Transcripts For CSPAN2 Center For Global Development Releases Ebola Report 20170814

Things brought beauty for coming to the center for Global Development today for this interesting discussion. I think that sound effect was appropriate. For the tension that might exist between the need to deliver humanitarian care when there is an outbreak as serious as the recent Ebola Outbreak in the need to actually learn, learn what works to address that and where the outbreak is of a disease which is emerging that is therapeutic, does not exist and even the vaccine does not exist. In those cases, the need for learning and how can that need for learning be accommodated when the humanitarian need is so great. Our speakers today who will be addressing not point are the leaders of the team at the National Cabinet of science to produce a report recently published on the topic of implementing epidemics. Im going to turn over the podium now to the cochair of that team who is dr. Jerry keusch at Austin University and hes also managing very important and exciting institution recently created bear where one could do research on dangerous diseases. This is an institution which we desperately need in the United States and is working hard to bring that to fruition. He and his copresenter david peters will be talking for 15 minutes each and we will have a Panel Discussion which we are going to welcome dr. Terry teicher from the humanitarian group that actually did most of did more in sync more ebola lies than any other group during the Ebola Outbreak and also chairman konydyk who is here with that at cgd and supported the United States after to control the ebola epidemic from his position as director of emergency, what is it, the office of u. S. Disaster assistance during that period. So now ill turn it over to jerry. Thinks, may. My thanks as well to everybody for participating and for those of you who are watching remotely. We are really grateful for your input. I am representing, with david as well, representing a committee that was formed at the National Academy of medicine to look at the issue of Clinical Research when there is an epidemic and there is a multiplicity of issues where president s at the start of the outbreak and critically, particularly for ebola was actually very little that was clearly known about how we manage a patient with ebola, just plain clinical support. Therapeutics or vaccines that it gone through human Clinical Trials and shown to be both effective and safe to use. That is sort of the genesys avoid this committee began. Ill tell you a little bit about that. What david and i are hoping to do today is to hear from you, get some of your thoughts, particularly around two of the questions. I dont think we need to delve into the technical aspects of statistics and study design, but how do you in fact integrate research into an epidemic response . We are past the time when we say that its the happening. We need to now know that has to happen. And secondly, how do you create the overall governance and Leadership Structure that can address this kind of an issue and what might be the criteria . So, i thought it was worthwhile to back up just a little bit to some fundamentals of how do you develop drugs and vaccines . The same thing could be said for diagnostic test except the issue of human safety is not really a significant as it is for drugs and vaccines. First in the Science Community figure out the target for a drug, the target for an Indian Response and what a molecule and pathogen would be useful to die. Same thing would apply to diagnostics. And now you have to fund that r d. A lot of that is funded at this upstream basic research, funded by public money. The Development Process is something that is done by industry, particularly in this country. But you need to determine ultimately whether these things work in humans, we start with animals. The food and Drug Administration has often lied a too animal rule where you need to show both safety and efficacy in two different species and thats in part because response to a single drug or single vaccine may differ according to sbcs new iran. Because it works into animals doesnt mean that works in humans or is actually safe in humans. When you have data from animal studies, you can get Regulatory Approval to start a phase one trial in human, which is a small study, looking for safety primarily. Not people at risk of infection or might need treatment. If you can show that its safe and the smaller study, you can move on to a larger study which looks at both safety and a Larger Population as well as an indication that these performance you expected and that a vaccine will produce an immune response that you think will be good. Ultimately, if all of that goes well and something is licensed and introduced, phase three trials are larger scale and we really begin to look at the efficacy and get much more safety data. Most of the candidates that enter into the process falloff before you get to phase three and even the results of phase three. So one of the questions that might be asked is why his research during ebola different than other things that were done in the past . The first thing is that higher mortality, no proven treatment and experimental human infection models are not possible. You can do that with colorado because we can treat you if you develop the disease and that has been done to develop vaccines. This kind of an infection like ebola, and outbreak is the only opportunity for a human trial. It now has a highly safety and highly affect the vaccine. How do we know how to treat antibiotics in the clinical course and is now already achieved in effect or vaccines . It is not difficult to conduct trials. There are large numbers of trials all the time and dengue is not typically a lethal disease. Ebola and diseases like it stand out is different. Why do you need to do research during an Ebola Outbreak . The first of Clinical Data to learn how to best care for infected patients. Im a physician. I look at what we do is appoint with two sides. One side is taking care of people. The other side is learning how to do a better than those to me are inseparable. Constant learning is part of the model of being in the health care profession. So to assess an investigational drug vaccine for safety and efficacy in humans because animal models in general do not reliably predict the human response so you actually have to go to the human trials to show that it works and its safe. Youd actually be able to use a Public Health approach and use it potentially to predict a future outbreak and when it fails to prevent an outbreak in europe people who are sick, you need to treat them affect early in the addition of drugs to the higher standard of Clinical Care may be a significant improvement in survival and reduction. So this part of advancing medical knowledge in general and patient care and this is that the fda says about clinical trial. We dont know if or how no anguish of them are better than one or another of the treatment will work and what is the context . What is the setting . You need the information before you can improve the mice in something and manufacture it and distribute and use it. And to rapidly as possible expand access to promising new approaches. They say Clinical Research is not necessarily the person who is involved in a clinical trial. Certainly to the future it is potentially available to individuals who are themselves suffering from the disease at the progress can be made and shown to be beneficial. So, to set up the Clinical Research that was done during the outbreak, we learned very little definitively. And because of that, the National Academy is to assess the trials and recommend improvements for future emergencies. Sponsors are three parts of the department of health and Human Services and the fda and the National Institute of allergy and infectious diseases, the academy created a 16 Member Committee from europe, africa. We had three public workshops. We had six Close Committee meetings, very comprehensive literature review, conference calls, email exchanges and incredibly expensive external and internal review process before the report was issued. Basically the context of the outbreak was actually patient zero was the two year old in getting ill towards the end of december 2013. In the middle of january, the trail of cases from that child who relatives and some of the Health Care Providers resulting in similar kinds of debts was recognized as unusual. This was the quaestor of unusual sound mean. The medical officer robin the boonies and getting notified and notice something is going on. They came to the conclusion that outbreaks in the past. They should not have been on their mind because thats not what happens in colorado. So they did not identify it. It wasnt until the latter part of february that the Ministry Said this is behaving differently. Were a little bit worried this may be Something Different and they asked doing work in the country to come and take a look at the response was immediate and strong and they said this looks like a hemorrhagic fever. They took samples come assented to france in the diagnosis was made in the middle of march. The last two months from the point at which an outbreak was identified and that was really important because at that point already did it cross the borders into the two contiguous countries, sierra leone and liberia. In effect, cayman and enterprise to take care of patients. And they quickly recognized this is out of control. This is different from anything theyve ever done with ebola and kept saying this is different, this is different. At least influenced by past experience with ebola, which is smaller and outbreaks that are relatively easily controlled did not recognize and did not agree with. They declared this as a moderate event which in their language is level, which can be supported at the Country Office and Regional Office provision. It didnt get the big Global Recognition that it needs and it wasnt until august the highest level of there and come in the Public Health was declared by who. Now the International Response started to kick in. Only then was the possibility of doing Clinical Trials appreciated. Six months have gone by america thousands of good people, which has never been seen before in an Ebola Outbreak. So ultimately, there were for 28,000 in fact did, over 11,000 who died here at the beginning there were no approved vaccines or treatments and when in august and september of 2014 when you start taking about Clinical Trials, they started coming out of the woodwork. When you eliminated the crazy things, there is still about 20 potential candidates that couldve been studied. This is a timeline of the outbreak in terms of cases. And so, the three lions here are the three countries, the three target countries. So here is the middle of march. Ebola is declared. Here is an International Concern was raised by who. Now the outbreak and response starts to kick in. It is sluggish and several months later before the out break starts to come down. Trials were done, the therapeutic trials, vaccine trials ill initiated in the out ricks really coming under control. There were a few case and not had major implications for the result that regained. Here are the results. Five therapeutic trials. None were conclusive that this works and is safe. One of those trials suggest efficacy, but not going to be sufficient for inducing a Regulatory Agency that is just okay. [inaudible] the original indication was that the therapeutics for not contributing to mortality, but safe in the context of Regulatory Agency wouldnt want to see at that point. No evidence. Thats the nature of the data. One had a probable effect, although it got publicized last december as 100 effect disappeared the problem with that conclusion from our point of view is the most appropriate Statistical Analysis was not applied. When you apply that analysis, so effect of the estimate about 65 efficacy, but the confidence around that estimate spans zero. So it could be coincidental and still could be not affect it. It looks promising. We may have one promising intervention vaccine. They still need to go through unnecessary Clinical Research, which ebola is really going to be the next outbreak. The next outbreak is unlikely to be as big as this one, which means that we really have to be prepared to move in as quickly as possible. So the Clinical Trials that were implemented here, sort of in january they go from september, october when they started to think about doing things in, getting it up route, logistics, the rapidity with which this happened was remarkable, unprecedented and not fast enough. That is the key lesson that its got to be more exact date and efficient. The conditions on the ground and kerry may talk about a couple were really chaotic. Because of that, focused on the people who are sick and dying for their families who are at risk. That was sitting right in front of you as something important. Why are we going to get involved in trying to do research, particularly when you have to deal with patients and protect equipment. Their ambient conditions that made it very difficult let alone having investigators they are in the data. A whole set of issues. There is no consensus on what to study or how to organize it. It was a very limited experience with ebola. They didnt have recognized ebola, although it turns out from epidemiological evidence that it was and north africa. It may have been it. Im recognized and unrecognized is unknown. There were big mistakes in how the messaging was. Data failure to engage the community in the process. Some of these experimental therapies were used in expatriate who are evacuated from west africa, what contract that ebola taking care of patients. They seem to do pretty well. Mortality was very low and suddenly there was this magic medicine, a magic sarah given to the foreigners, but not to the africans, which fed into all of the conspiracy theories and west africa lack of trust and their history of civil complex. And the Research Groups themselves were fully coordinated and competitive to get their products into a trial into triage of which are the most important things to do and how to do it and that was particularly true as the epidemic was being controlled. Some key messages from the report. Research is necessary in the best way to ensure it can be done under these kinds of circumstances is to integrate it into academic response. We think these can be organized to work together. The question is how do you do that . That is the challenge. Questions are raised about the ethics of doing randomized trials. The analysis of the report is clear. It is supposed ethical and proves to be feasible to randomized trial. What you needed to do was prepare the Community Engagement to be able to participate in research is going to be useful at all it has to be scientifically rigorous and designed in a way that would produce useful information. This kind of cleaning and organizing begins before an outbreak occurs. Both international and the National Coordination and across everything local Community Participation in the process is absolutely essential not only during the epidemic but before the next one happens. You cant do the research about it, but it also the community as a part of the effort, so excluding them makes to delete a separate increase adverse conditions trying to do it. The various capacity to do Clinical Research, but the key message to the key part of our message was pseudowant to separate the Research Establishment and agency going into liberia and building a beautiful award in a decrepit hospital where the level of Clinical Care is awful. It has to be across the spec to a Public Health and respond in the Clinical Research. These need to be linked together. Investment is needed now to start moving towards this kind of prepared processes and engage in coordination among the research and Development Agencies to cover the whole broad agenda is critical and how do you get the optimal leadership to do this . It may be different with Clinical Research then if youre trying to do a rapid clinical intervention. So that is the setup of my remarks for this broader picture of what was going on, what it means and why its necessary. Now if not quite apparent. David is that hopkins and is the chair of the department of International Health really has great expertise on these issues. Hes going to raise some of the questions about how we go forward, how we create the collaboration and leadership. Thanks for inviting me. Im very happy to be here. The point on the governance and leadership aspects of leadership. The ihr, this is a legacy that we have the legal regulations go back to the 1860s and revised from time to time of International Protection in response to epidemics for purposes of Public Health and trade in the difficulty they have not working very well. Its funny when there is no major outbreaks are the problem is that happens from time to time. What we saw and the failure of the ihr was basically not just the inability to have a surveillance in rapid response, but really the whole preparation side of things. Who was passed with preparing countries. Countries are obligated by legal agreement. 196 companies have signed up to have the capacity. They were supposed to be in places in 2012 and not the west african countries are in that position could liberia is the first one to do an assessment in 2017 and still has a long way to go. Currently, this is a problem with capabilities. At does have clear governance structure is led by who. Its really government to government you can call another expert and organizations using the roster of expert and Emergency Review Committee who last revised in 2005 after the start of the epidemic. It will be further revised in the area where we put a lot of emphasis in terms of making it work there. It doesnt work in large part not just because of capacity nationally, but lots of enforcement for public accountability and in fact never has there been a mandate and govern it structures. And what we see is this growing consensus that it needs to be part of the epidemic response and we need to find ways to bridge practice into the effort of epidemics. How do we do this Going Forward . This is really what i want to talk about in terms of this work in progress really. How do we fill the governance gap with leadership putting research into epidemics. Obviously a social construct highlighted in terms of need the institutions and the epidemic responses that these are really broad Multistakeholder Networks that have very different interests capabilities in mandate in very different asymmetric levels of power. We really need to have a governance model that recognizes and addresses these types of concerns. We need to learn how to do that. One thing the report said is highlight a broad set of stakeholders involved in the response. National governments, but many different agencies. Not just tall foreign affairs, but the Regulatory Agency in research and Public Health agencies are critical enough of not talking to each other and why you might have different designs and move on in terms of research. Obviously, who has a major role in humanitarian organizations certainly at the frontlines have played a Critical Role in the most prominent but others as well over 70 different humanitarian ngos were involved in the outbreak anonymously other groups related to research, professional associations and industry. Pharmaceutical and diagnostic and Civil Society. All of these are critical stakeholders. So what we did in the report was proposed that type of government structure for basically a set of functions and print a to be adhered to. The principles are not inclusive autonomous and independent organizations and the college during the interepidemic planning. So its an epidemic going on. Between major crises, we need to be better prepared. What is needed is really bringing together all of these types of stakeholders and not just the government to government occasional sets of select an involvement that because im typically that involving the full sets including the Community Representatives dealing with industry academia organizations. The purpose of this group is really to do things like how you prioritize the research that needs to be done, doing the research is being able to identify research designs, being able to identify standard agreements, all the things that slow down research when you have to respond quickly and identify the key players who can be there and be called upon for this next group in particular, the rapid response, and our three w. The idea is when an outbreak is emerging, but you have people who have expertise in those viruses. You need that kind of expertise. You need to bring in those who can do the regulatory work, the design and we propose that you need to have this kind of Group Brought on a need to have the operating procedures that had. These are the two kinds of functions and sets of organizations that need to be set up with coalition and we look at, what the Global Health security doesnt want the Organization Called coalition for epidemic preparedness and innovation does. There were huge problems with all of them in terms of capacity. We like the approach and the full set of stakeholders around International Coalition stakeholders. We dont have the perfect model right now. We have to move toward something that brings in the full set of stakeholders. We have to think of the key issues in terms of establishing the governance arrangement. What weve done to think about a working group in one of the things involved. And recognize their differences and commonalities of stakeholders. Look at the ideologies, power and accountability in how you set up governing that addresses these issues. One of the things about Global Health architecture as you have really unruly characters have a go at it with that bit of naivete or sort of this entrenched opposition to certain groups were sort of a favoritism. Certain academics or select. These kinds of patterns we need to get over. Its very hard for who to work with industry in particular. Its difficult for them to do that. They also have difficulty and how you bring in Civil Society organizations. I dont think its entrenched opposition. I think its lack of understanding of how to do it very well. One of the big lessons of the Ebola Outbreak is you really need Civil Society is a huge part of the outbreak response. That is a whole talk in itself. Not just principles of processes. Inclusiveness, authority and accountability. These are not new concepts and theres a really good book by Justin Parker these are things we should look at. Things that are going to be addressed. They seem that way, but they are things neglected or should be addressed. Right now a group of interested parties brought together there is bringing together collaborative Coordinator Research during crises. So that is great. There is some agreement around availability. What is the Research Agenda, which the passage includes Antimicrobial Resistance . Does it include Epidemiologic Research that you need during an outbreak . These issues around Capacity Building, when accountability is you and the sharing of an asset of who should benefit from this. This is all made explicit as we develop government similarly, the issue of interest ideology power. There are still even to this day who claiming the urbanization of vested interests. Maybe there are enough commercial interests, but they certainly are dependent on governance and foundations. Certain ideologies and organizations have their own beliefs about what is evident, intellectual property, but there is also a commitment to previous guidelines and things you have done whether its clinical guidelines or programs with a vested interest in these things in ideologies. The issue of powers critical. Whos going to pay for what goes on in whos going to implement it . That may ultimately determine whats done. Recognizing different agencies. This is a serious area of inquiry that is not to systematically address for this issue in many issues in Global Health. Working principles, yes, the group has put together global coordination mechanism with some good work in terms of some of these mechanisms. A group of scientists how to prioritize. This is not the only list. There is a list that has anything 39 pathogens that have potential to do this. There is a huge overlap, but if the differences in terms of how you poorer thais a political issue as well. Other principles theyve got in terms of using evidence and accountability, but a number of things arent there was stakeholders beyond government and Scientific Community and how do you get them to the table. Who gets to choose whos involved or not its edc china is going to be the biggest investor of Public Health infrastructure and if you dont have it at the table, you have to wonder if youre really having a Global Governance framework. Usaid has roles in terms of infrastructure Capacity Building universities in Civil Society are very clumsy in terms of how this is being done. One university is involved. So a big issue about how you have the conflict of interest and how do you properly balance. Related to the deliberative process, there is a default type of approach to governance for research should be under Single Agency by who just like the National Health regulation. So while the functions you need we will talk about that. The second is how do you avoid conflicts of interest in research because thats a big deal in research. The other notion is governance arrangements really needs to have a distributive approach because of the wide set of leadership in different areas and the need to balance accountability. We dont really know how to do that or we have to get her way around it. Others will have issues around these questions of legitimacy. Even if you have the mandate, theres a question of do you have the capabilities . This is a set of Research Functions from the report but basically the full cycle of Research Functions from how you do research and Development Prioritization of other research and the ethical review, analysis determination and then theres legal arrangements around intellectual property rates. An access to process as well as we are now in this watching the live stream version of this should know that you can submit questions via twitter and you should use cgt talks on the end. Now going to ask our two invited panelists to comment. We will start with terry, it has been mentioned several times during the talk and in particular i want to hear your reactions. You and i share the factories serve in the peace corps. So we were neighbors and not then. I know your experience in developing countries and crisis situations and gives you a unique insight here. Im wondering if you can respond. One particular thing im hoping youll speak to a little bit is this red squares that david presented the became apparent, manifest during the Ebola Outbreak Committee Organization structure. Great. Thank you for having us here today. We always are happy to be part of the discussion, especially when it comes to the experience weve had. Also the caveat im speaking from the experience and very much speaking my personal experience as a medical epidemiologist, in the field in which they work. We internally has the capacity to conduct Operational Research epidemiology and humanitarian contacts and ways had this experience for three decades. There is the capacity to do this, but at the very base of the, we are humanitarian Aid Organization, so we thank and applaud the idea of continuing research. We also have care and treatment has to be there as well and that is not for us to kind of start. We think you can have a Clinical Research agenda around therapeutic vaccine diagnostics and we applaud that effort, but also around Public Health and Clinical Care because delivering the care be a select and data physically by writing or trying to treat a patient on the ground needs to be looked into as well. Building on that, wed also like to state which was stated earlier come in the next epidemic is now. There is a lot about the scale that we saw in the ebola 2014, 2015 the. Today, but in 2017. Last year in nigeria and again this year there was ebola, so for us as a medical humanitarian Aid Organization would like to point out an on the ground the reality the next epidemic is here. Also reflect being is the scope of the 2014, 2015 epidemic was unique and we should be cautious or at least recognize extrapolating that experience and all events for which to engage in which is a little bit in terms of the need for flexibility. We also know for a earlier presentation we definitely had the who that is well known, but we would also like to reaffirm the legitimacy of who and include a blueprint is a step in the right. It reaffirms the rule and value in this process and the need to continue to fund them. Circulating back again, we are a medical humanitarian Aid Organization. If hypothesis testing in center field, we ensure its better. We are not sure why they are having most questions in that context makes sense. That gives us our example more recently of the nonthermal stabilized vaccine in which it has to be kept hidden, which even putting aside the very large regulatory issues about what we were able to use, we couldnt use it this past year, even if we were able to from a regulatory standpoint because you cant get something [inaudible] nonthermal stabilized vaccines where you work. It needs to be appropriate as well. We look at the report not only the key messages we think should be amplified. We would like to have flexibility. Phase three trials are difficult to forecast. We think about it in terms of vaccine trials in different protocols in the known data with the photo call in the report might have been more constraining than liberating for fast track of that time. However, protocols and ethical guidelines for Clinical Trials and from this experience its very clear he cant do that during the epidemic. I next accessibility we need to ensure the technology be at vaccine therapeutics are affordable, appropriate and available here. Its kind of our key while moving forward. Evolving effective communities as well as to when you think about the role of both national and local government as well as local communities, not only been part of the discussion and defining research priorities. The argument the epidemiological shift happened because of changes in behavior cracked this is and was largely driven by the community is something we should ignore. I wrote the number down here. There are 1400 staff working in our Ebola Treatment Centers and a bowler response. Over 4300 staff our staff are part of the community and we are part of the community. Whereas it has really been close to home and are involved in the conversation. You really spoke to the key issues they are. Lets go to jeremy now. Jeremy had the responsibility of directing a large part of the United States response to the ebola epidemic and position at the usaid and as i understand it was responsible for a large portion of all the financing of the external response and also the support and i would say jeremy also attempted to orchestrate and coordinate a lot of the american response is then perhaps even some of the coordination between the u. S. A. Chance and those people who are working france and other countries. Trying to deal with how to have the humanitarian support. The need to do research at the same time the humanitarian services were supported. Hopefully you can speak to how hard that was for you and if it had been available in 2013. Banks, mead theater when the office for foreign investor into the out rake in partnership with cdc i am not a doctor. Im not a scientist. I have the humanitarian field operation. I also now serve on the Oversight Panel that who established after the Ebola Outbreak to supervise the implementation of their postebola reform and management of some of those new structures. I also see that from that vantage point. This is an extremely important issue because we are very fortunate in an odd way that we have the tools at the outset of the outbreak we needed to contain, but it was a very close call. We came close to seeing the outbreak even more completely out of control to where its hard to imagine how it ever could have been contained without doing dramatically more damage than it did. So we didnt in the end need these Research Projects that did emerge to contain the outbreak, but we could have been its easy to imagine and i think we have to expect that sometime in the next 50 years we will see him out rake in the world cup and may be much sooner than now for the tools available to us at the outset will not contain it and we will need to realtime medical innovation to deploy in order to defeat the pathogen. This is a very important and very pertinent issue. One of the big challenges in any Emergency Response certainly in some future academic responses in the report is interesting to see the points of convergence around what this report identifies a new Realtime Research effort. We are seeing overall Response Rate lurch. Everyone, the researchers, operators, they are all jockeying and this seems day. Everyones got a finite end with. If you need to report talking about the importance of figuring out the legal and ethical parameters with the host government and host authorities. They are also charged with a million other things. This radar screen is going to have to jockey for states. This was a real issue because nih wanted to send and Research Teams and usaid have missed rons team on the ground. Just one very basic example of how this would play out, to manage all of these different visitors and it could be difficult for the ambassador was sometimes a little bit skeptical of why we need another u. S. Initiative showing up to do something they will do medical research and how important is that. These are some of the realities that this kind of a report is important and highlighting to an investor. They give clearance to the nih teams to do research. One problem we had at the outset of the Ebola Outbreak was the Public Health specialists, medical specialists and humanitarian specialists really didnt have much of a common language or a common operating platform. Inherent to the nature of the organization, the u. S. Government didnt have that in more broadly, most of the humanitarian field did not have that. That is one of the important aspects of what they are proposing here was this idea that begins to establish the touch points, the connective tissue between the emergency op raters and Public Health specialists and scientists so that when it is go time, their relationships that need to be placed are in place. And the sinks will need to be mapped very closely closer together. There were problems in the early days the response which is massive confusion about what the disease was, how do you protect yourself, what do you do, giving a clear and consistent message and establishing a clear and consistent authority, a trusted authority that is transmitting those messages is very important. There were interesting differences across the three countries in the level of Community Awareness and the level of, the types of Community Behavior you saw. Some of that has to do without trusted the government was and how effective the government was. Was. We saw interestingly much better uptake of some the key messages at Community Level in liberia that in sierra leone, in part with the populations trust of the government and trust of the particular avenues through which they were being engaged. So dropping another element into that can disrupt some of that balance and it can affect the credibility of the interlocutors. I need that needs to be very carefully handle. Dropping like a research element. You want to really hammer on these core messages of how you prevent this from spreading in your community, how do you protect yourself. Part of the core messaging is, the only way to protect yourself and your community are the best way is you have to get people isolated. Talking about what the treatment entails and research is inherently an unknown in that. Were going to treat some of you with this, without going to treat others of you. How do you explain, how do you map the explanation of an rct process into that Core Community mobilization messaging i think is potentially pretty delicate and needs to be very carefully handle. Would you say its impossible . I dont note its impossible. It was done, right . Its proven to be possible. But very delicate and difficult. And again i think my point is that needs to be mapped very closely within the over arching Community Outreach because if its done separately is going to create confusion. Also struck in the report might highlight on patient data and the difficulties with good patient data, and that was a huge problem force in the Operational Response. The data was terrible. At the outset. People could be counted one time in a case when their first identified in the community, could be counted second time as gays when they were admitted to the clinic and potentially a third time if the transfer to another clinic or a third time when, if they passed away and were buried. So you could have one case because of poor tracking, initially it was impossible to track people consistently across Different Centers and avenues. That made the numbers very, very difficult to track at that in turn made the response difficult because the response like this the moves so quickly and fluidly, you need to have good realtime information and understanding, good realtime visibility i have the disease is moving so you know how to orient your response resources properly. We didnt have it at the outset. You need that will because youre projecting out what this disease might do based on what you think its doing now. If you dont have a good picture of what its doing out its hard to protect project what is going to do. Huge issue for the Operational Response and so interesting to see how its manifesting in this issue. The challenge is how do you get a good Data Management architecture in a very lowtech, very difficult operating environment, compensated logistics, unreliable Power Sources and so on. Just spit bawling in real time here, there some faceting work thats been done with biometrics in other humanitarian context comes to using Biometric Registration for refugee arrivals, for example, which can be done in a very selfcontained way and very hostile environment. That may have some applicability here but in any case, whether thats the solution, this is an area we need a lot of progress and innovation because it was like he had to get in the of the response. It wasnt until hunts roselyn went out and took a few, we volunteered him a few u. S. Military personnel, just to do data entry india the soldiers and several light green counterparts just in an office in monrovia and scrub the data. Thats when we started getting much more accurate picture of what this outbreak actually looked like. So lets move now to the general discussion. I want to give a chance to both jerry and david to say one or two sentences only, please. But in response to the sets of comics. I think we are in general agreement with the point that are made. Lets go from words and thinking to taking some initiative of the time is now. It is true there are outbreaks and epidemics going on all the time. It is one of a scale, this i tha time when you can actually have these kind of conversations. I dont have much to add except that we are in agreement on the basic principles, and then really is not about what the next steps are. I think the point about needing flexibly in the design is critical, and i think you highlighted also the importance of what is the research trade. Its not just rn r d and not jut production but its really downstream access but also some of the other epidemic way research that needs to be done thats really kept behind. I think this is an opportune time to address those issues. I just want to emphasize something that jeremy said that resonates with me because of my long experience now in looking at the economics of the hiv aids response. And that is the safety of patient identifiers. One of the Biggest Challenges in managing hiv ages font which of course is on a much different timeframe over years or decades rather than only weeks as a was for ebola but one of the biggest problems is that the same patient gets counted multiple times and yet gets me is twitching for my treatment side to another. They get missed. When they get a dina titus hivpositive. We dont have as good information and would like with respect to whether patients are successfully making it through the entire treatment cascade. This issue of a patient identifier strikes me as a common theme with this, and im wondering if kerry and jerry and david would agree that as part of the technical fix that can be prepared now as we prefer for next adamic, that strengthening patient identifier systems in country is a necessary foundational step in order to prepare for the next outbreak. Jerry, how do you feel about that . Thats basic Public Health and Health System i think its absolutely essential. No argument. I think the answer for us is yes, except i think although a bit on the biometrics identification as a you managing Aid Organization we kind of step away from a little bit here and buy a little bit i mean a lot. So you agree i would help you with your epidemiology and your humanitarian tracking of patients, which are worried about some of the ethical applications . Exactly. So if those implications could be effectively addressed then youd feel more exactly. You can mitigate that end of it. Im not sure exactly how much time have but lets start to take some questions from the audience. And also, roxanne, if you have questions on twitter please let us know. This lady in the front. Im an anthropologist converted to a Public Health practitioner. I did my degree in the department of International Health at Johns Hopkins in the days before it underwent what i would call the social awareness revolution and became the bloomberg school. So im very happy to hear so much discussion about the importance of community, social awareness, et cetera etc. Theres one role that i did that are mentioned by anyone in this fascinating and very thoughtful presentation. And that is the role of the anthropologist. I would say the anthropologist with a capital a, because that would be a key role in the area, prevention, a key role in the air of stakeholder engagement, a mediation between the Different Actors and also between the researchers and the community to make the research possible. I would hope to see at some point that the anthropologist becomes a key player in this process. Lets collect two more questions and then turn it over to the panel. Two more questions. Can we get to more questions . If not the anthropology question is going to be featured. Okay. Im very curious myself, given the importance of biometrics. We have one more, okay. Stacy edwards. My question is about u. S. Government funding for research, which seems to be on the decline and the proper acting at some of the and Age Department six of that. Do you think there will be an appetite for this kind of work you are proposing . Good question. Please introduce yourself. I used to be with the world make and im interested in these fields. I used to sit on several bodies of research coalitions, Global Research coalitions and thats what you proposed for this very ambitious program. You may be could you may become it on some of the Lessons Learned from this kind of research coalitions, its not for the first time, right . I would be interested. Skepticism . You could hear the tone of my voice, right . Okay, so the role of anthropologist. Id be curious, none of you know did i mention that word. The funding possibilities Going Forward and some skepticism about davids very, very ambitious plans for international collaboration. The anthropologist i think of a Critical Role to play. During the outbreak the anthropologist platform proved itself be very useful and it has a leading part of what, the part of the Community Engagement. So i would say having that standing at the Party Platform and dispatches anthropologist. I think theres sociologist that are involved in the whole social science aspect as part of it. I would say thats with questions in terms of the broader what is the Research Agenda because i think there are huge questions on the applied research that it plays, as well as the actual programming. Its not just strictly research. Its actually an important part of the Community Engagement approaches. In rapid anthropological approaches to assessment engagements are critical to response and thats what liberia did early on. I would say its also important in terms of, theres some groups working on the anthropology and accountability space as well and i would say some of that research is particularly in terms of look at some accountability, mapping and accountability ecosystems that would help us as we move forward and thats more organization and individual so truly crossing disciplines really i think some of the same types of methods and tools would be useful both at the global level for the global mechanism as well as the practice and research around the response. Just quickly, he was formally my boss why do we take that i did what make one point i think you want to chime in as well. As you can imagine to these kinds of Clinical Trials on therapeutics and vaccines, expertise was coming from outside of west africa and that highlevel research organizations. It was interesting that at the beginning they really hadnt heard about social mobilization and Community Engagement and why you really needed to make those connections. Once that starts to happen, things began to move and, in fact, we said in the course of the presentation that, in fact, randomized controlled trials could be done. But only when the community was engaged and understood what the rationale was. So this connection is as intimate as could be, and has to be done better. Would you say that a key requirement is the community understand the depth of the ignorance in the medical community about what really works . Theres lots of therapeutic misconceptions, and no, im not saying the community itself at misconceptions. Im saying that i would think that for the community to endorse in rct and the concept of an rct they would have to be convinced actually that there is no cure. Currently there is no cure and that if they understand that, that youre trying, that the best people in the world dont know how to fix this. That might be sort of the first step. You want to talk about the early messaging . Go ahead. I think thats rather important. I think it would be difficult to assume that, because what we found was a lot of the early messaging that did not work was around ebola kills and and theres no. Right. Develop a sense of hopelessness and that undermined both the response and the research. I would say its really around therapeutics of hope and understanding some of the constraints of that is the approach. That was one of the issues that led families to hide patients, which led to more transmission. There was a very telling moment we had at one of our open meetings in monrovia, and one of the senior clerics in liberia who got engaged in this sort of late in the fall of 2014 when the discovered Community Engagement, social mobilization. So he said that in addressing his congregation and talking about say burials, very traditional religion, handson, the touching, of the things that exposed people, he said when christ talked about laying, he didnt necessarily mean skin to skin. You can lay on hands at a safe distance. Suddenly the acceptance of the safer burial practices turned around, and its those kind of insight and messages that need to be there from the very beginning. So when we call from what is quote interepidemic periods, its just to get the conversation going. Some of the lead researchers in this field said weve never heard about social mobilization, new concept to us. Now is the time to make that connection happen. Its fair to say ive never heard accountability announced before today. Msf conducted a lot of operational and applied research during the epidemic, both in the beginning when we heard deafening silence from our colleagues in a national and international across the board of not there in the field. When were in the field and when others joined us as well is that, and including most certainly with anthropologists who helped deliver some of our messaging and some of the research of Core Research which enable us to get patients to treatment. I think the role and the importance of anthropology is really well recognize now coming out of this. Anytime here social mobilization, Community Engagement, youre talking about a role, for executive function and the reinforcement. I know amongst the reforms of w. H. O. Is now carrying out is also building more of that capability into the w. H. O. Emergency response section. Just quickly on the funding. It remains to be seen yet what will actually happen. There have been cuts that a been proposed by the white house that are incredibly irresponsible and with the incredibly damaging. Im not a u. S. Government employee anymore so i can say that. I mean really deeply irresponsible. What is encouraging is those cuts have that got a lot of traction in congress and, of course, congress that will ultimately write the budget. I think there is some reasonable hope to hold out that some of the more damaging things that have been proposed will not make it through the congressional appropriations budget. Its hard to have the level of confidence in Congress Based on past performance, but i think there have been some strong signals. In fact, when the president s budget proposed reducing nih for this fiscal year, for the remainder of this fiscal year, by a billion dollars, congress increased it by 2 billion. That increase in 2 billion is at the set point, if theres a continue resolution for next year, the budget is now 2 billion more than it was a little while ago. So one of the things that we are trying to do as a committee, we are not getting into politics, but raising issues and in constituencies and in the public to respond to an challenge u. S. Government policies that are being proposed and sometimes implemented. We need to raise the alarm. We need to get the Larger Community in agreement that our health is tied to the health of people elsewhere, and that Global Health is relevant to us. Thats part of what were trying to do in disseminating the issues around this report and activities at the National Academies can do. Its not an implementing organization. Its not going to be in the field with you in taking care of patients. But it has some substance and trying to get that out there and this slice of the response agenda is part and parcel of what were trying to do. The cost to benefit on that then is so incredibly compelling. Because if you look again at ebola, by having a slow response that didnt have much in the way of therapeutic tools and vaccine tools ready to use government had to spend 5 billion to prepare for and respond, well, prepare on the homefront and respond in west africa to this crisis. That is an awful lot of money, and that is a very small amount of money compared to what it would, you know, what the nation would have to spent in the case of a truly deadly pandemic that probably will emerge at some point. So this sort of Research Spending pales in comparison to what we would have to spent and a Crisis Center and helps to avert those crises. You said that in the report pay now or pay a lot more later. Pay a lot more later is not just the treasurers money, but its death and morbidity and economic consequences that have huge implications. I wanted to respond as well about the Research Consortium and coalition. I dont see this as a research consortia. This is something that is different. This is about an integration of response and research, and thats different set of players. We havent done this before, not at the global level. What makes a Collaboration Network work is the same kind of principles around how do you add value and look at commonality of goals and the kind of things we talked about in terms of recognizing different interests and matching accountabilities. Once you start losing that, you lose the legitimacy, you lose the trust, you lose the ability to add value. So i think thats why were trying to be more explicit about what other things that you really have to take care of, understand, and going with your eyes open rather than just saying that well, it will take care of itself, or that unit and if you do something, then we will combat on the other side with government. We really need a new type of approach and i think we go into it with our eyes open and looking for that, looking for the data around how do we add value. Let me just, on this last point, you know, with the w. H. O. Monadic system with Single Institution responsible for the entire chain you identify so clearly, we always know who screwed up, right . Now, what worries me with respect to the proposal is that your accountability aye system may not allow us ecosystem may not allows to know that her im wondering, and i guess it would allow us to know that if the accountability part really works. It looks to me as if what theyre proposing is a more inclusive system, one which involves multiple entities in aa more peertopeer network sort of arrangement, but in peer to Peer Networks in Information Technology there are accountability systems felt each peer accountable to them wondering what you have in mind, how actually would you have a Network System where is accountability . Isaac is a question of balancing accountability and making them explicit. I dont think that, the problem with having a single hierarchy is that we havent invested and dont have the capabilities of both the capacity and to deal with the complex. Because there inbuilt conflicts that you doubt what the funder, the commission being the one who is chummy with the result are and then doing the ethical clearance. Its just not, you get confused messages and you get the wrong messages. And you get suspicion from outside. Exactly, and so you lose that trust. Im not talking about just a loose market with no restrictions on it. There needs to be real accountabilities for who is actually going to invest in developing the new product. Whos going to ensure against the financial loss, how do you make sure to you actually talk what happened to the prophets, who actually gets access to new vaccines and drugs. You can do that too a lot of transparency. It doesnt happen on its own and i think you do need to make, if you have this set of functions i would do it around responsibility for functions. You can still o have w. H. O. And czeslaw w. H. O. Leading the International Call to arms and the response and activating the network in terms of the epidemic response. I think that thats clear and we havent you invested enough in making that work. But i think just by the way of the International Health regulations there is a coresponsible for National Government to do a lot and they a failed terribly. Its not like there is ever a single responsibility. Its just that we need to be more creative and inclusive in terms of how we bring them together and what we lack is actually balancing independence. By putting it all in one post, by putting fixing agent is a soccer player, the referee, the person in the stands and commissioner, and the ball, you have a boring game. It doesnt work very well. So i think, unfortunate, its time to wrap up. I want to thank all of our participants, all four of you for coming in. Were glad to be able to help in the dissemination of this important National Academies report, and we hope that actually pandemic preparedness is going to be a continuing priority for the international Global Health community and for this administration here in washington, d. C. We think this report is pointing, points out some of the reasons why we need to prepare now, not wait for the next people epidemic and also get us some pathway, some direction which we can move and we need to do that fast. Thanks to all of you. [applause] [inaudible conversations] [inaudible conversations] today a discussion on the impact of the new u. S. Sanctions imposed on russia, how they will affect relations between the two countries as well as u. S. Interests and businesses abroad. Live coverage from the center for the National Interest beginning at 12 30 p. M. Eastern on cspan here. We have been on the road meeting winners of this years studentcam video documentary competition. At Royal Oak High School in Michigan First place winner won a prize of 3000 with his documentary on the rising costs of pharmaceutical drugs. The second place prize of 1500 went to classmate mary for her documentary on mass incarceration and mandatory minimum sentencing. Also thirdplace winner rebecca won a prize of 750 for her documentary on gender inequali inequality. And grace novak went and Honorable Mention price of 250 for her documentary on the relationship between the police and the media. Thank you to all the students who participated in our 2017 studentcam video documentary competition. To watch any of the videos go to studentcam. Org and studentcam 2018 starts in september with a theme the constitution and you. We are asking students to choose any provision of the u. S. Constitution and create a video illustrating the provision is important. Now a town hall meeting with senator jerry moran and great