Berliner Tageszeitung - US panel backs trendy peptides despite safety concerns

The vote came as part of a two-day meeting of the panel tasked with considering whether seven total peptides should be added to the approved compounding list, which allows facilities to create custom drugs that will in turn be more accessible to the public.

As of Thursday afternoon, the panel had greenlit recommendations that bespoke pharmacies be allowed to produce the peptides BPC-157 and KPV.

Peptides are short chains of amino acids, which are the building blocks of proteins. They occur naturally in the body, but synthetic peptides are increasingly buzzy in the wellness industry as the key to an optimized life.

Peptide proponents have made sweeping claims about their benefits, ranging from glowing skin and muscle growth to brain health and wound healing.

There's scant to no clinical evidence supporting such promises.

Medical experts accused President Donald Trump's health chief Robert F. Kennedy Jr of packing the Food and Drug Administration advisory committee with people who have strong ties to the peptide industry, given his personal interest in the products that he says he has used.

The substances under review are among those that the administration of Trump's predecessor Joe Biden restricted from compounding, notably over a lack of human clinical trial data.

But that hasn't thwarted their popularity in many cases -- peptides can be purchased online from chemical suppliers "for lab use."

They are widely touted on social media among influencers, celebrities and those inclined to follow "wellness" trends, like Kennedy.

Proponents of increasing legal access to peptides, including the health secretary, argue that restricting them would only drive Americans deeper into the gray market.

The panel's 8-6 vote, with one abstention, to recommend the FDA's addition of BPC-157 and then KPV to the bulks list was at odds with the expert opinions of career scientists at the agency.

Panel member Elizabeth Rebello, a pharmacist and anesthesiologist, told the committee she had voted no on BPC-157 "because of the lack of efficacy data" and "safety concerns."

Member Brian Lee also voted no on that peptide, saying: "I think this endorsement can be potentially harmful, and I cannot in good conscience vote yes."

But they were outnumbered by panelists who voted in favor, with those members citing reasons including "the greater good" and "medical freedom" for their decisions.

- 'Weak evidence' vs commercial benefit -

Before considering each peptide, panelists heard presentations by FDA scientists who warned against recommending greater access, as well as public comment on both sides of the issue.

Peter Lurie, president of the Center for Science in the Public Interest and a former FDA official, urged against easing restrictions on all of the peptides, calling such an action "inconsistent" with FDA standards and dangerous to consumers.

He dubbed the burgeoning world of peptides as one of "pseudoscience and grift."

Interviewed afterward by AFP, Lurie said "what I think we're seeing is the demise of the advisory committee as a useful instrument in scientific decision-making under this administration."

"They stacked the committee with a group of people who, in the face of extremely weak evidence, voted in favor of these products anyway, and the FDA's efforts to balance that out weren't sufficient."

Telehealth company Hims & Hers was among those providing public comment.

"I'm not going to tell you that the evidence for BPC-157 is strong. It isn't, and I won't overclaim," said Anant Vinjamoori, the chief medical officer of the online medication provider's "Hims" branch.

"What I'd ask is that you not read thin as nonexistent."

He did note the company he works for would "benefit commercially" if it were allowed to offer peptides like BPC-157.

The panel recommendations are not binding, but the FDA historically has given them significant weight.

P. O'Kelly--BTZ