Thinking About Ob/Gyn
A fresh and evidence-based perspective of all things related to obstetrics and gynecology. Follow us on Instagram @thinkingaboutobgyn or visit thinkingaboutobgyn.com for show notes and more.
Thinking About Ob/Gyn
Episode 9.6 New Birth Control Products and Other Updates
Antonia Roberts and Howard Herrell review several new articles:
• Epifoam for postpartum pain lacks evidence of effectiveness compared to simple ice packs while costing nearly $100 per unit
• AMH levels above 5.39 are associated with PCOS diagnosis, providing a specific threshold for clinical use
• External aortic compression demonstrated as a life-saving technique during severe obstetric hemorrhage
• Vaginal estrogen in breast cancer survivors shows no increased risk of cancer recurrence or mortality
• Delayed cord clamping in preterm twins reduces mortality by 30% and significantly decreases transfusion needs
Then they discuss new birth control options while questioning the value of expensive pharmaceutical products compared to established, less costly alternatives.
• New birth control options like Balcoltra ($280/month), FemLyv ($215/month), and Nextstellis ($250/month) offer minimal innovation over generic alternatives costing $10-15/month
• Marketing terms like "bioidentical" and "plant-based" are often misleading as all hormonal contraceptives are synthesized from plant precursors
• Progestin-only pills like Slynd provide only marginal DVT risk reduction (5 vs 4 per 100,000 person-years) compared to low-dose combined pills
Check our Instagram for more information and join us again in two weeks for our next episode.
00:00:00 Introduction and Epifoam Discussion
00:06:27 Financial Impact of Unnecessary Treatments
00:11:09 AMH Levels for PCOS Diagnosis
00:15:11 External Aortic Compression for Hemorrhage
00:20:22 Vaginal Estrogen and Delayed Cord Clamping
00:21:51 New Birth Control Products Overview
00:31:05 Analyzing Dissolvable Birth Control Pills
00:34:22 Slynd: Drosperinone-Only Pill Evaluation
00:42:09 Nextstellis and "Bioidentical" Estrogen Claims
00:56:37 History of Birth Control Development
Follow us on Instagram @thinkingaboutobgyn.
Welcome to Thinking About OBGYN. Today's episode features Antonia Roberts and Howard Harrell discussing new birth control options.
Speaker 2:Howard.
Speaker 3:Antonia.
Speaker 2:What are we thinking about on today's episode?
Speaker 3:Well, we're going to talk about a few quick new points from some recent articles, and then we're going to spend some time talking about some new birth control products that have come onto the market recently, or at least are on their way onto the market. But first, what's a thing we do for no reason?
Speaker 2:How about universally prescribing epifoam on the postpartum ward?
Speaker 3:Okay, all right. So it's common that many of our standing order sets for postpartum patients will include epifoam and or dermoplast, and a dermoplast is a benzocaine, menthol, lanolin, aloe vera combo spray, and the epifoam is a hydrocortisone acetate 1% and promoxine hydrochloride 1% product. So these analgesic products are meant to be for the pain related to lacerations or tears and I suppose also hemorrhoidal pain that somebody might have after pushing a baby out.
Speaker 2:Yeah, so both of these would be just either directly topically applied to the perineal laceration or maybe put on the little pads that someone is going to put on when they're wearing their huge diapers adult diapers after delivery. So I'm all about using the sting and definitely using ice packs too. So the question is how well do these meds work? There was a Cochrane review that found that there's no compelling evidence of these medications on the effect on perineal pain after delivery, and they might actually be inferior to cool gel packs, which can be very inexpensive. I have been seeing like in Target or online. You can pay more to get some fancy version of a nice gel pack and a little mom gift pack, but really you can also make these very cheaply and there's no data that suggests that these meds are going to decrease the need for using systemic pain medications.
Speaker 3:But ice packs in general cost a little bit over a dollar a piece. Dermoplast costs about $12.50 per unit and Epifoam almost $100 per unit. So the Epifoam in particular. For that one there is a substantial expense for a busy labor and delivery unit. If you think about that over the number of patients you might automatically be giving it to.
Speaker 2:Yeah, I think that price might surprise a lot of people who would go over counter. You can get an over the counter cream equivalent of that for five bucks.
Speaker 3:Yeah, a few dollars.
Speaker 2:Yeah, who would pay $100 for that? So it's surprising. It was surprising to me, but I know, at least early in my training for sure, epiphone was just ubiquitous. It was handed down to us as this is your order, set, order it. You better order it, or else we're gonna yell at you, but I don't think we use it too much at my current practice. I assume now it's because of the cost.
Speaker 2:We had talked earlier on a different episode, about simple cost saving issues. I don't think we talked about Epifoam in particular yet, though, so let's for easy numbers. Let's just say you have a unit that does a thousand deliveries a year Well, a thousand vaginal deliveries a year, maybe not counting C-sections Then routinely using Epifoam is going to cost $100,000 a year, and that's money that is not going to be reimbursed by insurance. The insurance is paying the same amount whether you use the epifoam or not, so you're just losing that $100,000 on epifoam. That's $100,000 that could have been spent on maybe a new ultrasound machine if you've got an old one that's about to die, maybe a new baby warmer, or maybe hiring some new nurses, for example, and really there's just an infinite number of other ways that $100,000 could benefit your labor and delivery ward and make it safer and provide a better patient experience than spending it on epifoam.
Speaker 3:Yeah, we should really make a list, maybe, of things like this and things from that prior episode and make a meme for the Instagram about how all these little small decisions can add up. Think about universal post-delivery, cbcs or some of the things we talked about before. Each one by themselves aren't that expensive, but they add up and, as we see an acceleration of labor and delivery closures across the country, mostly due to financial and funding issues, it's more important than ever to be conscious of how much we're spending on all these little things and how they add up. Little things like this may be the difference about whether your unit survives the financial situation we're in or doesn't.
Speaker 2:Yeah, survives the financial situation we're in or doesn't. Yeah, yeah, I remember how we've kept repeating on multiple episodes that, like Medicaid and the state insurance, reimbursements in the United States are really just a tiny fraction of the actual cost of obstetric care, so they're really truly a net negative in a financial drain on hospitals. So it's essentially like providing charity care, and that's only purely because the government, and specifically the RVU committees, have decided this is the reimbursement rate. So that means there's always the question of like, how do we keep the lights on, like, how do we remain financially solvent when we're just basically giving almost giving away free obstetric care to people with that insurance? And that means when you find, when you have something that costs money and it doesn't work, then the only wise thing to do is just cut it out.
Speaker 3:Yeah, for me, the classic example right now in this conversation is the fetal pillow. It's very expensive. It doesn't have credible scientific evidence that it improves maternal or neonatal outcomes. If it improved patient outcomes then it might perhaps be worth the price, whatever that price is. But it doesn't, and so that's the bottom line. We have to be mindful now more than ever about waste line. We have to be mindful now more than ever about waste. So we'll put a link to a discussion of Epifome from the ACOG website that provides literature review and an analysis of this If anybody's interested in doing a quality improvement project at their institution and maybe getting Epifome off their standing order sets.
Speaker 2:Yeah, this isn't us just like picking something to criticize, like this is actually coming from ACOG, like discussing value-based care, specifically. Okay, so let's get on to some of the newer studies. In February 2025 in the gray journal, there's an article about anti-malarian hormone and its use for helping diagnose polycystic ovarian syndrome. We did talk briefly about this before because there was a continuing medical education article about PCOS that mentioned high AMH could be useful, but it didn't say a number. So this adds to our knowledge by pinning down a number for what would be consistent with PCOS.
Speaker 3:Yeah, and I've actually found an opportunity to order an AMH for this purpose since that article came out. But this paper it doesn't intend to act as a definitive source for some diagnostic threshold number either. But previously, as you said, we were just told that a high number whatever that is is associated with PCOS and that might substitute for one of the other diagnostic criteria. But in this study they found that a level greater than 5.39 was associated with PCOS. That's a fairly high level and I think we at least have something to begin the discussion with here.
Speaker 2:Yeah, yeah, it's helpful to get some specifics. Their confidence interval was 4.57 to 5.27. Confidence interval was 4.57 to 5.27. And just for reference, the typical normal reference ranges listed are a level slightly over 1 in a normal reproductive age female. And that value you would expect that to predict a normal response to IVF treatments. And I've seen patients with levels, I think, as high as nine or 10. And these were patients that had PCOS. So without this guidance and this article I might have thought and maybe some other doctors too, that if I have a patient with an AMH of six or seven, yeah, that's high enough for IVF, but is that enough to confirm PCOS or does it really have to be the extremes of 9 or 10? So now we know, and as time goes on we may see more information about this and have it included in some actual established diagnostic criteria, but for now we can stick 5.4 in our heads and then on the flip side, that means if someone has an AMH of 3, that doesn't really increase your chance of having PCOS.
Speaker 3:Right, probably should stick with traditional diagnostic criteria there.
Speaker 2:Yeah, yeah. Of the Gray Journal from that same month, there was also a video of postpartum hemorrhage with external aortic compression being used as an intervention, and this was pretty neat. So, especially if you haven't seen this done before, then definitely look at that video. It was only about three minutes and we'll link to it. I know in January 2025, when you talked about cesarean hysterectomy with our Gynonc friend Stuart, you brought up the fist technique for compressing the aorta during a obstetric hemorrhage, and I think that was in the context of having an open incision on the abdomen, like when you're actually doing the cesarean or the hysterectomy. But to do this technique you definitely don't need an incision on the abdomen. You can just press on the skin of the belly, usually above the uterine fundus, and the video we'll link to shows several different instances of an assistant performing this. In one case they're riding the bed to the OR Someone might ride the bed while they're holding up the baby's head in a cord prolapse.
Speaker 2:There's someone just riding the bed, pushing straight down on the mom's aorta, and the posture they use to do this technique is exactly how someone would do chest compressions, except it's a little easier because you're not moving up and down.
Speaker 2:You're not counting how many compressions, except it's a little easier because you're not moving up and down, you're not counting how many compressions, you're just bearing your weight straight down. And I think they indicated having a hand and a fist. And then in another segment of that video there's actually a person doing chest compressions on a maternal, maternal code, while another person is down on the abdomen compressing the aorta. I'm imagining they don't give backstories but maybe an AFE where someone's hemorrhaging and their heart stops, and they show plenty of demonstrations on mannequin dolls too. In another one of the real life clips that showed a person was pushing down while there was maybe an interventional radiologist or vascular surgeon down in the femoral area getting ready to place the reboa through the femoral artery, and so the assistant was just blocking off the aorta with their hand while waiting for that to be placed.
Speaker 3:Yeah, if you have the print copy there's some schematics and drawings, but the video is pretty neat, Even just showing the degree of hemorrhage that can occur just so rapidly for patients like this. I think a lot of people have never seen hemorrhage to the degree that the first patient had it's like a waterfall.
Speaker 2:Yeah, yeah.
Speaker 3:And I remember that you're getting 20% of the cardiac output per minute right after delivery there. So it's amazing and again, some of them were simulations with mannequins, but several of these real life situations with faces blurred out were probably recorded because somebody a family member, a bystander had their phone out and started recording. And even when you're doing the fist technique as part of a cesarean, I'll say you're probably not, the incision probably doesn't matter, you're going to go unless you have a vertical incision which you might in a planned cesarean situation like we talked about, but you're probably going transabdominally above your incision anyway, so definitely worth looking at If you've never seen it done.
Speaker 2:Just very educational to see how fast someone can bleed out postpartum, honestly, and be prepared to do this very rapidly.
Speaker 2:Yeah, so if you have this technique in your mind and let's say it's kind of a surprise, maybe, whether you're in a delivery room or an operating room, let's say you don't have enough assistance in the moment, you can easily hold pressure while you ask for someone else to scrub in right now and come to the bedside.
Speaker 2:Just put your fist here and, like the video shows, they suggest switching out every couple minutes on, like you would for someone doing chest compressions, especially if they're not able to climb on top of the patient and just lean their weight down. If they're using their muscles to push down, it can get tiring. So another great option that would accomplish the same thing might be, if you're in the operating room, you could call in whoever is on call for surgery, like the general surgeon, or maybe trauma or vascular surgeon even, and ask if they could come in and help cross clamp the aorta, because they have special tools for that when for trauma surgery scenarios and these are tools that, like you, wouldn't want to take one of your c-section clamps necessarily and clamp the aorta. You could tear it and damage it. But if you have someone that can cross clamp the aorta, that can free up more hands and be less tiring for your assistance. So anyway, I have not had to use this, but it's.
Speaker 3:No, but the day you do, you'll be glad.
Speaker 2:Yeah, exactly. Well, let's move along. In the March 2025 Gray Journal, there's a nice systematic review about using vaginal estrogen in breast cancer survivors.
Speaker 3:Yeah, and I was glad to see that. We've discussed this several times before, I think and we still have undoubtedly a problem with vaginal estrogen cream being underutilized in women who've had breast cancer, of course, especially those who are estrogen receptor positive. So these authors did a meta-analysis of eight observational studies and found no increased risk of breast cancer recurrence, no increased risk of breast cancer mortality, and found no increased risk of breast cancer recurrence, no increased risk of breast cancer mortality and no increased risk of overall mortality in patients who used vaginal estrogen cream.
Speaker 2:All right. Well, that's straightforward. If a patient needs vaginal estrogen cream, we should be using it, and I've personally been very happy to see some patients who are breast cancer survivors that are already being prescribed this by their oncology clinics.
Speaker 3:Yeah, hopefully the tide is turning.
Speaker 2:Yeah, another thing we've discussed in detail on this podcast is optimal cord clamping, or some people call it delayed cord clamping. So there's also a systematic review in that same edition of the Gray Journal of delayed cord clamping in preterm twins.
Speaker 3:Same edition of the Gray Journal of delayed cord clamping in preterm twins. Yeah, and they looked at five studies and they showed that delayed cord clamping in preterm twins led to a 30% reduction in mortality, a 58% reduction in red blood cell transfusion need and a 50% reduction in retinopathy prematurity and there was no difference in the rate of interventricular hemorrhage or bronchopulmonary dysplasia or necrotizing enterocolitis.
Speaker 2:Yeah, so those are some pretty significant benefits, even just the mortality alone, but then all those other morbidities improved. So that's just even more evidence that this should be routine by now. I think it still comes up because in a lot of cases there's difficulty adopting this and sometimes it's from a conscious rejection from people that have been doing it a different way for many years. But I think in other cases it's more about just like an autopilot knee-jerk reaction to clamp the cord and forgetting. And I've definitely been in some deliveries where, even though the entire room of people was shouting wait one minute or wait 30 seconds, somebody still manages to swoop in and clamp the cord immediately, maybe just trying to be helpful, but by that time they clamp the cord down it's too late.
Speaker 3:Yeah, and we've talked about some of the reasons or let's call them excuses why delayed cord clamping doesn't happen in the last few seasons. It really needs to be a conscious team effort when we're talking about changing lifelong practice patterns, things that people are used to.
Speaker 3:You're describing instinct, but with the benefits being so clear, this really needs to be emphasized and reemphasized until it becomes the default. It needs to be the new instinct. But it should suffice to say now that a cesarean delivery or a cesarean delivery under general or any of those things that have traditionally been excuses are not reasons to avoid delayed cord clamping.
Speaker 2:Yeah, essentially, the only reason not to do this should be if the placenta has completely abrupted and we think maybe the baby has hemorrhaged and so they're not going to get any blood from delayed cord clamping, like a baby typically would. Or if you delay for 30 seconds, you're stimulating and by 30 seconds the baby is still limp and unresponsive and clearly they probably need chest compressions and oxygen. But even then they would still get 30 seconds of extra blood flow from the placenta, outside of the scenario of an abruption. But in most cases a minute is optimal, especially if they've got some tone and they're making some respiratory effort.
Speaker 3:Well, let's talk for a few minutes about some new birth control products that have come onto the market in the last few years. We talk all the time about different drugs and how they're marketed by companies and sold to OBGYNs, or new tests or new products, and there's really nothing historically more heavily marketed and influenced by salespeople than hormonal products, to our specialty at least, the majority of which are birth control products. There's tons of samples in the closet if you allow drug reps into your office, and obviously a significant number of OGOANs follow the marketing hype and switch patients or start patients on the latest, greatest, newest form of birth control, whatever that might be. But on average, these newer products end up being 10 to 20 times more expensive than many of the choices that we already have on the market.
Speaker 2:Yeah, there's something about the drug sales process that can have a great influence on prescribers, even if they don't think it does, and because it can be subtle and insidious.
Speaker 2:If it's a funny, charming, personable rep, like they really play that kind of thing up and they visit repeatedly and then they start asking like how are you doing, how are the kids, whatever, and they bring your favorite Olive Garden for me or something which is easy, and then they have really beautiful brochures that are glossy and colorful and my office doesn't even have a color printer. So I'm like this is great. I can give patients something that just they'll actually look at, because this is so, so pretty and I've got some convenient samples they can just try it, see if they like it. That's a subtle way that they can get their foot in the door and then actually get people or their insurances to pay these outrageous amounts of money for this medicine. And some of it probably is like this is a new drug. So the providers might think that they're really on the cutting edge with their prescribing patterns and they don't necessarily think about the cost effectiveness of the new products or whether the claims made by the drug reps have been scientifically rigorously validated.
Speaker 3:Well, I think we've talked before about Balcultra, which has been around for a few years now, but it's $280 a month. It's a birth control pill and it's a classic example that I talk about a lot, because it has the exact same hormones and same dosages of hormones as all of the generics for Aless, which was a pill that came out in 1978. And those generics Lutera, lasina, for example are typically around $10 or less per month if you buy three months at a time cash and they're identical to Bacoltra at $2.80 a month, except that with Bacoltra they added a small dose of iron to each pill.
Speaker 2:Yeah, I could tell you that would be a non-starter. I can't think of any of my patients that would go for that, and especially since iron, we know that's not worth 270, 280 per month if they just took the birth control and a separate iron pill. And this isn't even the first birth control pill with iron mixed in, is it? Yeah, that's not even a novel idea.
Speaker 3:Yeah, well, exactly. But they give plenty of samples and they make claims about their pill that are maybe true, but which are also true of the same pill that's been on the market for 47 years and is cheap. So the claims aren't necessarily not true, it's just. It's also true of the generics of lacina, and somehow prescribers fall for this. This is a very good selling drug.
Speaker 2:Okay, well, I haven't prescribed it at least, and I haven't seen any reps for Balcultra come around, but I have seen reps leave some brochures and things for some other pills I'm sure we'll talk about. One is Slend, and I think I've seen the low, low estrogen people come by. And then there was another one that has estetrol, a new type of estrogen that apparently makes it better than pills that have estradiol, and apparently I just saw on online I haven't seen a rep, but there's a new IUD option as well.
Speaker 3:Yeah, we can talk about the IUD first. So the FDA actually just approved, I think in February of this year, a new copper IUD that's good for three years, and I'm not sure how they pronounce it, but it's called Medela, medela.
Speaker 2:Yeah, so they put the letters IUD in the middle, like myudella or miudella.
Speaker 3:I read it as miudella, but the word IUD is in there shows the problems just conceptually with a lot of new birth control products. The birth control field, especially for pills, is at this point very mature and there are already for pills dozens of options that cover almost all aspects that we can imagine. And there's very little distinction or difference in these various pills on the market. But pharmaceutical companies need a new patent, they need a new wrinkle, to have some new branded thing that they can raise a price of and market to us.
Speaker 2:Yeah like adding $270 worth of a little touch of iron every month.
Speaker 3:Yeah, exactly so. We discussed last month about the thromboembolic side effects of different birth control products and the pill that, if you remember that we discussed, with the lowest rate of for pills at least of thromboembolism, was this generic of a less, which is a 21-7, 20-microgram methanol estradiol pill that's been around since the year I was born.
Speaker 2:Yeah, because they didn't analyze the 10-microgram low low estrin, but they went down to 20. Didn't analyze the 10-microgram low low estrin, but they went down to 20. And the 21-7, you mean it has 21 days or three one-week long rows of active hormone pills and then one row of placebo, or sometimes they'll have a vitamin.
Speaker 3:Yeah, and we have plenty of generics that are very inexpensive, for example of low estrin 24, 24fe, which is one that has iron, at least in the off days. There's one called Haley. These are about $12 a month. So if you want a 20 microgram pill that has an extended cycle, then we have that in a generic. So that would be a 24-4 pill. So between 24-4 20 mic pill and a 21, 21, 7, 20 mic pill, it's really hard to start arguing for other things beyond that.
Speaker 2:Yeah. So if you want people to just take the pills as is the 24, 4 would give slightly shorter periods with only four placebo days, like four hormone-free days. But you can also tell them to take any kind of pill pack and just turn it into extended cycle by just throw out the inactive pills and write for earlier B-fills.
Speaker 3:Sure, so a person could have four periods a year or two periods a year or whatever you wanted to by skipping placebos.
Speaker 3:And then ultimately we have intrauterine devices. So if a patient has side effects with birth control pills, we have several good options of hormonal IEDs which are, as a rule, far superior to the copper IED. We've talked about that before. They lower the risk of endometrial cancer, ovarian cancer and cervical cancer. They're highly effective. They don't increase the risk of thromboembolism, as we discussed last month. They give the most favorable bleeding patterns the hormonal IUDs do, and they have no noticeable systemic effects. And we have a very small device to minimize pain for patients who've never been pregnant. And it's also a nice option if they only want a few years instead of eight years of contraception, because they cost a little less and these hormonal IUDs even decrease the risk of pelvic inflammatory disease after they're inserted.
Speaker 2:Yeah, but social media still says hormones are bad, right, so the copper IUD ends up getting attention for that reason, and patients are increasingly wanting a non-hormonal option, without necessarily understanding why. They just think the hormone is like a toxin to their system. And we've talked a little bit about misinformation and disinformation about birth control. It's on TikTok and other platforms.
Speaker 3:Yeah, and a lot of that stuff is spread by companies who make non-hormonal products like Paragard and Phexxi, because the products themselves, well, they're not that good and the main selling point that they can make in marketing is that they're non-hormonal. So that's all they talk about, with the implication, of course, that hormones must be bad. They don't say that, but that's the implication.
Speaker 2:Yeah, but being non-hormonal is what actually makes them worse. The hormone is what prevents endometrial cancer and it gives a better bleeding pattern, among other benefits. Really, the only reason someone should medically avoid progesterone hormone is if they have, like active hormone, sensitive breast cancer or if they have the really case report level rare progesterone allergy that I've heard about maybe twice ever. But outside of those really rare issues, the hormone really is of benefit. So what do you know about this new IUD, the Myudella?
Speaker 3:Yeah Well, it does fix most of the problems, or some of the really negatives, of the Paragard IUD. It doesn't have to be manually loaded into an inserter, so that's a good thing. Compared to Paragards, it is much, much smaller and it has a more flexible framework. It's almost like a metal skeleton, so it should be tremendously easier to insert than the Paragards. But it only lasts three years, whereas Paragards last for 10 and probably 12 years. So it seems like the market for this is going to be younger patients. I assume there will be a market because many younger patients again due to TikTok and other platforms, are afraid of hormones and so this might fill an artificially created void for them and, unfortunately, their marketing, when it does come out, will probably create a lot more fear mongering around hormones because, again, that's going to be their selling point.
Speaker 2:Yeah, just because there will be a market doesn't mean that there should be a market Again. The market should be those rare, pr positive active breast cancer patients that still need birth control, which is very rare. The Kyleena and Skyla IUDs are also very small, like this new one is, and also relatively easy to insert in younger nulliparous patients. And the Kyleena, which has slightly more hormone than the Skyla, lasts for five years, and so it has all these positive benefits due to the hormone that lasts for five years, and so it has all these positive benefits due to the hormone that we've already discussed. So if a patient gets this new copper IUD instead of the Kylena or Skyla only because they've been scared out of the IUD hormones, then they're really getting an inferior product.
Speaker 3:Well, in just the Paragard the most common side effects in their clinical study are heavy uterine bleeding and dysmenorrhea, so I don't expect it to be much different than Paragard in terms of the bleeding issues that are often a source of dissatisfaction. I do think that they've had some innovation with the insertion system and we'll see that. And this might turn out to be the easiest IED to insert, so they might have some innovation there. That makes sense. And so the same company is working on FDA approval for a 52 milligram levonorgestrel IED, so the same hormone and dose as the Mirena or Lyleta, but it uses this insertion system of theirs, so maybe that'll be an advantage. We'll see what the pricing looks like. If it's the same price or cheaper than Lyletta and it's easier to insert or has a better inserter, then maybe they'll find a market there. But my guess is that it'll be more expensive than the Lyletta, particularly since the Lyletta is funded by a nonprofit who tries to keep the price down.
Speaker 2:So it's really just going to depend on insurance coverage of who can get what IUD. So let's talk about some of those birth control pills we were listing. So there's one called FemLiv that came out in 2024 and is touted as the first pill that is dissolvable in the mouth. So the idea here is patients with swallowing difficulties would benefit from this pill. This is a classic 21-day-of-hormone, seven days of placebo type of pill, and the hormones are 1mg norethindrone and 20mcg ethanol estradiol.
Speaker 3:Yeah, so for comparison, that's the same combination of hormones and doses as microgestin 120, which has been around for a long time, and microgestin costs about $12 to $15 a month cash.
Speaker 2:And there's no birth control pill. That's like a horse pill, as they say. They're all quite tiny, but for the microgestin you still have to swallow it. So if you'd like the same hormones to dissolve in your mouth without swallowing a pill, then of course you can get this dissolvable FemLiv.
Speaker 3:For how much?
Speaker 2:$215 a month.
Speaker 3:Yeah, Sometimes it's better to talk about this on the course of a year. We're talking about $150 a year for microgestin and all of a sudden you're talking about since there's 13 cycles birth control pill cycles in a year. You're talking about what? 20, almost $2,800 for the ODT version of microgestin. So this is how the industry works and this company isn't marketing this. They're not marketing it just for that tiny fraction of patients out there who have profound swallowing difficulties. They'll fill the sample closets with product and folks will use it indiscriminately as the nice new, modern birth control with the nice packaging and colorful brochures that you mentioned. Yet it has the same hormonal composition as a pill that's been around for decades. By the way, there are plenty of chewable birth control pills already on the market. That's been around for a long time. They're not dissolvable, but they're chewable for your patients who can't swallow a pill, and so, for example, there are generics of Generous FE, which has been around for a long time now, and a three-month supply is about $75,.
Speaker 2:So about $25 a month for a chewable birth control pill is about $75, so about $25 a month for a chewable birth control pill. Yeah, so again the question is did we really need this new dissolvable product? And even if we did, is it worth the extra $200 a month for the pill to dissolve, knowing that you could have one that's chewable? So the only demographic I can think of is people that cannot chew or swallow, which that exists, I know it exists, but hopefully is a very small minority and hopefully in that case I could make a case to their insurer that this is indicated because of the inability to chew or swallow. But for a patient like that I would just as soon suggest something else entirely, like a weekly patch instead.
Speaker 3:Or the ring or depo, or just a long active, reversible contraceptive, the Nexplanon. You could get a Nexplanon for four months of the cost of this pill, yeah, and you have to wonder what percentage of patients out there truly can't chew or swallow a pill and what the market size is for this. But again, they're not going to stop just with the patients who can't swallow or chew.
Speaker 2:Yeah, yeah, I don't know that personally I've seen a patient like this yet, so I think it's fairly rare. I'll definitely keep this in mind for a patient like that, but I would still say any one of these other options is going to be more convenient and give you less DVT risk and be less costly. So the next pill that we've been seeing more of in the little break rooms with reps and their brochures is SLIND, which is a drosperinone-only pill. It's, I believe, four milligrams per dose and I've already seen this quite a lot in use, and I've actually had some patients specifically request this, and we already had a number of progestin-only pills available that had been marketed towards people who were worried about estrogen-related side effects.
Speaker 2:So one classic concern with estrogen in birth control is breastfeeding. But, as we've discussed here before, the combined hormonal contraception does not stop lactation, nor does it negatively affect baby's weight gain or growth. The only possible effect that has shown up in some studies is some patients say they have to breastfeed a little bit more often. Initially. Their baby demands it more, so presumably in some cases the milk supply per feeding or per pump might decrease slightly. But then you, so you have to express a little more often to get to that same total daily milk production. So the babies are still fine. But if someone's really struggling to barely make enough milk I can see how that might dissuade them from starting the pill yet. But certainly it would never be an issue for those oversuppliers who are just constantly bursting and making 40 ounces a day.
Speaker 3:And the problem is that, even if there's not great science about it, the lactation consultants are anecdotally telling patients about this, so we're constantly fighting that and this creates the market for progestin only pills. But again, great selling points for IEDs and the Nexplanon. Too late for this episode, but a new study just came out that showed that Nexplanon a really good study even placed immediately postpartum in the hospital, didn't have any impact on breastfeeding. So we have other options if patients, if this was really a concern for them.
Speaker 2:Yeah, and the other thing with estrogen we talked about very recently extensively is DVT risk and that would include if someone has a history of migraines or smoking or just thrombophilias. These are all concerns with estrogen. But again, just as a reminder that the most updated numbers on this were probably a little bit surprising, where the progestin-only pills, like the low-dose progestin, had a rate of 4 DVTs per 100,000 person-years-of-use, compared to 5 DVTs per 100,000 person-years-of-use with that 20-microgram estrogen pill. So the mini pills are giving you a relative risk reduction of 20% or an absolute risk reduction of 1 in 10,000. So neither of those numbers are really particularly impressive if you're thinking about how much more efficacious the combined pills are and if you really are worried about DVT and you really wouldn't even do the mini pill honestly. And those are 0.35 milligram north endrone pills. So now with slind, which is four milligrams of drosperinone, you might actually have a higher rate of clots than that four or five per 10,000.
Speaker 2:And that hadn't been studied yet in the paper we talked about last episode. But we do know that the existing combination pills with drosperinone, like Yaz, were significantly more likely to be associated with DBTs than ones with other progestogens like Northendrone. So we don't have true data on that yet, but if the idea is to avoid a blood clot, then you probably should not give them Slynd. You probably should be looking at IUDs. And then I would also say, just in my own anecdotal experience, if we're trying to control other things like endometriosis or abnormal bleeding symptoms, I have not been impressed with SLYND. But again, that's just me and that's not from any hard and fast data.
Speaker 3:Yeah, but I think the literature is starting to bear that out Again. We didn't necessarily need this pill on the market, but once it's on the market, the company will have claims to make and ways to sell it. So I too have seen a ton of this being prescribed to patients, mostly from non-obstetricians. It's being heavily marketed. It's being marketed to the patients from non-obstetricians. It's being heavily marketed. It's being marketed to the patients. And I've seen from other providers I think I have prescribed it once or twice for similar reasons where they come in and they've already got it in their head, but usually there was no real discussion about this, only that this general idea. The patient was told that it's safer than combination birth control pills, that avoiding estrogen was the thing to do, but no discussion about efficacy or bleeding control or anything else. And so the general public out there of prescribers really thinks that this pill doesn't have the risks of regular birth control pills due to the marketing, when in truth, at least in terms of blood clots, it could have more risk.
Speaker 2:Yeah, we really do need those head-to-head comparisons of risks, but given how new this pill is, that could take many years, even decades, to come up with that. But the company straight up markets it as estrogen-free birth control and again the implication is that estrogen is the bad guy.
Speaker 3:Yeah, so how much does this one cost?
Speaker 2:This one's $200 a month, so so far on par with all these other new ones and, by comparison, the noradendron mini pill the classic mini pill is typically under $10 a month. Months of Slynd could have paid for a Kyleena IUD placement which lasts for five years and has fewer side effects and fewer risks and better satisfaction and tremendously greater efficacy at preventing pregnancy.
Speaker 3:Yeah, the marketing for Slynd is weird. We should do a whole episode talking about whether or not drug companies should be allowed to have TV commercials and direct consumer marketing. But they don't really talk about efficacy in their marketing, because that's not a strong point for them. They just keep talking about how they're estrogen free and they talk about how it's made for all body types, and then their website and ads usually feature plus size models. So the implication, I think, without stating it, is that heavier women shouldn't use estrogen.
Speaker 3:Now, they never explicitly say that and, of course, we don't have any recommendation in that regard, but if you spend some time on the website, you'll get this idea. We are body positive as if Kalina is somehow not body positive so you should use our product and we're safer because we don't have estrogen and that's important to plus size women. That's the message you get, and a lot of new drugs coming to market. You don't need to even go to your doctor. You can click through to one of their online partners. They have a link right there and they'll just do a telehealth visit with a nurse practitioner and get it straight on the mail to you.
Speaker 2:Even the over-the-counter O pill, which is progestin only containing norgestrel, is only about 13 a month in cash.
Speaker 3:Yeah, that's another relatively new pill on the market. It's not really new in a sense, but of course it's moved to. Being over-the-counter is new and the name is new.
Speaker 2:All right. Well, I want to talk about another one of these pills. This one is called Nextstellis and it's the one I mentioned earlier that has the S-tetral, like the fancy estrogen. Their sales force, I know, is well-funded and aggressive and they're taking clinic lunchrooms and break rooms by storm. And just to round out the theme, from Slend, this one does also contain drosperinone, but I think their main selling point is how amazing this S-tetral is compared to the ethanol estradiol.
Speaker 3:Right. Their product guide, their little handouts, say that this is the first new estrogen developed in over 60 years and that it mimics the estrogen that naturally occurs in women's bodies. And many of the reps will use the term bioidentical in describing this naturally occurring estrogen that's found in women's bodies. So, as a quick biochem refresher, estrone is E1, o-n-e Notice the naming nomenclature if you never have. This is a weak estrogen found in postmenopausal women. It's mainly produced in fat in the adrenal glands, and it can be converted into other forms of estrogen. E2, or estradiol, is the most potent of the estrogens and it's the main estrogen found in reproductive age women. It's made in the ovaries and it's mainly responsible for secondary sexual characteristics like breast development. Then there is E3, or estriol estriol, which is another weak estrogen made by the placenta, and so it's only present during pregnancy.
Speaker 2:I do love how systematically and plainly these different estrogens are named. Can you remind us what is the number referred to? I think it's about their chemical composition, right?
Speaker 3:Yeah, yeah. So E1 has one hydroxyl group, e2 has two, e3 has three, got it. And then that naming convention continues with tetra as tetral, or E4 has four of these hydroxyl groups. So otherwise they're identical. And this is another in that form weak estrogen that's only made by the fetal liver and therefore is only present during pregnancy and not ever in an adult woman, unless she's pregnant with a fetus that has a liver making it.
Speaker 2:Well, I'm glad there's no other ones, because it would be hard to name like S, pentol or going on. But so then that means marketing this as bioidentical is somewhat misleading, because no adult female body would actually make this.
Speaker 3:Or even saying that it's something that naturally occurs in women's bodies, Unless she's been pregnant. Plenty of women haven't been pregnant and will never be pregnant.
Speaker 2:Yeah.
Speaker 3:So, yes, I guess it occurs in their bodies in utero. Maybe that's what they're going for, but it's very misleading and it's like using these words in marketing, like organic or natural or any of the number of buzzwords that we see nowadays is it's all hype, right. It makes the assumption, in this case, that being bioidentical is a good thing. So we spend a considerable amount of time in our profession fighting the lies and misinformation of the bioidentical hormone movement in business industry, and then that language has now been co-opted and promoted by this company to sell this product and call it bioidentical, when this is not even a hormone that adult women or children or menopausal women have in their bodies, unless you're a fetus.
Speaker 2:And even the synthetic ethanol estradiol. It's metabolized into the same natural bioidentical estradiol that is actually made by ovaries once it's in the body. So it just doesn't make sense to say that one is bioidentical and one isn't. They end up in the same.
Speaker 3:Yeah, that's a good point. And again, we took biochemistry Some of us still remember a little bit of it and steroid synthesis and these pathways, and so they're preying on people who really have no concept about what happens in steroid synthesis and what happens with liver metabolism and hydroxylation and all these things that occur when we ingest these medicines. But both estradiol and ethanol estradiol, so E2, and then ethanol estradiol being the type of estrogen most commonly found in birth control pills, these are metabolized to become what are called catechol estrogens. In the body is intermediates and so the activity in the body is basically the same. There are advantages of not giving straight estradiol in a birth control pill, so we give ethanol estradiol. And when folks talk about bioidentical hormones, they're focusing too much on what's in the tablet and not enough on what's in your body, what's in your bloodstream, after the liver, and the cytochrome P450 metabolic pathway in particular, has had its impact on metabolizing these drugs.
Speaker 2:You're reminding me how little I miss studying for biochem tests in med school.
Speaker 3:Well, at least this is more relevant in the Krebs cycle. But, the point is that marketing is very misleading because they're implying to patients that somehow their product is more natural, whatever that means, or better. In fact, they're giving women something that their own bodies would never make on its own.
Speaker 2:You're giving them a fetal liver hormone whose purpose in the fetal liver we don't even completely understand yeah, so marketing it as a fetal liver hormone would probably be much less appealing, but it would be much more accurate yeah, well, and obviously they're not extracting it from fetuses. Yeah, that's good.
Speaker 3:So they also play up the fact that the hormone source is plant-based. That's all over the commercials and marketing that this is plant-based because it's just the buzzword of the day. I think it's meant to strike a chord with folks who are vegan or just have accepted the premise that everything from a plant is healthy and wholesome, just otherwise believe that plant-based medications or things that you can see in a garden somehow are healthier or more natural or something like that. But I can tell you that no plant actually makes this hormone. This is not. It might be from a plant precursor, but no plant makes this. And you know what else is made from the same plant precursors Ethinyl estradiol, so estrogens.
Speaker 3:In all the birth control pills that we currently have available I think this is true of every estrogen or every birth control pill in the world usually starts with diastrogenin, which is found in wild yams, or stigmasterol, which is found in soybeans, and then these undergo some enzymatic and chemical reactions and finally an ether group is added at C17A to create the ethanol estradiol. This makes the estrogen more resistant to liver metabolism and increases the bioavailability compared to plain estradiol. That's why we do it. It's not an accident that basically every birth control pill on the market in the US now, except for this one has ethanol estradiol in it, because that's not an accident, that basically every birth control pill on the market in the US now, except for this one, has ethanol estradiol in it, because that's a good thing and all you have to do, all this company had to do, was take the exact same ethanol estradiol from the same assembly line, from the same plant, and add two more hydroxyl groups to it and then claim that they've cured cancer or something. It's really tremendous.
Speaker 2:Okay, Well, so also in their marketing data they say Nextellis has a low impact on weight with less than 1.1 pounds mean weight change at six months.
Speaker 3:Yeah, and that's that is how the marketing works. Again, because that statement is true basically for every birth control pill, so that's nothing special. They don't say that's better than other pills. They don't make a comparison. They're just pointing out something that's nothing special. They don't say that's better than other pills. They don't make a comparison. They're just pointing out something that's true of birth control pills. In fact, if you want a pill that has drosperinone in it, like this one does and that's probably what gives this pill many of the unique properties that they claim Well, we already have all sorts of drosperinone generics available that are generics of Yaz and Yasmin and B-Yaz, and these generics are now in that $12 to $15 a month range, like Ocella, and in the original studies of Yasmin, those pills were actually associated with weight loss at six months. So if weight's really important to you, you should probably be using Ocella.
Speaker 2:Okay. Well then they also say that the rates of breakthrough bleeding are low.
Speaker 3:Yes, but again they don't say that the rates of breakthrough bleeding are low. Yes, but again they don't say that it's any better or lower than any other pill in the market. So in their clinical trials they actually had a worse rate of breakthrough bleeding than what most other pills have reported in their clinical trials, and that's probably because this has a lower potency, weaker estrogen in it and breakthrough bleeding is primarily a product of lower potency, weaker estrogen in it, and breakthrough bleeding is primarily a product of lower potency estrogen. So the benefit of the estrogen in the pill is to help with the breakthrough bleeding. So yeah, it's low, but it's likely worse than most of the competitor pills on the market.
Speaker 2:So if someone has breakthrough bleeding on another pill, you probably shouldn't switch them to this one to help the breakthrough bleeding on another pill you probably shouldn't switch them to this one to help the breakthrough bleeding. That sounds true, yeah, yeah, all right. Well, I'm just saying, I'm just parroting what they're saying, not that I believe this, but okay, they also say that the incidence of acne is low.
Speaker 3:Yeah, and they again. We know that that's true of all birth control pills. And we know that the generics of Yaz and Yasmin and B-Yaz, again like Ocella, which has drosperinone in it, they all have an excellent acne profile and are FDA indicated for acne due to the unique properties of drosperinone, which has an anti-mineral corticoid effect. So they too, just like Ocella, available for 12 bucks, are good for acne.
Speaker 2:Well, and they also say that the impact on sex drive is low.
Speaker 3:Yeah, and this is let's just get ahead of what we're going to be accused of a little bit. So that's really interesting, because the reason why drosperinone is good for acne is because it's the most anti-androgenic progestogen in pills, right? So that typically means it's worse for sex drive compared to a pill with, maybe, norethindrone in it, but that's also again why they're good for acne, so they want it both ways. And this is another example of where they're not making a comparison to any other pill. They're just saying in general that a low number of patients tend to complain about it. But I have to think if they did a comparison to pills that didn't contain drosperinone in it, they would actually see a greater impact yes, a low impact, but a greater impact on sex drive than other pills.
Speaker 2:Yeah. So basically none of this marketing is based on head-to-head data between other birth control pills and they don't claim to be better than other pills, at least not in the printed materials. They're just trying to claim they're better than placebo, maybe, but the impression that the drug rep is going to try to leave you with when they drop the samples and brochures off is that they are better than other pills in regards to these issues because of this unique fetal estrogen. But again, the active ingredient that actually works to prevent pregnancy and make it a birth control pill is the drosperinone.
Speaker 3:Well, don't say yourself or Olive Garden. But also, should I delete the email I was sending to the company to ask them to sponsor the podcast?
Speaker 2:I guess I should probably just delete that yeah.
Speaker 3:So how much does this one cost?
Speaker 2:$250 a month. But at least we can say you get 24 active pills a month and not just 21.
Speaker 3:So the most expensive one we've talked about so far, I think. Well, balculture might be a little bit more.
Speaker 2:Yeah.
Speaker 3:Only has hormones. That's been around for 47 years. Well, if you want a 24-4 birth control which this one is that contains three milligrams of drosperinone which this one is that contains three milligrams of drosperinone which this one does and an estrogen that's made from plants that delivers bioidentical estrogens once metabolized in an estrogen that's found in the bodies of reproductive age women, not just fetuses, then you should just use the generics of B-YAS, which are available for about $40 a month, and that's the 24-4 version of Yasmin. And if you just want the same thing in the 21-7 form, you can get the generics of Yaz, again for about $12 a month.
Speaker 2:And any of these. You can refill them four to seven days earlier every cycle and use them continuously. So there you go. But so what about the idea I think I've also seen mentioned that they say this form of estrogen has less impact on breast tissue?
Speaker 3:Well, that's undoubtedly true because it's a weak estrogen, and I think what they're implying without saying it is that it'll have less risk of breast cancer. So again, they're just piling on to tropes. But the breast complaints that women sometimes have with breast control pills is really breast tenderness, and that will be related to both progestogen and estrogen activity. Drosperinone-containing pills, since they have a bit of a diuretic effect, also minimize breast complaints because the diuretic effect minimizes breast swelling and tenderness. So the sleazy part here is, if they're making people think that there is less breast cancer with this pill, which is certainly not validated by any clinical studies, that also means it's weaker on endometrial tissue, which would lead to higher rates of breakthrough bleeding. So in the same way, the progestin-only pills might have less impact on breast tissue because they have no estrogen in them.
Speaker 3:Well, this one would, because it just has a weak estrogen in it. And if you want no impact on breast tissue, then you can get an IED for the cost of what? Five months of this pill Not even. And breast tenderness is also not a very common reason why women stop using birth control pills. It's not a complaint we hear a lot of in general, and if it is. We have plenty of options that don't contain estrogen or contain lower doses of estrogen to minimize that effect.
Speaker 2:I think it's safe to assume that the more clever and aggressive the marketing is for new drugs, the less valuable they actually are, because it's like they're having to make up for something that the drug can't just speak for on its own, with its own outcomes or patient testimonials. The website for this pill is really full of the buzzwords and doublespeak, but it's completely missing any true comparisons in efficacy or side effect profile with other birth control pills that are already standard, and my guess is you're probably not going to get a ton of positive word of mouth testimonials from patients, for example, because hardly anyone with what we've talked about is going to say this worked so much better than the other pills we were on before. I'm only going to stay on this pill now that has more breakthrough bleeding probably and is not great on sex drive and costs so much more than all the other pills.
Speaker 3:When reps visit and they don't have comparator studies, that's because the company chose not to publish them or to do them, because they knew that wouldn't look favorable. If this pill were going to match well against other pills in serious ways that matter, the company would be doing everything they possibly could to do comparator studies to show how much superior it is. Always ask, whatever the drug is, whatever the product is, always ask the rep about the comparator data and how it compares against the current gold standard. There are some real differences between different breast control products that are already on the market. So we've talked about the dose of estrogen, the length of active hormone 24-4, 21-7, et cetera the number of periods that you get per year, the type of progestogen in each pill, and some of these pills do work better for certain patients than others, and sometimes we'll use different pills to accomplish different goals. But it's already a crowded market full of different solutions and for patients who aren't doing well with their pill due to side effects, most of them need to at least consider something like an IED. That's how you their pill due to side effects. Most of them need to at least consider something like an IED. That's how you get rid of pill side effects.
Speaker 3:We haven't really needed new birth control pills in a long time. I think it would be nice to see a generic version of low estrogen, because that's still the only 10 microgram pill that we have, and I'd like to see that price come down. That makes sense to me as a movement of lowering the thromboembolic effects and maybe breast tenderness and things like that, and so that's what I'd like to see next to fill that void. But, as you said, like the absolute risk reduction, we don't know, and is it worth the extra cost right now? Should that be your go-to pill just because it has 10 micrograms? Probably not.
Speaker 2:Well, if we have time for a historical tidbit, why don't you try to quickly tell us the history of the development of the birth control pill?
Speaker 3:Quickly. Huh, there's a whole bunch of books written on this, but okay, we'll highlight. So the story of the birth control pill is pretty interesting. It really starts in the 1930s when a physician named Ludwig Haberlund found that hormones from pregnant animals could prevent pregnancy in other animals. Then in 1937, researchers, including someone named AW Makepeace, showed that progesterone had an anti-ovulatory effect. Now fast forward to the 1940s and a chemist named Russell Marker discovers that a Mexican wild yam called Cabeza de Negro contained a substance that could be turned into progesterone. This was huge for the ability to mass produce these and not just extract hormones from animal urine.
Speaker 3:Essentially, in the 1950s, gregory Pincus, with funding from Margaret Sanger and Catherine Dexter McCormick, started researching hormonal contraception and collaborated famously with gynecologist John Rock to conduct clinical trials.
Speaker 3:And there's a whole really interesting story about John Rock and his personal journey with his Catholic faith in the development of the pill. And I'll put a link to an interesting essay about this that was in, I think, the New Yorker many years ago by Malcolm Gladwell, if you're curious, but it's pretty interesting. But anyway, by 1954, min Chang, who worked with Pincus, had refined the experiments and established what they thought was the right hormonal formula, and clinical trials then began in 1956. And in 1957, the FDA approved a pill called Inovid for menstrual disorders. Now the intent was always for birth control but for legal climate, the legal climate and reasons it was easier to get approval and get distribution for menstrual disorders, but they knew obviously that it was a contraceptive. And then finally, in 1960, the FDA approved in Ovid as a contraceptive and of course there was the Supreme Court cases Connecticut, griswold versus Griswold. That had to happen for it to become legal everywhere. But that's the really short version of it.
Speaker 2:Again, I like the naming. It says suggests anovulation. But, it's interesting, kind of like, how even now there's a high dose oral progestin, like five milligram norethindrone, that is meant for bleeding and it's not really counted as birth control, even though absolutely it has that effect. But it's just meant to be for bleeding.
Speaker 3:Yeah, because the 0.035 North syndrome is marked as a birth control, but the 5 milligram isn't.
Speaker 2:Yeah Well, so back to the inovid. It didn't have ethanol estradiol yet as its estrogen. It had something else called mestronol, which is actually the pro-drug of ethanol estradiol.
Speaker 3:Metabolism, biochemistry. Back to biochemistry. But yes, the mestranol is the immediate pro-drug of ethanol estradiol.
Speaker 2:And they could have already put ethanol estradiol in there, because it was already available as a medication. It had been available commercially since 1943. It had been available commercially since 1943. And ultimately, as we know, it did find its way into pills by the late 1960s.
Speaker 3:So originally the birth control pill was developed to be progestin only and the progestin in it was called norethin and that's the progestogen that is in Ovid and this was being studied in the late 1950s in Puerto Rico in a clinical trial for contraception. Again, this was done in Puerto Rico for kind of like legal reasons about doing this in the United States. What they found out was that the more pure they were able to isolate the norethendrel, the more pure product they were able to make, the more patients had breakthrough bleeding. So the impurity that was being taken out as part of the chemical synthetic pathway for this progestogen was the 3-methyl ether of ethanol estradiol. They were actually synthesizing this progestogen, the norethinadryl. They were making it from ethanol estradiol which was, as you said, it was already available and we knew how to make in quantity and impurity, and so that's what mestrinol is. So they figured out that this impurity essentially, which had estrogenic properties, was decreasing the amount of raked through bleeding and so when they did that, they added the impurity back in and at a fixed dose, and that was 150 micrograms of estrinol per pill.
Speaker 3:And that was 150 micrograms of estrinol per pill and that in terms of estrogenic potency is roughly equivalent to 75 micrograms of ethanol estradiol, so still pretty high by our current standards. But then within the decade and it did take about a decade we figured out that this pill was causing thromboembolic events. It took a while for enough people to use it and enough data to come out to figure that out. So the companies replaced the mestrinol with ethinyl estradiol, figuring that they could have the same effect because it was twice as potent at a lower dose and then hopefully reduce the risk of thromboembolism. And I don't think it's clear that that original switch did it. Is it the dose, or is it the potency or whatever? But of course what happened in time very quickly was we got down from about 75 micrograms of ethanol estradiol to 20, again by 1978.
Speaker 2:And all of this was made from plants.
Speaker 3:All of it made from plants.
Speaker 2:All right.
Speaker 3:Natural bioidentical plant-based.
Speaker 2:Vegan, vegan.
Speaker 3:Vegan.
Speaker 2:Okay, do you have any time to talk about male birth control? Not condoms, but like hormonal.
Speaker 3:Yeah Well, this segues a little bit in this because of this same precursor to estradiol. So the compounds that are currently being experimented on for men work the same way. So one of the current ones in being evaluated contains Suggesterone, which is a progestogen used in some female birth control pills in other parts of the world. And then they add testosterone back to that for essentially what would be hormone replacement therapy, because the Suggesterone suppresses them. But before they were using Suggesterone they were using Mestrinol in the original ideas about male birth control. But the problem was it was very effective. After a few days it shut the guys down completely, but it caused decreased libido, erectile dysfunction and all the men had gynecomastia in the study.
Speaker 2:So I guess that wouldn't be very popular then Probably wouldn't sell a lot. Yeah, so the funding for birth control research was, you said, from Catherine McCormick. Is she related to the McCormick Harvester guy?
Speaker 3:Yeah, yeah. So she married into that family. She married Cyrus McCormick, who's the famous McCormick who really created the agricultural revolution by inventing the harvester. She married his son, stanley, and then inherited a very large portion of the McCormick fortune. The McCormick harvester again had revolutionized the 19th century agricultural production and really gave way to the Industrial Revolution and at one point that was among the richest families in the world and she actually financed much of the early 20th century endocrinology research. The journal called Endocrinology was something that she started with her money. During the infancy she funded a department at Harvard and things like that and originally it was because her husband, she thought had an adrenal problem, had been diagnosed with an adrenal problem. It seems like he probably had profound schizophrenia, but the interest in that led her to spend a lot of money trying to understand hormones and we have, throughout endocrinology, much to think for her, but especially the birth control pill.
Speaker 2:Well, I guess schizophrenia is a little beyond our scope here.
Speaker 3:And we're out of time anyway.
Speaker 2:Yeah, yeah, well, yeah, go ahead and wrap it up then.
Speaker 3:Yeah, Well, we'll be back in. You'll be back in a month.
Speaker 2:Yeah.
Speaker 3:You'll be back in a month, but we'll the podcast will be back in two weeks with something exciting, and we'll put some cool stuff on the Instagram from this episode too.
Speaker 2:All right.
Speaker 1:Thanks for listening. Be sure to check out thinkingaboutobgyncom for more information and be sure to follow us on Instagram. We'll be back in two weeks.