‘Incredibly irresponsible’: Hims Super Bowl ad downplays risks of compounded drugs

‘Incredibly irresponsible’: Hims Super Bowl ad downplays risks of compounded drugs

‘Incredibly irresponsible’: Hims Super Bowl ad downplays risks of compounded drugs

Telehealth provider’s splashy ad underplays risks of medications not approved by the FDA

The latest ad for Wegovy won’t stop anyone in their tracks. “Have you also had trouble with your weight?” a grinning actor says to the camera. “Same!” The blockbuster obesity medication sold by Novo Nordisk can lead to 15% weight loss, more actors claim. But as with many drug ads, more than a minute of its 90-second run time is monopolized by the less savory side of semaglutide: side effects like pancreas inflammation, gallbladder problems, diarrhea, and more.

By comparison, the Super Bowl ad for weight loss medications from direct-to-consumer telehealth company Hims & Hers released Tuesday is optimized to engage and infuriate. Over the refrain of Childish Gambino’s anti-racist anthem “This Is America,” its narrator makes the case that the weight loss industry, including drugmakers, are extracting profits from overweight and obese Americans without really helping them.

The multi-million dollar ad’s message isn’t bogged down by the same litany of disclaimers as Wegovy’s — even though it promotes a compounded version of the same class of medication, known as GLP-1s, as part of its solution to the broken health care system. It’s a paradox of pharmaceutical marketing that has left some health policy and pharmacy experts concerned that compounded medication ads from companies like Hims & Hers, will confuse and mislead patients seeking out obesity care.

“They don’t give ‘fair balance’ to the potential risks and side effects,” said Joey Mattingly, a pharmacy professor at the University of Utah who has written about the marketing and safety concerns around compounded GLP-1s, of the ad. “This is incredibly irresponsible.”

Drugs that are approved by the Food and Drug Administration, like Wegovy, have to meet detailed guidelines for direct-to-consumer marketing: They have to disclose what the drugs are indicated to treat and their most significant risks, and they’re prohibited from overstating benefits beyond the evidence or advertising off-label uses. But “advertising of compounded drugs is not subject to any of the advertising regulations that are typically applicable to prescription drugs,” said Dale Cooke, a consultant who counsels drug companies on product promotion.

That regulatory gray zone has become a topic of concern for public health watchers as compounded GLP-1s have become more widely used, with adoption driven by patients who struggle to access the FDA-approved drugs due to shortages and spotty insurance coverage. These drugs aren’t approved by the FDA, and the agency doesn’t evaluate them for safety, effectiveness, or quality. That means compounded drug ads can’t claim to be safe or effective — in the Super Bowl ad, Hims & Hers more generally refers to its products, which include GLP-1s and other compounded drugs, as “life-changing weight loss medications.” But that also means their ads aren’t required to disclose any of the risks or side effects associated with a drug, including those that belong to GLP-1s as a class and those that apply to compounded drugs specifically.

Hims is looking to capture Americans’ attention with the splashy Super Bowl ad at a time when telehealth providers are facing off against drugmakers over the ability to sell compounded versions of drugs that are not in shortage. Marty Makary, Trump’s nominee to lead the FDA, was an executive of telehealth company Sesame, which is also in the business of prescribing compounded weight loss drugs

In a recent analysis published in JAMA Health Forum, Yale researchers pointed out the limitations of marketing for compounded GLP-1s, looking at 79 sites that sell the drugs or prescriptions for them. Just as with Hims’ ad, they found that nearly half of sites marketing compounded GLP-1s didn’t include information about the drugs’ adverse effects, warnings, and contraindications. 

A Hims spokesperson pointed to information about side effects and other risks provided to patients on its website, but did not respond to questions about the company’s standards for sharing safety information in marketing materials specifically. “Every customer touchpoint, including our ads, is designed to be clear, accurate, and accessible so that customers have the digestible information necessary to understand what options are available for the treatment they may be seeking,” said the spokesperson. 

The Yale researchers also found that 37% of sites stated or implied that the compounded GLP-1s they marketed were FDA-approved. The biggest direct-to-consumer telehealth sites, including Hims and Ro, have more consistently labeled their ads with disclosures that their drugs are compounded and therefore not evaluated by the FDA. In the Super Bowl ad, Hims & Hers acknowledges that compounded drugs are not FDA-approved in fine print that appears for three seconds over images of its pills and vials. 

“I had to really squint to see that at the bottom of the video,” said study author Reshma Ramachandran, a physician and health services researcher at the Yale School of Medicine. “Small text for a few seconds of the ad doesn’t I think add a lot in terms of compounding education,” said Ramachandran’s co-author Ashwin Chetty, a medical student at Yale. 

“I’m pretty shocked by this advertisement,” added Ramachandran, “but also am impressed by how cleverly they framed this both in terms of playing to systemic concerns around weight loss and the high prices of novel weight loss medications.” The ad’s imagery hints at the influence of ultraprocessed food in obesity, an area of focus for some of President Trump’s health agency nominees. (Hims was a first-time contributor to Trump’s inauguration fund this year.) And like many ads for compounded GLP-1s, Hims’ Super Bowl spot emphasizes the affordability of its drugs. 

“There are medications that work, but they’re priced for profits, not patients,” the female narrator says over images of a pale-blue pen — the distinctive shade of Novo Nordisk’s Ozempic injector, but with the label blurred out — and clips of a news chyron that reads “weight-loss drugmakers grilled over high prices.” Later, the ad says that Hims’ drugs are “affordable, doctor-trusted, and formulated in the USA.” Along with compounded weight loss medications, Hims prescribes Wegovy and Ozempic.

The Alliance for Pharmacy Compounding, a trade group that includes Hims as a member, shared in an October document that compounders should “avoid promoting a compounded drug based on its price compared to a commercially available drug.” Compounded copies of FDA-approved medications are only allowed in limited circumstances, including when a drug is in shortage, and a lower price isn’t a remit to continue compounding once a shortage has abated. The industry association’s CEO Scott Brunner declined to comment on whether Hims’ ad aligns with that guidance, as a Hims spokesperson claimed. 

Marketing regulations aside, some see Hims positioning itself against the weight loss industry and profit-mongering pharmaceutical companies as disingenuous. Hims not only prescribes medications through its affiliated medical groups, it manufactures and distributes those drugs through compounding pharmacies that it owns. In the first nine months of 2024, it spent nearly half a billion dollars on marketing its drugs and their wraparound care. 

“They are using the narrative/argument that some people make to criticize pharmaceutical companies selling weight loss drugs,” said Chetty, “to then themselves sell weight loss drugs.”

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