More Americans are about to get scammed by the coming peptide rush

By Peter R. Kowey

The U.S. is deciding whether to reclassify certain peptides. Doing so will broaden the availability of the unproven treatments.

The Food and Drug Administration still has to decide whether to reclassify six peptides - a move that would likely open a new market for Americans.

In a striking rejection of scientific integrity, federal advisers recently voted to allow a slate of unproven, injectable peptides to be prepared by compounding pharmacies and then marketed directly to consumers. The decision directly overrode evidence presented by the Food and Drug Administration's staff scientists, who had researched the issue extensively and issued a strong warning against reclassifying these peptides.

What happened at that meeting, and what does it mean to the American consumer?

In an unprecedented intervention, the secretary of health and human services handpicked an advisory panel loaded with individuals with direct financial stakes in peptides. Many on the committee sell the very peptides they were charged with reviewing - a stark violation of the agency's usually high conflict-of-interest standards. The actual, unbiased scientists on the committee fought for a "no" vote, pointing out that the data presented was observational at best, often consisting of little more than testimonials from a few "patients." None of the information established safety beyond doubt.

If the FDA agrees with the panel's recommendation, six of the seven injectable peptides it evaluated will no longer be barred from pharmacy compounding.

Drug mills will be permitted to churn out compounds without names, such as BPC-157 and TB-500. The latter has zero data from medical studies conducted in humans, yet it's held up as a salve for everything from muscle building to treating ulcerative colitis and opioid addiction. The peptides are routinely used in "stacks" and chosen at random, with arbitrarily chosen doses, and two drugs from the same class may be included for reasons that defy explanation. They will be promoted on social media and television by washed-up athletes and unscrupulous influencers paid well for their perfidy.

The committee's decision was unusual and ignored the opposition of agency scientists, according to Time magazine. NPR described the outcome as a striking rejection of the FDA's stance, pointing out that every one of these compounds lacks the large, well-controlled clinical trials required to prove safety and effectiveness in humans. During the public meeting, the jaded panel members admitted several times that the science supporting the compounded substances was inadequate. Yet, a majority voted to permit their production, arguing with a straight face that having "regulated peptides" was somehow better than letting people buy unvetted black-market remedies.

Who suffers from this regulatory catastrophe? Patients, of course, who will order these cheaper, unproven products via an 800-number or the internet, skipping appointments with real doctors who can provide accurate diagnoses and proven treatments. When side effects or dangerous drug interactions inevitably happen, mainstream doctors will be left picking up the pieces with zero pharmacological data or labeling instructions to guide them.

If, or when, the FDA accepts the recommendations of the advisory committee, a whole new set of unproven injectable remedies will be unleashed on the American public.

Ads will invite individuals to speak on the phone with a hired "healthcare professional" who will rubber-stamp a prescription and authorize the compounded medication to be shipped directly to the unwitting patient. Since most of these peptides represent only a small dose of active medication, side effects may be unlikely, but so will any chance of a meaningful clinical effect. Without clinical supervision, many patients will misuse and then discontinue the bogus products and achieve no lasting benefit. Thus, the strategy of accessing drugs for cheap via a back door will ultimately fail.

As with so many land mines in our broken healthcare system, having a reliable and trustworthy practitioner to consult and query regarding the reality of compounded medications is the best solution. Working with such a learned person will prevent being scammed by a glitzy commercial. Unfortunately, a growing majority of Americans cannot afford the luxury of a primary-care doctor, now in short supply, let alone prescription medications that are proven safe and effective. The desire to look younger and slimmer or perform better in bed for a relatively small price can be overwhelming, especially when touted by gorgeous celebrities who recommend the purchase with all the fake candor they can muster. How many of them take the peptides and how much they get paid to promote them is never disclosed.

The ultimate way to protect the public is obvious. Everyone in this country needs to be able to access basic medical care at a reasonable cost, including medications that are required for their medical conditions, prescribed or at least sanctioned by their personal, licensed practitioner. In other countries, where medication is available for everyone who needs it, defrauding the public with worthless remedies is curtailed if not made impossible. Don't Americans deserve the same consideration?

Peter R. Kowey is emeritus chief of cardiology at the Lankenau Heart Institute, professor of medicine and clinical pharmacology at Thomas Jefferson University's Sidney Kimmel Medical College and the William Wikoff Smith chair of cardiovascular research. He is an internationally recognized expert in heart-rhythm disorders, has helped develop innovative therapies for cardiac arrhythmias, and has authored over 475 scientific publications and trained hundreds of cardiology fellows. He is the author of the award-winning book "Failure to Treat: How a Broken Healthcare System Puts Patients and Practitioners at Risk."

Read Peter R. Kowey's other commentaries:

-- Here's advice on how to pick a doctor - from a doctor

-- Getting a doctor's appointment will become even harder as a perfect storm hits the U.S. healthcare system

-Peter R. Kowey

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09-18-26 0723ET