Written by Jonathan Gao
Edited by Devika Baddhan
Welcome to the Savory Bistro! May I interest you in the dinner menu? Our esteemed chefs have prepared a unique selection of weight-loss treatments for you to try this evening.
Unwind, enjoy the music, and allow me to present a curated menu tailored to your needs:
Wegovy Injections, $900
A mystical dose, tastefully crafted with care and precision, to deliver a premium weight loss journey like no other.
Rybelsus Tablets, $1000
Transformative tablets to kickstart a rejuvenating experience towards enhanced vitality and livelihood.
Zepbound Shots, $1500
An opulent pen to immerse in the richness of a healthier lifestyle lies ahead.
Fancy our options?
Great! What would you like to have this evening?
Oh, the Wegovy injections with a side of Rybelsus tablets? Our sincerest apologies. Unfortunately, we are completely sold out of that.”
Here’s Why:
Weight loss medications have become the craze among Americans. Originally designed to be medications for controlling blood sugar levels in diabetic patients, drugs such as Ozempic have become highly sought after for their unintended, but desirable, ability to help patients dramatically reduce their weight (Kolata). However, the stark reality is that Novo Nordisk, the pharmaceutical company behind Ozempic’s production, is struggling to keep up with a sudden uptick in demand (Blank). Spurred on by the recent FDA approval of Eli Lilly’s Zepbound (“FDA Approves New Medication”) and immense popularity on TikTok surrounding drug-induced weight loss, a “quick weight loss ”frenzy has taken place almost instantaneously. This prompted everyone to want in, even at the expense of excluding diabetic patients, are the intended consumers.
Introducing Compounding Pharmacies!
As the “fast food chains” of the weight loss market, compounding pharmacies have provided patients with custom-made medications that have a high degree of efficiency, customizability, and accessibility. Here, pharmacists are stepping in to satisfy the increasing appetite for weight-loss medications. Although their responsibility has always been to develop tailor-made medications (“Compounding and the FDA”), they have also started to develop compounded semaglutide products. To accomplish this, they start by examining the “ingredient labels” of FDA-approved weight loss medications and twist them by incorporating semaglutide salts - a move that has raised concerns among FDA officials, as well as representatives from Novo Nordisk and Eli Lilly.
Because compounded salt-based semaglutide products are unapproved, their safety and efficacy remain in a contentious, gray zone. Nevertheless, the FDA’s stance on the matter is steadfast, asserting that “Compounded drugs are not FDA-approved” and that “the agency does not verify the safety or effectiveness of compounded drugs.” (“Compounding and the FDA”). As reported by the FDA, adverse events relating to the usage of these concocted medications have only further compounded this situation. In a September 2023 statement by Eli Lilly back in September 2023, the organization reported that they have begun to filing lawsuits, asserting: “These entities should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro.” (“Lilly Statement on Mounjaro®”).
Amidst the official statements and legal corporate battles, which highlight the balance between prioritizing patient outcomes and medical treatments, pharmacists have begun to play defense. Compounding pharmacists have stated that their process does not stray far from conventional cooking methods.
In an interview featured in a TIMES article by Alice Park, an anonymous compounding pharmacist expressed, “You look at recipes but often don’t have every ingredient in the recipe, so you make modifications based on experience” (Park). After reviewing the “ingredient label” for a weight loss medication, the pharmacist will shop for the ingredients sourced locally from FDA-registered manufacturers, and prepare the medication based on their adaptations of original labels.
This approach is part of the merit behind the compounding pharmacists’ craftsmanship. They are capable of customizing medicine by blending their expertise with the unique requirements of their patients. For example, some patients may find it difficult to administer injections and may prefer their medication to be provided in pill or tablet form. Furthermore, Park reported that the compounding pharmacy will send their compounded product to a separate lab, where its potency, sterility, and safety are further evaluated. The message behind doing this is to communicate that these products have not been assembled haphazardly. Rather, these pharmacies are showing that their work is held to the same standards and regulations as their official counterparts.
Moreover, compounding pharmacists have contended that they are simply endeavoring to address a significant pre-existing gap in the market. According to Tenille Davis, a compounding pharmacist in Arizona, "Compounding pharmacies are attempting to fill a crucial hole in the market. They’re not trying to make a million bucks doing this…They’re trying to meet an intense, overwhelming patient and provider demand for this product" (Blum). This “intense, overwhelming” demand perhaps reflects the inadequate measures taken by pharmaceutical companies in supplying medications to both those who need them and those who seek them for other health or lifestyle related choices.. As a result, compounding pharmacies around the country have positioned themselves favorably by offering their customizable services when the “conventional” route has not been able to satiate the country’s appetite.
With evidence to support both sides of the argument regarding the safety and accessibility of weight-loss medications, ambiguity remains regarding the extent to which compounding pharmacies can and should address this medication shortage. Questions have already arisen about the roles that both federal agencies and private corporations should assume in managing this contentious issue.
Striking a delicate balance is essential, but in the pursuit of this, it is crucial to ensure that medications such as Ozempic, Wegovy, and Zepbound are not only safe but also highly accessible and tailored to the individual needs of patients. As this debate continues, it is essential to reach an agreement that reflects the diverse perspectives within the weight-loss community, including those of diabetic and non-diabetic patients, compounding pharmacists, and executive decision-makers.
References:
Blank, Christine. “High Demand Keeps Some Diabetes Medications in Short Supply.”, Drug Topics, 8 Feb. 2023, https://www.drugtopics.com/view/high-demand-keeps-some-diabetes-medications-in-short-supply. Accessed 26 Feb. 2024.
Blum, Gina “Ozempic Is Hard to Find. Some Pharmacies Are Offering Unauthorized Alternatives.” The New York Times. 16 May 2023. https://www.nytimes.com/2023/05/16/well/live/ozempic-alternatives-semaglutide.html. Accessed 26 Feb. 2024.
Kolata, Gina. “We Know Where New Weight Loss Drugs Came from, but Not Why They Work.” The New York Times, 17 Aug. 2023, www.nytimes.com/2023/08/17/health/weight-loss-drugs-obesity-ozempic-wegovy.html. Accessed 26 Feb. 2024.
Park, Alice “What You Need to Know About Compounded Versions of Popular Weight Loss Drugs.” TIME Magazine, 20 Nov. 2023. https://time.com/6301552/weight-loss-drugs-compounding-pharmacies/. Accessed 26. Feb 2024.
“Compounding and the FDA: Questions and Answers.” U.S. Food and Drug Administration, 29 Jun. 2022. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers. Accessed 26 Feb. 2024.
“FDA Approves New Medication for Chronic Weight Management.” U.S. Food and Drug Administration, 8 Nov. 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management. Accessed 26 Feb. 2024.
“Frequently Asked Questions About Pharmaceutical Compounding.” American Pharmacists Association. https://www.pharmacist.com/Practice/Patient-Care-Services/Compounding/Compounding-FAQs. Accessed 26 Feb. 2024
“Lilly Statement on Mounjaro® (tirzepatide) Compounding Litigation.'' Eli Lilly, 19 Sep. 2023. https://investor.lilly.com/news-releases/news-release-details/lilly-statement-mounjaror-tirzepatide-compounding-litigation#:~:text=Lilly%20Statement%20on%20Mounjaro%C2%AE%20(tirzepatide)%20Compounding%20Litigation,-September%2019%2C%202023&text=Lilly%20filed%20this%20lawsuit%20to,not%20our%20own%20branded%20product. Accessed 26 Feb. 2024.
“Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss.” U.S. Food and Drug Administration, 10 Jan. 2024. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss. Accessed 26 Feb. 2024.
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