In just a few years, well-known branded injectable drugs such as Ozempic, Wegovy, Mounjaro, and Zepbound have become $1 billion a year in sales, used not only for weight loss but also to control blood sugar levels and reduce the risk of heart disease. It grew rapidly.
However, the price of these injections is high. It costs about $800 to $1,000 per month and is not covered by most insurances if used solely for weight loss.
Both drugs mimic the naturally occurring hormone GLP-1 to help regulate blood sugar levels and suppress appetite. It cannot be taken without a prescription.
The Food and Drug Administration announced that there will be an official shortage of the active ingredients in these drugs in 2022, but on October 2, 2024, the Food and Drug Administration announced that the shortage of the drug tirzepatide, the active ingredient in Mounjaro and Zepbound, will be eliminated. announced that it had been done.
Despite the rapidly increasing demand and limited supply of these drugs, there are no generic versions available. This is because the patents for Ozempic and Wigovy’s active ingredients, semaglutide (which is still in short supply) and tirzepatide, do not expire until 2033 and 2036, respectively.
As a result, the market is flooded with non-branded alternatives that can be purchased with or without a prescription. However, these products come with real risks for consumers.
I’m a pharmacist who studies weaknesses in federal oversight of prescription drugs, over-the-counter drugs, and dietary supplements in the United States. My research group recently investigated loopholes that allow alternative weight loss products to enter the market.
High demand is driving GLP-1 applicants
The nutraceutical market has tried to capture demand for GLP-1 with tablets, teas, extracts, and all sorts of other products that claim to provide similar effects as the brand name, but at far lower prices.
Although products containing the herbal berberine provide only a few pounds of weight loss, many dietary supplement weight loss products contain stimulants such as sibutramine and phenolphthalein, which increase the risk of heart attack, stroke, and cancer. Contains laxatives.
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Poison control centers are experiencing a surge in calls regarding off-brand weight loss drugs.
Role of dispensing pharmacy
Unlike dietary supplements masquerading as GLP-1 weight loss products, compounding pharmacies can create custom versions of products containing the same active ingredients as the real thing for patients who, for whatever reason, cannot use either branded or generic products. .
These pharmacies can also manufacture alternative versions of branded medicines in the event of official drug shortages.
Because demand for GLP-1 drugs far exceeds supply, compounding pharmacies legally manufacture a variety of semaglutide and tirzepatide products.
These products may come in different versions than brand name companies, such as vials of powder that must be dissolved in liquid, or tablets or nasal sprays.
Like any brand-name drug, you must have a valid prescription to receive it. Prices range from $250 to $400 per month, which is still too expensive for many consumers.
Compounding pharmacies must follow FDA sterility and high-quality manufacturing practices, but these rules for compounding pharmacies are not as strict as for commercial manufacturers of generic drugs.
Additionally, products created by compounding pharmacies do not have to be tested in humans for safety and effectiveness like branded products.
Proper dosing can also be difficult if the drug is in a complex form.
Company operating the system
For those who cannot afford compounding pharmacy products or obtain a valid prescription for semaglutide or tirzepatide, opportunistic companies are stepping in to fill the void. These include “peptide companies” that manufacture counterfeit drugs that are not approved by the FDA.
From November 2023 to March 2024, my team conducted a study to assess which of these peptide companies were selling semaglutide or tirzepatide products. We searched the Internet for these peptide companies and gathered information about what they sell and their sales practices.
We have discovered that peptide sellers are exploiting loopholes to sell these drugs. The companies say on their websites that their drugs are “for research purposes only” or “not for human consumption,” but they don’t say that the buyers are researchers or that the products are sent to research facilities. Haven’t confirmed anything.
Comment sections on company websites and targeted ads on social media make it clear that both buyers and sellers understand this travesty.
Unlike compounding pharmacies, these peptide distributors do not provide the supplies needed to dissolve and inject the drug, do not provide instructions, and usually do not answer questions.
Peptide distributors are said to not be selling to consumers, so a valid prescription is not required and they plan to sell the drug in any quantity that consumers want to purchase.
Companies will be happy to sell semaglutide and tirzepatide products without a prescription, even to people suffering from eating disorders such as anorexia nervosa. The average price of these peptide products ranges from $181 to $203 per month.
Baseboard regulations
Peptide sellers do not have to follow the rules and regulations of pharmaceutical companies and compounding pharmacies. Many companies state that their products are 99% pure, but an independent study of three companies’ products from August 2023 to March 2024 found that their products were far more pure than promised. It turned out to be low.
One product contained endotoxin (a toxic substance produced by bacteria), suggesting it was contaminated by microorganisms. Additionally, the product’s promised dose was off by 29% to 39%. Poor purity can cause patients to develop fever, chills, nausea, dermatitis, infections, and low blood pressure.
The investigation found that some companies did not ship medicines and told buyers they would have to pay additional fees to get the products through customs.
If a consumer is harmed by a low-quality product, it may be difficult to sue the seller because the product is clearly labeled as “not for human consumption.”
At the end of the day, consumers are concerned about products that may not arrive, may cause infections, may not be the correct dose, and do not include instructions on how to safely use or store the product. They are being led to spend money on products.
Will the prices of branded products go down?
To combat these alternative sellers, pharmaceutical company Eli Lilly began offering an alternative version of its brand name Zepbound product for weight loss in September 2024.
Instead of traditional injectable pen products that cost more than $1,000 for a month’s supply, this product comes in a vial that patients draw and inject themselves.
For patients who take 5 milligrams of Zepbound weekly, the vial product will cost $549 per month if the patient purchases through the company’s online pharmacy and can prove that the drug is not covered by insurance.
After the September 2024 mass shooting at the U.S. Capitol, drug company Novo Nordisk came under intense pressure to also offer lower-cost products under its brand name WeGoBe to patients without a prescription. .
Additional brand-name GLP-1 agonist drugs may come to market in the coming years. As of October 2024, several of these products, including active ingredients such as letaltortide, sulvodutide, and ecnoglutide, are in late-stage clinical trials, and more than 18 other drug candidates are in early stages of development.
If a new drug company were to enter this market, it would have to offer lower prices to patients than Eli Lilly or Novo Nordisk to gain market share. This is the most likely medium-term solution to reduce the cost of GLP-1 drugs and eliminate drug shortages on the market.
C. Michael White, Distinguished Professor of the Practice of Pharmacy, University of Connecticut
This article is republished from The Conversation under a Creative Commons license. Read the original article.
