Investors on the libertarian fringe of the biotech industry are making their dream of wide-ranging access to experimental drugs a reality in Montana.
Last year, they helped draft a state law to expand access to drugs that no regulator has deemed safe and effective. Now, Montana is relying on a privately run board to decide which treatments to offer — raising concerns about conflicts of interest and, in an industry rife with unfounded claims, whether patients will get value for their money.
A company that works with biotech firms in a regulation-free zone off the coast of Honduras is in charge. Last month, the board authorized its first treatment: Patients seeking a cure for hearing loss will take a daily antihistamine and listen to a Denver company’s proprietary sound mix for 60 minutes a day.
The treatment hasn’t been cleared by the Food and Drug Administration, and it wasn’t reviewed by the state. It was approved by a privately run review board created by a biotech investor named Niklas Anzinger.
Anzinger is a key figure in Próspera, a private city on a Caribbean island, where anti-aging startups can administer experimental treatments without government oversight or evidence that they are safe.
Próspera, whose investors include Peter Thiel and Marc Andreessen, gained attention last year when longevity influencer Bryan Johnson was filmed receiving a $25,000 gene therapy treatment there in the widely watched Netflix documentary, “Don’t Die.”
Now, players in the booming global longevity industry want to make Montana into a similar medical tourism hub.
More than 40 US states have adopted measures designed to increase patients’ access to therapies not approved by the FDA, and two federal programs also allow some patients to access unapproved treatments.
Montana’s “right-to-try” law allows a much broader swath of patients, including those who don’t have life-threatening illnesses, to access experimental treatments.
Anzinger argues that small biotechs can’t compete in a market regulated through large, expensive clinical trials and that they need a system like Montana’s to finance and develop therapies that patients would otherwise never get. He says that Montana’s system will cut costs and provide a top-tier clinical space for Americans who now travel abroad for everything from psychedelic drugs in Mexico to cutting-edge hair replacement in Turkey and stem cells in Switzerland.
“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.
The Montana experiment hinges on whether the Trump administration’s FDA chooses to take enforcement action against companies that participate. The biotech industry has reason to hope: Health and Human Services Secretary Robert F. Kennedy Jr. has pledged to increase access to longevity treatments that purport to extend life like stem cell therapies, peptides and chelation. Last year, he said he had traveled to Antigua to receive a non-FDA-approved stem cell treatment for a neurological condition that affects his voice.
The Alliance for Longevity Initiatives, a Virginia-based biotech industry group, helped draft Montana’s latest right-to-try legislation, along with Anzinger, who is a member of the alliance, according to the alliance and the bill’s sponsor, the Republican state senator Kenneth Bogner.
Anzinger, a 37-year-old German, is the founder of Infinita City Inc., which helped create a hub for biotech companies in Próspera, an autonomous city in Honduras. Anzinger’s venture-capital fund, Infinita VC, has invested in longevity startups there, 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.
Próspera is part of a movement among bitcoin millionaires, startup founders, and libertarians to create autonomous private cities. Anzinger has been promoting Montana in Próspera. In a co-working space for startups there earlier this year, tables and doors were decked with stickers that said: “SB535. Montana’s Longevity Law.”
Anzinger said Bogner, the state Senate president pro tempore, 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?'”
“Anzinger took action,” Bogner said in an interview. “He came out to Montana to learn how to make Montana a future home.” The senator said the state’s “longevity law” is a test case that he hopes will “spur changes to the U.S. health care system that, in my opinion, isn’t sustainable.”
The industry’s role in administering the program has raised concerns about ethics and conflicts of interest.
Arthur Caplan, former head of the division of medical ethics at New York University Grossman School of Medicine calls it a “risky endeavor.”
“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.
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 Montana law barely got through the state legislature last year amid intense opposition. It set parameters for licensed treatment centers where experimental therapies could be administered with the approval of privately run review boards.
Montana now allows people to access therapies that have passed small, Phase 1 clinical trials that establish that the product probably won’t kill patients, not that it works. FDA rules limit experimental treatments to people with serious conditions. Montana, by contrast, requires that patients give informed consent and have the money to pay and a provider’s recommendation.
Anzinger has set up the only review board so far, the five-member Montana Experimental Treatment Review Board, operated by a private company owned by Infinita City. It charges a $12,500 application fee to companies interested in selling experimental treatments in the state.
The board approved its first treatment last month, giving the green light to Parley Neurotech, a biotech company that seeks to reverse hearing loss with a 30-day treatment of sound therapy, in combination with an off-label, FDA-approved antihistamine. Patients can’t yet receive it because Montana hasn’t yet issued a license to an experimental treatment center. Two applications for a center are pending completion, the state health department said.
Sam Budoff, Parley’s CEO, said sales through the Montana program would help the company fund future clinical trials and allow access for patients who wouldn’t qualify for those trials. He declined to share the cost of treatment but said it would reflect out-of-pocket prices in the hearing aid market. He said the law was the “right balance of regulation,” and said he felt confident that the Phase 1 requirement and the review board structure would keep out bad actors.
Under Montana’s rules, which took effect in July, any experimental review board with five members — including a Montana-licensed physician, a researcher with expertise in clinical outcome data, and an ethicist — can approve treatments.
Unlike similarly structured Institutional Review Boards used by pharmaceutical companies and academic medical centers to approve clinical trials, those in Montana are not supervised by the FDA.
The chair of the review board is longevity scientist Matt Kaeberlein. Kaeberlein also serves on the board of directors of the Alliance for Longevity Initiatives, a volunteer role from which he said he planned to resign soon, citing other commitments.
Dylan Livingston, founder of the alliance, said that his group has no financial stake in any review board or treatment center. Alliance board members are unpaid, and their outside roles are independent of their work on the alliance, he said.
Kaeberlein said the Montana review board “has no financial incentive in whether a determination is yes or no.”
“The existing federal right-to-try, while on paper, can work, the reality is many companies are hesitant to use it, and so it’s not happening,” Kaeberlein said. “Is this the perfect solution? Maybe. Probably not perfect. Is it a possible improvement? I think it is.”
Anzinger told Business Insider that none of Infinita VC’s portfolio companies have submitted an application to the review board or have indicated plans to do so. The fund has no plans for further investments, he said.
Stephen Martin, who leads US initiatives at Infinita and handles intake for the Montana review board, said the board provided the credentials of its board members to the state. Board members must disclose conflicts every time they review an application, he said. No conflicts have occurred yet, he added. Infinita cannot direct or overrule board decisions, according to the board’s rules.
He said other companies could set up review boards as well.
“If you think we are not doing a good job at oversight, come compete against us, do it better, and put us out of business,” Martin said.
Montana’s law requires some oversight. The board must make a public report of treatment approvals and safety outcomes at least once a year. The state’s health department will confirm that each experimental treatment center contracts with a review board that complies with Montana’s rules.
In interviews, some members of Infinita’s review board said they wanted to open up access to investigational drugs, beyond one-off compassionate use cases. Other board members said they wanted to help bring rigor to a field plagued by risky, unproven longevity treatments. As injectable peptides have soared in popularity, for example, so have peptide injuries.
“The field of longevity is plagued right now by snake oil,” said board member Filipe Sierra, a former director of the Division of Aging Biology at the National Institute on Aging, a federal agency. Trials in experimental treatment clinics could help generate data on the efficacy of antiaging therapies, he said. Those trials could be challenging to administer through the FDA’s normal clinical trial pipelines, since the agency considers aging a natural process, not a disease with defined clinical endpoints, like cancer or heart disease.
Jamie Justice, who holds a PhD in neurophysiology and the physiology of aging, and is executive director of a competition that awards money for longevity startups, said she joined the review board because she wanted to help Montana’s initiative succeed, and for there to be “some adults at the table” when ethically thorny questions arose.
“There are a million ways that this could fail and only a few that could go right,” Justice said. “And so I think part of it really is taking our job seriously and thinking about the safety.”
Some biotech companies say they are wary of offering experimental treatments in Montana because doing so could spark an enforcement action by the FDA. In June, a group that included Infinita, patient advocates, and biotech companies met with FDA officials to ask for a guarantee that the agency wouldn’t take action against them in Montana. They said they have not received a direct answer.
An FDA spokesperson declined to comment.
To approve a treatment, the FDA typically requires three phases of clinical trials, including assessments of efficacy, dosage and adverse events. Under its compassionate-use program, the FDA grants requests for unapproved treatments for patients with severe or life-threatening diseases. Such patients can also bypass the FDA and access unapproved treatments under the federal right-to-try law enacted in Trump’s first term, although few drugs have been used through the program and critics have noted that companies don’t have an incentive to provide treatments outside of clinical trials. Companies aren’t allowed to make a profit under either program.
Infinita and the Alliance for Longevity Initiatives are now pushing for legislation similar to Montana’s in New Hampshire.
Without assurance that the FDA will allow companies to participate in Montana’s program, some patients say they may still have to look abroad for experimental treatment.
“We don’t want to get anybody in trouble…But if the FDA won’t support us, what else can we do?” said Kris DeVault, a parent of a 3-year-old son diagnosed with an ultra-rare genetic disease that has no treatment. DeVault wants to go to Montana to receive an experimental treatment for his son, but the manufacturer is wary because of the possibility the FDA could shut it down.
He is now exploring going to Próspera.
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