Montana is poised to become a focal point for experimental medical treatments following the passage of a groundbreaking new bill. Signed into law by Governor Greg Gianforte, this legislation allows clinics and physicians to offer experimental drugs to patients, provided the drugs have completed at least Phase I clinical trials. This move positions Montana as a potential hub for medical tourism, particularly for those seeking potentially life-extending therapies. However, the initiative has sparked debate, with proponents touting its potential benefits while bioethicists raise concerns about the inherent risks.
This new law builds upon Montana’s 2023 expansion of its “Right-to-Try” law. While Right-to-Try legislation typically focuses on providing terminally ill patients access to unapproved drugs, Montana’s revised law extends this access to anyone, regardless of their health status. Previously, there was no formal process for administering these treatments. The recently passed bill, SB 535, addresses this gap by establishing a licensing framework for “experimental treatment centers.”
SB 535 introduces a structured approach to providing experimental treatments. It mandates the creation of licensed “experimental treatment centers” and requires these centers to allocate 2% of their annual profits to support low-income patients seeking access to these treatments. Furthermore, the bill strengthens patient consent requirements, including mandatory recommendations from their current treating physician.
Longevity advocates have championed this legislation, arguing that it will facilitate the testing of anti-aging drugs and other cutting-edge treatments. They contend that individuals often seek these treatments outside the U.S., and this new law will keep these resources within the country. Some proponents, like Niklas Anzinger, who has funded the development of “startup cities” internationally, have even contributed to the bill’s language.
“Keeping experimental treatment within the U.S. offers advantages,” Dylan Livingston, founder and CEO of the Alliance for Longevity Initiatives, told MIT Technology Review. “It retains financial resources domestically and provides a safer, more regulated environment for patients compared to seeking treatment abroad.”
However, the law has drawn criticism from medical ethicists. They highlight the high failure rate of drugs in clinical trials, with approximately 90% ultimately proving ineffective. While Phase I trials assess safety in humans, their limited sample size may not reveal severe side effects that emerge in larger trials or even after public release. A 2020 study revealed that 133 drugs were withdrawn from the market between 1990 and 2010 due to safety concerns.
“Making drugs available after only Phase I testing raises serious safety concerns,” Sharona Hoffman, professor of law and bioethics at Case Western Reserve University, told MIT Technology Review. “The potential for patient harm is significant.”
Supporters of the law maintain that it strikes a balance between expanding access and ensuring patient safety. The inclusion of financial assistance for low-income patients and stricter consent protocols are cited as measures to mitigate potential risks. Ultimately, the effectiveness and long-term impact of this initiative remain to be seen. Whether Montana becomes a beacon of medical progress or a cautionary tale will depend on the careful implementation and ongoing evaluation of this bold new approach to experimental treatments.
