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It's insane to me that a group of educated and seemingly intelligent people seem to think they understand more about drug safety and prescribing than the FDA, r

It's insane to me that a group of educated and seemingly intelligent people seem to think they understand more about drug safety and prescribing than the FDA, researchers and physicians. This is reminiscent of the Texas district judge who decided to controversially overrule the FDA on a medication safety decision that recently made the news, not good company one wants to have and I'm hoping is coincidental than suggestive of similar biases.

warbeforepeace 3y ago
Its easy to figure out. Religion causes it.
- specialist 3y ago
  I no longer believe that's the root, or even the primary, cause. I keep thinking about Michael Crichton. He transmorphed from reality-based to nutter. What happened? Religion wasn't a factor. So what radicalized him? Historian Joanna Radin's theory, paraphrasing, is that Crichton's full faith and trust in The System was so completely shattered, by the Vietnam War and other outrages, that he completely flipped. The Speculative Present - How Michael Crichton Colonized the Future of Science and Technology https://www.journals.uchicago.edu/doi/epdf/10.1086/704047 https://www.journals.uchicago.edu/doi/epdf/10.1086/704047 The theme of the second season of Jill Lepore's The Last Archive podcast is about skepticism ("What fed Doubt?") S01E06 "It Came From Outer Space" includes the example of Crichton's radicalization. https://www.thelastarchive.com/season-2-episodes https://www.thelastarchive.com/season-2-episodes Lepore has completely opened up my mind about anti-science, conspiracy, and other social pathogens. Made me a bit more empathetic. Highest recommendation.
NoZebra120vClip 3y ago
[flagged]
- haldujai 3y ago
  What black box warning are you talking about? The only one I see for Zurzuvae is: "IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES"[1] [1]https://documents.sage-biogen.com/us/zurzuvae/pi.pdf https://documents.sage-biogen.com/us/zurzuvae/pi.pdf
  - caeril 3y ago
    I haven't yet read the clinical trial results, but suicidal ideation has turned out to be a shockingly common side-effect of many other types of anti-depressants. The comment was unnecessarily inflammatory, but the concern is reasonable.
  - NoZebra120vClip 3y ago
    My bad - not a black box in this case. Just a regular box. Sorry for the confusion.
    - haldujai 3y ago
      Black box (obsolete) and regular box are the same thing, they're simply called boxed warnings. In case you think this is semantics, boxed warnings are a determination by the FDA of a risk of adverse reaction so serious in proportion to the benefit of the drug it must be considered when assessing risks and benefits. The warning you are referring to is a regular warning which is used when there some evidence of a causal association but a causal relationship has not been definitively identified. In this specific instance it is based on an association of increased suicidality in a study looking at all antidepressants for all depressive indications and specifically in patients below the age of 25, not specific to this drug or drug class. This warning is accordingly present on all antidepressants. I won't go into the knowledge base behind this warning, its magnitude and variation between drugs but it is readily available online. Suffice it to say medical experts do not view the risk serious enough to merit a boxed warning and should the FDA have wanted to absolve themselves of blame as. you suggest it would be boxed.
- mtlmtlmtlmtl 3y ago
  Hey, you know what causes suicide more than anything else? Depression. Especially untreated depression. And no, cannabis is not a mental health panacea now matter how many times you claim it is. In fact it generally seems to worsen depression. Never have I been more depressed than when smoking daily. It's nothing but a crutch.
  - NoZebra120vClip 3y ago
    Charles Whitman received Valium, and he loved his Dexedrine. He brought along a goodly supply of Dexedrine when he climbed the clock tower at the University of Texas. The Columbine kids were well-medicated. Remarkably, despite their prescriptions, they were yet to be diagnosed with any mental illness. When you read about someone who committed crimes, or merely caused a police-involved disturbance, the media will often say that "they had a history of mental/behavioral issues", which means that they were likely taking psychotropic drugs at the time of the incident. Many people choose "suicide by cop" which has been notoriously easy to do. The FDA still grudgingly labels a few drugs with the "homicidal ideations" spiel, but not as many as they used to.
    - Moomoomoo309 3y ago
      The sample size is small enough that the correlation vs causation question still goes strong. You're arguing causation, the FDA argues correlation. Is it because they're taking the drugs, or because they're the type of person who would be taking those drugs and therefore have some kind of issue that needed help? It can be hard to know. Did they have these ideas or desires before taking the medication, or only after? If they are young, is it because of the meds, or because they're an angsty and hormonal teenager who has mental issues, or did the drugs exacerbate that? It's easy to say "look at all these very public cases where this bad thing happened, and they all have this in common!", but that doesn't tip the needle for correlation vs causation at all imo.
staticman2 3y ago
>>>"It's insane to me that a group of educated and seemingly intelligent people seem to think they understand more about drug safety and prescribing than the FDA, researchers and physicians." I'm currently on a psychiatrist prescribed drug which is illegal in Japan, which means I have to discontinue it before an upcoming trip. This is not a new drug, it's a generic. So is it "insane that a group of educated and seemingly intelligent doctors" in the U.S. are prescribing this drug or "insane that a group of educated and seemingly intelligent doctors" at the Japanese equivilent to the FDA are not authorizing this drug? I mean, it can't possibly be the case that neither group knows what it's doing, and that our scientific understanding of the brain is primitive, correct? One group has to be the insane one, right?
- afavour 3y ago
  I think there’s a meaningful difference there. A disagreement between two highly qualified groups of doctors seems valid. A disagreement between a group of highly qualified doctors and someone who did some research on the internet does not.
  - staticman2 3y ago
    "A disagreement between two highly qualified groups of doctors seems valid." Well... if we're talking psychiatrists, they choose the thing they wanted to be highly qualified in. So, any potential "expert" that would disagree with their research methods was selected out so as to not become an expert in the first place. I guess if I have a point it's that I don't think shouting "trust the science" or "trust the experts" and beating one's chest is contributing much to the conversation.
    - haldujai 3y ago
      What's insane is that seemingly intelligent people with zero medical training or research experience somehow think they have the capability to determine drug safety or whether a disease exists and merits treatment with pharmacotherapy. > So, any potential "expert" that would disagree with them was selected out so as to not become an expert in the first place. Anyone with some form of training or practical experience in an academic biomedical field (clinical or research) and has knowledge of how to synthesize and analyze evidence in order to make logical arguments may be considered a relevant expert, this is a much larger group than psychiatrists and is how FDA committees are constructed. Most notably this includes (and is not limited to) other physicians and providers, pharmacologists, pathologists, physiologists and epidemiologists. > I guess if I have a point it's that I don't think shouting "trust the science" or "trust the experts" and beating one's chest is contributing much to the conversation. One should absolutely "trust the experts" when it comes to determining safety of a therapeutic or definition of a disease. These are determined by scientific processes and debate based on evidence and not philosophical thoughts and feelings. Given how complex modern life is one has to defer to experts and regulators on many things beyond medicine. Some other examples: motor vehicles, aviation, building codes, financial institutions and encryption. > I'd also say that the more I've learned about psychiatry (including as a customer) the lower the opinion I have of it. The limitations in psychiatric medicine and research are widely acknowledged and not a novel insight that the FDA and medical community are ignorant of as many commenters here seem to believe.

warbeforepeace 3y ago

Its easy to figure out. Religion causes it.

specialist 3y ago
I no longer believe that's the root, or even the primary, cause. I keep thinking about Michael Crichton. He transmorphed from reality-based to nutter. What happened? Religion wasn't a factor. So what radicalized him? Historian Joanna Radin's theory, paraphrasing, is that Crichton's full faith and trust in The System was so completely shattered, by the Vietnam War and other outrages, that he completely flipped. The Speculative Present - How Michael Crichton Colonized the Future of Science and Technology https://www.journals.uchicago.edu/doi/epdf/10.1086/704047 https://www.journals.uchicago.edu/doi/epdf/10.1086/704047 The theme of the second season of Jill Lepore's The Last Archive podcast is about skepticism ("What fed Doubt?") S01E06 "It Came From Outer Space" includes the example of Crichton's radicalization. https://www.thelastarchive.com/season-2-episodes https://www.thelastarchive.com/season-2-episodes Lepore has completely opened up my mind about anti-science, conspiracy, and other social pathogens. Made me a bit more empathetic. Highest recommendation.

NoZebra120vClip 3y ago

[flagged]

haldujai 3y ago
What black box warning are you talking about? The only one I see for Zurzuvae is: "IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES"[1] [1]https://documents.sage-biogen.com/us/zurzuvae/pi.pdf https://documents.sage-biogen.com/us/zurzuvae/pi.pdf
- caeril 3y ago
  I haven't yet read the clinical trial results, but suicidal ideation has turned out to be a shockingly common side-effect of many other types of anti-depressants. The comment was unnecessarily inflammatory, but the concern is reasonable.
- NoZebra120vClip 3y ago
  My bad - not a black box in this case. Just a regular box. Sorry for the confusion.
  - haldujai 3y ago
    Black box (obsolete) and regular box are the same thing, they're simply called boxed warnings. In case you think this is semantics, boxed warnings are a determination by the FDA of a risk of adverse reaction so serious in proportion to the benefit of the drug it must be considered when assessing risks and benefits. The warning you are referring to is a regular warning which is used when there some evidence of a causal association but a causal relationship has not been definitively identified. In this specific instance it is based on an association of increased suicidality in a study looking at all antidepressants for all depressive indications and specifically in patients below the age of 25, not specific to this drug or drug class. This warning is accordingly present on all antidepressants. I won't go into the knowledge base behind this warning, its magnitude and variation between drugs but it is readily available online. Suffice it to say medical experts do not view the risk serious enough to merit a boxed warning and should the FDA have wanted to absolve themselves of blame as. you suggest it would be boxed.
mtlmtlmtlmtl 3y ago
Hey, you know what causes suicide more than anything else? Depression. Especially untreated depression. And no, cannabis is not a mental health panacea now matter how many times you claim it is. In fact it generally seems to worsen depression. Never have I been more depressed than when smoking daily. It's nothing but a crutch.
- NoZebra120vClip 3y ago
  Charles Whitman received Valium, and he loved his Dexedrine. He brought along a goodly supply of Dexedrine when he climbed the clock tower at the University of Texas. The Columbine kids were well-medicated. Remarkably, despite their prescriptions, they were yet to be diagnosed with any mental illness. When you read about someone who committed crimes, or merely caused a police-involved disturbance, the media will often say that "they had a history of mental/behavioral issues", which means that they were likely taking psychotropic drugs at the time of the incident. Many people choose "suicide by cop" which has been notoriously easy to do. The FDA still grudgingly labels a few drugs with the "homicidal ideations" spiel, but not as many as they used to.
  - Moomoomoo309 3y ago
    The sample size is small enough that the correlation vs causation question still goes strong. You're arguing causation, the FDA argues correlation. Is it because they're taking the drugs, or because they're the type of person who would be taking those drugs and therefore have some kind of issue that needed help? It can be hard to know. Did they have these ideas or desires before taking the medication, or only after? If they are young, is it because of the meds, or because they're an angsty and hormonal teenager who has mental issues, or did the drugs exacerbate that? It's easy to say "look at all these very public cases where this bad thing happened, and they all have this in common!", but that doesn't tip the needle for correlation vs causation at all imo.

staticman2 3y ago

>>>"It's insane to me that a group of educated and seemingly intelligent people seem to think they understand more about drug safety and prescribing than the FDA, researchers and physicians." I'm currently on a psychiatrist prescribed drug which is illegal in Japan, which means I have to discontinue it before an upcoming trip. This is not a new drug, it's a generic. So is it "insane that a group of educated and seemingly intelligent doctors" in the U.S. are prescribing this drug or "insane that a group of educated and seemingly intelligent doctors" at the Japanese equivilent to the FDA are not authorizing this drug? I mean, it can't possibly be the case that neither group knows what it's doing, and that our scientific understanding of the brain is primitive, correct? One group has to be the insane one, right?

afavour 3y ago
I think there’s a meaningful difference there. A disagreement between two highly qualified groups of doctors seems valid. A disagreement between a group of highly qualified doctors and someone who did some research on the internet does not.
- staticman2 3y ago
  "A disagreement between two highly qualified groups of doctors seems valid." Well... if we're talking psychiatrists, they choose the thing they wanted to be highly qualified in. So, any potential "expert" that would disagree with their research methods was selected out so as to not become an expert in the first place. I guess if I have a point it's that I don't think shouting "trust the science" or "trust the experts" and beating one's chest is contributing much to the conversation.
  - haldujai 3y ago
    What's insane is that seemingly intelligent people with zero medical training or research experience somehow think they have the capability to determine drug safety or whether a disease exists and merits treatment with pharmacotherapy. > So, any potential "expert" that would disagree with them was selected out so as to not become an expert in the first place. Anyone with some form of training or practical experience in an academic biomedical field (clinical or research) and has knowledge of how to synthesize and analyze evidence in order to make logical arguments may be considered a relevant expert, this is a much larger group than psychiatrists and is how FDA committees are constructed. Most notably this includes (and is not limited to) other physicians and providers, pharmacologists, pathologists, physiologists and epidemiologists. > I guess if I have a point it's that I don't think shouting "trust the science" or "trust the experts" and beating one's chest is contributing much to the conversation. One should absolutely "trust the experts" when it comes to determining safety of a therapeutic or definition of a disease. These are determined by scientific processes and debate based on evidence and not philosophical thoughts and feelings. Given how complex modern life is one has to defer to experts and regulators on many things beyond medicine. Some other examples: motor vehicles, aviation, building codes, financial institutions and encryption. > I'd also say that the more I've learned about psychiatry (including as a customer) the lower the opinion I have of it. The limitations in psychiatric medicine and research are widely acknowledged and not a novel insight that the FDA and medical community are ignorant of as many commenters here seem to believe.