Transcript
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Welcome to the Dear Menopause podcast.
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I'm Sonia Lovell, your host Now.
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I've been bringing you conversations with amazing menopause experts for over two years now.
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If you have missed any of those conversations, now's the time to go back and listen, and you can always share them with anyone you think needs to hear them.
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This way, more people can find these amazing conversations, needs to hear them.
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This way, more people can find these amazing conversations.
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Welcome everybody to this week's episode of Hot Take with Joanna Wicks and myself.
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Welcome, joanna.
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Hi Sonia, how are you?
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I'm good, thank you.
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I'm very excited about our chat this week for a couple of reasons.
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One, it's our last chat before Christmas and two, we've got some juicy, juicy topics to dive into yes, I know, and you before Christmas.
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And two, we've got some juicy, juicy topics to dive into.
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Yes, I know, and you may have to like stop me or shut me up if I keep going too much, because some of these topics I well, I've done a deep dive into and they're quite complicated, but I'm hoping to break it down and make it easy for everyone.
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I'm really excited when you pitched this idea to me, that this was like one of the topics that we should chat about on today's episode.
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I was really, really pleased that this is one that we can, because I do know how much work you have done in this space.
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It's also something that I'm getting a lot of questions about by email people I chat to on the street in my DMs on Instagram because there was a recent government announcement, which we'll dive into in a second, which doesn't impact menopause or perimenopause, but is absolutely a precedent for something that should.
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I'm going to preface this conversation by saying that Jo is the one that knows lots and lots and lots and lots of details about what we're going to talk about.
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She's done an absolutely huge deep dive into all things to do with this topic.
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It is going to be a robust conversation.
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It's a little bit tricky to understand, but we need you, the listeners, to be really across what we're talking about today.
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So, jo, we are going to talk about getting treatments added to the PBS.
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Now, for anybody that doesn't know what the PBS is, jo, tell us what the PBS is.
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So PBS stands for the Pharmaceutical Benefits Scheme, and it is part of the kind of the healthcare sort of safety net, I guess, whereby drugs that are often super expensive, once they go through a rigorous process by PBAC, which is the Pharmaceutical Benefits Advisory Committee, I think you know, can be assessed as to whether or not the government subsidises their cost.
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So there's many, many, many medications that are on the PBS, but it is quite a challenging process to get drugs on there.
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And, yes, so, whilst Sonia, you are correct, I've done a massive, deep dive into this because I wanted to get my head around it.
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You know, as a consumer, I'd always just gone oh, some drugs are on the PBS, some drugs aren't.
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But when I was working for Besins, I wanted to learn more about how drugs got on there, and so I certainly don't know everything, but there is a lot that kind of blew my mind and made me go, wow, more people should know about this.
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This should be part of health literacy, understanding how this aspect works.
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So the thing we were sparked because I think it was it last week that Ged Kearny and and the government announced a new drug that went onto the PBS for endometriosis I think it's called Visanne.
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And what was really interesting about that is it's the first drug for endometriosis to be approved on the PBS in 30 years, and that got us, you know, what's happening.
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It did and, of course, the other thing that happened, like I mentioned before, off the back of that announcement and all the media coverage that it got, was a lot of questions from women going okay, so when is HRT going to be added to the PBS?
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Why is, you know, aspects of HRT still so expensive?
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And it really is, and it was talked about in the Senate inquiry.
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It was one of the recommendations that was tabled.
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So let's talk about why HRT, or you know, the different components of HRT, the different drugs, aren't on the PBS right now, how they can go about being on the PBS and how long that can all take go about being on the PBS and how long that can all take.
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Okay, so, in a nutshell, pharmaceutical companies apply to have their drugs put on the PBS.
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So the first step is that a pharmaceutical company has to decide to make that investment to do that application.
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The application is massive.
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It's usually, you know, could be 70 to 100 pages, as they outline absolutely everything to do with the drug and why they think it's important for Australians to have access to it through the subsidised system.
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Okay, I'm going to stop you there for a second, because I think that's really important to highlight, because a lot of the questions that I get and a lot of the commentary I've noticed around the media is why isn't the government putting HRT onto the PBS?
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So the government can put pressure onto the pharmaceutical companies, but that very first step has to actually be taken by the pharmaceutical company, correct?
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And there is a cost I think it's actually about a quarter of a million dollars, I think it's around $250,000 to actually put in the application.
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Now you can put in an application and then it goes off to be assessed by an independent committee which is called PBAC so the Pharmaceutical Benefits Advisory Committee and you can go onto the website and you can see all the drugs that get looked at every quarter and there's, you know, there's often like 40 drugs, you know, and they've all got 100 pages of technical detail.
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So it's a big undertaking.
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But obviously getting on to the PBS is huge because it makes drugs more accessible and more affordable.
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Now, obviously, some of the drugs that are applying to go on the PBS cost half a million dollars for one individual per year, and so it is absolutely imperative that those sorts of drugs you know are really assessed and looked at so that, you know, your average Australian can afford them.
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Where it gets a little bit more complicated and where I've, you know, really wrestled with this deep dive is when you're talking about drugs that are taken by large amounts of people every month.
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There's a lot of emphasis on cost and cost benefit.
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Now, for example, I'm going to go back a little bit before we talk about MHT.
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But for example, there aren't any modern contraceptives that have been put onto the PBS for over 25 years Now.
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One might ask why?
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Because there is a lot of amazing new modern contraceptives for women to use.
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But this is where you start to unpack what happens.
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So the PBS looks at cost.
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It's very cost focused.
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You know I thought it would look more at healthcare savings and health outcomes, and it does, but they're sort of secondary.
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So if you're looking at contraceptives, some of the contraceptives on the PBS have been there in Australia since 1992, which is sort of when the PBS was created.
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Now some of these drugs were actually approved by, say, the FDA in America in the late 90s or 1960s and so these are really old drugs.
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So when they were approved in the Australian context go onto the PBS back in 1992, 1993, the cost of those drugs is now extremely cheap.
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So we're talking maybe it costs the government $5 or less per month for these drugs.
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So if you take a new modern drug that has only been developed in the last couple of years and you think about all the manufacturing and the logistics and the R&D and the raw ingredients that go into making that drug and they apply to the PBS.
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They pay their quarter of a million dollars and apply to get their drug on the PBS.
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The PBS looks at it and goes but there's another contraceptive pill already on here and women can just use that because that one is super cheap.
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It's $5 a month and you want $17 a month?
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No, so I'm going to give you a real life example of this.
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So this actually happened.
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In July this year, Bayer Australia put forward two of their drugs contraceptives Yaz and Yasmin for consideration by PBAC.
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Yaz and Yasmin are more modern contraceptives.
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So this was, you know, this was potentially exciting to those of us that were looking at what was happening in the PBS space.
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Yay, some modern contraceptives finally making it onto the PBS.
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Now the committee met and the PBAC outcome has been published, and the PBAC outcome actually recommends that Yaz and Yasmin go onto the PBS.
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Yay, you might say, but there's a caveat.
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There's a big fat caveat.
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Of course there is.
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Of course there is.
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So I'm just going to read this out because I think it's quite important.
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It says the PBAC considered that Yaz and Yasmin did not provide significant benefits in terms of greater efficiency or reduction in toxicity compared to other PBS listed oral contraceptives.
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So the PBAC therefore recommended listing Yaz and Yasmin on a cost minimization basis to the lowest cost contraceptive currently PBS listed.
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So in layperson terms that means they will only list Yaz and Yasmin at the price of the cheapest contraceptive currently on the PBS.
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Now that's extremely cheap and that's an extremely old contraceptive.
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So the next layer of that, I guess, is you might go well, what are the difference?
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And as women, I think a lot of us know.
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If you think about the old contraceptive, when I think about when the first contraceptive I took, it was a PBS listed one and it made me sick.
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It turns out I can't tolerate a lot of progestins.
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They make me very unwell.
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So very quickly I had to come off that PBS listed contraceptive and as a 19-year-old I had to go onto a private script for a low-dose progesterone pill which cost $35 a month.
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So it was a massive, massive difference for an 18 year old working for $7 an hour in a cafe.
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So what happens is all these modern contraceptives that are great for women tend to be newer synthetics which have less side effects, or they tend to be body identical and so therefore they don't have as many sort of side effects or interruptions on the human body.
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So there's lots of you know.
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You talk to people about contraceptive and they say, oh, it gave me acne, it gave me bloating, I gained weight, it gave me headaches.
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So a lot of people actually come off the oral contraceptives on the PBS because of the negative side effects.
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But what you see in the way that the PBAC looks at these drugs is none of that is taken into consideration.
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They just look and go same same, no difference, even though there's a big difference.
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What will be interesting to see and I couldn't find anything on this is when it comes to something like Yaz and Yasmin.
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I suspect that the pharmaceutical company is probably going to not progress with this PBS listing because it is not financially viable.
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Like a company in 2024 can't sell drugs for the price of a drug that was invented in the 1960s.
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It's just, it's not feasible.
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So then what happens is, even though PBAC has recommended the drug, it doesn't end up on the PBS because there is no acknowledgement of the decades of research or the increased costs of manufacture.
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So why this has, you know, sparked my interest?
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Is PBAC actually considered a whole lot of MHT in their November meeting and those results.
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Those outcomes are due on the 20th of December.
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So if you go on to the PBAC website, if you're going to nerd out on this sort of stuff, you can see all the drugs that they considered in November.
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So they considered slinder, which is a modern contraceptive.
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They considered estrogel, which is a body identical estrogen.
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They considered prometrium, which would be the first micronized progesterone to make it onto the PBS, and Estrogel Pro, which is the combination of estrogen and progesterone.
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All of these drugs were considered in November and all of them could be recommended to go onto the PBS in the next week.
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So this would be huge in the next week.
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So this would be huge.
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But obviously there's going to be that caveat around will they be recommended with a discussion on cost, or will there be this comparison to the lowest cost denominator?
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And I think what's interesting here for MHT?
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Mht is very similar to oral contraceptives.
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There has been very little modern MHT put onto the PBS.
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I think the last MHT.
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Mht is very similar to oral contraceptives.
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There has been very little modern MHT put onto the PBS.
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I think the last MHT related product was Vagifem, possibly about 10 years ago, but there's very few of the body identical products have been put onto the PBS recently and there are no progesterones on the PBS currently, and that's been one of the big issues that came up in the inquiry.
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Yeah, and for anybody that is taking Prometrium look, I am it really does add a significant amount onto your monthly costs for your MHT.
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So there's that Okay.
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So question that came up for me while you were talking about that.
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So let's just talk about Prometrium, because obviously we've got the four drugs that you mentioned that could potentially be added to the PBS.
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But let's talk about prometrium.
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What precedent is there already set on the PBS, like that example that you gave about the oral contraceptive, that could mean that they might say, yeah, sure, this can go on, but it's going to be at this ridiculously low price and therefore the pharmaceutical company might go yeah, no, sorry, not worth our while perfect question.
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Perfect question, sonia.
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Um, and because this is where my whole deep dive into the pbs started.
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Um, and it started in, you know, may last year and I think I've mentioned this before on the podcast I was at a workshop with dr jenny mansberg.
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She asked people um in the room.
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You know what?
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What it was on MHT, what MHT people were taking and a number of women put their hand up and said that they were on MPA.
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Which gosh, it's like.
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It's the not so good progesterone.
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It's a progestin.
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Yes, it's a progestin.
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That's the one, sorry.
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Something, something Acid.
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Yes, Long name Actually.
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You know what?
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I'm going to Google that while you keep talking.
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You Google that, so that we can actually be professional and I'll come back and say what it actually is.
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Actually so, mpa, I think on the PBS it's called Provera, so this is a fascinating drug.
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It was approved by the FDA in 1959.
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So it's probably one of the oldest drugs that women still take.
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It's been around an extremely long time.
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It is also the drug in Depo-Provera, so you can use it for contraception through Depo injections and you can use it as your progestin in MHT, and it is synthetic.
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It is a synthetic drug.
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Yep.
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Okay, let me tell you what it is Now.
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My pronunciation here is going to get tested Medroxyprogesterone acetate.
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That sounds exactly right.
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Yeah, there you go.
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So MPA has been on the PBS since day dot, before 1992.
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You know, it's kind of like there's no data from before 1992 that I could find and it is extremely affordable.
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I think the, you know, I think it's around, you know, $5 for the government per packet, and that's not even per month.
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I think you get 56 tablets per packet, so it lasts two months.
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Oh wow, so it's a good two months yeah.
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Yeah, so you know, I think the government you know I might be incorrect here because you know I can't see everything that the government can see, but what I as a consumer can see, it's probably around $2.50, you know, a month Unbelievably cheap.
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Now this is a drug that anyone who is knowledgeable in the menopause space doesn't prescribe.
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In fact, you know I have heard people say you know, get off it if you're on it.
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Yeah, now there are some women for whom it works when the other progesterones or progestins don't work.
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So there is a small percentage that still find MPA extremely beneficial.
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But for the majority of women it has a lot of side effects, most of which aren't pleasant, and in fact, if you're using it for contraception, it actually comes with some pretty significant warnings around, actually causing bone density loss Loss okay, yeah, so it's a pretty serious drug and it's MPA.
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That was used in the WHI studies as well, wasn't it Correct?
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yes.
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So it's the progestin that was linked to a very slight increase in breast cancer Breast cancer so it's really not recommended.
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In fact, you'd be hard-pressed to find any menopause doctor who actually prescribes, prescribes, and in fact, if your doctor suggests MPA, it's usually an indication that they're not up to scratch.
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So MPA cheap, it has a lot of side effects, it's synthetic and it doesn't have all of the benefits that a body identical progesterone do.
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But this is where it gets tricky.
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Like you said, sonia, it's been around for a long time and so if PBAC comes back and says, yes, we recommend Prometrium, but it's got to be cost compared, then we're going to have a very big issue.
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Now I have a number of issues from this, but one of them is, again, I find it so hard to break this stuff down and I still don't really get it.
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So Prometrium is a progesterone, it is a body identical drug.
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Mpa is a progesterone, it is a body identical drug.
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Mpa is a progestin.
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It is a synthetic drug.
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But they're lumped in together.
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They're lumped in as though they're the same product and I remember talking to people and saying, but but one is a progestin and one is a progesterone and they're very different what they do to the, to women's bodies, and they they have very different you know sort of side effects and benefits.
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So, so why are they being considered together, sort of like?
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Sort of like, I mean, with mineral water?
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Yeah, they've both got bubbles.
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They've both got bubbles Exactly.
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But PBAC doesn't take those sorts of differences into account.
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It sort of just goes well, you both used this and so we're going to compare you like as like when to anyone you, you know, immersed in this space, like the gps and the clinicians that you know I've spent two years talking to, they're like, they're not like for like, they're very different.
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They have very different side effects and you know progestins do have these you know this slight increased risk factors and they may negatively impact bone density.
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So there's a lot of argument that they are actually different and they should be considered differently.
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But this is what we're going to find out in a week as to whether or not PBAC has, I guess, looked at those broader considerations other than cost.
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Wow, but I have got something then.
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So this is going to lead down a slightly other little rabbit hole.
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So goody, when you about it.
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You know one of the things that I just read out in relation to Yaz and Yasmin was you know, this big submission that the pharmaceutical company put in did not provide significant benefits in terms of greater efficacy or reduction in toxicity compared to others.
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So this brings us back to another issue, and this is how it's all very cyclic and very frustrating.
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This is where the lack of research into women's health directly impacts what medications women can access via the PBS.
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So if you think about it, you've got very little money given to women's health for research.
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There's very little research done.
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So there's this massive black hole when it comes to hormones and women's health.
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So then we have no data.
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So then the pharmaceutical company, when it's going to do its submission, doesn't have any new data or anything to draw on because no one's done any research for decades.
00:19:26.560 --> 00:19:30.451
So if there's no new data, no new information, pbac just goes.
00:19:30.451 --> 00:19:51.916
Well, these drugs, you know they're the same and, for example, I was watching something this morning that Mary-Claire Haver had just put on her Insta, I think, in the last 24 hours, which was specifically talking about in the US, less than 9% of the National Institutes of Health's budget went to women's health.
00:19:52.679 --> 00:19:58.096
Of that 9%, the majority of it went for breast cancer, then it went to pregnancy and infertility.
00:19:58.096 --> 00:20:13.367
When you got down the list of women's health things that received funding and you got to menopause, it was 15 million, which equaled 0.03 percent of the National Institute of Health's budget that was looking at this.
00:20:13.367 --> 00:20:19.261
So you think 15 million for a population of 300 million, it's just nothing.
00:20:19.261 --> 00:20:31.176
So a recent committee in the US has recommended that to try and reduce this research gender gap, the US look at spending 11 billion into women's healthcare.
00:20:31.176 --> 00:20:38.893
Now I know that Research Australia are looking at what those figures are for Australia and I suspect they're going to be equally dire.
00:20:39.493 --> 00:20:40.234
I would imagine so.
00:20:41.155 --> 00:20:42.679
Because there's this big gap.
00:20:42.679 --> 00:20:49.586
And I know when, two years ago, I had a look at what NHMRC funding was happening for menopause in Australia and, yes, it was very, very small.
00:20:49.586 --> 00:20:57.172
And the other thing that I found fascinating about it is when you know, I had someone at the NHMRC pull it together and send it to me in an Excel spreadsheet.
00:20:57.172 --> 00:21:02.914
When I read the descriptions of what they considered menopause funding, I was like that's a bit of a stretch.
00:21:02.914 --> 00:21:07.015
Just because it includes a couple of middle-aged women does not make it menopause specific.
00:21:07.015 --> 00:21:09.704
So it was very broad.
00:21:09.785 --> 00:21:13.974
So they're being very broad with their description of buckets.
00:21:14.256 --> 00:21:19.991
Buckets, yep, and you know I can talk about research another time because there's a lot of interesting stuff there.
00:21:19.991 --> 00:21:24.289
I don't even think in HMRC funding in Australia, like if it's women-focused.
00:21:24.289 --> 00:21:27.530
That's not even a box that gets ticked so you can't even really search by.
00:21:27.530 --> 00:21:33.214
You know what's specifically for women's health, which of course keeps everything nice and murky, doesn't?
00:21:33.275 --> 00:21:39.326
it, don't?
00:21:39.365 --> 00:21:47.778
we love it when the government sent gives people funding, and then they're very murky with what the data has actually been spent on and so, for example, you know there was a bit of excitement with the budget this year and so I'm just going to squash that excitement.
00:21:48.381 --> 00:22:06.590
Yeah, so the government announced 53.6 million for women's health research, which you know you might initially go, oh, that sounds really good, but then, when you break it down, it was for pregnancy loss, infertility, chronic pain, menopause and treatment for alcohol and drugs.
00:22:06.590 --> 00:22:15.092
That's 53 million across one, two, three, four, five different areas over, I think, five years.
00:22:15.092 --> 00:22:18.518
So it starts to become very, very, very small.
00:22:18.518 --> 00:22:29.901
And if you're looking at the kind of information that PBAC needs to influence or make decisions on, we're not talking about a small survey, we're talking about really robust data.
00:22:29.901 --> 00:22:37.134
So they want to see, you know, randomized clinical trials which cost tens of millions, not 200,000.
00:22:37.134 --> 00:22:52.227
So 53 million, of which a tiny percent is going to be for menopause, is not going to fill any of these data gaps, which are going to be what helps change information when it comes to what drugs get on the PBS and what drugs we, as the consumer, get access to.
00:22:53.148 --> 00:23:08.155
Yeah, wow, it's really complex, it's very layered, it seems so antiquated and caught up in red tape and it's just so out of touch with the shift in treating this change in a woman's life.
00:23:09.028 --> 00:23:09.971
And it gets kind of worse.
00:23:09.971 --> 00:23:16.297
So the other thing that shocked me as a Commissioner, mayor, as I was diving into here, was so there's no review mechanism for the PBS.
00:23:16.297 --> 00:23:21.410
So that blew my mind as well, you know, having being involved with, with- government.
00:23:21.431 --> 00:23:24.298
So what you mean by that is once something's on the pbs?
00:23:24.846 --> 00:23:35.692
yes, no review system, they just stay there till the pharmaceutical company takes it off right, okay, wow, uh, there's no review mechanism to go.
00:23:35.692 --> 00:23:43.778
Is MPA still the best drug to be giving women for this, you know, health condition?
00:23:43.778 --> 00:23:45.829
It's been on there since 1992.
00:23:45.829 --> 00:23:46.573
So what are we talking?
00:23:46.573 --> 00:23:53.750
That's 32 years and as a result, I mean, I guess you know, in many ways it's in the government's favour.
00:23:53.750 --> 00:23:54.573
It keeps drugs cheap.
00:23:54.684 --> 00:24:05.632
They can say, well, we're not putting anything else on unless they price match this ridiculously cheap drug that doesn't have great side effects and that women don't really like using and it kind of makes women feel a bit well, but we'll just keep it on there because it's cheap, which is just.
00:24:05.632 --> 00:24:07.085
It's kind of not good enough.
00:24:07.085 --> 00:24:16.840
Because when you think about it, I think about all the women that come off the contraceptive pill when they're young because it makes them feel so bad and and then they may not go back on it, they might have an unintended pregnancy.
00:24:16.840 --> 00:24:22.204
You know then there are a lot of other potential ramifications down the track for that decision.
00:24:22.204 --> 00:24:24.513
It's not just about that cost at that time.
00:24:24.513 --> 00:24:34.191
So if you think about MHT, if women can't afford to take MHT and they choose to forego it, then they're more at risk of osteoporosis, they're at greater risk of heart disease.