Hamish Macdonald:
It's new drug taking Hollywood by storm, but as epic as it's known is not a party pill.
It's an injectable medicine originally designed for diabetics, but it's being promoted online for its side effect, which is weight loss. That's got Australia's drug regulator concerned.
It's now investigating the drug's popularity on social media, which has triggered so much demand that there's now, in fact, a worldwide shortage. Adjunct Professor John Skerritt is head of the Therapeutic Goods Administration.
Good morning to you. Welcome back to Breakfast.
John Skerritt:
Yes, good morning, Hamish.
Hamish Macdonald:
It is an injectable medicine, I suppose it is incredible in terms of what it's meant to achieve as well.
John Skerritt:
It is a very valuable medicine in diabetes and it's injected once a week. What it does if you have diabetes, is that it produces more insulin, it stops the breakdown of glucagon by your body. And what that does for diabetics is help them control their blood glucose, but it also reduces appetite and slows stomach emptying. And that's good for diabetics because it reduces their carbohydrate breakdown and absorption, but it also gives rise to weight loss, which is why it's become so popular for these other uses.
Hamish Macdonald:
So it's official name, I think is Semaglutide, is that correct?
John Skerritt:
Semaglutide is its scientific name and Ozempic, is the form for diabetes. There is another form of the product that's approved but not available in Australia yet called Wegovy, which is designed for weight loss in certain individuals.
And I really need to emphasise it isn't a magic pill that you can take a hamburger one day and have this pill the next. It's designed for a narrow group of patients at a different dose, in a different form.
But it's not yet available for weight loss.
Hamish Macdonald:
And what do we mean when we use the term prescribing off label? Because when I read about this story that's referenced quite a bit.
John Skerritt:
So let's go back a step. Both the Therapeutic Goods Administration who approved the drugs and then the Pharmaceutical Benefits Scheme, which, as you know, pays the major cost of these quite expensive medications, have certain conditions or indications that are approved.
It's not illegal for a doctor to prescribe something off label. So is the doctor does prescribe for weight loss they're not breaking the law, but they take the full medical and legal responsibility and at the end of the day, whether or not it is consistent with good medical practice.
Hamish Macdonald:
And so why has particularly Ozempic popped up on social media and become this big trend fad, if you like?
John Skerritt:
Well, everyone is everyone wants to be younger, better looking and slimmer. And of course, weight loss is one of the main things promoted, including a lot of quack cures that don't work for weight loss on social media.
And so the shortage of this product worldwide is really stimulated by two things. It's been a much more effective anti-diabetic drug - not for all diabetics though (as there are about seven or eight different types of drugs for diabetes). but for diabetics with particular characteristics of their diabetes, it's proved to be a lot more popular and a lot more valuable.
So that drove the original shortage and it was pushed along by all this social media promotion for weight loss.
Hamish Macdonald:
And how serious is the shortage in Australia?
John Skerritt:
It's a very serious shortage. It first started in April 2022 and we think it'll be April 2023 at this stage until the supplies will be back to normal. It's a very complicated molecule, so it's not as if someone could whip up a factory to start manufacture it in a matter of months locally.
It would take years to establish more manufacturing facilities because it is a very complex chemical substance. And so what it means is that there's so little product around that the relevant clinical groups have decided that newly-diagnosed diabetics can't be started on it, because the important thing with diabetes medicines (like a lot of other conditions) is you've got to keep taking the medicines once you have been prescribed them.
And there are alternatives and it depends on the nature of your diabetes. Doctors can point you towards either an alternative called an SGLT2 inhibitor if you've got heart problems or kidney problems. Or if your main problem is control of sugar, they’ll point you towards a drugs called DPP-4 inhibitors.
You've got to love these complex names!
Hamish Macdonald:
So what happens to the diabetes patients who are already on Ozempic?
John Skerritt:
So for those who are already on it, we have been able to bring in some supplies from overseas, from other countries through a couple of companies, but they are very, very short in supply.
And so some of those diabetics might be able to get those supplies. And pharmacists have the information about those companies, as do doctors. But many people who are already on it have had to move on to one of these other drugs - as I said before, SGLT2 or DPP4 type drugs, a couple of the other classes of the six or seven types of anti-diabetic medicines that exist.
Hamish Macdonald:
And so how are you engaging with the social media platforms where so much of this is going on?
John Skerritt:
They have been very co-operative and we work with them in many ways. Now, I can't comment on particular ongoing investigations that could result in fines or court action, but we're working with Tik Tok, Instagram, Facebook, eBay, Amazon and Gumtree because it's been all over a lot of them.
They can find certain keywords and they can block posts for posting that content. And again, they can refer or we can identify potentially unlawful advertisements and say to those media platforms “can you take them down”. And it is illegal to advertise prescription medicines to the public. There's a good reason because this medicine which you've indicated is injectable and is not harmless.
Apart from side effects like diarrhea, nausea and vomiting, there's some people who can get cancers or tumors in their thyroid. The pancreas can swell, stomach pain, depression, kidney damage and so forth. This is in a minority of patients, I should emphasise.
But that's why you have a doctor involved in prescribing a prescription medicine.
Hamish Macdonald:
And when you say these platforms are cooperating, are they genuinely?
John Skerritt:
Oh, yes, they are. I mean, one of the challenges of social media, of course, is that unlike broadcast media, they don't control their content the same way that the ABC decides what they put on their programs.
It is user generated and that creates a massive problem.
Hamish Macdonald:
It's a convenient get out clause for them, isn't it?
John Skerritt:
It's a get out of clause if they don't do anything. But we have been strongly encouraged by working with them, not just here, but also with advertising of other medicines and products illegally, and they're now well aware of the issue.
The trouble is, of course, there's many ways of saying “weight loss” without using the word Ozempic. And so their challenge is having algorithms that effectively block illegal ads.
And so it's a little bit like mushrooms. The advertisements spring up.
Hamish Macdonald:
And I know you said that you won't comment on specific investigations. But are you conducting investigations currently into this?
John Skerritt:
We are. And of course, we're mainly interested if there are commercial entities that are promoting it. One of the other things that we are strongly advising people not to do is to go online and try to buy this medicine from China or Eastern Europe or the US or North America.
Like any prescription medicine, you should be working with your doctor to see whether it is right for you. One of the other troubles with this and many other medicines is it interacts with other medicines.
And so if people are on certain antibiotics or certain drugs for rheumatoid arthritis or depression, it can quite significantly interact with those. So it’s really important that people only consider this drug for whatever purpose - diabetes or weight loss - if it's on doctor's prescription and they're working closely with their doctor.
Hamish Macdonald:
John Skerritt, thank you very much.
John Skerritt:
Thank you very much, good morning.
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