Semaglutide (Ozempic®) has been a weight game-changer for patients – but what happens now that a newer version of Wegovy® has finally been launched in Australia? What was the upshot of the US Senate Inquiry about weight loss drugs last month?
And what are the 1090 lawsuits against the manufacturer about? Here are some important new facts Australians need to know, courtesy of Melbourne Bariatric and Laparoscopic surgeon Dr Jason Winnett.
Wegovy ® is finally in Australia
In recent years, the widespread patient demand for semaglutide (Ozempic®) has created unprecedented challenges for GPs and patients.
“Due to global shortages, doctors were forced to choose between patients with diabetes who wanted to use the drug for the disease it was designed for – diabetes. And then we had obese patients who wanted to use Ozempic® off-label for weight loss,” says Dr Winnett.
He said diabetes patients felt they were short-changed by not receiving drugs when they needed them, and severely overweight patients believed they were being discriminated against by being denied access to a life-saving drug.
The situation changed significantly recently, when Wegovy®, the more powerful “sister drug” of semaglutide (Ozempic®) finally became available in Australia in August 2024.
For patients with diabetes, this means that Ozempic® will be the drug of choice, and patients who were using Ozempic® off-label for weight loss, will now be prescribed Wegovy®.
Pricing Challenges and Ethical Concerns
Dr Winnett says the debate has been further fuelled by a recent September 2024 US Senate enquiry, which asked senior management of Novo Nordisk, the manufacturer of both drugs, why Americans were charged prices 15 times higher than other countries – US$969 for Ozempic® and $1349 for Wegovy® per month.
Meanwhile, in Australia, there have been separate issues of fake compounding and price gouging in recent months. Dr Winnett says ‘questions should also be asked’ about the efficacy, standardisation, and ethics of online companies globally performing online telehealth consults and dispensing these drugs – often with significant fees on top.
“Ozempic® costs $40 a month under PBS for diabetic patients. However, when Wegovy® was recently made available in Australia in August 2024, pharmacists were advised they were no longer allowed to dispense Ozempic® for weight loss patients. The drug is not yet covered by PBS hence the higher price point of $460 per month in Australia for weight loss patients.”
“These drugs are clearly lifesaving for many people. But we need to ask why there are such huge discrepancies in pricing globally, and also based on where a patient lives, who they say and why one chronic disease should cost more than another that is similarly devastating.
A monthly price point of $460 also means many Australians will not be able to afford these life-saving drugs. And for severely obese patients at least, we need to look at what is fair and cost-effective in the long run. Treat the disease now or spend tens of thousands of dollars more on asthma, arthritis, sleep apnoea, cancer and hypertension complications of diabetes”, Dr Winnett concludes.
What was the fake Semaglutide “compounding” issue?
Following a Four Corners investigation earlier in 2024, the production of Semaglutide by compounding chemists was banned last month (October 2024).
The investigation found a compounding pharmacist illegally shipped replica products of semaglutide (Ozempic ®) overseas, creating widespread public safety concerns.
The Four Corners report found that the unlawfully compounded drugs caused extra side effects including loss of nerve sensation, due to elevated levels of Vitamin B12 and L-carnitine.
“It is important to use a trusted prescriber such as a GP, bariatric physician or bariatric surgeon and to use a reputable pharmacy when using semaglutide or any weight loss drug,” says Dr Winnett. “Medical oversight and pharmaceutical expertise is just as important as the medication itself.”
How effective is semaglutide anyway?
The potency of semaglutide was first confirmed in 2021 in The New England Journal of Medicine resulting in 14.9% weight loss compared to 2.4% placebo in 1961 subjects over 68 weeks.
A third of semaglutide group patients lost 20% of weight. Furthermore, 84% of patients with pre-diabetes returned to normoglycemia, compared with 47.8% in placebo.
Weight circumference in the semaglutide group was -13.4cm, compared with -2.4cm in placebo.
There was also no difference between benign and malignant neoplasms, and one death was recorded in each group.
The study’s dosing was slightly higher than the dosage used in Australia: 2.4mg weekly (Wegovy ®) compared with 1mg weekly (Ozempic®).
The two drugs are essentially the same ingredient – and just have different dosages.
“The reason why semaglutide has constantly been in shortage globally is because it is a very effective short-term weight loss solution. It also helps keep blood sugar under control for patients with diabetes,” says Dr Winnett. “Weight loss surgeons also tend to use it as a pre-surgery adjunct to enhance weight loss before surgery; thus, making it easier and safer to navigate through less fat.”
In May 2024, a second study in the New England Journal of Medicine found that the risk of a primary heart or kidney event was 24% lower in the semaglutide group. This study followed 3533 participants with Type II diabetes for 3.4 years.
“These studies show us that for people with diabetes, there is significant risk reduction of heart attack and kidney disease with semaglutide,” says Dr Winnett.
But is it a silver bullet?
Some patients may see semaglutide as a fast fix. Apart from weight loss, improved diabetes and reduced cardiovascular disease, a new study in Science News recently found semaglutide may potentially reduce addiction to alcohol, nicotine and heroin through a dampening effect of the brain’s reward centre.
But there are certainly some big downsides to consider. Much of the lost weight tends to pile straight back on after you stop taking it according to one study of 1961 patients in the Diabetes, Obesity and Metabolism Journal and there are side effects that are not insignificant.
“Semaglutide is not a “magic pill,” says Dr Winnett.
“The first landmark NEJM study in 2021 found that while there are significant weight and diabetes benefits, there is also a higher risk of pancreatic inflammation. In the semaglutide group, this was 2% v 1.2% placebo for gallstones, however all recovered,” says Dr Winnett.
“Common side effects included diarrhoea and nausea and there were some serious gastrointestinal side effects (9.8% in the control group and 6.4% in placebo).”
Semaglutide has also more recently been linked to the stomach-paralyzing condition gastroparesis, which has resulted in 1090 personal injury lawsuits in the US.
“Gastroparesis disrupts regular, spontaneous muscle movements in the stomach,” says Dr Winnett. This prevents proper stomach emptying and can be very uncomfortable and cause symptoms of feeling full, vomiting, weight loss, tummy pain and bloating. It tends to be a chronic and painful disease. Whilst not usually life-shortening, and a condition which can be managed, it cannot be cured.”
He explains that while weight loss drugs can rarely cause the condition, viruses, thyroid issues, and autoimmune conditions—including Type 2 diabetes—also increase the risk of gastroparesis.
“Despite gastroparesis being a rare side effect of semaglutide, patients still need to know the risks which should be discussed and carefully managed by an experienced GP, or weight loss specialist physician or surgeon,” he says.
“Any side effects must be carefully considered and weighed up against the “side effects” of not taking medications. This includes premature death for the morbidly obese as well as increased risk of heart attacks, cancer risk, joint pain, immobility, infertility and depression.
He also says semaglutide should be prescribed and used judiciously. “It has a place for extreme obesity, for surgical patients and for patients with diabetes. However, given the supply issues and the needs of these specific patients, it should be used and prescribed appropriately.
Pricing (October 2024)
Ozempic costs $40 a month under PBS for diabetic patients. However, when Wegovy® was recently made available in Australia in August 2024, pharmacists were advised they were no longer allowed to dispense Ozempic for weight loss patients. Wegovy® prices are below as RPP pharmacies. The drug is not yet covered by PBS, hence the higher price points.
At Winnett Specialist Group, we take a holistic approach to weight loss that includes injectables as part of a comprehensive plan. Alongside injectables, our method includes consultations with a dietitian, personal training sessions, and psychological support.If you would like expert advice, please contact us or call us at (03) 9417 1555 to learn more about how we can help you achieve your weight loss goals and improve your overall health.
Mr Jason Winnett
Laparoscopic and Bariatric Surgeon
P (03) 9417 1555 admin@winnettspecialistgroup.com.au
www.winnettspecialistgroup.com.au
Queens Terrace, 382 Victoria Parade, East Melbourne 3002
References
5 The weight-loss drug Wegovy may also help treat addiction (sciencenews.org)
7 Ozempic Lawsuit: May 2024 Gastroparesis Lawsuit Update (drugwatch.com)