Why Is Testosterone Still Off-Limits for Women? - Modern Endocrine

Testosterone in women is finally getting more attention, but what does that actually mean for women and their care? In this episode, I sit down with Dr. Terri DeNeui to discuss the FDA’s focus on testosterone, why there still isn’t an FDA-approved testosterone treatment specifically for women, and the questions surrounding safety, dosing, and access.

We also talk about symptoms of testosterone deficiency, why “normal” lab ranges don’t always tell the full story, and the larger conversation around medical freedom and individualized care.

 

Topics We Cover in This Episode: 

  • Why testosterone matters for women
  • What the FDA is currently considering
  • Why testosterone remains a controlled substance
  • When symptoms can appear
  • Why “normal” labs may not tell the whole story
  • How dosing and delivery methods matter
  • Where medical freedom fits into the conversation

Tune in to hear Dr. Terri DeNeui’s perspective on where women’s testosterone care stands today, what still needs to change, and what patients should be asking.

 

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Disclaimer:

The information presented including any materials discussed, referenced, or linked within this podcast are for general educational purposes only, not the practice of medicine.

No doctor-patient relationship is formed from you listening to this podcast or utilizing any of the information provided.

I am a doctor, but I am not talking to you as your doctor. The information provided is not intended to diagnose or treat health problems or take the place of the professional medical care provided by your doctor.

If you are experiencing any health problems, including problems you believe have been touched upon in any respect within this podcast, you should consult your doctor about the problems without delay. You may ask your doctor whether he or she believes the information I have provided would be helpful to you, but you should still consult your doctor immediately and follow his or her medical advice as your treating physician.

I’m just here to provide you with basic knowledge about the issues we discuss so you are more aware of them and can better discuss them with your doctor.

Join me on the next episode as we continue our journey.

 

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Transcript

Is testosterone and women finally making headway? Or is the system still treating testosterone in women like an afterthought? Today on hormones metabolism in you, I sat down with Doctor Terry Donihi. Again, we talk about testosterone, but with the FDA having a meeting this coming week, we talk about all the things you need to know. What is the FDA going to talk about as far as testosterone in women? Is there really a chance that testosterone a woman gets FDA approved? Why is testosterone a scheduled medication? Is there any chance that this testosterone becomes descheduled? Why do women need testosterone? Are there any studies that show its harmful, or are there any studies that show its beneficial? What is happening with medical freedom? Is it being impinged upon because women don’t have the right to take testosterone, and it’s not actually approved for any indication. All of this and more on this episode. Stay tuned till the end. It’s a great conversation. Happy to be talking to Doctor Terry again today, we are going to talk about something that’s amazing testosterone and women. Is it actually making headway or is the system still treating us. You know like it has been an afterthought. So we’ve spent years hearing that testosterone may be coming for women. The system wasn’t built for women to take testosterone. Now the FDA is having this public hearing this coming week. When you’re hearing this, it probably was last week. And so the question is, are we actually seeing progress or are we still stuck with testosterone and women?
Okay, there’s a couple of things. This is such a great topic. And I’m, I’m actually there’s a couple of things I want to say. Number one, this is the year that women’s health is getting a lot of attention in the early part of the year, with the FDA finally lifting the black box warning on estrogen after 20 years of data showing it’s safe and it doesn’t cause issues and cancers and all of those things. And now testosterone There’s been a lot of attention lately, obviously, around hormones in women in general, postpartum depression. And finally, now the conversation about testosterone is coming up. And like you and I both have been treating testosterone deficiency in women for a very long time, decades. And it’s a powerful hormone. So I think it’s beginning the conversation. But what will be had of it, and I hate to be a cynic, but God, the more I talk to people like we were just in a meeting yesterday with some people in the administration that are really trying to change things and make things not. So they really are having a real problem with all the influence the pharmaceutical industry has in the FDA and in the administration, and how duped people are. And unfortunately, when it comes to testosterone, it’s really because there is no FDA approved drug for testosterone in women at this time. So is it an afterthought? I don’t know. We’ll see what the FDA does with this information, really pushing it where I’m hoping that in patients, clinicians, people that have experienced some positive changes in their lives because of testosterone in women, divorce papers ripped apart. I mean, seriously, you know, you’ve got a thousand stories like I do, so I’m hoping so. But there’s a statistic that came out several years ago in a study that showed it takes up to 13 years for the medical community to change a practice after the evidence has come out that it’s a benefit to people. It’s crazy.
So when do you think the evidence started coming out? I mean, we’ve been seeing we know of evidence from the 90s, probably, but when do you think the medical community has really started latching on to this, just into the in the last year or the.
Last probably decade, within the last decade, but definitely it’s been a surge over the last five years, I think. And there’s there’s a lot of let’s talk about the hate, too, because there’s a lot of hate on a lot online around testosterone. And my comment to haters is you clearly need testosterone because if you had your testosterone levels optimized, you wouldn’t be hating, right? I mean, we see it all the time. So it’s honestly a lack of understanding, you know, that. I mean, you’re an endocrinologist. Did you learn about testosterone in women?
No, I didn’t learn about testosterone in women. I also didn’t really learn very much about testosterone in men. But I think it is important. You know, the haters. Yeah. The people that are spreading fear among women about testosterone. It’s really unfortunate because there are always two sides to a spectrum. And yes, if your testosterone as a woman is 600.
Yeah, that’s not good.
You may have some issues, but if your testosterone is where we want it to be, 100, 150, some people need to run a little bit higher. 200 you do well. Yeah. And also your free testosterone is important. And a lot of people don’t understand that. And so I same thing with you. I have patients who it helps their brain. It helps their mood. It keeps them from getting divorced. It keeps them from being depressed.
They want to have sex.
They want to have sex. We have this whole generation of younger women who aren’t having children because you have to have sex to have children. And in your 20s, if you don’t want to have sex, that’s a big problem. Not to say that 20 year olds need testosterone, but we have this epidemic of low testosterone. And so at least needs to be recognized, then addressed. And people need, you know, a roadmap of how to fix it.
Right? And I think that’s where the misinformation comes from, because there’s a lot of and I will say, I don’t well meaning clinicians, but because they didn’t learn it that way or they don’t understand it, or maybe they’ve gotten patients in their office that have had side effects from another clinician running testosterone levels too high, which is not unsafe, their nuisance side effects that can be reversed. But maybe because of that misinformation, they’ve got a preconceived idea. But you and I both know when it’s done right and people understand it, then it is life changing.
It’s life changing. So I want to talk a little bit about what is going on with the FDA, right? So we kind of talked about why testosterone matters in women. But explain to people a lot of people don’t understand with the FDA how this comes about or the process of it. So the FDA has recognized that maybe testosterone in women is an issue. And so what has happened or what is going to happen.
I’d love to know, and I’m going to find out because I’ll be in DC next week, but I’m going to find out what. I’m so happy this conversation is happening. But what prompted the conversation? I definitely know the current administration that is in HHS is very proactive with health and especially women’s health. And I think that there was such a positive feedback and a positive attitude towards the FDA when they lifted the black box warning, they liked that positive accolades like, okay, women’s health is important. Look at all this upswell of positive response that we’re getting just from paying attention to women’s health to estrogen and now obviously progesterone. So I think that probably has a lot to do with it. There’s been a lot of attention. Being focused on the light is being shined, on the fact that there’s not a lot of studies on hormones in women, maybe estrogen. That’s primarily it. And so we need more studies. But you asked a question earlier, when did we first discover that testosterone was of benefit for women? That was in the 40s. 40s. That was in the 1940s. Yeah. And in the 1940s, when pellet therapy first came on the market, they noted that women’s ovaries not only made estrogen and progesterone, but they also made testosterone. And so they started utilizing testosterone in these women that had hysterectomies. And the life change was profound. So not only did the estrogen help their hot flashes and vaginal dryness and their brain function, but testosterone made all that even better. Now their vagina doesn’t hurt and they want to have sex, right? Right. You know, so all of these things, but then you just said it and talk about this as testosterone’s impact on breast cancer protection. Talk about those studies.
Yeah. So I mean, in the 1940s, before we had chemotherapy and radiation, we gave women testosterone. We did mastectomies. And then we gave them testosterone because it decreased cancer growth and it made people feel better. And so it just is very frustrating to me. I was talking to a patient yesterday who I’ve taken care of for ten years. She’s been on testosterone and estrogen pellets. She’s 78. She got diagnosed with breast cancer recently. She was just due for her pellet, came in, had had an abnormal mammogram. So I said, let’s just wait. So she’s three and a half months out from a pellet, gets diagnosed with breast cancer, can’t have surgery for a month. And so I saw her last week and she was like, I am miserable. You know, I just want my hormones. And I said, well, here’s the deal then let’s just give you testosterone.
Yeah, absolutely.
I am totally comfortable with you having testosterone. Even though you have an active breast cancer, you need to go get it removed. Because she was literally crying. Just felt terrible. Yeah. So we gave her testosterone and she messaged me two days later and was like, I already feel better. So like, why are we withholding this hormone that actually doesn’t cause harm. We used to use to treat breast cancer before we had all of these chemotherapy agents. So it’s just kind of frustrating because of the misinformation, misinformation, and just the fear mongering that happens. And I think a lot of it is driven by the pharmaceutical companies.
100 it’s not a think I know factually, and it has now been. And I’ll tell you how I know that, because I keep referring to this meeting that I had with a really amazing woman in the administration that’s really trying to shine the light on the influence that big pharma pharmaceutical industry has on the Hill. They are literally lobbyists for the big ones. I won’t name them, but you can do your research, are on the Hill every day of every month of every year.
Yeah.
Lobbying for drugs and teaching the legislators a biased angle about medications. So they’re there. And it’s confirmation bias. How you learn it one way is how you’re going to. And so the. And so they’re very pro pharma on the hill. Well, what she is trying to shine the light on is that there’s other opportunities. There’s other modalities. There’s other options that could be beneficial for patients. She’s very pro compounding. She’s very pro testosterone in women. She’s got a big problem with the estrogen shortage that she called in February when we lifted the black box warning. She’s like, we’re going to have a we’re going to have a shortage. And she shared with me yesterday, this is really impactful to me because I’m on estrogen, I’m on patches. I, I don’t want to. And now she can’t get her patches right. And so it’s a real problem. So I think that what’s happening, you hit the nail on the head with the pharmaceutical industry. There is no number one FDA approved drug for testosterone and not for nothing. And I, I didn’t used to be such a cynic. And I’m not even a cynic anymore. I’ve seen it proven out too much. With how much time we spend in DC. The pharmaceutical industry makes money on disease. They want to keep us sick and on drugs. Correct. And we see this over and over. You experienced it firsthand as an endocrinologist, which you can talk about.
Yeah. And I think also what’s frustrating is like, there’s still no FDA approved testosterone for women, right? If the pharmaceutical company wants to make money off of it, then approve it and make it. But what they know is that if they put women on testosterone, then they’re going to come off their statins and they’re going to come off their blood pressure medicine, and they’re going to come off their antidepressants, and they’re going to come off of all these medications that they then make more money on. So they are terrified of women getting on testosterone because they actually know if you go look at the literature, wow, these women do better. They do better all across the board, across the board. And so they are terrified. But it’s frustrating that healthcare has come to a point where it’s just this big business, and this is insurance and healthcare companies. They’re in the same boat in my mind, which is which is terrible humans, but they will refuse to pay for your labs, but then they’ll go pay for all your medications. Well, why is that? Well, because it’s just like this. This feeding system where they want to keep you sick so that you need your insurance, so that you have to take your medicine.
And then the lab thing is changing too. You’ve seen this where we get patients all the time. Well what’s normal? Well, first of all, let’s clarify that there is no established normal level for testosterone in women. None. Zero. That’s why every lab has a different number, a different value. But also the thing that people need to understand is lab reference range are based on an average of a population. So we’ve seen this with liver function tests the normal the topping of a normal range when I was an Ma 30 plus years ago was like in the upper 20s and even.
Like 17 or.
18 in the teens. Yeah, yeah. And now it’s in the 40s. You know, it’s not that people have gotten healthier. They just moved the reference range because everybody’s so unhealthy with fatty liver. Yeah. That they were falling outside the norm. And you see this with insulin, right?
With insulin, you see it with well in prime example with testosterone. I saw a lady this week who was my age. She’s 40 and her testosterone, her free was 0.2, basically zero. And it’s like normal. I’m like, no, that’s not normal. And then she has brain fog and low libido, and she’s losing her muscle mass. And she has like vaginal dryness and just terrible mood. Can’t sleep. She has every symptom of testosterone deficiency, but her lab is normal. And so if I try to give her testosterone, everyone’s like, oh my gosh, this is crazy. You know, this isn’t crazy. It’s we don’t put people in boxes and we don’t look at just lab ranges. And to me, it’s crazy that your testosterone can be 0.2, which is basically zero rounded. And that is that’s normal because because we’re also I think it’s because we’re women. I really think men, obviously there’s a treatment for testosterone in men, but.
That reference range is still terrible.
But at least they have an FDA approval for testosterone for women. I think we’re finally speaking out and we’re expecting more. And so there should be a normal reference range for testosterone and limit.
I think what’s going to happen. And the only thing that I can think of why this is now getting attention at the FDA level, is there must be a female dose version of injectable or some sort of testosterone about to come on market, probably for a gazillion dollars, right. To give herself some shots because the oral testosterone modalities that have been on market in the past actually increased breast cancer rates because of first pass metabolism, there were metabolites that were more carcinogenic. And so it got pulled off market. Estratest syntest. And so there just hasn’t been another one on market. So that’s the only thing I can think of that there’s got to be some influence behind the curiosity. And maybe the FDA is having the forum at the prompting of one of the big pharmaceutical companies that is like, all right, let’s get some data. How important is this so we can get out there and launch, you know, a really expensive test. Testosterone is cheap. It’s cheap.
Yeah. But I mean, even if you’re taking an injectable form, it’s difficult to do as a woman because you need such a small amount. And ideally you dose it more frequently with an injection, but then you start losing your hair and your levels get high. And I mean, I’ve never been a huge proponent of injectable testosterone, but I just want to see some movement in testosterone.
Well, and that’s you’ve just made a really good point because what we don’t want is some form of testosterone to come out that has all these bad side effects, because they didn’t understand the modality and how to dose it. And now there’s like, see, women shouldn’t take testosterone and look, all this bad stuff happens, but we treat thousands of patients a month, tens of thousands a year between the two of us. And when it is dosed appropriately, the side effect profile is minimal.
They don’t have.
It. It’s the modality and the dose.
And you bring up a good point, especially right now with everything going on in just healthcare, I would hate for us to in six years from now, testosterone to come out. And then six years from now, we’re having a conversation like we are about the Covid vaccine.
Yeah, exactly.
Yeah. Like pushing things out that aren’t either well-studied or understood and forcing it upon people is not the answer. So if the pharmaceutical company has gone to the FDA and said, oh, women can have testosterone in an injectable form only, and this is the dose they should have, and then that gets out there and it’s too high of a dose. And then that causes side effects. Again, we’re going to have this this terrible thought. But we know that if you use lower doses, people do well and they have for years.
Many years, decades, in fact. And the other thing too, that just made me think of that as well, is one of the things that even if they did come out with some sort of injectable testosterone, and even if it did have a higher side effect profile, there’s nothing detrimental that can’t be reversed with testosterone unless you’re using male doses and jacking levels up. Obviously, in the 600 700, then you can have permanent voice changes, permanent changes. But when you get those levels up in a range that is appropriate for women in a free testosterone, the upper tertile of the reference range is what correlates with in studies with symptom relief. Then you’re going to be fine and you might deal with a little some nuisance side effects, maybe some hair growth where you don’t want it, but all of that can be treated and it’s nothing that’s life threatening.
Yeah, that was leading me to my next question, which is if testosterone does come out, what would be or if we get testosterone to be approved by the FDA, what would be the safety concerns or the side effects? Like why is in my mind, it’s like, why is the FDA not allowing this? I’ve been using it for years. You’ve been using it for years. We’ve been using it for decades. We used it in the 40s. So what is the FDA’s concern there supposedly in place for a reason to make sure we’re not harming people? What is their true concern in giving women testosterone and allowing it to be available for a diagnosis and be approved for actual indication? Right. And to your point, I can’t answer that because that’s what I tell women all the time. Like every now and then, sometimes we’ll have somebody on testosterone. Maybe their level gets to 300. Still, half the time they don’t even know. Yeah, half the time they don’t even know. They’re like, no, I feel amazing, you know? And so to your point, can you get a little bit of acne? Sure. But most acne is due to gut issues. Yeah. Can you get a little bit of hair growth in places you don’t want it? Sure. But we get that as we age because we aromatize anyways and we get hair growth as we age. So it’s like what? What is the actual problem other than people might get blood flow to their brain and gain some muscle mass back and have a good sex drive. I mean, yeah, and get better marriage, less depression. So I just to me, it’s frustrating because it’s like, what is your problem, FDA? Show me where this has ever actually been a problem.
Yeah. And I think the answer to that is the one and only FDA approved testosterone for women historically was in a combination drug with synthetic estrogen called estratest or syntest. And they did show it got pulled off market because there was an exponential increase rates of breast cancer because of how when you take an oral pill in a bad gut and it’s metabolized and those metabolites increase breast cancer risk. And so they’re looking at that. But we know non-oral modalities actually protect women against breast cancer, as shown in hundreds of studies. It’s what we call apoptotic. Or it can kill breast cancer cells. It creates breast homeostasis, as Doctor Rebecca Glaser likes to say. But, you know, I started thinking too, just now as we’re talking about this, there’s also a big upswell, like we talked about in the beginning of, of haters around testosterone because they don’t understand it. There’s no established reference ranges. So we have to be real careful, be really interesting in this all day forum to see there’s going to be a lot of opinions online about it. There’s going to be a lot of opinions. And so it’ll be interesting to hear what the angle is, what kind of questions they ask. I’m really curious about that because the questions that they’re going to be asking will give us context clues about what their ultimate goal is. Sure.
But I also think in this country, we’re getting to a very scary place around medical freedom. Yeah. Like, I mean, so, so if you want to take testosterone and I don’t, great. But if it’s not harmful, I’m a little frustrated. After I’ve done 15 years of higher education. I get really frustrated when insurance companies and the FDA and drug companies and whoever try to tell me as a doctor, what’s best for my patients, because I took an oath to not do harm to anyone and I never would. But if I feel like this drug medication supplement, whatever could peptide could help someone. I feel like as medical exosomes, stem cells, yes, as medical freedom, right. To the patient and the doctor in that relationship. I feel like we’re impinging on it quite a bit right now. If there was a true concern and to your point, there was in the past about testosterone, but the FDA doesn’t have any true concerns that we know of for creams, for pellet therapy, for.
So it was just the oral modality.
And so I kind of have a problem with the fact that this governing body tells me as a doctor, what I can and cannot do for a patient. Like it’s just kind of getting to the point where it’s very frustrating, right? Because it’s almost like impinging on a relationship.
As it is.
Yeah. I mean, it’s impinging on my ability as a provider to give what I want to a patient. And then there’s just all this hate. So, you know, it’s just kind of like chemotherapy. Chemotherapy is indicated. It’s approved. It can be used. There are people who are, no matter what, I’m never taking chemotherapy and they die of cancer. You should have that right with testosterone. Yeah. And so I’m just getting very frustrated because I feel like the FDA, you know, either show us that there is a study that this is terrible and harmful in women on creams or pellets, which I can show you 10,000, 20,000 that it isn’t or shut up and let me, you know, give it to the people who want it and the people who don’t stand over there and hate all you want. And then in 20 years, you’re going to realize, oh, wait, these women, they actually knew what they were talking about because in 20 years, there’s going to be so many studies and you’re going to be the one that can’t put your bag in the overhead bin and have vaginal dryness and actually end up getting cancer because you’re obese. And, and so I’m just kind of to the point where I’m like, you know what? Get out of the way and let me as a doctor, do what I want for my patients because I will never harm them. That’s right.
And, and we practice evidence based medicine. We’re not just willy nilly doing something because for no good reason. There’s a lot of really good evidence behind it since the 1930s. And on and and again, because we don’t have an FDA approved product in this country, nobody really knows about it. I mean, but people are paying attention and, you know, women that, uh, the so many times when bioidentical hormones and compounding has been under attack and we do this grassroots effort for email your senator, educate them because they’re only getting educated by the pharma lobbyists, etc., etc.. I can’t tell you how many patients go. Just said there will be a line across the country to the white House, to the HHS to go. If you stop my ability to get my pellets or my testosterone, there’s going to be mass mutiny. Because literally, it has changed so many lives from depression, moods, anxiety, irritability, not being able to sleep, not being able to concentrate, not having a sex drive, breast health, Alzheimer’s that plays a role in Alzheimer’s disease prevention, osteoporosis prevention. So, so many things. I was talking to this lady yesterday, the same one I was talking about previously, and she had this idea of maybe these hormones should be a part of the preventative task force. Yes, yes.
There’s a novel idea.
A novel idea, because when it’s a part of the preventative task force, insurance can’t dictate it. Insurance can’t refuse it.
Well, and here’s the other thing. Here’s the other thing I think of too. I would love to do a study just on GDP and productivity. Yeah. People who do hormones look at their productivity versus people who do not. And so if you take hormones away from the millions of people that do them, I mean, depression. We need people that are productive. We need people that are productive, happy, good brain spaces so that we can continue to evolve as a society and people are doing well. When you’re depressed and you don’t want to get off the couch, you’re not going to do anything productive to society. That’s also frustrating to me, and I think I would love for any person that is in the FDA, anyone who sits on these councils, anyone who has any decision making ability about this, who wants to be educated. I invite you to come to my clinic, spend a day in my clinic. And I say that because also, I mean, I have a cash pay based clinic. So nobody comes to my clinic that doesn’t want to. I don’t force you to come.
You choose to come back, you pay, spend your heart. You spend your money. In my clinic, I do very little marketing and people come and they continue to come, and they continue to pay for that care because it changes their life. And every single day I hear from people yesterday I heard from four people who were almost in tears. You literally have changed my life. And so how often does that happen in traditional medicine? Yeah. It doesn’t. You go and you pay your co-pay and you wait. And even insurance pays for it and it doesn’t. And so I think that the people who make these decisions, it’s frustrating because to your point, they hear from lobbyists and they’re not in the real world, like come to the real world with me, where I’m really dealing with people who are at their wits end, who are about divorce, who have been on every depression medication in the world, and we do something as little as give them testosterone and fix their testosterone. And it literally changes their life.
It changes their life, changes their.
And this is thousands of people, not just 1 or 2. Like, I’m not just this little person over here. So I would love for people that make these decisions to come follow me around for a day.
Well, another thing too is think about how we’ve got all of these FDA approved products to help men have a better quality of life. Testosterone. Viagra. Cialis. Men have high libidos and good erections, but their wife counterpart has low testosterone. Doesn’t want to have anything to do with it. That’s not going to work for that doesn’t work either. And that’s where we see a lot of benefit obviously is the relationship change. So it’ll be interesting. There’s a lot happening. There’s a lot of movement. I love it that there’s even any attention. Even if there is going to be some negative attention, it just gives us an opportunity to have these kinds of conversations.
I agree. So you know nothing on the inside as far as like whether this.
Is actually I do, I’ll be calling.
As soon as this is actually working or not. So I also want to talk about there’s been some talk back and forth about descheduling testosterone. And so for people listening that don’t understand testosterone is a controlled substance. Schedule three medication, meaning that you have to have a specific license to prescribe it. And when you prescribe it, there are all these holes you have to jump through. You have to pull what’s called a PMP report. See the last time it’s filled, make sure they’re not filling it with other providers, etc. it’s difficult. I have a license in 46 states, and so when I try to prescribe it in other states, sometimes they throw a fit. Won’t give it to the patient. They have to go and make sure I actually have a license. Why? I would try to prescribe something in a state. I don’t have a license. But they make it difficult, right? And it’s because it’s a scheduled controlled substance in the same class as things like benzodiazepines and sleep medications, oxycodone. So it’s like, I literally am a drug dealer, you know? And so there’s been talk about de-scheduling it, meaning that it wouldn’t be a controlled substance. And I think that would be huge, fabulous.
Huge for.
Access. But what is like. So explain to people what do you know about that?
Yeah. So years ago, the reason testosterone and all testosterone like related products got put on a controlled substance list was because in the baseball world, anabolic steroids were being abused. Right? And so what they were trying to do is mitigate the abuse of antibiotics, steroids. And so they put anabolic steroids and natural testosterone in every modality on the controlled substance list. It’s on a banned list for any kind of athlete, any kind of professional athlete, unfortunately, because what they don’t understand is every time a guy gets hit in the head, not only within 20 minutes is his gut breakdown, but his testosterone decreases exponentially. And so it’s such a big deal for for pro ball players, football players, anybody that’s getting hit in the head a lot. But back to the the de-scheduling, it was put on there for this specific reason. But the problem is it doesn’t even meet the criteria of a controlled substance that has an addictive nature. So. Right. The controlled substance list is to help protect patients from being put on long term medications that have more habit forming nature. Well, testosterone, especially natural testosterone, doesn’t even fit the criteria. So they’re looking at de-scheduling it, thank goodness, primarily because of access. Because if a clinician has to get a special license, a DEA license, that’s expensive, that’s 700 plus dollars.
888888 880 848 States do the math. It’s a lot. And not only that, you have to go in, you have to log it. You. They’re basically treating testosterone like OxyContin, oxycodone, Vicodin, morphine, Dilaudid, all of these true controlled substances. And so that keeps prescribers from prescribing or wanting to prescribe. And it decreases access. And I
can’t pull the exact data of how many hundreds of thousands of people are not being treated, men and women with testosterone that need it, that are truly low on their lab reference ranges and need it because it’s a controlled substance, it’s too hard to get. So access is huge. And I think that’s why the FDA is looking at it more from an access perspective, there’s been a big outcry of why is this even on a controlled substance? I mean, we have to keep strict DEA logs for every single testosterone pellet that we utilize in a patient for any prescription for testosterone shots that we give. It goes into this database. You mentioned where, oh my gosh, I got to go and check and make sure they’re not getting testosterone from five providers across the state.
You know, if you have a patient who travels somewhere, let’s say that they’re in Texas, and then they decide to go to Washington on vacation and they forget their testosterone, they can’t go pick it up in Washington because they’ve filled it in Texas and it’s against the law. So that would be like, if you leave your blood pressure medicine at home, you can’t go get it. And so then it’s just you have to feel like crap for a week when you’re on vacation because you forgot your testosterone. It’s just really frustrating. And if you have a license in 46 states, there are 46 different websites you have to go to for each state to pull it. So depending on what state you’re in, that provider has to go, you know, and just because I’m hard headed. I’m like, screw it, I’m still going to do it. But there are times I’ve been like, oh my God, I just don’t want to do this anymore because it’s so difficult, you know? But it’s not fair to the patient that just because they live in Maryland or just because they live in New Hampshire or whatever, you have to go to a different site. And so if we don’t deschedule it, we at least need to put it all in one location. Because in my mind, this doesn’t make sense. Anyways. If you get controlled substances, oxycodone, something addictive, and you live in Texas, you could drive to Oklahoma and see an urgent care and get another one. And the doctor in Texas is not going to know because they don’t all report together, which is insane.
Yeah, it doesn’t make sense.
They should all report together. And when you pull it. Yes. Now, the good thing about Texas, I will tell you, is that Texas has tried to report with a lot of states. And so actually, when I log into my Texas account, I can pull data from a lot of other states, but not all the states do that. We should have one. Like it doesn’t make sense. So also, the people who make these rules again come live in the world of the clinician for a few days, because these rules you make are ridiculous and they don’t even work. Because if I was a drug addict, I would go get some oxycodone here. And then I would drive to Oklahoma and go to an urgent care and get some oxycodone. And then I would go to a different state like nobody would know. And so if you were a drug addict, you could be a really smart drug addict. And the whole everything they put in place to make it difficult, would it work? Because again, the people making these rules aren’t the people who are actually on the front lines taking care of patients.
100%.
But it is killing like I hate it for people with testosterone who actually need care.
It definitely needs to come off. It’s again, like I said, it doesn’t even fit the criteria of a description of a controlled substance, so it doesn’t even belong there. And I think if we can get that win, that’s going to be huge. Now, like anything, these conversations are starting next week. Let’s see how long it takes to get any movement. Now, I know that RFK and I know the lady that I spoke with yesterday to see that they were trying to push, but there’s so many bureaucrats that are putting sand in the gears and stopping this at every turn. And that’s the problem. There’s too many career bureaucrats that are in there just doing their thing and don’t really want progress, don’t want to move the needle forward, and people don’t want to believe that that’s really happening. But trust me, it’s really happening. I didn’t want to believe it until I got involved in Washington a lot, and it’s painful. I was sitting with this group yesterday. I’m like, I don’t know how you do this every day. I really don’t know how to use it. You know what she told me? Because she gave examples of, you know, when trying to get monoclonal antibodies for a patient that was going to die without them. And just all these rules and regulations, she goes, because every time I move the needle forward, if I help one person, it’s worth it. Yeah. And I was like, applaud you. You’re right. Thank you for that reminder.
But it is true though, like these people that just have these like God complexes that just sit there and the, you know, if you knew something about it and were a physician and had taken care of 10,000 people, you’re like me, I might have a little bit of respect for you on a set, at a table and talk to you when you are not a physician, you don’t take care of patients, you just sit there with a God complex and make decisions that affect millions of people’s lives. And you’re hurting.
Us. Came and whispered in.
Your ear, or gave you money.
Or gave you money.
And you’re hurting them. That’s what frustrates me and me as a doctor. If I take money like that, I can be federally prosecuted, criminally prosecuted, lose my license. But we have people in Washington making decisions that get to take money from the pharmaceutical companies and make decisions about your life and my life and our patients lives. And they’re not federally prosecuted. It is insane.
It’s insane. I, it reminds me of another conversation we were having yesterday. Do you know about this vaccine in Japan that prevents type one diabetes?
I’ve heard about.
It. Yeah. So this has been used in Japan for a long time. Safe from birth vaccine. Their cancer rates are pretty much non-existent. They do not have type. They don’t even know what type one diabetes is. And there have been administrators. This one woman that I spoke with yesterday, I’m not sharing her name because I don’t want to do that without her permission. But she has been trying to get that in the States. Who do you think’s blocking it?
Oh, Eli Lilly, Novo insulin.
Makers of insulin. Oh, yeah. It’s too big. It’s too profitable.
Oh, no no no no. When I used to take care of diabetics, my biggest complaint was you would have people diagnosed with type one diabetes. And I would have to fight to try to get their insurance covered. And a lot of them would end up in the hospital because they couldn’t get their insulin paid for. And did you know the guy who invented insulin, the patent on insulin in the 20s, he sold it for $1. Wow. He made zero money on it. And he said when he sold it, I want this to be available to every human in the world because it’s his life saving. And it should be affordable and basically free. And then Lilly and Novo and all these people make mil, probably billions of dollars on it a year and charge astronomical prices for a medication that is life saving, that some man pretty much spent his life trying to find and then gave away for free.
And you know what else I found out? They had no interest in developing GLP one for diabetes because. Because it was too profitable. Yeah. Because. But you know what made them start doing it.
Because it was profitable.
Weight loss. Oh, yeah. When they realized in FDA trials that had a huge impact on weight loss at 100% of the diabetics in the trial lost weight on Victoza, that’s when they’re like, oh, yeah, this could make.
Us. And now and now they’re trying to prevent people from taking GLP one and micro-doses because it cuts into their profit. Correct. But the the doses that they make. So I did trials on GLP one. I unfortunately will tell you I’m very sad that I worked for Eli Lilly and Novo in a prior life doing clinical trials. And in the clinical trials, you have to give very high doses of the medication. So people have very bad side effects, but on very low doses, micro-doses people don’t have side effects and they do really well. And there was actually just a paper last week that showed people that are on GLP, ones that are not diabetic have a lower cardiovascular mortality. I don’t know if you saw that. And so it is a very powerful drug. But again, the pharmaceutical company is trying to do this God complex and not allow providers to prescribe the ones they want at the doses that they want. It’s not only is that medical freedom impingement, but it’s just it’s personal.
It’s good care.
Yeah. And so I don’t know, there’s a lot of issues. I’m glad that you go to Washington. If I went, I would probably cuss someone out and throw things at people really hard.
I have to practice all my Joe Dispenza.
I would probably lose my.
No, I would. I want to. Well, I remember when we were at an event last year and I introduced you to Marty McGarry. Yeah, I.
Was nice guy was like he was all excited. He got to talk to you. And then like, within five minutes, he was just like. Well, I was very nice to him, but I was nice.
But you were telling him, giving him the what for?
I gave him the option. It’s still available, Marty. I said, come to my clinic. See people who are actually sick. See people who take peptides.
He’s no longer the commissioner.
Yeah, but I’m like, you are welcome. President Trump is welcome. Whoever makes these decisions in Washington is always welcome to come to my clinic and just listen and hear patients out because it is just so, so frustrating.
We need to do a documentary.
We really do, because I don’t think people just like doctors, I don’t think anyone in the world wakes up in the morning is like, how can I be an a hole today and mess up a bunch of people’s lives? I don’t think that’s the case. But they do wake up and they go to Washington and drug companies come and they bring them coffee and they get in their ear and they tell them things that are not true. And they’ve heard it for ten years, and they think, oh, this is the only way, right? Which is very frustrating because that they obviously have an agenda. And again, you’re always welcome to come and actually see what happens on ground zero. That’s not what happens. Hormones make people better. Hormones save people’s lives. Hormones keep people from being super sick. They actually help our economy and our GDP because people are productive.
The economics, the jobs that are created, the whole nine yards.
We don’t have people sitting at home on wanting to to get help with disability because they can actually work, they can actually function. And so it’s just it’s very frustrating.
The other problem that she addressed yesterday, and this is true because. Dan so next week, there’s several things happening in DC next week, but one of them is Compounders on Capitol Hill. And this is where compounding pharmacists and people in the compounding world go and try to educate legislators on what is compounding. Now, remember, I already said pharma is in their daily daily talking, bringing gifts, bringing food, all the things.
Sending.
Checks. The staffers are the average age of the staffer is 25. They know. They don’t know what a hormone is. They don’t know what compounding is. They don’t know any of this stuff. And the staffer is who is in between the person that’s trying to educate the legislator and the legislator, right? So the staffer is here, and they’re basically blocking
anybody that doesn’t fit the profile of who they want to let in that door. Now, not all of the senators, not all the legislators are that way, but many, many of them are. And it’s very frustrating. So one of the things we were talking about yesterday is how can we educate these young staffers that are the gatekeepers to get in and educate the lawmakers? How can we educate them? And that’s a big problem right there, because they just don’t know.
Well, and they don’t have the symptoms yet. I remember when I was in my 20s, people talked about hormones and menopause, and I was like, yeah, that stuff my mom and grandma went through. That’ll never affect me. And then you turn 40 and you’re like, yeah, yeah, this is definitely even younger. Yeah. 30, my mid 30s because of med school. And so it’s true. It’s almost like when it doesn’t affect you, you’re just like, but what I would say is to those people that are 25 and in that position, look at your mom, look at your grandma. I mean, every single human.
Hell, look at yourself.
Every single human on this planet woman, every woman on this planet, God willing, you live long enough, you will have a hormone issue you will like. You will go through some sort of hormonal shift. You’ll have a baby. You’ll go through menopause with PCOS.
Pcos. We’re seeing it already, right?
And so it’s like, just you need to be informed. You need to understand. And men too. So here’s the other thing. Men on Capitol Hill, if you want to stay married to your, your wife and you love your wife and you see the struggle she’s going through, understand a little bit about hormones, like my poor husband. Sweetest guy in the world. He gets it.
He’s like, oh, I’m just gonna walk away. You’re having a hormone issue, you know, like, but men need to understand this too, because we have three hormones. You all have one. So we’re like juggling and you all are just pretty flat. And so men need to understand too, so that they can help their moms, their sisters, their wives, their daughters go through these things, you know, because a lot of times men are like, oh my gosh, women are so hormonal. Why are you crying? Why are you? Well, if you understood what was going on, then you would be a little more supportive, right? Yep. And every man is going to deal with this because if you have a daughter, she’s going to have a baby. If you have a wife, she’s going to have these issues if you had a mother. So like, I don’t understand why it’s not a whole I mean, why do we just have to? I mean, it’s testosterone and women. It’s you know.
It’s not that complicated, honestly.
So everyone needs to care about it.
Yep.
Everyone needs is the point.
Yep.
So what should women know if they think testosterone might be relevant to their care? As we kind of transition back to the person listening to this right now, if you’re a woman and you’re hearing all this and you’re like, well, how does this apply to me? Maybe you’re 25 and you don’t have hormones issues yet, but what should every woman know as far as testosterone and how it could ultimately relate to them?
Well, the symptoms, I think there’s two things. Number one, testosterone changes happen as young as 30. And even before that, if you’re on birth control pills, right? Because birth control pills suppress all ovarian hormones, not just pregnancy. And it raises another molecule called sex hormone binding globulin that binds up your testosterone. So the symptoms of testosterone deficiency, I guarantee you are happening in a lot of the 25 year old staffers that I just talked about depression, moody, anxious, irritable, can’t sleep, can’t focus, pain, weight gain, especially around the belly, not being able to build muscle. The list goes on and on.
Low sex drive.
Low sex drive. I don’t know why I always forget that one. Fatigue. Tired all the time.
Joint pain.
Joint pain. All of these things. And it gets worse after that second baby pregnancy. And I think that’s. Doctor Pete makes a really great. One of the gynecologists that we lecture with makes a great point about just the fact that a lot of women after that second baby, the reason their testosterone, their sex hormone binding goes up is because from an evolutionary perspective, your body is going, you need to take care of those babies and not make more babies right now. But that is really what happens. I can’t tell you how many women have said after that second baby, I never bounced back. I never could lose the weight. I’m tired all the time. I don’t want to have sex with my husband. I’m moody. Now. We have these two kids and we fight all the time, you know, kind of thing. And when they go to their doctor, they’re just told, oh, you’re just stressed.
It’s a part of aging.
It’s just a part of it. Here’s some antidepressants, here’s some sleeping pills, and here’s an anxiety pill. And oh, here’s a add medicine for your inability to focus. Now all of a sudden you have adult Add. Now they’re on the farm, a hamster wheel.
And that’s because we’ve never had a true diagnosis or an FDA indication to treat these people. So it’s not taught in school. And then doctors are just checking off the box and they don’t want to deal with it or have that drug.
Rep came by and told them about this medication.
Told them about Zoloft and fluoxetine. That’s the one. Oh yeah, that’s only $4, but it’s only $4. But it changes every neurotransmitter in your brain. It is not a benign medication, by the way. Antidepressants are not benign.
And so they were never meant to stay on indefinitely either. So.
So I think I want to wrap it up with one final question, which is are you genuinely optimistic that change is coming?
I am right now only because I know that the key decision makers at HHS are very dedicated, and it’s been very important to them. The health of Americans. I know that this is. And this woman I met with yesterday who’s been in the administration for a long time, she said, I’ve never worked in administration that was more focused at top tier level on the health of Americans as this from food to the farming practices to the dyes in our foods, to understanding vaccines in the schedule. And by the way, this administration doesn’t want to do away with vaccines. They just want to slow the schedule down and say, does it make sense for a newborn to get a hepatitis B vaccine? What’s their risk of exposure to hepatitis B? So let’s think about this logically. And so I do have hope, but I’m kind of optimistic, even though sometimes of the stories I heard yesterday, it just makes you feel like it’s a hopeless situation. But I do have hope because these decision makers really want this to happen. Now, what they need to do is to clean house of the bureaucrats that are inside, that are blocking all of the progress and causing the overreaching, the overregulation.
I think they also need to seriously go to Ground Zero and walk through it. Because I think if a politician, lawmaker, FDA person set in my clinic for a day, you can’t unsee, you can’t unhear that.
Yep. Nope.
I agree. So that’s my maybe.
That’s the.
Documentary. I mean, you can’t unsee it and you can’t unhear it.
Yep. We need to do that.
So.
Great conversation.
Well, thanks. I love it. I’m so glad that you are there fighting for us.
I’m sure I’ll be burning up your cell phone next week. It’s crazy. People. This is the swamp. Or am I be going? Oh my gosh, there’s hope. They really want.
There. There’s gonna. There has to be hope. I’m just gonna. There has to be hope because there’s. Imagining another world.
Where there’s enough people. There’s enough people doing the right thing. There’s enough women who are demanding it. We’re just going to keep pushing that. More and more people demand it. So at some point it’s going to change. But I’m glad you’re going and not me.
Yes. And you know, the last thing I’ll say about that is what you hit the nail on earlier is medical freedom. It’s medical freedom we need kills me shouting medical freedom from the rooftop that is. I am an educated, grown ass person and should be able to make my own decisions with my clinician. Yeah.
And that’s and I’ve been treating people for over ten years. I’ve never harmed anyone. I’ve never had any issue with a board. Thank God. I mean, I do what’s ethically right. I took an oath. It was the most serious thing I ever took in my life to never do anyone harm. But I also have worked my whole life to help people. And I feel with people, and I want them to be better. And that is literally my whole life existence and being. So when you start to come into that and tell me, I can’t do this and I can’t do that, and I can’t do this, and I know it’s right for the patient, I am furious. So that’s it.
Fight the good fight.
Yeah.
Peace out.
Talk to your legislators.
Yeah.
So that was such a powerful conversation with Doctor Terri. I hope that you learned something. If you know any woman who could be having any of the symptoms we talked about that may need to understand testosterone, understand the ability to use it, what symptoms it causes. Please send this to them. Also, if you know a man who you feel like he could benefit from hearing this because he has a daughter, he has a wife, he has a mother who could have testosterone deficiencies. Send them this episode. So please share this with everyone that you know. Make sure that you’re following the podcast, like it and subscribe. This is how I’m able to get it to lots of people so that they can hear it. If you feel like you’re struggling with testosterone, you want to find a provider that might be able to give you testosterone or help figure out what is going on or causing your symptoms. Modern endocrine is licensed in 46 states. We can prescribe medications in all 46 states. Visit our website at www.endocrine.com and click on Book a Discovery Call so we can figure out if we’re a good fit. Also, my book, Fix Your Gut Fixer Hormones, is available on Amazon. It is an Amazon best seller. It’s available on audible if you want to listen to it. And again, thank you for being here. Thank you for listening. Until next week.

Dr. Cassie Smith, MD

Dr. Cassie Smith, MD

Board-Certified Endocrinologist · Founder, Modern Endocrine

Dual board-certified in Endocrinology, Diabetes & Metabolism and Internal Medicine, and fellowship-trained at the Harold Hamm Diabetes Center, she is the author of Fix Your Gut, Fix Your Hormones. She treats patients in Oklahoma City and by telehealth across 47 states. Meet Dr. Smith

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