Does Removing the Black Box Open Pandora’s?

For decades, hormone therapy came with a warning — a literal black box stamped on every prescription. It shaped how doctors prescribed, how women decided, and how fear lingered in exam rooms.
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But now, the FDA is lifting that warning.
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So what does that mean for us — as clinicians, as women, as storytellers of our own health?
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This week, I sit down with Mary Heim, RPh of Rivertown Compounding Pharmacy, to unpack the truth behind hormone therapy: the science, the stigma, and the shift.
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We talk bio-identicals, myths, personalization, and how to reclaim clarity and care in the face of medical messaging that hasn’t always served us.
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This one’s for the women still asking, “Is it safe?”
For the practitioners ready to unlearn and relearn.
And for anyone wondering what happens after the black box fades.

Transcript

Mary Louder - 00:00
Welcome to our podcast, the Dr. Mary Louder show.
Today we're going to be talking about hormone therapy.
And there's a story that I've been wanting to tell you.
It's a story of how we as a medical culture have understood and misunderstood the role of hormones in women's health.
And this is a deep and complex conversation, but it's going to be great.
Well, let's begin this story.
and start with what we know as a small cream-colored pill way back in the 1940s.

Mary Louder - 00:29
Primerin, which was a hormone therapy made from the urine of pregnant mares.
That became widely available as a treatment for menopausal symptoms in women.
It promised relief, vitality, and even glamour, if you can imagine that.
And for many women, it helped.
But it was also a product of its time, and it was formulated in high doses, prescribed often without personalization, and it was rooted in a medical system that saw menopause not as a natural transition, but as a disease to be fixed.
By the 1960s and the 70s, hormone therapy had become a cultural symbol.
It was youthful femininity, staying attractive and balanced through, often without scientific backing.

Mary Louder - 01:20
And the marketing was very, very strong.
The research, not so much. Until.
the Women's Health Initiative, 2005, which was a large government-funded study.
That was halted early because the research showed the increased risk of breast cancer, stroke, heart disease, bone disease, and women using combined hormone therapy.
Panic swept the medical community, prescriptions plummeted.
Many women were abruptly taken off their hormones and were miserable, confused, felt frustrated.
As time passed, the data was more carefully understood.

Mary Louder - 01:54
More studies were out there.
more studies then came to the forefront.
And we found that the timing, the dosing, the structure of the hormone molecules themselves provided not a one-size-fits-all, but an individual approach to the care of menopause in women.
And so we've witnessed a powerful recalibration.
And today we know that timing matters.
how we take the hormones, when we take it.
And it appears not only to be safe, but for many women, potentially protective.

Mary Louder - 02:34
The black box warning is off.
Bioidentical hormones, lower doses, individualized compounding.
These are all now the tools we use and have access to as we prescribe for women more precisely, with reverence and with care.
But there is something that we can't ignore in this story that for too long, women's health has been marginalized, under-researched, under-funded, and sometimes even dismissed outright.
Hormones were seen as too complex, women's bodies unpredictable.
And that's a bias, and that still lingers.
It lives in how we talk about symptoms, how we train physicians, how we fund research, and most painfully, how some women are still made to feel when they seek care from their physician or provider.

Mary Louder - 03:20
And yet, here we are, reclaiming our clarity, our voice, grounding ourselves in both science and story, making space for informed choice, nuanced care, and the power of listening.
So this episode is a part of that reclamation, a conversation that I'm eager to share with a woman who stands at the heart of the shift.
That is Mary Heim, and she's a pharmacist and a hormone expert.
and owns Rivertown Compounding Pharmacy in West Michigan.
Together in conversation, we're going to explore what hormone therapy is when it's rooted in respect, precision, and dare I say, love.
So let's settle in and begin.
Welcome, Mary Heim.

Mary Louder - 04:07
Well, welcome.
This is the Mary's podcast.
Mary Heim, who is a pharmacist and a compounding pharmacist and myself, Dr. Mary Louder.
So welcome, Mary.
And I'm so glad that you joined me today.
It's a pleasure to be here.
Yeah.

Mary Louder - 04:25
And we know each other professionally.
You do work on behalf of the multitude of my patients.
I look to you for expertise in HR in hormone replacement therapy, not only just bioidentical, but just really understanding some of the nuances that patients get into a conundrum about.
And I feel that as a physician, you've got to have a team to care for patients.
And I've put you or requested you to be on my team because I just use the top notch folks.
So I really appreciate your insight, your expertise, how your pharmacy handles patients.
and how it serves West Michigan.

Mary Louder - 05:08
So I just want to give a shout out to that at Compounding, Rivertown Compounding Pharmacy in Grandville, because it's just an important service that you provide for West Michigan and Michigan.
And I'm really grateful to have you today.

Mary Heim - 05:23
Thank you.
I appreciate it.
I hope there's going to be more compounding pharmacies opening in West Michigan and giving patients lots of options.
I think it's a really, really necessary service.

Mary Louder - 05:36
It really, really is because what we're finding, and before we get into the nitty-gritty of the questions, but we're finding is personalized care is the roadmap through the change in life, perimenopause, menopause, maybe even areas of infertility and other gynecological diagnoses that women struggle
with their entire adult life.

Mary Heim - 06:02
Yes, yes.
It's, you can try commercial products, you know, and there's lots of good bioidentical commercial products, but if they don't fit, you need to have options and you need to have places to go for those patients.

Mary Louder - 06:17
That's right.
So take us right there to that definition between the bioidentical options.
the pharmaceutical options, and what does even bioidentical mean?
I think people get confused.

Mary Heim - 06:29
I get confused.

Mary Louder - 06:30
I'll throw my hat in on that one too, then.
But walk us through what the difference is and what those definitions really mean.

Mary Heim - 06:40
Okay.
And one of the things I get caught up with a lot is somebody will ask me if the hormones we compound are natural.
And that's a really hard question to answer because to be natural, we'd have to be taking them from another human woman.
And we're not really doing that.
You know, bioidentical hormones are chemically identical.
So the chemical structure is identical to the hormones your body produces.
So we know what the chemical structure of estradiol is, or progesterone is, or testosterone is.

Mary Heim - 07:16
And we can make that exact chemical structure and give it back to your body.
Is that natural?
Well, no, we're not taking it from another human being naturally.
A lot of times the source material is wild yams.

Mary Louder - 07:32
Okay.
Okay, so what I'm hearing then is the chemical structure, then that would hit the receptor, which would be the estradiol receptor, E2 receptor, in a way that would match how it would or maybe mimic what a woman's natural estradiol would look like.

Mary Heim - 07:50
Yes.
And when you metabolize it out of the body, those pathways are already in place in the liver to metabolize it out correctly.
So if we tweak that molecule and change it in some way, add a couple little side chains to it, it'll stick around in the body longer, but it's no longer bioidentical.
doesn't go down those pathways.
And that's what I call synthetic hormones when those molecules have been tweaked.

Mary Louder - 08:21
What would be the name, the most common name of a synthetic hormone then?

Mary Heim - 08:26
Medroxy progesterone or provera.

Mary Louder - 08:30
Provera.
Now, and is that the same as progestin?

Mary Heim - 08:36
Progestin is a group name.

Mary Louder - 08:38
Okay.

Mary Heim - 08:38
So progestins cover all synthetic progestins.
Got it.
So that would be the progestins that are in birth control.

Mary Louder - 08:49
There's a

Mary Heim - 08:49
whole bunch of them, norethadrone.
You know, so, but all those molecules are tweaked where progesterone is bio-identical to what the body makes.
There's no tweaking of that molecule, adding side chains, making it work differently.

Mary Louder - 09:07
So I learned many years ago that when you use a progestin or synthetic progesterone or progestin, it is like a master key going into a house that could open many, many doors versus progesterone that is bioidentical, no added aspects goes into a locking key within a room or a closet within the house.
It's very specific where it goes.

Mary Heim - 09:35
Correct, yes.

Mary Louder - 09:38
So it would be that master key that you could open up a lot of rooms and closets and areas that you don't really want to go to, right?
Yep.

Mary Heim - 09:52
I view it pretty simple as, you know, you're going to have side effects there that you're not going to have with the natural progesterone, you know, but you're also going to have effects that are sometimes desired.
We use progestins and oral birth control.

Mary Louder - 10:06
Right.

Mary Heim - 10:07
and it flattens out ovulation.
We're not gonna really do that with natural hormones.
We couldn't make a natural hormone birth control because your body can adjust to the natural hormones and metabolize them
out.

Mary Louder - 10:21
Okay, right.
So then that's, yeah, that's the other component is the molecules with added extras don't metabolize.
Correct.
And so then they gather.
Mm-hmm.
Okay.
Where's the most common spots they gather?

Mary Heim - 10:45
They'll stay stuck onto the receptors so they won't release.
So they'll stay stuck onto the receptors and not release.
So they won't gather in the blood levels.
You know, we won't see people will say, well, I got my blood levels checked and they're all low, so I need hormones.
And then they'll tell me they were on birth control.
Well, of course your blood levels are low.
We

Mary Louder - 11:12
don't see the receptors.

Mary Heim - 11:13
Yeah.

Mary Louder - 11:14
Because the goal is to
block those receptors.

Mary Heim - 11:16
Right, right.
So they're sitting in all those tissues and all the cells and not letting go.
And then they could also back up in the liver, which is what metabolizes out all the molecules in your body, the liver, kidney.

Mary Louder - 11:31
Right.
Okay.
This is a really important point because when women are taking the synthetic added on molecules and they have, uh, and they've taken them for years.
And then they go off of them and their cycles may be returned to normal, but they may be around menopause.
Or if a physician or provider prescribes birth control around menopause, just to control the irregular bleeding, just to make things not so bad, just to take care of the hot flashes.
All you're doing is blocking the receptors and you're not really allowing that natural phase of perimenopause into menopause to really progress very normally.
Am I understanding that?

Mary Louder - 12:24
Okay.

Mary Heim - 12:24
Yes.

Mary Louder - 12:25
That sounds like something we shouldn't do.

Mary Heim - 12:29
Again, it depends on the patient.
You know, for the majority of the patients know.

Mary Louder - 12:33
Right.

Mary Heim - 12:34
But sometimes there's rare patients where nothing else works.

Mary Louder - 12:39
Right.

Mary Heim - 12:39
So I'm kind of, let's individualize it again.
Let's make it individualized to what's happening.
You know, we'll have general guidelines.

Mary Louder - 12:49
Yeah.

Mary Heim - 12:49
And then we'll individualize it to each patient.

Mary Louder - 12:52
And I've always maintained that if we look at a woman's entire menstrual history, pre-menarche to menarche, which is when you have your first period, all the way through your menstruation and the different changes that you can somewhat predict relatively how they might handle menopause.

Mary Heim - 13:13
Yes.

Mary Louder - 13:13
Okay.

Mary Heim - 13:14
Yeah.

Mary Louder - 13:15
And so I've used menopause not as a disease to treat or as an affliction to have or something that's in your head and just get over it or just suck it up buttercup, right?

Mary Heim - 13:29
Yeah.

Mary Louder - 13:29
I use it as a time to pause because it's a menopause to see what's next?
What's life about?
What was life like?
What do I want the next stages to look like what do I need to learn from all of my menstrual history?
Because we have things that words that we throw around like estrogen dominance and progesterone intolerance.
And I mean, and then people go, well, how can you be intolerant to the things you're making?
And so these are real valid questions because, frankly, physicians haven't addressed them.

Mary Louder - 14:02
And frankly, physicians have dismissed this.
And, you know, I think that many women have questions around how does it make sense that we're intolerant to who we are?
Well, that might be an esoteric question or a soul level question.
And I'm willing to go there, but maybe not right now, but that's one part of it.
But how do you see that messaging about, well, I'm just this and I'm just that?
I mean, those labels are thrown around pretty quickly.

Mary Heim - 14:34
A lot of times it's a misunderstanding.
You know, it's I'm progestin intolerant, not progesterone intolerant, or I can't handle as high of a dose.
I'm not intolerant, I need a much lower dose.
So it's slapping a label on something instead of looking for the details, drilling down into the details.

Mary Louder - 14:56
So when I drill into the details, I use a genomic study and I use lifestyle, you know, medicine, genomic studies, and I also map the hormone pathways with their genes.
I also look at biotransformation and methylation and sulfation and glucuronidation and you know, and ubiquination and conjugation and hydroxylation.
I look at all those pathways.
And when I put that together, I get a very elegant map that it could be an adventure instead of a scary drive.

Mary Heim - 15:36
Right, correct.
Yeah, the more information you have, the better decisions you can make.
And like you said, we need to gather that information for these women.
We need to stop saying, get over it, or it's natural.
Yes, it's natural, but if you're symptomatic, that's not natural.
So if you're having symptoms, we have to figure out why you're having symptoms and resolve those symptoms.
And they may not be treatment.

Mary Heim - 16:07
They may be helping you metabolize things better.
You know, that's right.
Helping your own system work better.
There's so many options that, but we need to listen to those symptoms and help those women resolve those symptoms.

Mary Louder - 16:24
Yes, that's exactly right.
Okay, so next question.
Let's go into how the conversation has changed in the past number of years about hormone replacement therapy, bioidentical hormone replacement therapy, and then we'll go poke that black box.
Which has

Mary Heim - 16:49
been removed.

Mary Louder - 16:50
I know.
So let's do that kind of like systematic, you know, systematic pathway.
Let's follow our pathways and go and then see if the black box warning opened up Pandora's box instead, right?
I'm just, know, so go for it.

Mary Heim - 17:08
Okay, prior to about 2003, 4, 5, Women hit menopause in this country and they were put on Premarin, which is conjugated equine estrogens, which is definitely a synthetic.
It's not human.
And it was oral.
And if they had a uterus, they were put on Provera, the one I mentioned.
And that was pretty much standard therapy.
There wasn't a lot of other options.
And then in 2005, the Women's Health Initiative came

Mary Heim - 17:39
out.
And the takeaway that was presented to the public from that study.
And I'm not saying the study showed this.
This was the takeaway that was presented was all hormones are bad, hormones cause cancer, don't take hormones.
So since about 2005, we've been telling women Hormones are bad for you.
You'll just have to get through menopause without them.
We'll figure out something else.

Mary Heim - 18:11
We'll give you an antidepressant.
And some of the antidepressants do help lower hot flashes.
I'm not saying they don't
work.
but that's introducing another drug synthetic into the system instead of treating the problem.
So that's kind of, and then we moved a little bit back into, hey, hormones are okay for short periods of time.
You know, treat symptoms for short periods of time and then get off of them.

Mary Heim - 18:40
But that entire time we were doing this to our female population.
There's lots of studies out there that show, yes, medroxyprogesterone is a problem with developing certain types of cancer.
Yes, it has certain side effects.
Yes, it has certain cardiac risks.
But progesterone doesn't have those same risks.
right.
Estrogen doesn't have that same risk.

Mary Heim - 19:05
Oral estrogen increases risk of cardiac strokes.
Transdermal or vaginal do not.
All those subtle details were already available.
So it took the right practitioner to kind of walk the woman through this minefield.
And I'm hoping now that we've removed that black box warning and are hopefully just assigning it to the drug it should be assigned to, medroxyprogesterone.
we'll open up at least the dialogue more of how do we treat this properly?
And do hormones help with bone health?

Mary Heim - 19:43
Do hormones help with brain health, cardiac health,
if
we start them at the right time?

Mary Louder - 19:49
Yes.
Oh, that wasn't a quiz.
Yeah.
The answer is yes to all of you.
All of the above, right?
With your answer.

Mary Heim - 19:58
Yes.

Mary Louder - 19:58
Yeah.
And, you know, I prescribed bioidenticals from... 2000 forward.
I'll never forget the lady who brought in a Meyer bag, dumped it on the exam table and said, you gotta help me, none of this is working.
I'm like, what is this stuff?
It was Chase Berry, it was evening primrose, it was right, it was yam jam because it was topical yam cream, and I'm like, I have no clue.
I said, but this is fascinating.
And it piqued my curiosity And then I did the dive.

Mary Louder - 20:36
And so I had been prescribed and took everybody off of Primerin.
And I went through, of course, I went through medical school and residency knowing what Primerin was, but then when it hit me, like around 1997, it hit me.
I'm like, wait a minute, that's pregnant mare's urine, like horse pee.
I'm like, so then I adapted the line.
Well, if a horse is trying to get rid of it, I probably don't want to prescribe it for a patient.
And so that's kind of been my tagline for the last 30 years, you know, just not doing it.
And then Oprah did a big thing around 2010. Yes.

Mary Louder - 21:11
You get a hormone.
You get a hormone.
You get a,
you
know.
Look at your seat.
You've got a hormone.

Mary Louder - 21:17
And when I was practicing up in Traverse City at that time, and my practice just went kaboom because everybody needed and wanted hormones.
And we did such a fun job.
And at that time I was using the Dutch test.
And so that's, what is that, 15 years ago, right?
And walking women through things.
And I had some women who had had, you know, fibroid uteruses, who had endomyosis, or endomyosis, who had really bad PMS, really bad migraines associated with that.
And so I knew enough biochemistry that I started adding magnesium.

Mary Louder - 21:52
and some zinc and little doses of B vitamins, not a lot, because too much B vitamins made it worse.
And I just kind of made my way through by watching and treating.
And that's called clinical medicine, by the way.

Mary Heim - 22:05
Yes, yes.

Mary Louder - 22:06
And I did that for a decade, and then I added genomic testing.
And all of a sudden the pathways were right there.
The genes were right there.
The things that I knew to treat, but had questions about were right there.
My guessing went away.
Totally.
And people really need to hear this, that we can literally personalize your roadmap.

Mary Louder - 22:33
Not just for hormones, but for biotransformation, detoxification, oxidative stress, inflammation, cardiovascular health, the right foods to eat and the right exercise to do, and the right ways to make your bones strong.
Why wouldn't we be signing up for that in addition to having hormones that support it?
And then what I found is my doses of hormones decreased.

Mary Heim - 22:56
Right.

Mary Louder - 22:57
Once I understood the pathways and the patterns of the pathways, I didn't have to make people get hormone levels back to their 20s.

Mary Heim - 23:04
No.

Mary Louder - 23:05
because that's not what we're going for.
We're going for cardiovascular protection.
That means the lining of the blood vessels have hormone receptors that respond to estrogen.
Estrogen decreases inflammation.
Estrogen makes insulin work better.
Estrogen makes those receptors within the lining of the blood vessels stay open rather than shut.
It blocks and it helps the cholesterol stay healthy.

Mary Louder - 23:30
So it helps with that low density to high density ratio.
And so then all of a sudden the blood vessels were healthier.
And women, because the number one killer of women, is heart attacks.

Mary Heim - 23:42
Right.

Mary Louder - 23:43
Although when I put that out on social media, everybody thought it was husbands.
So apologies to the husbands.
It's not.
Although, no, it's not.

Mary Heim - 23:54
Was
it a multiple choice answer and they all
answered husband?

Mary Louder - 23:57
I got a lot of husbands LOL in replies.
And was really funny because I asked the question, what's the number one killer?
And boom, their thumbs went wild.
And so, but it's heart disease, which we haven't done well with women either.
And that's the other thing.
But then coming back about them, you know, the different ways, let's talk about the different ways you can apply hormones.
because everybody says you gotta swallow them, or you gotta slap a patch on.

Mary Louder - 24:29
And if that patch doesn't work, you change the dose to that patch, and that patch doesn't work, you change the dose of that patch.
I'm like, that's not a one-size-fits-all thing.

Mary Heim - 24:39
And the patch is just estrogen.
So,

Mary Louder - 24:44
and it's

Mary Heim - 24:45
just E2.
Right,

Mary Louder - 24:47
so let's do that.
So we've got the three types of estrogen that are primary functioners in women, E1, E2, E3.
So share with me how you approach explaining what those differences are.

Mary Heim - 25:02
Okay, so women makes all three of them.
And traditionally pre-menopausal, she makes 80% of the E3 or the estriol.
And I view that as the protective weak estrogen.
Doesn't have a lot of symptomatic control, maybe vaginal dryness.
But it's a great protective estrogen that your body makes, and we want to give it back to you.
E2 is estradiol.
This is the one that's bioidentically available in a tablet, in a patch.

Mary Heim - 25:41
These are commercial products.
So in a tablet, oral tablet, a patch, a vaginal cream, a vaginal tablet.

Speaker_02 - 25:49
Yeah.

Mary Heim - 25:49
So, estradiol is commercially available, viologenical estrogen, but it's just estradiol, and there's only certain strengths available.
That's a stronger estrogen, and it's about 80 times stronger than estriol.
Okay.
So, and it has lots of functions, 800 functions at every different tissue and cellular level in the body.
Okay.
The third estrogen is estrone.
Again, a very strong estrogen.

Mary Heim - 26:17
Your body will make estrone out of estrodial on its own.
We don't have to give you back estrone.
And estrone has three different metabolism pathways.
So there's a neutral pathway, a good pathway.
and a not so good pathway.
So the last thing we want to do is give you estrone and have you metabolizing down that bad pathway.
So traditionally in compounding pharmacy, we give you something called biest to estrogens.

Mary Heim - 26:48
Right.
Estrodial, the strong positive estrogen and estriol.

Mary Louder - 26:53
E3.

Mary Heim - 26:54
Yep.
And the normal ratio we used to give biest in was 20/80, 20% estrodial.
So we covered that 10 and 10% of the estrone estro dial, 80% estriol.
The only time I see that not working sometimes for women is vasomotor is really, really bad.
So the hot flashes, night flashes or night sweats are really bad.
And I'll swap that out to 50-50 to just get through that period.

Mary Louder - 27:19
Okay, gotcha.
So that's an important distinction because women are just slapping on E2.
Sometimes if they don't have a uterus, they don't even get progesterone.

Mary Heim - 27:33
Yeah, yeah.

Mary Louder - 27:35
Here's the thing about that, and this is what the question that I ask, it's rhetorical, maybe sometimes sarcastic or a little snarky, but the question is, if you had your uterus removed, did they also remove the progesterone receptors from your breast, from your bone, from your liver, from your
pancreas?

Mary Heim - 27:55
Brain

Mary Louder - 27:56
from your
brain.
Right.
And in your brain specifically, progesterone mixes with your GABA receptors.
So to not prescribe, and if a woman had a hysterectomy, it's usually for some reason.
Right?

Mary Heim - 28:16
Right.

Mary Louder - 28:16
And so, and it doesn't have to be a life-saving reason.
It's a, and I don't mean when I say the word convenience, we use the word elective.
So there's two types of surgeries, life-saving and elective.
Anything short of just literally saving your life is elective, even if, you know, you're miserable and you can't really carry on.
It's still elective technically.
So we say elective.
And so, so it's an elective procedure.

Mary Louder - 28:39
But they've had fibroids, they've had adenomyosis, they've had maybe a thickened lining that they couldn't sort through, maybe there's ovarian cysts, maybe they had PCOS, maybe they had multiple types of cysts that might put them at increased risk of ovarian cancer, because that just tips over and
we don't know.
And so women have hysterectomies for a variety of reasons.
but the other progesterone receptors are not removed.

Mary Heim - 29:10
Correct.
And it does make sense if you look at, again, what we did traditionally.
Traditionally, we gave them Premarin and Provera, medroxy progesterone.
So with the risks associated with medroxy progesterone, if you don't have a uterus, let's not give them that.
So it makes sense history-wise, but that's ancient history.

Mary Louder - 29:37
Like the earth is flat ancient history.

Mary Heim - 29:40
Yes.
So it's, you know, yes, no uterus, no medroxy progesterone.

Mary Louder - 29:48
Gotcha.

Mary Heim - 29:48
I'm no medroxy progesterone ever if you don't have to.

Mary Louder - 29:52
Right.
Exactly.

Mary Heim - 29:55
Okay.

Mary Louder - 29:55
You know, and that is a great point.
You know, I've never seen it that way because I'm like, how do people not get this?
And it wasn't like you people.
It was like, how do doctors not get this?
How do, how do, how do, but that's it, because it's the takeaway, again, from that test, from that study that then the,

Mary Heim - 30:16
Women's Health Initiative.

Mary Louder - 30:17
Yes.
That progestin was just not healthy and not safe.

Mary Heim - 30:22
Yes.

Mary Louder - 30:22
So then no uterus, no progestin.
And so, and I just was like, well, we got to have progesterone.

Mary Heim - 30:28
Yes.

Mary Louder - 30:29
Because then we put the woman right back in that same estrogen dominant state that caused the fibroids, that caused the adenomyosis, that caused the ovarian cysts, that caused PCOS and all that kind of stuff anyway.
The other thing is people say, can I, as we call, as they call it on the social media, on the social media, boy, I just dated myself on social media, on the World Wide Web, as they call it raw dogging.
Let's just raw dog our menopause.
I'm like, okay, how's that working?

Mary Heim - 31:05
Yeah.

Mary Louder - 31:05
So, you know, and I confess my mom did that.
She has passed, so I can talk about her, she won't get me.
And it wasn't pleasant.
I remember that.

Mary Heim - 31:20
My greatest fear for when that happens
is
they're ignoring the vaginal dryness, the vaginal pain and atrophy, which is also all the increasing bladder symptoms and blaming it on something else.
So by raw dogging it, you can be setting yourself up for needing depends when you're 80.
I am
not going to wear depends when I'm 80. I'm going to keep those tissues healthy.
Those tissues need a low level of hormones.

Mary Heim - 31:51
So if nothing else, think about the long term.
You know, the long term you can see, you can feel, you know, yes, you know, and the bones breaking, you know, and the hip breaking when you're 80. Right.

Mary Louder - 32:04
And the heart.

Mary Heim - 32:05
in the heart, in the brain.

Mary Louder - 32:07
And the breast health.
Yeah.
Because to be very sure, if estrogen was the cause of breast cancer, every woman would have it.

Mary Heim - 32:18
Yes.

Mary Louder - 32:19
It's the metabolism, the rogue metabolism of estrogen, which creates a metabolite that's stronger and more destructive.
that creates breast cancer, along with other toxins, viruses, and things that come from the microbiome that go boo in the night.
It's a complex chronic condition cancer is.
It is not a one thing causing a cancer.
It's never a one thing, because it's a chronic disease.

Mary Heim - 32:51
And in this country we've never looked at menopause, we lose a lot of our estriol, that protective estrogen.

Mary Louder - 32:58
That's
right.

Mary Heim - 32:59
Is that increasing our breast cancer risks?
We're just
not looking at that in this country.

Mary Louder - 33:05
Right.
So sometimes when I go through the Dutch, I see where the estriol is higher.
The E3, when that gets metabolized, and the E2 is lower.
And so what you're saying in that is it's because we just need to reverse that, have a little more E2 and a little less E3, and we'll take care of the vasomotor symptoms.

Mary Heim - 33:24
Yeah, yeah.

Mary Louder - 33:26
Yeah, okay.

Mary Heim - 33:27
Just need a different ratio for a short period of time.

Mary Louder - 33:31
Yeah, that makes perfect sense.
That makes perfect sense.
All right, so what do you think is the number one myth about hormone replacement therapy across the board?

Mary Heim - 33:45
I think it's the, it causes breast cancer.
I think so too.
I think that's a horrific myth and there's one particular synthetic hormone that increases your risk and it doesn't cause it, it increases your risk.
Smoking increases your risk of breast cancer more than any synthetic hormone.
I mean, there's so many things that increase your risk of breast cancer, but we've told women no hormones.
I had a doctor tell a woman that he won't prescribe her progesterone because his Hippocratic oath said he would do no harm.
So it's so ingrained.

Mary Heim - 34:27
It's just so ingrained that it causes harm.

Mary Louder - 34:32
We have
nothing to say
about this.
We know what to say about
this.

Mary Heim - 34:35
I
know.

Mary Louder - 34:37
Oh, Hippocrates rolling over in his grave, I'm sure.

Mary Heim - 34:42
But it's that misconception of progesterone is madroxyprogesterone.
It's not.
There's study after study after study showing it's not.

Mary Louder - 34:53
So then some women take progesterone and it is the natural or it is the, you know, the yeah, the natural one and they go, as they are saying again on social media, cray-cray.

Mary Heim - 35:05
Are they taking too much?
Are they taking it
alone and they need estrogen too?
Are they metabolizing it incorrectly?

Mary Louder - 35:13
Right.

Mary Heim - 35:13
You know, there's so many things to look at.

Mary Louder - 35:15
That's right.
And that's exactly what's happening.
So they're usually taking an oral capsule at bedtime.
They're told by their prescriber, their physician or provider, that this will cause them to go to sleep and all is well.
They're having like dreams or they're just, you know, going crazy in their dreams, can't sleep jumping out of their skin, their gut bloats, their skin crawls, their brain just swirls, they're foggy, you know, they're anxious, they're just off the chart.
And that is a, and it's interesting because the literature is calling that, this is the medical literature, progesterone intolerance.

Mary Heim - 35:52
instead of what's the dosage, what is the dosage form, what is the balance.

Mary Louder - 35:58
Right.
So, could we change that perspective and saying instead of saying intolerance is, okay, kind of like anxiety, I use that as a pointer to where do you need to feel safe and how can we help you feel safe versus that being an end diagnosis that requires a diagnostic code and a treatment.
Same with progesterone intolerance doesn't require a diagnostic code and treatment.
It requires understanding as to why you feel that.

Mary Heim - 36:29
Right.

Mary Louder - 36:30
And so if you have the GABA receptors that are extra excitability instead of relaxation, and we can see it in the genomic pathways, then topically, vaginally, lower doses.
I mean, one could even do a low dose a couple times a day versus one big dose at night.
Correct.
And so, you know, there's ways, you know, that you can approach your needs specifically with a lot of the options available.

Mary Heim - 37:04
Yeah, we compound oral progesterone capsules.
I've compounded as low as a five milligram capsule.
The commercial capsule out there is 100 milligrams.
That's the starting dose.
And
unfortunately, they put it in peanut oil.
Yes.

Mary Heim - 37:21
So, I mean, what's up with the peanut oil, do you think?
Progesterone is oil soluble.
So they went with an oil.
They just didn't go with a good You know, there's so many oils they could have chose and they went with peanut oil.
But once all the FDA studies are in, you're kind of locked
in.

Mary Louder - 37:41
Gotcha.
Oh, yeah, that's true.
And that's, I think that's a really good point because it just takes so long to get through that process.
Yes.
All right.
So I'm going to poke the bear here in your, like we haven't already, but this is wonderful.
Thank you for being so candid and transparent with just, this is just wonderful education.

Mary Louder - 38:02
Okay.
Why compounding?
How safe are you?
Who are you?
What do we know?

Mary Heim - 38:08
Okay.
There are... illegitimate pharmacies out there.
And they're in the news right now.
So there's internet pharmacies that are compounding, you know, Ozempic and Monjourno equivalents incorrectly right now.
But if you ask the state they're locating in it, if they have a pharmacy license.
The majority of them don't.
So if you're looking for a compounding pharmacy that your provider will feel comfortable with, that you'll feel comfortable with, you want to make sure it's a state licensed pharmacy.

Mary Heim - 38:49
There's a physical location.
There is a head pharmacist in charge.
We're regulated by so many different pharmacy regulations and on top of the pharmacy regulations, specific compounding regulations.
So they're called the USP Standards, United States Pharmacopoeia.
And they actually all just got revived in, there's a huge revision out there where they got very, very much strengthened two years ago.
So
compounding pharmacies follow state board of pharmacy guidelines.

Mary Heim - 39:22
The inspectors are in here about every two years to make sure I'm doing things properly.
And then we follow the USP guidelines.
And even the FDA can come in here and inspect us to make sure we're following FDA USP guidelines.
So we have lots of regulatory watching over us.
But the thing we're doing is we're taking a... FDA-approved starting medication, testosterone, estradiol, progesterone, or USP monograph-approved medication, estriol.
And we're combining it in different ways for the patient.
So end result is that end product is not FDA-approved.

Mary Heim - 40:03
It can't be.
We've changed it. So if I add flavor to your child's antibiotic, it's no longer FDA-approved.

Mary Louder - 40:11
But the child will take the antibiotic then and get well.

Mary Heim - 40:14
Yes, yes.
The starting product is FDA-approved, but I changed it and individualized it for your child.
Once I do that, but you have to make sure you're... you're comfortable with your compounding pharmacy and the way they do things.
There's different like accrediting associations out there.
I think there's three different ones now that can come in and accreditate different pharmacies.
It's an expensive process and very, very time consuming, but it can be done.
So

Mary Heim - 40:47
there's lots of ways to check your pharmacy as the appropriate pharmacy to go to.
But one of the best ways is I invite all practitioners and patients to come view my pharmacy.
It's all full of windows.
You can see what we're doing.

Mary Louder - 41:03
I put my
nose up
against that.

Mary Heim - 41:07
You can view what my compounders are  doing?
You can view the materials we're using.
I'll open my procedures to anybody.
Nothing's proprietary?
Proprietary for me.
Yeah, I'm an open book here.
I want everyone to know I'm doing things right and I'm doing them correctly.

Mary Heim - 41:25
I can pull documents for any compound I made by just looking up that date and pulling the document right out and showing you exactly what I used, how much I used.

Mary Louder - 41:33
Yeah.
And I don't think that the commercial pharmacies can say the same.
I'm just going to throw that out there because of my experience as a physician.
Sometimes they don't even know what's on their shelf.
And it's been very frustrating for patients just to get regular pharmaceutical support.
I have a great story from years ago when I was practicing in Colorado and I had a mom bring her teenage daughter to me who had seizures.
And she was on seizure medicine.

Mary Louder - 42:06
And she kept, despite being on the seizure medicine, she kept having seizures.
And so that impacted her ability to take driver's training to go on school trips and to attend to her functions.
And so it really impacted her life.
And the girl was devastated.
She was in a near state of depression because of that.
And it was just so disrupting to her life.
So they bring her to me and say, can you sort this out?

Mary Louder - 42:32
I'm like, yeah.
So what I did was a gut study and then what I did was a food sensitivity study and also an IGE, which has to do with food allergy.
We found she had a sensitivity and allergy, so IGG and IGE to corn and maltodextrin parts of the corn.
So I looked on the seizure medicine, Dilaudid, and it had corn and maltodextrin.
So, and what she had been, she had been to, there was only like one or two pediatric neurologists in the area, and she was kicked out of the practice because the neurologist thought she wasn't taking your medicine and that she was lying to him.
I mean, can you imagine the shame, the humiliation, the abuse that girl went through, and we found that it took me one visit, and then the follow-up visit I had the answer.
We had then her medication compounded, never had another seizure.

Mary Louder - 43:34
I mean, this is the power of compounding pharmacy.
This is the power of one size doesn't fit all.
This is the power of when your body does something in response to what you put in it, listen to Yeah.
Find your way through it.
Don't accept that there's something wrong with you, it's all in your head.
Don't let people marginalize you, become an advocate and say, I'm going to figure this out.
Now, I'm not saying go dive in the internet all by yourself.

Mary Louder - 44:02
I'm saying this is not the sink or swim method.
It is not because you can get into some really strong misconceptions about things.
Find your team that you can literally trust that you know has got your back and know it will listen to you and will believe you and understand that your experience that you're having as a patient is valid.
It's valid because it's you. And all of a sudden something that's rare becomes 100% because it happened to you.

Mary Heim - 44:32
Right.
You are a
population of one.
All of our medications in the United States that are FDA approved are based on statistical approval of populations.

Mary Louder - 44:46
Yes.

Mary Heim - 44:46
But, and they will work for, you know, a significant... amount of the population they'll work perfectly.
But for that population of one they don't work for, we have to figure out something else that works.
And that's why we exist as compounding pharmacists.

Mary Louder - 45:05
Yeah.
And that's why you're heroes in many people's eyes, because of the ability for people to have their lives impacted in a powerful way, to help them not just with symptoms, but solve problems by understanding really what's going on.
with all of our unique biochemical individuality.
That's the way to go and that's the way forward.
So parting words of wisdom, anything that you've got for us or I mean, we've really tapped your tank there today.
And I thank you for that.

Mary Heim - 45:36
You were asking about dosage forms.
You know,
we like transdermal, we like vaginal, we like putting hormones in something where they'll cross that skin barrier into the fat cells and get absorbed through the body without going through the liver first.

Mary Louder - 45:50
Yes.

Mary Heim - 45:51
So yes.

Mary Louder - 45:52
Okay.

Mary Heim - 45:53
There are other dosage forms when those don't work.
You know, yes, you can go to oral, but you have to understand oral estrogen will slightly increase your risk of cardiac events, heart attack, stroke.
You know, you can go to something we call a sublingual troche.
It dissolves against your cheek or under your tongue.
So there's lots of different options.
There's people doing injectables, you know.
And there's women doing injectable testosterone.

Mary Heim - 46:18
I'm trying to figure out how it works with what's available, but it's out there.
And there's people doing inserted pellets.
So there's lots of different forms.

Mary Louder - 46:28
And I've done pellets for both men and women.
If you're a woman and want pellets, you have to not have a uterus because I don't want to put a pellet in you and cause bleeding and not be able to stop it. So even if we put progesterone, because even if we give you a pellet, it's inserted under the skin and we give you progesterone, we still, the dose
is still, you know, so I always do it without a uterus.
And again, also we aren't aiming for blood.
We're looking at patterns, so that's going to be urine.
That's going to be urine patterns, that's going to be pathways.
And we don't have to then bring those levels back to when you were 20. We need to abate symptoms.

Mary Louder - 47:07
We need to see inflammatory markers come down.
Bone densities get stronger.
breast health and mammograms and MRIs change because those dense breasts, when handled correctly and metabolized correctly, can return to normal tissues.
I've seen that happen.
I've treated women who've had breast cancer and who've been on tamoxifen and want their life back, who can't tolerate things and they're just so miserable, they would rather die than have the treatment.
So the door is open, the possibilities are unlimited, and as long as we understand your individuality, your needs, in your biochemistry.

Mary Heim - 47:44
Yeah, I always say blood levels, if a doctor's looking at blood levels are you're on an eight-lane road in Chicago, and the blood levels are the outside bumpers.
You got
eight lanes between there.
All you're doing is trying to fix the symptoms.
You're not aiming for a specific blood level.
The blood might not move at all, but all the symptoms go away.
That's good.

Mary Louder - 48:08
I love it.
I just
saw somebody careening off the bumper.
Boom, That is a great picture.
I'm going to keep
that in
mind.

Mary Louder - 48:19
Well, thank you very much for your time.
I know you've got to get back to your clients.
And I'm going to press on.
I've got some patients as well.
But I thank you for taking your time today to handle this very important question and to give us a delightful, insightful, and just well-educated conversation.
Thank you, Mary.

Mary Heim - 48:35
It was my pleasure.

Mary Louder - 48:37
All right.
Thank you to all of our listeners who tuned in today to the Dr. Mary Louder show where our guest was Mary Heim.
And we talked about hormonal therapy, taking back our voice and our choice.
If you like this episode, rate and review, certainly share it with your friends because there's a lot of great information here.
and go to our website for more information, www.drmarylouder.com, and also note and show notes there'll be a document for you to have regarding the various types and forms of hormone replacement therapy that you get to choose from and use as an education form.
Take good care, see you next time.