The
first tip came into West Tennessee law enforcement about two months ago: A
resident in the area was selling cheap versions of Ozempic and other
weight loss drugs.
According to officials with
the West Tennessee Drug Task Force, the tipster believed the products couldn’t
be legitimate due to their unusually low prices: A 10-milligram vial of semaglutide,
the active ingredient in Ozempic and Wegovy, sold for about $100, for example,
and a 15 mg vial costs $140. The brand-name versions, from drugmaker Novo
Nordisk, sell for around $1,000 for a month’s supply.
Last week, officials said
they raided Emily Arnold’s home in Medina, Tennessee, and found more than 300
vials of counterfeit versions of semaglutide, tirzepatide — the
ingredient in the weight loss drug Zepbound and the diabetes drug
Mounjaro — along with other drugs used for weight loss. Syringes, alcohol
preps, mailers and other materials were also confiscated.
Officials
learned that she allegedly had also been supplying the drugs to two med spa
clinics in the state. Some
people who used the counterfeit drugs reported rashes and other pain from the
injections, officials said.
“We
stumbled into one room that was set up, sort of like a lab,” said Johnie
Carter, the director of the West Tennessee Drug Task Force. “We even found
three packages that were already packaged up and ready to go.”
“It was
very shocking,” he added.
Officials said Arnold, 41, has been charged with four felonies
and a misdemeanor, including impersonating a licensed professional. She will
plead not guilty, her attorney said.
As highly effective but pricey weight loss
drugs gain popularity in the U.S., experts and public health officials warn
that low-cost counterfeit versions are becoming increasingly common.
Counterfeit versions of Wegovy or
Zepbound are different from compounded weight loss drugs. Compounding is a
legitimate practice that’s monitored by the Food and Drug Administration. Compounded
medications are essentially copies made by a licensed pharmacist and
usually prescribed by a doctor.
The FDA is allowing pharmacies to dispense compounded versions of semaglutide and tirzepatide until shortages of the brand-name drugs are fully resolved. In October, the FDA said compounding pharmacies can continue making their own versions after a compounding trade group sued the agency, saying the drugs were still in shortage. Compounded versions of the drugs tend to cost less and are popular at online pharmacies and med spas.
Counterfeits, on the other hand, aren’t
licensed. They are manufactured and packaged to look like legitimate brand-name
medications, but often contain little to none of the actual drug.
Shabbir Safdar, the executive director of the
Partnership for Safe Medicines, an advocacy group that tracks counterfeit
drugs, said fake GLP-1 medications are “the No. 1 fraud issue” that group is
seeing in the U.S. and other parts of the world right now.
“It has exploded,” Safdar said. “I’ve never
seen the quantity of fraud and crime that is happening in this space right now
in anything for years. The criminals have been as active as the market
excitement about the medicines are.”
The packaging of the counterfeit weight loss
drugs can “appear like a perfect look-alike” to the brand-name versions, Safdar
said. At the same time, he said, they could contain wrong or harmful
ingredients, or contain too little, too much or no active ingredient at all.
West Tennessee law enforcement officials said that testing by Eli
Lilly, the maker of Mounjaro and Zepbound, after the raid revealed that one of the
samples sold by Arnold was nothing more than water, which could be dangerous if
not properly sterilized.
“No one will be bothered if you’re hurt,”
Safdar said. “They just want your money.”
The proliferation of counterfeit
drugs
The FDA is aware of and investigating reports
of counterfeit weight loss drugs being illegally marketed in the U.S., an
agency spokesperson said in a statement.
“We vigilantly monitor the internet for
fraudulent or unapproved products and have issued warning letters to stop the
distribution of illegally marketed semaglutide and tirzepatide,” the
spokesperson said.
If needed, the spokesperson added, the FDA’s
Office of Criminal Investigations will work with federal law enforcement
officials to carry on seizures, injunctions and criminal prosecutions. Last
year, the FDA announced that officials had seized thousands of units of
counterfeit Ozempic found in the U.S. drug supply chain, but noted that
some may still be available for purchase.
An Eli Lilly spokesperson said in a statement
that the company was pleased that regulators in Tennessee took action to “stop
one of the bad actors selling knockoff tirzepatide.” Lilly has obtained
shipments from China claiming to be tirzepatide that are packaged as dog food,
tea and facial masks or hidden inside of a box of T-shirts, the spokesperson
said.
“The proliferation of counterfeit and other
unsafe, unapproved tirzepatide knockoffs is dangerous and needs to be stopped,”
the spokesperson said.
Novo Nordisk said it’s fighting counterfeit
products and pursuing litigation against groups that sell counterfeit drugs.
“Producing counterfeit products and inserting
them into the legitimate U.S. supply chain is an illegal activity and puts
patients at considerable risk,” a Novo Nordisk spokesperson said in a
statement.
The risks of counterfeit drugs
Using a counterfeit medication can lead
to dangerous complications, said Dr. Daniela Hurtado Andrade, an
endocrinologist at the Mayo Clinic in Jacksonville, Florida.
“You never know what they are mixing them
with,” said Andrade, who spoke generally about the dangers of counterfeit
drugs. “There is the potential risk that they are mixed with electrolytes,
which for example, can put a person at risk of having cardiac arrhythmias.”
With counterfeit drugs, there’s no way to know
they’re following health regulations.
“If you are putting a contaminated substance
under your skin, you can certainly be at risk of developing infections,” she
said. “These are infections that are local, but then you could have certain
complications of local infections that can become systemic infections.”
Who is most at risk of
counterfeit drugs?
Anyone who buys a GLP-1 drug without a
prescription could be at risk of getting a counterfeit version.
The most vulnerable are people without
adequate health care coverage or without prescription drug benefits, or who
feel stigmatized by their weight and don’t want to see a doctor, Timothy
Mackey, a professor of global health at the University of California, San
Diego, said.
The nature of the weight loss drugs — large
amounts of people qualify for them and their high cost — make the problem
even more challenging to control, said Mackay, who studies counterfeit drugs.
“This situation is a bit different than prior
counterfeit medicine incidents, as arguably so many people are at risk,” he
said. “And consumers believe that they should be readily available,
conveniently.”
Safdar, of the Partnership for Safe Medicines,
said the best way people can protect themselves is to always get the brand-name
product through a prescription from a doctor.
He acknowledged that other people may not
qualify for the drug’s indicated use and will seek alternatives.
“I’ve seen people say, ‘I got it because I was trying to lose
that last 10 pounds,’” Safdar said. “People are finding telehealth providers
who will write that prescription and then dabbling in the market. None of that
is safe.”
This Article Source from NBC News Dec. 18, 2024, 4:29 AM GMT+5:30
By