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No there is no magical pill that reverses abortion...

Dang. The one thing I wanted to know from the article was the FDA's stance on using progesterone to reverse the effects of mifeprestone.

I figured it would either be an unapproved use, which I would expect to generate a lot more pushback on clear regulatory grounds than what is reported in the article...

... Or it would be one of those "off-label" uses where the FDA apparently doesn't care if you're using a drug that's good for one thing, to treat another thing?

But the article doesn't get into that at all. Casts a lot of aspersions on the guy's research, but as far as I can tell, the FDA doesn't actually have a problem with it? Seems weird.
 
I guess I don't really care about this. Just as long as they don't try to make it mandatory. It's a solution to a non-problem. I guess the imagined scenario is, "what if a woman changes her mind after taking the abortion pill"? Because, women, amirite? They can never seem to make up their mind about anything? So why not give them a magic pill to reverse the effect of the abortion pill? I just think that someone should be very sure about what they want to do before they take the abortion pill in the first place. If you're not 100% sure, then it's too soon to take the pill to begin with. Spend some more time thinking about it. Maybe sleep on it and see if you still feel the same way the following day. Of course, this can't go on forever but you can take a few days to think it over.
 
Yeah, I don't really get the thread either. From what I can tell, it's not a magic pill, and while the mechanism hasn't been tested, the hypothesis seems pretty straightforward and reasonable:

A dose of one hormone halts the development of the pregnancy (and then a followup pill triggers a purging of the undeveloped tissue).

A dose of a different hormone, if taken soon enough, can potentially resume the development of the pregnancy. However, this hypothesis has not been well-tested, and current data suggests it may not be very effective.

Which, yay? Nay? Who cares? Is Joe telling us about a problem that doesn't need solving? Or a solution in search of a problem nobody is actually having?
 
The key is whether or not progesterone is more effective than simply not taking the second medication that causes contractions. That has not been conclusively shown. But progesterone itself is not dangerous, it’s used in pregnancy all the time, and if there’s a chance for it to work, there’s really no harm in trying. Doing so will eventually determine whether or not it’s effective.

This is no different than any other off-label use of other drugs. Take a drug like Victoza. It’s a diabetes drug but it was used off-label for weight-loss. Now Novo has gotten a new indication for the drug and they market it under the name Saxenda.
 
Off label use seems like a weird gray area in FDA regulation. Cui bono?

The FDA doesn't regulate what MDs do. Like, at all, to my knowledge.
(I think it's the state medical boards that do that.)

They (the FDA) mostly just make sure the claims on the packaging of the drugs in production which have been approved for any use regarding safety and effectiveness (for the use listed on the packaging) are as likely to be true as possible. That's...actually a big oversimplification, but it's the products they deal with, not the doctors.

MDs are totally free to (with a patient's informed consent, which is often enthusiastic) use their patients (benevolently) as guinea pigs in whatever creative ways the doctors and patients dream up, with almost any drug (I guess the "drug war" drugs are the exceptions), and write up the results of the experiment for peer reviewed publication, thus adding it to the scientific literature, and expanding human medical knowledge.

It's kinda cool.

It sucks that republicans are apparently trying to make doctors mislead patients, but a doctor letting a patient know there's possibly some small chance progesterone could reverse the first pill phase of "the abortion pill" isn't medically-ethically unusual. It would only be unethical if the doctor didn't emphasize that it was still very experimental, and thus there was an obscure chance of something being awful about it that nobody's figured out yet because the use is still experimental.
 
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Off label use seems like a weird gray area in FDA regulation. Cui bono?

It's a common practice and has to do with the drug companies not investing millions to get FDA approval for new uses when a drug is already approved for the market. It's considered safe once approved for the market so it's then provider choice based on other research to prescribe off-label.

This is especially important prescribing for pediatric patients. Drug companies are reluctant to test drugs on thousands of kids, so the drugs get tested in the marketplace after approved.

It's not much less true when it comes to approved uses. Say a drug is tested on a few thousand people in trials before being approved. But if certain side effects only occur in 1 of 100,000 or even fewer, those risks don't show up until the drug is on the market. There's important reporting of adverse effects from meds, not just on vaccines. All drug manufacturers collect the post-market data on their products.

So off-label prescribing is part of standard practice.
 
The FDA doesn't regulate what MDs do. Like, at all, to my knowledge.
(I think it's the state medical boards that do that.)
This is correct.


And you are exactly right about this:
They (the FDA) mostly just make sure the claims on the packaging of the drugs in production which have been approved for any use regarding safety and effectiveness (for the use listed on the packaging) are as likely to be true as possible. That's...actually a big oversimplification, but it's the products they deal with, not the doctors.


But this is a serious distortion of the standard of care.
MDs are totally free to (with a patient's informed consent, which is often enthusiastic) use their patients (benevolently) as guinea pigs in whatever creative ways the doctors and patients dream up, with almost any drug (I guess the "drug war" drugs are the exceptions), and write up the results of the experiment for peer reviewed publication, thus adding it to the scientific literature, and expanding human medical knowledge.
Why would prescribers want to make guinea pigs of their patients? What's in it for the provider? Write up the results and get it published? :rolleyes: You have an active imagination.

But if I may go a bit off topic, drug companies use the tactic of recruiting MDs to collect data for their drug research. The reason though, might surprise some people. The drug companies then advertise said MDs were part of the study thus giving more cred to their products. They have a dozen tactics like this.


It sucks that republicans are apparently trying to make doctors mislead patients, but a doctor letting a patient know there's possibly some small chance progesterone could reverse the first pill phase of "the abortion pill" isn't medically-ethically unusual. It would only be unethical if the doctor didn't emphasize that it was still very experimental, and thus there was an obscure chance of something being awful about it that nobody's figured out yet because the use is still experimental.
I can't help wondering just how small of a patient population this could possibly apply to. People who take an abortion pill then in the next, what, 12 hours, change their minds?

It also sounds like something which it will take ages to collect enough data to know for sure the fetus won't be adversely affected.

Perhaps I'm not understanding what this pill is for.
 
I can't help wondering just how small of a patient population this could possibly apply to. People who take an abortion pill then in the next, what, 12 hours, change their minds?

It also sounds like something which it will take ages to collect enough data to know for sure the fetus won't be adversely affected.

Perhaps I'm not understanding what this pill is for.

No, that seems to be the only case where this would potentially apply.
Unless somehow a pregnant woman were to accidentally ingest an abortion-inducing drug. The only other conceivable case where it might be useful.
 
Just to clarify. To my knowledge in the USA doctors can only prescribe drugs approved by the FDA but they can prescribe them "off label": for treatment of conditions not specifically approved by the FDA. This is not necessarily bad. Oncologists often customize doses and combinations of approved drugs in slightly off label ways to deal with a particular nasty tumor or to minimize the toxicity a patient may be experiencing.

Prescribing off label does increase their malpractice liability risk if something goes wrong; much easier to defend oneself by saying you were just following fully on label, approved and established practice.

Having said that the evidence that progesterone is safe to reverse abortions is laughable. Incredibly dangerous to suggest it for ideological reasons. And frankly most women committing to an abortion do and further are required to consider it very carefully before going ahead: waiting periods, interviews, etc. I can't imagine many would reverse that decision in the couple of days between drug one and two. They shouldn't be pressured to do so.
 
But this is a serious distortion of the standard of care.
Why would prescribers want to make guinea pigs of their patients? What's in it for the provider? Write up the results and get it published? :rolleyes: You have an active imagination.

Because it really might help the patient, as much as anything.

True story: I was able to get to a neurologist once, who gave me my official dx of epilepsy. (I'd been hospitalized twice already, recently postpartum, after gran mal seizures. I also had a couple of gran mal seizures when going through puberty, but they were classified/misdiagnosed as convulsive syncope at the time. My grandfather was epileptic, and my uncle was epileptic. I knew I was having seizures, but I didn't know that literally WAS what epilepsy was, even if the seizures were that infrequent. I guess I was assuming it was only epilepsy if you had seizures at least once a week for years or something.

Anyway, after getting out of the hospital the second time, needing to know wtf was wrong with my brain was the thing that compelled me to finally get the internet for the first time, and I'd been google searching terms that would help explain why I had seizures at apparent times of great hormonal upheaval (puberty and postpartum,) and I was only getting from google original research articles which were taking me something like 20 hours to even read, because I had to look up the meanings of not just the words in the articles, but the meanings of words in the definitions, too, sometimes 4 or 5 layers deep, just to get through a single sentence actually comprehending what I was reading.

So, I'm in the neuro's office asking him if maybe I can get referred to an endocrinologist to see if my hormone levels are totally wacked out, talking about the role of neurosteroids in epileptogenesis, and maybe see if treating THAT, the possible hormone goofiness, prevents my seizures if so...and he becomes all giggly and delighted saying "Yes! Yes!!! Oh, you are the perfect subject to try this with and it really might work! We'll write up a case report together and it will be so exciting and will be a SIGNIFICANT contribution to neurological science! Oh, but I have to warn you, this is totally experimental and not the standard treatment. You are absolutely my guinea pig if we try this. We will be the first to ever try this."
Which...gave me pause, first because I really had assumed something like what I was thinking was probably the first line treatment for someone like me, and two, holy crap! Doctors and patients can just, like, conspire to MAKE SCIENCE LIKE THAT? How totally awesome, yet vaguely terrifying is that? I had learned as rote memory the process of "the scientific method" in school, but it had never actually really clicked...not like it did right then, where I'd inadvertently designed the experiment and volunteered myself up as the subject, too, all as the result of my existential terror over my mysteriously and dramatically malfunctioning brain.

I chickened out and decided to just take Lamactil, his current favorite standard of care treatment (because if kindling theory was right, I was probably one seizure within the same year away from have many, many, many more seizures much more frequently.)

As he was leaving the room, I asked "So, what's wrong with me?" and he was like "What do you mean?" and I was like "I mean, what's my diagnosis?" and he stares at me with this blank stare, and then burst out laughing, and says "You know about kindling theory and the role of progesterone in possibly preventing would-be seizures, but you didn't know the name of what's wrong with you? You're just epileptic. What you have is called epilepsy" and then went into how idiopathic means "we don't know" and how my family history means there's probably a genetic factor at play in addition to who knows what else. And I was floored for a week that I'd been an epileptic for at least 15 years without even knowing it, and that I'd just read all that neuroscience without ever even encountering the notion that an epileptic is just someone who has 2 or more seizures more than 24 hours apart, not caused by an immediate head trauma, or a tumor, or fever from poisoning or hyperthermia, or some other possibly deadly thing like that.

I can't help wondering just how small of a patient population this could possibly apply to. People who take an abortion pill then in the next, what, 12 hours, change their minds?

It also sounds like something which it will take ages to collect enough data to know for sure the fetus won't be adversely affected.

Perhaps I'm not understanding what this pill is for.

Pro-lifers are obviously banking on the pill's very existence and legitimization somehow magically increasing the number of women with after-last-minute regrets.

I do know factors like feeling bullied by parents or partners into getting a regular/D&C abortion, combined with the pain and invasive nature of that sort of procedure itself, does cause some small subset of women to regret having gotten an abortion.

No idea what the small number of women who regret doing the pill version are, though. It probably depends (like the D&C) on if they felt forced into it by other people, and if they're given pain meds.

I know I've never encountered even a single "I regret my abortion" "testimonial" (used as "propaganda" by pro-lifers, but many are obviously heartfelt) about regretting taking the pills. Maybe there's actual, real data out there on that question somewhere.
 
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Because it really might help the patient, as much as anything.

True story: I was able to get to a neurologist once, who gave me my official dx of epilepsy. (I'd been hospitalized twice already, recently postpartum, after gran mal seizures. I also had a couple of gran mal seizures when going through puberty, but they were classified/misdiagnosed as convulsive syncope at the time. My grandfather was epileptic, and my uncle was epileptic. I knew I was having seizures, but I didn't know that literally WAS what epilepsy was, even if the seizures were that infrequent. I guess I was assuming it was only epilepsy if you had seizures at least once a week for years or something.

Anyway, after getting out of the hospital the second time, needing to know wtf was wrong with my brain was the thing that compelled me to finally get the internet for the first time, and I'd been google searching terms that would help explain why I had seizures at apparent times of great hormonal upheaval (puberty and postpartum,) and I was only getting from google original research articles which were taking me something like 20 hours to even read, because I had to look up the meanings of not just the words in the articles, but the meanings of words in the definitions, too, sometimes 4 or 5 layers deep, just to get through a single sentence actually comprehending what I was reading.

So, I'm in the neuro's office asking him if maybe I can get referred to an endocrinologist to see if my hormone levels are totally wacked out, talking about the role of neurosteroids in epileptogenesis, and maybe see if treating THAT, the possible hormone goofiness, prevents my seizures if so...and he becomes all giggly and delighted saying "Yes! Yes!!! Oh, you are the perfect subject to try this with and it really might work! We'll write up a case report together and it will be so exciting and will be a SIGNIFICANT contribution to neurological science! Oh, but I have to warn you, this is totally experimental and not the standard treatment. You are absolutely my guinea pig if we try this. We will be the first to ever try this."
Which...gave me pause, first because I really had assumed something like what I was thinking was probably the first line treatment for someone like me, and two, holy crap! Doctors and patients can just, like, conspire to MAKE SCIENCE LIKE THAT? How totally awesome, yet vaguely terrifying is that? I had learned as rote memory the process of "the scientific method" in school, but it had never actually really clicked...not like it did right then, where I'd inadvertently designed the experiment and volunteered myself up as the subject, too, all as the result of my existential terror over my mysteriously and dramatically malfunctioning brain.

I chickened out and decided to just take Lamactil, his current favorite standard of care treatment (because if kindling theory was right, I was probably one seizure within the same year away from have many, many, many more seizures much more frequently.)

As he was leaving the room, I asked "So, what's wrong with me?" and he was like "What do you mean?" and I was like "I mean, what's my diagnosis?" and he stares at me with this blank stare, and then burst out laughing, and says "You know about kindling theory and the role of progesterone in possibly preventing would-be seizures, but you didn't know the name of what's wrong with you? You're just epileptic. What you have is called epilepsy" and then went into how idiopathic means "we don't know" and how my family history means there's probably a genetic factor at play in addition to who knows what else. And I was floored for a week that I'd been an epileptic for at least 15 years without even knowing it, and that I'd just read all that neuroscience without ever even encountering the notion that an epileptic is just someone who has 2 or more seizures more than 24 hours apart, not caused by an immediate head trauma, or a tumor, or fever from poisoning or hyperthermia, or some other possibly deadly thing like that.

Pro-lifers are obviously banking on the pill's very existence and legitimization somehow magically increasing the number of women with after-last-minute regrets.

I do know factors like feeling bullied by parents or partners into getting a regular/D&C abortion, combined with the pain and invasive nature of that sort of procedure itself, does cause some small subset of women to regret having gotten an abortion.

No idea what the small number of women who regret doing the pill version are, though. It probably depends (like the D&C) on if they felt forced into it by other people, and if they're given pain meds.

I know I've never encountered even a single "I regret my abortion" "testimonial" (used as "propaganda" by pro-lifers, but many are obviously heartfelt) about regretting taking the pills. Maybe there's actual, real data out there on that question somewhere.
I cannot imagine any doctor laughing at a patient.

One bad doctor anecdote is not necessarily applicable to the medical field.
 
I cannot imagine any doctor laughing at a patient.

One bad doctor anecdote is not necessarily applicable to the medical field.

He meant no harm, wasn't offensive, and he was possibly the nicest, friendliest doctor I've ever encountered. He had sat with me for probably 2 hours total, answering every single question I had to the best of his ability. And I was basically a charity patient, I think. He kept swearing that I was his #1 favorite patient he'd ever met. :)

My bad doctor laughing anecdote involves Beavis, MD., the first time I went to a doc for TMJ issues. My jaw was locked shut, after years of opera, and voice lessons starting as a kid, and an audible clicking when I'd chew by age 12 or so.

That doctor...I was probably 17, and he kept giggling, kind of snorting, and saying "It's always the young, attractive women with this. Heh Hehe heh." and "Now why would that be? Always pretty girls. Ha. Heh heh."

I didn't even figure out WTF he was implying till on the drive home. Super "does not even belong working in medicine" behavior.
 
In German, there was (maybe still is) an often used expression of "pregnancy interruption" for "abortion". As if one could resume it when it's more convenient...
 

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