Lauren Arora Hutchinson
A quick note before we start. This story reflects one person’s experience. It isn’t medical advice or an endorsement of any medication. Talk to your own healthcare provider about any treatment decisions. This episode also references suicide. If you or someone you know is struggling, the Suicide and Crisis Lifeline is available in the U.S. by call or text at 988. More resources are in the show notes. Take care while listening.
Ashley Womble
So I met my husband Barry, and after four years we got married. And I wanted to start a family, basically on our honeymoon. So for that reason I was always looking towards my wedding day to be the day that I stopped taking an antidepressant, my Lexapro, because everything that I had read up into that point just said, you know, it does carry risks, and I just didn’t want to have any risks. But as my wedding date approached, you know, I started to get nervous about not having this medication, because things were so stable.
Lauren Arora Hutchinson
This is Ashley Womble today. She’s a writer, a marketing professional, and a mother. But back in 2017 she found herself surrounded by uncertainty.
Ashley Womble
The research I was doing was reading magazine articles, probably some message boards.
Lauren Arora Hutchinson
She knew she wanted to start a family, but she didn’t know if she should stay on her medication, and the doctors she saw didn’t seem to know either.
Ashley Womble
I talked to a couple of medical professionals about my plan along the way. And the gynecologist I saw and my PCP were like, “Yeah, you’ll definitely just want to wean yourself off it with the professional.” There wasn’t a conversation about maybe I shouldn’t, or well, what if I would have any issues down the line.
Lauren Arora Hutchinson
Ashley became pregnant in 2017.
Ashley Womble
The first doctor visit I had after I became pregnant was with an OB. Had a lot of things to talk about with them, and one of them, of course, was that I was taking Lexapro, and I’d intended to take it, and they were like, “Well, if that’s what you think you should do.”
Lauren Arora Hutchinson
Every day in this country, pregnant women and women hoping to become pregnant find themselves in a situation like Ashley’s. They have to decide what’s best for them and for their developing baby: whether to treat or not treat, when both options carry risks and the evidence isn’t clear. It’s a dilemma made by design, one with deep ethical consequences and no easy answers. I’m Lauren Arora Hutchinson, Director of the iDeas Lab at the Johns Hopkins Berman Institute of Bioethics, and this is playing god? For Ashley, the risks of untreated mental illness weren’t theoretical. She had experienced them firsthand. In fact, it was that experience that led her to use an antidepressant in the first place.
Ashley Womble
I was very, very close with my brother because I was nine years older than him, and so I really kind of raised him in that big sister way. But in 2008, when I was in my late 20s, my brother had developed schizophrenia. He moved in with me and had a really, really severe experience with schizophrenia, and unfortunately never took any medication that he was prescribed. He ended his life. I, um, I really, I really lost my ability to keep it together. I just cracked. For me, cracking didn’t look like it did for him. I didn’t become homeless. I still paid my rent, but I was miserable. And I really, really wanted to die. I thought about it all the time, about how I could die. I would lay on the couch and just feel like I had this giant kettlebell just weighing on me. It’s a physical feeling. A couple people in my life were mentioning that maybe I might want to talk to someone about taking medication. So I saw a psychiatrist, and he diagnosed me with major depression and also generalized anxiety disorder. He prescribed a medication for me, which was Lexapro. And then it was just like I started to see the world in color for the first time. It was so clear to me once I started taking medication that I had had some sort of imbalance, that there was something chemically wrong that was now adjusted. It was just a new beginning of my life when I started to get treatment for my depression.
Lauren Arora Hutchinson
Ashley understood the toll depression could take on her own life. What she didn’t yet understand were the risks untreated depression could pose during pregnancy.
Crystal Clark
Ashley’s story, you know, she had had multiple depressive episodes, so we’re also thinking about that personal risk, like what’s been that person’s history with mental illness and how that severity might impact their pregnancy.
Lauren Arora Hutchinson
That’s Dr. Crystal Clark. She’s a reproductive psychiatrist.
Crystal Clark
A reproductive psychiatrist is someone who addresses mental illnesses across what we call the reproductive lifespan for someone born female.
Lauren Arora Hutchinson
Pregnant women with mental health conditions often don’t have the opportunity to see a reproductive psychiatrist, but in Ashley’s case, she did—not Crystal Clark, but another specialist like her.
Ashley Womble
We had the intake where I shared with her my history about my previous serious episodes of depression, but how I was fine now, and probably I could get through my pregnancy without taking Lexapro, if it meant that there would be no risk to my baby. And she said that probably I could get through my pregnancy. I could white knuckle it through, but the chance is also that I could develop a perinatal mood disorder. Because I had already had major depression, I was at much higher risk.
Lauren Arora Hutchinson
And it wasn’t just Ashley’s mental health that was at stake. She learned that untreated depression can also pose serious risks to the developing baby.
Crystal Clark
Preterm birth, low birth weight, developmental issues as it relates to cognition or social development—as we observe untreated patients that have a depression or anxiety disorder, that consistently shows up that there’s an increased risk of that. What’s the risk that, if they don’t have treatment, that they will do something that jeopardizes the pregnancy? So what about prenatal care, substance abuse for self-medicating that can be uncontrollable in the depths of a mental illness? And what about suicide? What about losing the mom and baby altogether?
Lauren Arora Hutchinson
But that’s only one side of the equation. What about the risks of staying on the medication? That’s where things become much less clear.
Marika Toscano
In many other fields of medicine, we have what’s called high-quality evidence, randomized controlled trials, where a group of women or a group of patients gets the medication, a group doesn’t, and we compare them and try and understand if there’s a benefit or harm. But those trials aren’t done in obstetrics.
Lauren Arora Hutchinson
That’s Marika Toscano, an OB-GYN at Johns Hopkins School of Medicine who specializes in high-risk pregnancies.
Marika Toscano
We just have this kind of middle- to low-grade evidence to work with, and there’s always some uncertainty there.
Crystal Clark
So, without having randomized controlled trials towards interventions that are medication related, we just don’t have that same level of confidence. We’re working with some… a little more unknowns.
Lauren Arora Hutchinson
Upon learning this, Ashley was stunned.
Ashley Womble
Why isn’t there any guidance around this?
Ruth Faden
The reasons why there is this evidence gap that’s not peculiar to mental health at all.
Lauren Arora Hutchinson
This is Professor Ruth Faden. She is a professor at the Johns Hopkins Berman Institute of Bioethics. And she’s spent decades looking at the ethical questions raised by medical research involving pregnant women.
Ruth Faden
Pregnant women, as a group, have been systematically disadvantaged from the beginning of modern biomedical science by their exclusion from that science. There is this view of pregnant women as vessels, not as independent autonomous agents who have to live in the world. The dominant narrative is: protect the emerging baby at all costs. Now, what’s lost in all of this is that there are serious, serious risks to a pregnancy and to the baby and its future if illness experienced by the mother is not treated during pregnancy.
Lauren Arora Hutchinson
But that doesn’t mean the ethical questions are simple.
Ruth Faden
One of the challenges in thinking about the ethics of research with pregnant people is that pregnancy is the only time that you have two objects of moral concern in one body.
Lauren Arora Hutchinson
That complexity, Ruth Faden says, has led many to simply throw up their hands.
Ruth Faden
People just said, “Wait, this is just too tough ethically.” Yes, it’s morally complicated. But just because it’s morally complicated doesn’t mean there isn’t an ethically acceptable way to generate evidence. It’s precisely because they’re in one body that it is in the interests of the developing baby, who is one of our objects of moral concern, that the other object of moral concern get proper medical treatment.
Lauren Arora Hutchinson
Ashley says she could feel this discomfort and uncertainty coming from her doctors.
Ashley Womble
There wasn’t a period of counseling one way or the other. It wasn’t so much that the practitioners were judging me. I don’t think that that was the case. I think that they felt scared. I think that they felt scared to have an opinion and scared to share their opinion.
Lauren Arora Hutchinson
Marika Toscano says Ashley’s experience reflects a broader pattern.
Marika Toscano
There’s definitely a spectrum of comfort across OB-GYN providers. And I think there’s also an anxiety about liability as well, and that’s a big challenge in obstetrics in general.
Lauren Arora Hutchinson
But the concerns about liability don’t just affect clinical decision making. They also shape the research landscape itself. Ruth Faden explains:
Ruth Faden
When something happens, either to a pregnancy or more typically with a newborn or an infant or even a toddler, there is some sort of anomaly or some sort of an illness, the obvious question that emerges is: why? And is anybody responsible for it? So, when a pregnant person is given a drug, or a medication, or an intervention, it’s not surprising that the question emerges: was that somehow responsible for this bad outcome? That possibility has a chilling effect on the interest of developers, especially the pharmaceutical industry, the biotech industry, to do research to understand the effectiveness, but especially the safety of a product in pregnancy.
Lauren Arora Hutchinson
The result is a paradox. We exclude pregnant women from clinical trials to protect them and their developing babies from the risks of research. But, pregnant women get sick and sick women get pregnant. In effect, Ruth Faden says, by nottesting medications in pregnancy, these pharmaceutical companies…
Ruth Faden
They transfer that whole risk over to practicing clinicians and pregnant women themselves. That’s a big problem.
Lauren Arora Hutchinson
This means we don’t have the same kind of high-quality evidence that comes from clinical trials, knowledge about how that drug affects women and developing babies. But that doesn’t mean that there’s no evidence at all. Doctors aren’t starting from scratch. When it comes to SSRIs, antidepressants like Lexapro, Ashley is one of many people who’ve had to navigate these types of decisions.
Crystal Clark
What we do have is a lot of research that has been more observational. With SSRIs, actually, we do not see an increased risk for congenital malformations. No matter how many times we look at it, how many women we follow who have had a child while taking an SSRI, we just don’t see a pattern of a bad outcome. So, as a practitioner, I feel pretty comfortable saying that, because we have looked at it so many times with, with established drugs.
Lauren Arora Hutchinson
And after taking all this in, Ashley came to a decision.
Ashley Womble
The truth is that my womb is in the same body as my mind, and I didn’t have the choice to create a perfect environment for my baby because my body isn’t perfect. I was terrified of postpartum depression, and having experienced that level of despair, I certainly didn’t want to do it when there was going to be a baby around. So for me, that was enough to not shake the apple cart, and to not take myself off of Lexapro.
Lauren Arora Hutchinson
For Ashley, the story has a happy ending. She didn’t experience postpartum depression, and today she’s the mother of a healthy daughter, but the dilemma she faced still remains for millions of people.
Ruth Faden
Without any experimental design, without good opportunity to be able to see what works and what doesn’t work for which pregnant women at what dose, I don’t want to frighten people too much, but it’s sort of like a mass social experiment. In the absence of evidence, clinicians are going to use their best judgment based on what they understand to be the risks of this new drug and the theoretical way in which it operates on the body, and then make either a weak or moderate or qualified recommendation, or in some cases I honestly can’t tell you what to do, all of which is very different from what a person experiences if they’re not pregnant with the same condition when that same new drug comes out.
Crystal Clark
I’m concerned about delays to care because of novel treatments coming out that we have no data on for the pregnant population. There are definitely some antidepressants out there that, you know, are newer. So we say, well, we don’t know enough about those. We aren’t quick to prescribe those in someone who is planning to get pregnant or pregnant.
Marika Toscano
Well, I’m thinking about a patient who has a seizure disorder and has failed every single seizure medication that has pregnancy safety data, now is on one of the newest medications, and her seizures are finally well controlled. And, it doesn’t make sense to revert her back to a different medication that has pregnancy safety data, because it won’t work for her. But it does make sense for her to not have seizures during pregnancy, for her own health and safety and to prevent adverse outcomes in her pregnancy. So, you know, for that patient we often do recommend continuing the medication that they’re on, despite the lack of available evidence, and that’s because we, we think the risks to the mom of uncontrolled seizures outweigh the possible risks of the medication to the developing fetus. But of course, it’s always a discussion.
Lauren Arora Hutchinson
But uncertainty has a way of resurfacing. Pregnant women often interact with multiple different kinds of health care professionals, and Marika Toscano and Crystal Clark say that this can create problems. Even in situations where they and their patient have come to a decision, a decision that acknowledges the uncertainty and charts a path through it, conflicting advice from another provider can leave patients questioning that decision all over again.
Crystal Clark
I have patients who go to the pharmacist after I’ve given the medication, and then they don’t get the medication filled because the pharmacist says, “Well, I don’t think you can take that in pregnancy.” That can be quite confusing to someone who’s already very concerned about doing the best for their baby.
Marika Toscano
I’ve run into that same situation, and patients can get really freaked out or mistrustful when you go through the counseling with them, and then they hear from a different provider kind of something contradictory to what you’ve told them. There’s different levels of training for all different types of medical providers, so the nuances of the discussion— I think sometimes, you know, a pharmacist, I think they’re thinking purely from a pharmacologic aspect, and they’re not always thinking about the risks of untreated depression to the mom and the baby, and so they’re making the recommendation based on only one piece of information.
Crystal Clark
Given that so many people get pregnant, why would we not have that be a standard part of training and education? Why are we still not educating patients early on and providing them with clear options?
Lauren Arora Hutchinson
What would it look like to protect pregnant women and developing babies, not from research, but through research?
Crystal Clark
How awesome would it be if we had that information when the drug came to market, so that we had a larger toolkit, so to speak, many more options for pregnant persons and lactating persons who want and need treatment? How awesome would it be that we prevent suicide, that we prevent bad outcomes? That’s what I hope to see in the future.
Lauren Arora Hutchinson
The solution, some say, is to treat pregnant women more like everyone else.
Ruth Faden
Some people have proposed before we have that horrible lag, years and years and years and years between when a new drug is approved and then evidence is generated for pregnancy, we start a pregnancy sub-study. The idea is to try to get the evidence base for pregnancy as close as possible in time to when the evidence base is secured for non-pregnant people, given our commitment to protecting the health of the pregnant woman, the pregnancy, and the baby.
Marika Toscano
Of course, there’s always consideration of not causing harm when you’re participating in a clinical trial, and when risks are unknown, completely unknown, that maybe is a different category, but there’s a pretty good sense about risks. It could be risk stratified to include more pregnant patients in drug trials and medications where we don’t think there’s risk. You know, pregnant women, they can go through informed consent for any medical procedure, and they can also go through informed consent for research. And they should be allowed the opportunity to think about the risks and benefits of participating in research, rather than being restricted from it from the jump. I think we can do a better job of just allowing women to make decisions about their own bodies and participation in research.
Ashley Womble
We can’t forget that there are so many people who are hurting and they are carrying the next generation in their bodies. We just need to have a lot more information, so that women can make up their own minds. We need choices, not black boxes.
Lauren Arora Hutchinson
That’s the final episode of season two of playing god? Thanks for listening. We’ve loved bringing you these stories, and we’re not done. Before we bring you season three of playing god?, over the next six months, we’ll present a run of miniseries, live events, and documentaries we’re calling playing god? presents… Tune in next week to find out more.
Many thanks to our guests in this episode—to Ashley Womble for sharing her story with us, and to Crystal Clark, Marika Toscano, and Ruth Faden.
playing god? is a production of the Dracopoulos-Bloomberg iDeas Lab at the Johns Hopkins Berman Institute of Bioethics, made in association with Sea Salt and Mango Productions.
This episode was produced by Irene Carter, Lyric Bowditch, and Redzi Bernard, with help from Brian Ricker.
Our Executive Editor is Tony Phillips.
Music and sound design by Alexander Overington.
iDeas Lab Producer, Lyric Bowditch.
Researcher, Brian Ricker.
Story Editor, Simon Adler.
Show art by Barry Pousman and Shawn Carney.
Our Production Coordinators are Leah Lord and Susan Snead.
Our Executive Producers are Jeffrey Kahn and Anna Mastroianni.
I’m Lauren Arora Hutchinson, host and Managing Editor.
Come back next week for a preview of what’s coming next.
