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Gray market grows for cheap weight-loss drugs imported

from

China

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Some users try small doses of substances not yet approved

by FDA

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Drugmakers call trend dangerous and illicit

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Online community says it's filling gaps in broken system

By Robin Respaut and Maggie Fick

SAN FRANCISCO, June 27 (Reuters) - In what she calls the

"wild west" of obesity medicines, Missouri-based Amy Spencer is

a pioneer.

Each week the mother of two injects herself with weight-loss

drugs, two of which are in clinical trials and not yet approved

for sale by the U.S. Food and Drug Administration. One comes

mixed with tirzepatide, the active ingredient in Eli Lilly's ( LLY )

Zepbound.

Spencer, 50, is not part of any drug trial but mixes the

cocktails herself, using tiny doses that she believes are safe.

The total cost is about $50 monthly, as little as one-tenth of

what she would expect to pay their makers for full treatment.

The drugs - glucagon-like peptide-1 (GLP-1) weight-loss

medicines - are manufactured and shipped from China, according

to the packaging. She orders them through online vendors.

Spencer belongs to a fast-growing group of Americans turning

to what many call the "gray market" for obesity medicines,

bringing cheap active ingredients from China often labeled as

for research purposes, according to import data and social media

postings. It's a trend that drugmakers Lilly and Novo Nordisk,

which makes Wegovy, say is dangerous as well as illicit.

Reuters tracked online forums and interviewed seven people

who said they bought obesity medicines through this market,

including an attorney in Arizona who works for a state insurance

agency, a retired nurse in Illinois and a Type 1 diabetic in

Louisiana, who said the medicine helped cut her insulin intake

by more than half.

For more than a year there has been demand for cheap

Chinese-made powders, exacerbated by limited health insurance

coverage in the U.S. Buyers told Reuters the gray market

received a boost from an FDA ruling last year that U.S.

compounding pharmacies - outsourcing facilities that create

drugs in shortage - must stop selling obesity medicines more

cheaply than the companies that developed them.

Shipments of such active ingredients from Chinese entities

not registered with the FDA jumped by 44% in January from the

previous month, according to research by the Partnership for

Safe Medicines, a public health group focused on the safety of

prescription drugs.

It said its findings are likely an undercount, because

unregistered vendors may not disclose that their parcels contain

medicines. Packages valued at less than $800 that enter the U.S.

under the de minimis rule are not included in the data.

Nearly three-quarters of U.S. adults are overweight or

obese, according to government estimates, but a survey by

nonprofit health policy research organization KFF found only

about 8% say they have taken medicine for weight loss.

Most of the gray market buyers Reuters interviewed had told

their medical providers they were taking GLP-1 medicines but not

where or how they bought them.

Insurance coverage for weight-loss drugs has recently

increased, but typically only covers branded versions, according

to consulting firm Mercer. Many Americans have paid out of

pocket for cheaper compounded drugs. Interest in taking small

doses of the drugs has also spurred the online marketplace,

buyers said.

Taking to platforms including Reddit ( RDDT ) and Telegram for

guidance, buyers import small quantities, often described as

research materials to sidestep regulatory scrutiny. They swap

advice for navigating the market, exchanging information on

vendors, shipping and dosage, and sometimes clubbing together to

cover the cost of testing the powders.

One forum is called StairwayToGray. It has more than 21,000

members on Telegram and recently was gaining nearly 1,000

members weekly. It did not respond to Reuters' inquiries, and

blocked access to the forum after receiving them. It has a

website where it says it does not facilitate group purchases.

"This community is filling the gaps and being our own

regulators, ensuring testing and access for everyone who needs

it. Because you shouldn't have to choose between your health or

your wallet," it says.

Spencer stores her stocks in her fridge and makes them up in

the kitchen - carefully measuring sterile water, rolling the

vial between her fingers until the powder dissolves, and drawing

the liquid into a syringe before injecting it into her thigh or

belly. She has lost 24 pounds.

"This is working so well for me. It's so easy. It's cheap,"

said Spencer, who assumes her health plan wouldn't cover the

drugs. "I don't know what I would do without this medicine."

"VERY DANGEROUS"

In February, 38 U.S. state and territory attorney generals

wrote the FDA seeking action against illegally sold weight-loss

medicines, including "research purposes only" ingredients from

China. "Much like with counterfeit versions, these active

ingredients come from unregulated, undisclosed sources ... and

pose risks of contamination and inclusion of foreign

substances," they said.

Shabbir Safdar, executive director of the Partnership for

Safe Medicines, said unapproved drugs can have problems with

sterility, purity and consistency.

"It can be very dangerous. You're playing the role of your

own doctor, pharmacist, and FDA inspector," he said.

Of those interviewed, only Spencer reported any problems:

She once got her math wrong and overdosed, resulting in several

days of severe flu-like symptoms.

Lilly said it had taken many steps to address patient safety

risks posed by the proliferation of unsafe or untested

tirzepatide. The company said it is filing lawsuits, educating

consumers and working with social media companies to identify

and remove posts that promote unsafe products, including those

described as "research use only."

"We will continue to take action to stop those who threaten

patient safety and urgently call on regulators and law

enforcement to do the same," a Lilly spokesperson told Reuters.

Novo Nordisk also said it continues to take action against

entities that violate laws and regulations and put patient

safety at risk.

America's Poison Control agency, which maintains the

nation's poison data surveillance system and monitors GLP-1

exposures, said it could not reliably track cases involving

unregulated "research chemical powders" because they are sold

under various names and formulations.

The FDA's goal is to stop illegal sales of pharmaceutical

medicines at the border, said George Karavetsos, former director

of the FDA's Office of Criminal Investigations and co-author of

the imports study. But understanding the true nature and

intended use of small parcels arriving from China can be

difficult, and the FDA rarely seeks charges against consumers

for personal use, he said.

The FDA said it urges consumers to buy from licensed

pharmacies and "avoid products of unknown quality," adding it

was actively protecting consumers by intercepting illegal

products at ports, and warning companies that market unapproved

weight-loss medicines, including those mislabeled as "for

research purposes."

Although the forums show suppliers purportedly in China,

Reuters was not able to verify where the drugs originate. None

of the vendors responded to requests for comment.

A Reddit ( RDDT ) spokesperson said the site prohibits facilitating

transactions involving drugs and it had shut down a group found

to be doing this. Telegram said it removes "more than a million"

instances of harmful content each day, but did not comment

directly.

MICRODOSE MISTAKE

Spencer has polycystic ovary syndrome and for years

struggled with weight gain and hypertension. She decided to try

obesity medicines after seeing claims on social media that

microdosing them could give fewer side effects, and bought

semaglutide, the active ingredient in Wegovy, from a compounding

pharmacy for about $200 per month.

She started on one-fifth of the lowest dose. Within days,

intermittent joint pain she often suffered had dissipated: "I

didn't realize how badly I hurt until the pain was gone."

The cost would reach about $500 a month if she bought the

drug from Novo, which recently introduced one-off discounts.

After a week, Spencer said, her blood pressure dropped so

low she thought she might pass out, so she stopped taking

hypertension medicine. Her pressure stabilized and she lost

three pounds.

She wanted to understand more about microdosing, and turned

to the gray market last summer. On Reddit ( RDDT ), users told how

another Novo drug in development, called CagriSema, had helped

reduce inflammation and hunger pangs better than semaglutide.

CagriSema is Novo's next-generation obesity drug candidate,

still in clinical trials so not available to the public. It

combines semaglutide with another molecule, called cagrilintide,

which intensifies the hormone-mimicking effects to regulate

blood sugar and reduce hunger.

Spencer was intrigued.

She found a U.S. reseller saying they tested Chinese-made

CagriSema through a third-party lab before selling it to

Americans. On microdoses of CagriSema, Spencer could enjoy food

in small quantities.

"I could say 'yes' because I knew I was only going to eat

four bites."

In October, Spencer saw on Reddit ( RDDT ) that tirzepatide might

also reduce inflammation. She placed a new order for vials that

contained cagrilintide and tirzepatide combined, dubbed

"cagri-tirz."

Now each Monday, Spencer injects herself with tiny amounts

of cagri-tirz. On Thursdays, she uses retatrutide, a new obesity

medicine by Lilly, also in trials.

As she was switching to cagri-tirz, Spencer made a dangerous

mistake. She calculated her new dosage without realizing the

concentration of cagrilintide in the combined vials was 10 times

higher than she had taken previously. "I was an idiot. I didn't

do my math. Or rather, I did the math for the tirzepatide but

not for the cagri," she said.

Almost immediately, she began vomiting. The reaction was so

severe she had trouble moving. She forced herself to drink water

but couldn't eat. After four days, when symptoms lifted, she had

lost seven pounds.

Despite the blunder, Spencer didn't consider returning to

compounded versions of the drugs or abandoning them altogether.

She is not regularly monitored by a healthcare provider, but

says her treatment has led to a "life-changing" reduction in

weight, joint pain and blood pressure.

"HONOR SYSTEM"

Gray-market buyer Marie, 41, shows how do-it-yourself

drugmakers are organizing. She describes herself as a "soccer

mom" from the Midwest and asked to be identified by her middle

name to protect her privacy.

Last year she bought a compounding pharmacy's version of

tirzepatide, paying about $470 monthly, and had lost more than

20 pounds when the FDA announced the ban on compounded

weight-loss drugs. She began to worry about her supply.

Browsing on Reddit ( RDDT ), she discovered links to Telegram and a

trove of detailed instructions from experienced users for buying

weight-loss drug ingredients from China. Customers said they

often paid with Bitcoin or through mobile payment service

Venmo.

After a month closely following the forums, Marie made a

purchase in January. The package that arrived contained 20 small

glass vials of white powder with red caps. There were no

instructions. The vendor who advertised the package on Telegram

said it came from China.

Marie returned to the forums and joined a group of 52 other

customers who paid a total of $1,020 to a Tennessee-based

company called Peptide Test. Six members mailed in a vial each

and the others chipped in their share of the fee. The lab found

the samples were pure. Peptide Test declined to comment.

"It's an honor system," said Marie. "These groups are very

supportive in a way I haven't seen on the internet before."

Before her first injection, Marie gave her husband details

of what she had done. They agreed that if needed, he would

disclose everything to the emergency medics. But she was fine.

In March, Marie volunteered to organize testing a new order

of tirzepatide. The group formed on Telegram after users

received vials from the same vendor which they judged to be from

the same batch based on the color of the caps. In all, 38 buyers

agreed to chip in for the $1,300 bill, and decided by poll that

five vials would be enough.

Five people sent drugs to the lab, Janoshik Analytical in

the Czech Republic, which found the vials contained tirzepatide,

as purported, with purity between 99.78% and 99.85%.

Janoshik's CEO, Peter Magic, is a former amateur

weight-lifter. He said his company started out more than a

decade ago testing performance-enhancing drugs for online

buyers. Last year, it tested 3,050 samples of obesity drugs, up

from just over 650 samples in 2023.

"We're testing hundreds of these every week," said Magic,

whose company helps customers navigate customs requirements for

shipping chemicals.