A private review board in Montana approved its first experimental treatment for hearing loss in September, positioning the state as a potential center for unproven medical therapies. The approved regimen consists of 60 minutes of daily sound therapy paired with an antihistamine used off-label, a combination cleared by a five-person panel established under a new law. This legislation expands access to drugs and procedures lacking FDA approval, unlike federal programs that typically restrict such access to life-threatening conditions. Patients must cover costs and provide informed consent, with no federal oversight required.
The Montana Experimental Treatment Review Board operates under Infinita City Inc., a venture linked to Niklas Anzinger, a German investor who co-authored the state’s Senate Bill 535 (SB535). Anzinger is also a key figure in Próspera, a private biotech hub in Honduras where firms administer experimental therapies without FDA involvement. High-profile investors in Próspera include Peter Thiel and Marc Andreessen, and the city gained visibility after Bryan Johnson, a longevity advocate, received a $25,000 gene therapy documented in Netflix’s Don’t Die.
Montana’s law, effective since July, reflects a broader effort by libertarian-backed investors to create regulatory exemptions for experimental treatments. While over 40 U.S. states have adopted measures expanding access to unapproved therapies, Montana’s approach is distinct: it permits treatments that have only completed Phase 1 trials, which assess safety but not efficacy. Federal right-to-try laws, by contrast, limit access to terminally ill patients.
Anzinger has framed the law as a shift toward grassroots-driven science, arguing that small biotech firms face insurmountable barriers in the FDA’s traditional approval process. Backers, including the Alliance for Longevity Initiatives, a Virginia-based industry group, predict Montana will attract patients currently seeking treatments like stem cell therapies in Switzerland or psychedelics in Mexico. State Senator Kenneth Bogner, a Republican, described the law as a test case for broader healthcare reform.
Sound therapy and antihistamines target hearing loss
The first approved treatment comes from a biotech company that combines sound therapy with an antihistamine to address hearing loss. The company’s CEO stated that Montana’s program would help fund future research while providing access to patients excluded from standard trials. However, the treatment remains unavailable—Montana has yet to license any experimental treatment centers, and two pending applications are under review.
The board’s structure has sparked ethical debates. Unlike FDA-supervised Institutional Review Boards, Montana’s panels operate independently, with no federal oversight. Companies seeking approval must pay a $12,500 fee, and members disclose potential conflicts of interest—though none have emerged to date.
Ethical concerns: Is this medical research or gambling?
Critics warn the system resembles a prediction market, where patients gamble on unproven therapies. Arthur Caplan, a former medical ethicist, called it a “risky endeavor”, saying, “This thing they set up in Montana is really a program to facilitate access to anybody and everybody who wants it, to novel experimental interventions for anything.” He said Montana’s program is closer to a prediction market than medical research. “It’s like, you want to gamble? OK, go ahead,” he said.
The FDA has not indicated whether it will challenge Montana’s program. In June, representatives from Infinita and biotech firms met with agency officials to seek legal assurances, but the FDA declined to comment. Without clarity, some patients—like Kris DeVault, whose three-year-old son has an ultra-rare disease, may still pursue options abroad, such as Próspera, where treatments lack FDA scrutiny. DeVault’s son’s treatment manufacturer hesitated to engage due to potential FDA repercussions, leaving families in legal uncertainty. “We don’t want to get anybody in trouble,” DeVault said. “But if the FDA won’t support us, what else can we do?”
FDA’s silence leaves patients in legal gray areas
The board’s approval of the hearing loss therapy represents the first step in a model that bypasses traditional FDA pathways. Unlike standard approval processes requiring Phase 3 trials to prove effectiveness, Montana’s law permits treatments that have only passed Phase 1, confirming safety but not efficacy. This lower standard draws parallels to the FDA’s compassionate-use program, which allows unapproved drugs for terminal patients, but extends access to non-life-threatening conditions if patients can pay and consent. Montana’s health department has not yet licensed any treatment centers, leaving the program’s implementation stalled. Two pending applications, one linked to longevity research, await review, though the state lacks the infrastructure to independently monitor long-term safety.
The program’s future depends on whether the FDA intervenes. After June meetings between Infinita, biotech companies, and patient advocates, the agency remained silent, leaving participants in legal limbo. The company’s CEO argued the Phase 1 requirement and board oversight reduce risks, but DeVault fears instability could drive patients to unregulated clinics. Without FDA support, families like his face limited options.
The Alliance for Longevity Initiatives, which helped draft Montana’s law, is now promoting similar legislation in New Hampshire, signaling plans to expand the model.
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