Ep 307: Informed Consent Isn’t a Form — It’s a Conversation

Speaker 1 (00:00.17)

If you've ever felt overwhelmed trying to understand what's actually in the medications you or your baby are offered or what are the potential side effects, you're not alone. In this episode, I'm talking with Alexandra Goloska, the founder of Just the Inserts, a platform dedicated to helping you make truly informed decisions. From her own challenging postpartum journey to the tools she's developed to help decode medical language,

Alexandra breaks it down in a way that's clear, empowering, and really refreshing. If you're pregnant, a new mom, or just someone who wants to feel more confident navigating your health choices, this one is a must listen.

Speaker 1 (00:46.604)

Welcome to the Birth with Power podcast where knowledge is power and power transforms birth. I'm Dr. Nicole Callaway-Rankins, mom of two and practicing board certified OB-GYN with over 20 years of experience and nearly 2000 births attended. I've seen firsthand how the hospital system can leave women feeling unheard and uncertain, but that doesn't have to be your story.

Here, you'll get the knowledge, support, and strategies to take charge of your birth experience so you can walk into the hospital feeling calm, confident, and empowered. Note, this podcast is for educational purposes only and it's not a substitute for medical advice. See the full disclaimer at drnclomaringgims.com forward slash disclaimer. Now let's get to it.

Hello there, welcome to another episode of the podcast. This is episode number 307. Whether this is your first time listening or you've been here before, I am so glad you are spending some of your time with me today. Today's guest is Alexandra Galasca, founder of Just the Inserts, a platform that teaches people how to find, read, and understand the official manufacturer information behind medications, vaccines, and other medical products.

Now, I'm gonna be honest. When I first came across Alexandra, I had some hesitation. Some, maybe a lot even, of her community leans heavily into anti-vaccine, anti-medication, anti-establishment kind of territory, which is not where I personally stand. But I was open, and the more that I looked, the more I saw that she herself,

is truly coming from a place of wanting people to feel informed, empowered, and respected in their healthcare. And that is something that I absolutely believe in too. So in this episode, we talk about what informed consent really looks like, how to understand those long and intimidating package inserts, and how to advocate for yourself without being adversarial.

Speaker 1 (02:55.896)

You'll also hear us discuss the real challenges, including the fact that most of us doctors have no idea how to interpret those medical inserts in detail. If you have ever felt unsure or overwhelmed when making medical decisions, especially during pregnancy and postpartum and for your children, this episode will help you feel more grounded and confident. So let's get into the conversation with Alexandra.

Speaker 1 (03:28.088)

Thank you, Alexandra, for agreeing to come onto the podcast. I'm so excited to have this conversation with you. I'm just excited.

Me too. Thank you so much for having me. Like we said before, each added anybody that's willing to talk about informed consent. I will be there. So love it.

Yeah, Yeah. So why don't you start off by telling us a little bit about yourself and your family.

Yeah, I'm a mother of three young children. I have a five year old, a three year old and a one year old. I am prior military, so I served five years in the military, got out, kind of had a little bit of an identity crisis, did some fitness certifications. And then I realized that I was in finance and budget and I realized I was really good at what I did, but I kind of hated it a little bit. so I,

loved the kinesiology aspect of things and the movement and the steady of movement and how the body worked and just the biology of it all. And so I was kind of already on my own personal journey. I had dealt with severe adult acne for about four or five years. Very, very painful. It's like I'm talking, I couldn't even sleep on the side of my pillow because the acne nodules hurt so bad just to be against them. So it really just forced me to look at my own health and I just overhauled and realizing that

Speaker 2 (04:41.762)

just because there's a product out on the market, maybe that you can go to a big box store at the pharmacy and get, it might work for somebody else, but it might not work for you. And so it really planted that seed to research what works for me, what works with for, I'm a huge advocate of bio individuality and understanding that we're all in diverse places in our lives, even through our own journey, you might be the same person, but where you were.

in high school and college or in the workplace and as a mother, it all changes. And so just embracing that change and taking the personal autonomy and responsibility to research all the products that I was accepting in my life. And it kind of spurred me to start researching medical products and we can talk more if you'd like on how I started Just the Inserts. I just realized that

there is this whole wide world of medical products that I didn't really know a lot about. And I kind of just took things for face value. And so I just started researching it and I started sharing it on the internet and I realized I wasn't alone. And I realized that there were plenty of other people, especially new moms, just trying to make informed decisions about all products on the market, including medical products, prescription pharmaceuticals, over-the-counter pharmaceuticals, vaccines, biologics, things like that.

And so I just started sharing and I'm a big fan of citing your research. And so I put all of my research available. I don't ever try to make a decision for anyone. I just want you to know what our own government and manufacturers say about their own products. And so that's kind of how it started, the genesis of everything. And it started with me and now it's blown up because there's so many other people like me that just want to make informed medical decisions.

Yeah, I love it. you and your organization or company, I guess it's called Just the Inserts. Yes. And you can tell us a little bit about what specifically that is. And then I would love to hear, I read on your website that you said your child experienced an and injury from a pharmaceutical product. So if you're willing to share that story, I'd love to hear.

Speaker 2 (06:47.566)

Yeah, absolutely. So Just the Inserts basically is just a training and resource platform. I have a free training course that teaches you how to find and read manufacturer inserts. Now, if you're thinking, why do I need to read a manufacturer insert? The basic foundation of it is informed consent, which I believe both of us align pretty well on. My goal is that you know.

everything that the government and manufacturers say about these products, the manufacturer inserts are freely available on the FDA website. It is all the information. So I teach you how to go through each segment of the insert. So if you're looking at contraindications, I teach you what is a contraindication. That's a medical condition that can increase your risk for a potential adverse reaction. I teach you the warning and precautions section. So these are maybe

Other things that you might have that increase your risk or things that you need to be aware of. It's what's the manufacturer communicating to the healthcare provider and to the patient or the parent about this product? So you can decide, okay, is this the right product for my child? Do I need to maybe have a different dose of it? There's also many manufacturers for the same product. So maybe there's one manufacturer that's better than another manufacturer for your personal situation.

for example, then synthetic vitamin K injection, there's a recent update for the preservative version in the warning and precautions section that states that all neonates, so all babies need to get the preservative-free version, because now there's data to support that the preservative version with benzyl alcohol can lead to gasping syndromes and potentially fatal adverse reactions for babies. And so that's important as a parent to know if you're deciding.

I want to accept the synthetic vitamin K injection. Now you know that the manufacturer and the government says, okay, you need to make sure you ask for the preservative free version, but still understanding that the preservative free version has polysorbate 80, has glacial acetic acid. And so just, I just teach you no matter what you're researching for you to be able to go to find that information for yourself.

Speaker 2 (08:51.404)

to assess the risks and benefits, to understand the ingredients, to understand the mechanisms of action, so that's how the drug or vaccine works in the body, and then you make the best decision for yourself. And I think where a lot of people might, if they're outside looking in and they kind of look at the face value of what I do or maybe that superficial level of what I do, it might seem like, well, she's very contrarian. She just wants you to reject her.

Yeah

Exactly. And that's not it. That's not my heart. That's not my intent. And so what I have said plenty of times before, if every single person that came to my website, consumed my social media, ended up accepting the product that I was talking about, I would be incredibly happy because then they would have the informed consent they deserve. They would understand what that manufacturer and search says. They can be observant to potential adverse reactions. They can be alert to any warning, early warning signals, and then they can seek immediate

medical attention if necessary and eliminate diagnostic confusion. So that's my heart behind all of it. And again, I put everything out, I cite everything and I would say 99.9 % of what I cite is from .gov information. And to answer the second part of your question, it's everything I wish I would have had with my firstborn. I had a very traumatic first birth. It was a 44 hour labor.

very horrible experience. My daughter was in the birth canal for about an hour and a half. And when I got out of that, I just thought that she needed the synthetic vitamin K injection and there was no informed consent given to me. thought it was just a vitamin. didn't realize that there were other ingredients in it. And she ended up being severely jaundice, like severely, severely jaundice. She was colic. She had neonatal acne, eczema, hives, just everything, everything you can think of she dealt with.

Speaker 2 (10:42.014)

And it was about six months I was going from just pediatrician to pediatrician trying to figure out what was wrong. I was a nanny growing up. I grew up around kids. I knew what painful cries were. I knew what hunger cries were. And this was a painful cry. so I just finally found a medical doctor. She was a family doctor. And I found her. And she was saying, well, this is all from the vitamin K. And I had already been researching other medical products. And so I went home and I read the insert. And I could not believe.

Most of the things I had been dealing with, most of the things that I had been spending hundreds of dollars in medical bills to try to identify were sitting here on the FDA website freely available. And it's the information I just, wish I would have had because if I would have known that this would have been tied to it, maybe we could have done something early on, early intervention or maybe I would have made a different decision. Maybe I would have asked for the preservative free version. So like I said before, it all started with my story and then.

I just realized I wasn't alone and I didn't want any other parent to have to deal with that anxiety and the unknowns. And so to have that more knowledge and confident decision, that's my goal. That's my intent behind everything that I do.

Gotcha, gotcha. And you kind of touched on this, but there's a difference between asking questions and being informed and sort of using the information to be anti or against something. So how do you walk that line between saying like, don't do this or being against something as opposed to just giving people information to help them make decisions?

Yeah, that's a really good question. And I think that really just comes to where your perspective is and where your journey is when you're talking about medical products. I have a business background, so I see all products on the market. There's going to be pros and cons, right? It's not necessarily an absolute decision that you have to have this tribal mentality for a product.

Speaker 2 (12:40.64)

I see the issues with that, but then I also see the opposite side of it, the pendulum swing to the opposite side where someone is completely against all modern medicine. There is no good in it. There's evil, evil, evil. And I know that's not true because I have hundreds, if not thousands of medical professionals in my community that contact me on a daily basis and tell me their stories of adverse reactions that they've witnessed in their patients and tell me their stories of...

what they have personally seen for their own family members or for themselves. And so it's very, it's a very delicate balance. And I always just go back to informed consent because informed consent doesn't require all of us to make the same decisions. I might accept a medical product that my neighbor could have an anaphylactic reaction to and die. Or maybe there is a product that I would accept, you know, I'm okay with those ingredients, but my Muslim neighbor down the road

doesn't want to accept those products because it has something that might violate their moral obligations. And so that's why I always come back to informed consent. It's just such a unifying force between a very diverse community of we all have our own personal medical situations. We all have our own health journeys and the ability to just take that information and make that decision for yourself is where I really dwell.

And I do get attacked from both angles. mean, I get whiplash in my DMs. get people mad at me saying, well, how could you support medical professionals? And then I get the other side of like, how could you provide, you know, the kind of more concerning parts of the insert? I'm like, well, that's what in form can set is. It's not, it's not pretty. It's not polished. It's not a marketing message. just what the manufacturer says.

Sure, sure. So then let's talk about what is informed consent. What would you say is informed consent and what you want women to understand, my listeners, about what informed consent truly is?

Speaker 2 (14:40.226)

I love this question. So informed consent is all the information that you need to make a well-considered decision. And that sounds really nice just saying it as a sentence, but I actually have been working on this kind of tool and it's called CLEAR. So, and you can think of it as informed consent is CLEAR. That C is your condition is explained. So whenever you go to a medical appointment,

What are you seeking help for? What's your diagnosis? Do you agree with the diagnosis? About 20 % of diagnoses are wrong in America. And so do you agree with whatever the medical provider is diagnosing you for or for your child? Are there maybe some other observations or anecdotal evidence that you can provide that might alter that diagnosis? Is there a physical exam that you can get or maybe a diagnostic test, a scan or a blood test or something like that that might change that diagnosis? So that's the first part.

of informed consent is that you agree on your condition and that it's explained and that all the information that is needed for that provider to provide that expert advice about that condition is attained. And then moving on to the L is that your layout is explained. So the layout of your treatment. So are we talking about a medical product? Are we talking about a procedure? Are we talking about a lifestyle change? Are we talking about nutrition?

or is it a mix of everything? So really understanding what is the layout of your treatment? Is it short-term, acute? Is it long-term, chronic? All of those different things laid out very cleanly so then you can understand when you're researching a medical product, there are certain parts of the inserts that might only be applicable to acute use or chronic use. And so it's important for you to understand and make that informed decision.

If I'm gonna be taking this product for a long term, I need to know if there's something in there that I should maybe, maybe I need to take a supplement to help prevent any gastro adverse reactions, or maybe I need to make sure that I get my blood tested every six months, because that's what the manufacturer said. I need to keep levels on how my liver's responding to this product. So that's why it's important to understand the treatment plan. Sure.

Speaker 2 (16:48.62)

And then moving on to the E in clear is effects. So understanding the risks and understanding the benefits of each part of the layout treatment plan. So how can this potentially increase your risk for cancer? Can this increase your risk for maybe some cardiovascular concerns? What are some things that you can do if you do decide to accept this product to ensure that you're keeping tabs on it or maybe the dosage needs to be adjusted or.

Maybe, like I said earlier, maybe there's a different manufacturer that doesn't have a excipient or an additional ingredient that might be causing those hypersensitivity reactions. So understanding all the effects of it, and then moving on to A is alternatives. So what are the alternatives to everything that was recommended by that provider, including doing nothing? Is there maybe an element of some watchful waiting that might be helpful for you to gather more information? Maybe.

going back to, you know, are there other diagnostic tests, maybe a specialist that you can go to. Maybe you can talk with some family members and see if there's other family history that you haven't been aware of and that might help play into your decision depending on whatever it is. And then R for clear is responses. So having the ability to have that interaction with your provider, it being a collaborative environment,

it being a very open environment, understanding that there's no gas lighting going on. Gas lighting is very common for women and people of color. understanding that can definitely happen in the medical space and being aware of it. just not having a hypervigilance response, because that can be toxic in itself, but just being aware so that if it is, you start to see the seeds of it, maybe you can seek a second opinion or find a different provider in that same practice. And so that's really what informed consent.

is and I'm kind of perfecting that tool but I think I'm pretty happy with it. think that covers a lot of aspects of it.

Speaker 1 (18:38.734)

does, it does indeed. So then what do you believe or what do you hear people in your community say is missing from that process when they're offered options and particularly in the setting of pregnancy and birth?

that's such a good question. I think for most people, especially brand new moms and young moms, they are not told all of their options. They're kind of just said, this is the standard of care. This is the, I guess, process. And you're just a cog in this process and you don't have any options. And I think that definitely is something that at least the DMs that I get from my community is they don't realize that they have options. And that's one thing I think you do a fantastic job at is that

There are so many different options available for a new mom or a mom trying to seek whatever kind of birth that she wants. And maybe if you are planning a home birth, you still need to be aware of potential emergency C-sections. have friends that have planned home births and then had C-sections. then there's that extra element of fear because there's unknowns and they feel like they were robbed of this opportunity. so

I think researching all of your options is really important because birth plans are just plans. Sometimes it doesn't go according to plan.

There's no such thing as planning birth. The baby is the one who plans and they don't tell any of us how they intend to get here.

Speaker 2 (20:01.474)

Exactly. I've had friends that have had scheduled elective c-sections and then ended up having an unplanned free birth. And so I think it's just very important, especially for pregnancy, that you just research everything. And again, it can be a little overwhelming. So I tell many people, if you can research this before you're pregnant, the better, because then you're not dealing with all of the emotions and hormones of pregnancy. can be a little bit harder.

So I've talked with a few college students and I was like, start researching now. This is the best time to do it. But yeah, I think that would be the biggest thing is understanding that you have options and that healthcare is a service. And if your healthcare provider isn't serving you, that you do have options to hopefully seek other care. You might have some limitations based on insurance or however, whatever state you're in, there could be some limitations, but.

Hopefully there is some wiggle room for you to find the best provider for you and your situation.

Yeah, yeah. And we're going to get to this, but my concern that I see on all sides is that sometimes people do research to confirm a pre, like a notion that they already have, as opposed to doing research to actually look at both sides of an issue. you know, to bring up home birth.

which I support for appropriate candidates and backup plan, all those kinds of things. Some people do research for home birth to confirm that it's okay to have a home birth without looking at some of the other sides. So how do you balance helping people know like, this is not about just, and this is a hard question for anybody, because I had the same thing myself, helping people know like, understand to keep an open mind about.

Speaker 1 (21:51.412)

hearing all of the information and not just confirming a specific opinion.

Well, I will say upfront, I believe everybody has a bias. I think it's impossible to be unbiased. And I actually think bias is kind of a beautiful thing because it's baked into how you have your life experiences and the different things that you've been exposed to. Someone that has been through conventional health care and the medical system, they've seen those extremes. They've seen those near death or fatal.

situations of a home birther and they've seen, you know, the complications of vitamin K deficiency bleeding. They've seen maybe hepatitis. So it's under, it's understandable why there are medical providers that definitely only advocate for that. No, no room for questions. That is 100 % the only option available. And then on the other side, you know, you've had people that have been in the healthcare system and maybe they did experience that gaslighting or maybe they were.

judged based on whatever situation that they're in and they've had a really negative experience from healthcare providers. And I get both of those and everybody in between in my community. And so for me, I just say that yes, we all are gonna have biases. We're all going to have a different perspective, but to respect other people and understand the beauty of our diversity and the fact that we can learn from each other.

and hopefully we can come together and realize that we all are just trying to make the best decisions for ourselves, our families, and our communities. I think when we get into this us-versus-them mentality, it can be very toxic and it's not productive. No, it's not. And I am here for productive conversations. I am here for furthering the culture to shift towards informed consent.

Speaker 1 (23:30.988)

It's not productive at all.

Speaker 2 (23:42.762)

And that's why I've said, even if someone makes a different decision than I would have in my personal situation, I'm still going to respect that. I'm going to still celebrate them seeking that informed consent and doing it in knowledge and confidence and not fear. think that making a medical decision to not accept a medical product out of fear is just as bad as accepting that product in fear. So I do try and there are some, you know, natural health is going to be emotional. There's going to be natural things to be fearful of. And so when you talk about it, that's just a,

a common thread that you're going to see in any conversation, but hopefully I've worked very hard to kind of cultivate that environment of knowledge and confidence and respecting everybody's decision. That's not a perfect answer.

It's a very difficult topic because sometimes the consequences of choices can be very significant potentially. So we have to be willing to accept that sometimes people are going to make choices that may have bad outcome. They may not, but they may. For an example, to use this as an example, like if someone

if I'm working with someone and their baby's heart rate tracing doesn't look great. And I've said, I think at this point, a C-section would be recommended and they decline a C-section. There is a part, and I've actually seen this happen, unfortunately, where the baby did not do well because a C-section was delayed, even a baby die. And so it can be hard for people to accept that, you know, this outcome could happen.

But that's what we have to do. We have to empower people to, I think it's just such a delicate line to walk of presenting information and trying not to sway people one way or the other and helping people understand that both options have consequences or whatever options, both, however they are. And then you're just trying to get a feel for what is the thing that makes the most sense based on your own unique circumstances. It's challenging.

Speaker 1 (25:51.214)

I think that what you're doing is important to help people get information because Lord knows we don't read package inserts. So it was interesting, you know, I got on your email list and somebody brought up a methanogen, which is a medicine that we use very commonly. And that the package insert says you're not supposed to breastfeed for 12 hours afterwards. I had never heard of that. I'm in practice for 22 years.

I think all of these things are important that we all need to learn and we're in a space where we're shifting to, I hope, come to a better place. I think we got to come from, there's like a middle somewhere that I think is where I hope that we will get to.

Yeah, and I'm not perfect. mess up. mean, emotions get into it. I obviously have a bias because my daughter has been injured by it. know, and I dealt with those medical providers that weren't listening to me and kind of didn't have that grace towards me in my situation. And, you know, it can cause a lot of scar tissue. And I see that.

What pains me is that when I get messages from people that just write off the medical community as a whole because they have experienced that, and I have too, but I've also experienced wonderful medical providers. For my first birth, I had midwives and my midwives were the issue. It was the nurse who was an angel. I can still imagine her face. She was the one that was giving me as much informed consent as she could because she wasn't the main provider.

so many different situations. I've had friends that have to have c-sections in order to have children, because they had a ruptured uterus for their second pregnancy. And they knew that they were going to have to have a c-section. And so I think a lot of people, when they've been burned by a medical professional, they don't have any, there's no nuance. And there's not respect for people that are in those situations. And that can be really, really, really dangerous, in my opinion. And that's when people start

Speaker 2 (27:53.838)

validating those preconceived notions, those biases, and that's when it starts to get, I start to get concerned because then they start to make decisions and I'm like, wait a second, that's not good either.

And I want to be clear, like 1000 % our system has so many problems, especially with women of not doing informed consent and a very patriarchal approach, particularly in the space of reproductive rights in general and telling women what to do with their bodies. that is men do it, women do it. It's, have issues. So I want to be very clear that we definitely have some work to go, work to do in terms of informed consent. And there are.

small things that are built into the way we practice that are even that we don't even realize an example that I use fairly frequently is like doing cervical exams. We just kind of walk in the room. I'm here to check your cervix and have it's not even taught to say, hey, is it OK if I do this? It doesn't even like occur to us that that's something that we're supposed to do because we're the doctor and we're here to do this thing, which makes absolutely no sense. This particularly invasive thing of

putting your fingers in somebody's vagina and understanding the difference between, I can ask nicely or I can say nicely, say something nicely, but that doesn't mean that there's consent. So I think that's an important thing I want people to know too. Like this conversation isn't about like, your doctor nice? It's really about you learning information to make the best decisions for.

yourself, we're both coming from that same really, really important place. So I guess along those lines, what would you say are a couple of questions that you think are important for people to like have in the back of their minds, particularly in relation to pregnancy and birth about asking their doctor or midwife?

Speaker 2 (29:49.486)

That's a really great question. I think the first thing that just popped into my head is, this product used off-label? There aren't a lot of medications used in the pregnancy and birth space that are actually used off-label, like Cytotec. It actually says in the insert that it shouldn't be used for induction purposes. And so I've actually had a few OB-GYNs and LND nurses that said, I never knew this. I had no clue. so just, not that it's inherently bad that it's used off-label, just to be aware of it.

And so that you can understand, maybe I need to do some more research and see, there something that might increase my risk for an adverse reaction? You know, during pregnancy, postpartum, is this going to affect me postpartum? There's quite a few epidural medications that can, that have listed anxiety and depression. And according to the National Institutes of Health,

one out of eight women in America suffer from postpartum depression. And so that's important to know, right? If you're accepting a product and it might affect your mental state afterward, that's really, really important. There are some drugs that can affect your breastfeeding experience. So understanding, maybe you need a little bit more. If you are gonna accept that product, if it is worth the risk for you to take that product, know, the benefits outweigh the risks.

then maybe you need to schedule a lactation consultant within your hospital. Many hospitals have free ones or there's lots of other options out there. If breastfeeding is something that you want to prioritize, maybe you need to make sure that you have some extra support. And so a lot of this that I go through is not necessarily like an automatic no or anti. It's okay. If I do decide that this product is going to be in my healthcare protocol, what are some other things that I can do?

to help support me to maybe mitigate some of these adverse reactions or any other complications that could occur.

Speaker 1 (31:41.198)

How do you help people speak in with the example of cytotech? It's, you know, actually, or mesoprostil, it was actually formulated to be a GI medicine. And I'm not sure the story of how it got figured out that it can cause contractions and bring on labor, but it's been used for quite some time. How do you help people understand that sometimes, in particular in this case, the manufacturer

doesn't always have an incentive to go back and do the studies to look at certain things and, you know, who's going to pay for that to kind of look for things. The manufacturer is like, well, OB is already using it. Like, why would I put myself at risk to study it and see? And then also take into account the experience of years and years of people using it. And it doesn't.

use when it's used in appropriate doses seems to be safe with the low risk of side effects or even the difficulty of the challenges of connecting like one thing with something that happens later on. So how do you wrap all of that into the discussion? It's very challenging.

100%. It's very, very challenging. I don't envy the FDA's position at all. What they have to go through is complicated. I was talking with an infectious disease scientist recently and she said humans are horrible test subjects. And that's so true because think about everything that we're exposed to. It's not just the medical products, it's your environment.

the toxins in your environment. Do you live down the road from something that might be emitting pollution that only you are exposed to? And so it's really hard to nail all that down. And so there is not a hard and fast, easy answer to that. However, I will say there was a federally funded study that was done and it found that less than 1 % of adverse reactions for drugs are reflected in FAERS, which is the FDA's adverse event.

Speaker 2 (33:44.75)

reaction reporting post marketing surveillance system. And so that's really concerning that that is such a low amount that's captured. And then, you you start talking to some providers and they say, okay, well, you know, I have experienced this, if you look at my whole panel size, it was pretty rare. But then you start looking at, okay, what are some of these adverse reactions? Some of these adverse reactions, they're not going to go to their OB where they're going to go to an emergency room.

So then you start talking to emergency responders and you realize, this is actually pretty common. And so there's so many silos of information and people aren't talking to each other. And so I do think there needs to be, and this is something that the government's going to have to do. don't think manufacturers even have the ability to do it because it be such a huge collaborative effort. But that is something that I think for the sake of humanity and for mothers, maternal health care rates are

very depressing for our nation, for the amount of money that we spend. I personally have been affected. I've lost a very close friend of mine. She passed away after giving birth to one of her children. it's something that could have been prevented. And so it's something that I definitely think is worth taxpayer money and something that we definitely should prioritize. But it's going to take a lot of collaboration.

Yeah, yeah. I think this is where people, we all need to understand the, I'm putting on my policy hat for a second, the importance of policy, because these things tend to come at a policy level that drives the change and the data capture. So just pay attention to those things because they actually impact us throughout our entire lifespan, our children's lifespan. So I think those things are important.

I 100 % agree.

Speaker 1 (35:34.125)

How do you help people have balance between being an advocate and not coming across as adversarial or I don't want to say questioning authority because that's not it. But in a sense, like, you know, how do you help people manage the inherent fact that there's a little bit of a power differential? Yeah.

in the way our system exists, how do you help people deal with that? That's something I talk about in my course about how to deal with that, but how do you help people manage that?

Well, I think there's just grace, a lot of grace and love and then having that ability to communicate your intent behind whatever it is that you're trying to accomplish together. And many of the conversations that I've had, and there are some times where I don't do a very good job, but there are some times where I realize that there are people that have had past conversations and past experiences and they might be projecting.

whatever it was that occurred in that previous conversation onto you and to realize that maybe if there are some kind of adversarial comments that it's not necessarily you, it's just something that they're still processing and they're dealing with. I say this because I was very, very, very hostile to a family member that was trying to share.

information about medical products with me when I was pregnant with my first child. I called them all these names and it was just, weren't, it was my mom and we weren't, I even didn't want her at my birth and it was just a very, very hostile environment. It really fractured our relationship because I couldn't see her heart in it and she wasn't respecting boundaries that I had put up for me and for my child, my future child.

Speaker 2 (37:23.894)

And so I think it's, again, like just going back to we are all just trying to make the best decisions for ourselves, our families and our communities. think if we make that assumption of each other, hopefully it will soften the hard edges of our conversations and maybe we can start to see each other's perspective and have that respect towards each other and have that more collective movement within our culture to, yes, there are these.

products on the market and sometimes they're incredible and they're life-saving and they're perfect for the situation and sometimes they can cause harm and so both things can exist at the same time and just creating space and respect for anybody who decides whatever they decide in their own personal situation. And also too, I've talked with a few medical providers. There are some people that have contraindications, maybe they have a medical condition that they don't want to tell everybody about. Maybe there's something that they're personally struggling with.

that this medical product could be potentially fatal or serious complications too, but they just don't want to share it. And so just also, you know, it's a little bit of HIPAA as well. Sure. You know, respecting people's personal decisions. It's hard. This is a very hard topic to be passionate about, but it's important.

Absolutely. So I do want to for sure if we can walk through quickly or just abbreviated because I'm not sure how long the process takes but walking through an insert. So say for example somebody wants to look at the medical insert for pitocin, a commonly used drug. So how would you tell people to approach?

Yeah, so in my free training course, I teach you exactly how to find it. It's super easy. It takes like two hours to go through and I screenshot exactly.

Speaker 2 (39:08.398)

how to find and read them, and they're all on the FDA website. So all prescription pharmaceuticals, all vaccines, all biologics, they are mandated and regulated by the FDA to have it freely and publicly available on the FDA website. So I teach you how to find them. And then most inserts, especially the newer ones past like the mid 2000s have the same framework. So they have...

what's called a highlight of prescribing information and that is all the high level things. Like what's the indication? What is this product approved by the FDA for? What are the dosage and administration guidelines? And I really don't spend too much time as a patient on that. Really only if you have a very specific situation, like you're a diabetic or you have liver concerns or something like that. Maybe then pay attention or if you suspect that there might be some misadministration concerns with other

clinic you're going to. But then there's going to be the warning and precautions and contraindication sections, which these are the things that the manufacturer is saying, hey, you need to be aware of these sections in case you have any of these medical conditions, in case of whatever this might cause, you need to be aware of these are the biggest things from clinical trial data and from post-marketing data. This is what you need to know. And then there's going to be

drug interactions, food interactions. So for example, Adderall, if someone's on Adderall, the manufacturer states that if you have vitamin C that it lowers the effectiveness of your Adderall. And so it's important if you're on Adderall and you're taking that, that you might not want to have anything with vitamin C in it. A lot of protein bars have that, which most people don't know. And so that's going to be the high level view. And then if you scroll down, each section is then broken up.

and it talks about their mechanism of action, how the drug or the vaccine or whatever it is works in the body. Is it known how it works? Are there maybe some limitations of effectiveness that you need to be aware of? There are special population sections. So if you are pediatric, if you're pregnant, if you are geriatric, there are different things that the manufacturer might say, hey, this is something that you need.

Speaker 2 (41:22.85)

to know from clinical trial what we know about this product in this certain population, you should be aware of this. Or maybe there was no studies. And you were talking about earlier with the patriarchy and things like that. There are a lot of drugs that were only tested on men and not women. And women, I'm sure you know, have a completely different endocrine hormone system. so that's important to be aware of if you're being.

the manufacturers saying this drug is safe and effective. Okay, safe and effective for whom? Did you test it on pregnant women? Did you test it on women or children? What are the limitations? And it can be, I'm gonna say upfront, it can be very overwhelming when you just open it up and you just look and see, oh my gosh, this document is huge. But hopefully that training course will help you break it up, find out the most important sections that you need to be aware of first, and then as you start to...

go deeper and deeper into whatever research that you are and whatever product and where it plays into that treatment layout for your provider, then you can decide, okay, is this product going to help me or is it going to hinder me? And maybe I want to accept it now. Maybe I want to wait a little bit and accept it later, or maybe I want to look somewhere else. So that's kind of a very high level breakdown. could spend hours on it.

No, that's great. No, that's great. That's great. That's great. So then as we wrap up, there are a couple more questions I want to ask. So let's say someone reads something online or they see something on social media and they're like, because we see a lot of bites of this, that, know, tiny bits. Social media to me is a blessing and a curse.

You took the words out of my mouth.

Speaker 1 (43:09.678)

How do you recommend people find clarity, especially when the algorithm is really just going to keep feeding them more of what they believe?

Yeah, that fear, fear sells. And that's something that I actually really don't like about social media. And I think there are a lot of people in the informed consent space that have the same passions as I do. disagree violently on how to deliver the message of informed consent. And they know based on the algorithm that if they will go for a more fear-based mentality on presenting inserts, that that's going to go viral.

And it's unfortunate. hate it. I hate that it's like that. And I hate that some of the, some of the posts that I do, you know, I might be sharing different parts of insert and it's all cited from.gov research, but it might, you know, cause some fear based on whatever it is. And that's the one that goes viral. And I hate that because I wish that it wasn't that mentality, knowledge and confidence, knowledge and confidence. That's all what I'm about. And so for me.

what I try to tell people that are just starting on this journey and they start to get overwhelmed and they just want to throw their hands up and say, I don't even care anymore. Whenever you're looking on social media and you do come across this, always try to find the sources, always try it. And it doesn't have to be hostile. can be like, Hey, that's really interesting. Do you mind sharing where you read that? And then go straight to the source and then you read it yourself because maybe there's a footnote that's missing or maybe there's something, there's maybe some external financial

factors that are playing into that piece of information that you need to be aware of. So that's where my recommendation is, is try to, okay, take that little tidbit. If it applies to your situation, ask for their source and then go research it for yourself and just protect your minds, protect your mindset. Maybe get some affirmations to say that you are just, trying to make an informed decision, but you're not going to allow it to cause you to spiral into fear.

Speaker 1 (45:13.742)

Yeah, I love that. love that. then what would you say is the most you might have just said it the most frustrating part of your work?

I would say dealing with the extremes, dealing with the ones that, and it's so funny, right? Because if you look at the extreme of the conversation, you have the people that are 100 % for, there's no nuance, mandates, mandate, mandates, and then you look on the other side and it's like no pharma, no medical, and they're actually very similar. Yes.

People don't understand that. They're the same person on different spectrums. The same thing.

I feel like you guys would be great friends. You would just come together a little bit. And that's why I said I deal with that whiplash because I get some people mad at me that I'm not on this side. then I'm like, which now I actually say it as a blessing because if I'm getting both sides mad at me, then maybe I'm more in that middle. If I start getting just one side mad at me, maybe that's an indicator that I've shifted a little bit too much to one side. So yeah, that's the hardest part.

Yeah, for sure. Then what is the most rewarding part of your work?

Speaker 2 (46:16.782)

just, well, I love that you said you signed up for the email list. It's those stories, the stories of the people that said, okay, I ended up accepting this product, but I was able to be making a firm decision about it. maybe they were, I've gotten this one story from this one woman and she took my training course and she didn't have any issues, but unfortunately her husband had a cardiovascular event and they were in the ER and they were recommending a product for her.

husband and she quickly pulled up the insert and then she saw that contraindication and she realized that her husband had a history of it and so she was able to say, wait, no, this is contraindicated and just those informed decisions. I just, I love that. That feeds me. That's so motivating to me that when everyone can make whatever informed decisions for their families, that gives me life.

Gotcha. So then what is your favorite piece of advice that you would give to a pregnant mom who's decided I'm going to look at inserts or a new mom who's decided I'm going to start looking at these things in more detail? What is your favorite piece of advice that you would give to them about approaching that process?

that's such a great question. I have so many things I would say, but I think the most important thing is that you are not going to know all the answers. You're not a fortune teller. You're not a predictor of what's going to happen in the future. Like you said earlier, we don't know what's going to happen. And so just having that elasticity and adaptability to whatever your situation is and not having any judgment of it, no matter what comes your way, not being in judgment of it, just taking it.

as, okay, this is what I'm in, this is the present moment, how can I exercise my knowledge and confidence in this situation? How can I find the information that I need to make that well-considered decision? And to realize it's not a process, or it's not just a one-time thing, it's a process, it's something that's gonna happen your entire life. And it's not an exploding offer, it's not something that's a singular event, it's something that you develop and it's a skill. And it's such a worthy skill to start developing.

Speaker 1 (48:20.386)

Yeah, I love that. I love that. So where can people find you?

Justtheinserts.com, you can find my free training course, you can find my book, you can find all my social media on there. It's Justtheinserts.com.

Okay, and we'll link that in the show notes. Thank you so much for agreeing to come on to the podcast. This was a great conversation. I'm really, really glad we got to have it.

Me too, thank you so much.

Speaker 1 (48:46.67)

Well, that was a great conversation, wasn't it? Now, you know, after every episode, I do something called Dr. Nicole's Notes, which are my top takeaways from the conversation. And here are my Dr. Nicole's Notes from my conversation with Alexandra. Number one, this is so important. Informed consent is more than signing a form. It is a conversation. This is something we do not do well enough in healthcare. Too often, consent becomes about signing a form.

not having a real discussion about risk, benefits or alternatives. At my hospital and many, if not most others, we have patients sign a blanket consent form when they come into the hospital that covers vaginal birth, cesarean, forceps, vacuum, all the possibilities. A nurse goes over it and she does go over it in some fair detail and then I sign it. But let me be clear, that is not true consent. That's a hospital policy form that needs to be filled out.

I always have an actual conversation before anything is done. And to be clear, you absolutely deserve that too. That piece of paper is not true informed consent. Okay, number two, most doctors, myself included, have never been trained on anything at all related to medical product inserts and information. Those things are often long, they can be very technical.

technical, they are definitely not a part of our day-to-day practice education or medical school or residency training or any of that. So Alexandra teaches people how to access those and break down that information. And that can be incredibly helpful, especially when you want to dig deeper than what's typically discussed in a quick office visit. However, this brings me to point number three of Dr. Nicole's notes.

Not every listed side effect is a guaranteed risk. Context really, really matters. Those inserts list possible adverse events reported in studies or post marketing surveillance, but that doesn't always mean that the product caused the issue. Some of this is about legal protection for the manufacturers. If they told you that it's a possibility, then that offers them some

Speaker 1 (51:10.466)

bit of legal protection if something happens. So the key is really understanding what is common, what's rare, and what applies to your unique health situation. Not making decisions based on fear, but instead making decisions based on thoughtful, contextual information, ideally in conversation with your doctor, your midwife, your healthcare provider.

And then number four, just to reiterate, you can absolutely ask questions without being combative. Social media can make it seem like you have to fight to be heard, like you got to go in, you know, ready to like square up, but that is not true advocacy. Advocacy actually is showing up with curiosity, with some clarity, with self-trust. And Alexander and I both believe in respectful communication.

That is so important, even when you're asking the hard questions. That is how you build real collaboration with your care team. And to be clear, the respectful collaboration or the respectful conversation and communication needs to go both ways. Like your doctor needs to be respectful about questions too. So you start from a place of respectful communication, asking questions in a kind.

Inquisitive way if you don't get the response or if people come back at you in a way that's inappropriate Well, then if you need to take it up a notch take it up a notch but you want to start with that respectful communication because that is what helps build a much better working relationship So that's it for this episode Thank you so much for listening today if this episode helped you share it with a friend and hit subscribe So you don't miss a thing and if we're not connected yet

come on over and follow me on Instagram at Dr. Nicole Rankins. My DMs are open and I really truly love hearing from you. Now do me one more favor, come on back next week and remember trust your power, take charge of your birth.