Montana’s new experimental drug rules are moving forward, positioning the state as a potential hub for unproven medical treatments. As of this week, the firms can pay a $12,500 fee to apply to a newly established review board for approval. This process is designed to be rapid and somewhat streamlined. Treatments that have completed preliminary testing—even with just 10 healthy participants—are eligible for consideration. Once approved, the applicants can sell them through experimental clinics, with the first set to open around the end of the year. Montana is carving out a distinct path for access that bypasses traditional regulatory timelines.
A new pathway for unproven therapies
This framework creates a unique “right to try” system. Unlike traditional systems that require extensive Phase 3 trials, the alternative route relies on the premise that early data, however limited, provides enough evidence for human application. Access is theoretically open to any adult who can provide informed consent. For people facing terminal illnesses or rare conditions where mainstream treatments have failed, it creates a direct line to potentially life-saving interventions via the new right-to-try law. The cost is steep, but it represents the price of bypassing the lengthy approval process that usually takes years.
Critics argue that allowing treatments with data from only 10 healthy volunteers to move to actual patients lacks the statistical significance required to ensure safety. While the longevity movement sees this as a breakthrough in patient autonomy, skeptics warn that fast-tracking these products could expose vulnerable individuals to unnecessary harm without guaranteeing efficacy.
The shift places the burden of safety on the individual, often leaving vulnerable patients to gamble with their health while companies recoup their investment. When mainstream medical pathways are blocked by red tape, desperate families often turn to the gray market, not out of recklessness, but out of a necessity to find any option that might work. The ethical tension lies in the commodification of hope, where those with the means can purchase access to the front lines of medical innovation, regardless of whether the science actually supports the treatment’s efficacy.
The urgency driving these rules
Kris DeVault is one such parent. His son, Brody, born in March 2023, suffers from creatine transporter deficiency, a rare condition that prevents the brain and muscles from developing energy properly. There is currently no cure.
Related: Barbell Weight Made Easy to Calculate
DeVault found a company developing a potential treatment that might help, but it remains in the early stages. It has only been tested on animals and a small group of healthy adults. Doctors cannot legally prescribe it. DeVault understands the risks. He knows the drug might not work. Still, he is attempting to access it. The statute offers a mechanism for him to try, despite the lack of thorough evidence.
The long-term effects of this plan remain debated. While the longevity movement sees this as a breakthrough in patient autonomy, critics warn that fast-tracking treatments without robust data could expose patients to unnecessary risks.
The process is simple: pay, apply, and sell.
Whether this creates a safe haven for innovation or a marketplace for snake oil depends on how the clinics and review boards operate in practice.
