Patients in China will be able to purchase the blockbuster weight-loss drug Wegovy for 1,400 yuan, or about $193, just a fraction of the US list price of $1,349, according to media reports.

The price in China is in line with pricing elsewhere outside of the US. As Sen. Bernie Sanders (I-Vt.) noted in a September Senate hearing, Wegovy, made by Novo Nordisk, is sold for $265 in Canada, $186 in Denmark, $137 in Germany, and just $92 in the United Kingdom. In the hearing, Sanders and other senators grilled Novo Nordisk CEO Lars Jørgensen on the "outrageously high prices" in the US of Wegovy and the company's other popular GLP-1 drug, Ozempic, used for diabetes.

"What we are dealing with today is not just an issue of economics, it is not just an issue of corporate greed. It is a profound moral issue," Sanders said in opening remarks about the prices of the highly effective drugs.

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Amid ongoing legal battles over coveted GLP-1 therapies, a drug vendor in Washington state is accused of running an outlandish scheme to sell do-it-yourself kits to make illicit knockoff versions of weight-loss and diabetes drugs, Zepbound and Mounjaro.

For the alleged scheme, vendor Pivotal Peptides has customers buy a set of ingredients they have to mix together to create their own injectable versions of the drugs. Customers don't need a prescription or even a medical consultation to order the kit, even though the brand-name drugs are prescription-only. That may not be surprising, though, since the dubious white powder customers receive is stated to be "a research chemical for lab research and veterinary purposes only." Once purchased, the kit's instructions recommend users disinfect their home work surface before beginning and stress the importance of using the sterile water included in the kit to dissolve the powder to the desired concentration. The instructions then explain how to inject oneself with the homemade mixture using a 30-gauge syringe.

That's all according to a lawsuit filed Monday by pharmaceutical giant Eli Lilly, maker of tirzepatide-based Zepbound and Mounjaro, which are sold as ready-to-use medicines in single-dose pens or vials. The lawsuit against Pivotal Peptides is one of three that Lilly filed this week, all accusing questionable drugmakers of unlawfully selling knockoff versions of its tirzepatide drugs that have not been tested or approved. But the one against Pivotal Peptides stands out for the scheme the owners allegedly used to sell their knockoff version.

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Facing a lawsuit, the Food and Drug Administration has decided to reconsider its decision to take popular weight-loss and diabetes drugs off of the national shortage list, which will allow compounding pharmacies to continue selling cheaper copycat versions—at least for now.

A trade organization representing compounding pharmacies sued the agency last week over its October 2 announcement that there was no longer a shortage of tirzepatide drugs, branded as Mounjaro for diabetes and Zepbound for weight loss. The products, members of the extremely popular and effective class of GLP-1 drugs, had been on the shortage list since December 2022.

Being on the list meant that compounding pharmacies were legally allowed to make "essentially copies" of the products; the only time these pharmacies—also called outsourcing facilities—can make imitation versions of approved drugs, such as tirzepatide, is when the products appear on the shortage list. So, with the FDA's announcement, compounders were immediately barred from making any more of the lucrative drugs and had 60 days to fulfill existing orders.

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Compounding pharmacies are suing the Food and Drug Administration so they can keep making imitation versions of popular—and lucrative—tirzepatide drugs, namely knockoffs of Mounjaro for diabetes and Zepbound for weight loss.

Generally, compounding pharmacies make customized formulations of drugs for patients with specific needs, like when a patient has an allergy to a filler ingredient or if a child needs a liquid version of a drug that normally comes as a capsule. But larger compounding operations are also legally allowed to make imitations of branded drugs if those drugs are in short supply, acting as a stopgap for patients.

Tirzepatide has certainly been in short supply in recent years. Given the high prevalence of diabetes and obesity in America and the drug's effectiveness, demand for tirzepatide and other drugs in the new GLP-1 class have skyrocketed, and many patients have struggled to fill prescriptions. The FDA placed tirzepatide on its drug shortage list in December of 2022—and that's where it remained until last week.

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Enlarge (credit: https://www.uschemlabs.com/product/semaglutide-2mg-5-vials/)

Buying counterfeit weight loss drugs from illegal online pharmacies that don't require prescriptions is, in fact, a very bad idea, according to a study published Friday in JAMA Network Open.

The counterfeit drugs are sold as equivalents to the blockbuster semaglutide drugs, Ozempic and Wegovy, which are prescription only. When researchers got their hands on three illegal versions, they found that the counterfeit drugs had low-purity semaglutide, had dosages that exceeded the labeled amount, and one had signs of bacterial contamination.

The three substandard drugs tested came from three different illegal online pharmacies, which sold them as generic semaglutide drugs for weight loss, appetite suppression, diabetes, and cardiovascular health. However, the researchers, led by scientists at the University of California, San Diego, and the University of Pécs in Hungary, had initially tried purchasing counterfeit drugs from six such sellers.

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Enlarge / Wegovy is an injectable prescription weight-loss medicine that has helped people with obesity. (credit: Getty | Michael Siluk)

The US Food and Drug Administration has approved two injectable versions of the blockbuster weight-loss and diabetes drug semaglutide (Wegovy and Ozempic). Both come in pre-filled pens with pre-set doses, clear instructions, and information about overdoses. But, given the drugs' daunting prices and supply shortages, many patients are turning to imitations—and those don't always come with the same safety guardrails.

In an alert Friday, the FDA warned that people are overdosing on off-brand injections of semaglutide, which are dispensed from compounding pharmacies in a variety of concentrations, labeled with various units of measurement, administered with improperly sized syringes, and prescribed with bad dosage math. The errors are leading some patients to take up to 20 times the amount of intended semaglutide, the FDA reports.

Though the agency doesn't offer a tally of overdose cases that have been reported, it suggests it has received multiple reports of people sickened by dosing errors, with some requiring hospitalizations. Semaglutide overdoses cause nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis, and gallstones, the agency reports.

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Enlarge / Ozempic is a GLP-1 drug for adults with type 2 diabetes. (credit: Getty | Steve Christo)

For patients with Type 2 diabetes, taking one of the new GLP-1 drugs, such as Ozempic, is associated with lower risks of developing 10 out of 13 obesity-associated cancers as compared with taking insulin, according to a recent study published in JAMA Network Open.

The study was retrospective, capturing data from over 1.6 million patients with Type 2 diabetes but no history of obesity-associated cancers prior to the study period. Using electronic health records, researchers had follow-up data for up to 15 years after the patients started taking either a GLP-1 drug, insulin, or metformin between 2008 and 2015.

This type of study can't prove that the GLP-1 drugs caused the lower associated risks, but the results fit with some earlier findings. That includes results from one trial that found a 32 percent overall lower risk of obesity-associated cancers following bariatric surgery for weight loss.

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Enlarge / Lars Fruergaard Jorgensen, chief executive officer Novo Nordisk A/S, during an interview at the company's headquarters in Bagsvaerd, Denmark, on Monday, June 12, 2023. (credit: Getty | Carsten Snejbjerg)

After some persuasion from Sen. Bernie Sanders (I-Vt.), the CEO of Novo Nordisk will testify before lawmakers later this year on the "outrageously high cost" of the company's diabetes and weight-loss drugs—Ozempic and Wegovy—in the US.

CEO Lars Jørgensen will appear before the Senate Committee on Health, Education, Labor, and Pensions (HELP), which is chaired by Sanders, in early September. The agreement came after a conversation with Sanders in which the CEO reportedly "reconsidered his position" and agreed to testify voluntarily. As such, Sanders has canceled a vote scheduled for June 18 on whether to subpoena Novo Nordisk to discuss its US prices, which are considerably higher than those of other countries.

The independent lawmaker has been working for months to pressure Novo Nordisk into lowering its prices and appearing before the committee. In April, Sanders sent Jørgensen a letter announcing an investigation into the prices and included a lengthy set of information requests. In May, the committee's investigation released a report suggesting that Novo Nordisk's current pricing threatens to "bankrupt our entire health care system."

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