Social media influencers were warned to stop promoting prescription medicines by the Therapeutic Goods Administration (TGA) in November.
The ‘influencers’ in question were mainly overweight mums in pyjamas and slippers, and less of the high-profile glamourous persuasion.
What prompted the warning were giddy promotions of Ozempic, a diabetic/weight-loss drug on TikTok – as seen by more than 100 million viewers.
Although Ozempic is reportedly “the hottest drug in Hollywood”, it isn’t being promoted by stars and celebrities of all stripes, who are keeping their weight-loss battles quiet.
The TGA warned these alleged pyjama-wearing influencers they were risking “jail time” – and criminal penalties of up to $888,000 for individuals and civil penalties of $1.1 million.
Early this month, presumably because the warning hadn’t been effective, the TGA announced it was now actively investigating these influencers in flannelette.
The fact is, the horse has well and truly bolted.
What’s really going on here?
In February 2021, we published a report about US researchers trumpeting a new drug – a bona fide “game changer” in the management of obesity – that has since become a global sensation.
And for good reason: The drug, semaglutide, is highly effective – unprecedented really – at causing weight loss.
In a large, gold-standard clinical trial, more than a third of the participants who took the drug lost more than 20 per cent of their weight.
This prompted the ordinarily sober New York Times, citing the researchers, to write: “For the first time, a drug has been shown so effective against obesity that patients may dodge many of its worst consequences, including diabetes.”
In fact, as we noted in our report, while people struggling with obesity were tested in the clinical trial, semaglutide was actually being developed for people with Type 2 diabetes.
The new Hunger Games
Once the drug was approved – in the US and then Australia – a version of the Hunger Games ensued, with diabetics competing with overweight people to get prescriptions.
Within a few months of the drug being launched, there were localised shortages that have since blown out to global shortages.
In the US, access to Ozempic or Wegovy – two of the brand names for semaglutide – was restricted to people who could afford the $1800-plus a month.
Ozempic was soon described as “the hottest drug in Hollywood” – with celebrities, such as a super-slim Kim Kardashian, pointedly denying they were users.
In Australia, competition for prescriptions was possibly even more feral because Ozempic was covered by the PBS.
Instead of paying $1700 per monthly, eligible patients are only paying $41 per script, or $6.60 with a concession card.
Not everyone entitled to the discount
Eligibility for the subsidy was confined to patients with Type 2 diabetes.
Were some doctors fudging their prescriptions on behalf of desperate obese patients?
Professor Michael Cowley, head of Monash University’s department of physiology, thinks it is possible.
There is the possibility of a GP saying to someone who is obese, ‘we’ll pretend you have diabetes and then you’ll get the PBS subsidy’,” Professor Cowley told The New Daily.
“I’m not saying it’s common, but it’s possible. I’m sure there are instances where someone feels justified in doing that.”
He said such a doctor “is operating in a naughty manner, but I’m sure where there are instances where a patient is in desperate need of weight loss, and there is nothing else available to them – they can’t afford bariatric surgery, maybe has pre-diabetes and maybe the doctor can stretch the definition into Type 2 diabetes”.
He said the ethical decision about who should get these drugs affordably isn’t an easy one.
The regulator steps in
These shortages were first identified in April, prompting the TGA to issue a directive to GPs to stop prescribing the drug for weight-loss management. But it became critical by November.
A newsGP report at the time stated the TGA advised that semaglutide would be unavailable in Australia until the end of March 2023.
As this puts pressure on diabetes patients who use semaglutide, the RACGP advised GPs “not to initiate either medication for new patients until the shortage subsides”.
Clearly there were GPs who ignored that directive.
Professor Cowley told TND: “If the GPs had followed that directive, we wouldn’t be having the supply challenges we are having.”
Dr Gary Deed, chair of the RACGP’s Diabetes Specific Interests Group, said the shortages couldn’t be wholly blamed on GP’s off-label prescribing, citing international shortages and supply issues.
TikTok influencers under investigation
In May, according to reports in The Guardian and Australian Doctor, the TGA blamed TikTok for the drug shortage. Influencers in the US are also said to be driving demand.
The fact is, Ozempic is now a cultural and social media sensation.
People weren’t simply documenting their weight-loss journey, they were injecting themselves with a kind of giddy Pulp Fiction cool. And then dancing around the room.
(Ozempic is injected with an epi-pen into the abdomen.)
A typical TikTok user was @taylor_gracve96, who documented her “first time injecting Ozempic” with the requisite fiddly preparation of the pen and lifting of her T-shirt, the squeezing of the abdomen, the pressing in the pointy bit, and using her thumb to drive the plunger and deliver the dose.
At that time, #ozempic had 74 million views and counting.
Now the TGA is investigating influencers on TikTok for promoting a prescription drug, which is illegal.
In its warning notice, the TGA advised: “Prescription medicines are higher-risk medicines and should only be determined as an appropriate treatment option in consultation with a professionally trained medical practitioner, rather than on the basis of consumer advertising.”
Targeting influencers may be more effective than going after GPs for writing off-label prescriptions of semaglutide.
GPS can ignore TGA advice
As the TGA explains in a statement: “Off-label prescribing is a regular occurrence in the Australian healthcare system, particularly for uncommon diseases and conditions or under-represented patient groups.
“The TGA does not have the power to regulate the clinical decisions of health professionals and is unable to prevent doctors from using their clinical judgment to prescribe Ozempic for other health conditions.”
The science of semaglutide
Semaglutide mimics a natural hormone called GLP1 – or glucagon-like peptide 1.
GLP1 is a gut hormone that is released in response to undigested food hitting the distal small bowel. Drugs mimicking the hormone make you feel full faster and longer.
At the same time, as your blood sugar levels rise, in response to you eating, GLP1 – and drugs such as semaglutide – trigger the body to produce more insulin. This helps lower blood sugar levels. This is why semaglutide is so useful for diabetics.
The first drugs to mimic GLP1 were developed nearly 20 years ago.
“We always expected them to cause weight loss,” Professor Cowley said.
“When we inject people with the natural hormone they report that they’re less hungry and nauseous. So it wasn’t a surprise that these drugs would work in obesity.
“The surprise has been how effective this particular one, Ozempic, is: The early versions didn’t cause much weight loss in most people.”
But wait. There are new drugs emerging that promise to be even more effective than Ozempic for weight loss. One of these appears to facilitate weight loss of 30 per cent of body weight.
Sounds good? Maybe not so much.
Muscle loss is an issue
Ozempic and other drugs mimicking GLP1 cause muscle loss.
According to one report, much of the weight loss resulting from GLP-1 agonists “is the loss of muscle, bone mass, and other lean tissue rather than body fat”.
What needs to be kept in mind, and GPs are no doubt aware of this, is that drugs like semaglutide are meant to be used in tandem with a healthy diet and exercise regime.
People who do weight training will be better at maintaining their bones and muscle, as well as their metabolism.
Professor Cowley told TND that the new drugs coming on to the market might be more effective for weight loss, but they will cause even greater muscle loss.
Another thing to keep in mind; as soon as you stop taking these drugs – which an unknown number of people are doing because of side effects – your suppressed appetite returns with a vengeance, and so does all the weight you lost.
Other possible side effects include: Inflammation of your pancreas,
changes in vision, low blood sugar and kidney problems. For more, see here.
Ozempic face
One of the emerging horrors for Hollywood stars using Ozempic is an older, saggier face – nicknamed ‘Ozempic face’ by a US doctor.
It’s a natural and common consequence of weight loss, especially in middle-aged people. As we age, and work to lose weight, we can end up looking gaunt.
The answer? Unfortunately, fillers or even surgery are required to fix your face while maintaining your new body.
A piece in The New York Times, detailing the horrors of ‘Ozempic face’, quoted the great French actor Catherine Deneuve: “At a certain age, you have to choose between your face and your ass.”
