A commentary published on Wonkette reports that Health and Human Services Secretary Robert F. Kennedy Jr. has announced a policy of "enforcement discretion" covering a group of peptides, meaning compounding pharmacies can make and sell them without clearing the usual testing requirements. The practical effect, as the piece puts it, is that the FDA will look the other way.

The compounds at the center of this are BPC-157 and TB-500, two synthetic peptides sold together as the "Wolverine" stack and marketed for faster healing from injury and muscle growth. Use of the stack has increased 33-fold over the last six years, according to the article, which also says there is no evidence of benefit in human beings and raises tumor growth as a reported concern.

What the policy actually says

HHS framed the move as a safety measure rather than a loosening. Its statement says the limited enforcement-discretion policy will "discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients," and that allowing limited compounding under safeguards gives patients "a more controlled alternative," citing recommendations from a recent Pharmacy Compounding Advisory Committee.

That is a coherent argument on its own terms: demand exists, the gray market is worse, so bring it indoors. The weak point is that nothing in the policy generates the safety or efficacy data that was missing in the first place.

The signal problem

John Hertig, chairman of the Collaborative for Evidence-Based Medicines, told The New York Times that consumers will read the decision as approval. "I think what it translates to for the average consumer and someone looking for these peptides is there's been a tacit recommendation from the F.D.A. and that it's OK," he said, "when really there hasn't been the diligence and the review and the scientific rigor that we deserve."

The Wonkette piece makes the same point through history, noting the FDA's refusal to approve thalidomide for morning sickness when European regulators allowed it. The worry is not only the people already buying peptides from overseas sellers, but the ones who were not and now will.

Bottom line

Enforcement discretion changes who supplies these peptides, not what is known about them. The open question is whether anyone now has a reason to run the trials.