Why Counterfeit Ozempic Is A Global-Growth Industry


                                                               By Katherine Eban

In early December, James Pinckney II, MD, stood in a cold warehouse in Elmira, New York, surveying what looked like the deal of the century.

Pallets of blue coolers stretched before him, each packed with boxes bearing the logo of Danish drugmaker Novo Nordisk: an Egyptian Apis bull, representing strength and fertility, balancing the sun between its horns.

Until recently, Novo Nordisk was a sleepy century-old insulin manufacturer. But in the past two years, its diabetes treatment Ozempic has swept the world. After a clinical trial confirmed that the drug, first approved by the US Food and Drug Administration in 2017, produces miraculous weight loss, influencers from Elon Musk to Oprah helped popularize it. The drug has brought new hope to those struggling with obesity and made Novo Nordisk Europe’s most valuable company even as it tore open a Pandora’s box of human vanity. The frenzy surrounding it has sparked global shortages.

Pinckney, an ebullient family medicine doctor married to a former Sports Illustrated swimsuit model, is the founder and CEO of Diamond Health, a concierge medical practice in Dallas. His quest for affordable Ozempic had brought him to the warehouse of F.M. Howell & Company, a midsize pharmaceutical distributor founded in 1883. Snapping photos, Pinckney closely examined the shrink-wrapped boxes of Ozempic, each containing a single four-dose pen of injectable semaglutide, the peptide developed by Novo Nordisk that increases the body’s insulin production, slows digestion, and decreases appetite.

Pinckney left favorably impressed with the potential windfall. Here was a reputable wholesaler with thousands of Ozempic pens at a relatively affordable price.

To be safe, Pinckney decided to ask for help vetting the merchandise. He reached out to Dennis Moore, a former California drug investigator who runs a company called Hudson Scientific that facilitates the manufacture and distribution of drugs and medical devices. Moore had been trying and failing for more than a year to become an authorized Novo Nordisk distributor. He’d also had his eye on the Ozempic for sale at F.M. Howell.

Looking closer, Moore and his quality director, Angela Powell, noticed other irregularities: The injection needles looked slightly different. And a small label on each pen was almost imperceptibly askew.

Powell realized something was gravely wrong when she scrutinized the boxes in the photos. Each box should have been marked with a unique serial number, but instead they all had the same one: 430834149057. Moore picked up the phone and called Novo Nordisk.

Three days later, on December 21, the FDA blasted out an alert. Counterfeit Ozempic had been detected in the legitimate drug supply, the agency warned, and no one should sell, distribute, or use any Ozempic pens labeled with lot number NAR0074 and serial number 430834149057. (According to a Novo Nordisk spokesperson, there was a real lot NAR0074 that “contained more than 100,000 units. Only products that have both lot number NAR0074 and serial number 430834149057 are counterfeit.”)

This looked like a fast response by FDA standards, but it wasn’t fast enough. Thousands of counterfeit Ozempic pens had arrived at F.M. Howell’s warehouse in the fall of 2023. Since then, some had been sold. Where had those doses gone?

And, just as pressing: Where had they come from?

Pinckney declined to comment for this article, citing the ongoing FDA investigation. In a phone call, Katherine Roehlke, the CEO of F.M. Howell, said, “We are bound by confidentiality agreements with our customers…. Your facts are incorrect,” then hung up. An FDA spokesperson said the agency “cannot comment further on an ongoing investigation.”

Under US law, drugs are supposed to travel seamlessly from a manufacturer’s loading dock to a distributor’s pristine warehouse to a pharmacy shelf through a protected chain of companies that follow strict requirements for handling medications and documenting sales.

But while the American drug supply is dominated by three large distributors, it’s also teeming with small-time middlemen with state licenses who buy and sell drugs like any other commodity. Sometimes, as they scour the marketplace for bargains, they may buy what are known as “diverted” drugs, which have been siphoned out of authorized sales channels. Some have been stolen, illegally resold by patients, or improperly hawked out of a pharmacy’s back door. The drugs may well be authentic, but they might also be expired, improperly stored, or contaminated. Under FDA rules, diverted drugs are considered adulterated and not fit for human consumption, because their safety and quality cannot be guaranteed.

Then there are outright counterfeits, drugs that have been criminally altered in some way: diluted, replaced with cheaper ingredients, or relabeled, for example.

In America’s pharmaceutical gray market, where the origin of drugs can be murky, counterfeiters may take advantage of a shortage by offering desperate pharmacies and wholesalers a bargain that’s too good to refuse, especially when it comes with a credible cover story. “Wherever you have illegal diversion, you’re going to have counterfeits,” says C. Todd Ratcliffe, president and CEO of the Pharmaceutical Security Institute, a nonprofit where pharma security directors pool intelligence on emerging threats.

The more popular or costly the drug, the bigger the gray market, the more middlemen clamoring for it, and the more criminal opportunity. To figure out where lot NAR0074 counterfeits originated required solving a complex puzzle with pieces potentially strewn all over the globe. The FDA was confronting a vast matrix of possible suspects, including organized crime rings with ties to the governments of foreign nations. All have been learning as they go how to breach America’s defenses in order to sell their counterfeit medicine in the most expensive, and lucrative, market in the world.

Ozempic belongs to a class of drugs known as GLP-1 agonists, which were originally developed to control diabetes. The first such drug to be approved by the FDA was developed in the 1990s after a team of Veterans Affairs researchers discovered that Gila monster venom contains a hormone that regulates blood sugar. The drug they helped create, exenatide, a precursor to Ozempic, has been used by millions of diabetes patients over the past two decades.

But the weight-loss potential of these drugs took center stage only in the past three years, after a clinical trial of Ozempic confirmed a surprise benefit: Those taking it could lose as much as 15 percent of their body weight. Social media and deft marketing by Novo Nordisk did the rest. The new generation of GLP-1 agonists have become household names, chief among them Novo Nordisk’s Ozempic and Wegovy, and Eli Lilly’s Mounjaro and Zepbound. (While Ozempic and Mounjaro are approved to treat diabetes, in practice doctors prescribe all four drugs to patients looking to lose weight.)

And with everyone from obesity patients to never-too-rich-or-thin celebrities demanding the drugs, they have become a hot commodity among transnational crime groups, homegrown counterfeiters, rogue compounders, shady middlemen, unscrupulous doctors, and medi-spas of dubious legality.

“Counterfeiters are like any other businessman,” says Geoffrey Potter, a US brand-protection attorney. “They wake up every day thinking, How do I expand my business?” For counterfeiters, the conditions for commercial growth are perfect: soaring prices, worldwide shortages, desperate patients, and ever-climbing obesity rates.

Back in its pre-semaglutide days, Novo Nordisk enjoyed a relatively serene existence. Headquartered in Bagsvaerd, Denmark, it has spent years quietly researching how to make insulin that lasts longer in the body. The Novo Nordisk Foundation, which last year awarded $1.3 billion in philanthropic grants and investments, helps fund climate change solutions and other causes. Yes, the company had run-ins with bad guys, like the crew that hijacked one of its insulin trucks in North Carolina in 2009. And it, too, occasionally was accused of being the bad guy: In 2017, the Justice Department alleged in a civil lawsuit that Novo Nordisk failed to warn consumers of the risks of a rare cancer from one of its diabetes medicines, Victoza. The company settled for $58.7 million without acknowledging wrongdoing.

But for the most part, the company was not on a war footing. It didn’t even have a global product security director until recently. Now, with a veritable Star Wars canteen of international criminals counterfeiting its products, Novo Nordisk has had to get tough fast. In September 2022, it hired its first director of global product security, Anne Devaud, a former French customs superintendent who had been in charge of investigations at Charles de Gaulle Airport outside Paris. “My first mandate was to confirm to the management, do we have an issue with counterfeits?” said Devaud. “A few months after, I was able to say yes, we have an issue.”

The scale and scope of those counterfeits is daunting. “The link with organized crime is increasing,” Devaud explains. “We can see now that the modus operandi of the counterfeiters [is] more and more sophisticated…. They are well organized. They have the channel to distribute.”

Novo Nordisk made available for the first time several of its top security and risk management officials to discuss the global proliferation of counterfeit Ozempic, but they declined to discuss any ongoing investigations. Through extensive reporting and interviews with pharmacists, doctors, security experts, law enforcement officials, private investigators, and attorneys, VF obtained details of specific counterfeiting incidents around the world.

Some counterfeiting schemes are industrial-scale efforts to replicate semaglutide, with uneven success. Others are cruder and even more dangerous switcheroos. Many of the patients whose adverse effects have been reported to the FDA have injected insulin that was relabeled to look like Ozempic. Diabetics use insulin to lower their blood sugar. For nondiabetics, accidentally injecting insulin can be “worse than life-threatening,” says Michael Wahl, MD, medical director of the Illinois Poison Center. “You can get irreversible brain damage if your glucose is too low for too long.”

The list of risks goes on: mystery impurities, improper storage conditions, dirty needles. According to FDA records obtained by VF, patients around the world have suffered horrifying consequences, including comas and seizures. One death has been linked to a suspected instance of counterfeit Wegovy. Fake versions of Ozempic have landed in multiple countries, from Lebanon and Serbia to Belgium and the United Kingdom. Between July 2022 and January 2024, the FDA fielded 12 reports of US patients harmed by counterfeit Ozempic, with symptoms ranging from loss of consciousness to swelling of the throat and face. There have also been reports of nine patients who suffered adverse events related to lot NAR0074, though it’s unclear if they used pens from the real lot or the counterfeit batch.

Meanwhile, the law enforcement agencies tasked with countering this global threat face a host of intractable obstacles. A key law in the US to better monitor the supply chain is still only partly implemented after more than a decade on the books. International laws range from weak to nonexistent. Corrupt governments look the other way at counterfeiting rings, if they aren’t participants themselves. “The good ideas are too late, they don’t keep pace with [evolving] technology, and there’s a fractured system of regulatory enforcement,” says Libby Baney, a lawyer specializing in online drug safety and distribution. “All these layers of complexity create criminal opportunity.”

In the US, this dysfunction was visible back in the early 2000s, when I spent three years in South Florida shadowing pharmacists and cops on the trail of domestic counterfeiters. The book I wrote, Dangerous Doses, prompted domestic reforms, including a pledge by the nation’s largest pharmaceutical wholesalers to stop buying from a poorly regulated gray market of middlemen, some of whom were convicted narcotics traffickers.

Since that time, however, the counterfeiters have gotten smarter, better, and, most importantly, bigger. Where once they operated out of shady neighborhoods, now they’re woven into the infrastructure of entire countries. Russian organized crime has moved into the Canadian online pharmacy space. China’s government is openly subsidizing companies that illegally buy and sell the ingredients for synthetic fentanyl. And counterfeit versions of cancer drugs including Keytruda and Avastin have been traced to Turkey. The relative lack of enforcement in that country is “a huge issue and a huge threat,” says Tara Steketee, the former director of product integrity at Merck, which manufactures Keytruda.

The pallets of counterfeit Ozempic pens in F.M. Howell’s warehouse looked good to the untrained eye and had come with a seemingly legitimate sales history. But the boxes had emerged from a pharmaceutical underworld that was primed for the emergence of a miracle drug. A global network of sophisticated counterfeiters, dodgy middlemen, and rank opportunists had each played their part. By now, the culprits—and the counterfeits—could be anywhere.

In the fall of 2023, a young woman in Salzburg, Austria, visited a plastic surgeon who was selling Ozempic pens illegally. Not diabetic and only slightly overweight, she made four visits to buy the pens. Each time, the surgeon’s price ticked upward, as supplies throughout Europe grew scarce.

The drug appeared to be working. But when the woman injected the fourth pen, she suffered convulsions and her blood sugar plunged. The counterfeit pen contained insulin, not semaglutide, and the hypoglycemic attack it caused could have been fatal had the woman’s boyfriend not rushed her to the hospital. Two days later, another of the plastic surgeon’s patients suffered a similar life-threatening reaction.

In a report to the FDA, Novo Nordisk described how another Austrian patient who took counterfeit Ozempic had a “seizure for circa 7 minutes, was foaming at the mouth, their eyes were open and was staring straight ahead, the patient was hyperventilating.”

European investigators tracing the origin of the counterfeit pens sold by the plastic surgeon followed the chain of custody through a web of distributors in Austria, Germany, and the UK and back to an all-too-familiar home base: Turkey. Specifically, an exporter in Ankara named AUB Healthcare was identified as being a conduit for the counterfeits.

Reached by phone, Hatice Bilir, a foreign trade specialist at the company and the wife of the owner, denied selling counterfeit Ozempic. “Why are we blamed for something we haven’t done?” she asked. “We have nothing to do with these baseless claims.” She said AUB had provided exonerating information to the Turkish health ministry but did not share it with VF. (Officials from Turkey’s health ministry did not respond to repeated calls or detailed questions.)

Lately, drug investigators in both the public and private sectors have found themselves increasingly preoccupied with Turkey. “Everything is linking back there right now,” says Kris Buckner, a Los Angeles private investigator who works with a number of international drug companies. “Turkey is rampant with diverted product, but recently we’ve seen a huge spike in counterfeit lifesaving drugs.”

Investigators at the National Intellectual Property Rights Coordination Center (IPR), a task force that steers the US government’s anti-counterfeiting efforts from within the Department of Homeland Security, say Turkey is a top priority this year. It’s one of five countries, they say, including China, Mexico, the UK, and India, from which the highest volume of counterfeited, diverted, and adulterated pharmaceuticals originate. “We’re going to work with our international law enforcement partners and try to make the biggest impact we can,” says IPR Center director James Mancuso.

Because Turkey subsidizes its pharmaceuticals and has some of the lowest-priced drugs in Europe, “criminals would come in, buy up all the subsidized pharmaceuticals, and then resell them” in other countries, says Nicole Johnson, a special agent and national program manager at the IPR Center. Before long, criminals were slipping sophisticated fakes into this stream of diverted drugs.

Last fall, the IPR Center partnered with Interpol and the Turkish National Police as part of a sweeping investigation called Operation Pangea, first launched in 2008. In October, there was a promising development when Turkish police seized thousands of counterfeit drugs from warehouses in southeast Turkey. But in the months since then, Buckner says, Turkey has failed to produce an inventory of the products seized, and there’s no indication that the criminal activity has been disrupted or that counterfeiters have been identified or charged.

A lawyer in Istanbul, Ezgi Baklacı Gülkokar, who represents international pharmaceutical companies, says, “In counterfeiting, especially the expensive drugs, it’s very hard to find the actual man behind it, and they usually use middlemen. At the end, the middleman gets the punishment.” Such cases, she says, are “very dangerous to investigate.”

An independent Turkish journalist, Murat Ağırel, has reported extensively on corruption within Turkey’s nationalized health care system, where he found evidence of government officials routing contracts to shady pharmaceutical suppliers. In 2018, the government purchased a cancer medicine consisting of acetaminophen. The fake medicine was also exported to countries including Iran, according to an indictment by an Istanbul prosecutor.

“The people involved in counterfeiting have political connections, and they are part of a vicious circle of bribery,” says Ağırel. “That is how they could fulfill the requirements to obtain” the government bids. To rein in Ağırel’s reporting, a Turkish court placed him under a type of restraining order typically used on domestic violence abusers.

In 2011, the Council of Europe established the Medicrime Convention, the only international legal instrument that fights counterfeit medical products. As one of the council’s 46 member states, Turkey ratified the convention in 2017, but it sends no representatives to meetings and has not appointed a formal contact person.

The scale of counterfeiting activities inside Turkey raises questions about the government’s complicity, says Buckner: “I don’t really think anything happens in countries at this level unless there’s some kind of [government] involvement. They can stop any problem they want to stop, if there’s a will.”

Back at Hudson Scientific this past December, Angela Powell was still trying to determine where the thousands of boxes of discounted Ozempic in lot NAR0074 had come from.

The drugs had been shipped last fall to F.M. Howell’s warehouse, according to shipping and inventory records with differing dates. A company called Chadwick Pharmaceuticals, in Madison, Mississippi, was listed in those records as both a purchaser and a consignee. Chadwick wasn’t a major company, nor was it some fly-by-night operation. Founded in 2015, it was licensed to distribute medicine in 22 states.

On November 30, Powell sent Chadwick an eight-page supplier questionnaire. It posed such important questions as: To whom does your company’s quality control manager report? Have any regulatory agencies inspected your facility in the last five years? Is a testing plan in place for all incoming products?

By law, Hudson Scientific had an obligation to ask questions, and Chadwick was supposed to respond promptly. As a drug supplier, says Powell, “they know they are required” to answer these questions. But there was no response.

On December 12, Powell resent the questionnaire to Chadwick’s president, Bobby J. King Jr. Again, nothing.

Under a federal law called the Drug Supply Chain Security Act (DSCSA), passed in 2013, everyone in the supply chain, from manufacturers and suppliers to pharmacists, is bound to vet their suppliers and customers. This reform was supposed to address the problem of dubious middlemen, who were selling stolen and sometimes counterfeit medicine out of car trunks, their own laundry rooms, and strip club parking lots. This expansive gray market had long obscured the origin of drugs, enabling counterfeits of such medication as Epogen and Lipitor to reach American consumers.

More than a decade later, however, the DSCSA is not yet fully in effect. One of its key provisions, for a system of easily accessible digital custody records, has been repeatedly postponed. It is now scheduled to be fully implemented this November.

For now, Powell was working off a paper trail. And the more she studied it, the less sense it made. According to one record, Chadwick had purchased the Ozempic in late September and had it shipped to 100 East Miller Street in Elmira, New York. But that was the address of F.M. Howell’s warehouse. Strangely, F.M. Howell’s name did not appear on the transaction history, even though its address did. (Chadwick’s president did not respond to detailed questions seeking comment.)

A separate shipping document that pointed to another party was unnamed in the official transaction history. Listed as a joint “consignee” with Chadwick was a Manhattan company called Assure Global LLC, which VF traced to a businessman named Roman Vintfeld, who’d previously had run-ins with state prosecutors in Florida and New Jersey.

In 2011, the attorney general of New Jersey accused one of Vintfeld’s companies, Industry Model and Talent Studios LLC, of committing fraud. A complaint accused Vintfeld of posing as a children’s talent scout at shopping malls and amusement parks and charging parents exorbitant fees for photo shoots and marketing campaigns that could lead to modeling contracts. The alleged swindle brought in more than 200 complaints. Vintfeld repeated the scheme in Florida, according to state charges. His companies settled both cases, and he went on to file for bankruptcy.

Vintfeld founded Assure Global in 2014. During the pandemic, the Defense Logistics Agency awarded the firm a $750,000 contract to provide hand sanitizer.

Reached by phone and asked why his company’s name appeared on a shipping document for a trove of counterfeit Ozempic, Vintfeld said, “That’s news to me.” Then he hung up.

The paperwork accompanying the phony lot NAR0074 was suspiciously opaque, with hidden names, intertwined corporate entities, and one company listed at the address of another. There are even conflicting records of how many boxes were delivered: One document lists 10,000 units and another 20,000. And that was all once the drug had infiltrated the US supply. What had happened before that? How had outright counterfeits gotten into our market at all?

Founded in 2005, the Obesity Action Coalition is a nonprofit that aims to fight bias and improve access to treatment. Every year it holds a convention with lectures and working groups, attended by the nation’s top obesity doctors as well as patients.

But with the stratospheric popularity of GLP-1 drugs, even the educational convention has become a hunting ground for gray market profiteers.

At last September’s event, the usual crowd of doctors and patients were joined by a curious character: Syd Karabel, a disheveled pharmacy rep in his late 70s who said he represented a Canadian company called UbaCare. Karabel had not preregistered for the conference, but he made his presence known almost immediately.

Approaching doctors at the conference, he held up a crumpled piece of notebook paper with his contact information and his product list. The sales pitch was simple: UbaCare could provide automated refills for “Ozempic, Saxenda, Mounjaro, etc.” at roughly one third of the going US price. He was “stalker-ish,” going so far as to ask patients at the conference where they got their meds, according to one attendee, Katherine Saunders, MD. He later peppered Saunders’s office with follow-up calls. His goal: to get doctors at the conference to steer prescriptions to him. “It was sketchy. Everyone was talking about it.”

The Obesity Action Coalition finally told Karabel to “knock it off,” says Joseph Nadglowski, the organization’s president and CEO. “I don’t know anyone who took him up on his offer, but he was very aggressive.” A month later, Karabel resumed his antics at an Obesity Week conference in Dallas.

Perhaps unsurprisingly, Syd Karabel is not a medical doctor. Nor is he Syd—not with a y anyway. A search for “Sid Karabel” turns up a Florida resident with a trail of shuttered businesses to his name and a history of bankruptcy proceedings.

Reached by phone, Karabel declined to comment. Over email, UbaCare’s vice-president and director of operations, Chad A. Robertson, said, “Dr. Karabel is not a representative of UbaCare past or present.... Our relationship with Dr. Karabel is that of a colleague that we collaborated with.” In a separate email, he said, “Dr. Karabel is an authority on cost containment and has businesses that operate globally in the healthcare space.” He added that UbaCare “is neither the buyer, dispensary, or shipper of record for any GLPs” to the US.

The supply chain is now overflowing with wannabe Ozempic distributors and online pharmacies looking to turn a profit by purchasing cut-rate weight-loss meds on the gray market and selling them to price-conscious patients. Last year, a cybersecurity firm took down more than 250 websites selling fake versions of GLP-1 drugs, Reuters recently reported. By February 2024, illegal pharmacies in the US were filling more than 734,000 GLP-1 prescriptions per month, according to data compiled by Translucent DataLab and the IQVIA Institute for Human Data Science.

Online meds sold illegally are frequently diverted if not counterfeit. The middlemen behind these operations prey on the desperation of patients suffering from obesity, who face a crippling shortage of doctors to treat them and a miraculous medication that is priced beyond reach.

A staggering 42 percent of American adults—more than 100 million people—are considered to have obesity. That number is projected to rise to 50 percent by 2030, the GLP-1 drugs notwithstanding. By contrast, there are only 146 doctors in America who are fellowship-trained in obesity medicine. A larger number, 7,747, are board-certified obesity specialists, but the quality of their training ranges widely. Only 30 academic medical centers have obesity treatment training programs.

Like their patients, these doctors must contend with the misperception that obesity results from insufficient willpower. It’s a “really complex disease, it’s chronic,” says Saunders. “Once somebody has obesity, they have [it] for life.” Though there have been great strides in recent years toward ending fat shaming and promoting body positivity, patients suffering from obesity still find themselves in a landscape of depleted medical services.

Every obesity specialist in the country has a waiting list of six to nine months, says Saunders, who was the first clinical fellow to graduate from Weill Cornell Medicine’s Comprehensive Weight Control Center with a degree in obesity medicine. She cofounded Intellihealth, a company that offers tools and clinical support to health care providers that treat obesity. Among its clients is the state of Connecticut.

The GLP-1 drugs, which Intellihealth’s staff members spend hours each day attempting to track down, “need to be used strategically, as part of a specialized plan,” says Saunders. “There is so much inappropriate prescribing, too little education and support. The medication needs to be part of a huge infrastructure.”

But that infrastructure doesn’t exist, says Caroline Apovian, MD, a pioneer in the field of obesity medicine, in part because the condition is “so stigmatized.” She adds: “Key opinion leaders in oncology, cardiac medicine, they can get donors” to help fund research. “I have Saudi princes and billionaires coming to see me” for treatment, and yet “I have trouble getting donations.”

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.)

One sample of compounded semaglutide sold by a Florida pharmacy contained “33% unknown impurities” that likely resulted from the use of non-pharmaceutical-grade semaglutide, according to a lawsuit Novo Nordisk filed last November.

Between February 2019 and December 2023, 352 reports of adverse events from compounded GLP-1 drugs rolled into the FDA, most submitted by patients and health care providers. Four people died, and many others suffered life-threatening reactions. One woman, who had obesity but was otherwise healthy, died suddenly from blood clots the day after injecting a dose of compounded semaglutide. The report submitted to the FDA says that a nurse practitioner felt the death was “possibly related” to the use of compounded semaglutide, due to the “proximity of product use.”

In January, the FDA warned consumers about reports of adverse events linked to compounded semaglutide and said some such products contained a variant of the peptide, semaglutide sodium, that had not been proven safe or effective.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, says the criticism of compounding is due to “misplaced anxiety” and a fundamental misunderstanding of what pharmacy compounders do. They can only purchase active ingredients from FDA-approved sources that are accompanied by a valid certificate of analysis, and they can only sell to patients who present a doctor’s prescription.

In their critiques, the brand-name companies are conflating state-licensed compounding with illegal online pharmacies that sell “an illicit substance that you buy without a prescription. That’s not even pharmacy,” Brunner says. “That’s drug dealing.”

But John Hertig, associate professor at Butler University’s College of Pharmacy and Health Sciences, says that some compounders are illegally sourcing ingredients from the gray or black market, resulting in products that “at worst will harm or kill you,” he says. “Not every pharmacy compounder is equal in adherence to the law.”

Down a bleak network of access roads off John F. Kennedy Airport in Queens, New York, sits the US Postal Service’s International Mail Facility. It’s an eerie place, with interlocking warehouses the size of football fields containing the remnants of a conveyor belt system from the 1970s. Overhead, pigeons flap around, searching for an exit.

One million parcels from overseas land at this facility every day, making it the nation’s busiest port of entry. An overhaul is planned so that, one day, AI-powered robots will sort the illegal shipments from the legit ones and the fake from the real. But for now, the effort to stem the tide of counterfeits falls to an overwhelmed assemblage of federal agents from Customs and Border Protection, the National Intellectual Property Rights Coordination Center, the FDA, the Department of Agriculture, the Fish and Wildlife Service, and other agencies.

While they are guided by data and intelligence, they are also using hunt-and-peck methods to intercept what amounts to the work product of some of the world’s most ruthless profiteers. First, there are the illegally smuggled goods, like the live finches sold by gambling rings that bet on which birds sing loudest and longest.

Then there are the counterfeits of varying lethality: cigarettes containing rat feces; phony makeup laced with cyanide and lead; bogus car airbags that either fail to inflate on impact or contain shrapnel and explode. “They don’t care if you die,” explains Steven Nethersole, a Customs and Border Protection officer, as he shows me some recently seized goods.

From the 100 fake Rolexes packed in bubble wrap to the Christian Louboutin knockoffs that arrived in a dilapidated box, there’s usually a tell. On a table in front of Nethersole, there’s a “Coach” handbag with a “Michael Kors” zipper and a designer coat with a label that reads “Burbelly.”

Next to that is a table piled with small boxes of intercepted Ozempic, many of the shipping labels stamped “medication for personal use.” Though it’s illegal to import medicine from overseas, Americans are permitted in certain circumstances to order small amounts of drugs that are unavailable in the US.

Those small exemptions translate into a tsunami of imported medicine. Each one of the orders on the table will have to be “scrutinized,” says Andrew Solarsh, a CBP supervisory officer.

Approximately 60 percent of the counterfeits coming through JFK originate in China, some of them routed through Turkey, Thailand, or the Netherlands, Solarsh explains. The biggest obstacle to intercepting them is the sheer volume.

The USPS and other entities operate hubs like this one at JFK and other ports of entry, and the counterfeit Ozempic in lot NAR0074 likely passed through it or a similar facility. The boxes were accompanied by paperwork, obtained by VF, that intermingles real and fake information: shipping and export records, a packaging manifest, and product tracing data.

According to an air waybill, the Ozempic pens were shipped on China Airlines from Shenzhen, China, on November 10. They were shipped by an entity calling itself the Shenzhen Lisheng Import & Export Trading Company to “New York, JFK.” The waybill number corresponds to a package that arrived at JFK on the evening of November 12, 2023. The separate packaging manifest shows that 10,000 units were transported in cold storage by a third-party shipper, PIF Global Logistics, and had been purchased with a bank transfer for $2 million. At $200 for a monthly pen containing four doses, that’s about one fifth of what a patient might pay out of pocket at a drugstore. (PIF Global did not respond to a request for comment. Shenzhen Lisheng could not be reached for comment.)

According to the packaging manifest, the pens were manufactured at a Novo Nordisk China facility in the northeastern city of Tianjin. The manifest carries the trademark Apis bull logo balancing the sun between its horns, along with the name of a Novo Nordisk sign-off manager: Desheng Wang.

Except Novo Nordisk doesn’t supply the US market with Ozempic manufactured in China. As a company spokesperson explains, “Most products in the US are made at US manufacturing sites, and some products are received from Novo Nordisk sites in Europe.” And no one named Desheng Wang—a common name in China—is employed by Novo Nordisk in any country, the spokesperson says. In other words, some of the data on the packaging manifest is as fake as the product itself.

The export certificate, stamped in Shenzhen on September 25, 2023, appears to be authentic. It identifies the cargo as Ozempic from lot NAR0074, but it lists a product code for leather items such as handbags, which may have enabled the shipment to slip past Customs. When the FDA briefed Congress on its investigation, it said at least some of the counterfeit product had been smuggled illegally into the US through ports of entry, according to a source familiar with the proceedings.

Who actually counterfeited the Ozempic pens remains unclear. But the sales date listed on the packaging manifest—August 10, 2023, a few days before Novo Nordisk’s CEO arrived in China—raises the possibility that the pens, which contained real semaglutide, though not the exact dose, could have been manufactured during the period when Ozempic’s patent protection there had been paused.

Asked about this possibility, the Novo Nordisk spokesperson said, “We cannot speculate on whether the [patent] invalidation has had a causal relationship of counterfeit products given the complexity of this case.”

As Novo Nordisk scrambles to ramp up its worldwide supply of Ozempic and Wegovy, purchasing manufacturing plants to expand production, it is also under pressure to reduce the medications’ explosive costs. A recent study found that GLP-1 drugs could be manufactured for less than $5 a month. While a price reduction would help many more patients access the drug, it could have an additional benefit of making the drugs a less attractive target for counterfeiters.

The question of how at least 10,000 units of counterfeit Ozempic entered America’s drug supply, bearing fake repetitive serial numbers, undetected by authorities including the FDA, is still being unraveled. But for Dennis Moore at Hudson Scientific, the takeaway is simple: “The system failed. That’s the key piece.”


Articles in this issue:

Leave a Comment

Please keep in mind that all comments are moderated. Please do not use a spam keyword or a domain as your name, or else it will be deleted. Let's have a personal and meaningful conversation instead. Thanks for your comments!

*This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.