Mifepristone and the Judicial Review of Drugs
In this mini-sode, Tyler and Devan discuss the various court rulings about the drug Mifepristone and the recent decision by the Fifth Circuit regarding its status.
Read more on the developing situation here:
Background information on the FDA approval of Mifepristone 23 years ago.
Read about the two cases that led to the DOJ asking the Supreme Court to restore access to Mifepristone.
Opinion letters reflecting views of people across the country.
Key points and take-aways of the various lawsuits.
How this ended up at the Supreme Court.
The consequences of banning Mifepristone.
How the Texas ruling might impact health and science.
Information on the Texas ruling and how it changes access to Mifepristone.
Transcript
0:18
So, Tyler I know the answer to this, but for the rest of the podcast listeners, what have you been obsessed?With, not just this week but the last three weeks?Well, I think unsurprisingly, there's been a bunch of legal.I don't know.
0:33
Shenanigans, is that the right word?So, there's been lots of legal activity about this.One particular medication that I thought it would be really helpful if we kind of talked through a little bit.And so the drug is Is he ready for it?
0:51
Yes, we say that the same time, when I you say it, and I'll say, if I think that that's the right way to say it, okay?One, two, three cocaine.No, it's my Presto own if a presto, okay, that's right.If the priest own, right.
1:09
So, mifeprex town is this medication.That is the heart of a bunch of legal activity, and political maneuvering and man, Just really is a it's all over the news right now.That's right.
1:25
So I think maybe we should just start off with like, what we know about mifeprex tone as a drug, right?So it's it's being called an abortion drug.We know it's about 50 percent of abortions are medical abortions.Used this drug in combination with another drug, but we also know that it is used for a few other things, some off label things, it's also used for miscarriage.
1:50
So it's not as if it's only used for medication.Ian, but that is seemingly the biggest use of this drug.And so, it's being targeted, given our sort of post-ops world as another access to abortion, that some states would like to restrict is that, is that fair?
2:10
Yeah, I think that's, that's, that's right.Usually, when we think about abortions, I think that most people in their mind think of surgical abortions, which there's a large number of abortions.And when we're talking about abortions, I think it's important.And to highlight that we're talking about both wanted and unwanted terminations of pregnancy, right?
2:31
So some people very genuinely, do not.They want a child, the pregnancy is intended and they want to have the baby but for whatever reason sometimes it's medical that they decide to not go forward with that with the pregnancy and sometimes that requires surgical intervention and sometimes the pregnancy is not far enough is far is early enough that medications can do the same function, right?
3:01
So there's two drugs that are used in tandem one like you said is myth oppressed Stone and the other one is called misoprostol and again, like we're not real doctors, so the pronunciation of these is probably a little bit different.
3:17
But so yes, if a stone is used to actually it, Sir, interacts with the hormones of the woman and if that gets interrupted, then the next drug is used to contract the the uterus and actually expel the uterine context, right?
3:37
So it's kind of a two-step process and mifeprex stone is being targeted as the kind of the first step in that in that two-step process.And after Dobbs which for those of you who are keeping up on the Cream court rulings.
3:56
Recently Dobbs is the case that overturned the Protections in row row row versus weight.So row allowed a nationwide access to abortion and it didn't specify surgical or medical abortions and then so that was 1972 ish.
4:22
And then What was it?Almost two years ago.That Dobbs was overturned.It was it just last year.Oh man, I can't even remember.Hey, you're the legal expert?Tyler supposed to do these things.I know.It's been a it's been a year.But so Dobbs is the name of the case that went to the Supreme Court and the Supreme Court said this right to abortions underneath the, the Privacy protections of the Constitution, doesn't make sense anymore or never did make sense actually And therefore States should have the power to regulate how.
5:00
And if and when and what Manner, abortions can take place in their states, then as predicted all of the states, then create their own rules about whether or not abortions are available.And then also how abortions and when abortions can take place.
5:16
So that's kind of big picture where the legal landscape is states that have the goal.I would I'd say the interest in reducing the number or the type of abortions performed in their state have taken a couple of different approaches to how to limit the number of abortions.
5:34
And that's how we get laws about certain timing of when abortions can or can't take place.So, six weeks, 10 weeks, 14 weeks, 22 weeks.Sometimes there's cut offs and then there's also reasons for the abortion.
5:49
And so, this is something that gets brought up all the time, is there If abortions are prohibited within the state are there exceptions, whether it's a medical exception or whether it's because the the pregnancy was the result of a rape or incest or something like that, the health of the mother is at risk.
6:12
So so there's all these different exceptions that may or may not be created within the states to actually either limit or put some sort of rules on abortions.Good.That's like a really good overview.I'm glad that you are our legal expert if you're not our timeline expert.
6:31
Okay, so something really big then happened.It's about been about 3 weeks.Now in the Glorious state of Texas, a judge made a pretty controversial ruling Texas already has now, three laws about abortion that have restricted abortion, but this was I think in some ways unexpected what he said about mifeprex tone, so can you walk us through?
6:58
Kind of what the judge in Texas said initially.Yeah.So I think before we get to what he exactly said, I think it's important to highlight the ways in which laws get created in our country.So the if you'll remember the how does a bill become a law school of rock video.
7:19
So the one way that law is get Didn't this is true for States, it's true for the federal government.So a legislator, someone in the legislative, branch can propose a bill.It gets debated and then either gets written into law signed into law or not.There's a lot more that goes into it.
7:35
Another way in which laws or public policy gets enacted in the United States is through the judicial branch.So a judge can say, this is the law or this is the way the law is going to be interpreted, or this is the way it's going to be applied.
7:52
And for Public Policy or changes in kind of social policy that are really problematic to get through the legislative branch.So say that there aren't enough votes or whatever in the in the legislature to actually change laws.
8:08
That may actually be really harmful.Sometimes the best way to change.Those laws is to go through the judicial branch and so a good example of this is Brown versus the Board of Education.That's a classic case where the It, the state laws and the about this notion of separate, but equal education in the United States, it was going to be really hard to get that change through the legislative branch.
8:35
So, actually a change in the statute, but instead, they went through the judicial process and had that law or that portion of that law, declared to be unconstitutional.And so people who are interested in equality and interested in equal access Us education and stuff like that.
8:54
Went through that process to the judicial activist litigation is, is one of the terms.It's used to describe it.They are able to change the laws and so that's what's happening.That's what happened here.Is that instead of going through the legislative process, they went through the judicial review, and a group of people organized themselves in a jurisdiction in Texas that they thought, Got it again.
9:23
We're kind of, I think we're kind of armchair quarterbacking this a little bit trying to read into them, into their intentions, a little bit from just, what's publicly available information.But regardless of what their true intentions were they, deliberately, they intentionally organize themselves within a jurisdiction that had what was known to be publicly known to be a very conservative, a judge, who had a very conservative interpretation of abortion.
9:50
Abortion, rights, and abortion access.And filed a lawsuit, claiming that mifeprex stone was actually, should not actually be legally permissible to distribute or to use or to order prescribed within the United States.Yeah, I don't think it's too much of a stretch to say this National group of Physicians Incorporated.
10:12
In a part of Texas that only has one judge that they knew they would draw for this case so it doesn't, you know, Maybe where it's just conjecture.But why would they have chosen Amarillo as the place to incorporate?
10:28
It's pretty transparent.What their objective was is we talked about this sometimes with like, oh, it's so hard to know people's intentions.When you talk about in medicine like well double effect, who knows what somebody's intention is and my response is always, nope.You know, by their actions.
10:44
All right, you can kind of you.Often can tell people's Intentions by the thing that they do.Right?Maybe it's a little bit of mind reading.But if that Wasn't their intention.It's quite the coincidence.Yes.All right, I think that's fair.Maybe I was trying to be too dainty to politic being to magnanimous with my interpretations, but I think that that's probably not think that's true.
11:10
So this group filed, this lawsuit in court in the court where they knew that the judge was going to at least their suspicion.Was that he had this particular view because he had Published about he'd written about it.It was very open about not just the issue of abortion but also other other kind of social policy type of issues.
11:31
So they filed this lawsuit, claiming that mifeprex stone was and when you file a lawsuit, you know, this that that you can file multiple claims at the same time, right?It's not just a this is my claim.Decide this mr.
11:49
Judge it is here's a whole list of claims that I'm making all the same time and you can kind of rule on each one of those as it as you want.And so this this judge was presented with the case that their mifeprex Stone specifically was unsafe and it was ineffective in doing its job and and that is exactly what medications are intended to do and that's what The FDA process of approval is intended to decide, is it safe?
12:22
And is it effective?It's pretty bold claim, right?That that these doctors are going to, you know, they're their authorities on medicine and so they might have evidence that this is unsafe but really the it's the job of the FDA to decide if something is safe and effective.
12:39
And they this has been FDA-approved whatsoever 23 years.It was approved in 2000.So it's a pretty Bold claim right to say, I don't know, maybe the FDA didn't do its job or there's been more recent evidence that the FDA is not looking at that.We have that this huge group of scientists has been ignoring.
12:58
Yeah, that's right.That is literally, the fda's job is to look at the look at the science.Look at the studies that are presented and to make a determination on efficacy and safety.And yes, twin 20 in 2000 year 2000.
13:15
So it's been 23 years, 20, And a half years since this was approved, it's really hard.If you take away the political aspect of it it's really hard to wrap your mind around.Why now for this case and there hadn't been new studies.
13:32
There haven't been, there's not new science that undermines this.This this drug so.So that's what their claim was.Number one, it's ineffective.It shouldn't have been approved will because it's ineffective.Because it's unsafe.
13:47
There's also a third claim which we'll talk about in just a minute which has to do with an old law from the Civil War era that will talking always good to bring up.Yeah.The Civil War was a great time for making laws and so it seems super relevant to today so I'm anxious to hear about that, you know?It's surprising how often that's coming up.
14:05
Isn't it that these yes current laws are being under you know, removed from the books and then all of a sudden we've got a law from 1873 that we're trying to apply to Current times itself.All right.So the judge ruled in Texas ruled that while he basically, he bought their, the argument of these Physicians and whether or not he actually, there was actually standing, which means that in the United States legal system in order to file a claim, you have to have been the one that was harmed.
14:38
So if you are in a car accident, I can't sue somebody on your behalf because I'm really upset that you were hard And in this car accident, right?I have to be the one who is harmed and that's called standing I.So I have to have standing in front of the before the court, in order to file a lawsuit and the standing claim that these in that this group made is a little, I don't know.
15:03
Squishy.Is that except the right word?I, I think.So what I heard it, I was surprised that they could have standing because what they claimed was, as far as I understand it, that there are Men who come in after using the first time because they're concerned about excess bleeding.
15:23
And I think that that's fair, right?Any sort of miscarriage or abortion can have a lot of, a lot of bleeding in it.Understandably, freaks people out or they could have some sort of complication with are claiming lots of complications from this drug which are pretty suspect, but they are afraid that a woman would come to them with this urgent need and that they would have to treat her because emtala says that we have to treat people in a medical crisis.
15:49
We can't turn them away but and not only with this e unfair to these Physicians who think that abortion is wrong.So it would be sort of a you know, they'd be treating somebody against their conscience but also that would take up time and energy, they could have spent with other patients that needed their care.
16:07
So it is distracted from the job they want to do because women would hypothetically come to them with this need Right.That's how I understand it as well.And that, I mean, I am not their lawyer.
16:23
I've not anybody's lawyer, but gosh.That's a it's, a will say, creative claim for standing, but judge bought it.And that's and, you know, the a good legal argument is validated when a judge says, okay, I'll buy it, so he granted standing whether or not that holds up is, that's a different story.
16:44
But so they're standing and then the judge ruled that Basically, you know, he, he bought all of their arguments and wrote a really long opinion, and it says that number one, it is unsafe.
17:03
And number two, it's either not effective or not as effective as other interventions.And so then we get to the third claim that they made, which is that if it's not safe and effective and also because it is deals with abortions, Civic leaders in 1873 law called The Comstock law, which prohibits the u.s. mail system from Distributing quote indecent or other material.
17:34
That is against, you know, public policy or against basically, you can't send, you can't use the u.s. mail system to distribute things that should not be distributed upsetted.
17:51
Jean material, indecent material, the word lewd, and lascivious or used, which are two of my favorite word's.Great words.Great words.Yeah.So then the judge said, because of the Comstock law, prohibits prohibits the distribution of this stuff, then it has to.
18:11
What follows from that is that a nationwide ban on distribution of this medication, which puts All types of non surgical abortions at risk because this is the drug.This two-step drug process is the standard of care.
18:29
It's the safest most effective way to accomplish the medical goal.Yeah, so a combination of really interesting rulings, but he says in his wisdom, would this make sense this won't go into effect immediately?
18:47
Let's wait to see if this gets a peeled up.The line to the fifth circuit.So let's give it seven days to see if there's an appeal process that needs to go through recognizing that this would probably be a controversial ruling.Yeah.So I think the smartest thing that he ever liked The most correct accurate thing that he said in his opinion was this may be controversial and up for appeal, right?
19:14
And I mean the same day, there was a similar case different, a little bit different legal argument in a different jurisdiction in the United States up in Washington.That came to a different conclusion.So you have these two courts in two different parts of the country.
19:30
Make making or issuing rulings that are Seem to be at odds with each other.So there's a conflict between them and when that's the case in the Federal Judicial System, that is almost an immediate appeal to the United States, Supreme Court to figure out that the circuit split or the difference within this federals because we can't have inconsistent laws in the federal system, right?
19:58
That's the that's the reason for the review.So, So I tell it, I wonder if it's worth mentioning and maybe you'll get to this, but we'll post a bunch of links on the website.But is there any good scientific evidence to say that if a person really is unsafe, the ineffective claim is odd.
20:21
It only makes sense.If you say that, surgical abortions are more effective and more safe, I think that that's the effective sort of side of it, but the unsafe is really what got a lot of attention because I looked up all the studies, there's I've been a meta-analysis of a lot of these studies of thousands of patients.
20:39
And really, it seems very safe which isn't to say that there are never adverse effects.There's never sort of risk.Every medication has risk, of course, but there's been a lot of claims in the media and by groups that have supported the initial ruling that this really is unsafe.
20:55
So, what do we know about safety?I-i've been reading the same stuff that you could reading.It's, I, I don't, I don't see it.But again, like they're, there are other smart people involved that are making this claim.
21:11
But I there are definitely more risky, drugs, more dangerous drugs on the, on the market that are used routinely.And if, if if that's the case, then it's really hard to draw the Illusion that this is anything other than an over attempt to limit abortions for other reasons.
21:35
It's hard not to draw that conclusion.So we'll put the studies up on the site.But I looked, I mean, there are a couple studies that showed some some level of risk and it's it's just up to thousands of people.I mean, this is, it's such a low percentage, it's such a safe drug.
21:53
I don't see the evidence for it.So we'll put those up and let people decide for themselves, but I've looked at the studies, I can't make sense of this claim, unless you think that anyone getting hurt from a drug ever, should make the drug unlike unavailable to anybody, in which case we have to withdraw, almost every drug on the market.
22:13
It just can't be the way we go about doing this because there's always some level of risk in any medication that you'll ever take.Yeah.We that's your talent all bottle is a lot of risk.Exactly.And that's setting aside the whole issue of whether or not abortion Options should be permissible or not and right.
22:31
And you, we can have very different opinions about whether abortions are morally or ethically, permissible, and under what circumstances, they might be, but what concerns me about this case.In the way that this is progressing is that it's giving a federal judge.
22:47
An unelected federal judge, the power to undermine the entire FDA process and the process.I mean medications in the United States.Pharmaceuticals are expensive because and we always we hear this all the time that because of the research and development is so expensive.
23:05
Right?And the research and development is expensive because of all of the studies and all of the steps and all of the Hoops that have to be jumped through in order to get FDA approval to Market in to sell it at actually make money off of it.So it has to be proven to be safe and effective and go through all this process and this judge, you know, with a stroke of his pen has undermined that whole process.
23:27
Is in a way that's never been hacked never happened before.This has never been the case in the United States.That a federal judge has unilaterally, or on his own authority said that a specific drug ought not to have been approved and should be with removed from the market.
23:46
Yep.I agree.I think there's lots of good debate to happen about the ethics of abortion, but that this particular drug is unsafe.Doesn't seem to be to be the strongest claim.If you are somebody, who's taking a pro-life position that it shouldn't be available in which case maybe resorting to The Comstock tact makes more sense.
24:08
Yeah.So you know that that's what that's what's going on with those two rulings and then the Supreme Court, it gets fast track to the Supreme Court where because of the the previous administration had the power of appointing three.
24:26
Judges to the Supreme Court.There is a conservative bias of bias or leaning towards the Supreme Court in the Supreme Court right now.And so they have the opportunity to make this ruling.It's going to be really interesting to see what happens in the Supreme Court.
24:44
And so what happened a week or two ago is that the Supreme Court Judge Justice alito's?The one who's kind of been to spokesperson from the supreme court site about what about this case?Case initially said, we'll have a ruling by the timber 17th or 18th of April that time came.
25:03
And then he's reissued or extended this day and stay is just a fancy legal term for a pause on the impact of a decision to be to be put into effect or to be activated.
25:20
All right, so what should we be looking for?So it makes sense.So they're going to Who knows what's going to happen, right?But didn't didn't say.It needs to be pulled off the market right now.So, good news for some people.Bad news for other people, but will rule presumably on whether there is sufficient evidence to say that this is a not safe drug and might rule on these other issues that we didn't get so much into about, whether it can be mailed, whether the drug.
25:48
So a few years back was it 2018 the FDA extended some of the use of this drug to a little bit further?Into pregnancy and said, it could be mailed and that will become, presumably an issue as well.So this increased access over the last few years might become restricted.
26:07
Again, might be pulled off the market altogether.I hear states are hoarding the medication.So worried that the Supreme Court will say, no have been stockpiling the medication.There might even be worries that the manufacturer will stop making so much because they, if they anticipate that it'll not Not be approved anymore.
26:28
What else should we be worried about?Yeah, those are the big issues so think about a pharmacy or pharmaceutical manufacturing like the pipeline right there is this has caused disruption throughout that process.
26:45
So there are their pharmacies in hospitals and in communities that have this medication on, it's shelves right now.It's not used very commonly.I mean it's not like You know, don't like antibiotics that are constantly being.Prescribed an administrative used up so it's imagine a pharmacy at a small, local hospital in Texas that has this medication.
27:09
Then all of a sudden this judge says, Thou shalt not administer this medication.Do they go into there and pull it off their shelves?If it's already if there's already a prescription for it, do they do they cancel that prescription and how do they order more?
27:25
And when and it just is hugely disruptive to the The to the whole process of the FDA approval and provision of these medications.And so I think that's going to be something that the Supreme Court has to deal with is what do we do?
27:44
If they decide that it should be taken off, which is going to disrupt all kinds of things in the FDA approval process.And I'm not an FDA lawyer and we don't spend a lot of time talking about the FDA approval process and there are people way smarter and way more involved in that process.
28:00
But one of the things that is most important about our legal system, is the predictability of it and the regulatory system like we have to be able to predict how things are going to progress in order to make plans and develop new drugs and stuff, like stuff like that.
28:16
And, and this undermines that in a really, I think, harmful way if the FDA approval process needed to be redone.That's fine.Let's have that conversation.But going through it through the judicial.Process.I think is something that the Supreme Court needs to figure out and need to needs to rule on.
28:35
So that one and then the that's the availability issue and then access States administering or stockpiling or hoarding this medication in ways that may impact the availability of it in other states or what happens when somebody's state says you can't administer this if that's if that's the outcome of this.
29:00
Is it okay for them to cross state lines to go to a different state that has it?If the Comstock ruling is stands up, then you can't mail it.So what if you transport it on your person?Like I mean there's just a whole bunch of other issues that come out of this but and which is interesting from a from a lawyer's perspective because of the process and how it messes up the is impact in the process.
29:25
But you know, that's setting aside the whole ginormous issue of Of should abortions be available at all?Which I think most people are focusing on and not focusing on the, the implications of what this type of really, what happened, right?
29:42
We're here to bring you the B-side of other horrifying things, this might my Endeavor in the future.So we'll just have to see and hopefully we'll have an update later next month when we know more but this is kind of what we know so far.
30:00
Far and that apocalyptic at all.Tyler's just saying that maybe the FDA won't exist in the future.That it'll just be up to judges to say whether things are safer.Yeah.Yeah.Can you imagine that?If the process was, you have to convince one judge that your medication is safe and effective and they have the ability to say yes or no.
30:24
Whether you can my gosh.Craziness.Okay, so that's what I'm obsessed with before, Prestone and the mostly, I mean, abortion is interesting topic.It's something that I think is endlessly debated endlessly discussed, not only in the public, but also in in bioethics Worlds, but all of the legal maneuvering and implications, I think is that's what I've been obsessed with this week.
30:53
Good.Well, thanks for the primer on how to understand the legal system, Tyler.I bet that's well, it was helpful for me to hear Sure, it's helpful for lots of our listeners.Sure, it's helpful for lots of our listeners.