#135 | Covid Vaccine Research for Breastfeeding Moms with Dr. Kaytlin Krutch of Texas Tech University's Infant Risk Research Team

November 17, 2021

Breastfeeding women have been having a difficult time knowing whether to get the Covid vaccine, given that the vaccine is new and neither the CDC nor vaccine manufacturers have studied whether vaccine ingredients make their way into breast milk. Meanwhile, pregnant and breastfeeding women have been told to get the vaccine despite this lack of research. It has been the historical norm for vaccines not to be tested on pregnant or nursing mothers, making informed consent difficult, if not impossible.

We provide no recommendation for or against the Covid vaccine for breastfeeding women, as we believe the decision is only yours to make. Whenever there is unknown/potential risk on either side of a decision, freedom must accompany choice.

We do, however, want to empower you to conduct your own research. We begin by demonstrating how easily misleading and biased information makes its way to major news outlets, and how it's carefully designed to look like statistically-valid research when it is actually rhetoric. If you've listened to our podcast before, you know "medical rhetoric" in pregnancy and childbirth is a recurring theme in obstetrics and maternity care, and one of our missions is to help our listeners develop an ear for recognizing rhetoric. In the first half of this episode, we cite specific headlines (e.g. New York Times Parenting; Apple News, Reuters) and point out that the underlying "research" does not adequately support the headline, nor are the sources necessarily independent/objective.

In our own quest to find vaccine information for breastfeeding mothers, we invited Dr. Kaytlin Krutch from Texas Tech University's Infant Risk Center, which, for years, has studied the effects of drugs and medications on breast milk. In September 2021, the Infant Risk research team published the first known study of the Covid vaccine and its possible impact on breastfed newborns. They did this research because curious/concerned breastfeeding moms flooded their call centers all year with questions about the vaccine. Dr. Krutch shares the results of the Infant Risk team's study while also pointing out the gaps in their own research and what work still needs to be done.

Our hope is that, whatever parents choose, they will learn from this episode (a) how to recognize research versus rhetoric in all areas of healthcare; (b) how to interpret whether research is valid and significant, and (c) what is meant by certain scientific terms such as "confidence interval"; "control group"; etc. 

This is an important topic affecting millions of breastfeeding women today who simply seek evidence of risk and safety.  We hope it empowers you in your healthcare decisions both now and in the future.

Please share this episode with others who might benefit from the discussion. We thank the Infant Risk researchers, who are self-funded and independent, for their work and contribution to this episode.

The Infant Risk Center

The VAERS (Vaccine Adverse Event Reporting System) Database

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Connect with us on Instagram @DownToBirthShow, where we post new information daily related to pregnancy, childbirth and postpartum. You can reach us at Contact@DownToBirthShow.com. We are always happy to hear from our listeners and appreciate questions for our monthly Q&A episodes. To submit a question, visit the Down To Birth website or send us a voice memo through Instagram messenger.

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View Episode Transcript

So I continued reading, and it went on to say the doctor who led the study noted that vaccine ingredients have a short lifetime and have no way of making it into breast milk. Well, now I'm definitely not believing what I'm hearing. Because breast milk comes from blood, and anything that is in the blood obviously has some way of getting into breast milk. Right?

Absolutely, we we do see that all the time. A lot of times what our providers are using is rhetoric. So what we did is separated out moms that reported that they had symptoms, and moms that did or did not have symptoms after the vaccine. And so the moms that said that they did have symptoms, their babies were four times more likely to have symptoms than the others.

I'm Cynthia Overgard, owner of HypnoBirthing of Connecticut, childbirth advocate and postpartum support specialist. And I'm Trisha Ludwig, certified nurse midwife and international board certified lactation consultant. And this is the Down To Birth Podcast. Childbirth is something we're made to do. But how do we have our safest and most satisfying experience in today's medical culture? Let's dispel the myths and get down to birth.

Welcome, everyone, to a very important and special episode, we have Dr. Kaitlyn Krutsch with us from Texas Tech University School of Medicine. Welcome, Dr. Krutsch, thanks so much for being with us today.

Thanks for having me.

Let's just we know we're going to talk about vaccine study that you guys have done on breastfeeding moms. And the key goal and objective of this episode is to help the parents out there recognize rhetoric versus research. And also by the end of the episode, I'd like you to be able to educate us and teach us a bit on understanding how to read research when we don't have a background in science. But let's just start by having you tell everyone who you are your background, your degree and what you guys are doing at the infant risk center.

Absolutely. So I've been at the infant risk center here for a couple of years with Dr. Hale who is known worldwide, for his work on medication transfer into breast milk. And so that's what I work with with him. And what we try to do is not just do the research, the reason that we ended up starting the center here is because it was something that no one was looking at, unfortunately, what happens a lot with lactating women is they you know, it's it's pregnant and lactating, and everyone looks at pregnancy, and there's not a lot of looking at lactation. And so that's our one of our very central purposes here. So my background is I have a degree in nutrition degree, a degree in business and a degree in pharmacy. So it is quite the wide breadth. And soon I will have a degree in translational science as well, which is helping understand why the research that we do the things that we that we define as known why that information doesn't get to the final user in a way that they are willing to, to accept it and to use it. Because you know, a lot of times, we'll know many things that are good for us that we choose not to do. And so there's so many steps along the path of your decision and your medical providers decisions and even just the decisions of people in sharing information with you so that you have the opportunity to see it. And so by the time you get to the end, we want decisions to be evidence based, you know, so we want those best decisions to be put into practice. And like I said, you know, it's it's something that's inherent, we all probably have thought about it before, you know, you think about how you know that you should exercise, you know that you should eat right? You might even know what good exercise or good food looks like. And we don't always make the best choices. And so, you know, it's just kind of moving that information along until people make the best choices that they can.

We see that so often in breastfeeding that women think they can't breastfeed because of something that they're doing in their life or a medication that they're taking. And I personally as a lactation consultant, I'm so grateful for the work that Dr. Hill and you are doing because there it's so different pregnancy versus breastfeeding, what you can do and what you can't do, and most people just don't know. And it's a major reason that people just continue breastfeeding.

It is and the risks are so you know, the risks are so so different between pregnancy and lactation. But I think that when people are lactating they think they have more control over it. And they think that there's these constructs of what a good mother looks like and what doesn't sponsible woman looks like. And so a good mother will give up anything for their child, including their own health. And that's what we see happen a lot. Because the responsible woman takes care of their body and listens to their doctors when they say that they need medication or they need to change the way that they're doing. But what happens when those directly conflict against each other?

And boy, have we seen an example of that in the last year with the COVID 19 pandemic? And the vaccine? Absolutely, absolutely. And I think it's an easy thing to for people to look at as if it's black and white, when it is so far from the truth, which leads us right into why we're here today. So I want to share the background with everyone as to how we got connected, because I just I still can't get over this. And I think our listeners are going to be so surprised by what they're about to hear. So I was on Instagram very late one night. And I truly believe for the first time ever, I saw a New York Times, parenting post show up in my feed, and the headline said, breastfeeding and the COVID vaccine, breastfeeding after the vaccine is safe. And I thought what I am so happy and impressed someone finally cared enough to do this research because the story of vaccines among the many stories, one of the facts about vaccines is they simply haven't valued pregnant women and breastfeeding women enough through the decades to even test us. I say us as a group of women globally. It went on to say as I continue to read, this is a quote, researchers say they know enough about how vaccines generally affect breast milk not to be concerned. Now red flags are going off all around my thinking. So I continued reading. And it went on to say the doctor who led the study noted that vaccine ingredients have a short lifetime and have no way of making it into breast milk. Well, now I'm definitely not believing what I'm hearing. Because breast milk comes from blood. And anything that is in the blood, obviously has some way of getting into breast milk. Right?

Absolutely. We we do see that all the time. And it's it's a question for us about how much and that's why we really focus on that here at the infant risk center is is doing that very difficult quantification. How much is in the milk? Because that like, that's the real question for us to be able to decide how much risk is involved, usually?

And it varies tremendously, correct. I mean, not all things pass into breast milk at the same rate. So that's No, no, no, I it's so important to do this work, absolutely not. So everything that a mom is in contact with has the chance of getting into her breast milk, and probably is there to some degree, so anything that they put in their mouth. Most times, whenever you're dealing with things in your environment, and you're touching it, some things are absorbed through your skin. And so if you could quantify down to those tiny, tiny levels, you can probably find it. And that's what we have seen this happened here. And then, for us, you have that question how much gets into your milk there, there's passive transfer, which is what we usually look at, there are also things that are actively transported into your milk. So they are in higher concentrations in your milk than they are in your blood. And we really worry about things like that here, which is why we think that research is so important. And then you have to take it to the next step two, because you say okay, so if Mom, if it's a medication, for example, there's a reason not to taking it, right, for the vaccine or for other medicine. So if that then goes to the baby, you know, what is the risk involved there. So there are so many different things that we could quantify. And unfortunately, we're just never able to do everything that we really want to.

So it was untrue. And it was frankly irresponsible of any doctor to come out and say the words No way, there is no way for it to get into the breast milk, just not true. And I think quite unethical to declare such a thing because people will read it and believe it.

I think it was a very strong statement. And a lot of times whenever we work with physicians, you know, physicians, we call it the art of medicine for a reason, right, that we have evidence and we'd like to have evidence, but there's a lot of gaps. And so you have to interpret and put those through. So I think it's, there's a difference in a researcher, a doctor of research and a doctor of medicine, because that's kind of their specialty, right is to take the research and to turn it into something that their patients can use. And I would say that that it probably was something more along those artistic flourishes that I would, I would put that statement in that boxes.

I think that's, I think that's fair. I think the statement was, it was disappointingly conclusive, where we shouldn't be so conclusive. To say there's no way.

I think that that's a fair way to say that, yes.

Okay. Then I'll keep all my other my, my private outrage a little more to myself.

Well, I think it's, uh, you know, whatever, we're here researching the field, it's so hard, because I'm so happy to see your outrage. It's, it's great, we have the same outrage. But I'm much more familiar with it. And I've lived with it for a lot longer, because it's so whenever you take this look at the COVID vaccine, I feel that way about almost every drug that we have every woman that comes to us and says, Hey, is this safe, and I have to say, you know, I can't say anything conclusively, but what I can tell you is that your milk is still valuable. A lot of times, even if there is are things in your milk, it can still be valuable. And it's it's about that risk benefit, because there are benefits that your baby is going to get from that breast milk. And there are benefits that you are going to get from breastfeeding. You know, it's it's a dose intense response, which is just so beautiful, you know, your, the longer you breastfeed, the lower your risk of things like ovarian cancer, or cardiovascular disease later in life, we're finding out all of these really great benefits for mom, on top of all of these things that we've known for the past maybe decade or two about the benefits for baby and the antibodies that are in there. And all of these extra ingredients that your body provides to baby, that formula just doesn't have, you know, what you're saying reminds me of something important that I learned from one of my favorite nutrition books I've ever read in my life, by Dr. Robert Young, the pH miracle, that book taught me more about nutrition on the body than anything I've read in my life. And I remember, you know, he talks about the effects of, you know, non organic coffee or pesticides on produce, and you know, you're halfway through the book, and you're thinking, Oh, my God, like, you're just so scared of everything you're eating. But then he says something very important. After emphasizing the harm of pesticides, he said, listen, make no mistake, you're still better off eating the conventional red pepper than not eating a red pepper at all. Because the nutrients in it, your body still needs those nutrients. There is never a question that you're better off eating that and it's kind of exactly what you're saying about breast milk, I think.

Yes, yes, absolutely. You know, you have to have the saying don't throw the baby out with the bathwater. It's the same thing. We don't want to throw the milk away, because we're afraid of anything that can be in it. Because the reality is, whatever you're in, that's in the milk.

Absolutely. And it's not like we can live a toxic free life, we go out we breathe air that is impure, it's okay. We want as many nutrients in our bodies as possible to detoxify and to keep us healthy despite those, those potential pollutants. Right.

Right. Right. And I really want to hone in on the point though, that the problems that we have here with the COVID vaccine, and the questions that we're left with, about what is safe and what isn't safe, those are the questions that we deal with every medication because this is not new, this is not different. The fact that pregnant women and lactating women were excluded from trials. This is what we deal with, with every drug. And so whenever we're making any kind of medical decisions, it's always, a lot of times what our providers are using is rhetoric, you know, there's maybe a third of the drugs on the market have been looked at to try and quantify. And so what we rely on a lot of times is So what have people done in the past? So what have mother other mothers chosen to expose their children to? And what can we learned from that? And whenever you have a brand new drug that other people are using, like the COVID vaccine, and no one has tried it before, and everyone has to try it at the same time. That's why we you know, that system really breaks down very quickly.

So can we talk a little bit about the this New York Times study specifically in why the doctor was able to come to the conclusion that breastfeeding is safe after the vaccine?

Yes, so the headline said, breastfeeding is safe after the vaccine. Now to me and probably to a majority of parents, they would think the vaccine ingredients have been shown to be non-harmful to the breastfed baby. That was certainly my assumption. As I read I found that they were that that the conclusion of the study and we're gonna get to that in a second that's quote study said vaccinated breast milk contains antibodies. So I said, Oh, my goodness, first of all, she said there's no way certain things in blood can get into the breast milk. Now the conclusion of the study is yes, certain things did and it was the vaccine antibodies, and they're calling that the good news, which is fine. Some people might agree that that's good news, but they put it under the headline safe. So she basically concluded nothing harmful can possibly she use the words No way can get into the breast milk, but yet showed the antibodies did get into the breast milk. All under the term, the headline safe, highly misleading and contradictory. As I continued on, I said, Well, let me get the name of these researchers and find the research because I'm really not trusting all the rhetoric embedded in this New York Times headline. So there is reason to be excited. Six researchers agreed. It said that newly vaccinated mothers are right to feel as if they have a new superpower. The antibodies generated after vaccination can indeed be passed through the breast milk. But whether that milk contains antibodies from the vaccine actually says nothing about whether that vaccine is actually safe for breastfeeding mothers. So that's when I dug deeper, I pulled up the research, I found a whole lot of other big headlines. By the way, they were very successful at getting that headline out there, the Associated Press, Apple news, they all jumped on that headline and spread it around the world about how safe the vaccine is. But then when I pulled up the study, I found the following. First, as I already indicated, the study never tested whether the vaccine is safe in those babies only whether antibodies were transferred into the breast milk. Big difference to the study was funded by the Bill and Melinda Gates Foundation. And the researchers were paid $600,000 to do that. Third, there were 50 women in the study 31 and another, the 31 were almost entirely health care workers from the same city, which is about the opposite of what randomized controlled studies are 31 breastfeeding mothers who are healthcare workers in the same city, it truly sounds like those doctors walked around the hospital and found whatever breastfeeding staff they had in the hospital and collected their breast milk for this study that made its way around the world. In fact, according to the American Journal of Obstetrics and Gynecology, and this is a quote, this study did not achieve statistical significance. So now we're getting to some of the facts here. Go ahead.

Yes, a lot of times, whenever you're trying, whenever you're trying to prove safety, it's actually much, much more difficult than if you're trying to prove harm. Because if you're trying to prove harm you, you're looking for an event and you would expect it to be at a certain rate. And so you actually calculate your sample size, to try and be large enough to actually detect a difference. And it's so difficult and research to to be able to foresee how many you need to find what big of a difference. And so that's why we have standard conventions. And that's the entire field of statistics, that that will help you determine if your results are due to chance. So normally, whenever we talk about statistical significance, we're talking about if we find something true, if that is in fact true, or if it's just, you know, part of that random nature of the world, whenever you are trying to show that there is no difference, it's actually much, much harder, and it takes a lot, much larger sample. And so what I would say whenever they don't reach statistical significance for that type of study, what they actually should say is that they they were not powered enough to find a difference. And now so when did that article come out? You have to remind me around April, just out of curiosity, why were they not able to look at 1000s of people? Why only 31 there were plenty of people vaccinated. breastfeeding women, it probably had something to do just the design of the study the the way that they enrolled their women. So if they were looking only at the same hospital, they just didn't find enough lactating women.

But is there a possible is it possible that they were hoping to not find any harm by having a small sample size?

Um, you know, I think that if if you didn't trust your researchers, you could definitely go down that path.

Or if it's funded by the Bill and Melinda Gates Foundation, you could go down that path.

You could go down that path too. Generally, I like to assume that if you are not the case, I know, I know, you'd like to assume that the people that you're working with and the people that are doing research, our art do have good intentions and are looking to find the thing that they're saying and that's typically what we rely on statistics to be able to say and that is what if you had a researcher reading that paper, that's the conclusion that they would come to and say like, Well, okay, they didn't find safety, but they actually weren't looking for safety. And they also weren't powered to say No, there wasn't a difference, which is part of what's so challenging whenever you're reading Search. So whenever you say that you're trying to assume that a researcher has good intentions, it's a, it's a little bit of a tricky subject. So what we do to try and control for that is we look at their study. And we try and have multiple studies to look at. So not just this one, but then over time, and that's, again, another unfortunate thing over time, we have to have the time that multiple people will be able to generate the same results.

Alright, let's continue. I finally just want to add that in the footnotes of the study, conflicts of interest were listed. And it showed that the researchers all had personal financial interest in at least eight different biotech companies, between consulting seats on their boards and owning Big Pharma stock. So this is what the public doesn't see. So we're looking at a misleading headline at the New York Times and other major news outlets indicating safety when safety wasn't tested. Declaring opinions like this is good news and reason to celebrate. And what Tricia and I know from the work that we do is parents simply want to make informed decisions. They don't want to be told what to do, they want to just be able to look at some of the research themselves. This was at about a week after your September 16 research was published, you in fact, looked at safety in breastfeeding moms who have the COVID vaccine and whether there is a transfer to the infants, you did find results. If I recall, it was 4.0. But you'll get into all of that. And and then that's when that's when I reached out to you and I was just so happy that you returned the call and we had a conversation about and you agreed to come on and talk to us about that research and then to to help empower the listener with how to how to interpret research themselves going forward. So why don't we start talking about why you did the study? And what you did?

Yes, yes, absolutely.

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So part of what we have here at the if at rest center, not only do we do the lab research, but we have a call center and some apps as well to help people make better decisions. And we know that it's it's a topic that you get a lot of opinions from a lot of different people. And not all of them know how to to look at the research for lactation or even know where to go to find it. And so that's what we did here at the infantry Center, Dr. Hill, who I worked very closely with, was getting these questions all the time. And so about 10 or 15 years ago, he opened the infant wrist center for that purpose. It's staffed with nurses and we go through kind of like the the textbooks that we write to educate our nurses and they can whenever a caller comes in, who is either a mother or a healthcare provider, because health care providers are not actually educated in lactation many times. So not at all. And it's so sad. So they can call in and say, Hey, I have a mom, that I'm going to start on these medications, is it safe for them to breastfeed? And we can inform them on what we believe the risks to be. And unfortunately, we have to base that on a lot of shaky evidence. But it is at least evidence. And so what we were seeing whenever people were calling it was our number one request for very long time is is the COVID vaccine safe and lactating women. And what the moms would ask whenever they call us is what's going to happen to my baby. And so whenever we go out and look for the research to try and give them an answer. It was we found the exact same thing that you found is that there are a lot of very smart people working very hard to find answers to a question. That wasn't actually the question the moms were asking. And so they would look for things like the antibodies in the breast milk and sometimes They will look for things like the mRNA from the vaccine, actually in the breast milk. But whether you can say yes or no, even if you find a definitive answer to that question, that's not the one the moms were asking. So we knew that there were so many healthcare providers that were working directly with COVID patients, you know, if you think about your nursing staff at hospitals, they're usually young women, is your nursing staff. And those young women have babies, and they are lactating, and they are pregnant. And so they were at the highest risk of being exposed. And what we found is that a lot of them were deciding to get the vaccine regardless. And in the beginning, they were being denied the vaccine, even if they chose and said I want the vaccine, many women would tell us that they were told that they could not have it, even having done their own risk benefit evaluation. And so, being in this world, we thought, well, if there are all these people that are already doing it, we want to benefit from them. We want to gain the any kind of information that they could give us on what was happening to them and to their infants. And so that's exactly what we did, we put together that survey, and just sent it out to to our network and to the world. And we ended up getting about 6000 people who responded, and I think it was about 4500 people who actually qualified and were able to finish the survey. And, you know, we tried to give them that that requisites for you to participate in a survey, we wanted them to have enough time to actually see what would happen to the infant afterwards. So there was a waiting period. And what we did end up finding is that some moms were recording that they thought that their infants were fussier, or, or were being fussy, or were having a little bit of sleep sleep issues. And I think it goes to back to your question to of how do you evaluate what is good research, if you're doing any, any kind of research that's retrospective, it's never going to be as good as research that you start with the group and you see what happens in the future. But we wanted to be able to get the information out to people as quickly as possible.

And so you had a much larger sample size, much, much larger by the rules, really 100 folds. Yes. Right.

And you were looking at very different outcomes.

Oh, absolutely. They were looking for antibodies, and we were looking for infant symptoms.

And this their responses and the babies. It does seem mirrored common vaccine responses, generally speaking,

yes. But again, we don't have a control group. So that's it's such a big problem. And we so wish that we had designed it a little, you know, slow down a little bit and said, Okay, we want a group of moms that didn't get the vaccine that are lactating, to just tell us what their babies were doing. You know, what percentage of them were fussy and not sleeping? Because now all we have is all right, well, we know that some of them were fussy. Some of them were sleepy, or some of them, you know, had a fever, where the mothers asked if they were though fussier than usual. I mean, it didn't. Weren't they asked if there was a change in that movie, if they were fuzzier than usual? Yes. But yeah, so that that so the, the, the control, so to speak, was the baseline is the mother's own experience with her baby versus the mother's experience with her baby after the shot? So you know, from a return is kind of I mean, you could interpret it that way. I, I still think you're, you're asking a mom, if your baby is fussier than normal on one day versus the next. You know, it's some of them are going to say yes.

But part of the problem with vaccines in general is we have had moms, let's just say moms, but parents who say I know my child, I know there's a difference in my child. And when you have enough of these out there, I like at what point do we just take the mother seriously, because no one knows our babies like we do?

There's a lot to be said for that. Right? And that's how all good research questions come about, is by listening to people and saying, Okay, what do you see? And then what can we go and design a study to try and find the root cause of that, you know, is it the vaccine? Or is it you know, there are other things that could be into play that we don't think of? And as a researcher, that's your, you have to listen to what people want to know, in order to be able to answer their question.

Were there any other prominent side effects?

Yes. So we asked moms about directly if they had a fever or rash, diarrhea, vomiting, if they've slept more than usual or less than usual if they were eating more or less than usual, or if they were more fussy, or if they had any other symptoms, which they could report to us in a free text field. And so the biggest things that we found the biggest positives were that they slept more than normal and that they were more fussy than normal. And we also found that moms that reported that they were feeding works. Also, you know, there was a big difference in what they reported in their infants. And so there, there are good questions about that. So that's the kind of thing that whenever you're a researcher, you see that and you say, okay, so could this What could this be? Could this be the vaccine actually affecting baby? And we would need to design some sort of trial so that you could see, is it the vaccine? Or is it because mom's more tired? Was it directly due to the vaccine? Or was it due to mom not feeling good?

Well, we're looking at fussiness whether the baby slept more, what were some of the less common responses you received?

The least common was that they that changes in feeding, and we didn't have almost no moms that they were less fussy than normal. And then rash, vomiting, diarrhea and fever, were all almost nothing.

Can you talk about the stats, the 4.0 is fully adjusted logistic regression model reports of post maternal vaccination symptoms in the breastfed child were associated with a four times greater odds of adverse breastfeeding events. Yes. So this is what I was saying that this is in the moms that had symptoms, vaccine symptoms, those are the breastfed babies, that they had four times greater of having an adverse effect. That's what that saying. Does that make so?

Yes, so mothers who experienced their own symptom from the COVID-19? Yes, vaccine, those babies of those mothers who are breastfeeding had four times greater the four times greater chance of their baby having an adverse reaction such as sleeplessness, yes, or sleep yet change in sleep, more fuzziness. If the vaccine was disruptive to the mother, then it would a high correlation and being disruptive to the baby. Right? Right. Can you explain the 4.0? Again, just one more time.

Okay. So if you because we don't have a control group, we can't say it's against non respite moms. So what we did is separated out moms that reported that they had symptoms, and moms that so did or did not have symptoms after the vaccine. And so the moms that said that they did have symptoms, their babies were four times more likely to have symptoms than the others.

Were there any women who didn't have any adverse reactions to the vaccine, but they did notice a change in their babies.

So that's a difference in that that's the statistically significant, you expect to have numbers in both groups. But we did find a statistically significant difference. And if you look at the confidence interval in that, so a confidence interval is how we were 95% Sure, that the actual number because we're just looking at a sample of 4500 women, right, when we know that there are hundreds of 1000s of women that are out there, so we're trying to see if our sample would be representative of that actual entire population.

A confidence interval is yes, yes. And what confidence interval is, and we found that range of those infants, if we want to say we're 95% Sure, we think that that number is somewhere between 2.3 and seven.

Right? And that's based on the standard deviation. Yes. Okay.

That's me explain the explain that 2.3 and seven.

So for us to be 95% sure that we're capturing the the actual odds ratio, that there's a difference in these women who didn't have symptoms and women who did have symptoms? For us to be sure 95%? Sure. We're saying that there's a 2.3 to seven times difference in their babies 2.3 to 7.0 times difference, the difference?

Yeah, we want to be very sure 95%. Sure, then we know at somewhere between those two numbers, it's really just about if you can be sure if your result from your sample is representative of the entirety 19 out of 20 times, the actual number of the population will be found in this group. So if you want to not be very sure, you could decrease your sample size to maybe 3131 to 31. Yes.

Do we have any long term studies on vaccines and breast milk? Looking at long term outcomes and babies?

I would have to look it up. I feel like there might be epidemiologic data, perhaps there's some data out there. I would be really surprised if you could find it actually. With COVID. So in the beginning, that's why they said you know, okay, let's not let pregnant women or get the vaccine. And then what they ended up finding out is that pregnant women who have COVID have such a higher risk of these these risks. horrendous events. So we have moms in hospitals that have things like clots in their lungs and clots in, you know, in their heart, they'r having heart attacks and things like that. And we don't really know, know, is that related to, to COVID itself? Or what's related to the risk of having the vaccine with those kinds of issues? Yeah, but we, for every, let me find this so that you can.

But one of the things I want to point out Dr. kretsch, that that is really, I think, unfortunate in how they're collecting this data is, if someone isn't 14 days out from their second shot, they're calling them unvaccinated. And that's unfair. I think that's incredibly unfair. So if someone has the vaccine, or even their second dose, and two days later has a clot, they're going into the hospital with that clot. And they're going under the category of the unvaccinated, which I think is highly misleading. And I don't think that's accidental.

It's hard. Um, you know, I think that it's part of the simplification that happens with with any kind of data collection, and it is hard. It sounds like part of an agenda. Well, I think they shouldn't be another category risk of adverse reaction, the highest in the first couple of days. So yes, so they're calling eliminate Trisha. Right. And they're calling them unvaccinated?

I mean, that is that is really unfair, because you're eliminating the highest risk time of an adverse reaction.

I think that that is the reason that we have the adverse event collection systems. That's why we have those recorded in the the various database. So there's a virus database, and there are a couple other ones as well, unfortunately, the virus database is actually only intended to capture pregnancy. Because while we're here concerned about lactation, unfortunately, because researchers don't see that it is a large risk, the risk is so much smaller than in pregnancy or in other phases of life, that that's why they don't research it, right. They want to reallocate those resources to areas that they think are more risky. So in the end, they have said that other researchers are collecting information on lactation.

But that this comes back to the what I think is so unfair to these earnest couples who are educated, they're trying to get good information, and they go to these doctors they trust, and they're told, get the vaccine, I think it would be more fair to say it is your choice what to do, we really don't have much data one way or the other. This is the risk of getting the vaccine potentially, we don't even really know, this is the risk of getting COVID, potentially, we don't really know. And even that data in hospital is very clouded. Based on when people had the vaccines and what category they're put under. I just think it would be more fair to say, to expecting couples, this is a really hard decision. And it's yours to make.

It is a really hard decision. And I think it's really hard. The people that are making the decisions for public health, it's a hard decision for them to make too. And at a personal level, it's really challenging. It's really challenging, especially when, what your ultimate goal is to keep you and your baby healthy. Right.

So what is your best advice to parents as far as seeing big headlines? Receiving pressure, recognizing rhetoric? And then actually looking for data? I mean, what's your How do you tell someone who doesn't have your pile of research degrees? And experience? How to get to this data? Or, or motivation? Like I had to put a couple hours in defining all this stuff? I mean, what do you what do you say to those people, it's an uphill battle. It is, it's very hard. And I think that the best thing that you can do is try and surround yourself by healthcare professionals that are willing to have discussions with you and help you so that you can if particularly if you find information and and do that research and look through it, that you can take it to them and have a conversation with them. Or, or to use resources like the interest center, you know, this is our job. This is what we look at every day. And so we try and put that information together in a way that we can, we can say, alright, this is the the conclusions that we're coming to and this is the research that we're using to support it. Anyone who is going to tell you that you need to do something without having a discussion without being willing to talk to you about why, you know, that's a red flag. That's that's whenever you need to say I think I need to find someone who wants to listen and wants to help me instead of just move on to the next person.

This COVID-19 vaccine is sort of an unprecedented time. We've never really seen the pressure for vaccines like this ever before. Is this is going to prompt some better research on vaccines and pregnancy and lactation. Is it already happening? Is there going to be the ability to do randomized control trials are we going to get some real data I so I Sure, hope so. There have been some good opinion pieces that have come out from very prominent people saying, I can't believe this is a problem because we're protecting pregnant and lactating women from research, not with research. And that's sad, that needs to change. And and we are working on that I think that almost every researcher that is in this field, that's one of their their goals, is this needs to be a bigger part of the decision. And when you approve a medication it has to be you can't just ignore all of these women.

So can you tell us as we're wrapping up now, more about the infant risk center, and why our listeners can go to your website, get some of your resources? How can they make use of all that you guys are doing and all that you have to offer?

Absolutely, we have a lot of resources on our website that anyone can find and poke around on. And hopefully, we're answering the questions that you really want answered. And if we're not, then we're more than happy to talk with you on the phone. That's what our nurses do day in and day out. And whenever we are presented with a question that they don't know, they'll come straight to Dr. Hill into AI to say, hey, you know, this is something that we haven't seen before. And then we'll we'll try and answer that. And that actually usually becomes our next research question. So it's, it's really self, it's very satisfying to work with women and give them the answers that they want. Unfortunately, answers that they want are a lot of times a little bit more lofty than what we can give them because of the quality of the information that we have. But but we're working on it. And we're trying to amass the amount of information to be able to go to the people at the FDA, for example, and say, Hey, this is a problem. All of these women are coming to us, because our university has decided to allow us to do this without any funding. We have no external funding, and the university supports us in doing this. But what if we weren't here?

I would like to just add to for our listeners that any mother out there any breastfeeding mom who is told by another care provider that they need to discontinue breastfeeding because of something their provider wants to put them on? should prompt a call to you guys, because most of the time, that's not the case, we see it all the time. We see it all the time. It's actually the number one reason medications is the number one reason that healthcare providers tell women to stop breastfeeding. Exactly. That's and it can be for reasons like they have mastitis and they need an antibiotic.

And we just know that that is not true. I mean, so many medications are actually safe in breastfeeding, or we're how you take them and how you breastfeed, you can work it out so that you can continue breastfeeding.

Yes, about 90% of the women who call us we are able to identify a way to keep them breastfeeding, whether that be you know, the drug is actually safe, that we think. And what we also can do is help them come up with the schedule, so that they can miss those those times when the drug is going to be in the milk. And they can limit the exposure to their baby or tell them that okay, for two days, you need to stop breastfeeding, and then you can return to breastfeeding. And I think that, you know, for most providers, it's just you know, that's the end of the story. And it shouldn't be just out of curiosity, how often do you get calls about alcohol and breastfeeding? And what do you tell moms?

Oh, this is great. We actually are going to have a new article come out with for that right before the holidays.

So drinking article, I'm guessing I wouldn't, we have to hesitate. We try not to say pro drinking because of almost everyone, every Governmental Organization says you know, it's best just to not do that. But really, I mean, so what we're doing is coming up with a calculator that instead of it being based on blood alcohol concentration, which is what almost all online tools will give you is, you know, there's this rule of thumb that says wait two hours for every drink. But that's a lot less accurate if you're a very small or large person, and if you have multiple drinks. And so there was actually some research, some great research done, I think it was in the 90s. Looking at how much alcohol actually gets in based on those two parameters and height, they did a bunch of other things. But what they found is height and number of weight and number of drinks are the two things that matter. And so we're gonna have a calculator for that on our website shortly. And it is based on actual alcohol concentrations in milk rather than in blood.

And the logo is going to be like a little sketch of a breastfeeding mom with a martini in her hand, right?

Actually, I had some friends and we got together and they had champagne glasses. And so we took a picture with those champagne glasses with a a pump in the back like a manual action Freshman pump. I did that this weekend? That's what I do in my free time.

This is what those with doctorates do multiple degrees. Couple of quick questions. One is, my first question is, is the extent of your service to the public? Around whether drugs get into transfer into breast milk? Or do you do anything beyond that? That's my first question. The second is about whether it's a free service you provide.

Okay, so I would say that the pillar of what we do is based on medications and milk, but we are working to expand that, you know, we would like to also look at how it affects the infant, and how maternal nutrition affects these kinds of decisions. Because, you know, just like drugs get into milk, such as your food, so your food is so important. So we actually have a PhD that has joined us. So she does her research on nutrition, she's from Cornell, and she's fabulous, she's joined the team, and we really want to be able to focus on the bigger picture. But in the meantime, we're still going to keep doing our work on medications and breast milk. And on translating that. So we do have the free service to call our nurses, it's from eight to five Central Time, Monday through Friday, regular business hours. And those nurses are on the phones all day long. And unfortunately, sometimes you have to wait. Because we are not able to to get to about 30% of our phone calls. So the volume is pretty high. But because we know that that way does is kind of long, we've developed an app called mommy meds, it is $3.99 per year, but it goes directly to fund our research and the work that we do to get to the answers. So luckily, I think that that's a good way to get information 24/7 on all the drugs that we know about. I think if you compare us to any other group of special interests, what's happens is you have a mom who's breastfeeding, and then they stop. And then that no longer is a primary concern of hers. So if if you remember, if you remember the issues that you have, and you can take those to your legislators and just say, you know, this was a really big problem for this phase of my life, and I'm out of it, but it still matters to other moms and support them in that way. I think that's the reason why we don't have the change that other groups have been able to make. And it's because we don't have that that group of people that stand up and say, this really matters to me. And it needs to change and we need to keep going.

We don't have lobbyists. Exactly. It's like the whole perinatal industry at large, the change, the improvement has to come from us, it will not come from the politicians or the hospital administrators. It has to come from us.

It has to come from us. And it's a lot to ask because this is a phase of your life where now you have a child. Now, now you have a child your whole life is different. You're very busy, but just please remember us and remember what needs to happen and make it happen.

Thank you for joining us at the Down To Birth Show. You can reach us @downtobirthshow on Instagram or email us at Contact@DownToBirthShow.com. All of Cynthia’s classes and Trisha’s breastfeeding services are offered live online, serving women and couples everywhere. Please remember this information is made available to you for educational and informational purposes only. It is in no way a substitute for medical advice. For our full disclaimer visit downtobirthshow.com/disclaimer. Thanks for tuning in, and as always, hear everyone and listen to yourself.

I have to ask you, you said you're getting another degree. Yes. And is it another doctorate and other masters? What are you getting another degree? Um, no. So I have you know, my Bachelor's is in nutrition. And I've got the Master's in Business and the doctorate in pharmacy. And this will be a doctorate in translational science and you'll have a double doctorate.

Yeah, so one is a research doctorate. And one is a professional doctorate, which I think is is really valuable because like we've talked about, you have these clinicians that have to bridge all of these gaps of questions. And then you have all these researchers that are answering the wrong question. And so we really need people to bridge that gap in the middle. And we're working on it. So there's a field called Translational Health Science for a reason. It's been a long hard road but it's so rewarding. It's just, I have the best job in the world. You know, I get to help people and use the science that I love to do it.


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About Cynthia Overgard

Cynthia is a published writer, advocate, childbirth educator and postpartum support specialist in prenatal/postpartum healthcare and has served thousands of clients since 2007. 

About Trisha Ludwig

Trisha is a Yale-educated Certified Nurse Midwife and International Board Certified Lactation Counselor. She has worked in women's health for more than 15 years.

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