FDA approves a novel drug for schizophrenia

https://www.washingtonpost.com/business/2024/09/26/fda-antipsychotic-mental-illness-alzheimers/

by tintinnabula • 2 years ago

229 286 2 years ago

It's this https://en.wikipedia.org/wiki/Xanomeline/trospium_chloride

kstrauser• 2 years ago

M4 and M1 receptor stimulation indirectly rebalances dopaminergic and glutamatergic circuits involved in the symptoms associated with neurological and neuropsychiatric diseases such as schizophrenia and Alzheimer's disease.

Whoa. Wonder if that's being evaluated?

jmcgough2• 2 years ago

Yes, it's being tested for autism as well.

therein• 2 years ago

Co-administration of an agonist and an antagonist for the same pharmacophore seems like an interesting approach.

nwienert4• 2 years ago

Looks like the antagonist is only outside the brain, so it works to counteract the side-effects, pretty cool.

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.

boingo• 2 years ago

https://archive.is/BYzWs

KomoD• 2 years ago

Cobenfy, set to launch in October, will have a list price that would cost about $22,500 a year. The influential Institute for Clinical and Economic Review this year estimated that a price in line with expected clinical benefits to patients should be in the range of $16,000 to $20,000 a year. Bristol Myers Squibb executives say most eligible patients are covered by Medicare or Medicaid and wouldn’t pay the list price.

givemeethekeys4• 2 years ago

Didn't some bro from the pharma industry get mercilessly shat upon for charging so much for a life saving drug?

the_sleaze_• 2 years ago

You're being downvoted for using an easily google-able factoid incorrectly because you're pattern matching on "high drug prices"

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.

desumeku• 2 years ago

Legends say that Shkreli was actually trying to rip off insurance companies and left individuals alone, even going as far as to give it away for $1 to people without insurance, but I'm not sure.

photochemsyn• 2 years ago

The FDA is under regulatory capture by the pharmaceutical industry, and their approval or lack thereof is one of the most unreliable measures of the safety and efficacy of psychiatric drugs in particular. Schizophrenia diagnoses are almost entirely subjective in nature (there's no reliable biochemical or biomolecular or biophysical test for the presence or absence of the condition) - really the whole field of psychiatric care for mental health issues is about as useful as tuberculosis experts were in the 1850s, before Koch's demonstration of the infectious microbial nature of the disease.

olliej• 2 years ago

No it’s under pressure from people who go to the press saying “the FDA won’t let me use this drug to help me/my family” who ignore “because there’s no evidence it works” as the reason.

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.

dmix• 2 years ago

Regulatory capture doesn’t mean the entire of idea of FDA as a safety mechanism is bad… nor does a legitimate reason for their existence mean that capture doesn’t exist

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.

77pt77• 2 years ago

Game changer in treatment of disease we can't even define

Doesn't quite have the same ring to it, now does it?

fnordpiglet3• 2 years ago

I’m sort of surprised to see someone claiming schizophrenia is subjective. Schizophrenia has extraordinarily pronounced symptoms. It’s like claiming lupus doesn’t exist because there’s no single reliable diagnostic test for it. Schizophrenia has very specific and easily observed symptoms and is specifically affected by medications such as Zyprexa that doesn’t cause similar changes in behavior for people without schizophrenia or psychosis. However that and related medications have horrible side effects leading most patients to avoid taking it. For people who are or have family members ravaged by schizophrenia this is some of the best news you can imagine - a medication with similar beneficial effects on their loved ones but without turning them into zombies. It feels callous to an extraordinary degree to deny the existence of schizophrenia and to not recognize the benefit to a minimal side effect mediation that can give the schizophrenics life back.

niemal_dev8• 2 years ago

This is actually a ridiculous answer. So you claim if you get get cold turkey'ed on Zyprexa you won't hallucinate or have mania? You claim, there are people out there, who take a dopamine antagonist without getting diabetes, organ issues, loss of self (fundamentally this is what these drugs do, deprive of brain function) and ultimately sudden death?

mikhmha• 2 years ago

I see this take on the internet a lot usually combined with some statement of how Schizophrenics are secret geniuses and were the prophets of olden times. It just doesn't square off with my own observations of schizophrenics in real life. How is the condition subjective when you see the same types of symptoms across people? I've seen it with men and women afflicted by the condition - always the persecutory delusions, belief that they are some king or prophet/chosen one, disorganized thinking, and word salads. Why is it always the same symptoms? You're telling me that's not rooted in any common condition?

niemal_dev8• 2 years ago

always the persecutory delusions, belief that they are some king or prophet/chosen one, disorganized thinking, and word salads. Why is it always the same symptoms?

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.

amanaplanacanal• 2 years ago

Pain is entirely self reported by the patient. There is no objective measure of it. Painkillers must also then be a scam, by your logic.

rozab• 2 years ago

I can't stand this term 'game changer', I started noticing it being used a lot during early covid and then the Ukraine war, all for things which did not turn out to be 'game changers'.

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...

drdaeman• 2 years ago

An unfortunate requirement of modern attention/engagement economy. Readers hate this one trick, but for the media outlets, if you don't crank up hype clickbait engine to 11, you're out, or running some very niche business.

olelele• 2 years ago

Readers hate this one trick, click to find out why!

howard941• 2 years ago

At $22.5K/yr it'll be more money changer than game changer.

beautifulfreak• 2 years ago

"Double down" has a similar chart, another annoying phrase.

unsupp0rted• 2 years ago

In the early days just before and just after AGI, all of a sudden a lot of games will be changed in a short period of time.

dang• 2 years ago

Ok, we've unchanged the game in the title above.

ck2• 2 years ago

The audacity of pedaling a drug pricetag of $22,000 to solve someone being homeless when government safetynets won't even offer a fraction of that.

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...

johnisgood9• 2 years ago

Wait till Europe gets generics, it will cost less than $5 per month. My MS medication would cost me $8k per month in the US, costs me $2 here.

devin2• 2 years ago

What medication?

rafram2• 2 years ago

It would cost you $2 with insurance in the US too. It’s a terrible system, it doesn’t make sense, but you have to understand that approximately no one pays the list price for prescription drugs - even people without insurance.

crooked-v5• 2 years ago

The US will do anything and everything to solve homelessness as long as it doesn't actually involve building more homes or giving homes to people.

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.

microbug• 2 years ago

imagine thinking that the "homelessness" crisis is only lack of homes.

go talk to a sample and you'll quickly find out it ain't the lack of home.

the_optimist• 2 years ago

What qualifies to you as a home? Is it “nice”? Fully finished? Large? In a nice area? In an area with good weather? In good repair?

oatmeal13• 2 years ago

The US simply needs to undo the zoning laws, parking minimums, and setback requirements that make it illegal to build affordable housing.

datavirtue2• 2 years ago

First, you need a politician to say: "your home is not an investment, it's an asset."

They would be flayed. Might as well just belt out a "Dean scream" at a live event.

NHQ• 2 years ago

Healthcare in the US is an elite graft, the system will pay the full price. That is actually why prices are so high and hospitals try to keep price tags a secret, because the bill does get paid, and all those executives and investors and even the insurance companies all make off with riches, increasingly paid for by the public. The real crime is setting up indigent people now using drugs on the street to become a massive market for psychiatric medication on the pretense of a pseudo-scientific "disorders" like schizophrenia.

rafram2• 2 years ago

pseudo-scientific "disorders" like schizophrenia.

Are you saying you don’t believe in schizophrenia?

chiefalchemist• 2 years ago

If the FDA was truly interested in game changing it would lead. As it is, it's a sock puppet for Big Pharma.

https://michaelpollan.com/books/how-to-change-your-mind/

EasyMark2• 2 years ago

As long as the government can’t cut deals with pharmaceutical companies it will continue to be like this. I’m sure the current SCOTUS will somehow make sure that is unconstitutional though if such a law did pass.

pjmorris4• 2 years ago

a price in line with expected clinical benefits to patients

What would a price in line with recouping R&D and production costs and, say, a 20% profit margin be?

thefounder2• 2 years ago

It may not be fair math. The company may bet on 10 different things and just one pays off. It needs to pay off for the bad bets as well.

gramie• 2 years ago

in line with recouping R&D and production costs

That's the "recouping R&D" part.

datavirtue2• 2 years ago

It seems like a previous comment pointing out how investors actually fund new drug development seems to track with the loads of pharma startups working on one thing each.

Run some stock screeners on your brokerage account. You have to work to generate a list without a pharma startup on it.

jdietrich• 2 years ago

In their last 10-K, Bristol Myers Squibb reported an operating income of $8.4bn on sales of $43.7bn, giving them a gross profit margin of just over 19%.

https://www.sec.gov/ix?doc=/Archives/edgar/data/14272/000001...

cma3• 2 years ago

You shouldn't look at R&D on one product, since lots fail. Would be like saying a record label that funds 100 artists with 1 being profitable should have a strict 20% profit cap on the profitable one. That wouldn't allow ongoing funding of the broader pool of bets.

givemeethekeys4• 2 years ago

How much of the record label's music production is funded by tax dollars?

throwup2384• 2 years ago

Bristol Myers Squibb acquired Karuna Therapeutics, the company behind Cobenfy (formerly KarXT), for $14 billion earlier this year so that’s their break even for the drug and presumably what their investors thought was fair. I don’t think Karuna had anything else interesting in trials so they have to recoup all of that from Cobenfy before they’re in the black on the acquisition.

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.

tomrod• 2 years ago

Per wikipedia, wholesale for the drug is $1,850/month.

I think I echo my prior comments on the US health and pharma system: why?

[0] https://en.wikipedia.org/wiki/Xanomeline/trospium_chloride

relativ575• 2 years ago

Why not?

Software engineer in the US makes 100K or higher. Why?

If you have reasons to believe the price is too high, present them?

slibhb3• 2 years ago

1. If prices weren't this high then there wouldn't be incentive to develop these drugs in the first place. There's a reason most novel drugs come from the US!

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

guerrilla3• 2 years ago

then there wouldn't be incentive to develop these drugs in the first place.

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.

explodes• 2 years ago

This drug was developed for $11M in the UK, bought by a company for 18B and is being sold at outrageous prices to cover that $18B.

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).

imperio59• 2 years ago

Let's remember it was recently proven that there is little to no evidence that serotonin levels are linked to depression: https://www.nature.com/articles/s41380-022-01661-0

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.)

throw183766• 2 years ago

i'm curious what is the longest conversation you've ever had with an untreated schizophrenic person?

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.

crooked-v5• 2 years ago

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.

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.

catlikesshrimp2• 2 years ago

Antibiotics (Most of the time) Everything surgery, I would include gene replacement therapy and auto transplants in its viccinity.

ClassyJacket• 2 years ago

Yes there are? Antibiotics for one.

Etheryte• 2 years ago

This is so misguided that it's hard to even know where to begin. People who develop high blood pressure without a known underlying cause take a pill for it every day for the rest of their life. You could say the same thing, they're not cured, but what actually matters is that they get to live a full life, unconstrained by the disease even if we don't know the underlying cause. Of course it would be better if we were more advanced of a civilization and figured it out, but the important thing is that these people get their lives back.

toast0• 2 years ago

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.

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.

smeej• 2 years ago

I'll raise my hand here. Took antidepressants for a year. Successfully weaned off of them. Have not had recurrence of symptoms.

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.

toastau• 2 years ago

We don't have cures for diabetes, HIV/AIDS, allergies, plenty of ailments. Having treatments is totally valid even if they are taken forever.

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.

catlikesshrimp2• 2 years ago

What is your doubt about paracetamol? This drug's pharmacology is rather well understood.

About the analgesic activity https://pubmed.ncbi.nlm.nih.gov/31734950/

About the antipyretic activity https://pubmed.ncbi.nlm.nih.gov/29738273/

nullindividual2• 2 years ago

An enlarged salience network may be responsible for depression in some patients[0]. Some individuals are pre-disposed to being depressed and it may be a chronic condition, like any other chronic condition. For others, it could "simply" be a chemical imbalance that taking medication for a set period of time resolves (lucky them).

[0]https://www.nih.gov/news-events/nih-research-matters/mapping...

jmcgough2• 2 years ago

I work as an EM scribe and routinely see patients experiencing psychotic episodes. My background is in neuroscience and I'm interviewing for med school right now.

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.

FollowingTheDao4• 2 years ago

by thoroughly ruling out other causes of schizophrenia.

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.

idunnoman12222• 2 years ago

After one meeting with her doctor, they gave my daughter antidepressants a the class of drug that’s meant to be taken for life. She was just an angsty teenager during covid.

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

throw183766• 2 years ago

look, if someone has actually have a new drug that works like antipsychotics but doesn't have the nightmare side effects, i am very happy for that person to get filthy rich.

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.

throwup2384• 2 years ago

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.

lukan2• 2 years ago

"frankly (again if this pans out) our homelessness crisis would look very different if this drug had existed 20 years ago"

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.

dgacmu• 2 years ago

It's actually quite high. 10%+ in this meta-analysis, and 21% with some form of psychosis.

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.

throw183766• 2 years ago

this is completely true, but they take up a very disproportionate amount of time and energy from social service providers, people who work in shelters, etc, and make all spaces for homeless people much more chaotic.

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.

112358132134556• 2 years ago

Even those who are not, will probably develop some sort of schizophrenia due to their marginal lifestyle, but I wonder if it's really a "disease", I feel like it's an adaptation to their environment for people who are more sensitive than others. I feel like the pain is more due to the lack of solutions, especially in a city centre, where it's a constant hell for these guys (and for most any other animal actually, except a few who adapted to that: pigeons, rats, some insects but not the most beautiful ones), just my thought

codedokode• 2 years ago

Homeless people are unlikely to pay $20 000 per year which is the price of the drug though.

toxicdevil• 2 years ago

Homeless people are unlikely to pay $20 000 per year which is the price of the drug though.

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.

asveikau2• 2 years ago

I agree that price feels shockingly high. However, the government can subsidize treatment. As can private insurance policies, before the sufferer becomes homeless, or if they qualify for a family member's plan.

The population suffering these illnesses are already costing the public a lot of money in various forms, it could be worth the investment.

BurningFrog2• 2 years ago

If they're homeless because of schizophrenia, and the drug cures that, $20k/year is easily a profitable investment!

ninetyninenine• 2 years ago

a necessary evil in a capitalist system. Is capitalism perfect? No. Do we know of a better system yet? Maybe. But as of right now better to have a possible cure for 20k rather then nothing.

rs999gti9• 2 years ago

Drugs become generic eventually and costs come down.

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.

throwaway0665• 2 years ago

What are "Novel" Drugs?
"Novel" drugs are new drugs never before approved or marketed in the U.S.

rendx8• 2 years ago

The Role of Childhood Trauma in Psychosis and Schizophrenia: A Systematic Review https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8858420/

"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."

throw183766• 2 years ago

i'm getting very argumentative on the internet today (under a pseudonymous account because as you might guess from my incessant posting, this issue is personal for me)

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.

rendx8• 2 years ago

once that's done its done

"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...

maybelsyrup• 2 years ago

but it is a biological disease

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...

throw23478• 2 years ago

Are there any consistent biomarkers for people with schizophrenia?

gosub1002• 2 years ago

with support, you can find a path to recovery from schizophrenia

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.

rendx8• 2 years ago

Hardy, A., Keen, N., van den Berg, D., Varese, F., Longden, E., Ward, T., & Brand, R. M. (2023). Trauma therapies for psychosis: A state‐of‐the‐art review. Psychology and Psychotherapy: Theory, Research and Practice. https://doi.org/10.1111/papt.12499

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.

rendx8• 2 years ago

"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."

hn727742• 2 years ago

I lost a good friend to this. Hope it helps other people.

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.

hilux• 2 years ago

Same story here, more or less. Freshman roommate.

It's probably a common story.

112358132134556• 2 years ago

Oh man, I'm probably half schizophrenic, tried some antipsychotics at some point and had same reaction, and recently started to spend most my time outside (sleeping too), I found a nice spot. Fortunately I still have my remote developer job, and try to remain stable but I'm over sensitive and in the long run I can't sleep in my apartment (noise, smells - cigarette, here in France, it's horrible, maybe WIFI waves too). But isolation tends to makes me a bit more tolerant to people, I love birds and any really natural living being though

iaaan• 2 years ago

Just out of curiosity (no obligation to respond): how long have you been experiencing these difficulties? Have you always been sensitive to these things?

stndef2• 2 years ago

I'm not a professional, and I'm not diagnosing, but I am diagnosed autistic and I share some of what you're talking about here.

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!

heraldgeezer5• 2 years ago

maybe WIFI waves too

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.

FollowingTheDao4• 2 years ago

The meds helped him but he didn't like the side effects so he stopped taking them.

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.

shermantanktop• 2 years ago

It appears there is more suffering and misery out there than any single concerted effort could solve.

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.

rs999gti9• 2 years ago

The meds helped him but he didn't like the side effects so he stopped taking them.

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.

t0lo• 2 years ago

Does anyone else feel like this is just some sort of population control measure?

jacobjjacob• 2 years ago

No, what’s your rationale?

nucleardog• 2 years ago

The schizophrenics certainly do!

https://my.clevelandclinic.org/health/diseases/23348-paranoi...

codezero• 2 years ago

If you have ever known someone suffering from schizophrenia then you would know they are keen to not suffer from schizophrenia. The disease itself is a form of population control, as few who have this condition live a full natural lifespan. Since 2020 I lost two friends age 50 and 40. Both very high functioning people with college degrees who were never homeless.

hindsightbias• 2 years ago

They already have Chemtrails and TV for that.

sqeaky6• 2 years ago

"Netflix and chill" is surely a different take on "population control".

ndynan2• 2 years ago

https://www.sciencedirect.com/science/article/pii/S014067362...

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.

throwup2384• 2 years ago

From your linked paper:

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-...

ndynan2• 2 years ago

Thanks for the info - curious to look at these trials and see if there are sustained long term positive outcomes on the PANSS or these are just safety /tolerability studies.

bombi• 2 years ago

Schizophrenia can be cured with niacin (vitamin B3). Search for Adam Hoffer's achievements

the_gorilla• 2 years ago

Every single time someone has told me a disease could be cured with vitamins, it was scurvy or bullshit.

FollowingTheDao4• 2 years ago

Enzymatic cofactors (vitamins) many not a be cure, but maybe a better, cheaper, less harmful, treatment. Take pyridoxine (B6) as an example.

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_...

smolder2• 2 years ago

It's weird that you would state that so confidently when, as wikipedia says, "Hoffer's ideas about megavitamin therapy to treat mental illness are not accepted by the medical community." It didn't pan out.

niemal_dev8• 2 years ago

Didn't pan out because it's not the plan to pan out. The plan is to make people think there's something wrong with them and recycle them with insurance.

dailykoder• 2 years ago

RIP in peace Terry Davis. If you only had that :(

heraldgeezer5• 2 years ago

May he run over many CIA glowies in heaven <3

pcrh• 2 years ago

Nice to see!

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...

hackernewds2• 2 years ago

That's quite a handsome return. Which BMS feels empowered to do to since they can charge exorbitant amounts for it

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.

greenish_shore15• 2 years ago

Want to buy it cheaper? ALWAYS look for the molecule's CAS number in your search engine of choice.

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.

notQuiteEither• 2 years ago

You're suggesting to people that they should buy research use only chemicals and attempt to compound them at home? That is incredibly irresponsible and dangerous.

greenish_shore15• 2 years ago

If you don't trust people to compound a drug for their own use, why would you trust them to not jump off a bridge, to not kill or injure a passerby, or not to perform other serious antisocial actions? Of course this is a way deeper issue, but I tend to approach it this way. In the Western values, we tend to value freedom, also as freedom of people to self-define, very high, despite the risks it takes. And this, this is a modern part of exactly the same dilemma.

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.

xutopia• 2 years ago

1850$ a month at wholesale cost. That's prohibitively expensive and it could save lives.

ThinkBeat• 2 years ago

This reads like a happy clappy advertisement.

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.

smugma• 2 years ago

My read on the one reference to homelessness in the article was that a life-changing medication that can help with a disease like schizophrenia can prevent homelessness in the first place.

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.

2close4comfort• 2 years ago

After seeing how much they are going to charge for it, I am not sure if it will not cause more homelessness.

morserer• 2 years ago

That isn't how that works. That isn't how any of this works.

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...

[2] https://www.thewayhomehouston.org/

omegaworks• 2 years ago

A majority of homeless people do not have access to even basic healthcare.
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.

rs999gti9• 2 years ago

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.

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.

lazide• 2 years ago

Improperly supervised psychiatric patients are a nightmare, if for no other reason than they often don’t take the drugs that make them not a nightmare.

That means stand-alone housing just won’t work properly.

debacle• 2 years ago

"The only way to do this is to give the person a place to live."

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.

mik0n2• 2 years ago

New drugs are sorely needed

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).

rs999gti9• 2 years ago

Remove the stigma of mental illness and new drugs are not really needs. The current class of drugs are excellent at controlling psychosis.

Sure there are side effects, but in this case the side effects are better than the psychotic behavior and breakdown of the patients.

mik0n2• 2 years ago

Wouldn't it be better to have a drug with NO severe side effects, so we can actually get people to eat them? Which is exactly what they are trying to do. So many quit their meds, then wham another psychosis.

I just don't understand the negativity in this thread. They are doing gods work as far as I'm concerned.

BiggerComputer• 2 years ago

After things got weird I got taken out by an obese guy and other nurses. Woke up in a hospital, which turned out to be a very strange week, surrounded by clues that I was going to get killed. I was let go by agreeing to an injected medication administered every month. Years later I changed to Zyprexa pills. I don't even have a doctor yet I'm taking schizophrenia pills by intertia since my mom is programmed to continue that. When I cut the dosage in half I start feeling like exercising, moving more, right now I don't feel like moving. My brain feels like it's rotting, akin to the covid mind-fog reports. I don't feel pleasure or happiness. I'm in a constant state of anxiety and self-hatred. This thing is killing me and I part of me doesn't care since it's suicidal, enjoying the punishment. My guess is that eventually I get out of this since nothing is permanent and evil is a caricature.

FDA approves a novel drug for schizophrenia

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