In just a couple of years, brand-name injectable medications comparable to Ozempic, Wegovy, Mounjaro and Zepbound have skyrocketed to fame Billion dollar annual sales for weight reduction in addition to controlling blood sugar levels and reducing the danger of heart disease.
But the worth of those injections is high: they cost about $800-$1,000 per 30 daysand when used alone for weight reduction, they are usually not covered by most insurance firms. Both medications mimic the naturally occurring hormone GLP-1 to control blood sugar and reduce food cravings. They can only be taken with a health care provider's prescription.
The Food and Drug Administration announced an official shortage of energetic ingredients in these drugs in 2022, but on October 2, 2024, the agency announced that this is able to be the case The shortage of the drug tirzepatide has been resolvedthe energetic ingredient in Mounjaro and Zepbound.
Despite the increasing demand and limited supply of those medications, no generic versions can be found. This is because of the patents for semaglutide – the energetic ingredient in Ozempic and Wegovy, which remains to be briefly supply – and tirzepatide won’t expire until 2033 and 2036respectively.
As a result, Non-branded alternatives Medicines, available with or with no prescription, flood the market. Still, these products pose real risks for consumers.
I’m a pharmacist Who is investigating weaknesses in federal supervision? recipe and over-the-counter medications And Dietary supplements within the USA My research group recently investigated loopholes which enable alternative products for weight reduction to enter the market.
High demand is driving GLP-1 wannabes newbies
The complement market is attempting to capitalize on GLP-1 demand with pills, teas, extracts and all types of other products claim to provide similar effects just like the brand names at a less expensive price.
Products containing the herb berberine only provide a a couple of kilos of weight reductionwhile many contain weight reduction supplements Stimulants comparable to sibutramine and laxatives comparable to phenolphthaleinthat increase the danger Heart attacks, strokes And Cancer.
The role of compounding pharmacies
Unlike the dietary supplements disguised as GLP-1 weight reduction products, pharmacies that manufacture supplements can produce customized versions of products that contain the identical energetic ingredients as the unique for patients who for some reason are neither branded nor Can use generic products.
These pharmacies may produce alternative versions of brand-name medications when official drug shortages exist.
Because demand for GLP-1 drugs far exceeds supply, compounding pharmacies legally produce a drug Variety of various semaglutide and tirzepatide products.
These products may are available different versions than those offered by brand manufacturers, comparable to vials containing powder that have to be dissolved in liquid, or as tablets or nasal spray.
Just like with brand name medications, you will have a legitimate prescription to acquire one. The prices range from $250 to $400 per 30 days – still a high price for a lot of consumers.
Compounding pharmacies must comply FDA sterility and quality production methodsbut these rules are usually not as strict for compounding pharmacies as they’re for business manufacturers of generic drugs.
In addition, the products that pharmacies produce are manufactured don’t must be tested on humans on safety or effectiveness, as is the case with branded products.
Even with compounded drug forms, getting the proper dosage is usually a challenge.
Companies using the system
For individuals who can't afford a compounded pharmacy product or can't get a legitimate prescription for semaglutide or tirzepatide, opportunistic corporations are stepping in to fill the gap. These include “peptide companies,” manufacturers that produce non-FDA-approved copycat versions of the drugs.
From November 2023 to March 2024, my team conducted a study to evaluate which of those peptide corporations were selling semaglutide or tirzepatide products. We searched the web for these peptide corporations and gathered details about what they sell and what their sales practices are.
We found that peptide sellers a Loophole for the sale of those drugs. On their web sites, the businesses state that their drugs are “for research use only” or “not for human consumption,” but they do nothing to confirm that the buyers are researchers or that the product is meant a research institution goes.
Reading the comment sections on company web sites and targeted ads on social media, it's clear that each buyers and sellers understand the farce. Unlike drug pharmacies, these peptide sellers don’t provide the materials you want to dissolve and inject the drug, don’t provide instructions, and typically don’t answer questions.
Because peptide sellers supposedly don’t sell to consumers, they don’t require a legitimate prescription and sell consumers the quantity of medication they want to buy. Even if an individual has an eating disorder, comparable to: Anorexia nervosaThe corporations are completely satisfied to sell you a semaglutide or tirzepatide product with no prescription. The average prices of those peptide products range from $181 to $203 per 30 days.
Base regulations
Peptide sellers would not have to stick to the principles or regulations that drug manufacturers or compounding pharmacies follow. Many corporations claim that their products are 99% pure, but a independent investigation of three corporations Products from August 2023 to March 2024 revealed that the purity of the products was far lower than promised.
A product contained endotoxin – a toxic substance produced by bacteria – suggesting it was contaminated with microbes. Additionally, the products' promised dosages were reduced by 29 to 39%. Poor purity may cause discomfort to patients Fever, chills, nauseaSkin irritation, infections and low blood pressure.
In this study, some corporations didn't ship the drug in any respect and told buyers they might must pay an extra fee to get the product through customs.
If a consumer is is broken by an inferior productit could be difficult to sue the vendor because the products specifically state that they’re “not intended for human consumption.” Ultimately, consumers are tricked into spending money on products which will never arrive, could cause an infection, may not have the proper dosage, and will not contain instructions on safely use or store the product.
Will prices for branded products fall?
To combat these alternative sellers, pharmaceutical company Eli Lilly began offering an alternate version of his brand name Zepbound Weight loss product in September 2024.
Instead of traditional injection pens, which cost greater than $1,000 a month to provide, this product is available in vials that the patient picks up and injects themselves. For patients taking 5 milligrams of Zepbound each week, the vial products would cost $549 per 30 days if patients purchase it through the corporate's online pharmacy and might prove they would not have insurance coverage for the drug.
After one Grilling on Capitol Hill In September 2024, the pharmaceutical company Novo Nordisk got here under intense pressure to supply patients without prescription insurance a less expensive product for its brand name Wegovy.
Additional brand-name drugs containing GLP-1 agonists are expected to come back onto the market in the following few years. As of October 2024, a A handful of those products are in late-stage clinical trialswith energetic ingredients comparable to Retatrutid, Survive And Ecnoglutideand greater than 18 other drug candidates are in earlier stages of development.
As latest pharmaceutical corporations enter this market, they have to offer patients lower prices than Eli Lilly and Novo Nordisk to be able to gain market share. This is the most definitely medium-term solution to scale back the fee of GLP-1 drugs and eliminate drug shortages in the marketplace.
image credit : theconversation.com