In 2019, the TGA approved Ozempic for the treatment of Type 2 diabetes in adults. However, with growing popularity in its off-brand usage for weight-loss, demand for the drug has skyrocketed as increasing proportions of the Australian population continually look to it to help accelerate a lifestyle change. This brings into question, the potential long-term implications for Australian public health. Though the drug has its benefits, how it compares to other weight loss drugs and its implications for diabetes and obesity in Australia must be considered. Furthermore, the risks of the drug, regulatory implications for off-brand usage and the potential for perpetuated reliance suggests that the benefits are not without cost. Finally, within the context of uncertain legitimacy and differing government stances worldwide, what can we really expect for the future of Ozempic?
What are its benefits?
Whilst Ozempic is widely known for its effectiveness in the context of weight loss, many forget the original use of the drug. Ozempic was initially released to assist in managing type 2 diabetes, providing an alternative treatment than the common Metformin medication. However it is Ozempic’s active ingredient, Semaglutide, that proves to be the key for the array of Ozempic’s other positive effects. Semaglutide works by mimicking the incretins naturally produced in your body when you eat. Your body responds to the level of incretins in your body by producing a corresponding amount of insulin. Thus with heightened levels of incretins, the blood sugar levels decrease as there is a greater amount of insulin. It is these decreased blood sugar levels that are causing the positive effects that have been surfacing recently. Decreased likelihood for heart attack, stroke, kidney decrease and Alzheimer’s disease have all been linked with long term usage of Ozempic, due its effectiveness in decreasing blood sugar levels. Moreover, mental and well-being aspects of Ozempic usage should not be underestimated. With consistent weight loss, patients can improve their quality of life and improve their emotional well-being.
How does it compare to other weight loss drugs?
Weight loss drugs are not a recent invention. Humans have been seeking the wonder pill that can decrease weight, without any severe implications for many decades. Contrace, Saxenda, Xenixal, Qsymia are drugs that all work off similar principles of decreasing appetite, which is the same concept for Ozempic. In terms of effectiveness it can be seen that Ozempic typically outperforms traditional weight loss drugs, with Ozempic reporting almost 15% reduction in body weight, whereas standard drugs only result in a 5% to 10% decrease in weight loss.
It is difficult to compare costs with Ozempic and the most commonly used weight loss drug Phentermine. This is due to Ozempic only being authorised for use of type-2 diabetes rather than weight-loss, which is most likely the reasoning for it being upon the PBS. This means Ozempic is a third of the cost of Phentermine. In terms of alternative positive effects, Phentermine is only defined as an appetite suppressor, there has not been any other positive effects found with long term usage. However as Ozempic was predominantly created to combat diabetes, there are inherently more benefits as outlined above.
What could Ozempic mean for Obesity and Diabetes in Australia?
Whilst Diabetes rates have been decreasing, 4.6% of Australians still live with type-2 diabetes. Typical treatment for type-2 diabetes is Metformin which, like Ozempic, increases your body’s response to insulin, and such controls blood sugar levels similar to Ozempic. However it is Ozempic’s weight loss benefit which could prove to be a more effective alternative for adults with type-2 diabetes, as this increase in quality of life has the potential to initiate lifestyle changes required by people to reverse their type-2 diabetes.
Graph of Percentage of Australians Living with Type-2 Diabetes since 2000
Obesity in Australia has been consistently increasing with 32% of Australians obese and 66% percent of Australians Overweight. Treatments like Ozempic, have been acknowledged that if people were to come off Ozempic they may regain the weight they lost on the drug, and it is not suggested that the entire population rely upon medication to maintain a healthy weight. However this initial weight change when taking Ozempic could be enough to inspire lifestyle changes of people, and could push people to live a healthier lifestyle. Potentially stopping obesity in people before it becomes life-threatening.
Graph of percentage of population that is overweight in Australia since 1995
Continued Reliance by Users
Growing evidence suggests much of the improvements associated with Semaglutides, dissipate when consumers stop taking the drugs, with participants regaining 67.1% of lost weight within a year. Similarly, associated cardiovascular and blood-glucose improvements curtail after ceasing use. Resultantly patients are encouraged to remain on the drug in perpetuity or risk regressing.
This stands to transform Semaglutides into lifestyle drugs, tethering patients’ livelihoods to continued usage. With Ozempic costing between $100-$200 per month, transitioning to expanded and long-term use presents a clear financial burden. Parallels are clear with the Uk’s National Health Service’s (NHS) struggles in practically and equitably distributing lifestyle drugs, grappling with rationing and cost blow outs. Further, Ozempic parodies the quick acting insulin Fiasp, which in revolutionising diabetes management with improved ease relative to traditional insulin treatments left patients reliant on continued subsidised access.
Resultantly, when the producer limited access by withdrawing from the PBS and patient prices increased 40 fold, many were faced with the daunting task of independently meeting the drug’s exorbitant costs or experiencing sharp deterioration in livelihoods. This presents the risk of Australians effectively being extorted into paying excessive amounts for Semaglutides, with the risks magnified by the greater more widespread use of Ozempic like drugs. Thus, Ozempic risks instigating dependence which would be financially burdensome and making patients reliant on continued access under price control schemes.
Off-Brand Usage
Whilst offering revolutionary benefits in tackling chronic conditions including diabetes, the extension to novel use cases perhaps underestimates drawbacks. Despite being developed to combat diabetes, Ozempic has been further promoted for perceived cosmetic benefits. Popular interest however is incongruent with medical advice, with relative search volumes disproportionately weighted to Ozempic over more potent competitors indicative of the factual flaws underpinning the viral popularisation of these drugs.
Relative search volume of “Ozempic” vs “Wegovy” vs “Mounjaro”—June 2021 to February 2023
Further, with safety studies focussing on weighing drugs’ benefits against significant impacts of diabetes, the emerging off-brand use informally encouraged by influencers may challenge the current regulatory environment. Off-label usage ballooned 256% between 2018 and 2022, outstripping labelled usage growth. This stresses the importance of Australia adopting both clear guidelines for approved use, alongside advice to minimise unregulated usage.
Medical Risks
With potentially severe, albeit rare, side effects including promoting pancreatitis and thyroid cancer Semaglutides present tangible risks. Further, by mimicking natural hormones, Ozempic reduces free dopamine levels within the brain. Emerging research and correlated adverse incidents raise concern about these drugs’ psychological impacts, particularly for those with preexisting conditions. Ozempic misuse is also an rising issue, with patients suffering anorexia and other eating disorders employing the drug to inhibit their appetites, with experts suggesting this to be exacerbated by Ozempic’s viral popularisation promoting negative weight stigmas . Thus, the unfettered promotion adoption of Ozempic presents long-term risks potentially outweighing its temporary benefits.
U.S. Government Stance
Despite the U.S Food and Drug Administration (FDA)’s approval of semaglutide products like Ozempic for type 2 diabetes, the US government remains vigilant in addressing the drug’s impact on healthcare and pharmaceutical policies. The primary challenge the government faces is regulating the disrupted market for Ozempics. While not approved by the FDA, the off-label usage of these “weight loss” products has become widespread practice, largely due to its effectiveness in suppressing appetite (Wang et al., 2024). This put additional pressure on semaglutide medication, driving up prices and limiting accessibility for diabetic patients. Consequently, compounded and counterfeit versions of semaglutide entered the market, masked as cheaper alternatives, despite FDA’s concerns about their safety. Because compounded drugs are not subject to the same rigorous testing like FDA approved medications, they are prone to contamination and improper dosage.
FDA Warns of Safety Issues With Compounded Forms of Semaglutide
Further, American policymakers have cited concerns that medications like Ozempic, are costing over 1000 USD per month. Current president Joe Biden warned that if half of obese U.S adults started using these drugs, the cost will rapidly advance to $411 billion annually, jeopardising the financial sustainability of America’s healthcare system.
In response, the U.S government has been proactively addressing the price surge of such products caused by patent-related issues. The Federal Trade Commission (FTC) has recently challenged the patents on 20 brand-name drugs, including Ozempic, for filing misleading patents to block competition while maintaining high prices. For example, Novo Nordisk, the creator of Ozempic, has received warning letters regarding patents that prevent cheaper alternatives from entering the market, and acting as a pricing barrier.
Stance of Governments in EU
Parallel to America’s predicament, governments of Europe are addressing issues with the off-label usage of Ozempics, and the consequential shortage in semaglutide medication. Nonetheless, while the U.S gravitates on a private health system where the financial burden lays mostly on patients and insurance companies, in the European model, the public healthcare system bears the strain.
The European Medicine Agency (EMA) prioritises equitable distribution of semaglutide through public healthcare systems. In Europe, semaglutide is publicly funded for approved use in treating medical conditions such as diabetes. Nonetheless, the increasing off-label use for weight loss– which is not covered under public healthcare– builds additional pressure on public healthcare to expand its coverage. This ultimately adds pressure on public budgets, and could eventually lead to rationing of medicine and delays in treatment to those in critical conditions.
To address this, the EMA is urging its member states to implement national guidelines that prioritise patients who are critically dependent on the medicine, including those with Type 2 diabetes and obesity-related medical issues. Moreover, European countries with a market-based health insurance system like Switzerland, can negotiate directly with pharmaceutical companies to secure favourable pricing. This allows governments to purchase semaglutide at discounted prices, ensuring that they remain affordable for the public and can be included in healthcare plans without overstretching the budget.
Australian Government Stance
Despite Therapeutic Goods Administration (TGA)’s approval of Ozempic for strictly diabetic treatments, many Australians are using it off-label for weight loss, driven by social media endorsements and celebrity usage. Hence, similar to America and Europe, Australia faces supply shortages of semaglutide medicine, amplified by issues related to the prevalence of compounded products
Nevertheless, Australia’s approach to addressing compounded versions of semaglutide is stricter than that of the U.S and Europe. While Europe’s EMA tackles this through public health systems, and America’s FDA confronts patent-related pricing, Australia’s TGA has decided to completely ban all compounded variants of Ozempic and similar products starting in October 2024. Australia’s emphasis on regulatory loopholes related to compounding practices, connoting the more direct Australian approach in controlling drug safety and supply.
Conclusion
It is clear from earlier analysis that the presence of Ozempic can bring about both negative and positive implications for public health within an Australian context. It is apparent that the drug can have varying health benefits for diabetic and obese patients alike and compares well against other weight loss alternatives.
However it is important to consider the medical risks of the drug, the implications of off brand usage such as supply shortages and the chance that it may turn into a ‘lifestyle drug’ for users. Therefore, it is recommended that Australia proceed with caution in the use of Ozempic if it wishes to continue to maintain the long-term wellbeing of its population.
References:
Ann Mayer, B. (2023). Ozempic and Eating Disorders: Why Experts Are Raising Concerns. Retrieved from Healthline: https://www.healthline.com/health-news/ozempic-and-eating-disorder-risks
Australian Government. (2024). Overweight and obesity. Retrieved from Australian institute of Health and Welfare: https://www.aihw.gov.au/reports/overweight-obesity/overweight-and-obesity/contents/about
Australian Government. (2024). About the Ozempic (semaglutide) shortage 2022 – 2024. Retrieved from Therapeutic Goods Administration: https://www.tga.gov.au/safety/shortages/information-about-major-medicine-shortages/about-ozempic-semaglutide-shortage-2022-2024
Australian Government. (2024). Diabetes: Australian facts. Retrieved from Australian Institute of Health and Welfare: https://www.aihw.gov.au/reports/diabetes/diabetes/contents/how-common-is-diabetes/type-2-diabetes
Australian Government. (n.d). SEMAGLUTIDE. Retrieved from The Pharmaceutical Benefits Scheme: https://www.pbs.gov.au/medicine/item/12075M-14163K
Ball, L., & Burch, E. (2024). Considering taking a weight-loss drug like Ozempic? Here are some potential risks and benefits. Retrieved from The University of Queensland: https://public-health.uq.edu.au/article/2024/04/considering-taking-weight-loss-drug-ozempic-here-are-some-potential-risks-and-benefits
Bolton, M. (2023). Ultra-fast insulin drug Fiasp to be removed from PBS making it unaffordable for many diabetes sufferers. Retrieved from ABC news: https://www.abc.net.au/news/2023-03-02/ultra-fast-insulin-fiasp-diabetes-drug-removed-from-pbs/102043628
Bonyhady, N. (2024). Replica Ozempic and Mounjaro will be banned by October. Retrieved from Australian Financial Review: https://www.afr.com/technology/replica-ozempic-and-mounjaro-will-be-banned-by-october-20240521-p5jfgh
diabetes australia. (n.d). Medicines for your diabetes. Retrieved from diabetes australia: https://www.diabetesaustralia.com.au/managing-diabetes/medicines/
FDA. (n.d). Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss. Retrieved from FDA: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss
Australian Government. (n.d). OZEMPIC (Novo Nordisk Pharmaceuticals Pty Ltd). Retrieved from Therapeutic Goods Administration: OZEMPIC (Novo Nordisk Pharmaceuticals Pty Ltd)
Guerdjikova, A., Ontiveros, M., & McElroy, S. (2024). Semaglutide Misuse in Atypical Anorexia Nervosa—A Case Report. Retrieved from Journal of Clinical Psychopharmacology: https://journals.lww.com/psychopharmacology/citation/2024/03000/semaglutide_misuse_in_atypical_anorexia_nervosa_a.15.aspx
Han, S., Safeek, R., Ockerman, K., Trieu, N., & al., e. (2023). Public Interest in the Off-Label Use of Glucagon-like Peptide 1 Agonists (Ozempic) for Cosmetic Weight Loss: A Google Trends Analysis. Retrieved from Aesthetic Surgery Journal: https://academic.oup.com/asj/article/44/1/60/7218900
Itzstein. (2020). Introducing Ozempic. Retrieved from Diabetes Australia: OZEMPIC (Novo Nordisk Pharmaceuticals Pty Ltd)
Jia-Rui, L., Jinya, C., Jing, W., & Geng, W. (2023). Case Report: Semaglutide-associated depression: a report of two cases. Retrieved from PubMed Central: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10495976/
Kim, W., & Egan, J. (2008). The Role of Incretins in Glucose Homeostasis and Diabetes Treatment. Retrieved from PubMed Central: https://medlineplus.gov/druginfo/meds/a618008.html#:~:text=Semaglutide%20injection%20is%20in%20a,it%20is%20used%20for%20energy
MARI, E. (2024). Ozempic is running short and private clinics are to blame, says EU watchdog. Retrieved from POLITICO: https://www.politico.eu/article/ema-blame-private-cosmetic-prescription-diabetes-weight-loss-drug-shortage/
Mailhac, A., Pedersen, L., Pottegård, A., Søndergaard, J., Mogensen, T., Sørensen, H. T., & Thomsen, R. W. (2024). Semaglutide (Ozempic®) Use in Denmark 2018 Through 2023 ‒ User Trends and off-Label Prescribing for Weight Loss. Clinical Epidemiology, 16, 307–318. https://doi.org/10.2147/CLEP.S456170
Meacham, J., & Ajmera, R. (2024). Are Weight Loss Medications Effective? A Dietitian Explains. Retrieved from Healthline: https://www.healthline.com/nutrition/weight-loss-medication
MedlinePlus. (2024). Semaglutide Injection. Retrieved from MedlinePlus: https://medlineplus.gov/druginfo/meds/a618008.html#:~:text=Semaglutide%20injection%20is%20in%20a,it%20is%20used%20for%20energy
NHS. (n.d). Understanding medicine. Retrieved from NHS: https://www.nhs.uk/conditions/type-2-diabetes/understanding-medication/
Noxon-Wood, V., Moore-Schiltz, L., & Tkacz, J. (2024). Off-Label Use of Semaglutide in the United States: Increasing Prevalence, Variability in Prescribing Provider Specialty, and Patient Characteristics.Retrieved from Ispor.org: https://www.ispor.org/docs/default-source/intl2024/semaglutide-off-label-use-poster—4-26-2024final136048-pdf.pdf?sfvrsn=6aa1eb42_0
Pace, J., Bartlett, A., & Wheate, N. (2024). Ozempic isn’t approved for weight loss in Australia. So how are people accessing it? Retrieved from The Conversation: https://theconversation.com/ozempic-isnt-approved-for-weight-loss-in-australia-so-how-are-people-accessing-it-224859
Perez, A., Davidson, K., & Van De Walle, G. (2023). Does Phentermine Work for Weight Loss? A Diet Pill Reviewed. Retrieved from Healthline: https://www.healthline.com/nutrition/phentermine-weight-loss
Perrone, M. (2024). US challenges ‘bogus’ patents on Ozempic and other drugs in effort to spur competition.Retrieved from AP news: https://apnews.com/article/ftc-drug-patents-prices-fda-6ee880c52028115a83b79553c486ec01
Rapaport, L. (2023). Ozempic Shortage: How a Weight Loss Fad Has Slashed Access to a Diabetes Drug.Retrieved from Everyday Health: https://www.everydayhealth.com/type-2-diabetes/ozempic-shortage-how-a-weight-loss-fad-has-slashed-access/
Roy, A. (2019). What Medicare Can Learn From Other Countries on Drug Pricing. Retrieved from FREOPP: https://freopp.org/whitepapers/what-medicare-can-learn-from-other-countries-on-drug-pricing/
Staff, M. C. (2022). Weight Loss. Retrieved from Mayo Clinic: https://public-health.uq.edu.au/article/2024/04/considering-taking-weight-loss-drug-ozempic-here-are-some-potential-risks-and-benefits
Stearn, E. (2024). EU drug chiefs hit out at ‘excessive cosmetic use’ of jabs like Ozempic that’s causing shortages with ‘serious consequences for public health’. Retrieved from Daily Mail Australia: https://www.dailymail.co.uk/health/article-13575171/EU-drug-chiefs-hit-excessive-cosmetic-use-jabs-like-Ozempic-thats-causing-shortages-consequences-public-health.html
Tyson, A., & Kikuchi, E. (n.d). How Americans View Weight-Loss Drugs and Their Potential Impact on Obesity in the U.S. Retrieved from Pew Research Center: https://www.pewresearch.org/science/2024/02/26/how-americans-view-weight-loss-drugs-and-their-potential-impact-on-obesity-in-the-u-s/
Wang, G., Rahim, E., Bari, S., Haque, H., Rahim, F. O., & Palakodeti, S. (2024). Public Health Responsibilities in the Era of GLP-1 Receptor Agonists. Journal of Public Health Management and Practice, 10-1097.
Wilding, J., Batterham, R., & Calanna Salvatore, e. a. (n.d.). Once-Weekly Semaglutide in Adults with Overweight or Obesity. The NEW ENGLAND JOURNAL of MEDICINE.
Wilding, J., Batterham, R., Van Gaal, L., & al., e. (2022). Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Retrieved from Obesity and Metabolism: https://dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.14725
Wingrove, P., & Mishra, M. (2024). Novo Nordisk, Lilly must cut US prices of weight-loss drugs, Biden says.Retrieved from Reuters: https://www.reuters.com/business/healthcare-pharmaceuticals/biden-says-novo-nordisk-must-cut-prices-diabetes-weight-loss-drugs-2024-07-02/
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