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Editorial Comment|Articles in Press

Weighing in on the Scale of Justice for Equity and Access to Weight-Management Drugs

Published:March 10, 2023DOI:https://doi.org/10.1016/j.clinthera.2023.02.008
Weighing in on the Scale of Justice for Equity and Access to Weight-Management Drugs
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      Of the recent drugs to emerge on the market, perhaps none has garnered as much enthusiasm or media attention as semaglutide. First approved by the US Food and Drug Administration (FDA) in 2016 for the treatment of patients with type 2 diabetes mellitus, semaglutide is a glucagon-like peptide (GLP)-1 agonist.
      • Dhillon S.
      Semaglutide: first global approval.
      Drugs. 2018; 78: 275-284
      Its numerous mechanisms of action via the GLP-1 pathway include the augmentation of insulin secretion (glucose dependent), inhibition of glucagon release, suppression of hepatic gluconeogenesis, delayed gastric emptying, and reductions in appetite and energy intake.
      • Mahapatra MK
      • Karuppasamy M
      • Sahoo BM.
      Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes.
      Rev Endocr Metab Disord. 2022; 23: 521-539
      Reported adverse effects of the drug include hypoglycemia, gastrointestinal discomfort, pancreatitis and pancreatic cancer, thyroid C-cell tumors, gallbladder events, cardiovascular events, acute kidney injury, diabetic retinopathy, and injection-site and allergic reactions.
      • Smits MM
      • Van Raalte DH.
      Safety of semaglutide [erratum in: Front Endocrinol (Lausanne). 2021;12:786732].
      Front Endocrinol (Lausanne). 2021; 12645563https://doi.org/10.3389/fendo.2021.645563
      Available in both injectable and more recently oral formulations, by 2020, semaglutide ranked as the 129th most prescribed drug in the United States, with more than 4 million patients per year prescribed the drug.

      Semaglutide [Wikipedia website]. Available at: https://en.wikipedia.org/wiki/Semaglutide. Accessed February 22, 2023.

      A beneficial and highly coveted effect of semaglutide is weight loss.
      • Christou GA
      • Katsiki N
      • Blundell J
      • et al.
      Semaglutide as a promising anti-obesity drug.
      Obes Rev. 2019; 20: 805-815
      The original STEP-1 (Research Study Investigating How Well Semaglutide Works in People Suffering from Overweight or Obesity) trial,
      • Wilding JPH
      • Batterham RL
      • Calanna S
      • et al.
      Once-weekly semaglutide in adults with overweight or obesity.
      N Engl J Med. 2021; 384: 989-1002
      published in The New England Journal of Medicine in 2021, reported that in nondiabetic patients prescribed semaglutide once weekly for 68 weeks—at dosages higher than that approved by the FDA for use in the treatment of patients with type 2 diabetes—weight loss was 14.9% compared to 2.4% in those who received placebo (P < 0.001). In 2021, the FDA approved the higher dosage of semaglutide for use in weight loss—the first weight-management drug approved by the FDA since 2014.

      FDA Approves New Drug Treatment Chronic Weight Management, First Since 2014 [FDA website]. 2021. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014. Accessed February 18, 2023.

      Candidates for the drug have obesity with a body mass index of >30 mg/kg2, or have a body mass index of >26 mg/kg2 with at least one additional risk factor for cardiovascular disease (eg, hypertension, hypercholesterolemia).

      FDA Approves New Drug Treatment Chronic Weight Management, First Since 2014 [FDA website]. 2021. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014. Accessed February 18, 2023.

      However, as recently reported by multiple news outlets from The New York Times

      Those Weight Loss Drugs May Do a Number on Your Face [The New York Times online]. 2023. Available at: https://www.nytimes.com/2023/01/24/style/ozempic-weight-loss-drugs-aging.html. Accessed February 18, 2023.

      to the Cable News Network (CNN),

      Chelsea Handler Says She ‘Didn't Know’ She Was on Ozempic [CNN online]. 2023. Available at: https://www.cnn.com/2023/01/26/entertainment/chelsea-handler-ozempic/index.html. Accessed February 18, 2023.

      semaglutide has become a go-to drug of the wealthy and famous for quick weight loss, even if they do not qualify for the drug based on medical guidelines. Due to a combination of manufacturing-related concerns that arose in 2021 and the need to stay on the drug long-term for sustained weight management,
      • Rubino D
      • Abrahamsson N
      • Davies M
      • et al.
      Effect of continued weekly subcutaneous semaglutide vs placebo on weight loss maintenance in adults with overweight or obesity: the STEP 4 randomized clinical trial.
      JAMA. 2021; 325: 1414-1425
      a shortage of Weguvy emerged. This shortage resulted in the off-label use of the lower dose, high-dose semaglutide for weight loss v. low-dose semaglutide for diabetes management. The average estimated out-of-pocket cost of the off-label use of semaglutide is nearly 1000 US dollars/mo,

      Those Weight Loss Drugs May Do a Number on Your Face [The New York Times online]. 2023. Available at: https://www.nytimes.com/2023/01/24/style/ozempic-weight-loss-drugs-aging.html. Accessed February 18, 2023.

      making it affordable enough to a select few while limiting access to the drug in those to whom it is prescribed.

      As the Market for New Weight Loss Drugs Soars, People With Diabetes Pay the Price [CNN online]. 2022. Available at: https://www.cnn.com/2022/12/28/health/weight-loss-diabetes-drug-shortages/index.html. Accessed February 18, 2023.

      Societal expectations for a slender appearance of the idolized, juxtaposed with the reality of the obesity and diabetes epidemics of the masses, have once again brought to light disparity in drug access. The questions "Who gets the drug?" and "Who decides?" are not new to managed health care. At times, answers to these questions are straightforward: the cost of botulinum toxin for cosmetic use should be out-of-pocket; botulinum toxin for the treatment of muscle spasticity in the setting of cerebral palsy should be readily available, and the cost should be covered by insurance. But when drug supply is limited, access to the drug falls along the racial and economic divides that plague the health care system. While obesity and diabetes do not discriminate based on patient profile, the risks for both diseases do. In poorer communities, a lack of access to healthier food options, coupled with limited green spaces and playgrounds safe for exercise, have resulted in a disproportionate number of black and Latino populations being affected by both diabetes and obesity.
      • Thornton PL
      • Kumanyika SK
      • Gregg EW
      • et al.
      New research directions on disparities in obesity and type 2 diabetes.
      Ann N Y Acad Sci. 2020; 1461: 5-24
      In addition, lower-income families may lack the resources and time to obtain antidiabetic drugs, even with a proper prescription. As a result, the patient populations with the greatest need for access to these treatments are precisely those most likely to be affected by drug shortages.
      Limited access to life-altering medications based on social, racial, ethnic, and/or economic status undoubtedly has a profound detrimental health effect on the most vulnerable of patients. The ways in which disparities to drug access will be resolved in the coming months to years remain to be seen. Yet, the impact that these inequities will have on patients is already coming into focus. Failure to provide access to emerging weight-management and antidiabetic therapeutics to at-risk populations, in lieu of those who can pay for the drugs regardless of need, not only will result in an unfavorable "tipping of the scale" but also will continue to unfavorably tip the proverbial scale of justice. Prioritization of those in need of access is mandatory for much-needed balance in equity.

      References

        • Dhillon S.
        Semaglutide: first global approval.
        Drugs. 2018; 78: 275-284
        View in Article
        • Mahapatra MK
        • Karuppasamy M
        • Sahoo BM.
        Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes.
        Rev Endocr Metab Disord. 2022; 23: 521-539
        View in Article
        • Smits MM
        • Van Raalte DH.
        Safety of semaglutide [erratum in: Front Endocrinol (Lausanne). 2021;12:786732].
        Front Endocrinol (Lausanne). 2021; 12645563https://doi.org/10.3389/fendo.2021.645563
        View in Article

      4. Semaglutide [Wikipedia website]. Available at: https://en.wikipedia.org/wiki/Semaglutide. Accessed February 22, 2023.

        View in Article
        • Christou GA
        • Katsiki N
        • Blundell J
        • et al.
        Semaglutide as a promising anti-obesity drug.
        Obes Rev. 2019; 20: 805-815
        View in Article
        • Wilding JPH
        • Batterham RL
        • Calanna S
        • et al.
        Once-weekly semaglutide in adults with overweight or obesity.
        N Engl J Med. 2021; 384: 989-1002
        View in Article

      7. FDA Approves New Drug Treatment Chronic Weight Management, First Since 2014 [FDA website]. 2021. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014. Accessed February 18, 2023.

        View in Article

      8. Those Weight Loss Drugs May Do a Number on Your Face [The New York Times online]. 2023. Available at: https://www.nytimes.com/2023/01/24/style/ozempic-weight-loss-drugs-aging.html. Accessed February 18, 2023.

        View in Article

      9. Chelsea Handler Says She ‘Didn't Know’ She Was on Ozempic [CNN online]. 2023. Available at: https://www.cnn.com/2023/01/26/entertainment/chelsea-handler-ozempic/index.html. Accessed February 18, 2023.

        View in Article
        • Rubino D
        • Abrahamsson N
        • Davies M
        • et al.
        Effect of continued weekly subcutaneous semaglutide vs placebo on weight loss maintenance in adults with overweight or obesity: the STEP 4 randomized clinical trial.
        JAMA. 2021; 325: 1414-1425
        View in Article

      11. As the Market for New Weight Loss Drugs Soars, People With Diabetes Pay the Price [CNN online]. 2022. Available at: https://www.cnn.com/2022/12/28/health/weight-loss-diabetes-drug-shortages/index.html. Accessed February 18, 2023.

        View in Article
        • Thornton PL
        • Kumanyika SK
        • Gregg EW
        • et al.
        New research directions on disparities in obesity and type 2 diabetes.
        Ann N Y Acad Sci. 2020; 1461: 5-24
        View in Article

      Article info

      Publication history

      Published online: March 10, 2023
      Accepted: February 27, 2023

      Publication stage

      In Press Corrected Proof

      Identification

      DOI: https://doi.org/10.1016/j.clinthera.2023.02.008

      Copyright

      © 2023 Published by Elsevier Inc.

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      Access this article on ScienceDirect

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