Sawbones: A Marital Tour of Misguided Medicine - Sawbones: The Abortion Pill

Episode Date: April 18, 2023

Mifepristone, known colloquially as the abortion pill, has recently been in the news as its future availability in the United States comes into question. Dr. Sydnee and Justin go through the history of the medicine, from how it was discovered to how it was approved to what happened over the summer to change that.Music: "Medicines" by The Taxpayers https://taxpayers.bandcamp.com/

Saw bones is a show about medical history, and nothing the hosts say should be taken as medical advice or opinion. It's for fun. Can't you just have fun for an hour and not try to diagnose your mystery boil? We think you've earned it. Just sit back, relax, and enjoy a moment of distraction from that weird growth. You're worth it. that weird growth. You're worth it. Alright, talkies about some books. One, two, one,'ll tour Miss guided medicine. for the mouth. Wow. Hello everybody and welcome to Saul Bones, my idol tour of Miss Guy and Medicine.

I'm your co-host, Justin McElroy. And I'm Sydney McElroy. And I think probably a few people probably could guess this at any time. Healthcare is making a lot of headlines. I can assume there's a Saul Bones episode to follow, especially when you come to me shaking your head and holding up your phone, I can tell that probably there's going to be an episode. Well, I think I think this is an important thing to talk about. And there are a lot.

By the way, when you say like something that's happening in the news related to healthcare and especially like the restrictions of healthcare, there's a lot going on, unfortunately. It's not just one issue. Specifically, because this is kind of impending news, like it's happening now, and things are going to change. As of when we're recording this, things will change tomorrow. So actually, the day our show comes out, there will probably be updates to this. So this is unfolding news. But you may have read something about the Meefa Pristone, which is commonly called the abortion pill. Are you 486?

I feel like there's those of us of a certain age. Are you 486 is more familiar to me? For some reason, I must have been bombarded by that in high school or something. Well, as we go through the years of when this pill was approved and everything, it would make sense. But that is, it's funny that a collection of letters

would be more familiar. Like more letters and numbers would be more familiar. But are you 486, Meafoprestown, or the abortion pill, as many of us, when we first heard about it, called it, was recently, so it is still available, but it is its future in this country, the United States of America, as being able to be legally prescribed by physicians,

is right now in question. So that is the, is in question. I don't want anyone to, it's very important with this kind of thing that you not be too alarmist, I think, because then people think that something is gone when it isn't, and that doesn't mean it might not be in the future, but I don't want to, you know what

I'm saying? I want to be clear. Yeah. So if you've heard anything about it, you may be wondering, first of all, a lot of people might not be familiar with what this pill is, what it does, how frequently this is how abortions are performed. I think a lot of people are not familiar with that. And why in the world, if it's been around for a long time,

are we just now deciding that the FDA approval was wrong? Because that's basically what we're getting at, is should this drug that was approved by the FDA a long time ago, should it have been and can we now take action to stop it? And if you start to think about the ramifications of that and we'll get into that, that's like a giant legal question.

Right. So let's start off by saying that Meefoprisome was approved in the US in the year 2000. True. This may be why you and I think about it as like, are you 486 the abortion pills? So this would, but this would have been the year before I graduated high school. My first year of college, yeah. So like right when you're thinking, you're really

paying attention, you're thinking about a lot of like political things and activism. And this was right in there for me. And listen, my first year of college, I had to think about birth control a lot. If you know what I mean, I was an immediate sort of splash with the population there. And I mean, I can understand why I remember this because birth control was really high on my mind at that point. I like to imagine that when you say that, what you mean is like, you were very quick to like counsel people on various methods of contraception and like offer rides to the family planning clinic at the health department as needed.

And like, listen, said I would love to say that's true, but when you're living with your parents, it doesn't give you a lot of free time to do that kind of helpful work. Yeah, to help friends who can give birth and getting contraceptive services. So it has a very long track record of being safe and effective, and it is always used in conjunction with another medication. Usually mesoproestal is what most frequently is used in the US, and I'll get into the ins and outs of that first. So prior to me for prestone, pretty much if you needed an abortion, it was a procedure.

Okay. It wasn't a medicine. You went into an office, it was a procedure. Okay, it wasn't a medicine. You went into an office and you had a procedure performed. Hopefully legally prior to the 70s in this country, unfortunately, illegally and then very dangerously with high rates of complications and mortality. And we've covered that. We've done a whole episode about that. Now, there are ways of performing abortions without mefapristone with just pills and we'll

get into that regimen that exists today. Those were not commonly used prior to mefapristone being developed because the drug that we now use that we can use singly has other uses. So all these drugs are old. And the way that we do a medical abortion nowadays typically in, in countries where Mephyrstone is legal, because not all places can you access this med. You give someone a 200 milligram dose of Mephyrstone first, Mephyrstone first. In some states, you actually have to go in and see the doctor or provider to get that.

There are some places where you actually have to take it there. Now this all changed during COVID with telehealth and medicine by mail, but there were certain restrictions placed on it. Like, it wasn't something like, I am a physician, I couldn't just like send a prescription for this to the pharmacy for you. This was not something,

this was, there are some meds that are restricted. Like a commonly suboxone, the med medically assisted treatment of substance use disorder, the same thing, okay? Okay. So what this drug does is it blocks progesterone. You need the hormone progesterone for the early development of a pregnancy.

So if you don't have it, then basically you have a period. You have the lining of your uterus, the endometrium comes off and sheds and you bleed. Got it. And any other cells that are in there are going to be evacuated as well. Everybody out. Everybody out.

That's how periods happen anyway. Like, progesterone levels drop, a period happens. So the lining starts to shed, along with anything else that's in there. So the way that it would work, as Mepha Pristone being a legal drug, is you take it. You can keep on with your normal activities at first, and then in about 36 to 48 hours, your provider will tell you exactly when they will have prescribed you the follow-up pill. So there's two different drugs. The second one is a prostaglandin, usually, mehisoproestyl.

You take four, 200 microgram tablets of this, and you can do this at home. You don't have to do this in a doctor's office or anything. You can take these at home. And what this will do at this point is cause what we call like cervical ripening. So it softens the opening of your uterus, the cervix. And it causes some uterine contractions. And you can actually use it to induce labor as well. This is a very old drug.

The mesoprostal was originally developed for the treatment of stomach ulcers back in the 70s because it does that too by blocking acid secretion. So mesoprostals and old drug use for other things. We know what it does. It's a prostaglandin, incredibly safe. So you take meephypryst stone, then you take me for a postal. And we only do this by the way I should say up until specifically day 71 since the first day of your last period. That's how we

mark days and weeks when we're like calculating how pregnant someone is, how far along they are. We do from the first day of their last period. So this is around like 10 weeks. Okay. But because we need that exact dating, you do need to see a provider at first or at least talk about those dates, figure that out. You need to talk to someone who understands the med to make sure it's appropriate for you, to make sure that you are at a stage in pregnancy where this will be effective and safe. And you understand all the things we always do with a medicine, risk benefits, alternative side effects. I actually, in my charting, I always put our base, our BAS, that's my shorthand for saying,

I have discussed with the patient at risk benefits alternative side effects. That's with every medicine. I've got it. For our base, there you go. For all your medical students out there, let me give you this piece of advice. Our base.

Write that. It is effective. You have to know it, right? Just write it, right? Or you'll just do it. No, no, do it. And then put that instead of having it tight belt. Well, you've raised it. It's sort of like this will really keep them off your back.

No, no. I'll make them think you really took your time. No, no, no. I mean, it's moving on to the next cash cow. If you're like me, you want to spend more time talking to your patients and being with your patients than you do writing about it. So after you do all of this, after you discuss all those things, instead of then writing out the words, I discussed risks, benefits, alternatives, and side effects with patient

and they understood, I say, I discussed our base with patient. But then everybody's got to call you and say, tell me about the slang you invented our base. We've never heard of it. I didn't. I saw another doctor. I just handed down through the centuries of medicine. I don't know.

It was a plenty of the elder invented it. That's not true. I don't know that that's true. So it's effective. The vast majority of time studies say that around two to 5% in different areas with different medication regimens may need some sort of follow-up care after one of these medically induced abortions.

If you look at rates of effectiveness, they're up in the high 90s. And it depends exactly on where and who and different factors. So it's an incredibly safe and effective regimen. Mifopristone was first developed in France in the 80s. That's how old this drug is. It was approved for use in France in 1988. So they figured out that this was something that would work. We already knew that prostaglandins like mesoprosyl could induce labor, which would also induce an abortion, but we found this other drug, me for pristone in France, that would, like I said, it would block

the progesterone, so the combo seemed like a safer way to go about it. So that's why it was first developed. Okay. The French company that- Can you help me, sorry, can you really help me understand real quick why we couldn't just do the second one? There was some concern early on with dosing regimens about like we didn't know exactly the perfect dose and remember it was not, Misa Prostal was not developed for abortions, it was developed for stomach ulcers. Right. What we figured out is that pregnant people shouldn't take it because it couldn't induce an abortion. So it's a side effect. However, as with many drugs, sometimes you figure out that it has a side effect that actually you want, but you don't know the exact dosing regimen, you don't know how early.

So we hadn't figured all that out about mesoproestal yet. Mephyrpristone seemed a better way to stop the growth of a pregnancy, stop the process. Let's stop it. Measoproestal just starts labor. Why don't we stop the process and then start labor? And then we can ensure that everything goes along completely and that there's nothing left over. That's really important.

And whether we're talking about a spontaneous abortion, which colloquially is known as a miscarriage, or we're talking about an induced abortion, It's important that everything comes out for the safety of the pregnant person. So anyway, it was approved in France in 1988, but the French company suspended distribution like almost immediately. It lasted like, like, they were like, all these anti-abortion groups came out and were like, no, no, no, no, no. This is terrible. We don't want this.

This makes it too easy. And so they'd suspend a distribution almost immediately after they released it because of the backlash. And that lasted two days. This suspension before the French health minister came out and said, no, we're putting it back on the market because actually our country, France, owns part of your company. And I am going to ensure that people have access to this drug.

He said, from the moment governmental approval for the drug was granted, Mifha Pristone became the moral property of women will update it for the times and say pregnant people, not just the property of the drug company. Inspiring. Yes. It was then in following years, it was approved in China, it was approved in the UK, it was approved in Sweden, throughout the 90s, it was approved in like a dozen more

countries, still not the US yet. And there was a big push throughout the 90s. Pro-choice groups were constantly advocating to the US government, hey, we need this, we need this. Look, all these other countries are approving this. It's safe, it's effective. Why are we doing surgeries all the time when we could do this as a safer, more effective regimen?

The FDA banned the importation of Mifapristone as soon as it was approved in France. So 1989, it's banned here. So there were pressures already taking action to prevent that from happening. The manufacturer banned it in the US and a lot of this was just we don't want that mess. We're a simple stomach ulcer pill company. No, no, this is me for Preston. This isn't the stomach ulcer pill. Yeah. But still, no, they were just like we don't want this noise. Listen, it was hard enough here in France.

We know how you people over there in the US get. Just, we don't want any of that. So basically, what ended up happening is that a woman named Leon Abentin was stopped by US customs bringing me for pristone into the country from the UK. So at that point, even though eventually it's just she lost because she was bringing a bandrug into the country from the UK. Oh. So at that point, even though eventually I should, she lost because she was bringing a band drug into the US. So whether or not morally, she was on the right side.

It doesn't really matter in the eyes of the law, right? But it brought a lot of attention. And so then when Clinton became president in 93, he said, hey, everybody's talking about this. I want the Department of Health and Human Services to look back into me for press down and let's decide if it's a good drug for the US or not. So kind of like started over the conversation in this country in an effort to move towards lifting the band.

And the company that originally made me for press down who didn't want any of this US noise. In 1995, gave a United States group called the population council the rights to it in the US and just said, it's your problem now. You decide what to do with it. We're done with it. How weird. Right. I mean, I think that it, I think that it just shows how, what a lightning rod this issue is.

And how, I mean, I think when I say protests, you've got to remember that people who protest abortion rights, sometimes we're talking about your normal, what we in this country would think of as like peaceful, first amendment right. Yeah, demonstrators. Yeah, demonstrators. They stand with signs and

chant. Somebody's got a megaphone. Somebody comes up with clever rhymes. The usual protest. I'm not just talking about that though. There are people and we all know this who protest abortion rights by committing acts of violence. And so these drug distribution, I mean, these drug companies acts of violence. And so these drug distribution, I mean, these drug companies were, I mean, they were receiving threats. Of course. Yeah. Their lives were at risk. Of course.

Yeah. And that often is the case, whether you are the manufacturer of an abortion pill, or you are someone who works at an abortion providing clinic. Your life may be in danger because of the evidence-based medical care that you provide. And so I think it's important to just not say like, it's not always just optics. Sometimes it is with drug, I'm not going to sit here and give drug companies a pass. I think you know that. But it's not just optics.

It's your very life that can be at stake. It pains sitting greatly during COVID to be cheering for drug companies and defending them against. We're good at it. We're defending them against. We're good at- That's a good time, Axeble. Here's a little spoiler. We're gonna end up on the side of drug companies again towards the end of this episode.

I know. No, Sydney, this is so confusing. Politics makes strange bedfellows. Did you have been taking their free lunches and pins this entire time? No. So refusing them? No, I am.

You're gonna be such good pals. We are not good pals. I still refuse your pizza. I have to be such good pals. We are not good pals. I still refuse your pizza. So anyway, the Russo Uclaf, who was a company that had it, gave it over to the population council in 1995 and said, you deal with the US. This is your thing.

So at that point, the FDA said, okay, we're going to take it up again. We think that their advisory branch actually recommended, like, okay, this can be approved here. They've done all the work. This is safe and effective. We can prove that here. But it wasn't that quick. It took a long time, many, many regulatory like trials because it was such a hot button issue,

because the spotlight was on it, because of all the protests. And because when I say protest, there were influential people within the government who were using their money and power to try and stop this drug from coming to the market in the United States. Naturally. So it took until the year 2000, when finally it was on September 28th, year 2000. Mifapris Stone was approved for medically induced abortion in the United States of America. Long time ago.

12 years after it was synthesized, of America. A long time ago. 12 years after it was synthesized, yes, and a long time ago, 23 years ago, almost here. It could drink. So that should have been it. We've been using it since then. We have a long track record of it being safe and effective. So you do all the trials,

and then you release into the population, and you see as anything going wrong with it, and you find no. Well, I gotta say, it's a think we should episode but still very interesting uh that's going to do for us on sub-hands this week thanks to downstairs for using the so unfortunately we have some updates as many of you know to the story but before i get to all that let's go to the building department let's go the medicine the medicine that i skill at my cards for the mouth.

Hey there beautiful people. I am your favorite author, Rest Trayville, and the son of we see each other of Lacktrades, Jürte, through TV, and feel you. You know, this is supposed to be a promo for our show, Fantai, and not your book, right? It's called Motte Task, and I can't with you right now. Treval and I have an award-winning show called Fantai, and not your book, right? It's called Motie Tasking. I can't with you right now. To Val and I have an award-winning show called Fantai,

that we both host and it's a podcast where we dig into the complex and complicated conversations about the gray areas in our lives. Perhaps there is a public figure of some sort, and you're like, oh, they're person so smart and so charming, but you're also like, oh, that person gets on my nose. Okay, okay, you can catch us every week right here on MaxFund, or wherever you get to

slayworthy audio. And you can watch us on the YouTube every Friday! That's Fantai, F-A-N-T-I. Since we reached our highest milestone during the MaxFund drive, we are creating a MaxFund Foley Library full of sound effects from your favorite hosts. The whole Max Fun community will be able to use it. So, what would you like it to feature? People high-fiving, walking through mud, chicken-clucking, jazz-cazoo, head to maximumumFun.org slash Foley. That's MaximumFun.org slash F-O-L-E-Y and submit your ideas. We're excited to make this silly thing together and even more excited to see what you all create with it.

And thank you again for a great Max Fun Drive. Max Fondry. Ever after. It's the second. Yeah. Yeah. This is like into the woods. To stop it at the end of the first act, trust me. It's all happy. So as I alluded to, that isn't the end of the story.

So first of all, just because it was approved in the year 2000, it wasn't easy to get. There were certain restrictions placed specifically on this medicine that, again, as I mentioned aren't on most, right? If you come to me as a doctor and I say, hey, I think you need this blood pressure medicine. I will send it to your pharmacy and we'll both move. I'll talk to you about it. Of course, we'll do all the things, all the our bases. And then we'll both move on with our lives. You'll go get it to your pharmacy and we'll both move, I'll talk to you about it of course, we'll do all the thing, all the our bases. And then we'll both move on with our lives.

You'll go get it from your pharmacy, you'll take your pill, I'll see you, we'll check your blood pressure, whatever. Well, with me for Prestone, you had to actually go in person and pick up the medicine. In some states, you actually had to take it there. Oh wow. Sometimes you could get it and take it home.

Yeah. Now this was until COVID. In July of 2020, there was a temporary injunction that placed specifically to allow me for pristome to be mailed. Because a lot of other medicine shifted that direction during the pandemic, right? And so as that was happening, as you can imagine, people were saying, well, shouldn't we do the same for me?

Why are we requiring people during the pandemic to go in person to an office to get a pill? To date, you could get, yeah. That we could just mail to them, right? Like, why would we do that? Yeah. And so this was allowed as a lot of meds were. I mean, this was common during COVID.

A lot of things were shifted to telemedicine. And with a good basis for how we can manage that and how we can continue to safely monitor these medications. But everything changed last summer because Mephyrstone is a medication that induces abortion. Of course, the dobs ruling last summer, which overturned Roe v Wade, has an impact on Mephyrstone as well. I think a lot of times when you think about a state that may have banned abortion,

you think about like, wait, now you can't go into the clinic and get that procedure that I think I know about that's an abortion. Because I think a lot of people, unless you've had one, although a lot of people have had them, which is also something we don't talk about enough. They're very common. But a lot of people who haven't had one in the medical field, you don't really know what that entails. Well sometimes it's just some pills.

And those were banned as well to be used for that specific. And there'd be no other reason to prescribe me for Prestone. That's the only thing it's for. Measuprost also has other indications, but you can't use it in states where abortion was banned. You can't use these pills for that either, right? Like West Virginia, for instance, the state that we live in. But this doesn't change the fact that Meefe of Pristone is still

an effective and safe drug that has been used since 1988 in France, that has been used since the year 2000 in the US and has a long and strong track record of, you know, being a safe medication. So deciding that, like, all the sudden, the FDA approval that it got was wrong is really an unprecedented decision to take a medication that is two decades old in this country. We'll just focus on the US because we do our own thing, right? Like we don't, we didn't just follow France's approval. We had to, we had to check them, see for ourselves.

Doing this is, I mean, this isn't something that is done because if you think about the process of FDA approval, this isn't like one person. It's not just like they get three dudes in a room and say, what do you think? Yeah, you're right. And so the idea that one judge would be able to counteract that. To counteract the years and

dozens of scientists and doctors that go off-processed. It seems like maybe judges shouldn't be able to do that. Well, maybe they've never done that before and so all the sudden we're in new legal territory. Is this why? Is this something they should do? Can do? We'll do more of. So I think in order to understand,

why would a judge take this sort of unprecedented dramatic activist action, which is what it is? Yes. You know, you hear a lot of these activist judges. Yeah, this is really what it is. Yes. You know, you hear the... A lot of these activist judges. Yeah, this is really an activist judge. Yes. So, anti-choice activists have been trying for a very long time to do this exact thing, to call into question the FDA approval of Mifapristone.

And there are a lot of different ways if this is what you're going to invest your life into doing is fighting abortion care, there are a lot of different ways to go about it. And this is one pathway that groups have tried for a while. So there have been petitions from groups like the American Association of Pro Life Obstetricians of Gynecologists that have tried to say, no, the FDA was wrong. We know we're doctors, the FDA was wrong, and have tried to do this in the past. There are other groups that have started aligning with them.

They're called the American College of Pediatricians. That sounds like that's just, oh, that must be a pediatric group. It's not. It's a specific advocacy group for specifically this issue. There's the Christian Medical and Dental Associations, the Coptic Medical Association of North America, and the Catholic Medical Association that have all joined together in similar efforts. And as you can tell, a lot of these groups are religiously motivated. and the Catholic Medical Association that have all joined together in similar efforts, okay? And as you can tell, a lot of these groups

are religiously motivated. That is the basis, yes, they are doctors, but they are coming from a shared religious perspective. Because of all this kind of noise, there was a congressional review of this in 2006. The house held hearings on it to say like should the FDA approved it. And in 2008

There was this big report issue that said yeah, it's safe It's fine. This was fine But what has happened in recent because of the last presidential administration is that a lot of districts Have been stacked with far right conservative activist judges And that's something I think none of us really pay enough attention to right. Yeah. Do you know when presidential administrations appoint new judges? Do you pay attention to that?

Now, honey, if you're looking to establish a baseline of American intelligence, I'm not sure that I'm the best person to be using here. I shot my phone with a taser. I, you know, I'm not a smart man. My dad once knocked himself out, dumbing bleach into kitty litter. I don't come from good genes in that regard. I just think if you're trying to establish like an every man,

I'm like, so like I'm sub that. Listen, well then let me go ahead and throw a shade on myself. Okay. I don't pay enough attention to this. And I like to think I'm someone who pays attention to all that stuff that you're supposed to. I like to think that I'm watching and you know, involved and thinking about the implications

of all these. I forget about the fact, and I think a lot of us do that presidential administrations, especially when they have the Congress on their side, can appoint a lot of judges very quickly, and they don't necessarily, I think the Supreme Court sort of highlighted this for a lot of us, because for many of us,

maybe we now look at the Supreme Court and think, are they making judgments based on all of our best interests now? And ask ourselves that question, do we agree with that statement now? Well, that's happening on every level. And we forget about every level that isn't the Supreme Court a lot too often. So in late 2021, all of those activist groups that I mentioned formed the Alliance for Hypocratic Medicine. Now, what is the mission of the Alliance for Hypocratic Medicine? Just to keep it real, like with the Hippocrates' stuff, just to keep it.

They uphold and promote, this is from their website. They uphold and promote the fundamental principles of Hippocratic Medicine. These principles include protecting the vulnerable at the beginning and end of life, seeking the ultimate good for the patient with compassion and moral integrity and providing health care with the highest standards of excellence based on medical science. Yeah, seems good. Seems good. Yeah, that's great. They quote some of the oath on their page. If you go to their web page, there's not much there to look at. You have to be a member and have a password, I guess, to look at all the juicy stuff there.

But they quote, some of the oath, I will say they don't quote all of the oath, they leave out the part about how they won't cut for the stone, because you know, that's surgery. And like, we do do do that. Some of us do, yes, some of us do surgery. It also, by the way, and we've done a whole episode of the Hibocratic oath, so just as a refresher, it starts by swearing to Apollo and all the other Greek gods and goddesses.

This is in the first part of the Hippocratic Oath. Yeah. I have to imagine that these Christian medical organizations do not swear fealty to their remnant. Yeah, to Apollo. But and also they don't conveniently medical students. They don't mention the part about where hypocrite said, I'll never charge for teaching people medicine.

We never mentioned that part because hypocrite has also said that. You should teach people medicine and not charge them for it. So I don't think they'd be comfortable with any of that, but they leave that out. They leave that they leave the parts they don't like out. I also think that a group that, but they leave that out. They leave the parts they don't like out. I also think that a group that says that they are for Hippocratic Medicine and we do a medical history podcast, so I feel like I'm allowed to comment on this.

So do you mean the four humors? Because that is what that means. That is what that, I mean, that was the system of medicine. The humoral system medicine is what hypocrite is followed. So do you, where is my flim and black bile and yellow bile and my blood and like, how is that in order and what, what hot or cold things do you want to do? And do you mean you're going to put leeches on me?

I just think that if you're going to say we follow hypocrite's maybe you should know what you're talking about before you start. Yeah. But that wasn't the point, the point of forming this organization was to incorporate it in August of 2022. That's how recent this is. So it was formed in late 2021. It was incorporated formally in August of 2022 in Amarillo, Texas. Why there? It's strange because none of these organizations that make up their group are based there and they're mailing addresses in Tennessee.

So why would they incorporate it in Amarillo, Texas? I don't know, Sid. Because cases filed in that area, 95% of any cases filed in that specific area of the country fall to Judge Matthew, Kazmar, Kazmaric. Kat, I don't care, Kazmaric. I don't care, Kazmaric. I don't want to get into his entire history. You can look up the history of his opinions and the briefs that he's followed in the past. He has worked to deny

contraception to patients, like to allow pharmacies to deny contraception, to allow doctors to refuse treatment to transgender patients. He has worked very hard in anti-choice efforts to allow doctors to refuse treatment to transgender patients. He has worked very hard in anti-choice efforts to deny, to use legal methods to help groups deny abortion care and abortion in different parts of the country. So this is his thing. This is the background he comes from. And so filing this in this district was very specifically, this was a, there's a word for that. You do like judge shopping. You find the district where you know, you'll

get the opinion you want. Right. And inevitably, he ruled that the FDA approval of the drug was not done appropriately. And it was fast tracked. And well, basically, we're not, it shouldn't, we should go back to the FDA. We should stop its approval and go back to the FDA and make them prove it again. But then he did stay his ruling for seven days to basically say, well, allow the government to take action if they want to. So, you may be asking, was it fast tracked? Like, that's the, that's the, well, was it a good, do you want me to ask that?

Was it fast tracked? Like, that's the, that's the, what was it? Good, do you want me to ask that? Was it, was it fast tracked? That was the core argument of the Alliance for Hippocratic Medicine. They're the lead plaintiff. There are other people who filed it, but they're the lead group. Was it fast tracked?

No. The core argument that they're making is that the, the expedited approval process that we all heard so much about during COVID, during the vaccine approval process. That was actually not used in the approval of Mepha Pristone. So the core argument is not true. Yes. When the drug was submitted for approval in 1996,

it went through multiple rounds of evaluation and everyone, it was approvable and then it had to go on to the next one. There were elements, and it's really important. I'm not a lawyer, but it's really important that you ask somebody who knows this stuff. I actually, and I should preface, I was not given any formal legal advice, just thoughts and opinions from a certain first-year law student that I know named Riley Smirle, who gave me her thoughts and opinions.

But again, as she said, multiple times, this is not legal advice, Sydney. So as they went through this process, they used a couple of the elements from the accelerated approval section of the FDA accelerated approval process for some of the safety elements. But it didn't actually follow that pathway. It followed the traditional pathway for drug approval.

So it didn't receive accelerated approval. It went through the normal check. It went regular fast track. It was not fast track. And based on major studies from France, and also they had said initially, we want to wait till this major US study is done before we approve it. After that was done, and it replicated the same results that they found in France, then they approved it. So it met all the usual requirements. None of that is true. So the core reason that the judge issued this opinion is not true.

Whoa. Uh, meepha prestone has been used for 35 years. The side effect rate is extremely low. It's safer than a surgical abortion, that does not mean that a surgical abortion procedure is not safe, but this is, if it is available to you, if you're early enough into a pregnancy, this is considered the most safe and effective. Safe is almost always a question of degrees, right? Yeah. Safe is, there's always some little, you know, nothing is 100% perfectly safe all the time.

No, and they're always like safe as like, okay, obviously we would prefer to do an elective procedure over an emergency procedure, but if your appendix has ruptured, we can't do an elective procedure on you. That doesn't mean that the emergency surgery you receive is unsafe. No, it's safe. You are having a safe surgery. So I mean, I think it's important to know that. And in fact, in 2020, that was the first year that the majority of legal abortions performed in the United States involved medicine, 53%. So more than half of abortions in the US,

as of our last tally, were done through medicines, not through procedures. No, we don't, that be talks about that. No, we don't, that'll be talks about that. No, I don't, I don't think, I don't think a lot of people realize that. And while there are complications to any medications, there are side effects. It, of course, of course, you expect that. That's with every single medicine and procedure that we do. There can be complications or side effects. As of our last accounting, the chance of dying from a legal induced abortion in the US

is less than half a person per 100,000 performed. Wow. It's like 0.43. Your chance of dying in pregnancy in the United States of America as of our last accounting was 32 people per 100,000. So it's more dangerous, exponentially less dangerous than being pregnant? Yes. Just to throw that out there, and that's not to make everybody afraid of being pregnant.

Our maternal mortality rate, our pregnancy mortality rate is still something that the United States should be tackling and doing a lot more, but that's another podcast. So not another podcast. That's a different episode. but that's another podcast. So, not another podcast. That's a different episode. So to be clear, even if me for Pristone, even if this is upheld by the Supreme Court, and we cannot obtain that, I want you to know this

if you are someone who may need this care. A mesoproestal alone regimen is still safe and effective. There are many countries who only have access to that and who only use that regimen, and it still works. Our feeling is that if you use from studies that we've done so far, Meef or Prestone and Meef's are postal together, then you have fewer side effects. That is why we try to do that regimen preferentially when it is available because you are less likely to have side effects than with a mesoproestal alone regimen. But the World Health Organization will say, these are essential medicines and both regimens are safe and effective. So please do not, whatever the future holds,

do not take away from this episode that a mesoproestal, a single drug regimen for medical induced abortion is unsafe. It is safe, is effective. However, we are restricting a drug that is safe and effective and is our preferred regimen based on false arguments. I think that's the important thing to know. Just so you kinda know where we are because a lot happened all at once.

So that judge ruled that basically the approval of me for press zone was not in accordance with law. And he said the FDA had to suspend its approval until they do whatever he wants them to do. But then he stayed his own order for seven days and said, now the government can fight back. They've got a weak fight back. Within an hour, another judge, Rice in the Eastern District of Washington, ruled in a separate lawsuit

that the FDA should not reduce the availability of Mifapris Stone anywhere in the United States. So these are conflicting rulings, for judges kind of at the same level. So this Supreme Court has to decide. So now it's gotta go to the Supreme Court. So the Supreme Court said, nobody do anything. You've got until Tuesday to file your briefs. So Tuesday, April 18th.

This is tomorrow as of when we're recording this. That's when you have to file all the briefs for us to look at and decide what we're going to do about this incredibly safe and effective drug that has been approved in the United States of America since the year 2000, that has been approved worldwide since 1988, and has a long track record of doing exactly what it says it's going to do in a very safe way, and they will decide what to do with it. And I really think it's important, especially if you're in the medical field to pay attention to what's happening right now

because the pharmaceutical lobby has always been more effective than the doctor lobby, right? Much to our chagrin. The pharmaceutical lobby has taken steps to come out and issue statements and write a letter, an open letter to say, you don't know how dangerous this could be. Not just because restricting access to this drug is dangerous.

Preston, the precedent. Yes, because if at any point an activist judge can decide based on their own personal, religious, moral, whatever beliefs, I mean, that's what this is about. Their own personal belief of one human can look at a drug and decide they don't think people should be able to take it. And what other drugs might that have an impact on? I mean, initially, immediately I start to think about the hormone therapies we use for our trans patients, or hormone blockers that we use for trans patients who are younger. Start thinking again about various forms of contraception.

I mean, think about how many people out there don't believe in certain psychiatric conditions and would restrict access to different psychiatric medications that they feel are unnecessary or in some way violate their own religious feelings. I think the implications of a single judge being able to overturn all the processes that the FDA has in place to approve these medications

are terrifying. And it's something that could impact all of us. And it's unfortunate that when something only impacts a certain segment of the population, we're supposed to let it slide. And we have to worry that like, well, but what if food impacted me? But that's the truth. This could impact every single one of us if this goes forward.

And so I hate to be on the same side of the pharmaceutical lobby. But they're right. It would also pressure through financial pressures. If you're a company that's developing a drug that might be subject to these sorts of rulings, if you're maybe a drug that would prevent HIV or treat HIV, maybe vaccines that are controversial, maybe you just decide, and this is not worth it. We don't want to deal with the regulatory headaches. So we'll just start working on other drugs.

Yeah, and it's not that wild considering literally 20 minutes ago in this episode, we had an incident of a company making that exact choice, the French company deciding to not be involved with this medication because it's not worth it. It's important that those of us in healthcare are standing up to speak about this too. Activist groups are doing it. The pharmaceutical lobby is doing the right thing. Where are we? Where are our voices?

I'm here, okay? We are not loud enough. I'm doing a pot. Okay. Thanks for listening to saw bones. A marital tour of Miss Guy to Medicine. We hope you, well, enjoyed the weird. Got something out of this and can maybe use that knowledge

in your day-to-day life, fair? Thanks to the taxpayers for using their song medicines as the intro, not your program. Sit any final thoughts before you looked like you had final thoughts. No, I don't want to, again, I'm not trying to alarm people, but please pay attention to this because obviously abortion care is healthcare and it is important in its own right just

because of what it is. But the implications of allowing some groups, personal religious beliefs to dictate healthcare access for everyone in this country are, it's a really dangerous place to put us in. And especially my fellow healthcare providers, we have not been vocal enough in fighting this. And at the end of the day, we are the ones who are gonna have to, are gonna be put in a position where we provide bad care because we are not legally allowed

to provide standard of care. And that is happening every day. And I just, I think we all need to be paying more attention and being more vocal about our part in this. That's gonna do it folks. Thank you so much for listening. We will be back with you again next week until then, my name is Justin McRoy.

I'm Sydney McRoy. And as always, don't drill a hole in your head. Alright!