Why Counterfeit Ozempic is a Global Growth Industry

Meanwhile, the cost of the GLP-1 drugs – about $12,000 a year without insurance – makes them inaccessible to most patients who need them. Apovian’s clinic, the Center for Weight Management and Wellness at Brigham and Women’s Hospital in Boston, saw 12,000 patients last year and had a year-long waiting list. “We were all exhausted,” she said. “We cannot get medicine. Either they’re short or insurance won’t cover them, because if they do, they’ll go bankrupt.”

In April, North Carolina’s state health plan stopped providing the drug GLP-1 to teachers and other employees. “It’s going to create a lot of desperate people,” says Jamy Ard, MD, co-director of the Wake Forest Baptist Health Weight Management Center in North Carolina.

It has become common for patients to tell doctors at Ard’s clinic that they want to continue treatment at his center but use discount drugs they buy themselves. Invariably, his answer is no. It was “really unacceptable” to care for patients who were taking mystery drugs, he said. “Without chain of custody, no one can prove it’s clean.”

But “that fear of missing out, that sense of urgency,” Ard said, has turned patients into freelancers, each on the hunt for some special deal, some secret source, to they can reap the game-changing benefits of semaglutide.

Lin August, Novo Nordisk Chairman and CEO Lars Fruergaard Jørgensen has arrived in Beijing for a charm offensive. According to a government press release, he met with the Deputy Director of China’s State Food and Drug Administration to discuss drug research and “protection of intellectual property rights.”

The visit coincided with the arrival of Denmark’s Minister of Foreign Affairs, who attended a series of meetings with Chinese officials on deepening business ties between the two countries.

The impetus for these meetings is an urgent one.

In China, Novo Nordisk is embroiled in a legal battle to maintain its patent on semaglutide; The loss of intellectual property protection there could open the door to a flood of sophisticated counterfeit goods.

In June 2021, Hangzhou Zhongmei Huadong pharmaceutical company applied to invalidate Novo Nordisk’s patent on semaglutide, which had been approved in China five years earlier. In 2022, the Chinese company’s proposal was approved. 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 is “not unusual,” said a lawyer specializing in Chinese pharmaceutical patent law. Still, it’s a major setback for Novo Nordisk. Not long after, more than 10 different companies applied to China’s Drug Evaluation Center to produce semaglutide. Novo Nordisk appealed to the Beijing Intellectual Property Court.

The charm offensive last August, while the case was pending, seemed to have had some effect. In November 2023, in a highly unusual move, the property court fully reinstated the Ozempic patent. Hangzhou Zhongmei Huadong appealed the decision to China’s Supreme People’s Court, but as of last November, Novo Nordisk’s intellectual property appeared to remain safe in China.

Novo Nordisk declined to comment on ongoing litigation.

Justin Fiala, MD, was on duty in the intensive care unit of Northwestern Memorial Hospital in Chicago a week before Christmas when the first patient appeared. They had clammy skin, slurred speech, and seemed confused. According to a family member, the patient received an Ozempic pen from a nurse in Oklahoma who was a friend of a friend. Upon examination, it turned out that the patient’s blood sugar was dangerously low.

A few days later, two more patients were admitted to the ICU, Fiala recalls. They injected the Ozempic pens they received at the Botox party after a day of drinking. Within minutes of the injection, one person had a seizure and lost consciousness. “Alcohol actually complicates glucose control,” says Fiala.

All three patients were looking for weight loss solutions in a sea of ​​risks they didn’t fully understand.

Wahl, the center’s medical director, said the hospital reported the incident to the Illinois Poison Center, which turned over the pens for analysis to the FDA’s office of criminal investigations.

What did these patients, all of whom did not have diabetes, actually inject? Fiala said the resident doctors on duty did some online investigation and stumbled upon the possible culprit. The Apidra SoloStar insulin pen manufactured by Sanofi provides immediate results, can save the lives of diabetics but is fatal if injected into a non-diabetic. The pen is a dark gray-blue color, close enough to the brighter blue of the Ozempic pen to be relabeled and considered authentic.

Novo Nordisk product security manager Devaud said the exploitation of that passing similarity by counterfeiters was “extremely worrying”. She said her team and their counterparts at Sanofi, where she once worked, are compiling intelligence and collaborating on cases of suspected product switching.

A Sanofi spokesperson said the company “is aware of some counterfeit Ozempics…originating from illegal mislabeling of Apidra pens” and is “collaborating with stakeholders to protect patients.”

Ithat’s obvious Rampant counterfeiting is extremely dangerous. A less obvious risk arises from the proliferation of “compounded” versions of GLP-1 drugs of inconsistent quality.

State-licensed compounders create custom-made medications for patients with allergies or other special needs. They serve as key backstops in the U.S. drug supply and are authorized to produce small amounts of commercially available drugs that are in short supply under certain conditions. But their products, although legal, do not undergo the same rigorous testing and oversight as FDA-approved drugs.

In 2022, the FDA placed both Ozempic and Wegovy on the shortage list, allowing mixture manufacturers to ramp up production. The result was a quality control disaster. A lawyer and former FDA official with expertise in compounding said some compounding manufacturers are sourcing active ingredients from unregistered foreign sources in an attempt to evade customs review by way to transport their products inside cat food bags or rolled-up mats.

Both Novo Nordisk and Eli Lilly found dangerous impurities in their mixed versions of the drug. In an open letter to patients on January 4, Eli Lilly warned that it had “discovered products believed to be synthetic tirzepatide containing bacteria, high levels of impurities, chemical structures different and different color than Mounjaro or Zepbound. In at least one case, the product was nothing more than sugar alcohol.” (Tirzepatide is the active ingredient in Mounjaro and Zepbound.)