In a dim corner of drug regulation, we’re on the cusp of “a hot peptide summer.” That’s the word from Dean Stattmann at GQ. Writing as a men’s health and lifestyle reporter (not a health professional) he explains:

“In late February, health secretary Robert F. Kennedy Jr. joined Joe Rogan on his podcast, revealing that that he’s directing the FDA to loosen regulations on over a dozen previously banned peptides. The move, which seems likely to be announced in the coming weeks, would largely reverse the FDA’s previous decision to place 19 peptides on the agency’s category 2 list, which effectively bans pharmacies from formulating them for human use—and, by extension, restricts doctors from prescribing them. (Not that the initial decision to ban these peptides prevented surging demand from fueling a booming black market online).”

What could possibly go wrong?

Already Getting Out of Hand

Over at The Atlantic, Nicholas Florko says “the peptide boom is getting out of hand.” He describes how “experimental drugs that lack any FDA-approved ingredients” are in use for a stunning range of sex, weight loss, and lifestyle purposes. “We don’t even know what’s in these bottles,” says Christopher Robertson, a Boston University law professor. The recklessness of this is difficult to describe adequately.

Writing in the Journal of Advertising, Minhey Chung, Erin Willis, and Janelle Applequist document how social media advertising has served to “normalize off-label use for aesthetic goals, raising ethical concerns about health equity and informed decision-making.” Do you think business ethics require any fig leaf of balanced risk and benefit disclosure? If so, you are out of touch with this gray zone.

A Nuanced Strategy for Retatrutide

Meanwhile, Lilly is pursuing a nuanced legal and regulatory strategy for retatrutide. The company is developing this peptide for obesity and diabetes treatment. It promises to offer a major advance in potency. But long before the evidence for safe and effective use could justify it, so called “peptide labs” have been selling it with a wink and a nod “for research use.” Wrote Sara Zhang in The Atlantic, it feels “just like ordering socks.”

So Lilly sued FDA to have them classify retatrutide as a biologic rather than a drug. This is a nuanced distinction, but it has the potential to give Lilly more leverage to prevent compounders from infringing upon its rights to sell retatrutide for therapeutic purposes. Last fall, Lilly won a partial victory in this litigation.

An Inevitable Consequence of Marginalization?

Yes indeed, this is an awful mess of exploitation for vulnerable consumers. You can blame the victim and we suspect that this is exactly what dismissive policymakers might do. But the truth is that blame rests – at least in part – with biased health professionals who help to marginalize real human concerns that motivate people to seek help with sexual health, obesity, and other conditions that those professionals dismiss as “lifestyle” problems.

This, in our view, is one more way that stigmatizing and marginalizing people gets in the way of their pursuit of health.

Click here for more on RFK Jr.’s plans to open up access to dubious peptides and here for free access to Florko’s reporting in The Atlantic. For the analysis by Chung, Willis, and Applequist, click here.

Peasant Burning Weeds, painting by Vincent van Gogh / WikiArt