Niklas Anzinger | Medicine Without Permission

“Imagine we had the technology and we would say, oh, for a reason X, Y, Z, we don’t allow people to use it. That would be like withholding life-saving medicine from someone, which is equivalent, ethically speaking, to killing someone.”
Episode 185
Niklas Anzinger is a German entrepreneur who has probably done more than any single person to put Próspera on the longevity biotech map. He is the founder and General Partner of Infinita VC, the first venture capital fund based in the Free City of Próspera in Honduras, and the founder of Infinita City, a network of hubs for longevity biotech acceleration. He also hosts the Stranded Technologies podcast, which has featured guests including Naval Ravikant and Balaji Srinivasan. Niklas now splits his time between Próspera and the United States, where he is working to import a version of the Próspera regulatory model into Montana and New Hampshire through new Right to Try laws. He is a returning guest to the show.
Timothy Allen sits down with Niklas in Austin, a few days after spending a month living alongside him in Próspera, for a conversation about why aging might be the most under-regulated disease nobody calls a disease, the FDA’s 1962 turning point, China’s rise to 30% of global pharma licensing deals in a decade, the insurance-based regulatory model that could replace the FDA monopoly, and the question at the heart of it all: why do you need permission to try to save your own life? Recorded in a borrowed penthouse between events, the result is one of the sharpest conversations of the year on medicine, liberty, and what comes next for the free cities movement.
Key topics covered:
- Why Niklas is in Austin: building a supplementary regulatory pathway to the FDA, modelled on what CLEAR does for TSA airport security
- Why aging isn’t technically a disease, and why that distinction is holding longevity biotech back from the most well-funded industry in the world
- The FDA’s 1962 efficacy mandate: when drug costs exploded by 100 to 200 times, and why pharma fought it before being forced to comply
- Sid Sijbrandij curing his own cancer, and the Australian who built a personalised cancer vaccine for his dog using AlphaFold and ChatGPT for $3,000
- China going from near zero to 30% of global pharma licensing deals in ten years, and why Eli Lilly’s CEO says cost is forcing trials offshore
- The three regulatory models: the FDA monopoly, the Dubai private-certifier model, and the Próspera insurance model based on Robin Hanson’s ideas
- Right to Try in Montana and New Hampshire, how private certifiers work, and the cannabis Cole Memo as the precedent for how the whole thing could scale
- Why Próspera should focus on phase one clinical trials rather than medical tourism, and why credibility has to come before commercialisation
- Robin Hanson’s end game: fusing your doctor and your life insurance company into one organisation so they have an incentive to keep you alive
- Massimo Mazzone’s profit-first model at Ciudad Morazán versus the venture capital model at Próspera, and why the three Honduran ZEDEs map onto the three sectors of the economy
- The Free Cities Conference coming to Próspera in September, and why this is the phase where the whole ecosystem either scales or stalls
Enjoy the conversation.
Read transcript
Timothy Allen: Right, Niklas, I think it’s a bit ironic that I’ve just spent a month in Próspera and I’ve ended up speaking to you here in Austin. Why are you in Austin? Let’s start there.
Niklas Anzinger: I’ve got no itinerary here. We just talk about what we talk about. So I’m in Austin with my company, Infinita. Right now we’re focusing on the United States. We want to create an alternative or supplementary regulatory pathway to the FDA. What CLEAR does for the TSA at airport security, we want to do for the FDA. And that came from the fact that we built the biotech ecosystem in Próspera, but there are two problems we’re facing. One is we need a lot more medical infrastructure, which will take a couple of years. And second, we need to go to a larger market. So with the changes happening in the United States, and seeing things like the Montana law, which we might talk about, we thought it was a great opportunity to build regulatory reciprocity in the United States for Infinita, where Infinita is accelerating biotechnology. That’s complementary to Próspera, where we think we can focus on the early-stage clinical trials. But that’s why I’m in the US right now. And Austin specifically, there’s a big network of people with aligned interests and ideas to help bring some of these changes through. Eventually, hopefully, also for Texas to be a Right to Try state.
Timothy Allen: Is that something to do with Austin itself, or is that the whole state?
Niklas Anzinger: Austin has somewhat of the California refugees from the tech scene, and it has a libertarian streak generally. So I think Austin was the place that built up as an alternative to California. Elon Musk came here, Joe Rogan came here. Some of our common friends like Patri Friedman came here. Joe Lonsdale is here. So there’s a lot of overlap in our networks in the United States. I thought this was a good place to spend more time and nurture that network.
Timothy Allen: And biotech in particular here? What’s the biotech centre of the US?
Niklas Anzinger: Austin isn’t yet a biotech centre, but Minicircle is here, the first Próspera biotech company, really. They’re here. And I mentioned Joe Lonsdale. He has a VC fund called 8VC that’s investing very heavily in biotech. But within the broader world of biotech, it’s a smaller location. Most of the biotech happens in San Diego and San Francisco, and then Boston.
Timothy Allen: Does the biotech world, as in big biotech, does it know about Próspera?
Niklas Anzinger: It does, especially in the longevity biotech world, which is a subsection of the broader biotech world. Longevity is about aging biology and how we can prevent diseases before they happen, not when they happen. So it has a more preventative approach, a precision and personalised medicine approach. But there’s not yet a wide availability of longevity drugs or treatments. It’s intended as a paradigm change to the pharmaceutical industry. Within the mainstream pharmaceutical industry, I’m sure we’re not known yet.
Timothy Allen: The reason I ask is because I think biotech is one of the most well-funded industries in the world, probably. I’m just wondering whether the idea of charter cities, free cities, is anything to them. Because they’re so large, the amount of money it could save them is phenomenally large as well. And they normally respond well to economics. So I’m wondering whether they even think about stuff like this.
Niklas Anzinger: Biotech as an industry has a fascinating history. I’m these days digging more into history books of how the pharmaceutical industry came about. Penicillin, insulin, all these life-saving scientific breakthroughs that are now leading many more people to have many more healthy and active life years. And then there’s the regulatory history with the FDA, where it especially tightened its grip in 1962, which led to the modern approval system we have today. Before 1962, the FDA had a mandate to just look at or approve new drugs or treatments for safety. Then in 1962, it got the additional mandate that efficacy needs to be proven for a drug to be allowed to market. That’s when costs started to explode and increase by 100 to 200 times. There are many different ways you could count it. And what might be surprising to a lot of people, a lot of people think, oh, there’s regulatory capture and the industry wants to regulate it to do their bidding. That’s not entirely untrue, but surprisingly, the pharma industry in 1962 fought it very hard. There was a long history of litigation cases where the pharma industry went against the FDA. And many of those were settled in about the 1970s, and the FDA won and came out stronger. So the pharmaceutical industry from then on basically had to do the FDA’s bidding. They were forced into it. So you read quotes from biotech CEOs, the FDA is your boss. What they tell you, you do. And that’s largely the standard today. Any sort of bigger institution that has a stake in biotech will be very, very careful to not offend the FDA. Now, what might also be surprising is that the FDA is actually quite open to innovation and to alternative pathways. So, for example, Expanded Access is a program under which a patient can apply to get a treatment that’s not approved yet. And the FDA actually approves 99% of requests within 24 hours. So as a patient, you do have very good options, and the FDA is very accommodating of these kinds of things. It constantly creates new breakthrough designation therapies and things like that. So there is a willingness to change. It’s just that 1962 is still very hard-coded into the regulation, and any federal change is very unlikely to have very large outcomes considering how harm-strung the innovation already is. So I think the mainstream industry is not yet looking at charter cities as an alternative. But some of the fringes of the industry, like when I mentioned longevity, they are. Because they’re especially harm-strung by the current regulatory system, because aging is not considered a disease. So pharma and the FDA have this model of what they call endpoints, or disease indications. An endpoint is a concrete disease. That’s like Alzheimer’s, ALS, neurodegenerative diseases. It’s basically a long list. So if you need to get clearance or approval for a drug, you want to prove it has efficacy for this endpoint, for this disease, in reducing it. For longevity, that’s very difficult, because it’s basically saying aging is an underlying process that causes other diseases or endpoints. But you can’t get drugs approved for that. You need to select one endpoint and be approved for it. So it might have beneficial effects on other things, but that’s not what you get approval for. And that’s not what the science actually wants to solve for. Longevity is inherently difficult to study because it’s so long-term. If you’re starting earlier, before the disease is happening, like 10, 20 years early, then you also need that amount of time to prove the effects. There are ways to do it in the designs, some of which the FDA is accommodating with, others not so much. So it is possible to study, but they’re especially looking for alternatives, because they have the most to gain from it, because the current system doesn’t work that well for them. So longevity was the beachhead industry interested in seasteading, really. When I was at Zuzalu, Vitalik Buterin’s pop-up city, I met many people in the longevity industry. They were aware of seasteading, and some of them had actually thought to do biotech or longevity seasteads. Most of them weren’t yet aware of Próspera, but it immediately got a very positive reception. So, for example, Aubrey de Grey, one of the major thinkers in the field, who created the field, he has this very famous TED talk from 2006. Very quickly after we met, he jumped on a plane and visited us in Próspera in November 2023, and came out and spoke in support of it, which got us a lot of interest from the longevity biotech industry for the Vitalia pop-up city, and up until now.
Timothy Allen: I’ve got to ask. Most people I know would agree that they don’t consider aging a disease. Do you think that’s going to change? Are we about to have a paradigm shift where mainstream people start understanding that aging is a disease?
Niklas Anzinger: I think the disease model in general has problems. I think it’s technically not correct to consider aging a disease. But then again, the logic of classifying diseases and then selecting drugs and treatments only to target those specifically is also wrong. Because it’s just the case that different interventions have different effects on different endpoints. That’s just how biology works. So yes, it’s one way to create scientific discipline, to have these disease endpoints, but it’s not the only way, and it prohibits innovation in other ways of approaching the problem. Just to give you one example, there’s a company called Unlimited Bio. They’re based in Próspera, and they’re working on something they call combination therapies. So imagine you have a disease, or a health goal that you want to achieve. Let’s assume it’s a disease. Why not do multiple treatments to fight that disease? Pharma doesn’t like it that much, and doctors don’t like it, because there are interaction effects. It just introduces uncertainty. Was it this one, or was it that one? But it’s actually possible, and actually necessary, if you want to conquer a disease as a patient. Another example recently was Sid Sijbrandij, the founder of GitLab, who cured his own cancer. From a first-principles way of thinking, that’s what you want. But your doctors can’t give you these parallel treatments at the same time, because that’s not covered in their liability insurance. So it’s a system where, as he calls it, doctors are minimising liability. But as a patient, you want to survive, so of course you’re trying different things. And there are first-principles reasons why you want to parallelise certain things. You shouldn’t do it randomly. You need to know what you’re doing. But there’s something unexplored here. And it’s already a problem that this is unexplored. So right now in the United States, if you go to a doctor, you get one treatment for your disease. And then you get a side effect from it. And then you go to the doctor and, oh, here’s another medication to deal with that side effect. So especially at a certain age, the number of medications people take is increasing. When you’re older, you’re often on 10 or 20 different medications, and the interaction effects are not studied. It’s just a complete blind spot. So this is getting a bit away from your question, should aging be considered a disease. For practical intents and purposes, yes, because this way the industry can make progress. It needs a very specific regulatory code. But in general, we need to rethink our approach to health. I like the words, the three P’s. Precision medicine, preventative and personalised medicine. These are big potential paradigm shifts. And they’re trying to overcome what’s currently called the sick-care system, where you only care when you’re sick. But caveat there, a certain amount of sick care also makes sense. Don’t fix it when it ain’t broken. So it’s not that we don’t want to have any sick-care system at all. We just want to supplement it more and allow the science that lets us do the more preventative and especially the personalised part. The personalised medicine part is now getting more attention, with Sid Sijbrandij, for example, or the Australian man who used AlphaFold and ChatGPT to develop a cancer vaccine for his dog and successfully got rid of the cancer of that dog. And the whole process cost him $3,000.
Timothy Allen: Hold on a minute. I can imagine using ChatGPT, but how did he form this compound or whatever?
Niklas Anzinger: So you have the genome sequence of the dog. And you put it into, I think that’s AlphaFold, basically. So that’s the Google, was it Google? It’s a tool that Demis Hassabis originally developed, one of the main AI pioneers, that allows you to discover new protein folding structures. So what you do is, and I’m not a scientist, so I’m butchering some parts of how you make this work, but you can basically discover proteins, molecules, that are very specific to something you might be responsive to based on your genetic profile.
Timothy Allen: And in the dog’s case, what did that mean? Did he create a pill and give it to the dog, or did he change his diet?
Niklas Anzinger: It was a vaccine.
Timothy Allen: A vaccine? How do you make your own vaccine at home? Did he have a lab or something?
Niklas Anzinger: I’m not entirely sure in this case. I’d be butchering it if I tried to explain. But there is manufacturing, there are labs that allow you to do these things in easier and easier ways. The technology is advancing so much that the labs are more automated, and the infrastructure is more accessible and more shareable. So you don’t necessarily need to go to a big company to do it. Much of that technology is available, and there are several companies constantly producing new things. The COVID vaccine was another example. You only had to change the genome sequence of the virus strain to update it for the current virus. So we had Delta, Omicron, or whatever. That’s something that originally got me thinking, hmm, this makes no sense. Because you had the first version of it and it had a certain efficacy, but then the virus was mutating, so the efficacy was declining. So you just needed to give it the new genome sequence of the virus, and then it would be more effective again. But then it had to go through re-approval. I was like, that makes no sense. The delivery mechanism and the risk profile are the same as the other one. So it should be automatically approved, but it wasn’t. So the vaccines basically decrease in efficacy over time unnecessarily. We could have just adapted it with the technology we have.
Timothy Allen: I take it, because this is literally the first time I’ve ever thought these thoughts, I take it you imagine in the future medicine will be something you do in a self-sovereign way at home with a bit of technology and some AI. Is that right? Is that where this is heading?
Niklas Anzinger: It’s partly heading there, yes. I think there will still be a patient-doctor relationship. We tend to forget that there are several layers of regulation. It’s not just the FDA, but also your doctor. You have a relationship with your doctor, and that’s meant to help you find the things that work for you. So I don’t think it’s advisable for most people to do this at home. This is still very powerful stuff and very complex stuff. But some people are very smart and have a very scientific mind and want to take risks for themselves. I think that’s totally fine. It should be allowed. But we still need doctors, and we still need some forms of oversight and testing, to be able to decide what we should give more credence and credibility to, cover by insurance, produce at scale, and things like that. So I think these two things can coexist. It won’t be that everyone is treating themselves, but many more people will be able to access the tools they need to develop treatments that might work for them, and generate data from that, which helps other people figure out what works.
Timothy Allen: So you’re not one of those people who thinks doctors are going to be out of a job in 10 to 15 years?
Niklas Anzinger: Well, I’m doubting. On the one hand, I think there are good first-principles reasons to have doctors, because they should be hubs of medical and scientific knowledge. They should have done what you’re trying to do, to solve your stuff, more often, so they can guide you to an informed assessment of what could work for you, or lay out the choices in front of you. But the way doctors have been educated for the last decades, or hundreds of years, is not that model of looking at data or looking at the science. It’s a model where doctors are very largely delegated to have very little autonomy. They have very strict liability conditions set by their insurance, so they can only do treatments that are standard of care, and they can afford very little of their own opinion. Because if their opinion deviates from what the insurers or the regulators consider the standard of care, they’re at risk. So in the current world, doctors are often passive risk-takers. I do think there is ideally a world where doctors are no longer passive risk-takers but are more active hubs of scientific and medical knowledge.
Timothy Allen: I was under the impression that they’ll succumb to the hive mind of an AI that would know much more, especially once you start sequencing your own genes and having drugs catered to your very specific needs. I would imagine you can’t, as a human being, really compete with an AI, except in terms of the human experience. But even that, within a certain amount of time, an android will feel just as warm and friendly as a good doctor would, I suppose. So you think doctors are going to stick around, maybe in fewer numbers potentially?
Niklas Anzinger: I forget what the effect is called, but they thought in the 1960s that accountants would be redundant, or when credit cards came out, that bank tellers would become redundant. But what you actually see in many of these technological changes is that you now have more bank tellers and more accountants. So I think there’s a world where it’s even possible we have more doctors. They’ll just do different things, and they’ll use AI, and they’ll use ways to administer treatments and help you make informed choices in ways where they have knowledge or skills you don’t have.
Timothy Allen: Going back to aging as a disease, because I’m not convinced, obviously. Maybe you can tell. Where I find an issue with it, and I probably need to completely change my frame of observation on this, is, in the end, is there such a thing as dying of old age? Is age a thing, or are you dying of a process that’s happening to you in your latter years? You’re dying of a cancer, or you’re dying of a broken heart, I don’t know, something. Do we actually die of something, or does age have a… how do you quantify that? How do you say age is a disease?
Niklas Anzinger: You can, with a very high degree of confidence, say that with increasing age, your risk of a list of diseases increases. And it increases very predictably. Your risk of heart disease, cardiovascular disease, cancer, and all these other lists of diseases. The older you get, the more likely you are to get diseases. So that’s known. Now, the theory is that these diseases have common causes that have to do with the aging process. We see aging as something natural, something inevitable, but there are animal species that aren’t aging, or aren’t aging at nearly the rate at which we age. The Greenland whales, the naked mole rats, even the hydra. So we know there are cellular structures that can rejuvenate, not age. And there are things in the biology of humans, and of nature in general, in the living species, in the way we reproduce or divide or destroy or rejuvenate cells, mitochondrial dysfunction, telomeres. There are many different things that contribute to aging. We can say that with very high certainty. We know aging is a very, very complex process, probably, and maybe even too complex for us to really deterministically or mechanically understand. There are too many different factors. It’s a system we didn’t build, that was created over hundreds of millions, billions, of years of evolution. But we do know some of these things we can influence, and they might lead to positive downstream consequences down the road. So aging as a disease is, as I mentioned, not entirely precise. But it’s just an approach to prevent further diseases down the road. And I think it’s valid, in the sense that if you start earlier, there’s something quite powerful about this. And it’s something we should investigate scientifically very deeply, and hope that it works.
Timothy Allen: Do you have a personal opinion on death itself? The process of death has evolved over millions of years, so it obviously serves a function. Probably something to do with certain genes needing a refreshing bit of competition. Different generations need to happen in order for species to change, I suppose. I’m purely guessing this. But do we now think we’re reaching this paradigm where, you mentioned naked mole rat, turtles, whales, I know about their life cycles, but they don’t live forever. They still die in the end.
Niklas Anzinger: Hydras do.
Timothy Allen: Do they?
Niklas Anzinger: Yeah. Hydra is biologically immortal, if I’m not mistaken.
Timothy Allen: And hydras, as in, they live in the sea and they’re a bit like a coral?
Niklas Anzinger: Yeah, that kind of hydra.
Timothy Allen: Okay. All right then. As a species, are we heading for, for want of a better word, immortality? And I don’t mean it in some grand way. I just mean, problem solved, we can live until we have an accident that kills us.
Niklas Anzinger: The reasonable specification of immortality is biological immortality, where our biology is not killing us. So literal immortality is not possible, not desirable. Imagine you’re trapped under a rock, in a lot of pain, and you can’t die. You don’t want that. So I think with biological immortality comes actually the ultimate libertarian goal, which is choice. You want to have a choice. So if you’re saying, do you want to live longer? No, I’ve had enough of it, seen it all, it gets a bit boring, I’m done, thank you. You buy it, then you can go, of course. And vice versa. Imagine we had the technology and we said, oh, for reasons X, Y, Z, we don’t allow people to use it. That would be like withholding life-saving medicine from someone, which is equivalent, ethically speaking, to killing someone. So I think there’s a very good argument why we should do it, because of liberty and because of choice. So the question is, can we do it? And if we can do it, I think we should have the choice.
Timothy Allen: Talking of withholding life-saving medicine, earlier you were talking about Right to Try. And as far as I can see, that’s currently one of Próspera’s quite big selling points, Right to Try. But in the States now, it’s something that’s changing and moving, and I know you’re part of that. Can you just talk a little bit about that?
Niklas Anzinger: Sure. On a high level, it’s about more different regulatory models. Right to Try is a moral argument for a certain regulatory change, but the regulatory model, to me, is the important and interesting part. So imagine the current regulatory model of how we do things, the typical US FDA, or the FAA, the Federal Reserve, the SEC. This is what’s called a regulatory monopoly. There’s only one regulator you can go to, and they say yes or no, and if they say no, good luck. You can’t go to anyone else. And then there’s a second model, and that’s the Dubai model. The Dubai model is, you can be an approved private certifier under a regulatory body. So, for example, there’s a health authority, and you can be a private accreditation provider for hospitals. So it’s partly privatised, but still with a final backstop in one health authority. What’s good about that is that a public agency is just not good at the legwork. Private companies are just better at that, so why don’t we privatise more of that process? And it works very well in a couple of industries. It’s not only Dubai, it actually exists in Europe too. Medical device approvals are done through what’s called notified bodies, so it’s also a partly privatised system. Also in the United States, you have what’s called IRBs, Institutional Review Boards, that approve new research. Also privatised. They can do it for profit, non-profit, as part of a research institution or independent. So the problem with these models is that the regulator can just be too demanding, and become more like a monopoly regulator. And then the Próspera model is actually the new way of doing regulation. That is basically saying, and as far as I know it’s based on an idea from Robin Hanson, a very well-known futurist in our circles, especially about governance, we don’t have one centralised regulator. We just have a statutory requirement to get liability insurance. And when you have the liability insurance, and you’ve probably talked about this on the podcast many times, you can have private regulators in a competitive way, with the right incentives to do good regulation, not bad regulation. Now, Right to Try is a moral argument that is already won in the United States. But on its own, it’s not suggesting a regulatory model. What we see happening now, and what we’re quite involved in in Montana and New Hampshire, is giving the regulatory underbelly of how Right to Try can be effectively used in practice. What Right to Try means is patients can access typically life-saving medicine even if it’s not fully approved. Everyone understands and buys that argument. But it was just not effectively used. It didn’t have enough of a regulatory underbelly for enough companies and clinics to participate. So that’s what could be changing now with Montana and New Hampshire. And FYI, the influence there is more the Dubai model. You can have private certifiers now in Montana. Montana issued its department regulations after the law was passed last year, and it has these private certifiers, but they’re still under the Montana Department of Health. The clinics have licenses, that’s under the Department of Health, and they need these private certifiers. So that’s a bit more Dubai model, not the entire all-the-way Próspera model. Because we think that’s more amenable and possible to argue for in the current environment.
Timothy Allen: How does it work in the federal system? Because the FDA, they’re federal. So how does it work, say, at a state level in Montana?
Niklas Anzinger: What’s very interesting is, if you’re a constitutionalist wonk in United States history, you know there are these different conflicts in the US Constitution. On a libertarian reading, libertarians all agree the FDA is actually unconstitutional. Why? Because there is what’s called the enumerated powers. The idea of the Constitution was limited government, to make sure the government can’t abuse its power and go into all these different areas where it has no business. And what it tried to do is, we just spell out exactly what the government can do. And everything that’s not clearly spelled out here, that’s up to the states. That’s the 10th Amendment. So that was probably the intent of the founders. Now we don’t live in that system anymore. For several Supreme Court rulings later, there’s basically established federal supremacy. So the FDA and the 400-plus other agencies had, for a very long time, pretty unchecked power. They could even have their own courts. Regulatory law has become its own underbelly that’s actually not checked by Congress in some meaningful ways. It could be, but Congress is also very dysfunctional. And there were several court cases that gave very strong deference to all these agencies, including the FDA. Now that’s changing a bit. There’s the overturn of the Chevron deference. So these agencies are actually now more bound to Congress. But even more importantly, one thing that’s been overlooked for a long time is that the states actually have more autonomy than you think. States have autonomy over medical practice. So the question is where the FDA’s jurisdiction applies. It’s a very specific technical term, which is basically the development or the commercialisation of drugs into interstate commerce. Now, the interstate commerce part is the really important one, because that ties back to the US Constitution. The way that these various Supreme Court rulings, and the Progressive Era, Woodrow Wilson, FDR, justified the expansion of state power is the interstate commerce clause, which said that Congress has the power to regulate trade between the states and nations, which was back then intended to protect free trade. They didn’t want the states to go to trade war with each other. So it was a fundamentally libertarian clause, on that interpretation. Not everyone would agree, of course. But then they interpreted that extremely broadly, saying any interstate commerce of any sort of different goods can be regulated by us. And that’s where almost all the agencies are justified, plus a couple of other important rulings. But that’s the key one. So the FDA’s power technically stops at the point where you just stay in the state. And it stops generally at medical practice. So you can’t do your own drug approvals, and you can be confined to medical practice in one state. So there’s some interesting leeway to play with. And states are now using that. Right to Try has been passed in more than 40 states, but it hasn’t been that successful. More recently, you have the Utah and the Florida stem cell laws, you have Texas, even California has stem cell access laws. They’re now making more use of that state sovereignty they have. And the FDA could, in many cases, actually say, hey guys, that’s illegal, we’ll shut you down. Because that interstate commerce can be interpreted extremely broadly. It’s almost impossible to do things just within the lines of the state, and even if you do, they could still make an argument. But the FDA is not doing it. They’re looking the other way, or what’s called exercising enforcement discretion. So it’s like, okay, you’re compliant with state law, we’re not doing anything about it, we look the other way. Which is actually an interesting flip side of the power of these regulatory agencies. For a very long time, and still, they have much of the power even if there’s not an explicit mandate by Congress. So they’re making their own law that goes beyond what Congress is telling them. But they can also say, hey, we’re not enforcing every law literally the way Congress formats it. We have leniency to interpret it in our ways, which includes, and this is happening all the time, the FDA constantly releasing enforcement discretion policies. Because this is just not a workable system if states can’t do their own thing, and they would risk political conflicts. And, frankly, many people at the FDA are pro-innovation, and try to actually make things work, not undermine innovation. So now we enter into this legal engineering topic, the competition with China. China is basically eating the United States’ biotech lunch. It’s in a staggering way. You might think, all right, there are fewer patient protections, and maybe the data is bad or whatever. But you have to recognise that in the last 10 years only, China went from almost 0% to more than 30% in pharma licensing deals. And these big pharma companies, you can’t fool at scale that these drugs work, the data is good, or at least comparably good to data from other states. So in just 10 years, China went from 0% to 30% market share. Early-stage trials are going to China in droves. You even had the Eli Lilly CEO speak on podcasts publicly about that, and they were saying, for cost reasons, we have to go to China. But you know what, I don’t want it. If there’s the option to do it in the United States, we should do it. So that’s why there’s discussion now, hey, we need to catch up with China. And it’s a very clear recognition that this is because our regulations are too stringent. The way China got there was making mostly the bureaucratic process, not the substantial part, much easier. And now Washington, and much of the biotech and pharma industry, is looking at Australia as a model, because Australia has actually done many things better for several decades. So there’s now a very strong appetite to change things at the federal level in the United States. And there are many different proposals that would improve things and include Australia-style regulation. With my background in charter cities and special economic zones, I was looking at that and was like, okay, great, but if you really want to succeed with this, with something you already want to do, then federalise it, decentralise it, let the states innovate. So that’s the proposal that differentiates us and that we bring to the federal discussion. We’re kind of the only ones doing that.
Timothy Allen: When you talk about devolving from the federal level, would it happen as a legal challenge that sets a precedent that means the states have more power? Or is it something else? What do you actually have to change? What are you working on?
Niklas Anzinger: It would be very simple. The FDA could just say explicitly, all right, we exercise enforcement discretion. Right now it’s kind of implicit. There are the Florida stem cell laws, and there are hundreds of clinics and thousands of people using it. And the FDA has sent like two enforcement letters. And when you look at whom they sent them to, these were pretty egregious cases. They were pretty justified in saying that. But that’s kind of not enough. It means if you’re a stem cell clinic or a startup that’s willing to take a bit of a gamble, you do it. But who you’re not getting is a biotech company with 100 million in funding and careful attorneys, or a multi-billion pipeline of drugs. They want something written down. So if the FDA just says, all right, as long as you’re compliant with these state laws and conditions X, Y, Z are fulfilled, then you’re fine, then you don’t have the risk of us using your participation, or the data that’s generated in these states when patients take these drugs, against you. So that’s very simple. Someone like a Marty Makary or RFK Junior, or a senior official in the FDA, could unilaterally just sign that, and off it goes. It wouldn’t require any legislative change. And the parallel to that, by the way, is the cannabis industry. The cannabis industry until 2013 was in that situation. Many states had their own laws, but technically speaking it would be illegal. The DEA could actually enforce it, which meant that industry was a bit shadowy, shady, or at least uncertain. There are lots of people who are very genuine and want to make it work, but that grey market also attracts actors that are willing to be in the grey market. And instead of saying, all right, we shut it all down, the Department of Justice under the Obama administration actually issued what’s called the Cole Memo. The Cole Memo was just a policy stance. It was not law or anything like that. And it said, all right, as long as you comply with the state’s law, we exercise enforcement discretion, so the DEA won’t come after you. And that’s when the industry really started exploding, or thriving. So technically, legally speaking, the DEA could still enforce the law. But at this point there are billions on the line, millions of consumers, thousands of businesses.
Timothy Allen: So the risk isn’t there for it to be reverted at a later stage?
Niklas Anzinger: Of course it is. And this is actually why our suggestion for the Montana and New Hampshire laws was, all right, don’t be too libertarian about it. The Florida stem cell laws, I haven’t read them in deepest detail, but there is oversight by the state. The states have certain mechanisms, but states often have low enforcement capacity. They can’t check all the actors. They’re not the most efficient regulator. So if something bad happens, then federal will jump in, saying, all right, the states are not capable on their own, so we have to jump in. So our argument was, well, we don’t want that to happen, so why don’t we create a private market for private certifiers, where you can be authorised by the state to approve drugs or treatments, and you review for safety. So there’s another layer of scientific expertise in between before any of these treatments go to market or reach patients. The clinic needs that approval of that private body, which can function in a very lean way, just like IRBs are already done and used widely. And then you have something you can point at. And you also have a market that increases the robustness and rigour of these approvals. In a system where you have a functioning market, we presume, and it’s our intention, and libertarian economics teaches us, it’s going to be efficient. So there are some very strong and highly credible players, and there’s a process you can point at that’s in many ways the same as the federal process. You have credible scientists looking over the stuff before allowing it into people, into patients. And we think this is a model that can survive when a bad case happens. And bad cases will happen eventually, no illusion. But there’s no drug or treatment that has no side effects. And there’s absolutely no research where nothing ever happens to anyone. That’s why we call it research. We don’t know what happens. We need to test it on people. So this is why we thought we actually need a robust process and institution to point at, while applying libertarian economics to it.
Timothy Allen: Is the fact that you’re in New Hampshire, as well as Montana, anything to do with the New Hampshire Free State Project and the number of libertarians out there?
Niklas Anzinger: Yes. Some of the free staters I met facilitated some of the connections in New Hampshire that were lobbying for this. And, by the way, this was not coming from us initially. There was an existing coalition that we just jumped on the bandwagon of, both in Montana and New Hampshire. In New Hampshire, there was already, and it was interesting, the person that did it, his name is Ian, was actually working as a lobbyist for the organisation of churches.
Timothy Allen: Of what?
Niklas Anzinger: Of churches.
Timothy Allen: Oh, churches.
Niklas Anzinger: And he was a free stater and libertarian himself, but he actually convinced the churches and Christians in the state to support biomedical innovation, which is very interesting. He has a whole piece out on our Substack, Infinita City Times, on the Christian case for longevity and against death, actually.
Timothy Allen: Wow. But as far as the actual lawmaking part of it, does New Hampshire have an advantage because of the Free State Project? I’m in two minds. I know there are a lot of libertarians up there, and slowly but surely they’re working their way into positions of power. I’m just wondering whether you could say there’s actually a bona fide effect right there.
Niklas Anzinger: I think New Hampshire has a lot of potential for libertarians. I’m very positively impressed. And I think the Free State Project and libertarians laid the groundwork for that. The House Republicans especially are very libertarian-leaning. The Senate Republicans a bit less. And there are also some institutions of the state that can block some things. But the House Republicans lean very libertarian, they’re very open-minded, and they’re actively implementing the kind of changes we want to see. They’re implementing laws to try to enable nuclear power. There’s even this flying cars bill. And they’ve done crypto-friendly legislation and things like that. I think it can be a bit more systematised, because libertarians have such a big potential influence in that state. But I see that happening, and I see the potential for that.
Timothy Allen: And why Montana? I’ve not heard Montana being a centre for this kind of stuff. Is there anything unusual going on there?
Niklas Anzinger: Montana has an ethos as a frontier state. And it has a very quiet libertarian ethos. This is my homestead, this is my farm, I do my things here. General skepticism of big government, but in a very quiet way. Not in a way that you’re very public about, or arguing or debating with people about.
Timothy Allen: Going back to something you were saying earlier about China commandeering this market, can you talk a little bit about the difference between what China is doing and what you can do in, say, Próspera? How is China just very deregulated?
Niklas Anzinger: The Próspera system would still be far better if it was at a similar scale to China. That’s kind of why I’m doing this. China is doing some deregulation that I can talk about, some of which is very competent, but you could do far more. But China just has the scale. One example is it reduced the time for INDs, which are basically new drug applications, to be cleared, from several hundred or even a thousand days to like 40 days. That’s an approval step you need to start the research. And going through that approval step took years before in China. And to this day, it takes very long in the United States. I’m not entirely sure how long, but it’s definitely in the range of a couple of months. And it also costs a lot of money. Doing a new drug application costs $150,000. And getting one meeting with the FDA, which you need to get the input required to approve your study design, costs $20,000. So China has basically made that process much more streamlined, more efficient. And then there’s just a lot of scale. China has gotten very good at manufacturing. I’m not sure exactly what they did on the manufacturing, but they definitely have an advantage there. Also, patients are cheaper to get, simply. You can get a lot more patients, and it’s much cheaper for them to participate. And then there’s other stuff, like creating incentives for drug companies. I don’t remember exactly, Cremieux told me about it, a famous Twitter poster that I think you also had on the podcast, but they also did something more clever than the most-favoured-nation pricing that the US recently did. I can’t remember exactly what it is, but they basically wanted their companies to be profitable. So the socialists are actually helping their companies be capitalist. So China is not to be underestimated in their competence on these things. But it’s also my impression that it’s possible to do far more, and this is winnable for the United States, to deregulate even more, especially with this state model, and especially applied to some larger states like Florida and Texas. And with the deepest capital markets, and especially much of the scientific discovery coming from the United States, it still has a very good fighting chance with more deregulation.
Timothy Allen: Can you compare and contrast, so I understand all this, you were talking about the Dubai model earlier, how does Unlimited Bio, for example, work in Próspera? Under what model do they work?
Niklas Anzinger: They work under the Próspera model. Próspera is better than Dubai, in my opinion, but they’re also the only ones doing it. Basically, if you’re Unlimited Bio and you have a gene therapy you want to bring to the market and your patients, you need mandatory liability insurance. So you register a business, and then you say, all right, who’s your insurance provider? And then your insurance provider is like, okay, what regulation do I want you to be under? Then you can negotiate it with that insurance provider. The insurance provider can give you a menu of options. Próspera famously has the 30 different peer countries. There are 30 different developed countries, and you can adopt their regulatory framework. And then you even have some other options, you have custom options. So Próspera has a system where you can have a custom regulatory framework, where you pick and choose what’s best for you. It needs to be approved, and the insurer needs to agree on it. You might get higher premiums because it’s not proven, and they might need to pay for expert assessment instead of going with what’s tried and tested. But once a custom regulation is out, then anyone else can use it. So it becomes a public good. And there are actually two custom regulations in Próspera. One is the GARM regulation, the other is the Minicircle regulation, what they colloquially call them, because these companies initiated them. So the GARM regulation is basically saying, well, GARM is your FDA. If they approve it, you can do it. Simple. And GARM has an IRB and a review board, so what they review is basically a drug approval for their use. And I guess they could technically also approve it for use in other clinics if they wanted to. They’re a purely private FDA, a private regulator. And then the Minicircle regulation is more open-ended. You can actually do things even without an explicit regulator reviewing or approving it, as long as you have very strict processes around informed consent. So if you have a patient that comes there and takes a treatment, you need to have, I think, interactive or video-recorded informed consent, where it’s very clear that you gave them information and they understood it, that it’s not misleading, and it’s truthful. And also the patient needs to be registered. I’m not sure with Próspera if it can be a private registry, but there’s oversight, because that outcome needs to be reported. And if you in any way violated the regulatory framework, if you were misleading or fraudulent about what you were doing, or insufficiently careful about obtaining the informed consent, then you’re liable. So then the insurance doesn’t cover you. Versus, if you go through all the processes and something happened anyway, and the patient sues, then the insurance would basically cover the liability and pay for the legal process.
Timothy Allen: Is it fair to say that, at its most essential, the insurance part is the innovation?
Niklas Anzinger: Yeah, that’s the big one.
Timothy Allen: I don’t understand why that hasn’t been done before. It seems like such an obvious way to operate.
Niklas Anzinger: Well, look at Robin Hanson’s career. Robin Hanson had many of these ideas very early. Look at prediction markets. He started writing about that stuff in the early 90s. And now we see it succeed 30 years later.
Timothy Allen: But arguably the current systems will evolve into that model, won’t they? What’s stopping them, other than entrenched regulation and big institutions and all this kind of stuff?
Niklas Anzinger: Yeah, we’ll see. The big part of why I’m doing what I’m doing in free cities and charter cities is that we don’t want structures to succumb to the same incentives that make it take 30 years from a really good, obvious idea like prediction markets to them being adopted at wide scale. We want to make that process faster. And the big problem prediction markets had was that they were regulated like gambling. There was, oh, you can bet on terrorist outcomes and then be the terrorist that does that, all these arguments. And now they’re commonplace, and there are still regulatory debates about them today, but it just takes too long. So this is part of what motivates me to do what I’m doing. Once we have a current governance model in mainstream jurisdictions and nation-states that assumes monopoly, and monopoly is what slows everything down, versus if you have more decentralisation of governance services, then you’re better able to price in innovation and price out bad actors. But there hasn’t been that innovation for a very long time. And then we can go through the entire history of why our industry exists, what Dubai added to the mix, and Shenzhen and Hong Kong, and now what we’re trying to do with free cities, with Próspera, and with the Honduran framework. So now, this is the vector we could go towards, with this decentralised insurance model. But I think it will take a very, very long time until that’s broadly accepted.
Timothy Allen: Do you think the ZEDEs will have an edge for quite a while then? Because at the moment, according to you at least, they have the best model for operating in the longevity space. Is that fair to say?
Niklas Anzinger: You mean Próspera?
Timothy Allen: Yeah, or the ZEDEs in general, but yes, Próspera.
Niklas Anzinger: Yes, but you have to also acknowledge that they just don’t have a lot of scale yet. There’s a limited market side, a limited number of patients and of medical infrastructure to support the biotech companies. So the very important thing for us in Próspera will be to specialise. I would right now say we need to specialise in phase one trials. Phase one trials are with healthy volunteers. They’re relatively small. They’re quite expensive. They cost $5 to $10 million in the United States, and you can do them for a couple of hundred thousand. And the infrastructure build-out required for that is not that high, a couple of millions. So that’s what I think we should specialise in. And then, with our model with Infinita, we can bring it to market in the United States, post phase one. The Montana and New Hampshire law, with the review boards that we have, would allow that. So we need to make sure that in Próspera we fulfill all the requirements of what a high-quality regulator would do, which we’d have to set up. That would require some focused work over the next two years or so. But then Próspera could have a huge edge for phase one clinical trials. It could also have an edge on medical tourism and things like that, which I think also makes sense to pursue. But the challenge there is, we need to develop a better brand than an offshore medical tourism hub. Offshore medical tourism is generally seen skeptically, and that’s not entirely rightfully so, but in some part it is. There are many offshore clinics that exploit you, that have bad medical practices or scientific practices. And there are some very good ones. And frankly, that’s also true in the United States. There’s bad medical practice there even though it’s regulated and technically under the law, and there are good ones, and sometimes we don’t even know which. But it just has more inherent built-in credibility for a very large market. So that’s why I think we should rather focus on the research and phase one side, because there, with Infinita, we’ve already built that brand recognition. We’re now able to attract some of the best scientists in the world. And the scientists, I think, front-run the medical practice. For the review board in Montana, we’ll have some of the most famous people in that field, very highly decorated scientists that we’re able to get. And we can use that same credibility to build a research hub in Próspera as well. For medical practice, I think it’s better to come after we’ve built that credibility. But of course we need some basic medical practice infrastructure to do all the trials and treatments. But this would be my proposed bet on how we can position Próspera.
Timothy Allen: I must admit, and bear in mind I’m an outsider looking in, having just spent a month in Próspera, the medical tourism side of things seemed like a no-brainer. But it’s interesting to hear that you’d say, from your perspective, maybe the best option isn’t to do it immediately.
Niklas Anzinger: I think it can be complementary. I just think it won’t succeed on its own if we don’t build the credibility part. My goal is to build the credibility part. And if I’m successful with this, or someone else is, then we also make the medical tourism part easier and more sustainable in the long run. But if nobody does the credibility work and we just do the medical tourism part, then I think at some point it might just come back to the case when something happens, and something will happen eventually. What is then the structure of the defence when there’s someone in Honduras that wants to shut it down, or, at this point we’re also well known, the United States and the FDA come up with something where they have jurisdiction over us? That’s why, from a first-principles point of view, I think the credibility part is what we need to go for. And I compare that a bit to Coinbase and the rest. Lots of people in crypto took more the pirate approach, and that’s our ethos and where we’re coming from. But Coinbase was the one, okay, there’s going to be a whole new industry and we’re going to be the credible provider. And they benefit a lot from their credibility now, even if that means they’re sometimes going the harder way. When you do their KYB process, when you register a new business, it’s very annoying and not very conforming with the crypto ethos. But they’ve also done a lot of good work for the credibility of the whole industry. They’ve been the one mainly out there to establish the relationships in DC, done the lobbying, contributed to the Genius Act. Stand With Crypto was a very successful initiative, and everyone benefited from it. So I wouldn’t see it as either-or, we have to go with the full libertarian pirate ethos or build institutional credibility. I think we need to have those things side by side, and one player needs to build that credibility.
Timothy Allen: But I would have thought there’s a fair amount of risk doing stage one trials as well. That’s how you’re saying you build your credibility up. But that’s quite a minefield, stage one trials, isn’t it?
Niklas Anzinger: I think it’s much less of a minefield than medical tourism, simply because phase ones are an accepted and known regulatory structure. There are very known safety processes for it, and reporting processes. So we can simply do them just like anywhere else, and just say, right, we followed the process. Something happened anyway. What’s happening when something is happening? Well, the same thing that’s happening elsewhere. So we’re not leaning too far out of the window there.
Timothy Allen: I don’t know whether it was you I was talking to a while ago, or someone in the Próspera biomedical scene, who was saying that actually the truth of Próspera is, we’re not actually doing radical things there.
Niklas Anzinger: I was going to be saying that. It was me, right.
Timothy Allen: Is that a long-term strategy, or are you planning on doing radical, and don’t take it the wrong way, you and I both know what I mean, groundbreaking stuff? Because in a way, what you’re describing is not necessarily groundbreaking. It’s just using regulations from another country. But when I think of Próspera, I think of the opportunity to do actual groundbreaking stuff.
Niklas Anzinger: That’s an interesting one. I would not advise Próspera to go into the far end of the cutting-edge stuff. That stuff is already done in the United States, and gets a lot of bad press. Reviving the woolly mammoth, or organoid replacement, all that stuff is done in the United States, and they get very bad PR there. Imagine we were doing it, the PR we’d be getting.
Timothy Allen: So what is the Próspera edge then, in a nutshell?
Niklas Anzinger: The edge is the commercialisation. The problem is not so much, I mean, there are problems with how we do the science too, but broadly speaking, there are the stages of preclinical research, and clinical research. Clinical research is the FDA approval, you do the clinical trials and then you go into humans and you’re commercially available. Preclinical is before you do it in humans, meaning you do animal studies. And animal studies can already be done well. There are lots of problems to fix there, but I don’t think we have a huge advantage there. It’s not necessarily what’s holding the field back, in my interpretation. In my interpretation, it’s the in-human clinical part, and the fact that it takes 15 years and costs a billion before it’s in the market. That’s simply too expensive to even start, and to collect points of data. So the fact that in Próspera we can more quickly commercialise something that’s already been relatively de-risked. And Unlimited Bio is, again, a perfect example. They have a treatment, a gene therapy, that’s been used on more than 10,000 patients in Russia, but the FDA doesn’t recognise that, even though it’s just data. It should just be science. But if it’s just science, why doesn’t the FDA do more medical reciprocity with other countries? That’s where you see the regulatory capture. Of course there are companies, especially big pharma, and that’s where it’s true, especially with phase three trials, they want it to happen there, because that’s where they make a ton of money. So all this is to say, I think the best path to market, lowering the risk of too much bad PR for doing too crazy things, which frankly may not work, most new ideas are bad and don’t work, and somebody has to absorb all the PR for it, the very big improvement we can make is on that stage of the process, the clinical research to commercialisation, through phase one trials, where we can save companies between 80 and 95%, and people can access these treatments. Much has been made of the Minicircle, and become a gene-edited human or whatever. It’s not that the approach is super new. It’s just that you can do it much earlier than you can elsewhere. If you talk to the scientists in the field, they’re already five to ten years ahead. So we’re just accelerating, or shortening, that time window to market, which makes it often appear as very new. And in some way it is. You can access it still before anyone else can. But the science is already relatively out there.
Timothy Allen: And if the Right to Try stuff takes off the way you want it to in Montana and New Hampshire, what’s the Próspera edge after that? Is it still the same?
Niklas Anzinger: Yeah, phase ones. Because in Montana and New Hampshire, the requirement is that it has passed a phase one trial. But then there are still other edges beyond that. You can innovate in manufacturing, for example. Manufacturing is a very big bottleneck, and Montana and New Hampshire are not solving that yet. And it’s very, very difficult to solve for in the United States. We have potentially the Satuyé port, and nearshoring and things like that. You need some arrangements with the FDA probably, but still the manufacturing is making a lot of gene therapies and biologics, especially, or some of the personalised vaccines, cost-prohibitive. If you have to do full GMP, it would cost like a million per person, versus if you did a more first-principles risk-based approach, you could do it for a couple of tens of thousands. So there’s an edge there. There can also be edges in the design around things like insurance. Robin Hanson’s model is that the final end game is that your healthcare provider and your life insurance company are the same organisation, because this way they have an incentive to actually make you live longer. Each additional life year is them deferring the payment for the life insurance. Then there are things like human challenge trials, or the combinatorial trial designs that Unlimited Bio was talking about. So Próspera is the right innovation hub for these ideas that we know should have been done a long time ago. We’ve already thought them through, we’re not risking a crazy amount there, but we can do it 10 or 20 years before it will be brought into mainstream jurisdictions like the United States.
Timothy Allen: All right, before we go, give me your prediction for the US stuff and for Próspera. How quickly do we see any reasonable change in, say, Montana and New Hampshire? And then on the Próspera side, what will be the new innovations coming in the future?
Niklas Anzinger: The US will be quite interesting. It’s very dynamic right now. But I’m actually really, really optimistic, just because there isn’t really anyone who has any complaint about it. We thought of everything. We’re trying to construct an argument, or create a structure, that I can’t only convince libertarians of, but that sits within what’s already proven and established. So I’m quite optimistic for that. It could happen quite soon, the next couple of weeks or months, that we see that Montana and New Hampshire model recognised. And if that’s the case, I’ll play a very active role in trying to bring it to more US states and have lots of patients be able to use it. So things can get very fast this year already. And that could fundamentally change the biotech landscape. We’ll have stories of patients who’ve been treated in New Hampshire and Montana. And there will be a website where you can apply to have your treatment approved, post phase one, in these Right to Try states like New Hampshire. And there’s going to be some very credible scientists on our review board, so, okay, these people have reviewed it. It might also be, as usually happens, a strong media storm. But I feel like I’ve been thinking about that moment happening for years, and the answers I would have. So it will be very interesting to observe. And I think part of that will also help some of the efforts in the United States for acceleration zones. Bringing much of the ideas from Próspera, SEZs, free cities, into the United States. This is where I’m more observing what our friends at Próspera and Trey are doing there. But it does seem there’s an appetite. It’s a bigger lift than what I’m trying to do, but it could also come together well. As you can imagine, Texas already has Starbase, and there are a couple of projects there and in some other states. Even California has Esmeralda and California Forever. So there does seem to me an appetite there in the United States, but it’s also very high variance. There’s a lot of geopolitical risk. When something like Iran, or another China, dominates the headlines, these things can quickly fall by the wayside. So the United States is generally very high variance, for positive and negative. But the positive stuff then reverberates to the entire world. If the United States does it, then others can adopt it. And then for Próspera, I think there’s also a lot of variance in what they’re doing from now. Now we’ve survived the big risk, the government shutting us down. I think we’ve talked about that on the podcast repeatedly, how impactful that can be. But now the challenge is to make it work operationally. And I do see my role in the tech governance hub side. But they’ve got to figure out what to focus on. And, if I may be a bit critical, I think they need to really focus on one thing. You may read the article by Thomas Pueyo, who met us in Próspera at the Liberty Acceleration Summit recently. That’s one really key point he drove home. Guys, focus on one thing. And it might be too early for the expansion. Even having Bay District and Pristine may be too much, and now the Honduran politicians want the Satuyé port, which I think each on their own can make sense, but doing all three at the same time, plus the US acceleration zones or other zones in Latin America, might be a bit too much. With the Bay District and the governance sites, that’s where we have the biotech and the crypto part, that’s contained there and where the regulations are valuable. And now Pristine is tourism, maybe the family-friendliness. Do you need the advanced regulatory framework for it? I don’t know. And then the manufacturing and logistics side will be a completely different kind of operation than what we’ve been doing so far. So I think the biggest challenge Próspera now has is that they really need to be an operationally successful company that can scale. The most important thing is that, and I’m not part of the Próspera leadership, but I consider myself a key part of what I’m trying to see work, they make the right decisions, focusing on the right things, attracting funding for it. And hopefully, as we go back at a future Liberty Acceleration Summit, or free cities conferences like the one coming up in September, we can have very concrete progress to point at each time. And the other thing that’s also very important is that Honduras continues with the zones, whether they call them ZEDEs, whether there’s a rebrand, or they just continue with the brand. That is ultimately our thesis, that competition leads to better outcomes. Right now we have Próspera, we have Ciudad Morazán and Massimo, we have Orquídea, they’re a bit more quiet. But before the government came in, there were 27 applications for ZEDEs. And this shows how much demand there is from industry and from privates to make it work. And that would be, I think, the ultimate proof and the ultimate governance innovation. If we do this, we can turn Honduras into Switzerland or Dubai, or even, not all the way there, but at least into a middle-income or more developed country. And that, I think, would be the ultimate catalyst for our space. So here’s the framework, we know how it works, we know about the legal protections, we know it can survive when there’s a future government that doesn’t like it. So we now have some best practice and some experience. And, again plugging in Thomas Pueyo’s “Charter Territories” article, then we need to start experimenting. He had multiple, here’s one article of like 20 ideas for new charter cities and what to focus on.
Timothy Allen: That’s what I was going to say. When you say focus, do you think going forwards, or at least in the future, a good idea would be to have, say, for example, Próspera would be the biotech hub. Another one, one new one, would be focused on something completely different. I don’t know, AI, say, drone technology. Is that what you mean by focus?
Niklas Anzinger: Exactly. I think Próspera’s strength is also its weakness. The strength, and I appreciate it for the strength, that’s why I’m there, is that it’s just so encompassing, so full-scale. Here’s a fundamentally different full-stack governance system based on the first principles, many of which we care about. But the weakness of this is, okay, what specifically do we focus on to grow as a business? So what Próspera did is it really pushed the envelope, this is all possible. Now we have a template that increases the surface area for specific things we can do with it. But then, again, we need to succeed with very specific things. So some zones might be tailored for the residential part, like Massimo and Morazán have proved, and they’re doing really well with it. Others for the biotech, others for the drones, others for manufacturing, others for AI data centres, and others. Ultimately we need to develop products for people that they want to buy, not just be there and have the right philosophical principles.
Timothy Allen: I was chatting to Patri at your event. I think Alpha City have got a similar idea, is that right? They’re creating cities with a different business intention, which is obviously the best way to start a new city anyway, to have a business idea first. I think the regulatory stuff, the ZEDE framework, has to exist. But really, I think I understand what you mean now. Próspera started with the idea that, let’s push the ZEDE boundary, because it was all a frontier and an experimentation. But now going forwards, people should be thinking, right, with this framework, what should we say is our business model? Is that what you mean?
Niklas Anzinger: Exactly. That’s a great insight, actually. I don’t think I’ve ever heard anyone talk about it in those terms before, frontier. I think Massimo has talked about it in these ways. He’s been saying, hey, the point of Morazán is not that we’re all libertarians who agree on everything and have constant debates all the time. It’s that you have a functioning product for people. And, hey, I’m looking at a market that needs two things. One is an affordable roof over their head, and security. And that’s what I’m delivering to them, based on principles that I think make this work, which are based on libertarian ideas. But this is a business approach, delivering a product for people. The libertarianism, the principles, are the back end, but not the front end. The front end is, most people don’t think about these things all the time, but they shouldn’t. It should benefit them, they should get value out of it, and they should enjoy the fruits and the products of that better back end.
Timothy Allen: I suppose when I think of Próspera, Próspera’s business model was the governance itself. And in that sense, it served an incredibly important purpose, as you say, in proving the model, because someone had to prove the model. And also Próspera, don’t forget, at least, Próspera put ideas out. Bring us your ideas. Here’s the governance model, here’s the way it operates, now bring your ideas. And that’s worked, because you found yourself there.
Niklas Anzinger: It worked for me, yeah.
Timothy Allen: Well, exactly. But it’s also proven that it works for you. And now someone else doing it again needs to already have that idea. Maybe not biotech, because Próspera could become the biotech hub, we don’t know that for sure. I’d say it’s quite likely, because you’re the biggest industry there. That’s fair to say, isn’t it?
Niklas Anzinger: Yeah.
Timothy Allen: Well, put it this way, Niklas. Having spoken to a lot of people in Próspera now, they all look at what you’re doing and see it as a very important part of what’s happening in Próspera. And I didn’t hear that about anything else, other than people working for Próspera themselves. So, I’m not trying to flatter you necessarily, I’m just showing that Próspera’s model is, we’re creating this space, now it can be populated by anyone who wants to. Bring us your idea, and if it’s legal, you can do it here, which is what Gabe told me. I love that. If it’s legal, you can do it here. You actually took the call to arms, came in, and created something. And anyone could have done that, really. And I think yours is the biggest in scale. Plus you’ve also been the one who worked out the model in real time, i.e., you realised you needed to do events. And here’s how I see it. This is why, having lived there for a month, the whole medical tourism thing is so obvious to me now. Because people come to your events, and the last one that I went to was very well attended, with lots of really important people there. That’s what brought them into the ecosystem. They just happened to be all biotech, well, not necessarily all biotech, but doing it from the biotech angle. Doing it from the biotech angle means it’s very easy to implement that business model. Okay, we’ve got a place we can do trials, we’ve got the infrastructure, say a couple of million dollars’ worth of stuff, we’ve got accommodation, we’ve got the regulatory environment. It’s a no-brainer. We’ve even got nice beaches, and a yoga studio if you want, and a nice sunset every evening. That seems like the perfect ingredients for biotech retreats, or come and get your peptides or whatever. So in a sense, I think you’ve been an important part of coming up with the idea that that’s actually what you need to do. Because I don’t think anyone started Próspera necessarily thinking about a specific industry. I think the most important part of starting Próspera was the ZEDE framework, right?
Niklas Anzinger: Yeah. I just took the startup approach. As a startup, you need to find product-market fit. Lots of startups make the mistake, people are very technical and very in love with this new idea for their blockchain incentive design or something like that, but then the question is, do people want it? Is that something people want to buy from you at scale? And you need to test that. You don’t know it. People are way too in love with their own ideas, or their own vision of the world. So you need to constantly put yourself out there and get real feedback from real people who could be customers. And basically, when I arrived in Próspera, having done startups before, that’s the approach I took. All right, here are three or four different hypotheses, let’s put it out there in front of people and see which one works. We also looked at crypto. We also looked at insurance, drone and hardware stuff, education even. And it very clearly turned out that healthcare and biomedical is resonating the most, and it makes the most sense to people. We get people to come and visit all these conferences, some of them bringing their businesses, the longevity-themed pop-up city and all of that. That was ultimately the market signal. And that requires constant effort to continue. Because in the beginning, in startups, you have the technology adoption lifecycle. In the beginning you have the innovators, and then you have the early adopters, the early majority, the late majority, then the laggards. With anything new or fundamentally different, nobody’s going to like it in the beginning, because otherwise it would already be done. Most people are in the early majority or late majority, so most people are not seeing the value in what you’re doing. You might not even have the value yet. So the way innovation starts, and this is pretty well documented also by people like Matt Ridley, is with something very small, a kernel of something that can make things a lot better if it was at scale or in a bigger market, but in the moment actually adds value to a small group of people. Like how Apple started with hardware hobbyists that could tinker and put stuff together, or Linux with open source, build it on your own. In the beginning, these are the innovators, the ones that have some inherent or ideological value from it. And then the early adopters, and that’s where we’re at right now, they get substantially high value from this compared to the alternative. That’s where we found the biotech. And now we need to, there’s a famous book about it, cross the chasm. And crossing the chasm is scaling this early traction into a bigger market. It’s actually the most difficult part. Because we know we have good proof points on some biotechs now, but now we need to put the medical infrastructure there, build the clinics and the guardrails for all the clinical trials, the clinics that administer these treatments to people, all the real estate, and things like that. So that’s the phase we’re in right now.
Timothy Allen: When I think about the whole ecosystem now, you have two ways of doing it, which has already shown itself in the ZEDEs anyway. You build for locals, like Massimo did, or you build for investment from outside, in which case you need to be very specific about what you’re doing. That seems to be the kind of 2026 model. Is that fair?
Niklas Anzinger: I think these are the two right models to think about things. Massimo has this profit-first approach, which I honestly think is genius. I admire that so much. He has this complete aversion to spending money that you don’t make back. He hates venture capital. It’s absolutely anathema to him. And he’s proven right. He’s a super successful businessman with this approach, profit first, which I really, really admire. In our case in Próspera, the other side is the venture capital model. You’re taking very high-risk, high-return bets. Most of these things are not going to work out and you lose money, but one of them works really big, and the one that works really big returns all the other ones that didn’t work out. So these are the two different approaches. And I would not say one is inherently better than the other. My question is, what’s more scalable for more people to start? In some way, Massimo has an advantage and a disadvantage. The advantage is, obviously anyone can start something without funding. But the disadvantage is, not everyone is Massimo, and has that credibility and training and business acumen that he has to make these things work. But it could ultimately scale. If he succeeds, it will be a lot easier and more transparent for others to see how he did it, and then you don’t need to be as accomplished or experienced to do it. And the same with the venture capital model. The advantage is, there’s funding for more people with more crazy ideas. But the disadvantage is, it will take, we’re still talking about all sorts of different ways and approaches, and there’s not one template yet that works, and we don’t know if there will be one. Versus Massimo is proven, it’s already profitable. Versus Próspera, or Infinita, or the biotech case, isn’t yet. We have very strong proof points to eventually get there, but it’s not there yet.
Timothy Allen: It is interesting the way Massimo has done it. I know what you mean about highly respecting his ideology, especially because he’s even more resolute about it. The fact that he talks about it in terms of making profit out of essentially poorer people than the venture capitalists is a beautiful thing to say, because he has no problem admitting things like that, because it’s something that’s important to him. The profit must exist. Even though, when you look at his model, the people living there live a higher standard of living at a lower cost, and he’s making money, and he continues because he’s making money. It’s a beautiful model, and it goes against so many things that people intuitively believe. But it proves the model, and it proves that, like you say, currently it’s the one that genuinely works. I mean, I’d say the Próspera model works because, well, I suppose, making money, I don’t know, probably not, I don’t know. But yeah, it’s amazing.
Niklas Anzinger: It has advantages and disadvantages. The one thing I’d say in favour of Próspera’s model is, we got funded to take this risk. The government wants to shut us down. This is normal risk for a startup. Versus in Massimo’s model, it’s not part of his ethos to spend money to lobby for it and defend it. So I think it’s in that sense more vulnerable to the political pressure. Versus the Próspera model is a bit more agentic, we’re creating the political conditions, or taking a risk on that coming through or not coming through. Versus, you know, Morazán, we can only do if we’re lucky that we live in the country where others are doing that kind of lift. So I’m not saying that as a criticism, maybe Massimo is proven right and it’s the right model to achieve scale. But we also need to recognise the efforts, and to some degree that was Octavio Sánchez and Carlos Pineda and the Honduran framers and pioneers, but then also Próspera in defending it, using the time and creating the attention and the lobbying power and everything to have it stay in place after.
Timothy Allen: They’re both relevant, I think, is what you’re saying. And not in a diplomatic way, I think it’s genuinely true, having watched over the years. I’ve heard people talk about what Massimo’s doing, and what happened during this last six-to-twelve, two-year period, when there’s been a lot of uncertainty. And I think every single part of the ZEDE framework, the group of ZEDEs, they played a specific and important part. And I think actually it’s got everyone to this point now, which I find super exciting. Isn’t it amazing that there are these three typical sectors of the economy, and each of the three cities is one of them?
Niklas Anzinger: Yes.
Timothy Allen: Orquídea is agriculture, Ciudad Morazán is manufacturing, and Próspera is knowledge work. These are the three sectors of the economy. Do you happen to know why? Was it just pure luck that only those three managed to get ZEDE status, and the other 27 didn’t? Was that just a timing thing?
Niklas Anzinger: I think it was purely a timing thing. What I do know is, it took a very long time for the first ones to even come or start. The framework was adopted in like 2013, and then I think the first approval was granted in 2017 or 18. And much of this was that the bureaucratic process was not clear, and things like that. I’m not sure what happened after, and what caused all the other applications, and what they were for. I only heard that from anecdotal hearsay, that these 27 others were out there. But I think there’s just something to these things where in the beginning you’re banging your head against the wall, drilling for something, and nothing is happening, and you’re constantly questioning whether this is what you should be doing, because you don’t see the progress. But at some point you hit something, and there’s a fountain of oil or something, and then the dams break, and others imitate it. And it becomes a parallel history with Bitcoin, with crypto as well, and many others.
Timothy Allen: Well, anyway, look, it’s an exciting time to be doing, well, I was going to say what you’re doing really, because I feel like I’m observing it. Sometimes I feel like I really wish I was doing something, but it is an important part of what’s going on as well. Anyway, thanks for having me in this gorgeous penthouse that you’re borrowing. I won’t say that it’s yours. And good luck going forwards, both with the bill, obviously, is it a bill?
Niklas Anzinger: Yeah.
Timothy Allen: With the bill, and with what’s happening in Próspera. Do you see yourself focusing more or less on one or the other?
Niklas Anzinger: In the more immediate future, the next two years, my stronger commercial focus will be on the United States. I need that to succeed for our commercial model to work. But I’ll still be doing the events, the Liberty Acceleration Summit, these kinds of things in Próspera. I’ll still be doing some things to advance ways in which we can build out the medical infrastructure, or build a phase one niche. I do rely a bit on others coming through to help me with these plans in Próspera. I’ve built a very good team there, and so that will stay in place. And I think if I’m successful with the US efforts, then I’ll have many more resources, capital and credibility, to further that biotech build-out.
Timothy Allen: Because Infinita, in a way, is also an events business, right? Is that fair to say?
Niklas Anzinger: Yeah, that’s kind of how we started.
Timothy Allen: But that’s not the long-term strategy? Or it would just be a small part of it?
Niklas Anzinger: The first-principles view was simply, all right, we need to get more people here, and we need to find the growth industry. Okay, that’s biotech. How do we get these people here? Well, people are asking all the time, when is something happening? So you need to create these bundled entry points, and then I hope it sticks for some of them, and some of them will stay and build businesses. So it’s like a funnel. Again, plugging in Thomas Pueyo, he had just “funnel,” actually very explicitly. So events are a pragmatic choice as a funnel, and then I hope it sticks, because if there are no people or businesses, then nothing else will work. And that’s where we are. I think it’s still the funnel. For Próspera, it’s doing more events. There are other layer twos, like the Bitcoin district and the nomads, that are doing some of their events, that will also be supporting the free cities conference, doing events. We’re actually, with Infinita, looking to supplement some of that, because we have a lot of infrastructure to do events. My team is very experienced now, we have the dome. So we’re actually looking, because Massimo-style, we don’t want to lose money with our event preparation, and we’re a bit more liberated because we don’t need to make millions within a couple of years like the VC case, because that’s the US side. So we’re actually looking to work with more third-party event organisers that have their own audience, like the Free Cities and others, and also from the longevity space. We’ll provide some of that infrastructure and logistics to help them do a good job. So we do continue in that business to some degree. Our goal is just not to lose money with it in Próspera, but we’ll continue doing those events.
Timothy Allen: Better plug the Free Cities Conference then, coming up in the future. First time we’ve… it’ll be the biggest event Próspera’s ever held, I would imagine, is it?
Niklas Anzinger: Yeah, probably.
Timothy Allen: I know you guys are capable of bringing that audience. How many people came to the Acceleration Summit?
Niklas Anzinger: I think in total we had about 150.
Timothy Allen: Oh yeah, we’ll get more than that, hopefully. Anyway, can’t wait for that. I’m already missing Próspera, having just left three days ago. And as I’ve said to many people, it’s now a yearly part of my schedule. I’m going to be working out of Próspera for at least one month each year, because it was so exhilarating being there. And do March.
Niklas Anzinger: Well, I think, because we want to do the Liberty Acceleration Summit again in March, and also the Infinite Games. Mostly over one month. And I also want to do that month because my birthday is on March 14. And I’m an extrovert, I like to have lots of people at my birthday. We do board games for the entire day, and we sing karaoke.
Timothy Allen: Okay, March it is then. But the point is to use an event that’s happening as the pivot point around it. And, as I say to anyone listening to this, I highly advise, if you’re in this business or in this space, or even adjacent, or just curious, it’s a brilliant idea to come and base your stay long term. I think this is the phase Próspera’s going through for visitors like myself. You remember, we were talking about Zuzalu earlier, and I went to Zuzalu as well, and I looked at that and thought, this is never going to work. It’s actually working in Próspera now. And the reason I don’t think Zuzalu was working was because everyone came there and then left, and the place itself, there was no long term. Próspera is making me want to come for a month and stay, and go, and come back, because Próspera doesn’t leave. And that’s another thing Próspera is good at, giving you these working examples of things.
Niklas Anzinger: Yeah. And going back to the arguments we had on our last episode here, with Gonçalo. He was pointing out, and everyone was discarding the nomads, oh, they’re not permanent or whatever, don’t waste your time with that. But he was pointing out, guys, there’s a funnel. The average nomad is around for two years and then they stay wherever they like the best. And then I was thinking, huh, that’s what I did. Me and my wife, we were nomads for two years, and then, this is the place we like. And actually now many of the people who are also staying, including several couples, have the same story. They’ve been nomads for two years, and it’s like, okay, this is where we’re most values-aligned, we move here. And also, nomads are now legitimately building businesses there. Nomad village, nomad retreats.
Timothy Allen: I agree. But like I say, this is all a learning curve. I’ve had some opinions that a year ago have completely flipped 180 degrees.
Niklas Anzinger: That’s cool.
Timothy Allen: That’s why I like having these conversations. Anyway, Niklas, thanks for talking. And good luck with everything. And I’ll see you in Próspera for our event coming up.
Niklas Anzinger: Thanks for having me on again. That was fun.
Notes:
This transcript was reconstructed from the episode’s raw machine timestamps. Speaker labels, timestamps, repeated fillers, obvious false starts and ASR line breaks were removed or tidied for readability. The meaning, voice, swearing and main order of the conversation were preserved.
The Veritas Villages sponsor read and Timothy’s solo episode introduction were omitted from the conversation transcript.
Proper nouns were checked against web sources. The following ASR errors were corrected: “Nicholas Anzinger” to Niklas Anzinger; “Patrick Friedman” to Patri Friedman (Timothy later refers to him as “Patri”); “Minisocle / mini circle” to Minicircle; “Demis has” to Demis Hassabis; “Chachiput / ChedGPT” to ChatGPT; “tzibrandi / Sitsi Brandy” to Sid Sijbrandij (GitLab founder); “Marty McCarty” to Marty Makary (FDA); “coal memo” to Cole Memo; “Cremeo / Cremio” to Cremieux; “Tomas Poello / Thomas Pollo” to Thomas Pueyo (his article series is “Charter Territories” on the “Uncharted Territories” Substack); “Gonjalo” to Gonçalo (Gonçalo Hall); “Carlo Pineda” to Carlos Pineda; “Okidia / Orkidea” to Orquídea; “cedar mozano / Zidane Morazana” to Ciudad Morazán; “Massimo” surname is Mazzone; the Substack is Infinita City Times; the company Infinita City was previously called Vitalia.
Two proper nouns could not be confirmed and should be checked against the audio before publication. The deep-water port Niklas refers to (rendered by the ASR as “Satu Yiport / statuier port”) is given here as the Satuyé port, but the exact name and spelling are uncertain. The New Hampshire church lobbyist is named only as Ian in the audio, with no surname given.
The Próspera district names (“Bay District,” “Pristine”) are transcribed phonetically from the audio and should be verified against Próspera’s own materials, as should “Trey,” the name of the person Niklas mentions working on US acceleration zones.
No external fact-checking has been applied to factual claims made by either speaker.
