Taboo Trades
Taboo Trades
Bonus Episode: NFTs for Biobanking with Marielle Gross & Brian Frye
Today, I'm joined by two fabulous guests: Marielle Gross, Assistant Professor of Obstetrics, Gynecology, and Reproductive Sciences at the University of Pittsburgh, and renaissance man, Brian Frye, the Spears-Gilbert Professor of Law at the University of Kentucky.
Marielle provides clinical care at UPMC Altoona and her research focuses on the application of technology and elimination of bias as a means of promoting evidence-basis, equity and efficiency in women’s healthcare. Today, we’re discussing heny, Inc., a start up that Marielle founded that utilizes NFTs to allow breast cancer patients to remain connected to their biopsy results. When patients participate in research studies, their names and identifying features are taken off of their samples – in other words, they are deidentified. What this means is that if researchers find medically relevant information, they can’t pass that on to the patient. Nor can patients share in any of the profits that research on their tissue might generate. As we discuss in this episode, Marielle was inspired by the infamous Henrietta Lacks case to create a non-fungible NFT-like token that allows breast cancer patients to track and learn about research on their donated tumor and tissues.
That’s where Brian Frye comes in: he teaches courses on patent and intellectural property law, and has published widely about NFTs. Many of his articles are linked in the show notes. Brian is also a filmmaker. He produced the documentary Our Nixon (2013), which was broadcast by CNN and opened theatrically nationwide. His short films and videos have shown in the 2002 Whitney Biennial, the New York Film Festival, and the San Francisco International Film Festival, among other venues, and are in the permanent collection of the Whitney Museum of American Art. If you don’t get enough of Brian in this episode, then make sure to listen to my earlier bonus episode: The Plagiarism Taboo with Brian Frye.
Further reading and listening:
Marielle S Gross, MD; Amelia J Hood, MA; Robert C Miller Jr, BA, Nonfungible Tokens as a Blockchain Solution to Ethical Challenges for the Secondary Use of Biospecimens: Viewpoint, JMIR Bioinform Biotech 2021;2(1):e29905) doi: 10.2196/29905; https://bioinform.jmir.org/2021/1/e29905
This Pitt professor’s startup applies NFTs to bioethics, Technical.ly, Sept. 13, 2022; https://technical.ly/startups/heny-nfts-bioethics-marielle-gross/
The Plagiarism Taboo with Brian Frye, https://www.buzzsprout.com/1227113/episodes/11050801
Frye, Brian L., NFTs & the Death of Art (April 19, 2021). Available at SSRN: https://ssrn.com/abstract=3829399 or http://dx.doi.org/10.2139/ssrn.3829399
Frye, Brian L., How to Sell NFTs Without Really Trying (September 25, 2021). 13 Harvard Journal of Sports and Entertainment Law 113 (2022), Available at SSRN: https://ssrn.com/abstract=3930430
Frye, Brian L., After Copyright: Pwning NFTs in a Clout Economy (November 25, 2021). 45 Colum. J.L.& Arts 341 (2022), Available at SSRN: https://ssrn.com/abstract=3971240 or http://dx.doi.org/10.2139/ssrn.3971240
Frye, Brian L., The Art of the Token (March 16, 2022). Stanford Journal of Blockchain Law & Policy, Available at SSRN: https://ssrn.com/abstract=4059574
Well, in a variety of contexts, de-identification or otherwise anonymous distance has been proven to associate with dehumanization and commodification of human beings. In fact, perhaps this is overly visceral, but in the anatomy lab, we cover the person's face to dissect them. Hey, hey, everybody. Welcome to the Taboo Trades Podcast, a show about stuff we aren't supposed to sell, but do anyway. I'm your host, Kim Kravick. I'm super excited today to welcome two fabulous guests, Marielle Gross, Assistant Professor of
SPEAKER_01:Obstetrics, Gynecology, and Reproductive Sciences at the University of Pittsburgh, and renaissance man Brian Fry, the Spears Gilbert Professor of Law at the University of Kentucky.
SPEAKER_03:Marielle provides clinical care at UPMC Altoona, and her research focuses on the application of technology
SPEAKER_01:and elimination of bias as a means of promoting evidence basis, equity, and efficiency in women's health care.
SPEAKER_03:Today, we're discussing Henny Inc., a startup that Marielle founded that utilizes NFTs to allow breast cancer patients to remain connected to their biopsy results. When patients participate in research studies, their names and identifying features are taken off of their samples. In other words, they are de-identified. What this means is that if researchers find medically relevant information, they can't pass that on to the patient,
SPEAKER_01:nor can patients share in any of the profits that research on their tissue might generate. As we discuss in this episode, Marielle was inspired by the infamous Henrietta Lacks case to create a non-fungible NFT-like token that allows breast cancer patients to track and learn about research on their donated
SPEAKER_03:tumor and tissues. That's where Brian Fry comes in. He teaches courses on patent and intellectual property law and has published Thank you so much
SPEAKER_01:for joining us.
SPEAKER_03:If you don't get enough of Brian in this episode,
SPEAKER_01:then make sure to listen to my earlier bonus episode, The Plagiarism Taboo with Brian Fry. Hey, Brian. Hi, how are you? How's it going? Good,
SPEAKER_02:good, good.
SPEAKER_01:How are you? Thanks for joining us.
SPEAKER_03:I'm great. So, Marielle, how do you want to proceed? So, Brian and I talked the other day, and we thought it might be most helpful... to have you just lay out in kind of layman's terms with follow-ups from us for to clarify where necessary first sort of what the problem is that you're seeking to solve and then second how this program solves it, right? How your NFT program solves it. Brian and I might argue with each other as we frequently do when we're podcasting.
SPEAKER_00:Yeah, exactly. And in particular, I'm really interested to know sort of how your pilot program works now and what you envision it sort of like developing into in the future. Because my understanding is it's still like, in development stages, I could be wrong, but that was my sense. And like, I'm really interested to see sort of where you see it going as it matures into a kind of a fully formed product.
SPEAKER_03:Yeah. Well, so I'm a bioethicist turned OBGYN physician turned technologist. And I really, my entire medical career was through the lens of bioethics. And structural injustice in particular. And that's what landed me in women's health because the intersectional nature of structural injustice as it applies to health and then just broader issues in society was so obvious. And in particular, I specialize in what I consider the ethics of evidence in health systems. And really thinking through what I call the health data supply chain, like soup to nuts, how the data is created, captured, stored, analyzed, shared. converted into policy or synthesized and then evidence-based practice. And what does that mean? And how is that impacting people on the basis of various properties and usually in ways that makes people who are underserved worse off. And so that was really my whole perspective and reason for going into women's health. And I went to Hopkins to learn about the idea from bioethics perspective that you know, we separated healthcare and research and that we treated them as ethically and then therefore legally and programmatically and enterprise lead as separate things. And the people at Hopkins were like, no, this is a system. And, you know, this idea, of course, fast forward to today of precision medicine is the ultimate intertwining of care and research and learning and implementation all as the plane is flying. And the plane is you. And there's only one of, it's the N of one, this new paradigm. In any event, I became fixated on this, the opportunity to learn from digital data in the 21st century of medicine where I grew up. And the mechanism by which we do that is through de-identification. And I had this realization that an entire system that learns by de-identifying does so in a way that's inherently structurally unjust because it means that the person doesn't benefit from or has no way to benefit from what you learned from them, even about them, and that it becomes an ultimate accelerant of disparities in healthcare, right? And the fact that I was, you know, a bioethicist training in OBGYN at Johns Hopkins left, you know, the prominent case of Henrietta Lacks looming large over the entire experience. And so the problem is that if you or your loved one donate your bio samples, your tissue for science today, you do not benefit from that research. You'd never find out what happened and you're not entitled to share in any of the profits. of your own bodily byproduct. You mentioned several times, there's no way for them to benefit. And I was going to get you to just elaborate a little bit on what the benefits are that you would like to see. You mentioned profits. So one then clearly is some sort of sharing in the financial upside of the value of their tissue. What other benefits? And I know you foresee more benefits than that. So can you just kind of lay them out for us? Yeah. So I think of them in three different categories. There's We talked about financial. The holy grail is the health benefits, right? The research we're doing on your tissue is relevant to your health. How could we ever deliver precision medicine if we don't have continuity of care for your data or your samples or what we learn from them? As physicians, we're constantly applying and trying to make decisions with patients based on imperfect information. And here, there's this whole category of cutting-edge science using that same person's literal body as its substrate, and we don't have access to that information. Take the example of metastatic breast cancer. There's 50 therapies that are FDA approved for metastatic breast cancer. You have metastatic breast cancer, you want to know which ones, they're not benign. They all have side effects, they're expensive, and it's like cutting a diamond. You don't get multiple chances to get it right. Sometimes you do, but with decreasing at opportunity cost of your life itself. And so the fact that that was the reason that really got me into this. And there's a third category, which is respect and acknowledgement and personal meaning. And that, you know, if you read the story of Henrietta Lacks, Deborah Lacks, that was really the key insight I took from it. And one of the key ones from her whole story was the thing she cared the most about was the recognition. And in a really non-trivial way, what self-knowledge of your own impact on science and your family's impact on science. And now that I'm doing all this deep work with cancer patients, the idea that you're suffering could benefit others or somehow not be a zero-sum game. When you're facing what I believe cancer is an existential crisis by definition.
SPEAKER_02:And
SPEAKER_03:so it's a whole category. It's like a category of invisible value that is largely left on the table in the enterprise of today and is universally relevant, whereas the health benefits are not always there. The respect can be.
SPEAKER_00:So I'm particularly interested in both the health benefits angle and the the respect angle. What I'd love to hear you talk a little bit about is those two categories in relation to the decision to de-identify in the first place. So why was de-identification adopted by medical researchers? And when they made that decision, at least as far as you know, were they weighing those questions about medical benefits and respect against the decision to de-identify and any benefits that might have or any you know positive consequences that might have flown uh flowed from that and i guess part of my question really is like especially when it comes to medical benefits i mean i i can't help but suspect that maybe like the science of medicine has changed in such a way that maybe that information is more valuable to patient care today than it might have been a long time ago
SPEAKER_03:the the risks and benefits are totally different um and i think although the respect has always been a part of it, the lack of a technological solution is relevant and the sort of general pace and potential of science and what's reasonable expectations are relevant, right? Even in the law, right? And so, you know, this was really the focus of my postdoc was on this idea of the ethics of de-identification. And the critical point is that it's not about privacy. It's about using the data and the sample. It's about extracting the value while mitigating the potential risk. And the way that the risks were seen were solely through the risks to a specific subset of privacy, right? Because you could be, you know, the picture of you nude or the way I like to think about it, like I could be standing with a bag over my head at an intersection naked and my privacy is being violated even if people don't identify me. So there's different kinds of privacy, right? But the privacy of attaching your name and your identity in a social and financial and clinical context with your sample, that kind of privacy. And it wasn't even, right, it was never even really about separating the ability of anybody else to know that it was you. Because in order to learn from the stuff, you have to know what happens to the person. to learn from the samples. You have to know what the clinical, what you learn. And when you grow a sample, right now we grow living models of patients' tumors in the lab. So this is the perfect example of the potential clinical benefit. The idea is we can do an experiment on your cancer with every drug that exists that could be used to treat it using AI and high throughput testing. And instead of right now, we're doing a clinical experiment based on static data and trying to make an informed decision in what basically is an experiment on your life. But we could be running that experiment on a model of you, and we should be. And in fact, that's the goal. The question is, how do we get that technology to scale? But in the meantime, the 200 patients that we're doing it for in our lab haven't benefited. And so the fact that that kind of information can be learned, and there's this great article I'll share with you all in Wired about it, I think it really helped make that.
SPEAKER_00:So if I understand correctly, then what you're saying is the costs to patient health of de-identification are higher now, significantly higher now than they were when de-identification was adopted. So it's like, maybe it's a moment to rethink how we, yeah.
SPEAKER_03:You know, I don't mean it to be punitive. We were so careful, of course, in our manuscripts and everything to not be like, dismissive of the fact that it's true, like on a population level, right? Like what you gain is the ability, you know, specifically, you gain the ability to, for research to proceed with less administrative burdens. Part of it's an artifact of like what, right, what IRBs have become, which I love, one of the oncologists I work with calls them a straitjacket, which is to say, you know, the least. And we can talk separately about my own dealings with the IRB for this project and what I can. That'd be interesting. Yeah. Samples in our system. But yeah, the point is, like, I think at the time, right, of Henrietta Lacks, which, by the way, it was like, oh, my God, the light bulb was like, Hila was our de-identification. Well, it was meant, it was perfectly illustrates the point that we want the people who knew, knew. Or they knew it was the woman with cervical cancer and this, that, the other. And it sort of nominally allowed for the upholding of privacy in the Hippocratic sense. But the thought of that research benefiting her clinically, I think, was arguably pretty minimal. Although not totally non-zero, right? Like, how did we get vaccines? Because of human experiments that benefited people because it was worth the risk. But so, but in general, I think it was very, it was reasonable to say that the chance that the science was not going to be clinically relevant was plausible, at least, and at least a certain category of what we call preclinical science. But what researchers tell us now is that, you know, a decade ago, even in their labs, they didn't find the research to be clinically relevant, or it was sort of, they could treat it as preclinical research. It wasn't clear, wasn't this, that, the other, but like one person said the other day, you know, when I started this project two years ago, it was preclinical research. Well, now a new drug came out and I have identified which of these patients are candidates for it because I'm studying the receptor that that new drug target. Well, now she is the burden of this information and knowledge of who might benefit, or at least, you know, reasonable knowledge that any of us, if it were us, if it were our mother, that we would want to know. And this was how the project really crystallized was around this, you know, me presenting about the theory of it and somebody, a researcher standing up and saying, yeah, you know, we find BRCA mutations in our tissue samples and we have no way to let the patient or their doctor know. And, and that is such a good example of like how you might be doing some testing on, on a patient sample and, With actionable clinical information, it's like not even questionable whether it's like actually well described clinically, there would be things that you would do differently for that person and their entire family. And yet we don't test every breast cancer patient today. We test less than half of them for BRCA because of the cost effectiveness and the insurance and everyone's a hot potato and everything. And I think from a legal perspective, that was one of the things that really aligned, right? Because there's ethical, legal, socioeconomic, and technological challenges here. And the Braca case is so profound and it's been carried forward to the Supreme Court before as an example of this unacceptable information asymmetry.
SPEAKER_00:So you talked about respect as well. I mean, I wonder for a lay person like myself, if you could talk a little bit about how the kind of medical establishment thinks about respect toward patients in relation to de-identification now, sort of what the kind of conventional wisdom or framing is and what you think is maybe could be improved or is not so great about that.
SPEAKER_03:Well, you look in a variety of contexts, de-identification or otherwise anonymous distance has been proven to associate with dehumanization and commodification of human beings. In fact, I mean, perhaps this is overly visceral, but in the anatomy lab, we cover the person's face to dissect them. And you do that because there's a visceral inhumanity of what we're doing. And not to say that there's never a good reason to distance yourself for scientific purpose, but it comes at an expense and it's so incentivized. I guess I'm getting away from the answers, but this basic idea that acknowledgement and respect, stakeholdership is erased when the person is a number. I mean, look, like no shortage of examples in history where that was true. And so the fact that you know, the researchers in, you know, sort of in the deep lab space are like, they view it as a, it's a supply chain for, for one of the things that they, you know, one of the resources, their lab need, not pieces of, you know, of your loved one, but in fact, it is also that. And there's a dual, a duality there that is being, um, uh, disserviced because really that, that's the really core thing is like, Patients want to contribute to learning. They want us to learn from their disease. They want us to maybe help them in the future, certainly help their loved ones that might get this disease that are at risk or whatever. But they expect that if you learn something from their body that was taken out under the auspices of the fiduciary duty to benefit them from a surgery here, or something as invasive as we're putting them under anesthesia and cutting their tits off, if you learn something from my body that could benefit me, I, they, and we've heard this so many times, I would assume my doctor would be informed, but that's just not true. And my goal is to not correct their belief because their belief is legitimate. It's to, it's to fill the gap in the system that makes it so. And so that solution, you know, we didn't get to talk about that yet because I kind of get fired up about the problem, but. Yeah.
SPEAKER_01:So this is important to understand the problem. I was going to ask, I don't know, Brian, if you were going on that. I actually
SPEAKER_03:wanted to back up one second because I had a question, like a threshold question about de-identification and especially because you brought up Henrietta Lacks. Yeah. Was she ever even really de-identified? How did they find her descendants if she had truly been de-identified? Nobody's truly de-identified, right? Okay, this is what I wanted to know. Okay, so what is de-identification really then? It's a mechanism for commodifying data and samples from patients for use without owing them anything.
UNKNOWN:Okay.
SPEAKER_03:An extractive enterprise. But somebody, so how does it, I mean, sort of, what are the mechanics of it, right? I mean, you're separating the identifying information from the sample, but at least in the case of LAX, somebody was able to put it back together again, right? I mean, so like, what does it really mean? you know, as procedurally, when you, we're lawyers, we like to know what procedures are. Like what, when you de-identify something, what does that really mean about who knows it and who has access, who can put the parts together and who can't? Well, the patient doesn't know it. Yeah. Because it becomes, it's a detachment legally from them. This is where one of the interesting things about how biobank, maybe to explore, I mean, I feel like we could use a couple of conversations about this. There's so many legal issues here. Biobanks are really interesting. They're almost, they sit between two tax shelters, right? Because hospitals are nonprofits that make a profit and provide profit and services. And universities are nonprofits that rely on grants and tuition. And biobanks are sitting at the intersection of those. So every, every basic major university, it's Johns Hopkins hospital and Johns Hopkins school of medicine. And it's the UPMC. not the same thing as University of Pittsburgh, not the same thing as McGee Women's Research Institute. Even though they have the same name on the building and nobody outside of the city would ever know the difference, if you work there, you know, like I get two paychecks. They have different CEOs. They have different fiduciary responsibilities. And the university takes possession of the sample and it belongs to them. And that's what it says usually on the paper. So the university takes possession of the sample and they have no responsibility to the patient except the nominal de minimis duty to not reveal the identity of the person. But they can share, sell, whatever, extract, whatever. 18 identifiers are one of the classic, I think, useful for visualizing this legalistically. There's two policies that are most relevant. There's HIPAA and there's the common rule. And under HIPAA, one of the definitions of de-identification is to remove specifically 18 classes of identifiers. And then it's no longer that person. Even though somebody has to know who it is, of course, Because tissue samples, if you create a living model and then you want to prove that that model is good, that in fact it is a model, well, what do you have to do? You have to follow the patient's clinical course. So of course those back channels exist. It's just not transparent to the patient in any way. So de-identification applies to the patient, but... also to the
SPEAKER_01:downstream purchasers of perhaps of the tissue. I'm just trying to sort of, again, figure
SPEAKER_03:out exactly how they're, what it means, right. For, for third parties. Yeah. So, you know, there's a, there's a company called I specimen, which calls themselves the Amazon for human tissues, which I like saying with a straight face. Yeah. Great. And, you know, everything's compliant. They're following all the regulations. And it's true. In fact, there's no, there's like some, I have some slides. I often dig up some of my slides on this, but I have some slides from, you know, the Code of Federal Regulations. It's like, yeah, if something's, you know, de-identified, there's no restrictions on sharing or selling it. Well, that's what I was saying. Even your privacy could be pictures of you, you know, in a compromising state. that's shared for some purpose with business associates of the hospital. I mean, God knows how many people. And it's not, there's no restrictions on that whatsoever because the labeling has changed.
SPEAKER_00:Okay, got it. So I had a question about that. Again, in relation to what you were talking about in respect to these values of respect, right? So like, In your experience as a doctor and working in this area and studying this area, what do patients expect? What do patients think is happening with these samples and with this information? And how well does that map onto what's actually happening? I mean, do patients really understand what this stuff is going to be used for?
SPEAKER_03:True idea.
UNKNOWN:Okay.
SPEAKER_03:First of all, like at least a third in our in our study, for example, breast cancer patients in Pittsburgh, a third of them didn't remember whether or not they had signed up to donate their samples. The other ones did. But these are people self-selected to take our survey, of course. So probably over sampled people who remember. Yeah. And about half of them had wondered what happened. I think one person had done some effort, although it was never described, to try to find out what happened. But the vast majority of people just completely forget about it. Even if they wonder, they never know. And there's zero transparency. And in fact, part of the problem is that we're collecting things prospectively without always knowing what they are going to be used for or knowing whether or not it's going to be relevant. Because that's the nature of science. We were looking at some comments from a researcher we had interviewed earlier today, and she was describing the San Antonio Breast Cancer Research Program, which is really famous for breast cancer research. And she was attributing their success to the fact that they got money to start collecting tissues without a plan. So there's like an inherent unknowability. Perspective-informed consent is, I believe, insufficiently transparent.
SPEAKER_00:Regardless of what you're going to do. To the extent that you know, or that you've kind of had experience with this, when patients learn the truth about how this material is being used, how do they feel about that in general, just based on your experience?
SPEAKER_03:So what's really cool is we now have experience with a few people. So first of all, most people who sign up to donate don't actually have samples in the particular biobank that we're looking at. It doesn't mean they don't have samples in other biobanks because it's a total silo effect. Technically speaking, by law, a small piece of everyone's tissue is kept as part of the medical record for a minimum of 10 years. So the biggest biobank by far is what they call the clinical archive, which is owned by Pathology. In Pittsburgh, to give you an idea, UPMC has so much pathology samples, they're filling old mine shafts with them. And they're useful for research. So they can also be de-identified and used for research without informed consent or anything like that. But it's not the same as like a research consent that we then package with the identification to fully extract you from liability. And so the patients, I have no idea, but the most people don't have samples. The ones that do, the crazy thing is that 90% of the samples haven't been used. There's a lot going on here, right? Because you can't, and part of this is where Mario and I connect, right? Because I believe a market for human tissues is morally repugnant if those people are not involved. And so there's all of these constraints on, you can't just like create an Amazon for human tissues and solve the problem. Even if it is compliant, it's just there's something wrong with it. And so it constrains the market. But the consequence is that most samples go unused and most biobanks are losing money hand over fist.
SPEAKER_00:But I guess specifically when it comes to respect, I mean, it seems to me that's like a kind of bilateral thing. How do the patients feel about it when they learn what's actually happening?
SPEAKER_03:Yeah. So I'm so bad at this. I should have led with, well, what's really exciting is the one. And actually I'm going to just pull up something for you here. We did a little case study for the first patient who happened to be, she signed up for our project pilot before her, before her surgery. So this is Liz. She's 48, has neurofibromatosis. She took our survey, our first survey where we were asking all the questions about, we asked questions about profit sharing. We asked questions about what you want to learn. If there was, clinical data that could be impactful for your care? Would you want to learn if your samples were commercial? You know, we ask all these things and she happened to have heard the, I think the radio lab story about Henrietta Lacks and said, you know, the survey reminded her of it. She was at the time undergoing evaluation for finding on a routine mammogram. So she was really in the beginning of her whole process. And that biopsy shortly thereafter confirmed that she had an early stage breast cancer. And so I share some of the details. Would you want to know about the research studies? Would you want to know if your doctor decides to do research on your sample? The answer choices here, including this one about the burden for the researchers, was generated by many interactions with patients who do want to contribute and don't want to allow their own curiosity even to take resources away from the research enterprise. But when presented with some things that maybe that she could do to find out about the research, she selected some of these options. She wants to see pictures of them if they're available. You know, we're obsessed with the pictures of the organoids that are so cool. That's just like something easy to share. We asked about two different policies here where she wants to be asked for permission, but they have to learn. We asked questions about re-identification, which is a whole separate topic. And then we ask this question, if there are profits from your samples, how should they be shared? So looking at the profits question, the question is being shared among whom? The patient and... So if there's profits, if profits from the products of using your sample are shared with patients, how should the money be shared? And we had... created a gradient from each person should get their own share. The person should, you know, if they have especially valuable stuff, they should share it with, split it with the group of patients who signed up to donate. And then the other extreme should be all shared equally amongst the patients.
SPEAKER_01:Okay. But the
SPEAKER_03:question is about sharing among patients, not the split between patients and researchers or patients. We explored in another question. Oh, can you share the answer to that question? Sure. We submitted the manuscript recently, so I will share that with you. Absolutely. So anyway, this has been deeply backed by our research over a long period of time. But to get to the point of the answer, she signed up to donate at the time she was confetted for surgery. She actually remembers she told us she was told that her tissues would be interesting for research because she had an underlying genetic mutation. And then we interviewed her and she expressed that she's very eager to participate in research. These are some other patients we engage with. She signed up for our pilot, participated in downloading and opening her bio wallet, and then underwent surgery. And after surgery, she received updates about... you know, what happened to her samples. And in fact, she had samples collected, eight of them, and two of them had already been distributed for two different research projects at the time that she found this out, which was within two weeks or so of having surgery. So the quote from her was, is right here. And she ended up co-authoring a blog post about the experience with one of my developers. And she said she wants to be recognized, you know, it was like, it was a total mirror, of what we already knew. It was really inspiring. And then- And so were these answers fairly typical? So in other words, when you asked these patients, what was it that they would like out of an attempt to have greater access to information about their own samples? Do you recall what was most important to most of them or did it just vary? I mean, the answers for clinical benefit- or genetic findings that could be relevant to their health or the strongest signal. Okay. So that was the most prominent thing that they cared about. When it comes to, yeah, when it comes to being re-identified for research, for sample, use of their de-identified samples being re-identified for, it was like 90% if it was clinically relevant. Okay. And, but, you know, over 50% just to find out the results.
UNKNOWN:Okay.
SPEAKER_03:And so, you know, there, and in terms of the more qualitative, you know, aspect of it, it's a part of it's hard because there's no, you know, this, this expectation was kind of foreclosed and it's sort of invisible. It's all kind of under going on under the hood. So it's not necessarily a space that a lot of patients have intuitions about until you tell them, well, it could be relevant. It could be financially valuable, you know? But we don't tell them, oh, it could be respectful. They come up with that on their own. And not everybody feels that way, but many people do want to know. In fact, they even want to know if the result was it was never collected
SPEAKER_02:or
SPEAKER_03:the result was we dropped it on the floor and contaminated the sample and threw it away.
SPEAKER_02:They
SPEAKER_03:want to know stuff like that, too, because people worry. The biobanks worry. We have this responsibility to use these samples, and we're not fulfilling our responsibility. We feel bad. that. 90% of the samples haven't been used. That's pretty bad
SPEAKER_02:over
SPEAKER_03:20 years. And they're kind of, they feel inadequate. And our view and what we found from the patients is really that if it's been used, they definitely are excited and want to learn more. They find just value in knowing that it's been used, period. Something's being done. But if it hasn't been used, then it creates this great opportunity, I think, to put it to use. it becomes like I have this thing that I didn't know I had. Other people have them too. And we have unanswered questions and maybe we can find a researcher to study us. Brian, do you, shall we talk now about like sort of how the platform works and how it's then helps, might help to facilitate these, the three categories of things we've talked about, financial health benefits and respect and acknowledgement?
SPEAKER_00:Yeah, I think so. I think this is an appropriate moment. So you've created this new platform blockchain-based NFT system for keeping track of biological samples. Can you talk a little bit about how it works and why you saw that as being a kind of effective tool for accomplishing some of the reforms that you've been talking about?
SPEAKER_03:So we call it the app, it's called Debuy, short for decentralized biobank. And the first part, it shows you sort of, you have to orient people to the context, right? Because it's like, what can they expect? They don't know about biobanking. They didn't know what a biobank was. So we show them different types of samples. We show them organoids, which is one of our favorites. The pictures are cool. It's just a way of, you know, introducing it. And then the core of the app is a bio wallet. And this shows a patient with some breast samples, some lymph node samples. Our core thing that we're really excited about is the labs. And so we have The patient can connect with other patients with similar diagnostic conditions and research interests in patient labs. And then they could follow researcher labs that have different protocols that might be using their samples. This ductal carcinoma, how many patients, how many researchers, how many protocols, then lists of the protocols. And you can request to meet your lab members in a lab meeting. And really, it's just the very beginning of it. But that's really the framework that we could see being useful for allowing for the use of those unused samples, which is solving a different problem than the problem of enabling the researchers who have those 10% of samples in use to have a way to flow information back to the individuals, all without violating the terms of their research protocols.
SPEAKER_02:And
SPEAKER_03:doing it in a way that's sustainable and at least semi-automated is critical for making it feasible. So we'll never change We'll never close the loopholes in the law if there's no solution to make this doable at scale. So there's something
SPEAKER_00:I don't understand, I think. You've been talking about how a lot of these samples are being unused. I don't really understand why they're unused. And I don't really understand why the system that you've created is going to make it more likely that they do get used. And I feel like I'm missing something.
SPEAKER_03:I think the basic thing is that, you know, we have, so take our example, 60,000 samples, 10,000 patients that signed up to donate. We think of like the informed consent form. We are reframing it from what I consider accepting the cookies for research is what it is now. And we reframe that as a membership in a community of really a collective, an investment collective that's pooling assets, bioethics in this case to be invested in research protocols or protocols in general that advance their shared mission. And so we really reframe that as an investment community. And the potential users, you think about all the world of people doing breast cancer research, which is many. Well, how many of them are at University of Pittsburgh? Most of them are not. 10 of them are collecting samples. 10 breast cancer researchers right now are collecting samples, and they're all looking for needles in a haystack. The haystack is small. It's local. So it could be a decade before you have enough samples of any one particular type to do the project you would want to do because everything in the era of precision medicine, right, all disease is rare. And it's come full circle to this context of how you're looking for that, you're studying that one mutation, that one specific thing. We don't have that many of those. And so the power of decentralizing the biosamples and putting the ownership, clarifying the total morass of ownership is right. The question, the first sort of first round of our stakeholder interviews, the most prevailing question was who owns the tissue?
SPEAKER_00:Right, right, right. Okay. So if I'm, so if I'm understanding correctly, then a big part of the problem here is that the, organizations that are collecting this information and these samples aren't sharing it as broadly as they could to make it as useful and as valuable to researchers. Is that right? Because
SPEAKER_03:the incentives are misaligned for that to occur, right? If University of Pittsburgh is paying, you know, hand over fist again for this biobank resources and their business model is grants and tuition, right? What accrues value to the university is research that occurs at the university, intellectual property to an extent that comes from the university. And so they want to use their assets to further that, and they're disincentivized to take these assets that they captured, created, invested in to create, because they're expensive to collect logistically, and they're expensive to store. So it's a great expense. You're not going to just, quote, give it away to a researcher at Harvard.
UNKNOWN:Mm-hmm.
SPEAKER_00:Even though if they collectively shared all this data, it would be more valuable for everyone.
SPEAKER_03:Yeah, but there's no– this is where tokenization is required because to align incentives across more– right now that occurs in very constricted little like friend groups basically of reciprocity of, oh, we'll send you my sample because I know in the future if I need samples that you have, you might send them to me. So
SPEAKER_00:what you're describing is a big coordination problem. Right. I mean, everybody knows that if everybody shared, everybody would be better off. But the problem is it's hard to make that happen.
SPEAKER_03:Well, it's the the system for I think an effective marketplace is missing and you can't solve that without the patients.
SPEAKER_00:Right. Right. Right. So you're you're you're you're solving a market failure. Basically, you're saying
SPEAKER_03:market failure.
SPEAKER_00:This is
SPEAKER_03:I think thinking about it that way helps you to understand the problem a lot better than if you fail to think of it that way. If you only think about the research and the clinical and you forget that it's not just an ethical or scientific problem, it's an economic problem. And so, Maria, why does solving it require the patients themselves? Because you would need more information about the patients than just their samples in order to do effective research? No, because, and people right now, in fact, people are making the, largely the institution and people are saying, it's good enough, which, you know, in the foreseeable future, right? There's a total thing about, I call it a civil attack on science because every researcher has a sliver of a patient. It's like a different account. They have no idea who else has other accounts of this patient. They're different time places. They've different, you know, things going on. They're not combining. They're not sharing their lab notebooks with those people who are studying the same case. Well, that's absurd. Or if they, if the person goes, you know, from Hopkins to Dana-Farber, When they recur, when they move, then the trail goes cold on science. And so it's like, because the new institution is the steward of that data and the owner of that data rather than the person. So everybody's sort of behaving in this way that's like rational within the parameters of the framework of institutions as the owners of this stuff, not of people as the owners of this stuff and the necessary hub. And I think that the- It doesn't
SPEAKER_01:even sound,
SPEAKER_03:okay, I must be missing something because so far it does not sound rational to me, even from an institutional perspective. If the data is expensive to collect and expensive to store, why do you let it sit there doing nothing? Like that's the part I'm missing. Yeah, I think that there's a lot of, again, I think there's a lot of fear. When we get calls from companies all the time, like on average 40 calls a year, actually it's been tracked just to one person who runs one biobank.
SPEAKER_02:this
SPEAKER_03:particular biobank that I'm talking about to get access to the samples from people, usually like biotech companies, things like that. People want this stuff. It's not, you know, it's an asset. It's a frozen asset, quite literally.
SPEAKER_01:Right. And so I don't let my assets sit around wasting. So I'm wondering why that's the part that I'm struggling with.
SPEAKER_00:And what's more, these are assets being held almost entirely by charitable organizations. I mean, couldn't the government just mandate sharing? Just say, if you want to be able to do this in the first place, you have to pull it and share it.
SPEAKER_03:Perhaps.
SPEAKER_00:Perhaps in the future they will. I mean, is the, and I guess part of my question then is like, is, is de-identification part of the problem or like our privacy concerns and compliance concerns part of what's making these institutions like less, less willing? It's
SPEAKER_03:not really privacy preserved, right? You can't, de-identify something that contains somebody's DNA. I mean, come on, give me a break. Again, that's what I think is really interesting. It's a lexical process more than it is even anything in reality. I
SPEAKER_00:guess I mean less privacy and more compliance, right? They don't want to get in trouble, right?
SPEAKER_03:Yeah, right. So again, it goes back to their business model. What's the business model of the university is how they make how they do business. They, and they never bothered to think they're, Oh, we're, we're establishing biobanks, their financial institutions. How are we going to make them sustainable? They got these very large multi-year grants established and they were incentivized to maximize their spend. And now they're having, now they're all running out and they're all just trying to struggle to justify more funding, but the vast majority of the, of the resources haven't been used. But I think there is a fear both compliance wise, but again, there it's actually like, You could just create an Amazon for human tissues. And in fact, somebody has. And why is the problem not solved? Because it doesn't solve the problem of the moral repugnance being a constraint against that. Not just because the policy is not explicitly a constraint, but it is morally repugnant. Do you think it's morally repugnant to most people in the medical profession, not folks on the street, but to medical researchers? And well, I can tell you this much. The, uh, the biobank that we're working with, they throw away samples quarterly. They call it calling. This is a sample that they paid to collect and store and keep frozen for years that are valuable. And I asked him, uh, the, this guy, if you would consider listing for stale ones that you plan on throwing away just even a month in advance and see if anybody comes to collect them or pay, you know, you're losing money. I
SPEAKER_02:mean,
SPEAKER_03:give you money for them. Um, And his response was, well, you know, the patients donated these for them to be used for us to use for research, not to sell them. Right. And I said, well, they definitely didn't donate them. So you throw them away. Right. Exactly. So it's not really it, but it's like people get really like, you know, you know, there's there's an ethos and a culture around nonprofits. Right. And around health care. Right. Like what's
SPEAKER_00:that almost sounds like a kind of incoherence rather than. I mean, the point here is like, unless you give or sell them to someone, they're not going to be used for anything. And that's why I say compliance, right? I mean, it does seem to me like there are transactions costs on efficient use. of this information and material that are caused by, it sounds like a wide range of different factors, including the fear of potential liability of one kind or another for what's perceived as misuse of the material.
SPEAKER_03:I think it's more about the perception than it is about the actuality of it, because it is, by the way, the entire Biopharmaceutical industry relies on this public private partnership because every major cancer center is a university basically in this country. And they're all giving samples or giving the intellectual property created from those samples to companies to commercialize. And in fact, the patients that over 70% of the patients in our study said that we should maximize collaboration with industry as opposed to the direct other alternative was to minimize the chance that companies could profit from patients tissue. Because they see that as relevant for advancing cures, therapies, diagnostics that they want to happen. That's fascinating. I mean, I'm not surprised by it, but it does strike me as being the opposite of what some of the anecdotes that you've been telling us today, right, about the presumptions and views are within the industry. This is where involving the patient is like clears the air on so much of the BS. Yeah. Because the whole question of who owns the tissue, is it the PI? Is it the research institution? Is it the hospital? What about the university? What about the funding organization? That's what the head of the cancer center said to me. But he's not the only one. It's everyone else. And then when they end up in this deadlock, because they can't decide who owns it and what they can do with it. And the most rational actor could be the patient or their family to say, no, we want it to be used. Oh, we want it to be used for this instead of that if there's an option. But we definitely want it to be used.
SPEAKER_02:Like
SPEAKER_03:it allows for an alignment of incentives where they're currently misaligned. And I think that that's really at the core that you can't solve that problem without involving the patient. It's not just about, it's not good for science without the patient's direct involvement. That's what everybody else is. That's why kind of our approach is orthogonal because everyone in the industry is thinking, well, it's just totally impractical to involve the patient. There's going to create all these problems and drama. And for sure, we'll live three times when that's true. Yes. But right now, the way we treat informed consent is we say on, you know, the dicto, you can withdraw at any time, but it's complete and utter bullshit when there's no transparency. It's like, who do you even, where do you, and when I ask people, you know, what, when have they, have this, has this occurred? And you know what they say? Well, in 17 years working here, yes, I've gotten seven emails as the head of the, seven people have emailed me. I've had to figure out, track down. They don't know who's, you know, it's like, Who are you saying, you know, and I do understand what's going on in those circumstances. And invariably, it's somebody who's pissed off at the institution or had a bad outcome or had something else. And it's retaliatory, which is also not really fair to the scientists or relevant to their, you know, it's not as though their samples were ill gotten. They were obtained appropriately with IRB approval and blah, blah. But. You know, the fear that that's going to then you have to be pulled out of the research, they have to redo their work or somehow invalid. And the fact that that. Fear like, that's a, that's a market that's not safe. Like, if we, if we don't make new terms for what patients can and can't do in the, in this marketplace where they are stakeholder. then the researchers won't want to participate in it, right? And they'll prevent it from being realized to protect their own livelihoods. Your platform is enabled by technology, but it strikes me that the first step... or it strikes me is that that's not sufficient, right? As I hear you talk, it sounds like it's really going to require a rethinking of the conception of control over biosamples and patient empowerment within the medical profession as a whole, and certainly medical researchers. Is that, I mean, based on everything you've told me, right? It I would be shocked if you were able to just like sort of unveil this tomorrow when everybody's like, oh, that's the fix we've been looking for all along. We're going to shift control. You have? I have, yeah. In fact, I have a good story about that. I think one really important distinction for me is that it's about ownership, not control. And it's about the right to share in the benefits and knowledge of what's generated. not about the right to control it. And many patients, in fact, say, you know, we ask them if you, you know, if researchers are buying over your tissue, which happens in some cases in particular, and there's a total, you know, like unofficial process for how that gets adjudicated.
SPEAKER_02:It's
SPEAKER_03:like, you know, pecking order based and whatnot. Would you want to choose who gets it? And many patients say no, because they abdicate themselves. They recognize that they're not qualified to to decide what the best use of the samples is. But that's just an illustration.
SPEAKER_00:Yeah, so I had a question about that. I mean, is this a problem of like scarcity? Like, is there like... when these samples are collected is it the case that like only a limited number of uses are like it can only be used so many times like once or twice or three times or like why you know why does it have to go only one researcher
SPEAKER_03:right so i mean it's a physical good first of all and so you could slice it smaller and smaller but you know sometimes especially in the breast cancer world right there's all different it's it may there's like slightly different issues each case so Sometimes scarcity, there's definitely local scarcity. Again, because, you know, say you take triple negative breast cancer, notoriously difficult to treat. And because those patients receive as part of the standard of care chemotherapy before they have surgery, there's very rare untreated tumors that come through, like six a year. So it could be that like half, five of the 10 researchers at their institution, that study breast cancer are studying triple negative breast cancer. Well, they all want them. We can give one to each.
SPEAKER_02:That's not a research
SPEAKER_03:project, right? You need numbers of some kind to-
SPEAKER_00:But it wouldn't be possible to share all the material with all of them. There just wouldn't be enough of it physically or-
SPEAKER_03:Physically, it's an excludable good, which I think is also extremely important here in terms of, right? Because everyone thinks about, oh, health data and own your data and blah, blah, whatever that means. But you can't copy and paste these. They're finite. They're non-fungible, genuinely. They have all the features that a non-fungible token tries to emulate in a digital way. And they have opportunity costs, and you can't double spend them.
SPEAKER_02:And
SPEAKER_03:you need to centralize them in some way in order to learn... systematically from them, whatever you're trying to do.
SPEAKER_00:And so then as part of the concern then that we have, like the current system misallocates in the sense that we're not doing a good job of getting the samples, like especially the most valuable samples to the best and highest user, like the person is most likely to be able to make a productive use out of them.
SPEAKER_02:They
SPEAKER_00:might know, like whoever is willing to pay the most, presumably, Well,
SPEAKER_03:not necessarily, right? So then there's a whole, you're highlighting another whole thing, which is like, well, the people have raised is what if pharma just is willing to pay more than an academic researcher can? Are we going to tip all of the scales towards commercial research, especially if the patients are deciding? But I think that that's so underestimates patients. That is a concern that people have raised. Oh, yeah. Every concern that you could think of they've raised. Every concern they've raised. It's just, there's no way around the bottom line. There's, you know, as far as I see, like there's, this must occur. It will not stand that you could track, you know, you know, your package, but not your tumor.
SPEAKER_00:So, so, and this, this, this is an area where I, as primarily an IP scholar and someone who actually has done a fair amount of empirical work on university patent practices, I'm a little bit, concerned because you know a lot of what i have been looking at and my co-authors have been looking at in that area is the fact that university patent practices unfortunately have incentivized universities to turn into in effect patent trolls right so basically what universities do at this point is they patent really really broadly and then they end up selling those patents to NPEs who use them to effectively just collect litigation profits rather than pursuing any actual innovation of any kind at all. And I'm a little concerned that depending on how you set up a market like this, you could potentially incentivize the creation of a kind of biobank equivalent of a patent troll, right? Or a biobank- About how you mean that? Well, so for example, if you create a situation where patients have NFTs that they can alienate to whoever they think is most likely to use the material most effectively, somebody could come into the market and say, hey, you don't know which ones are going to be valuable in the future. Chances are yours isn't going to be. valuable in the future. So we're happy to pay you a very low price for whatever it is that you're selling. We're going to buy as many of them as possible. And once we have enough of them, we're going to be able to sit on that and then monetize that by volume rather than use it for any kind of actual research purposes ourselves. I'm very sympathetic to the project as a whole. As you were saying before, I think you got to think about incentives and market incentives for what's likely to happen when you operationalize a market that enables people to actually trade this stuff in real time at scale? Who's going to see financial opportunities? What opportunities are they going to see and how are they likely to exploit them? I don't know. It seems to me that looking at university tech transfer offices and what's happened there could be at least somewhat analogous to what you're describing and maybe help think about how to design the market more efficiently.
SPEAKER_03:I'd love to talk more about it because I don't think I totally follow or understand the analogy yet, but I definitely know all about the, from firsthand experience and even my family's experience, the problems with university patent offices and how they're, you know, dysfunctioning.
SPEAKER_00:Well, and part of it was interesting to me when I heard you describe these university biobanks, they sounded so much different. like tech transfer offices, right? They're like, oh, we're collecting, we're doing a lot of stuff. We're collecting a lot of stuff and then we're sitting on it, right? And like, we don't have like, you know, it's like underpants gnomes, right? We, you know, get all the underpants and then we don't know what's next, but we're sure we're going to make money in the future, right? I mean, that's how kind of like, this is the
SPEAKER_03:sort of the- Well, they too are disconnected from the benefits of the products of that research. Yeah. So that's a really interesting point, right? So the problem with the patent attorney working at the university tech transfer office is that if our company, I created a company to commercialize the technology because it must be done at scale. And there's no way if we can't figure out how to do it sustainably, that's never going to happen. And that guy sees no financial upside if we're successful. And he makes the same salary working 35 hours a week, regardless of, you know, whether I come or go. And it's just like getting it off his desk, that's what matters.
SPEAKER_00:That's right. And they look better the more patents they get, whether or not those patents are actually innovation, right? And they create incentives, unfortunately, and this is like maybe not so relevant necessarily, but it might be, like it creates incentives to pursue research because it's patentable, not because it's a good thing to research, right? They're also supposed to, by law, commercialize them. They're not, though. I mean, they're like they're supposed to in theory, but nothing in the law compels commercialization of in any way. Right. The law just says you're allowed to get the patent. It doesn't say what the university you have to do.
SPEAKER_03:They own the patent and that they profit. But
SPEAKER_00:they don't, they're not obligated to commercialize. And in fact, the overwhelming majority of university patents end up getting sold to patent trolls, to NPEs, to organizations that don't produce anything that are in the business of litigating patents.
SPEAKER_03:It would be so easy if only all we had to say was use NFTs for bio samples and that explained what we're doing. That's not explaining our technology really at all. It's just like, oh, we're using a wheel while we're making a car. And so like, the NFT is functioning as the wheel in the car. It's like not strictly speaking, not necessary, definitely not sufficient, but a lot of the core NFTs in our model are really what we're called now soul bound tokens, which is not,
SPEAKER_00:not alienable at all.
SPEAKER_03:You can, right. You can't, you can't write because that's the principle here, which I thought was interesting because I wrote the patent before the papers about that were written or before Vitalik started writing and talking about that. But it was the concept was that the core of it is always goes back to that person because it's not extricable from them in any way. And even if they regard those three categories of value track differently and might have different tokens associated with them in a fully functioning marketplace, right? Like you're always going to need clinically relevant information that comes out of your sample, whether or not you're getting financial rewards.
SPEAKER_02:And
SPEAKER_03:your children are going to always have to inherit the benefits of what's learned from genetic data that they inherited, even if they're estranged to you and you wouldn't bequeath them anything in your will. Like what they've already gotten from you, they're going to get and they have to for our health care, for our ideal of health and how health information should be handled to be coherent.
SPEAKER_02:Mm hmm. So
SPEAKER_03:those things track differently, but we don't believe, just like you can't sell a person or a piece of them without them, that you can't sell them. This is literally a piece of you. And this is where our work is really informed by labor practice and the whole idea of data as labor. Because to me, this is like the most, if you can't own a piece of your body, you'll never own the data. created about you. So it's this really important, I think, step.
SPEAKER_01:Well, this kind of brings me
SPEAKER_03:back to when I asked you earlier sort of what de-identification is. And I'm paraphrasing here. I won't remember your exact words, but it was something along the lines of it's a mechanism for separating patients from the benefits of their tissue, both monetary and otherwise. And so I guess this goes back to Brian's question about sort of incentives, especially at the organizational level. Is that by accident? Are you saying that that's by accident and that there's now no vested interest in keeping it that way? Because if there is, I mean, that's, I think, why I was asking
SPEAKER_01:you about the hurdles to implementation. I think it's convenient to point to laws and mechanisms and compliance as an impediment to doing some of these things
SPEAKER_03:that... No, it's not. It's that they don't want to do it very hard. And so I think that's why I was pressing you on that point, which is how much rehabilitation or education or just sort of norms shifting needs to take place within the profession in order to make this become a reality. So you agree a lot. Okay. A lot. A hell of a lot. It's a total reframing that's required. But the patient A are going to make this happen. Once we introduce to them that this is possible and we demonstrate it, you know, it becomes, why aren't we doing it? What's the excuse for not doing it? And we have software that can solve this, that's compliant with all of the existing regulations and that keeps everyone de-identified, but yet allows the benefits of provenance and distribution of profits and sharing of information to be automated or semi-automated at least with smart contracts. It's like, I mean, researchers can keep doing what they're doing and a computer program can do the reporting out and do it in a way that's transparent and that's acceptable if and when the person or their loved one's defendants want, you know, You could beat them over the head with all of these answers until the only one that was left for them is, we just don't want to share the money, right? And
SPEAKER_01:that's an unacceptable
SPEAKER_03:answer. In sunshine, it will be. Right now, I just have a tiny little pocket right now shining. Because it's cloaked behind stories about how it's impossible to do. Yeah. And, you know, layers of institutional thought, you know, it's total paternalism too, by the way, which is a point that one of my colleagues has been really interested in, like how, you know, medicine had to go through this transformation of away from paternalism and all of the growing pains around that. And now research is like, oh, you wouldn't, you patients, we don't need them. We don't need to know. We just need, you know, we don't, we just need the data and the stuff and like, get out of here. And we don't want to be bothered by emails from them. And you know, none of that's going to stand up in the light of day. It just won't because of the fact that this could be life-saving information. That's where it's really going to like the, none of the other arguments are going to matter. And because of the fact that it was, this is data and tissue that was collected under the fiduciary context of healthcare, where certain duties apply. And so the idea that we could just have this whole, you know, healthcare system, research, you know, research arm of the healthcare industry, like a leech on top of, on top of a clinical relationship will, you know, have these really untoward. This is the real, so this is the real burden, right? Is that, and I feel like we're racing against the clock because think about the BRCA case. It makes it so clear, but 10 years ago, even that case would have been less clear. And, and, and those cases in five, 10 years from now are going to be so many. that the institutional harm, like the fear around the litigation of proving, like this is why I think the BRCA case is so important to explore, like how many undisclosed BRCA cases are there? Because those are provable deaths, provable diagnoses that are missed, provable harm that can change the law. But it's only going to change the law if we have an enabling solution that makes solving the problem doable. Otherwise, everyone's
SPEAKER_00:stuck.
SPEAKER_03:And a ton of sense, ethically, But legally, we can't comply all of these companies and all of these research institutions and all of these hospitals to essentially air their dirty laundry. But it's going to start piling up really big. You think the power of the computing and everything that just could take all of the data that was created over the past 10 years and turn it into clinically meaningful insights. And we're going to keep that from people? Yeah.
SPEAKER_00:I mean, I have to say, it seems to me like... This project, I love the idea, and I think you've identified a problem that really needs addressing. I've made some really interesting suggestions about how to do it. It seems to me that the elephant in the room is our entire pharmaceutical patent system, which is what's generating all of these profits that make... a lot of the sort of incentives that Kim is describing that much harder to negotiate. And I really wonder what you're saying tells us about that system.
SPEAKER_03:Well, I can tell you why I think pharma is going to ultimately be along for it and why they're going to pay for is that their patents are all right. They're racing against the clock with those patents that they have. And so their assets are depreciating on the parking lot, so to speak. And it's access to this tissue that's gonna tell them all of the yet unknown uses for their existing patented drugs.
SPEAKER_00:Right, right, right. But I guess my question is, why should we give them that value if what they're getting it from is what, like, why not just, like, doesn't this say we should be thinking about the entire system? If we aren't. Yeah.
SPEAKER_03:But the question is, how do you change it from a status quo where everyone's so locked in place with the existing incentives? And that's one of the major challenges with the identification. You know, the problem is that it incentivizes behavior that's misaligned. It contributes significantly to the fact that, you know, this like I feel like I've always heard since I've been in health care, incentives are misaligned in health care. Potentives are misaligned. Why, you know, ye olde, you know, Lehman Brothers, you know, is curing disease ever a profitable business model? But what we're doing actually better allows for at least the potential of incentives.
UNKNOWN:Mm-hmm.
SPEAKER_00:And again, not to harp on this too much, but it does seem to me like the one place where I have a little bit of a sticking point is about the profit thing, right? Because I get the idea. I'm totally sympathetic to the idea of wanting to distribute profits more equitably. But part of me responds by saying, why are there profits?
SPEAKER_03:This is where Brian and I start arguing usually, Mariel.
SPEAKER_00:Like maybe the problem is the profits. Maybe there shouldn't be any. if all of this is being government funded in the first place, right? And ultimately the profits are being generated on the back of- Literally. Effectively federal research money. Why are we letting people have property interests? Why are we letting companies generate profits in the first place? Maybe we ought to take this as an opportunity to take a step back and say, we shouldn't be giving them these exclusive rights in the first place. But I think much in the way that you're looking at the way we deal with bio samples and asking, are we doing this in a good and efficient way, right? I mean, I think we can look at the patent system and say, are we doing this in a good and efficient way? Is it producing the outcomes that we think are desirable? And, you know, the more, when I read your paper and the more I talked to you about it, the more I feel like, you know, what you're talking about and what's happening in pharma, the pharma patent world are really closely connected to each other in a lot of really deep, deep ways. And the markets have a lot of parallels. They're not identical, but I mean, like, I don't know, the more I hear you talk about it, I'm like, wow, this is so, these dynamics are so familiar.
SPEAKER_03:Maybe we can end with one little nice story of when you said people aren't going to just be like, oh, you know, I'm going to start doing like a high, like we should, I see the error in my way. That's not, not how it's going to work. But, um, I was at a conference at Friends of Cancer Research in DC, right? The cancer lobbies, cancer research lobbying group. And I ran into a oncologist from Johns Hopkins and she's like, you know, what are you doing here? You're not an oncologist. And I showed her our app and she said, oh my God, I need this because I just told, I'm part of this tissue sharing consortia. And we're supposed to send these fallopian tubes from Hopkins to MIT for this advanced, you know, next-gen diagnostic thing, whatever. And I told them that ethically I could not do the research project if we would not be able to use the findings to benefit the patients whose tissues we're using and to add it to their medical records. Because the scientists and the physicians who are devoting their lives at their own great personal expense to curing cancer, to taking care of the people who are suffering from it, are growing, are increasingly going to have these experiences where they can simply not keep their heads in the sand. Thank you guys so much for your interest in the project. It's a great project. We're so excited. We're going to do our part to embarrass the university researchers into adopting it.
SPEAKER_00:100%.
