In this important public health episode, Dr. Hirsch discussed how this industry got its wings, and how it is taking advantage of women seeking help during menopause and midlife.


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As confusion and seemingly conflicting messages are being sent to women in menopause about the safety of hormone therapy, more and more women are choosing unregulated non-FDA approved hormone therapy. In this important public health episode, Dr. Hirsch discussed how this industry got its wings, and how it is taking advantage of women seeking help during menopause and midlife. In this episode, Dr. Hirsch discusses the history of compounded non-FDA approved hormone therapy, and the many dangers these compounds have on women.

SHOW NOTES:

Hey everyone, welcome back to this show. Well, it’s a little noisy in my house. We are excited because we are renovating the attic space and I just can’t wait because I’m going to put my office up there. We’re doing the shiplap, the whole HD thing, totally psyched about it, but they’re literally one floor above, pounding nails and hammering away. So if you hear any of that noise during this episode, that’s why. This episode today, I wanted to talk about pellet injections, as well as the other non-compounded, non-FDA approved hormone therapy regimens that are out there. And specifically, I want to talk about this because I want to explain a little bit more behind the boom in this industry and the dangers of using these types of medications and then ultimately a why and how to get yourself off of them. And if you have a friend in a similar scenario, how to talk her out of it as well, certainly she could listen to this episode, but my dream is that you also gleam some background information that can help explain this to someone else because when we can explain it to someone else, that means we’ve learned it.

So for many of you who’ve been listening to my show for a long time now, you know that there was a lot of misleading information from the initial results of the Women’s Health Study or the Women’s Health Initiative that came out in the early 2000s. If you had not already listened to my podcast episode on the Women’s Health Initiative, it’s a few episodes down so scroll back and I would definitely listen to that before you complete listening to this, because it will put it in a lot of context. But because of those fears from the use of commercially available conjugated equine estrogens, which was Premarin at the time, and it’s combination buddy medroxyprogesterone acetate, which is the progesterone component if you had an intact uterus, there grew a new field of air quotes, safe, and air quotes, hormone therapy.

Now, if you really think about it, this was a pretty genius move. People who were looking to invest, or to make money, or who were burned out of their traditional either academic positions, or some of these folks were pharmacists or other allied healthcare professionals looked around and said, “Ah, there’s a niche here for women in menopause who don’t feel good. There’s a niche to help women with vague symptoms. There’s a niche that women are going to fill. They’re going to do anything they can to improve the look and feel of their bodies, their sexuality, their hair, their weight, anything.” We certainly live in a society where getting a miracle cure is a really great marketing tool.

So these wellness clinics formed. Now, I use the term wellness clinics, but it could be a hormone clinic, it could be an anti-aging clinic, any kind of along those lines type of clinic. These clinics formed and they were providing a service that academic professionals or clinicians and doctors were no longer filling. They were so confused about the results of hormone therapy, they grew fearful and then that trickled down into not teaching young doctors how to prescribe hormone therapy or have those conversations. So it just simply disappeared, it seemed from doctors’ hands and it went into these wellness clinics.

Now, these wellness clinics really jumped on the term bioidentical. Bioidentical is a slang term and it means estradiol. Now again, you’ve probably heard me say that you can get estradiol, which is a plant-based estrogen, but as a prescription estrogen in an FDA-approved commercially available product from a clinician but these wellness clinics really jumped on the use of the word bioidentical. These are marketing terms, simply put marketing terms. Anything that sounds like body identical, bioidentical, natural, plant-based these all sound like they’re supposed to be healthy, just naturally.

We envision sunflowers and plants, or herbs and things that seem so much more natural, so much more safe. But the problem is is that that imagery is just downright wrong. It’s a really great marketing tool that we’ve all been marketed to since our first day on this Earth and it’s really a big problem.

Now, these clinics really promise really great results by these bio identical compounds and they were supposed to be so much safer because they were bioidentical and it wasn’t the compounds used in the WHI because those were not bioidentical. But the main problem that you have to understand with bioidentical compounded, non-FDA approved medications is that they’re simply that. They’re not FDA approved. There’s no regulation of these medications. You are injecting something into your body or taking something orally that has not been studied. Literally tell me how that is safer than something that has been rigorously studied and actually found to be very safe and very efficacious, which is just a sidebar and why I really want you to listen to the podcast earlier I did on understanding the WHI because in actuality, even those compounds were found to be really safe, especially for women when they use them within 10 years of menopause.

So back to wellness clinics, they’re usually injecting you if we’re talking about pellets or giving you creams or other compounded non-FDA-approved medications. A lot of women are horrified to learn that these are not FDA approved. They’re horrified to learn that there’s no regulatory pattern here. Now, before I go a little bit further here, I’m really focusing on pellets as well as compounded hormone therapy that is not regulated and I’ll get to that too. It’s not that compounded is necessarily in itself evil, it’s just that there is a lot of safety concerns that go along with it and unless you have a doctor who really, really understands the safety concerns i.e. has been in the menopause field for a while, is a North American Menopause Society certified practitioner, really has a great track record of providing evidence-based information, you should be really, really wary.

At times, I have to compound medications for my patients. Now, one thing I compound regularly is testosterone and that’s because it is not FDA approved in the United States and it is really only available if you get it compounded or its alternative is to use AndroGel and you use a 10th of a dose of that, which is a male dose of testosterone. Very infrequently, I do compound hormone therapy preparations for patients based on severe and well-documented allergies to all commercially available options. I ensure through whatever way I must that they are maintaining safety by either checking ultrasound to check on that uterine lining or that I’m checking levels of their doses very consistently. So it’s not that I don’t do compounded medications, but I have never and would never recommend pellet injections. So that is really more of my main thesis here.

So when women go to get pellet injections, they are seemingly promised a lot of things. First, and I only know this because my patients tell me, I should probably go undercover and act as someone in menopause to get a pellet injection. I wonder how that would work. But my patients tell me that they get there and they’re given a lot of information on its safety. Maybe even something that looks like a randomized control trial or a well-documented study. But again, it is impossible to study the consistent safety of these because every time you make one, it is a little different. It’s not completely different and in fact, it’s not identical to you because remember bioidentical means plant-based not Nancy-identical or Sarah-identical. It’s not identical to you, I have to just rip that bandaid off and tell you that. And they do a slew of blood work, it seems like.

Now this is a huge problem in and of itself. It hurts my soul because again, that’s so unnecessary. They’re taking advantage of the fears of FDA-approved medications. They’re taking advantage of the fact that clinicians, my colleagues, are not well-educated in FDA-approved options and so you have to go to these wellness clinics. They are financially abusing you by taking all of your money to run a slew of labs that is absolutely unnecessary. There is no reason you need your estradiol, estrone, and estriol. There’s no reason you need a progesterone. There’s no reason I’m going to go so far as to say you need a cortisol.

If you’ve heard any of my podcasts before, and I talk about lab work, you know that it’s really a very small percentage of the picture. The majority of determining your menopausal status and how you’re going to feel is mostly what you tell the doctor, what you are experiencing. Now, I know that there is this inherent want to lean on labs because we all want answers. We want yes from no answers, but menopause, perimenopause does not work in that sphere.

So a great contrasting example of this is high blood pressure. We know you have high blood pressure. When the number on the blood pressure cuff is greater than 140 over 90. It’s simple and we use those numbers and then we give you a medication and then we increase that medication if again, your blood pressure is still greater than 140 over 90.

Now, menopause is not like that at all. Lab work is really frustrating, it doesn’t tell the whole story. I call lab work data points. But the majority of what I need to know about where you are in your menopause transition is what you tell me. Menopause is a retrospective diagnosis. Meaning in five years, if you were my patient, you and I could look back and say, “Aha, that was the time you were in menopause and we had to play around with that dosing and now we know that this dosing works really well for you.” So much of it is feedback based at labs are really, really quite irrelevant. In fact, if you’ve listened to me talk before I usually check an FSH and estradiol, and maybe your testosterone and I monitor those levels once or twice after your dose has been initiated and we’ve found what works for you, but there’s no need to check a slew of labs every three months. So financially, this is abusive.

Now, what is also financially abusive is it cost of these medications. Patients will tell me they cost anywhere up to several hundred dollars to several thousand dollars for each round. That is mind-blowing. It is no surprise to me and sad to know that this is a billion dollar industry. People working in this industry are reaping significant financial benefits. It is completely unfair because what I say to my patients is, “I know with almost all certainty that I can get you on a FDA-approved option, where you are going to not have to pay this kind of crazy money where you are going to be safer and I promise you, you’re going to feel just as good if not better, because you’re not going to burn out on these crazy doses of medications.” That’s the truth. So they’re really using you as a Guinea pig in some way and they’re really financially taking advantage of you.

Now, before we get into some more of the dangers of pellet therapy, this is where I want to take a short break to tell you why I understand how you’ve ended up in this spot. I just want to remind you that my course, The Complete Guide To Menopause, everything you ever wanted to know, your doctor never told you, is available for you to take on online at your own pace. This six-hour course that I created covers everything you could ever want to know about menopause. Ideally, it’s like sitting with me in an office and having a long conversation about menopause, the definitions, the facts, and the evidence behind making the right decision for you. In this course, I really walk you through how to come out of this journey, feeling confident and successful instead of confused and frustrated, which is what I find so many women go through and why I became a menopause doctor, and why created this course for you. If you want to learn more about the course, simply go to my website, heatherhirschmd.com/course. There, you can also find all the wonderful reviews and you can browse through all of the different lessons and the first one is free, so check it out today.

Okay, back to what I was saying before I rudely interrupted myself, I understand why you may have gotten pellet injections. I understand why those lab works seem enticing. And I understand why you might be hesitant to come off of them. It’s no secret that the medical profession, in my opinion, has failed women’s health at midlife and menopause. It’s not because they’ve chosen to, but it’s because of some systemic errors in education and internal biases that I am really working on every single day. It is the reason I jump out of bed in the morning, is because I want to change the way we look at women’s health at midlife, and particularly at menopause because of how immense of transition it presents to us in our lives.

But due to these inherent failures in medical education and healthcare providers understanding hormone therapy, you wanted to feel better. And I congratulate you, you are proactive enough to go to the computer and google, and look, and join chat rooms, and join support groups, and listen to people who have gone before you and have found solutions. These are the solutions that you have been presented with. So many women who have gone to their clinician, their local doctor, either their internist or family medicine doctor, or their OBGYN have asked about menopause and they’ve been time after time, after time, after time dismissed or told completely incorrect things. Who are you to really think your doctor is wrong?

Some people do think their doctor is wrong, but deep down, you wonder, “Well, they’re the professional they’ve gone to medical school. They must know something that I don’t know.” FDA-approved hormone therapy is dangerous, or I can’t take it because of some crazy thing someone told you that’s incorrect. A family member had breast cancer, so you can’t take it. You have a family member who had a blood clot, so you can’t take it. You’re not old enough. You’re not young enough. You’re not right enough. It’s just, there’s nothing that you can do. All of these things are terrible, terrible myths and dismissive statements that I hear on a daily basis again, which is why I became a menopause doctor. I actually did a whole podcast on that as well.

So I understand why you may have gone to a wellness clinic because you wanted to feel good. There’s a lot of support groups out there. There are lots of Facebook chat groups with lots of women. The problem is in these chat rooms, there’s just no authoritative clinician putting the advice in there. And so we learn best sometimes from other people as opposed to healthcare professionals. Certainly, that’s why social media is so popular, Reddit threads are so popular because that’s how we learn when something just isn’t in a regular culture that we need help in, which menopause is one of the most taboo things I think.

So I completely understand, I understand why the media has given you these images and also that, that first time you get a pellet injection, you might feel really, really good. So let me walk you through a little bit more about pellet injections and again, compounded, non-FDA approved hormone therapy.

Pellet injections, I’ve actually never done one, or seen one, or thought about doing one, but typically they are a large amount of testosterone and estrogen, and/or progesterone or progesterone is given separately, injected into your tush and these last three months. So that means once you’re given something, you can’t take it back for a good three months. Oftentimes, the testosterone levels are astronomical.

So, what’s normal testosterone? Well, for women reference range in the lab is anywhere from about eight to 60, at least in my current lab. And for men is around like 300 to 500. So you can see women make testosterone does not nearly as much as men, they don’t need that much testosterone. In menopause, you are naturally going to lose your testosterone. So typical ranges I see of testosterone are less than 10, or can’t be calculated, or sometimes 12, or sometimes even 20 or 30. Sometimes people still do make a little bit of testosterone from their adrenal glands.

So do you need testosterone menopausally? No, you don’t. Testosterone’s main role is really in libido. Now, maybe it does play a role in some other things like energy or metabolism, but these are very, very limited. We don’t have a lot of great research on it. So much of your weight, i.e your metabolism and your energy level are based on numerous other things besides testosterone levels. Just think common sense wise, how you sleep, how you drink coffee, how much water you drink. It’s so much more than just testosterone. But with a whopping dose of testosterone, you might feel like you are a brand new woman, you could take on the world and people feel great after the first round of pellet injection. So it’s like, Well, why would I not keep doing that? I feel great. I want to live.” Gotcha, I’m right there with you. I have plans for myself at menopause, don’t even worry about it. I think everyone should live their best quality of life and feel good, and I think women should feel safe and be educated and not be taken advantage of.

Now, the problem with really high levels of testosterone is that they are really dangerous. Now, people always ask me, “How are they dangerous?” Well, let’s go from the most benign to some things that are the more worrisome. Well, your hair can fall out, that’s actually the more benign one. But if you’re like my patients, that’s going to totally turn you off because hair loss is such a huge problem. So if you’re already losing hair at menopause, which is common, due to the loss of estrogen, a whopping dose of testosterone is going to cause more hair loss.

It can also cause acne because testosterone causes acne, that’s why … You think about high school teenage boys. So a high level of testosterone is going to cause you to get a lot of acne and this acne is really that cystic acne, which can cause a lot of scarring. So I’ve seen patients with permanent scarring on their face from really high levels, persistently high levels, of testosterone.

Next it can cause permanent deepening of your voice. This is what folks do when they’re transitioning sexes, they take a high amount of testosterone to deepen their voice, and it will leave your voice permanently deepened. So, that’s something you probably don’t want. It can also cause permanent enlargement of your clitoris and that’s because it’s actually doing almost what it would do in utero, which has given you so much testosterone that a clitoris becomes a penis. Now it’s not going to become a penis, but it will potentially become permanently enlarged.

Now, more other things that can be potentially dangerous are that a high level of testosterone can also be really bad for our heart, potentially our bones. We don’t know about its long-term effects in terms of cancer risk, especially when given at these really high levels, so that’s why it is really quite dangerous.

Now, what are these really high levels? Well, when I see patients in my clinic, I’ll see levels of a man’s, I’ll see 200, 220, 225, sometimes in the high 100s, but these are still astronomically high for women. Remember the reference range for women is between 80 and 60. Now, when I do topical testosterone, which I mainly do for low libido, i.e. if it’s distressing and it’s bothersome to you and your testosterone is already low, then I will do some compounded testosterone. I might see your levels go from 10, or eight, or 12 to 30, or 40, or 45 and women feel so much better. So a smidge, a teeny bit goes a long way.

The other thing that I like to do in my clinic is that I check in with my patients very frequently, every six weeks, and because those doses are daily, we can really scale back very quickly. When you were given a huge amount of testosterone that is injected you can not change that dose my friend, you are slam dunk, stuck with it.

Heather Hirsch:

So the first round can feel really good but typically then what I start to see is with repetitive rounds of pellet injections, women start … their bodies almost start to burn out. It almost has a worse effect because you’re just getting so much testosterone that it’s potentially throwing off so many other things in your body and again, causing a lot of long-term side effects.

So after a while, I do see patients almost burnout from this and they start to actually feel worse than they did at the beginning. That’s because, I hate to say it, but something that seems too good to be true is probably too good to be true, but it’s not your fault. That’s why I wake up every single morning dedicated to giving you podcasts, free resources, my YouTube channel, making menopause courses, so that you really understand hormone therapy and can find something that’s going to be really safe and efficacious.

So remember, you’re getting high doses of testosterone, sometimes really high levels of estrogen. You don’t need that high level of estrogen and we don’t know about its increased risk at levels that are exceedingly high. Like with compounded creams and gels, what I worry about is a huge imbalance of estrogen and progesterone.

So, let me divulge into this for a second. When you’re getting a compounded cream that is not FDA approved, the biggest concern is for women who have an intact uterus, that that imbalance of estrogen progesterone could lead to your uterus not getting enough progesterone and then you getting precancer or uterine cancer. I’ve seen it more times than I wish I have and it is extremely dangerous side effects of using non-regulated compounded creams. For anyone using a progesterone cream, we also know that progesterone does not get absorbed through the skin. So anytime I see someone with an intact uterus using an estrogen or progesterone testosterone cream, it really sends me into overdrive and I worry about you. I worry about your future health. I worry about the financial abuse that may have happened, and I worry about how I can get you off of those and onto something that is safe. So, that is a concern with something that is compounded. Remember, these are not regulated so every single dose that you’re getting, every time you pick up a new prescription, it’s different than the one that you got before.

Heather Hirsch:

Now, how do we get you off of these? Well, education is first, and not being dismissive is second. So again, it is my mission to tell you that you didn’t do anything wrong. You were trying to fix this problem. You were trying to come up with a solution. You were trying to be the best wife, the best colleague, the best mom, the best you and you didn’t go to medical school most likely, maybe you did, or you might even be an allied healthcare provider, but options can be really limited. Again, even when I was an internal medicine resident in a wonderful institution, I learned menopause education wrong, which is why I was floored when I went to fellowship. I just simply had to be in this space because I couldn’t believe the way we were mistreating women and the way physicians were miseducated.

You’ve probably listened to this podcast because you may have a sinking suspicion that there might be something that is off with those, or there might be a better solution. The better solution really is FDA-approved options and a menopause doctor who rocks. So a menopause doctor who rocks is going to understand and help you transition off of pellet injections or compounded non-FDA approved medications and get you on something that’s really safe and very efficacious and walk you through why. Why is it safe and efficacious? Because it is so important that you are knowledgeable.

Women are smart. Women are curious, women are inquisitive. Women will go home and google it if you don’t explain it thoroughly, which is why I created this podcast. So if I can explain to you how it’s safer and why it’s safer, and I have many episodes here on my podcast again, on my YouTube channel, on my website, heatherhirschmd.com, then you will feel really good coming off of those. Then what I usually do is say, “Don’t worry, I’m going to see you in a few weeks. I want to be sure that you feel just as good as you did on those other medications or actually better and safer.”

So thanks guys for listening. This is a topic that’s really important to me. It really hits home, it is really one of the root causes of me wanting to become a menopause clinician, because I think there are social and cultural misbeliefs and misconceptions. There are holes in education and also marketing to women in their 40s and 50s is a really, really big industry and they’re marketing at you hard. I want you to know what’s right and what’s wrong.

If you guys want to see a menopause provider, always check menopause.org and look under, find a provider. I did a podcast a few episodes back on how to find a menopause doctor. You absolutely should, but don’t forget to talk to your clinicians and urge them to do more education if they don’t give you satisfactory answers.

Okay guys, thank you so much for listening to the podcast. I hope the upstairs noise wasn’t too much and part of me hopes you just feel like you’re sitting here with me, hanging out with me, eating breakfast, or going on a walk and having a great discussion on women’s health. Thank you. Please share this episode with a friend, share it on your Instagram, your Facebook, your social media platforms. We want this podcast to grow and grow and grow, and really show that women in midlife are not going to accept the BS that they have been taking any longer.

Heather Hirsch:

Thank you guys so much. You are my reason for getting up and doing this podcast and I hope to see you guys next week. See you then, bye.

MORE ON DR. HEATHER HIRSCH BELOW:

GET THE FREE MENOPAUSE HEALTH GUIDE: https://view.flodesk.com/pages/5f787bdd57796e835ea84e10

Follow Dr. Hirsch on youtube for weekly videos on YouTube: https://www.youtube.com/channel/UCrAeWep_qZiP7QeR7ogcCPA

Say hi on instgram: https://www.instagram.com/hormone.health.doc/

Follow on Twitter: https://twitter.com/heatherhirschMD

For a deeper dive, Dr. Hirsch hosts the course “The Complete Guide to Menopause” which is available at this link: https://the-menopause-course.teachable.com/p/menopause/?product_id=1681827&coupon_code=MENO

Website: www.heatherhirschmd.com


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