Reports the Trump administration plans to allow some compounding pharmacies to dispense peptides that have not been fully tested for safety have a University of Auckland professor worried.
The Washington Post reports its sources as saying there are plans to allow the sale of some previously restricted peptides while health officials devise new regulations for the controversial products.
However, Food and Drug Administration scientists have raised alarms about the move because the products’ claims have not been through FDA-approved clinical trials to assess safety and efficacy, the Washington Post reported on Friday.
A compounding pharmacy prepares custom medications for prescriptions that cannot be filled with mass-produced formulations.
Professor of cellular signalling Peter Shepherd said it was worrying for the whole world when politicians were making decisions about access to unproven medicines “and overruling the safety procedures that have been built up over the last 50 or 60 years”.
“The fact that it’s gaining some sort of validation and approval in America will justify to many New Zealanders that these are somehow safe when they’re really not.
“They haven’t been proven. There’s very little data on many of these peptides that we’re talking about and really could lead to people getting into some serious harm.”
Peptides were a whole range of drugs targeting different things and it was not known what some new ones did or how they worked, Shepherd said.
He was also concerned that many people were using peptides for cosmetic rather than true medical purposes.
“When you start using quite dangerous products for cosmetic reasons, that to me is also very worrying.”
The companies developing the drugs would be taken out of the loop and the work they had been doing to validate the safe use of the drugs “could be totally undone by a few terrible incidents”, Shepherd said.
In the long term that could mean they get banned, and “drugs that could have been really potentially useful may never see the light of day”.
The increase in imports and sales of unregulated peptides prompted medical regulator Medsafe to issue an alert in May. It warned that claims such as “clinically proven”, “safe”, “approved”, or “for research purposes only” did not make these products legal or safe.