Across the world, the growing class of weight-loss drugs called GLP-1 agonists has been a game changer. These include the blockbuster drug semaglutide, better known by its brand names Ozempic, and the more potent Wegovy. These drugs have helped people lose weight, feel more confident and be healthier.
But rising demand and high prices have led to a surge in counterfeit versions of the drugs, leading to hospitalisations around the world.
Among them is Mike Benson of Chicago, who fell into a coma after taking a counterfeit version of Ozempic. Benson, who on the advice of a lawyer declined to comment, told a local television station in January: “I don't remember ever feeling like this in my life. I thought this might be the end.”
Michelle Sword, a mother of two living in Oxfordshire, England, suffered hypoglycemia and seizures, which led to her being hospitalized.
With multiple such incidents, regulators are concerned not only about counterfeit drugs, but also about what drives consumers to take such risks.
In May, U.S. Customs and Border Protection officials seized 11 shipments of counterfeit versions of Ozempic at an airport in Cincinnati, Ohio, one of the country’s main hubs. The federal agency intercepted the illicit drugs originating in Colombia. The shipments, which contained more than 100 injections each, were destined for locations across the United States, from New York to Texas. CBP said the seizure was valued at about $887,000.
A similar situation occurred at Chicago O'Hare International Airport last month.
Nearly 10,000 kilometers away in Beirut, Lebanon, allegedly fake vials of Ozempic were the cause of nearly a dozen cases of dangerously low blood sugar levels in patients, including one case requiring hospitalization in November.
In October, British officials seized counterfeit versions of the drug that were imported from “legitimate” suppliers in Germany and Austria, indicating the challenge lies in the supply chain.
This month, Austrian courts announced they would take legal action against a seller who supplied fake doses to a plastic surgeon in Salzburg.
This follows a report late last month by 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 from 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 are desperate for them,” said Dr. Melanie Jay, director of the Comprehensive Obesity Program at New York University's Grossman School of Medicine.
“There is a lot of advertising for other places where you can get it for much less money, but it is impossible to know how safe those alternatives are,” he added.
Cybersecurity firm McAfee found hundreds of fake ads selling doses of Ozempic on Craigslist. The firm also discovered examples of scammers posing as doctors on Facebook. McAfee says that often, if these scammers follow through on their promises, they send fake versions of the drug, including saline-filled pens and EpiPens.
Consumers have also turned to Reddit groups, such as the now-banned Ozempic Source USA, where consumers often sold doses to each other.
Last year, Al Jazeera discovered that patients were able to order these drugs from online pharmacies without having to consult a doctor.
Last month, the World Health Organization (WHO) warned of the “unpredictable range of health risks or complications” posed by counterfeit medicines.
“You have something that could be toxic, whether it’s contaminated or they’ve been given insulin, and the person is in the hospital,” Jay said.
“There have been shortages. There are malicious actors who have tried to take advantage of the situation,” Dr Bruce Y Lee, a professor of health policy at the City University of New York’s Graduate School of Public Health, told Al Jazeera.
But with some people's need increasing and others' vanity, 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 sales of semaglutide more than doubled in the first quarter alone.
Prohibitive costs
Seventy-one percent of Novo Nordisk's GLP-1 agonist drugs have been sold in the United States. Novo Nordisk charges Americans an average of $936 for a one-month supply, more than five times more than the nearest peer country, Japan, which charges $169.
“The cost of the drug can be problematic or even prohibitive for many people, and whenever a situation like this occurs, there is more likely to be a secondary market where people sell counterfeit versions,” Lee said.
The cost has raised some concerns in Washington, with Sen. Bernie Sanders calling Novo Nordisk’s price “outrageous.” In June, Novo Nordisk agreed to testify before Congress in September amid pressure from Sanders.
Supply remains tight. Semaglutide injections have been in short supply since March 2022 due to a combination of factors, including explosive demand in recent years and the company's struggles to keep up with production demands.
The Senate Health, Education, Labor and Pensions Committee, which Sanders chairs, released a scathing report suggesting that Novo Nordisk's weight-loss drug prices have the power to bankrupt the entire U.S. health care system, including Medicare and Medicaid.
Novo Nordisk has attributed its prices to the high cost of developing the drug, but 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 Europe's most valuable company, with a market capitalisation of $570 billion, making it larger than the entire Danish economy.
“That’s not generating a reasonable return on investment. That’s price gouging. That’s corporate greed,” Sanders said in June. “And if Novo Nordisk won’t stop its greed, we have a responsibility to stop it.”
The company rejected the senator’s characterization. “Each country has its own healthcare system and making isolated and narrow comparisons ignores this fundamental concern. What remains constant is the undisputed value and cost savings that 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 reduce the costs of the drug, including an $8 billion investment to build a new production facility in Denmark. It has already reduced the price of the drug in the US by 40 percent, it said.
However, a report from Yale University found that producing a dose of the drug costs about $5.
Novo Nordisk told Al Jazeera that 80 percent of US consumers can get the drug semaglutide 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 archived internal data from Novo Nordisk, which the company declined to share for verification purposes, saying the figures are “private.”
Amplified risks of injectable drugs
While Novo Nordisk is making efforts to increase production, it is doing little to reduce prices, including not providing pharmacies with the chemical compound to make generic forms of the drug.
This is done in so-called compounding pharmacies. Unlike conventional pharmacies that sell pre-packaged drugs from pharmaceutical companies, compounding pharmacies mix their own versions from raw ingredients sold to them in bulk for a discounted price. The local pharmacist mixes the drug. In this case, Novo Nordisk refuses to provide these pharmacies with its ingredients, but some continue to make versions of its slimming and anti-obesity drugs.
Compounding pharmacies are generally cheaper and offer safe alternatives, but in this particular case, there are significant concerns from agencies such as the U.S. Food and Drug Administration (FDA).
That's because Novo Nordisk holds the exclusive patent on the chemical compound that makes up Ozempic and Wegovy. The compounded formula uses a salt version of the base ingredient, something that neither Novo Nordisk nor independent agencies like the FDA can guarantee, in part because pharmacies that sell compounded drugs are outside the agency's purview.
“It is important for patients to know that… the FDA has not approved any generic version of semaglutide,” the Novo Nordisk spokesman said.
These combined versions of the drug have been reported to cause high blood pressure, which can lead to heart attacks and strokes. On the other hand, Novo Nordisk's drug has been shown to reduce the risk of cardiovascular events.
During its inspections, the FDA examines drugs, the containers in which they are stored, such as a vial or cartridge, and the syringes used to inject the drug.
“Everything that is produced in a manufacturing plant is tested for sterility,” Michael Ganio, senior director of pharmacy practices and quality at PharmD at the American Society of Health-System Pharmacists, told Al Jazeera.
This includes microbial contamination testing and endotoxin testing, which is intended to ensure that there is nothing living in the dose.
“The end result would be that everything that the patient receives or injects into themselves has been subjected to the appropriate quality controls to ensure that it is not going to cause any kind of harm. When there are counterfeit products, it is not known what they are,” Ganio added.
A recent report from Hunterbrook Media showed that wellness brand Hims and Hers has been selling a compounded version of the drug made by BPI Labs, which has allegedly caused serious illness in some cases.
Novo Nordisk has filed 21 lawsuits nationwide against medical spas, weight loss clinics and pharmacies that sell and illegally market prepared medications, claiming they contain semaglutide.
While compounded drug pharmacies generally adhere to their own strict safety standards, that doesn't mean serious problems can go undetected.
In 2012, a contaminated injectable drug manufactured in a New England pharmacy caused 753 fungal infections in 20 states. Sixty-four people died, making it one of the worst cases of drug contamination in history.
“There’s a reason why drugs have to go through a regulatory body like the FDA. They make sure that there are no unacceptable levels of impurities and that the products are not contaminated,” Lee said.
