Around the world, the rise of weight-loss drugs called GLP-1 agonists – including the blockbuster drug semaglutide, better known by the brand names Ozempic and the more powerful Wegovy – has been a game-changer, helping people lose weight, feel more confident and healthier.
But soaring demand and rising prices have led to a rise in counterfeit drugs, resulting in hospitalizations around the world.
That includes Mike Benson, a Chicago man who fell into a coma after taking a counterfeit Ozempic. Mr. Benson declined to comment on the advice of his lawyers, but told a local television station in January, “I’ve never felt this way in my life. I thought this was it.”
Michelle Sword, a mother of two from Oxfordshire, England, suffered hypoglycemia and seizures and was forced to be hospitalized.
The recent spate of cases has regulators concerned not only about the existence of counterfeit medicines, but also about why consumers are taking these risks.
In May, U.S. Customs and Border Protection (CBP) agents seized a shipment of 11 counterfeit Ozempic tablets at the airport in Cincinnati, Ohio, one of the major U.S. operational hubs. Federal agents seized the illegal drugs from Colombia. The shipment of more than 100 injectables was destined for destinations across the U.S., from New York to Texas. According to CBP, the value of the seized items was approximately $887,000.
A similar incident occurred at Chicago O’Hare International Airport last month.
About 10,000 kilometers away, in Beirut, Lebanon, vials of suspected counterfeit Ozempic were linked to nearly a dozen cases of dangerously low blood sugar in patients, including one who required hospitalization in November.
In October, British authorities seized counterfeit copies of the drug imported from “legitimate” sources in Germany and Austria, suggesting the problem was coming from further down the supply chain.
This month, an Austrian court announced it would take legal action against a distributor who supplied counterfeit drugs to a Salzburg plastic surgeon.
This coincides with a Vanity Fair report late last month that some counterfeit vaccines were unwittingly finding their way into the hands of legitimate medical organizations.
Similar reports have come from Brazil and Russia.
“I have great concern because not all of my patients have access to these medications. They really want them, they desperately want them,” said Dr. Melanie Jay, director of the Comprehensive Obesity Program at New York University Grossman School of Medicine.
“There are so many advertisements for places where you can get it cheaper, it’s impossible to know how safe these alternatives are,” she added.
Cybersecurity Company McAfee The company found hundreds of fake listings on Craigslist selling Ozempic doses. It also found examples of scammers posing as doctors on Facebook. When these scammers do follow through on their promises, they often send fake medication, such as a saline-filled pen or an EpiPen, McAfee said.
Consumers have also turned to now-banned Reddit groups like Ozempic Source USA, where consumers frequently bought and sold the drug to each other.
Last year, Al Jazeera discovered that patients could order the drugs from online pharmacies without seeing a doctor.
Last month, the World Health Organisation (WHO) warned of an “unpredictable range of health risks and complications” from counterfeit medicines.
“Some of it is contaminated or has insulin in it, which can be toxic, and patients are being hospitalized,” Jay said.
“There are shortages going on, and there are bad actors trying to take advantage of the situation,” Dr. Bruce Y. Lee, a professor of health policy at the City University of New York’s School of Public Health, told Al Jazeera.
But as necessity grows for some and vanity grows for others, patients will be at the mercy of Novo Nordisk for both the availability and price of these drugs.
In its first-quarter results report in May, the Danish company said sales of semaglutide more than doubled in the first quarter alone.
Exorbitant costs
Seventy-one percent of Novo Nordisk’s GLP-1 agonists are sold in the U.S. Novo Nordisk charges Americans an average of $936 for a month’s supply, more than five times the price of $169 in Japan, the closest comparable country.
“The cost of the medicine may be an issue or prohibitive for many people, and in these situations there is a high likelihood that there will be a secondary market peddling counterfeit products,” Lee said.
The cost has raised concerns in Washington, with Senator Bernie Sanders calling for Novo Nordisk’s price to be “no way”In June, Novo Nordisk, under pressure from Sanders, agreed to testify before Congress in September.
Supplies remain tight: Injectable semaglutide has been in short supply since March 2022 due to a combination of factors, including a demand explosion over the past few years and companies struggling to keep up with production demands.
Sanders chairs the Senate Health, Education, Labor and Pensions Committee. report This suggests that the price of Novo Nordisk’s weight-loss drugs has the power to bankrupt the entire U.S. health care system, including Medicare and Medicaid.
Novo Nordisk blames the drug’s pricing on high drug development costs, but the drug remains cheaper in other countries, costing the equivalent of $186 a month in Denmark.
Ozempic’s success has made Novo Nordisk Europe’s most valuable company, with a market capitalization of $570 billion, bigger than the entire Danish economy.
“This is not generating a reasonable return on investment. This is price gouging and corporate greed,” Sanders said in June. “If Novo Nordisk won’t stop their greed, we have a responsibility to stop it for them.”
The company rejected the senator’s position: “Every country has its own healthcare system, and making individualized and limited comparisons ignores this fundamental concern. What remains constant is the indisputable value and cost savings that Novo Nordisk’s medicines bring to patients, healthcare systems and society,” a Novo Nordisk spokesman said in a statement to Al Jazeera.
Novo Nordisk told Al Jazeera it was working to bring down the cost of the drug, including investing $8 billion to build a new manufacturing facility in Denmark, and said it had already cut the price of the drug by 40% in the United States.
But a Yale University report said it would cost about $5 to make one dose of the drug.
Novo Nordisk told Al Jazeera that 80% of US consumers can get the semaglutide drug for just $25, but Al Jazeera was unable to verify the validity of this claim.
When pressed, a spokesman said the claim was based on internal data held by Novo Nordisk, but the company refused to make the data available for verification, saying the figures were “proprietary”.
Increased risks of injecting drugs
While Novo Nordisk has tried to increase production, it has done little to lower prices, including by refusing to provide pharmacies with the compounds they need to make generic versions.
This is done by so-called compounding pharmacies. Unlike traditional pharmacies that sell already-packaged medicines from pharmaceutical companies, compounding pharmacies compound their own versions from raw materials sold in bulk at a discount. Pharmacists mix the medicines on-site. In this case, Novo Nordisk refuses to provide these pharmacies with raw materials, but some still produce versions of the company’s weight-loss and anti-obesity drugs.
Compounding pharmacies generally offer cheaper and safer alternatives, but in this particular case, there have been serious concerns from agencies such as the U.S. Food and Drug Administration (FDA).
That’s because Novo Nordisk holds exclusive patents on the compounds that make up Ozempic and Wegovy. The preparations use salt versions of the base ingredients, but neither Novo Nordisk nor an independent agency like the FDA can guarantee this, in part because compounding pharmacies are outside the FDA’s jurisdiction.
“It is important for patients to be aware… the FDA has not approved any generic versions of semaglutide,” a Novo Nordisk spokesman said.
There are reports that combined versions of these drugs can cause high blood pressure and lead to heart attacks and strokes, while Novo Nordisk’s drug has been shown to reduce the risk of cardiovascular disease.
During an inspection, the FDA will examine the medication, the container in which the medication is stored (such as a vial or cartridge), and the syringe used to inject the medication.
“Everything that comes out of the manufacturing facility is subjected to sterility testing,” Michael Ganio, senior director of pharmacy operations and quality at the American Society of Health-System Pharmacists, told Al Jazeera.
This includes testing for microbial contamination and endotoxin testing, aiming to ensure no living organisms are present within the dose.
“Ultimately, what patients receive or self-inject has been subject to proper quality control to ensure that it does not cause any kind of harm. If there is a counterfeit product, we don’t know what it is,” Ganio added.
A recent report from Hunterbrook Media alleges that wellness brand Hims & Hers is selling a compounded version of a drug made by BPI Labs that has caused severe illness in some cases.
Novo Nordisk has filed 21 lawsuits across the country against medical spas, weight loss clinics and compounding pharmacies engaged in the illegal marketing and sale of compounded drugs purporting to contain semaglutide.
Although compounding pharmacies generally adhere to their own strict safety standards, that doesn’t mean serious issues don’t go unnoticed.
In 2012, contaminated injection drugs manufactured at a New England pharmacy were responsible for an outbreak of 753 fungal infections across 20 states, ultimately killing 64 people, making it one of the deadliest outbreaks in history. Drug contamination in history.
“There’s a reason drugs have to go through a regulatory agency like the FDA – to make sure they don’t have unacceptable levels of impurities, that they’re not contaminated,” Lee said.
