Latest / Mom Wars / Pregnancy and Antidepressants

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Pregnancy and Antidepressants · Mom Wars

• 0:01
  Speaker 1: From the front lines of the mom Wars. Here's Bethany
• 0:04
  Speaker 1: Mandel and Kara Kennedy.
• 0:08
  Speaker 2: Hello and welcome to another episode of your new favorite podcast,
• 0:12
  Speaker 2: although we're not even that new anymore. My name is
• 0:15
  Speaker 2: Bethany Mandel. I am one of your co hosts. I
• 0:18
  Speaker 2: am a mom of six and a frequent contributor to
• 0:21
  Speaker 2: places like The New York Post and The Washington Examiner.
• 0:24
  Speaker 2: And I am joined by my beautiful braided co host.
• 0:27
  Speaker 2: And if you guys subscribe on the substack, you can
• 0:30
  Speaker 2: watch the video of this and see Car's beautiful braids,
• 0:33
  Speaker 2: because we're posting the video now for subscribers on substack.
• 0:36
  Speaker 2: But I am joined by.
• 0:39
  Speaker 3: Car Kennedy and let's skip over my stuff because we
• 0:42
  Speaker 3: have so many much more interested than we want to
• 0:44
  Speaker 3: speak to.
• 0:45
  Speaker 2: I So okay, Mom of one spectator fab We are
• 0:52
  Speaker 2: joined by Tracy Beth Hogue. Doctor Tracy Beth Hogue. She
• 0:57
  Speaker 2: earned that doctor and she is Senior Advisor for Clinical
• 1:01
  Speaker 2: Sciences at the FDA. I don't really understand what that means,
• 1:06
  Speaker 2: but she was one of my north stars during COVID
• 1:10
  Speaker 2: and I was joking with her right before we started
• 1:12
  Speaker 2: recording that she is at the FDA what I voted
• 1:16
  Speaker 2: for when I voted for Donald Trump, because we needed
• 1:19
  Speaker 2: someone with fresh eyes who was able to just barrel
• 1:25
  Speaker 2: through those front doors and like make me trust science again.
• 1:29
  Speaker 2: And you're doing that at the FDA. And so I
• 1:32
  Speaker 2: want to talk a little bit about what you're doing
• 1:34
  Speaker 2: at the FDA and what that fancy title means. And
• 1:37
  Speaker 2: then I want to jump into a conversation that you've
• 1:39
  Speaker 2: been having at the FDA that I think interests a
• 1:41
  Speaker 2: lot of our listeners about SSRIs and pregnancy. So first,
• 1:46
  Speaker 2: tell me what are you doing at the FDA these days?
• 1:49
  Speaker 4: Very good question.
• 1:51
  Speaker 5: So I work in the Office of the Commissioner at
• 1:54
  Speaker 5: Doctor Martin McCarey, and I work in SEBER, the Center
• 1:58
  Speaker 5: for Biologics Evaluation and Research. So that's the center that
• 2:01
  Speaker 5: evaluates vaccines and other and biologics that's led by Vani Prasad.
• 2:07
  Speaker 4: So I work with both of them. I'm a senior advisor.
• 2:10
  Speaker 6: It combines clinical and science because I have an MD
• 2:13
  Speaker 6: and PhD and my PhDs and epidemiology, so I do
• 2:18
  Speaker 6: a lot of sort of background research and there's a
• 2:21
  Speaker 6: very fast pace here, lots to learn, and it's incredibly exciting.
• 2:25
  Speaker 5: To get to investigate different topics that are important to
• 2:29
  Speaker 5: the American public and that can make a difference in
• 2:31
  Speaker 5: people's health. So yeah, it really it rapidly changes what
• 2:36
  Speaker 5: I'm looking into from day to day, and.
• 2:38
  Speaker 4: I absolutely love it.
• 2:39
  Speaker 5: I've been here since the end of March, so I
• 2:42
  Speaker 5: guess it's almost four months now.
• 2:44
  Speaker 2: So it's a dream job for me, and it's a
• 2:47
  Speaker 2: dream job for the American people. The three people that well,
• 2:50
  Speaker 2: the two people you just mentioned, Marty and Vine, were
• 2:53
  Speaker 2: both beacons during COVID, And something that I loved about
• 2:56
  Speaker 2: all three of you was that you know, there was
• 2:59
  Speaker 2: this narrative that took over the entire science and health
• 3:03
  Speaker 2: community of like this is the only way to think
• 3:05
  Speaker 2: and talk about COVID and mitigating it, and you three
• 3:10
  Speaker 2: put your necks out there to say, no, this is
• 3:13
  Speaker 2: not the way to do it. This is not the
• 3:15
  Speaker 2: right way to handle it. And something I love about
• 3:18
  Speaker 2: the three of you also is that you take that
• 3:21
  Speaker 2: that lens that you look through COVID of like the
• 3:25
  Speaker 2: way isn't the only way I'm looking at and I
• 3:28
  Speaker 2: wish I had it behind me. Marty's most recent book,
• 3:31
  Speaker 2: Blind Spots, I read it covered like front to back.
• 3:34
  Speaker 2: It was amazing and I love that you all you
• 3:38
  Speaker 2: have it with you also, So all three of you
• 3:43
  Speaker 2: look at science and health through like really fresh, innovative
• 3:49
  Speaker 2: eyes that are not popular, Like I don't think of
• 3:53
  Speaker 2: the many things I could say about you, I don't
• 3:55
  Speaker 2: think you're very popular in the science community. Is that
• 3:57
  Speaker 2: a fair characterization?
• 3:59
  Speaker 5: Well, I don't know. I think people have learned that
• 4:01
  Speaker 5: if they agree with me, they better stay quiet because
• 4:04
  Speaker 5: you never know how you're gonna get attacked, you know.
• 4:08
  Speaker 4: So but I will say that.
• 4:10
  Speaker 5: I feel like I get a lot of secret support.
• 4:13
  Speaker 4: So but I totally agree.
• 4:15
  Speaker 5: With you that Marty and and I were two people
• 4:17
  Speaker 5: that I really looked up to as well during the pandemic.
• 4:20
  Speaker 4: And I think it's contagious.
• 4:23
  Speaker 5: You know, when people start speaking out and saying things
• 4:25
  Speaker 5: that make.
• 4:25
  Speaker 4: Sense and looking at things through a different lens, you.
• 4:28
  Speaker 5: Realize, yeah, actually that that sounds right.
• 4:31
  Speaker 4: Why are we not doing that? And you know you
• 4:34
  Speaker 4: did that too, Bethany.
• 4:35
  Speaker 5: I mean I have to say, like my admiration, that
• 4:39
  Speaker 5: the admiration is mutual, Like I looked up to you
• 4:43
  Speaker 5: as well because you are also a mom, your mom
• 4:45
  Speaker 5: of six. I only have I have four kids, so
• 4:48
  Speaker 5: a lot more to do than I and you, you know,
• 4:52
  Speaker 5: you understood the problems with closing schools, how how now
• 4:57
  Speaker 5: nonsensical it was given what we knew about the science.
• 5:00
  Speaker 5: I mean, I don't know exactly what your background was,
• 5:03
  Speaker 5: but you always spoke up and said things that made sense,
• 5:07
  Speaker 5: you know, scientifically and just logically against the mask mandates,
• 5:12
  Speaker 5: and so I really appreciated your voice as well. So
• 5:16
  Speaker 5: I was super excited that you invited me to be
• 5:18
  Speaker 5: on this podcast because I've been a fan of yours
• 5:21
  Speaker 5: for a long time. So so thank you for the
• 5:23
  Speaker 5: work that you did during COVID and your writing and
• 5:26
  Speaker 5: your you know, podcasting and tweeting men a lot, a
• 5:30
  Speaker 5: lot of more.
• 5:31
  Speaker 2: I think that what's really special about like taking that
• 5:35
  Speaker 2: because I think that the world has moved on from COVID,
• 5:38
  Speaker 2: for for better and for worse.
• 5:39
  Speaker 5: As you probably could, even though we don't want to
• 5:42
  Speaker 5: repeat what happened.
• 5:43
  Speaker 2: Yeah, so I think it's worth litigating the mistakes that
• 5:48
  Speaker 2: we made. And I don't I don't know how much
• 5:49
  Speaker 2: of that that. I mean, it's just not going to
• 5:51
  Speaker 2: happen at this point. I'm just gonna be honest, it's
• 5:52
  Speaker 2: not gonna happen. I wish that it would, but I
• 5:54
  Speaker 2: don't think it will. But this like sort of critical
• 5:58
  Speaker 2: lens that you became famous for over COVID, you're taking
• 6:03
  Speaker 2: now with you to your work at the FDA. And
• 6:07
  Speaker 2: one thing, like a very specific thing that I wanted
• 6:10
  Speaker 2: to have you on because this is a shorter episode
• 6:13
  Speaker 2: and we want to pack as much as we can.
• 6:16
  Speaker 2: I really wanted to talk to you about SSRI use
• 6:19
  Speaker 2: in pregnancy because I have friends who took them when
• 6:24
  Speaker 2: they were when they were pregnant, and they told me
• 6:28
  Speaker 2: that they were informed by their doctors. It's totally safe.
• 6:32
  Speaker 2: It's it's been it's been tested, it's been safe, it's
• 6:36
  Speaker 2: and that did not make sense to me because anything
• 6:40
  Speaker 2: that you take, I mean, I had to be careful
• 6:42
  Speaker 2: with my tile in all usage when I was pregnant,
• 6:45
  Speaker 2: Like I took children's tile in all when I was
• 6:47
  Speaker 2: pregnant if I absolutely had to. And so for someone
• 6:52
  Speaker 2: to say like something as powerful as an SSRI was
• 6:55
  Speaker 2: completely and totally fine and safe in pregnancy when I'm
• 6:59
  Speaker 2: taking like little grape versions of tail and all didn't
• 7:04
  Speaker 2: didn't jive with me.
• 7:06
  Speaker 3: So maybe we can start with like talking about SSRI
• 7:11
  Speaker 3: usage in America as a whole, and like, how many
• 7:13
  Speaker 3: people are on this, how many pregnant women are on this?
• 7:17
  Speaker 5: Yeah, I mean this is just it's such a great
• 7:19
  Speaker 5: topic because I think that was one of the things
• 7:21
  Speaker 5: that got me interested in it from the get go,
• 7:25
  Speaker 5: was realizing that over five percent of women take SSRIs
• 7:29
  Speaker 5: during pregnancy in the United States. And I, like you, Bethany,
• 7:34
  Speaker 5: I was like, wait what because normally I think women
• 7:39
  Speaker 5: sort of have that intuition of like, you don't want
• 7:41
  Speaker 5: to put some chemical in your body during pregnancy, because
• 7:45
  Speaker 5: this is you know, I don't know, this is part
• 7:48
  Speaker 5: of our intuition and also just what we hear like
• 7:50
  Speaker 5: growing up. You know that, and it makes sense, it's
• 7:53
  Speaker 5: common sense, right. So it's hard to get recent statistics
• 7:57
  Speaker 5: on what s SRI use is in the United States,
• 8:01
  Speaker 5: so a lot of what we're quoting now goes back
• 8:03
  Speaker 5: like ten years, if not more. And we know that
• 8:06
  Speaker 5: SSRI use has been increasing, especially among younger people and
• 8:10
  Speaker 5: women of childbearing age.
• 8:11
  Speaker 4: So when I.
• 8:13
  Speaker 5: Made the video on our FDA YouTube channel about it,
• 8:17
  Speaker 5: you know, I said, at least ten percent of women
• 8:20
  Speaker 5: of childbearing age are taking SSRIs. Now we know it's
• 8:23
  Speaker 5: probably twenty percent of women in general, because actually as
• 8:26
  Speaker 5: women get older, they tend to be taking more SSRIs.
• 8:31
  Speaker 5: And then we know that about half of those women
• 8:33
  Speaker 5: who are taking during childbearing years like go on to
• 8:37
  Speaker 5: take them during pregnancy.
• 8:39
  Speaker 4: And one thing that I didn't and.
• 8:41
  Speaker 5: I thought, wow, so why are women not stopping the
• 8:44
  Speaker 5: SSRIs once they become pregnant at a higher rate. One
• 8:48
  Speaker 5: thing that I learned, you know, from this panel and
• 8:50
  Speaker 5: doing the background research for this, is really how hard SSRIs.
• 8:54
  Speaker 4: Are to come off of.
• 8:56
  Speaker 5: And then you know, there's this issue of like, of course,
• 8:59
  Speaker 5: you you don't always know immediately when you're pregnant, and
• 9:04
  Speaker 5: and and so you may stop it, and you may
• 9:06
  Speaker 5: be you know, a few weeks along in your pregnancy
• 9:08
  Speaker 5: or if not, if not more, and you know, the
• 9:11
  Speaker 5: critical time for embryonic development is somewhere, you know, around
• 9:16
  Speaker 5: that eight week period, and so women may not even
• 9:20
  Speaker 5: be off of that man or some may not know
• 9:22
  Speaker 5: they're pregnant if they have irregular periods or whatever.
• 9:25
  Speaker 4: You know.
• 9:25
  Speaker 5: I was, I was surprised at what it's a sort
• 9:28
  Speaker 5: of a high rate of SSRI use there is, and
• 9:32
  Speaker 5: it is across the world. It tends to be higher
• 9:34
  Speaker 5: among women, but the United States has one of the highest,
• 9:38
  Speaker 5: of not the highest rates of SSRI use in the world.
• 9:42
  Speaker 5: I think like Iceland is close, but otherwise, like we're
• 9:46
  Speaker 5: way beyond most other countries and so in terms of
• 9:51
  Speaker 5: what SSRIs do to the fetus. So this is the
• 9:54
  Speaker 5: other thing that a lot of women don't know is
• 9:56
  Speaker 5: that there's actually a boxed warning on one of the
• 9:59
  Speaker 5: s sris about them causing heart defects. And so you know,
• 10:05
  Speaker 5: I thought, wow, that really that that is not clear
• 10:09
  Speaker 5: I think to the public, and it wasn't even clear
• 10:11
  Speaker 5: to me as a physician. Now I'm I don't actually
• 10:14
  Speaker 5: prescribe SSRIs. So I have prescribed s nrized for five
• 10:18
  Speaker 5: or miles of just maybe a handful of times in
• 10:21
  Speaker 5: my career. So I was a practicing physician before I
• 10:25
  Speaker 5: started at this job, as well as a researcher at MIT.
• 10:28
  Speaker 5: But it's something I very rarely prescribed. But I didn't
• 10:32
  Speaker 5: actually know about that Paxel black box warning, but that
• 10:36
  Speaker 5: I will say, that's not when I prescribed. But then
• 10:38
  Speaker 5: I started looking into this issue more and I thought, so,
• 10:41
  Speaker 5: why is it only on Paxel. Are these SSRIs really
• 10:45
  Speaker 5: that different. And then you look at the label that
• 10:49
  Speaker 5: FDA has for Paxel and you're like, oh, persistent pulmonary
• 10:53
  Speaker 5: hypertension of the newborn and postpartum hemorrhage of in the
• 10:58
  Speaker 5: mom and then basically like this withdrawal syndrome once the
• 11:01
  Speaker 5: baby is born, and then in animal studies, increase miscarriage rate,
• 11:06
  Speaker 5: increase pre term birth. And I'm like thinking, this is
• 11:10
  Speaker 5: like written on page sixteen of the label, and I'm
• 11:15
  Speaker 5: like what. And so we're saying this is it's only
• 11:18
  Speaker 5: this is only this particular SSRI and then you know
• 11:22
  Speaker 5: the other labels contained some of that information, all of
• 11:25
  Speaker 5: it for the other SSRI products. Just so people know
• 11:29
  Speaker 5: these are antidepressants.
• 11:30
  Speaker 2: Every time I say SSI, I was just about to say,
• 11:32
  Speaker 2: we should explain.
• 11:35
  Speaker 5: People, but this is the by far the most commonly
• 11:38
  Speaker 5: prescribed type of antidepressant. So like zoloft, Celexa, Lexapro, those
• 11:45
  Speaker 5: those medications, prozac, and so basically you say, so you
• 11:50
  Speaker 5: think about serotonin, and serotonin is known to play a
• 11:54
  Speaker 5: critical role in fetal development. It's basically like a signaling molecule,
• 11:59
  Speaker 5: and so if you alter the way and it crosses
• 12:02
  Speaker 5: the placenta and so if you alter the way the
• 12:04
  Speaker 5: body is using serotonin, like, it only makes sense that
• 12:08
  Speaker 5: it's going to have some impact on the baby. And
• 12:11
  Speaker 5: clearly what we see is that it does have an impact.
• 12:14
  Speaker 4: And you know, we.
• 12:17
  Speaker 5: Don't have randomized control trials in pregnant women of the SSRIs.
• 12:21
  Speaker 5: We have animal data, and we have observational data, and
• 12:25
  Speaker 5: you know, in terms of like let's say we're looking
• 12:27
  Speaker 5: at cognitive outcomes, like the effects on the brain, the
• 12:31
  Speaker 5: studies have been somewhat mixed, like some find increased risk
• 12:36
  Speaker 5: of adverse outcomes with cognitive development, some don't. But there's
• 12:41
  Speaker 5: still ongoing questions. There's still like ongoing sort of uncertainty
• 12:47
  Speaker 5: about what the implications might be, you know, during when
• 12:52
  Speaker 5: babies are exposed during pregnancy.
• 12:55
  Speaker 2: And so.
• 12:57
  Speaker 5: I felt like that that's important information to get out
• 13:01
  Speaker 5: to the public, and we wanted to bring in and
• 13:05
  Speaker 5: I was really happy that doctor McCarry also really wanted
• 13:09
  Speaker 5: to do this roundtable, and we wanted to bring in
• 13:12
  Speaker 5: a group of experts that had like differing opinions so
• 13:16
  Speaker 5: we could have a wide ranging discussion, you know, looking
• 13:19
  Speaker 5: at sort of both sides of the evidence. And you know,
• 13:24
  Speaker 5: I think it was a really fascinating discussion, and I
• 13:27
  Speaker 5: hope that everyone tuning in today will go listen if
• 13:29
  Speaker 5: they haven't listened to it yet, because I've gotten so
• 13:32
  Speaker 5: much positive feedback and I think, you know, people learned
• 13:35
  Speaker 5: a lot from the panel and if nothing else, they learned, Wow.
• 13:40
  Speaker 5: There sure are a lot of women who take SSRIs
• 13:43
  Speaker 5: during pregnancy, and a lot of them don't seem to
• 13:45
  Speaker 5: know that that could potentially impact their baby.
• 13:48
  Speaker 3: So is this more about giving women the right information
• 13:52
  Speaker 3: to make a choice, or kind of recommending women to
• 13:57
  Speaker 3: come off during pregnancy, because I just like, I don't
• 14:00
  Speaker 3: know because I've never taken them what the withdrawal period
• 14:05
  Speaker 3: is like, but I can imagine it's probably pretty intense
• 14:08
  Speaker 3: to put on top of early pregnancy, you know.
• 14:10
  Speaker 5: Right right, That's that's such a good question. So so
• 14:14
  Speaker 5: one of the issues is I think women should be
• 14:16
  Speaker 5: informed about the potential risks so that they also have
• 14:19
  Speaker 5: time to come off if they want to when they're
• 14:23
  Speaker 5: trying to get pregnant.
• 14:24
  Speaker 4: So that's one issue.
• 14:25
  Speaker 5: The other issue is, of course, depression during pregnancy is
• 14:30
  Speaker 5: a serious problem, and no one, you know, we all
• 14:34
  Speaker 5: would take that seriously, like we don't want to have
• 14:37
  Speaker 5: a pregnant woman you know, go through serious depression and
• 14:42
  Speaker 5: that can also you know, lead to problems with the
• 14:44
  Speaker 5: pregnancy as well. And so so another question is, you know,
• 14:48
  Speaker 5: how effications are the SSRIs during pregnancy and are the
• 14:54
  Speaker 5: you know, potential benefits worth the potential risks and so
• 14:59
  Speaker 5: so basically, again I'm going to come back to the
• 15:01
  Speaker 5: fact that we don't have randomized gold standard data on
• 15:06
  Speaker 5: the efficacy of these antidepressants in pregnancy, and that we
• 15:11
  Speaker 5: really don't have good evidence that SSRIs reduce as actually suicidality,
• 15:17
  Speaker 5: and they may, for randomized control trials, may in some people,
• 15:22
  Speaker 5: you know, reduce the symptoms of depression. I think that
• 15:27
  Speaker 5: was kind of like my take home is and we
• 15:29
  Speaker 5: had a good discussion about that during the panel of
• 15:32
  Speaker 5: really what we know and don't know about how well
• 15:36
  Speaker 5: these medications work. And I think it's important for women
• 15:40
  Speaker 5: to get that sort of context so they're not like, oh,
• 15:43
  Speaker 5: if I just start taking this pill, it's going to like.
• 15:45
  Speaker 4: Cure my depression. That's not how it works.
• 15:48
  Speaker 5: It's not like we you know, we've been sold this
• 15:51
  Speaker 5: story that we have like a like some sort of
• 15:54
  Speaker 5: a serotonin deficiency or like imbalance in our brains, but
• 15:59
  Speaker 5: that actually hasn't really panned out to be the case,
• 16:02
  Speaker 5: and so it's more of like they SSRIs tend to
• 16:08
  Speaker 5: make you sort of like dampen your emotions. At least
• 16:11
  Speaker 5: that's my understanding of it. I haven't personally taken one.
• 16:14
  Speaker 5: I feel like if I had, I would know more.
• 16:17
  Speaker 4: About what the events are like.
• 16:18
  Speaker 5: But yeah, so they kind of can alleviate some of
• 16:22
  Speaker 5: the symptoms of depression and maybe anxiety.
• 16:24
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• 17:10
  Speaker 3: It's also difficult because you're in pregnancy and afterwards. I
• 17:15
  Speaker 3: think as a society we kind of move towards now
• 17:19
  Speaker 3: branding ourselves with postpartum depression and depression, and sometimes I
• 17:25
  Speaker 3: don't think it's the case. I think a lot of
• 17:27
  Speaker 3: times women can have an off day or and off
• 17:30
  Speaker 3: week and straight away they postpartum depression.
• 17:34
  Speaker 5: That's so important because actually diagnosing someone with a disease
• 17:39
  Speaker 5: is a serious thing, because that's like a label that
• 17:41
  Speaker 5: they carry with them with the feeling like you know,
• 17:44
  Speaker 5: now I need to get treatment. But you know, it's
• 17:46
  Speaker 5: one of the experts I think rightly pointed out like
• 17:49
  Speaker 5: people can go through periods of depression and completely that
• 17:52
  Speaker 5: can completely resolve and they no longer you know, have depression.
• 17:56
  Speaker 5: And so I think that's another thing like the pharmaceutical
• 17:59
  Speaker 5: industry is really trying to sell to us that it's like,
• 18:03
  Speaker 5: you know, we have this disease that we need to
• 18:05
  Speaker 5: keep taking a treatment for to get rid of. And
• 18:09
  Speaker 5: I just want to add I think also that especially
• 18:12
  Speaker 5: in the United States, I think it gets a little
• 18:15
  Speaker 5: bit lost that there are so many other ways that
• 18:18
  Speaker 5: you can handle depression that don't need to involve taking drugs,
• 18:22
  Speaker 5: and like I mean, I just you know, good relationships,
• 18:26
  Speaker 5: the way that you eat, the exercise has been shown
• 18:29
  Speaker 5: to be so effective and is very good for the
• 18:33
  Speaker 5: mom and the baby during pregnancy, and I feel like
• 18:35
  Speaker 5: that's quite under discussed. That's certainly what I used for
• 18:40
  Speaker 5: my mood during pregnancy. But I think, you know, just
• 18:43
  Speaker 5: a lot of you know, meditation and just that yoga.
• 18:47
  Speaker 5: There are many different there are many alternatives that I
• 18:50
  Speaker 5: think really we should be looking at and also sort
• 18:53
  Speaker 5: of like the underlying cause for that particular woman's depression,
• 18:57
  Speaker 5: and that of course involves time with the healthcare provider,
• 19:01
  Speaker 5: which is you know, hard to come by in an
• 19:04
  Speaker 5: American society because it's like you're into the doctor five
• 19:07
  Speaker 5: minutes later, it's like it's over and you didn't get
• 19:11
  Speaker 5: your questions answered, but you have a prescription. You know.
• 19:14
  Speaker 3: I have a lot of issues with my home country's
• 19:17
  Speaker 3: medical establishment, the NHS, but I will say when it
• 19:21
  Speaker 3: comes to SSRIs, having a free healthcare system that is
• 19:26
  Speaker 3: very apprehensive to give you expensive drugs is a good
• 19:30
  Speaker 3: thing because it is all difficult to get ssriyes prescribed
• 19:35
  Speaker 3: to you in Britain, and a lot of people miraculously
• 19:39
  Speaker 3: figure out that they're not actually depressed enough to want
• 19:41
  Speaker 3: to go through the whole very difficult process of getting them.
• 19:46
  Speaker 4: Yeah, I mean that's right.
• 19:47
  Speaker 5: And I spent a number of years living in Denmark
• 19:49
  Speaker 5: and actually worked as a physician there and had my
• 19:51
  Speaker 5: set in my second pregnancy there, so I got to
• 19:53
  Speaker 5: compare the two systems, and man, everything was just there
• 19:57
  Speaker 5: was focus on being natural every step of away in Denmark,
• 20:01
  Speaker 5: and I would say also like that with SSRIs, I
• 20:04
  Speaker 5: know that they are notoriously difficult to get in Denmark too.
• 20:08
  Speaker 5: Now I don't know if that's that's changing because it's
• 20:10
  Speaker 5: been ten years since I was there, but yeah, it's
• 20:14
  Speaker 5: it is a very cultural thing in the United States,
• 20:16
  Speaker 5: and maybe it has to do it direct to consumer advertising,
• 20:19
  Speaker 5: but man, the Americans take a lot of pills for
• 20:22
  Speaker 5: their problems. Yeah.
• 20:23
  Speaker 2: Do you think that there's any ethical questions for the
• 20:28
  Speaker 2: fact that these were prescribed to pregnant women? Like, I
• 20:34
  Speaker 2: think that there's some ethical things that happened here, Like
• 20:39
  Speaker 2: what does sort of all this research that you've put together,
• 20:45
  Speaker 2: how does that impact, you know, what women are told
• 20:47
  Speaker 2: moving forward?
• 20:49
  Speaker 5: So I just want to say that I think that
• 20:52
  Speaker 5: physicians in the United States, for the most part, almost
• 20:56
  Speaker 5: every single one really mean the best and want.
• 20:59
  Speaker 4: To help their patients. And I think that.
• 21:03
  Speaker 5: When SSRIs are prescribed, it's because it during pregnancy, it's
• 21:07
  Speaker 5: because they really think that they will be helping, you know,
• 21:10
  Speaker 5: that that person in front of them. And it's also
• 21:14
  Speaker 5: I will say, it is an easier thing to do.
• 21:16
  Speaker 5: And so you know, I don't want to put the
• 21:19
  Speaker 5: blame like that.
• 21:20
  Speaker 4: I just don't.
• 21:21
  Speaker 5: I don't want to make it that simple, because I
• 21:23
  Speaker 5: think like it's it's also a question of sort of
• 21:26
  Speaker 5: getting you know, the information out to physicians, but it's
• 21:30
  Speaker 5: also physicians responsibility to like look at the the actual
• 21:34
  Speaker 5: you know, science and the data and not basically just
• 21:38
  Speaker 5: sort of pass along what they were told because of
• 21:40
  Speaker 5: course that's that's an easier thing to do. It's just
• 21:43
  Speaker 5: sort of like, well, I knew this is what we
• 21:45
  Speaker 5: tend to do. We tend to prescribe a SSRIs and
• 21:51
  Speaker 5: and so I think I don't want to say it's
• 21:53
  Speaker 5: like an ethical issue. I think this is more a
• 21:55
  Speaker 5: society wide issue and it includes physicians, and I think
• 21:59
  Speaker 5: it's an awareness issue. And like I said, I do
• 22:02
  Speaker 5: think part of it is like this sort of it's
• 22:06
  Speaker 5: not brought up to women before they're pregnant, and then
• 22:09
  Speaker 5: they may feel like if they go off of the medication,
• 22:12
  Speaker 5: they feel worse and they're already pregnant, and I kind
• 22:15
  Speaker 5: of wonder if that's a lot of what is going
• 22:17
  Speaker 5: on here. But I also think like that it should
• 22:22
  Speaker 5: be made more clear to the public and to physicians,
• 22:27
  Speaker 5: like that there are these safety issues that are on
• 22:31
  Speaker 5: the FDA labels, and there are studies that are highly
• 22:35
  Speaker 5: concerning and SSRIs are a drug that affects serotonin levels
• 22:41
  Speaker 5: and it crosses the placenta gets into the baby. We
• 22:45
  Speaker 5: have seen adverse events that we have on the FDA label,
• 22:48
  Speaker 5: So you know, that information that needs to get out.
• 22:52
  Speaker 5: And I think once people understand sort of those simple things,
• 22:56
  Speaker 5: including physicians, that the conversation is going to change and
• 23:00
  Speaker 5: with a pregnant women, with women who are trying to
• 23:03
  Speaker 5: get pregnant, at least that's what I hope, because we
• 23:05
  Speaker 5: all want like informed consent and we want women to
• 23:08
  Speaker 5: be able to make the choices their best for them
• 23:11
  Speaker 5: and their babies.
• 23:12
  Speaker 2: So is there any way for like, if I'm prescribed
• 23:17
  Speaker 2: this and my chart says pregnant, or I just like
• 23:20
  Speaker 2: walk into a pharmacy and I'm like visibly pregnant. Is
• 23:24
  Speaker 2: is there a mechanism like if you know, all of
• 23:28
  Speaker 2: this research and all these recommendations don't reach the ears
• 23:32
  Speaker 2: of doctors, which they should, but you know, doctors or
• 23:34
  Speaker 2: humans just like we're humans. Is there sort of a
• 23:38
  Speaker 2: fail safe that like the FDA can put in at
• 23:41
  Speaker 2: the pharmaceutical level to say, like, you know, these need
• 23:44
  Speaker 2: a warning now, because like I picked up a prescription
• 23:47
  Speaker 2: today that I'm not pregnant, but it said, like the
• 23:50
  Speaker 2: very first thing do not administer to a pregnant woman
• 23:53
  Speaker 2: is will those kinds of warnings appear when on the
• 23:57
  Speaker 2: pharmaceutical end, So.
• 23:59
  Speaker 5: There is like a sentence about that on the on Paxel,
• 24:03
  Speaker 5: but not on the other.
• 24:04
  Speaker 4: Uh, you know SSRIs.
• 24:07
  Speaker 5: That it was so in the past, we used to
• 24:09
  Speaker 5: at the FDA like twenty fourteen, twenty fifteen, I believe
• 24:12
  Speaker 5: it stopped like ten years ago, where we would have
• 24:14
  Speaker 5: like pregnancy.
• 24:16
  Speaker 4: Category A, B, C, d X.
• 24:19
  Speaker 5: We don't have that anymore now personally, you know, I
• 24:22
  Speaker 5: thought that was that was a good system.
• 24:24
  Speaker 4: Now there different system.
• 24:26
  Speaker 2: Yeah.
• 24:26
  Speaker 5: So, so Paxel used to be category D. The other
• 24:31
  Speaker 5: SSRIs were category C, and basically category C means we
• 24:35
  Speaker 5: really don't have the data to know one way or
• 24:39
  Speaker 5: the other about the safety during pregnancy. And even that
• 24:43
  Speaker 5: would change the conversation, right because you're not like saying, oh,
• 24:46
  Speaker 5: it's it's it's safe, you know, it's it's a different
• 24:48
  Speaker 5: way of looking at it. So you know, I think,
• 24:51
  Speaker 5: you know, we we can discuss these things, you know,
• 24:54
  Speaker 5: internally at the FDA, and and you know, I can
• 24:57
  Speaker 5: advocate for what I want and I don't want to
• 24:59
  Speaker 5: say know on behalf of the FDA what may or
• 25:02
  Speaker 5: may not be done? But there I think there are
• 25:04
  Speaker 5: ways on the label that it could be made more clear.
• 25:08
  Speaker 4: And maybe I'll just leave it at that.
• 25:13
  Speaker 2: What advice. So we're I mean, we have thousands of
• 25:16
  Speaker 2: listeners and one of them is bound to be pregnant
• 25:19
  Speaker 2: and on an SSR right now, Like guarantee, what speak
• 25:25
  Speaker 2: to that woman? What are you going to what are
• 25:27
  Speaker 2: you going to say to that woman?
• 25:29
  Speaker 4: Yeah, I mean I.
• 25:29
  Speaker 5: Guess the first thing I would say is like, don't
• 25:31
  Speaker 5: feel guilty. I mean, you know, and and and and
• 25:35
  Speaker 5: don't feel like you're necessarily doing harm to your baby.
• 25:38
  Speaker 5: I mean, there's a reason that we were having a dispute,
• 25:41
  Speaker 5: like in in and a debate because it's like there
• 25:45
  Speaker 5: are defined risks, but the ones that are defined are
• 25:48
  Speaker 5: very rare that we know of, right, So it's like
• 25:51
  Speaker 5: I don't want women to sit there like freaking out,
• 25:53
  Speaker 5: what have I done? Because there are plenty of healthy
• 25:55
  Speaker 5: babies that are bored with women who take SSRIs, and
• 26:00
  Speaker 5: so what I guess what I would say is, you know,
• 26:04
  Speaker 5: it's good to think about the fact that it might
• 26:06
  Speaker 5: not actually be like the optimal treatment for the depression,
• 26:10
  Speaker 5: and to think more about like, what what is the
• 26:12
  Speaker 5: underlying reason for my depression and is there an alternative
• 26:17
  Speaker 5: that might suit me better? And is that something I
• 26:19
  Speaker 5: should look into? And then also to be aware of
• 26:22
  Speaker 5: the fact that like when you get take stop taking
• 26:24
  Speaker 5: the SSRI, if you decide to do that, that you
• 26:26
  Speaker 5: might you might have a period of time where it's
• 26:30
  Speaker 5: it's difficult, And so I think that's where it would
• 26:33
  Speaker 5: be you know, good to get potentially medical advice or
• 26:35
  Speaker 5: at least to be aware that that's a potential.
• 26:38
  Speaker 1: Yeah.
• 26:39
  Speaker 3: I think a lot of it is given the women
• 26:41
  Speaker 3: the the information to let them decide themselves.
• 26:45
  Speaker 5: For sure. Yeah, I should I should have mentioned that
• 26:47
  Speaker 5: because the issue with the fetal development in the heart,
• 26:51
  Speaker 5: I mean that happens earlier in pregnancy. I mean it's
• 26:53
  Speaker 5: different issues later in pregnancy, So it would be more
• 26:56
  Speaker 5: like that, you know, what we know later in once
• 27:00
  Speaker 5: the baby is born if you're taking it later in pregnancy,
• 27:02
  Speaker 5: that your baby can be born with like withdrawal symptoms
• 27:05
  Speaker 5: and things like that. So I do think that just
• 27:08
  Speaker 5: kind of providing the information is really about what we
• 27:12
  Speaker 5: do and don't know is the best thing that you
• 27:14
  Speaker 5: can do. And you know, you can only do the
• 27:17
  Speaker 5: best you can with the information you have, and you
• 27:19
  Speaker 5: can't go back. And so you know, all of us
• 27:22
  Speaker 5: have done things that probably weren't perfect during pregnancy, and
• 27:25
  Speaker 5: you know, things do tend tend tend to work out.
• 27:27
  Speaker 5: But again it's like, this is one of those things
• 27:30
  Speaker 5: that you know, we do want to make sure that
• 27:32
  Speaker 5: we are communicating the known risks and and and what
• 27:37
  Speaker 5: we do and don't know and could you know, maybe
• 27:40
  Speaker 5: find out, you know, with with future research.
• 27:43
  Speaker 2: So yeah, what else do you have on your plate
• 27:47
  Speaker 2: at the FDA, because this is not the only thing
• 27:49
  Speaker 2: that you're doing and I'm here for it. What what else?
• 27:53
  Speaker 2: What else are you going to do that's going to
• 27:55
  Speaker 2: revolutionize our listeners' lives and my lives on my life.
• 27:58
  Speaker 5: Well, that's a really good question. And like you said,
• 28:01
  Speaker 5: I think I mean that we are very open minded
• 28:05
  Speaker 5: people who who think outside of the box, right, And
• 28:08
  Speaker 5: that's kind of the whole team that doctor McCarey is
• 28:10
  Speaker 5: putting together, and that's why it's so much fun to
• 28:13
  Speaker 5: work here. And like, you know, I've been involved in
• 28:16
  Speaker 5: the initiative actually to reduce animal testing that's being done.
• 28:20
  Speaker 4: That's been another big thing that I've been a part.
• 28:23
  Speaker 5: Of, and I've been speaking about that and we're you know,
• 28:26
  Speaker 5: in different area places and so we held the workshop
• 28:29
  Speaker 5: on that that was actually live streamed as well, and
• 28:34
  Speaker 5: so basically looking at we have these novel ways of
• 28:37
  Speaker 5: predicting toxicity and efficacy that we didn't have in the past,
• 28:42
  Speaker 5: so we can maybe move on, you know, to the
• 28:44
  Speaker 5: greatest extent possible for moving animals, from using animals to
• 28:50
  Speaker 5: using something that may be more you know, predictive of
• 28:53
  Speaker 5: what drugs are going to do. And this could certainly
• 28:55
  Speaker 5: play into the whole serotonin story if we can get
• 28:59
  Speaker 5: the answers from like AI and so organ on a
• 29:04
  Speaker 5: chip organoid like different modality. Is there lots of different
• 29:08
  Speaker 5: ways that we can predict toxicity now that we may
• 29:11
  Speaker 5: be able to get answers without using animals, and so
• 29:14
  Speaker 5: that's just kind of one of the things that I've
• 29:16
  Speaker 5: been working on but lots of other projects behind the scenes,
• 29:20
  Speaker 5: and I don't want to get into anything that I
• 29:22
  Speaker 5: shouldn't be talking about, so I'll just say I've been
• 29:26
  Speaker 5: extremely busy, but really enjoying it.
• 29:29
  Speaker 2: So yeah, that's amazing. Thank you so much for joining
• 29:34
  Speaker 2: us to talk about all of these issues. If I'm
• 29:37
  Speaker 2: sure that there will be a lot of listeners who
• 29:39
  Speaker 2: want to learn more, and we're going to put the link.
• 29:42
  Speaker 2: So there was the panel that you had that is
• 29:44
  Speaker 2: available and we can put that in the show notes.
• 29:48
  Speaker 2: Is there anything else that you're sort of thinking and
• 29:51
  Speaker 2: looking at from the pregnancy and like maybe new motherhood
• 29:55
  Speaker 2: angle at the FDA right now or is this sort
• 29:58
  Speaker 2: of the tip of the iceberg and there's more to come.
• 30:00
  Speaker 5: I would say there's more to come. Stay tuned, definitely,
• 30:05
  Speaker 5: but I think it's a topic I'm super passionate about.
• 30:09
  Speaker 5: And uh, and so they're they're making more to come
• 30:13
  Speaker 5: related to safety of different things during pregnancy and we
• 30:18
  Speaker 5: may be learning a lot together.
• 30:20
  Speaker 4: So so excited.
• 30:21
  Speaker 2: Well, then we're going to have to have you come
• 30:23
  Speaker 2: back when we learn more things.
• 30:25
  Speaker 4: Awesome, Thank you so than all.
• 30:27
  Speaker 2: Right, thank you all so much for listening. And thank
• 30:30
  Speaker 2: you doctor Tracy for coming on and joining us today.
• 30:35
  Speaker 2: If you liked this episode, and only if you liked
• 30:38
  Speaker 2: this episode, please head over to our podcast page on
• 30:42
  Speaker 2: Spotify or Apple Podcasts and click five star and leave
• 30:46
  Speaker 2: us a review and hit subscribe. And until next time,
• 30:50
  Speaker 2: satell up
• 30:54
  Speaker 5: Ricochet Yeah, join the conversation