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haldujai
searching PlanetScale…
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271.
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haldujai
3y ago
> People are rightly highly suspicious of Big Pharma. Absolutely, but that should only trigger scrutiny which in this case would provide several answers for why this is a good thing and not a BigPharma scam. > efficacy over older chea
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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
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haldujai
3y ago
Good question, first thing to note is for FDA approvals adult is generally defined as 17 years of age. For the lack of pediatric indication, it's almost certainly because the clinical trials used 18-45 as the inclusion criteria. This i
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haldujai
3y ago
I'm glad to hear you're feeling great having received treatment and that you're hopefully now getting to enjoy time with your healthy son. On a personal and professional level I'm greatly appreciative of your decision to
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haldujai
3y ago
UpToDate is paywalled but here is a relevant excerpt for you on postpartum paternal depression which is a very real diagnosis: New fathers may develop depressive symptoms or disorders. Postpartum paternal depression can interfere with pate
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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/zurz
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haldujai
3y ago
> By going straight to medication Initial treatment recommendations: For mild to moderate postpartum unipolar major depression, we suggest psychotherapy as initial treatment. This approach is consistent with multiple practice guidelines
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haldujai
3y ago
It's claimed to but it's worth noting that supportive evidence doesn't exist, small albeit possibly underpowered RCTs suggests it does not and there are potential harms in doing so. This review article provides an overview fo
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haldujai
3y ago
It's shockingly true. I don't think any solid numbers are available on how common it is, but it at least appears to be relatively common in out of hospital births (and is becoming a trend). > This relatively modern phenomenon
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haldujai
3y ago
I'm not sure how to communicate this more clearly. I'll try one last time. My only question to you is this, you said: "The FDA mostly harms the population by not approving drugs fast enough." Do you have a source that sa
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haldujai
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. This is reminiscent of the Texas district judge
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haldujai
3y ago
The science behind the claims is being scientifically discussed and the preponderance of available evidence provide no experimental or theoretical support. We're separately discussing the author's credibility as the claims cannot
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haldujai
3y ago
Unless I'm missing something this is completely unrelated to and does not substantiate your argument that drug approvals are harming patients with the "mostly harming" argument implying more harm is being caused than prevente
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haldujai
3y ago
The only valid reaction to this news is "Wonderful, we have a new tool in the arsenal to treat a very difficult to treat and potentially serious illness." > It's deeply worrying the lack of support and proactive care new m
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haldujai
3y ago
It is entirely unethical to conduct lactation safety trials on children. It would also be a violation of HHS regulations for pediatric research which clearly state the research must be of minimal risk, not unknown, or present direct benefit
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haldujai
3y ago
Without getting into a philosophical discussion of whether ad hominem is ever appropriate. This is, in fact, the opposite of ad hominem. Ad hominem would suggest we are attacking the claim based solely on the author's credibility. In f
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haldujai
3y ago
For drugs approved between 2011 and 2015 the FDA approval time was a median 303 days, faster than the EMA at 369 days.[1] For drugs approved between 2000 and 2010 (for all 3 agencies, the FDA gets more applications) the FDA approval time wa
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haldujai
3y ago
It's already labelled for breastmilk excretion.
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haldujai
3y ago
> Of all the things that seem wrong with solving this with a pill Is this based on any experience (clinical or research) in postpartum depression or some philosophical objection? In case you were unaware of what severe postpartum depress
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haldujai
3y ago
> but such papers have never come under the scrutiny of peer review process as well. Except that such pre-prints far outnumber the supportive pre-prints, are from verifiable scientists at reputable institutions, are in agreement with ea
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haldujai
3y ago
> It is simply unwarranted ad-hominem When the authors/executives of a private research company are making fraudulent affiliation claims to established corporations and research universities it's actually very warranted to be d
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haldujai
3y ago
Strange, only seems to be happening to me on mobile. This should work: https://web.archive.org/web/20230808072418/https://explore.z...
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haldujai
3y ago
Do you have any idea on what the ballpark cost is to do these replication experiments I keep reading about? Or the more complicated experiments you mention? Asking out of curiosity as I would have assumed it's very expensive but there
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haldujai
3y ago
The BAA ( https://explore.zoom.us/docs/en-us/baa.html ) looks the same. Did you mean to the TOS (which is subject to change as has now happened twice)? The BAA still states: Zoom shall not Use and/or Disclose
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haldujai
3y ago
Got it. Apologies if it came across like I was questioning you, I'm just trying to understand the only part of this I potentially can (not the physics) and I'm clearly ignorant of how hosting works with SK providers. I couldn'
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haldujai
3y ago
Interesting, so that's the expected parking page for such a situation? I have no idea how web hosting works in SK and was going off this article, my interpretation was that this was changed after the traffic warning hence why I assumed
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haldujai
3y ago
Adding on to that: the researchers are from a private corporation that falsely claimed partnerships with several South Korean enterprises and universities which have all disavowed any connection, the "Quantum Energy Research Centre&quo
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haldujai
3y ago
Speaking of pinky promises: > We will not use ... protected health information, to train our artificial intelligence models without your consent. > We routinely enter into ... legally required business associate agreements (BAA) with
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haldujai
3y ago
You'd be surprised how often companies use PHI (legally) and healthcare provider networks don't care. The few with smarter lawyers and IT departments, usually academic, do but a majority of all of the new "AI" health tec
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haldujai
3y ago
Happy to help. Let me know where to send the invoice for my non-legal legal expertise, if your rate is anything like my startup's lawyer you'll find me a bargain! Haha.
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