What Every Parent Needs to Know: The Truth About Medical Inserts with Just The Inserts | Ep. 107

0:00The government knows, the manufacturers know, but the parents don't know. And I would also argue that most of the healthcare providers don't know. And what is the most heartbreaking messages that I get are nurses and pediatricians in my DM saying, I had no clue. I have persuaded so many parents to accept this product. I have administered myself not knowing, and it feels like betrayal to them. Yeah.

0:28Learning To Mom:Hey, mom friend, welcome to the learning to mom podcast. First off. Hi, hello. Welcome. I'm your official mom friend, Layla. Here you get the answers to all your gazillion first time mom questions. As I ask experts, all our motherhood questions and seek tangible information without making you feel overwhelmed. Please note that the content presented in this podcast is designed for general educational purposes only, and is not a substitute for personalized professional medical advice, diagnosis, or treatment. You're going to get a lot out of this week's episode, mom friend. So let's get right into it.

1:03Learning To Mom:Hi, Alexandra. Welcome to the Learning to Mom podcast. Thank you so much for having me. I'm so excited to be here. You said that and you are so sweet, but I think I'm more excited to have you. I am a raging fan that when your team reached out to me to have you on, I was like, oh, they know I'm alive. It was a big moment for me. So I'm so thrilled to have you. That's so sweet. Okay. We have so much to cover today. So do you mind just briefly introducing yourself and sharing what spurred you to start just the inserts? And then we'll get into like the good stuff. Not that that's not good. Yeah, no, absolutely.

1:46Well, it's all kind of tied together. So my name is Alexandra. I'm the founder of Just the Inserts. So my journey started with Just the Inserts with my firstborn, my daughter. When I was pregnant, I was researching everything, reading all the books. Oh man, if I would have had this podcast, I would have just gobbled it all up. But I just was so overwhelmed by the research that when it came to the point where my midwife handed me a one-page sheet on the Tdap vaccine, I just could not comprehend researching one more thing. So I asked my mom to research for me. And when she provided her research, I found it to be very polarizing.

2:26I found it to be very fear based and not a lot of logic, in my opinion. I thought it was based on just very specific, in my own opinion at the time, rare circumstances. And it was conflicting with everything else that I was seeing on social media, everything that the medical experts were telling me. And so I just had this internal conflict. And unfortunately, I acted very emotionally. And my mom and I were not very good relationally for a while, which was very heartbreaking because we were very close prior to that. And it just proves that this can be such a polarizing and such a hostile conversation, even when it's between two people that love each other and are very close.

3:07So if you've been in that situation before, I completely understand how that is. So because of that, I knew that I needed to research it. So as I was starting to research more about vaccines, I made this kind of rule in my mind that I only wanted to hear from.gov resources because I figured if the government's saying this, if the manufacturer is saying something about its own product, they are the most intimate with it, surely that must be the most credible and valid. And so I eventually found what are called manufacturer inserts. And it are very important documents, so much so that I ended up creating an entire organization based off of it.

3:46But what they are, are basically just if you were to get an espresso machine, if you were to get a curling iron or anything on the market, you get that little pamphlet from the manufacturer. And it's just the manufacturer guidance. That's basically what a manufacturer insert is for pharmaceuticals for vaccines. And all of them, all prescription pharmaceuticals and all vaccines on the market have a manufacturer insert on the FDA website. So I found them, started reading them, realized, oh my gosh, everything that I'm reading from just.gov resources completely obliterates what I had preconceived notions about.

4:20And I was just completely flabbergasted that this was not common knowledge. So I started sharing and it blew up. I realized that other people were in the same mindset that I was. We saw how just at war everybody was at about this conversation. And hopefully by talking about the inserts, it was a little less abrasive, a little less hostile, and we could just have fact-based, open and honest conversation. And so that I started in the fall of 2020, and it has just blossomed. We have a beautiful community of just diverse people, of people who accept medical products, who delay medical products, and who decline medical products.

5:02And we have many, many medical professionals and pharmacists and all kinds of people, infectious disease scientists, and then moms and dads and grandparents, and just people who care about humanity all coming together, all having these open and honest conversations. So that is kind of in a nutshell of what I do and why I show up. So Just the Insert started with my story, but it continues with everybody else's story because this is such an important topic to continue talking about. Yes. Oh, my gosh.

5:32Learning To Mom:That was so good. And I love that you are just so pro-informed consent. And I say that as you're literally wearing a sweatshirt that says informed consent. And I think that that, I mean, that's what matters. Like, I don't freaking care if you decide to vaccinate your kids or not. but like just doing so because your doctor told you to is not a good enough reason. Right. Exactly. I agree. I just absolutely love that there is always a seat at the table for anyone like in your audience and your community. But it just focuses on informed consent, you know, like it doesn't matter what you do, but just make sure you freaking know why you're, why you're making the decision that you are.

6:14Right. Exactly.

6:15Learning To Mom:Let's talk a little bit about what the inserts are. You said it's like a manufacturing thing. So historically, the inserts were kind of just these secret things that only medical professionals could get. They're like folded up pieces of paper that are in, say you get a vitamin K injection or you get a vaccine or something like that. It's the folded up piece of paper in that box. However, it's widely known now that the FDA has all of those inserts freely available, publicly accessible on the FDA website. So all US licensed vaccines have a manufacturer insert on the FDA website. And it can be kind of tricky to find them because they are under either marketing names, which are called trade names, or they're under generic names, which can be maybe the active ingredient in whatever pharmaceutical vaccine you're looking at.

7:08So as someone who's not medically trained, it can be very, very overwhelming to try to find what you're looking for. You could go onto that database and be completely overwhelmed. And especially because there are vaccines that can be preventative towards several different diseases. So if you, for example, are trying to research measles, there's the MMR vaccine, but it's not just measles, it's measles, mumps, and rubella. And then there's also the MMRV, which adds the varicella component. And then there's ProQuad, which has all these other combo vaccines. So again, And if you just got overwhelmed just with that one little sentence that I just said, you're not alone.

7:44It's very, very common for us because we're not taught this and it's not common knowledge. So what I do is I try to break it down from.gov resources. And I have a free training course on my website and it's called How to Read an Answer. And I take screenshots of an FDA training course that was meant for medical providers, but I made it more accessible to the public. And so everything is cited for you because I don't want to replace your research. I want to streamline your research. And I took everything that took me forever to find and put it in a very comprehensive, beginner-friendly guide for you to walk through.

8:21So by the time that you finish it, it typically takes about two to three hours altogether to go through. You know how to find and read manufacturer inserts. All inserts follow a structure. So once you learn what each of those sections are, then no matter what you're researching, you understand, okay, if the manufacturer has this listed in the contraindications section, contraindications are medical conditions that might increase your risk to an adverse reaction. So if there is hypersensitivity to a certain ingredient or maybe an autoimmune condition or a circulatory condition or something like that, if you know that you or your child has that condition and it's listed in the contraindication of that medical manufacturer insert, then you know the manufacturer is communicating to you that you could be at an increased risk for an adverse reaction.

9:11So it's important to understand that structure of the insert so then no matter going forward, whatever you're researching, you can make the most informed medical decision for you and your family. Did you know it takes less than 30 seconds for your body to absorb whatever

9:26Learning To Mom:you put on your skin into your bloodstream. Your skin is the largest organ of your body, and since it is porous, it absorbs whatever you put on it. So it's important to pay close attention to the ingredients in our makeup and skincare products. If the products you use contain harmful ingredients such as harsh toxic chemicals, colors, and fragrances, those ingredients make their way into your body, your blood, your lymphatic system, and the truth is the majority of mainstream body care products contain a cocktail of harsh chemicals, allergens, and irritants. To eliminate a lot of toxic chemicals, preservatives, and fragrances that are harmful to our bodies, choose certified organic and natural skincare products.

10:11Learning To Mom:My favorite makeup and skincare brand is called Crunchy. They are completely toxin-free. They prioritize certified organic ingredients and perform just as well, if not better than conventional brands. And I understand how overwhelming a website can be sometimes. So if you don't know where to start, go to learningtomompodcast.com slash makeup, where I linked everything that's in my makeup bag to help you get started. Or you can go straight to their website. I linked both of those in the episode show notes for your convenience. Go check that out. How do the inserts help manufacturers with liability or lack thereof?

10:51That's a great question. So it's tricky. I know that you talked pretty heavily about in the previous podcast with Dr. Meg, which was great, by the way. I only listened to the first part. I was so impressed by it. So if anybody hasn't listened to that, definitely go back because it was good. So right now there's actually a lawsuit going on with Gardasil, which is HPV, the HPV vaccine. So in that law, in the 1986 law, it stated that if manufacturers provided in their inserts what they know about those products, and they would not be liable for any, you couldn't sue them in the court of law. You couldn't go, and if you had an injury, you could go and sue them.

11:28You have to go instead through a government process, and you never see a manufacturer. You end up petitioning to the government your vaccine injury or death, and then you're compensated from a tax that is on every single vaccine that's given. So if you have ever accepted a vaccine, about 75 % or 75 cents per vaccine or disease that's prevented goes towards an injury compensation program for injury of vaccines and death that's caused by vaccines. But a lot of people don't know that. And that's per the disease that's prevented. So for the flu vaccine, you're paying 75 cents per shot. And then for MMR, that's actually$2.25 because it's per disease, which was mind-blowing to me when I first learned that.

12:12So that's traditionally from that legislation was created, that whole program. But what is important in this current conversation is if a manufacturer is fraudulent in reporting to the FDA certain studies or certain aspects of the studies or maybe some adverse reactions that were reported to them and they didn't report it to the government, then they can be liable for any suing from civilians. So what's happening right now is there were about 200 lawsuits going on with Merck for the HPV Gardasil vaccine. And just real quick, we'll pause real quick. So when I say HPV, that's the kind of generic name of that vaccine.

12:56And then Gardasil is the trade name or the marketing name. That's why you might hear certain terms when they talk about that vaccine. So anyway, so there was a federal judge that said that Merck was okay. They did disclose all of the information on their insert and therefore can't be sued. However, at the state level, they can be sued. So if you see a whole bunch of different things going on right now with Merck and HPV and Gardasil, it's because it's very murky and it's kind of very hard to weed out what is truth and what is maybe something that was fraudulent. and there's a lot of just internal investigation.

13:34So there's a lot of things going on with that law right now. And it's important for us to know as consumers to keep a line on that because if there was kind of fraudulent activity, then that would affect the 1986 Act. That would affect the vaccine information statement that we get whenever we're told that this is something that we need to provide for our children. And especially if in your state where it's mandated, you need to know about this. So it can be, as you can tell, it can get kind of messy. But it is important.

14:03Learning To Mom:So when – okay. So kind of back to the logistics. Sorry. I know we're covering like so much here. When you're talking about like it's important to know da-da-da-da-da-da, could you maybe go through like the sections of – or like what the most important things are so that way we can know like why is being able to read them important and what parts of them are important? Yeah. I'll give a great example. So a few years ago, my two oldest kids got impetigo. So when I went to my family doctor, brought my older daughter, and I was worried because it was on her face. So I was obviously like worried about blindness.

14:39And I just wanted to make sure we were doing our due diligence. And so she prescribed an antibiotic. And she even told me at the time, she's like, look, this antibiotic, it's not, it's for eye, you know, issues, but it's not necessarily the first line defense for impetigo. You can, you know, research more, research more about it. And so I, while I'm standing in the pharmacy, I pulled out my phone and I took like a screenshot of what my doctor had written down, the name of it, because nobody can pronounce any of those things. And I just followed the steps that I have in my own training guide. And I found the insert.

15:12And as I'm standing in the pharmacy, I like went through certain sections. So these are the sections that I would recommend. If you are getting ready, like you're standing in the line at the pharmacy and you're getting ready to accept a product, these are the ones that I would focus on. So those contraindication sections, that's the first thing that you need to be aware of. Okay, are there any lifestyle red flags or medical red flags that I need to be aware of that might increase my risk or my child's risk for an adverse reaction? Because according to the CDC and FDA, if you have a listed contraindication, you should not accept that product.

15:44So that's really important. And then after that, and maybe before that is kind of equal to that, is to read the indication section. So that is what the FDA has approved that drug or vaccine for. About 20%, I believe is the statistic, about 20 % of drugs that are prescribed or vaccines, well, not necessarily vaccines, but drugs, they are used off-label. So they are used for a different reason than what the FDA or the manufacturer produced that drug for. So if you're reading the indication section and it's completely off the wall, it has nothing to do with your condition, then most likely that drug is being prescribed off-label.

16:22And that just warrants a deeper conversation either with the pharmacist or with your doctor to say, okay, can you just walk through your diagnosis and your prescription of this just so I can understand how this drug works and then be more aware of, okay, maybe the titration or the dosage is too high and you can just be more involved in that process to make a better, more informed decision.

16:47Learning To Mom:There's a little bit of a change that's happening to the Learning to Mom podcast, and I am so stoked about it. Now, when I say change, don't freak out. It's really, really small. But essentially, there's going to be a new segment that is implemented into every episode of Learning to Mom podcast that's called Mom Mail. This is where you write in your tricky situation, and I give you advice only a real friend would give. I'm starting this because I want to serve you better, to really know what you're walking through, what you need, and how I can help. Think of it like we're chatting on a hot mom walk together or over brunch with Bloody Marys or mimosas, whatever your vibe.

17:25Learning To Mom:Here's this week's scenario. Am I overreacting? My mother-in-law insists on kissing my 15-month-old on the lips every time she sees him. I've asked her nicely more than once not to do it because I don't want him catching anything. Plus, I just don't like it. She brushes me off and says I'm being dramatic and that she kissed all her kids this way and they turned out fine. Now I feel like I'm the bad guy for even bringing it up again. Should I let it go or stand my ground? I think you'd need to stand your ground. You have a boundary that's not being respected. Why is it on you to change your boundary because it's not being respected?

18:03Learning To Mom:It's not on you. It's on her for not following through. What I would do as your mom friend, the advice that I would give you, take it with a grain of salt. Of course, I don't know your specific relationship, but set the tone for the boundary. If that needs to come from you or due to your relationship with your mother-in-law, perhaps it would be best for your husband to take that conversation and say again, we have this boundary. No one else is allowed to kiss him. Don't share why. If you share why, there's room for negotiation. Just state the boundary. Then state the consequence. If you kiss him, we're going to take him back.

18:46Or if you kiss him, you're not going to be able to hold him for the rest of the day.

18:50Learning To Mom:Whatever that consequence is. And then follow through. It's only going to take one or two times of that consequence being followed through for that boundary to be respected. But if you loosen up this boundary now when your child is only 15 months old, then the boundaries that you're going to have in place for the future, other boundaries, whether that be screen time, whether that be dietary restrictions, whether that be, you know, we feel uncomfortable with your neighbor and we don't want him going over there. your boundaries aren't going to be respected if you don't show that they need to be respected now.

19:32Learning To Mom:That's my two cents on the matter, and I hope that helped. You are absolutely not overreacting. Trust your mother's intuition. You have every right to decide what flies and what doesn't. If you've got a situation you want me to weigh in on, email me at learningtomompodcast.mommail at gmail.com. So indication section, which is typically at the very top, the contraindication section, that would be the second one. And then I personally scroll all the way down to section 6.2. That is the post-marketing adverse reaction section. So section one is huge. And the section 6.1 section is going to like rock your brain.

20:14You're going to be standing in that pharmacy line for hours trying to go through all of that. That's the clinical trial data. And it is important to go through that. However, it's also important to understand that most of those clinical trials, especially if you're talking about a vaccine, the placebo for those clinical trials were either that same vaccine administered at a later date, or it's another vaccine, or maybe it's part of that vaccine without the antigen, or it's a different part of the vaccine without one of the adjuvants. And so it just gets very messy. Because there's no true medically trained.

20:49Exactly. And sometimes you have to go to clinicaltrials.gov to really understand exactly what happened in that clinical trial because it's only summarized in the insert. So I personally scroll past it until I have a lot of time to sit down and research it. And I go to section 6.2, which is the adverse reactions that have been reported from the general public after the product went to market. I find that to be a lot more applicable because the CDC states that rare or delayed adverse reactions may not be known until millions of people accept a vaccine. That's important for us to know. If we know, and according to the FDA and the CDC, an adverse reaction is an undesirable medical condition known to be caused by a vaccine.

21:31So we know that there's causation there. A lot of people will say, well, correlation isn't causation. Yes, that is true, but causation requires correlation. And if there is an adverse reaction listed in section six on the FDA insert, then there has been some kind of causation tied to that adverse reaction in that medical product. So scroll all the way down. And it's typically, the newer products are typically broken out by different bodily systems. So it might say like circulatory adverse reactions, or it might say skin adverse reactions. It's typically broken up. so then you can go through and read through all of them.

22:08So if your child is prone to eczema, then you look and you say, okay, dermatitis is listed as an adverse reaction. There's something in here that might cause my child's eczema to flare up. Or maybe there's gut issues that your child tends to deal with. You can look in the gut section and say, okay, this is known to be caused. So I need to research more about this. I need to maybe have a pause and find out a little bit more and have a more pointed conversation with that pharmacist, with your doctor, and maybe still get the prescription, go home, put it on your table, and then have a conversation with your spouse or your partner, call up your doctor, have a follow-up conversation with the nurse, just to have that insight before you accept a layer decline.

22:53So those are the three sections that I personally prioritize. There are way more important sections that are still there too, But if you're crunched on time, that's what I would focus on.

23:03Learning To Mom:Okay. That was so great. Talking about informed consent and how it relates to authority and responsibility. This is so tricky. Just like, why do you think today's system is set up in a way that makes informed consent so hard to come by? Yeah, that is such a great question. It is the question of our generation sometimes, I feel like. So I think a lot of it has to do with a misunderstanding of what informed consent is. And for those that are listening that aren't really sure exactly what it is, it's basically the right that you have. It's a fundamental right. It's a human right that you have to understand everything about that product that is known from the manufacturers, from the dock of resources.