The world over, the rising class of weight-loss medication referred to as GLP-1 agonists has been a sport changer. These embrace the blockbuster drug semaglutide, higher identified by its model names Ozempic, and the stronger Wegovy. These medication have helped individuals drop pounds, really feel extra assured and be more healthy.
However rising demand and excessive costs have led to a surge in counterfeit variations of the medication, resulting in hospitalisations all over the world.
Amongst them is Mike Benson of Chicago, who fell right into a coma after taking a counterfeit model of Ozempic. Benson, who on the recommendation of a lawyer declined to remark, advised a neighborhood tv station in January: “I do not keep in mind ever feeling like this in my life. I believed this is perhaps the tip.”
Michelle Sword, a mom of two dwelling in Oxfordshire, England, suffered hypoglycemia and seizures, which led to her being hospitalized.
With a number of such incidents, regulators are involved not solely about counterfeit medication, but additionally about what drives customers to take such dangers.
In Might, U.S. Customs and Border Safety officers seized 11 shipments of counterfeit variations of Ozempic at an airport in Cincinnati, Ohio, one of many nation’s most important hubs. The federal company intercepted the illicit medication originating in Colombia. The shipments, which contained greater than 100 injections every, had been destined for areas throughout the US, from New York to Texas. CBP stated the seizure was valued at about $887,000.
An identical scenario occurred at Chicago O’Hare Worldwide Airport final month.
Practically 10,000 kilometers away in Beirut, Lebanon, allegedly pretend vials of Ozempic had been the reason for practically a dozen circumstances of dangerously low blood sugar ranges in sufferers, together with one case requiring hospitalization in November.
In October, British officers seized counterfeit variations of the drug that had been imported from “legit” suppliers in Germany and Austria, indicating the problem lies within the provide chain.
This month, Austrian courts introduced they’d take authorized motion towards a vendor who provided pretend doses to a plastic surgeon in Salzburg.
This follows a report late final month by Vainness Truthful journal that stated some counterfeit doses ended up within the arms of legit medical practices with out their data.
There have been related reviews from Brazil and Russia.
“I’ve loads of considerations as a result of not all of my sufferers can get these drugs, and other people actually need them and are determined for them,” stated Dr. Melanie Jay, director of the Complete Weight problems Program at New York College’s Grossman Faculty of Drugs.
“There’s loads of promoting for different locations the place you will get it for a lot much less cash, however it’s not possible to understand how protected these alternate options are,” he added.
Cybersecurity agency McAfee discovered a whole lot of faux adverts promoting doses of Ozempic on Craigslist. The agency additionally found examples of scammers posing as medical doctors on Fb. McAfee says that usually, if these scammers comply with by way of on their guarantees, they ship pretend variations of the drug, together with saline-filled pens and EpiPens.
Shoppers have additionally turned to Reddit teams, such because the now-banned Ozempic Supply USA, the place customers typically bought doses to one another.
Final 12 months, Al Jazeera found that sufferers had been capable of order these medication from on-line pharmacies with out having to seek the advice of a health care provider.
Final month, the World Well being Group (WHO) warned of the “unpredictable vary of well being dangers or problems” posed by counterfeit medicines.
“You’ve one thing that may very well be poisonous, whether or not it’s contaminated or they’ve been given insulin, and the particular person is within the hospital,” Jay stated.
“There have been shortages. There are malicious actors who’ve tried to reap the benefits of the scenario,” Dr Bruce Y Lee, a professor of well being coverage on the Metropolis College of New York’s Graduate Faculty of Public Well being, advised Al Jazeera.
However with some individuals’s want growing and others’ self-importance, sufferers are on the mercy of Novo Nordisk, each when it comes to availability and the value they pay for these medication.
In its first-quarter earnings report launched in Might, the Danish firm stated gross sales of semaglutide greater than doubled within the first quarter alone.
Prohibitive prices
Seventy-one p.c of Novo Nordisk’s GLP-1 agonist medication have been bought in the US. Novo Nordisk prices Individuals a mean of $936 for a one-month provide, greater than 5 instances greater than the closest peer nation, Japan, which prices $169.
“The price of the drug may be problematic and even prohibitive for many individuals, and each time a scenario like this happens, there’s extra more likely to be a secondary market the place individuals promote counterfeit variations,” Lee stated.
The fee has raised some considerations in Washington, with Sen. Bernie Sanders calling Novo Nordisk’s worth “outrageous.” In June, Novo Nordisk agreed to testify earlier than Congress in September amid strain from Sanders.
Provide stays tight. Semaglutide injections have been briefly provide since March 2022 as a result of a mix of things, together with explosive demand in recent times and the corporate’s struggles to maintain up with manufacturing calls for.
The Senate Well being, Schooling, Labor and Pensions Committee, which Sanders chairs, launched a scathing report suggesting that Novo Nordisk’s weight-loss drug costs have the ability to bankrupt all the U.S. well being care system, together with Medicare and Medicaid.
Novo Nordisk has attributed its costs to the excessive price of growing the drug, however nonetheless prices much less in different nations (together with the equal of $186 a month in Denmark) for the drug.
Ozempic’s success has made Novo Nordisk Europe’s most dear firm, with a market capitalisation of $570 billion, making it bigger than all the Danish financial system.
“That’s not producing an affordable return on funding. That’s worth gouging. That’s company greed,” Sanders stated in June. “And if Novo Nordisk received’t cease its greed, we have now a accountability to cease it.”
The corporate rejected the senator’s characterization. “Every nation has its personal healthcare system and making remoted and slim comparisons ignores this basic concern. What stays fixed is the undisputed worth and value financial savings that Novo Nordisk medicines deliver to sufferers, healthcare techniques and society,” a Novo Nordisk spokesperson advised Al Jazeera in an announcement.
Novo Nordisk advised Al Jazeera it has been working to scale back the prices of the drug, together with an $8 billion funding to construct a brand new manufacturing facility in Denmark. It has already lowered the value of the drug within the US by 40 p.c, it stated.
Nevertheless, a report from Yale College discovered that producing a dose of the drug prices about $5.
Novo Nordisk advised Al Jazeera that 80 p.c of US customers can get the drug semaglutide for as little as $25. Nevertheless, Al Jazeera was unable to verify the validity of this declare.
When pressed, the spokesperson stated the declare comes from archived inner information from Novo Nordisk, which the corporate declined to share for verification functions, saying the figures are “personal.”
Amplified dangers of injectable medication
Whereas Novo Nordisk is making efforts to extend manufacturing, it’s doing little to scale back costs, together with not offering pharmacies with the chemical compound to make generic types of the drug.
That is carried out in so-called compounding pharmacies. Not like typical pharmacies that promote pre-packaged medication from pharmaceutical firms, compounding pharmacies combine their very own variations from uncooked elements bought to them in bulk for a reduced worth. The native pharmacist mixes the drug. On this case, Novo Nordisk refuses to supply these pharmacies with its elements, however some proceed to make variations of its slimming and anti-obesity medication.
Compounding pharmacies are typically cheaper and provide protected alternate options, however on this explicit case, there are important considerations from businesses such because the U.S. Meals and Drug Administration (FDA).
That is as a result of Novo Nordisk holds the unique patent on the chemical compound that makes up Ozempic and Wegovy. The compounded system makes use of a salt model of the bottom ingredient, one thing that neither Novo Nordisk nor impartial businesses just like the FDA can assure, partly as a result of pharmacies that promote compounded medication are exterior the company’s purview.
“It is vital for sufferers to know that… the FDA has not authorised any generic model of semaglutide,” the Novo Nordisk spokesman stated.
These mixed variations of the drug have been reported to trigger hypertension, which might result in coronary heart assaults and strokes. Then again, Novo Nordisk’s drug has been proven to scale back the danger of cardiovascular occasions.
Throughout its inspections, the FDA examines medication, the containers during which they’re saved, comparable to a vial or cartridge, and the syringes used to inject the drug.
“Every little thing that’s produced in a producing plant is examined for sterility,” Michael Ganio, senior director of pharmacy practices and high quality at PharmD on the American Society of Well being-System Pharmacists, advised Al Jazeera.
This consists of microbial contamination testing and endotoxin testing, which is meant to make sure that there’s nothing dwelling within the dose.
“The tip end result could be that all the things that the affected person receives or injects into themselves has been subjected to the suitable quality control to make sure that it’s not going to trigger any form of hurt. When there are counterfeit merchandise, it’s not identified what they’re,” Ganio added.
A current report from Hunterbrook Media confirmed that wellness model Hims and Hers has been promoting a compounded model of the drug made by BPI Labs, which has allegedly brought about severe sickness in some circumstances.
Novo Nordisk has filed 21 lawsuits nationwide towards medical spas, weight reduction clinics and pharmacies that promote and illegally market ready drugs, claiming they comprise semaglutide.
Whereas compounded drug pharmacies typically adhere to their very own strict security requirements, that does not imply severe issues can go undetected.
In 2012, a contaminated injectable drug manufactured in a New England pharmacy brought about 753 fungal infections in 20 states. Sixty-four individuals died, making it one of many worst circumstances of drug contamination in historical past.
“There’s a purpose why medication should undergo a regulatory physique just like the FDA. They guarantee that there are not any unacceptable ranges of impurities and that the merchandise aren’t contaminated,” Lee stated.