A production line of Wegovy injection pens for the Asian market on the Novo Nordisk A/S pharmaceutical manufacturing facility in Hillerod, Denmark, on Wednesday, Nov. 27, 2024.Â
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One interpretation of the law of supply and demand is that when demand outstrips supply, scammers get busy. That is actually the case with the super-popular weight-loss drugs from Eli Lilly and Novo Nordisk.
As hundreds of thousands of Americans are prescribed injectable Ozempic and Mounjaro to treat type 2 diabetes, and Wegovy and Zepbound for obesity — and countless more without prescriptions seek them as “vanity drugs” to shed unwanted kilos — the manufacturers cannot sustain production. The GLP-1s, as they’re known, are pricey, too, and insurance often doesn’t cover them, provided consumers can find them.
That confluence of things has laid the groundwork not just for a confusing online marketplace for compounded versions of the drugs — allowed by the Food and Drug Administration when proprietary ingredients are determined to be briefly supply — but a proliferation of nefarious scams offering to sell each brand-name and counterfeit GLP-1s on web sites and social media platforms.
Consumers have received Lilly- and Novo-branded GLP-1s from unauthorized sellers, counterfeit versions, completely different medications or nothing in any respect — apart from an expensive rip-off. Most annoying, Novo told CNBC that as of mid-November, it’s aware of 14 deaths and 144 hospitalizations of people that had taken compounded semaglutide, the lively pharmaceutical ingredient in Ozempic and Wegovy. It recently asked the FDA to ban the copycat drugs.
Throughout the past yr, cybersecurity experts, consumer advocates, pharma researchers and media investigators have uncovered scores of accounts and content on TikTok, Facebook, Instagram and other social media platforms, in addition to quite a few web sites, where bad actors have been doing business, much of it illegal or a minimum of unethical.
In May, a joint investigation by the nonprofits Digital Residents Alliance and Coalition for a Safer Web revealed how consumers are flocking to TikTok — which faces an uncertain future after a federal court on Friday upheld a law that will seek to ban the corporate within the U.S. on Jan. 19 — and other social media platforms and web sites to buy branded and illicit GLP-1s, often with no prescription. In response to the report, scammers create accounts promising to sell the drugs for between $200 and $400 for a month’s supply — far below market prices — paid through Zelle, Venmo and PayPal reasonably than traditional bank cards in order to avoid tracking.
“Scammers make the most of human emotion and human want, and the emotion and need now could be that everyone desires to shed weight,” said Eric Feinberg, vice chairman of content moderation for the Coalition for a Safer Web. “It’s an ideal audience to make use of online to make the most of people psychologically and emotionally.”
A standard ruse the investigation exposed was sellers saying the drugs were coming from overseas after which claiming that the order was held up in customs, requiring a further $300 to $500 payment to release it. The scammers were devious, said Tom Galvin, executive director of Digital Residents Alliance. “They send a tracking number from a delivery service that shows you where your package is, however the tracking number is BS.” Digital Residents shelled out just over $3,000 to buy GLP-1s, and yet the cash yielded no deliveries of the drugs.
No-delivery ploys can exact a serious financial toll on victims, but “the more scary ones are where you do get a product and do not even know whether you may trust [it] or if it’s a legitimate company,” said Abhishek Karnik, director for threat research and response for cybersecurity firm McAfee.
Phishing for weight-loss drug victims
Tracking activity over the primary 4 months of this yr, McAfee’s Threat Research Team uncovered just how prolific weight-loss scams have grow to be across malicious web sites, scam emails and texts, posts on social media and online marketplace listings. From January through April, McAfee researchers discovered 449 dangerous website URLs and 176,871 dangerous phishing attempts centered around Ozempic, Wegovy and semaglutide, a rise of 183% in comparison with October through December 2023.
Karnik’s team has continued to watch these criminal activities. “We have identified [a total of] 367,000-plus phishing attempts, and between May and August, the variety of [risky] URLs we found increased by 135%,” he said.
JAMA Network Open in August published the outcomes of a study by a global group of researchers who searched the worldwide web to ferret out web sites for online pharmacies promoting semaglutide on the market. Among the many 317 operations found, greater than 42% were illegal, operating with no valid license, selling medications without prescriptions and shipping unregistered and falsified products. Six purchases were made, but only three were delivered.
A recent CNBC investigation explored the murky international world of counterfeit weight-loss drugs. Amongst its findings, investigators recounted the seizure within the UK last yr of tons of of what gave the impression to be Ozempic pens, but were the truth is insulin pens relabeled as Ozempic. In addition they discovered from Lilly that its retatrutide, a novel GLP-1 drug still in clinical trials and never FDA-approved, was being marketed to the general public.
Counterfeits and diverted drugs — branded GLP-1s sold on the black market — originate from many countries, including India, China, the UK, Mexico and Turkey. One in every of the destinations where they make their solution to the U.S. was Latest York’s JFK International Airport. In response to the U.S. Customs and Border Protection, since January 1, the agency had made greater than 198 seizures of products labeled as Ozempic.
In response to this glut of fraudulent activity, social media corporations and web operators have employed human monitors and machine technology to discover and shut down online scammers. A TikTok spokesperson, without detailing its various monitoring efforts, referred to the corporate’s community guidelines. “We strictly prohibit the trade of medicine, and we don’t allow attempts to defraud or scam members of our community,” the spokesperson said. “Our promoting policies also prohibit the promoting of weight-loss products, including weight-loss injections and fat-burning pills.”
Despite official policies, nevertheless, undeterred violators find workarounds when their accounts are shuttered. They may arrange one other account with the drug names misspelled, spaces between letters or mash-ups of semaglutide and terzepitide. Many instruct interested buyers to direct message them or send links to Telegram and other dark web sites that encrypt content and supply anonymity.
“The social media platforms are the brand new street corners for drug dealers, and so they move from place to put,” Galvin said. “It is a game of whack-a-mole.”
Bags of counterfeit Novo Nordisk A/S Ozempic and Wegovy, foreground, and other fake drugs at a warehouse operated by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) in London, UK, on Monday, Feb. 27, 2024. The UK task force tracks down illegal web sites, monitors social media and even carries out raids to stamp out sales of faux “skinny jabs” as each organized crime and unscrupulous lone entrepreneurs look to capitalize on the weight-loss frenzy.
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For this text, CNBC found greater than a dozen TikTok accounts that gave the impression to be selling GLP-1s in violation of its policies, including @ozempic_weightloss, @sema.irel and @semaglutideandtr. Soon after relaying the knowledge to TikTok, we were told that every one had been removed, except one, which was not in violation.
The widespread compounding of GLP-1s is one other contributor to the dodgy marketplace for the drugs. In April and December of 2022, respectively, the FDA determined that semaglutide and tirzepatide were briefly supply, opening the floodgates for compounding pharmacies and outsourcing facilities to fabricate, distribute and market copies, typically sold through telehealth corporations, medical spas and wellness centers.
Compounded GLP-1s, unlike Lilly’s and Novo’s brands, will not be FDA-approved, which implies they don’t undergo the agency’s review for safety, effectiveness and quality before they’re marketed. As an alternative, the FDA and state boards of pharmacy register, license and inspect compounding facilities and ingredients. And while some compounders meet regulatory requirements, akin to Henry Meds, Noom Med, Ro and Hims & Hers Health, many others don’t.
Publicly traded Hims & Hers launched its gender-focused telehealth platform in 2017, adding compounded semaglutide to its weight-loss program this past May. “We waited until we were capable of find the correct compounding partner,” said Dr. Patrick Carroll, the corporate’s chief medial officer. Besides that partner, BPI Labs, Hims & Hers acquired one other, MetasourceRx, in September. The corporate also sells branded Ozempic and next yr will offer liraglutide, the primary generic GLP-1.
FDA scrutiny
Within the meantime, the FDA is investigating the bad actors within the compounding world. “Purchasing pharmaceuticals from unregulated, unlicensed sources with no prescription is dangerous,” a spokesperson for the agency told CNBC. “We urge consumers to be vigilant and to utilize suggestions tools from the FDA’s BeSafeRx campaign to assist them safely buy drugs online.”
In May, the KFF Health Tracking Poll found that about one in eight adults (12%) said that they had taken a GLP-1 drug, with about half, or 21 million, actively using the medications. Nearly 80% purchased the drugs or a prescription for them — at a value between $936 to $1,349 per 30 days before insurance coverage, rebates or coupons — from a primary care doctor or a specialist, in response to the survey. Fewer reported getting them from a web based provider or website (11%), a medical spa or aesthetic medical center (10%), or from some other place (2%). But that does not count the inestimable number of people who’ve obtained GLP-1s without prescriptions through unregulated online channels and illicit online compounding pharmacies, many operating overseas.
While social media corporations police illegal sellers of GLP-1s, tons of of influencers are touting the drugs and their journeys using them across the platforms with impunity, in response to a Fast Company report. Many influencers are recruited and paid by telehealth corporations.
Meanwhile, household names have been increasingly speaking out about their personal use of those drugs, which increases familiarity and curiosity amongst the general public. In October, People profiled 64 celebrities — including Kathy Bates, Elon Musk, Oprah Winfrey, Andy Cohen, Billie Jean King and Rob Lowe — who’ve talked about their weight-loss drug experiences, totally on social media.
Currently, Lilly’s and Novo’s GLP-1s are prescribed just for type 2 diabetes and obesity. But as researchers find additional conditions that could be treated with the drugs — including heart problems, kidney disease, dementia and addiction, and most recently even knee pain — prescriptions will increase exponentially.
In September, an article within the Annals of Pharmacotherapy warned against manufacturers that use a legal loophole to sell vials containing semaglutide and tirzepatide to consumers with no prescription by stating that the drugs are for “research purposes only” and/or “not for human consumption.” The authors conducted an online seek for such scofflaws, uncovering 40 web sites selling what were labeled as “peptides” to consumers.
The FDA has sent warning letters to a handful, including Miami-based US Chem Labs in February, citing several violations and requesting motion inside 15 days. As of Dec. 6, CNBC found that the corporate still listed compounded semaglutide as available on its website. US Chem Labs couldn’t be reached by phone and an email request for comment was not returned by press time.
The authors of the Annals of Pharmacotherapy article also identified three corporations that were promoting GLP-1s on Facebook, owned by Meta. “Our policies prohibit content that defrauds people by promoting false or misleading health claims, including those related to weight reduction, and we remove this type of content once we grow to be aware of it,” a Meta spokesperson told CNBC. CNBC subsequently sent Meta the names of the three corporations, and a number of other days later their Facebook pages were removed.
Eli Lilly, Novo Nordisk battle with copycat drugs
Staff walk past manufacturing equipment at Eli Lilly & Co. manufacturing plant in Kinsale, Ireland, on Sept. 12, 2024. Lilly has been bulking up its production capability since 2020, investing greater than $17 billion into developing latest plants and expanding existing facilities for the weight-loss and diabetes drugs which can be expected to grow to be a few of the best-selling medicines of all time.Â
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Lilly and Novo are in a quandary regarding compounders. The copycats have filled a void while the branded GLP-1s are in shortage, attracting patients who cannot access or afford them.
But now the manufacturers want their domains to themselves. Lilly has sent cease-and-desist letters to quite a few compounding sellers, and each corporations have filed lawsuits against quite a few compounding pharmacies, alleging trademark infringement and deceptive marketing.
On October 2, the FDA declared that Lilly’s tirzepatide was now not briefly supply, ostensibly putting compounders of that ingredient out of business. Two weeks later, though, after a public outcry from compounders’ patients and a federal lawsuit brought by compounding pharmacies, the FDA backtracked, saying it might reevaluate whether the drug is out there and make a call in mid-November.
Yet, on November 22, the FDA said it was still assessing the situation and agreed to not take motion against compounders of tirzepatide until December 19, unless the agency makes an earlier decision.
Novo’s semaglutide continues to be listed as “currently in shortage” by the FDA, although the agency also lists Ozempic and Wegovy as “available.” A Novo Nordisk spokesperson told CNBC, “It is vital to notice that availability doesn’t all the time mean immediate accessibility at every pharmacy. Patients may experience variability at specific locations, no matter whether a drug is in shortage.”
Lilly and Novo have advocated for broadening insurance coverage for the drugs, and the Biden administration recently proposed that Medicare and Medicaid extend their coverage for obesity medications. Although that plan could possibly be scuttled by the incoming Trump administration. Robert F. Kennedy, Jr., Trump’s nominee to move the Department of Health and Human Services, has suggested that obesity needs to be tackled through healthy eating, not drugs.
The obesity drug market volatility has shown up in recent earnings. In its third-quarter report on October 30, Lilly fell wanting profit and revenue expectations, partly because of disappointing sales of its GLP-1s, at the same time as demand for them continued to soar. Every week later, Novo reported third-quarter earnings in keeping with expectations, strengthened by robust sales of Ozempic and Wegovy. Nonetheless, the Danish company narrowed its 2024 full-year growth guidance, reflecting, in response to an announcement from the corporate, “expected continued periodic supply constraints and related drug shortage notifications.”
Each pharma giants proceed to take a position billions to extend production facilities and capability. This week, Lilly said it was investing $3 billion to extend obesity drug production at a Wisconsin plant.
Regardless, demand for GLP-1s — irrespective of in the event that they’re branded, compounded or counterfeit or where they’re purchased from — is for certain to continue to grow. That may put more pressure on social media platforms and web operators to protect against scams.
Galvin suggested that the businesses have to work together to discover scammers as they navigate between platforms to avoid detection. “Too many platforms take a look at this as a PR problem and never an online safety problem,” he said. “In the event that they were collaborating with one another to discover the bad actors and shared that information, people would find lots less of them.”