America's FDA Approves First New Drug for Schizophrenia in Over 30 Years (go.com) 65
Thursday America's Food and Drug Administration approved Cobenfy, "the first new drug to treat people with schizophrenia in more than 30 years," reports ABC News:
Most schizophrenia medications, broadly known as antipsychotics, work by changing dopamine levels, a brain chemical that affects mood, motivation, and thinking [according to Jelena Kunovac, MD, a board-certified psychiatrist and adjunct assistant professor at the University of Nevada, Las Vegas, in the Department of Psychiatry]. Cobenfy takes a different approach by adjusting acetylcholine, another brain chemical that aids memory, learning and attention, she said. By focusing on acetylcholine instead of dopamine, Cobenfy may reduce schizophrenia symptoms while avoiding common side effects like weight gain, drowsiness and movement disorders, clinical trials suggest. These side effects often become so severe and unpleasant that, in some studies mirroring real-world challenges, many patients stopped treatment within 18 months of starting it.
In clinical trials, only 6% of patients stopped taking Cobenfy due to side effects, noted Dr. Samit Hirawat, chief medical officer at Bristol Myers Squibb. "That's a significant improvement over the 20-30% seen with older antipsychotic drugs," he added...
Schizophrenia is a mental health disorder that affects about 24 million people worldwide, or roughly one in 300 people, according to the World Health Organization.
"Studies for additional therapeutic uses, including the treatment of Alzheimer's disease and bipolar disorder, are also underway."
In clinical trials, only 6% of patients stopped taking Cobenfy due to side effects, noted Dr. Samit Hirawat, chief medical officer at Bristol Myers Squibb. "That's a significant improvement over the 20-30% seen with older antipsychotic drugs," he added...
Schizophrenia is a mental health disorder that affects about 24 million people worldwide, or roughly one in 300 people, according to the World Health Organization.
"Studies for additional therapeutic uses, including the treatment of Alzheimer's disease and bipolar disorder, are also underway."
The regulators (Score:2)
The regulatory agency was of two minds about it.
Schizophrenia drugs amaze me (Score:3, Interesting)
How a drug can control symptoms that very much appear to be a failure of hemisphere coordination, I don't know. But it's nice for schizophrenics to have another option to try that might not leave them like zombies.
And as a member of the public, I really like NOT having people around who can't tell the difference between reality and their imaginations. I know the vast majority of them aren't dangerous... but I can't tell from simple short term observation so people with weird ticks talking to themselves scare the crap out of me (unless it's obviously Tourette's). I've had a couple of experiences with afflicted individuals that were not of the benign variety.
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Fundamentals of the DSM (Score:5, Insightful)
The whole field of psychology, as it exists today, is a pseudoscience and the DSM is complete BS. DSM just lumps together a bunch of behaviors together and calls them some mental "disorder." Go to two different psychologists and you'll get two different diagnoses.
This was a criticism of the original DSM; specifically, that two doctors seeing one patient would disagree on the diagnosis. Newer versions have attempted to correct this problem.
I'm not sure you can state that psychology is a pseudoscience. You start with the definition of a pathology, which states in essence that the condition is so severe as to prevent a person from proper functioning in life. For example, everyone gets angry now and then, it's considered normal. If you get angry all the time and it prevents you from entering into relationships, we consider that a problem and look for a cure.
The original DSM listed homosexuality as a pathology. Nowadays we have reexamined that position and realized that it does not affect one's ability to have a life in society, so that particular pathology was removed.
Also, psychology has some notable successes. For example, panic attacks can be cured in a single session, phobias can be successfully cured, and we can turn down the volume on past traumatic experiences. For example in the case of phobias, we've tried different methods and identified the ones that work and discarded the ones that don't: exposure therapy doesn't work, but progressive exposure by patient choice *does* work: the difference being whether it's done by patient choice or not.
Where psychiatry falls it falls down badly, and these are the ones that make the news. Is drug addiction a pathology? Psychiatric care worsens the outcome of drug addiction treatment. Is the patient schizophrenic? Psychiatric care doesn't know what causes this, drugs are probably masking symptoms and not addressing the base problem, and there's an enormous market for expensive drugs that don't cure and have to be taken for the rest of your life.
Saying "the whole field of psychiatry" is painting the field with too broad a brush.
Psychiatry has some successes, it just doesn't cover everything just yet.
Re:Fundamentals of the DSM (Score:4, Interesting)
Back around the turn of the century, I had a girlfriend who was in the psych program at a major university. I was living with her and they'd have symposia where people would present their papers, which I attended. At this school, the medical study of the brain as an organ was in the same department as what we would more properly call psychology. So you heard papers being presented on both subjects.
The brain study papers were interesting and sounded very medical. They made no claims that were unsupported by evidence. I was thoroughly impressed by them. I'm a geek so that probably was why.
The psychology papers were mostly composed of studies with data derived from questionnaires. I have a little bit of a background in polling, and when I read these questionnaires, it was obvious in many/most that the people in the program hadn't had that same basic background in avoiding leading questions. Made me wonder about the faculty advisors that didn't correct this stuff before it polluted their studies. Perhaps the faculty themselves didn't understand that their data was impacted by their poor choices in verbiage.
I'm not going to go as far as to say it's a pseudoscience, but I do think that study replication is as least a big of an issue here as it is elsewhere. A lot of garbage data, in other words.
DSM (Score:1)
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I'm not sure you can state that psychology is a pseudoscience.
Replicability/Reproducibility. Without it - you have pseudoscience.
That and the fact the DSM grows by 1000%, (complete exaggeration), year-on-year instead of admitting that there is no such thing as a "sane mind". Every mind is broken in its own unique way and to compare any two is ... insane.
But mostly replicability. Mind is stupidly complex and made even more so by the fact that so is brain.
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Newer versions have attempted to correct this problem.
It can't be corrected. A new approach is needed.
The original DSM listed homosexuality as a pathology.
It's a coping mechanism for feeling emasculated/defeminized.
Saying "the whole field of psychiatry" is painting the field with too broad a brush.
Hardly. Once you understand the underlying causes, everything makes sense and becomes easy. As alwa
Re:Non-political post (Score:5, Insightful)
But thanks for claiming you wanted a nonpolitical discussion about misinformation where you bemoan people misleading others and insert your own misleading political pot shot.
Re: Non-political post (Score:1)
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I don't think they created anything. I think they put pen to paper and wrote down what had been an assumption all these years. Nixon's people had believed this to be true (based on their court filings) back in 1973-74 and it was never put to the test since the Congress of the time was prepared to impeach and convict him. Ditto with Andrew Johnson back after the Civil War. In this polarized environment where impeachment happened but never a conviction, the actual nature of sovereign (presidential) immuni
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>I'd like to make an attempt to put this discussion into a non-political frame.
By hijacking a thread about mental illness and making it totally and unnecessarily political.
Jesus. Fucking. Christ.
If you have to start your post with deceit do you really think anyone will give a shit about the rest of it?
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And with lots of folks wearing not-obvious earbuds, I increasingly get the feeling that I'm surrounded by schizos!
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There is a fine line between genius and insanity.
Price (Score:1)
Re:Price (Score:5, Insightful)
That's a lot, BUT, the public cost for someone with uncontrolled schizophrenia can be much higher -- homelessness, crime (or being a victim of crime) and potential incarceration sadly, time in courts, social service involvement, lost work and productivity (many with the disorder can indeed work). I'm not dismissing that it's not cheap, but IF it works and alleviates a lot of other issues, it's actually cheaper.
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This is also a good argument for making these drugs free to the end user, and paid for by tax money. It's an investment that would save tax payer money by reducing other public costs.
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Knowing the US, the argument from taxpayers or legislators would be more along the lines of "I don't want my tax money spent on those people!", with the implicit message being that "those people" are undeserving. Never mind that taxpayers (and society in general) already spend a lot more than that in other ways ($50-100k/yr to incarcerate someone, $40-80k/yr for renal dial
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Sorry, we were talking about medications for schizophrenia and obesity. Are you suggestion those don't exist among Americans?
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Why bother spending a billion dollars to invent a new drug if you can't make a reasonable profit on it?
It sounds like $19.95 is at least the reasonable profit price point. Or the drug makers would just tell the likes of Canada, Mexico, the EU and others that this drug is not available there. You don't expect them to sell for a loss, do you?
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Well then, they can sell at a loss here too.
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Don’t worry. You’ll be able to fill the prescription in Canada or Mexico for $19.95.
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That's all that matters really, cheap drugs don't get tested.
Hell, Lithium alone probably works better but you'll never get a trial to prove it.
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That's all that matters really, cheap drugs don't get tested.
Hell, Lithium alone probably works better but you'll never get a trial to prove it.
Lithium works well for many people, which is why it's one of the oldest drugs. But - it doesn't work well enough for everybody, and it can have nasty side effects.
We don't know why some meds work for some people and not for others. For most psychiatric illnesses, the state of our knowledge is probably around where our knowledge of TB was before we understood bacteria.
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I thought lithium was largely for stabilizing mood swings, like in bipolar. I know the overlap between bipolar and schizophrenia is substantial, but I don't know of evidence that lithium is a good first-line drug for schizophrenia alone. It's been around a long time - longer than antipsychotics - so I expect that if it had benefit, we would know about it.
Re: Price (Score:1)
Are you feeling OK? (Score:2)
I Have to Admit (Score:5, Funny)
A question (Score:2)
This drug seems to work through simulating the effects of Muscarine, which is an alkaloid found in some mushrooms, notably the fly agaric, which is known to have some psychedelic properties (Caribou deer are known to actively search for these shrooms and ingest them, and get high in the process; some natives collect Caribou urine and get high in turn by drinking it).
The question is: Can Schizophrenia be treated by eating these shrooms instead of giving $$$$$ to the pharma industry?
Re: A question (Score:2)
Did you read the question carefully? I didn't suggest that psychedelic mushrooms might treat Schizophrenia, I only asked could it be so provided that the new expensive drug just simulates the shrooms' action by binding to the same receptors etc. Your question might be valid, but you should ask it the pharma company and the FDA, not me.
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I suspect if that was a possibility, they'd have figured it out by now.
Regardless, Muscarine is super dangerous, and the last person I'd be trusting to dose themselves with something whos medical and toxic levels are so close would be someone with a medically broken grasp on reality. It'd never pass the FDA, not because of any spooky pharma $$$ thing, but because the FDA is not in the habit of permitting actual poisons as medicines
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Yes, you are probably right. However, one of the new drug's components, Trospium, seems to be a specific antidote for Muscarine. Plus, it apparently can't enter the brain, so it won't interfere with Muscarine's therapeutic action. And the best thing is that it's an old drug with expired patent, so it can be generic and cheap. So, just use shrooms with Trospium and S is gone /s
I can tell from reading the comments so far... (Score:4, Insightful)
I've dealt with 2 family members with schizophenia in different generations.
None of this is a laughing matter. Lives and familes are destroyed by this
Any hope of a drug that could help is welcome to anyone who live with these realities.
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That no one commenting here knows anything about the realities of schizophrenia. I've dealt with 2 family members with schizophenia in different generations. None of this is a laughing matter. Lives and familes are destroyed by this ... condition.
Any hope of a drug that could help is welcome to anyone who live with these realities.
Amen.
Re: I can tell from reading the comments so far... (Score:1)
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Would you make cheap jokes about cancer? If not, then maybe think twice about mental illness.
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I mean...are they funny jokes? Sometimes, when confronting something as devastating and implacable as cancer (or schizophrenia) - comedy can be pretty damn useful.
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I mean...are they funny jokes? Sometimes, when confronting something as devastating and implacable as cancer (or schizophrenia) - comedy can be pretty damn useful.
Agreed. But before making the joke about mental illness, think of whether you would make the same joke about cancer.
And don't make the joke if you are not coming from a place of love and support. (See original post).
Good news (Score:2)
The voices in my head approve of this
Side note (Score:2)
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This is good news (Score:2)
The go to drug ( clozapine) has been around for 80 years and has some major side effects, most noticeably nuking a patients WBC count.
Re: This is good news (Score:2)
aids memory, learning and attention? (Score:2)
Does it improve or diminish "memory, learning and attention" in normal people? If it improves those qualities, what can it do for those of us with moderate ADD or will normies start taking it to get smart?
huge news (Score:1)