Peptide puffery

The rise of anti-science has undermined evidence-based medicine and will inevitably lead to iatrogenic harm and worse health outcomes.

Journalists are often accused of using the following aphorism to determine the newsworthiness of a story: “Once an accident. Twice a coincidence. Three times? A trend. Go for it!”

Using that habit of mind to drive journalism is a bad idea. People will be misinformed. Using it to drive the practice medicine is worse because people will get hurt.

This past weekend, I read a recent story in The New Yorker about “the seductive world of unapproved peptides,” written by Dhruv Khullar, an outstanding medical journalist. The physician-writer visited several clinics run by board-certified physicians pushing these protein snippets on gullible people looking to heal ailing muscles, improve memory and live longer lives, among other alleged benefits.

The testimonials offered by physicians promoting various peptides defied every standard of medical evidence developed since Founding Father Benjamin Rush gave up bloodletting. Charleston, S.C.’s Craig Koniver, trained in family medicine, called one peptide used for tissue healing (BPC-157) “supersafe” and said “almost everyone I could think of” will benefit from it. A few paragraphs later, he says, “I’m not a big vaccine guy. A lot of them don’t have the data.”

What’s the data behind BPC-157? There are exactly two clinical trials for that peptide in the federal government’s clinical trials database. One is an early-stage safety trial of unknown scope and status that is taking place in Tijuana. The second is an efficacy study based in Shenzhen, China, which is still recruiting patients. Vaccines, on the other hand, have undergone extensive testing and they’ve gained FDA approval, which means there are reams of data documenting both their safety and efficacy.

Koniver goes on to say “anecdotal data means a lot to me. Two days after a vaccine, someone has a stroke. Two days later they’re dead. … You see enough of that, it makes an impression.”

There’s no shortage among his 1,000 patients, who pay $15,000 a year for the services of his concierge medical practice (it doesn’t take insurance), willing to attest to peptides’ benefits. After all, wait long enough and most tissue tears eventually heal. Koniver (is a Charles Dickens doppelganger now the resident fact-checker at the New Yorker?) has 6,000 people on his waiting list.

Many of the people lining up to spend their hard-earned money on peptides may have heard the siren call of the ultimate peptide guru, Robert F. Kennedy, Jr., who sits atop the Health and Human Services Department. He frequently claims he benefited from injecting peptides to cure injuries sustained during body-building exercises.

He appeared earlier this year on the Joe Rogan podcast (the world’s most popular with 11 million listeners). Rogan frequently touts peptides on his show. The field also received an unexpected boost from the FDA’s approval of semaglutide (Ozempic, Wegovy, Zepbound), a peptide for diabetes and weight loss. If that one works, won’t they all?

Semaglutide is the exception, not the rule when it comes to data on peptides. There is almost no evidence beyond individual anecdotes that most of the peptides now in circulation, mostly produced by compounding pharmacies, actually benefit patients or are safe.

Earlier this year, Kennedy removed the limited regulation of unapproved peptides that had been put in place during the Biden administration because their manufacturers failed to submit data to the FDA proving they could be safety injected in patients. The Kennedy reversal hurled peptides back into the regulatory vacuum enjoyed by dietary supplements, where the only rules that apply involve purity (does it contain what it claims to contain) and a ban on making medical claims (which is routinely violated by industry advertising).

For a dispassionate dissection of Kennedy’s views on peptides as expressed on the Joe Rogan podcast, watch this YouTube video by Matt Kaeberlein, a professor pathology at the University of Wisconsin Medicine and co-found of UW’s Health Aging and Longevity Research Institute.

“There are numerous cases out there where people have been harmed by peptides … Nobody has come forward with any good data on the safety of these peptides.” — Matt Kaeberlein

Good data on peptides, whether for efficacy or safety, requires someone conducting randomized clinical trials that test whether the products are better than a placebo or the current standard of care. The tests need to be in a sufficiently large population to show statistical significance in any outcomes differences between the two groups. Absent clinical proof of efficacy in such trials, there will only be the risk of harm or unpleasant side effects.

The Biden administration upheld evidence-based medicine when it required most peptides undergo such tests. The Trump administration via Kennedy opted instead for allowing money-hungry physicians and compounding pharmacies to conduct what amounts to an uncontrolled science experiment on gullible Americans, where no one takes a measure of the outcomes except the individuals and families who will be harmed both physically and financially.

The peptide craze is following the same trajectory of the anti-vaccination movement (also championed by Kennedy); the evisceration of National Institutes of Health research into the many social causes of disease; and the degradation of the Centers of Disease Control and Prevention’s ability to promote population health. It is anti-science, pitch perfect for a society addicted to addictions, promoted by someone who admits he once snorted cocaine off a toilet seat, who now jabs needles in his body in the evidence-free pursuit of faster healing and better health.

Peptide proponents claim it is their right to try unapproved substances based on claims made by family, friends or their concierge physician. It’s my body. I willingly take the risk. Whom else does it harm?

Actually, everyone. Who pays when you end up in the hospital and wrack up huge treatment bills? Two people fell desperately ill during an Las Vegas “anti-aging” event after injecting peptides and had to be intubated. Widespread allergic reactions to the shots, some of which were life-threatening, forced regulators in Australia to issue a safety alert. Health Canada has issued a warning that unauthorized peptides can cause blood clots and liver and kidney damage.

The U.S. used to have a regulatory agency that the rest of the world awarded a gold medal for how to manage the entry of medical products into the marketplace. Today, under this government, it isn’t even in the race.