[HN Gopher] FDA approves a novel drug for schizophrenia
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FDA approves a novel drug for schizophrenia
Author : tintinnabula
Score : 89 points
Date : 2024-09-29 18:02 UTC (4 hours ago)
(HTM) web link (www.washingtonpost.com)
(TXT) w3m dump (www.washingtonpost.com)
| RobotToaster wrote:
| It's this
| https://en.wikipedia.org/wiki/Xanomeline/trospium_chloride
| kstrauser wrote:
| > 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?
| therein wrote:
| Co-administration of an agonist and an antagonist for the same
| pharmacophore seems like an interesting approach.
| nwienert wrote:
| 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.
| swores wrote:
| Would the opposite (work in the brain but not the body)
| also be a healthier alternative for people addicted to
| getting high on opiates?
| johnisgood wrote:
| Yeah, because it is the high they are after, but not
| working in the brain would make opioids completely
| useless for depression and anxiety (for which it really
| does wonders).
| nwienert wrote:
| My want is for relieving pain in the body without making
| me feel high, I actually assumed you want it in the body
| not brain, as the brain effects are the feel-good
| effects, but really not sure or familiar with how they
| work.
| Scoundreller wrote:
| > I wanted sort of the opposite of this for opioids - work
| in the body, not the brain
|
| 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
| nwienert wrote:
| Yes but loperamide doesn't alleviate pain, which maybe
| just that opioids only alleviate pain if they do reach
| the brain, but I did see trials for non-bbb crossing ones
| that were for pain so not sure what's going on there.
| boingo wrote:
| https://archive.is/BYzWs
| KomoD wrote:
| > 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.
| givemeethekeys wrote:
| Didn't some bro from the pharma industry get mercilessly shat
| upon for charging so much for a life saving drug?
| the_sleaze_ wrote:
| 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.
| givemeethekeys wrote:
| How people feel about facts is much more important than the
| facts themselves.
|
| 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?
| desumeku wrote:
| 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 wrote:
| 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 wrote:
| 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 wrote:
| 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 wrote:
| > Game changer in treatment of disease we can't even define
|
| Doesn't quite have the same ring to it, now does it?
| fnordpiglet wrote:
| 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.
| mikhmha wrote:
| 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?
| rozab wrote:
| 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 wrote:
| 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 wrote:
| Readers hate this one trick, click to find out why!
| howard941 wrote:
| At $22.5K/yr it'll be more money changer than game changer.
| beautifulfreak wrote:
| "Double down" has a similar chart, another annoying phrase.
| unsupp0rted wrote:
| 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 wrote:
| Ok, we've unchanged the game in the title above.
| ck2 wrote:
| 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...
| johnisgood wrote:
| 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.
| devin wrote:
| What medication?
| crooked-v wrote:
| 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 wrote:
| 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.
| crooked-v wrote:
| The point of my comment, in response to its parent, is that
| people in the US are willing to support _immense_ amounts
| of money being spent on the homeless as long as it doesn 't
| involve housing anyone.
|
| 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.
| the_optimist wrote:
| 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?
| crooked-v wrote:
| In short, a couple of hundred square feet with decent
| temperatures, a sturdy lock, and basic facilities. I
| believe that the de facto illegalization of SROs in US
| cities is one of the more prominent factors when it comes
| to both invisibly and visibly homeless populations.
| NHQ wrote:
| 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.
| chiefalchemist wrote:
| 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/
| pjmorris wrote:
| > 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?
| thefounder wrote:
| 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 wrote:
| > in line with recouping R&D and production costs
|
| That's the "recouping R&D" part.
| jdietrich wrote:
| 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...
| cma wrote:
| 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.
| givemeethekeys wrote:
| How much of the record label's music production is funded by
| tax dollars?
| throwup238 wrote:
| David Bowie, Mick Jagger and Keith Richards, John Lennon
| and Paul McCartney. The list of musicians who were "on the
| dole" to support their music careers before they made it
| big is huge. It's almost a cliche at this point. And when
| they do make it big, their biggest concerts are usually
| held in stadiums that were heavily subsidized by tax
| payers.
|
| 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.
| cma wrote:
| That's fine but even considering that, is 20% only on
| successes enough to fund the rest of the portfolio that
| fails? And will it pass the risk free rate of return you
| can get from money markets or treasuries or whatever?
| s1artibartfast wrote:
| In what sense are you proposing pharma production is funded
| by tax dollars?
|
| Selling a product to the taxpayers is not the same as
| funding.
| cma wrote:
| Fundamental research is slants towards public
| institutions, advertising and the clinical trials are the
| main spending the drug companies do, though they have
| research too. Lots of acquiring university spinouts as
| well.
| pjmorris wrote:
| 'Bristol Myers Squibb executives say most eligible
| patients are covered by Medicare or Medicaid and wouldn't
| pay the list price.'
| throwup238 wrote:
| 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 wrote:
| 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
| imperio59 wrote:
| 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.)
| throw18376 wrote:
| 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-v wrote:
| > 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.
| catlikesshrimp wrote:
| Antibiotics (Most of the time) Everything surgery, I would
| include gene replacement therapy and auto transplants in its
| viccinity.
| Etheryte wrote:
| 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 wrote:
| > 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.
| toastau wrote:
| 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.
| catlikesshrimp wrote:
| 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/
| throw18376 wrote:
| 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.
| throwup238 wrote:
| _> 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.
| lukan wrote:
| "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 wrote:
| 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.
| throw18376 wrote:
| 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.
| lukan wrote:
| "drug addiction (but basically lucid and rational) "
|
| 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)
| throwaway0665 wrote:
| > What are "Novel" Drugs?
|
| > "Novel" drugs are new drugs never before approved or marketed
| in the U.S.
| rendx wrote:
| 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."
| throw18376 wrote:
| 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.
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