WEBVTT - Ozempic's mental health warning

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<v Speaker 1>Just a quick heads up. Today's episode discusses distressing themes,

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<v Speaker 1>including suicide. Listener discretion is advised. If you or someone

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<v Speaker 1>you know need support. Help is available twenty four to

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<v Speaker 1>seven through Lifeline on thirteen eleven fourteen. Already and this

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<v Speaker 1>this is the Daily Art. This is the Daily OS.

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<v Speaker 1>Oh now it makes sense.

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<v Speaker 2>Good morning and welcome to the Daily OS. It's Wednesday,

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<v Speaker 2>the third of December. I'm Emma Gillespie, I'm Billy Fitzsimon's.

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<v Speaker 2>Australia's Medicines Regulator has issued a safety alert for ozempic

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<v Speaker 2>and similar drugs over a potential risk of suicidal thoughts.

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<v Speaker 2>The updated warning follows a spike in reports of suicidal

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<v Speaker 2>ideation linked to weight loss medications to the Therapeutic Goods

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<v Speaker 2>Administration the TGA. Today, we are going to explore what

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<v Speaker 2>led to this moment and what it means for patients

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<v Speaker 2>and everything else that you need to know in between.

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<v Speaker 1>And when this came out on Monday, I believe it was.

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<v Speaker 1>It was so interesting and I immediately thought of you

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<v Speaker 1>because you have spent most of this year looking into

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<v Speaker 1>weight loss medication, looking into ozen pic. I'm sure many

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<v Speaker 1>of the people listening to this episode have probably listened

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<v Speaker 1>to your investigation into ozen pic. Yeah, if you haven't,

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<v Speaker 1>we will link it in the show notes. But before

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<v Speaker 1>we get into what the announcement on Monday from the

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<v Speaker 1>TGA was, do you want to just kind of give

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<v Speaker 1>us the lay of the land about what I know,

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<v Speaker 1>I'm referencing just ozen pic, but I know it's much

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<v Speaker 1>broader than that. How long it's been around all of

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<v Speaker 1>those kinds of details.

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<v Speaker 2>Yeah, of course. So ozen Pic, as you mentioned, is

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<v Speaker 2>the big one. It was first approved by health authorities

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<v Speaker 2>here in Australia as a medication to treat type two

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<v Speaker 2>diabetes in twenty eighteen. Now, Ozempic is a brand name

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<v Speaker 2>for a drug otherwise known as semaglue tide and that

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<v Speaker 2>falls into this family of drugs called glp ones. So

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<v Speaker 2>you'll often hear these drugs described as glp ones or

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<v Speaker 2>as ozenpic as kind of a captural phrase. But they

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<v Speaker 2>are taken as an injection, usually once a week, and

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<v Speaker 2>they start working almost immediately within hours in some cases.

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<v Speaker 2>Ozenpic is the name that gets talked about so much

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<v Speaker 2>in the media, but there are now some very popular alternatives.

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<v Speaker 2>We go vi, Munjaro, Saxender that you might have heard of,

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<v Speaker 2>and they all work in the same way. So glp

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<v Speaker 2>ones act on hormones in our body, and for patients

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<v Speaker 2>with diabetes, they make sure that their cells work better

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<v Speaker 2>with insulin. But also, and importantly, these drugs slow down

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<v Speaker 2>what's called gastric emptying, so in other words, you feel

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<v Speaker 2>fuller faster. That is the side effect that has meant

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<v Speaker 2>these drugs have become increasingly popular for weight loss. And

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<v Speaker 2>you know, we've seen the kind of global surge, They've

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<v Speaker 2>become viral, the kind of butt of celebrity jokes almost,

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<v Speaker 2>and that's pretty much the lay of the land. In

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<v Speaker 2>as short of as summary as I can give you

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<v Speaker 2>on the world of glp.

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<v Speaker 1>Ones, I'm interested in how popular they have become because

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<v Speaker 1>I think, you know, if we go back three years

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<v Speaker 1>when I feel like we were all kind of first

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<v Speaker 1>hearing about it, maybe not even three years ago, maybe

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<v Speaker 1>two years ago, it felt like something that I mean,

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<v Speaker 1>I didn't know anyone who was on it. And now

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<v Speaker 1>just anecdotally, I think that I hear of a lot

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<v Speaker 1>more people who don't have type two diabetes who are

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<v Speaker 1>on it. It does feel a lot more common. Do

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<v Speaker 1>we know exactly how popular they are?

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<v Speaker 2>Yeah, they have really shifted into the mainstream. I think

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<v Speaker 2>four or five years ago we heard about ozepic. Is

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<v Speaker 2>this kind of celebrity joke or you'd hear about celebrities

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<v Speaker 2>being quote unquote on it, But it wasn't really in

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<v Speaker 2>our backyard or in our faces and in our world.

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<v Speaker 2>But that has shifted in recent years. So Ozepic is

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<v Speaker 2>a PBS listed drug four type two diabetes treatment, meaning

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<v Speaker 2>if that's why you take it, it's subsidized by the government,

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<v Speaker 2>costs about forty bucks a month and PBS scripts are tracked,

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<v Speaker 2>but GLP one prescriptions for any use other than type

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<v Speaker 2>two diabetes treatment aren't tracked. So if you are taking

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<v Speaker 2>glp ones for weight loss you don't have diabetes, that's

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<v Speaker 2>a private prescription. We have no way of knowing how

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<v Speaker 2>many people are doing that. It's virtually impossible to determine

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<v Speaker 2>the scale of GLP one use. It also means that

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<v Speaker 2>most people who use them are spending up to four

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<v Speaker 2>hundred dollars a month to access them because they're not subsidized.

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<v Speaker 2>Now globally, we know there has been a surging demand

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<v Speaker 2>for these drugs it's created shortages, supply chain issues, and

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<v Speaker 2>that demand has also made pharmaceutical companies very rich. Just

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<v Speaker 2>a few weeks ago, Eli Lilly, that is the manufacturer

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<v Speaker 2>of Munjaro, became the first drug maker to reach evaluation

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<v Speaker 2>of a trillion US dollars. It's about one and a

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<v Speaker 2>half trillion Aussie dollars.

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<v Speaker 1>Yeah, I saw that, and I think it does speak

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<v Speaker 1>to just how popular this is becoming for private use.

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<v Speaker 1>I want to talk a bit more about side effects,

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<v Speaker 1>because that is what the TGA talked about in their

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<v Speaker 1>announcement on Monday.

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<v Speaker 2>Yeah.

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<v Speaker 1>Before we get to that specific announcement, though, what are

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<v Speaker 1>the common side effects that we know other than weight loss?

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<v Speaker 2>Yeah, So while we don't know how many prescriptions of

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<v Speaker 2>GLP ones are issued in Australia, we do know the

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<v Speaker 2>kinds of negative side effects that are being reported. And

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<v Speaker 2>that's because GPS and healthcare providers can report adverse side

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<v Speaker 2>effects relating to GLP ones to the TGA. So there's

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<v Speaker 2>this Adverse Event Notifications database that those reports are listed

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<v Speaker 2>on that anyone can publicly see. Now. Between July twenty

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<v Speaker 2>twenty three and July twenty twenty five, the database shows

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<v Speaker 2>that gastro Intestinal disorders were the most frequently reported side

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<v Speaker 2>effects associated with semaglue tides, so that include odes, nausea, vomiting, cramping, constipation, pancreatitis.

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<v Speaker 2>Those complaints make up around half of all negative side

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<v Speaker 2>effects on the database relating to these drugs. But another

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<v Speaker 2>really concerning one that has emerged is suicidal ideation, so

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<v Speaker 2>that makes up one in every twenty adverse GLP one

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<v Speaker 2>reactions reported to this database. In the two years to

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<v Speaker 2>July twenty twenty five, there were seven deaths linked to

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<v Speaker 2>psychiatric disorders and GOLP ones. Ozenpic was the only product

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<v Speaker 2>suspected to be related to two deaths by suicide in

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<v Speaker 2>that period. But the TGA does note that it uses

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<v Speaker 2>these reports to identify when a safety issue may be present.

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<v Speaker 2>It says, assessing the safety of a medicine quote cannot

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<v Speaker 2>be made using the tracker alone.

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<v Speaker 1>Right, And I remember from your investigation into Ozenpic that

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<v Speaker 1>you actually spoke to someone who had experienced suicidal adiation

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<v Speaker 1>whilst on ozeen Pic. What can you tell us about

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<v Speaker 1>that conversation.

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<v Speaker 2>Yeah. I interviewed Mackenzie earlier this year. She is a

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<v Speaker 2>twenty six year old who sought out ozen Pick for

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<v Speaker 2>weight management through Juniper. Now. Juniper is one of a

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<v Speaker 2>growing number of online platforms that prescribed weight loss medications

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<v Speaker 2>without requiring in person consults. You've probably seen their ads

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<v Speaker 2>or heard from them in some way on your social

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<v Speaker 2>media feed. They are a massive company, and Mackenzie disclosed

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<v Speaker 2>to them that she had been taking antidepressants since her

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<v Speaker 2>early teens, so she had a history of depression. But

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<v Speaker 2>she was approved to use Ozeenpick by Juniper. Here is

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<v Speaker 2>a little bit about her story.

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<v Speaker 3>So I guess for me, I kind of had peace

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<v Speaker 3>of mind that it would cover everything that was in

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<v Speaker 3>my medical history. So I started receiving that in the

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<v Speaker 3>mail and injecting that as per kind of the recommended gidelines. I,

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<v Speaker 3>for no reason whatsoever, and I hadn't felt like this

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<v Speaker 3>for a very long time, became unable to work. It

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<v Speaker 3>was really quite unexplained. I was really really concerned, and

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<v Speaker 3>I chatted with my partner about it, and he was like, well,

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<v Speaker 3>the only thing that has changed in your life is

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<v Speaker 3>you going on this particular medication. So Mackenzie has a

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<v Speaker 3>long term history of depression which was being managed by

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<v Speaker 3>her antidepressants, but then she started on ozen pic and

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<v Speaker 3>then began experiencing suicidal ideations essentially out of nowhere.

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<v Speaker 2>Yeah, exactly, And so she expressed her concerns to her

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<v Speaker 2>regular GP, so not who she was prescribed the golp

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<v Speaker 2>one through, and he told her that he'd actually seen

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<v Speaker 2>this in a number of patients. His explanation was that

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<v Speaker 2>golp ones slow the digestive system and as a result,

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<v Speaker 2>they can have a negative effect on the absorption of

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<v Speaker 2>other drugs. So if you're taking other medications whilst you're

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<v Speaker 2>injecting ozepic, maybe it will influence how your body absorbs

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<v Speaker 2>those other meds.

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<v Speaker 1>So ozempic potentially stopped her body from absorbing the antidepressants

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<v Speaker 1>that she had been on for the past decade.

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<v Speaker 3>Yep.

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<v Speaker 2>That is basically what her doctor explained, and so Mackenzie

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<v Speaker 2>ended up being in such a bad place her GP

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<v Speaker 2>suggested she go to the hospital stop taking oze pic immediately.

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<v Speaker 2>I did ask her about the kind of information that

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<v Speaker 2>she was given by Juniper at the time. She said

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<v Speaker 2>she thoroughly interrogated all of it, and the resources at

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<v Speaker 2>that time did not explain anything or flag anything to

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<v Speaker 2>do with mental health. So she never held that as

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<v Speaker 2>a concern when she started taking.

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<v Speaker 1>Oceepic, and did mackenzie speak to Juniper the prescriber about

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<v Speaker 1>the suicidal ideation.

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<v Speaker 2>So she did tell the provider that her doctor had

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<v Speaker 2>advised her to stop taking ozmpic. She explained the side

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<v Speaker 2>effects that she had been hospitalized, and the response that

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<v Speaker 2>she told me she got was basically, well, that's not

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<v Speaker 2>a listed side effect. It shouldn't affect your antidepressant absorption

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<v Speaker 2>at all. TDA put these can concerns to Juniper earlier

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<v Speaker 2>this year, and they dispute any relationship between these medications

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<v Speaker 2>and an increased risk of mental health related side effects.

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<v Speaker 2>The clinical director of Juniper, doctor Matt Vickers, cited specific

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<v Speaker 2>guidance from the UK Health Regulator, which stated in September

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<v Speaker 2>twenty twenty four that the available data does not support

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<v Speaker 2>a causal association between JLP ones and suicidal ideation. Vickers

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<v Speaker 2>also pointed to some data from the US mind you.

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<v Speaker 2>This was a preliminary evaluation of an ongoing study by

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<v Speaker 2>the Food and Drug Administration, which said last year that

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<v Speaker 2>it didn't find an association or clearly demonstrated relationship between

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<v Speaker 2>GLP ones and the occurrence of suicidal thoughts. However, an

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<v Speaker 2>analysis of adverse reactions within the World Health Organizations Global

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<v Speaker 2>database painted a different picture. Findings from an international study

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<v Speaker 2>published in August actually identified a disproportionate link between suicidal

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<v Speaker 2>ideation and these medications.

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<v Speaker 1>Okay, so what I'm hearing is there was not a

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<v Speaker 1>lot of evidence at the time when we were looking

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<v Speaker 1>into this about the link between suicidal ideation and taking

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<v Speaker 1>GLP ones, saying that the WHO, the Weld Health Organization

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<v Speaker 1>did say that there was a possible link. But then

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<v Speaker 1>on Monday, the TGA, which is Australia's medical regulator, came

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<v Speaker 1>out and said that this link between GLP ones, which

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<v Speaker 1>is ozen pic and suicidal ideation is a bit more clear.

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<v Speaker 2>Now, yeah, there has been I suppose a lot of

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<v Speaker 2>contradictory information. If you wanted to argue either way, you

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<v Speaker 2>could kind of cherry pick some data to reflect that.

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<v Speaker 2>But what has been in black and white is that database,

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<v Speaker 2>the adverse event database that the TGA publishes, which shows

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<v Speaker 2>us an increase and frequency in suicidal ideation being reported.

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<v Speaker 2>We had that global data from the WHO, and now

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<v Speaker 2>we have an update from the TG. So on Monday

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<v Speaker 2>it released advice on GLP one's warning about the potential

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<v Speaker 2>risk of suicidal thoughts. The regulator said that patients taking

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<v Speaker 2>these medications should quote tell their health professional if they

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<v Speaker 2>experience new or worsening depression, suicidal thoughts, or any unusual

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<v Speaker 2>changes in mood or behavior.

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<v Speaker 1>So what does this mean in practical terms for anyone

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<v Speaker 1>who is taking it and is now concerned, or if

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<v Speaker 1>you know someone who's taking it, yeah, atn't concerned.

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<v Speaker 2>The biggest immediate change is that there's going to be

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<v Speaker 2>labels now on GLP one, so all GLP one medications

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<v Speaker 2>will note the risk of suicidal thoughts or behaviors. But

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<v Speaker 2>I also think what is really significant about this announcement

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<v Speaker 2>is it sends a really important message to patients who

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<v Speaker 2>have felt ignored to be honest or even gas lit

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<v Speaker 2>by the system by prescribers who have kind of downplayed

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<v Speaker 2>their experiences. If you are someone taking GLP ones and

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<v Speaker 2>you are worried about this, it is a small percentage,

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<v Speaker 2>So I would say, you know, there's no need to

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<v Speaker 2>immediately be alarmed if you don't have a history of

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<v Speaker 2>mental ill health, or if you are feeling a certain

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<v Speaker 2>way and maybe you have been doubting yourself. I think

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<v Speaker 2>that this is really affirming to tell patients to, you know,

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<v Speaker 2>trust themselves. Now, given this update, this new advice from

0:13:17.640 --> 0:13:22.360
<v Speaker 2>the TGA, I reached out to Juniper again. A statement

0:13:22.520 --> 0:13:26.680
<v Speaker 2>from doctor Matt Vickers, their clinical director, said that the

0:13:26.760 --> 0:13:30.960
<v Speaker 2>TGA's recent updates to GLP one product warnings reflect the

0:13:31.000 --> 0:13:35.679
<v Speaker 2>outcome of a review after what it called isolated reports

0:13:35.800 --> 0:13:40.800
<v Speaker 2>of suicidality quote. As with reviews by other global regulators,

0:13:41.280 --> 0:13:45.080
<v Speaker 2>no causal link has been found between GLP ones and

0:13:45.240 --> 0:13:48.960
<v Speaker 2>suicidal or self harming behavior. So they said that they

0:13:49.240 --> 0:13:52.360
<v Speaker 2>caution patients about the potential risk, and that they have

0:13:52.520 --> 0:13:57.120
<v Speaker 2>done since the service was established. However, that contradicts I

0:13:57.160 --> 0:14:00.920
<v Speaker 2>suppose what we have heard from some of them former patients.

0:14:01.360 --> 0:14:06.040
<v Speaker 2>And finally, Junipers said, with millions of people now treated

0:14:06.080 --> 0:14:11.040
<v Speaker 2>with GLP ones globally quote, the safety profile has continued

0:14:11.120 --> 0:14:15.440
<v Speaker 2>to strengthen. Interestingly, the TGA also said on Monday that

0:14:15.600 --> 0:14:18.600
<v Speaker 2>it couldn't rule out whether Munjarro, one of the popular

0:14:18.640 --> 0:14:23.200
<v Speaker 2>GLP ones, reduces the strength of the oral contraceptive pill.

0:14:23.400 --> 0:14:26.080
<v Speaker 2>We had heard a little bit about this before from

0:14:26.280 --> 0:14:30.240
<v Speaker 2>previous studies from other health bodies, and now the TGA

0:14:30.400 --> 0:14:34.880
<v Speaker 2>is advising that patients use non oral contraception for four

0:14:34.880 --> 0:14:39.800
<v Speaker 2>weeks when starting munjarro and four weeks after increasing their dosage.

0:14:39.800 --> 0:14:42.160
<v Speaker 2>So they're basically saying, give yourself a bit of a

0:14:42.160 --> 0:14:45.120
<v Speaker 2>four week window if your intake changes or when you

0:14:45.120 --> 0:14:48.600
<v Speaker 2>start the drug to ensure that you're protected. So, for example,

0:14:48.800 --> 0:14:50.040
<v Speaker 2>user condom for four weeks.

0:14:50.720 --> 0:14:54.320
<v Speaker 1>Interesting and just quickly before we wrap up, I also

0:14:54.360 --> 0:14:58.320
<v Speaker 1>saw that there was another big announcement from the WHO

0:14:58.440 --> 0:15:00.400
<v Speaker 1>this week about GLP ones.

0:15:00.560 --> 0:15:02.800
<v Speaker 2>What was that, Yeah, it's been a big week for

0:15:02.880 --> 0:15:07.800
<v Speaker 2>GLP ones, Billy. The WHO has released new guidelines on

0:15:07.880 --> 0:15:11.240
<v Speaker 2>the use of GLP ones for the treatment of obesity

0:15:11.360 --> 0:15:15.760
<v Speaker 2>in adults. Now, this is a global framework that acknowledges

0:15:15.800 --> 0:15:19.800
<v Speaker 2>a need to treat obesity quote as a chronic, relapsing

0:15:19.880 --> 0:15:23.840
<v Speaker 2>disease rather than a lifestyle choice. So just quickly, the

0:15:23.960 --> 0:15:28.120
<v Speaker 2>WHO said, while medication alone won't solve this global health crisis,

0:15:28.360 --> 0:15:32.440
<v Speaker 2>GLP one therapies can help millions overcome obesity and reduce

0:15:32.560 --> 0:15:35.880
<v Speaker 2>its associated harms as part of a comprehensive approach that

0:15:35.960 --> 0:15:41.400
<v Speaker 2>includes healthy diets, regular physical activity, and support from health professionals.

0:15:41.560 --> 0:15:45.560
<v Speaker 2>Now it's significant because this is a global Health body

0:15:45.920 --> 0:15:50.600
<v Speaker 2>basically endorsing or recommending GLP ones as an obesity treatment

0:15:50.920 --> 0:15:55.160
<v Speaker 2>and also formally recognizing obesity as a chronic disease associated

0:15:55.160 --> 0:15:57.920
<v Speaker 2>with high numbers of deaths a high economic burden on

0:15:57.960 --> 0:16:01.200
<v Speaker 2>health systems. Now, look, it does solve the issue of

0:16:01.320 --> 0:16:05.640
<v Speaker 2>suicidal ideation, of long term side effects and concern around

0:16:05.760 --> 0:16:09.880
<v Speaker 2>mental health impacts. But if there is a global health

0:16:09.920 --> 0:16:12.800
<v Speaker 2>body saying we need to take this treatment really seriously,

0:16:13.200 --> 0:16:16.040
<v Speaker 2>saying that it is critical to solving the obesity crisis,

0:16:16.360 --> 0:16:18.200
<v Speaker 2>I think that means we will see a lot more

0:16:18.240 --> 0:16:22.600
<v Speaker 2>investment in understanding these side effects. So with more attention

0:16:23.040 --> 0:16:27.920
<v Speaker 2>will mean more funding, more research, more transparency, and hopefully

0:16:28.120 --> 0:16:31.560
<v Speaker 2>that will give patients a clearer sense of side effects

0:16:31.640 --> 0:16:35.280
<v Speaker 2>and some more answers around the suicidal ideation piece.

0:16:35.520 --> 0:16:37.960
<v Speaker 1>I mean, you said before that these medications have really

0:16:37.960 --> 0:16:40.920
<v Speaker 1>only been around since twenty eighteen, So the fact that

0:16:41.160 --> 0:16:44.600
<v Speaker 1>it is constantly changing and there is still new research

0:16:44.680 --> 0:16:47.440
<v Speaker 1>still coming out about it, it does make sense given

0:16:47.480 --> 0:16:48.160
<v Speaker 1>how new it is.

0:16:48.360 --> 0:16:51.800
<v Speaker 2>Yeah, exactly, and we will continue to learn more as

0:16:51.880 --> 0:16:54.800
<v Speaker 2>time passes, and you know, as the global conversation continues.

0:16:55.200 --> 0:16:57.400
<v Speaker 1>Thank you for taking us through it, M and for

0:16:57.520 --> 0:16:59.240
<v Speaker 1>all of the work that you've done this year on

0:16:59.360 --> 0:17:02.680
<v Speaker 1>looking into it. What a timely announcement from the TGA.

0:17:02.880 --> 0:17:05.320
<v Speaker 1>Thank you so much, Billy, and thank you so much

0:17:05.400 --> 0:17:08.639
<v Speaker 1>for listening to this episode of The Daily Os. If

0:17:08.680 --> 0:17:11.840
<v Speaker 1>you've got a personal story about GLP ones that you

0:17:12.080 --> 0:17:14.040
<v Speaker 1>want to share with us, we would love to hear

0:17:14.080 --> 0:17:17.240
<v Speaker 1>from you. You can dm us on Instagram at any

0:17:17.280 --> 0:17:22.040
<v Speaker 1>time or send an email to helloatthdalilyos dot com dot au.

0:17:22.280 --> 0:17:24.920
<v Speaker 1>And just a reminder that if this episode has raised

0:17:24.960 --> 0:17:27.919
<v Speaker 1>any issues for you, you can contact the lifeline on

0:17:28.040 --> 0:17:31.400
<v Speaker 1>thirteen eleven fourteen. We'll be back this afternoon with your

0:17:31.400 --> 0:17:37.879
<v Speaker 1>evening headlines, but until then, have a great day.

0:17:38.119 --> 0:17:40.400
<v Speaker 3>My name is Lily Maddon and I'm a proud Aarunda

0:17:40.640 --> 0:17:43.760
<v Speaker 3>Bungelung Caalcutin woman from Gadigol Country.

0:17:44.040 --> 0:17:47.199
<v Speaker 1>The Daily oz acknowledges that this podcast is recorded on

0:17:47.240 --> 0:17:49.720
<v Speaker 1>the lands of the Gadighol people and pays respect to

0:17:49.800 --> 0:17:52.440
<v Speaker 1>all Aboriginal and Torres Strait Island and nations.

0:17:52.760 --> 0:17:55.680
<v Speaker 3>We pay our respects to the first peoples of these countries,

0:17:55.800 --> 0:17:57.000
<v Speaker 3>both past and present.