Opinion is divided over who should be able to access the controversial weight loss medicine.
For around a year, an injectable drug meant for diabetes control has been at the eye of a social storm of sorts.
Ozempic (semaglutide, Novo Nordisk) found fame online for its weight-loss properties, and the bump in demand meant it quickly went into shortage worldwide.
The TGA has publicly blamed social media influencers for the supply problems and has all but begged doctors to only prescribe it to people with type 2 diabetes.
This has not gone down smoothly.
The drug is still in shortage, but non-diabetic patients are still presenting to GPs and asking for a prescription by name.
So, with supply low and demand high, who deserves Ozempic?
There are three sides to this coin, each with its own pitfalls – there’s the pure evidence-based published-research approach, the obesity-as-disease view and the emerging health-at-every-size paradigm.
At the centre, though, is the way obesity and weight loss are perceived both medically and on a social level.
Despite mounting evidence to the contrary, obesity is still often seen as a lifestyle choice or inherently linked with negative personal attributes like laziness and greed.
But first, a semaglutide refresher
Ozempic is a brand of semaglutide approved in Australia for insulin-resistant type 2 diabetes management.
People on the medicine typically report experiencing a sustained feeling of fullness, or even a revulsion to food.
The biggest randomised control trial of its weight loss properties so far, which followed 2000 US patients, found that people on the medicine lost about 15% of their body weight after 68 weeks on semaglutide.
Another trial found the effect holds long-term – patients who had been on the medicine for two years were able to keep that 15% of baseline bodyweight off.
In 2022, it went viral online for its weight-loss properties and quickly went into low supply globally.
There are a few other brands in the same glucagon-like peptide 1 receptor agonist class which have been approved in Australia; the sudden increase in demand has put all of them into shortage.
It’s worth noting here that Novo Nordisk does not advertise Ozempic as a weight loss drug. It does have another semaglutide formulation, marketed as Wegovy, which is specifically for chronic weight management.
Wegovy is approved in Australia for this indication, but the point is somewhat moot given that there is currently no supply of the medicine.
Novo Nordisk has told TMR it is working to bring Wegovy to Australia, but has not given a date.
The TGA’s medicine shortages database indicates that Australian supply of most brands of GLP-1 agonists is expected to return to normal in April, and the Pharmacy Guild of Australia anticipates “limited stocks” to return over the next few weeks.
Industry sources tell TMR that the shortage itself is likely to last into June. The TGA announced this week that stocks had started arriving in Australia, but warned it would be some time before stock levels stabilised.
Complicating matters is the fact that the PBS price for Ozempic is set low compared with what private insurance companies in countries like the USA are prepared to offer, making Australia a low priority for supply.
Some pharmacies have been able to order in overseas stock of Ozempic under a section 19A approval, but pharmacists say that even this supply has become more expensive and harder to find.
Just the facts, ma’am
When focusing only on the published evidence on Ozempic, it makes perfect sense to limit use of the medicine just to patients with type 2 diabetes.
The main point to take into account, says medical ethicist Dr Kathryn MacKay, is Ozempic has only been approved by the TGA for a single use.
“It seems to me that if you’ve got on-label and off-label prescription practices, and then you have a shortage of a drug, you ought to be prioritising the actual issues for which the drug was approved,” she tells TMR.
Because off-label prescribing tends to be more informal, Dr MacKay argues that there is less information about adverse events in people without diabetes.
“I think that it would be really important to gather together [data on] what is happening to people when they stop, or if they’re on it long-term,” she says.
According to Novo Nordisk, the serious side effects of Ozempic include possible thyroid tumours, pancreatitis, hypoglycaemia, kidney failure, changes in vision and gallbladder problems.
The more common side effects are nausea, vomiting, diarrhoea, abdominal pain and constipation.
Recent evidence also indicates that Ozempic weight loss is temporary; one study found that a year after going off semaglutide, patients gained back two-thirds of the weight they lost.
“There are so many different [factors] that contribute to people’s bodyweight,” Dr MacKay says.
“This particular drug, with its particular mechanism, which has this side effect of inhibiting appetite – how is that different from a regular appetite suppressant?
“What are the side effects going to be that eventually harm people or make it impossible for them to be on this long-term, and therefore they’ll gain weight back?
“We haven’t got a single thing yet that is a lifelong permanent fix [for obesity].”
In theory, there are a range of different options available to manage obesity, but relatively few options exist for people with insulin-resistant type 2 diabetes.
Obesity-as-disease
The counterargument here is that people with obesity have often explored lifestyle changes and interventions – sometimes for years – with little or no success.
“After weight loss there is a change in the hunger-controlling hormones in a direction that makes you more hungry,” endocrinologist and obesity specialist Professor Emeritus Joseph Proietto tells TMR.
“The hunger-causing hormone, ghrelin, goes up and all of the others that take hunger away go down,” the University of Melbourne clinician says.
In 2011, Professor Proietto co-authored a paper which found that those hormone changes are long lasting.
Essentially, his research indicates that the body “never gives up” trying to regain weight.
“That’s why no public health measures that educate the public will ever work,” he says.
Professor Proietto is also a firm proponent of the research which has pointed to a genetic cause for obesity.
“[Most people] have not one but two negative feedback systems to prevent [obesity],” he says.
“The first one is leptin, a very powerful hormone that inhibits hunger … as you accumulate fat, you make more and more of this hormone that tells you to stop eating.
“And [secondly] a few years ago rat and mice study was published which [suggested] our own bones can weigh us and the osteocytes then send a signal to the brain to make us eat less if they detect higher weight.”
In order to develop obesity, Professor Proietto says, a person would therefore need to have some form of genetic resistance to both those systems.
Then there are the potential complications of obesity.
“Obesity has more complications than diabetes, and top of the list of complications of obesity is actually diabetes,” he says.
“Then there’s sleep apnoea, infertility … no system is spared in terms of complications.”
It’s by no means a fringe opinion; last year, the American Endocrine Society updated its page on obesity to reflect that “obesity results from a complex biology whereby the body increases the amount of fat it wants to hold on to”.
There’s also emerging evidence that obesity is tied to inflammatory conditions like psoriasis and psoriatic arthritis.
Under Professor Proietto’s reasoning, patients with obesity who may be at risk of developing diabetes should have access to Ozempic as a preventative; he even wrote to the TGA saying as much.
The idea is that, essentially, people living with obesity are victims of a disease just as much as people with type 2 diabetes and should have equal access to the medicines.
GPs who do want to treat patients for obesity will find themselves hard up for a clear set of rules on what to do. The last set of clinical practice guidelines for the management of overweight and obese Australians was rescinded back in 2018.
While those guidelines are still accessible online, they only ever received minor updates after their release in 2010 – nine years before the first semaglutide product was even approved in Australia.
Deakin University is working on a new set of guidelines, but the release date is currently set at mid-2024.
“It really is ridiculous, given that [obesity is] the number one public health issue that we’ve got,” Dr Natasha Yates, a GP with special interest in obesity management, tells TMR.
“And yet … we’ve been flying blind for years on it.”
Prior to the shortage, she had been writing scripts for Ozempic for some of her non-diabetic patients.
“I was happy to write it for certain patients, but I was making that judgement clinically, based off my kind of assessment and experience as a GP,” she says.
“And the problem is there are no guidelines – so what I decided is an appropriate prescription might be different to what my colleague decides, and there’s no protection for either of us.”
Health at every size
Dr Yates takes a similar line of reasoning as Professor Proietto – that managing obesity doesn’t just come down to telling the patient to eat less and exercise more – but comes to a slightly different conclusion.
“For most people it’s not a choice to live with obesity,” she says.
“The blame and shame they feel is impacting them beyond their weight, it’s impacting them emotionally and physically.”
When Ozempic does come back into stock, Dr Yates says, the easy thing to do will be to write patients with obesity a script for semaglutide.
But just managing weight will not necessarily improve that person’s overall health.
“There’s always a genetic component, an environmental component or a societal component [to obesity]; there is no one cause so there’s no one cure,” she says.
The multifactorial approach more closely aligns with a growing recognition that people can be, in a holistic sense, healthy at any size.
No one is pushing the narrative that obesity is benign, but there is a growing movement to not use kilograms and BMI as a finite marker for ill-health and poor nutrition.
Molecular nutritionist Dr Emma Beckett, who has published more than 50 peer-reviewed articles on nutrition and health science, tells TMR that rapid weight loss – the kind that happens on Ozempic – puts people at risk of malnutrition.
“We have this simplified idea that if someone loses weight, they’re nutritionally better,” she says.
“But if you suppress someone’s appetite without giving them training in how to choose healthier foods, if they’re just eating the same foods they always ate at a lower volume then yes, they will lose weight, but they will not necessarily be well nourished.”
Nutritional health and eating habits have not been investigated at length in the published research on Ozempic so far.
“It’s really important that whenever we do manage people with weight loss, that we don’t just look at [the number of kilograms shed] as the one metric, but that we do look at it in the context of their actual nourishment,” says Dr Beckett.
Further complicating matters is the fact that weight and weight loss is tied up in how people talk about health on a social level.
For example, distaste for someone’s appearance may be couched in language like, “I’m just worried about your health”.
Without addressing the other factors that play into obesity, prescribing Ozempic alone can reaffirm the idea that weight alone is the only problem worth addressing. For this reason, Dr Beckett and Dr Yates urge clinicians to use caution.
“Generally, you don’t see people going around telling their friends to put down their beer because they’re worried about their health.
“If we’re all truly worried about each other’s health in that way, surely we would see that kind of behaviour for other [risk factors], not just weight.”
