Telehealth Is Selling GLP-1s for Addiction Before the FDA Has Said Whether They Work

STAT’s Katie Palmer opened her Thursday story with a photograph of GLP-1 prescriptions sitting in a refrigerator at Caron Treatment Centers in Pennsylvania, where providers have prescribed the drugs to more than 650 patients with substance use disorders. That is a residential program with doctors down the hall. The story’s real subject is the version with no hallway: online addiction clinics that have, over the past year, started marketing GLP-1 prescriptions for alcohol use disorder and other addictions, branded and compounded, before any of these drugs has an FDA approval for that use.

A prescription is not a trial, and a telehealth checkout page is not a doctor who knows your drinking.

Two translations first. “Off-label” means a doctor prescribes an approved drug for something the FDA has not approved it for. It is legal and common. “Compounded” means a pharmacy makes its own version of the drug, which is not the same as the product that went through testing. Palmer’s piece, reporting what experts told STAT, argues that online platforms can shift the work of vetting an unproven drug onto the patient. The rest of the article is behind STAT’s paywall, so what follows rests on the free portion and on the trial data.

The trial data are real and early. On July 28, Altimmune announced topline results from RECLAIM, a 100-person, 24-week, placebo-controlled Phase 2 trial of its drug pemvidutide in alcohol use disorder. The company reports a statistically significant drop in heavy drinking days against placebo. Note who is reporting: the manufacturer, in a press release, for a drug that is not on the market and is not the same molecule as the ones being prescribed in the telehealth boom. Eli Lilly and a startup called Baseline Therapeutics are also testing GLP-1-family drugs in alcohol, cocaine and methamphetamine use disorders, per STAT. Phase 2 means a few hundred people at most, and the question of whether it holds in the messy population a telehealth platform serves is exactly what a larger trial exists to answer.

The same day, the FDA announced a new neuroscience program, the Neuroscience Advancement and Innovation Nexus, whose stated scope includes substance use disorders. It is a coordinating office, not an approval, and the release says nothing about GLP-1s. Treat the timing as a coincidence.

If you are thinking about one of these prescriptions, three questions cost nothing. Who is monitoring me, and how often? Is this the branded drug or a compounded copy? What happens if it doesn’t work, or if I stop? And if alcohol is the problem, you already have three FDA-approved medications for it (naltrexone, acamprosate and disulfiram), available as generics. The new thing is not automatically the better thing.

If you are a provider, put one line in your intake: “Are you taking or considering any GLP-1 or weight-loss injection?” People are starting these without telling anyone.

The people who most want this to work are the ones who have tried everything else, which is also who a checkout page reaches fastest.