The Dr Louise Newson Podcast - 052 - The Benefits of Body Identical Progesterone - Professor James Simon & Dr Louise Newson

Episode Date: June 16, 2020

In this podcast, Dr Louise Newson is speaking to Professor Jim Simon, a Clinical Professor of Obstetrics and Gynaecology and Reproductive Endocrinology at George Washington University in Washington DC.  Dr Newson and Professor Simon talk about the Women’s Health Initiative (WHI) study and more specifically about the different types of progestogens and progesterone. He clearly describes and explains how body identical progesterone is the safest to take as well as the benefits women often experience when taking body identical progesterone. Jim also explores and explains the evidence regarding the reported risks of breast cancer with HRT and he and Dr Newson also talk about how important it is that women receive the best care and treatment during their menopausal years.  Professor Jim Simon's Three Take Home Tips: Listen to your own body - it will tell you the truth! Address each of your symptoms with a healthcare profession and know your treatment options. Your symptoms are not 'a right of passage' that you have to put up with. You are likely to live a very long life, take the big picture into account and try to practice preventive medicine. Remember that whatever you decide on with your healthcare professional, doesn't have to be for the rest of your life. Make the best choice for you today and live it out until things change - you can always make a different choice if it's warranted tomorrow. Find out more about Professor Simon by visiting his website here. Find Professor Simon on Facebook: @IntimMedicine Twitter: @IntimMedicine Instagram: @menopause.whisperer

Welcome to the Newsome Health Menopause podcast. I'm Dr Louise Newsome, a GP and menopause specialist, and I run the Newsome Health Menopause and Wellbeing Centre here in Stratford-upon-Avon. Today I'm absolutely delighted to introduce to you Professor Jim Simon, who is a clinical professor of obstetrics and gynaecology and also reproductive endocrinology at the George Washington University in Wynacin. Washington Z.C. And he also runs a very busy private clinic with the largest independent research in women's health in the USA. So I connected with him at the British Manipause Society meeting a couple of

years ago and quizzed his brain a lot and wouldn't leave him alone because I wanted to get as much information as possible from him while he was there. So I'm absolutely thrilled and honored that you've agreed to do a podcast today. So thank you. It's my pleasure to be here. really and glad we have an opportunity to reach your audience. Brilliant. So what I wanted to do in the next half an hour is really talk about HRT, that three-letter word that scares so many people, so many women, so many healthcare professionals. And it is only three letters, isn't it?

Hormone replacement therapy. So I wanted to talk about the different types and about the risks. I want to get right out there at the beginning and talk about the breast cancer risk because this is the thing that women and healthcare professionals are mainly concerned about when it comes to prescribing. So before we launch straight into that, could you just talk a little bit about your phenomenal background and your medical career, just to put us in the picture about what you do? Sure. I started out in a more traditional way of looking at reproduction and infertility and was around for the conception of Louise Brown in the UK, which makes me old and gray,

and did a lot of assisted reproduction in my earlier career, including quite a bit of research in non-human primates, in monkeys, where we can do things or at that time could do things that were not acceptable to do in human primates. And it was extraordinarily illustrative both scientifically and to me personally making, if you will, hospital rounds on 400 female and eight very happy male monkey every morning. Afterwards, going home and showering and cleaning up and then going to see my human primate patients. and recognizing that we've come a long way as humans, but maybe not as long and as far as one would

believe. And that anchored me very definitely in the science of evolution and of human biology, which I've carried with me as I've aged and as my patients have aged to taking care of women in the post-women reproductive era of their lives and into aging. Amazing. Yeah. So when women are pregnant, they obviously get a lot of attention, don't they? And when they have babies, they often go back and forth to their physicians or their pediatricians. And then suddenly women become menopausal, not suddenly, but it gradually become menopausal. And then for a lot of women, they don't have any healthcare provision. They don't get seen by anyone. But it's really important time of our life.

isn't it, that women have, like you say, postmenopausal years are really important to be looked after optimally. Yeah, I think one thing that we don't have a good concept of is just how recent menopause is in the evolution of humans. There have always been, as far as we know, a very small number of long-lived women and men, but now in both the UK and over here in the U.S., the average life expectancy is more than 80. And that means that the average woman is likely to live at least a third of her life after menopause,

and maybe as much as a half of her life after menopause, which if you think about it, means we should be spending half of our attention to her health, not only her menstrual health and her reproductive health and her conception, but a lot more energy effort and money on her healthy aging to a ripe old age. And I believe that part of that, or maybe the inflection point in a woman's life is right around menopause, where she is typically taking care to understand what's happening with her own body, taking account of her family and her significant partners and life, work, et cetera. It's a real big opportunity for us to help her in long-term health planning. Absolutely. And it's so important.

And many of you listening know that being a physician, I'm really interested in. It's not just about the quantity of years we have. It's the quality and it's our health is so important. And a lot of women really look after themselves and then they suddenly go through the menopause and they find it very difficult. And they often don't realize this increased risk of other diseases. And one of the things I'm very keen to do is almost rebrand the menopause and think of it as a long-term female hormone deficiency. Because once you start talking about a deficiency, people will then say, well, how do I get replacement? If I told a woman she has vitamin D deficiency, the first thing she'll do is go and buy vitamin D or get a prescription for vitamin D. And I really feel this is what we need to think about for

the menopause. I'm sure you'd agree. Absolutely. And we used to call it an end-degree. You know, as a reproductive endocrinologist, when the thyroid fails, you give thyroid replacement therapy. When the person develops insulin resistance or diabetes, we give insulin replacement therapy or medications that act to improve insulin action, et cetera. These are classic endocrinopathies. And we used to think of the menopause, surgical menopause being the paradigm. but natural menopause being also an endocrinopathy, and the need to replace those hormones that are lost at that time, there's abundant information on the impact of hormone loss at menopause on health and disease.

There's less good information on hormone replacement and the prevention of those disease entities, but there's quite a bit. Yes. And this is what people don't realize. I think when people talk about HRT, they always think about the risks. They don't think about the benefits for, not just for symptoms, but for future health as well.

And there are many benefits. So why is it that we're not all taking HRT? Why is there so much resistance, then? What's the story behind it? So I see this, having lived through the 60s, at a time when women's empowerment and focus on independence, et cetera, was extremely important. I see this as a battle between self-determination and what might be considered a natural event versus a medicalization of a time, a naturally occurring event,

time in a woman's life for her benefit, but counter to one's self-determination and independence. So on the one hand, you have menopause is natural, it happens to everyone, it's just part of the natural process of aging, and then on the other hand, you have, it's associated with disease, some of those diseases need to be prevented or ultimately treated. Those diseases affect quality and quantity of life. And those two diametrically opposed positions aren't easily reconciled. Absolutely. And I think it is difficult, isn't it? Because people do think it is, well, obviously it's a natural condition. It's not a disease. But like you quite rightly say, women are living longer than they used to. So evolutionally, you could almost say that we're not designed to live for decades without

our hormones. Let me give you another example that I think kind of bridges the same gap that I've just enunciated. Pregnancy is a natural event. And historically, women had no preventive therapies to avoid pregnancy. It was just a natural event. But we've accepted that women may want to be engaged in sexual activity, or intimacy without the consequence of getting pregnant, even if they're fertile. And so we accept contracept contracept all different types of contraception, including hormonal contraception.

And yet, this falls apart, this concept falls apart when we talk about women and menopause. Which is so sad. It really is very sad. But if we think about why that's happened and why there is so much negativity towards HRT, a lot of it stems from this study in 2002, the Women's Health Initiative study, doesn't it? So this was, many of you have listened, have heard me talk about this before, but it was based on older types of HRT in a different population that we often start HRT for. And what I found really interesting, I've read a lot of your papers, but you wrote something about how the WHA would be if a different type of HLT was given.

So if the estrogen through the skin was given as a patch or gel, and this micronized progesterone, which is the body identical progesterone, was given. And the results would have been very different. There's no doubt about it. So can you just talk us through first about what the WHA was and talk about the paper that I'm alluding to because I think that would be really interesting? Certainly. So the Women's Health Initiative, the WHOI, came into being in the early 1990s.

It was planned and put into a process, a long, arduous, expensive process in the early 1990s. And lots changed since the early 1990s. And honestly, during the planning stages of the Women's Health Initiative, And as a result, some of the products that were used in the Women's Health Initiative were chosen because they had the market prevalence to cast light upon the benefits or risks of those products at the time. But during the time of the Women's Health Initiative and following it, there's been a general trend away from the products that were used in that study because of the findings of the study itself, but also because of many others that were developed and studies that were done outside the U.S., mostly in Western Europe, France, Belgium, Scandinavia, and to a lesser degree, but to some degree in the U.K.

And when you put all that together, the testing of an older preparation, because of the that's what was being used, and the accumulation of both problematic information from that big study and new information from other studies on non-oral estrogens and micronized progesterone, then you come up with a totally different view of the results and how to prevent them. One of the more important issues was that in the UK, oral progesterone was a very late comer to the market. And so early studies in the UK, when they talk about progesterone, they weren't actually even talking about progesterone. And there's a lot of negative information, for example, in the well-publicized million women's study, which suggested that progesterone

caused breast cancer was not even about progesterone. progesterone, as we are going to discuss in the next moment, wasn't even available in the UK at the time. So we have the problem of language and misinterpretation of what the facts are. Which is so important. You know, words are so important. And in fact, I've done a lot of writing, medical writing, for quite a long time. And about four or five years ago, I was writing something about micronized progesterone. and a doctor wrote in and said, how dare Dr. Newsom write about something I've never heard about?

And it has been around for a few years in the UK, but a lot of people haven't heard of it. And like you say, it's very easy. We talk about the progesterone-only pill. Well, that doesn't contain progesterone. It contains a progestogen or progestogen, you know, depending on how you pronounce it or whereabouts you are. But it's a synthetic.

It's not the same, is it? And explain what the differences are then between progesterogens and progesterone. So progesterone is a very ubiquitous compound in reproduction, human, non-human reproduction alike. It's an extremely old compound evolutionarily, and it's completely natural and what we would call bioidentical, meaning identical in its composition and structure to what occurs naturally in this case in the human female. Now, progesterone having that long evolutionary history and being associated with pregnancy, it's present in bucket load amounts during pregnancy, has to be safe.

Otherwise, all of our offspring would have been disease, disordered, or in some way adversely impacted. So progesterone has a biological history and multitude of activities that are incredibly safe. One of the problems with natural progesterone is it's quite difficult to get into the human body as a pill or a patch or a lotion or a gel because it's very poorly absorbed through the skin. skin and actually very poorly absorbed when you swallow it as a pill. So formulations had to be developed to allow it to be absorbed in adequate amounts that it could be used in menopausal therapies. And that's why it came so late to the market, both in the US and the UK. So that's why we call it micronized, don't we, progesterone? Right. There are a number of of ways to make a poorly absorbed compound more easily absorbed. In the case of progesterone,

there were two processes that were brought to bear to make it more bioavailable, meaning more easily absorbed when taken by mouth. The first was, as you mentioned, the process of micronization. There's nothing surprising about micronization. It just means taking a big rolling pin and smashing the particles into little teeny ones. Anyone who's used rock salt in their cooking and then wanted to get it finer and milled it down or beat it down or pulverized it into smaller pieces has the concept of micronization right front and center. To make it smaller, made it more easily absorbed. The other technique was to mix it, with a fatty substance.

In the case of micronized progesterone, it's either sesame oil or peanut oil or some other kind of oil, which allows progesterone, which doesn't absorb well in water-based systems like that we have in our stomachs, to be more easily absorbed. Think about it in this way.

Everyone knows that salad dressing, which has oil and water components, separates out if it sits on your dining room table. And the same thing would happen with progesterone and oil if it were in just a water-based solution. Instead, if you take and shake it up really hard that salad dressing, you get a mixture that you can then use on your salad and get a little oil and a little vinegar and a little of your spicy. Well, the same thing was done in a very scientific process. When you take progesterone and mix it with an oily substance, you get this homogenized material that's much more easily absorbed. So, and then how, what are the differences between, we know the structure is different, but can you just explain the differences for women who take a synthetic progestogen with the natural body identical progesterone?

because there are differences with the risk of breast cancer and also the risk for clot and heart disease is different as well, isn't it? Yeah, so one of the advantages of using a natural substance like progesterone is that Mother Nature over tens of thousands of years has selected it for certain properties. I mentioned the safety and pregnancy property, that's one, but it also has very specific targets in the body. very few off-target effects. And that's not the same as when we look at testosterone-based progestogens or completely synthetic progestogens that are not natural to humans. And why do we

have these either testosterone or synthetic progestogens? Because they're easier to absorb. They're easier to mix into multi-compound systems, and they remain stable at room temperature, a requirement for all the regulators around the world. We want to make sure that the last pill in your pill bottle is just as effective as the first pill in your pill bottle, so it has to be stable at room temperature and resistant to going spoiled. These reasons have made synthetic forms of progesterone, the less expensive, the more available, and the more stable types of products, but they suffer because they're not natural, and they do have off-target effects.

For example, and your listeners know because some of the same synthetic forms of progestogen are used in birth control pills as they are in menopausal therapy. And they know that sometimes they will take a new pill or a form of birth control and they'll get acne or oily skin, some other off-target effect that would be undesirable to them. And that is not the case for progesterone. Yeah. So a lot of women, they also suffer from mood changes. Some people find that they feel quite flat, quite low, with the synthetic progesterogens,

and this effect isn't there with the micronized progesterone or the body identical progesterone. A lot of women, when we give HRT to women who have still got their womb, so who need a progesterone, actually find that taking it at nighttime, that it helps with sleep. It can help them feel more relaxed. It has quite a sedative effect as well, doesn't it, for a lot of women? Yeah, so one of the,

unanticipated side effects was that when you take progesterone orally, as opposed to as a suppository, for example, one of the metabolites that happens is a form of breakdown product of natural progesterone that has a mild, sedative hypnotic effect. And it's also good for anxiety, something that many menopausal women suffer from in addition to hot flushes and night sweats and disturbed sleep. So improving sleep and reducing anxiety may be too off-target benefits, if you will,

from taking oral progesterone. I'm not the least bit sure that it was intended to have that effect when it was first developed, but it certainly is a benefit that many women that are going through the menopause find beneficial. And then let's think about, or if you don't mind talking a bit about breast cancer risk with HRT, because this is something that everyone wants to know. So could you just explain what it is? Absolutely. So breast cancer is a very prevalent disorder in women around the world. In the U.S., the data are very clear that about 8% of women, by the time they get to be 90 years of age, will have developed a breast cancer. That means that 8% of women, or 8 women out of 100, are walking around. with breast cancer, whether they know it or not, whether it's big enough to find on a mammogram or on

an exam. Regardless, there are eight women in a hundred that have breast cancer. And if one takes estrogen, which is a universal growth factor, it makes all kinds of things grow that we like. It makes hair, skin, and nails grow, if we want to talk about cosmetic effects. It makes the vaginal cells grow, which makes sex pain less or less painful and more enjoyable. It makes the bones grow, which prevent osteoporosis fracture and deformities as women age. These are all growth-promoting effects. Well, you can't have growth promotion in all of the, those tissues without the possibility of estrogen causing growth promotion of those breast cancers

that pre-exist in eight women out of 100. Didn't cause the breast cancer, but it may bring it to light earlier because it makes it grow to a size that one can pick up on their mammography. Now, progesterone, the subject we've been spending most of this discussion on, also has an effect, and we believe it also causes some growth of breast tissue and some breast cancer tissues, not causing breast cancer, but again, promoting its growth. the problem has been that if you do a study of a defined period of time, let's say five years, and you promote the growth of breast cancer by giving women hormones in one group, and you don't promote the growth of breast cancer in a matching group of women because they're getting a matching placebo, then you're going to find more breast cancers in that group of women who got hormones over the course of the study those five

years. All it meant was that you found more breast cancers. You didn't cause more breast cancers. But that subtlety has really been lost in our conversation. The one little piece of the whole story is that there's abundant literature that demonstrates that if you find a breast cancer in a woman who's on hormone therapy when it's found that her prognosis is better, her chance of death is lower than if that woman were not on hormones at all. And so you have this what I call push-pull effect. more, but it's of less severe disease, not always agreed upon in the breast cancer community, but in general, that's what the day we say. And so is hormone good for you, bad for you,

but it doesn't cause breast cancer? I mean, that's just so important. And it's a lot of information, obviously, to take on board there. But it is so important to know, because I certainly see a lot of women or talk to women who have had a diagnosis of breast cancer and they've been told that their HRT will have caused their breast cancer. So I think it's really important that women know this because, you know, for those 8 in 100 women who do have a diagnosis of breast cancer, they're always going to look at reasons for why it's happened. And what I would hate is for them to be blaming something that they've taken. And so this is really, you explained it so eloquently and clearly that it is not a cause, you know, and I think that's really important to know.

And, you know, to know that there's not been a study to show there's an increased risk of death from women with breast cancer who take HRT is really important. Because it's a common disease, isn't it? But not every woman who has a diagnosis of breast cancer dies from breast cancer. Most women die from cardiovascular disease who have had breast cancer. Absolutely. And there's one other thing that I think your listeners need to know. the Women's Health Initiative, because it was big, because it was expensive,

because there was a tremendous amount of publicity around the original publication and findings. Most doctors, most practitioners of all sorts, never read past the original publication. And for those of us who follow this very closely, there was a publication that came out six full years following those original data, which demonstrated that the hormone therapy, albeit synthetic, in the Women's Health Initiative, the hormone therapy that was used did not actually increase the risk of binding a breast cancer in spite of all the publicity. what they found out was that because the groups of women in the study were not of equal risk as it related to breast cancer when they started, that the hormones didn't cause the increase in the findings of breast cancer,

but it was a difference in their baseline risks that caused the findings of breast cancer. Remember, the Women's Health Initiative keeps touting itself as a randomized placebo-controlled clinical trial. The peak, the most advanced, the sacrament, if you will, of clinical research. But it was randomized and placebo-controlled for cardiovascular risk at baseline. It was not randomized and placebo-controlled for breast cancer risk at baseline. And once those baseline data were, in fact, balanced for baseline risk, the data show that there was no increase in breast cancer risk whatsoever, in spite of the fact that these were synthetic hormones used in the women's health initiative.

which is so important and it's very difficult isn't it um i'm not a researcher i'm not a statistician and when you're a busy clinician you just read the take-home messages you read what's been given to you and sadly this has happened time and time again over here in the UK and i'm sure for you as well in the USA and more recently there was a meta-analysis there was a review of published and un-published data that was published in the lancet journal and a lot of the data was using older type of HRT and the MHRA have now given a warning to all GPs to say that HRT should now be used for the lowest dose, the shortest length of time because the risk of breast cancer is higher than they even thought before. And lessers have gone out to women taking HRT from the MHRA,

so endorsed by the government over here, which quite rightly has scared healthcare professionals and GPs. And, you know, everything that you're saying is still relevant. and it really saddens me that women are being denied a very cost-effective treatment, but also very health effective for their future health. You know, I get incredibly frustrated, as I'm sure you realize and people listening know, how women are being denied it for the wrong reasons. Yeah, I think that the biggest problem is that sometimes politics and a superficial understanding of the science rather than digging down,

deeply into the science is what we take home. What we learn is from the broader media who are on one story one day, the next story the next day, and frequently what they say has long-lasting effects on who we are, what we are, what we do, that we're never anticipated. Yeah, absolutely. So I really hope and I'm sure that this podcast will help so many women. And, you know, we're not here to say that every woman should take HRT. We're here that women can be given the right information and then they can make the right choices. And the words that you've shared with us today will help in so many ways. So I really appreciate the time that you've given. Before we finish, I always do three take-home tips. And so I'm wondering, maybe just three sort of messages for women who are

concerned about HRT, maybe some three sort of tips to reassure them if that would be possible. Certainly. So I try and live by these three tips in taking care of my patients and they seem to ring true. Listen to your own body. If you can listen to your own body, it will tell you the truth. And so if you're having hot flashes and disturbed sleep or pain with sex, don't accept those symptoms as being a right of passage. Address each and every one of those symptoms with a health care professional who understands all of your choices, not just the ones that may be on the, in your case, the NHS, that understands all the choices. Now, you may not be able to afford or may not want something in terms

of treatment that isn't covered by the NHS, but at least know what your options are for each and every one of your symptoms. So that's number one. Number two, you are likely to live a very long time more than age 80. And if you're a member of my family, more than 100. Wow. So take The long view, take the big picture into account. What's happening to you today or what's in today's newspaper is going to be used for fish and chips if you still have them in the UK. Tomorrow, take the long-term view and try and practice good preventive medicine, which may or may not for you, include hormone therapy.

I think it will include for the majority of women hormone therapy. And last but not least, whatever you decide with your health care professional doesn't mean it has to be immutable and last that whole lifetime. We go through changes. We acquire diseases. We get fatter. We get thinner. We have different changes in our sexual activities and our partners,

all of which impact who we are as individuals. And so make a good decision with your healthcare professional today, live it out till you need more intervention or you have a lifestyle change, and make a different decision if it's warranted tomorrow. Brilliant. I love those tips. I think the whole long-term view and knowing that no decision is irreversible either is really important. Thank you again so much Jim for your time today. It's just been invaluable. So thank you.

My pleasure. Thank you. For more information about the menopause, please visit our website www. www.menopausedoctor.com.