2007 Johnson & Johnson Lecture: Ethical challenges in preparing for a Pandemic

good afternoon I'm mark Becker Provost in the University of South Carolina and on behalf of President Andrew Sorensen and the entire Carolina family it's my pleasure to welcome you to the 2007 Johnson & Johnson health care lecture the School of Law has proudly hosted the Johnson & Johnson health care lecture on issues relating to health wall since 1999 this lecture series provides an excellent opportunity for faculty in medicine law public health the humanities and the sciences to work together to see that important issues relating to health law are discussed in a public forum on our campus and for the general public on behalf of the university I express our sincere appreciation and thanks to Johnson and Johnson and particularly to mr. George Irving for their generosity and underwriting this lecture series thank you very much past speakers in the Johnson Johnson lecture series have included for example Vice Admiral Richard Carmona Surgeon General the United States Randolph smoke president of the American Medical Association Henley Henry T Greeley professor of law Stanford University and Judith R professor of law Whittier Law School and dr. David Hyman special counsel to the Federal Trade Commission and professor law at the University of Maryland and from the private sector dr. Thomas kasky CEO and president of cogent biotech ventures past lectures of considered timely topics ranging from human cloning mapping the human genome the federal patients Bill of Rights HMO liability malpractice liability to the obesity epidemic that vexes policy makers and citizens alike today today once again the johnson and johnson lecture brings a timely and challenging topic to our attention and for our consideration what to do and expect if the unthinkable were to happen preparing for a pandemic to give you some idea of just how timely as topic is consider in the March April issue of Foreign Affairs a policy journal not a law journal not a health journal but a policy journal March April issue of Foreign Affairs is an article by osterholm at the University of Minnesota entitled unprepared for a pandemic and touches on many of the issues that we'll consider today the March 1 issue of vaccine Medical Journal Public Health Journal includes an article by Zimmerman of the University of Pittsburgh entitled rationing of influenza vaccine during a pandemic ethical analyses and not long ago in November December 2006 an issue of the American Journal of bioethics include an article by wynia of the American Medical Association entitled ethics and public health emergencies rationing vaccines I could go on and on in citing other articles in mainstream journals of broad scope policy health medicine law and ethics but I think you get my point of both the breadth the scope and the magnitude of this issue and how timely it is today it's challenging many of the best minds concerned with the public's health they are challenged to craft answers that are neither easy nor comfortable again I want to thank Johnson and Johnson and mr. Irving for making this possible today's lecture is indeed timely it's indeed important and I think we will hear from our speaker that it's indeed terrifying to think about somebody is going to have to make decisions quite likely not about whether a few individuals will live and die but quite possibly about whether or not millions of individuals will live and die or in particular who among millions among hundreds of millions in fact on a global scale among billions will have the opportunity be protected by the vaccines that exist and those who will not get that opportunity I look forward to hearing what our speaker a recognized expert of an international distinction has but share with us today so I now turn the podium over to Professor Jacqueline Fox to introduce him welcome Thank You Provost and I'd like to add my thanks to the Johnson and Johnson people for funding this Alexander Cameron is really someone marvelous to be coming here to talk to us about this he recently served as the first director of ethics trade in human rights and health law at the World Health Organization in Geneva was the first person to serve in that plays prior to that he's been on a number of presidential commissions and committees of that that level in this country trying to resolve very important bio ethical problems he has the expertise in this field plus he's taught at a Georgetown Pennsylvania University of Southern California schools of law and health law and torts which I always think is a great course package and I hope that you listen to him and think about the questions you might have because we're gonna have some questions afterwards that he brings to this so um one other point which happened this summer is that a number of people got together trying to come up with a way of approaching how we're gonna do with the financial implications of what we do to try and limit the spread of avian flu and a professor capron was one of the people on that and they've come up with a manifesto which i think is very romantically titled the bellagio manifesto and it's very important because right now we're cutting the livelihood of a number of people in southeast asia to try and prevent the spread of avian flu which is one of the sources of this so there are innumerable implications so please listen carefully and think about what you'd like to ask at the end of the talk and I present you professor Alexander quebra Thank You professor Fox Provost Becker after Irving it's a pleasure to be here at the the other USC and I will indeed today be talking about some of the ethical challenges in preparing for a pandemic another challenge I have will be in in going through this rather rapidly professor Fox told me that she did her hour-and-a-half torts class today in half an hour and some of you may have been in that class today and realized the lightning speed that was necessary I have a lot that I'd like to get through and I'm going to give most of my attention to the topic which was highlighted by the Provost the topic of allocation but I will address some other topics I want to begin by asking why is there a need to prepare and that has two parts that is to say what is the impetus in medical terms in in terms of public health emergency and the emphasis on preparation because this is not one of those problems which we'll be able to deal with once it arises this is if we have a pandemic it is going to be fast moving and I also want to suggest from a public health point of view the importance of preparation which requires involvement of the communities I want to say a few words about the role of ethics and to a certain extent human rights and their relationship to legal reasoning I'll describe the four major areas in which whu-oh is working on this topic work that I was involved in obviously when I was there and continue to give advice on I think that over all these different problems are all manifestations of the central ethical conundrum of the interests of individual versus the interest of the group and I will suggest at the end that the way forward involves preserving our moral foundations and that is mostly going to be around fair Rossi's rather than one particular set of outcomes that is fair in all circumstances so what are those four topics the first is the question of equitable access to health care in a pandemic the question of how to allocate vaccines and antivirals we will by any estimation not have anywhere near enough vaccines we already are short of the number doses of antivirals the Tamiflu that you hear about and although production by Roche is at as brisk to pace as they can make it and there are some generic versions being manufactured we will not be able to treat all the people in the world who would need treatment the second set of issues has to do with ethical and human rights issues that arise in the public health arena the public health actions here begin with surveillance and the dissemination of information those will have consequences for the people and the countries and regions identified as the sources and then as it spreads the routes by which a pandemic would spread it will then have issues as well for what actions are taken to cut animal to human transmission and then what actions are taken by way of quarantine or the like to prevent human to human transmission and the new international health regulations of the World Health Organization are going to be put into place early if needed they will come into effect officially in June of this year but if we were to have a pandemic before then countries have agreed to implement them voluntarily in the meantime the third set of issues about which I will say less because of time involve obligations of and obligations to healthcare workers in a pandemic and these include not only physicians and nurses but potentially people on the front lines providing other services even delivery or cleaning services for hospitals and of course the people involved in making vaccines and want to ask a little bit about the origins of such obligations to the extent that they arise because we're dealing with professionals that have certain ethical traditions versus people who have abilities that society needs now these can be in parallel but they may be fairly distinct I mean garbage collectors do not have ethical traditions of obligations to serve but they might be in a situation where their service would be as important as that of doctors and nurses and finally say a few words about obligations among in between countries and of international organizations since there will be not only an unequal distribution within a society of the risk but there is certain to be an unequal distribution of risk among countries and of their own ability to meet the needs of their citizens why then to deal with the first question is there a need to prepare influenza on a global basis already is responsible for about a million and a half deaths a year and most people who died of influenza died because of the burden that influenza places on their system when they already have cardio cardiac and pulmonary problems principally or other things which affect their endocrine system or the like so that people who are at greatest risk are the very young who have no immunities and whose systems are less strong and the old as well as those who are compromised by existing pre-existing conditions and the figures on death from any cause of course are always controversial why do we count something as an influenza death versus a death caused by underlying heart problems or lung problems or the like this is actually something to keep in mind when we look back at historical data because some people have done a reanalysis of the 1918 Spanish flu which killed by varying estimates I mean the the public health data are not what they would be today anything from twenty to fifty million people and that's a pretty wide range although it's only two and a half fold difference there sometimes estimates of what something will do are ten or a hundred times in a range but we don't know exactly how many people died and it has certainly been suggested that if you look at historical data there was to a certain extent simply an acceleration of deaths that probably would have occurred over a two or three-year period and they occurred all at once but the fact that some of these people or maybe even most of them would have died within that period does not lessen the impact of sudden deaths caused by a pandemic because the effects of the deaths are not only the deaths but how and when they occur and they're the social disruptive effects we now face as the provost suggested to you a fairly strong view in most public health circles that we are overdue for a pandemic the last major pandemic was really the 1957 Asian pandemic that killed a couple of million people there was a milder so called Hong Kong flu in 1968 which killed 700,000 people and then of course there was the 1976 swine flu which killed almost no-one and ended up being one of those things that caused rather a backlash against public health efforts because of the occurrence of the game bar a syndrome and a number of the people who had taken the vaccine but because in historical records it appears that human populations have these waves of pandemics as people get to the point where they have no in born at quietly rather no acquired immunity against the the fact the influenza virus and you get a mutation in one of these a viruses and the current one that is causing concern is as most of you probably know the h5n1 which began appearing in the 1990s in poultry and it caused concern because of its lethality basically in certain poultry chickens it is as far as I know virtually 100% lethal if chickens get the flu they will die from it on the other hand other poultry such as ducks do not acquire the the influenza but they can be carriers for it and spread it through their feces and so forth there was concern then as cases began to arise and beginning in 1997 the first confirmed cases of h5n1 in human beings occurred this was as far as we can tell a rare occurrence connected to very close association with infected chickens and these would be people who in handling chickens or handling dead chickens were massively exposed to the virus and in those cases the virus was apparently very lethal now there's always a problem of having an under counting of people who are infected but don't become so ill that they end up in a hospital where they are observed but among the cases the hundreds of cases now of confirmed infection the lethality is at 50% there is no thought among the the viral ageist that I know that if the virus mutates and becomes capable of human-to-human infection that you would see a rate of mortality anywhere near that and indeed things like Ebola which are very fatal burn themselves out very quickly because they kill everybody who comes in contact with them and there is no route for transmission but even if we had a virus that was capable of killing one or two percent of all the people infected and if it were very infectious so the infection rates were 25 or 50 percent of the population with the worldwide population of six and a half billion people you can see that we would be facing the probability of hundreds of millions perhaps up to three four five hundred million deaths and that would be on a scale that has not been seen before now at the same time it's important to recognize that the one thing that would protect people namely a vaccine is dependent upon having the actual virus that is causing the human-to-human transmission some work is now going on with several of the companies to develop an h5n1 virus vaccine and that will be useful and of course it's possible already in a version that immunizes poultry to have to stop that virus but the virus that actually becomes transmissible human-to-human will be a different virus it will be a mutation probably some combination of one of the annual flu viruses and h5n1 and therefore it will be probably four to six months before vaccine production can start from the time that there would be an identification of that virus and what that will mean is that in the first year a maximum if all the vaccine capacity of the world were used a maximum of four hundred and fifty thousand doses probably closer four hundred fifty million doses probably closer to 300 million which would therefore be enough for only about five percent of the world's population now there are there are some people who look at what's happened so far in the ability to contain outbreaks among the poultry and to suggest that maybe we will not have the problems that were predicted a couple of years ago maybe it will be possible to contain this and in countries where there have been very effective methods of culling all infected poultry and poultry in the area where you have an outbreak they have been able to cut this short and to prevent further occurrences of human cases but in other case other countries where the ability to monitor public and animal health is less extensive in other parts of Southeast Asia in Indonesia in Africa there has there have been cases that have arisen in places where the worry is we could have an outbreak that would get rolling before we have an ability through the surveillance methods to cut it short with the poultry and that's really the the locus of concern the World Bank has estimated that if there were to be a pandemic there would be 800 billion dollars in direct economic costs and as I think you can imagine the social cost that the bank doesn't begin to calculate are likely to be even greater most people will have heard most of you in the health-related field some recitation of some basic principles of bioethics and those that were set forth in the governmental Belmont report from a Presidential Commission in 1978 and further elaborated by Tom Beecham and Jim Childress in their principles of biomedical ethics which is now in something like its fifth edition are usually boiled down to three or four beneficence and non-maleficence respect for persons and justice and these principles are very useful I think we need a broader set when we turn to public health because those are principally the ideas that drive clinical care and clinical research we need also to attend to the principle of utility which is acting so as to produce the greatest good we need to balance that with a principle of fairness the formal statement of fairness is usually treating like cases alike and of course in many contexts the need to avoid unfair discrimination based on irrelevant or illegitimate characteristics of a person or group when we when we deal with public health we are also concerned with the principle of Liberty that is to say imposing the least burden on personal self-determination which is necessary to achieve legitimate goals that is to say broadly not to trade all freedom for security given the fact that we're not likely to have full agreement either on those principles or their implications for the facts that we face it will be equally important to recognize some procedural principles and the ones that I find the most useful here are first the principle of transparency information has to be available to affected populations and this is a principle which not only rests on ethical but very much on human rights roots because there are clear articulations in the International Human Rights documents of the need to share information of the right of people to have information about actions which will affect them it's not enough to have the information of course the second principle is one of participation the affected populations need to be involved in the process of formulating objectives and adopting policies this will require us to be fairly creative because a lot of the kinds of decisions that are related to the ones we're facing are now ones which are made in an invisible fashion they're made deep in budget appropriations they're made through processes in hospitals and through what seemed to be the technical guidelines that medical associations groups of doctors put out for practice when we deal with the application of the notion of participation to pandemic influenza we are going to need to find a more active way of engaging the community and I suggest that that is of particular importance in our country where we rely on a mixed public-private means of delivering health care in countries that have more of a unified national system of health care their mechanisms their governmental mechanisms for deliberation are more directly involved with and responsible for allocation and people are aware that they are in effect all in the same boat and that there's a limited budget and we have to have means of allocating it in our country we have so many private actors who are making crucial decisions that I think it is even more important if we are going to have policies that will stand up in the face of social disruption caused by a pandemic to have had deliberations that involve people another principle is the principle of review and revise ability that is to say stakeholders should have a means of appealing any decision and policies and plans should be subject to review and revision in light of experience and those of us from a legal background are very familiar with this notion and it is I think a very important one yet we also have to recognize that in the face of an actual pandemic as opposed to in the process of preparation beforehand we may have limited ability to engage in a very formal judicial process indeed it's not even clear that in the heart of an epidemic the courts and other institutions of government would all be open for business as usual they might not be and then the question is what is that process of review and revision can we have processes that are not the usual due process of going to a court but which satisfy the same objectives and finally of course a principle of effectiveness that is to say once we go through all this process of developing things will they be implemented now the the reason I've suggested these additional principles and framing it in this way is it does seem to me that the usual principle astrology the Beecham and Childress view sometimes called the Georgetown mantra because it gets recited without a lot of thought a lot of the time particularly the notion of respect for persons or autonomy does not suit well some of the concerns of public health and I think that we can draw also on the legal method which is very much a method of reasoning by analogy of taking cases that exists and seeing how they can be extended being aware that that extension becomes a new precedent and itself has to fit within our settled moral judgments and I take indeed the law at its highest to be a human manifestation of our underlying social commitments and moral commitments so that when we have laws that prevent discrimination and so forth they don't just spring full-blown from the minds of lawyers they in their best way and when they are most effective not only guide people but reflect our our moral foundations and I think we're going to face the same process of reasoning by analogy saying if we're doing something different than we've done before what's the distinction what's the difference here that makes it sensible to do something different we not only have to have a set of principles that are to come out of ethics but we have to recognize that in metter many settings particularly of course in countries that have a tradition of greater reliance on human rights instruments as opposed to our own reliance on our Constitution that there are obligations of governments and I'll talk a little bit later about how those would have an application in this arena finally in addition to using these ethical principles and analyses to judge the moral rightness of decisions ethicist can also have a role in bringing out the ethics that are buried in supposedly technical arguments for example looking at a lot of the pandemic plans that have been developed by countries around the world very heavily the European countries are quite far along in all of this many of them begin with the assumption stated as their objective as saving the most lives and this might seem very straightforward isn't that what public health is all about yet you know a that will if applied literally give you a preference for treating certain people and indeed the the usual way you would say the most lives are treat the healthiest that is to say someone who has only recently developed the symptoms of flu and is otherwise healthy if you treat them if you give them the antiviral the Tamiflu the chance that they will survive is very great that's different than a very common medical view which is to treat the sickest if we allocate organs right now for example oh they usually go to people who get to the top of the list in part because their need is the most urgent and sometimes that coincides with the notion that they've been waiting the longest but someone could go right to the top of the list if they developed a very bad irreversible acute problem a liver failure and there was nothing else that could save them there are all sorts of different standards that can be used and so something which I think a lot of the public health people took is unproblematic may be the right choice but we should recognize that it has implications for who is treated and it is in effect an ethical choice in itself so let's go through those four topics and as I say I'll spend a little more time on the first one than the others in this kind of zooming train ride through these issues I think that the question of access actually implicates three questions when we talk about fair distribution we're talking first about what kind of justice is going to be sought there are various forms there's compensatory justice which usually your torts class is probably thinking about that worries about making up for a special burden that a person has borne and reference was made to that bellagio statement a good deal of what we were looking at there was not the human side but the animal side of avian influenza and the question what is owed to the farmers and is there a reason to differentiate between someone who is running a large industrial scale poultry operation who has a potential large economic loss but probably has an investment base and a financial base to survive versus the small farmer who makes his living with chickens but has a relatively small number of them versus a family that has three or four chickens which provides their major source of protein through the eggs and occasionally butchering one of the chickens and in each of these cases one's response to what is owed what would be good compensation in order from a Prudential point of view to induce them to cooperate since a lot of this depends upon voluntarily acknowledging a that you have the poultry you haven't hidden them away and be that there's that they're showing signs of illness or dying these are the kinds of questions then which combine both an ethical and at Prudential aspect but what compensation is due and would it vary depending upon the circumstances there's distributional forms of justice or fairness looking to equalize the burdens and benefits that are involved and here the question is always do we look beyond the immediate problem that is to say this person is hurt by what is happening right now to the underlying question of distribution of welfare in society so there are those like Rawls who would argue that that is the correct way of operating and so we always want to operate so as to make the the worst off better off relative to the rest of us and this would then have obvious implications for the distribution of the flu vaccine or the Tamiflu to those who are either sickest that's one form of worse off or poorest and have less access to less enjoyment of the benefits of living in our society and then finally we also talk about justice in the procedural sense that we have fair processes and that doesn't mean just processes that treat people equally but also process these that enjoy transparency and reviewability and participation and so forth the next question embedded in the question of fair distribution is what is the basis of comparison is it comparing lives is it comparing well-being rather than lives themselves is it comparing the social or economic impact of an action as against what would happen if we didn't act and finally what is the context I've been using the word allocation here because it is the word that's most often used but in some ways I think it's misleading because in a way the word allocation suggests that were engaged in the kind of normal process by which we try to use resources most effectively and all of us do this in our own families you have children you tried to allocate your time and your money in a way that's fair to the needs of each they don't have all comparable needs or any one stage in their life their needs are not equal and you make those judgments as to what would be fair in that way you're allocating but you're not assuming that any of your children are gonna starve or any of your children they're not going to be educated or any of your children are going to be lacking your love and attention you're going to give some to all of them all of them will have something that they need but we may be faced with something which is really not allocation but it's rationing that is to say it is making choices where we have good things we can do that if we don't do people will face very bad results disability and death and we will not be able to intervene with an awful lot of them probably worldwide eighty ninety percent would not get that intervention and even in our own country a huge proportion would not particularly if the flu strikes soon because we were very slow to get around as a national government to putting in our orders with Roche for all that Tamiflu and we're not first in line to get it we have very low stocks on a per capita basis compared to a lot of the other developed countries and so we will face what seems to me not a question of allocation but rationing now you may say aren't those too it's just more or less the same I think so they're very close but the suggestion I want to suggest to you is that it is a different thought process because of the fact that there will be some people who will really get nothing other than being told stay home stay hydrated don't infect other people but don't expect us to give you treatment we cannot do it we're dealing with others who have been prioritized for one reason or another and not seeming to get any reaction from this there we go now what is the basis for making the allocations and one way has been an argument that because of our commitment as a country and because of our ethical traditions of valuing all lives the same that we actually should not use a discriminating basis and indeed some people suggest a lottery drawing lot is back to biblical times the notion of a fair way that somehow for those of you who take a view that God guides the hand what comes up in the lottery would be a reflection of divine will for others who say well at least it gives everybody a priori an equal shot it seems fair what we've been talking about a principle of utility however the suggestion is well that is going to miss something is there any way of combining the two and one way of doing that is a view associated with Ronald Dworkin with his concept of equal regard and what that says is in certain circumstances our actions towards people are not going to be exactly equal but we begin from a presumption of equal respect to concern for all and we don't devalue anyone's life and that has some implications then for the next two categories that are here the notion of medical utility and social utility medical utility is something that's very familiar to to doctors in all sorts of triage situations in hospitals and emergency rooms and also to public health people the idea is medical utility looks at what an intervention can do for the people who are at greatest risk and and decides on the potential to benefit them and you can have as I've already suggested different outcomes from that but it's looking at what the medical indications are and what difference the medical intervention will make the idea of social utility is different that then says are there certain lives of greater social Worth because of their contribution to society in the light and it is that idea which is most directly in tension with either a pure version of equality or even with Dworkin's view of equal regard but there may be another way of looking as we focus our question of social utility not getting into a business of saying some people are worth more than than others to society as a general matter but recognizing that a pandemic would that need to ration and the need to make choices when not everyone is going to be saved or benefited is like a lifeboat and in a lifeboat you need someone who can steer the boat and that's one of the people that you're going to make judgments about and there may be other people that you make judgments about so I want to look at two different things for a little bit I want to look at medical utility and social utility and to look at medical utility I want to begin with an interesting exercise what seem to be going the wrong way here an interesting exercise developed by some colleagues at the Harvard School of Public Health principally professor Dan Brock and what he suggests is let's suppose he was doing this for the Massachusetts Department of Health to get them to think this through let's suppose that there's a novel strain of influenza A which has affected people in your community and there are now 500 cases and 50 deaths a high mortality rate 10% and Tamiflu is the only drug that will be effective to reduce the mortality of the ill patients however the supplies are limited and the hospitals across the country are independently making decisions in this hypothetical community suppose there are four major academic medical centers and that they've established these four different policies the first is hospital a which recognizes the importance of protecting its workforce in order to minimize absenteeism and ensure continuous response capacity and so it's decided to use its remaining cash of Tamiflu for prophylaxis of the staff who were exposed while caring for influenza patients that is that one extreme on the lifeboat idea these are the people who are steering the boat Hospital B in an effort to save it's very ill patients Hospital B has decided to reserve its remaining cash of Tamiflu for treatment of the sickest influenza patients this approach is consistent with the usual practice of the providers at hospital B who were accustomed to focusing primarily on treatment Hospital B is relying on airborne infection isolation and personal protective equipment namely the n95 respirators gloves and gowns to protected staff and is not using Tamiflu for prophylaxis in order to maximize survival rates hospital C has decided to reserve its remaining cache of Tamiflu for treatment of the patients most likely to benefit namely those who present within 48 hours of disease onset this plan will deplete their stock faster and so they are not using it for prophylaxis and Hospital D assuming that its cache of kami flu will soon be depleted regardless of the distribution strategy is using the antiviral for prophylaxis of exposed staff and treatment of all probable and confirmed cases this is obviously the most comprehensive approach and so it will reach its limits the fastest so which is right if we had enough time and you all had those little magical clickers or something here I we could take a vote hospital a hospital B Hospital C Hospital D and there are reasons why each of these might appeal to you so the first question is given that probability that different ones appeal to different of you can we take these independently and simply say that each is fair and reasonable although each is different but viewed in the context of the community what are some potential challenges that may arise as the result of the different institutions utilizing these different strategies if the strategies are as they probably should be transparent then won't we just have a distribution of the cases to those hospitals that are most likely to treat so if you're very sick to start off with most likely to die you'll go to one hospital ikely to benefit go to another if you're a healthcare worker you want to be at hospital a hospital v apparently will take all comers just get in line as soon as possible so that doesn't sound very coordinated so should it be made at the hospital level or at a community level level and if so is that a process led by public health officials what about at a state level or is this something where we ought to regard this as a national problem and have a national policy so that we don't get this competition and diversity now some people have suggested that going beyond this kind of rationalization based on medical differences how sick the person is so forth we ought to emphasize social utility and Hospital a was doing that to a certain extent because they were treating their own health care workers first there have been several attempts at this mostly around initially stimulated by the question of the seasonal flu because as you recall in 2004 I guess 2005 we had a huge shortage of the seasonal flu vaccine because one of the factories that was responsible for manufacturing it and did not pass the FDA requirements and we were suddenly very short and so at that point various by vaccine related groups put out standards and almost all of them say and and certainly we'd be true in a pandemic that there has to be prioritization for the health care workers and the vaccine workers because their health is crucial to the functioning of the healthcare system as a whole and many people within that say well that doesn't mean every doctor you know I'm sorry mr. cosmetic surgeon you don't qualify unless you give up cosmetic surgery and become a public health official for the interim but those people who are on the front lines this is not as far as the best predictions go like SARS where it is very unlikely to get the disease in the community and it's very likely to get it if you're a health care worker traditionally there is a greater exposure I mean Ebola mostly affects a few people in the community and then the health care workers who come in and take care of them have a very high mortality rate probably the the chance of getting influenza is going to be more or less equal so it's not that the frontline workers are at that much greater risk although they they may be at somewhat greater risk and indeed we have to know the facts before we decide on which policy but assuming that it's a community based acquisition we still have concern not of paying them back for for true their willingness to treat but just keeping them able to treat but after that who gets priority and some people have argued for a life cycle principle that's something that norm Daniels the philosopher calls a fair innings principle and that is to equalize everyone's chance to live through each stage of life the farthest implication of that would be that you would treat six months old in preference to one year olds and preference to two year olds and so forth because each group would then by having access to the vaccine have the better chance of being able to move on to the next stage in their life but that that has some very odd implications one implication is that we would have an awful lot of healthy little orphans because all their parents and grandparents would be dead and Zeke Emanuel and colleagues at the National Institutes of Health argued therefore for a refinement of the life cycle principle based on preservation of public order and what they call an investment refinement and their argument is that up until about the age of 13 you would not give preference but the people from their teenage years to about 40 who are at a stage where they have invested and others have invested a great deal in them that's what we should be trying to preserve so it turns thing around and says up until then you don't have the life cycle principle the fair innings operating at that point you do and it's in part the notion of investment the problem pushing that very far is it becomes that that view of social Worth in a way because social investment is a way of saying the the likely reward from that investment to society let me go very quickly through the other topics the second topic as I mentioned is the question of Public Health there all sorts of measures quarantine eing expose people isolation of sick persons social distancing that is to say closing down the malls telling people not to go out in public not having church services and so forth border control to keep the movement internationally and various measures of personal hygiene wearing masks and so forth it's not clear how effective ordinary masks are but but they may have some effect obviously a fundamental question in all of this will be do we have the evidence that these things are going to work in this circumstance and if so how do we compare the burdens that they impose on individuals in this I think that Jim Childress has very usefully argued that what we want are those measures to be taken which are most likely to express community rather than to impose community and so if we look at what happened when Toronto was faced with SARS they relied very heavily on voluntary quarantine the people who were exposed voluntarily stayed home if we're going to have that work we have to have a system which is in place to support the people so you have to if you're if you're staying at home so it's not to expose people somebody has to get you what you need whether it's your other medicines or food and water or whatever we have to therefore find a way of expressing the community to support that voluntary action we may however be dealing with something where we have to go beyond voluntary actions and one of the questions will then be going back to those hospital ABCs is do we need some way of treating the relevant vaccines and drugs as community resources to be actually allocated by some choice rather than just what anybody can get their their hands on and likewise would there be a national plan of distribution so if the the conditions start showing up in some places and not others and we lock down to the extent we can on people traveling target our resources and try to slow down the spread of the disease always of course we're looking for the least restrictive alternative among interventions and being made by people who have the authority under the law to do so using the best evidence what about obligations of and to health care workers as I suggested when I introduced this topic this is something where there are different rationales for saying that people with these special skills have special obligations part of this is the notion going back to Hippocrates and the epidemics is to say that the doctors obligation to patients in ordinary circumstances extend to those patients into the community in need and there are throughout history great stories of physicians who were the last to leave in the face of the plague and so forth in more recent years physicians have expressed a lot of anxiety more or less like soldiers signing up for the peacetime army and finding themselves fighting without adequate protection in a war they feel I've been asked to take on risk which weren't part of my bargain when I became a doctor and in the early years of the AIDS epidemic when there was a lot of anxiety in the medical community how can we protect ourselves and so forth a lot of doctors said I'm just not going to treat HIV positive patients the medical community came together and eventually said no that's not the right approach if the the standard for physicians should be within your practice abilities you have an obligation to not to turn away patients because they are HIV positive and indeed you ought to be using the means that would protect you against infection with all your patients so that you don't infect them and they don't infect you because you may not know who's hiv-positive and I think that has now become more than norm but I know from teaching medical students that there are some who still are choosing what branch of medicine to go into what specialty to have because they don't want to take on those risks and so the question then is is this a part of being a very privileged person in society having had this education and in effect being part of a social contract or is it simply that in times of need we would be drafting people and we'd be drafting the delivery man and the cleaning workers as well as the doctors because the hospitals and and the the society are not going to work without that and that then becomes a question linked with the obligations of the healthcare professionals are the obligations to them if they are placed at greater than community level risk and obviously in the end we would be better served with voluntary participation in regarding this as a super Roget ory act an act of sacrifice to a certain extent rather than an obligatory act that is mandated but in all cases whichever it is we must provide to physicians and nurses and others who are engaged in this work the means to make it as reasonably safe as possible I'm going the wrong direction finally just a few words about the International there are obligations which rests on national governments but it's important to recognize these are not solely obligations under the human rights instruments to other governments they are obligations to the populations who are at great risk and who face a humanitarian crisis the UN Charter talks about the principles of the UN to achieve international cooperation in solving international problems of humanitarian character the Universal Declaration of Human Rights talks about the respect for economic social and cultural rights including matters of health which are indispensable for human dignity and proclaims they should be realized through national effort and international cooperation one of the problems with these statements is that they are rather vague on their implementation and they are focused largely on long-term development so that they talk about progressive realisation of these rights there are really also within these documents no criteria for judging how a state should assess the extent of its obligations and to whom such obligations attached and it's obvious that governments are most likely to act if they know that other governments are acting so that when there is inaction and the greatest need the inaction feeds on itself practically the ability of states to respond appropriately depends on several things first that they are aware of the problem and the threat that it poses that they possess the knowledge that enables them to control the problem and that they have the logistical administrative and financial capacity to act effectively reciprocally their obligation to respond depends on the extent to which their own capacity to deal with the problems in their own country exceeds that which is probably going to be necessary that there is a means for organized international response and and this is the crucial part that the recipient countries have themselves set up effective inequitable systems because while it seems to me that American leaders should be prepared in the face of a pandemic to say we have to take some additional risks here at home by sharing our financial our logistical our human and our medical resources with countries that are facing the first wave of a pandemic we would feel very hard justifying that if the regimes to which those supplies went did not have effective ways of using the supplies that they were as it were rotting on the docks waiting for use or that they were going to be used in a very inequitable fashion they were going to be used for an elite or for a military or not for the general population and so the very countries where the need will be the greatest and the exposure of people to inequitable and vulnerable situations is the greatest may be the ones which will be the hardest to aid because they're really it's very difficult totally to go around the government although the obligation is to those populations and if there are memes through NGOs and so forth to reach those populations it seems to me they have a very strong moral claim I've suggested to you that all of these various examples are examples of individual versus group interests and therefore part of the communication is recognizing the scarcity and result and the resulting need for collective action it seems to me that we ought as a country to engage in what curving Janus years ago called in a different context the context of individual choices about healthcare as the work of worrying the need to anticipate and work through a problem in advance and in the clinical context I sometimes hear from physicians the view well I don't want to worry my patients unnecessarily I don't want to give them details of all the bad things that could happen they're so improbable but what Janis found was that wasn't harmful to people that indeed going through that process left no residual harm if those things didn't arise people didn't just start developing every symptom they'd ever heard could happen but conversely where they hadn't engaged in the work of worrying then the upset of dealing with the reality was much greater and I think as a community and as a country and internationally through w-h-o we need that process now all of the ethical issues really are species of this question of individual versus group the interest of country a versus the community at large the interest of people to be vaccinated versus to her the interest of the person who wants access to Tamiflu versus the interest of those who are judged to have priority the interests of subjects and clinical trials versus the interest of people who receive a vaccine or drug after the trial process as is always true with ethical dilemmas even more than with following human rights norms we're dealing here with a bunch of choices where we have Goods competing with each other there is no simple solution to this and therefore reasoning publicly debated is going to lead to very doubt comes but the test is not the incontrovertibly ility but the public understanding and acceptance of whatever those outcomes are in the end I think we come back to what Guido Calabresi and Phil Bobbitt in their book tragic choices talked about in the context of allocation but I think applies more broadly achieving the moral foundations and preserving the moral foundations of our social collaboration it is clear therefore that the process will be very important in dealing with allocation decisions the standards need to be articulated publicly debated and justified the greater barrier in our context and around the world to success may be public skepticism about the fairness or a perception of actual discrimination particularly when such discrimination already occurs in health care for many populations and so we have to put that issue on the table and our desire to avoid that discrimination but we have to elevate the conversation above that and I think that is a process in which those of you who come from law or will be in law certainly have a role those of you who come from medicine and public health recognize your role obviously but I think more than that it is something about which we all need a frank and informed discussion and I hope that these remarks are helpful to you in framing some of the issues that that discussion must address thank you [Applause] we're gonna get a microphone screw over-the-air where you are just raise your hand looking a lot about the the giving the public the chance to worry about getting going on the work of worrying and that's something that we worry about a lot because it's not so easy to get started it has to do with the whole business of doing transparency and and helping the public to get involved in decisions of how we're going to allocate scarce resources and how we're going to impose limitations of personal freedom in order to to contain spread in the community of isolation when you're sick school closings terrible dilemma and we've been holding public meetings in every county called summits to try and get groups of the public involved have been going on since this last late spring and my own personal take is that it's not easy there seems to be a period of sinking in and getting getting a sense this is real and understanding some of the right realities before you can start worrying effectively and we've not I think really been that successful in getting a public debate going except in certain professional groups and in certain businesses and in certain certain subgroups of the population that that had a chance to understand this better and we can focus more on so do you have any thoughts on on to what extent it's it's necessary to really get this whirring widely out and especially to the people who are less powerful and received less communication and haven't heard as much about it and how do you do it your question raises three points to me the first I totally agree with we know that it's very hard to get people to engage in things that are not right before them and when I talk about the work of worrying I'm not talking about the work of panic that is to say I don't think that a Michael Crichton approach is probably the right one here just have everybody worrying about a superbug escaping it is possible to get attention to this now obviously if some of the attention in recent years has come about after dramatic events we worried about bioterrorism after 9/11 and when we had the anthrax scare in those cases it was possible to get people saying well what do I need to do to protect their what steps are being taken how safe are things the second thing that you emphasize is the the need to reach out actually I through its level and have small discussions of people and I think that is going to vary from community to community what are the natural modes of discussion since many of these issues are issues that are will affect people in their schools because school closures are going to be a major thing it seems to me using PTAs or whatever the South Carolina equivalent of that is if that's not the right word is is one idea and developing a set of lay materials that that people could be a few people could be trained to use and then have these discussions many of the questions here are obviously questions about fairness to human beings and so forth and our faith traditions are all full of views about that so again finding religious education leaders and so forth and making this something that will be talked about in church groups like part of what needs to go out here and this is my third point is the realization that in that process I suspect we will learn a lot of things because people will see and that that work of worrying will get them to worry about things that maybe are not the first things to occur to people one thing that maybe you all I know you're in public health maybe you thought of but I have would never have thought of is one of the reasons that sited for people not leaving New Orleans was because they didn't have any way of transporting their pets and some people stay behind or delayed long enough that they were caught because they said I can't if there's gonna be a flood I can't take all my animals but I can't leave them ok so if there were some discussion in this area about what this is going to mean in the community and you've got some people thinking we might get some ideas bubbling up oh we've got a problem we have to anticipate we have to plan for what to do about that because this is how people are really gonna be worried and I don't know I'm not gonna suggest a new one you hadn't thought of my point is I wouldn't know how to think of it and maybe you wouldn't need it even though you're in the public health field because these things come up from a community level and so it's both the difficulty I mean how do we get people to change their diet it's very hard to get people to think how do we get teenagers not to smoke well it turned out from what I know it's much more effective to get people to stop smoking if you tell them their breath smells bad and no one wants to be around them then they'll get cancer in 30 or 40 years that doesn't and the notion that oh there might be something coming along like this it is hard to get people's attention but it's real enough and that you know there there are the reports of deaths around the world and so forth I think we could get people's attention realistically there was a good deal of attention two years ago when we were very short of the seasonal flu and that was in every newspaper all the time and different communities you saw people lining up at hospitals even I think one or two people died waiting in line because they were already very frail people so that got people's attention reminding people of that and saying now how are we gonna deal if it's a much bigger problem with much fewer resources I think we could get people's attention but I'm not surprised that you've tried and found it difficult we're lucky here I think we have the resources to do that I'm much more worried frankly giving this advice to countries where the health system is hanging on by its fingertips and I'm not sure it's entirely ethical to tell them that they should spend a lot of resources what is only a possibility I mean could be here two years from now and say remember that crazy guy who came through and talked about pandemic influenza well they've now wiped out h5n1 and we're not going to have a pandemic haha what a fool he was and I would feel particularly badly if this were Uganda instead of South Carolina because I'm not sure their public health officials should be spending a lot of time on this compared to immediate needs we have the luxury that we do have the resources to address this and do other important public health work in my view please interested in if there's been any talk about you know right now there's a lot of worry about things like a pandemic coming about and there's a lot of media saturation on the topic and so is there any worry in the public health world that it will be so saturated now that the farther it gets before we were to have an actual outbreak that there's going to be a problem like almost a desensitization process where people won't as I'm talking about this the public in particular not necessarily officials that they won't take it as seriously when it when it does start to you know spread like you know just a few cases here and there but is there is there a worry that people won't take it as seriously because they've been hearing about it for so long let me give you an answer which isn't based on empirical work I can't tell you I haven't done questioning of people who do like the Pew Center that does all those public opinion polls I don't know if they've tried to figure out how they would answer that I suppose that if we had only worries and didn't know what to do with it eventually either you get tired of the worry when the thing doesn't happen or you as you put it become desensitized and just stop worrying and don't notice whether it's happening I don't think we're dealing with that kind of a situation and I think that if we had responses that people could see now we've talked about it we saw that there was a problem we got together and we know if we're in this community has these four hospitals that they've debated among themselves and they've decided that they need one common policy for our community and this is what it's going to be and we recognize that that will mean that certain people get treated and others won't but we know why we got to that point and this was not just a few doctors making a decision behind closed doors that's different and then if you get to the point where it comes up of course the people who will be as it were on the losing end of whatever that calculation is may say oh gee I'm still not really happy with it but I think we have experience I know at the HIV area some work that's been done in Africa where they face the same question about not having enough of the antiretroviral treatments for everybody who was going to need treatment they still have that problem that where there have been these community discussions and people feel that their concerns were taken into account Dworkin x' idea of equal respect and concern then they can live more because of that fair process with an outcome with which they may disagree and it's where rules seem to come out of nowhere and they don't seem to have taken account of the views of people that you're most likely to have unhappiness with them and in this case unhappiness can mean social disruption either civil disobedience in the sense people go off and get their hands on Tamiflu even though they're not supposed to have it because they're not at the priority list they get their doctor to write a prescription and the doctor agrees because he likes this patient or whatever or actual social disruption in the sense of people marching in the streets and you know trying to break down the hospital doors not obeying rules if it is very likely that the rule of social distancing will mean if you're sick don't come to the hospital because we're going to face a lot of problems in the hospital and we don't want to spread this disease that everybody coming into the hospital is exposed to it so stay at home and here's the mechanisms we have to take care of people who are at home here's the number you call to say I need my groceries delivered or whatever if we have those things in place we're more likely to have success if we don't and then we get people disobeying the rules of social distancing and so forth because they don't see why they should why me I don't buy into this I don't think it was fair I don't know how you got to this point it's a stupid rule those are when you have problems so I'd be worried if we only had worrying but if we have worrying and then transparent policies come out of that process with ground up participation I don't think we should worry that that will desensitize us it will prepare us it's not clear to me whether you are suggesting that it doesn't make any difference which of these allocation or principles one applies so long as there's transparency is is that your basic contention or do you favor one allocation principle over another or have some priority among them well I wasn't saying that in my view all are equal I have particular problems with ones which would use outright social utility as the criterion and one of the problems I therefore have with Zika Manuel's view of this investment refinement to the lifecycle principle this notion of fair innings is that it does seem to me to carry the seeds of saying some people are more valuable to society because we've invested a lot of them and we haven't reaped that fully so that people who are younger and haven't had the investment or more dispensable people who are older who've had their life chance and maybe aren't as productive anymore are dispensable and we and that that does worry me but but I'm not as worried by a more focused lifeboat sort of view of utility that says we do need to keep broadly understood front line people able to do their jobs because to a certain extent our our health system the ability to manufacture vaccines to distribute them the the ability to give nursing and medical care to people is going to be very important for saving lives and therefore we need the core available and as I say I didn't restrict that to the narrow traditional professions of Nursing and medicine I I would say the people who were in the hospital cleaning the hospital the people who are the morticians who are taking care of dead bodies and so forth that's all part of that system that needs to be in place and that focused kind of hand on the tiller of the of the lifeboat seems to me different than saying well a group of people are better within any group if we if we only had say a hundred million doses of vaccine we might not even be able to treat everybody within Zeek Emmanuel's preferred investment life Investment Group we would still need lotteries I think across the lifespan we need that but we do need a sensible approach and it's here that I would turn to the community again and I can't imagine some communities saying you know we really would prefer to let the children go first and we think we will have enough we would give in the way this illness strikes we will have enough people who will be caretakers and even if a child were to lose both its parents we know we will take care of them we don't abandon and other communities saying we want to make sure that in every family there's a a parent who survives so when you treat children you've got to treat one of their parents to give to maximize that I mean I can imagine differences there and it doesn't seem to me that one of those is automatically right and the other they do depend on social circumstances and certainly looking internationally I would I would say that we should be willing to regard as an equitable system to which we would give some of our scarce resources one which would reach a different judgment that we might reach because of that society's traditions and for example as a society that very much venerates the elderly because very few people make it through to old age there and they say we want to protect them as well and not just give it to the 20 and 30 year olds I would say if that is consistent with their society and they've gone through a fair process and this really represents not just the few people would power in the community the elders but really represents the community I would be satisfied with that having those kinds of democratic processes around the world may be a dream it may not happen everywhere I think we can do a lot of it here I think a lot of many countries that can do that it seems to me that because our health system is going to face more and more issues that aren't just issues of allocation but are of rationing because the ability of the health system to do more of benefit than we can afford this exercise of recognizing our common interest in the fair allocation of resources can have benefit even if we never have a pandemic it seems to me this is looking at a specific set of facts but we're gonna face these questions with every passing year more and more how do we decide when not to spend something because the marginal benefit of doing it for this category of illnesses with this category of patients is not worth where else those resources could be better spent and I think that to the extent that we recognize this as something where we have a common interest and we ought to have discussions about it that's all to the good so I don't think this is in any case going to be wasted but particularly if we have a pandemic I think it's going to be essential for that social cohesion and that preservation of what calibration bhavat called the moral foundations of our social collaboration [Applause] you you