Speaker 1: Just a quick heads up. Today's episode discusses distressing themes,
Speaker 1: including suicide. Listener discretion is advised. If you or someone
Speaker 1: you know need support. Help is available twenty four to
Speaker 1: seven through Lifeline on thirteen eleven fourteen. Already and this
Speaker 1: this is the Daily Art. This is the Daily OS.
Speaker 1: Oh now it makes sense.
Speaker 2: Good morning and welcome to the Daily OS. It's Wednesday,
Speaker 2: the third of December. I'm Emma Gillespie, I'm Billy Fitzsimon's.
Speaker 2: Australia's Medicines Regulator has issued a safety alert for ozempic
Speaker 2: and similar drugs over a potential risk of suicidal thoughts.
Speaker 2: The updated warning follows a spike in reports of suicidal
Speaker 2: ideation linked to weight loss medications to the Therapeutic Goods
Speaker 2: Administration the TGA. Today, we are going to explore what
Speaker 2: led to this moment and what it means for patients
Speaker 2: and everything else that you need to know in between.
Speaker 1: And when this came out on Monday, I believe it was.
Speaker 1: It was so interesting and I immediately thought of you
Speaker 1: because you have spent most of this year looking into
Speaker 1: weight loss medication, looking into ozen pic. I'm sure many
Speaker 1: of the people listening to this episode have probably listened
Speaker 1: to your investigation into ozen pic. Yeah, if you haven't,
Speaker 1: we will link it in the show notes. But before
Speaker 1: we get into what the announcement on Monday from the
Speaker 1: TGA was, do you want to just kind of give
Speaker 1: us the lay of the land about what I know,
Speaker 1: I'm referencing just ozen pic, but I know it's much
Speaker 1: broader than that. How long it's been around all of
Speaker 1: those kinds of details.
Speaker 2: Yeah, of course. So ozen Pic, as you mentioned, is
Speaker 2: the big one. It was first approved by health authorities
Speaker 2: here in Australia as a medication to treat type two
Speaker 2: diabetes in twenty eighteen. Now, Ozempic is a brand name
Speaker 2: for a drug otherwise known as semaglue tide and that
Speaker 2: falls into this family of drugs called glp ones. So
Speaker 2: you'll often hear these drugs described as glp ones or
Speaker 2: as ozenpic as kind of a captural phrase. But they
Speaker 2: are taken as an injection, usually once a week, and
Speaker 2: they start working almost immediately within hours in some cases.
Speaker 2: Ozenpic is the name that gets talked about so much
Speaker 2: in the media, but there are now some very popular alternatives.
Speaker 2: We go vi, Munjaro, Saxender that you might have heard of,
Speaker 2: and they all work in the same way. So glp
Speaker 2: ones act on hormones in our body, and for patients
Speaker 2: with diabetes, they make sure that their cells work better
Speaker 2: with insulin. But also, and importantly, these drugs slow down
Speaker 2: what's called gastric emptying, so in other words, you feel
Speaker 2: fuller faster. That is the side effect that has meant
Speaker 2: these drugs have become increasingly popular for weight loss. And
Speaker 2: you know, we've seen the kind of global surge, They've
Speaker 2: become viral, the kind of butt of celebrity jokes almost,
Speaker 2: and that's pretty much the lay of the land. In
Speaker 2: as short of as summary as I can give you
Speaker 2: on the world of glp.
Speaker 1: Ones, I'm interested in how popular they have become because
Speaker 1: I think, you know, if we go back three years
Speaker 1: when I feel like we were all kind of first
Speaker 1: hearing about it, maybe not even three years ago, maybe
Speaker 1: two years ago, it felt like something that I mean,
Speaker 1: I didn't know anyone who was on it. And now
Speaker 1: just anecdotally, I think that I hear of a lot
Speaker 1: more people who don't have type two diabetes who are
Speaker 1: on it. It does feel a lot more common. Do
Speaker 1: we know exactly how popular they are?
Speaker 2: Yeah, they have really shifted into the mainstream. I think
Speaker 2: four or five years ago we heard about ozepic. Is
Speaker 2: this kind of celebrity joke or you'd hear about celebrities
Speaker 2: being quote unquote on it, But it wasn't really in
Speaker 2: our backyard or in our faces and in our world.
Speaker 2: But that has shifted in recent years. So Ozepic is
Speaker 2: a PBS listed drug four type two diabetes treatment, meaning
Speaker 2: if that's why you take it, it's subsidized by the government,
Speaker 2: costs about forty bucks a month and PBS scripts are tracked,
Speaker 2: but GLP one prescriptions for any use other than type
Speaker 2: two diabetes treatment aren't tracked. So if you are taking
Speaker 2: glp ones for weight loss you don't have diabetes, that's
Speaker 2: a private prescription. We have no way of knowing how
Speaker 2: many people are doing that. It's virtually impossible to determine
Speaker 2: the scale of GLP one use. It also means that
Speaker 2: most people who use them are spending up to four
Speaker 2: hundred dollars a month to access them because they're not subsidized.
Speaker 2: Now globally, we know there has been a surging demand
Speaker 2: for these drugs it's created shortages, supply chain issues, and
Speaker 2: that demand has also made pharmaceutical companies very rich. Just
Speaker 2: a few weeks ago, Eli Lilly, that is the manufacturer
Speaker 2: of Munjaro, became the first drug maker to reach evaluation
Speaker 2: of a trillion US dollars. It's about one and a
Speaker 2: half trillion Aussie dollars.
Speaker 1: Yeah, I saw that, and I think it does speak
Speaker 1: to just how popular this is becoming for private use.
Speaker 1: I want to talk a bit more about side effects,
Speaker 1: because that is what the TGA talked about in their
Speaker 1: announcement on Monday.
Speaker 2: Yeah.
Speaker 1: Before we get to that specific announcement, though, what are
Speaker 1: the common side effects that we know other than weight loss?
Speaker 2: Yeah, So while we don't know how many prescriptions of
Speaker 2: GLP ones are issued in Australia, we do know the
Speaker 2: kinds of negative side effects that are being reported. And
Speaker 2: that's because GPS and healthcare providers can report adverse side
Speaker 2: effects relating to GLP ones to the TGA. So there's
Speaker 2: this Adverse Event Notifications database that those reports are listed
Speaker 2: on that anyone can publicly see. Now. Between July twenty
Speaker 2: twenty three and July twenty twenty five, the database shows
Speaker 2: that gastro Intestinal disorders were the most frequently reported side
Speaker 2: effects associated with semaglue tides, so that include odes, nausea, vomiting, cramping, constipation, pancreatitis.
Speaker 2: Those complaints make up around half of all negative side
Speaker 2: effects on the database relating to these drugs. But another
Speaker 2: really concerning one that has emerged is suicidal ideation, so
Speaker 2: that makes up one in every twenty adverse GLP one
Speaker 2: reactions reported to this database. In the two years to
Speaker 2: July twenty twenty five, there were seven deaths linked to
Speaker 2: psychiatric disorders and GOLP ones. Ozenpic was the only product
Speaker 2: suspected to be related to two deaths by suicide in
Speaker 2: that period. But the TGA does note that it uses
Speaker 2: these reports to identify when a safety issue may be present.
Speaker 2: It says, assessing the safety of a medicine quote cannot
Speaker 2: be made using the tracker alone.
Speaker 1: Right, And I remember from your investigation into Ozenpic that
Speaker 1: you actually spoke to someone who had experienced suicidal adiation
Speaker 1: whilst on ozeen Pic. What can you tell us about
Speaker 1: that conversation.
Speaker 2: Yeah. I interviewed Mackenzie earlier this year. She is a
Speaker 2: twenty six year old who sought out ozen Pick for
Speaker 2: weight management through Juniper. Now. Juniper is one of a
Speaker 2: growing number of online platforms that prescribed weight loss medications
Speaker 2: without requiring in person consults. You've probably seen their ads
Speaker 2: or heard from them in some way on your social
Speaker 2: media feed. They are a massive company, and Mackenzie disclosed
Speaker 2: to them that she had been taking antidepressants since her
Speaker 2: early teens, so she had a history of depression. But
Speaker 2: she was approved to use Ozeenpick by Juniper. Here is
Speaker 2: a little bit about her story.
Speaker 3: So I guess for me, I kind of had peace
Speaker 3: of mind that it would cover everything that was in
Speaker 3: my medical history. So I started receiving that in the
Speaker 3: mail and injecting that as per kind of the recommended gidelines. I,
Speaker 3: for no reason whatsoever, and I hadn't felt like this
Speaker 3: for a very long time, became unable to work. It
Speaker 3: was really quite unexplained. I was really really concerned, and
Speaker 3: I chatted with my partner about it, and he was like, well,
Speaker 3: the only thing that has changed in your life is
Speaker 3: you going on this particular medication. So Mackenzie has a
Speaker 3: long term history of depression which was being managed by
Speaker 3: her antidepressants, but then she started on ozen pic and
Speaker 3: then began experiencing suicidal ideations essentially out of nowhere.
Speaker 2: Yeah, exactly, And so she expressed her concerns to her
Speaker 2: regular GP, so not who she was prescribed the golp
Speaker 2: one through, and he told her that he'd actually seen
Speaker 2: this in a number of patients. His explanation was that
Speaker 2: golp ones slow the digestive system and as a result,
Speaker 2: they can have a negative effect on the absorption of
Speaker 2: other drugs. So if you're taking other medications whilst you're
Speaker 2: injecting ozepic, maybe it will influence how your body absorbs
Speaker 2: those other meds.
Speaker 1: So ozempic potentially stopped her body from absorbing the antidepressants
Speaker 1: that she had been on for the past decade.
Speaker 3: Yep.
Speaker 2: That is basically what her doctor explained, and so Mackenzie
Speaker 2: ended up being in such a bad place her GP
Speaker 2: suggested she go to the hospital stop taking oze pic immediately.
Speaker 2: I did ask her about the kind of information that
Speaker 2: she was given by Juniper at the time. She said
Speaker 2: she thoroughly interrogated all of it, and the resources at
Speaker 2: that time did not explain anything or flag anything to
Speaker 2: do with mental health. So she never held that as
Speaker 2: a concern when she started taking.
Speaker 1: Oceepic, and did mackenzie speak to Juniper the prescriber about
Speaker 1: the suicidal ideation.
Speaker 2: So she did tell the provider that her doctor had
Speaker 2: advised her to stop taking ozmpic. She explained the side
Speaker 2: effects that she had been hospitalized, and the response that
Speaker 2: she told me she got was basically, well, that's not
Speaker 2: a listed side effect. It shouldn't affect your antidepressant absorption
Speaker 2: at all. TDA put these can concerns to Juniper earlier
Speaker 2: this year, and they dispute any relationship between these medications
Speaker 2: and an increased risk of mental health related side effects.
Speaker 2: The clinical director of Juniper, doctor Matt Vickers, cited specific
Speaker 2: guidance from the UK Health Regulator, which stated in September
Speaker 2: twenty twenty four that the available data does not support
Speaker 2: a causal association between JLP ones and suicidal ideation. Vickers
Speaker 2: also pointed to some data from the US mind you.
Speaker 2: This was a preliminary evaluation of an ongoing study by
Speaker 2: the Food and Drug Administration, which said last year that
Speaker 2: it didn't find an association or clearly demonstrated relationship between
Speaker 2: GLP ones and the occurrence of suicidal thoughts. However, an
Speaker 2: analysis of adverse reactions within the World Health Organizations Global
Speaker 2: database painted a different picture. Findings from an international study
Speaker 2: published in August actually identified a disproportionate link between suicidal
Speaker 2: ideation and these medications.
Speaker 1: Okay, so what I'm hearing is there was not a
Speaker 1: lot of evidence at the time when we were looking
Speaker 1: into this about the link between suicidal ideation and taking
Speaker 1: GLP ones, saying that the WHO, the Weld Health Organization
Speaker 1: did say that there was a possible link. But then
Speaker 1: on Monday, the TGA, which is Australia's medical regulator, came
Speaker 1: out and said that this link between GLP ones, which
Speaker 1: is ozen pic and suicidal ideation is a bit more clear.
Speaker 2: Now, yeah, there has been I suppose a lot of
Speaker 2: contradictory information. If you wanted to argue either way, you
Speaker 2: could kind of cherry pick some data to reflect that.
Speaker 2: But what has been in black and white is that database,
Speaker 2: the adverse event database that the TGA publishes, which shows
Speaker 2: us an increase and frequency in suicidal ideation being reported.
Speaker 2: We had that global data from the WHO, and now
Speaker 2: we have an update from the TG. So on Monday
Speaker 2: it released advice on GLP one's warning about the potential
Speaker 2: risk of suicidal thoughts. The regulator said that patients taking
Speaker 2: these medications should quote tell their health professional if they
Speaker 2: experience new or worsening depression, suicidal thoughts, or any unusual
Speaker 2: changes in mood or behavior.
Speaker 1: So what does this mean in practical terms for anyone
Speaker 1: who is taking it and is now concerned, or if
Speaker 1: you know someone who's taking it, yeah, atn't concerned.
Speaker 2: The biggest immediate change is that there's going to be
Speaker 2: labels now on GLP one, so all GLP one medications
Speaker 2: will note the risk of suicidal thoughts or behaviors. But
Speaker 2: I also think what is really significant about this announcement
Speaker 2: is it sends a really important message to patients who
Speaker 2: have felt ignored to be honest or even gas lit
Speaker 2: by the system by prescribers who have kind of downplayed
Speaker 2: their experiences. If you are someone taking GLP ones and
Speaker 2: you are worried about this, it is a small percentage,
Speaker 2: So I would say, you know, there's no need to
Speaker 2: immediately be alarmed if you don't have a history of
Speaker 2: mental ill health, or if you are feeling a certain
Speaker 2: way and maybe you have been doubting yourself. I think
Speaker 2: that this is really affirming to tell patients to, you know,
Speaker 2: trust themselves. Now, given this update, this new advice from
Speaker 2: the TGA, I reached out to Juniper again. A statement
Speaker 2: from doctor Matt Vickers, their clinical director, said that the
Speaker 2: TGA's recent updates to GLP one product warnings reflect the
Speaker 2: outcome of a review after what it called isolated reports
Speaker 2: of suicidality quote. As with reviews by other global regulators,
Speaker 2: no causal link has been found between GLP ones and
Speaker 2: suicidal or self harming behavior. So they said that they
Speaker 2: caution patients about the potential risk, and that they have
Speaker 2: done since the service was established. However, that contradicts I
Speaker 2: suppose what we have heard from some of them former patients.
Speaker 2: And finally, Junipers said, with millions of people now treated
Speaker 2: with GLP ones globally quote, the safety profile has continued
Speaker 2: to strengthen. Interestingly, the TGA also said on Monday that
Speaker 2: it couldn't rule out whether Munjarro, one of the popular
Speaker 2: GLP ones, reduces the strength of the oral contraceptive pill.
Speaker 2: We had heard a little bit about this before from
Speaker 2: previous studies from other health bodies, and now the TGA
Speaker 2: is advising that patients use non oral contraception for four
Speaker 2: weeks when starting munjarro and four weeks after increasing their dosage.
Speaker 2: So they're basically saying, give yourself a bit of a
Speaker 2: four week window if your intake changes or when you
Speaker 2: start the drug to ensure that you're protected. So, for example,
Speaker 2: user condom for four weeks.
Speaker 1: Interesting and just quickly before we wrap up, I also
Speaker 1: saw that there was another big announcement from the WHO
Speaker 1: this week about GLP ones.
Speaker 2: What was that, Yeah, it's been a big week for
Speaker 2: GLP ones, Billy. The WHO has released new guidelines on
Speaker 2: the use of GLP ones for the treatment of obesity
Speaker 2: in adults. Now, this is a global framework that acknowledges
Speaker 2: a need to treat obesity quote as a chronic, relapsing
Speaker 2: disease rather than a lifestyle choice. So just quickly, the
Speaker 2: WHO said, while medication alone won't solve this global health crisis,
Speaker 2: GLP one therapies can help millions overcome obesity and reduce
Speaker 2: its associated harms as part of a comprehensive approach that
Speaker 2: includes healthy diets, regular physical activity, and support from health professionals.
Speaker 2: Now it's significant because this is a global Health body
Speaker 2: basically endorsing or recommending GLP ones as an obesity treatment
Speaker 2: and also formally recognizing obesity as a chronic disease associated
Speaker 2: with high numbers of deaths a high economic burden on
Speaker 2: health systems. Now, look, it does solve the issue of
Speaker 2: suicidal ideation, of long term side effects and concern around
Speaker 2: mental health impacts. But if there is a global health
Speaker 2: body saying we need to take this treatment really seriously,
Speaker 2: saying that it is critical to solving the obesity crisis,
Speaker 2: I think that means we will see a lot more
Speaker 2: investment in understanding these side effects. So with more attention
Speaker 2: will mean more funding, more research, more transparency, and hopefully
Speaker 2: that will give patients a clearer sense of side effects
Speaker 2: and some more answers around the suicidal ideation piece.
Speaker 1: I mean, you said before that these medications have really
Speaker 1: only been around since twenty eighteen, So the fact that
Speaker 1: it is constantly changing and there is still new research
Speaker 1: still coming out about it, it does make sense given
Speaker 1: how new it is.
Speaker 2: Yeah, exactly, and we will continue to learn more as
Speaker 2: time passes, and you know, as the global conversation continues.
Speaker 1: Thank you for taking us through it, M and for
Speaker 1: all of the work that you've done this year on
Speaker 1: looking into it. What a timely announcement from the TGA.
Speaker 1: Thank you so much, Billy, and thank you so much
Speaker 1: for listening to this episode of The Daily Os. If
Speaker 1: you've got a personal story about GLP ones that you
Speaker 1: want to share with us, we would love to hear
Speaker 1: from you. You can dm us on Instagram at any
Speaker 1: time or send an email to helloatthdalilyos dot com dot au.
Speaker 1: And just a reminder that if this episode has raised
Speaker 1: any issues for you, you can contact the lifeline on
Speaker 1: thirteen eleven fourteen. We'll be back this afternoon with your
Speaker 1: evening headlines, but until then, have a great day.
Speaker 3: My name is Lily Maddon and I'm a proud Aarunda
Speaker 3: Bungelung Caalcutin woman from Gadigol Country.
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