Thursday, July 25, 2024

Wegovy and Ozempic have ignited a gold rush in the pharma industry

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Both organized crime and unscrupulous lone entrepreneurs are looking to capitalize on the weight-loss frenzy with concoctions that range from useless to potentially deadly. Their packaging mimics Novo Nordisk A/S’s Ozempic and Wegovy, the sister drugs that made the company the most valuable in Europe last year.

“This is a brand new criminal threat for us,” Morling said, speaking from an office outside London that sits adjacent to a secure warehouse filled with thousands of seized medicines, including large sacks of fake Ozempic. “It was born essentially last spring.”

That’s when the Novo medicines became a social media phenomenon, fueled by Hollywood celebrity endorsements, even as supply shortages kept them out of reach for many, especially outside the US. Wegovy, the weight-loss successor to the diabetes drug Ozempic, was first introduced in the UK last September, but its maker restricts how much can be shipped.

When there aren’t enough legitimate products to meet demand, Morling said, “criminals are very quick to find a way into it.”

Morling doesn’t work for the police. He heads the criminal enforcement team at the UK’s Medicines and Healthcare Products Regulatory Agency, or MHRA — a government agency better known for reviewing medicines than catching criminals.

Yet his team tracks down illegal websites and monitors social media to stamp out sales of fake “skinny jabs.” They even carry out raids. Their hands-on approach stands out in Europe, where some other agencies don’t actively seek out bogus treatments.

The UK medicines agency has seized 869 fake Ozempic pens so far — more than its counterparts in Denmark, Ireland, Switzerland, Iceland and the Netherlands combined. The pens found in Britain include crude fakes as well as ones distributed in bulk by more sophisticated criminals.

Some contained insulin — a potentially lethal filling — rather than semaglutide, the active ingredient in both Ozempic and Wegovy. While vital to people with diabetes, insulin can cause seizures and even death for the average person.

Patients have been hospitalized after taking suspected falsified Ozempic beyond the UK, with reports from Austria, Lebanon and the US. The US Food and Drug Administration says it’s aware of five adverse events linked to the counterfeit drugs.

Wegovy and Ozempic have ignited something of a gold rush in the pharma industry, with drugmakers vying to capture a piece of the $100 billion market opportunity. While Novo was first, Eli Lilly & Co. has since introduced a similar injection and others are snapping at the drugmakers’ heels.

Morling’s team initially started to hear from colleagues at the UK border about Ozempic pens being seized, he said. The products were fake — crudely disguised insulin pens with the label peeled off and replaced with an Ozempic sticker.

But the trade grew in sophistication, culminating in the seizure of 500 counterfeit pens at two UK wholesalers. To the uninitiated, some of them could be confused for the real deal, according to Morling. The fakes at the regulator’s warehouse include bar-codes and packaging that appear similar in color, size and shape to legitimate pens.

To date, the UK border force has seized 369 fake Ozempic pens on the medicines agency’s behalf. The bigger tranche of counterfeits — 500 in total — were found “knocking on the door of the regulated supply chain,” Morling said.

The products showing up in legal channels “concerns me greatly” because of the health risk, said Morling, who spent 37 years leading intelligence at government agencies including the Serious Fraud Office and the National Crime Agency.

Falsified drugs are big business for criminals globally, with pharmaceutical crime spiking by 50% between 2018 and 2022 and impacting the majority of countries, according to data from the Pharmaceutical Security Institute. The World Health Organization has estimated that one in ten medical products in low- and middle-income countries is substandard or falsified. 

With the advent of online pharmacies, it’s becoming harder for customers to distinguish between real medicines and imitations. 

“It only takes one or two rogue pharmacies to have a negative impact,” said Bernard Naughton, assistant professor of pharmacy at Trinity College Dublin

In Britain, whose supply chain Morling describes as one of the safest in the world, fake drugs have rarely been an issue for the medicines agency. 

So when the weight-loss imitations started to trickle in last year, his team sprung into action. The first task was to ensure that the border force had the latest intelligence.

There was no shortage of places to look. Notices had started to pop up on TikTok; Facebook forums were advising people which beauty salons to attend, and suspicious websites were promising stock. 

Multiple sites and Facebook pages still advertise “skinny jabs” for sale in the UK. Several claim that their injections contain semaglutide. Some of the prices advertised are also well below the roughly £195 ($249) charged by high street pharmacies like Superdrug for a four-week course — and there’s no question of a prescription.

The MHRA’s criminal enforcement unit can take a page from the police’s playbook and go undercover to trace a product’s provenance, according to Morling.

“We will sometimes form relationships with the people behind these websites to try and understand who’s doing what to whom and we will conduct test purchases as well to trace things through bank accounts,” he said. 

But the team can also take a softer approach, for example if a beauty salon is selling what they claim is semaglutide and advising on how to mix it with water.

“We don’t go in with the big stick to begin with,” Morling said. “I’ll reduce the threat in whatever way I can. If the most appropriate way of doing that it is to go and knock on the door and have a quiet word in somebody’s ear, then that’s what we’ll do.”

The MHRA is willing to prosecute those who put patients’ health at risk, said Alison Cave, the agency’s chief safety officer. That hasn’t happened yet in relation to Ozempic fakes.

For Danish drugmaker Novo, the proliferation of counterfeits is a “critical issue” that the company says it’s investigating with international and local health authorities. 

The company is also taking action on its own, working with a third party to monitor illegal online sales of drugs purporting to be Ozempic or Wegovy. In some cases, Novo works with a private-investigations firm to try to identify a manufacturer and report it to the authorities.

While Morling and his team believe they have come down early and hard on fake products entering Britain, the weight-loss counterfeit market globally looks like it’s only just getting started. 

In December, South Africa’s drug regulator issued a warning about potentially fake Ozempic. That same month, the US said it had seized thousands of units

While the rest of Europe is also working to prevent fake Ozempic entering their supply chains, in many places, the approach is distinctly different from the UK drug regulator’s. 

In Austria, criminal intelligence lead the investigations, with medicine agencies acting as support. Denmark, Austria and Belgium’s drug regulators don’t monitor social media for potential counterfeits, although Belgium hopes to do so in the future when a new law comes into place. Denmark, Austria and the Netherlands also said that they mainly rely on reports from external sources such as the police or citizens before carrying out investigations. 

Ireland and Switzerland’s regulators have taken an approach more similar to that of the UK, actively monitoring for fakes. Ireland has detained 286 units of products claiming to be semaglutide between 2022 and October 2023. 

In the US, the FDA also takes an active role and is continuing to investigate counterfeit semaglutide in both the legitimate and illegitimate supply chains, a spokesperson said. The agency has also issued warning letters to stop the distribution of illegally marketed semaglutide.

In Britain at least, Morling believes the worst of the fake Ozempic surge is behind him. 

The situation was unique, he said, because there was “a supply challenge at the same time as huge social media and mainstream media interest, plus this brand new thing that had been licensed, all coming at the same time — it was the perfect storm.” 

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