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    "text": " Hello, everyone. Thanks to Nina and everyone at Biohack Village for having me. My name is Anthony DeFranco, and I'm one of the founders of the Open Insulin Project. And I'd like to tell you a little bit about the general problem that we're addressing and how we're approaching it, and how you all can maybe get involved if you're interested. So let me begin. The basic fact is that worldwide 50% of the people who need insulin to survive don't have access to it. And when we take that figure into account, and also look at the population of people worldwide with diabetes, and some bounds that we have on the death rate that's directly attributed to it, and we also look at the insulin access statistic here, and we put all of the information we have together to get a rough estimate of what the impact of this situation is, where, you know, fully half of people who need insulin to survive can't get it. A very rough order of magnitude estimate is that about 20 million people, you know, 10 to 20 million people a year are dying due to lack of access to insulin worldwide. And to put that in perspective, 12 million people per year was the rate that people were dying due to World War II from all causes, which was the deadliest conflict in history. So this situation where half of the people in the world lack access to insulin is really a crisis on a historic level, you know, it's something that it's hard to find anything that compares to this. However, unlike a war or, you know, a very kind of complex problem like that, the fundamental technical realities of making insulin and getting it to people are fairly simple. So we're going to look a little bit at why, despite that, there is a problem of this magnitude and how we can try to approach and how we are trying to approach it in the Open Insulin Project. So that's kind of the worldwide situation. Here in America, where the many people in the project are based, we know a little bit more. Now, the worldwide situation is largely due to, you know, supply chain issues and the kind of geopolitics around different countries' access to markets. So those issues don't really exist within the U.S. The U.S. has plenty of infrastructure to get insulin to people. You know, the technology to produce is well established here. So it's a little even more puzzling to note that there's still a significant problem in the U.S. So we want to look a little bit at that. So here are some figures on just the prevalence of diabetes in the U.S. You know, almost half of people have either diabetes or a risk of developing it in a fairly short term. Just diagnosed diabetes alone is a over $300 billion a year cost for everyone. Having diabetes significantly increases overall health care costs. And there's a bit more detail on how, you know, diabetes is contributing to the global death rate. So this is another kind of data point, a little bit more specific about what we were talking about earlier, where, you know, we can actually say that the deaths are directly attributable to diabetes, also quite significant. So, you know, why is this eminently treatable disease still causing so many deaths? And why is lack of treatment even in an industrialized, advanced technologically and infrastructurally country like the U.S., you know, why is this disease still causing so much harm and so much clearly preventable death? Well, one of the factors is that the, you know, supply of insulin, even though it's very easy to empirically speaking, just has a lot of trouble reaching the people who need it. And the first step in that process is the manufacture of it. And globally, three manufacturers control almost the entire supply of insulin. And that is true in the U.S. as well as true everywhere. So, you know, already we're seeing that at the very first step in the supply, there is a kind of a restriction that may prove significant. And as a result, the list prices have risen on a, you know, roughly exponential trajectory. So this has been part of a pattern of all of the major manufacturers raising their prices at about the same time by about the same increment for decades. And, you know, this has resulted in the list price becoming unaffordable for many people. And because of the complexities in the U.S., for instance, you know, the U.S. kind of has a strange healthcare system where, you know, some aspects of the prices are subsidized in various ways by different parties who negotiate amongst themselves. You know, there's a very complex system involving insurers and manufacturers and pharmacy benefits managers and pharmacies. And there's a set of complex and mostly secret agreements among them as to, you know, what people are actually paying. But anyone who doesn't have insurance, which, you know, is tied to having a job largely in the U.S., you know, they're likely to have to pay that list price and to be unable to afford it. So this is, you know, implicated in what the problem may be as we come to understand it more. And then the result of that has been that one in four people with diabetes in the U.S. have reported rationing their insulin and not taking as much insulin as you need puts you immediately a much greater risk of the complications of diabetes. In the short term, you can develop diabetic ketoacidosis, which is potentially deadly within hours or days. And in the longer term, if you're not taking as much insulin as you need, you can develop the longer term complications of diabetes, which are many of which are listed here, you know, blindness, cardiovascular disease, and amputations, for example. So it's a rather grim situation, but it's kind of difficult to understand why this would be the case since insulin in some form or another has been produced as a medicine for almost a century. And even the state-of-the-art forms of insulin, you know, the most modern forms that we have are largely off patent. So why is it that there's still this access crisis? Why are only, you know, three manufacturers still controlling almost the entire market and able to price the insulin out of reach of many people? So there have been some investigations into this where people have looked at the price increase patterns and are, you know, finding evidence that there may be collusion. So some of these cases are still in progress here. But, you know, the fundamental reality is that, you know, whether or not there is explicit collusion here, there is this pattern of price increases and it has become unaffordable. And at the technical level, there's really not that much of a challenge to making insulin. So that's what we're focusing on now in our project is how to make insulin. So this is part of a broader problem in how health care and the economy around medicine is, you know, thought to what the kind of dominant philosophy and how to manage it is. There was a kind of economic theory that gained a lot of credibility in policy circles in the mid-20th century that said that, you know, making medicine is kind of different from other economic activities in that subsidies are needed to do all of the research involved and that a monopoly is an expedient form of subsidy. So that, you know, that would be a sensible policy to tolerate and even encourage monopolies around medicine. And these claims actually collapse fairly quickly under scrutiny. You know, most of the R&D involved in making medicines is already done with public money and universities and the companies themselves spend much more of their own budgets on other things like marketing and executive compensation than they do on R&D. Also, this belief that monopolies are essentially harmless has been, you know, roundly debunked since then. But nonetheless, that's the system that we've inherited. So the result of this is that, you know, we've had this complex system of agreements grow up around it, you know, with all those other, you know, parties like pharmacy benefits managers that we'll look a little bit more at later in the presentation. And, you know, they kind of partition up the market and it's very difficult to do anything outside of one of these kind of proprietary partitions, or to go between them, you know, even to the point that some people who are allergic or don't tolerate one brand of insulin are unable to get it covered by their insurance because the insurance only covers one brand at the preferred tier. So even when there's clear medical necessity, it still doesn't matter in this system. So, you know, it's not much of an economy in the end, because it's so thoroughly, you know, shot through with monopolies and monopolistic arrangements. And we see, you know, the problems that are typically associated with this. And, you know, one of the most notable is pricing the poor out of the market, but also, you know, you can see that progress that would threaten an existing line of business is discouraged. And, you know, one example of that was that, you know, an analyst here at Goldman Sachs is asking, is curing patients a sustainable business model? You know, the answer in an economy where competition is essentially impossible is no, because, you know, the profits are already being maximized by chronically treating things, and so curing them doesn't make any sense if people don't have any alternative. And so that's kind of the unfortunate result of this. And this is something that, you know, many have researched this. One of my favorite theorists of this is Mr. Schmitz at Minneapolis Fed. So, you know, he has looked at how monopolies actually do cause the harms that we've discussed. And in the case of medicine, the harms aren't just economic, they are directly related to you know, lost lives and, you know, really tragic and tragically avoidable health consequences for people. So one of the things that is noted in general that we've seen in insulin is, in the case of insulin in particular, is that, you know, we have seen people, you know, turning to crowdfunding because the cost of insulin when they lose health insurance or health coverage of some sort is, you know, more than many people make in a month. It could be many thousands of dollars a month. So this is really a quite egregious example of how, you know, people get priced out of the market fairly quickly. And, you know, it's not just a subtle effect, it is a really, you know, a very large difference in prices that people have to bear to the point where, you know, it'll be exceed everything else that they're paying for in life by quite a bit. So just to make that a little bit more concrete, the cost of manufacture of insulin is about $5 per vial, but the list prices have risen to the point where they're around $300 to $600 per vial in some cases. And, you know, these conditions have persisted for decades, and they've only gotten worse. There hasn't been any successful pushback against them yet. So what we are trying to do is kind of invert everything that we've observed in our project. So instead of relying on proprietary development and mechanisms of monopoly, we are sharing everything that we develop in a commons, and we are looking to produce insulin in low overhead distributed networks of small scale manufacturing sites. And instead of having this really strong conflict of interest between the producers who are motivated by profits and to deliver profits to investors, instead we're looking to have the people who use the insulin actually be directly involved in the governance of the organizations that are making the insulin so that they'll be able to make decisions as to how everything is managed in the interests of themselves and each other and the people using the insulin. And a helpful side effect of this will hopefully be that we'll be able to be a lot more nimble and actually make a lot more improvements and not be incentivized to keep old things around just because they're already profitable and actually move things forward and hopefully make progress And in part, we're inspired by other successes in the diabetes community. So although we're the first effort I know of to make insulin itself open source, for about 10 years now, people have been working on artificial pancreas systems, which is essentially a software algorithm that controls an insulin pump to determine the timing and the amount of the dose of insulin automatically, usually based on feedback from a continuous glucose monitor. And this is something that was already possible with technology from the 80s, but the manufacturers just never seemed to be able to bring it to market for whatever reason. But once the technology to do this became more widespread, you know, once embedded computers became cheaper and easier to work with, and knowledge of software and how to write these kinds of algorithms became more widespread, individual diabetics and small groups were able to just pick up this work and bring it to completion within the space of a few years. For almost a decade, there have been DIY artificial pancreas systems that, you know, many people have been relying on and trusting with their own lives and the lives of their children, and, you know, they're working very well. And this was done without any, you know, large R&D budgets or institutional overhead. It was just people collaborating in these horizontal networks to solve their own problems and each other's problems. So we're working on enabling this for the insulin itself so that we can kind of complete the open source economy for treating diabetes. And it turns out that the same trends that made the DIY artificial pancreas systems possible are also going to help us. The, you know, more pervasive and cheap computing technology is going to play some role in letting us automate different aspects of the production and purification, and it also just makes it easier for us to collaborate with each other. And so we're seeing signs that we can reproduce this kind of success. And, you know, the result of that will be ideally to move this activity from these, you know, proprietary fiefdoms and into the commons. And this is something that is good for people. It's very good for business as well, you know, judging by how it's gone with, you know, open source software businesses. But, you know, major difference is that it actually respects and promotes competition and innovation instead of sabotaging it and, you know, trying to go on needlessly suffering and dying for no reason. So that's our goal. And we're working on developing both the technology and the organizational forms that are associated with this to, you know, create a comprehensive alternative for the status quo. And we're trying to prioritize the people who currently lack insulin and need it most in how we develop things so that we can most directly address the most urgent problems that people in society have. So this is a closer look at the existing supply chain just so that we can contrast it with what we're setting up. So I mentioned earlier that there are, you know, these multiple middlemen who operate in these complex networks in between the manufacturer and the consumer. And so I won't even really try to go through this in any detail, but you can see that there are, you know, quite a few complex patterns of interrelationship among them. And most of these are done in secret, so there's no transparency into how this works in any detail. And, you know, it involves kickbacks being passed up and down the chain and, you know, all kinds of things that just are in themselves a great challenge to making any sense of things. And so when the system produces the nonsensical result of, you know, denying people insulin that they need to survive that costs very little to make, you know, this is kind of how that is able to grow and that kind of problem can grow and sustain itself in this environment of artificial complexity. So we're going to address that by making things as simple and as direct as possible. So right now we're working in our community labs to develop the microbes and the technology, and then we're going to publish the information associated with them. And then using that public information about how the technology works, we're looking at setting up a system of cooperatives where the insulin users can participate directly in the ownership and the governance of those organizations. And we may also be partnering with hospitals and local pharmacies that already do work that is similar in some technical aspects to this, and they already have, you know, people who would need the insulin, they have relationships with them, and we may also be looking at collaborating with local and state governments. And, you know, aside from these fairly small and simple low overhead organizations, it's going to be as direct to the users as possible. So a closer look at some of the technical work that we're doing. And this is, you know, this is just a general look at how protein production purification works and how this applies to insulin. So right now we've designed some genetic modifications to some microbes. We have actually three systems we're working on now, this is two of them, but we have two yeast-based systems for producing insulin glycogene, which is a long-acting insulin, and one E. coli-based for producing LISPR, which is a rapid-acting insulin. And so we have ongoing work with the microbe engineering. Some of it has produced some small yields already, but we're working on getting the production to be reliable in the practical level. And then once the microbes are engineered, we're going to focus on a small-scale purification system, initially using proprietary equipment, but we're also working on making open-source equipment for that. And we've also started to look at the verification and quality assurance questions of making that product suitable for use as a medicine. And so once we've got all of these aspects in place, we've got all the technical problems for making insulin in a small-scale setting solved. So here's a look at a kind of demonstration version of a bioreactor. So it is essentially just a bit of plumbing, and aside from having to keep it sterile, there isn't anything terribly technically complex about it. You're going to have some, you know, some pumps and some valves and temperature sensors, pH sensors, and that sort of thing. And then for the purification, you're going to have, you know, perhaps a column, which is a, you know, just a tube with certain ports filled with some materials that may be a little bit costly, but for the most part, this is something that, you know, you can, as these people have for this demonstration unit, they fit everything you need to do it onto a tabletop. So, you know, we can work in a similar envelope. You know, the corner of a room could be enough to produce insulin for you know, a small city if we are, you know, running at a reasonable efficiency. And as a result, we can bring the cost of insulin back down to what the cost of production already is. So our own projections for what our cost of production be are in line with what they are for the large-scale production that dominates right now. So based on our preliminary model, we could be providing this to people for seven dollars a vial, which is, you know, very close to the three to five dollars a vial that it's usually produced for. So, you know, we're seeing that there isn't really any economy of scale here and that, for the limited supply that we see right now. So as I mentioned, we are still working on the microbe engineering, but we have started to work on the open hardware as well. So we're making progress on the technical aspects of this process and we're looking forward to reaching some of the milestones on that fairly soon. And we've, you know, begun working not just on the open hardware but also on some of the regulatory and organizational research to make that hypothetical system of cooperatively organized production a reality. So, that's going to involve some outside-of-the-box thinking and we're, you know, getting into looking at a lot of interesting precedents like ideas from personalized medicine and other forms of cooperative medicine and health care and state-level frameworks for things like direct public offerings, you know, financial mechanisms, and so it's really taking us on both a deep and a broad look at a lot of very promising alternative ways of doing things that we hope will apply not just to insulin but to perhaps medicine in general and business in general in the near future as well. So here's a closer look at the bioreactor design that we have just recently completed the first look at. So, as you can see, the bioreactor, when we break it down to the specifics, as I was saying before, it's kind of some pumps and some sensors and, you know, an air pump and some heating pads and this is a design that was based on one that another fellow in the community, Sebastian Kosioba, was working on. So he was kind enough to show us around his design and we have a group of interns that's working on this right now. So this was made by Paige Hanoka and it took her just a couple of weeks to come up with this and the bill of materials for this comes out to $115.80. So this would have a capacity of a few liters and a capacity of a few liters if you run it fairly close to continuously that can supply insulin for a few thousand people. So, you know, this is still leaving out the purification and the QA aspects but, you know, those don't add an order of magnitude more cost to this. So you can see that the, you know, capital requirements for doing this are negligible. So we've talked a bit about how we're looking to organize the production ultimately but we are also organizing the R&D work that we're doing right now in a similar way. So we're a fairly horizontal open source oriented organization. We're taking cues from other open source foundations that are stewards of different kinds of technology. So we have groups working on the wet lab R&D, the hardware supporting software for our organization, developing the business plans, doing the legal and policy research, and doing communications with our supporters and touching on fundraising as well. And here a few folks from the team, you know, we are a loosely organized network of volunteers so people kind of come in and out. We weren't able to list everyone but here are a few of the more regularly involved folks. You know, Jan is our chief scientist working on the microbe stuff and David and Max are also working on that here in our Oakland lab. Alex Hay recently developed an open source glucometer which we have a blog post up on our blog about which is very interesting. Nicole has been helping us with the legal work that we're doing. Yifei has helped with software. Louise is working on communications and fundraising with the interns. Jessica is also working on the microbe engineering in the wet lab and with an intern group as well. Remy has helped us with some collaborations and Kadi is actually one of our international collaborators in Senegal who is getting her lab set up now to join us and perhaps help us look at some new possibilities involving plant-based production. So, very interesting potential there. Within our group, we are fairly horizontal as I said. So, you know, we kind of go on the open source credo of, you know, loose consensus and working protocols we could say and just take on tasks on our initiative. For the most part, so we've had to collaborate remotely. So, you know, we're doing things in online meetings, which anyone is welcome to join. And, you know, if anyone is interested in that, you can go to our website, openinsulin.org. And we have some posts up there that will give you some contact information and information about the meetings. So, you know, with that, I'd be happy to hear from any of you if you're interested in learning more about what we're doing or, you know, helping with any aspect of this. And the more the merrier and the more people are helping out, the faster we're going to be able to solve this very urgent problem. So, it would be a pleasure to hear from you. And, again, thank you for having me here. And thanks to Nina and the Valhack Village folks."
}