Leadership1 publisher3 min readPublished
Montana let an investor's private board approve the experimental treatments patients can buy
Montana's first right-to-try authorization, a daily antihistamine plus an hour of proprietary sound for hearing loss, came from a privately run board created by Niklas Anzinger, a longevity investor who helped draft the law.
The Board Room · Leadership desk
What happened
- Montana is relying on a privately run board to decide which treatments may be offered under its expanded law covering drugs no regulator has deemed safe and effective.
- The board's first authorization, last month, pairs a daily antihistamine with 60 minutes a day of a Denver company's proprietary sound mix for patients seeking a cure for hearing loss.
- The FDA has not cleared that treatment, and the state of Montana did not review it either.
- Anzinger, who created the board, helped draft the legislation along with the Virginia-based Alliance for Longevity Initiatives, according to the group and the bill's sponsor, state senator Kenneth Bogner.
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Why it matters
- exposure Patients hold the risk of a mistaken approval, because they pay for a protocol that no regulator and no state official has assessed, and Business Insider reported the open question is whether they get value for their money.
- precedent Other legislatures now have a working template: hand the review function to a private board, with drafting help from the people who will use it.
- decision Any biotech weighing a Montana clinic is really pricing the odds of a federal enforcement case, since prosecutorial discretion is the layer that decides whether the model is usable.
- contradiction Anzinger describes a bottom-up system "with oversight and everything" while the state performed no review of the first authorization, so the parties are using the word oversight to mean different things.
The company in charge of the board works with biotech firms in a regulation-free zone off the coast of Honduras [4]. Anzinger is a key figure there, in Prospera, a private city on a Caribbean island where anti-aging startups can administer experimental treatments without government oversight or evidence that they are safe [8]. His venture fund, Infinita VC, has invested in longevity startups in Prospera, including Minicircle, which sells a gene therapy intended to increase muscle mass, and Unlimited Bio, which is testing a gene therapy for circulation, endurance and hair growth [17]. There is no reported financial link between Anzinger and the Denver company whose sound mix the board cleared [21].
The protocol is a daily antihistamine and 60 minutes a day of listening [5], which is seven hours a week [22]. Business Insider reported that the arrangement raises conflict-of-interest concerns and, in an industry rife with unfounded claims, questions about whether patients will get value for their money [3].
Anzinger's case for the design is an economic one. He argues that small biotechs cannot compete in a market regulated through large, expensive clinical trials, and that they need a system like Montana's to finance and develop therapies patients would otherwise never get [11]. He says the system will cut costs and give a top-tier clinical space to Americans who now travel abroad for psychedelics, hair replacement and stem cells [12]. "This is really kind of a potential paradigm change in how we do science instead of top down, more bottom up, but still in a controlled way with oversight and everything," Anzinger said on a recent podcast [13].
More than 40 states are already on this road, and two federal programs also let some patients reach unapproved treatments [9]. Montana has gone a step further. Its statute opens experimental therapies to a much broader swath of patients, including people who do not have life-threatening illnesses [10]. And the reviewer is a board the investor built [7].
Anzinger said Bogner invited him to Montana and "basically asked me, 'Well, what else do we need to do? How does the law need to look like to bring you and the biotech companies that you're talking to?'" [18]. "Anzinger took action," Bogner said in an interview [19]. In a Prospera co-working space for startups earlier this year, tables and doors were decked with stickers that said: "SB535. Montana's Longevity Law." [20]
Whether any of it holds sits with one federal agency. Business Insider reported that the Montana experiment hinges on whether the Trump administration's FDA takes enforcement action against companies that participate [14]. The statute writes in no protection above the board, so enforcement discretion is the only oversight sitting there today. Health and Human Services Secretary Robert F. Kennedy Jr. has pledged to increase access to longevity treatments including stem cell therapies, peptides and chelation, and said last year that he had traveled to Antigua to receive a non-FDA-approved stem cell treatment for a neurological condition that affects his voice [15].
What to watch
- Whether the FDA opens an enforcement action against any company treating patients under Montana's SB535.
- Which treatments the board authorizes next, and whether any comes from a company Infinita VC has backed.
- Whether another state copies the private-board model or writes a state agency back into the review chain.