Number of fake weight-loss drugs grows as demand soars

Extraordinary demand for Novo Nordisk’s Ozempic and other drugs used for weight loss is fuelling a global surge in counterfeit versions, according to interviews with law enforcement, anti-counterfeiting and public health officials.

The US-based Pharmaceutical Security Institute (PSI), an industry-backed organisation that counts drugmakers Novo Nordisk and Eli Lilly as members, said it is working with agencies, including Europol, Interpol and US 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 kilograms, as is Lilly’s Mounjaro, which is currently approved for diabetes and expected to get a greenlight from the US Food and Drug Administration (FDA) 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 organisation, that’s the next opportunity I go ahead and exploit,” said Jim Mancuso, director of the US department of homeland security’s Intellectual Property Rights Co-ordination Center.

Mancuso said the agency was also working with Europol, Interpol and about 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 such as 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 the US for their use off-label as lifestyle treatments.

Novo said in a statement that it worked closely with PSI and other organisations to “share data accurately and provide an informed picture on the status of these crimes”, and collaborated with law enforcement and other authorities.

Lilly said its strategy included deterring major counterfeiters of its products through investigations, internet monitoring and legal actions and partnering with government and non-government organisations 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 authorised to speak. Fake weight-loss drugs will be a key focus in the agency’s annual counterfeit medicines report, due in 2024, 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 after 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 Organisation 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,” BrandShield CEO Yoav Keren said. “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, were 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 Mounjaro, had risen from two in 2022 to as many as 20 in 2023.

Ireland’s Health Products Regulatory Authority said it had confiscated 233 units of counterfeit semaglutide compared with 32 units in 2022.

Reuters