SURGING DEMAND, SOARING PRICE TAGS LEAD TO FAKE OZEMPIC DOSES

Around the globe, the growing class of weight loss drugs called GLP-1 agonists has been a game-changer. This includes the blockbuster drug semaglutide, better known by its brand names Ozempic and the more potent Wegovy. These have helped people lose weight, feel more confident and be healthier.

But a surge in demand and a high price tag have led to a rise in counterfeit versions of the drugs – causing hospitalisations around the world.

That includes Mike Benson of Chicago, who fell into a coma after taking a counterfeit version of Ozempic. Benson, who on the advice of counsel declined to comment, told a local TV station in January, “I don’t know that I’ve ever felt that way in my life. I had thought this could be the end.”

Michelle Sword, a mother of two living in Oxfordshire, England, had hypoglycemia and seizures, requiring her to be hospitalised.

With multiple such incidents, regulators are concerned both on account of the counterfeit medications but also about what is causing consumers to take this risk.

In May, United States Customs and Border Protection (CBP) officials seized 11 shipments of counterfeit versions of Ozempic at an airport in Cincinnati, Ohio – one of the nation’s key operations hubs. The federal agency intercepted the illicit medications from Colombia. The shipments of more than 100 injections each were bound for locations across the US ranging from New York to Texas. The CBP said the seizure was valued at roughly $887,000.

A similar situation unfolded at Chicago O’Hare International Airport last month.

Nearly 10,000km (4,000 miles) away in Lebanon, Beirut, suspected fake Ozempic vials accounted for almost a dozen instances of dangerously low blood sugar in patients, including one case that required hospitalisation in November. 

In October, British officials seized counterfeit versions of the medication that were imported from “legitimate” suppliers in Germany and Austria, signalling the challenge is coming from down the supply chain.

This month, Austrian courts announced they would pursue legal action against a seller who provided fake doses to a plastic surgeon in Salzburg. 

That echoes a report late last month from Vanity Fair magazine that said some counterfeit doses ended up in the hands of legitimate medical practices without their knowledge.

There have been similar reports out of Brazil and Russia.

“I have a lot of concerns because not all of my patients can get these medications, and people really want them and they feel desperate about it,” said Dr Melanie Jay, director of the Comprehensive Program on Obesity at New York University’s Grossman School of Medicine. 

“There’s all this advertising for other places where you can get it for a lot cheaper, and it’s impossible to know how safe these alternatives are,” she added.

Cybersecurity firm McAfee found hundreds of fake listings selling Ozempic doses on Craigslist. The firm also discovered examples of scammers impersonating doctors on Facebook. McAfee says often if these scammers do deliver on their promises, they send fake versions of the medication, which include pens filled with saline solution and EpiPens.

Consumers have also turned to Reddit groups like the since-banned Ozempic Source USA, in which consumers often sold doses to each other.

Last year, Al Jazeera found that patients could order these drugs from online pharmacies without any doctor consultations.

Last month, the World Health Organization (WHO) warned about the “unpredictable range of health risks or complications” from falsified medicines. 

“You have something that could be toxic, whether it’s contaminated or whether they put insulin in it, and the person’s up in the hospital,” Jay said.

“There have been shortages. There are bad actors who’ve been trying to take advantage of the situation,” Dr Bruce Y Lee, professor of health policy at the Graduate School of Public Health at the City University of New York, told Al Jazeera.

But with the growing necessity for some people and vanity for others, patients are at the mercy of Novo Nordisk, both in terms of availability and the price they pay for these drugs.

In its first-quarter earnings report released in May, the Danish company said semaglutide sales more than doubled in the first quarter alone.

Prohibitive costs

Seventy-one percent of Novo Nordisk’s GLP-1 agonist medications have been sold in the US. Novo Nordisk charges Americans an average of $936 for a month’s supply, more than five times higher than the closest peer nation – Japan at $169.

“The cost of the medication can be problematic or even prohibitive for a number of different people, and whenever you have a situation like this, you’re more likely to have a secondary market where people are hawking counterfeit versions,” Lee said.

The cost has fuelled some concerns in Washington with Senator Bernie Sanders calling Novo Nordisk’s price tag “outrageous”.  In June, Novo Nordisk agreed to testify to Congress in September amid pressure from Sanders. 

Supply is still low. Injections of semaglutide have been in short supply since March 2022 because of a combination of factors, including explosive demand in the past few years and the company struggling to make headway with production demands.

The Senate’s Health, Education, Labor and Pensions Committee, which Sanders chairs, released a scathing report that suggests the prices for Novo Nordisk’s weight loss drugs have the power to bankrupt the entire US healthcare system, including Medicare and Medicaid.

Novo Nordisk has attributed its prices to the high cost of drug development, yet it still charges less in other countries – including the equivalent of $186 a month in Denmark – for the drug.

Ozempic’s success has made Novo Nordisk the most valuable company in Europe with a market capitalization of $570bn, making it bigger than the entire Danish economy.

“That is not making a reasonable return on investment. That is price gouging. That is corporate greed,” Sanders said in June. “And if Novo Nordisk does not end its greed, we have a responsibility to end it for them.” 

The company rejected the senator’s characterisation. “Each country has its own healthcare system and making isolated and limited comparisons ignores this fundamental concern. What remains constant is the indisputable value and cost savings Novo Nordisk medicines bring to patients, healthcare systems and society,” a Novo Nordisk spokesperson told Al Jazeera in a statement.

Novo Nordisk told Al Jazeera it has been working to lower costs for the drug, including investing $8bn to build a new production facility in Denmark. It has already lowered the price of the drug in the US by 40 percent, it said.

However, a report from Yale University found that it costs roughly $5 to make a dose of the medication.

Novo Nordisk told Al Jazeera that 80 percent of American consumers can get semaglutide medication for as little as $25. However, Al Jazeera was unable to confirm the validity of this claim.

When pressed, the spokesperson said the claim comes from Novo Nordisk’s internal data on file, which the company declined to share for verification purposes, saying the figures are “proprietary”. 

Amplified risks of injectable drugs

While Novo Nordisk is making efforts to ramp up production, it is doing little to drive down prices, including not providing pharmacies the chemical compound to make generic forms of the drug.

This is done in what are called compound pharmacies. Unlike conventional pharmacies that sell already packaged drugs from pharmaceutical companies, compound pharmacies mix their own versions made from raw ingredients sold to them in bulk for a discounted price. The pharmacist on site mixes the medication. In this case, Novo Nordisk refuses to provide these pharmacies with their ingredients, but some are still making versions of its weight loss and antiobesity drugs.

Generally, compound pharmacies are cheaper and offer safe alternatives, but in this particular case, there are significant concerns from agencies like the US Food and Drug Administration (FDA).

That is because Novo Nordisk holds the sole patent for the chemical compound that makes Ozempic and Wegovy. The compounded form uses a salt version of the base ingredient, which neither Novo Nordisk nor independent agencies like the FDA can vouch for, partly because compound pharmacies are outside the purview of the agency.

“It’s important that patients are aware … FDA has not approved any generic versions of semaglutide,” Novo Nordisk’s spokesperson said.

There have been reports that such compounded versions of the drug have led to high blood pressure, which can lead to heart attacks and strokes. Novo Nordisk’s drug has, on the other hand, been shown to lower the risk of cardiovascular events.

In its inspections, the FDA looks at medications, the vessels they are stored in like a vial or cartridge and the syringes used to inject the medication.

“Anything that is produced at a manufacturing facility undergoes sterility testing,” Michael Ganio, PharmD senior director of pharmacy practice and quality for the American Society of Health-System Pharmacists, told Al Jazeera.

That includes testing for microbial contamination and endotoxin testing, which is meant to make sure there is nothing alive in the dosage.

“The end result would be that whatever a patient is receiving or is self-injecting has undergone suitable quality controls to make sure that it’s not going to cause any sort of harm. When you have counterfeit products, you don’t know what those are,” Ganio added.

Recent reporting from Hunterbrook Media showed that wellness brand Hims and Hers has been selling a compounded version of the medication made by BPI Labs, which has allegedly caused severe illness in some instances.

Novo Nordisk has filed 21 lawsuits nationwide against medical spas, weight-loss clinics and compounding pharmacies engaging in unlawful marketing and sales of compounded drugs claiming to contain semaglutide. 

__________________________________________________________________________

https://whatsapp.com/channel/0029VaAtNxX8fewmiFmN7N22

__________________________________________________________________________

While compound pharmacies generally abide by rigid safety standards of their own, that does not mean that serious problems do not fall through the cracks.

In 2012, a contaminated injectable medication made at a compounding pharmacy in New England led to 753 fungal infections in 20 states. Sixty-four people ultimately died, making it one of the worst instances of medication contamination in history.

“There’s a reason why medications have to go through a regulatory body like the FDA. They make sure that there aren’t unacceptable levels of impurities and make sure things are not contaminated,” Lee said.

By Andy Hirschfeld