FDA approves a novel drug for schizophrenia
washingtonpost.com
washingtonpost.com
The meds helped him but he didn't like the side effects so he stopped taking them. Went in and out of homelessness. In the end he thought he had superpowers and could fly. He could fly, but he could not land. It eventually took him.
It's probably a common story.
Source: the closest hospital to me is 30 minutes and it sucks out loud for anything but basic injuries.
Maybe it’s just me, I only once in almost 40 years required urgent medical attention and would have survived without.. so I don’t understand the worry about not having an hospital close to home.
Rural living definitely is relaxing and helps you connect with nature. But the isolation can be difficult. Hit me up if you want tips on how to cope. I am not schizophrenic, but I do have Tourettic OCD which makes it hard to 'fit' into society at large.
I do want to stress, if you have untreated mental illness, rural life is not a cure. It can make it worse.
I'm sensitive to noise, smells, lights and vibrations (living next to a very busy road, I can feel almost every large non-electric vehicle go by -- makes working from home hard at points).
Worth reading into if you have the energy. I do know folks who are diagnosed with schizophrenia and they seem to have an underlying component of some neurodivergence (arguably schizophrenia should also be considered neurodivergence) and went through an extreme burnout/traumatic event.
Hope you're able to get some peace!
Certainly in my experience and from talking to others who identify or have been diagnosed similarly, in the majority of cases you don't get used to certain things. You can't acclimitise and that's why a load of people who are autistic aren't employed.
I might seem okay in the office, but what isn't seen is my complete inability to function at home if there have been too many inputs and distractions. Lucky I can work from home a couple of times a week and my hours are flexible in that I can start earlier so not to travel into the city when it's busy -- busses are quiet at 05:00/06:00 thankfully!
Having a small office I share with a few people helps. My last place went all in on the open-planned office and it was hell. I can't see how anyone is getting much work done in environments like that, haha.
- Autism can make one prone to detail-oriented thinking, focusing on small details, requiring logical connections to understand and apply ideas. Constraints are well understood and considered. This can result in stuff like OCD.
- Schizophrenia can make one prone to disconnected thinking, focusing on big pictures, fitting together ideas that may seem entirely unrelated. Even constraints that seem obvious may be completely ignored. This can result in stuff like conspiracy theories and convoluted delusions. Delusions happen because beliefs may not be constrained by what's actually realistic, the big picture could be more prominent.
I don't know how true this analogy is, but it certainly seems interesting to consider.
I think 'autistics' is a better term here; 'autists' can make... not the best impression.
Anyway: no, autistics aren't necessarily more shy/introverted/asocial. I'm autistic and I'm definitely not that way; I usually try to connect to as many people as I can and I have to speak to people essentially every day or else I get extremely lonely/depressed. Part of this is probably due to ADHD and possibly also B(orderline)PD, but it's also because that's just the way I am.
Isn't it? My understanding of the word is "anyone who experiences the world differently from the social 'normal'", which would certainly include schizophrenia and other kinds of mental disorders.
I cant wait for the TikTokers to find out about Schicofrenia where they can actually think they are god!!
Nope never!
I have experience with schizophrenia and it can never be confused with anything else. The person with it is devoid of reality and does not know they are sick. They resist treatment and sometimes would rather go homeless, stop eating or taking care of themselves, in order to avoid treatment. They pull down everyone in their lives trying to help them, and it really takes a toll on family and relationships.
Certified nutcase comment lmao, WIFI waves do not do anything are you gonna buy some shugnite rocks too like the two timer, also smoke smell, move then or move out of city. Im mentally ill too but its mild autism, adhd (takes me all day to watch a 2h movie I pause adn pause and pauise and pause and pause and pause) and depression (I recently cleaned my fridge from 4 year old rotting food) but astleast I sleep inside.
The poster needs to seek actual help.
>I don't feel especially good in my apartment, the difference with outside is incredible
You have a mold issue in your apartment or some other problem like that then.
No really I probably have some light autism, when I see someone being wrong online I cannot help myself.
Having wifi allergy or electric allergy is a mental illness and symptom of shcizo. No need to sugar coat this man he is an adult.
There are plenty of other hugboxes online.
This is frustrating to me as a long time psych med user. If the meds have intolerable side effects then the meds do not help. Period. I do better off my meds than anything they ever tried to give me.
The system failed your friend. Not his ability to tolerate these horrible side effects.
IF we actually cared about human life we would have done much more to help your friend, but we did not. We care about human life up to the point it starts diminishing our comfort, and I am afraid we are valuing our comfort more and more than we care about others who are suffering in the last thirty years.
I’m in NYC and just yesterday saw a homeless guy pick up a used needle from the street and check to see if it had any drugs left in it. The story that led him that state, and where that story goes from here, multiplied by thousands of people in a big city alone…it’s hard to imagine solving that.
They, their family, or guardian should have consulted their psychiatrist to tune the meds for less side effects or to switch them. That is what psychiatrists are there for.
Especially for schizophrenics, they should never have the option to get off meds, in fact there should be a long acting backup med to go with the normal treatment in case the patient were to skip a dose.
Those with experience with schizophrenia know this is the hardest part of dealing with this mental illness - getting the patient into treatment and onto meds. Sure it is easy to maintain meds, but on boarding is the biggest challenge - that once it is setup, working, and bringing the patient back to reality it needs to be maintained, otherwise the patient and family have another long, uphill battle getting the patient back under treatment.
(I have Schizoaffective Disorder)
The meds do not work and they have horrible and even deadly side effects. To say I should never be allowed to stop them denies me of my agency and would force me to endure a life of misery. I am no longer on medications and better than I have ever been. I am rare. Even psychiatrists do not like this idea.
We could open up psychiatric institutions again like they were when my mother was in one. It was great for her. Now we have these prisons they call psychiatric hospitals run by fro profit companies. (Just google Holly Hill Hospital in Raleigh, NC for an example.)
What we need is better research that is not dominated by funding from Corporations. All funding should come from the Government.
Believe me, "they" tried. Just finding him was hard and he moved to a remote location. Gave away all of his possessions, including cell phone. Lived in a temperate climate where it was easy to get "lost" in the vegetation and live off the land.
It is often not the common side effects: "gain weight, fall asleep and experience involuntary muscle jerking" that cause people to stop taking meds. It is that their brain feels different, not like how it should be.
Now involuntary muscle jerking has a high stigma. It can, in the worst cases be highly visible. The new drugs seem to stop this drawback and instead introduces vomiting. That would be even worse.
The worst part of the article though is the frequent reference to homeless people. and that seems to be written by someone who has no idea of the realities.
A majority of homeless people do not have access to even basic healthcare. There are different reasons for this, but it is true of the majority. You dont have a look that closely to see open wounds, some infected, esp on feet and legs. These are basic healthcare concerns. Probably they have several other conditions that require treatment, and deficiencies due to a lack of food period, and certain lack of food that is nutritious and healthy.
Are the doctors just going to walk up and down the lines of homeless giving out bottles of pills and hope the world will change?
These types of drugs should always be closely monitored by a psychiatrist. Which is made nearly impossible with homeless people. (not to mention the cost. It could have high co-pays but I hope there are programs that can mitigate this.
The only way to do this is to give the person a place to live. Ensure the person has healthy and decent food. This will require time and treatment so build up a new sense of safety.
Once achieved treatment for schizophrenia could start with the drug and be closely monitored by professionals.
None of the drugs to treat mental health issues will work on all, And some people will have strong side effects.
I have a close family member that had a psychotic episode during the pandemic. They were hospitalized but were eventually able to get effective treatment and medication and now live a mostly normal life.
Had they not had the support to get proper medication, I have a hard time seeing how they wouldn’t end up homeless.
The thing is you don't even need this new drug, from the article "Risperdal and Zyprexa" are very effective antipsychotics. Even more effective when combined with a long acting to prevent backslide from missed does.
Who cares about the TD, tremors, etc. when that patient can rejoin society? Really what needs to change is reopen US mental hospitals to get these patients treatment and end the stigma around mentally illness.
Sources: https://www.oecd-ilibrary.org/docserver/sti_scoreboard-2009-... https://www.who.int/observatories/global-observatory-on-heal...
21% [1] of homeless have a serious mental illness that predates their living situation, of which an even smaller chunk is schizophrenia. The major reasons for homelessness are predominantly financial (also [1]). We think that the sequence of events is mental illness/drugs → homelessness → poverty, but the true sequence is an averse financial event + lack of support → homelessness → mental illness (as a result of the homelessness) → drugs to cope.
We saw the most pronounced examples of this in Houston's homeless program, which has a 90% success rate by providing housing first [2]. For many, having a safe home is the only resource needed to get clean.
Homelessness is torture. Anyone in that situation would turn to drugs to cope. Demonizing the drugs is flying straight over the cause of the drugs themselves. If you want to fix homelessness, give homeless people homes.
[1]: https://www.samhsa.gov/blog/addressing-social-determinants-h...
> 21% [1] of homeless have a serious mental illness that predates their living situation
This seems to suggest that mental illness does lead to homelessness. I would agree that financial strain is a major cause of homeless, but it seems likely that this is because it leads to other behaviors that then lead to homelessness. And those behaviors are probably not exclusively caused by financial strain.
Additionally, from the conclusion of your first link (my italics added for emphasis):
> SAMHSA utilizes its national surveys and grantee data to create effective programs and services to prevent and end homelessness among people with mental and substance use disorders.
Secondly, I agree that housing is an important first step for fixing homelessness because it seems like a precondition for stability.
But this:
> For many, having a safe home is the only resource needed to get clean.
seems misguided to me. "Housing First" != exclusively housing. From your second link:
> we move people into permanent housing as quickly as possible and then provide them with supportive services (like case management, health care, substance use counseling, income coaching, and more)
> The only way to do this is to give the person a place to live. Ensure the person has healthy and decent food.
> This will require time and treatment so build up a new sense of safety.
In many ways, just meeting people's basic needs would go farther to address mental health than any miracle drug.
> Once achieved treatment for schizophrenia could start with the drug and be closely monitored by professionals.
At least for mental illness, the US state run mental hospitals should be reopened to put the mentally ill under care, monitoring, and to get them back on medicine.
Modern psychiatric medicine could reverse the issues that used to stigmatize the mentally ill.
That means stand-alone housing just won’t work properly.
The people who are homeless are homeless because they, due to drugs, alcohol, or mental illness aren't safe to have around others of extreme poverty.
My friend operate several halfway houses. Almost weekly he has to kick someone out because they are a danger to staff or other clients. Generally this is at 2am, and the police are involved.
Our society has decided that institutionalizing people is inhumane. Well, if someone isn't safe enough to be in a halfway house and institutions are inhumane, the only place for them to go is the street, and, eventually, if they are lucky, prison.
https://www.google.com/search?q=131986-45-3 (Xanomeline) https://www.google.com/search?q=10405-02-4 (Trospium chloride)
Now you see, they're selling it with a huuuuge markup, just for that FDA's "stamp" on the box. But inside the packaging, it's just... this. But to everyone their own, I guess.
People already do exactly that, and with some basic knowledge (which should and probably will be in 20-30 years a common knowledge) it's much safer than one could expect.
Of course, it'd be ideal if they wouldn't need to worry about it and could leave this to a person who is guaranteed to be more knowledgeable in doing that, but with all the over-regulation burden, drug patents, drug schedules, it's not happening. Example of that is, precisely, the price of this. It could literally be 2000x smaller if we only get rid of that burden, which was created to give some people profit. And if we subside that with taxes, these taxes go to the pocket of a gatekept and protected-by-the-state manufacturer. That's not how taxes should even work, they should benefit the society instead.
TL;DR: This is a much wider issue.
From what I understand - may be wrong - the 2000x has more to do with IP protections than production safety.
By the way, I'm not even sure does IP protections itself apply here. Both parts of this fixed combination drug were known for quite some time (particularly trospium chloride is very old, also often used in research settings). But if they would apply (if the molecule itself was patentable as someone's intellectual property), they would be additional HUGE problem. But what constitutes (or creates) that "2000x" problem here isn't even that, this is most likely the FDA regulations regarding drug approvals and so on, exclusively.
It could be a good idea to wonder about, what if FDA as a governmental agency limited itself to "trusted" information campaigns to the public on efficiency of all medicines, but not doing anything which touches, notably, revenue matters of pharmaceutical companies (as that's why, in my opinion, corporations actually lobby for big FDA influence, they can make more profit off that).
Also, definitely FDA in that model wouldn't be setting themselves as an "authority" for "approvals" of drugs and so on, which for my taste is completely contrary with both the whole putative role of (federal) government, and further, with the Western values (as I outlined in my previous comment) themselves.
That new role and "definition" of FDA would be exactly akin to what NIH is doing even now in the area of nutrition. If you don't know what they do, look at the USDA FoodData Central or all the micronutrient factsheet they publish - it's my go-to resource when I wonder anything about food.
But the FDA role would then be like that, but in regard to man-made substances of medicinal use, as opposed to these occurring in abundance in nature (which, in a great simplification, when they're essential to a human body, we consider "food"). And DEA's complementary role here would be to go after manufacturers who do not label their products according to the truth.
In the present information age, you don't need to give them such wide powers to avoid precisely what you're afraid about avoiding.
However, your point made me realize that, in fact, probably what you generally described as the most capable individuals, are probably even now mostly immune to the harm which FDA creates as "side effects" of what they consider good. So, if we assume that FDA's action don't "touch" them in most ways, should these most capable individuals be trying to reform it? But I don't think that the FDA's action don't affect the most capable individuals much. We're all one society and even if it doesn't influence them much directly, it still very much does so in more indirect ways.
Also think, why do you think that "predators" even exist? It could be either evil nature of the humankind itself, if we assume there is such, or something else creating a place for them. If it's the first one, we're fucked regardless. But maybe it's not?
Whoa. Wonder if that's being evaluated?
I'm assuming such a drug would have drastic drawbacks in terms of how Autistic people think. Similar to other drugs that address mental state, they might not feel like themselves.
Knowing how I think, and how I use knowledge, I'm not sure that I'd be better at anything if a drug altered my ability to think in detail. Even if something made me non-autistic like magic, I have a lifetime of autistic knowledge that is structured differently than what a non-autistic brain would need. I could have to learn everything all over again if I were to become unable to comprehend/assemble the logical building blocks that I normally use to do everything.
So I have to assume the drug doesn't actually attempt to treat the core defining trait of autism and only attempts to treat some of the side effects.
As far as I'm aware, even though autism is a spectrum, every brain that is autistic has a particularly distinctive redistribution of connections, which is what results in basically everything. This redistribution is likely what results in the overly logical/analytical thinking (whether it's bottom-up or top-down), although I don't think anyone's been able to prove or disprove that, it's just a correlation.
I wanted sort of the opposite of this for opioids - work in the body, not the brain. There's been a few attempts but non that passed trials.
https://www.aafp.org/pubs/afp/issues/2018/0301/p348.html
I believe there are other studies besides this that points to these two OTC pain relievers as being 'just as good' as opiates.
Opiates could near make you not feel your arm being chopped off, ibuprofen couldn’t prevent a light pinch from hurting.
If I were to have fever, I would not take opiates though, I do not think they reduce inflammation or fever.
It wouldn't surprise me if either were true - it's definitely the case that different people need different opiate doses to get the same effects (even for their first dose, not considering developed tolerance), I've known people for whom OTC (over the counter, no prescription needed) cocodamol - 8mg codeine + 500mg paracetamol, x1-2 per dose - contained enough codeine for them to feel a bit high, meanwhile other people like me need prescription strength (30-60mg) codeine to feel any benefits at all, and don't feel remotely high from it.
I also had a friend once who literally couldn't get high from weed, it has no effect on him - at least up to the amount tested, which was him smoking & vaping several grams of a strong strain of cannabis that got the rest of the room extremely high with much less of it. He tried on various other occasions, included edibles from a coffeeshop in Amsterdam, never any effects.
Most substances do not affect me the way they affect others; I have depression & anxiety and I have tried almost all antidepressants (along with mood stabilizers) to no effect.
I suspect it may have to do with my brain lesions (I have MS), but I am not quite sure.
That said, opiates do help with my physical symptoms, and only them, unfortunately.
> people like me need prescription strength (30-60mg) codeine to feel any benefits at all, and don't feel remotely high from it.
It is interesting though. Oxycodone is way stronger than codeine, and 80 mg is considered a very high dose yet it does not make me high, with or without tolerance.
My sister has defective P450 and your experience is the same as hers with opiates and other drugs, e.g. they are entirely ineffective when taken orally.
That's already how some anti-diarrheals work like loperamide. And some anticonstipation drugs like oral naloxone and methylnaltrexone that work as peripheral or locally-acting antagonists
This was developed in the UK for £11million and sold to Bristol Myers Squib for USD 14billion...
https://wellcome.org/news/new-treatment-for-schizophrenia-Co...
I often am against the narrative that every pill should be priced at the cost of manufacturing + healthy margin, since by that logic the first pill should cost billions to cover for the R&D. In this case, it doesn't quite translate.
"Childhood Trauma is probably the most important environmental factor associated with Schizophrenia. There is evidence of multiple paths between traumatic experiences and psychosis. Mental disorders are systems of interacting symptoms through a framework of networks. Psychotic symptoms in patients with a history of child abuse are more severe, persistent, and refractory to treatment. In developmental years, exposure to neglect and abuse reveals severe adverse effects on the average neurobiological growth, leading to vulnerable neurobiology preceding disadvantageous psychiatric outcomes."
https://www.theguesthouseocala.com/understanding-the-connect...
"The guiding principles of trauma-specific care can give you the space to uncover the root of your schizophrenia and trauma. Thus, understanding how your early traumas have impacted you opens the door to dismantling maladaptive coping mechanisms. As you deepen your self-understanding, it encourages you to lean into adaptive coping strategies to process your experiences and life stressors. Furthermore, with support, you can find a path to recovery from schizophrenia and trauma that considers you and your specific experiences."
trauma (at any time), drug use, other experiences -- all can make schizophrenia more likely in those susceptible. absolutely true.
but it is a biological disease, and healing trauma won't stop its progression. as your source notes, the trauma causes differences in brain development, and once that's done its done.
i don't think coming up with a new drug, the main advantage of which is it doesn't numb you the horrible way existing antipychotics do, is a bad thing.
this is basically a drug that was only created to improve the QoL of people with schizophrenia. if society just wanted to numb them, we already have drugs for that and could just be much more aggressive in violently coercing treatment.
investing in these drugs isn't "looking away", it's putting in a huge investment of many billions of dollars to help the victims live better lives.
"As such, the hippocampus and hippocampal neuroplasticity may also play a key role in resilience and recovery from stress. This is supported by the current finding that hippocampal volume increased following psychological therapy."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5943737/
"we found a significant [hippocampal] volume expansion during a 12-week treatment period, which correlated with clinical improvement"
https://www.biologicalpsychiatryjournal.com/article/S0006-32...
Increased hippocampal volume and gene expression following cognitive behavioral therapy in PTSD
https://www.frontiersin.org/journals/human-neuroscience/arti...
However, I think the best treatment involves both.
2. The argument brought up was that brain 'damage' "just is", and cannot be reversed; which is where any neuroplasticity research can be used to show that it is not that simple, and that even brain structures can and do continue to change over the course of a lifetime, not only on the level of transmitters.
3. The positive effects of psychotherapy for schizophrenia are well researched.
Schäfer, I., & Fisher, H. L. (2022). Childhood trauma and psychosis-what is the evidence? Dialogues in clinical neuroscience. P. 360 – 365. https://doi.org/10.31887/DCNS.2011.13.2/ischaefer
Outcomes are what we’re hoping to improve. Your data looks like we get brain recovery, which is an improvement to outcomes. Necessary, maybe not sufficient.
When you look at the studies I posted initially, one theory is that schizophrenia is a result of posttraumatic stress caused by childhood trauma, and a coping strategy (flashbacks, intrusions, dissociation). It may not be in all cases, but in the cases where that is, PTSD treatment seems to work to fundamentally heal schizophrenia.
Remission of schizophrenia after an EMDR session https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8820797/
Applications of Trauma Treatment for Schizophrenia https://www.tandfonline.com/doi/full/10.1080/109267710037051...
Making meaning of trauma in psychosis https://www.frontiersin.org/journals/psychiatry/articles/10....
Even if you believe schizophrenia to be first and then lead to traumatic experiences (which it certainly will), it makes total sense to do a trauma assessment and heal the maladaptive strategies and broken beliefs related to these traumatic experiences, which is where again PTSD treatment comes in.
"In the last 2 decades, it has become obvious that child abuse, urbanization, migration, and adverse life events contribute to the etiology of schizophrenia and other psychoses. […] I expect to see the end of the concept of schizophrenia soon." (Murray, R. M. (2016). Mistakes I Have Made in My Research Career. Schizophrenia Bulletin, sbw165. doi:10.1093/schbul/sbw165)
basically admitting psychotic episodes kicks you out of most programs before you can even start, because the anticipated overreaction to slight triggers can only be handled by the most experienced counselors, or so they believe.
In that sense I appreciate you sharing these papers while pointing out that it's still a looong way to have this currently "esoteric" knowledge mainstream.
Build a stable base camp. No need to go in deeper yet. But if you are preparing to go in and face the truth, you cannot do it with meds that blind you.
I want to be charitable because I think I know the point you're trying to make in your comment, and what I want to say is mostly to the side of that. But I think that this statement at best glosses over what's been a long, expensive, and heated (though sincere) scientific conversation about schizophrenia over the past century and change. It's one that not only includes a substantively fruitless search for any underlying pathophysiology, but a spirited conversation about the validity, reliability, and plain-English usefulness of the concept itself! Further, this conversation is far from the stomping grounds of cranks and scammers; it has taken place inside what you might call the most orthodox psychiatric and psychological institutions: the APA, the major high-impact journals, fancy universities etc etc.
So when an eminence like Robin Murray, knighthood and all, can go into Schizophrenia Bulletin (2017) and write something like ...
"I expect to see the end of the concept of schizophrenia soon. Already the evidence that it is a discrete entity rather than just the severe end of psychosis has been fatally undermined. Furthermore, the syndrome is already beginning to breakdown, for example, into those cases caused by copy number variations, drug abuse, social adversity, etc. Presumably this process will accelerate, and the term schizophrenia will be confined to history, like 'dropsy.'" [1]
... saying that we know it's a biological disease as part of broader claims about treatment effectiveness doesn't tell the whole story. (I encourage everyone to read Murray's reflections in the linked article, as it's a fascinating retrospective on an illustrious career in psychosis research and psychiatry.)
[1] https://academic.oup.com/schizophreniabulletin/article-abstr...
however, the reality is, psychosis frequently prevents people from recognizing their own impairment. it's just true that this is very common, and maybe shouldn't be so surprising, since in many other cases (alcohol, drugs, dementia, brain injury) people also are prone to underestimate how impaired they are.
it's very different than the common anti-psychiatry claim that the schizophrenia diagnosis is a social construction that gets applied to healthy people who violate social norms.
They misspelled "medication". There are narrow situations where very skilled psychiatrists have successfully treated schizophrenics using non-pharma (read: traditional) psychotherapy, but they are truly exceptional cases.
Being schizophrenic is not a lack of "deepening your self-understanding" that blocks them from "uncovering the root of " their illness! That is absolutely horse shit and belongs in a new age Homeopathy boutique.
Schizophrenics firmly believe their delusions and paranoia. In fact, one of the worst things you can say to them is "it's all in your head! The voices aren't real!". Commonly, they split the world into allies and suspects, so the moment you try to invalidate them, they add you to the list of agents/spirits/whatever is after them.
This disease requires a psychiatrist and medication, full stop, and is fully orthogonal to child abuse.
Schäfer, I., & Fisher, H. L. (2022). Childhood trauma and psychosis-what is the evidence? Dialogues in clinical neuroscience. P. 360 – 365. https://doi.org/10.31887/DCNS.2011.13.2/ischaefer
Schlesselmann, A. J., Huntjens, R. J., Renard, S. B., McNally, R. J., Albers, C. J., De Vries, V. E., & Pijnenborg, G. H. (2022). A Network Approach to Trauma, Dissociative Symptoms, and Psychosis Symptoms in Schizophrenia Spectrum Disorders. Schizophrenia Bulletin https://doi.org/10.1093/schbul/sbac122
etc.
"there is evidence of a causal relationship between developmental trauma and psychosis, including clear temporal sequences between exposure and outcome, plausible mechanisms and dose–response relationships"
"Ccongruent with the idea of an association between stressful life events and dissociative experiences, research has established a link between the presence and severity of dissociation and reported interpersonal traumas such as sexual, physical, and emotional abuse, with multiple traumas being linked to more severe symptoms.
In SSD populations up to 60% of individuals report a history of interpersonal trauma. The core explanation for the mechanism linking trauma and symptoms of SSD states that trauma leads to a vulnerability rendering the individual susceptible to the experience of perceptual and sensory intrusions. In line with the idea of trauma as a vulnerability factor for psychotic as well as for dissociative symptoms, studies have shown that more frequent dissociative and more severe psychotic symptoms in SSD are linked to reported trauma in a dose-response relationship."
if this pans out the way they hope, by all means give the lead guy a couple yachts or whatever he wants. space tourism, gold statue of himself, whatever. big bonuses all the way down the org chart.
there's the potential to reduce an absolutely staggering amount of human misery here. frankly (again if this pans out) our homelessness crisis would look very different if this drug had existed 20 years ago, when the mechanism of action was discovered.
the people who cared enough and took a huge concentrated risk to do this should just get rich, if in fact it pans out.
They already did. Bristol Myer Squibb acquired the company behind this drug for $14 billion earlier this year.
Are there numbers, for how many homeless people, are suffering from schizophrenia?
I would assume only a very small number of homeless people has the clinical condition, but those who have it, are just very visible. Most homeless people are hidden usually and avoid attention.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6880407/
If I were to guess, I would say that while many people may experience bouts of homelessness, the ones with schizophrenia are more likely to be persistently homeless.
the crisis would look very different if it was just a mix of people dealing with drug addiction (but basically lucid and rational) and with poverty.
Serious drug addicts are seldom lucid and rational.
But I very much do get the point, that solving the schizophrenic problem, would help a lot with everything else. (I am just way more sceptical, that this drug can deliver that)
Not a disease but a real illness, with no cure but treatment like cancer.
Even with effective treatment, sometimes the psychosis wins, and the patient can backslide into full blown illness.
True, but think about all the people who are fully functioning and productive members of society and got afflicted with this disease. This med will increase the likelihood that they continue to be highly functioning and compliant with the treatment. This will allow them to keep their jobs and cognitive abilities.
Every person I know with this disease has trouble sticking to meds due to side effects, and not sticking to the meds and relapsing multiple times is probably one of the most important reasons that their condition regresses.
Both are recommended. Why? Daily meds are not only effective, but remind the patient that they have an illness that needs daily maintenance, it makes them involved in the treatment. Long acting injectables are added monthly to prevent backslides in case the patient forgets or does not want to take their medicine.
The population suffering these illnesses are already costing the public a lot of money in various forms, it could be worth the investment.
I know plenty of people without mental health issues who can't get jobs that make 20k and I know a few with degrees who can't.
Making healthcare a for-profit venture guarantees that poor people suffer disproportionately. Making chemicals is cheap and most of the innovation happens on government grants and funding. A government run healthcare system is obvious a cheaper solution with less suffering.
This is true of literally every industry; the poor always get less than the rich. Why not nationalize everything so that the poor always get the same as the rich? Surely if the government can run healthcare it can run toy shops and grocery stores.
Capitalism simply doesn't work in an environment where one side has infinite leverage.
These other countries didn't nationalize their industries. They simply use spending controls. The government says we "will pay $X and you can take it or leave it". The US is rather rare in that we say "We will take it no matter the cost".
Companies are more or less greedy in different countries. They are the same companies!
There can be specific individuals or organizations that seek no profit, but they are almost always working with and through other for profit entities.
To say something like an entire industry should be nonprofit is pie in the sky, which is what I am trying to highlight.
Overly broad moral sentiments like people should not seek profit when it comes to healthcare quickly break down when examined in any detail.
I think What people usually mean is simply that they think health insurance should be funded by taxes and accessible to all. Instead of simply saying this, they end up justifying it with overly broad and poorly thought out moral laws.
A kid not getting a toy is sad, but it's not the end of the world. However, healthcare is literally life or death. It makes complete sense to single out healthcare.
This isn't just the NHS, however. Virtually every developed nation's public option, because pretty much all but the US have them, outpaces the US in virtually any metric you can choose.
Not only do we pay much, much more, but we also get lower quality care. We also get slower care. We also get more extreme care.
The core issue with the private sector is they have absolutely zero incentive to provide good care. If they're smart, they should provide suboptimal care and unnecessary care - that way they can get more money in the long run.
The "free market" is not the magic bandaid to fix everything on planet Earth. You HAVE to think about incentives. What will the free market actually do here? Even a cursory, naive analysis will show the free market should promote sickness because sick people don't have options. This doesn't delve into insurance, which quite literally has an incentive to not give out treatment.
Turning away from the elephant in the room because it is "vile" doesn't help anyone and just entrenches the status quo.
If it was taxpayer funded research it would still cost this much.
Who might pay the $20k of course varies a lot, depending on the health care system.
One thing I've learned over the years is to not try "reading between the lines" to suss out what people are "really saying". It's just too error prone, and you rarely end up communicating.
I would think it's plainly obvious that schizophrenic homeless people don't have $20k to spend on anything, so I didn't interpret it that way.
Zyprexa, which was mentioned in the article, is almost always prescribed as generic Olanzapine. Cost as of 2024 for generic - 9 USD, brand name 476 USD.
What would a price in line with recouping R&D and production costs and, say, a 20% profit margin be?
That's the "recouping R&D" part.
Run some stock screeners on your brokerage account. You have to work to generate a list without a pharma startup on it.
https://www.sec.gov/ix?doc=/Archives/edgar/data/14272/000001...
Besides, Bristol Meyers Squibb acquired this drug for $14 billion which is bigger than the annual budget of the entire NSF. For a single drug. Tax payers weren’t the ones on the hook for that.
Selling a product to the taxpayers is not the same as funding.
Buyer typically do not have a direct say in how businesses are run. They exert influence by either buying a product or not.
If Medicare and Medicaid cover hamburgers.
I could be wrong, but it looks to me like the fact that there's a built-in government-funded ('tax dollars') market is an aspect of pharma calculations.
Customers vote by buying products or walking.
> In what sense are you proposing pharma production is funded by tax dollars?
I am proposing that the pharma strategy of capitalizing on Medicare and Medicaid tax dollars is a significant component of pharma production. I think this is about executive decisions rather than customer decisions.
It is literally the same exact pharma companies selling to the US Medicare, UK NHS, and communist China. What differs is the customers.
Pharmaceutical companies offload most of the risk onto institutional investors and the public (most biotechs IPO pre-revenue to fund clinical trials) but the flipside is that they have to pay eye-watering sums to acquire promising drugs.
> "Novel" drugs are new drugs never before approved or marketed in the U.S.
The current crop can best be described as chemical lobotomy. Impossible to focus on anything for more than 30 seconds. And it's not even a pleasant stupidity.
There's Abilify, but unfortunately doctors don't like it (due to it being perceived as less effective).
Sure there are side effects, but in this case the side effects are better than the psychotic behavior and breakdown of the patients.
I just don't understand the negativity in this thread. They are doing gods work as far as I'm concerned.
It will probably be sold for $220 in other countries.
But hopefully the compounding pharmacies and anti-pharma hacking collectives will solve the pricetag problem here.
https://www.vice.com/en/article/how-to-make-your-own-medicin...
So... needless to say, I am lost.
I mean that in a fully genuine way. Just look at how much money gets set on fire cycling the same homeless people in and out of jails and emergency rooms and you can see that nobody actually cares about the amount of money being spent, but only that homes themselves aren't easier to get.
go talk to a sample and you'll quickly find out it ain't the lack of home.
I think the institutional structure of most US states and cities wouldn't blink at spend huge amounts on schizophrenia drugs as long as it doesn't involve any kind of inpatient treatment (forced or not) that would put a roof over anyone's head.
If building more homes solves 30% of the problem and this drug solves another 10%, that is 40% of homeless taken care of.
That would be a huge victory that would save hundreds of thousands of lives.
In order to have a life, you must have a job. This is the underlying assumption that fuels everything. This assumption has a critical flaw: not everyone can have a job.
For some segments of the population, we just "bolt on" fixes to this fundamental problem. 401k's so that workers may still get their money when they no longer work. Foster care, so that abandoned babies who cannot work can still live.
For the severely mentally ill and drug addled, we haven't figured it out. The reality is these people cannot work a job and most will never be able to work steadily. Advancements in drugs may help, but even then there will always be some segment of the population who simply cannot work.
Previously, we took an "out of sight, out of mind" approach. Institutionalize these people. It's cheap, particularly if we treat them like dogs. We've evolved and realized such an approach is inhuman and evil. Now, though, what do we do?
If these people had a basic income available, they could at least pay to help themselves. This isn't a silver bullet, but I believe it's better than the current problem we have.
The true solution is fixing the fundamental problem modern society has: everyone has to work. This is really hard.
What are SROs?
It's a category that's been mostly legislated out of existence in the US today.
They would be flayed. Might as well just belt out a "Dean scream" at a live event.
Are you saying you don’t believe in schizophrenia?
I think I echo my prior comments on the US health and pharma system: why?
[0] https://en.wikipedia.org/wiki/Xanomeline/trospium_chloride
Software engineer in the US makes 100K or higher. Why?
If you have reasons to believe the price is too high, present them?
2. The vast majority of drugs do not pan out and most fledging companies formed to study them fail
3. In the US, insurance mostly covers the cost of drugs
4. In 14-20 years, the drug will be turned into a generic and the prices will plummet
This isn't true. The incentive is to help people. There are many people who are calable of doing that but can't do it afford to. We can just pay for their cost of living and research directly, cutting out the profit entirely.
The incentive to help people is insufficient alone.
Also, Nurses are a relatively well paid position, ~150% us the US median salary.
Meaning, such philanthropy does not require every single soldier ant to be a philanthropist. But it does require them to not seek a "get rich" mentality. Such a mentality is inherently incompatible.
And, for the rich philanthropist, he must be ready to lose money. You and I are but lowly ants, and to us losing money is bad. But consider for someone like Rockefeller, there was 0 quality of life decrease after opening those libraries. Of course, if I open even one library, I'm broke.
For this reason I think the idea that healthcare should not be contingent on profit seeking individuals to be a pretty hollow statement.
It also seems that we have a shortage of Rockefellers to bankroll the US healthcare system as active charity with no profit motive.
That seems inconsistent to claim that people will do the work and donate money without returns in the face of reality where very few people do that.
The response seems to be that people in our current system are forced to seek compensation to survive. This seems easily testable. Cut back doctor and healthcare workers salaries to a subsistence income or even the median and you will quickly see if people flock to the profession or leave it
It is for the benefit of society as a whole that people be healthy. Therefore, it is in the interest of each and every person our healthcare be funded. Therefore, they should all fund it.
It's not like other goods where some people want a toy, and some people don't. It's more in line with education. Everyone needs it, and if everyone has it then things improve for everyone - even those who can't get it, for one reason or another.
In my eyes, healthcare as a field almost perfectly fits the description of what should be a nationalized service. We've taken the jump with other low-hanging fruit, like education. And society as a whole has benefited greatly from no longer having the majority of the population be illiterate.
Also, the idea that if "something is in everyone's interest, it should be nationalized" doesn't address the fact that free markets are better at matching supply to demand. For example, the UK and Canada have significant healthcare supply shortages that only seem to be getting worse.
To put the previous paragraph another way: having "a right to healthcare" in the abstract is nice but if you need to see an oncologist, waiting weeks/months/years is going to get you killed. In the US this is much less of an issue. Yes it's expensive but when the alternative is "dying of cancer," people are okay going into debt!
I've heard this argument again and again and nobody has ever given me any hard proof.
SOME drugs are developed in the US. Not this one the post focuses on. How many drugs does the US produce as compared to the rest of the world? I dunno, nobody has any numbers. But you're assuming it's enough for it to qualify as a type of "welfare". That, to me, is more of a wishful belief than a hard reality - i.e. you're coping. The drugs are extremely expensive and it's hard to accept that maybe you're being scammed, so people retroactively create plausible reasons to explain this so they don't feel scammed. At least, that's what I see.
> In the US this is much less of an issue
This is actually incorrect. Health outcomes in the US are worse than pretty much every developed nation. This is where my previous paragraph comes in.
People would like very badly to believe our high prices are because the service is good, but this is not actually true, this is just a coping mechanism. Not only are our prices higher, but our standard of care is much lower.
> For example, the UK and Canada have significant healthcare supply shortages that only seem to be getting worse.
This is largely conservative propaganda. If you delve deeper, you will find out that wait times are typically lower in the UK and Canada as opposed to the US. Conservatives cherry pick examples of longer wait times, but again, you have to delve deeper than "oh it takes three months to get random tendon you've never heard of surgery!"
There is no such thing as a major US Pharma company. Major Pharma Companies and the industry are multinational. Revenue from the US is what makes drug development profitable, no matter where the companies are located. If the US paid the same as Europe, most drugs would not be economical to develop.
When you sit in a go/no-go decision to develop a new drug, you model US revenue and ROW revenue to see if the product is worth developing. US Revenue is usually 2x what can be made elsewhere, and pushes the product into the green.
The new drug in this article is Cobenfy, by Bristol Myers Squibb. Bristol Myers Squibb (BMS), is a multinational pharmaceutical company. BMS Revenues from US sales is 32 Billion. Revenues from every other country put together is 13 Billion. [1, pg 19]. The Company Bristol Myers Squibb has a profit Margin of about 14%. IF US paid like Europe, the profit margin would be -35% per year.
This is the way the US props up the global pharma industry. Now, I personally dont think this is something to be proud of. I think it would be better to simply not have many of the drugs we do, than pay the high prices. Alternatively, if somehow the US price matched with Europe, perhaps Europe would be forced to raise their prices.
The current state is like splitting the electric bill with a housemate who will only pay 25%. As long as you are scared of the power getting cut off, you are stuck paying most of the bill and being exploited.
The US health industry is deeply flawed, but it isnt just the private/public distinction. Many European countries have private healthcare and still have lower costs. It is systemic dysfunction and fear that drives the costs.
https://www.bms.com/assets/bms-ar/documents/2023/2023-bms-an...
https://wellcome.org/news/new-treatment-for-schizophrenia-Co...
Point 1 is wrong, point 2 doesn't apply, insurance is now bearing the borden for this capitalistic endeavor for point 3, and in 14-20 years many people who stand to gain a significant quality of life improvement from this drug are likely to be dead (point 4).
What happened was Martin Shekreli purchased patents for existing life-saving drugs and raised the price for them from $1.50 to $30 to cover the cost of the purchasing the patents themselves.
This is an entirely different.
The perception of the drug price increase much more than the details, along with other asshole things he did made him an easy target for outrage.
What is the cost of mass producing this new drug? How much profit should the company be allowed to make? Where's the outrage?
How can we expect companies like this to continue researching such drugs if not? Especially when, more often than not, the research leads to a dead end or failed trials, and they can't even bring the drug to market?
You can see its explosive rise on Google Ngrams. Looks like we're still not quite at the peak
https://books.google.com/ngrams/graph?content=game+changer&y...
Also, did you know vitamin C deficiency not only casues scurvy but mood disorders as well? The neuropsychiatric effects of vitamin C deficiency: a systematic review https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7302360/
on Pyridoxine:
Pyridoxamine: A novel treatment for schizophrenia with enhanced carbonyl stress https://onlinelibrary.wiley.com/doi/full/10.1111/pcn.12613
Vitamin B6 deficiency hyperactivates the noradrenergic system, leading to social deficits and cognitive impairment https://www.nature.com/articles/s41398-021-01381-z
Vitamin B6 as add-on treatment in chronic schizophrenic and schizoaffective patients: a double-blind, placebo-controlled study https://pubmed.ncbi.nlm.nih.gov/11838627/
Decreased serum pyridoxal levels in schizophrenia: meta-analysis and Mendelian randomization analysis https://www.jpn.ca/content/43/3/194.abstract
Treatment of Pyroluric Schizophrenia(Malvaria) With Large Doses of Pyridoxineand a Dietary Supplement of Zinc https://isom.ca/wp-content/uploads/2020/01/JOM_1974_03_4_11_...
https://my.clevelandclinic.org/health/diseases/23348-paranoi...
It's pretty much likely to be the same deal here.
Since there is no chemical or biological test one can do to confirm a schizophrenia diagnosis, it's a subjective diagnosis by practitioners, treating such subjective diagnosis with powerful brain-chemistry altering drugs. Worse, we do not yet know whether these new drugs will be easy to get off of. Some of the other anti-psychotic type medication is VERY hard to get off of, such as abilify, where most drug treatment centers will not deal with Abilify withdrawals or take on those patients because those are so severe (extreme violence, self harm, etc during withdrawal).
Until Psychiatry can reform itself to become a real science, using the scientific method (repeatable, provable results and not just a "theory of how brain chemistry maybe works sorta but we're not sure"), it will continue to just be a big cash cow for Big Pharma while hooking many patients who do not need these drugs onto them for life, while failing to effect ANY cure on the things they are treating (Have you heard of someone getting "better" after taking anti-depressants and being able to come off them? No. They have to take them for life. That's not a cure.)
it's so obviously a "real disease" even if we don't fully understand the biological basis. it's subjective but honestly, there are just a ton of completely obvious cases.
abuses of the psychiatric system are very bad, but schizophrenia is so so clearly real.
There is no medicine in the world that you can take for a limited time to fix problems forever. That's not how medicine works. That's not how the world works.
Some people with acute depression can take the meds, work on the underlying issues and taper off, yes.
People with chronic depression likely need to take the meds for life.
People with type I diabetes can't get insulin one time either. People with allergies often take the allergy meds when exposed to allergens, which is always for some.
That's not big pharma being greedy, that's a chronic condition requires chronic treatment.
I needed the boost to be able to get out of bed often enough to do the work in therapy. That led to being able to take other actions that helped my brain chemistry too, like eating better food, which reduced inflammation, and getting outside more often.
My doc said her experience was about half and half. Half of people were able to wean off successfully. Half ended up deciding it was better to stay on.
Recovery does happen. For lots of us.
People with the guidance of their doctor stop taking antidepressants all the time. External factors aren't static and often these can change. (separately or because of the treatment) You do not need to stop treatment unless you and your doctor have decided it is going to be better for you.
Another point I'd make is that we don't have exact mechanisms for action in other treatments like paracetamol. That doesn't make it invalid treatment.
About the analgesic activity https://pubmed.ncbi.nlm.nih.gov/31734950/
About the antipyretic activity https://pubmed.ncbi.nlm.nih.gov/29738273/
[0]https://www.nih.gov/news-events/nih-research-matters/mapping...
> it was recently proven that there is little to no evidence that serotonin levels are linked to depression
This has been the consensus of the psychiatric community for the last 20+ years. The serotonin hypothesis was heavily pushed in marketing as a way to medicalize depression and convince people to seek treatment for it. Probably a net positive when it comes to reducing stigma, but few people have been seriously arguing the serotonin hypothesis. As it takes about a month for effects to kick in, most people believe that it's compensatory changes to the brain that happen in response to upregulation of serotonin, such as downregulation of 5ht2a which has an overdensity in people with depression.
> Since there is no chemical or biological test one can do to confirm a schizophrenia diagnosis, it's a subjective diagnosis by practitioners
This is true to some degree - we don't have a blood test or an fmri scan that will definitively point to schizophrenia, the diagnosis is (for now) based on DSM criteria and by thoroughly ruling out other causes of schizophrenia. We do have tests for a number of other causes of psychosis, like lumbar punctures for NMDA-receptor encephalitis.
I'd like to emphasize that there are MANY diseases and conditions that we treat empirically for based on subjective symptoms which are just as real as schizophrenia. There are no tests we can perform for concussions or migraines. The brain is very challenging to perform tests on because of the blood-brain barrier and the skull.
> Worse, we do not yet know whether these new drugs will be easy to get off of.
Cholinergic drugs are VERY well understood and used in the treatment of a number of diseases. This "new" drug is a drug that was discovered 20+ years ago and is being used in a creative way to mitigate its GI side effects. Everything so far points to this being more effective at treating the negative symptoms of schizophrenia (loss of motivation, cognitive impairment), with milder side effects (some mild GI issues which typically resolve after a few days), which is a huge deal considering how many people with schizophrenia quit dopaminergic drugs due to the side effects.
One of the biggest problems with our for-profit system is that schizophrenia is comparatively rare and largely affects those with a lower socioeconomic status, so there isn't a huge financial incentive to work on schizophrenia drugs. This one was being developed for another purpose entirely.
> Until Psychiatry can reform itself to become a real science, using the scientific method (repeatable, provable results and not just a "theory of how brain chemistry maybe works sorta but we're not sure"), it will continue to just be a big cash cow for Big Pharma while hooking many patients who do not need these drugs onto them for life, while failing to effect ANY cure on the things they are treating
It sounds like you have an ax to grind against the profession, but I can assure you that there is a huge need for it and that people largely see benefits from medication. For me, SSRIs got me stable and functional so I could better address the root causes of my depression. Psychiatric drugs aren't perfect, but for many people they're truly life-saving. There is evidence to support kindling in some diseases such as bipolar as well - that if you remain unmedicated, manic episodes become progressively worse as the brain becomes more damaged.
Additionally, psychiatrists treat more than just depression. Some specialize in sleep medicine, addiction medicine, toxicology. They are trained to tease apart primary depression from other non-psychiatric diseases masquerading as a psychiatric disease. I saw a patient once who had been treated with a number of antipsychotics by his PCP and mid-level providers for persistent visual hallucinations. He met with a psychiatrist who tried increasing his anti-seizure meds, which resolved what was likely a recurrent partial seizure.
Every drug (sans some off-label use) goes through an FDA approval process and is, over the course of several years and millions of dollars, shown to be effective and relatively safe. I can assure you that psychiatry is as scientific as any other field of medicine. It's still in its infancy compared to some other specialties - the brain is a very complex organ and difficult to study - but we have as good of an understanding of most psychiatric illnesses as we do neurodegenerative diseases such as Alzheimer's, which have been equally as difficult to study and treat.
Psychiatry is not even close to the most profitable area of American healthcare. Psychiatrists are one of the lower-earning specialties, and most people with mental illness never obtain treatment for it. Compare that to the 10% of all seniors who are on Eliquis to prevent blood clots, which costs a thousand dollars a month without insurance.
Trust me, if there was a way to permanently cure a psychiatric disease with one procedure or pill, we would all be in favor of it. Just because a diabetic needs to take insulin for life doesn't make endocrinology a scam.
This never happens. "thoroughly" never happens. There are many examples of this. Recently a woman who was in psychiatric care fro over 20 years was finally diagnosed with Lupus (NPSLE) and cured.
They did not thoroughly do anything for me. I had to figure it out for myself.
> people largely see benefits from medication
I have a friend with depression and they had her on two adrenal receptor inhibitors (trazadone and risperidone) and she only got worse. They they went to ECT. She had severely constipation (treated with yet another drug, Linzess) and hypotension as well. They they started her on ECT, which did not work and she lost some memory.
The doctors failed to see that adrenal blockers could be causing her depression. I showed her the science, she asked her doc to stop those meds. She she no longer depressed nor has hypotension or consipation. And now she is angry.
They diagnosed her with schizophernia after they started her on antidepressants 25 years ago.
I am not saying medication are not sometimes useful, but I cannot count the times I have seen patients get worse on psych meds.
> He met with a psychiatrist who tried increasing his anti-seizure meds, which resolved what was likely a recurrent partial seizure.
You are still in med school so I hope you learn more. Anti Seizure meds have been the go to for these disorders fro years. They put me on depakote for my modo disorder 20 years ago.
> Psychiatry is not even close to the most profitable area of American healthcare.
Psych pharm businesses are very profitable though, and that is what we are talking about here.
> Trust me, if there was a way to permanently cure a psychiatric disease with one procedure or pill, we would all be in favor of it.
There is not pill, but there is a method. It is called Personalized Medicine.
And by the way KaRXT is not going to work. You should learn about receptor density changes when people take these receptor modulating drugs. This is why they always fail. There are better ways to manage the glutamate/GABA balance if that is the persons issue which it many cases it may not be, or may not be the fundamental problem. And if the acetylcholine is the problem in schizophrenia, why does M1 and M4 receptor in the body have bad side effects but whil in the brain it is good?
I will tell you why, they are using this drug to sedate the patient, not treat the patient.
She didn’t take them, shes fine, but yall are the devil frfr
Admit this: if you go to a doctor and say anything about the inside of your head that makes them uncomfortable you’re getting a chemical lobotomy immediately
It's not typical to get antidepressants after a single meeting with a general practitioner. In fact, I don't even know if that can happen.
That being said, depression is real, and it does take lives. I've known many people who have successfully survived depression via SSRI's and no longer take them. That's the flip side you're not seeing. I've also seen unmedicated people take their lives.
-Gaslight and hand wave
-Slippery slope
I do agree that women are disproportionately affected by the over prescription
Here is the drug trial results for EMERGENT-2 which was one of the two phase-3 trials that lead to the approval.
I think its striking that the trial is only 5-weeks long and this medication gets approval.
> Results from additional trials, including the identical EMERGENT-3 trial and the 52-week, open-label EMERGENT-4 and EMERGENT-5 trials, will provide additional information on the efficacy and safety of KarXT in people with schizophrenia.
EMERGENT-4 and EMERGENT-5 concluded last year [1], which was the reason for the approval. EMERGENT-2 was mostly a milestone Karuna Therapeutics used to get enough funding for the rest of the trials and inform their design.
[1] https://news.bms.com/news/details/2024/Bristol-Myers-Squibb-...
The pharmaceutical just has to tell those people that it does work in their particular case and just ignore the studies that say it doesn’t, and the media and politicians uncritically report that as “the FDA is mean, let pharmaceutical companies sell new and expensive snake oil and re-victimise these people”, then in a few years later the same reporters and politicians berate the “ineffectual” FDA for allowing snake oil.
It is good to hold federal agencies with large power to a very high standard. But that’s often not the case as any critiques get dismissed with the “well they have good intentions and can you imagine if they didn’t exist?” hand wave tactic.
Doesn't quite have the same ring to it, now does it?
By the nature of these drugs, each and every symptom of what you pronounce Schizophrenia would be your daily life once on the poisonous neuro-toxic agents.
https://www.madinamerica.com/critical-psychiatry-textbook-2/
A background on the author:
There’s nothing to glorify in schizophrenia- it’s in many ways worse than losing your loved ones in a tragic accident. It’s even worse for the schizophrenic who after having a normal life descends into paranoid delusion and take on an existence of misery.
I know the right answer here is for me to ignore and walk on but it’s hard to do so and leave statements like these unqualified.
https://en.wikipedia.org/wiki/Martha_Mitchell_effect
Your argument is as good as calling Martha Mitchell crazy and dismissing entirely possible organized exploitation on a premise of made-up symptoms that are composed of zero scientific evidence.