Risks You Should Avoid When Buying Injectable Semaglutide For Weight Loss Online
[ad_1]
Poison control centers are seeing a sharp rise in people calling for help due to dosing errors with their injectable weight loss medications such as semaglutide (the generic form of Ozempic). The risk is greater with compounded semaglutide, which can be easier to overdose on and increases the medication’s side effects such as nausea and gastroparesis.
People desperate to lose weight have been flocking to online businesses that advertise easy prescriptions for a new generation of drugs that cause dramatic weight loss, known collectively as GLP-1 receptor agonists. Some of these internet weight loss programs appear to conduct minimal medical evaluations, and some hawk unregulated “compounded” versions of the drugs.
The drug manufacturers have taken notice. Novo Nordisk, the company that makes semaglutide (Ozempic, Wegovy, and Rybelsus), has announced it’s suing med spas, weight loss clinics, and compounding pharmacies “to protect U.S. patients from the unlawful marketing and sales of non-FDA [U.S. Food and Drug Administration] approved counterfeit and compounded semaglutide products claiming to contain semaglutide, while reinforcing the responsible use of Novo Nordisk’s FDA-approved medicines.” The company also warned consumers to watch out for counterfeit Ozempic.
Research has shown semaglutide helps users lose 15 percent of their body weight on average, though only Wegovy is indicated for use as an anti-obesity drug. Ozempic and Mounjaro (tirzepatide) are approved to treat type 2 diabetes, but that hasn’t stopped many doctors from prescribing the latter two medications “off-label” for weight loss. A recent analysis found that more than half of new Ozempic and Mounjaro users did not have type 2 diabetes.
Meanwhile, faced with an overwhelming demand for these expensive anti-obesity drugs, health insurers have begun to crack down on coverage. So how are these people getting the medications? Some are bending, and sometimes breaking, the rules.
Working the System
As Everyday Health network site Diabetes Daily notes, the Ozempic craze has been substantially driven by social media, in particular by celebrities and influencers on venues such as TikTok, where #ozempic has now tallied over one billion views. In communities such as Reddit and Facebook, Ozempic, Wegovy, and Mounjaro weight loss support groups number tens of thousands of members each.
In these forums, members share success stories and tips for managing side effects and some offer ideas on how to secure prescriptions and insurance coverage. Much of the advice is constructive, as when members explain how to craft convincing prior authorization requests — but can veer into more questionable territory. Some compare which individual doctors are more or less likely to prescribe Mounjaro off-label through online platforms. Some comments describe outright fraud, such as falsifying information on savings card applications or lying about one’s weight to a telehealth physician. And a black market has emerged, with individuals posting photos of stockpiled medications and soliciting direct messages to negotiate illegal sales. Manufacturer Novo Nordisk has released guidelines reminding consumers the medicines are:
- Available by prescription only
- Should only be used for appropriate patients consistent with their FDA-approved label
- Should only be prescribed in direct consultation with, and under the supervision of, a licensed healthcare professional
Counterfeit versions are extremely rare to date but Novo Nordisk has also created guidance to help spot the difference.
One Bay Area Mounjaro user, who obtained her medication legally online via telehealth, shared how she became an anonymous patient advocate on social media. “Nicole” declined to give her real name because she feels stigma around using the drug to lose weight. She does not have type 2 diabetes, but received an off-label prescription for Mounjaro almost effortlessly over the internet:
“I go onto [social media] to read about Wegovy and I learn about these telehealth providers that will prescribe it for you, so I create an account. … In about 10 minutes I have a prescription, only it’s for Saxenda, which I’d never heard of.”
At the time, there was a shortage of Wegovy starter doses; Nicole’s online provider planned on later switching her from Saxenda, a less powerful GLP-1 receptor agonist, to a higher dose of Wegovy. As it happens, Nicole’s insurance didn’t cover Saxenda, but it did cover Mounjaro:
“So I message the provider and I say hey, my plan doesn’t cover Saxenda, but it will cover Mounjaro, can we try that instead?
“She says yes, asks me for my insurance info, and the next morning I wake up to a text … saying that my prior authorization for Mounjaro has been approved.”
The medication was life-changing. Nicole lost 60 pounds in a matter of months, and noticed many secondary benefits, from help with her perimenopausal symptoms to anxiety relief. She says she’s never felt better, physically or mentally:
“It opened my eyes to how much I had been held back by my own weight, my lack of confidence. And once I got through that, I wanted others to experience it, too.”
Nicole has made it a mission to help others achieve the same success — turning herself into an unpaid amateur expert in the esoteric world of health insurance red tape. She now spends much of her spare time offering free advice and encouragement to others struggling with access to, or coverage for, the new anti-obesity drugs.
She says she hopes that by teaching others to work the system, her lessons will be employed by patients with a true medical need for weight loss who would otherwise struggle to pay for their medications: “I think about the fact that obesity is so much more prevalent in marginalized communities, in poor areas, in people of color … that may also be what’s driving me to try to help others with their insurance coverage.”
Insurers Try to Throttle Demand
Navigating the complexities of reimbursement has only become more difficult. As employers and insurers grapple with the enormity of the demand, many have tried to tighten standards and close loopholes to restrict coverage, making it difficult for some patients to get reimbursed for the drugs that they have come to rely upon.
The Washington Post recently reported that insurance companies have begun putting up new barriers to discourage the off-label use of semaglutide and tirzepatide, and are even writing letters to chastise doctors that have granted prescriptions liberally.
Sean Hashimi, MD, the regional director of clinical nutrition and weight management for Kaiser Permanente Southern California, states: “Every single insurer out there is trying to create guardrails around this. Because if everyone who was eligible in America got the drug, the entire country would be bankrupt.”
Dr. Hashimi predicts that “the demand for these drugs is going to shoot through the roof” as more options are approved and enter the market. The FDA is widely expected to approve the use of tirzepatide as a weight loss drug before the end of 2023. Novo Nordisk will soon seek approval for a new high dose of its oral semaglutide formulation that matches Ozempic and Wegovy’s effectiveness. And many other related drugs are in development, such as danuglipron, one more potential blockbuster.
Online, patients frequently share their fear that they will soon be unable to afford the medications that have resulted in such magnificent health improvements. Some initially took advantage of cost-savings programs, such as Mounjaro’s $25 savings card, and are now faced with the prospect of paying as much as $1,000 per month to maintain their weight loss.
Nicole, the anonymous internet advocate, has lately only been injecting herself “every 10 to 12 days,” rather than weekly as indicated on the FDA label. This allows her to amass a stockpile of Mounjaro in case she finds her access restricted in the future. She’s not alone. Many users are asking for larger dosages than they intend to use and then “counting clicks” to administer smaller doses, according to Diabetes Daily, an Everyday Health network site. And they’re doing it with or without their doctor’s approval.
What Happens if These Medicines Get Into the Wrong Hands
Even as insurers tighten coverage, it’s only getting easier to find a prescription for new anti-obesity drugs, and experts fear that the powerful medicines are falling into the wrong hands.
Some telehealth businesses require bloodwork or a brief online medical consultation; others seem to require neither. And while it’s easy enough to lie about one’s weight or other risk factors on an online form, both CNN and the The New Yorker have reported that even people who divulge that they are not overweight can sometimes secure prescriptions.
“It’s a concern,” says Robert Gabbay, MD, PhD, the chief science and medical officer of the American Diabetes Association. “We certainly want people to have greater access to medications, but having these [drugs] available in channels that may not do the due diligence or provide the care is not what we want to see.”
“It’s completely upsetting,” says Rekha Kumar, MD, who previously served as the medical director of the American Board of Obesity Medicine and is a practicing endocrinologist and the chief medical officer of Found, an online weight loss program. “That’s not what this medicine is for! It’s to treat medically complicated obesity and diabetes.”
Dr. Kumar says if consumers lie about whether they qualify for medications, it could hurt them. She fears that some of the potential risks of semaglutide and tirzepatide — including muscle loss, as reported by Diabetes Daily, an Everyday Health network site, or nutritional deficiencies reported in The New York Times and reproductive health complications covered by Vox — are far greater in people without a clear medical need to lose weight:
“We’ve been prescribing drugs in this family for 10 or 15 years. No one has ever mentioned anything like Ozempic face or Ozempic butt, because we prescribed them appropriately, to people who had excess fat to lose. If somebody who is of normal weight or even mildly overweight uses these medicines, they will lose more muscle, and they’ll lose fat in areas they don’t want to because there’s not that much excess fat on them.”
Hashimi is concerned that tirzepatide, which confers even greater weight loss than semaglutide, may present higher risks to these users: “When you go to an even stronger medication, does that mean that there’s an even stronger effect? Is the risk of lean body mass loss higher? We know none of these answers.”
Hashimi and Kumar agree that there is no undue risk to off-label Ozempic or Mounjaro use when it is prescribed for people that meet the FDA’s official criteria for Wegovy, the only GLP-1 approved for the treatment of obesity: a body mass index (BMI) 30 kilograms/meter2 or greater, or a BMI of 27 or greater in those with at least one comorbidity. The problem is when people outside of these criteria gain access.
Compounding Pharmacies and Off-Brand Ozempic
Some users have courted additional danger by turning to compounding pharmacies, which create and dispense unauthorized versions of semaglutide and tirzepatide. Though the FDA has recently warned against using compounded semaglutide, these off-brand alternatives remain popular for patients looking to skirt drug shortages or save money.
Compounding pharmacies are allowed to operate largely free of FDA oversight in order to create custom medications, ideally for individual patients with uncommon needs. But a review published in 2013 described how some pharmacies have “seized upon a burgeoning business opportunity to expand their activities beyond the scope of traditional pharmacy compounding,” transforming themselves into large-scale manufacturers. This practice is “clearly outside the bounds of traditional pharmacy,” the FDA has stated, warning that compounding “can result in contamination or in products that don’t possess the strength, quality, and purity required.”
Hashimi says, “From a safety perspective, there’s a huge concern.” But many telehealth doctors knowingly prescribe compounded semaglutide and tirzepatide, and both TikTok and YouTube host many videos of doctors and pharmacists arguing for their safety and efficacy. When asked why so many doctors endorse their use, Hashimi chuckles and says, “It’s a great moneymaker.”
There’s a schism in the online community on the matter. Some groups explicitly ban any mention of compounded drugs, while others are devoted entirely to discussing their acquisition and use. It’s not yet clear how Novo Nordisk’s lawsuit may affect outlets offering compounded GLP-1 receptor agonists.
How to Use Telemedicine Safely for Anti-Obesity Drugs
The online healthcare landscape, Dr. Gabbay stated, “is challenging to sort out. It’s a little bit of the wild west.”
If you choose to use an online healthcare provider to request a prescription for anti-obesity medication, it may pay to be cautious. The American Telemedicine Association suggests protocols but its membership is voluntary. You want to ensure you don’t end up with an inappropriate drug, or with a program that is unable to provide the proper ongoing support.
“Buyer beware,” Gabbay added. “If it sounds too good to be true, it’s probably too good to be true. If you’re getting your prescription in 15 minutes, that’s a red flag.
“The more evaluation they’re doing, that’s an encouraging sign. They’re spending the time to get to know you a little bit and understand your health. Be a wise consumer. There are virtual care options that are doing a good job, that have the right kind of oversight.”
Margaret Zupa, MD, an endocrinologist and assistant professor at the University of Pittsburgh, believes that it’s worth checking the credentials of the doctor that will actually furnish the prescription. “Are they board-certified in their field? Are they affiliated with an academic center, or a large health system?” Dr. Zupa has studied the real-world impact of diabetes telemedicine.
Zupa advises that consumers should “try to understand the economic model and motivations.” Any business that solicits cash rather than working with health insurers, as is common with some online compounding pharmacies, “is less likely to be adhering to guideline-based care, or really to have your best interests at the forefront.”
Another important consideration is whether or not the provider seems likely to provide “guidance on the use of the drug, and how to tolerate it,” Gabbay said. “Eating too quickly, high-fat foods, alcohol for some people, those can all increase the side effect profile. Having that kind of dialogue is important.”
Hashimi thinks that patients should be suspicious of any online weight loss program that does not offer a structured lifestyle management program:
“You can absolutely do telemedicine, but the folks that you want to talk to are the ones that encourage you to focus on this being part of a lifestyle program.
“A bunch of my patients have gotten outside semaglutide from telemedicine, and they’re doing that because of the fact that my clinic will only prescribe weight loss medication as part of a comprehensive program. The challenge we have is that everyone wants to look for a shortcut.”
Gabbay also emphasized the wisdom of incorporating healthy lifestyle changes into the use of anti-obesity medications: “Following a healthy lifestyle is important. We had this when statins came out, ‘Now I can eat anything! I can have the double-bacon cheeseburger!’ No, that’s still not good for you.”
[ad_2]
