Berliner Tageblatt - US panel endorses more unproven if buzzy peptides

Friday's recommendations wrapped a two-day meeting in which the advisory committee considered whether to greenlight adding seven total peptides to the US compounding list, which allows facilities to create custom drugs.

The panel assembled to advise the US Food and Drug Administration backed semax and epitalon on Friday.

Wellness clinics push the former as a treatment for numerous conditions including depression and anxiety. The latter is promoted as a substance that can prevent aging, and help with insomnia.

They narrowly voted to exclude emideltide, which has been considered for insomnia, narcolepsy and opioid withdrawal, with numerous other marketing claims including stress, pain and cancer.

David Pope, the chief pharmacy officer for the medical technology company Xifin Pharmacy Solutions, cast a deciding "no" vote, despite having voted "yes" on all prior peptides.

He cited "potentially dangerous downstream consequences."

Friday's decisions followed a marathon meeting on Thursday, when the panel recommended to add popular peptides BPC-157, KPV, TB-500 and MOT-c to the list despite alarm bells from physicians and public health advocates across the country, who warned that safety and efficacy of the substances are far from proven.

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.

- Sweeping claims -

If the peptides are ultimately 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.

In opening remarks on Friday FDA staffer Russell Wesdyk said it was both "shocking" and "encouraging" how many public commentators and committee members "noted significant quality problems" with the substances, as well as issues with their common names that could hinder identifying exactly what's in them.

He said he appreciated calls for "quality guardrails" but warned that "we lack the regulatory authority that put those guardrails in place" on the bulks list.

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.

There's scant to no clinical evidence supporting such promises, and doctors have voiced concern that endorsing weakly understood if trendy substances could direct patients away from treatments backed by evidence.

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 that were 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."

J.Bergmann--BTB