Fake weight-loss medication in tablet form could flood Britain, experts warn | Weight-loss drugs

Experts warn that fake weight loss treatments could become more widespread as tablet drugs, currently only available by injection in the UK, are launched.

They say tougher regulation and enforcement are needed to prevent fraudsters from profiting from tablets that will be easier to counterfeit.

Although weight loss drugs in pill form are expected to be much cheaper, and therefore more accessible, than injectable versions, experts have warned they are also an easier target for fraudsters.

“Pills are much easier prey for fraudsters than injectables because they require relatively accessible equipment to make the pill – something to mix powders and a pill press – and can offer the possibility of vast production,” said Bhavik Patel, professor of clinical and bioanalytical chemistry at the University of Brighton.

In the UK, demand for weight loss vaccines such as Wegovy and Mounjaro has increased, with trials suggesting they can help people lose on average around 14% and 20% of their body weight respectively after 72 weeks.

However, vaccines are expensive, require an injector pen and needles, and must be refrigerated.

Pharmaceutical companies are now working on oral versions of these drugs, creating tablets containing drugs that mimic the GLP-1 hormone.

A pill form of Wegovy, produced by Novo Nordisk, was approved by the US Food and Drug Administration (FDA) last month and is being assessed by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), while Eli Lilly’s Orforglipron has completed phase three clinical trials and has been submitted for FDA review.

Dr Bernard Naughton, associate professor and researcher in pharmaceutical regulation and innovation at Trinity College Dublin, said counterfeit pills could include medicines removed from the legitimate supply chain – and potentially stored incorrectly – while they could also be contaminated, or contain an incorrect dose, an incorrect active ingredient or no active ingredient at all.

“We can already see that there have been some examples of injection tampering,” Naughton said. “It’s relatively easy to simply create a pill and, if the packaging is good, misrepresent it as a legitimate product.”

Naughton said his own research into patient behavior with other medications suggests people appear more likely and willing to take risks online with tablets than with injections.

“So even when they think there might be something wrong, I’ve seen examples of people still going ahead and buying it and accepting it,” he said.

Novo Nordisk said its Wegovy pill contains not only the active ingredient semaglutide, but also a substance called SNAC (salcaprozate sodium) that improves the absorption of the drug.

“Only Novo Nordisk manufactures FDA-approved semaglutide drugs with this SNAC technology,” a spokesperson said. “Compounded semaglutide is not approved by the FDA and may contain impurities, unnecessary additives and untested doses.”

There is precedent for fake weight loss drugs, with the MHRA having repeatedly issued warnings about the importance of only purchasing vaccines from registered pharmacies or legitimate retailers.

Oksana Pyzik, associate professor at UCL’s school of pharmacy, said demand for drugs such as Wegovy and Mounjaro had outstripped regulated supply, while rising prices for some products were also linked to people looking for cheaper alternatives online via unlicensed routes.

“While oral weight-loss medications may improve access, they will also expand opportunities for criminals to tamper with GLP-1,” she said.

In October last year, the MHRA revealed it had raided a factory in Northampton, seizing more than £250,000 worth of counterfeit weight loss vaccines, including injector pens for the experimental drug retatrutide, which is not authorized in the UK.

At present, it is unclear whether any arrests or prosecutions have been made in relation to the raid, with the MHRA saying it is unable to release information about ongoing investigations.

However, a Guardian investigation found that the company whose name appeared on the vaccine packaging, Alluvi, continued to advertise its branded retatrutide pens on the social media platform Telegram.

Patel said the recent raid showed the MHRA was very proactive in protecting the public from counterfeit medicines. “However, the use of social media and online marketplaces provides widespread access to consumers who want to access medicines, which poses a risk,” he said.

“With the huge demand, there will be [for] “

Eli Lilly and Novo Nordisk said they were taking steps to combat counterfeits, with the latter noting that for Wegovy’s pill form this included online monitoring and removal of, for example, websites or posts; share information on the flow and characteristics of the pill supply chain with authorities; and providing pill samples to the FDA’s Forensic Chemistry Center for further testing and investigation if necessary.

Andy Morling, deputy director of enforcement at the MHRA, said weight management medicines must meet rigorous standards of safety, quality and effectiveness before they can be authorized in the UK.

“We work tirelessly through robust regulatory and enforcement processes to identify and take action against the illegal supply of unlicensed and falsified medicines, ensuring that the UK’s legal supply chain remains strong, responsive and effective as new treatment formats become available,” he said.

“Authorized medicines are subject to rigorous regulatory processes and ongoing monitoring, including controls on how they are manufactured, supplied and monitored once on the market. Any medicine supplied illegally or without authorization poses a risk to public health and patent security, regardless of its format.”

Pyzik, academic chair of the Fight the Fakes Alliance, said the UK was starting to use AI tools to detect fake online adverts, but stronger regulation and enforcement was needed.

“Patients should know that they should only access these products with a prescription, under medical supervision and avoid purchasing pharmaceutical products on social media,” she said.

Pyzik added that the importation of falsified medical products into the UK had moved to increasingly sophisticated domestic operations.

“When an illicit counterfeiting factory can be raided, shut down, and then reappear online shortly thereafter, seemingly without arrest or prosecution yet, this does not serve as an effective deterrent and reveals real regulatory gaps,” she said.

“Not only does this signal to criminal groups that the risk of prosecution is low and the rewards are high, but it also encourages them to break new laws and take even more drastic measures to sell falsified pharmaceutical products. »

Naughton said that, among other actions, the UK should ensure it is easy for patients to verify they are buying medicines from a legitimate online pharmacy – and develop public health campaigns targeting groups with different motivations and attitudes to risk when it comes to buying medicines online.

“I think it’s really important because there’s value in buying medicine online and it gives access to a lot of people who wouldn’t have access to it otherwise,” he said.