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FDA Approves First Oral Treatment for Postpartum Depression

fda.gov

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Re: FDA Approves First Oral Treatment for Postpartum Depression

#31

> The primary endpoint of both studies was the change in depressive symptoms using the total score from the 17-item Hamilton depression rating scale (HAMD-17), measured at day 15. Patients in the Zurzuvae groups showed significantly more improvement in their symptoms compared to those in the placebo groups. Why would you mention the number of items on the scale, but not mention the number of points the drug gained? I…

On the 17 item HAM-D here are the typical score ranges [1]

Not depressed: 0–7 Mild (subthreshold): 8–13 Moderate (mild): 14–18 Severe (moderate): 19–22 Very severe (severe): >23

So, a 4 point difference vs placebo is what I would consider a "clinically significant" improvment, e.g. about the difference between mild vs. moderate, or moderate to severe.

https://en.wikipedia.org/wiki/Hamilton_Rating_Scale_for_Depr...

Re: FDA Approves First Oral Treatment for Postpartum Depression

#33
post #18

[flagged]

My wife is scared shitless of postpartum depression. People don't think of it as a problem because it's a "woman issue" and not a big deal. Coupled with the medical profession being notorious for discounting black womens' issues, I don't blame her for being scared.

We'll be first in line for getting the pill if she needs it.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#35

Earlier quoted context omitted.

Or , a helpful drug that helps people in a risky situation.

Likely far more of the former than the latter per medicine's track record in the last couple decades

>Likely far more of the former than the latter per medicine's track record in the last couple decades

I'd say that "medicine" has advanced quite a bit over the last few decades.

Five year survival rates for cancers are up 40%[0] since 1975.

AIDS treatments, when administered properly, extend the lives of infected persons by more than 500%[1] over those who don't receive such treatment.

Advances in orthopaedic (especially arthroscopic surgery) and spinal surgery have completely transformed the quality-of-life of numerous folks I know -- including myself.

And that's just a few things that "medicine" is getting right. How about developing and distributing a safe, effective vaccine for a a dangerous pathogen within a year of getting access to its genetic sequence, with several more to follow within 24 months?

While there certainly are problems in the US pharmaceutical industry/regulatory environment which have caused incalculable harm to millions, "medicine" is more than the rapacious, incompetent scumbags in Big Pharma.

However, the only way to reverse that is to fix the perverse incentives that rewards the singular pursuit of profit over the health and well-being of humans.

There are a variety of ways to attempt such fixes, but it won't be easy to pull off, as there's a lot of money behind these folks. And more's the pity.

But I'll say it again, "medicine" is more than just Big Pharma, insurance companies and healthcare conglomerates. Medicine has made our (mostly for those in the the "Global North", but also for many in the developing world too) lives demonstrably better in many, many ways.

[0] https://progressreport.cancer.gov/after/survival

[1] https://pubmed.ncbi.nlm.nih.gov/27349729/

Edit: Fixed subject/verb disagreement.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#36

[flagged]

Of all the things that seem wrong with solving this with a pill, I think this is the single most grotesquely negligent element of this approval.

Is the FDA immune from suits if this results in a generation of damaged kids? Was it so hard to say "oh..... It ends up in breast milk. We should compare the kids"? Even if it defers the approval by some years?

Re: FDA Approves First Oral Treatment for Postpartum Depression

#37
post #25
post #18

[flagged]

For 99.9999% of humanity's history, penicillin was "never needed". Antidepressant usage is universal throughout Europe. It makes more sense to treat postpartum depression, not less, because it's so likely to have a straightforward chemical cause. That's why there is an oral treatment specifically targeting it.

[flagged]

Re: FDA Approves First Oral Treatment for Postpartum Depression

#38
post #18

[flagged]

> In humanity's history it was never needed, but will be suddenly needed thereon.

Until like 1950s modern medicine was never "needed" but was "suddenly" needed. Last ~80 years is blip of blip merely a moment in human history yet few now would think medicine is not "needed". What humans "need" is tremendously more complicated than you imply.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#39
post #36

[flagged]

Of all the things that seem wrong with solving this with a pill, I think this is the single most grotesquely negligent element of this approval. Is the FDA immune from suits if this results in a generation of damaged kids? Was it so hard to say "oh..... It ends up in breast milk. We should compare the kids"? Even if it defers the approval by some years?

[flagged]

Re: FDA Approves First Oral Treatment for Postpartum Depression

#40
post #36

[flagged]

Of all the things that seem wrong with solving this with a pill, I think this is the single most grotesquely negligent element of this approval. Is the FDA immune from suits if this results in a generation of damaged kids? Was it so hard to say "oh..... It ends up in breast milk. We should compare the kids"? Even if it defers the approval by some years?

Yes the FDA is immune from all the harm id does the the population.
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