Across the globe, the rising class of weight reduction medication referred to as GLP-1 agonists has been a game-changer. This contains the blockbuster drug semaglutide, higher identified by its model names Ozempic and the stronger Wegovy. These have helped individuals shed some pounds, really feel extra assured and be more healthy.
However a surge in demand and a excessive price ticket have led to an increase in counterfeit variations of the medication – inflicting hospitalisations all over the world.
That features Mike Benson of Chicago, who fell right into a coma after taking a counterfeit model of Ozempic. Benson, who on the recommendation of counsel declined to remark, instructed an area TV station in January, “I don’t know that I’ve ever felt that manner in my life. I had thought this could possibly be the tip.”
Michelle Sword, a mom of two dwelling in Oxfordshire, England, had hypoglycemia and seizures, requiring her to be hospitalised.
With a number of such incidents, regulators are involved each on account of the counterfeit medicines but additionally about what’s inflicting shoppers to take this threat.
In Could, United States Customs and Border Safety (CBP) officers seized 11 shipments of counterfeit variations of Ozempic at an airport in Cincinnati, Ohio – one of many nation’s key operations hubs. The federal company intercepted the illicit medicines from Colombia. The shipments of greater than 100 injections every have been sure for places throughout the US starting from New York to Texas. The CBP stated the seizure was valued at roughly $887,000.
An analogous state of affairs unfolded at Chicago O’Hare Worldwide Airport final month.
Almost 10,000km (4,000 miles) away in Lebanon, Beirut, suspected faux Ozempic vials accounted for nearly a dozen situations of dangerously low blood sugar in sufferers, together with one case that required hospitalisation in November.
In October, British officers seized counterfeit variations of the remedy that have been imported from “reputable” suppliers in Germany and Austria, signalling the problem is coming from down the provision chain.
This month, Austrian courts introduced they might pursue authorized motion in opposition to a vendor who offered faux doses to a plastic surgeon in Salzburg.
That echoes a report late final month from Vainness Honest journal that stated some counterfeit doses ended up within the fingers of reputable medical practices with out their data.
There have been related experiences out of Brazil and Russia.
“I’ve a whole lot of issues as a result of not all of my sufferers can get these medicines, and folks actually need them and so they really feel determined about it,” stated Dr Melanie Jay, director of the Complete Program on Weight problems at New York College’s Grossman College of Drugs.
“There’s all this promoting for different locations the place you may get it for lots cheaper, and it’s unimaginable to know the way protected these options are,” she added.
Cybersecurity agency McAfee discovered lots of of pretend listings promoting Ozempic doses on Craigslist. The agency additionally found examples of scammers impersonating docs on Fb. McAfee says usually if these scammers do ship on their guarantees, they ship faux variations of the remedy, which embrace pens full of saline answer and EpiPens.
Customers have additionally turned to Reddit teams just like the since-banned Ozempic Supply USA, by which shoppers usually offered doses to one another.
Final 12 months, Al Jazeera discovered that sufferers may order these medication from on-line pharmacies with none doctor consultations.
Final month, the World Well being Group (WHO) warned concerning the “unpredictable vary of well being dangers or issues” from falsified medicines.
“You may have one thing that could possibly be poisonous, whether or not it’s contaminated or whether or not they put insulin in it, and the particular person’s up within the hospital,” Jay stated.
“There have been shortages. There are dangerous actors who’ve been attempting to reap the benefits of the state of affairs,” Dr Bruce Y Lee, professor of well being coverage on the Graduate College of Public Well being on the Metropolis College of New York, instructed Al Jazeera.
However with the rising necessity for some individuals and self-importance for others, sufferers are on the mercy of Novo Nordisk, each by way of availability and the worth they pay for these medication.
In its first-quarter earnings report launched in Could, the Danish firm stated semaglutide gross sales greater than doubled within the first quarter alone.
Prohibitive prices
Seventy-one % of Novo Nordisk’s GLP-1 agonist medicines have been offered within the US. Novo Nordisk expenses Individuals a mean of $936 for a month’s provide, greater than 5 occasions greater than the closest peer nation – Japan at $169.
“The price of the remedy might be problematic and even prohibitive for a lot of completely different individuals, and at any time when you’ve gotten a state of affairs like this, you’re extra more likely to have a secondary market the place persons are hawking counterfeit variations,” Lee stated.
The fee has fuelled some issues in Washington with Senator Bernie Sanders calling Novo Nordisk’s price ticket “outrageous”. In June, Novo Nordisk agreed to testify to Congress in September amid strain from Sanders.
Provide continues to be low. Injections of semaglutide have been briefly provide since March 2022 due to a mixture of things, together with explosive demand previously few years and the corporate struggling to make headway with manufacturing calls for.
The Senate’s Well being, Training, Labor and Pensions Committee, which Sanders chairs, launched a scathing report that means the costs for Novo Nordisk’s weight reduction medication have the facility to bankrupt the whole US healthcare system, together with Medicare and Medicaid.
Novo Nordisk has attributed its costs to the excessive price of drug improvement, but it nonetheless expenses much less in different international locations – together with the equal of $186 a month in Denmark – for the drug.
Ozempic’s success has made Novo Nordisk probably the most beneficial firm in Europe with a market capitalization of $570bn, making it larger than the whole Danish economic system.
“That’s not making an affordable return on funding. That’s value gouging. That’s company greed,” Sanders stated in June. “And if Novo Nordisk doesn’t finish its greed, we have now a duty to finish it for them.”
The corporate rejected the senator’s characterisation. “Every nation has its personal healthcare system and making remoted and restricted comparisons ignores this basic concern. What stays fixed is the indeniable worth and price financial savings Novo Nordisk medicines deliver to sufferers, healthcare methods and society,” a Novo Nordisk spokesperson instructed Al Jazeera in a press release.
Novo Nordisk instructed Al Jazeera it has been working to decrease prices for the drug, together with investing $8bn to construct a brand new manufacturing facility in Denmark. It has already lowered the worth of the drug within the US by 40 %, it stated.
Nonetheless, a report from Yale College discovered that it prices roughly $5 to make a dose of the remedy.
Novo Nordisk instructed Al Jazeera that 80 % of American shoppers can get semaglutide remedy for as little as $25. Nonetheless, Al Jazeera was unable to substantiate the validity of this declare.
When pressed, the spokesperson stated the declare comes from Novo Nordisk’s inside information on file, which the corporate declined to share for verification functions, saying the figures are “proprietary”.
Amplified dangers of injectable medication
Whereas Novo Nordisk is making efforts to ramp up manufacturing, it’s doing little to drive down costs, together with not offering pharmacies the chemical compound to make generic types of the drug.
That is carried out in what are referred to as compound pharmacies. Not like standard pharmacies that promote already packaged medication from pharmaceutical firms, compound pharmacies combine their very own variations created from uncooked components offered to them in bulk for a reduced value. The pharmacist on website mixes the remedy. On this case, Novo Nordisk refuses to offer these pharmacies with their components, however some are nonetheless making variations of its weight reduction and antiobesity medication.
Typically, compound pharmacies are cheaper and supply protected options, however on this specific case, there are vital issues from businesses just like the US Meals and Drug Administration (FDA).
That’s as a result of Novo Nordisk holds the only real patent for the chemical compound that makes Ozempic and Wegovy. The compounded type makes use of a salt model of the bottom ingredient, which neither Novo Nordisk nor unbiased businesses just like the FDA can vouch for, partly as a result of compound pharmacies are exterior the purview of the company.
“It’s vital that sufferers are conscious … FDA has not permitted any generic variations of semaglutide,” Novo Nordisk’s spokesperson stated.
There have been experiences that such compounded variations of the drug have led to hypertension, which might result in coronary heart assaults and strokes. Novo Nordisk’s drug has, however, been proven to decrease the chance of cardiovascular occasions.
In its inspections, the FDA seems at medicines, the vessels they’re saved in like a vial or cartridge and the syringes used to inject the remedy.
“Something that’s produced at a producing facility undergoes sterility testing,” Michael Ganio, PharmD senior director of pharmacy apply and high quality for the American Society of Well being-System Pharmacists, instructed Al Jazeera.
That features testing for microbial contamination and endotoxin testing, which is supposed to ensure there’s nothing alive within the dosage.
“The top consequence could be that no matter a affected person is receiving or is self-injecting has undergone appropriate qc to be sure that it’s not going to trigger any form of hurt. When you’ve gotten counterfeit merchandise, you don’t know what these are,” Ganio added.
Current reporting from Hunterbrook Media confirmed that wellness model Hims and Hers has been promoting a compounded model of the remedy made by BPI Labs, which has allegedly prompted extreme sickness in some situations.
Novo Nordisk has filed 21 lawsuits nationwide in opposition to medical spas, weight-loss clinics and compounding pharmacies partaking in illegal advertising and marketing and gross sales of compounded medication claiming to include semaglutide.
Whereas compound pharmacies typically abide by inflexible security requirements of their very own, that doesn’t imply that severe issues don’t fall by way of the cracks.
In 2012, a contaminated injectable remedy made at a compounding pharmacy in New England led to 753 fungal infections in 20 states. Sixty-four individuals in the end died, making it one of many worst situations of medication contamination in historical past.
“There’s a motive why medicines should undergo a regulatory physique just like the FDA. They be sure that there aren’t unacceptable ranges of impurities and ensure issues aren’t contaminated,” Lee stated.
