FDA scientists oppose change; panel faces conflict questions
Every day, Dr. Alexander Weber, chief of sports medicine at the University of Southern California, fields questions from patients about whether injectable peptides can help them recover from sports injuries or surgery. His answer, he said, is consistent: “We just don’t have enough data.”
Weber, who authored a review of the research published early this year noting the lack of clinical evidence for the therapies, said anecdotal reports from patients who say the treatments help them are not a substitute for rigorous trials. “The anecdotal evidence, even from patients that I see, is that they feel like these injectables help them, but we just need to study it,” he told NPR.
The cautionary words from the medical establishment have done little to cool public demand for the substances, which are promoted widely in wellness and longevity circles for injury recovery, muscle growth, skin health and metabolism. None of the seven peptides under consideration — including BPC-157, TB-500 and MOTs-C — have undergone the large-scale human trials required for FDA approval.
Peptides are short chains of amino acids that act as signaling molecules in the body, helping regulate the immune system, metabolism and other functions. Synthetic versions can be delivered as drugs. Among the most sought after is BPC-157, based on a peptide found in human stomach juices; TB-500 is related to a molecule found in many cell types called thymosin beta-4.
In a review of the evidence posted last month, FDA scientists recommended against changing the regulatory status of any of the seven peptides, concluding there was insufficient data on safety and efficacy. The nonprofit Institute for Safe Medication Practices echoed those concerns in a white paper, warning that much of the evidence comes from preclinical animal studies, not human trials.
“With anything that you’re taking, whether it’s an FDA-approved product or a supplement, you always have to weigh the risk versus benefit,” said Rita Jew, the institute’s president. “These peptides really do not have established effectiveness, so the only thing you have is risk.”
Peptide proponents argue that the current restrictions have created an unregulated gray market supplied by overseas manufacturers, raising additional safety concerns. Lee Rosebush, a pharmacist and attorney who represents peptide makers, said pharmaceutical companies have little incentive to run costly trials on molecules that cannot be patented.
“These products will likely never go through an FDA approval process,” Rosebush said. “So without allowing compounding pharmacies to do this, patients will never get access.”
Rosebush described the Biden-era restrictions as having “opened up the Wild Wild West.” He added: “Nobody is recommending these peptides. This is about ensuring patients have safe and effective access to these medications.”
But Dr. Aaron Kesselheim, an expert on FDA law at Harvard Medical School and Brigham and Women’s Hospital, said the composition of the advisory committee raises concerns. Many members have ties to the peptide industry, work for clinics that offer injectable peptides or for compounding pharmacies that would benefit from the change.
“I think what’s going on here is the advisory committee may be stacked with people who are known to have certain viewpoints on a topic rather than who are coming at this in an unconflicted and unbiased way,” Kesselheim said.
A spokesperson for the Department of Health and Human Services said all committee members “have undergone an ethics and vetting process” and the agency is “committed to robust, transparent discussions about the products.”
The committee’s two-day agenda specifies it will review data on the peptides for specific indications, including migraines, ulcerative colitis and osteoporosis. The FDA is not bound to follow the committee’s recommendations but typically does.
Kesselheim said that if the agency ultimately reclassifies the peptides so they can be compounded, patients will have no trouble finding doctors willing to prescribe them for all sorts of conditions. “That’s why this discussion is so important and why the FDA’s authority here is an important one to exercise appropriately with optimal outside advice,” he said.