7.4 Menopausal Psychosis and Hormone Therapy: FLAWED Women's Health Initiative/WHI Study

[00:00:00] In this segment, Doctors Wood and Grider and I discuss the impact of the Women's Health Initiative and the potential covert influences pushing us towards newer medicines and away from older medicines. But first, a little more about the WHO. Somebody get this guy some help! The Women's Health Initiative, or the

[00:00:29] WHI, was a study funded by the National Institutes of Health and started in the early 1990s that

[00:00:37] was supposed to finish in 2005. It was cut short in 2002 when the authors of the study interpreted

[00:00:44] the results as stating hormone therapy, combination estrogen and progesterone, increased the risks

[00:00:50] of coronary heart disease, invasive breast cancer, stroke, and venous thromboembolism,

[00:00:57] or clotting. However, multiple re-analyses of the WHI data revealed some major problems

[00:01:04] with patients recruited for the study, with the average age of women enrolled older than

[00:01:09] 63 in most 10 years beyond starting menopause. The 2022 North American Menopause Society

[00:01:17] hormone therapy position statement reveals that experts in the OBGYN field currently

[00:01:23] believe there is reduced risk of coronary heart disease in women who initiate hormone therapy

[00:01:28] prior to the age of 60 or within 10 years of menopause. While the risks of initiating

[00:01:34] hormone therapy in women older than 60 or more than 10 years since menopause onset leads

[00:01:39] to greater risks of heart disease, stroke, blood clots, and dementia. All cause mortality,

[00:01:45] fractures, and diabetes in women less than 60 on hormone therapy are all reduced. The

[00:01:51] WHI provided some really faulty information about the risk benefit profile of hormone

[00:01:57] therapy and the major media outlets created a culture of fear surrounding the use of HRT.

[00:02:03] HRT use in the United States dropped dramatically after widespread media reports on its dangers.

[00:02:10] Almost 50% in a 6 month period from June 2002 to December 2002. Almost 15% of the qualifying

[00:02:19] population being on it to less than 8%. If the original results were accurate, you

[00:02:24] would expect a reduction in the incidence of hormone related cancers, cardiovascular

[00:02:29] disease, and bone fractures in the years following this massive societal discontinuation.

[00:02:36] But instead, we had increased incidence of endometrial cancer, cardiovascular disease,

[00:02:43] and bone fractures. There was a decrease in the incidence of breast cancer, however coincidentally

[00:02:49] the use of screening mammography increased dramatically throughout the 1990s in the US

[00:02:54] from 25% in 1987 to more than 70% by 2000. This provides a more likely and reasonable

[00:03:02] explanation for the reduction in breast cancer cases. Several other studies post-2002 have

[00:03:09] shown an increase in cardiovascular events following mass HRT discontinuation with one

[00:03:16] finished study showing an increased risk of death from heart attacks and strokes in women

[00:03:21] who were abruptly stopped on their hormone therapy, especially in those younger than

[00:03:25] 60. A USA report analyzing data about all cause mortality between 2002 and 2006 showed

[00:03:33] a decrease in male mortality, but actually an increase in female mortality. An Italian

[00:03:39] analysis estimated an additional 43,000 bone fractures per year in the United States associated

[00:03:47] with decreased HRT use. Interestingly, the updated risk benefit profiles have not been

[00:03:54] widely reported by the media. What do you make of that? It's almost as if there's a

[00:03:58] concerted effort by those in positions of power who had a lot to gain financially to

[00:04:04] promote newer treatments for menopause symptoms with less proven efficacy and safety data,

[00:04:10] and demonize cheap, natural, and widely studied hormone treatment. As with many natural and

[00:04:16] proven treatments, hormone therapy is not advertised on TV, not because it isn't effective

[00:04:21] and safe, but rather because it is not patentable or brandable by any one company or entity,

[00:04:28] and any company willing to fork over the money to study it and get FDA approval for any new

[00:04:33] indications would be splitting profits with any other company wanting to utilize their

[00:04:39] hard-earned data for FDA approval.

[00:04:42] Newer, more expensive, and branded medications that work in a more roundabout way to impact

[00:04:47] hormonal systems or their downstream effects implicated in causing hot flashes, vasomotor

[00:04:53] symptoms, depression and psychosis, and more are marketed heavily touted as state-of-the-art,

[00:05:00] most of their kind, and most importantly, deemed safe and effective, despite lacking

[00:05:05] long-term data and oftentimes independently funded research. As with lithium, the companies

[00:05:12] and businesses that profit off brandable, newer medications and treatments in the media

[00:05:18] have created a culture of fear around hormone therapy. It's the same story told over and

[00:05:24] over again. Whether it's MAOIs, lithium, hormone therapy, or touting an opiate like Oxycontin

[00:05:32] as non-addictive, when Americans' health outcomes stand in the way of financial gains,

[00:05:39] profit inevitably trumps progress. Whether it's falsifying and misrepresenting data to

[00:05:45] inflate the benefit risk ratio of a new drug, or fear-mongering and mass-media messaging

[00:05:51] to demonize an older proven drug, the system prioritizes profit over progress at the expense

[00:05:58] of our health. You were training in the 90s, right when the SSRIs came to market and the

[00:06:09] Women's Health Initiative study was going on, then in 2002, when the results came out,

[00:06:16] all of a sudden hormone therapy for nobody. The risks are way too great of breast cancer,

[00:06:23] uterine cancer. Breast cancer was the big one. Up until the Women's Health Initiative

[00:06:29] came out, we pretty much thought that all menopausal women, unless they had a major reason

[00:06:34] they couldn't take hormones, should be on hormone therapy. We didn't think that there

[00:06:38] was a protection for breast cancer, but the Women's Health Initiative took women average

[00:06:43] age in their mid-60s and they were hormone naive, which means that they had not been

[00:06:48] on hormone therapy. They started an oral estrogen and if she had a uterus, she got a

[00:06:55] progesterone. If a woman has a uterus and she takes hormone therapy, because estrogen

[00:07:00] thickens the lining of the uterus, then you have to get the progesterone for your uterine

[00:07:05] protection. Because a thicker uterine wall means more uterine cells and more cells just

[00:07:10] like a woman with more breast tissue has a higher risk.

[00:07:13] of developing breast cancer. Unopposed estrogen to the uterus is a risk factor for

[00:07:19] uterine cancer. Even for women who don't ovulate regularly and they get years of unopposed

[00:07:24] estrogen in their reproductive years or if someone takes unopposed estrogen after menopause,

[00:07:29] that increases the risk of uterine cancer. If you add the progesterone to it, then that

[00:07:34] actually lowers the uterine cancer risk compared to their baseline. So actually hormone therapy

[00:07:41] reduces a woman's uterine cancer risk. Just like birth control pills, when birth control

[00:07:46] pills had their 60th anniversary several years ago, it was estimated that there were 300,000

[00:07:52] cases of women worldwide of uterine cancer that had been prevented, which is really dramatic.

[00:07:57] And that's not the include the people like me who've took birth control pills for years

[00:08:00] and years. Birth control pills and uterine cancer protection is like unbelievable the

[00:08:05] reduction in uterine cancer, but that's a little on a side note. But getting back to

[00:08:07] hormone replacement. So hormone replacement lowers your uterine cancer risk after menopause

[00:08:12] if you take your progesterone. So you can't take unopposed estrogen. The reason that

[00:08:16] that women's health initiative study arm that was the estrogen in the progesterone was

[00:08:22] stopped early was because they said there was an increased risk of breast cancer. And

[00:08:29] really it wasn't significant. There was a comparable reduction in colon cancer. So

[00:08:34] nobody really made a big deal that the colon cancer risk was lowered. All they talked about

[00:08:39] was a breast cancer risk. So the arm of the study that had the estrogen only ended in

[00:08:44] 2006 and when that came out will lo and behold, there actually was a slight reduction wasn't

[00:08:50] statistically significant. And nobody thinks that estrogen's protective of breast cancer.

[00:08:54] But there was a slight reduction of breast cancer. And that got the bottom of the back

[00:08:59] page of the newspaper. And there's been a lot of controversy about the politics involved

[00:09:04] and everything that was involved with the blast of women's health initiative. And so

[00:09:08] the physicians even in my specialty that trained after the women's health initiative have a

[00:09:13] completely different impression of hormones than I do and those of us that are older.

[00:09:20] And not only the breast cancer, but the other was the cardiovascular risk as well. So we've

[00:09:24] always known the estrogen increases are clots. So highest lifetime risk of clot is pregnant

[00:09:28] and postpartum because of the estrogen. But we took women who had not been on estrogen

[00:09:33] with our society, women in their mid sixties are going to have some atherosclerotic disease,

[00:09:38] particularly in the first year, we increased their cardiovascular events. Then it just created

[00:09:44] this big hoop law. People didn't really pick apart. And the media doesn't want to hear

[00:09:50] that's not really quite what it's being portrayed to be physicians and even people in my specialty

[00:09:55] in their training don't get as much about hormones until you either get to that age and

[00:10:00] you really do the deep dive yourself. But most programs don't really teach people and

[00:10:05] particularly the internal medicine, the family practice residencies. They aren't really taught

[00:10:08] the same. And even the OB gen residencies now compared to before I was very blessed and

[00:10:13] I was at university of Cincinnati. We had a lot of reproductive endocrinologists that

[00:10:17] you know, wrote the books and did the research on a lot of that stuff. So like I had a different

[00:10:20] perspective, but our OB gen interpretation now of hormone replacement and women's health

[00:10:28] initiative is that hormones are still heart protective, like we thought in the nineties.

[00:10:35] But a woman needs to start hormones and be on hormones from menopause onward to get that

[00:10:42] heart disease protection. So there's a significant reduction in cardiovascular death for an 80

[00:10:47] year old who's been on hormones since menopause. But that 65 year old, I don't really need

[00:10:51] to start her on because I may thicken her blood and particularly in that first year.

[00:10:55] What the women's health initiative study didn't do a great job of was age stratification in

[00:11:02] terms of risk. Is that correct that having a lot of women who are significantly post men

[00:11:08] opausal was really damaging in terms of the results? Yes, the big time that women need

[00:11:13] their hormones to feel good is early menopause in those first few years. And all of the controversies

[00:11:19] don't really even apply to them. And it's hard to get that through somebody's head that

[00:11:23] this is a controversy discussion for us to have, you know, 10 years from now, not right

[00:11:28] now. So now you need to take this to help you feel better. Why would you not do it?

[00:11:32] But that message as they get from the medium from other people and their friends and people

[00:11:36] is so pervasive. And then for all of the women who are on hormones, a big percentage

[00:11:42] of people back in 2002, it was just sweeping that everybody just stopped and they abruptly

[00:11:47] stopped. So a lot of those women were miserable. Many of the women starting through menopause

[00:11:51] now, they weren't at the age then that they even paid the attention to it. But it's just

[00:11:54] that whole message that's just been pervasive.

[00:11:57] My experience to go to your earlier point in my training was in a nutshell, you don't

[00:12:03] do hormone replacement therapy. It's dangerous. It's very risky. And something that was trying

[00:12:10] to get to earlier was in the 90s, the SRI's came onto market. Then all of a sudden hormone

[00:12:16] therapy goes out the wayside. And so the first line for a long time was SSRI's for postpartum

[00:12:25] or postmenopausal depression.

[00:12:28] For the depression, yes. And certainly postpartum, it would be. And then it evolved a little

[00:12:32] bit where SSRI's were used to treat like the typical vasomotor symptoms of menopause.

[00:12:37] There's a big push right now. So people are seeing all the commercials. They started

[00:12:41] out a year or so ago with what's VMS. They've stopped people on the slide about the symptoms.

[00:12:46] So that really is the hot flashes and the night sweats that many, many, many, many menopausal

[00:12:51] women have. And that's probably the number one symptom that is life disrupting for most.

[00:12:59] There's many others, but that's the number one.

[00:13:02] Now, what I found was there are two first line treatments. Hormone therapy is now considered

[00:13:08] first line along with SSRI's. But to me, it's interesting because now all of the SSRI's

[00:13:14] are off patent. They're generic. There's multiple companies that are making them.

[00:13:19] So nobody's making nearly as much money off of them. And I just wonder because I'd like

[00:13:25] to think about motivations for why things happen in medicine. And obviously, there's

[00:13:30] a lot of financial incentives to having your branded drug marketed for certain conditions,

[00:13:38] which is why we see the ads about certain diagnoses, the company who puts the ad out.

[00:13:44] They just so happen to make a drug that treats that condition.

[00:13:46] Well, then what came out so last year or so, it was what's the MS? What's the MS? And

[00:13:51] then they were preparing people for VOs as the new medicine. For me and our practice

[00:13:57] in my office, hormone therapy is number one for everybody, unless they have a reason they

[00:14:02] can't take it. And sometimes it's very difficult to fight that impression that's out in society

[00:14:08] and what their friends are saying and what their other doctors are saying. So it's hard

[00:14:11] to fight that misconception.

[00:14:14] What you talk about with hormone therapy and how the media, I would say kind of sensationalize

[00:14:20] that women's health initiative or didn't provide nearly enough nuance, it reminds me a lot of

[00:14:26] the fear that surrounds

[00:14:27] lithium, which is probably, I mean, I'll say it is the best drug in all of psychiatry. It has

[00:14:34] so many benefits. It's natural, can't be patented. It's used in 10% of bipolar patients in the United

[00:14:41] States versus almost 50% of bipolar patients in other first world countries, which tells me there's

[00:14:49] a push to get people in my profession to use depacode or lemictol or tagretol that is going

[00:14:57] away because those are also going off patent. But it's interesting the parallels between those.

[00:15:02] You probably get the same reaction with some of your patients discussing starting hormone therapy.

[00:15:08] They may look at like, are you crazy? Don't you know what the news says about this? That I get

[00:15:13] when I recommend starting a low dose, even a lithium supplement. More of it is there. Like,

[00:15:18] I'm going to do it without. And you know, it's like a badge of honor that they've made it without

[00:15:22] hormones. Like, just want to make sure you know what you might be giving up and missing. And then

[00:15:26] I have something to come back and okay, I think I'll give this a try. As far as menopausal symptoms,

[00:15:31] big ones, they use a motor symptoms, hot flashes and night sweats. And that lasts on average

[00:15:36] five, six, seven years. And for African American women, it lasts longer. But there's about 20% of

[00:15:43] women that forever feel better on estrogen. You know, 20% of my little 85 year old ladies are

[00:15:48] going to feel better on their estrogen. She might suffer through and say, well, I can do without

[00:15:52] or whatever, but she's going to feel better on her estrogen. But now there's this like a badge of

[00:15:58] honor feeling of trying to do without, which is sad because women are passing up. And I fight the

[00:16:03] battle day in and day out with what the media is saying and trying to educate women that, you know,

[00:16:09] hormones are a good thing. Have you seen women who have such a difficult time with it that their

[00:16:14] depression leads to the worst outcome that we have in psychiatry, which is dying by suicide?

[00:16:21] I've seen many people say, I don't care what the risk are for hormones. Life would not be worth

[00:16:27] living without my hormones. So it's a quality of life issue. So even if it doesn't increase my

[00:16:33] risk of this or my increase of that, like I have to have my hormones. I think many of the people who

[00:16:38] might be to the point of being suicidal that hormones may help, they're probably not in front of me

[00:16:44] getting their hormones. They're seeing you. The people in front of me are the ones that say,

[00:16:49] please keep giving me this because I feel so much better that life would not be worth living without.

[00:16:54] And that's a small percentage of you people. Did hormone therapy help your patients?

[00:16:58] No. I mean, you're talking about a second, third year resident, bringing it up to my attendings and

[00:17:03] trying to get OB involved. Nobody's willing to go there. And I think a lot of it comes from that

[00:17:10] women's health initiative study and fear of litigation, really. I mean, I'm not going to prescribe

[00:17:17] hormone therapy because I don't know how to dose it or any of that. What kind of advice would you

[00:17:22] give to either psychiatrists or OBGYNs who do have fear of litigation? So nobody's looked at

[00:17:31] estrogen, hormone replacement? People are looking at it. It's just not widespread and certainly not

[00:17:36] something locally that I've found anybody who's really willing to go out on a limb. And really,

[00:17:43] you're not going out on a limb. You're giving somebody what they're lacking. And that's what

[00:17:48] blows me away or that's what I don't understand is there's a lot of information

[00:17:52] about this in psychiatry. And it's pretty clear that in women with those illnesses,

[00:18:00] those major changes in hormone status cause severe disturbances in their psychiatric condition.

[00:18:08] It should be. Have them see their gynecologist. But I know there are many women who seek out help

[00:18:15] and they are not given that help that is there and available and safe for them. There was a big

[00:18:20] article in the New York Times just earlier this year. And she was one of the keynote speakers at

[00:18:24] the menopause society meeting a few weeks ago. And she was told by all these editors, don't

[00:18:29] write on this. And then she says, now it's been one of the biggest articles of her career. And

[00:18:33] they were like, you know, you don't want to address that because nobody wants to talk about it.

[00:18:36] I don't think there's the fear. So it might be from other specialty. So I don't have any fear

[00:18:41] of litigation with a patient with hormones. So I give them the pros, the cons, tell them what we

[00:18:46] think. And many times it's, let's try it and see if it doesn't help and you don't want to do it,

[00:18:50] we don't have to do it. And it's not a forever decision. It's a visit to visit decision. And

[00:18:54] it's a personal individual decision with that individual patient. So I try to put together

[00:18:59] what is the latest evidence based medicine? And what is specifically going on with that patient?

[00:19:04] And what do we think that she really needs and then give it a try? I can't imagine anybody having

[00:19:11] something that they come to their doctor with that their doctor won't at least give them a trial

[00:19:16] unless they have some major contraindication. Unfortunately, I don't think a lot of people

[00:19:21] in my profession realize or make a major note of the fact that this person hasn't had any illness.

[00:19:28] And actually what we're taught in medical school and residency and on the test is that there is a

[00:19:34] second peak of severe mental illness in females. Oh, and it just so happens to be right around the

[00:19:41] age of Perry menopause. I don't think that there is some magical peak of what really are like,

[00:19:47] for example, schizophrenia and bipolar disorder, what really are neurodevelopmental conditions

[00:19:54] that very consistently come on in the late teens early mid 20s. When I see somebody who's 45 and

[00:20:02] having the onset of that, I don't think the right treatment is a mood stabilizer or an antidepressant.

[00:20:10] For me, it's always been give them what they're lacking. Yeah, I think most of us in the GYN world

[00:20:18] would not really think that the underlying cause would be menopause that maybe when it's manifest.

[00:20:24] So I tell women all the time, you know, for whatever component menopause is playing in what's

[00:20:32] going on for you, I can give you hormones and I can fix that. If there's other things with your

[00:20:37] insomnia, I'm not treating the psychosis, but your insomnia, your mood, whatever other components

[00:20:44] are involved that's related to hormones, I can fix that. What I'm saying is that I think their

[00:20:51] psychosis is related to hormones. But let me ask you this first, with your patients who have

[00:20:57] perimenopausal mood symptoms, do you see the same females struggle with postpartum depression?

[00:21:04] Yes, we do. I think we probably still feel like there is some underlying predisposition

[00:21:10] and hormone changes, exacerbate that. Yeah, I think I agree with you because there's almost a type of

[00:21:17] mania to it. Mania to me doesn't just mean external hyperactive, talkative, really, mania is inside.

[00:21:24] And for people who are severely depressed, what we used to call biologic or melancholic depression,

[00:21:31] there is a very hyperactive internal milieu. It usually looks like an undiagnosed bipolar

[00:21:38] disorder. Somebody tracked women who had post-part

[00:22:08] Trudum/psychosis. 95% of the women, by the time they were menopausal age, had gotten a diagnosis of bipolar disorder. So it's like there's a predisposition to something that can cause psychosis, but that change in hormones. This is a trigger. And this is what you'll find interesting in patients who have schizophrenia and bipolar disorder. The earlier onset of menarck or a woman's first period of birth,

[00:22:11] related to the age of menopause, aka the longer the number of years of childbearing age, the less severe their psychotic symptoms of their underlying psychiatric illness are.

[00:22:27] And actually, most medications, you need less of them to control your symptoms as you get older. Schizophrenic women actually need higher doses of antipsychotics to control their positive symptoms, like hallucinations.

[00:22:41] So there's something protective, I assume estrogen, in established psychotic conditions, it's the opposite going the other direction. If they have a really short duration of childbearing age, they have more severe psychotic symptoms.

[00:22:57] I think what I see is the most severe end of the spectrum, where probably women who already have a predisposition to some psychotic condition, with that change in hormones that comes with perimenopause, it tips them over the edge, and probably most of the time it's not recognized that there's a relationship to hormones.

[00:23:22] Don't call me a conspiracy theorist, but I don't know if you looked into Katarina Dalton's work at all with progesterone. There are people who believe that based on when her results were coming out in the 90s, early 90s, and she was really pushing to use more progesterone in these transitional periods.

[00:23:48] And that just so happens to coincide with when all of the SSRIs started to come to market and be prescribed a lot more. And to go back to something that has come up over and over again in the podcast, medicines have a patent for 20 years for a specific indication, and they can stretch it out for another five years here or there if they get additional indications for that medication.

[00:24:13] They have exclusivity for that brand name medicine, and then it goes generic, and any other drug maker can enter the market and start to produce that medicine.

[00:24:25] So it just so happens that now they're both considered first line, but the timing of that is very odd, and the fact that for a while there it was no HRT.

[00:24:39] You do not prescribe hormones. I learned, well, it's going to increase the risk of breast cancer. It's going to increase the risk of uterine cancer.

[00:24:47] But if you look at that study, it threw all postmenopausal women into the same group. And what we know now is if you are going to use hormone replacement treatment or hormone therapy, you have to catch it in the right window.

[00:25:02] Before they've gone through the entire transition so that you can make that process a lot more gradual.

[00:25:08] Interesting points. I do think about that a lot because you're right. I got taught the same way, like hormone replacement therapy as it was called then.

[00:25:15] It was pretty much a no-go for like the vast majority of women for all those risks. But yeah, it's more subtle than that. It's not as black and white.

[00:25:24] And if someone is really, truly suffering from perimenopausal depression or psychosis, those have real world consequences.

[00:25:34] And if you have a treatment that you know is going to work, yeah, maybe I'm being cavalier here because I'm also not an OB joy yet and I'm not prescribing hormone therapy.

[00:25:43] But it seems like, well, I think in many women, the benefits can outweigh the risks.

[00:25:47] Yeah, definitely. I mean, there's very overt examples of the industry's influence and we can point it out and we can say, look at this congressional hearing on Vioxx or let's look at Oxycodone and what we allowed these companies to do with opiates.

[00:26:04] But this one is definitely a lot more subtle, but follow the money, right? And there's a lot of money in the antidepressant market, especially at that time.

[00:26:16] So I'm not going to come out and outright say it, but if you made me bet on it and with knowing the outcome after the fact, I would probably bet that there was at least some influence.

[00:26:28] And especially now reviewing this stuff and seeing that now it's all of a sudden it's okay.

[00:26:35] Now that all of those antidepressants are no longer on patent. They're all generic. So treat what you're missing.

[00:26:44] Yeah, I don't want to discount the severity sometimes of the vasomotor symptoms that come along with menopause and perimenopause because those can be quite significant.

[00:26:54] If you're having night sweats that are severe, not able to sleep, it's just feeling jittery all the time.

[00:27:00] Those are symptoms that can in turn worsen depression and probably worsen psychosis too.

[00:27:06] So, you know, if you have a treatment that can address all of those things, you know, why not streamline it? Why do I go for that?

[00:27:13] Well, and hormones are super cheap. They are very easy to derive and that's another loss of profit by providing something that is very easy to get and very cheap to the patient.

[00:27:28] In AKA, good patient care, replacing what they need replaced or what they're lacking, what they're deficient in, it just pisses me off.

[00:27:36] The more that I do this, the more that I see that influence and it drives me crazy sometimes. And this is all I can do about it.

[00:27:47] But it's a good step.

[00:27:51] I get this guy some help.

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