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Wednesday, January 18, 2023

Mix-it-yourself Wegovy? Some are trying risky sources for weight-loss drugs

 With a few clicks, Daniel added the chemical to his online cart and ordered it. In less than a week, a vial containing white powder arrived at his house. He used a syringe to measure out sterile water and eject it into the vial to dissolve the powder.

Then, with a different syringe, he drew up about a quarter of a milliliter of the solution and injected it into his lower abdomen.

The product was what an online chemical supplier says is semaglutide. Similar websites offer what they say is tirzepatide. Those are the active ingredients in a new generation of diabetes and obesity drugs that have become immensely popular for causing significant weight loss.

At least a dozen websites that specialize in a class of protein-related products called peptides now list semaglutide and tirzepatide. Though they say their chemicals should only be used for lab research purposes and not for human use, individuals have been ordering from the websites to make their own injections at home.

People in bodybuilding and biohacking circles have long gone to these sources for chemicals to try to build muscles and burn fat, and now, some people with clinical obesity are also turning to the websites for the first time, hoping to obtain semaglutide or tirzepatide as the original medications from Novo Nordisk and Eli Lilly remain difficult to access.

Novo’s semaglutide, sold under the brand names Ozempic for diabetes and Wegovy for obesity, is recovering from months-long shortages. Lilly’s tirzepatide, sold under the name Mounjaro for diabetes, also recently fell into short supply. The chronic medications each cost over $1,000 a month, and few insurers cover drugs for weight-loss purposes.

Daniel, a delivery worker, ordered from these suppliers starting in August because he couldn’t afford the list price of the drugs. So far, he said, he’s been losing weight and has felt nausea and fatigue, similar to side effects associated with the original medication. “I’m willing to take the risk if it means I can get it,” he said. STAT is publishing only the first name of people who ordered from peptide suppliers in light of potential legal action from the suppliers.

People are also turning to compounding pharmacies, which mix the active ingredients with other chemicals to offer ready-made compounds.

These alternative routes can be risky, doctors say, since Novo and Lilly aren’t selling their drugs to any other manufacturers, so it’s unclear what exactly is inside the alternative products. They also aren’t regulated in the same way that traditional medications are.

“It just shows you the level of desperation that people have and the level of unmet need that we have when it comes to treating obesity effectively,” said Jamy Ard, co-director of the Atrium Health Wake Forest Baptist Weight Management Center.

The excitement around the new medications, known as incretin drugs, may also be leading some people to jump straight to them as a treatment option, “skipping from A to Z,” Ard said. “There are some people who definitely need an incretin treatment strategy, but it is not the only thing, it is not the absolute solution for everyone.”

Novo said in an emailed statement that it does not provide or sell bulk semaglutide, and alternative compounded products “do not have the same safety, quality, and effectiveness assurances as FDA-approved drugs, and may expose patients to potentially serious health risks.”

In an emailed statement, Lilly said Mounjaro, the company’s branded tirzepatide, “is only available in a pre-filled single-dose pen manufactured by Lilly. Mounjaro is not commercially available in any other form (e.g., powder).” 

Josh is a patient who repeatedly tried to get the original medications. He got insurance coverage for Wegovy back in September, but he couldn’t pick any up since the drug was in shortage. He then got a prescription for Mounjaro, but in early December, the medication also fell out of stock at his pharmacy.

Josh has congenital heart disease and obesity, and he fears that having both heighten his risk of serious cardiac issues, so he rushed to look for other options. He found a telehealth provider that prescribed him semaglutide from a compounding pharmacy.

He also ordered semaglutide from a peptide supplier. He never ended up using it because Wegovy has come back into stock, but he’s keeping the chemical on hand in case he can’t obtain the original medications again.

“It became frustrating and gave me anxiety when I started to consider that I would have to pause treatment just simply due to the lack of availability,” he said.

Ordering from peptide suppliers can be dangerous because it’s unclear what’s inside the chemicals and people may be mixing wrong amounts or not doing so in a sterile manner, opening themselves up to potential infection, said Jaime Almandoz, medical director of the University of Texas Southwestern Weight Wellness Program.

While the peptide suppliers say their products are meant for lab research purposes, they appear to be marketing in a way that appeals to individual consumers. Extreme Peptide, for example, says on its website that people can earn rewards on their orders to use for future purchases. SAF-Research’s site says it offers a buy now, pay later option. Emails and calls to the suppliers went unanswered.

Almandoz said compounding pharmacies may pose fewer risks since professionals are expected to be mixing the products in a sterile environment. But, he said, it’s also unclear where the pharmacies are getting the active ingredients, and there’s no data on the safety or effectiveness of the compounded products.

If the pharmacies are registered with the Food and Drug Administration, the compounds that they produce don’t have to be approved by the regulator, as typical marketed drugs have to be.

Pamela Mitchell, a 52-year-old journalist near Houston, said she feels comfortable getting compounded semaglutide since her doctor prescribed it to her after she could no longer get refills for Mounjaro.

She wanted to lose weight to alleviate the menopause symptoms, like brain fog, that were interfering with her work. Her blood work also showed indicators of nonalcoholic fatty liver disease. “It was important to me to find a tool that would help me continue to lose weight so that the health concerns that come with menopause and obesity — I could continue to treat them,” she said.

Mitchell gets compounded semaglutide from Empower Pharmacy, which didn’t respond to requests for comment.

Almandoz of UT Southwestern said though he understands the desire to obtain some form of the newest medications, whenever his patients ask about compounding pharmacies “I get very anxious and I try to counsel them away” from that option. There are other drugs and procedures like bariatric surgery that could be considered, he said.

Ultimately, “people are desperate to have better health,” he said. “The fact that people are resorting to nontraditional pathways to get medications which may be risky speaks to their desire for better health.”

STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.

https://www.statnews.com/2023/01/18/risky-sources-wegovy-ozempic-obesity-drugs/

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