The peptide craze sweeping America has a fan in RFK Jr

This could lead to less FDA oversight just when more is needed

The post The peptide craze sweeping America has a fan in RFK Jr first appeared on Science-Based Medicine.

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[Note: Dr. Gorski had a death in the family Saturday night and, as a result, won’t be posting anything this week. He will return to regular posting next week.]

So-called “peptides” are a fad that rivals some of the riskiest past health crazes I’ve seen, including unproven stem cells, but the peptide mania poses unique risks.

For context, more than 100 peptides have been FDA approved for legitimate purposes since the introduction of insulin in 1923, all the way up to and including GLP-1 drugs. These scientifically-proven peptide drugs are currently prescribed for conditions including diabetes, osteoporosis, chronic pain, and rare genetic disorders. But those peptides and uses are not what this post is about.

Instead, I’m covering the unproven and non-FDA-approved peptides that seem to be everywhere now. This fad also has become wrapped up in politics related to HHS Secretary RFK Jr, who apparently is a peptide enthusiast. There are notable parallels between marketing of unproven stem cells and peptides, including Kennedy’s interest in both.

The peptide craze took off in the US around 2020 when a constellation of physicians, wellness influencers, and firms like compounding pharmacies started making these unproven snippets of amino acids available to Americans. Many of those cashing in on the half-dozen or so most popular peptides like BPC-157, GHK-Cu, TB-500%20is%20a%20synthetic%20heptapeptide%20that,tissue%20repair%2C%20reduce%20inflammation%2C%20and%20improve%20flexibility.), and others (I’ll loosely call these “pop peptides”) claim without any solid evidence that these substances can do many good things in people ranging from increasing muscle to regenerating tissues to making you live longer.

Prescription not always required

As compounders and others started preparing pop peptides for customers, you’d think that a prescription would be required, but I’m not sure that always happened. I also wonder if some firms were producing peptides in bulk for dubious suppliers, who then sold them to influencers or directly to consumers. In the summer of 2022, a compounding industry newsletter rightly urged caution on pop peptides. It noted, “Wise prescribers will stay away from any entity that prepares or distributes peptide products for individual patients without a prescription. They’re not compounding pharmacies, and they’re likely violating state and/or federal law.”

Whatever the source, Americans either popped the peptides orally or got them injected. Some laypeople were even self-injecting. For a few years the FDA wasn’t carefully overseeing this space or maybe trying to play catch up, and these peptides floated in a regulatory gray area. The same kind of thing happened with unproven stem cells, where eventually more than one thousand stem cell clinics had spread around the country before the FDA did much of anything, such as seeking injunctions.

FDA action

Fortunately, in 2023, the agency put most of the pop peptides off limits to compounding by reclassifying them as Category 2, effectively barring compounding pharmacies from making them due to safety concerns, lack of data, or impurities. As a result, BPC-157, GHK-Cu (for injectable routes of administration), and most of the other pop peptides could no longer legally be compounded. This law firm webpage cautions potential suppliers on the legality of such peptide use now that they have beenplaced in Category 2. Note that the FDA seems to allow topical use of the peptide GHK-Cu, an application that is not considered Category 2. However, to be clear, no pop peptide has FDA approval for any supposed wellness application.

The Category 2 classification of most pop peptides was a positive public safety move by the FDA. To my knowledge, there hasn’t been even one medium-sized, well-controlled clinical trial of injection of BPC-157 or similar peptides in humans for a specific condition. Most of the studies on the pop peptides were done in rodents or in cell cultures in plastic dishes in the lab.

What does the research tell us?

I found only one vague listing on Clinicaltrials.gov for a phase 1 study of BPC-157 where the results were submitted but then cancelled before quality control took place. Yet somehow there are 207 articles on PubMed. They report a hodge-podge of animal and cell culture studies, along with opinion pieces sometimes touting the peptide. Other peptides like GHK have also been the subject of many animal and cell culture studies. Here too, the publication record contains little data on human use including especially by injection.

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*Original source*

📄 2022-08-Prescriber-Briefing-Peptides_4-Aug-2022-2.pdf