Miffed about Mifepristone with Dr. Kristyn Brandi

I'm your host, Dr. Abdul El-Sayed.

You hear a lot about freedom from certain political circles now. If you're a regular listener of this podcast, you probably know my politics by now. Freedom to me is more about being free of crippling medical debt if you get sick than the freedom to carry a gun into a school. It's more about being free to live, learn love as you choose than it is about starting wars over oil abroad. And it's certainly about being able to decide what medication you want to take to control what's happening in your own body. Assuming that someone's certified that that medication won't hurt you in ways you don't know about.

Today, we're going to talk about the ongoing turmoil let loose by ideological, cultural warrior-turned-district-court judge Matt Kaczmarek and his ruling to ban Mifepristone. The first of two medications used in the safest and most effective medication abortion regimen. But first, let me wax philosophical, for a second, about hypocrisy, because this isn't the first time a right-wing ideologue has had issues with the F.DA, the agency at the heart of this. Kaczmarek's ruling argues that the F.D.A. failed to take into account the full suite of available safety data when it ruled that Mifepristone was safe. Back in the year 2000, apparently, the safety data they were supposed to consider weren't data collected from clinical trials or safety data from other countries, where MIFI had already been available for decades.

Instead, it was anecdotes from a set of right-wing blogs that were only published decades after the drug was approved. But I digress, let's leave their argument at. The F.D.A. didn't fully account for safety data. But before the right-wing obsession with forcing people to stay pregnant got in the way, Conservatives were obsessed with doing exactly the opposite of what this ruling did.

With the right-to-try law, I'm signing today, patients with life-threatening illnesses will finally have access to experimental treatments that could improve or even cure their conditions. On May 30, 2018, Donald Trump signed the first federal right-to-try legislation into law. It would allow doctors and patients to fully bypass F.D.A. approval for drugs to treat terminal illness. And for medications that could theoretically be helpful, but haven't been vetted as safe or effective in clinical trials. In fact, Senator Ron Johnson threatened to hold up F.D.A. reauthorization in the Senate in 2017 if the legislation wasn't pursued. But look, this isn't an episode about right-to-try, and perhaps we'll do one on that later.

But you see the hypocrisy here, right? Conservatives want folks to be able to use medications that haven't even gone through the FDA's process when it comes to safety or efficacy in the case of right-to-try. But when it comes to Mifepristone, a medication that's got sterling safety data, both from clinical trials and from 23 years of use. In the public, they want to question the FDA's process, which just proves what we already know. This ruling had nothing to do with safety, it had everything to do with ideological opposition to what this drug does.

And that opens up a whole world of precedent. Are the same judges about to go after prep for HIV prevention?

Is this an argument that they somehow promote sex among LGBTQ people or unmarried people? Look, it is not often that you're going to find me on the same side of an argument as pharma CEOs. But literally hundreds of them signed an open letter against this judge's ruling. I would have signed it, too. Let's catch up on where things stand now. The case had been appealed to a three-judge appeals court.

They ruled that Kaczmarek's ruling went too far, that he couldn't conceivably challenge the approval since it happened so long ago, but that he could appeal. 2016 rule changes designed to make the drug more accessible. That's equally preposterous. Think about it. If the drug is safe and effective, it's safe and effective, and hence it should be available to anyone who needs it. Which means that limitations on access should be lifted.

There's no halfway on this. That appeals court ruling would have blocked Miffy from being sent by mail. A drastic reduction in access for a medication responsible for more than half of all abortions in this country. And if you're a woman in one of the 24 states that have banned abortion since the fall of Roe last June, you would have lost one of the last best hopes you had for getting the healthcare you ought to be entitled to. Justification is absolutely preposterous. But then Justice Alito, the same dude who wrote the opinion killing Roe last June, jumped in.

On Friday, he issued a stay of the Kaczmarek ruling through Wednesday, which means that until then the ruling has no effect. But the question, of course, is, what happens on Wednesday? We'll stay tuned. I wanted to give this whole saga more context, so I reached out to Dr.

Kristen Brandy, an ob-gyn and family planning specialist who serves as a fellow at the American College of Obstetrics and Gynecology.

Consequences of this ruling? Keep in mind. We taped this on Friday just before Justice Alito stepped in. And this is, of course, a swiftly moving story. Here's my conversation with Dr. Kristen Brandy.

All right, can you introduce yourself to the tape?

It existed since the 1980s. It's been approved in other countries, but we had gotten it approved through the F.DA in the year 2000..

But this is a medication that's used in other forms of healthcare as well. No.

And so this medication inherently should not be stigmatized, it shouldn't be something that's controversial. It has a lot of different uses, but because many people associate it as the abortion pill, it carries that stigma with it.

And it just shows a blatant disregard for the wellbeing of people in this country and the failure to think even through what the blast radius of this choice is going to be independent of the fact that putting yourself ahead of people's bodily autonomy and, in effect, forcing pregnancy is itself a real problem. But even if you were to say no, I am going to irrigate myself to that level and put myself in that way. It's like all these other people you didn't think through. Which just highlights the fact that this person has no concept of science or medicine, but also highlights the just supreme arrogance of this action. So we talked about mifepristone, that is the drug that is targeted by this ruling. I want to look at this from a different perspective, though, just because I do think it's illuminating. What is a medication?

Abortion and how do we think about that?

But in this case, it causes bleeding and cramping to expel the pregnancy. That's the majority of what medication abortion looks like now, which I'll remind listeners, is over half of all abortion care currently is medication abortion. But there are other medications that we can use. And we may have to revert to that now that Mifepristone may no longer be available to people.

They are really safe and effective. But we have all this data that suggests that what we're using now is the gold standard of care, that's what we should be using. But as you mentioned earlier, that's not really a consideration in this court case.

And on the most extreme front, you take away a lot of this access. And you're talking about reverting to a system of abortions that we saw, unfortunately, decades ago, half a century ago. Before this ruling, which was extremely unsafe and often involved going to folks who are practitioners of medicine to do things that could ultimately be deadly. I want to ask you, just thinking about access before this ruling, what was the usual approach to accessing a medication abortion?

That being said, MifiProtonin has always been in this special category, something we call the REMS criteria from the F.D.A. that has always been regulated different, until very recently. So it's always been something that you had to get approval from the company. To be able to give it to people you can't like. Get out my prescription pad and write a prescription for it, you have to actually have it stocked in your clinic. Pharmacies didn't have it.

And so often people had to come in person to get the medication. There are new rules that literally just came out this year in January, that changed a lot of that. That made it so that pharmacies could prescribe this medication for the first time ever. And people were so excited that we could finally be able to treat this like any other medicine. And then all of this happened. It really shows how this medication has always been in this separate category of, you know, medications.

That has been really frustrating, and we've been using the science data to hopefully push that further and further to meet the science. But it feels like we're just going back in time now.

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Now we all know that the attack on MifidPristone has nothing to do with safety, it has everything to do with ideology. How safe is MifidPristone?

It is an incredibly safe medication, very few side effects or complications afterward. But again, that's not what we're really actually talking about here.

That's because what an erection is is effectively an opening up of arteries, such that you have blood into the penis that causes an erection. And so it was extremely effective at doing this thing. But you've got to imagine we're telling folks who are usually older and therefore are more likely to have more sensitive cardiovascular organs just as a function of being old. Even if they don't have diagnosed cardiac disease, that they can go on ahead and take this medication to get an erection, to do a thing that's quite vigorous, which is to have sex. By its nature, while empirically, Viagra is pretty safe and pretty effective. You've got to imagine, mechanistically, that you're opening up a bit of a Pandora's box. Which is why there are known cases of cardiovascular events on the medication, and why they recommend against it for people with known cardiac disease. When you're talking about mifepristone, it targets a hormone whose main actions are generally in reproduction, that's what progesterone does.

It's quite a surgical medication, it specifically does the thing that it's supposed to do if it involves progesterone. All of the points that you made around endocrine disorders, around fibroids, these all map to the physiology involved in that system. We're talking about trying to apply a safety criterion based in, I don't know, the nether regions of the internet. And the mind of this particular judge. And other folks trying to find an ideological argument to make to take away that use of the drug. If you were to apply the same arguments to something like Viagra, you might as well go ahead and decertify Viagra too.

This is specific targeting of a specific drug, specifically because one judge doesn't like what it does.

Any single medication, and, I worry, particularly stigmatized care at risk of what's the next thing that a judge is going to decide, did not go through the proper approval process. And let's just get rid of it, which is not how healthcare should be, that's not how medicine or science should work. But it's crazy to think that, like any medication, could, just, like, just poof, be gone because of this process now.

I want to move to the ruling. Can you tell us a little bit about the group that brought the case and why they brought it?

And the path would be this judge, Fifth Circuit and Supreme Court. It was a straight shot. And so it's really frustrating one to know that there's colleagues of mine, like Obgyns, other healthcare providers that would go through such meticulous length to overturn this very safe medication. But knowing that they did it with this intention, that it's a new group that was invented post-Dobbs for this purpose, it's just so frustrating.

That's just not the reality of this medicine. But that's their claim and this judge agreed with them. So that's where we're at right now.

In fact, a new study just came out that more than half of all people surveyed representative sample were affected by gun violence in this country. If you look at life expectancy numbers in this country, they are being drugged down by gun violence in both homicide and suicide among young people. And so, I mean, I really wish the Alliance for Hippocratic Medicine would have decided we're sick and tired of having to treat people for gunshot wounds. We really should sue the manufacturers, No.

Instead, they decided to target this particular medication that has been in use safely and effectively for 23 years. I mean, this is the other thing about it is that the proof's in the pudding. At some point. If you were at the point of an F.D.A. approval, you might be able to look at the information and say, Listen, we don't actually have enough data. And there's good theoretical reason to believe that this is unsafe. It's been 23 years, right?

There are people showing up in droves right with grievous injuries because of Mifepristone.

And so it was very clear if they got anything on their desk that would be remotely related to abortion, that they would have taken the opportunity. It's just it's really hard to think about. This was all done by design.

We were really excited about this one. That was actually using the data and the evidence to suggest that Mifflin-Prestone no longer needs to be regulated by these restrictive rules that the F.D.A. has put under it. So it was a great ruling, something that would have improved access to care. The issue is that it is in direct conflict with what happened in Texas. And so now we're at this place where there's these two rulings that the F.D.A. is supposed to follow, and they don't necessarily know which one to answer to. Which is why it's kind of going up the process and very likely will be heard by the Supreme Court. What the fifth Circuit did was conclude that. You couldn't necessarily go all the way back and say that this medication didn't go through the proper process because it just was too long ago.

But what they did was there were some changes in 2016 again to make the F.D.A. Follow the evidence and get it more in line with what evidence was saying. As far as the best regimen, the best timing, the number of in-person visits, they threw those out the window and said that the 2016 changes don't matter anymore. So now we're back to the initial approval of what Mifepristone was in 2000. What that means is that if that is all allowed to pass, we would go back to. Having used potentially a higher dose of Mifepristone. So three times the dose that we know is safe and effective.

Currently, people would be required to come in person three times in order to go through the process. They would have to get the Mifepristone in person, they then have to get the second medication, Misoprostol, in person, and then have a follow-up visit in person, which is no longer required. Most people are getting this by Telehealth and entirely doing this remotely.

And so we're adding on these additional requirements, including potentially back in the day it.

Now, it's currently approved up to 10 weeks gestation, so we're also rolling back. Who's a candidate for this medicine?

And it's rolled back that other clinicians, advanced practice clinicians, like there's practitioners, midwives, people that are providing this care and providing it just as safe as physicians. They are no longer allowed to provide this medication. The big asterisk to all of that is that this seems to be the rules if you are not one of the states listed in the Washington case. That perhaps the Washington case will protect the places that were in that lawsuit from these rules. So those are mostly liberal places, although I'm in New Jersey, and New Jersey and New York were not part of that lawsuit. So even though we have great laws to protect abortion care, we may still have to revert back to these old Mifepristone rules, which is really frustrating. So, yeah. So there's so many things in conflict right now that people are really at a standstill and trying to figure out what are they going to do.

Because many of us have patients on Saturday. And so how are we going to apply these new laws and figure out what is safe and effective, but also what's legal in our area?

They have not been so friendly around abortion issues recently, and so it's concerning about what that end result will look like now.

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I mean, they kicked this whole thing off in June. And the thing that kills me is that. The ostensible argument that they were making is that this ought to be a states rights issue. And what this judge did is he saw their wink and a nod and went ahead and tried to make medication abortion inaccessible throughout the entire country. Now, if they followed their own ruling, you would imagine right, or at least their own legal reasoning underneath their ruling, you would imagine that they would strike that ban down. Because, of course, this is supposed to be a decision made by states.

And I think this is going to be a really important tell for them.

And I think this just it's so brazenly an incursion on people's rights that. I hope that this will spur politicians to action, and people to the polls to elect the politicians who are willing to take action. I want to ask you, though, right? So stepping back?

But also as an advocate, how are you feeling right now? I mean, how are you trying to make sense of this, and, even worse, how are you talking to your patients about this?

That it's been a hard week on top of a hard year.

And I name the fact that, you know, I'm privileged to work in a place where I'm able to provide care. But it's just been overwhelming the emotional toll of, you know, the care that you provide. I've spent quite a bit of time in school. I'm a subspecialist in complex family planning, so I did extra fellowship training just to provide complex abortion care.

To think that people that are not medically trained, that do not have this expertise are just making decisions about the way that I and my colleagues can provide care is just frustrating to no end. But to see how it's impacted communities and patients has been truly heartbreaking.

I remember the day that Dobbs went down and had friends that were providing care in clinic. And then all of a sudden just had to, like, turn the next person away. And it's just been a lot of that moral injury of just I have the skills, I have the tools. There's someone in front of me that needs my help and I can't help them. It's just unimaginable.

And it just keeps happening and I think now it's really hitting home. Because now this is going to impact everybody, that my patients that have been okay, that have had access to care, this will impact them now. And I see that not only for the fact that they won't be able to get this medicine that works really well to help manage their care. But also, particularly when we dissect some of these rules that may come up for this new Mifepristone regulation. Like the three in-person visits. That's going to mean that people are going to come three separate times to get care, which is like two to three more visits than they need.

And that's going to mean that two or three less people are going to have that spot to get the care that they need. Because we have to accommodate that first person. So the health care system has already been suffering since Covid, the abortion health care system has been in crisis since Dobbs, and this is only making things worse. And so it's been a lot of self-care, a lot of supporting each other.

I think the abortion care community is a really tight-knit group and we have always been a tight-knit group. Because we've been trying to survive all these attacks for so many years now, but we are tired, it is exhausting to keep doing this. And I know many people are leaving their communities or leaving this care altogether, because it's just too much for a lot of people.

And I shudder to think about all of the lives that are going to be lost because people are now pursuing or forced to pursue unsafe abortions. Or all of the lives that are just changed irreparably in circumstances where they do not have bodily control. And all of that because of an ideology that says that some people get to make those decisions for them. Right now we're in a moment and you talked about this where it just keeps happening and things keep getting worse, but we have to believe in a moment where things can be better. And when you talk to folks who want to be a part of making it better, what do you tell them to do?

What are the things that our listeners can do to help push and drive? For an America where reproductive justice is a true guarantee and is not taken away by people like this judge?

I mean, I have to keep seeing patients because my patients need me, and that's the same as everyone across the country. Like, we're going to keep going to work and taking care of people. I think one thing that people can do, especially if you're not an abortion provider, you're not in this space at all, is just talk about it with your friends, with your colleagues, with your family. Like anybody that's willing to listen, abortion care has been so stigmatized for so long.

And I think since the Dobbs decision, we're really starting to break open. What is the impact if people don't have abortion care accessible? We've seen that since SB8 and now with Dobbs, that it impacts people broadly. People that have desired pregnancies, that have a complication and now they can't access care. And so just hearing these stories and telling stories, I think is a really powerful tool that we can share to help people understand that going to get worse if we don't do something about it. And through that, hopefully, that will move people to vote, to talk to their legislators, to share their own abortion stories, which they may not have told anyone before. But are really powerful to be able to move people to action.

And just even though we're all tired, just to keep going as best. We can do things like donate to abortion funds, donate to organizations that are helping speak out on these issues and that are talking to legislators directly. There's a lot that can still be done. And we knew that Roe was always the floor, it was never the ceiling, We always needed something bigger than Roe.

And now that it's very clear that the courts are not going to save us, they're not going to be the place that is going to protect this care. It's really going to have to come from people leading legislators to making laws that are going to actually protect this care. So we have to keep moving and doing something and thinking about how the intersections, particularly, are really important. One thing just to mention is that we are talking about this abortion health care crisis. But we forget that it is part of bigger maternal health care crisis or reproductive health care crisis. In this country. That since Covid, we've lost a lot of labor and deliveries, people are closing their labor delivery wards.

People deliver and they have nowhere to go. This is a systemic problem about how are we helping people that become pregnant get care they need, regardless of their choice, regardless of what their needs are? This is such a huge problem within health care right now and we need legislators to do something to fix it. So that people can have healthy pregnancies if they want them, to end pregnancies if they don't. And making sure that all those options are available safely to people at this moment.

This will force the auto industry's hand. The EPA is proposing two new rules. One will require that upwards of two-thirds of cars sold will be all electric by 2032..

Heavy-duty vehicles think big rig trucks and buses will require that up to 25 be all electric by that time. Experts estimate that together, the rules would eliminate the equivalent of two years worth of American CO2 emissions. Yeah, big effing deal. The rule, while sweeping, isn't catching the automotive industry by surprise. Look, I'm a Michigander and we're car people.

We account for more combustion engines than any place on Earth, and I do not say that proudly. In fact, my dad moved to America to build them. But even Detroit thinks this is the right move. They've seen this coming for a while now, which is why nearly every major auto company has dumped billions into developing new EVs.

Now you might wonder why this is a health story. Well, think about the very name of the law that enables the F.D.A. to act, it's called the Clean Air Act. We forget sometimes that every single ounce of polluted air that carries greenhouse gases into the atmosphere gets sieved through our lungs before it gets there. Idling trucks, for example, are one of the worst sources of air pollution in communities like southwest Detroit. The most polluted place in the most polluted city in the most. Where I happen to serve as health director.

That polluted air accounts for higher rates of asthma, chronic lung disease, and lung cancer. Never mind the fact that, on the back end, the climate crisis is a public health crisis. Destroyed homes and infrastructure, forced migration of both humans and wildlife. That brings us in contact with them. All of those are public health issues. So yeah, I support the rule.

Finally, this happened last week.

Importantly, this is different from the public health emergency slated to end on May 11th. The administration had expressed opposition to the bill, which cleared the democratically held Senate 68 to 23, in effect forcing the president's hand. All of this does signal the beginning of the end of the official infrastructure. Stood up to tackle the greatest public health crisis of all of our lifetimes. An unprecedented mobilization of everything from testing to vaccines to treatment. As I've expressed so many times before on this podcast, that kind of unprecedented action should not have been necessary.

But it was because our existing public health infrastructure had been so badly hobbled in the decades before the pandemic. My hope now is that we upgrade that infrastructure so we're never caught with our pants down again. But that that's not really happening. And that should be its own emergency.

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