 Please stay on because we're about to come to the award presentation of the McLean Prize and I'd like to take this opportunity then to introduce Kenneth Polanski, who is the President of the UChicago Medical Health Systems and Dean of the Division of the Biological Sciences and the Pritzker School of Medicine and the Executive Vice President of Medical Affairs who will be introducing Dr. Bernie Lowe, our this year's well-deserved McLean Prize winner. So thank you all very much for a great panel. Good morning. Thank you all for joining us for the University of Chicago's 33rd Annual Dorothy J. McLean Fellows Conference on Clinical Medical Ethics. The conference is named after Mrs. Dorothy Jean McLean, the matriarch of the McLean family and a great supporter of education programs at this university and at many other universities around the United States including Colorado College, Smith College, Yale University and Dartmouth University. Dorothy McLean always believed that education was the best way to improve the world. Today marks the tenth time that the McLean Prize will be awarded. This $50,000 prize is one of the largest prizes in the field of ethics in the United States and was established in 2010 by the McLean family to recognize physician scholars who have made transformative contributions to clinical medical ethics and to healthcare in general. Previous winners of the prize include the foremost scholars who have made clinical medical ethics the robust field that it is today including doctors John Wenberg, Peter Singer, Susan Toll, Laura Roberts, Norman Fost, Paul Farmer, William Foggy, Stephen Miles and Mark Siegler. I now have the great honor of introducing the recipient of the 2021 McLean Center Prize in Clinical Medical Ethics, Dr. Bernard Lowe. Dr. Lowe is Professor Emeritus of Medicine and Director Emeritus of the Program in Medical Ethics at the University of California, San Francisco. He is also the President Emeritus of the Greenwell Foundation which funds medical ethics research. He has received many recognitions for his scholarly contributions and is a member of the National Academy of Medicine. Dr. Lowe and his colleagues have made fundamental contributions in several areas of bioethics. They conducted empirical studies of decisions regarding life-sustaining interventions and showed that patients with serious progressive chronic illness wanted to talk to physicians about their preferences for life-sustaining interventions if they became unable to make decisions for themselves. These studies provided justification for advanced directives and advanced care planning. Dr. Lowe and his colleagues have also studied ethical issues in research. In basic research they made recommendations regarding consent for derivation of human embryonic stem cell lines, consent for future research with induced pluripotent stem cells so-called IPSCs, prohibitions of reproductive cloning using IPSCs, and broad consent for research with biological materials. In clinical research Dr. Lowe and colleagues have made recommendations for responsible sharing of clinical trial data and regarding informed consent in randomized quality improvement trials carried out with electronic medical records. In public health Dr. Lowe and his colleagues have analyzed how to balance respect for individual liberty with protecting others from harm during public health crises. During the HIV epidemic Dr. Lowe and colleagues made recommendations on practice restrictions on HIV-infected health care workers, parental refusal of interventions to reduce postnatal HIV transmission and the legal issues regarding routine universal prenatal HIV testing. During the COVID pandemic Dr. Lowe and colleagues analyzed the allocation of scarce resources under crisis standards of care in the context of triage of critically ill patients, allocation of remdesivir and modifications of cardiopulmonary resuscitation policies. Dr. Lowe is the author of Resolving Ethical Dilemmas, a Guide for Clinicians, which released its sixth edition in 2019. It is a comprehensive textbook on ethical issues in clinical practice. Dr. Lowe continues to care for a panel of primary care general internal medicine patients. We are honored to present Dr. Bernard Lowe with the McLean Center for Clinical Medical Ethics Annual Prize. Dr. Lowe's lecture today is entitled Clinical Medical Ethics. How did we start? Where are we headed? Please join me in welcoming Dr. Bernard Lowe and in congratulating him on his outstanding career accomplishments. Thank you. Thank you very much, Dean Polanski. Thank you also to McLean family and to Barry McLean and to Rachel Kohler, the chair of the McLean Center Advisory Committee. And most of all, thanks to Dr. Mark Siegler, a good friend and a towering inspirational figure in medical ethics and academic medicine. In terms of conflicts of interest, I'm a member of the Ethics Advisory Committee for Takeda Pharmaceuticals. I want to start by just celebrating the accomplishments of the McLean Center under the visionary leadership of Dr. Mark Siegler. McLean Center identified clinical medical ethics as an integral and essential part of medicine. And for decades, it's kept in the forefront of the field. It's set up a world-leading training program for over 600 fellows, the audience today, the speakers today, who in their own right become real leaders in the field. So the outline of my talk is first, I'm going to discuss how did clinical medical ethics start. And then secondly, where's bioethics heading? I'm going to talk about empirical research on medical ethics, institutional ethics, ethical issues in research and public policy. How did I get started? Mark Siegler and I, I think, have had similar parallel careers and minds a little bit different. So as a resident in 1976, I was paged one night to the bedside of a 17-year-old with pulmonary fibrosis, progressive hypoxemia, and restlessness. He had graft-versus-host disease after a bone marrow transplant, and he was worsening on 100% oxygen and maximal ventilator support. When I walked into the room and after I'd read the chart and chatted with the nurse, his father came and grabbed me by the arm and said, pointing to the ventilator, I keep telling them to stop. He does not want this. I called my attending physician, an eminent, distinguished wise professor at home, and asked whether he'd be willing to withdraw the ventilator. He said that the bone marrow transplant team did not want to do so, and although he personally thought that was a reasonable option, he didn't feel comfortable countermanding the wishes of the bone marrow transplant team. So I gave the patient some diazepam to try and settle in down a bit, but later that night he died still on maximal ventilator support and still very uncomfortable. The next morning my attending took me aside and said, he wished he had called me back that night to withdraw the ventilator and concentrate on making the patient comfortable. So this is the kind of case that keeps you up for many nights. I think we've all had such cases. And at the time, ethical dilemmas were not discussed on rounds or at conferences. There wasn't the teaching that many of you are doing in your home institutions. And I couldn't find any publications at that time that gave practical, useful advice in the particular situation. As a result of this case and others that I kept collecting during my training, I decided to try and go into a career in medical ethics and to write the articles that would get read, distributed, cited on rounds and discussed at conferences. I wanted to publish these articles in the journals that physicians subscribed to, routinely read and respected. I didn't know Dr. Stigler-Mark at the time. I wish I did. I think it would have been fun to learn from him and interact with him. So to jump ahead to 1984, this was one of the articles I wrote with a colleague that I think really was a successful use of a case presentation. This involved an elderly patient with severe dementia who was cared for at home rather than being put into custodial care. And her family very patiently fed her by hand with a spoon. But she began to refuse feedings, clamping her mouth shut, turning away and spitting out her food. I wanted to just read a bit from one of the paragraphs. There are no easy solutions to these dilemmas, speaking of inserting a feeding tube. Difficult trade-offs among conflicting values and goals must be made, and reasonable, well-intentioned people may disagree. During a clinical crisis, there's often no opportunity to discuss issues fully. Unanalyzed assumptions, generalizations and slogans may pervade discussions. A lesson in this case for me was to collaborate with a geriatrician who faces this dilemma repeatedly in her clinical practice. And there's also an ace writer and editor. And this case taught me, this article taught me a useful criterion for when a work is successful. Over the years, when physicians have faced this dilemma in their own family, many have told me that the specific practical advice in this article is useful, both to them, their families, and often the physicians in the case. This is years later, 2005, an article titled Palli Dissidation and Dying Patients. This is the follow-up to that case of the young teenager after a bone marrow transplant about ventilator withdrawal. Over the years, I realized that it wasn't just weather and why to withdraw a ventilator, but also how to alleviate the distress that patients experience as mechanical inhalations withdraw. How to distinguish palliative sedation from killing a patient, and how to write specific orders to the nurses for sedation. Moreover, we found that it was important to address physicians and nurses' reluctance to provide adequate palliative sedation in this setting. So, I think there are many advantages to an analysis of rich cases. I noticed many of the speakers yesterday and today have started their presentation with a case that really grabbed attention. Narratives, stories do tend to capture the attention of readers or listeners. And in ethics, a rich case can show how to resolve cases in real-world settings. It illustrates the importance of context and complexity. It gives a chance to discuss practical strategies that a physician could try. And it also enables the writer to suggest words to say to try with patients and with families. And the rest of the talk, I think you'll hear that trying to suggest words that physicians can use in discussions is a theme that we think is important. So I want to now switch from how clinical medical ethics develop to where is bioethics heading. And I use bioethics to say that it's more than just clinical medical ethics. And I think the McLean Center and many of you today have expanded the scope of issues you've discussed. One area is empirical research on ethics. Important empirical research questions can be suggested by the clinical dilemmas that you grapple with as physicians and discuss as ethics case consultants. This is early in the AIDS epidemic before there were antiretrovirals. Patients often presented with full-blown AIDS. This gentleman has wasting syndromes, you can see. And patients commonly presented with opportunistic infections such as respiratory failure due to pneumocystic security pneumonia and an unresponsive due to CNS and central nervous system infections such as cryptococcal meningitis, toxoplasmosis. Often patients got so sick they couldn't participate in decisions when they were hospitalized. Now many of these patients in San Francisco were knowledgeable about opportunistic infections because they had seen friends contract these infections and many died. Many patients clinically wanted their partners or friends to make decisions particularly if they were strange from family members and didn't want family members who were often in the dial about AIDS to make decisions for them. So this to us suggested a research question. Was it feasible to discuss these predictable situations as opportunistic infections with AIDS patients in advance to get some idea of what they would want done in that situation? So this is an article that we published in 1986. We administered questionnaires to consecutive patients in the AIDS clinics at UCSF in San Francisco, January. And to go right to the findings, we found that patients had thought a lot about life-sustaining interventions in the context of scenarios I mentioned. They had preferences about what care they wanted in these scenarios and who they wanted to make decisions for them. And third, they wanted to talk to their physicians about these issues. And even though they had very mixed feelings about thinking about talking about these issues, they still wanted to talk to physicians even if they felt sad or depressed thinking about these issues. So 1995, about a decade later, we continued research on empirical research on actual commerce omission. It's now on actual conversations between doctors and patients in this case about do not resuscitate orders on hospital admission. And it was an innovation at this time, and Dr. Talski was really important in this, to record actual discussions between patients and physicians and to then analyze them in a rigorous way. Again, just to state the major findings, we found major shortcomings, deficiencies, and health physicians did these DNR discussions. But these also allowed us to identify missed opportunities to improve these discussions. And in future and further years, others I've worked with have done more studies of actual physician or staff conversations between patients and family members. I'm not going to cite, but there's a series of articles on conversations, actual conversations between physicians and family members of patients who are intubated, sedated in intensive care on mechanical ventilation. I think this has had a great impact thanks to the work with Doug White on ICU care and conversations. Now, to emphasize the usefulness of empirical research, it can demonstrate the need for better approaches to resolving dilemmas in clinical medical ethics. And also empirical research findings can serve as the justification for randomized trials of interventions to better address ethical difficulties. And several of my former trainees and colleagues have conducted, led randomized controlled trials of interventions to improve end of life discussions between patients and physicians or families and physicians and improve decision making. So second area in which bioethics I think is headed is what I call institutional ethics. And I'm sure the majority of you in the audience have been involved at your home institutions with policies and practices on such issues as do not resuscitate orders, family meetings in intensive care units, and in the past year and a half on COVID policies. And again, I think that almost all of you have been involved in ethics education for students, residents and researchers. I will spend a few minutes talking about requests from colleagues and institutional leaders for help with the dilemmas they are responsible for. And we're going to talk about a request that I received in 2003 from the Chancellor at UCSF. And at the time, stem cell research was really just starting to flourish. And he wanted to establish a cutting edge stem cell research program at UCSF, but to make sure it was done under the highest ethical standards. So he asked me to chair an interdisciplinary committee that included basic translational and clinical scientists involved with various aspects of doing stem cell research. Our remit was to recommend and actually to set institutional policy. And the committee decided to do more than that, but to publish our recommendations and the reasoning for those recommendations. This is an article from Science in 2010 on the derivation of human embryonic stem cell lines from frozen embryos that were no longer needed for reproductive purposes. And a major dilemma in this is that even if frozen embryos are de-identified and therefore fall under a permissive category of research under federal research guidelines, the embryo and gamete donors might not want them used for human embryonic stem cell research. Our group recommended and published a recommendation that there should be explicit consent from both embryo and gamete donors for the use of the frozen embryos for stem cell research, as opposed to used by other couples for reproduction. This actually became an ethical and regulatory standard, both in NIH guidelines for eligibility for NIH funding and also for Institute of Medicine guidelines, which had an international scope in setting professional standards. The lesson here was that research on bioethics can strengthen cutting edge innovative science by putting it on a firm or ethical foundation. And I think as somebody mentioned earlier today, the ethics and the cutting edge science should proceed hand in hand. And how to do this, I think, is a challenge, but also a tremendous opportunity for those who are working in bioethics. So the final area I want to talk about in terms of where bioethics is headed is public policy. So in 2005, the public health crisis at the time was SARS and anthrax bioterrorism. And this is an article I wrote with Mitch Katz, who is, at the time, was the director of public health in San Francisco. He's now the head of New York City Health and Hospitals. There are several lessons I learned from doing this work and I continue to use. One is that when writing about policies for public health, particularly pandemics, it's really useful to work with a frontline public health official. Ratchy lives through, takes responsibility for these decisions. Secondly, I learned that it's really important to keep working on a topic even after the particular public health crisis has passed. And beyond that, to be open to changing one's mind as new evidence comes forth. And other people think and publish good ideas that you can learn from. Finally, research can have unanticipated impact and significance many years later. So this is a line of research. I've tried to keep up it. This is an article on allocation of scarce resources during the 2009 H1N1 influenza pandemic, which luckily didn't happen. But thinking about how to prepare for it as an example of how to allocate scarce resources during a public health crisis was useful because it was grounded in an actual situation. Jump ahead a little more than a decade later. With COVID, obviously, as the pandemic emerged, there were scarcities or projected scarcities of important resources such as ventilators or actually critical care staff. And there's a real issue of how do you develop crisis standards of care? And I think one lesson we learned, unfortunately, from Hurricane Katrina is unless crisis standards of care are worked out in advance, it's really impossible to develop them on the fly in an affair. So just to acknowledge that this work has been done with Doug White, really taking the lead here on a series of articles, which we wrote and then revised as new ideas emerge, new data, and we actually changed your minds in some ways. So I want to say a little bit more about public policy beyond just publishing articles. I mean, we all like to publish. It's the currency and academic promotion. But I think there's a great value to serving on policy recommending bodies. So just a few examples where I was privileged to serve. With regard to regulations for human stem cell research, California passed the initiative to fund, to give public funding to stem cell research under the California Institute for Gender Medicine. And I was asked to co-chair committee that would set the medical and ethical standards for funding such research, and our recommendations were adopted as statewide regulations for publicly funded stem cell research. As a member of the Institute of Medicine, which is now called National Academies of Medicine, I've been asked to chair another number of consensus development committees. And two that I think looking back, I was very, very glad I served on, even though they're very difficult at the time, was a report in 2009 on conflicts of interest in clinical practice, practice guidelines, medical information, medical, clinical practice and medical research, which has really had, I think, important impact in many ways. And then later in 2015, another committee on sharing of clinical trial data, and recently I think many of us have been following that. The NIH now is requiring that NIH funded clinical trials need to publish their results, make them available in a timely manner. And finally, the allocation of scarce resources during this unprecedented COVID crisis. I served on some local committee, state and local committees, which I think was important to do. I served on a COVID vaccine recommendation committee in the state of California that really made recommendations on who should get priority early on when there wasn't enough vaccine for all. And then subsequently on another committee by the University of California, which has 11 campuses statewide, on what would be the vaccination policy for students to come back to campus and really have an in-person learning experience, and also for faculty and staff in terms of vaccination. So I want to finally turn to future topics and bioethics. These are some suggestions, and some of you have already started to do this work. It was really wonderful to hear some of the presentations over the last two days. So one is artificial intelligence in clinical care. And I think some of the challenges are to develop actionable consensus standards for the validity of AI algorithms, and also standards for clinical effectiveness of predictive algorithms. Particularly the case with machine learning algorithms, which are often not explainable, not transparent. Second question is, will a particular algorithm improve or worsen health disparities and structural injustice? I think the code is earlier on alluded to how predictive algorithms in the real world in terms of setting bail, suggesting sentences, screening job applicants, loan applicants, really works to the disadvantage of people who are already disadvantaged. I'm also interested, I think it's also important to think about the long-term and indirect impact of artificial intelligence, and particularly on provider workflow. We've all seen how healthcare providers are stressed to the breaking point due to COVID. What does the introduction of that AI do to workflow, roles, and responsibilities? I think it's a real challenge for ethics scholars to collaborate proactively with real-world AI researchers who are actually developing the algorithms. I think it would be better to try and address the efficacious upfront as the AI develops, rather than to try and correct them after the AI's program has been developed. The future top is to get more difficult. I think many of you have addressed the issue of health disparities in real-world clinical care and practice, and how the U.S. really lags behind many other countries in terms of health disparities. So how can scientific breakthroughs be translated into equitable implementation that reduces health disparities? And as we've seen, the wonderful breakthroughs in COVID science with vaccines antivirals, how will they, they haven't yet been translated into equitable distribution and implementation? And finally, I think perhaps the biggest challenge is how do we explain recommendations in bioethics or clinical medical ethics and the reasoning for those recommendations persuasively? I think what we really have seen, not just in the U.S., but worldwide, has been a rejection of evidence in the sense that we've all studied it in clinical epidemiology and public health, and evidence-based public policy, particularly public health policy. There are many people in this country and around the world who reject those approaches, and how do we interact with them and deal with them? Because they are part of, we are part of the same society as they are the same communities. So just a couple of summary slides. Strategies for medical ethics. First, to focus on important real-world dilemmas and to provide practical advice to people who have responsibility for making decisions on the frontline and in real-time. Secondly, to collaborate with other specialties and disciplines. And third, to be strategic, opportunistic, to be open to new topics and to serendipity. And I would add to that, as a bullet I didn't put in, also to have continuity in your work, because your prior work may be ripe for impact years later. So take home message, ethical issues keep us up at night. But they're also a core part of finding meaning, satisfaction, and joy in our work. There's a creative interplay between trying to think about and resolve or make recommendations in specific cases and broader ethical frameworks, principles, and policies. And it's important to become adept at moving between the case and the broader framework. And finally, I want to end with best wishes to many, many more successful and productive years at the McLean Center. You folks have a tremendous track record, and it's only going to grow in years to come. And I know many of you are regretting not being able to have this meeting in person. I personally regret not being able to see many of you who I've known over the years. Next year in Chicago, I hope that comes to pass. So thank you very much, and it's been a pleasure and an honor to be here with you all the way it works. Thank you.