Since every top level comment here is a borderline tire fire, let me be the first to say:
This is great news. We need better treatments for PPD, which is real and very serious that can cause long term lasting effects in serious cases without treatment, and can sadly even be fatal.
Quality of life has risen steeply over the past several decades but mothers still walk an unpaved road. It's deeply worrying the lack of support and proactive care new mothers receive from medical professionals, though it is getting better, just very slowly.
I hope this helps many new families survive and thrive.
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 mothers receive from medical professionals, though it is getting better, just very slowly.
Agree, I don't treat or interact with PPD patients in my professional practice but my closest friend is an OBGYN and we've had many discussions about this over the years.
At least in most academic practices all patients are provided with education during the later stages of pregnancy and prior to discharge postpartum with typically one routine follow-up visit planned.
It's better than when I was a medical student but it seems a significant gap still exists between that and transitioning back to the patient's primary care provider who also tend to be more heterogenous in availability and knowledgeability about PPD.
People are rightly highly suspicious of Big Pharma.
I like the idea of a novel class but I won't pay attention to this new, expensive drug until it proves significant efficacy over older cheaper drugs (like Alprazolam and Zolpidem/Zopiclone).
Technically it's a Z-drug (like Zolpidem/Ambien) which are non-benzodiazapine positive allosteric modulators of GABA_A
However, since it's a neurosteroid most will probably not think of it as such. (It's name does begin with Z though... And end in -one like a steroid).[Note below]
Anyways, it's licensed for 2 weeks only, side effects are drowsiness, sleepiness and cognitive impairment. You mustn't drive within 12 hours of a dose.
It's best effects are where the depression is associated with insomnia and anxiety.
It was compared to placebo not Alprazolam (Xanax) which has some antidepressant activity. That's just how you seek market Auth when nothing else is licensed. That's just smart.
But you have a GABA agonist you must only use for the short term with primary anxiolytic and hypnotic effects. That will be widely used because otherwise you need off license script and will likely put even more people on the path to SSRI.
[0] this is a reckless insightless cognitive impairment think Roseanne Bar racist tweet.
> 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 cheaper drugs (like Alprazolam and Zolpidem/Zopiclone).
This drug, and the IV formulation it is based on (Zulresso), are not the same as and have different mechanisms from sedative-hypnotics which as an aside are not indicated as monotherapy for PPD (or any depression, don't give a downer to someone down). The mainstay of treatment is SSRIs.
This class (which is the only FDA approved drug class for PPD) is an analogue of the endogenously produced metabolite of progesterone and the mechanism is not fully understood.
To your point of head to head trials, you are correct they do not exist at this time and will eventually be done however all of these are still new.
What we have right now are indirect comparative analyses which while limited show stronger magnitude effects than SSRIs.
> But the network meta analysis did not show zuranolone beating placebo due to wide effect size.
It did not, using 1 of the studies, but my optimism is that the drug it was based on (brexanolone) was significant and is unfortunately only available IV (so difficult to access and expensive), so the hope is that this will play out similarly and why I feel is sufficient reason to give Big Pharma the benefit of the doubt that this isn't purely a money making play.
> Alprazolam beats SSRI for depression with significant anxiety and insomnia with faster onset but treatment must be time limited.
Sure, for anxiety-predominant scenarios but as you're alluding to there are significant dependence and abuse risks and hence why they're used as adjuncts.
If this turns out to work in the same pathway but safer that would be a huge win. If it turns out to work in the same pathway but not safer than non-benzo sedatives then you're right it's a scam. With that said:
> That's uncanny to me esp as both are PAM for GabaA
My clinical pharmaceutical resource lists mechanism not fully known. This is getting outside of my comfort zone to comment on validity or fully understand but this editorial (citing for my own accessibility) suggests a different mechanism from benzodiazepines:
Antonoudiou et al. (6) offer key insights into the potential mechanisms of rapid affective switching following brexanolone treatment of postpartum depression, despite the use of male subjects for all the studies. The remarkable discoveries include the parallels in human and rodent brain network dynamics associated with depression that are responsive to GABAergic analogs of allopregnanolone, the role of δ-subunit–containing receptors in some of these effects in mice, and the lack of effect of benzodiazepines on the electroencephalographic network dynamics, consistent with the lack of antidepressant efficacy of these compounds.
It’s supposed to be an oral version of Allopregnanolone. I’d definitely be a little bit more comfortable with it than with zolpiderm, which we tried to transition everyone off of if possible.
Thank you. I'll never understand why there's such a dominance of luddite thinking, bad takes and conspiracy theories on HN, when it comes to the topic of mental health. Especially when it comes to drug treatments.
Psychiatry no doubt has a lot of problems with it. But it's also the only game in town for a huge amount of people. What's the alternative? Prayer circles? Ayahuasca tourist traps? Cannabis? Homeopathy? Give me a break. Conventional medicine has always been imperfect, and has always improved over time. That's no less true of psychiatry than any other subfield. Whatever "alternative" therapies are truly effective tend to be incorporated into it eventually. In psychiatry we've seen this with meditation, and we're seeing it now with psychedelics.
> I'll never understand why there's such a dominance of luddite thinking, bad takes and conspiracy theories on HN, when it comes to the topic of mental health
I imagine there are many professional forums filled with people who know topic X inside out therefore assume they must also be an authority on unrelated topics Y and Z. But I also suspect there’s something about software engineering, perhaps the ability to succeed despite being deeply antisocial, or being very male dominated that means women’s mental health in particular is always going to be a dumpster fire discussion topic.
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.
>>>"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?
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.
"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.
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.
>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.
One might expect someone who acknowledges the limits of psychiatry wouldn't be chest beating so aggressively about the greatness of the scientific process.
One might also expect a person concerned with mental health issues wouldn't throw around the term "insane" so casually.
>These are determined by scientific processes and debate based on evidence and not philosophical thoughts and feelings.
Who needs philosophy? Just have faith, am I right? That's what science is all about. What do we mean by science? Don't ask that kind of philosophical question. Just have faith.
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 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.
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.
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.
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.
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.
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.
It’s very easy to explain. By going straight to medication you are treating the symptom not the cause. And you don’t even know if it works.
SSRIs don’t work for many people and we only found out 2-3 years ago.
Opioids were prescribed to half of America for back pain.
That gives scope for healthy scepticisms at least. Just because you might have some anecdotal evidence of some chemicals working, doesn’t mean it works for others or that it leads to a good place.
Lastly - there are clearly lifestyle and even moral choices that people make or don’t make that can lead to mental health issues. Just from a common sense perspective it seems much healthier to try and deal with these first, with therapy, than just medicating. And not just therapy. Exercise, diet. We know these affect mental health, yet pills are easy, and they make doctors money.
medicating is much easier than searching, finding and healing the cause. Therapy takes years, if not decades. I can understand why people pick the easier route, but easier is not always better. Also, are you just permanently going to be on pills then? I mean it’s a great subscription business, I can see that.
It's not some earth shattering revelation that "SSRIs don't work for many people". This has been known since SSRIs first appeared on the scene. This is also true of any other treatment you can think of. The reason they became the first choice as far as antidepressants go is they were a lot safer and better tolerated than the older alternatives. Besides, there's a lot more to psychiatry than just SSRIs. But with people like you it's always about SSRIs. Can't shut up about the SSRIs. If you hadn't noticed, this new drug is not an SSRI!
Psychiatrists recommend therapy, they recommend changes in diet and they recommend exercise. Clinical psychology, though technically a separate discipline from psychiatry, not being under the umbrella of medicine, is very much developed, researched and practiced in tandem and cooperation withpsychiatry, and vice versa.
You're constructing an elaborate strawman here, where the only reason for using drugs is some evil financial motive. It's just not that simple. There bad apples, and perverse incentives, but not only bad apples. Most doctors do in fact care about helping their patients.
Therapy can't fix everything. Therapy alone is not always sufficient and can be just as hit and miss as medication. Not everything is some deep personal issue that needs to be analysed and resolved. Mental disorder is often genetic, even neurological in nature. All the therapy in the world won't stop a bipolar person from cycling between mood disturbances, or someone with ADHD from being unable to concentrate.
We can't throw the baby out with the bathwater. Medication, therapy, meditation, diet, exercise, sleep hygiene are all part of the psychiatric toolbox.
I agree with you, but what we are arguing about is how much, and when?
Looking at how many people are medicating for mental health issues in the west (or world), I find it extremely unlikely this is because all these people have gone through therapy, exercise and diet and they have to take medication.
No. It’s the easy route to some sort of medicated happiness, and it’s profitable, so everyone does it.
But this many people shouldn’t be doing it. They shouldn’t be taking the easy route, because it’s not dealing with many issues we should be dealing with, as society and as individuals.
This particular drug is about post partum depression. Sleep deprived women, often functioning as milk machines, while experiencing major hormonal changes and possibly recovering from major abdominal surgery. These are not people “taking the easy route”. Save the bootstraps talk for other patients.
Sorry, but no. I have two children. I as a father probably had mild PPD, and so did my wife after our second child.
You know why my wife had PPD? Because being a mother is hard, and she also had a lot of unresolved anger and issues towards her own mother, and she was reminding herself of her own mother and causing quite a bit of anxiety. We were also at an extremely difficult part of our relationship, we basically hated each other for a year.
What did we do? We both went to therapy, and asked the hard questions about why this was happening, and how to resolve them. My wife spent 6 months in therapy and resolved the issues with her mother, and now she is happy with her own performance as a mother. We went to couples therapy, which was extremely hard, but after over a year, we are basically in love again, and we are STARTING to understand what patterns are causing our issues, and how to deal with them.
We took no medication. But we were on the road to depression, but decided to actually look behind WHY this was happening.
Popping pills of course is much easier. You don't need to face your demons, or your parent's demons.
The trouble is it is at crucial times in life like childbirth when these demons emerge. Yet hardly anyone wants to face them anymore. This is not mentally healthy. And what's even worse, you are very likely to pass on many of these issues to your children if they remain unresolved.
I know this is counter to 70% of what americans believe in, but it's the hard truth, and I think many people deep down know this is the truth, but it's just much easier to take pills and bury the fact that EVERYONE has mental issues that need resolving, without taking medication.
I'm not talking about the extreme cases btw. I know in some instances medication is necessary. But it is WAY overused, to get out of making hard choices.
The resources to send everybody to therapy simply don’t exist. There aren’t enough therapists, nor money to pay them, for what you are suggesting. People aren’t taking the easy way out, they are taking the only path available.
As GP may be aware therapy is recommended first-line either in isolation or combination with pharmacotherapy for every type of depression.
To further illustrate the accessibility point when I lived in Canada therapy was not covered by the public health system and is entirely out of pocket.
In the US it obviously depends on the highly variable coinsurance/copay and assumes you can either take time off work or find a provider that works outside of business hours.
A 30-day supply of Lexapro is $4.50 and also has evidence that it works.
Different people have different experiences. Some people don't experience PPD or PPA at all. For many people PPD and/or PPA are significantly harder than what you experienced, and for a tragically high number it can be fatal for them and sometimes for others, including children and other family members.
You and your spouse have had your experiences which are completely valid and true. Your truth does not invalidate others' truth. This medicine is for them, not you.
However your experience seems to prevent you from seeing the bigger picture.
"Popping pills" is probably chosen not because people don't want to solve problems and change their lives. It is probably because it is only available solution at that time to actually function as a person and member of the society.
It is great that you had money and event time to go to therapy for 6 months as new parents. A lot of parents of newborns will simply not be able to afford it both financially and because of time constrains. Did you bring your new born to the therapy? How much did it cost? Would every single mother be able to afford 6 months of therapy? Some middle-lower class family? Some family in very rural area? Please try to see a bigger picture here and befriend more people from different paths of life.
People take pain medication for back pain not because they don't want to fix their backs. If anybody could fix their back today instead of taking pills they would do it.
It's not the "easy route". It's a route that _works_.
Saying it's "medicated happiness" is ridiculous fearmongering. Antidepressants do not make you happy. They do not change how you think or how you act. They can't. If you think they do, you do not know what you're talking about.
> SSRIs don’t work for many people and we only found out 2-3 years ago.
If you only found out 2-3 years ago that SSRIs don't work for many people that's decidedly a you-problem. Psychiatry has known this for ages, which is one of the reasons that depression treatment is still tricky. You have to try what works for each person individually. And usually it's a combination of things.
For mild to moderate postpartum unipolar major depression, we suggest psychotherapy as initial treatment. This approach is consistent with multiple practice guidelines, and is especially useful for lactating patients who do not want to expose their infants to antidepressants.
However, antidepressants (eg, selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors, bupropion, and mirtazapine) are a reasonable alternative if psychotherapy is not available, not successful, or is declined, or if the patient has previously responded to antidepressants.
In addition, combination treatment with pharmacotherapy plus psychotherapy is useful for some patients.
Source: UpToDate.
> And you don’t even know if it works.
While evidence for SSRIs is weak in meta-analyses this is not one of them. I will also agree that a single trial (i.e. the original post and what led to approval) is not definitive but does in fact suggest it works and will continue to be assessed in post-market studies.
Shit, I needed SSRIs before I was in any way capable of processing and dealing with my internal issues. I wasted a decade before giving in and trying the SSRI route and I regret not doing it sooner. It would've saved me and my loved ones a lot of suffering.
>What's the alternative? Prayer circles? Ayahuasca tourist traps? Cannabis? Homeopathy? Give me a break.
PPD aside, if we're talking about the issues that psychiatry seeks to alleviate, every one of those 'solutions' has had thousands of advocates/adherents/patients that claim to have gained positive effect.
and before I get considered a proponent of any of those; i'm not -- but I recognize the cohort of people who claim to have gained benefit just as I recognize the group who claim to have benefited from psychiatry.
mental health needs not be a monopoly; many people go through issues that they fix through specific personal events or patterns that are specific only to them.
You can complain about the style of thinking that you encounter on HN without disparaging the things that have helped people outside of clinical settings.
Mental health and well-being is one of the most mysterious things that we study, if a suicide or otherwise bad decision is staved off by chanting in makeup and visiting exotic locations then so be it, that's what worked for them.
And another aside : psychiatry will never incorporate extreme things that may help certain individuals, nor should they -- but that means that the breadth of things that are helpful is greater than the breadth of things that will ever fall within the umbrella of clinical mental health; so you should probably hold off on judging things based on whether or not the industry has adopted them.
This is completely and utterly wrong. Psychiatric treatment varies in effectiveness, but there are drugs like lithium which have a fast and marked effect on the diseases they treat (e.g. Bipolar disorder, a crippling illness if left untreated). Depression drugs are less effective overall than other psychiatric illnesses, but even these have proven clinical effects in huge double-blind trials.
You really should read up on the literature, or hang around some people with serious mental health problems before spewing such garbage.
actually, where I live people used to live in multi-generational homes, where first time mothers had already had the chance to be trained on maternity from a young age by watching their sisters, wives of their brothers, sisters of their parents etc... also by having a chance of taking care of children younger than them including babies, all of this being group activities where girls get to collaborate, so highly educative. I'd argue parenting and maternity was not a problem in that lost society (although there were other problems)
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 for the curious.
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 is practiced predominantly by white, middle class, married women in the global North, and has grown rapidly since the 1970s
> Whilst prevalence is difficult to estimate, placentophagy is known to be practiced in North America, Oceania and Europe, plus parts of Latin America, the Middle East and Asia and is apparently growing in popularity. In a 2018 study of a medical records dataset for births outside of hospitals containing 23,242 birth events in the United States, 30.8% of mothers consumed their placenta. From 2009 to 2015 Google searches for “placenta encapsulation” increased 100-fold.
I don't normally like to talk about matters this personal in a forum like this—especially given that I use my real name as my username here, but if it ends up helping one person then I think it'll be worth it.
My son was born a little over 9 months ago. He's healthy, delightful, and utterly normal—and yet I, his father, still ended up with postpartum depression. I think it's underreported and under-appreciated that fathers can also have serious postpartum mental health issues.
I've been taking Lexapro since January to manage the symptoms, predominantly anxiety, and feel great from it. I haven't experienced any noticeable side-effects that you might normally associate with SSRIs, and I'm incredibly grateful that I was in a position to start taking it.
New dads: if you feel unusually down, anxious, frustrated, angry, or depressed, consider talking to your PCP about treatment. Taking medication is not an admission of failure. Being a father is tough, but it shouldn't feel impossible.
edit: see my replies for exactly why I don't like discussing this.
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 share your experience and contribute to the destigmatization and increased awareness of male mental health despite anticipating attacks.
I think I share exactly the same experience and the very same thing helped greatly for me. I was just not diagnosed any postpartum depression but rather good old GAD.
After the birth of a son life changed 180 - no free time, no personal time etc etc. All you can expect. Less sleep, a lot of unknowns and anxieties. Again - expected. Less time with wife. Feelings of down, depression. Some anger problems. But it all looks like everyday life and everybody experiences stuff like that.
Then my father died. So I became "the man of the family".
Then corona hit. Then unknowns at work.
Then one day I was playing with my son and he hit his back and I felt so sick. However x-rays just nothing and he was just fine the next day. Life continues.
And one day I was just chilling and having some alone time and it all hit me like a train. Suddenly I thought I am gonna die. Somehow my heart will fail (my father had heart problems) and basically I could not function as a person. I just wanted that somebody would take me to the hospital or something and just care for me so if my hearts starts failing medics would be near. I couldn't work. One of the worst weeks or so of my life.
Of course my heart was just fine.
All these things were accumulating for some time already. The very same Lexapro helped me a lot. No side effects whatsoever. After a few months I felt like I was actually young again. Things started to improve both at home and at work. Anxiety is 99% gone. I am just so glad I got help. Actually I was forced to as I couldn't function.
For me there was no "after" yet. Psychiatrist suggests to be on meds for at least a year or so. Combine with therapy. Going off meds should be very slow and take a month or so of dosage lowering.
I guess body should have be adjusted to increased levels of serotonin and lowering the dose very slowly should help the body to adjust the levels by itself. Nothing that was not done by millions of people already.
Sorry to hear that you had PPD but glad you were able to get help and feel better. I had a child around the same time and I can empathize with your experience. It's a wonderful time but can also be very overwhelming, especially for a first child (which is the case for me). It's like you take a major life change, natural anxiousness about your kid (are they hitting all their development milestones, eating enough, getting enough sleep, sleeping too much, etc, etc, etc) and mix in a big dollop of sleep deprivation.
> New dads: if you feel unusually down, anxious, frustrated, angry, or depressed, consider talking to your PCP about treatment. Taking medication is not an admission of failure. Being a father is tough, but it shouldn't feel impossible.
Amen. Being the internet, people are going to be jerks but I for one appreciate you sharing your experience.
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 paternal-infant bonding and is associated with adverse effects upon child development.
Prevalence — Based upon studies that used diagnostic interviews, the estimated prevalence of postpartum paternal depression ranges from 3 to 5 percent:
●One study interviewed fathers (n >2000) of infants and found that the prevalence of postpartum major depression was about 5 percent.
●A study of a clinical database that included new fathers (n >86,000) found that by the time their children were one year old, an episode of postpartum depression had occurred in 3 percent.
Given that you acknowledge depression I expect your misunderstanding is the fact that postpartum depression is defined as unipolar major depression occurring within 12 months after birth, it is not sex specific and can be either maternal or paternal.
Just some unsolicited advice for you: your comments read as antagonistic and arrogant, and are neither going to get you useful information nor make you any friends. If you're genuinely curious about how this is possible, why not ask good-faith questions about their experience, and then make a judgment quietly to yourself? Instead, you're invalidating them from a position of ignorance. Even in other cases where you might be right, you still look childish and insufferable.
Although I agree that a different name for this type of depression could be useful in a medical context (as the root cause of post-partum depression is likely to be different in the father vs the mother, so the distinction does matter), "post-partum" as a modifier can clearly apply regardless of who is going through the "partum". e.g, the father is experiencing depression after the birth of his child, therefore "post-partum depression".
Edit: and as others have pointed out, a separate name is probably not needed as medically this is generally referred to as "post-partum paternal depression".
Technically it's a Z-drug (like Zolpidem/Ambien) which are non-benzodiazapine positive allosteric modulators of GABA_A
However, since it's a neurosteroid most will probably not think of it as such. (It's name does begin with Z though... And end in -one like a steroid).
Anyways, it's licensed for 2 weeks only, side effects are drowsiness, sleepiness and cognitive impairment. You mustn't drive within 12 hours of a dose.
It's best effects are where the depression is associated with insomnia and anxiety.
It was compared to placebo not Alprazolam (Xanax) which has some antidepressant activity.
Drugs can be variously classified by their chemistry and/or by their effects. It's worth noting that GABA-A receptors have multiple allosteric sites, and different chemical classes of PAMs (positive allosteric modulators) may have differences in effects. (There certainly seems to be substantial overlap in effects, of course.)
Benzos attach to the benzodiazepine subunits on GABA receptors, and according to this paper[1], neurosteroids like this one also attach to similar subunits on GABA receptors[2]. Both act as positive allosteric modulators when activating their respective subunits on GABA receptors.
This cited paper[3] also tested similar neurosteroids in progesterone receptor knockout mice and still found anxiolytic effects.
> further research shows they haven't tested for it's presence in breastmilk yet.
What? This claim is easily falsifiable. Section 8.2, Lactation:
> Available data from a clinical lactation study in 14 women indicate that zuranolone is present in low levels in human milk.
> A steady-state milk study was conducted in 14 healthy lactating women treated with daily oral administration of 30 mg of ZURZUVAE for 5 days. At steady state (Day 5), the calculated maximum relative infant dose for ZURZUVAE was < 1%. The daily infant dose was low (approximately 0.0013 mg/kg/day), reflecting a mean relative infant dose of 0.357% compared to the maternal dose. Concentrations of ZURZUVAE in breastmilk were below the level of
quantification limit (BQL) by 4-6 days after the last dose.
I wonder how much of post-party depression is caused by isolation.
In the past, new mothers were surrounded by a whole village of women who would help care for the woman and the baby.
Many times now, women are isolated with maybe the father present. And even then there are pressures to get back to work.
This isn’t to discount or minimize postpartum depression, but if we as a society set up people for failure which require them to take a pill to get better, maybe something needs to be rethought.
> Additionally, prevalence was significantly higher in women from low and middle income countries compared to women from high income countries (OR 1.8, 95% CI 1.4–2.2). The overall pooled prevalence was 11.9% of women during the perinatal period (95% CI 11.4–12.5).
I suppose I don't know which countries are more or less alienated from their extended families, but the US is surely more than averagely sprawled since it's so large and so suburbanized.
Good question I guess. It's not fixed by being surrounded by a village. A village helps, but if you've never experienced PPD before then let me elaborate. PPD at its worst can bring psychosis. Read that again, psychosis. This is not something you can hug to make better.
> I wonder how much of post-party depression is caused by isolation.
I don't know how we would have managed the little one in the first years just the two of us. It really does that a village to raise a child, literally and figuratively.
My daughter went to daycare at exactly 18 months, but it was quite a ride before that. I work for home so I was there for my family, but let's just say that my productivity was sacrificed to do that.
Without any data, I suspect the incidence rate of PPD is unaffected by social factors but having a support system definitely helps mitigate the effects on the family (i.e. more hands to help with the baby). Fortunately my family has never had to deal with it but it's definitely not some minor illness for people.
Quickly looking at the research, seems you are right. Like most diseases, it's interplay between genetics and environment.
Social support is less important risk factor, while factors like marital satisfaction and partner's depression are more important. For women, adverse events such as loss of a loved one, husband's loss of job or serious economical issues seem to be important too (Escriba-Aguir et al. 2010).
This is also quite concordant with the fact that PPD is more common in less developed countries, as mentioned in another comment.
Does a positive allosteric modulator of the GABAa receptor cause addiction the same way any old GABA agonist does?
I love GABA agonists from
benzos, benzo likes to phenibut and really wonder how it feels. If it feels the same way, then it feels like being wrapped in comfortable cotton, with all worries gone -heaven on earth. Hence the extreme addiction risk.
The addiction potential and the associated risks vary greatly from benzos to phenibut. Benzo withdrawal can kill you, pregabalin or phenibut withdrawal will cause only moderate discomfort.
Technically it's a Z-drug (like Zolpidem/Ambien) which are non-benzodiazapine positive allosteric modulators of GABA_A
However, since it's a neurosteroid most will probably not think of it as such. (It's name does begin with Z though... And end in -one like a steroid).
Anyways, it's licensed for 2 weeks only, side effects are drowsiness, sleepiness and cognitive impairment. You mustn't drive within 12 hours of a dose.
It's best effects are where the depression is associated with insomnia and anxiety.
It was compared to placebo not Alprazolam (Xanax) which has some antidepressant activity.
It's effects are likely best in short term depression related to anxiety and insomnia. PPD is just usually that type.
The biggest factor is that this stuff is basically a Z-drug like Zolpidem/Ambien and so treatment is time limited.
That makes it harder to use with MDD.
At the same time it did not conduct comparative studies to TCA, SSRI or other modern antidepressants.
"Treatment as usual" would likely be a short course of Z-drug.
If a man went to the doctor and said I've lost my dad and I'm low, anxious and can't sleep one would imagine this would work. We don't know if it would work better than an antidepressant, or sedative because no comparison was done.
> Alongside Friday’s approval, the partners also received a rejection for Zurzuvae in adults with major depressive disorder (MDD). The FDA told the partners their application didn’t provide “substantial evidence of effectiveness” and that additional studies would be needed. Sage and Biogen said they are reviewing possible next steps.
It just means they haven't done enough clinical trials with younger people. Getting FDA approval for pediatric use is more difficult (as it should be).
Eating fish a few times a week won't lower your IQ, but if you're pregnant, the mercury content could leave your child permanently mentally disabled. Still-developing bodies and minds can be much more sensitive and delicate than an adult. Just because a drug has been shown to be safe and effective for adults doesn't mean it will be equally safe and effective for children.
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 is typically done as it is (expectedly) easier to get Institutional Review Board ethics approvals for adults and considerably easier to recruit patients both simply because it's easier to recruit adults as well as the relative prevalence of adult PPD patients.
I'm not a psychiatrist but the similar intravenous drug this is based on (brexanolone) is approved at ages 15 and over so I don't expect there is any reason this would be ineffective.
A general "stopping point" for human brain development tends to be around 25 years old, iirc. It wouldn't surprise me at all to learn that antidepressants might not function as well for teenagers- I certainly went through a fair few before going without any for a few years, and ending up on (and staying on) Lexapro when I was around 30.
Not disagreeing with your idea, but the age 25 thing is basically a myth. Different brain processes do continue developing into adulthood, but many finish developing younger while others never finish developing.
> When we spoke, I told Steinberg his work had been referenced in this way. “Oh no,” he said, laughing. I then asked whether he had insights about where the figure 25 came from, and he said roughly the same thing as Cohen: There’s consensus among neuroscientists that brain development continues into the 20s, but there’s far from any consensus about any specific age that defines the boundary between adolescence and adulthood. “I honestly don’t know why people picked 25,” he said. “It’s a nice-sounding number? It’s divisible by five?”
> Kate Mills, a developmental neuroscientist at the University of Oregon, was equally puzzled. “This is funny to me—I don’t know why 25,” Mills said. “We’re still not there with research to really say the brain is mature at 25, because we still don’t have a good indication of what maturity even looks like.”
Uh, if you're reading off table 1 at section 5.3, that's across all chronically-administered SSRIs -- not this drug in particular. Zurzuvae was evaluated in much smaller clinical trials of 347 women 18-44 and as far as I can tell, did not have any incidences of discontinuance due to suicidal ideation.
The suicide warning for AD is misleading. They don't _cause_ suicidal thoughts, but they can give you energy and the ability to function before they start lifting mood.
So if you're already suicidal, you can regain the ability to act on it before you get relief
That's not what the label warnings say. You're specifically contradicting the label's clear language, and you're saying that the FDA and the drug manufacturer are not telling us the truth when they put that label on a drug.
QED.
Furthermore, subjects with suicidal ideations or attempts are disqualified from clinical trials. In practice, this also means that any subject with depression is disqualified and shall not participate in any clinical trial for "antidepressants".
How does it feel to know that a drug that's supposed to treat depression, and may cause suicidal ideations and attempts, was never tested on anyone who was depressed?
I'm literally telling you word for word what my doctor told me, my guy.
Also, this rant is hilariously incorrect. You...do know that manufacturers continue to collect reports on side effects outside of clinical trials, right?
> That's not what the label warnings say. You're specifically contradicting the label's clear language, and you're saying that the FDA and the drug manufacturer are not telling us the truth when they put that label on a drug.
SSRIs and suicide risk remains controversial, habinero is describing one possible explanation and what I was taught in medical school over a decade ago. The label language is clear but you are failing to understand the complexity and rationale behind the warning and actual clinical implications. This is not unexpected as monographs are intended for a medical expert audience who are trained in their interpretation.
To keep it simple for everyone I suggest we defer to the Chair of the FDA proceedings that led to the boxed warning for his explanation as he is undoubtedly more of an expert than any of us on this matter (shortened for brevity):
It seems inconceivable that antidepressants would induce suicidality in the absence of other associated or antecedent behavioral changes. The essential message of the Black Box is to remind prescribers and consumers about the importance of monitoring closely for adverse behavioral changes during ... antidepressant therapy in order to reduce the risk of suicidality in patients through age 24 years. The intention was not to discourage appropriate prescribing of antidepressants for youth with depression, OCD or anxiety disorders.
In fact, some evidence .... suggested substantial reductions in antidepressant medication prescriptions in children and adolescents following the Black Box Warning ... For the majority of these patients, the benefits of antidepressants greatly outweigh the risks. Nevertheless, we agree ... that prescribers have a “duty to warn” and highlight the need for adequate training for all potential prescribers during medical school and residency programs.
I found these 2 pharmacotherapy RCTs on patients with suicidal ideation within 30 seconds of Googling.
> In practice, this also means that any subject with depression is disqualified and shall not participate in any clinical trial for "antidepressants".
> was never tested on anyone who was depressed?
How are you making this leap that none of the RCTs enrolled patients with depression? You do realize it's a minority that have suicidal ideation right?
This is fantastic. Anything that helps folks through postpartum depression will save lives — if you’ve never seen it in person or experienced it yourself you can’t understand how intense this stuff is.
The standard or care is education and it’s… well… well intentioned but deeply insufficient sometimes.
For anyone else following along, all of the above is factually wrong.
Emtricitabine/tenofovir is used to treat and prevent HIV infections, and is on WHO's list of essential medicines. Literally millions of people are using it to control their HIV infections and prevent it from developing into AIDS. It can be bought on online pharmacies for $15 per month, so it's not exactly a trillion dollar drug.
It's 100% certain that HIV causes AIDS. This is uncontroversial. It's true that scientists continue to learn more about how it infects humans and causes disease. This is why treatments are so much more effective than they use to be.
Absolutely amazing progress has been made in treating AIDS. There are medications available now that are able to reduce your viral load to below the limits of detection, you can live a reasonably normal life as someone HIV positive. A small number of people have even been cured.
Discrimination within the medical profession is real and a problem, but I have to doubt the sincerity of your concern for marginalized people when you spread FUD like this. I am forced to conclude you have some bone to pick with the medical profession and are deploying marginalized people as ammunition.
That's not cool. I'd appreciate it if you wouldn't do that.
You've failed to demonstrate that this is authoritarian. And I haven't criticized you for criticizing the FDA. I've criticized you for defending your position with misinformation, and for deploying marginalized people as a smokescreen.
If your best rebuttal is to put words in my mouth and frame my criticism as censorious, it's time to reevaluate. It's a form of motte-and-bailey argument, you've abandoned your position that no breakthroughs have been made in the treatment of HIV in order to defend something more vague and less falsifiable ("the FDA is authoritarian"). You can choose to either consider whether your position was flawed (my recommendation in this case) or to discard your arguments and find better ones, but if you can't defend your position, there's a problem with your argumentation.
Marginalized people? What are you talking about? The first cases of AIDS was identified in homosexuals. That's a fact.
My position is not that there have been no breakthroughs in the treatment of HIV at all. My argument is that HIV does not cause AIDS.
When you don't have empirical evidence to support your fake claim that HIV causes aids then yeah, you need to go authoritarian. Hence endless government and para-government agencies dictating truth through biased and hopelessly flawed studies.
When your argument is built on BS you need to argue at the upper levels and never look at the foundation.
This is too far a leap, that haven't said anything overtly homophobic. It's likely they aren't homophobic, who knows.
When we make leaps like this we risk the conversation devolving into something where the germane criticisms are lost. It's a lot easier to critique their position and rhetoric than to interrogate the content of their soul, and they will always have the home court advantage there.
I'm not the rhetoric police, but that is my advice.
You got it exactly right. Simply stating a fact is not an attack on anyone. In any scientific inquiry one needs to consider all the similarities and differences in the data. Most notably, if HIV is spread through sexual contact, why was it most prevalent in gay men of a particular lifestyle in a particular place? If it were straight white Amish people that it was attacking, I would say the same thing.
Not that it matters, but my sister is gay and I am going to be in her wedding this October. I have a much more nuanced understanding of homosexuality as my twin falls into this category.
> if HIV is spread through sexual contact, why was it most prevalent in gay men of a particular lifestyle in a particular place?
You've answered your own question. Because they were a community of people in sexual contact with each other, and/or sharing needles.
Please consider that, whether or you are homophobic, you are repeating homophobic talking points. The idea that HIV was caused by "lifestyle" rather than a virus was invented to discredit the idea that it was an epidemic requiring urgent medical intervention. It's rhetoric which was invented to frame a disease as a moral failing in order to deny or delay the development of lifesaving care to a population some would prefer to see suffer and die (as well as deny or delay interventions like educating people and distributing protection). This is "gay plague" stuff. Frankly, I can understand why the other commenter took the impression you are homophobic.
Sincere congratulations to your sister. I hope the wedding is lovely.
The LGBTQ community doesn't at all benefit from you spreading misinformation about HIV. You are using their marginalization to your unrelated rhetorical ends, because for whatever reason you have a gripe with the FDA. That's messed up.
> My position is not that there have been no breakthroughs in the treatment of HIV at all.
That's rather at odds with this statement you made:
> It's a multibillion dollar industry and 0 progress in the treatment of AIDS for decades.
"At all" is a goalpost you've introduced, but the difference between "at all" and "for decades" is negligible at any rate.
> When you don't have empirical evidence to support your fake claim that HIV causes aids then yeah, you need to go authoritarian.
I think it's interesting that you say that, when you haven't responded to the specific and factual claims made by 'kstrauser (https://news.ycombinator.com/item?id=37057357). 'kstrauser, I will readily admit, made the superior argument to mine, and responded more directly to your empirical claims.
If the empirical evidence is on your side, I have a hard time understanding why you're talking to me and not them.
> When your argument is built on BS you need to argue at the upper levels and never look at the foundation.
It's been my experience that people with BS arguments are likely to gish gallop between incredibly narrow and specific claims, which are often true or half true, and broad sweeping generalizations. This gives the impression of supporting the generalizations, but when they're placed in the proper context it becomes clear they are massive leaps.
There was a large gap between discovery of HIV in human populations, including people getting AIDS and dying of trivial infections due to their immune systems being wiped out. Once people started looking deeper it was also discovered that it was far from a "gay" disease. All of this happened before a single human tried AZT for an HIV infection.
Beyond all the scientific evidence we have real world Darwin Award trials: various HIV denialists infected with HIV have refused to take drugs to treat HIV and they have died. Others got very sick and were cured almost immediately after starting standard treatment.
We also have numerous clinical cases of people with undiagnosed HIV infections getting sick from common bacterial/fungal infections, get diagnosed as HIV positive, start the standard drug regimen, and their problems go away.
Not to mention SIV (the simian relative of HIV) causes an AIDS-like disease in some primate species which gives us both another line of direct evidence and almost certainly the original source of HIV.
You're just plain wrong.
We can squirt HIV in a dish and watch it kill the normally unkillable T cells. We know 100% what happens when your T cells collapse: your immune system stops working and some normally benign organism takes over your body then you die. We've sequenced HIV. We know how it mutates so rapidly. We know why it is able to attack T cells.
There is no mystery and no need for conspiracy. All lines of evidence point to HIV as the culprit.
Immunocompromised people die from opportunistic infections that don't normally cause illness at all. They would acquire immunocompromised status from HIV. Hence nobody would die "from AIDS", they would die from complications with the annual flu. They would be dead and still be HIV positive.
That's why you haven't seen your goal because you have an unfalsifiable viewpoint where there is no competing information to alter your view because it is an impossible standard. AZT has bad side effects and is antiquated technology. Okay. Yes, there was a lot of hysteria in the 1980s and pharma companies aren’t held accountable for their role in that. There is also competing information that can be reproduced easily regarding HIV to immunocompromised status and opportunistic infections killing people.
I would implore you to look at the things that are substantiated. In the 21st century, there are now drugs that keep your t-cell count high, such as PrEP. These aren't killing people and prevents progression to immunocompromised status, it also prevents spread of HIV.
I'm sorry you'll never get to your resolution about drugs from the 1980s, but there is nothing to build upon with that information and you’re extrapolating from a position thats been a dead end for a long time, in comparison to what we can build upon with successfully protecting t-cells.
>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.
I'd argue you're far more forgiving and optimistic than what's realistically happening with respect to ""medicine" is more than just Big Pharma, insurance companies and healthcare conglomerates"
My experience with a semi-edge-of-medicine chronic condition has been absolutely atrocious nearly across the board and even with the absolute experts. And there's multifactorial reasons for it.
>My experience with a semi-edge-of-medicine chronic condition has been absolutely atrocious nearly across the board and even with the absolute experts. And there's multifactorial reasons for it.
Your anecdote (as vague as it is) isn't very helpful in making any sort of point. I'd add that your interaction with the healthcare system wherever you may be is irrelevant in the aggregate WRT medical advances that have provably and measurably made folks healthier and live longer.
My goal here isn't to persuade you of anything. Rather, it's to point up that your attitude and (claimed) experience is, at best, orthogonal to my comment.
Care to share where that sentiment comes from? Also, a bit ironic considering the recent n of 1 trial they approved for DMD.
Have you heard of the oncologist that did a murder suicide on her 4 month old baby in Westchester this weekend? Not every disease has the luxury of waiting around decades for safety and efficacy fact sheets.
I have nothing to say about this particular drug, but it's without a doubt that the FDA carries water for the pharma industry.
My own personal anecdote is that I've been taking NMN as a dirt-cheap supplement for years, until recently, when the FDA decided that one of their pay-pigs is going to turn it into a prescription drug, and likely charge much, much more for it:
The alternatives that are prescribed also show up in breast milk and aren’t evaluated in infants.
No one is going to sign their infant up for that double blind study. PPD can be life or death, so it’s up to the provider to choose the risk to the mother vs. the risk to the infant. I don’t think there are any easy answers there
A newborn whose mother has severe postpartum depression is unfortunately in more danger from the mother than from any clinically-tested pharmaceutical she might be taking.
It sounds unethical to conduct human trials on babies when the mother could simply stop breastfeeding while taking the medication. I wonder if doctors recommend that for this or other drugs? I'd hope they inform the mother at the very least.
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 to the children which this does not.
> ... simply stop breastfeeding while taking the medication. I wonder if doctors recommend that for this or other drugs?
Yes, all the time. It was part of the study protocol too.
> I'd hope they inform the mother at the very least.
It's in both the patient and physician handouts to discuss the risks/benefits and alternatives. Formula is available as are breast milk donations in certain regions.
This is neither the first nor last medication that may be excreted in breastmilk we have to deal with in medicine and there are systems and processes in place to address these situations.
Stopping breastfeeding can also deepen depression and increase stress (talking from experience here) so it's really a difficult choice here, depending on the level of danger the mother is to herself.
Hopefully some data is compiled in the next years on the actual safety for infants.
This is such a lazy comment and the fact that you didn't copy paste the paragraph that followed makes me think you have some agenda to push.
"The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZURZUVAE and any potential adverse effects on the breastfed child from ZURZUVAE or from the underlying maternal condition."
Obviously this bit is implied. But, they should have done the safety studies so people can make a fully informed decision. It seems very unlikely they're going to direct all people taking this to stop breastfeeding, because it's going to make it sound like a poison and people won't buy it. Got to put profits first, I guess.
You should educate yourself on the drug development process and FDA regulations.
"More" data is always better, nobody disagrees. But more data costs more and takes more time to gather. So the trade off is - do we approve this medicine now, knowing what the risk are, are do we not and deny patients this medicine?
There is no "safe" drug. There is no drug where all the risks are known. Even the FDA will tell you that. It's all a risk-benefit trade off.
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?
Because there is no currently approved treatment for postpartum depression, what they’re comparing here is the danger of untreated PPD against the danger of either discontinuing breastfeeding or having the newborn ingest a small amount of this medication. Untreated PPD is no joke. Not only does the mother’s suffering matter in itself, it has serious documented effects on the baby.
And there is nothing wrong or negligent about “solving this with a pill.” It needs solving. It is a serious issue.
> And there is nothing wrong or negligent about “solving this with a pill.” It needs solving. It is a serious issue.
Your points are well made, though this isn't really what I said.
For what it's worth, while I'm worried the decision was made on what essentially amounts to an assumption, the option for using formula exists for parents worried about the drug making it into breast milk. So it seems there's at least one mitigating factor. But it wouldn't surprise me if the drug ends up being labeled for leeching into breast milk later on.
> 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 depression can look like:
Severely ill patients often report suicidal ideation and behavior, typically demonstrate obvious impairment of functioning, and often manifest poor judgement that places the patient and others (including children) at risk for imminent harm. In addition, patients are more likely to develop complications such as psychotic and catatonic features and have a history of severe or recurrent episodes. Patients with severe major depression should be referred to a psychiatrist for management and often require hospitalization.
Source: UpToDate
> Is the FDA immune from suits if this results in a generation of damaged kids?
Sued for what? It's clearly stated in the drug monograph.
Available data from a clinical lactation study in 14 women indicate that zuranolone is present in low levels in human milk (see Data). There are no data on the effects of zuranolone on a breastfed infant and limited data on the effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZURZUVAE and any potential adverse effects on the breastfed child from ZURZUVAE or from the underlying maternal condition.
All patients enrolled in the trial were asked to stop breastfeeding. It is unethical to perform the study you are suggesting and even if it were no IRB would approve per regulations.
Should the FDA be immune from suits for the invisible graveyard of people who would otherwise be saved by drugs that take years longer than they should to get to market if at all?
We are having regular threads on HN about how the FDA is not approving drugs fast enough and someone in our community is dying and cannot access the experimental drug that may have saved them.
If your concern is that it's present in breast milk, it seems pretty easy to address - feed the baby formula while the mother is taking the medication, and about a week after (I am not a doctor, this is not medical advice).
Presumably, that's why prescribing information says:
> The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZURZUVAE and any potential adverse effects on the breastfed child from ZURZUVAE or from the underlying maternal condition.
The benefits are presumably being weighed because they don't anticipate the mother breastfeeding the infant while she is on the medication.
Have you considered that perhaps they didn't test it on infants, not because they're a corrupt rubber stamp, but because there is no ethical way to do so? There is no possible benefit to the infant, but there is potential risk; that would violate the principle, "first, do no harm."
Why put children at risk when the problem is avoidable in the first place by not breastfeeding?
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 was a median of 268 days, faster than the EMA at 356 days and Health Canada at 366 days.[2]
Based on your assertion and the data this means that you think all three of these agencies are harming the population, with the FDA being the lesser of all evils, by not approving drugs fast enough. Do you have a source for this claim?
It's still true, we still don't have them. Obama even passed a law about it and it didn't help.
> Based on your assertion and the data this means that you think all three of these agencies are harming the population, with the FDA being the lesser of all evils, by not approving drugs fast enough. Do you have a source for this claim?
This is obviously true. Are Americans, Canadians and Europeans all different species? No. Are all three countries slash political unions capable of running clinical trials? Yes. Do the FDA or Health Canada trust each other enough to allow things the other approved? No.
Although the FDA is sometimes surprisingly relaxed - here's a nootropics company selling drinks with at least two unapproved medications in them, adrafinil and omberacetam: https://www.trubrain.com/products/drinks.
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 prevented by current approval processes.
Once again, source?
> This is obviously true.
As you only mentioned the FDA, and keep only mentioning the FDA, it is not obviously true that you are arguing against all Western drug approval agencies and not specifically the FDA.
> Are Americans, Canadians and Europeans all different species?
All being the same species does not mean all have the same regulatory framework and in fact they don't. I am sorry but I really don't understand any of the points you're trying to make.
> 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 prevented by current approval processes.
Not having sunscreen harms people by giving them skin cancer.
> As you only mentioned the FDA, and keep only mentioning the FDA, it is not obviously true that you are arguing against all Western drug approval agencies and not specifically the FDA.
I didn't say anything about them in my original post so I'm certainly open to believing they're also too slow.
Europeans certainly seem to believe a lot of strange things about American food that are just protectionism from their farmers.
> All being the same species does not mean all have the same regulatory framework and in fact they don't. I am sorry but I really don't understand any of the points you're trying to make.
Yeah but that's bad. It's also eg bad that every American city has completely different housing regulations.
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 says on the whole the FDA harms more people by not approving drugs more quickly, MORE than any safety added by this process.
Please note this would mean a citation that has looked at MANY approvals and timelines while ALSO looking at rejections for potential harm and concluding that the process is more harmful than beneficial.
To explain to you why yours is insufficient, even if we accept that this ONE example has caused harms you have not addressed any potential safety issues that have been prevented in OTHER therapeutics by the long process, this may in fact be zero or less than the harms caused by delays but requires evaluation in order to draw the conclusion you are making.
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.
I wonder why the American natives got so much sicker from European diseases than the Europeans did from the local native disease. It's almost like cities are petri dishes.
Because the old world had plagues (diseases that spread fast and kill) and the new world did not. Plagues and pandemics are zoonotic, and the new world just didn't have any domesticable animals except llamas.
You haven't convinced me that there were no domesticable animals in the new world, or that that was the major factor.
It also doesn't explain why new world people already had a need penicillin formulations (earlier comment).
But if you are right, it sounds like the trade-offs that come with domestication may not be worth it except as accidental biological warfare. https://pubmed.ncbi.nlm.nih.gov/15539148/
Also, the rats that carried the black plague were not domesticable. Don't you think open sewers in the streets contributed to disease a bit..
The proof that there were no domesticable animals in the new world is that...no animals besides the llama [0] were domesticated. People lived here for tens of thousands of years. If something could have been domesticated, it would have, because that's what humans do.
And yes, the black plague is zoonotic, as I said. And yes, cities do contribute, because packing a lot of people together give plagues fuel. Plagues are almost always zoonotic, because any disease that kills all its hosts also dies. Plagues usually have a reservoir in animals, mutates to jump to humans and kills them by accident, really.
[0] And guinea pigs, I guess, but you can't build an empire on overgrown squeaky toys.
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.
If you think this is a risk, have a plan for it, and not just for her. For you as well. The knock on effects of trying to do everything for the newborn, manage your partner’s symptoms and help in their treatment, and try to sleep while furiously doing laundry, cooking, scrubbing bottles, etc… you need support. You need people staying with you 24/7, people that aren’t on some vacation with a couple photo ops with the new baby.
I’m in a week between family staying with me right now and I had to pull from savings to get a night nanny every other night to even have a chance for sleep.
Make a plan for help, don’t be afraid to cash in on help you’ve given your friends and family, and get treatment early.
edit: I’m a US Marine. I’m not scared of sleep deprivation, hard work, or suffering. How single moms do this without PPD, let alone with, while holding a job is something I can’t fathom. I thought I was tough. Incorrect.
That's really kind advice - I appreciate it. Luckily the folks pretty close-by, but you spelling all of that out really changes my perspective how hard it'll be.
We got a young puppy a year back now which seemed like good practice - with the lack of sleep, constant attention, constant pooping/peeing. But yea, a baby's absolutely going to be another level's worth of difficult.
Personal experience, I don't know if it's backed by studies. We think that there are a bunch of factors you can control that help reduce the risk, you probably know them:
* sleep deprivation: take turns taking care of the baby and let the mom sleep whenever she can, naps during the day, when the baby is napping, when the baby is with you, etc; getting as much sleep is <<super important>> for the mom
* moral support: no matter how much things suck, you're in this together; talk to the mom and ideally, make fun of the literally shitty situation :-)
* as mentioned by others, get more help if you can; no shame in doing it, you said you were a military man, wouldn't you want to greatly outnumber "the enemy" (the baby)? :-p
* take the longest leave possible, don't save PTO; you're probably not going anywhere interesting this year, use that time to offer support during this super stressful period.
FYI, statistically the pressure goes down at about 3 months old and again at 6 months old.
I thought a puppy was similar too, but we get a puppy at like 8 weeks old and someone else did the early care. The early care, when you have to feed constantly and you can’t even put them down in a bouncer to sleep… it’s taxing.
But worth it. I was just reading my 2 year old a book before bed and I can confirm that it gets better. They are a lot of fun.
My wife an I are currently expecting baby #5. She had a only mild amount of PPD with 2. We foresee no need of this drug with this one nor any of our future babies.
> 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.
Postpartum depression is much lower in places where mothers get a lot of sunshine, live among numerous family and friends, eat whole diets, walk a lot, and don't suddenly go from rat-race identity-capturing careers to soloing a screaming infant inside all day.
I'm not saying PPD is non-existent in those societies, just that in western societies like the US I'm more surprised when new mothers don't get PPD than I am when they do.
This may be the opposite of true: metastudies show lower incidence of PPD in developed countries, and further the incidence of perinatal suicide is higher in developing and "non-western" countries.
>Postpartum depression is much lower in places where mothers get a lot of sunshine, live among numerous family and friends, eat whole diets, walk a lot, and don't suddenly go from rat-race identity-capturing careers to soloing a screaming infant inside all day.
In humanity's history, people were routinely ostracized, beaten and killed for deviating even slightly from a strict set of norms, including family members. Imagine you are a new mother and are deeply depressed, or worse yet even have hateful thoughts towards your child. How do you think fiercely patriarchal societies would deal with it if you spoke out? Or your husband/boss? Just because people are more outspoken about their personal experiences now does not mean those experiences are some "sudden" phenomenon.
oftentimes if there is a difference in this sort of situation, it's preferring to bind to a specific subtype of receptor (GABAa is made of 5 different subunits which can be alpha, beta, gamma (or one of 16 other proteibs). the combo of which units are expressed determines the subtype). usually, receptor subtypes are expressed differently throughout the brain.
this is (probably) why benzos and z-drugs have qualitative differences for example--they act on different neurons as they have varying affinities to GABAa subtypes
I’m in this right now, my wife has symptoms that are in a word, scary. The rug pull of hormones that happens after birth, they can turn a stable, well adjusted, incredibly good mom into someone who is afraid to hold their own baby.
We’re in 3 groups, we have a private therapist for this, and if it’s anything like last time there will be another light switch at 4-6 weeks where she is suddenly back to normal. This pill is another layer of support, and a necessary one so new moms with PPD can bond with their baby, and so their partner doesn’t have to manage a two year old full time during the day and a feeding every other hour at night.
I think your care and concern is well founded, it sounds like your heart is in the right place, but I think you should re-think this take.
Absolutely. My wife also has it and talk therapy was not enough. She’s now on anti depressants so I’m thrilled theres a new drug specifically for post partum.
My wife suffered from PPD after the birth of our first. She also suffered antenatal depression during her second pregnancy.
SSRIs literally saved her life.
The difference to her personality was profound: the woman I knew and loved came back.
Was it a societal structure and support issue? No. She had support from myself, our families, family doctor, her obstetrician and a psychologist. My work provided me with paid time off to manage it. We had no financial concerns; she had 12 months of legally protected maternity leave with the first 6 months fully paid.
If you are not a researcher, or a physician, or some other expert, and if you have not given birth yourself, please don’t throw out this kind of ill-considered opinion. Post-partum depression (and anxiety for that matter) is more severe than just the effects of sleep deprivation and lack of support. Anything we can do to treat it, even partially, is worth doing.
I don't think he was trying to downplay the severity of postpartum symptoms....
In reality, it does take months for oral psychiatric drugs to cause a state of homeostasis in a patient, so perhaps, while it's another option in an arsenal, there are more serious healthcare industry related issues that need fixing as well
My wife couldn’t sleep after giving birth to our second kid and it spiraled quickly into full blown psychosis. My wife still can’t sleep right nearly 10 years later.
There’s no shame in taking antidepressants. Some of us have brains that don’t work quite right and we should have more options than “cope” or self terminate.
Ew why would someone even if they love micro services go from go to node? Just seems dumb.
Write the micro services in Go lol.
But yeah I agree to some point. We medicate far too fast and easily these days. Half these drugs have insane side effects, and yet people shit on shrooms. At least I won’t die from blood clots or some random shit.
Nobody is forcing anybody to take depression medication. The fact that it's there for people who are suffering and feel that they need it is a good thing. True, depression is a complex phenomenon, and I don't think any good doctor or psychiatrist would deny that you need social and emotional support in addition to medication. However, antidepressants seem to be a useful tool for a lot of people to manage the symptoms to a point where they can function well enough to make the more holistic changes. If you've ever experienced depression, you'll know how hard it can be to just get out of bed, go grocery shopping, or do light exercise. Add that on top of the stresses of being a new parent and I imagine it can be extremely difficult.
Agree with this statement wholeheartedly. Antidepressants can help many feel better and help get things moving and enable the person to make even more life changes to get even better.
Is is that crazy to think that a wild swing in steroid hormone levels can lead to depression - similar to what we observe when men come off of steroid cycles? If so, is something like post cycle therapy for women recovering from pregnancy really that crazy of an idea?
I don’t know enough to speak intelligently about the underlying biology, but an interesting theory I heard from someone more knowledgeable than me is that the sudden drop in progesterone - which tamps down neuroinflammation - sends the microglia (immune cells of the brain) into overdrive which results in rapid destruction of neural tissue which is experienced by the patient as profound feelings of unhappiness / depression. This is not unlike the runaway inflammatory response that kills people with COVID — which is why dexamethosone (an immunosuppressant) reduces mortality.
The chemistry of your brain literally changes, so yes, it's an issue that pharmaceuticals can help with tremendously. I am often the first person to rail against overprescribing of medication, particularly psychiatric medication, but this is categorically a Good Thing. And nothing in the article suggests this is anywhere close to a "just take this pill" type of treatment. This is part of a holistic treatment plan.
All that being said, if you want spiritual support go to your church, you shouldn't be getting that from your OB or pediatrician.
The brain is an electrochemical machine. Your brain chemistry changes when you're happy, hungry, sad, angry, bored, horny, sleeping; pretty much every human experience is mediated through brain chemistry changes.
And in any other machine when something breaks you fix it. If your rotator cuff gets torn you don't say "just stop having shoulder pain" or "shoulder is a natural part of the process of life and you have to deal with it," you go to a PT, maybe have surgery, maybe even take a pill or two.
If you think PPD (or any other form of depression) is "brain chemistry" on the same level and getting hungry or horny you grossly misunderstand what depression is at a fundamental level.
The serotonin imbalance hypothesis of depression, widespread as it is in popular culture, has actually been pretty thoroughly debunked at this point[1]. We know that SSRIs do have a therapeutic effect, but it seems their effect is oddly enough unrelated to serotonin levels.
What they seem to do is mask the depressive symptoms to the point where you're given a sporting chance to "behave" less depressed, which is what seems to be the most effective treatment. It's fairly analogous to how painkillers can cure back pain by permitting you to move around more.
Not acting like you're depressed is the real cure, which is of course very cruel, because as anyone who has had a depressive episode will attest to, just getting out of bed may be a struggle.
> Is this really a pharmaceutical issue or a societal structure and support issue.
Any if it is? We surely can't solve every, or even most societal issue that causes it.
You can continue to support improvements to the societal issues of the world while still supporting pharmaceutical interventions for those who need it right now.
They're saying we should make sure expecting mothers are well informed on the effects pregnancy and birth has on their body. Not give them unrealistic expectations that pregnancy will be easy and that everything will go back to being the same after they give birth. A miss match in expectations can help drive someone into depression. Prevention by supporting new mother's.
I think they go too far though. Everyone's situation is different not all depression is preventable, many people need SSRI and other oral treatments. But let's not throw strawmen around.
Lots of people became parents suing pandemic lockdowns and didn’t really have a choice or say in surrounding support structures being available or possible.
Which is itself completely irrelevant because support structures or lack thereof don't have anything to do with PPD in any way. Plenty of people with amazing support in their family and community end up with crippling PPD. Plenty of people with zero support don't have the slightest bit of PPD. It's irrelevant.
How is it completely irrelevant? I think you might not know as much as what you're talking about. And/or be out of date. I'm normally don't reply to posts that contain petulant dismissal and minimization of others.
Knowing how there is a much larger silent group who is reading and might disagree with you, or how your words will actually do harm to deny a mother what she may be going through.
It's up to you, but I hope you read the below with an open mind and eyes.
Isolation in a pandemic CAN make PPD worse.
The rates of PPD during the pandemic WERE much higher, and from what the data is saying more intense.
Imagine: Becoming a mother alone in a hospital room, without a single woman figure in the family who exists and would have been present otherwise is very easily a magnifier and amplifier of any conditions. Some mothers had to enter the hospital for weeks before birth alone from complications.
No visitors allowed, or only one. No support people allowed. Hospitals also had shut down most of the pre-natal and ante-partum programs and check-ins with dieticians, other parents to be, etc.
It was pretty much solitary confinement, and dismissal of it for those parents who went through it is pretty surprising since you seem to be an authority on what does or doesn't make PPD symptoms or experiences worse. It just kind of shows how out of touch your position might actually be.
So, onto the logical proof of explaining something that will only exist once science has studied it for your logical brain.
1) "Pandemic isolation is leading to more postpartum depression, anxiety. Everything that we tell postpartum women to do, like connect to other people, get out of the house, establish a routine, they can’t do that.”
2) "A third of new moms had postpartum depression during early COVID.
People who delivered babies during the pandemic also reported more distress and anxiety. ... One in three new people who had babies in the beginning of the pandemic experienced postpartum depression – potentially triple pre-pandemic levels – while one in five had major depressive symptoms, according to research led by the University of Michigan School of Nursing and Michigan Medicine."
3) "New moms, experts worry about postpartum depression during COVID-19 as services cut back Many in-person services now being offered by phone, video or have been cancelled altogether"
5) "We believe the present study to be the first to demonstrate that fewer supportive persons during pregnancy is a predictor for postpartum depression. This finding points to the benefits of early intervention to increase the number of support providers for pregnant women19."
I hope this helps with undertaking a search yourself to learn more about PPD.
As an aside, it's questionable if there's a reason you feel it's acceptable to harshly dismissing the words of strangers as harshly as you might with your own inner dialogue? The world's eyes and ears are not a toilet for you.
As for support structures having nothing to do with PPD, I can only speak to what I've witnessed and what the doctors in our lives have pointed out.
Since you weren't there, and it might not exist for you unless you can understand it, it's pretty easy to search for topics on the internet these days.
I don't see it. We know people in the past were much more willing to suffer quietly, if not required to do so. And we know the damage that causes down the line. What I see is another in the endless examples of society finally letting people out of the hype-narrow boxes of acceptable behaviour and experiences and listening to what they have to say as who they are, not what cruel and ancient conventions demand they should be.
I mean, it's not like the FDA are the ones who control legislation around what kind of support new parents can get. Take it up with the people to vote, repeatedly, to strike down paid parental leave, medical care, and other support systems.
> now you are physical/spiritually/ and emotionally bond to a new human life who is 100 percent dependent on you for its survival and well being.
Not to mention that this is the best case scenario. Unfortunately deliveries of non-alive babies carry the same postpartum problems, without the joy of life
> Postpartum Depression holistic patient view versus commercial pharmaceutical treatment.The shear emotional, physical and life changes involved in having a baby is in many ways similar to PTSD. In just a few weeks your body has been physically exhausted, your mentally and emotionally drained and now you are physical/spiritually/ and emotionally bond to a new human life who is 100 percent dependent on you for its survival and well being.Now imagine this leads to a period of depression in the patient. Is this really a pharmaceutical issue or a societal structure and support issue. Perhaps even more than just that.It is depressing to me to see things like this get pushed out … just take this pill and it will help move you up a few points on our 17 point scale and cope.Instead of wow, let’s really look at what’s happening with the birthing process on how we prepare mothers and support them emotionally, physically and maybe even spiritually.Nope just take this drug and in 6 weeks you will be back to work and we can get that new kid in daycare :/#rantover
absolutely true. i am not at all surprised we're suffering from low birth rates. we should have done what japan is doing very long ago. the amount of support new parents receive in modern society is a joke
Postpartum depression is not a societal illness, it's a medical problem.
This comment is no different than telling a depressed person "you have no reason to be depressed, so cheer up". Plenty of women with strong support networks get postpartum depression.
As a Canadian, I can confirm 12 months is not enough let alone 6 weeks… I am deeply saddened at the thought of mothers having to go back after so little time
My wife suffered from PPD, you can take your opinion here and shove it where the sun don't shine. In the midst of her anguish, no amount of having family support could help her. I wish this would have been available.
Typical HN upvoted bullshit from people who are trying to be contrarian to every fucking good thing that's done..
Cannabis can also cause fetal harm. And fetal harm is also irrelevant here because this is a treatment for postpartum depression, I.e depression after birth, at which point there is no fetus to be harmed.
There's also no credible evidence that cannabis is an efficacious treatment for postpartum depression.
But sure, why even bother with science? Just smoke a joint...
I'll get back to you once I've figured out how to stop the ongoing deterioriation of American democracy. Right after getting off the phone with the nobel committee.
Well, considering that science is wrong far more often than it’s right (and done poorly), blindly appealing to it as sole arbiter and authority is maybe a bit hubristic?
Also - you can acquire postpartum depression while pregnant. You can get pregnant soon after having a baby. But hey, science.
The suicide warning for antidepressants is misleading. They don't cause it, but what happens is antidepressants start giving you more energy and more ability to function before it starts helping with mood.
So if you're already suicidal, you can get the ability to act on it before you start getting relief from ideation.
The idea that improvement was endogenous or exogenous is itself important for that person's resilience and esteem. So I wonder if there is a bit of a white lie there?
That’s darkly humorous. That a persons depression is the only thing stopping them from killing themselves. And to get to a better state they have to cross the stage where they are still depressed but have acquired a “can do” attitude.
End of day I think scrambling the brain is almost always the wrong choice. That these things are so heavily prescribed and marketed - what does that say?
It says nothing. They don't "scramble" your brain, or artificially make you happy, or any of the other ignorant things people have said. You are exactly the same person on AD as you are off of them.
This is like pretending that anyone who gets antibiotics is weak and if you just exercise, you can beat infected wounds.
Before antibiotics, people just died from wounds. Before AD, people spent their whole lives trapped by things we can do something about now.
I don’t think it’s anything line antibiotics. I don’t judge people for taking brain scramblers but I think it’s obvious they are vastly over prescribed. 20% of women are on some form of them. There’s no way that’s natural. There must be a reason you don’t see the mass adoption of these kinds of drugs in most other countries.
It’s also created a culture of using a pill to solve a problem and yes in some extreme cases it’s probably necessary but I think there’s bigger issues and lots of people with very poor values that create lasting unhappiness.
Why would you consider that not to be normal? Humans have plenty of inherent physical flaws - we have terrible backs and knees, for example. Also, plenty of other countries have similar adoption of ADs.
There was no magic beforetime when we were all happy peasants or hunter-gatherers, singing in the countryside. Humans have always lived with pain and depression and suffering, and to pretend there's any moral good to that is ridiculous, no more than there's any moral good to dying from an infection. Dying from infected wounds is "normal". Being permanently crippled from breaking a bone is 'normal".
People are so weird about things that actually help others.
> You are exactly the same person on AD as you are off of them.
Psychotropic pharmaceutical drugs are mind-altering substances. They place people in an "altered state of consciousness". Does this sound familiar.
When my cousin was allegedly afflicted by "chronic major depression", and he was prescribed Prozac, his mother commented "it's like I have my Joey back!" because his mood had lifted and he was acting very differently, different from his behavior in the past year or so, perhaps more like he was as a small child. His Mom always referred to them as Happy Pills. This was the regime when she would remind him to take his dose in the morning. "Take your Happy Pills."
Of course this behavior was mostly because he had been seeing a therapist and was getting some positive attention and reassurance. The SSRI drug soon triggered progressively more intense outbursts of rage and irrational behavior, and it would not be discovered for 5 years that he actually had a more serious mental illness, and the diagnosis and administration of SSRIs had been hasty and improper, exacerbating his condition.
I'm sorry, but your cousin's mom's goofy nickname for them is not a relevant anecdote.
I have been on several and I'm speaking from experience. They do not make you happy. They do not induce euphoria. What they do is relieve depression. Instead of being nonfunctional and crippled, you get some energy and mood back. Ideally, enough to let you work on other things and help you get back to stable.
Plenty of people only need them for a limited time, and that's just fine.
> 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? Is it that professionals normally refer to it as the "17-item Hamilton depression rating scale"?
That they're mentioning the number of points in the scale, but not the number of points gained, makes me wonder if this barely limped into significance under the most favorable conditions.
> Why would you mention the number of items on the scale, but not mention the number of points the drug gained? Is it that professionals normally refer to it as the "17-item Hamilton depression rating scale"?
Correct. "17-item Hamilton depression rating scale" (or HAMD-17) is the precise name of the scale; "17-item" is required to
distinguish it from other variations with different numbers of questions.
The precise improvement in scoring is undoubtedly present in the clinical trial paper, but isn't relevant to a FDA press release about their approval of the drug.
Apparently the brand name `Zurzuvae` in the first paragraph links to a PDF of the full prescribing info from the FDA. Pages 17-18 list the exact changes in HAM-D score over the first 15 days on the drug and the following 30 days after.
Both Zurzuvae and Placebo showed improvement in HAM-D over the 15 day period, but Zurzuvae showed a greater improvement. (From 28.6 to 13, vs 28.8 to 17.2, for a difference of -4.0 points, where lower is better.)
> The precise improvement in scoring is undoubtedly present in the clinical trial paper, but isn't relevant to a FDA press release about their approval of the drug.
Exactly. If it isn’t harmful, it doesn’t have to be very helpful — the effect can be small and significant.
FWIW: the full prescribing information warns about risks of physical dependance and withdrawal symptoms. The drug also ends up in the mother's breast milk at low levels. (See full prescribing info PDF linked in the article.)
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.
This is a uniquely American problem and an American solution. American healthcare and society fails new mothers. Others have done a great job of pointing out the physical and emotional distress a new mother goes through. However, I'd like to point out the social aspect. New mothers in America are not supported by paid family leave. Vast majority of women are required to go back to work in about 2 weeks after birth. Fathers have no time off, leaving a Post Partum woman at home with a new born with zero support. This is incredibly hard. Other places in the world either have governmental assistance with paid maternity (and paternity) benefits and support of cheap / free healthcare behind it. In absence of governmental assistance, other places have societal support in the form of extended family, neighbors, friends, etc. Unfortunately America fails on both fronts.
> This is a uniquely American problem and an American solution.
No, it is trivially easy to find out that PPD is neither uniquely American, nor does the US appear to be the country with the highest rates of occurrence.
This is great news. We need better treatments for PPD, which is real and very serious that can cause long term lasting effects in serious cases without treatment, and can sadly even be fatal.
Quality of life has risen steeply over the past several decades but mothers still walk an unpaved road. It's deeply worrying the lack of support and proactive care new mothers receive from medical professionals, though it is getting better, just very slowly.
I hope this helps many new families survive and thrive.