 Well, welcome back everybody just as we are getting settled. I just want to Welcome someone who's joined us dr. Joe Kersner. Who's there dr. Kersner. Would you just raise your hand? Dr. Kersner who is obviously well known to many of you is a professor of medicine I would think but I'm not sure emeritus and He is one of Mark's main teachers in terms of the art of clinical medicine Which is what mark has has told me so all those stories. We've heard over the last day or two about about about marks exploits including a 20,000 feet in the airplane, which was a great way to start and all the Experiences you heard from Mark's patients who were at dinner last night for those of you who had a chance to hear from them Are attributable not only to mark not only to the other people we've heard from like Al-Tarlaw But very very significantly to dr. Kersner. So welcome to you and thank you for joining us this afternoon session which I'm very pleased to host is called the three pillars of academic medicine research teaching and patient care and the first focus Panel session is on clinical ethics research and research ethics consultation. It's scheduled to go on for an hour and a quarter We're going to try and make it a little bit less than an hour and a quarter to make the Medical education session slightly longer. So we'd love to end this sometime between two thirty two forty five and switch into the Other one I'm going to be a bit ruthless with the time this afternoon because the one thing we want to do is make sure mark starts talking at Five as you know mark scheduled to talk for 15 minutes That's May or may not happen, but if he starts after five o'clock. We'll be here a Long time and so we want to make sure that mark starts right at five o'clock I also want to ask I noticed that in the morning session John You had a panelist there and he was often sitting in this chair and He had a lot of things to say he wasn't on the program It does anyone know who that was I? Asked John Lantos that question. He said it was Zeleg But we'll see if it's we'll see if it's the same guy that's going to show up at five for his Final remark so this session is called clinical ethics research and research ethics consultation And what I'd like to do is introduce the three speakers ask them then to come and give their talk sequentially They'll take a maximum of 15 minutes each So we should have at least 15 minutes maybe a little bit more time for for discussion The three speakers are Carol stocking Rick Kodish and Chris dockerty Carol stocking we already know who Carol stocking is as she's the person to whom Mark is the number one collaborator on on on her list In her life mark is a little bit like the number one fan on on Hanna, Montana for those of you who have Who've watched that she spends two decades actually at the National Opinion Research Center Before joining mark at the McLean Center where she served as the director of research She has a PhD from the University of Chicago She as you know is Mark's number one co-author and Maybe at least as significantly, I think she's very much facilitated the empirical research career of very many maybe every fellow That passed through passed through the center I'd like to introduce all three people on the panel and then I'll ask Carol to come up and start the second speaker is going to be Rick Kodish Who's the FJ O'Neill professor and chairman of the Department of Bioethics at the Cleveland Clinic Foundation and a professor of Pediatrics at the Lerner College of Medicine of Case Western After fellowships here at the University of Chicago in pediatric oncology and in at the McLean Center He joined the staff of the rainbow babies and children's hospital Where he's founding director of the Rainbow Center for pediatric ethics And I think of Rick a bit as the type of person that Jack Wenberg was talking about yesterday a Coralette of the shared decision-making utilities understanding a little bit of empirical research Side of the equation with some others who are here Chris Daugherty is associate professor of medicine in section of hematology oncology here at the University of Chicago He received his MD from Indiana University in 89. He completed his residency there in internal medicine in 92 He came to the University of Chicago as a fellow in Hemok and also in the McLean Center joined the faculty here in 96 and subsequently has risen to become the chair of the Institutional review board in the biological sciences division at the University of Chicago and since 2005 has been the co-director of the program in cancer and the social sciences in the cancer research center at the University of Chicago So there's the three introductions our focus is on clinical ethics research and research ethics consultation our first speaker is Carol stocking Our first speaker is Carol stocking am I right about that? Yes Carol Please thank you and welcome on to the show today Thank you for all three introductions. I virtually deserved all three and Mark is this working okay mark. Thank you and to the McLean family The title of my talk is informal remarks about the first decade ish of the center I will start with full disclosure. I hate to speak at meetings I have vowed several times never to agree to do it again But here I am this time bolstered by a script which I plan to read word for word. I Will maintain adequate gravitas. I will not make Associationally I will not be reminded of anecdotes. I will just plow on But don't worry. I won't plow on too long. Peter has sternly warned me I'll focus my comments on what I see as Mark's overall contribution to empirical research in clinical medical ethics I've used only two sources. I'm a researcher mark CV Which increases all but almost by the minute in my memory which decreases at about the same rate Oh, yes, and one more source. I called human resources to find out when I started to work here April 22nd 1985 thus Possibly fixing the year in which the center began At least I got the impression from mark that the center had just started when he recruited me to be the director of research No, make that director of research programs make no small plans Of a center, which was not exactly extant As far as I could tell when I arrived the center was an energy field emanating from mark That energy field is still the center of the center There was more some of which we heard about yesterday. There was an established interdisciplinary a seminar and Mark was in conversation with the neurologist about the troubling ethical issues that that Physician and his colleagues were facing about offering the then newly available for this purpose Option of mechanical ventilation to ALS patients who were no longer able to breathe on their own Mark wanted to talk to the patient Still an early agent early stages of the disease about their wishes for care at the end of their lives And he was in another conversation with orthopedic surgeons and an effect an infectious disease doctor about the attitudes of surgeons who were then being asked to operate on Patients infected with the then always fatal HTL v3, which was renamed HIV as the project went on so before you Before all of the research done by all of the fellows and marks center faculty colleagues mark was out there Jinning up empirical projects related to clinical ethics and the projects were based on real issues clinicians faced in the care of patients I Mentioned that before the center Mark had already generated Interdisciplinary seminar, and he was doing quantitative research with neurologists orthopedic surgeons and an infectious disease doctor I'm not sure what to call it. Maybe intellectual networking It's a somewhat different take on the term interdisciplinary I'm not sure what the best term for it is but mark is a master at it and that mastery has enriched the field My job description, which of course really didn't exist in 1985 Was to help mark and his fellows and his colleagues Develop and implement empirical projects related to clinical medical ethics And I was supposed to do as much or as little as when we needed to be done My role on various projects could be described as colleague ship or Leadership or a follower ship. I know that's not really a word. Whatever was useful on a given project Mark's notion was to provide a well-trained person But one who was assigned to move the agendas of other people forward Mark knew that database articles were one way discussions about ethics could be published in medical journals And that was the readership he wanted to reach so he supported me not only intellectually but financially It seemed perfectly reasonable to me How was I to know that there was no one else in the whole medical center with a role like mine? I could immerse myself in the project of others and just sort of do whatever needed to be done It was a lot of fun for me very stimulating I did teach a course in research methods and for perhaps the first decade fellows and I worked together closely on projects It provided very practical experience for them. We did interviews. We coded responses We entered data together some people in this room, and I figured out how to use sass Which was famously undocumented at that time We analyzed data and the fellows wrote papers with marks assistance and enthusiastic support Back to April 1985 There weren't any fellows, but I knew I was expected to work with fellows and then in July John Puma arrived and Then fellows arrived every July every July thereafter in the first perhaps decade of the fellowship was full-time or at least four days a week So that it was feasible a stretch But feasible for a fellow to complete the two quantitative papers during the year that were suggested in Mark's Fellowship acceptance letter. I think Susan toll said 10, but Mark had published widely in both medical and other journals before Quantitative studies began to appear in his bibliography then on page 16 of mark CV publications of quantitative studies with fellows as first authors begin to appear and they continued to be Sprinkled through Mark's list of publications thereafter most often in the early period Fellows brought their own interests and clinical experience to the center They were stimulated here by the faculty their colleagues and the discussions in seminars and conferences at the center They designed and implemented extremely varied quantitative research projects during this time and On their way to publication fellows presented posters and papers at meeting Developing their own networks and Incidentally publicizing the center The fellows marketing maybe I don't the fellows as first authors Published their quantitative work with mark at the center in JAMA archives JG im Mayo clinics proceedings New England Journal American Journal of Medicine Lancet, which I think of as kind of general medical journals and in public health reports academic medicine Journal of Clinical Oncology neurology nephrology Anals of emergency medicine chest the American Journal of kidney disease critical care medicine head and neck I read the list to demonstrate how successful Mark's fellows were in publishing Ethics articles based on empirical studies the fellows did during their terms at the center in both the general and specialty medical journals One cannot be sure how many fish physicians who subscribe to those journals chose to read these articles But certainly some of them did During this period only one quantitative article a fellow wrote with mark was published in an ethics journal and Included with the first author fellow and mark as co-authors of the publications I just mentioned were many other center fellows 20 faculty members from other sections and departments often from the specialty Mentioned in the journal title. There were also fellows and nurses from outside of the center and medical students among the co-authors and Of course those and subsequent center fellows have gone on to publish empirical studies After their fellowship ended some have studied empirical methods others have relied on statistical expertise of colleagues Some may not have involved themselves in empirical research again, but contribute to continue to contribute essays Commentaries books to the literature Some now have very long bibliographies and of course some are publishing with their own students and fellows But all of this was inspired and nourished in the first generation by mark So in retrospect mark always considered empirical research to be a facet of clinical medical ethics He contributed his energy and his charismatic spark to train by now more than 200 fellows They and he with others have written dozens of articles based on empirical research and have encouraged others to do so And as for me, I've had the pleasure of thinking hard about diverse problems Conjuring ways of studying some of them and working very closely with many of you We've gone together to the most interesting places mark and colleagues. Thank you Carol let me just take this occasion to say that I think everyone in this room knows that The the movement that mark started the field that I think mark helped create the experience of all these Fellows would have been Very different and not not to the good without without what you've done And I think now would be a good time for us all to So, thank you very much Carol Rick could I ask you to come and and present we're looking forward to your talk. Thank you very much Dr. Seagal Good afternoon. I Think that my remarks Will be brief and will hopefully serve as a little bit of a bridge between Carol's talk and Chris's talk Carol spoke to us about Research in medical ethics another way to frame this session is Research about research ethics Specifically the ethical issues that happen when human Beings become research subjects and I think for the field It's a really important dichotomy and one of the amazing thing about marks success is that although the term clinical ethics I think most people hear as relating to Ethics in medical care a lot of the seeds of how we currently think about research ethics We're also sown in those early years, and I know Chris will pick up on that theme I'm going to do a two-part talk here that the first Is going to use some slides and then I'll close with some personal reflections and I've entitled this when mark picked up the phone What you see here is the first paper that appears on my CV. It's called ethical considerations in randomized clinical trials and this paper which was published in cancer in 1990 has some important ideas that I think are still very relevant to randomized clinical trials They pick up on some of the ideas related to the autonomy Beneficence tension that we spoke about earlier today and yesterday afternoon one of the key paragraphs here says The RCT arose in an era when patient autonomy was less widely respected or encouraged than it is today And that today was 1990 Reflecting a paternalistic tradition which tolerates some coercion of patients either for the good of society or more importantly for the patient's own good Today medical paternalism is less acceptable than it was in the past as Result a more limited role for the randomized clinical trial may be compatible with both ethical and scientific needs and may improve support for clinical research By both patients and physicians. This was long before people talked about community-based participatory research There were no CTSA is going on. This was really very very very prescient. I think and remember that this is published in a journal called cancer the journal of the American Cancer Society and The suggestion here in this paragraph is that one should maybe consider a more limited role for randomized clinical trials a threat to the dogma of Clinical research and then the last piece I'm going to read of the about this Goes as follows it says finally This is the section that deals with patient autonomy It says patient autonomy in an RCT is completely safeguarded only if the patient is free to choose Without agreeing to participate in the RCT Any therapy which they might have received by participating in the RCT and is equally free to choose the randomization alternative That's that's a really interesting thing. You have arm a and arm b arm a is the best current proven Treatment arm B is the experimental arm The suggestion here is that patients who are being considered for a randomized trial should be free to choose arm B if they want right of course a patient may Abnegate the freedom to make specific treatment choices by a prior voluntary And then coerce consent at the time of enrollment in the RCT if a patient may obtain one treatment only through randomization However, then enrollment in an RCT may usurp patient preference and compromise autonomy So these were I think really interesting ideas and back in 1990 and in one way the mark of a good ethics paper is This if you look at the editor's note the views expressed in this paper are those of its authors and do not Necessarily reflect the views of the editors and reviewers of cancer I didn't quite know what to make of this at the time, but I now view this as a badge of honor Here's another view of this and and and I think this also says something very special About mark and his style. You can't see it here. It's in the fine print. So I Blow it up for you. This was presented at the ACS workshop on clinical trials the Ritz Carlton in Naples, Florida September 14th and 15th 1989. I'm sure mark has fond memories of delivering this paper while I was here freezing in Chicago So a potential t-shirt slogan about this my mentor went to the Ritz Carlton in Florida and all he brought me back Was this opportunity for my first peer-reviewed publication? And I think probably many of us have had that even this morning mark said someone send me some notes about that Right, this is part of the style and what what Richard Epstein said this morning asking you for a favor It's really a favor to you. You just don't realize it at the time So I think it's important for each of us to have what I like to call an attitude of gratitude to mark and say say Thank you for this. I Also want to get back to research ethics I had a lot of other research projects that I was interested in as a fellow And I'll speak about one of them in a minute, but later on we did Continued work on randomization and I hadn't really realized it until I was preparing for this talk But the conceptual platform for the work that we we did it toward the end of the 90s and early 2000 Which was published in this JAMA paper is also related to randomization the observation that When kids are diagnosed with leukemia, they are almost always recruited to become participants in randomized clinical trials and This was a piece of empirical work We did that linked very closely to the conceptual questions that were raised in the cancer paper that I showed you before so what I'm trying to do here is is Show a thread of continuity to the conceptual work and research ethics that came out of the the early days of Mark's Mark's work and I know we'll talk on the panel about the ethical issues in phase one cancer trials in In human subjects Chris will talk more about that We're doing an empirical study now and we're audio taping the consent discussions in those those trials So this I think need to continue to do empirical work in in bioethics is still very important and a real tribute to Mark Okay, I'm gonna now move to the little bit more personal remarks and then turn it over to Chris So if I was a clever and creative person, I would say it was 20 years ago today that Mark Siegler taught the band to play But I wasn't able to make up a song So it was 20 years ago that I first encountered Mark Siegler I was a senior resident at Children's Memorial in Lincoln Park And I came down to the south side to meet with the director of what was then a fledgling ethics fellowship program I was a newlywed and my wife Parof needed to spend one more year in Chicago to finish her degree I was looking for a one-year gig I was planning to do pediatric he monk at Johns Hopkins and all that changed when Mark picked up the phone I'd always been more interested in ethics and humanities than in molecular Hematology and oncogenesis in some ways the the sort of wounded medical student that was described yesterday, too I had a strong medical school curriculum called human values in medicine During my senior year in medical school I spent a month with Norm Faust up in Madison These sort of things had instilled an interest in me to make me think a year of ethics training After residency would be fun if not worthwhile professionally I've been given advice by the chair of pediatrics at Northwestern where I was a resident that a laboratory research program was a sine qua non for career success and That ethics could be nothing more than a sideline or even worse a potential distraction It's true. I Was warned but mark was persuasive with me sitting in front of him mark behind his desk Did he offer me a cigar? No, he picked up the phone and he called Len Johnson Who was the head of pediatric he monk here at UFC at the time and he said Len I got this guy codish here He's finishing his residency in June. I think we should offer him a four-year combined ethics Pediatric hematology oncology training program. It would be the first of its kind in the country Mark did not obtain my informed consent Mark picked up the phone His powers of persuasion were effective with dr. Johnson and with me Having a glass of whiskey with John Lantos later that night I think sealed the deal and before I knew what had happened my life had changed One year turned into four years my career trajectory was realigned With the innocence and naivete of youth. I was probably oblivious to the risk I was taking with my future Later in my training a different mentor from the field of oncology said to me You ethicists you're always on the side of the tumor True. I know I know that he was only joking But but I also appreciate that deep within most humor is a kernel of truth His joke may reflect the perception of many clinicians not just oncologists in the war against disease Ethics consultants, maybe bioethicists more largely can be viewed as having Complicity with the enemy so casting my lot with this group was in some sense a leap of faith But one that in retrospect I'm glad to have leapt I won't go through the cast of characters that were here at the center at the time They've been mentioned before it was was really a terrific group. We were going through the first Gulf War at the time We were figuring out how email worked with something called bit net it was a Time when ideas were floating that would go on to really shape our careers We had lunch at the div school coffee shop where God drinks coffee, you know, it sort of says it all So after four years on the oh one one more story The the the paper that that was also important during my fellowship was bone marrow transplant for sickle cell disease a study of parents decisions When we got the letter from the New England Journal saying we cannot accept your manuscript I went to mark despondent and he says codish. It's an acceptance letter. Look at it. So I and that's something that I've done many times Subsequently and I'm sure many of you have done with your trainees as well How do you read a rejection letter? Well in the in the C. Glary and vein a rejection letter means this is accepted You just have to revise After four years on the south side of Chicago and then 11 years combining the care of children with cancer and a Research academic career in ethics. I made another leap Four years ago to become chair of a department of bioethics at the Cleveland Clinic The course that mark had set in motion by picking up the phone Seemed to have inevitably led to a commitment that resulted in my current identity as a recovering pediatric oncologist In building a faculty group with now nine members in the department. I've continued to rely on mark for advice We do 250 consults a year We've established an ethics fellowship with mark on the advisory board Collaborating with case and university hospitals metro and the VA in many ways the program that we have now takes its Inspiration from the successful training of so many bioethics leaders that I believe to be marks signature accomplishment Mark has continued to be a wise and valued advisor to me As I've navigated some of the political complexities in the past four years and I attribute our continued success to his good counsel So I'm going to end with with what I considered be the two M's to describe mark Siegler The first is that mark is a mench and that has not been been said before But I think it's very important to say that mark is a real mench The second is that one has many mentors in in a career For me mark Siegler has been a mentor with a capital M may he have many more years of success satisfaction and good health Thank You rick. That was really nice, and so one way to think about the last 25 years is mark spent 25 years rejecting rejection letters But he's changed a lot actually because I looked over now and I always remember him writing notes on a large legal sized yellow pad and He's now writing notes on a letter sized yellow pad. So there's been a lot of change over the years Chris would you give us your talk? Thank you very much Good afternoon. It's an absolute pleasure to be here. I'm supposed to talk about these two papers But I think I have a bit of an impossible task because I think everybody who's gotten a chance to come up here to Do these presentations Is obligated to talk about the papers that they're supposed to present but feels enormous desire to talk about mark So I have I normally would never have ambivalence about presenting data that I've helped create But I have real ambivalence about creating that data particularly in the presenting that data particularly in the time frame But I'm supposed to talk about these two papers. I probably am going to pass up some slides To try to keep within our time frame and also because I do want to talk about about mark I suppose I could have titled my talk when mark put the phone down Because I remember being a fellow a couple of months old a fellow in 1992 having been in the so-called phase one clinic here at the University of Chicago and having lots of questions about what was taking place in that clinic in terms of giving experimental drugs to To terminally ill cancer patients and so found my way up into the ethics Center and I Think it probably was an experience where it was a Friday afternoon I went in his office. He had the phone in the crook of his neck. It was probably I don't know it was probably Tony Fauci on the phone and he was probably yelling for Karen Rainey to get Art Kaplan on the phone Because he was ten minutes late for a conference call and he had his pen in his hand And he was scribbling in the margins for some report that was due to the Hastings Center last week But I came in and he put the phone down and the door closed and he then spent the time with me To talk about the things that I was interested in and of course the shared interests that would would be there and And I was hooked at that point and then became an ethics fellow for four years Was two more years a research associate So six years in in training to do the things that I thought that I wanted to do And these are the first two papers that came from all that that work with mark and with the center and certainly with Carol as well So that's what I'd like to do to find the issues of interest. What are these papers about and what is their significance? I feel somewhat obligated to review the papers and their data But I think we'll do that pretty quickly and then present research about what has come subsequent to these papers at this institution and a bit elsewhere and discuss the impact of these papers on other research in research ethics and On the researchers themselves and the overarching theme of course is that this is all a result of marks mentorship and stewardship So what are the issues that at stake in these papers these first of these initial papers? It's it is the study of the ethics of clinical research involving experimental agents and terminally ill cancer patients giving drugs for the first time to those who are going to die of their disease and The role of the McLean Center and mark specifically in creating the environment for this study To become a productive area of research here is of course goes without saying But but it needs to be understood that that environment created here has spawned other significant amounts of work and environment at other institutions and So then try to put these papers and their subsequent research in context with the study of research ethics in general as as Rick did and The impact of this work on other research ethics So what are the issues we're talking about those with advanced cancer? That's half a million people a year in the United States 550,000 people die every year in the United States of advanced cancer and of course these deaths you don't drop dead from cancer It takes months before your death comes Yet we know and clinicians know in advance. There's no possibility of cure But there are months sometimes even years before death occurs and so presumably there's ample time for patients to make decisions and informed decisions What are their options for care? Apologize for any fellow of the last decade who's seen these slides at least once before They are continued efforts with standard non-experimental chemotherapy or radiation Which really is the standard of care for 85 to 95 percent of the cancer patient population Certainly we recognize supportive or palliative care as it has evolved over time has always been an option for cancer patients Sometimes well employed sometimes seemingly not well employed and specifically hospice care And then there's this option of experimental agents as available in clinical trials or phase one trials This is a schematic that that only is attempt to represent The alternatives it's not meant to represent a time course of any given patient because of course patients can do all three of these Things before their death occurs. They might even move back and forth between these boxes before their death occurs So this issue about experimental drugs phase one trials We all know that these trials that the clinical trial process begins at the phase one where drugs come out of the lab for the first Time been given to two animals shown to have some kind of antitumor effects But no knowledge about whether or not they'll work or whether or not they're even safe in humans And the process begins with the phase one trial We're going to expose patients patients exposed to these drugs Patients who don't have other options for treatment because you wouldn't want to lose an opportunity obviously to provide good anti-cancer therapy to patients and that opportunity could get lost if you were to Put them on a clinical trial of an experimental drug when there was otherwise good therapy for them And that's something that of course would not happen So that the the issues at stake with regard to phase one trials are a result of how phase one trials are Conducted how they're designed because they are designed to determine safety not to determine efficacy Although occasionally efficacy results sometimes get published. There are most phase one trials will be published with no results on anti-cancer efficacy and The methods by which they're employed is where where many problems begin because they're taking patients with very advanced disease And sometimes exposing them to nearly least traditionally nearly homeopathic doses doses Well, we would not expect anti-cancer efficacy where we did not where there was not was not seen anti-cancer efficacy in the laboratory And only minimal toxicity in the animal bodies models, but that's where we start and then as Time progresses and new patients come into the trial new subjects doses are escalated with the specific intent of producing harm And I think there's there's truth in saying specifically that it's both a provocative term But the goal of a phase one trial is to produce harm It is to identify toxicities so that you can back away from that dose and and eventually study its efficacy in the phase 2 setting So moving along quickly. What are those issues then? There really is in published trials and presumably probably if you include the unpublished trials even less possible Potential for efficacy in these phase one trials at least in the cancer setting and the published rates Both in the early 1990s as they were available from the literature at the time and even subsequently as recently as 2005 in jama the response rates are on the order of about 5% where you actually can see documented anti-cancer efficacy If you remove the experience of one or two drugs from the published research Where there might have been a few remissions the likelihood of remission is essentially non-existent The median prognosis that have been described for these patients is on the order of six to eight months So 50% of patients who enroll in phase one trials will be dead within six to eight months The vast majority 85% of them will be dead within it within a year So we're we're talking about participation of patients with advanced terminal incurable illness as human subjects And one of the underlying things that we've been interested in since the beginning is do they really understand their prognosis because I think there Is a gut response about if anybody really understood their prognosis and really understood what phase one trials are about who in their Right mind would do such a thing and in fact The only kind of publications that were available at the time in the early 90s About phase one trials were editorials about the design of these trials and that specifically said that what did they say? They specifically said they can only these trials can only be ethical They can only be ethical at first we agree that there's a need to serve society's interest in drug discovery for new treatments for cancer But of course as in any clinical search research There is this conflict of interest with regard to the goals of the patient who's becoming the subject the goals of society and having To use patients as means to an end to serve society's interest in developing new therapies So that can happen Patients can voluntarily allow themselves to be used as research subjects to be used as research as means to an end That can allow them these presumably allow these trials to go forward But it requires more than adequate if not even ideal and maybe on maybe even unreachable informed consent And of course the question was at the time. Are we getting it? Are these patients really informed? Do they really understand and they really except for one small study of 10 European cancer patients in the late 80s. There was absolutely no empirical work on Research subjects experiences in the phase one setting and I and I'll just go ahead and say it and and someone can correct me If I'm wrong, there was no evidence There was no data in the literature with regard to any kind of terminally ill cancer patient participating in any kind of research and perhaps even more broadly no information about Terminal illness and patients with terminals participating in any form of research Carol mentioned the ALS study, right? It was Woody Moss study. Yeah, right So So yes, they're ethical if these things are met and if if finally and this is where where many people believed it to be the case They're ethical if subjects participate in phase one trials for altruistic reasons. I know I'm going to die I know I'm not going to benefit, but somebody else will society will future patients will as a result of my participation and for years many argued that phase one trials were are unethical Are ethical only if subjects participate for altruistic reasons So that's where it began when mark put the phone down And allowed me an opportunity to interact with Rick who was still at the center with Jean Grichowski Who was a fellow at the time and of course with Carol and It then led right you do it once well Then you do it again and you do it again and you do it again and that's what we did and now I don't know 12 well cheese 15 16 years later. I think actually it's probably nearly a thousand Patients have been interviewed who participated in phase one trials, and I don't know phase here some say, where are you? There's a there's virtually one person who has interviewed every single one of these patients except maybe the first hundred and fifty And that's faith who Baki who's here with me today But we've said let's look broader right than just this issue about because after you do it for 200 patients And you realize they don't seem particularly well informed you have to move on and think about the reasons why they don't seem Why they don't seem to be informed? And so we've looked at multiple issues not just about informed consent But have gotten very interested in trying to examine how these patients understand their prognosis and trying to figure out How you actually measure that in an empirical setting we've also surveyed involved oncologist and other cancer investigators And then we've embarked on attempts to produce decision aids Okay, how am I doing for time? Okay So this first study a couple dozen patients Subsequent to that we then continued to use pretty much the same survey instruments studied another hundred and forty four Survey regarding their motivations and their reasons for trial participation Survey regarding the so-called vital elements either as in the codified regulations or as we would think about them from from from a Ethics perspective the vital elements of informed consent. Do you understand the purpose of these trials? Do you understand what your alternatives are to trial participation? What are your expectations of benefit? Do you understand the potential for toxicities and then we surveyed oncologists? Like I said There's the data So the papers are there That the significant and impact of this initial work I think at least in the small world that I live in is Is almost in estinable in estinopal? It was defining work regarding what cancer patients really understand regarding enrollment in clinical trials of experimental agents These initial papers have been referenced as near as I can tell at least 400 times in the subsequent peer-reviewed literature I don't know whether that's a large number or not The only person I know who pays attention to how often they're referenced Is mark retain here in our section of hematology oncology mark says this is a big number and It was at the time the virtual the only recent study cited as the kind of research needed to understand current issues in research Ethics in the in the acre report right the advisory committee on human radiation experiments report Which at least from my perspective and others is that the finding text of the last 12 years with regard to research ethics And specifically in their conclusions they talk about research is needed to understand Subjects perspectives in participation and they reference this study almost in isolation to anything else that was out there That the first paper the 95 paper There's no question that the acre report led directly to the NIH's request for applications They're they're call for research in this area on research ethics There's no question that that RFA led led to the still standing long-standing program announcement called research on research ethics And it I know personally that I know that it has spawned at least four RL ones I think we include Rick at least five RL ones at different institutions Not just here focusing on phase one or including phase one cancer trials the evidence About the impact of that paper is I know I can't speak for Rick's I'll go back to four I know that that initial 1995 study was the most significant preliminary evidence used for those grant applications here Duke Hopkins at Fox Chase and Subsequently hundreds of articles. I mean we don't even try to track them and we don't even collect them anymore Faye doesn't even track them down anymore There are hundreds of articles in the literature on the ethics of phase one trials and this is basically become a cottage industry To do phase one trial subject research so We were obligated then once we did those in that initial work Well, they don't understand I present this data others represent mark would present this data They say well, what are you going to do about it? What are you going to make people better understand better the issues here? So we set out to do that and that specifically What George Zimmer was about George Zimmer the senior author on this paper published in Annals? 95 or 97 George Zimmer was actually a former patient On a phase one trial. He was a PhD literature professor And he wrote this essay that he left behind with his wife and shared with With the investigators in the phase one clinic and it had been floating around Between the ethics center in the phase one clinic for a couple of years when I came along and it was an argument to say Though we submit ourselves to be guinea pigs. We should be allowed to decide What amount of toxicity we're going to be exposed to let us choose the doses It was I think a theoretical kind of piece but mark said, you know Let's let's put it out into the literature Let's put out arguments about whether or not this is an appropriate argument with regard to phase one trials And so we did that and then we tried to do it. We tried to allow patients to choose their doses in phase one trials Like I published in 1998 We are literally allowed enrolled subjects with terminal cancer to decide when dose escalation would occur and allowed them to choose From predetermined dose escalations my interest in it our interest and it was if you did this if you allowed people to choose their dose How could they not understand that the stud the trials were about dose escalation? So we did that It's never been replicated here or elsewhere and it was very difficult study to do We then went on to other more sophisticated interventions and were involved with Hopkins and Duke looking at a CD rom that had spent a couple of years in development and Then a randomized control trial with a CD rom that was done here at Duke and at Hopkins There's the data Conclusion from that intervention was that well one thing was that over a million bucks got spent in NIH money Combined resources of some pretty good institutions Hopkins Duke and UFC and the bottom line was it really didn't work Or it certainly didn't work very well this was state-of-the-art touchscreen technology with surrogate patients talking about their experiences and Surrogate physicians talking about their expense experiences with faithful trials and it was basically a negative study However, even such a negative study is valuable information As it speaks to how difficult it really may be to change or improve the decision-making and informed consent processes in these in this setting So what have what mark hath rod otherwise regarding this research? I couldn't get it all I tried to get it all on one slide and summarize it It is some of the most influential data related to the study of research ethics of the last 15 years Certainly from the perspective of cancer clinical trial research and our research on those with terminal illness It may be the most influential data of the last 15 years Here we have been able because of Mark's mentorship and stewardship to develop a very comprehensive program focused on Research ethics and cancer care and now advanced cancer patient decision-making defined more broadly And we're able to Employ a variety of surveying interview methods from multiple discipline been doing it for a long time now In over a thousand patients. I think interviewed looking at other issues besides just informed consent and Looking at interventions and have begun to study physicians and mailed surveys and interview studies as well What are we doing now? We have about 350 recordings of these conversations in the phase one clinic and are at work trying to evaluate those We've begun to work on what role cognitive function plays in these patients ability to understand They're heavily pretreated often some of them are well past the age of 65 And it's a reasonable question to wonder whether or not they even have the capacity to understand some things and now would like to look at I think more fundamental Interventions helping people to understand what their alternatives are to care and what their prognosis understanding is Most important so I'm done. So most importantly We will continue to bask in the warm and plentiful environment the mark is created within the McLean Center and will continue to enjoy the freedoms that come from his support mentorship and advocacy and I'll always be grateful for the opportunities mark has afforded me and Mark knows I don't like to come down here on the weekend So but how much do I owe him how much is happiness? Well happiness Happiness means much to me. These are smiles on my on my family's faces My son whose basketball game I missed today because I had to come down here told me to make sure that I thanked mark So we continue we all continue to be productive and happy Thank you very much Please call it I Can hardly wait Well, I really would prefer not to answer that exactly But I will say that the and you'll see why the paper I'm most proud of is that one mark has is one that mark subsequently says he doesn't any longer agree with So the next time you've seen me with a glass of wine in my hand ask the question again, okay? Well, yeah, let's ask him later Bill So Chris I have a question for you. I mean that's terrific stuff about asking Patients in phase one trials what they know about stuff. Do you know of comparable data about any other? Ability of doctors talking to patients in non phase one trials where people have demonstrated more understanding than that There's a follow-up, but that's the first question Yeah, no, it's people are criticizing phase one research In general and the problems that it that it I always say well nears I know they're the best informed subjects in the literature because it was for a long time no other literature now there is literature now on randomization and On unrandomized control trial saying cancer therapy and there was a definitive study It actually goes back now even 10 years trying to improve the process in the randomized control trial setting similar kind of thing of lots of by an educational psychologist who spent their entire career Gearing towards the study and trying to make an intervention that would improve understanding about the randomization process And it didn't work there either that's my guess and so the next question to all three of you and The rest of the assembled multitude is other than sort of the Aesthetic warm feeling we get from informing patients in this way. What's the good of doing this sort of informing? Why bother Well, I think it's ritual and I think I think rituals very important and I think ritual builds trust Yeah, and let me talk about some rituals that aren't so trust building now. I don't I don't want you to do that But I think it's an aspirational sort of thing We're never gonna get perfect informed consent, but it doesn't relieve us from the obligation to try to get better And the purpose of the obligation to try to get better is It is to more closely Approximate shared decision-making even though all the data are that everything we do fails. I don't think that's all the data Ah, okay. So are there others? Yeah, I mean the study we have coming out in academic medicine shows that the intervention that we just finished up does improve Understanding of having a choice about a trial. It's a very narrow context. It's the context of kids diagnosed with leukemia But all such research is going to be inherently sort of narrow in a particular context Great Christian Carol. Are you gonna wait in while we figure out who's next? I suppose from a historical perspective the requirement that we are under To to to be forced to focus on these elements at least in the research setting Comes from the Belmont report code by regulations and he said well, what did that come from? Well, that came from United States Public Health Service simplest study and that subjects were not informed appropriately But if you look at that kind of historical perspective that we're being forced to do this and is it a is it a Kind of false paradigm to think that it can happen and the federal regulations say you must inform these nine elements And it also says you must promote an understanding now They were I mean the Belmont folks knew what they were doing and they were certainly sophisticated enough to say and you must document that They do understand before they can enroll they didn't say that they said you must make an attempt to promote their understanding So there's there's no predefined threshold at which the certain number of subjects must understand all these elements So you can you can look at that and say well We then have this obligation to do these things and we're not required to make sure they understand But I am challenged by the realities and by the historical perspective Which essentially it had to be law to make us do it to pay attention to these things which then says well if it's Why are we doing it? Is it for legal purposes in some respect? Carol you want to add something to that or I think it is aspirational and And failed at this point Great. I'm looking to see Ella. Are you somewhere with somebody else any other questions or comments? There's one here As was mentioned earlier in the day in the conceptualization of the Belmont report and how they think about respect for persons is that there are kind Of two parts to it the first is respect for autonomy And the second is protection and it seems that most of the time we divide keep research subjects into two categories There are those who are able to show their autonomy through informed consent and those who require protection And it sounds like what you're saying is that informed consent is at best always incomplete It's always imperfect and I wonder what you think about the role for protection for subjects who we traditionally think of as being able To give consent or to have autonomy So I usually teach this as the three eyes that there's investigator integrity IRB review and then informed consent and the first two are much more important at protecting people from research risk But it doesn't mean I would amputate the bottom I and I think on the Other side you have to think about the Abigail Alliance case recently something that this phase one ethics stuff brings up and Access to the latest greatest newest thing that people clamor for so so, you know There's a pendulum sense to all of research ethics, too. I think great any other questions or comments for this panel You know the Zimmer paper Argue specifically against that That is he as a terminal cancer patient said Don't condescend to me. Don't protect me I can make my own decisions and I'm capable of doing that and at least in Cancer research world when there's been talk about that take the terminally ill cancer patients and lump them with the other Truly defined vulnerable populations to say define and fabric lump them with those that are have mental that are mentally impaired with children and with prisoners From a practical perspective, of course, that couldn't happen and in this day of patient advocacy It would be I think absolutely the wrong thing to do to make assumptions and say, okay if you have this Kind of illness then you you are a vulnerable population The no question though that the potential for vulnerability in the population is enormous and their potential to be To be enrolled without their full understanding is there maybe I could just ask you guys a question And I see that panelist is wanting to comment, too. So we'll hear from you mark on this topic Going back to the reflection yesterday. So this is a panel on empirical research in In bioethics is you think back over the last 10 or 15 years and it's a version of Caleb's question What? Finding what empirical paper if any Here or elsewhere? Do you think has made led to a fundamental change in patient care or research practice and by saying what paper in general has? What paper has changed medical care and patient treatment of any kind? I mean, how many have there been? An intriguing thing to me is when something is Found how it ignored it is. I think that's amazing to me There are several studies which fellows have been involved in Michael Green is the one I'm thinking of right now where respondents know a guideline and Don't follow it and the same thing happens medically. So I think that they're No, but it's a very fair comment for calibration. However, there are examples, you know the NASA trial Around can't write in our activity. There are examples generally, but you're absolutely right They're very few and far between and I'm just wondering what our best examples are in the field of ethics I want to I cannot believe I'm doing this, but I'm gonna argue with you about the support project And that is not a very brief argument before it was done Everybody said if there were a controlled trial, we would know if we Informed doctors it would work and then when it came out negative and for ten gandillion trillion dollars People now Disclaim the study, but I want to say that word in support of the support study No, that's fair enough And I think the support story is very two-sided There's a lot of positive things to say about it including that and I just raised a little question So that's totally fair enough back to the overall question though. Do you? fellas have an idea of I mean do you have an NASA an ethics NASA in your mind or an ethics, you know, there's other examples What's a good example of an empirical study in ethics? And I mean quantitative qualitative anything that relies on real data that's fundamentally changed Patient care or research practice or maybe even not so fundamentally I Can say where the where research Research finding would have changed patient care except that reality intervened and that was in our first ALS Study we found out that there's patients I don't for those of you who don't know the disease toward the end you can't talk I mean on our and that's how you sound when you talk and your caretaker can usually get that mumbling in a way that a stranger can't and The patients wanted to talk to the doctors alone but For speed they had to have the caretaker there So that we recognize that there was a real need and and the neurology clinic tried to introduce Private patient time, but it turned out Yeah, that's a good example. Do you fellas have anything you want to cite? You know the challenge in any published data Here and change in clinical practice here is being able to show that that's cause-and-effect Yeah, I mean I breast cancer therapy. I think about the randomized controlled child trials that showed that lumpectomy Was equal to mastectomy and everybody says see what it did to physician practices and yet It's possible that it had nothing to do with changing physician practices Papers published New England Journal of Medicine Community becomes aware of it women become aware of it and it's not that the surgeons read the paper and changed their practice This is the women knew the data and they came in and began to demand lumpectomy had nothing to do with the fact on physician practices So I don't know I mean it you know the I can think of papers that should have changed The problem in research ethics is that there are federal regulations That put in this bureaucracy that make these requirements that even when we know that there ought to be changes They make it becomes very difficult to change the federal law in the 25 years of interpretation of that law This Terry Davis paper that was published in JNCI in 1998 I mean it's as good as any paper and those that are interested in interventions on improving informed consent in clinical trials Look at that paper and say my god how hard you have to you try this hard You do this much the CD-ROM that we did the efforts We spent trying to get patients to choose their own doses and yet it doesn't seem to affect that I think it's possible that that in and of itself those negative studies change clinical care Because we thought I think we talk about the need the obligation for informed consent So much more now than we used to and I think there are clinicians that really do try to do things It isn't just given the form and leave the room. They say I know the form is it relevant I know it from my own personal experiences and now I know that it's in the data that the form doesn't provide help And so it's all on me or it's on the research nurse It's a really perform the vital obligations better now So I can make the arguments that I think you know it has changed Rick you want to pipe in here before we turn to the first shifty just again the world of childhood cancer I think things are different because of some of the work that was started here. Whereas in the old days Kids were just put on studies I think the younger generation of pediatric oncologist really does inform consent and they accept when parents say no thanks I don't want to be in that in that study and the kids are still going to get good care despite their non Let me just reflect mark that there I think there are Examples of this and some of them are probably moderate. Maybe we could even identify some that are that are major I think the pulse that we heard about this afternoon might be an example of but I just want to reflect collectively in the room Why don't we start thinking this way on the impact end and then and and work backwards because until we Calibrate the until we sort of catalog those successes and start to argue about impact of the research It'll always be a bit of a niche push strategy until you've really got those successes to build on and mark your reflections And then I know Laura has a comment But maybe you can make that in your in your talk as well because I want to shift I'll be very brief, but I Think the panelists I thought your question was a great question And I think the three panelists are being too modest in certain respects With regard to the Zimmer paper Which is one of the papers in the book and the one that that Chris mentioned The Zimmer paper is an extraordinarily radical paper and if you talk about changing attitudes in a field You have to read that paper carefully. It was the reflection reflections of a dying Anthropology professor Brilliant obviously, I didn't know him. I just knew him from his writing About his attitudes towards the dying process and his commitment towards clinical research what what Chris and Mark retain That then did with that with that With that document is they developed this really radical understanding of two attitudes to society two different societal attitudes towards clinical research One that they regarded as rather cautionary conservative and prohibitory Which came to be called the Nuremberg paradigm that that researchers always have to be suspect and that the patient or the subject is always vulnerable and likely to be taken advantage of and Then the paper contrasted Contrasted that traditional attitude towards clinical research with the attitude that had been emerging in the late 1980s and early 1990s that that paper came out of 95 And they called it the AIDS paradigm The AIDS paradigm was contrasted with the Nuremberg paradigm was a very different social attitude Towards medical progress and towards the people who create medical progress the investigators It was an attitude in which the subjects were not vulnerable, but in fact were Co-investigators with the researchers They were saying that we have potentially lethal diseases or actually lethal diseases like advanced cancer or like AIDS and we insist we demand that we be participants with you in Trying to overcome or discover solutions to that It is I believe Attention that continues to exist in the American research community and the ethics community also as between these two fundamentally different attitudes towards clinical research and And that paper clearly took sides with one of them I so I point to that paper a second paper on Which Rick referred to and and Carol was a part of Was again an extraordinarily radical paper the one that Rick was lead author in the New England journal on bone marrow transplants for sickle cell disease That that paper I think John Lantos was on it and with John John and Bunch of other people. Yeah other people. I mean that paper That that paper which studied which studied only 57 Only 57 children and their surrogates turned out that 56 of the 57 surrogates were their mothers in in the University of Chicago sickle cell clinic Essentially showed Something that had never been showed before and that is that when parents make decisions for children With respect in this case to pretty terrible Disease sickle cell disease and in its worst manifestations They often do so Not only based on the child's needs but also Based to a degree on their own needs and values that is there now being the parents needs and values a radical Interpretation of the millions upon millions of decisions that go on in this country Every week every month in not only in pediatrics But in all the adult situations in which surrogates are participating in decision-making A paper whose whose implications I think have never been fully explored or Discovered but but those are the kinds of papers that really can change can change fields My point isn't that they're not there. My point is we're not good at Analyzing that and talking about them. So I think the sort of if it's 10 seconds because we're moving on in 10 seconds Can you do it in 10 seconds? You know your Absolutely right and what a great segue to our next session on teaching ethics. So with that I'd like to thank this panel Now just before introducing the next couple of speakers, there's a gentleman here who's Trying to escape and I just want to acknowledge him before he does Dr. Pellegrino is obviously obviously one of the giants of medical ethics and Ed Ed just wanted to Knowing that you're leaving for three Just wanted to acknowledge on behalf of mark and everyone here how much we appreciate Not only the 25 years of work. You all have done together the both of you together inspired many of us You're a giant in the field of medical ethics I wanted to acknowledge that wanted to thank you very much for spending a couple of days here with all of us and For so graciously participating in this meeting Ed's a little too young for a festrift, but at some point we'll The next session then is on teaching ethics and thank you so much for that segue I'd like to introduce both of the speakers and then ask them to Come and give their presentations Jordan Cohen is actually a giant of US medical education. He's the president emeritus of the Association of American Medical Colleges Having served for 12 years as the president of that organization In addition, he's now the chairman of the Alfred P. Gold Foundation Which advances humanism in medicine through innovations in medical education? He also serve serves on the boards of the Josiah Macy junior foundation of New York the foundation for biomedical research The Morehouse School of Medicine National Medical Fellowships the Cotter Foundation and And other groups. He's also member of the special medical advisory group of the Department of Veterans Affairs Like also to introduce our second speaker at the same time and that's Laura Roberts Now many of you heard John Lantos introduction of Laura Roberts Yesterday, I think the key words there. I won't repeat the day were people here yesterday. Do you remember that? Yeah, so that might be part of the story I'd like to try an alternative approach to introducing Laura Roberts and we'll see which one works for you Laura is the Charles E. Kubli professor and chairman of the Department of Psychiatry and Behavioral Medicine at the Medical College of Wisconsin where she's also the chair of the Department of Psychiatry and behavioral medicine She founded and serves as director of the empirical ethics group Which is a multi site multidisciplinary research team devoted to exploring clinical ethics issues in medicine She's received fellowship training and served as the director of the programs at the Center for Clinical Medical Ethics here at the University of Chicago the McLean Center and then she joined the faculty at the University of New Mexico before moving to Wisconsin and For those of you who may not be aware Laura really has gone included her medical ethics roots, but has gone well beyond she's really one of the true leaders of Academic psychiatry in the United States. So with that Jordy, could I ask you to come and give your presentation and thank you very much for being with us? Well, thank you, Peter Despite that very generous introduction. I really have to start with a caveat. I have no authentic Bonafides for being up here If I could paraphrase Lloyd Benson when he had that famous debate with Dan Quayle I know Mark Siegler and I am no Mark Siegler I'm not a clinical ethicist. I'm not an ethicist. I'm not even sure I'm ethical, but I Really am just enormously honored and privileged to be here to to pay tribute to mark who I do know And I got to know mark first in 1982 when I took a somewhat bold leap of faith leaving a very comfortable division chief this chief's ship at Tufts New England Medical Center to Come here to take a flyer as the chairman of medicine at the late and lamented Michael Reese Hospital At that time I was Somewhat related to the University of Chicago. I think there was a fairly ambivalent view about the relationship between the University and Michael Reese at that time. But one of my very early memories was of this teddy bear walked into my office Nounced himself as Mark Siegler Said he wanted to welcome me to Chicago and invited me to participate in one of his Sessions where I was interviewing a patient who we were discussing some of the Interesting ethical issues that were arising there. So I was enormously grateful for Mark's Initial overture of friendship and his continued nurturing of my academic life while I was sequestered over there In Michael Reese. Well, I stayed at Michael Reese until 1988 Which is an interesting year because it marks the beginning of this lecture series 20 years ago And I figured that when I left The ethical climate in Chicago improved to such an extent that it was possible to start this So I'm want to at least take some credit for the initiation of this series. So from that Spanish point Well seriously, I wanted to say a few words about this very seminal paper that Mark wrote in 1978 30 years ago in fact 30 years ago Mark said that the design of medical ethics curricula remains in an experimental phase We're about to tell you that we are still in that phase He pointed out though that there were ethical activities going on in medical Education that there were ethics seminars courses lectures workshops these issues as I learned yesterday where I think a Reflection of the fact that that time Clinical ethics was really not a field that was well recognized within the ethical community that there was the Philosophers and the religious thinkers that were dominating the teaching of ethics and that it was done in a classic Academic setting and not in the clinical arena. He also pointed out that ethics grand rounds were about where we're being started at that Time does anybody know where ethics grand rounds began? It was at Stony Brook. You know who the Dean of Stony Brook was at that time Ed Pellegrino, I'm really sorry that had left when he did Because I'm going to make additional references to him But Ed was obviously a pioneer in this field and he did begin ethics grand rounds that concept when he was Dean at Stony Brook in the in the early 70s Well mark pointed out that this mode of teaching medical ethics really lacked a Certain authenticity and that the basic rationale and I think also as I think was pointed out in that article as well a rebuttal at the same time about teaching clinical ethics at the bedside and what mark said was it is counterproductive to remove ethical considerations from the holistic concerns of the competent clinician And I think that statement can and was read two ways one way was that you can't teach ethics in that setting because it's inherent in the way clinical medicine is Produced is and it's in its legitimate and authentic form and that it's it's artificial to think about ethics as somehow being embedded rather than being sort of inherent in the in the Clinical activity on the other hand. It's also fair to say that the arguments for teaching clinical ethics at the bedside in the context of teaching clinical medicine are very powerful And I think they're virtually axiomatic and that clearly was marks point in this in this seminal article first of all The intensity the immediacy what I would say is the poignancy of the bedside encounter Just gives that Relationship between the learner and the and the teacher a certain emotional and contextual Sense that is simply not possible to duplicate in any other setting having the immediacy of that patient Issue right before you and involved in the in the actual issue gives that Teachable moment if you will and the court an incredible amount of power Secondly the patient as teacher the Oslerian tradition that mark actually the title of the article was Included a an allusion to Osler as the sort of the the architect the archetypal and the inventor if you will Of the clinical bedside teaching and at this notion of teaching clinical ethics at the bedside was very much a part of that Very strong and dominant powerful tradition of teaching clinical medicine in the presence of the patient and seeing the patient as Really the predominant teacher in that in that setting So this was another strong argument for teaching clinical medicine at the bedside and as another argument that mark noted that that when ethicists in the previous iteration Tried to impose or suggest or offer ideas about how to teach medical ethics to the physician Was often seen as an intrusion on the physicians so rightful Domain it's the hegemony of the doctor being Suggested being invaded by these outside forces that we're telling the doctor something that he or she Should have known already So the notion that teaching clinical ethics having the clinicians teach ethics at the bedside was a counterweight or a resistance to this notion that Ethics was not something that ought to be included because it was an outside force looking in Medical ethics will become an integral aspect of professional life when it is taught to medical students at the bedside and when it is No longer artificially divorced from the practice of medicine a quote from that article another strong argument for teaching clinical ethics at the bedside and Finally modeling the true physician the complete physician, which is probably the most I think compelling argument for Teaching clinical ethics at the bedside and what mark said then was to practice ethical or humanistic medicine effectively The physician's first and principal obligation is of course to become technically competent Simply being ethical is obviously not sufficient technically competent The ethical issues of caring for the patient should not be arbitrarily divorced from the act of caring for the patient Again an echo one. I'm sure here's a Francis Weld Peabody's famous aphorism that to care for the patient Is to care for the knowing how to care for the patient is to care for the patient Well that Gives me an opportunity to take a brief aside and talk a minute about the Arnold P. Gold Foundation that Peter mentioned Is one of my current activities the chair of the board? It's interesting that the Arnold Arnold P. Gold for some of you May not know is is still a pediatric neurologist at Columbia Very very respected very effective pediatric neurologist who exactly 20 years ago 1988 the same year that this series began Started this foundation because he was so frustrated by what he was seeing as the as the tendency of Students and residents in particular to be so captivated by the technology that was growing up in medicine that they were losing touch With the humanistic aspects the ethical aspects if you I'm using humanism here Very much as a synonym for clinical ethics because I think there's a tremendous amount of overlap in those two in those two Concepts and just to back up a square the ethical issues of caring for the patient should not be arbitrarily divorced From the act of caring for the patient what what Arnold Gold was observing was in fact that there was being a Divorce of forced separation if you will not forced on but was something that was spontaneously seeming to emanate from the over Concerned of the the the power of the technology being so persuasive and seductive that it was taking at least in his view the viewpoint away from the Ethical issues the humanistic issues amongst so he started this foundation that in the past 20 years is I think had a very interesting Relationship to the McLean Center and it's its activities It's trying to embed in medical education the attitudes and preserving the attitudes of humanism and humanistic care Among young physicians as they are learning their craft and becoming acculturated to to the profession Many of you may know about the white coat ceremony, which is the signature Activity of the of the of the Gold Foundation does many other things for professorship small grants also has formed Gold humanism honor societies and now 72 medical schools across the country where Students in their third year select 10 or 15 percent of their peers peer selection of those students that they think are most emblematic of these humanistic qualities to form not only an honor society, but also a change agent group that is Poised to affect cultural change in their institutions to keep these ideas of clinical ethics and humanism alive Well with that aside, let me also get back to the paper and Mark's pointing out that there were many barriers to teaching Clinical medicine at the bedside that he recognized 30 years ago. They were physicians are Questionably qualified to teach medical ethics. Do they really have the necessary grounding to carry that? Curricular activity through to the students at the bedside Medical students may be ill-prepared to learn medical ethics at the bedside considering They're limited of any background in the humanities or certainly in in philosophy and in the ethical grounding of the profession So could they actually gain that knowledge many important issues in medical ethics may not be encountered at the bedside Currently, that's clear and we've heard a lot about them Yesterday and today that there are issues that simply don't arise in that setting that are also critically important for students to know It didn't seem to me that that's an argument at all against teaching clinical medicine at the bedside But simply points out that it has some inherent limitations and finally and I would say perhaps most importantly and certainly Reference to today that physicians may be reluctant to formally teach medical ethics at the bedside even if they may feel themselves confident And I would argue that each of these four issues certainly the three that are directly related to the bedside issues Are very much alive and well today unfortunately in fact more so particularly the the last issue here I think everybody knows that the the plight of the of the of the clinician educator the physician is trying to Be both a clinician and an educator on the wards or even in the ambulatory setting is so pressed for time So burdened with the need to be productive in the in the marketplace of Academic medicine these days that the amount of time available to devote to the teaching mission is one of the most important I think limitations that were currently challenges that were currently facing as Educators to try to figure out how to preserve that precious resource namely the time of the clinician teacher to involve him or herself in this important activity and Clearly to teach clinical ethics at the bedside in addition to the other Agenda items or curricular items that the clinician teacher has to Fulfill is a daunting task under today's circumstances So I think the the expectation that we're going to find clinicians at the bedside that are actually going to carve out time Or find the space in their lives to really fulfill this expectation is is at least dubious in my view which is to me on the positive side an absolutely Compelling argument for what the most important way in which clinician educators teach clinical ethics and that is by role modeling by simply being ethical and Observing the ethical norms in their day-to-day activities in their day-to-day treatment Not only of their patients But of each other and of the staff and of the students and all around that so-called a hidden Curriculum that we all I think have recognized for years as being the most powerful Learning device that exists in medical education perhaps in other forms of education as well But certainly in medical education the power of the hidden curriculum the way in which Physician teachers role models interact in their own lives in their own with their own patients are the messages that students learn Most effectively and carry forward in their own Modeling of that behavior in their own lives So the fact that that the clinicians have I think limited time to fulfill the sort of expectations that mark was laying out 30 years ago. I think is a is is true But I think it also underscores the importance critical importance of those individuals Remaining themselves the valid authentic role models for for clinical ethics that they must be if we're going to really sustain This activity and this set of values for the future Well mark quoted Ed Pellegrino, and again, I'm sorry Edison here to recall this but five years ago in 1973 in an article in a book that was published published by the Hastings Center Ed said the following a number of students will need to be trained Both in ethics and medicine and in medicine as some are trained now in biochemistry or physiology in medicine a Combined program in medical ethics deserve serious consideration as a source of future teachers in this field So here it was 30 years ago that mark was recognizing the wisdom of his teacher Ed Pellegrino in what I assume was one of the Formative ideas that led to why we are here today celebrating this last 20 years or more of Fellowships and of the enormous enormous impact that mark and obviously through all of you have had on this field And I'm just just enormously enormously proud of what mark has accomplished in this regard And I'm sure he acknowledges his debt to Ed Pellegrino for pointing out the need to really institutionalize this activity in a way that's been so dramatically effective in the McLean Center's Activities and its and as many many successes So mark through down finally a gauntlet that I want to end my my beef remarks with and it's the following Moral discourse in the context of clinical medicine will not become a legitimate enterprise for medical students and house Officers until it is used by their clinical mentors at the bedside again the mentoring idea and Until attention to these moral ethical issues can be shown to improve patient care and Physician satisfaction an issue that Peter raised yesterday and his remarks and just came out in the discussion We just had in the previous panel now I'm not a student in this area But I gather from the quarter conversations that I've had that there is precious little evidence in fact That there is been an effect the positive effect on patient care or on physician satisfaction for that matter but particularly on patient care on the outcomes of patient care that can be accounted for a lot of two clinical Ethics and I would sort of now Suggest out of total naivete a research agenda that I would wonder whether or not it's worth trying to pursue Recognizing how difficult it may be but one of the thoughts that has occurred to me during listening to these activities over the past day and a half is that it seems to me that the basic rationale for teaching clinical ethics is the Assumption that there's some gap between the optimal Nature of clinical decision-making from the ethical point of view and what is actually going on That I think we all Must agree that there's something to be gained from teaching clinical ethics because we think that there are Decisions being made out there in the real world that fall short and by some measure of the ideal we'd like to see Characterized the profession more generally Well, is that true? If so to what degree is that true would it not be possible to do a Study in which one took a period of time in it in a particular setting a hospital setting a clinic setting both office setting whatever and just look at the decisions that are actually being made by practitioners in the real world and Evaluate them as to whether or not or how close or not they approach what you would regard as an appropriate standard of clinical ethics and in that way having some Measure of what we're trying to accomplish in some way of Calibrating whether or not this ethical this educational activity over time is producing an effect be interesting I grant that it's probably an impossible study to do But you have some very bright researchers here who can perhaps figure out how to mount such a study But I wonder where whether that would help Not only ratify the work that you're doing in the teaching of clinical ethics But would actually give you an opportunity to fulfill this expectation of this gauntlet That marked through down 30 years ago. So with that, I thank you again. Thank you for your attention Thanks, and Laura could ask you to come and give your paper. Thank you Well as we're getting started What Peter didn't want to say is that I was the person who was introduced yesterday as the barefoot pregnant medical school drop out 20 years ago and in fact I met mark when I was 21 and It's really a joy for me to be back here And and let me express my appreciation to Laney and to John and to Peter and also I also want to tip my head to Dr. Cohen, I was a medical student at Michael Reese in 1986 and Dr. Cohen was there and when I learned that I was going to be presenting today with Jordan Cohen It was like you know, Prince it co-presenting with God And so here I am and I thought rather than over viewing medical education I would kind of talk about the unique perspective I have on mark with respect to leadership and medical education and I think with both mark and with dr. Cohen one of the great formative Experiences I had when I was 21 to 25 was that real people real people become great and Influential individuals in American medicine and can really do good, but they're real people. They're not somebody else They're us and that's one of the core issues in leadership is accepting that we are the ones who are responsible for carrying that forward But saying all that and I hope you know I have tremendous admiration for mark I will also tell the story of how I avoided him like the plague my god I was told because I was one of these liberal arts kids at University of Chicago I still don't we've got to meet mark Siegler So I was kind of wandering around the halls and I ran it bumped into mark and he learned my name And he said oh, I've heard of you come come talk with me And he brought me into his office and this waft of cigar smoke came out Honest to Pete. He was wearing a big purple bow tie Do you still have it? No good Good judgment. He had He had a spittoon. He I never saw him use it, but he did have it he had a Thing besides like of a hubcap that was filled with cigar ashes and old cigar butts on his desk And he says oh you must come work with me And he said and you could help me with this and along the whole side of the wall Were a bunch of garbage bags paper garbage bags and what he would do is he would read the New England Journal He would like pitch it into one of those bags against the wall if it missed it was okay It was like near and so he had done like a dozen of these garbage bags I'm telling the truth and you know it and he was like come work with me. I was like, you know, I have good judgment I am not coming anywhere near you so so I hid I hid for a year and a half and then he was Sneaky and put me into his small group and physical diagnosis in the medical school and thus began a great great partnership and This person who I avoided like the plague actually really gave me the greatest lessons in leadership and mentorship and In the fulfillment of duty in in this life, and I'm going to talk just a little bit about that When we think about teaching which is really this Source article that we're supposed to be discussing now. I really want to talk first about leadership You know mark is a great leader in education He's a great leader in research is great leader in ethics great leader in medicine and the reason he is is because People turn to him. They trust him. He is the one who they believe should carry the responsibility for certain kinds of things His vision his creativity His strengths his the courage and intellect the unique combination of courage and intellect which was a little bit adolescent back in the day Okay, but still was very fair very thoughtful fundamental decency fundamental kindness Generosity that was amazing and you know everybody talks about the vision of leaders, you know what they see the imagined world And I honor that but what is really amazing about great leaders to me is what are the givens? What are the absolutes? What are the things that you cannot? Continue what cannot happen? If it continues to happen you cease to be you you cease to be who you are because you've permitted that to happen around you So Annette talked about how you know mark didn't write in the literature a great deal about African-American issues or about women's issues But he went ahead and he brought in African-American women to help lead and develop the field for me I was in a medical school where nobody was pregnant. This was not an accepted behavior And yet he brought me into the fold gave me room to create and develop things He's almost as good as a feminist in fact you might be better than a feminist through action not through necessarily the words themselves So the idea is leaders do what they cannot not do Leaders do what they cannot not do and they stand for something so great that other people turn to them and in this paper what you see is an Elaboration of things like the importance of multidisciplinary thinking Mark cannot help but think about history as he's living out this moment He cannot help but think about the intellectual History the impact across multiple disciplines as he's living out this moment and that is how he leads It's through that example. It's through that intellectual commitment. He carries the wisdom of the past He believes in the human condition as the greatest teacher He believes in the human condition as the greatest teacher He believes that by putting medical students at the bedside with people living out illness and disease showing courage and heroism As Helen Keller describes here at the same moment of immense suffering That that itself will be a great instructor, but not alone You have to have the intellectual kind of cultural Mill you and refinement the revision of your thinking through the information that shared through these intellectual Backgrounds so it's the combination of experience and intellectual history the experience the theory and the evidence together And I will tell just one story about how I became a psychiatrist and an ethicist It was when I was I had been in school here I went to work at the orthogenic school do people know the orthogenic school school for mostly disturbed kids Started by Bruno Betelheim many years ago in that school Many children with a variety very very diverse diseases were placed in this school It was which is a basically a longitudinal residential treatment center But back in the day in the 1980s 1970s children there did not receive Diagnoses because it was felt to be stigmatizing children there were all treated as All potentially healthy children, but who had had misguided parenting and so for example They were separated from their parents for a full year not permitted to have any contact with their parents when they were enrolled in the school They were not given diagnoses because that was felt to be Diminishing of each child and yet I kind of naively at 20 whatever years old walked in That there were children who came and they couldn't put a thing down They had to put it down like 15 20 times. They had to walk into a room and count count count count They didn't speak they went for years without words And so it was very clear that it wasn't just that they were like fine and like maybe their mom was like mean to them there was There was something fundamental Biologically different about these children and so what I became as a psychiatrist and an ethicist because in that moment I realized that very wonderful people worked there tried to do good You know the issues of Bruno Betelheim and his psychopathology came out later But the fundamental issue of other people who worked there they were attempting to do good through their work But they lacked a medical model. They lacked a biological understanding of the diseases that were Driving the experiences of these children and so in that moment It was very clear that evidence the biological phenomenon a lot phenomenology was incredibly important and that by failing to recognize it There was an ethical harm that was being done because children were deprived essentially of an ethical standard of care and appropriate Standard of care by being in the school you see so in a moment It became both a psychiatrist and an ethicist and this is why along with mark I also believe that the care of patients is the greatest instructor of ethics as well as of medicine So let me tell you some more about his leadership and it was really through leading through example It's just the point that dr. Cohen made a few minutes ago We heard earlier from dr. Moss about how mark struggled with the issues are as ethical consultation good our committee's good How do we do this the constant? Wrestling and relentless struggle with different issues fantastic role modeling for all of us in this room We should not have pat answers for these really hard questions. This relentless questioning was extremely important You don't have to agree with mark for him to honor your perspective This role modeling where he caused people to think hard come to their own conclusions Revise their conclusions change their minds later because they knew more was fantastic role modeling that leading by example And that was very very important in terms of the educational impact that he's had I also want to tell you one other story about this leading by example and the education that he did in clinical at The bedside and I kind of disagree with you dr. Cohen and with respect to one thing I think Every moment that we are in medical settings. We're teaching. We're providing care every moment every interaction is potentially therapeutic And every moment is potentially an educational moment and you probably agree with that But the fundamental experience of watching mark in the clinic was like Education in motion and I want to tell one story and I don't know if the patient was at the dinner last night but more than 20 years ago I Followed mark to clinic because he was frantic doing a million things and I had to kind of pick up pieces of paper behind them or something And he introduced me to a medical to a patient and he said he took her hand in his hand And he said I want you to tell Laura. She's a medical student. She's becoming a physician I want you to tell her about the mistake I made in your medicine So here I am dumbfounded and the patient turned to me And she said, you know dr. Siegler gave me too much of this one heart pill and it made me feel funny But I called him right up and he said don't take any more Which I thought was good good judgment again. Yes, and and so the patient came in and they talked through What was the medication? What was the right amount? What was the symptoms that she's experiencing? But can you imagine I mean really can you imagine being a medical student and hearing a Professor invite his patient to talk about a mistake that they clearly and honestly had worked on together Whether it was truly a mistake or really a dose adjustment. I really don't know you were very Gracious in terms of how you described it, but it was very honorable towards your patient And she got the chance to teach me something which was you know special for her But the idea of being self-afaced being humble being a person who could make mistakes was really an amazing Experience for me as a medical student at that time Here's a slide can you see it says and give me good abstract reasoning ability interpersonal skills cultural perspective Linguistic comprehension and high socio-dynamic potential It's a great slide if you want it. Let me know I Include this because and I'm coming close to that in my remarks relax Peter Because you know mark doesn't believe that ethics comes down from your mother's knee come down from the Lord It is something where there's an intellectual connection with it There's a self-observation capacity. There's an interpersonal and emotional intelligence piece to it If I could use the jargon of the day, but that it is something that is a skill that is to be cultivated It developed be informed in a rigorous intellectual and heartfelt way it's not a gift and I always include this because it's just so fabulous Thank God a panel of experts I like this one too because In truth, he actually does value expert perspectives But the the beauty of this slide is it gets right down to this is life or death and You know somebody talking fancy etch is not going to help you in that particular day And that I think really captures some of the issues from our key is always Thoughtful about the intellectual history Gathering expertise, but always staying riveted on what is the fundamental question So Florence Nightingale said it well, I think one's feelings that waste themselves in words They ought all be distilled into actions which bring results Mark is a man who needs results. He cannot not have results to feel that he is doing good in this world And if there's one thing of importance to him He is an individual who through action brings about good ideas are wonderful the inform action, but they are not enough So let me close with Just a couple final comments, you know life is hard Life is very hard people in this room have been through a lot I've been through a lot and those who know this say that you know life dishes up both joys and sorrows and I think for me one of the great treasures is having a mentor of this extraordinary quality and it leads me to treasure mark this perspective of You know how life can be quite rigorous But it also makes me treasure you because you're here and you're people that mark himself treasures So I encourage you all To think about what it is that you cannot not do What must you do to be who you are? And to think about what that is and what that gift is as you propagate this work further. Thank you great jury and Laura could I ask you guys to come up here? So we've got to sorry. We've got about six or seven minutes to have some questions or comments from Jordan or Laura Lainey, please. So first I want to thank both of you for just very very informative Dr. Jordan and Laura for such a heartfelt talk My question is actually this seems to be the whole professionalism movement which has started about within the last decade Has sort of usurped the ethics concepts and yet uses a very different group of people to teach And so we have when you read the professionalism literature in fact, there's a whole professionalism Journal that just came out of perspectives and biology and medicine and there are actually two ethicists in that But that's actually quite rare and we just did a survey of pediatric program directors and the ethics programs are in the sense Disjoint and separate. I thought I'd like to hear you comment on it because in my mind ethics I mean professionalism is just subsumed within and through ethics Want to start Jordan I just I absolutely agree with your with your observation I think the professionalism movement really has focused a good deal more attention in recent years on Some of the fundamental values that we're trying to preserve in clinical ethics and professionalism humanism I think they're they're one can parse those words and Categorize different elements, but I think they overlap tremendously and I think the professionalism The focus on professionalism is an opportunity to really enliven the whole area of clinical ethics And I agree. I think it's not been I mean It's hard enough to teach these issues as we as I try to talk about as Mark pointed out in his paper Place to teach it is at the bedside and that's where I think the acculturation the professionalism the professional identity of students really is either is reinforced or emerges as they go through their education and training and I think we do a dreadful job of Modeling the kind of values and behaviors that we that we rhetorically talk of is normative But which clearly is not normative in our culture because of the way we actually do behave in the way people See the way we behave. So I think we really have to pay much more much much more attention to the so-called hidden curriculum I think it's obviously important to have the didactic sessions to have the seminars to have the research done to have all The scholarly work done that underpins clinical ethics But until it gets actually embedded into the into the culture of the Institutions that we are dependent upon for teaching and in our students are learning in we're going to be fighting I think at a losing battle and I don't think there's been enough attention paid first of all To analyze that hidden curriculum to really understand what the elements are that that are that are dispositive in terms of Forming attitudes and behaviors and as I said before we need that we need to measure it We need to find some ways to calibrate what is actually going on and and reflect that Reality that that empirical evidence against what we're trying to accomplish and and then defies ways to improve our performance It's it's not it's not rocket science. I think we haven't applied sort of the methodologies that I think we understand to be Essential for advancing understanding in any field to this very critical area of our responsibility Laura and Jordy what I'd like to do is very briefly is collect up a couple of other questions and comments and then have you both respond Do you have something you want to say very quickly? I mean, you know, you can get pretty caught up in the oh The complexity of it and the politics and territoriality of it for me I think be very my advice to all of us is be very pragmatic view ethics is the intellectual discipline that is the platform for all of this work with You know history law Social sciences with moral philosophy all informing it and use that and let's not get into a clash the Titans Let's just assume the intellectual basis of the field is informing professionalism Great. Can we have a question or comment? I think that's Mary, right? and then and then John if it's okay with you Laura given the way he introduced you yesterday and Then we'll get you guys to respond and we'll take our break Mary. Please go ahead ladies question Brings up a thought that I've been ruminating about a little bit. A lot of us here may have taught I certainly taught Medical ethics to undergraduates for a lot of years before I moved, you know to a medical hospital setting a long time ago and All of our conversations everyone here. It seems to me the entire discussion is Is directed from the standpoint of the clinician and in fact Medical ethics and clinical ethics doesn't only have to do with that perspective It also has to do with tations whom all of us are at some time in our lives as well and So I guess when I try to teach clinical ethics whether in the classroom or at the bedside It seems to me I want to retain. I think we all ought to retain That sense that ethics is never from a single person's Perspective that it has to be viewed and actually even sometimes mark I Sometimes think of this when I hear so many discussions of the doctor patient relationship and That comes across to me sometimes as kind of an abstraction Because as a matter of fact There is a not an abstract duo here There are sometimes Not too often actually, but there are sometimes a Single clinician and a single patient in conversation, but both of those individuals are right there and Meshed in a bunch of relationships that they bring to this and and I think there's a danger of our thinking of medical ethics as just this sort of one-way Function or as a single professions Function towards others and so I'd like to hear Whether you agree with that and if clinical ethics or medical ethics is broader Than that single perspective. What would be some ways that? We could broaden our Discussions of it and you will hear that along with their response to John's question who's going now I'm just trying to sort out the Competing vectors between teaching ethics at the bedside and this O's flurry and model that You exemplified in the story of going to clinic and having mark teach and all the bad things that we say about the hidden curriculum Because the hidden curriculum is all the teaching at the bedside that people get that Presumably we are trying to counter with our Didactic or explicit or non-hidden curriculum in ethics classes So if you set it up that way it seems that most of ethics teaching at the bedside is in fact bad That people are getting negative role models in this hidden curriculum that we're trying to oppose So if that's true, should we do less teaching at the bedside and more didactic? So a couple of comments when you guys go first other go second Yeah, I'll just comment a couple things I mean you've provided Mary the entire basis of all the research work that I do which is to look at the perspectives people living with HIV Schizophrenia diabetes cancer All different whether they live in rural settings whether they live in inner-city settings What their experiences are in the context of research and clinical care and trying to integrate that into educational Settings, we've done some pretty interesting even a randomized Educational trial looking at how introducing patient perspective and family perspectives What impact that has on the attitudes beliefs and intention behavioral intentions of Physicians in training regarding integrating ethics in their work and so I would just like to say that there are models out there There are a lot of data that relate to this There are historical vehicles for including patient perspectives family perspectives in teaching I just think you're right. They should have greater primacy throughout all of the work that we do Well comments about the first set of comments as well first of all, I think you're absolutely right I think that the view ethics is as doctor to patient is is a very myopic and Distorted view and I what brought it what two things brought were brought to mind by your comments one is that Back to professionalism that the single most important pillar of medical professionalism is the primacy of patient interest And I think if we think about what we're doing always is being what is in the interest of the patient Which means we have to understand what that interest is first of all We have to engage the patient in a in a some sort of a communication so that we can in fact Evaluate what's in their interest and then be on her bound dutifully to Fulfill our obligation to meet that interest as best we can and you're right about the fact that that Certainly in modern medicine is very it's less often a dyad than a multi ad I don't know if that's a word, but there are multiple relationships that that are Important in terms of Delivering proper care and and certainly over a lifetime of the illness for a chronic disease patients And there is I think in addition to the sort of the individual Providers having their own individual responsibilities. There's something over and above Called I don't know whether this is the proper term of organizational ethics. There's a certain way of organizational behavior certain Standards of organizational behavior that are not just the sum of the individuals who are in those organizations But really has to do with policies and ways in which organ seek organizations are are or are put together and The patient's interests obviously in mind that they're I think that's an area that hasn't been as well examined as individual physician and other provider Education and I could comment on John's point You're I mean that the observation is that much of the of the clinical Ethics teaching is bad because it's going on in this in this bedside Domain where we are seeking so much of the What we'd like to see you avoid it But I don't see any way around as long as we're wedded which I think we we should be and will continue to be to The Oslaurian model of teaching clinical medicine largely in the patients In the presence of escape that classroom that that point of Learning and hence we've had great Laura you want the 15 second closer far away those last words were where we need to Improve our clinical ethics teaching Just very quickly. I think this is an issue of leadership Also, this should be a given it should be a given that every interaction is therapeutic and respectful And that needs to be very widespread And I think the key to that is to be in touch with people's own personal experiences their own health The experiences of their loved ones because if you've ever been treated as an object in a health system You will never do it to the next person. So creating educational Situations where there's some recognition that creates greater empathy for the patient experience I think is a really a critical method for getting there So let's thank this wonderful panel