Montana is now the first state in the U.S. to become an officially sanctioned playground for experimental medical treatments. Thanks to a recently signed law, Senate Bill 535, anyone can legally access drugs that have passed just one Phase I clinical trial. That’s the phase where scientists mostly make sure a drug won’t immediately kill you. That’s it. That’s the bar.
There’s a whole lot of research that usually follows Phase I testing, and now Montana is allowing anyone and everyone who wants to be a guinea pig to take drugs that have not been fully put through testing.
SB 535 doesn’t just greenlight access to these barely-tested treatments. It also opens the door for Montana to become a hub of medical tourism, complete with a new licensing system for “experimental treatment centers.”
Experimental Drugs With Minimal Testing Get Green Light in Montana
Clinics can get certified, sling new, barely tested therapies, and rake in the cash. It’s like how, in the world of video games, you can start playing a game that’s in “early access,” meaning you can play a game that’s still being developed.
But instead of a harmless video game, it’s a drug that can have horrible side effects that wouldn’t have normally been caught until phases two and three.
In exchange, companies have to kick 2 percent of their profits toward helping low-income patients afford treatments. The bill builds on Montana’s 2023 “Right-to-Try” law. That law already expanded access to drugs that hadn’t yet been approved by the FDA from only the terminally ill to everybody.
The Right-to-Try law had one big problem: it didn’t give doctors a way to administer these drugs. 535 fixes that, giving any medical practice that wants to hand out experimental medications the legal cover necessary to become “experimental treatment centers.”
Bioethicists are raising the alarm. Drugs in Phase I trials have only been tested in small groups, meaning severe side effects might still be hiding, waiting to be discovered in the following Phases. It isn’t until Phase 2 that the trials test to see if the treatment works.
It seems like a bit of an understatement to say that allowing people to take experimental drugs that only made it out of Phase I clinical testing is an enormous risk that mostly the richest and most terrified of death among us will take advantage of. That is underscored by the fact that, according to a 2022 study, an astounding 90 percent of drugs fail clinical trials.
Drugs that make it to market are a part of such an incredibly small minority that have been rigorously tested to ensure that they’ll safely do what they say they’ll do. Critics argue that Montana’s drug-free-for-all law will prey on desperate people and put them at serious risk.
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