Extraordinary demand for Novo Nordisk’s Ozempic and other drugs used for weight-loss is fueling a global surge in counterfeit versions, according to Reuters interviews with law enforcement, anti-counterfeiting and public health officials.
The U.S.-based Pharmaceutical Security Institute (PSI), an industry-backed organization that counts drugmakers Novo Nordisk and Eli Lilly as members, said it is working with agencies, including Europol, Interpol and U.S. Homeland Security, as well as companies that help identify counterfeit products such as Israel’s BrandShield.
Their combined efforts include opening inquiries into complaints of fake drugs, trolling e-commerce and social media for purchase offers or advertisements and teaching customs officials how to spot counterfeits.
Novo’s Ozempic, approved to treat diabetes, contains the active ingredient semaglutide, which is also used in the company's weight loss drug, Wegovy.
Both are being used by people seeking to shed pounds, as is Lilly’s Mounjaro, which is currently approved for diabetes and expected to get a green-light from the U.S. Food and Drug Administration to treat obesity in the coming months. All three medicines are in short supply amid a global obesity epidemic and high rates of diabetes.
"These weight loss drugs are a hot topic right now because they’re on TV and getting a lot of media attention. If I’m a criminal organization, that’s the next opportunity I go ahead and exploit,” said Jim Mancuso, director of the U.S. Department of Homeland Security’s Intellectual Property Rights Coordination Center.
Mancuso said the agency is also working with Europol, Interpol and around 23 other law enforcement agencies on tracking weight-loss drugs to quell what they believe could become the worst tide of counterfeit lifestyle medicines since erectile dysfunction drugs like Viagra.
Though Novo stresses that its medicines Ozempic and Wegovy are indicated for the treatment of diabetes and weight-loss, respectively, the weekly injection drugs have become household names in America for their use off-label as lifestyle treatments.
Novo said in a statement to Reuters that it works closely with PSI and other organisations to "share data accurately and provide an informed picture on the status of these crimes”, and collaborates with law enforcement and other authorities.
Lilly said its strategy includes deterring major counterfeiters of its products through investigations, internet monitoring and legal actions and partnering with government and non-government organizations and trade associations.
'SO MANY CASES' Ozempic is the biggest target so far in Europe, according to a Europol official who requested anonymity because he was not authorized to speak. Fake weight-loss drugs will be a key focus in the agency’s annual counterfeit medicines report, due next year, the official said.
"We have counterfeit products and stolen products,” the official said. "We have so many cases.”
Counterfeit Ozempic has already been found in at least 14 countries, including the UK, Germany, Egypt and Russia. Several have issued warnings to pharmacies and consumers to be vigilant about counterfeits, since it is not clear what they actually contain.
Germany's federal drug regulator last week urged pharmacies and drug distributors to be vigilant following the discovery of wholesale batches of fake Ozempic.
Britain’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), then said on Wednesday that injection pens falsely labelled as Ozempic had been identified at two UK wholesalers.
A World Health Organization spokesperson said use of such drugs could pose significant health risks.
"We will look online and if we find something that infringes (obesity drug trademarks) we'll get it taken down,” said Yoav Keren, BrandShield CEO. "Sometimes PSI and its members will do sample purchases," he said. When a consumer buys those fakes, "what you get are expired drugs, counterfeit drugs, or nothing,” he added.
An officer for Interpol said that counterfeit obesity drugs because of their high prices are largely being sold in affluent countries, including those in North America, Europe and the Middle East, unlike most fake drugs that tend to be marketed in poorer regions.
MHRA said reports related to potentially falsified GLP-1s, the class of drug that includes Wegovy, Ozempic and Eli Lilly’s diabetes drug Mounjaro, had risen from two in 2022 to as many as 20 this year.
Ireland’s Health Products Regulatory Authority told Reuters that it has confiscated 233 units of counterfeit semaglutide compared with 32 units in 2022.--Reuters
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