 The next speaker will be Dr. Stacy Tesla Lindau, an associate professor of obstetrics and gynecology and medicine and geriatrics at the University of Chicago. Dr. Lindau received her MD degree from Brown University, completed a residency at Northwestern and holds a master's degree in public policy from the University of Chicago. Dr. Lindau's interests are wide-ranging. She investigates female aging and sexuality and urban population health improvement and fairness in health care. Dr. Lindau is the director of the program in integrative sexual medicine at the University and also directs a different program, the Southside Health and Vitality Studies, for the University. But today Dr. Lindau will speak to us on the topic of the ethics of sustainability. Join me please in welcoming Stacy Lindau. Andrew, great job. So Andrew spoke a little bit about the ethics of success and we'll have to talk more because I think I'm speaking on a related topic, the ethics of sustainability. So this is the first time I'm speaking on this topic and it really emerged as an issue in my own work. The tie that binds the work in sexuality and issues of urban health, especially for underserved populations, is an interest in engineering solutions to injustice. And the way that I have described previously, my interest in the medical treatment of female sexuality or lack thereof and my interest in underserved communities focusing first on the Southside of Chicago, we've taken an interest in looking and sort of nobody else wants to look down there. And looking where nobody else has been interested to look has created some very interesting both opportunity and challenges. So in contrast to Andrew's no disclosures, I have a robust disclosure slide which has been negotiated with multiple agencies including the University of Chicago. It is in some ways the essence of this lecture. So the lecture I'm going to present today, it represents work supported heavily by the Centers for Medicare and Medicaid Services but also by the National Institutes of Health, the New York State Health Foundation and others. Very important to know that the contents and my comments are solely mine, do not hold the federal government responsible. And also very important and relevant to the topic at hand is under the terms of the funding opportunity specifically from the Centers for Medicare and Medicaid Services, we were expected to develop a sustainable business model which will continue to support the work after the funding ends and it's ended. It ended on June 30th. In service to this deliverable, I have become the founder and owner of a social impact company called Naupow LLC. And this entity is not supported by the Centers for Medicare and Medicaid Services, it's not supported or endorsed by the University of Chicago. And it's also not the responsibility nor is it supported by any of the many stakeholders and partners involved. I'm going to add to the disclosure that my business partner in Naupow, just to complicate matters further, is Rachel Kohler who is the chair of the Ethics Center. And Rachel and I met doing our jobs. I actually was pinch-hitting to give a lecture for a colleague who had to cancel last minute, last summer for the Ethics Fellows. And Rachel came to the lecture and this is where we met. So in the course of earnestly doing our jobs, specifically for the Ethics Center, we met and now are taking this venture forward. So those are the disclosures. And these are the partners, or at least these are symbols of literally dozens, if not more than 100 or hundreds of individuals. If we count all the youth who've been involved, who over the last seven years have contributed to the creation of CommunityRx, which is the project I'm going to talk about specifically. It's impossible to name all the individuals, but I do want to give a special acknowledgement to colleagues who have been co-investigators on the work, including Dr. Daniel Johnson in Pediatrics, Dr. Dorian Miller in Internal Medicine here at the University of Chicago, Dr. Abel Koh at Northwestern, Fred Rockman and other physician at the Alliance of Chicago. And then other colleagues on the NIH grant, including Albert Wong in Internal Medicine, and Dave Beiser in Emergency Medicine, and Chick Makle and Jonathan Ozick at the Computation Institute. So what about the ethics of sustainability? There actually is a literature on this idea and it relates to sustainable development in the economic, sorry, in the environmental development context. But I'm going to speak today about some professional ethics issues that arise in the course of attempting to sustain a large scale health innovation. The ethics of attempting to engineer solutions to injustice. And I'm going to use CommunityRx, the work I've been doing for the last several years, as a case study. So I'd like to give some context about sort of very short history that frames this work. And if you look at the date at the bottom there, November 14th, 2011, I cannot believe that literally tomorrow will only have been four years since the federal government conceived of the idea of a healthcare innovation award. And you'll see through this talk that fast forward, the work is done. So the context was the economy. I heard Axelrod speak earlier this week and he said it was the worst economy since the Great Depression. The Congress was gridlocked and President Obama exercised his executive powers to stimulate the economy in multiple areas. So he was put forth policies to allow loan forgiveness for students, mortgage forgiveness and for healthcare, this healthcare innovation award program that came through the new Centers for Medicare and Medicaid Innovation Center. So the call for applications for this award came out in December. This is a blog entry by Anish Chopra, who was the first chief technology officer of the United States government. Some of you may have seen him. He was on campus just a couple weeks ago with the Institute of Politics. And what the Centers for Medicare and Medicaid was looking for were ideas from entrepreneurs and innovators. And Anish Chopra specifically described the list of people who might be these entrepreneurs and innovators. And number one on the list were physicians. And they were looking for ideas from entrepreneurs and innovators who had pent up energy about how to solve costly and wasteful problems in the health system. But who really hadn't been given the channels to do so. So they were looking for ideas that would promote what the Institute for Healthcare Improvement called the triple aim, what CMS called the three part aim, better healthcare, lower costs. And if that's not enough, something that would stimulate the workforce of the future, remember the economy was really bad on employment at very high rates, and would produce a sustainable business model. And the focus or the interest was ideas that would impact the underserved and address health disparities. So when my lab saw this opportunity, we really resonated with the workforce of the future and the work on health disparities. Because for several years, we had been focused on, in collaboration with the community, employing youth to gather data about all the resources, the community that could be brought to bear on the problems of health in the region. And we thought, wow, this could be a good differentiator. How many other people are going to come to the table with an idea that's employing youth in underserved communities? So I talked a little bit about this last year. It's a program called MAPS Core, Meaningful Active Productive Science and Service to Community. And MAPS Core in 2011 had just completed its third year. So if you look at the yellow, the turquoise, and the purple, those were the geographies we had already mapped. And we had experience employing, at that point, I can't remember exactly, maybe 60 or 70 high school students, we had a curriculum that was engaging them and understanding how the resources of their community were relevant for health of their community. And we thought we had a pretty good argument about a workforce of the future. So what could we do with MAPS Core that would further this aim of better health and better health care? Well, the idea was, and this idea came through the process of disseminating the basic data that were generated by MAPS Core. We didn't just collect the data, we made the data available to the public, and then we proactively went around telling everybody we could about the data, because we thought the meaningful work in MAPS Core would be only meaningful if people used the data the youth collected. And we wanted the youth to know the value of their work. So in one of those conversations, I was talking with Abel Coe at Northwestern and Fred Rockman at the Alliance and Karen Lee in my lab. And what we talked about was, wouldn't it be great if we could take the data the youth are generating about the resources of the community and connect them up with the electronic health record? So I, as a physician, know where in my patient's neighborhood she can go to do all the things she needs to do to stay healthy outside of the doctor's office. She needs maybe to lose weight, she needs to exercise, she needs access to fresh fruits and vegetables. Her child may need learning skills, she may need alcoholics anonymous. Where do I have access to that information? Well, I don't, I need it. So let's propose to CMS that we can make health better and healthcare better. We can take the data that MAPS Core generates and plug it into the health workflow. And so we did that, that's what we were funded to do. We were funded in the first round of healthcare innovation awards. David Meltzer also received one of these awards. The University of Chicago has won a very few institutions that received two. And we had three years. The funding's really started in June of 2012. Actually, technically the funds didn't start flowing until November, 2012. And part of the commitment was that you had to have your innovation up and operating within six months of the funding. So we had four months because the timing of the funding started late. Within four months we had to have this e-prescribing system integrated into electronic medical record delivering what we call the HealthERX prescription to patients with information about how they could connect to resources in their community. So in several sites we did this and we started delivering these HealthERXs and we started to hear from patients that gather data that indicated some patients were actually using this information to support their health needs. And what was really exciting about this work in an underlying theme that came heavily from the input of community stakeholders was the idea that if patients were doing more in their community to take care of their health, they would also be lifting up the local economy. They would be strengthening local businesses and organizations. And then there would be more places for the youth to map. So this was the cycle, this was the idea that we worked on. There was another piece to this, like I said, the sustainable business model. And we had to write a business plan when we wrote the application demonstrating how this was going to pay for itself. I just want to point out the language that was in this award because it was very unusual. In my experience, which has been primarily thankfully grant funded by NIA but other and other grant sources, I'd never come across a passage like this in a grant application. So this is an excerpt from the actual innovation challenge and there's a section on model sustainability. Proposed models are expected to define and test a clear pathway to ongoing sustainability. There should be a business model and the business model should include the plan to sustain the activity beyond the three years of the program. And it goes on to give us even ideas about what sorts of business models might be reasonable, public-private partnerships, multi-payer approaches, et cetera, et cetera. So imagine if every grant you wrote, you had to present a business plan for sustainability of your idea after the funding ended. And I partly why I was motivated to give this talk today is I believe that this is going to be something we see increasingly in our opportunities for funding, both from government and from private foundations. So what was the government looking for? Well, there was interest in measuring health outcomes. There was interested in measuring healthcare utilization, but the holy grail was could you reduce percent PVPY? Now raise your hand if you know what that means. Okay, now I don't feel well, Katie Fruin, who's here for my lab, and by the way helped tremendously in producing this work today. My lab was the same way, so my team was really, this was a really hard grant to write and we were strongly with it and somebody said, well, on top of all that, we have to show percent PVPY reductions. And so we all sort of looked at each other and I was like, somebody Google that. I mean, I don't, so percent per beneficiary per year reductions in a cost. We had to show that employing youth to gather data about the resource of community, plugging that into the healthcare workflow, sending people to local resources so they could be healthier, would actually reduce the cost of care for Medicare and Medicaid beneficiaries. And in our model, because we thought we could reach more than 100,000 people in that short period of time, we had to save about a half a percent per beneficiary per year to pay for the system. And if you could reach more people, you have to save less per person. So we really obsessed about percent per beneficiary per year and I don't have the answer on that yet because we enrolled our last people in June and it takes about a year to follow everybody up and we're being externally evaluated by the government until they give us those data. We won't be able to speak publicly about them anyhow. So we deployed this system. This is the city of Chicago minus O'Hare. The orange area is the demonstration area, 16 zip codes where we deployed this community Rx system, 33 sites. I don't have a pointer, but the first sites is number one in turquoise to the east side, sort of the northeast side of this geography. And we deployed there on March 27th, 2012. And between March 27th, 2012 and April 13th, 2015, we implemented the, no, was it 2012 or was it 2013? 2013, March 27th, 2013, we deployed at our first site and then over that two year period, we deployed at 33 sites, ultimately reaching about 115,000 unique individual patients and having to train about 1,000 healthcare providers. And one thing that's interesting about this map from the perspective of sustainability is you see there are some turquoise boxes outside the demonstration area. And this occurred when one physician who had been trained at the pioneer site, Comed Holman Health Center, liked the solution so much that when he went up to the clinic, affiliated with his clinic on the north side and saw patients from the demonstration area, he wanted them to have the Health Air X-2. So he sort of hacked the system and this resulted in unexpected spread, which was very important starting, it was the technology already moving to market ahead of the research, ahead of the translational process. And I just want to point to the translational process for a moment. So this would be NIH's framework for translational research. It keeps iterating over time. There's debate about how many Ts there are in the translational research model. But unlike drug development, where you might have a molecular biologist engineering a new molecule in the T-zero basic science research phase, and then a totally separate team bringing those hepatitis C drugs to clinical trials. And it might be happening over 15 years or 25 or 30 years like Andrew showed us. In our case, we had done the basic science research, which was gathering the data about the resources of the community. And within a three year period we had to get from T-zero to probably T-three. And then that spread by people who weren't even part of our team brought it already to the community in a very rapid period of time. So I just want to reflect on that dynamic for a moment because it is the essence of the tension that we encountered. Essentially, if you look at the community RX line, we had three years from start to finish. And then if we wanted to continue to provide service to the patients and sites that were using the system, we had to figure out a way to bring it to market very, very quickly. In contrast, a new drug starts with a molecule. You might have a tech transfer a few years out of developing a molecule with a patent. And then some other company might take it forward for another 10 or 15 years before it ever goes to market. And I didn't realize this difference. I really didn't realize this was the dynamic until we started to go through the tech transfer process. So my lab tried to entertain, cheer me up. I think around the time we were at this crossroads, two years into the project by making this silly cartoon. But this is unfortunately me at this crossroads. The Innovation Award funding is nearing an end. We had one year left and we really had three choices. We can do what we usually do and write another grant to try to sustain this innovation. We can unplug the system, which would have cost money and had to be done by that June 30th, 2015 date so we could pay for it with the grant funding or somebody could start a business to continue to operate this system. So we wrote the grant, we hedged our bets, we wrote the NIH grant, fortunately we were funded but that wouldn't pay for the continuation of the whole system, it would pay for the research. Unplugging is something we talked about with all the partners who were using the system and nobody wanted to unplug. There was one site switching its EMR so they asked to come off the system for short term but nobody else wanted to unplug the system. And so then there was start a new business. And ultimately it's a longer story but I became the founder of that new business. The business model that we're working with is a collective social impact business model. And really it was Rachel who brought this model to the table among the many that we have been looking at. So looking at the definition from Stanford Social Innovation Review, the collective social impact business model, it solves a problem that affects people across sectors and it requires a group of actors across sectors. It commonly involves a public-private partnership and remember that was the first on the list of potential business models in the CMS application and it requires a convening organization as backbone to get it off the ground. And right now the New York State Health Foundation in New York is serving as a convening backbone to test this collective social impact model there. So you see the same cycle I showed you before but to sustain this thing we now are forming a 501C3 organization for MAPS Core, the youth employment component and we have founded a for-profit social impact company. A for-profit company meaning I could personally profit if this were successful and that of course raises part of the conflict. So what is the ethical dilemma of sustainability? Well there are two kinds of conflicts. One is one we all have, it's a conflict of obligation. For those of us if we work in academic medicine we have conflicts every day between the primary interest of our patient and the primary interest of our student. We oftentimes have to make a decision about which of those interests we're going to support. We typically will err on the side of the patient but we have the conflict. There also in this case as a researcher we could extend the primary interest to include the funder. I was the agent, the fiduciary agent responsible for executing the work, $5.86 million of government taxpayer money and so I had to think about how to balance the interests of the community people who were using the technology, the community people who paid for the technology and the patients. And then of course conflict of interest which there are many dimensions to conflict of interest but financial conflict of interest is the one that worries us most. And in this case it arises from the investigator's role in this case my role in bringing the innovation to market. So I want to, this summarizes the tension. There is one way to avoid conflict of interest in a scenario like this with rapid scale innovation that goes from T0 to T4 in three years. There is one way and that is to choose no conflict of interest and also therefore no sustainability. It just wasn't possible. So then we have to take risk on the conflict of interest side. I had successfully avoided financial conflict of interest my whole career and the sexuality work but I get called to comment because I'm the one who doesn't have those conflicts of interest and that was an asset for me. So this is not something I wanted to do but I had to balance the risk of being perceived as self-interested. The risk of being perceived as profiting off of this social impact solution versus unplugging the whole thing to avoid the conflict. So thank you so much. I will end there and I'd be happy. I have a minute or two to take a question. Thank you so much. The window of this paper is open for questions or comments. Right here. Could I ask you to go back to that part? Please. David, did you have the mic? Did you have the mic? Have you got the mic? Thank you for your talk and especially your last slide which I think is really interesting. You know, we're all influenced by our milieu and I think many of us in bioethics have this sense that we should be allergic to conflict of interest and I haven't ever seen it articulated like that. At the Cleveland Clinic we call it the Innovation Management Committee and I was skeptical of that at first but I've seen it play out in some positive ways. I haven't seen it linked specifically to sustainability and I guess my question is you sort of declared there are no other models. Has anyone suggested another model that might work for you? Another model with respect to managing conflicts or another model for the business. With respect to sustainability, a mechanism for sustainability without, you know, should we be this allergic to conflict in bioethics? Yes. Well let me see if I can get to the heart of your question. If you're asking is, were there other business models that we could have pursued? I mean, I think the way that I personally could have avoided financial conflict of interest in this scenario. Assuming we knew on day one that the technology would work and people would want it, there would be an appetite for it and, you know, that it would be successful in the demonstration phase, is I could have brought a business partner to the team of stakeholders from the very beginning. You know, had I known Rachel then and she were in the business of social impact or there had been another business entity, for profit or not for profit, that said, yes, we're interested in what we're doing. We want to be part of the demonstration and if it's successful, we'll then have enough brain power and brain trust to carry it forward. I think in retrospect, that is really the only way I could have solved this problem because the rapidity of, with which we had to move from demonstration to market, which was the day the grant funding ended, we had to have another revenue source for the project meant that there wasn't time like there is in the drug development world to shop around or to put it out for bid and if my brain wasn't part of the going forward piece, it's hard to imagine how the tech transfer could have been successful. Another question is could there have been and could we just have taken a not-for-profit route and that was studied heavily. I just want to show one click, quick slide mark and then I'll be done. So this is a map from the maps core mapping in 2014 of all the churches on the south side of Chicago. This is the single most prevalent asset in the region. 8.4% of all businesses and organizations are churches and they only represent a fraction of all the not-for-profit organizations. So as I looked at my partners in the eye and thought about how we're going to move this forward, there was not a lot of appetite for another not-for-profit organization. My community partners see a business that pays taxes and employs people in high-tech jobs as a good return on their investment for this work and that's only one of several reasons for why we chose the path forward. The other is the technology market is exceedingly tight in Chicago and trying to attract the talent we needed on this pace to a not-for-profit was even riskier. There's also social impact investing dollars that make it easier to develop support for this. David, a quick question. It's a comment. I think the microphone's on. It's a comment. Stacey, first of all, congratulations on amazing work and I hope it continues and is sustainable. My comment really is that conflicts of interest aren't always bad. There is certainly probably an inflection point where benefit to the community, benefit to others who get jobs, benefit to you where this might be acceptable and perhaps that's in your mind as well. But I don't view the graph you drew at the end, your last slide, as necessarily having sort of an infinite increase. I think that managing conflict is important, but capitalism and having mutual goals that somehow converge and provide greater benefit can be okay, so that's my point and maybe I'm conflicted in saying that. Well, I'll just leave with this and I won't read it, but while David, you're coming up to give your slides, I've really struggled with this issue personally and probably Rachel had to bear the brunt of that, but this is from Lisa Rosenbaum who wrote a three-part series in the New England Journal of Medicine. She's a physician and national correspondent for New England Journal 2015. Really a comment back to Arnold Relman's work on this topic in 1980. So if you're interested, I'd recommend you read this series and I think it speaks to David's comment. Thank you so much. Stacey, thank you. Yeah.