Deceptive information and online sales of compounded GLP-1 drugs put consumers at risk, advocates say

The National Consumers League used this slide to illustrate the potentially deceptive or dangerous products awaiting online for consumers seeking new GLP-1 RA antiobesity medications.
_{© National Consumers League}

Patients seeking compounded GLP-1 RA drugs to treat obesity could fall victim to an infodemic with bogus claims and phony products all too accessible online, said advocates who hope to counter that misinformation.

The National Consumers League (NCL) has launched The Weight Truth, a new campaign to reform laws and policies around compounded glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs.

The antiobesity medications Wegovy (semaglutide) and Zepbound (tirzepatide), and antidiabetes drugs with weight-loss effects Ozempic (semaglutide) and Mounjaro (tirzepatide), have become pharmaceutical market bestsellers. But they are costly, so consumers have turned to versions mixed by pharmacists and often sold online.

The situation is confusing for patients — and quite possibly dangerous when consume adulterated substances that show up at their home. Bad information and deceptive practices put consumers’ health at risk and create mistrust in legitimate medical authorities, said NCL CEO Sally Greenberg.

“It’s a wild west situation that puts consumers at risk of dosing errors and bad reactions to the wrong ingredients,” she said.

Sally Greenberg
_{© National Consumers League}

Greenberg was one of six analysts with expertise in medicine, law and consumer behavior who spoke May 1 in a news conference held at the National Press Club in Washington, D.C.

Among the problems, Greenberg said, particularly in online sales:

• Pharmacies, often overseas, peddling phony GLP-1 RA patches, oral drops and lozenges and counterfeit products
• Active pharmaceutical ingredients created for research but sold for consumers to mix their own medicines

As a result, the U.S. Food and Drug Administration has logged more than 775 adverse event reports related to problems in patients, and huge growth in calls to poison control centers from people reporting side effects and overdoses, Greenberg said.

Policy directives

NCL posted its recommendations in the list, “Nine Priorities for Improving Policies to Combat Disinformation on GLP-1 Drugs and Protect Consumers.”

• Make combating infodemics a national priority.
• Increase coverage and affordability of FDA-approved GLP-1 RA drugs.
• Enforce existing drug advertising rules.
• Explore a new role for the Federal Trade Commission in enforcement.
• Increase pharmacovigilance of online pharmacy websites.
• Intensify federal and state efforts to protect consumers from counterfeiters.
• Implement labeling rules for drug compounders.
• Require drug compounders to submit adverse reaction reports to FDA.
• Require drug compounders to disclose information on the composition and distribution of compounded drugs.

State actions

The problem is a legal one as much as a medical one, and states will have a role to play. South Carolina Attorney General Alan Wilson spoke by video to discuss leading a bipartisan coalition of 37 state and territory attorneys general asking FDA for stronger enforcement against the online sellers. The unapproved drugs, many coming from China or India, may be contaminated or contain foreign substances.

The phony drug landscape

Nancy Glick, NCL director of food and nutrition policy, displayed photos of bogus antiobesity drugs or ingredients packaged to look like cat food, cosmetic face masks and adhesives.

Nancy Glick
© National Consumers League

“There's a lot of smuggling going on, and it's very creative, because, you know, I mean, that's what smugglers do,” Glick said. Regarding the cat food packaging, “I hope the pets are losing weight,” she quipped, and misspelled labels also might tip off people that the product is not something good to buy.

In reality, products potentially dangerous to people are getting into the country past customs inspection, she said.

NCL staff also created a mock-up advertisement stating “doctor approved,” bearing government logos or links to scientific studies. Those all are used to dupe potential buyers, Glick said. A constant stream of social media pushes out information encouraging consumers, she said.

NLC conducted its own survey of 1,500 American women aged 18 to 55 years. Among them, 61% understood what compounded drugs were, and 81% said claims in the fictitious ad were credible. Regarding compounded drugs, 71% of respondents said for those medicines to be on the market, they must be tested and proven safe, Glick said.

“So if you put this together, what you really see is the extent of the problem that we're facing, and the very important need for us to get out there and try to counter this with science-based information,” Glick said.

The new pandemic

The American Medical Association and other organizations now recognize obesity as a disease, said Angela Fitch, MD, immediate past president of the Obesity Medicine Association. But the American health care system has put treatment of obesity into the media because obesity treatment is not a standard benefit. Patient’s don’t have a comprehensive, high-quality medical home for treatment, so they seek it elsewhere, she said.

When the most popular GLP-1 RA drugs were in shortage, many patients turned to compounded versions and found effective treatment, Fitch said. They also are part of a giant, uncontrolled, unconsented human experiment, because there could be differences in the effects of the active pharmaceutical ingredient used in compounded versions and the manufacturers versions, she said.

“I’ve said for a long time that this should be a public health emergency, that obesity should be a public health emergency, and we should solve the problem in front of us, just like with COVID,” Fitch said. “It is a pandemic, it's a worldwide pandemic. We have data on that, and we now have effective treatment for it. So let's sit down together, everyone together, and find a solution instead of what's happening right now.”

Compounding pharmacy

Fitch noted she has nothing against compounding drugs. That is a process that has existed since the origins of pharmacy, said Joey Mattingly, PharmD, associate professor and vice chair of research at the University of Utah College of Pharmacy.

“Compounding is phenomenal,” Mattingly said. “The problem that we’re maybe seeing here is that because of the opportunities to make a lot of money, there’s a lot of people entering the market that maybe shouldn’t be entering the market. And that’s why when we hear these scary stories of a counterfeit medication entering the market, I think sometimes it gets associated with compounding.

“It may or may not have anything to do with compounding,” he said. “It may have to do with the bad company behind it, but it’s hard for a patient to tell the difference, right?”

Mattingly discussed patients, concerned about overdosing, calling the Utah poison control center, and a YouTube video purportedly showing how to dilute an imported high-dose GLP-1 RA drug for regular use in a patient’s kitchen.

State boards of pharmacy and FDA regulate pharmacies, but patients may not know the difference, and pharmacies selling the drugs illegally are skirting those rules. Mattingly recommended state boards and the Alliance for Pharmacy Compounding (APC) as resources for consumers or physicians to learn more. APC was not part of the NCL news conference, but it maintains the “Is It Legit?” website with a search for state boards of pharmacy websites.

Regulatory actions

Pharmacy compounding is permitted in special circumstances, such as during a shortage of a drug. It also is allowed for patients with special needs, such as a child who cannot tolerate a bad-tasting oral medicine, or a person with a swallowing disorder who needs a dosage different from what is being manufactured, said Steven Grossman, JD, former executive director of the Alliance for a Stronger FDA.

Special needs compounding is not intended to be the place for shortage compounding to move once a shortage is concluded, Grossman said. He added he anticipates that will be challenged.

FDA has initiated paperwork to survey 250 compounding facilities, which reflects continued concern about quality and safety of compounding, he said.

Grossman recommended at least three regulatory actions:

• Existing restrictions on drug advertising and promotions need to apply to compounded drugs in the shortage category.
• Online pharmacy websites are a cauldron of wild claims and questionably sourced products, and they need monitoring and corrective action under state and federal laws.
• FDA needs more information about how much compounding is occurring, the materials used, and reports of adverse events. Grossman said he believes that is the origin of the FDA survey.

A consumer education campaign also is needed to assure patients receive truthful information, he said.