People who said they were harmed by unapproved peptides such as BPC-157 said their accounts are being drowned out as HHS moves to widen access to the compounds, KFF Health News reported Oct. 13.
Five things to know:
1. Patients describe symptoms lasting months.
Dylan Meetze bought BPC-157 from online vendor Researchem to improve his weightlifting. Within three days he had severe fatigue. Months of fatigue, anxiety, and eye and muscle twitching followed. Researchem labels its products “solely for laboratory research” and did not respond to KFF Health News.
Another man, identified only as Dominik E., a 46-year-old software engineer, took BPC-157 with TB-4, a combination sold as the “Wolverine Stack.” He developed a severe migraine and numbness on one side of his face, and the migraines lasted about two months. Lois S., a Michigan elementary school worker, stopped taking BPC-157 and retatrutide after she felt pain.
“No one wants to believe that this wrecks some of our lives,” Mr. Meetze said.
2. Data on harm is thin.
An unpublished analysis of millions of de-identified health records found more than 1,000 people had told physicians they used BPC-157 since 2020, and use is growing, according to KFF Health News. The analysis has not been peer reviewed.
The FDA’s adverse event database includes a 36-year-old woman who was hospitalized and a 48-year-old man hospitalized with a “life-threatening” condition.
Last summer, two women were hospitalized and intubated after getting peptide and vitamin injections at an antiaging conference in Las Vegas. Nevada’s pharmacy board cited the physician running the booth and his colleagues for practicing without a state medical license.
Patients often can’t confirm what was in their vials. Spending on third-party purity testing fell an estimated 88% per buyer as the gray market passed a $100 million annual run rate. Buyers now lean on vendor certificates that often don’t screen for sterility.
3. A reshaped panel backed easier access.
In July, the FDA’s Pharmacy Compounding Advisory Committee voted to recommend six of seven peptides for the 503A bulks list. That list governs which substances compounding pharmacies can use. HHS reshaped the panel before the vote, and eight of its 12 voting members run wellness, longevity or regenerative medicine clinics. FDA scientists opposed the move.
4. The FDA has not issued a final decision.
HHS Secretary Robert F. Kennedy Jr. has called himself a “big fan” of peptides. “If you want to take an experimental drug, you ought to be able to do that,” he said. An HHS spokesperson told KFF Health News that the FDA, “not podcasts or politics,” decides what goes on the list.
The administration is reportedly preparing a stopgap that would allow sales of some restricted peptides while new rules are written.
5. Clinical leaders warn evidence may never arrive.
Fewer than 10% of substances that look promising in animal studies prove effective in clinical trials.
“The chances of clinical trials getting done now are diminished,” said Eric Topol, MD, executive vice president of La Jolla, Calif.-based Scripps Research. The ECRI and the Institute for Safe Medication Practices have warned about immune reactions to repeated injections. They also flagged possible tumor growth in patients with undiagnosed cancer.
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
