, it activates our dopamine pathways.
5:10So, if we take that drug or eat that sugary substance or even exercise, all
5:17of these things release dopamine in our body, and it rewards us.
5:21It makes us feel good.
5:22Sometimes those things... are good for you, like exercise, and some of the things, they're
5:27bad for you, like illicit drugs.
5:30And now the opioid system, we have opioid receptors in our brain, which people don't
5:35talk enough about. They're stigmatized in the sense of the opioid epidemic.
5:40But opioid system in our brain plays a major role in pain, our stress response,
5:46and even emotional bonding. So now when these systems, all three of them are dysregulated,
5:52that's when we start to see depression, post -traumatic stress disorder like PTSD, addiction, conditions
5:59that can be incredibly difficult to treat because it's not black and white.
6:04And for decades, most of our medications that have been prescribed have focused on just
6:09one of those pathways, primarily serotonin, as I mentioned.
6:13It's the most popular and has been the most targeted by big pharma.
6:17But what if that's not enough?
6:18What if we need therapies that work across multiple systems at once?
6:23Well, that's exactly why this conversation is gaining so much traction right now.
6:27Because as I said, this weekend, the White House announced an executive order aimed to
6:33accelerate the research and access to psychedelic medications, those that can activate and affect all
6:40three of those pathways, not just one.
6:44So to understand why this is happening right now and why there is such urgency,
6:48we have to understand the scope of the problem.
6:50We are in the middle of a mental health crisis.
6:53It didn't happen yesterday. It didn't happen last year.
6:56We have been in the thick of it even before COVID.
6:59COVID has made it much worse.
7:00More specifically, though, we're in a crisis of treatment failure because we've had mental illness
7:06for a long time. We've had access to treatments for a long time.
7:09And what we're seeing is they're not working because for a significant number of patients,
7:15what we currently offer, it just isn't enough.
7:17It's just not working. Like, talk about depression.
7:20About a third of patients with major depressive disorder will go on to develop what
7:24we call treatment -resistant depression, meaning they've tried multiple medications appropriately, and they're still not
7:32getting better. And I'm not just talking about having the blues one day and feeling
7:36fine the next day. Depression can be debilitating.
7:40Depression is when, true depression is when it affects your day -to -day life.
7:44Maybe it impacts your job, your relationships with your family, your friends, whatever it may
7:49be. There are all various different forms of depression and varying levels of severity.
7:53But for many people, as I said, a third of people with severe depression, the
7:59medications aren't working. These are patients who cycle through medications for years.
8:03They're functioning. Maybe they're going to work.
8:06They're raising their family, but they're not thriving.
8:08They may be surviving, but they're not thriving, and they're not getting better.
8:13But where this becomes even more urgent, and this is what we talked about a
8:18bit in the White House this past weekend, is PTSD.
8:22Roughly six to eight percent of Americans will experience post -traumatic stress disorder at some
8:27point in their lives. Now, among veterans, that number jumps significantly, often into the double
8:33digits, depending on the conflict area, if they were in a war zone, or just
8:39around high -stress environments. And the reality is, we just don't talk about it enough.
8:44Even when we treat PTSD the right way, with therapy, with medications, a large percentage
8:50of our patients, they just don't go into remission.
8:53We rely on medications, but very common ones, sertraline, paroxetine, and they can help, but
8:59they're modest. These are the SSRIs.
9:01You know, they're focusing on serotonin.
9:03Oftentimes, they can take weeks to months to work, and for many patients, they just
9:09do not get enough relief.
9:10Up to half of patients with PTSD will not achieve meaningful remission, meaning no matter
9:17what they do in terms of medications and therapy, they're just not getting back to
9:21their baseline. And somewhere in that range of 30 to 40 percent are what we
9:27consider treatment resistant. They are still having a difficult time functioning despite all efforts of
9:33treating themselves. That means they've done everything right, and they're still struggling.
9:39And the consequences, they're not abstract.
9:42Among veterans, we see about 70 to 20 suicides every single day in this country.
9:48PTSD is a major contributor to that list.
9:51It's not just about mortality or how many people are killing themselves or how many
9:56people are dying. It's about quality of life.
9:59Our veterans do everything for us.
10:01They put their lives on their line for our freedom, and then they come back,
10:06and they're struggling, and they're trying everything they can to get better, and it's just
10:12not working. These patients tend to struggle more with substance use, chronic illness, unemployment, social
10:20isolation. We see a lot of veterans who are homeless because of it.
10:24This is not just a psychiatric condition.
10:27It's a full -body life -altering disease, and even our best therapies have limitations.
10:33Psychotherapy, for one, can be incredibly effective, but it's time intensive.
10:37It's hardly accessible to everybody, and dropout rates can be really high because it takes
10:44a lot of work and a lot of time, and it can be expensive.
10:47So then we're left with medications, and medications require...
10:52are daily adherents. They often have a ton of side effects themselves, and those side
10:57effects can lead the patients to not wanting to use them.
11:00Maybe they can't drive a car while on them.
11:02Maybe they just don't feel like themselves.
11:04Whatever it is, a lot of people stop the medications because they don't like taking
11:07them. So now we're left with a group of patients, especially veterans, who are still
11:13suffering despite doing everything medicine has asked of them.
11:17And that is exactly the population being targeted in the conversations around new psychedelic research.
11:23It's not about replacing first -line treatments of what we're already recommending.
11:28It's about what comes next when those treatments fail.
11:31And this is where the real conversation begins.
11:34The substances we're talking about, psilocybin, MDMA, LSD, ibogaine, they've been around for decades.
11:42Nothing novel has been produced.
11:44What's different now is how they're being used.
11:46Now, in clinical settings, they are not casual experiences.
11:50They're structured, supervised, often combined with psychotherapy.
11:54It's not like people are going out to the sweat hut out back, and they're
11:57like, hey, let's try some psychedelics and see how crazy we can get.
12:01Absolutely not. That is not what's happening.
12:03It's very controlled, and they obviously start out at very low dose.
12:07Now, they do appear to work by altering brain connectivity, loosening rigid patterns of thought,
12:14and really allowing patients to process trauma in a very different way.
12:18In simple terms, they may help the brain do something it has been unable to
12:23do on its own. Think like hypnotism, where you're trying to get your brain to
12:29just forget certain things so you can really work deeper and deeper.
12:33That's kind of the goal in a lot of psychotherapy.
12:35But sometimes we're just not able to get past that blockage in our brain.
12:41So these medications, in theory, are getting past that blockage.
12:46In depression, psilocybin has shown rapid improvements, sometimes after just one or two sessions, with
12:52effects lasting weeks or even months in some patients.
12:55In PTSD, MDMA -assisted therapy has produced some of the most compelling data we've seen
13:02in years. Patients with severe chronic PTSD, many whom have failed other treatments, have shown
13:09significant reductions in symptoms, and in some cases, no longer meeting diagnostic criteria of severe
13:16depression. With addiction, compounds like ibogaine and psilocybin are being studied for their ability to
13:22reduce cravings and interrupt those deeply ingrained behavioral patterns that sometimes are so difficult to
13:29break in addiction. Underlying all of this is something we're still trying to fully understand,
13:36which is neuroplasticity. Now, these drugs appear to increase connectivity in the brain, allowing people
13:43to break out of just these entrenched patterns and just process experiences differently.
13:50That's fundamentally different from what our current medications do.
13:53Our current medications are trying to blunt the feelings of some of these hormones in
13:58the brain. These psychedelics are trying to have your brain think a different way and
14:04maybe open itself up to experiencing the trauma, working through the trauma, and maybe even
14:09make psychotherapy give it a chance of being much more successful.
14:13Now, for me, the use of psychedelics sounds incredibly drastic and dramatic.
14:18I am a bit of a prude when it comes to experimenting with certain medications.
14:25Between us, I've never even tried a cigarette, let alone anything else.
14:29So certainly never dabbled in the psychedelics back in the day, although I did have
14:34friends in high school and college who I knew they did.
14:37But yeah, it seems a little bit scary to me.
14:40But I am starting to believe there may be clinical use of some of these
14:44medications in a very low -dose controlled environment after reviewing a lot of the data.
14:50Now, while early data on psychedelics, you know, in my opinion, does look like it
14:54could be promising, the risks are real and they're measurable.
14:58It does not come without risks.
15:00I feel like these medications may be considered as a last case resort.
15:05When you have someone who you're worried if you don't do something drastic, suicide may
15:10be a very viable outcome for them.
15:13And you want to do everything you can to avoid that.
15:16So in a controlled clinical trials, from what I've read, 10 to 20 percent of
15:21participants report acute anxiety or like a panic attack during the experience.
15:26I probably would be one of those people if I started hallucinating a little bit.
15:30I'd probably be one of the 20 percent having a panic attack.
15:34Now, this is sometimes referred to as a quote -unquote challenging trip, you know, where
15:39you get a little crazy when you're quote -unquote tripping out, I guess.
15:43Even in supervised settings, these can be very scary and can be dangerous, again, if
15:47it's not controlled. There are also concerns about more serious psychiatric effects, particularly in vulnerable
15:54individuals, with case reports linking psychedelics to psychoses and mania, especially in those with underlying
16:01risk factors, like, you know, family history of someone who had psychoses or they themselves
16:07already had some. Now, on the medical side, some of the compounds have very unique
16:12dangers, ibogaine being one of them, which is the one that we've been talking about
16:17mostly, because it's been associated...
16:19with cardiac arrhythmias, or meaning your normal heartbeat goes out of whack and has been
16:24linked to dozens of deaths globally, largely due to what we call a QT prolongation,
16:30or essentially the electricity that goes through your heart.
16:34It causes kind of a slow slowing down of it being able to go through
16:40the heart from the atrium to the ventricle.
16:42And this puts your heart into an arrhythmia and you can have a heart attack
16:45and you can die, has been well -documented globally.
16:48And other fatal heart rhythm and disturbances.
16:51And even with more commonly studied agents like the psilocybin MDMA, averse effects such as
16:58transient increase in blood pressure and heart rate are also well -documented.
17:04Now, long -term safety data remains very, very limited.
17:07One condition that has been observed is hallucinogen persisting perception disorder.
17:13It's a bit of a tongue twister, but it's a rare but distressing syndrome involving
17:18persistent visual disturbances. So even when you're not on the medication anymore, you're still hallucinating.
17:25That can't be good for anybody.
17:27You're essentially giving someone schizophrenia, psychoses.
17:31And perhaps most importantly, while many of these studies are conducted in highly controlled environments,
17:37the real -world risk profile, especially outside of medical supervision, it's not fully understood at
17:45all. Now, the good news is, specifically when it comes to some of the cardiac,
17:49the heart concerns, it has been shown if you give these medications with magnesium, magnesium
17:55is an electrolyte that helps stabilize the cardiac rhythm, you see the risk of cardiac
18:03issues drop drastically to like almost zero.
18:06So that's a good thing.
18:08If someone has pre -existing cardiac illness or high risk for cardiac illness, obviously I'd
18:14be very concerned with them still taking these medications, even with magnesium.
18:19Again, unless it is very, very dire and refractory and they have just run out
18:24of all options. What's important to know about this announcement from the White House over
18:29the weekend, it doesn't mean that all of a sudden these psychedelic medications are accessible
18:34and available and you can go to your local pharmacy or your doctor or the
18:38convenience store and go pick it up.
18:39No, absolutely not. The White House did not legalize psychedelics.
18:44Do not believe the headlines.
18:46They didn't approve a new drug.
18:48What they did was something more strategic and in many ways will be more impactful
18:53because they issued an executive order directing federal agencies like the FDA to move faster
19:00on researching and developing psychedelic therapies for serious mental illness.
19:05That includes prioritizing these medications at the FDA level, particularly those that have already been
19:11labeled as breakthrough therapies. So it essentially just puts them at the front of the
19:16line for review so they're not lost in the shuffle.
19:19It also expands access through what's called the right to try pathway.
19:24You may remember that President Trump in his first term was a huge supporter of
19:28that, meaning patients with severe treatment -resistant conditions may be able to access these therapies
19:35before full FDA approval. Now that's a big shift because historically access to these treatments
19:41has been limited almost entirely to clinical trials.
19:45So if you were not enrolled in a clinical trial, you couldn't try the medication.
19:50And unfortunately, just like we see in cancer care, a lot of people don't qualify
19:53for clinical trials. So they're out of luck.
19:55They don't get to try these potential life -saving medications.
19:59And in some cases, patients traveling outside of the United States.
20:03We can't give them to people here, but sometimes people can leave the United States
20:07and go get them. I mean, I've never understood that.
20:10Now, there's a real effort to bring this into a regulated medically supervised framework because,
20:16again, I don't think people should be walking around taking recreational psychedelics.
20:21I absolutely don't. I don't care how responsible you are, how well you think you
20:27can tolerate or manage it.
20:29It should be structured and it should be under the supervision of a physician, and
20:34not just any physician, but a physician who understands these medications, these side effects, potential
20:40benefits, and how are they going to maximize the benefit of using these medications?
20:45It can't just be throw these medications and then let people deal with it.
20:48They still need to be doing the work.
20:50They still need to be going to therapy.
20:52They need to make sure that they are in safe social environments and so forth.
20:56And on top of that, there's a heavy emphasis on collaboration between the FDA, the
21:01Department of Health and Human Services under Secretary Kedney, and also the veterans hospitals and
21:07private researchers. So I guess in theory, we're like, oh, good, everyone's going to work
21:11together. Everyone's going to care for our veterans and treatment -resistant PTSD because everyone stood
21:18in the Oval Office. And if you stand there and you take a picture, it
21:22makes it look like you actually care.
21:24Well, so what we usually say, what?
21:26Put your money where your mouth is.
21:28Well, good news. They actually did that too.
21:30The order also includes $50 million in federal funding channeled through the ARPAH or whatever
21:38that is, some funding pathway to support research and build out the infrastructure to ensure
21:43that our veterans and others who are suffering with treatment -resistant PTSD.
21:47ESD and mental health illnesses like depression are first in line to get access.
21:53And currently, these psychedelics like psilocybin, MDMA, sit in the most restrictive category, a scheduled
22:00one. The order is also laying groundwork for rescheduling these drugs once sufficient data is
22:07there. And we can only hope that that data shows benefit with a very low
22:12risk profile. We're not there yet.
22:14We still need more research.
22:15We still need more data.
22:16But they're doing what they can to accelerate it and if there is a benefit
22:21in these medications to get it to the people that need it.
22:23So when you step back and look at the full picture, this is not about
22:26bypassing the system. It's about accelerating it.
22:29We saw this through Operation Warp Speed with COVID pandemic and President Trump is doing
22:34it again now with psychedelics for treatment refractory mental illness.
22:37As for all the advances we've made in medicine, there are still millions of people
22:40who are suffering quietly, persistently, and often without relief.
22:44Patients who have tried the medications, they've done the therapy, they've followed the recommendations, and
22:49they're still struggling. That is who this is really about.
22:52And here's where we have to stay grounded.
22:54Because while innovation is important, speed can also be equally important when lives are on
22:59the line. But in medicine, safety has to come first.
23:02We cannot rush something because lives can be lost.
23:06We have seen lives lost with the use of psychedelics.
23:09So this is exciting, but we cannot allow excitement or desperation to outpace the science.
23:15We see what happens when that balance is lost.
23:17So the right approach here is not to dismiss psychedelics, but it's also not to
23:22embrace them blindly either. I'm certainly not there yet.
23:25It's to do what we should always do.
23:27Follow the data, protect the patients, and try to move forward.
23:30And I want to end on something that matters just as much as anything that
23:34we discussed today. If you're listening to this and you're struggling, whether it's depression, anxiety,
23:41some sort of trauma you faced, I assure you, you are not alone.
23:45There are people walking around beside you feeling the same thing.
23:50And there are people who want to help you.
23:51Reach out to someone you trust, a friend, a family member, a physician, a therapist,
23:56whoever it may be. Not chat GPT.
23:58Make it be a real person because no matter how promising these new treatments may
24:03be, connection, real human connection still matters probably more than a lot.
24:08And it can be life -saving.
24:10I'm Dr. Nicole Sapphire. Thank you so much for listening to Wellness Unmasse.
24:13Be sure to listen to Wellness Unmasse on iHeartRadio, Apple Podcasts, or wherever you get
24:17your podcast. It's Dr. Nicole Sapphire from Wellness Unmasse.
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