Montana’s first experimental treatment review board has brought three longevity heavyweights into the state’s effort to expand access to experimental therapies.
How much regulation is too much?
Many people in the longevity field will tell you that regulation is holding it back. Sensible oversight of novel therapies is essential, but an overly cautious interpretation of “do no harm” can itself cause harm by delaying or denying access to potentially beneficial and life-prolonging therapies. The balance between protecting patients from risk and allowing them the freedom to seek better health and quality of life may currently be tilted too far toward the former.
Some people turn to therapies that are unproven even in terms of safety, sometimes administered by unlicensed practitioners. We have covered one case in which this led to loss of life and another in which it nearly did. Other people engage in medical tourism, seeking treatment in more permissive jurisdictions, which is expensive and not always safe. A different group has instead set its sights on advancing right-to-try legislation in the US.
The Montana way
Traditional right-to-try laws are generally limited to people with terminal illnesses, allowing them to try therapies that have not yet been fully approved by the FDA. Montana enacted a law along these lines in 2015: eligible products had to have completed Phase I and remain in an FDA-approved clinical trial. In 2018, the federal Right to Try Act became law, covering patients with life-threatening conditions who have exhausted approved treatments and cannot participate in a clinical trial involving the investigational product.
In 2023, Montana lawmakers passed SB 422, sponsored by State Senator Ken Bogner and supported by the Alliance for Longevity Initiatives and other members of the longevity community. In what was widely described as a US first, the law removed the terminal-illness restriction, potentially making the pathway available to any patient. Importantly, it did not require patients to exhaust standard care, only to have “considered all” FDA-approved options. Despite the polarized political climate, SB 422 enjoyed substantial bipartisan support.
While SB 422 removed restrictions, it did not provide investors and clinic operators with a licensing framework for establishing facilities. This was addressed in the follow-up bill, SB 535, which passed on a knife-edge in 2025.
It was designed to create that missing infrastructure by establishing a new category of health facility: the experimental treatment center. Such centers can charge for treatment and establish payment arrangements involving digital or alternative currencies – an unusual provision consistent with the legislation’s entrepreneurial and biohacking roots. The bill also loosened its predecessor’s language further, requiring patients only to have “evaluated other” approved options.
Welcome aboard
Under final rules that took effect earlier this month, an experimental treatment center must establish or contract with an experimental treatment review board, or ETRB. Board members may have no conflicts of interest involving the centers they review. ETRBs are envisioned as an important guardrail intended to improve patient safety.
The first such board has now been formed, and developers can submit eligible therapies for review for a fee of $12,500. Most eligible treatments will have completed Phase I, although Montana law also permits an alternative route based on equivalent documented safety evidence. Phase I trials primarily investigate safety and dosage and generally do not establish the treatment’s efficacy. Importantly, approval by the board does not amount to FDA approval or confer any federal legal status.
The five-member board includes three prominent figures in the longevity field: Matt Kaeberlein, a longevity researcher affiliated with the University of Washington; Jamie Justice, executive vice president of XPRIZE’s Health Domain; and Felipe Sierra, former director of the Division of Aging Biology at the National Institute on Aging. The other two members are bioethicist Jessica Flanigan and Montana oncologist James Burke.
The caliber of the board lends immediate credibility to the initiative, which was launched by Infinita, an organization founded by Niklas Anzinger and based in the Próspera special economic zone on the Honduran island of Roatán. “It’s been a lot of work, almost three years since the first bill,” Anzinger said. “Montana’s framework has been strongly influenced by the wishes of the longevity community. A patient does not need a defined disease state to be eligible – which is important because aging is not classified as a disease. This is a genuine first and only in recent history.”
Setting an example
Dr. Kaeberlein has long argued that the current development and approval process for new therapies is too slow and expensive. At the same time, he has frequently criticized the “Wild West” approach to longevity medicine.
“What interests me about Montana’s approach is that it attempts to create a middle ground,” he said. “Rather than pushing patients toward medical tourism or unregulated clinics, it seeks to establish a framework with independent review, physician oversight, informed consent, and systematic data collection. Whether that framework ultimately succeeds remains to be seen, but I believe it’s worth trying to make it as rigorous and scientifically credible as possible. That’s why I agreed to participate.”
“I joined Montana’s ETRB because this was too important an opportunity to pass up,” said Justice. “In many cases, testing of experimental therapies has moved offshore, and Montana has a chance to be at the forefront of bringing it back onshore. The board provides an opportunity for promising treatments to move forward, but with transparency and accountability built in from the start.”
Justice noted that, to avoid conflicts of interest, she will recuse herself from reviewing or making decisions involving competing teams, advisors, or other groups affiliated with XPRIZE Healthspan.
Given how narrowly SB 535 passed last year – and the reservations raised by both Democrats and Republicans – the first ETRB has an opportunity to address some of those concerns. By conducting rigorous reviews and producing meaningful safety and outcome data, it could offer a model for other states and, perhaps eventually, for federal legislation. Montana rules require review boards to publish annual summaries covering the treatments reviewed, safety outcomes, serious adverse events, and general review timelines.
“Local scientific review boards are a big part of China’s and Australia’s clinical trial success,” said Anzinger. “US states can really innovate before Washington catches up, and in the process generate valuable insight for national reform.”
View the article at lifespan.io
