In just a few years, injectable drugs with brands such as Ozempic, Wegovy, Mounjaro, and Zepbound quickly became famous. Billion dollar seller per year It not only helps you lose weight, but also controls blood sugar levels and reduces your risk of heart disease.
However, these injections are expensive. Approximately $800 to $1,000 per monthit has no effect if used only for weight loss. covered by most insurance. 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 would be an official shortage of the active ingredients in these drugs in 2022, but on October 2, 2024, the Food and Drug Administration announced: The shortage of pharmaceutical tripeptides has been resolvedthe active ingredient in Mounjaro and Zepbound.
Despite the rapidly increasing demand and limited supply of these drugs, there are no generic versions available. This is because the active ingredients in Ozempic and Wigovy, semaglutide (which is still in short supply) and tirzepatide, are not patented. Does not expire until 2033And in 2036respectively.
As a result, unbranded alternative The market is flooded with products that can be purchased with or without a prescription. However, these products come with real risks for consumers.
i am a pharmacist Someone who studies weaknesses in federal government surveillance prescription and Over-the-counter medicine and nutritional supplements In the US, my research group recently investigated a loophole Enabling alternative weight loss products to enter the market.
High demand is driving GLP-1 applicants
The nutraceutical market is trying to cash in on the demand for GLP-1 in tablets, teas, extracts, and all sorts of other products. claims to have similar effects Like the brand name, but at a much lower price.
products containing herbal berberine provide only Losing a few pounds of weightwhile many dietary supplement weight loss products contain: Stimulants such as sibutramine and laxatives such as phenolphthaleinThe risk of heart attack, stroke and cancer.
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 We can also manufacture alternative versions of branded medicines in the event of official drug shortages.
Compounding pharmacies legally manufacture GLP-1 drugs because the demand for them far exceeds the supply. Various 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. price Ranges from $250 to $400 per month – Remains too expensive for many consumers.
Dispensing pharmacies must comply with the following: FDA Sterility and Quality Manufacturing MethodsHowever, these rules are not as strict for compounding pharmacies as they are for commercial manufacturers of generic drugs.
In addition, the products produced by dispensing pharmacies are No need to take a test about humans As with branded products, safety and effectiveness are required.
Proper dosing can also be difficult if the drug is in a complex form.
Companies that utilize 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.
Peptide seller Loopholes for selling 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. Even if you have an eating disorder, anorexia nervosacompanies are willing to sell semaglutide or tirzepatide products without a prescription. 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 claim that their products are 99% pure; Independent research by three companies An investigation of the products from August 2023 to March 2024 revealed that the purity of the products was significantly lower than promised.
1 product Contains endotoxin – Toxic substances produced by bacteria – suggests contamination by microorganisms. Additionally, the product’s promised dose was off by 29% to 39%. Poor purity can cause patients to experience symptoms such as: fever, chills, nauseaskin irritation, 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.
consumers Damaged by low quality productsit’s difficult to sue the seller because the product clearly says “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 compete with these alternative sellers, pharmaceutical company Eli Lilly has Alternative version of brand name Zepbound Products 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.
rear Grill at the Capitol hill In September 2024, pharmaceutical company Novo Nordisk came under intense pressure to offer a low-cost product under its brand name Wegoby to patients without prescription coverage.
Additional brand-name GLP-1 agonist drugs may come to market in the coming years. As of October 2024, Some of these products are in late-stage clinical trialsContains active ingredients such as. Retatortide, Sabodutid and Ecnoglutideand over 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 He is a Distinguished Professor of Pharmacy Practice at the University of Connecticut. This article is republished from conversation under Creative Commons License. please read original article.
