Meanwhile, the cost of the GLP-1 drugs—roughly $12,000 a year without insurance—places them beyond the reach of most patients who need them. Apovian’s practice, the Center for Weight Management and Wellness at the Brigham and Women’s Hospital in Boston, saw 12,000 patients last year and has a yearlong waiting list. “We’re all exhausted,” she says. “We can’t get medications. Either they’re in shortage or insurance won’t cover them, because if they covered them, they’d go bankrupt.”
In April, North Carolina’s state health plan discontinued coverage of GLP-1 drugs for its teachers and other employees. “It’s going to create a lot of desperate people,” says Jamy Ard, MD, codirector of the Wake Forest Baptist Health Weight Management Center in North Carolina.
It’s become common for patients to tell the doctors at Ard’s practice that they’d like to continue treatment at his center but use discounted medications they’ve sourced themselves. Invariably, his answer is no. It’s “really untenable,” he says, to care for patients taking mystery medicines. “There’s no chain of custody, no one has demonstrated it’s pure.”
But that “fear of missing out, that sense of urgency,” says Ard, has turned patients into freelancers, each on the hunt for some special deal, some secret source, so they can reap semaglutide’s game-changing benefits.
Last August, Novo Nordisk’s president and CEO, Lars Fruergaard Jørgensen, arrived in Beijing for a charm offensive. He met with the deputy director of China’s State Food and Drug Administration to discuss drug research and “intellectual property protection,” according to a government press release.
The visit dovetailed with the arrival of Denmark’s minister of foreign affairs, who had come for a series of meetings with Chinese officials on the deepening of business ties between the two countries.
The impetus for these meetings was an urgent one.
In China, Novo Nordisk was locked in a legal battle to maintain its patent for semaglutide; a loss of intellectual property protection there could potentially open up a geyser of sophisticated knockoffs.
In June 2021, the Hangzhou Zhongmei Huadong pharmaceutical company had applied to invalidate Novo Nordisk’s patent for semaglutide, which had been approved in China five years earlier. In 2022, the Chinese company’s motion was granted. Just like that, Novo Nordisk’s patent went up in smoke—at least temporarily.
In China, pharmaceutical patents are “an endangered species” and the decision was “not that unusual,” says a lawyer expert in Chinese pharmaceutical patent law. Nevertheless, it was a major setback for Novo Nordisk. Before long, more than 10 different companies had applied to China’s Center for Drug Evaluation to manufacture semaglutide. Novo Nordisk appealed to the Beijing Intellectual Property Court.
The charm offensive last August, as the case was pending, appears to have had some effect. In November 2023, in a highly unusual move, the property court fully restored the Ozempic patent. Hangzhou Zhongmei Huadong has appealed the decision to China’s Supreme People’s Court, but as of last November, Novo Nordisk’s intellectual property appeared to be safe in China.
Novo Nordisk declined to comment on the ongoing litigation.
Justin Fiala, MD, was on duty at the intensive care unit of Northwestern Memorial Hospital in Chicago the week before Christmas when the first patient turned up. They had clammy skin, slurred speech, and seemed confused. According to a family member, the patient had gotten an Ozempic pen from a nurse in Oklahoma who was the friend of a friend. Upon examination, it turned out that the patient’s glucose levels were dangerously low.
Several days later, Fiala recalls, two more patients were admitted to the ICU. They had injected Ozempic pens they’d gotten at a Botox party after a day of drinking. Within minutes of the injection, one had suffered seizures and lost consciousness. “Alcohol really complicates glucose control,” says Fiala.
All three patients were fishing for a weight-loss solution in a sea of risks they didn’t fully understand.
The hospital reported the incidents to the Illinois Poison Center, which turned over the pens for analysis to the FDA’s office of criminal investigations, says Wahl, the center’s medical director.
What had these patients, all nondiabetics, actually injected? The medical residents on duty did some online sleuthing and stumbled across the likely culprit, says Fiala. The Apidra SoloStar insulin pen, made by Sanofi, offers immediate results that can be lifesaving for diabetics but deadly if injected by nondiabetics. The pen is a darkish gray blue, close enough to the Ozempic pen’s brighter blue to be relabeled and passed off as authentic.
The exploitation of that passing resemblance by counterfeiters is “super worrying,” says Novo Nordisk product security director Devaud. She says her team and their counterparts at Sanofi, where she used to work, are pooling intelligence and cooperating on cases where switched products are suspected.
A Sanofi spokesperson says the company is “aware of some falsified Ozempic…originating from illegal mislabeling of Apidra” pens and is “collaborating with stakeholders to protect patients.”
It’s obvious that out-and-out counterfeits are extremely dangerous. A less obvious risk arises from the proliferation of “compounded” versions of GLP-1 drugs of uneven quality.
State-licensed compounders create custom-made medicines for patients with allergies or other special needs. They serve as an important stopgap in the US drug supply, and are allowed to make small amounts of commercially available medicines that are in short supply under certain conditions. But their products, though legal, don’t undergo the same testing and scrutiny as FDA-approved drugs.
In 2022, the FDA placed both Ozempic and Wegovy on its shortage list, enabling compounders to ramp up production. The result has been a quality control disaster. Some compounders are seeking out active ingredients from unregistered foreign sources who evade customs review by shipping their wares inside cat food bags or rolled-up rugs, says an attorney and former FDA official with expertise in compounding.
Both Novo Nordisk and Eli Lilly have found dangerous impurities in compounded versions of their drugs. In an open letter to patients on January 4, Eli Lilly warned that it had “discovered products claiming to be compounded tirzepatide medicines that contain bacteria, high impurity levels, different chemical structures, and different colors than Mounjaro or Zepbound. In at least one instance, the product was nothing more than sugar alcohol.” (Tirzepatide is the active ingredient in Mounjaro and Zepbound.)