'The Wild West' of weight loss

SAN FRANCISCO:

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 US Food and Drug Administration. One comes mixed with tirzepatide, the active ingredient in Eli Lilly's 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 "grey market" for obesity medicines, bringing cheap active ingredients from China often labelled 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 US Buyers told Reuters the grey market received a boost from an FDA ruling last year that US compounding pharmacies – outsourcing facilities that create drugs in shortage – must stop selling obesity medicines more cheaply than the companies that developed them.

Risky business

Shipments of such active ingredients from Chinese entities not registered with the FDA jumped by 44 per cent 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 US under the de minimis rule are not included in the data.

Nearly three-quarters of US adults are overweight or obese, according to government estimates, but a survey by nonprofit health policy research organisation KFF found only about 8 per cent say they have taken medicine for weight loss.

Most of the grey 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 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 US 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. Reuters