New York (AFP) – A US review panel on Thursday recommended loosening restrictions on multiple trendy peptides, endorsing proposals that specialized pharmacies be allowed to produce such substances despite alarm bells from medical experts over 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. By the end of the marathon meeting, the panel had greenlit recommendations that bespoke pharmacies be allowed to produce four peptides: BPC-157, KPV, TB-500, and MOT-c. They will consider three more substances Friday.
The panel recommendations are not binding, but the Food and Drug Administration historically has given them significant weight. And the positive votes are a rebuke of the agency’s career scientists who urged maintaining restrictions over lacking data and safety concerns. 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. Proponents offer sweeping claims about their benefits, ranging from glowing skin and muscle growth to brain health and wound healing. However, 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 FDA advisory committee with people who have strong ties to the peptide industry, given his personal interest in and use of the products. The substances under review are among those that former President Joe Biden’s administration restricted from compounding, notably over a lack of human clinical trial data. But they’re still popular: peptides are available 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 legal access to peptides, including the health secretary, argue that restricting them only drives Americans deeper into the gray market.
Panel member Elizabeth Rebello, a pharmacist and anesthesiologist, told the committee she voted no on BPC-157 “because of the lack of efficacy data” and “safety concerns.” Member Brian Lee also voted against 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.
Panelists heard presentations by FDA scientists who warned against recommending expanded access, as well as public comments. 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.” Lurie told AFP that “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.” A representative for telehealth company Hims & Hers noted the company would “benefit commercially” if it were allowed to offer peptides like BPC-157. “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.”
Should the peptides ultimately be added to the bulks list for compounding, that does not mean they are FDA-approved. The bulks list rather dictates what ingredients compounding pharmacies can use when mixing custom medications for patients with a specific prescription.
© 2024 AFP
