 Good afternoon, everyone. I'm Jeff Flyer, Dean of Harvard Medical School, and it's really a great pleasure for me to welcome you this afternoon as we consider the question, why care about bioethics? Justice for this. Why, indeed. Before we hear from our distinguished guests on this critical topic, let me say that Harvard Medical School has a long history of caring about bioethics, and this field has a very bright future at Harvard Medical School. First, just a couple of words about history. The original George W. Gay lecture in medical ethics was delivered in 1922, making it the oldest endowed lectureship at Harvard Medical School, and quite possibly the oldest medical ethics lectureship in the United States. Since we don't have definitive evidence, we'll say quite possibly. The fund was established in 1917, a gift of $1,000, allowed it to begin. It was a gift from Dr. George Washington Gay, an HMS alum, from the class of 1868, and actually went back and looked up the terms of the original gift. And I'll quote, the original terms were to support a lecture to the classes of the medical school upon medical ethics and upon wise and proper methods of conducting the business of physicians as relates to fees, collections, investments, et cetera. So while the Gay lecture series still addresses medical ethics, it's gone far beyond the ethics of physician fees and collections, although this topic remains one that we talk about every once in a while today. Past speakers have included Margaret Mead, Felix Frankfurter, Elliot Joslin, E.O. Wilson, and Elizabeth Kubler-Ross. Closer to her own day, we've heard from Elie Wiesel, Marion Wright-Eleman, and Cass Sunstein, among many others. I'd like to say thank you to President Gutman for joining that illustrious list, and to thank Provost Garber for being here with us today as well. Today's event marries the old and the new lectureship that goes back to 1922, hosted by an almost new Center for Bioethics established this year. Harvard Medical School's growing commitment to the field of bioethics was underscored last year when we evolved the division of medical ethics, which goes back quite a long way, into the independent Center for Bioethics. And just last month, we welcomed the Center's inaugural class of 22 students in our new Master of Bioethics degree program. And having met them at an introductory dinner a little while back, I can tell you they are a remarkable group. These extraordinarily talented students joined 12 new members of the long-running fellowship in medical ethics, whose past fellows have gone on to assume major leadership roles locally at their home institutions nationally in their own countries and globally as they work to make the world a better place. Bioethics as a discipline is rapidly evolving in many different settings, many different fields, and geographies. Almost every day in the news, there are stories about situations that call for attention from skilled bioethicists. Just one example. In our own community, we've recently been carefully focusing attention on the potential of the CRISPR-Cas9 technology to edit our genomes and the parallel and really quite pressing need for ethical examinations of how best to use that remarkable new capability. As medicine advances, and we all know that the pace of medical technology and science advancing is accelerating, this will become more pressing every day. So I look forward to hearing today's discussion. I'm sure it'll give us much food for thought on a critical topic that really connects with every aspect of the mission of Harvard Medical School, whether it's education, research, or clinical care. So thank you, Amy and Alan, and now I'd like to turn the podium over to the director of the Center for Bioethics, Bob True. Thank you, Dean Flyer, both for the background to the George W. Gaye lecture, but more importantly for your unwavering support of bioethics here at Harvard Medical School. So this lecture is the flagship annual event for our Center for Bioethics. But as Dean Flyer observed, we have a very active program here. We have almost 100 affiliated faculty, many of whom are here with us tonight. If any of you are interested in learning a little bit more about our Center and our many activities, we have a booklet just outside the back of the auditorium there with separate brochures highlighting our Master of Bioethics degree program, as well as our fellowship program. So in the interest of getting more quickly to what we all came to hear, I will keep my introductions brief. So we are first so grateful that President Amy Gutman agreed to be the 2015 recipient of the George W. Gaye Lectureship. Dr. Gutman is the president and the Christopher H. Brown Distinguished Professor of Political Science at the University of Pennsylvania. As president of Penn since 2004, she has instantiated her lifelong commitment to the value of education and has opened up the possibility of a no-lone college degree to many young men and women who otherwise would never have had an opportunity to attend Penn. She has also continued to be an active scholar in political philosophy and her interest in deliberative democracy. Most recently, authoring the book, along with our colleague Dennis Thompson, entitled The Spirit of Compromise, Why Governing Demands It and Campaigning Undermines It, a remarkably timely theme on full display in last night's presidential debate. And most relevant to the topic this evening, since her appointment by President Obama in 2004, President Gutman has chaired the Presidential Commission for the Study of Bioethical Issues, which over the last several years has comprehensively addressed a wide range of important topics in bioethics, many of which I'm sure we'll be exploring tonight. Now, this evening's format will involve a conversation between President Gutman and our own provost, Dr. Alan Garber. We anticipate that this discussion will last about an hour or so, and then we will have a few minutes for questions from the audience before finishing up promptly at 6 o'clock. By way of introduction, Dr. Garber has been provost of Harvard University since 2011, where he also serves as the Mallon Crot Professor of Healthcare Policy at Harvard Medical School and holds professorial appointments in economics and health policy, in the Faculty of Arts and Sciences, the Kennedy School of Government, and the Th Chan School of Public Health. With his experience and background as both a physician and a social scientist, Provost Garber is a leading expert in issues such as technology evaluation, comparative effectiveness, and health policy. Please join me in welcoming our two gifts for the evening as we listen in on their conversation about why we should care about bioethics. So thank you for that warm welcome on behalf of both President Gutman and me and I especially wanna thank President Gutman for joining us for this conversation. Especially wanna thank Bob and Jeff for their introductions and as Jeff recounted the history of the gay lectureship, it demonstrated two phenomena that I think are extremely important. One of them is the longstanding interest in ethics and bioethics, topics that I think will be with us forever. And the other is the power of compound interest. That may be some of our theme I'm afraid this afternoon, Amy. So this is a great turnout of some people who I think come from varied perspectives who are I assume deeply engaged in the issues that bioethics engages with. And you're at the center of probably the most visible national effort in thinking about what bioethics has to contribute. But for the maybe one or two possibly imaginary people who have the question, why should we care about bioethics? Yeah, so why should we care about bioethics? First of all, we're here, so you are gonna care about it for the next hour and a half. But thank you, Alan, for taking time out of an incredibly busy schedule and thank you all for being here. Everything I say is gonna be what are my opinions. I'm not representing the University of Pennsylvania or the Bioethics Commission. Neither will I try to be intentionally provocative, but I will say what I believe. So why care about bioethics? Well, first of all, and I think it's important for all of us who care about bioethics to recognize that even if you're not interested in bioethics, bioethics is interested in you. So one of the first assignments that we had as a presidential commission on bioethics came about because of revelations decades after they happened about how individuals in Guatemala were treated by the Public Health Service agents of the United States, that's a long time ago. But a timely example is an assignment we had about anthrax and testing anthrax vaccine on children. So let me use that just to show why you should be interested in bioethics and even if you're not, it's interested in you. So anthrax in its natural form doesn't pose a big danger to human beings, but it can be milled and vaporized and when it is, it is a lethal agent. So the defense portion of our government did a hypothetical experiment on a city about the size of San Francisco and determined if some agents who could easily do this released anthrax on San Francisco, upward of eight million people would likely die in the whole, I mean it would just have huge effects. And then they asked a commission, not our ethics commission and one of members of our ethics commission is here is on Harvard Medical School faculty, Raju Kuchila Party, so Raju will remember this very well. They asked a commission which had no ethicists on it to recommend what to do and that commission said test anthrax on children, test an anthrax vaccine on children. The secretary of HHS consulting with the president thought that might not be the best thing to just decide to do without getting an ethical opinion on it and so asked us what should be done. So if you go, there are a lot of Americans, I'm not gonna tell the whole story, but here's the answer in a nutshell. A lot of Americans vote, even more Americans don't vote. A lot of Americans, many more Americans than vote follow sports. Some of us don't follow sports that much. Some Americans go to synagogue, others to churches, others to mosques. We're very diverse. You ask any American, do you want an anthrax vaccine tested on your one-year-old child and everybody will have an opinion on it? It will be an instinctual opinion. The reason we should and we do care about bioethics is that is not an easy question to answer as to whether you should test anthrax vaccine on children. It takes a lot of hard thought. It takes disciplined thought. People will disagree even after they think they thought hard about it, but we had better think hard about these questions. And that's a kind of hot button issue. The other issue is the Affordable Care Act. That's all about bioethics as well. So we should, the simple answer is we should because we care about humanity and even if we don't think we care about it, we do. Thank you, that's a great answer. And I have to say that virtually every hot button issue touching on health could be construed as a bioethical issue where a bioethical perspective could be helpful. I'd like to ask you a bit more about what it means to have a bioethical perspective. And in particular, if one looks at the very distinguished membership of your commission, they represent people who come from different backgrounds, different disciplines. You yourself are a political scientist and as you spoke about the issues with anthrax and with the Affordable Care Act, these have extraordinary political dimensions. And after all, the commission is appointed by the president. How has your perspective as a political scientist affected how you view bioethical issues? So because the commission is not an academic body, I think it's really important. Here we are at a preeminent academic institution. The commission is all of its members. All of our members are academics. We did have one member of the public, Lani Ali who was wonderful. She's the wife of Muhammad Ali and she had to step off recently because of the demands of caring for Muhammad Ali. But it's overwhelmingly, the membership is academic. But we're not an academic body. We're a public body that advises the president of the United States and his deputies and by extension we're a public body that advises the public. All of our deliberations as well as all of our reports are public. That is, it's that context that's the reason why being a political scientist is helpful in that context because we could, and I think some previous commissions aimed to try to come up with the most cutting edge original ideas about distributive justice in healthcare or about, you name it, in bioethics. We think that's not our mission. It's not the opposite of that which is to not care about that. We care about the best ideas. But our mission is to come up with the most defensible and useful advice to the president and the administration and by extension the public. So being a political scientist helps a political theorist because naturally we are educated to think practically as well as ethically. And I could give you some examples of that. Well, I'm just curious about one thing when you say we the political scientists are encouraged to think practically as well as theoretically and ethically. How about the other disciplines? So it depends on the discipline and what it really does. So the great thing about our commission is that we have a wide range of disciplines and in fact all the disciplines represented and they're not representing their discipline. They're just there for what they can contribute. All of them are not, they don't focus on political science but they are practical disciplines. So when we issued the report on neuroscience, it was very helpful to have a neuroscientist on the commission from Stephen Hauser from University of California, San Francisco. It was very helpful to have Raju on the commission who had the experience of how self-regulation in a new field at the time genomics really is better than waiting for external regulation. It was very helpful to have a legal scholar, Nita Farhani, who's at Duke, who again, not all law is practical, but the way Nita thinks about it is. So it's very helpful to have theoretical and practically thinking people who are expert in fields on the commission. And that is also different. It's a credit to our president that he constituted a commission. I believe that, I think it's a credit that they're not all bioethicists. So people might call me a bioethicist. I wrote an article in the 1980s for and against equal access to healthcare. That was my first foray into bioethics. But I think it's good for not just bioethics, but for most ethical fields to have people who know the empirical as well as the theoretical part of the subject and are committed to bringing them together. So you were going to give us some examples, but I was just curious about another aspect that you touched upon. You said that the meetings, everything is open. And anybody who has worked on a commission that's covered by FACA, I don't know whether that's what applied to you. The Federal Advisory Committee acts knows that that generates some opportunities in terms of transparency, as well as some practical challenges very often. How do you have a candid frank discussion when everything is public? How have you managed that and have you felt that? I'm just curious how you felt that influenced the sorts of discussions that you've had. So all of our meetings are conducted in public, but we go one step further and we are committed one of our major principles in thinking about hard cases, as well as in practicing the thinking is to be committed to democratic deliberation. Dennis Thompson and I have written several books together on this subject and we like, depending on who's speaking, since I'm speaking, we like to joke that I represent the democracy and he represents the disagreement in democracy and disagreement. He can turn the tables on me on that, but the fact is that it's not just discussing in public, it's actually deliberating in public and it works very well for advisory commissions in that we have no power to legislate. And I'm gonna talk about legislation in a second because the issue is much more complicated for legislation. So, but let's just talk about advisory commissions. Our power is the power of influence and the first order power is the power of influence over the government. How do you influence a government on difficult issues? They never give us easy issues. There's not, the easy issues, they don't need us. Are you speaking about your presidency? Yeah, that's my presidency too. By the way, Alan, I do say, people ask me why did I agree to chair this commission and what I say is, look, the president asked me to do it and when a president asks you to do something, you should do it. You're not at Penn, but I say that at Penn. So, remember that, you could say it about the process. It applies here too. Right, right, right. So, back to our topic. We can influence the president or the secretary of HHS and by the way, I just brought this, one of our nine reports is on safeguarding children, pediatric medical countermeasure research and I know there are people here who are eminent researchers and clinicians in pediatrics. This was, you could think of this as the assignment from heaven or from hell. It had anthrax, children and vaccines in it. We made very specific recommendations here and we did all of our deliberations in public and the government accepted our recommendations. Now why? I think they're right, they're correct and I think that's necessary, but it's not sufficient. The sufficient condition was we asked every possible constituency to tell us what they thought, we had them at public meetings, we answered their concerns, we didn't satisfy everyone. People are deeply divided on this, but we got enormous positive response to this report because of how respectful we were of people which you can't do in private, you can only do in public and frankly I think how carefully reasoned it was in a public way. So that's deliberation in practice, it doesn't always work out as well as it does in our advisory council and then I can talk a little bit about if we want about why it's much more difficult in our legislative climate to do it. Oh, let's all, we should definitely get back to that, I think people may have some interest in that. I just wanted to ask you to think, maybe comment a bit more about this issue of involving the public. I've been involved in a number of issues where we seek public input and in the area technology assessment in the UK they have a very elaborate public participation process in things like deciding which drugs will be offered by the NHS through NICE and the National Institute for Clinical Excellence and Health and in that context there are often very technically detailed issues that need to be considered. Things like trying to interpret the results of randomized trials, sometimes more than one where they may conflict with one another and the question arose in the UK how do you ensure meaningful public input where the questions that you're addressing have this rather complicated scientific component and their approach included actually training members of the public to serve on committees as public representatives in addition to the people who might come up and testify which is generally our approach and it sounds like it's that on the commission but actually training members of the public to be very effective at analyzing the data giving them many courses and maybe we could develop a Harvard X course for this actually that would be our contribution but has that been an issue in your interacting with the public i.e. where they may represent constituencies and so on but you're dealing with some extremely complex issues and some of these undoubtedly involve a fair bit of scientific and other kinds of evidence. How have you managed that? So we get public testimony from people who are experts and that we require that testimony to be in ordinary accessible language. It turns out that most of the issues we have to deal with somebody who is educated as you say they do more systematically as they do in the nice example than we do here but someone who is educated can understand what needs to be understood for the sake of the decision. The bigger problem Alan is the broader public and the lack of science and ethics education early and often in our public school system our K through 12 and throughout higher education because I think the bigger misunderstandings are ones that have to do with seeing what the actual intersection is between ethics and science for example. So the Ebola, the other report I brought was the one on ethics and Ebola public health planning and response. When the Ebola epidemic hit the reaction and the misreaction first of all the slowness of the lack of preparedness of response not only in developing countries which we all understand why but in our country and the media overreaction which was followed by a public reaction was staggering in its incomprehension of very basic facts and so the fact that there were surveys done first in August and then in October. This is really important to understand now so we take measures as we recommend to prepare before the next big thing happens. So there was a survey done in August of public opinion and 37% of the American public said that they thought that they were very concerned or concerned that there would be a massive outbreak of Ebola in the United States. Several months later, October, after there were months of time and it was over, it was on the news all the time, it was in every major news outlet, that 37% went up to 50%. The actual probability of dying from Ebola in the United States was roughly one 10,000th of the probability of dying from the flu and yet there are millions of people, Americans who don't get a flu vaccine in this country. So we have a lot of, this is technical, yeah it is technical but it's not esoteric. It's less esoteric than what public officials and the media were spouting about Ebola and the 21 day quarantine was a travesty of public health response and a travesty of justice. We had somebody, Bill Fogge, who's a hero in the vaccine community. He's a great, great guy and he said it very bluntly after doing all the details. He said, every medical student is taught and we all know do no harm. What many, many people don't recognize is by not acting you often do tremendous harm and by overreacting you often do tremendous harm and Ebola is an example, the Ebola lack of preparedness and the overreaction is an example of both. There was a nurse who deployed to Liberia, volunteered and she was asked to redeploy and she said the first thing, she was asked to redeploy for 10 days and the first thing she thought was 21 day quarantine. How can I justify redeploying for 10 days when I'm gonna have to be quarantined for 21 days? I'm not gonna be able to save lives for 21 days. Doesn't make any sense. We had a doctor, Trish Henwood, who went and she said far worse than thinking about all of the isolation and stuff was thinking about the fact that when she came back, she could not spend Thanksgiving with her family or anyone because they would be ostracized because of the, so I think these details are, that's not the problem. The problem isn't that people can't understand, it's that we don't teach them and we don't teach them because we don't take it seriously until there's a crisis and then it's too late. I mean, you have to do something but it really, you've lost the battle and the war. Well, I think Ebola is a great example of where there is tremendous public skepticism about authority basically and you think about the role of the CDC and how basically what you've just cited are the difference between statistics which were largely compiled and disseminated by the CDC, often through other agencies and what people believed. CDC also has promoted flu vaccination and we all know about what you just mentioned about the relatively low uptake. Was there any kind of explicit attempt to link the work of your commission without of the CDC at this period of intense public scrutiny? So we actually enlisted, as you might imagine, CDC officials and talked to us. So here are the things we found. First of all, the CDC was underfunded in being able to prepare for this. Secondly, they weren't prepared with a clear public message. So as much as we admire the officials there, it took them far too long to get out a clear public message about what should be done. By that time, Chris Christie and Andrew Cuomo had both declared 21 day quarantines and there was no, was not preceded by clear. Then the Defense Department declared a 21 day quarantine for all of it. So by that time, by the time the CDC was in public action, it was actually they had, that's what I meant by they lost the battle and the war. And then they did the right thing afterwards but they were underfunded. The WHO was a mess as far as its organization goes. It's admitted that it was disorganized. We underfund the WHO. The infrastructure in Liberia, Guinea and Sierra were terrible. So there was a perfect storm. And the question really is, are we going to learn some of the lessons from that one of the lessons we learned was we now are have an Ebola vaccine that's moving fast along, but that's the Ebola crisis. Most Americans think we over, we spend too much money on foreign aid, right? And then you ask them how big a percentage of our budget is foreign aid and they think it's 25, 30% when it's actually 1%. If you ask them how much they think it should be, they'll say maybe it should be 10%, right? So. Well, this leads me to a different question. Maybe you could talk about legislation which I know you want to speak about. So Dennis Thompson here in the audience, your co-author and you wrote a book, a recent book, The Spirit of Compromise. That sounds like it's a history book actually. But it's, you call for greater cooperation in contemporary politics in this book. And how has that perspective you have on compromise influenced your work with the Bioethics Commission? So we literally wrote the book on compromise but I think it's not, I think it's more likely the odds makers would give it greater odds of becoming the next Broadway smash rap hit by Lin-Manuel Miranda, the sequel to Hamilton Compromise. Then it will be enacted by this Congress, right? So the, and that's, it's partly history because you have to know history and the fact that the way this country, first of all, was formed and moved forward. There would be no United States of America without compromise. You might think that was the compromise with the devil but the people who think today that compromise is compromising with the devil are all in favor of that compromise. So note the, you know, the illogic there. But everybody who has studied the history of the United States of America or the history of any society takes South Africa. How did South Africa get beyond apartheid? Nelson Mandela, my hero. There is nobody in my lifetime who I've met who, or not met but I've actually had the privilege of sitting down and meeting one on one with Nelson Mandela. There is nobody I more admire. How did he manage to keep South Africa together? Compromise, was it? Now, not in favor of every compromise, you're in favor of compromises that move the ball forward from your perspective, but you can't get everything. And if you go from getting everything from your perspective, you might be able to be a monk, but you can't be a provost and you can't be a politician. And Edmund Burke went so far as to say that all of life is compromise. I dare say it would be very hard to have relationships in life without compromising. So in the commission, I'm so admiring, I guess, but also bonded with our commission members because there is no topic we've taken up where we agreed at the beginning. And yet every single report, all of our recommendations, and I think we've made 92 recommendations, the last count of all, through the six years we've been, they've all been unanimous. And that's not because we agree on everything, it's because we say to ourselves, if we, as a 12-person commission, cannot agree on the most important recommendations to give our government, how could we possibly expect them to enact it? And so it's really important and what's happened in Washington. So let's fast forward to Washington. What's happened this week in Washington is a great example that proves the major point of our book, The Spirit of Compromise, why campaigning undermines it and governing demands it. How did you get a compromise, a deal in Congress, in our Congress now? What you do is you go and close the doors, go and, John Boehner, close the doors, goes in secret session, comes up with a deal, announces it and leaves town, resigns, right? He can no longer lead the Republican majority in the House. And that's a shame. And that's not good for the country. So we have to, so what's the lesson for academics? What's the lesson in medicine and bioethics? What's the lesson for running any institution where you wanna make progress? I think the first lesson is really an educational one. We have to teach. We have to teach history, ethics, science and medicine. We have to, and politics altogether. I don't mean always altogether, but I mean we have to really educate our, we have the privilege of being so educated and we have to also call on our public officials to practice what we've learned. And I think now in the, now I'm talking the political, scientists and political philosopher, I think the reversal of what's going on in our country, which is necessary for the funding of good research and for the progress of medicine, for the progress of arts and culture, the whole thing. I think the reversal will only come when the American public gets fed up with what's not going on, with the fact that we are not being governed right now. Thank you, that's, bioethics is a very broad, It's a call to be engaged. It's a call to educate, but it's also a call to be engaged. And it's really important. I can see that there are medical school students here and young people here. It's really important. Actually, the younger you are as a citizen, the more important it is to be engaged because people like me who are older are overrepresented in politics. Alan Simpson said this, I chaired a session with him entitled Is America Broken? And Alan Simpson looked out in the audience and there were hundreds of pen undergraduates there. And he said, don't let people as old as I am bamboozle you. Go out and vote and get involved in politics because they're determining your future. So the same thing I said about bioethics is, even if you're not interested in it, it's interested in you. So that's, I think it's something we all have to be really attentive to. And that's a message that we should all take home with us. But I also wanted to ask you, when you think about these huge challenges in the political and legislative arena here, can you tell us a little bit more about an example of one study of your recommendations and how it worked its way through government and how it had impact? So let me give you an example of one that worked its way, had an impact on one that hasn't. I think it would be good to do both because there are challenges moving forward. So let me give you just, because time is limited, a really simple one that's at the core of almost everything we do. So we did a report on human subjects research in the wake of the revelations about what happened in government. And for those of you who may not know what happened in Guatemala, Public Health Service officials, one of whom, John Cutler later became the interim Dean of Public Health at the University of Pittsburgh in the 1960s. In the 1940s, post-Nuremberg intentionally infected individuals in Guatemala with sexually transmitted diseases, syphilis, gossips, and so on. Syphilis, gonorrhea, chancroid, in order to test whether penicillin would be a prophylactic on them. So we did a report that asked, that in order to do it, we had to look at all of the human subjects research that our government was doing. And it was very important to look at what the Defense Department was doing, for example, as well as NIH and NSF and so on. It turns out there was no, that the Defense Department itself did not have access to all of the experiments that they were funding. And so we made the recommendation that there be a public database for all human subjects research conducted by our government. And the Defense Department, to its credit, took up our recommendation and has developed one. And I give them great credit for that because they could have made all kinds of excuses, including the budget, because after all, there's a sequester. And they did it. And they did it really promptly. And that also goes back to why public deliberation's important, because it was a major black eye for them not to do it. So that's one example. An example of a recommendation that we made that has not been adopted in which, and it's not an original recommendation on our part, in fact, almost every bioethics commission prior to us has made the same recommendation. And we are the only major democracy, we're the only major developed country that doesn't have a system of compensating people who volunteer for research that does not directly benefit them, compensating them if they are injured. And we didn't recommend a specific, we said, and this was in light of the fact that the government wants to be able to test a minimally risky anthrax vaccine on children. So if you want to test a minimally risky anthrax vaccine on children, you had better be able to say, if this causes harm, we will compensate the families for it. And we've made no headway there. There's just a, and that's because it requires legislation. So is that the common denominator? That's the common denominator. There are two common denominators. The one and the big one is, and if you haven't figured this out, I will tell it to you as the big revelation. If you want any legislation that doesn't have poison pill writers on it, you're gonna have to wait quite a while. So it's just, and that's why so many good people are leaving our federal government. It's a very, very discouraging situation. So that's number one. The number two, which is lesser, but we occasionally have found it is, but for medical research, it's not lesser. It's at least as great. Is that the number of agencies that have to come together to, for example, reform the common rule. Suppose as we, I'll speak for myself. Suppose you think that if you have a research collaboration among several different units and universities, you ought to have a streamlined way of doing IRBs. So not everyone has to repeat the same thing. So you need a bunch of different agencies to agree to that. And the bureaucracy in Washington, let's say is not as nimble as would be optimal. Anyone here who's, how many of you have done research grants? So this is not news to you, right? I mean, and what we're doing actually, I chair the American Association of Universities, which is the 64 biggest research and teaching universities in the United States. And we've been asked by both an official in OMB and the Office of Management and Budget, and by Lamar Alexander in Congress to give a list of the ways in which we could streamline regulations so that we would save money and not lose any of the goals. And I will not hold my breath before Congress, does it? But I think OMB will actually do some things in that regard, and we've given them a joint list. But this is, it's a real challenge. It's one of the reasons why it's so important that there is excellent biomedical research going on in our great universities, because there's no place else that's going to do it efficiently. And as slow as you may think, it is to work at Harvard Medical School or at Harvard. Nobody thinks it's slow at Penn, right? We're just, but it's so much better than the government bureaucracy. Well, I thought it was very positive comments about government. All right. You know, I work for President Obama. I don't, without pay on this commission, I think it's very important and worthy. But I also, and I don't think anybody I know in government would disagree with me. The problem is, and I just want to be very clear, a lot of people who say that think the problem is government, and that's a mistake. We need government to do lots of good things. You need to have rules for human subjects research, and you need people to believe in those rules. But you have to, they ought to be streamlined. They ought to be what our commission has done is basically run with this rule of regulatory parsimony. You ought to do it in a way that makes most people who want to do the right thing feel good about doing the right thing, rather than feel like they've been having to go through the ringer to do it. One could hardly disagree with that. And given your experience, Amy, I think that it's pretty sobering when you talk about the realities in Washington and how that influences the work of the commission. So at this point with your experience to date, how do you think about the ideal kind of project for the commission to take on? Do you deliberately seek projects where the outcome when you might anticipate wouldn't require legislation, or you try to aim toward executive branch agencies? How does that work? So first of all, I don't think that most things should, that you can make, most of the things you can make progress on in universities and in government don't require new legislation. You can interpret laws, you can reinterpret the way regulations are done. So I don't think that's a huge limitation to what we do. And so most of our recommendations haven't required new legislation and a lot of them have been put into effect. They're doing HD escalation studies for anthrax vaccine, which means that instead of starting and just testing anthrax on children, you test it, because we know it's a safe vaccine on the youngest adults, you see what dosage you need for the youngest adults and then you start with the oldest children. That seems so commonsensical. It took so much thought to get to that point. So I think there's a huge runway that bioethics commissions and people working in bioethics have, even if they don't think about, they think that legislation for now is blocked. That's federal legislation. Then there's of course at the state, a lot of things happen at the state level as well. And again, I wouldn't go for legislation before I'd go for the simpler ways of doing things. So you have a very strategic approach, it sounds like, to dealing with this broad range of issues. How do you judge your success as a commission? So we think we're wildly successful, of course. But seriously, we're not the best judge of the success of whether our recommendations are right. So in the sense of substantively correct, what we can judge is how they're received, both by the public and by experts. And they've been received, we do track that, and they've been received extremely well. Even by people who disagree with us have said, so when we did our report on synthetic biology, we rejected something called the precautionary principle, which is very popular in the EU. And the precautionary principle basically says, do not move ahead with a new technology if there are unknown risks. Find out what the risks are, assess them before you let research go forward on a new technology. And we said that violates a principle of intellectual freedom and responsibility, that there has to be a balance between allowing intellectual freedom to move forward, but not letting science rip, but taking calculated risks. And we knew we couldn't convince people who were avidly in favor of the precautionary principle, and they disagreed with us, but they very much respected that they were heard and that we address their concerns. And that's part of what deliberation tells you to do. So that's the qualitative. On the quantitative side, we actually measure our effect. We measure the number of people who we tweet daily. This is the new, we have a live blog, which averages about 100 views a day. We've been written up in the media from the New York Times, then in New Yorker, and the Washington Post and LA Times to Nature and Science and Lancet and the New England Journal of Medicine. So we've gotten a lot of coverage and we have a pretty broad audience for a small commission, so we measure it. That's terrific, and I hope that that's standard within presidential commissions, but if not, it certainly should be. I'm curious that as I look around the room again and there are many familiar faces, some I don't know, but some people here may be very interested in clinical bioethics, as it's called. And I think of it very much as the kinds of decisions that you make at the bedside, and I think every hospital today has a bioethics committee. And oftentimes, that's a way to help physicians, families deal with very difficult decisions. How does that kind of work relate to the work of the presidential commission? So we, several of our reports had to do directly with clinical research and clinical practice. Let me give you one example of that. We did a report on how should clinicians approach what are called incidental findings. So those of you who are clinicians all know this and shake your head, but let me just, for people who might not know what that means. So you go to a doctor because you have indigestion and you think there's something wrong with your stomach and he does whatever an MRI or whatever is prescribed and he finds out you have something else that he wasn't looking for. I mean, she wasn't looking for, right? And the question comes up, what is the responsibility of the clinician to report to the patient that incidental finding? By the way, we've now called it secondary findings because they're not always incidental. Sometimes you wanna see everything. So it sounds, this is a little bit, it's a totally different realm, but it has the same lesson as reacting to anthrax vaccine or Ebola. If you just tell someone what I just told you, the typical reaction would be, of course they should tell the patient what the secondary and incidental findings are. It turns out it's not at all that simple and it is both ethically not that simple and if you actually talk to people who have experienced being, having secondary findings reported or not reported, they will divide quite dramatically as to whether they wanted to know or didn't want to know it. There is a very important lesson here, which is a lesson of bioethics and political ethics and clinical research and one of the reasons I love these cases of clinical research is they highlight, they put it in high relief, which is you have to have a practice or a policy ahead of time as to what you're going to do and inform your patient or have it clear that if you get this test and I find out something I will tell you do you want to know or don't you wanna know, you have to have some policy and practice and in this country we have almost none and so this is a frontier for the future and it's really important. We had one person testify about how her life was saved by an incidental finding and another person testify about how her life was ruined, how she was told something she could do nothing about and it absolutely ruined her life and it's too late now for her to figure out what she would have said beforehand but something along the lines of advanced directives which have different forms and different practices could be very helpful. In other words to state of preference ex ante for what you wanna be told with these. At the very minimum clinicians should have a professional standard for what they as professionals are going to do and how they're going to justify it and justify it publicly at the very minimum. At the maximum there ought to be some practices about how you inform your patients about this in a way that isn't like a five page single space informed consent form that nobody reads and understands. So we're not very far along on this at all and we made some very good recommendations in our report on it. That's great. One thinks about the rapid decline in the cost of gene sequencing for example which will make these recommendations all the more timely. And they're not just self regarding because gene sequencing is a good example if you find out something about the anomalies in your whole genome sequencing the also question is who do you tell in your family who might be affected by it? Yeah. So these are great comments but I'm sure that people have a number of questions for you that they would like to ask. So let's just open it up. I'll go ahead and moderate. And I actually, this was such a wonderful and wide ranging conversation. But I'm sure the conversation will continue to be wide ranging. But I thought I would maybe start us on a particular theme. One thing that ran through a lot of this was the importance of education. And looking around as you pointed out we have a lot of students here. And of course for those of us who do teach bioethics we think a lot about how to do this effectively. How we can help our students to see the relevance of bioethics in their lives and how we can be effective, most effective in communicating the things that we think are important to communicate. So I thought I would start anyway with the person who's most responsible for our education here at Harvard Medical School, Ed Hundert, who's our Dean for Medical Education. And maybe starting us on this theme and then we'll see what things got. Okay, thank you. Take it away Ed. All right, I'm good to see you guys. I think as you were talking, I was thinking about one of the things that comes up a lot with the students is attention that the history of bioethics is mostly what Allen was saying at the beginning about the doctor-patient relationship. Most of the themes in bioethics through history have been about individual patient doctor confidentiality and so forth. And more and more of the emerging topics are these population level questions about just distribution of resources and so forth. And there sometimes is a tension when an emerging doctor is trying to be taught in this new way that we want you to think about populations and not just always about the patient before you. And they say, well, but I want to be an advocate for the patient and sometimes they feel that tension. So I was wondering, do you think, did that sort of tension come up in the commission's work? And then also what advice do you have as an educator for how we should think about the next generation of physicians in how to deal with that tension? Okay. Do you mind if I stand up because we're so far down that mine. Is that okay? Do you like what's actually come over here? No, no, I'm okay over here. It's fine. I mean, I may wander, but the, so you asked a few questions actually. So is there a tension, so one question is, is there a tension between the bioethics focus on the doctor-patient relationship and the more macro issues of population and distributive justice issues? I think they're very related issues, but, and I don't think it's actually not accurate. I just have to say, I know that there are some people in bioethics who have said this, but it's actually not accurate that bioethics began with the doctor-patient relationship and migrated to distributive justice. So bioethics is, by one measure, so some of the things we measure is the number of articles written in bioethics from 1980 to now has increased 10 fold. So there's been a huge burgeoning of it, but in the 1980s, there were articles like mine on distributive justice and the Hastings Center, which was one of the first major centers, spent a lot of time on doctor-patient relations, but also talked about distributive justice. Now it depends on how broadly or narrowly you interpret bioethics, but from my mind, you can't really be expert in bioethics without having some deep understanding of issues of distributive justice. And if you had to ask me what I think the biggest issue today as in 1980 is before us, it's the equitable distribution of healthcare in this country and around the world. And every doctor and every citizen should be taught to think rigorously about that. I would say the same thing about doctor-patient relations. Every doctor and every citizen should be taught to think rigorously about that. Now the tension is if you're a doctor, you want the best for your patient regardless of what it might cost, right? The best for your patient regardless of what it might cost. But you ought to also think that you're part of a profession which is justified by the way the profession serves people in society and that has to be scalable to being, there being an equitable distribution of resources that doesn't mean by the way that you should deny your patient what your patient needs but it does mean you should advocate for the system that will allow what your patient gets assuming your patient has the resources to be available to everybody else in a similar situation. And I ran over that really quickly but and it may sound really simple but it's actually pretty darn profound and a lot of people don't ever get that lesson taught and argue about, I mean, we can do a lot of arguing about it but basically what I said is one of those things that if what I said is true there are profound consequences for the practice of medicine and for politics in our society and for what everybody is a citizen whether you're a doctor or not. I really believe that medical ethics should be taught at the undergraduate level to people who don't wanna be doctors or nurses. I think it's really important, I think it would be better for the practice of medicine, it would be better for doctors and nurses and it would be better for all of us. I also think that questions about distributive justice which we can disagree about but we can't ignore them. They're just hugely driving. One of the questions that Alan didn't get to ask me but he had sent that he was interested in that I find very interesting is what's the role of economics in this? And I wanna answer that because I think it's often misunderstood so I'm gonna take your question that's so important to another point. The economic perspective dominates a lot of our public life and a lot of what we have to think about and it's true for doctors as well as for administrators and so on but economics asks the question how, what are the costs, the net costs and net benefits of doing something? It doesn't tell you what the goal of doing it is. So if you're a doctor and there are two equally safe effective cancer drugs have the same absolutely equal and ones cost 10 times the amount of the other. Economics doesn't tell you, it tells you what the cost is but ethics tells you you prescribe the cheaper drug. If it's other things totally equal they're both sustainable, right? Go to anthrax, testing anthrax vaccine. Suppose that the age de-escalation that I just said cost 10 times the amount of just testing an anthrax vaccine on children. Go right. The cost is irrelevant. You can't do it. Doesn't matter that it costs one-tenth the amount. There's an ethical principle that says you can't expose children to undue risk. Doesn't matter what the cost is. So I think it's really important that we know the economics. Sometimes economics determines what you do because the goal is given. Other times the goal is violated if you choose the cheaper way. And something similar is true with you treating your patients. If you give them something that is not, you're not allowed to do because it's not provided by the society then you have to argue to change the policy. All right, we'll go over here and please say your name and what you do. I'm a fairly recent graduate of the wonderful University of Pennsylvania in political science at my BA. So I would love to ask you a question that kind of comes at the intersection of bioethics and political science which deals with medical malpractice. Okay. We're taught at some of the bioethics courses at Penn and in other places that when a patient is wrong essentially in an interaction with the provider that often the best thing that you can do is essentially disclose that wrong to say you're sorry and that even from an economics perspective that ideally health systems that have programs in place that encourage that sort of behavior save quite a bit of money actually. I just love to know if you have any perspective as a bioethicist on the state of medical malpractice law in the United States and if the commission also has made any recommendations or is planning to make any recommendations about it. Yeah, so because Penn has a school of medicine and we also run now by hospitals I'm very familiar with medical malpractice which is a state by state. It's state by state regulated. We haven't as a commission taken on medical malpractice. It's an extraordinarily complex the state of the law and things but what you said at the beginning is absolutely fundamental and important to recognize. And let me put, I'll do it step by step. Number one, you can't have the practice of medicine at its best, the practice of medicine, the real practice of medicine without having some malpractice, it will happen. Doctors make mistakes. Number two, the doctors who do and don't confront them are, you know how they say it's not the crime, it's the cover up in politics? The same thing applies to doctors. It's not the malpractice, it's the cover up of it. So that is malpractice per se is terribly tragic and unfortunate when it sometimes yields terrible death but it's a moral abomination when it's covered up. Number three, there is good evidence that doctors who admit it immediately get sued a lot less than doctors who don't. So not everything virtue is not always rewarded in life if you haven't noticed, but sometimes it is and there is overwhelming evidence in this case that it is. And number four, which you didn't mention, so this is really important that a first year medical student knows this. He has been very well educated at Penn, I should say. But number four, I would add to this that when you know this, so it's not enough as individuals to know this, there's an institutional lesson here. We at Penn have instituted a practice of taking those doctors who have been, had complaints and teaching them and requiring them and teaching them how to confront their patients when they do that and we now teach it to all of our doctors. And that's a very, so education, we always think education is broad and warm and fuzzy. It is that sometimes, but sometimes it's very directive. And this is a case where it's very directive and the evidence is overwhelming. Student, I'll come back to you, Frances, yeah. Could you say who you are? Oh, hi, I'm a second year medical student. Yeah. What's your name? Anand. Anand? Anand, yeah. We've spent more or less the past hour talking about hard cases, difficult issues and huge challenges and I'd like to return back to something that Dean Hundert brought up which is sort of the everyday ethical quagmires that both patients as individuals and health professionals deal with. And it seems like in my opinion, biomedicine has become unmoored from the moral and existential practice of caregiving and bioethics has embedded this. Rather than promoting the education of virtuous health professionals, bioethics promises to uncomplicate the complicated by rendering ethical problems as rational choice among abstract principles. And the upshot of this is that patient consent may not be informed, paternalism persists and on the justice front, race remains one of the foremost prognosticators of patient outcomes. So in your opinion, again, coming back to the question of education, what is to be done and can bioethics regain its potential as an independent critic within biomedicine? So you said a lot and you characterized a last hour of being dominated by rationalist thinking, blah, blah, blah. I mean, I don't know what I could have said that would have not had you said that but let me say what I think, okay? And you can tell me whether I'm still talking, you know, past you, okay? I thought I'm now talking to you in the language that I use. I said and I believe that the biggest problem in the area of bioethics is the equitable distribution of health care to people. And I mean care, not technique and so on. I mean caring, helping people care and live healthy lives. Everything else in life, almost everything else in life depends upon that. We didn't talk very much about the inequities that are based on race, on gender, on sexual orientation, on nationality, and they're huge in our society. But I was referring to all of those when I said the biggest issue is the inequitable, the biggest plot, you know, I would, I think, so, and that doesn't just refer to a doctor-patient relationship because at that level you cannot solve these problems. You have to solve these problems or address these problems at a larger level. I think you agree with that. I, at the same time, I think that we need to recognize bioethics shouldn't just be seen as you're dealing with these difficult problems. And that's, I really do, when I was talking, I also felt that we were just talking too much about these problems. I think it's an elevating and inspiring pursuit to think about how you can create a world in which more people can live healthy, wonderful lives. And if you don't think about bioethics broadly and my mind correctly, you won't confront that. So you may have wanted to denounce what I said, but I actually embrace what you said. So I really, except for the rationalist part, because we have to be, it's not irrational. I mean, we have to be caret, I believe, and I think it's probably important. And it may be, I think it's really important for those of us who feel passionate about the things that we study and we practice to show that passion and rationality go together. So thank you for that question. Professor Cam? History and the pricing of drugs, the rapid increase in escalation of drugs, prices and things of that sort. And I was wondering to what degree the commission feels it's confined in the topics that can deal with by whether it can be practically important or have effects, or whether they're constrained by political considerations. But the other thing I was noticing about, So that's two questions, so can we stop at two? Just very broadly about the drugs, but the methodology of previous commissions, by contrast, I'm just wondering if in contrast with yours, you said that you can't recommend anything to the president unless there's a consensus. No, I didn't say that, but go ahead. Okay, good. I wanted to know that, but previous commissions have always allowed dissenting opinions. Okay, we have three questions, Frances, you gotta stop now. I feel more senior than I am, but I'll give it, you're running the show, president, so I'm not always true to the president's ass, I must say, I define everything, but yeah, so just with that, I mean, I just want to know about the... Three questions, we're three questions, okay? The first is what about, let's see if I can remember them, the first is what about drugs? The second is, are we constrained by things that we think will be useful? And the third is, do we require consensus, okay? So let's start with the third, we don't require consensus, we aim for it. That's as simple as that. So there are dissenting reports? We don't have any dissents, but we aim for consensus, but we don't require it, and I gave you the reason for that. We can all write our academic articles and we have some, Nita Farhani has written on neuroscience and brain science, but as a commission, we happen to agree that we will be more useful as a commission if we can achieve consensus. So that's the third, okay? We don't require it. The second is, are we constrained by the politics, the fact that we report to the president? And the answer is no, we're not constrained at all. The majority of our reports are ones we chose to do on our own, they're not because the president or the secretary of HHS has asked us to do them, and then we get to the first. One of our reports actually does talk about drugs. The neuros, so we did two reports on neuroscience, on brain science, and in one of them, we spent a significant amount of time talking about and hearing some testimony also, making recommendations on what should, how should we deal with drugs that are said to be very prevalent on college campuses, Ritalin, Adderall, and are also said to be overprescribed and used off-label to get competitive advantages and so on. So we actually, I think, came up with some very good recommendations there which have to do with the very little that's known about these drugs. Secondly, that there are things that are much, that are known to be safer than drugs to give people the ability to do better cognitively. So we have actually taken up some of the issues about, but not all of the issues about drugs. A pricing of drugs, we have a principle that we have said about why, but we haven't done a big study on it. Let's take, I mean, squeeze in one more question. I think I got all. Hi, I'm Donnish. Donnish. I'm a student this year in the bioethics program two weeks ago. Yeah. And one of the questions that I asked him and that my whole cohort and colleagues have been wrestling with is, what makes bioethics? At one point, you know, especially the recipe. Right, exactly. So, I mean, yeah, I would love your thoughts on that. I can give you a recipe for really good souffle. It's tasty. Out of which a bioethicist will emerge. Yeah, right. I'm going to go by the ingredients now. Right, right, right. So what makes a bioethicist? That's a question. Okay, this is great. This is great. So first confession, I was very reluctant. I came reluctantly to ever use the term bioethicist, right? And that may tell you something about why I think that there isn't a single recipe for the bioethicist, right? So I think, let's start with what I think bioethics is. Bioethics is not a single discipline. It is multidisciplinary by its very nature. It is the application of ethics to a realm of science, medicine, technology. That's very big. And so even the bio is stretched there. It's not just medical ethics. And symbiotically, it means, so now I'm going to segue into what a bioethicist needs to know. So a bioethicist ideally needs to both know ethics and philosophy and takes principles seriously. Also needs to know the subject matter of science and medicine or technology. Nobody, this is going to be the bioethicist who walks on water, who knows everything, but has to be interested in that. And then also, bioethics is a practical pursuit. It's not purely theoretical. So you have to actually be interested in the history and the politics and sociology and so on in which these practices happen. So it's not, so here's my conclusion. It's a mistake to think that there's a platonic ideal of a bioethicist. It's a multidisciplinary field. It requires many different intellectual tools and appreciations. Any single bioethicist should appreciate the whole range that it requires, but no single bioethicist should think that she needs to have all of those expertise. And I will conclude by saying that's my pitch for why there ought to be more education in ethics and science and medicine from the beginning. And it should be brought together and groups as large and varied and even larger and more varied than the one assembled here should take the issues seriously enough to develop the kinds of expertise and do the deliberation that's necessary to bring different expert and public perspectives together. And we have a lot of work to do, not only in our universities, but in our country to drive it forward. The stakes are high. The stakes are as high as treating every single human being with the respect that she and he deserves, not only in this country, but all around the world. So thank you very, very much. Thank you. Thank you.