Desperate for an affordable source of the new generation of potent anti-obesity drugs, some people have turned to a potentially dangerous technique: mixing their own semaglutide (Ozempic, Wegovy) or tirzepatide (Mounjaro) at home.
DIYers purchase the raw materials, active pharmaceutical ingredients of mysterious origin and unknown safety, online, with no prescription necessary. While these materials carry warning labels — “for research only” or “not allowed for use in humans” — that hasn’t stopped people like Carlos Alvarez, 58. He moderates an internet forum devoted to the search for sources of tirzepatide, the active ingredient in the blockbuster drug Mounjaro. At his home in Phoenix, Arizona, Alvarez reconstitutes freeze-dried tirzepatide powder with sterile water, creating a solution that he injects under his skin.
Alvarez, who has prediabetes, felt frustrated that his insurer wouldn’t cover Mounjaro, the drug that he determined would be the best remedy for his high blood sugar levels. The cost, he says, was “astronomical.” Wanting to avoid “the mercy of a medical system that I feel has left me without help … I went the full DIY route. It’s in my nature anyway.”
But experts say what Alvarez and others are doing poses many risks.
“It’s not safe to make it in your kitchen. It’s just not safe at all,” says Stephanie Young Moss, PharmD. Dr. Young Moss is a trained pharmacist and healthcare consultant. While she acknowledged that “people are desperate” for the game-changing anti-obesity drugs, she expressed suspicion of any vendor who would sell drugs marked “for research only” directly to consumers.
“Who’s behind this website? Where are they getting this drug? Is it the right form? Is it clean, is it sterile?”
The U.S. Food and Drug Administration (FDA) warns consumers about the practice as well.
In a statement, the FDA said that “peptides marketed as ‘sold for research use’ … pose significant risks to patients because they have not been reviewed by the FDA before they are marketed to ensure safety, effectiveness or quality, and they are obtained without a prescription or prescriber oversight.”
Scott Brunner, the CEO of the Alliance for Pharmacy Compounding, says that reconstituting such drugs at home is a risky idea. “The obvious advice for anyone purchasing research-grade semaglutide (or something purporting to be semaglutide — how do they know?) online without a prescription, and self-administering, is: don’t.”
How Do People Make Their Own ‘Ozempic’?
Propelled by immense social media hype, the demand for semaglutide and tirzepatide has skyrocketed, resulting in shortages despite very high prices. At the time this article was written, a Mounjaro prescription was listed at over $1,000 per month at most pharmacies, and insurance coverage for the drug can be hard to find, especially for those without diabetes. The high cost and inconsistent access have already driven some users to procure their medication from a variety of sources, including online compounding pharmacies, which can legally mix off-brand versions of the popular medications. In late May, the U.S. FDA warned consumers against compounded semaglutide, which the organization does not evaluate for safety or effectiveness.
DIYers are going a step further and are taking the practice of drug compounding into their own hands.
The DIY process starts with lyophilized (freeze-dried) semaglutide or tirzepatide, a powdered form of the active pharmaceutical ingredient (API) used in Ozempic or Mounjaro. Using insulin syringes and sterile glass vials, do-it-yourself ‘pharmacists’ mix the powdered active ingredient with bacteriostatic water, which has been formulated to prevent the growth of bacteria. Reconstituting the drug in this manner creates a liquid solution, purportedly the equivalent of the brand-name drug, which can then be injected under the skin. Instructions for these homemade injections can be found on TikTok, YouTube, and elsewhere on the internet.
As the practice has grown, new online communities have sprung up in which users share their experiences finding these powdered drug ingredients, which are known as “peptides.” Some community members fear that suppliers are providing peptides of dubious safety or potency, or running outright scams. Others worry that a trusted source will become too popular, leading to shortages or legal troubles. The most reliable peptide vendors, some assert, don’t even have websites, just email addresses that are passed from one user to another.
It’s difficult to gauge the scale of DIY reconstituting, but Facebook groups and subreddits largely dedicated to the use of semaglutide and tirzepatide peptides can count hundreds of members, and much discussion can be found in larger forums more generally devoted to the use of peptides or of compounded weight loss drugs.
Alvarez, who moderates one such forum, also creates YouTube videos to demonstrate the reconstitution procedure. Alvarez has no pharmacological training — he’s just an enthusiastic amateur: “You might say that I’ve jumped into this topic like a skydiver without a parachute.”
Alvarez has used several different sources for his powdered tirzepatide, including a Chinese vendor that offered a low price for a larger shipment. He reports that tirzepatide — he has alternated between official Mounjaro and self-mixed versions — has brought him “exceptional, life-changing, massive results,” including rapid weight loss, improved blood sugar levels, better sleep, and less desire for alcohol.
Semaglutide and tirzepatide, originally developed to treat hyperglycemia in type 2 diabetes, have widely been hailed as the most effective weight loss drugs ever approved. In one clinical trial of semaglutide, adults without diabetes lost an average of 14.9 percent of their body weight. In another, tirzepatide users without diabetes lost even more, an average of 20.9 percent of their body weight at the highest dose.
Though he acknowledges that there are risks inherent with injecting drugs from suspect sources, Alvarez argues that the alternative — stopping his use of anti-obesity medication, regaining weight, and watching his blood sugar climb back up — is the greater danger. “I believe that it’s reasonable to conclude that [my prediabetes] was much worse than the potential risk.”
There are, of course, many reasons why drug preparation and distribution are reserved for trained and certified professionals. Offering an example of the dangers of contaminated drugs, Young Moss referred to a 2018 incident in which a single compounding pharmacist ignored standard safety procedures and infected 793 patients with fungal meningitis; 64 died.
Some of the infrastructure for the gray market sale of peptides was erected long before #ozempic went viral, largely for the distribution of a different type of pharmaceutical product: growth hormone peptides and other performance-enhancing drugs. Bodybuilders and athletes have been mixing and dosing their own solutions in the same manner, with insulin syringes and bacteriostatic water, for years. Others use peptides for skin care or sexual health, among other issues.
While the FDA declined to discuss the legality of the sale or use of weight loss peptides, in the past the organization has pursued legal action against suppliers. In 2016, for example, the owner of Precision Peptides was sentenced to house arrest and ordered to forfeit over $2 million for selling unapproved peptides to bodybuilders. A press release from the U.S. Attorney’s Office described how in “a ruse to avoid FDA scrutiny,” the peptides had been labeled “for research/laboratory use only.”
Brunner states that the use of such peptides, which come from unknown and possibly unregulated manufacturers, is risky: “For a patient to trust and inject that substance into their body is incredibly dangerous.”
Even when the active ingredient is safe, DIYers open themselves up to other risks when reconstituting their medicine. The manufacturers of Ozempic and Mounjaro have created standards to make dosing as streamlined and easy as possible: one injection, once a week, with a pen designed to administer only a single dose. The math involved with reconstituting peptides is considerably more complicated, requiring facility with conversions between milligrams, milliliters, and insulin units. The risk of dosage error may be astronomically higher.
During his brief time championing DIY Ozempic and Mounjaro, Alvarez has seen some heinous and potentially very dangerous blunders on social media, including elementary math errors that have led users to self-administer gargantuan quantities of medicine. “I saw a lot of mistakes being made by a lot of people,” he says. He hopes that his comments and videos can help others use the drugs safely.
Though his behavior may seem reckless, Alvarez shares a concern with many experts that the inaccessibility of semaglutide and tirzepatide is only exacerbating healthcare disparities. These medications can have revolutionary health effects — “life-changing is an understatement,” contends Alvarez — but their high costs, combined with the reluctance of insurers to cover those costs, threatens to reserve the therapies for affluent Americans.
“I believe that these alternatives provide a free-market solution to the problem,” Alvarez states. “I think that consumer anarchy might force change in how we price these drugs.”
It may seem simple for conscientious patients to avoid DIY weight loss drugs, but the lines between reputable and disreputable suppliers are getting blurred. Voracious demand for (and shortages of) Ozempic, Mounjaro, and Wegovy are inspiring more clinics and telehealth providers to offer the weight loss medicines, and it can be difficult to know which providers have their patients’ best interests at heart.
In a statement to Everyday Health, Novo Nordisk said that it “does not supply semaglutide to companies selling research-use only products to patients,” a practice which it says “exposes patients to potentially unsafe products.”
The National Association of Boards of Pharmacy (NABP) publishes a “Not Recommended” list of thousands of websites that are suspected of selling “fraudulent and unsafe” medicine. The NABP verifies that pharmacies are fully licensed, comply with all relevant laws, and accept only valid prescriptions. In the event that there is any ambiguity about a supplier’s trustworthiness, it might be wise to check any online medicine supplier against the list, though it should not be considered exhaustive.
In a statement, Brunner and his organization advised the following:
“Don’t buy any substance purported to be semaglutide from an online entity if you do not have a legitimate prescription for it from a licensed prescriber, and you cannot verify that the seller is a licensed U.S. pharmacy.”
Read the full article here