Restoring Faith in Science

A multi-part series about the peptide world's unregulated gray market

This is the fourth installment of a four-part series. Read the other installments here:

Inside the Strange World of Peptide Group Buys

Peptide Cults and Cartel Bosses: Down the Group Buy Rabbit Hole

Wellness Optimizers and Self-Experimenters: The Peptide Wild West

Peptide Research, Done Cleanly — Peptide Partners. Independent HPLC/MS, batch COAs, and endotoxin screening to USP <85> validate identity and purity of peptides for research. Browse inventory and view certificates at Peptide Partners.

Part 4: Restoring Faith in Science: the Importance of FDA Oversight

Dr. Matt Kaeberlein is a biogerontologist, which is a fancy way of saying that he’s a biologist who studies how the human body ages, and what mechanisms of aging are conserved across our evolutionary patterns. He’s also a professor of pathology at the University of Washington in Seattle, and he believes that peptides ought to be rigorously studied before being administered in a clinical setting, much less self-administered from an untested, grey market purchase.

“Broadly speaking, peptides are bioactive molecules, and some peptides will definitely have beneficial effects, [like] GLP-1 agonists for people who have obesity or diabetes,” Kaeberlein said recently on his Optispan podcast. “But I think for a variety of reasons, the scientific research has not actually been done to be able to use [other popular peptides] in an effective way medically.”

Kaeberlein asserts that randomized controlled trials (RCTs) over long periods of time are the gold standard for determining a given treatment’s effectiveness. This would involve the recruitment of a statistically significant number of individuals, the random assignment of those individuals to control and experimental groups, and the monitoring of those individuals’ reactions to peptide treatments over time. Unlike Bryan Johnson snorting stem cells in the Bahamas, an RCT would produce empirical data about the impact of a given treatment on a group of individuals, and would inform safety protocol for future clinical use. Though an RCT takes time, in other words, it pays massive dividends: more people get safe and affordable access to a potentially life-changing treatment.

It’s easy to imagine the cavalier self-optimizer laughing this off as so much pointless noise. I’m sure you’ll recall the “high risk tolerance” tech founders Jasmine Sun encountered in San Francisco. The guy who just founded a startup valued in the hundreds of millions and feels impervious to the realities of the world. The guy who’s sick of being a pale ginger and so starts injecting melanotan he ordered from his “guy in China.” But no matter how rich you are, or how much you trust pepbrother888 in Beijing, it doesn’t change the fact that regulatory agencies like the FDA exist for a reason. Without rigorous RCTs and the FDA overseeing when and how drugs that have cleared all phases of clinical trials enter the mainstream for public consumption, we’re left with what Verge reporter Victoria Song calls the “wellness wild west.”

But how to remind a distrustful population that the scientific method is, in fact, the consumer’s friend?

Though clinical trials are slow-moving, they are still happening.

Contrary to RFK Jr.’s conspiratorial sabre-rattling about the FDA “suppressing” helpful peptides, a number of them are currently in clinical trials to determine their safety and efficacy for medical use. These include tirzepatide, retaglutide, and peptide-based radiopharmaceuticals for use in the diagnosis of neuroendocrine tumors. Data from these studies will help inform how to safely administer peptides that are already popular on the gray market. Even better: if and when these compounds are approved by the FDA, they’ll be more affordable for pharmaceutical companies to manufacture and for consumers to obtain, and even more affordable/widely available when specific drug patents expire.

FDA guidance and oversight means high-purity, non-toxic peptides.

China’s comparatively lax regulatory climate has facilitated the quick manufacture of many peptides, including the gray market varieties that aren’t up for clinical review in the United States. And it’s that same regulatory climate that has resulted in the manufacture and shipment of untested and potentially impure research chemicals.

It’s certainly unnerving to receive a vial of peptides that tests low on purity, or has a falsified COA. But, as we’ve seen before, a high-purity test result isn’t a complete guarantee of safety. Even the purest peptides are susceptible to developing endotoxins, or lipopolysaccharides from the gram-negative bacteria used to synthesize amino acid chains. Endotoxins are some of the most potent biological toxins in existence, and are very harmful – even fatal – if ingested.

The facts are clear: taking peptides that haven’t been submitted to third-party testing and independently verified to be safe and non-toxic is like playing Russian roulette with your health. The path to the normalization and standardization of these practices will come through scientific research and the guidance and oversight of the FDA.

The relationship between clinicians and scientists is a symbiotic one.

While many clinicians do currently offer therapies using peptides that are still undergoing clinical trials, these therapies must be informed by scientific findings in order to yield any sort of efficacy. A good clinician is someone who stays abreast of current scientific literature and weighs the risks and the benefits for individual patients before initiating a given health protocol – risks and benefits that should not be informed by the patient’s emotions, the political climate, pressure from colleagues, or any other social or economic interests. We would all do well to remember that clinicians are in service roles, not research ones: they don’t have access to the mechanisms for producing empirical data. Rather, it’s their job to implement the data researchers produce in lab settings.

Finally, a clinician’s willingness to explore new peptide therapies is not a guarantee alone of his or her trustworthiness. We’ve seen this with the case of Dr. Kent Holtorf, whose peptide injections at last year’s RAADFest in Las Vegas left two attendees in critical condition. Holtorf also received a warning from the Federal Trade Commission after making scientifically unfounded claims that certain peptides could “protect” patients from and even “cure” COVID.

There are only two things that can protect the health of consumers: research and regulatory oversight. If we abandon our faith in empirical data, then we render ourselves vulnerable to the whims of profit-driven manufacturers, vengeful vendors, and a Bay Area startup culture convinced it can move faster than the scientific method. The problem with all this lies in the major fallacy of its logic: it was the scientific method – rigorous testing, close observation, trial and error – that gave us these peptides in the first place.

In our next research peptide deep dive, we’ll learn more about Research Use Only sites, how they work (or don’t) with compounding pharmacies, and how they’ve responded to FDA warnings.