A December 2023 report revisits menopause hormone therapy’s risks of breast cancer. Dr. Mindy Goldman explains the study and shares her experience as a menopause specialist who treats at-risk women.
If you’ve ever heard that menopausal hormone therapy can increase the risk of breast cancer, this new health report may surprise you.
In this bonus episode, women’s health and menopause management expert Dr. Mindy Goldman sheds light on the complex world of Menopause Hormone Therapy. We explore pivotal insights from the Ester Trial, revealing potentially safer transdermal estrogen. We talk about a fascinating Today article that uncovers the impact of statistical manipulation on reported studies, especially concerning the relationship between breast cancer and hormone therapy.
Dr. Mindy Goldman shares her expert opinion on how estrogen alone might be safer than we thought, and why synthetic progesterone requires a closer look. We also discuss the controversial use of testosterone in women, the challenges with federal laws, and FDA-approved options for improving libido.
Dr. Goldman is a Clinical Professor in the Department of OB/GYN at UCSF and the Director of the Gynecology Center for Cancer Survivors and At-Risk Women. In addition to her role as Midi’s Chief Clinical Officer, she’s a nationally recognized expert in the management of women’s health issues, including menopause, for women with cancer or at high risk. She helped author guidelines for the American College of Obstetrics and Gynecology (ACOG) and has won several notable awards.
Discussed in this episode:
Dr. Mindy’s work with breast cancer survivors as an OBGYN
Common myths of menopause hormone therapy
A discussion on the ESTHER Study and recent menopause data release in Today
Risks and safety of estrogen, progesterone, and testosterone therapy
FDA-approved drugs for women’s sexual function
Gender disparities in medical research
Hormone therapies and other treatment options for high-risk populations such as cancer survivors
Menopause symptoms in breast cancer treatment
Hormone therapies, medications, and lifestyle strategies as post-cancer treatment options
Dr. Mindy Goldman’s professional experience as a menopause advocate combining breast oncology with gynecology
“It's important to realize that there aren't national guidelines that talk about the use of hormones in people at high risk for cancer, which includes people with a family history, people who have had prior biopsies with atypical change, people with genetic mutations, and people with cancer. The standard of care has always been not to use hormones in those situations because the thought was that hormones could increase the risk of breast cancer or increase the behavior of breast cancer.” - Dr Mindy Goldman
Related to this episode:
Related episodes: www.fempower-health.com/perimenopause-menopause
Menopause resources: www.fempower-health.com/menopause-years
Menopause health report (Dec 2023): https://pubmed.ncbi.nlm.nih.gov/37847875
ESTHER Study: Learn more.
Dr. Goldman’s story: www.joinmidi.com/post/mindy-goldman
Dr. Mindy Goldman on Linkedin
Midi Health: www.joinmidi.com
Menopause book recommendations: www.bookshop.org/lists/top-picks-for-menopause
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Transcript
Georgie Kovacs:
Today we'll explore a critical review of the Women's Health Initiative study, aptly titled Tis But a Scratch a Critical Review of the Women's Health Initiative evidence associating menopausal hormone therapy with the risk of breast cancer. And it was released on December 1, 2023. This review challenges previous perceptions and opens up new discussions about the safety and efficacy of hormone therapy. Our conversation will not only focus on the study, but also delve into the various formulations of hormone therapy. It's critical for you as a listener to be informed about these options. Understanding the nuances of hormone therapy empowers you to have proactive and informed discussions with your doctor. After all, effective healthcare is a two way street. It requires clear communication about your symptoms, needs and concerns.
Georgie Kovacs:
So get ready to be equipped with the tools and knowledge to take charge of your health journey. And remember, for more resources specifically tailored to perimenopause and menopause, check out the Fempower Health website. And now let's hear from Dr. Goldman. Dr. Mindy Goldman, thank you so much for joining me on the Fempower Health podcast. And apologies for my raspy voice. I tend to always catch a cold when I'm most excited about an interview.
Georgie Kovacs:
So we are here to talk about menopausal hormone therapy or menopause hormone therapy because there's so much being discussed about menopause, which is fabulous, but I think there's still confusion and you are quite the expert here to be talking with us today. So why don't you give us your background and then we can dive into all the nuances.
Dr Mindy Goldman:
Sure. First of all, I'm very excited to be here, so thank you for having me. My background is I am trained as an OBGYN and for almost my entire career up until recently I have been on the faculty at the University of California, San Francisco as a general OBGYN. And based on a personal experience of helping my dearest friend navigate breast cancer and unfortunately dying of breast cancer, I got interested in doing more for breast cancer survivors. And this was in the early two thousand s and I approached our BreastCare center saying, hey, I want to learn more about women's health and breast cancer and how that intersects and what I could do. And at that time they were having a tough time getting people into the cancer center because luckily most people were living and they were having a tough time getting new patients in because they had so many follow up patients to see. So they were sort of looking for someone to do follow up care. And all of a sudden I come along saying, hey, I want to do more for cancer survivors.
Dr Mindy Goldman:
So with a lot of negotiations, I ended up joining our cancer center. And what started happening was people would approach me and say, hey, my patient was thrown into menopause from chemotherapy, how do I treat them? Or this person's having bleeding on tamoxifen, what do we do? This person wants to get pregnant, is it really safe? And I start looking in the literature and went, oh my gosh, there is almost nothing out there about this field. So fast forward now 20 years, I feel very lucky that I have been able to help forward a field that didn't really exist, sort of bridging breast oncology and gynecology. And I've been able to work with the American College of OBGYN and help write guidelines of how to follow the gynecologic implications for women with breast cancer. I work with the National Comprehensive Cancer Network and chair their survivorship panels on hormone health, menopause and sexual functioning, and so have been able to really help this field evolve and develop, still has many ways to go and much more to do. So I've really developed this whole specialty in caring for survivors and at risk women. And in doing that I sort of found that the visits that you do with patients are long and complicated and I say the same things over and over again, and I was really interested in being able to have a bigger impact. And Midi Health approached me and they were developing a telehealth company focused in perimenopause and menopause, and they said, we think survivorship is an unmet need.
Dr Mindy Goldman:
And I said wow, finally someone is listening to what I've been saying. And I was able to partially jump ship from UCSF. I'm still there part time where I started a fellowship that's combined with our breast surgeons and survivorship, but I really joined Midi as a full time employee where I supervise our clinical care. So I'm our chief clinical officer, and I'm very excited because hopefully in the next year we're going to be developing a survivorship platform, being able to help people who've had cancer or high risk for cancer focus in on effective treatments for menopausal symptoms.
Georgie Kovacs:
I saw a stat today on social media as I was prepping. And I also ran across a study that just got published. I want to talk about that. I think it's 90% of women will experience symptoms and only 10% will be taking hormone replacement therapy. And so I think this is an important topic because the Women's Health Study has really created a lot of misinformation. But before we dive into this, like, is hormone therapy safe or not? And do folks who are at risk of breast cancer, et cetera, need to worry about it? I guess what I'd love to do is so that people understand drawing this picture between your expertise with these cancer patients and menopause so they can see how everything weaves together to how we can get to hormone therapy. Because the way I view this is a woman's going to enter this and say, oh my goodness, I'm so scared of breast cancer, I'm not going to do hormone therapy. And you are the person who is kind of at that point, of someone who has survived it and is now trying to manage it, plus working at a company where you're managing these symptoms.
Georgie Kovacs:
So I guess, can you just maybe draw that picture of like, why are we talking to someone who is an expert in this space about hormone therapy just so that the audience can understand?
Dr Mindy Goldman:
Let's talk a little bit about in cancer survivors, why you even see all of this. So one big time that you see a lot of the symptoms that are very similar to what we see in natural perimenopause and menopause is when cancer survivors get chemotherapy. Chemotherapy targets rapidly dividing cells and it targets the cancer cells, but it's not specific only for the cancer cells. So it can affect the ovary where those cells are rapidly dividing. And we know that chemotherapy will shut down ovarian function. Whether it's permanent or not depends on how much chemotherapy you get and the age of the patient. So with chemo, people will experience the same symptoms that they see in perimenopause and menopause. And the issue is treatment options are hormone therapy, which we know no one will ever argue that it's the most effective treatment for symptoms.
Dr Mindy Goldman:
But for many breast cancer survivor survivors, that's not an option. There are some cancer survivors that can take hormones, but that's one reason why you see chemotherapy and the effects of chemo on the ovaries. The other is that some of the hormonal treatments that are used to treat breast cancer can cause menopausal side effects. So two thirds of breast cancers are sensitive to hormones. And that doesn't mean that hormones cause someone to get cancer, but it means that hormonal therapies will be used as part of the treatment to modify the tumor environment. And typically those hormonal therapies are drugs like tamoxifen, which is used in premenopausal women, and then this other class of drugs called the aromatase inhibitors, which are used in postmenopausal women. And those drugs can cause menopausal side effects like hot flashes. And so it's both a function of treatments like chemotherapy as well as hormonal therapies that cause this intersection of cancer and what you see with natural perimenopause and menopause, because the symptoms can be exactly the same.
Dr Mindy Goldman:
On top of in cancer patients, they may be experiencing other things cognitive effects from chemotherapy that they call the chemo brain. Now we see that in menopause, but it can be even more pronounced in cancer patients, certainly pain, fatigue, there's a whole bunch of symptoms that are unique, I think more unique to cancer survivors. But the Hormonal stuff overlaps completely and is very similar to what you see in natural perimenopausal and menopausal women.
Georgie Kovacs:
I do still want to ask generally about that Women's Health study. So do you mind if we just start there and then we'll take the journey of that cancer patient? Just because I want to keep having every expert in menopause I bring on to talk about this study. So first, today, December 1, which is when we're recording this, a study came out. It is a critical review of this Women's Health study. So do you want to talk about that? Because that's really the latest that we have and even your reaction to that. If you want, I can read the excerpt. Would that help? It said that more recently, the publications acknowledged that hormone therapy as the most effective treatment for managing menopausal vasomotor symptoms and report that cee, which is the conjugated equine estrogen alone, reduces the risk of breast cancer by 23% while reducing breast cancer death by 40. That is confusing to me, by the way, reading that statement.
Georgie Kovacs:
And their sole remaining concern is a small increase in breast cancer incident with cee and medroxy progesterone acetate, but with no increased risk of breast cancer mortality and so on and on and on. They talk about more data. So can you digest that for us, please?
Dr Mindy Goldman:
Let me start from the statement that I entirely agree with the premise of that article, which is I do think that the Women's Health Initiative, while well designed and hoping to answer very important questions, did a huge disservice to women. And I think that anyone who has trained in medicine since that was published, so since 2002, when the press totally took off with those results, really didn't get adequate training in menopause, really doesn't understand the risks and benefits of hormone therapy. It's affected the public it affected the public's perception of hormones as well as it affected medical training. An interesting survey that was done by the Menopause Society in August showed that only a third of all residency training programs in OBGYN, that's where you typically are going to go if you have these symptoms. And only a third of training programs in OBGYN had programs that were even training programs focused in menopause. So I think that all of this really, I think, is a fallout from the women's Health Initiative. So I sort of say that as a starting point. And then let me give you my take on sort of what the Women's Health Initiative was, how we got to it.
Dr Mindy Goldman:
And then I'll comment on the really wonderful article that came out. If you look anecdotally at women using hormones and this is going way back more towards like the there was a lot of anecdotal evidence that women who had risk factors for heart disease and we know heart disease is the number one cause of death. Women who took hormones who had those risk factors had a lower likelihood of having subsequent heart disease or things like heart attacks, fatal heart attacks. But that was sort of observational and anecdotal data. And so then in the late 1990s were the first well designed trials that said, well, let's look at hormones in people who are really at high risk for heart disease. They had already had a cardiac event and see, if you gave them hormones, did it prevent a secondary event? These were the hers trials, and lo and behold, it didn't. And people thought, well, that's sort of interesting, but you really want to look at healthy menopausal, women who don't have heart disease to see, if you give them hormones, does it prevent heart disease? And that was sort of the design of the Women's Health Initiative, even though that started accruing before these cardiac studies came out. So in that group, this was considered and has been considered sort of the gold standard multicentered trial, many thousands of women, more than 16,000 women in the hormone therapy arm.
Dr Mindy Goldman:
And there were two groups of people studied, women who had a uterus and women who had had a hysterectomy. And we have known since the 1980s that if you have a uterus and you take hormones, the estrogen component is the component of hormones that tends to make you feel better, but you need some form of progesterone to protect against uterine cancer. No uterus, no progesterone needed. And there was a lot of bad press in 2002, which this article nicely outlines, when the estrogen progesterone arm of the study was stopped early with the finding that it didn't prevent heart disease and it surpassed the threshold for breast cancer. That's what the press totally took off with. People misunderstood and thought hormones must cause cancer. Everyone's calling their GYNs and their primary cares, get me off of hormones. And that fallout has persisted to this day.
Dr Mindy Goldman:
Now, interestingly, one of the things that they talk about in this article today is what didn't get highlighted is when that study stopped, the estrogen only arm of the study didn't find those findings and continued. And it stopped one year earlier than planned, not because of a higher risk of breast cancer, but because it didn't prevent against heart disease and it surpassed the threshold for stroke, and they found a lower risk of breast cancer that didn't get publicized and the question was what was going to happen? Was that just a fluke and what would happen when you followed those women longer and reported on outcomes? And that was some of the data that they quoted in this study. So there was a really wonderful article that was published in JAMA in 2020 that was 18 year follow up from the Women's Health Initiative looking specifically at breast cancer outcomes. And what didn't get highlighted was the fact that for the women who had had a hysterectomy who got estrogen only, there was a statistically lower likelihood of getting breast cancer and a statistically lower likelihood of dying of breast cancer. That's what was discussed in the article that came out today. And in that article, similar to what they found, they had found a higher risk of breast cancer in the group that got estrogen and progesterone no difference in dying of breast cancer. Now, before talking a little bit about what the article that came out today talked about, I want to talk about some other things, which is the Women's Health Initiative has been looked at in a multitude of different ways. And one of the things about that study was it was designed to look at heart disease as an outcome.
Dr Mindy Goldman:
So they chose to look at an older age population. The average age was 63, but the average age of menopause is 51. And most people coming in, talking to their providers about hormones are usually in their forty s and fifty s and not in their sixty s. And the results of the Whi for women in the younger age group were entirely different. Hormones did prevent against heart disease, were associated with a lower risk of dying. And that led to what's called the timing hypothesis. So the timing hypothesis says the risks and benefits of hormones differ depending on how old someone is and the years since menopause. And if you're within ten years of menopause or under age 60 when you start, the benefits clearly outweigh the risks with lower risk of dying of the number one cause of death, heart disease.
Dr Mindy Goldman:
And that didn't get publicized much. That's one thing. We've also done studies since then looking at different types of hormones. And in the Women's Health Initiative, they looked at a very specific oral drug. It was called the estrogen was Conjugated equine estrogen. The trade name was Premarin. The estrogen with progesterone was Conjugated equine estrogen and hydroxy, progesterone acetate or Prempro. And it turns out if you look at other formulations of estrogen like transdermals or non oral forms, when those are metabolized, they avoid first pass metabolism through the liver and they're thought to affect clotting profiles less, which means lower risk of blood clots and strokes.
Dr Mindy Goldman:
And there have been some really good quality studies, this trial called the Ester Trial that showed transdermal forms of estrogen are not thought to increase the risk of strokes. And that also hasn't gotten a lot of publicity. But we know that types of hormones that we are using nowadays are much safer. And so many people will recommend a transdermal form of estrogen for first line where you may not increase risks of blood clots or strokes at all. Now, taking that, if you go to Today, the article, I think what it really highlighted to me was depending on how you look at the statistics of a study you can manipulate how that data is reported out. And I think that while well intentioned, that report made it sound like that risk of breast cancer was much, much higher than they actually saw. And it's questionable whether, from this article, in my understanding, I only got to briefly look at it this morning, it's questionable whether there really was a higher risk of breast cancer, because when they corrected it, there was a much lower risk than expected in the placebo group, which is going to inadvertently make the relative risk seem higher. I can tell you my take on the data is I think that there's more and more of an understanding based on at least the 20 year follow up that was published that estrogen alone is safer than we thought.
Dr Mindy Goldman:
I think if there is a higher risk of breast cancer associated with hormones, my take is that it's more the progestin component that impacts that risk and not so much estrogen. In fact, I just reviewed an article from a well respected oncologist, it's not yet published, but really looking and thinking that progesterone has more impacts on the breast than we previously thought. I'm also of the view that different progesterones may affect the breast differently. And in that study they used a very strong synthetic form of progesterone that binds to the receptor tightly. And there's some studies more out of Europe that suggest the natural bioidentical formulations of progesterone that we tend to use nowadays may not increase the risk of breast cancer at all. So my own view is that hormones are a lot safer than we previously thought. I think that the article today really helps Colin to question the fact that the numbers that were quoted appeared much higher than they actually were. I think we use formulations that are a lot safer.
Dr Mindy Goldman:
I think we should individualize a lot because transdermal may not be right for everyone. If you have eczema or skin reactions, maybe that's not right for you. And I think that unfortunately the fallout from that study has persisted and women aren't getting the care they needed. They were told just have to suffer. There's nothing that can be done. And physicians who are the ones that they're going to to look to for this education didn't get the training and don't know the literature and frequently will just tell women this is a natural part of aging, the symptoms will go away. Don't do anything. Hormones can increase your risk of breast cancer.
Georgie Kovacs:
First point of clarification the synthetic form of progesterone. Was it progestin?
Dr Mindy Goldman:
So the synthetic form that they use, this was this Madroxy progesterone, acetate. So the micronized progesterone, or the trade name Prometrium, which is also a bioidentical form of progesterone, those are very different types of progesterogens. I wanted to make sure I'm using the term correctly. And again, hormones are not hormones are not hormones. And that brings up the whole bioidentical. I always love to comment on that, if that's okay. The bioidentical versus compounded and all of that and brings in pellets and different formulations. So I'd love it if I can comment on that.
Dr Mindy Goldman:
So bioidentical means formulations that are similar to what's produced in the body. And there are many bioidentical formulations of hormones, of estrogen as well as progesterone that are commercially available, that are covered by insurers. Unfortunately, bioidentical and compounded get confused a lot. Compounded formulations frequently include nonstandard formulations where they are made in specialized pharmacies and they are natural. So people assume that they must be safer. And they're often touted to be made in a way that they are targeted more for the individual as opposed to giving a standard dose. And that may include cream formulations of multiple different types of estrogens. It might include creams or pellets or trophies.
Dr Mindy Goldman:
And the large guiding organizations in the US. Like the Menopause Society and the National Endocrine Society have all put out position statements on these compounded formulations which essentially say that until we have randomized control trial data looking at those formulations, you cannot assume, because they are so called natural, that they are safer than any of the standard formulations, including standard bioidentical formulations that are available. My concern with some of those formulations are, as I mentioned before, if you have a uterus and you take hormones, you need some form of progesterone to stabilize the lining of the uterus, to protect against uterine cancer. And sometimes in compounded formulations, they'll use a topical cream of progesterone. And it turns out progesterone is not absorbed well through the skin. And so when people are doing those types of formulations, they may not be getting enough progesterone to protect their uterine lining. And in fact, I have not too many years ago, diagnosed endometrial cancer in someone who was on one of these compounded formulations, came in with some spotting and wasn't getting enough progesterone for uterine protection. I know people are approaching those thinking they're safer, they're natural, they're targeted just for me.
Dr Mindy Goldman:
We really don't have good data that says you should be checking people's hormone levels and creating a dose that's based on those hormone levels. You want to treat someone based on their symptoms. And hormone levels don't always correlate with what symptoms someone has. So if someone is in front of you and they are complaining of hot flashes and night sweats and mood changes and sexual dysfunction, and you check their levels and they're not out of a range where you think they should be that doesn't mean you say to that person, hey, good thing your levels are okay. You want to treat them based on the symptoms they have. So when I am approaching a menopausal women, I will recommend standard bioidentical formulations that are covered by insurance. I think cost is a big issue for people and those compounded formulations aren't covered by insurance. And I really try to impress upon people that compounded is not the same as bioidentical.
Georgie Kovacs:
What about testosterone? I just want to bring that up specifically because that's usually where I hear about the Pellets.
Dr Mindy Goldman:
Testosterone is not FDA approved for women. Let me put that out there. And there were actually some typically testosterone is used for improving sexual functioning in women. And in fact, there were some well designed studies in the early 2000s looking at the use of a testosterone patch for treating sexual functioning in postmenopausal women who are already on hormones. So their menopausal symptoms were treated. They didn't have vaginal dryness, they were randomized to these patches, and they actually found improvements in sexual functioning. And they never got through the FDA because it came on the heels of the Women's Health Initiative. And the FDA said, we want more safety data with regards to the breasts.
Dr Mindy Goldman:
And to this day, testosterone has never been FDA approved for women. So that's one thing to realize, that it is not an FDA approved formulation for women. There are people that think testosterone should be added to hormone therapy, that it improves fatigue, overall well being, metabolic health, cognitive health, bone health, in addition to sexual functioning. When you look at the data, there was a large expert consensus group that got together a few years ago and published a really well thought out guide for the use of testosterone in women. And really the best data supports the use of testosterone in improving sexual functioning. So, low libido in postmenopausal women, we have data for improving muscle mass and bone health in men, not in women. So all those other things that people talk about, you're really extrapolating. We know it can be used to improve sexual functioning because it's not FDA approved in women.
Dr Mindy Goldman:
People have to get it in other formulations so they can go to a compounding pharmacy. This is one of the times that I will recommend working with a compounding pharmacy. You want to make sure your compounding pharmacy does third party testing to ensure that it's a quality product. But you can get a compounded form of testosterone where the doses are low enough that you won't see male hormone or androgenizing side effects in women. You can also use one 10th of a male hormone dosing or sometimes people are using some of these Pellets. And again, the problems I have concerns with the Pellets because you can't take it out once they're in there. Absorption is variable for women. And so in this position statement about the use of testosterone, really the formulations that are recommended are either a compounded formulation or one 10th of the male hormone dosage.
Dr Mindy Goldman:
Now, the other thing to realize is testosterone is a controlled substance, and some of the federal laws surrounding controlled substances are changing. And so they are requiring face to face visits with women more often. So it makes it a little bit more difficult to give patients testosterone for their sexual functioning. So one thing I try to tell someone is, look, if you are pre menopausal and you have low libido, there are FDA approved drugs that are out there for improving libido. Flibanserin is one. The trade name is ADDYI. Bremelanotide is another. The trade name is VYLEESI.
Dr Mindy Goldman:
Those are FDA approved drugs for improving libido. They've been studied at least Flabanterin has been studied in postmenopausal women. It's not FDA approved, but could be used. There's no reason it couldn't be used. It just has to be used off label. But I tell people, certainly if you're pre menopausal, go for something that is FDA approved, postmenopausal. If women do notice changes in sexual functioning, it is a very reasonable thing to think about adding testosterone to their regimen.
Georgie Kovacs:
I'm so glad I asked, because that nuance is so important. Can I just make a statement where when you were saying how it hasn't been studied in women but it has in men, I'm like, haven't most things been studied in men and they apply it to women anyways? I mean, hello, ambient disaster. And I was listening to you, I was like, this is ridiculous.
Dr Mindy Goldman:
This is just yeah, no, I totally agree. A lot of what we tout is oftentimes studies that have been done in men that are extrapolated to women. I think a lot of the heart disease stuff, finally, we're starting to see studies appropriately being done in women so that we can understand things. But that was a big problem in the past.
Georgie Kovacs:
The more I think about it, I actually think the 92 FDA approval or FDA mandate for women to partake in clinical trials is probably what led me to be in the sciences, because I wrote that I was a science major in college, and I wrote that, I think, right before college or my freshman year. And it kept me staying in the sciences because I was like, I'm smart. I can do the sciences. Women aren't doing it. This is back then.
Dr Mindy Goldman:
Yeah, it's sort of interesting if that was in 1992, and you would think in almost 2024 that we would be further ahead than we are.
Georgie Kovacs:
I know, it's crazy. Okay, so thank you for that hormone course. I really think it was an important foundation because I think that clarity and that 101 is so important as people make decisions. So now let's transition into these cancer patients. So walk us through that journey of they're struggling with these menopausal symptoms. Tell us how you're addressing that, especially now that we have all this data that you've. Shared.
Dr Mindy Goldman:
It's important to realize that there aren't actually national guidelines that talk about the use of hormones in people at high risk for cancer, which includes people with a family history, people who have had prior biopsies with atypical change, people with genetic mutations, and people with cancer. The standard of care has always been not to use hormones in those situations, because the thought is that hormones could increase the risk of getting breast cancer if you're already at higher risk, and if you've had cancer, that hormones could impact how that cancer behaves, whether it increases the risk of recurrence or impact survival. But there aren't national guidelines that really talk about that. And we don't have randomized control trials. It's really hard to do a randomized control trial saying, okay, you're at high risk for cancer, let's put you on hormones and follow you prospectively and see what happens. So most of the information we have is on retrospective data. And before talking about the cancer survivors, let me just comment that I entirely agree with the article that came out today that talked about the use of hormones in people who are higher risk. We do not have any data that says people who are high risk for breast cancer can't use hormones.
Dr Mindy Goldman:
That hormones is going to add on to the risk that they already have. If there is a risk, it's likely an independent risk, and I think the study today calls into questions whether it's even a risk at all. But certainly if someone has a family history or even a genetic mutation, they can use hormones. That doesn't mean they don't need close breast follow up, which is clinical breast exam for high risk people. Imaging every year, which is at least a 3D mammogram, sometimes includes an MRI. Lifestyle measures like regular exercise specific amounts, 150 minutes a week divided times interval cardio may decrease the likelihood of getting cancer, at least for breasts, and possibly even colon minimizing alcohol. Those are all things that people who are high risk should do. If someone has had atypia, like a breast biopsy that showed atypical ductal hyperplasia or even precancer like DCIS, it's more controversial about whether those people should use hormones.
Dr Mindy Goldman:
There's actually a large study going on in the US right now. There are multiple centers that are accruing patients that are looking at a drug called Duavi that has conjugated estrogen in it to treat menopausal symptoms. And instead of using progesterone to protect the uterus from uterine cancer, it's using a drug similar to tamoxifen. And Tamoxifen, we know is FDA approved for prevention and treating breast cancer. And so this drug is being looked at as a drug to treat symptoms and prevent breast cancer in high risk women. And there's some preliminary data out of the University of Kansas Medical Center that suggests it does indeed prevent cancer. So that's one of the things at midi that we do talk to our high risk patients if they're in states where this trial is going on, we try to get them to the appropriate coordinators for the study. And if not, we have been willing to talk to people to say, hey, we don't know if this truly does prevent cancer, but we are willing to offer if you understand that that may be an option and it can be an effective treatment for your symptoms.
Dr Mindy Goldman:
Use of hormones, again, a little bit more complicated in that situation. And then if you shift to cancer survivors, if you've had invasive disease, generally it is considered a contraindication to use hormones. However, that does not mean that someone has to suffer. There are a multitude of options that can be used. So there are low doses of a number of medications, including certain antidepressants neuropathic pain medicines, antiseizure medicines, older studies with a blood pressure medicine, overactive bladder medicines that all in low doses have been shown to improve hot flashes. Now, the only thing those drugs have in common is they cross the blood brain barrier. And previously we would say we don't know why they work, but they impact this temperature regulation zone in the brain. And we have randomized control trial data that show they can be effective.
Dr Mindy Goldman:
We sometimes choose certain ones to target the side effects. So, for example, if a woman's having a lot of hot flashes at night that are interrupting her sleep, I may offer a drugs like Gabapentin because that can cause sedation as a side effect. So that can help out for nighttime hot flashes that are disrupting sleep. Just this year in May, we had a new drug that hit the market. It's called fezolinetant or VEOZAH. I love that they even advertised for it at the Super Bowl this year. Like, who thinks that you're advertising that shows menopause is having a moment right when they advertise about a hot flash drug at the Super Bowl. But this drug is the first drug that specifically targets the thermoregulatory center within the hypothalamus.
Dr Mindy Goldman:
It targets what's called the candy neurons. And it's the first drug that is really helping us understand the mechanism by which hot flashes occur. Now, this drug was not studied in breast cancer survivors mainly because it was easier to get through the FDA if you exclude cancer survivors. But there's nothing about the drug that implies it can't be used. It is non hormonal and it's a great option. So it just gives another tool for women who have cancer to be offered. The biggest problem is it's new. It's not yet on all insurance plans.
Dr Mindy Goldman:
So sometimes you're having to fight and do prior authorizations. Certainly that is a drug that we are recommending for our cancer survivors. Then there's a whole other class of when you think about breast cancer, you need to think breast cancer is not breast cancer is not breast cancer. So for people, one third of people have breast cancer that's not sensitive to hormones. Again, that doesn't mean hormones had no impact. It means they won't use hormonal therapy as part of the treatment. And that's probably a worse disease up front because all you have is chemotherapy. And sometimes those are more aggressive diseases.
Dr Mindy Goldman:
But if those patients don't recur after three to, certainly by five years, they likely cured of that cancer, doesn't mean they couldn't get a new cancer. And that's different than hormone positive patients where you can sometimes see recurrences late, like 1520 years later. But so for hormone negative patients, if they've done well, they finished their treatment and they're having menopausal symptoms, frequently we will offer them hormone therapy. And although there's still some people that think it's controversial, there really isn't data that says it impacts recurrence or survival. So meaning those patients could get oral contraceptives or postmenopausal hormone therapy. So I think the big thing for breast cancer survivors is understanding what type of cancer you have, realizing cancer is not cancer, is not cancer. Don't let anyone tell you, be lucky you're alive, just suffer with these symptoms. There are plenty of options that's just from the hot flash standpoint, we have lots of options, including certain hormonal options for treating all the vaginal dryness and sexual dysfunction that you see.
Dr Mindy Goldman:
We know. And through the national comprehensive cancer network, the NCCN, we have survivorship guidelines that talk about the use of vaginal hormones and which ones we recommend and which ones we don't for people even with hormone positive disease. So that's sort of the biggest takeaway that I really try to impress upon cancer survivors. And what I'm hoping to do as we develop out at midi, our national cancer platform, is, please don't let anyone tell you you have to suffer. There's so many things to do and that's not even, we haven't even talked about. There's a whole bunch of lifestyle things that we talk about. There may be certain supplements, even herbs. We know less about some of the herbs, but things that can be offered.
Georgie Kovacs:
So I just want to make a couple of points of clarification with the great information you were just sharing. So one is the hormone related breast cancer, is that all? Because everyone right now is talking about the BRCA gene. So I just want to make sure we're aligning terminology. So when someone's thinking BRCA, is that always the hormone related? Or could there be just because you need to know that you're cancer? So can you talk a little bit about that just to make sure people are very clear?
Dr Mindy Goldman:
80% to 85% of breast cancers just happen, and we don't know why. We know there may be risk factors, but we don't really know why someone got cancer. 15% to 20% of breast cancer is thought to be something that runs in the family. And of those, about 15% to 20% of those cancers are thought to be related to genetic mutations, the most common being BRCA. And so BRCA represents a small percent of breast cancers. There are different BRCA genes. BRCA, one mutation, is most often associated with what's called a triple negative cancer, which means it's not sensitive to estrogen progesterone. And there's another marker that they test for that's called her too new.
Dr Mindy Goldman:
BRCA two is more often associated with hormone positive cancer, meaning either sensitive to estrogen, progesterone or both. So BRCA doesn't necessarily you can have breast cancer that is hormone positive that has nothing to do with BRCA, and only a small percent is BRCA. And then also realize now that we have the ability to do these multi gene panel testing, there are other genes that we have learned about in addition to BRCA that can be associated with a higher risk of breast and or other cancers.
Georgie Kovacs:
So if you are BRCA too, is it okay to take these hormone therapies?
Dr Mindy Goldman:
Yeah, even the National Comprehensive Cancer Network, I think in their guideline, they will say people can use it with caution. Again, my take on the literature is that there is not good data that says hormones increase the risk further in someone whose risk is already really high by having BRCA. If it does, it is a negligible risk. And that's one of the things that I think the article talked about today, that we don't have good data that says in people who are higher risk that hormones really add significantly onto that. And so just because someone has BRCA doesn't mean they can't use hormones. But that doesn't mean they still need to get their close breast follow up. So they still need to get their exams, they still need to get their mammograms and MRIs if they're choosing to take a drug to prevent breast cancer like Tamoxifen. Typically we haven't given hormones in that situation, and more often we haven't done that because the concern is that Tamoxifen is a drug that can increase the risk of blood clots, as can hormone estrogen in hormone therapy.
Dr Mindy Goldman:
And so would they be on a drug that's additive for Clots. Now, in Europe, they do give HRT to alleviate the side effects of Tamoxifen. And if you look at this new drug well, it's not a new drug. It's back on the market. Duavee that I mentioned before, that is a conjugated estrogen. We know estrogens can increase the risk of Clots, and it includes a drug like Tamoxifen, which can have Clot risk. So I think that that's being called into question. Even could we potentially consider giving hormones to women who are also on Tamoxifen for breast cancer prevention? Little yet, not quite clear, but big take home is just because you have BRCA, do not feel like again, you have to suffer if you choose not to do hormones.
Dr Mindy Goldman:
I tried to say there are a lot of other options available, but I think hormone therapy is still a reasonable option.
Georgie Kovacs:
Okay, and then real quick on VEOZAH. So word on the street is expensive, lots of side effects. Why bother? You have said you recommend it. I would love to hear your thoughts on that.
Dr Mindy Goldman:
Yeah, I think a I will clarify that I haven't had enough patients that I have seen followed long enough. Again, the drug just came out in May to really get a good handle on how well it's tolerated. Fighting with insurers to get it through. I think that it's just another option. Right. The more options we have available and certainly we need to see maybe there's going to be I did read studies looking at other doses, so maybe that's going to be studied more and we'll be able to find lower doses that have fewer side effects. But just having options is a really great thing.
Georgie Kovacs:
I've hit menopause and I'm like, I tell my friends, they're here, I got the hot flashes. And it's very different because I used to get just really hot and like major night sweats in perimenopause, but now I get like that actual flash. But I will say wine and sugar. I tell you, cutting that out makes such a huge difference.
Dr Mindy Goldman:
Yeah. And that's why when we're talking particularly to cancer survivors, there's a bunch of lifestyle things that they can do of looking at dietary factors. Fans can work, dressing in layered clothing, decreasing stress. We know that stress can impact hot flashes and night sweats. So I tell people, don't forget about lifestyle. It's really important.
Georgie Kovacs:
Wow, this was incredible. Again, when I researched your background, knew you'd be the perfect person to talk to about this. And it has been just an incredible learning lesson for me and I really appreciate your dedication and I know people have learned a lot from this discussion.
Dr Mindy Goldman:
Thank you so much. I really enjoyed talking to.
Disclaimer
**The information shared by Fempower Health is not medical advice but for informational purposes to enable you to have more effective conversations with your doctor. Always talk to your doctor before making health-related decisions. Additionally, the views expressed by the Fempower Health podcast guests are their own and their appearance on the program does not imply an endorsement of them or any entity they represent.**
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