 Good morning, everybody. I think we'll go ahead and try to get started. I know we still have a few folks working their way in upstairs, but they'll be able to join us as they arrive. So first of all, welcome to all of you. I'd also like to welcome our web audience. I think we have more than 100 people joining us via webcast for our discussion this morning. And of course, a very warm welcome to Ambassador Gooseby for joining us today. Before we get started, I'd like to make a quick promotional announcement for a CSIS-hosted event that will be happening later today. We're going to be releasing a report on the contributions of the Department of Defense's medical research labs to global health research broadly. They're a quiet and under-known, under-recognized success. There's, I think, five of them around the globe. They've been working for 40, 50 years in some cases on very fundamental issues of scientific research, including HIV vaccine, malaria vaccine. We have a very interesting event organized around that report launched this afternoon. It's going to be over in Arlington, and there are flyers in the back if you're interested in joining us. It starts at 2.30 this afternoon. So now to today's discussion. I think we'd all agree that we are at a very significant and urgent turning point in the AIDS response, both here in the US and globally. It's a time of great optimism and hope because the rate of new infections is starting to level off and even decline in some places because more people than ever before are on treatment and because there are a number of very promising new innovations in prevention that could help to very significantly reduce new infections. Just two weeks ago, more than 100 governments met in New York at the UN High-Level Meeting and reaffirmed their commitments that AIDS would remain a top global priority. Yet it's also a time of great concern. For the first time in more than a decade, funding for HIV is not increasing. There is still a very significant treatment gap and stigma and legal and societal obstacles still limit access to many of those most in need. Women continue to be disproportionately affected particularly in Sub-Saharan Africa. We're all well aware of the difficult budget trade-offs that will have to be made here in Washington and also of the fact that they will have a ripple effect around the globe, putting major new demands on the US to think even more strategically about the role US programs play globally. I think there is no one better to help navigate this difficult period than Ambassador Eric Gooseby. I know he needs no introduction but I feel compelled to offer a brief one because his resume is so impressive and speaks of such deep commitment to these issues. Ambassador Gooseby's early medical career took him to San Francisco General Hospital where in 1987 he was appointed the director of the hospital's AIDS clinic. In 1981 he was named the first director of the Ryan White Care Act at the Department of Health and Human Services. He served as director of the AIDS Policy Office at HHS from 1994 to 2000, concurrently serving for a period as interim director of the White House National Office of AIDS Policy. Ambassador Gooseby returned to San Francisco in 2001 to lead the Pangea Global AIDS Foundation where he played a key role in the development and scale-up of treatment programs in dozens of countries. He was appointed US Global AIDS Coordinator in February 2009. As the director of the world's largest bilateral HIV program, he has overseen a strengthening of PEPFAR's approaches to high-risk groups, expanded programs to prevent mother-to-child transmission, scaled-up access to male circumcision, and a new dialogue around PEPFAR's thinking about how to engage partner countries and plan for long-term sustainability, quite a significant series of accomplishments in a relatively short period of time. Ambassador Gooseby, welcome. We're really very delighted to have you with us today and we look forward to hearing more about your vision for how even in these difficult times the US can continue to lead the global AIDS response. Thank you. Really look at this as an opportunity to have a dialogue, so we'll go through these slides, which speak to general accomplishments and then end in the UN high-level meeting that occurred a couple of weeks ago. So, let's see. So, changing the course of the epidemic, we're gonna go over some issues around strategy, smart investments, shared responsibility, and then, as I say, end it with a discussion about the meeting that occurred in New York. PEPFAR has really been a remarkable contribution to the global fight. It has been a central foundation for much of the sustained activity over the last seven, eight years that has joined really all of the partner countries and develop donor country efforts that really span back to 1981 in an attempt to respond to this extraordinary epidemic. 36 million people worldwide in infections in 1981, 16,000 new infections daily in 2001. At the end of 2002, 2003, there were about 50,000 people in Sub-Saharan Africa on antiretroviral therapy and that clearly, as most of you in this room have seen firsthand, the medical delivery systems were congested and overwhelmed with HIV-related illness. PEPFAR has been a remarkable deployment of capability and prevention care and treatment, focusing on the populations that are most impacted, children, mothers, preventing infections among those most vulnerable to transmission and trying to reach communities that are made up of individuals who have not had a voice in terms of the impact of community civil society to be in a dialogue with decision makers around the planning and appropriateness of allocation decisions for the response. President Bush launched this effort and a remarkable moment and I would like to think that President Obama has spent resources and time and energy in his administration to make sure that the PEPFAR promises are delivered. It has changed the course of the HIV AIDS epidemic along with everyone else's orchestrated efforts, the Global Fund, partner country efforts, other bilateral programs and I'm truly humbled by how profound an impact this program continues to deliver. In 2010, the Obama administration supported treatment for 3.2 million men, women and children. That's up from 1.7 at the end of 2008. Directly supported ARV treatment to mother-to-child transmission for 600,000 HIV positive pregnant women, which in 2010 alone prevented 114 infants being born HIV positive. Directly supported 11 million people in care and support and 3.8 million of which were orphans and vulnerable children from birth to 18 years old, housing, food, clothing, education, job training and social support. Supported counseling and testing and 33 million people in 2010 alone, a remarkable number. At the same time, we realized that we are in a situation where the emergency response that PEPFAR represented needed to look aggressively at what will better ensure that we are able to sustain these responses, that they become a permanent part of the medical architecture, the topography of the country, that the strengthening of capacity in our partner government efforts, both in the government as well as civil society are critical components to that and that looking for every opportunity to integrate and coordinate largely to save money, to save more lives has been the theme over the last two years. We believe that the platforms that PEPFAR has presented with our implementing agencies as our conduits through which we move to our programs to ground have led to innovative ideas that were not apparent to any given effort, but when you look collectively at 15 to 30,000 feet, you begin to see many opportunities and we'll go through some of these to become more efficient, to increase the number and availability of resources to move back into program and that has been a strong theme of the last two and a half years. Leadership at the State Department is where PEPFAR resides. It affords certain opportunities in dialogue, in ongoing dialogue, in our ability to intervene in issues that arise in country implementation or lack of, in representation of individuals that are at high risk within communities that are not embraced by the medical delivery systems and in creating and ensuring these safe spaces for high-risk populations to reside in and access services from becomes a definite goal of what we're trying to create. The model of one USG as characterized by the Global Health Initiative and the Obama Administration has afforded much of this discussion and has moved us toward the innovative approaches that we'll outline here very quickly. It has allowed us to combine the relative strengths of each of our agencies that we coordinate through and has resulted in, I think, a more cohesive, smart, effective, higher-impact portfolio of activities as we put our footprint in each country. The deaths dropping in the red, the green showing the funding and all programs going up, we clearly have had an impact that is rarely demonstrated in program funding for other diseases. I'm very gratified to show that in all of these arenas we've been able to demonstrate this profound drop in deaths. Each country that we work in has a similar 15 to 40% drop in deaths, usually in the third year after antiretrovirals hit 35% or greater. That will continue to go up. Treatment, total care, as well as treatment, PMTCT, PMTCT, receiving antiretrovirals, just differences that we see in the scale-up rates, orphans and vulnerable children as well. The reference that was made to a drop in new infections from 16,000 new infections per day in 2001, 2002 to 7,000 new infections in 2009 we're gonna have similar data in 2010 for 2010, but in all of the countries that were early target countries for PEPFAR you can see these precipitous drops. This is the first time we have seen and been able to document such data and I believe that except for the Uganda at the end there we are moving in the right direction in all countries. This is a little bit for greater than 10% prevalence countries, the minus 10 to minus 81% range that we see here, again in the 5 to 9% countries the plus in the Uganda is the outlier for this in all those original countries. This in terms of the 114,000 infections averted in the pediatric arena, this is again the 114,000, these are each year cumulative so 96 and 09, 114 and 10. This is a trajectory that we hope to increase and move to higher numbers in each year, get better at it and move our ability to really start to diminish and eliminate pediatric HIV. The increasing efficiency, decreasing costs relationship you can see in the green line the overall aggregate from 2004 to 2009 we're now at about $450 per person per year for antiretroviral therapy. That includes some of the human resources, the laboratory monitoring and evaluation package. It's not just the antiretroviral drugs. Drug costs are as low as $125 in the countries that we're working in now but it's different in each country. As you know, we're now 98% using generic formulations. Treatment scale up trajectories in each of the countries to just show the relative rapid growth that we have 83% now coverage for, this is less than 350, Botswana, Ethiopia's 52%, and Rwanda 95, Guiana, Zambia, et cetera. So we're getting there moving rapidly towards it as we now partner differently in each country with the country's resources now being explicitly defined through our partnership framework process and with our attempts to partner more intimately with global fund resources, we are going to identify further savings. Treatment scale up trajectories in these other countries, again, these are less than 50% coverage but again at 350. Just to show you that South Africa at 36% now is actually above the one million mark. They're at 1.3 million people on antiretrovirals in their country. That's the largest number of people on antiretrovirals in the world in any country in the world. So we have attempted to try to maximize, to look specifically at our impact in each of our program arenas in each country and then try to from our epi data, look at where the new serial conversions are occurring, where incidents is, and then go backward with our prevention and care programs to make sure that we are one interfaced with these populations and if not challenge our in-country teams and partner governments to explain why not. And if we are aligned, are we aligned appropriately or are we redundant, duplicative, overlapping catchment areas? All of these type of managerial interventions have afforded significant savings in our program country operating plan budgets. So much so that we have been able to increase our rate of accrual for patients on treatment, for women to be tested, for women to be placed on antiretrovirals, for HIV pregnant women, and our orphan and vulnerable children accrual rates. All have gone up and it has been in a setting of real budget constraints. The cost savings expanded use of generics. We talked about 98%. A big savings was realized when we moved from air freight for distribution, procurement distribution, to ground transportation and train only. Saved a significant amount of money. And I think that our next big area that we hope will realize significant savings will be as we begin to plan and implement together with the Global Fund resources. This all requires country convening and our partner country leadership to convene that process. So it's really everybody. So the Paris declaration around country ownership, we won't win this without countries embracing and being in the leadership role around management, oversight, monitoring and evaluation and eventually hopefully resources. But we will go a long way toward realizing the savings that we can tease out out of these parallel systems of reimbursement, specifically Global Fund and PEPFAR with the partner country being the convener. The convener of both the dialogue that defines unmet need and the definition of that unmet need being prioritized. So one unmet need relative to another is agreed upon and defined. The CCM process in conjunction with a PEPFAR dialogue or a new dialogue that comes out of a Ministry of Health convening with the critical ingredient of civil society, especially those who use these services being at the table creates a self-correcting mechanism. So programs that are responding to needs of a population can change their response as those needs change. Having a prioritizing and allocation making body based in Geneva or Washington eliminates that feedback loop. Having it in country allows for that dialogue to be present and strong enough to create a self-correcting program over time. So we believe that country ownership is the central pivot and fulcrum of that successful dialogue. Our tool for that has been a partnership frameworks. This is a formal dialogue between country leadership and the United States government. We look at a five year timeframe over which this will be implemented, specifically defining what the country's contribution in year one through year five will be both in human resources, resources in kind, programmatic kind of diversity of the portfolio, the focus of the portfolio, and what the USG's contribution will be over time. It's a living document, it can be revisited, but it is signed by senior leadership in government as well as in US government, frequently ambassador level or secretary of state level to concretize this agreement. We have been surprised, pleasantly surprised at how effective this document has become, how it has been a mechanism through which we can engage in a new dialogue as new issues present themselves, new areas of concern, especially in response to MARPS populations. And it has been a measure against which we can hold ourselves and our partner colleagues in country accountable to the goals that were identified. It has also given us another instrument to influence movement of civil society and high risk populations into planning and implementation dialogues and women, girls and gender equity issues. The emergency response, building to a sustainable response, we've talked about the importance of country ownership, the importance of engagement in those who use these services, civil society. Together, that grouping allows us to move to this self-sustaining response that PEPFAR and the Global Health Initiative is now keenly focused on. So I'm now gonna turn to what you originally asked me to speak to, the UN high level meeting. We have gotten through what was a very difficult kind of crescendo dialogue that went over many months. My office was the focal point of that dialogue at both the security council piece as well as the high level document that was written to. It came off of the security council session in 2001 where the declaration of commitment on HIV-AIDS was demonstrated leading, hopefully, to substantive discussion around the development of a resourcing mechanism that eventually became the global fund. The 2006 special session on HIV-AIDS renewed our commitment to targets and put universal access as a focal area as a focal goal for the global effort. The meeting really did result in really everything that we had intended to come out of it. We were able to reaffirm the USG and global commitment to fighting HIV-AIDS, to increase efficiencies and shared responsibility for the global AIDS epidemic to put that in the language, to affirm linkages of public health response with respect for human rights, which was, I think, perhaps one of the most significant contributions of this document. Call for global goal to eliminate the pediatric HIV-AIDS burden through accelerated strengthening of our PMTCT plans and continue to promote and focus on the role that women play and are victimized by much of the delivery system's inability to identify, enter and retain women and girls in substantive care in the portfolio and to emphasize that as a central focus. So, created the global action plan, eliminating new infections among children by 2015 and keeping their mothers alive. The United States, on top of the 300 million that PEPFAR currently puts in their country operating plans toward this effort, we increased in addition to that added another 75 million in new PEPFAR funding for PMTCT. In the private sector, we started a pledging process that continues to date. At the Gates Foundation, presented 40 million new dollars toward this effort, Chevron, 20 plus million toward this effort, new. And Johnson and Johnson put 15 towards it. We've also, since the meeting in the last two weeks, had extraordinary interest in the foundations coming in, such as CIF, ELMA type organizations that tend to be regionally focused in aligning their current program portfolio with the strengthening exercises that are going on in the 22 most heavily impacted countries. And in private sector donations, which we've also been very gratified to see such a high interest in trying to contribute. So we believe that with a shared responsibility with a focused effort on identifying resources that may have entered countries and been a separate, somewhat isolated effort to create a planning platform on which they can align their programmatic portfolio to maximize impact, to deal with areas that we're not focused on in a geographic sense in the original program footprint but to now look and insist that those synergies and that planning advantage be part of the process in each of these countries. I think that the shared responsibility theme is something that President Obama and Secretary Clinton feel very strongly about that we are at a moment where we can see, begin to see the light at the end of the tunnel with HIV-AIDS in general. But in order to achieve that, we need to continue our own effort and increase it. But we also need to challenge our colleagues in Europe and the rest of the world to play their part. Dialogue in the G8 and G20 is gonna be critical for that evolution to be realized. Our leadership in both the White House and the State Department see this as the pathway to a more durable and sustained response so that the programmatic imprint that PEPFAR has made with and through its agency colleagues implementing will be something that lasts and becomes part of the medical delivery system of the partner countries in which we work. The human rights issue, I think, we are very proud of the language that was inserted, speaking to human rights and associating human rights with MSMs, IDUs, and CSWs. The dialogue was extraordinary, but we were able to hold it. And I'm happy to go into any of that with you in the question period. The unanimous approval of the Security Council Resolution was a real achievement as well. It expanded on the 2000 Security Resolution which really focused on peacekeeping forces as their main area that they were speaking to in the original document. This opened the women and girls as a particular target for the response to consider in their planning and implementation and acknowledged the importance that gender-based violence in the peacekeeping moments of a peacekeeper entry into a conflict situation also carries and the need to identify and respond to it. And the issue around security and stability to continue a coordinated challenge call to action for the international community to combat HIV and AIDS and the importance it plays in the security of the region. Our multilateral partnerships, our commitment to the Global Fund, we need the Global Fund. PEPFAR's ability to be successful is directly dependent on the Global Fund continuing. And our ability to move to a more sustainable configuration is predicated on the Global Fund being a strong foundation of support for the partner country. Together we will continue to do better and increase our ability to reach more and save more lives. Without the Global Fund, our ability to do this is markedly diminished. So we are still very much involved in working in and with the Global Fund to increase their effectiveness, their impact and their ability to target their resources in a way that allows for a capacity expansion in our partner government's portfolios. I'm gonna end here with a kind of visual reflection of the US contribution to the donor community's AIDS HIV AIDS effort. We make up about 58% of that effort and you can see UK, Germany, Netherlands, France, Denmark, et cetera coming in with their respective pieces of the pie. The collective total in all added up at 7.6 billion is still below what is needed as we move forward to try to move toward the universal coverage goal that was put out in the New York meeting. And our commitment to do this as the United States to continue to play a leadership role is solidly in place. But we know that we need to have a different expectation and hold our colleagues in the global context accountable for their fair share of this responsibility. There is an international responsibility that they have as well as a domestic responsibility to respond to this epidemic and we hope to foster an increased dialogue around that issue. So thank you. Ambassador Gooseby, thank you very much for the comprehensive overview. And just before we even get started formally with the exchange between us and then we'll invite the audience as well. I mean, the thing I think I was most struck by in your remarks was your use of the phrase light at the end of the tunnel. And I think that's very significant coming at this time and particularly coming from someone like yourself who's been at this for a very long time. But there are still fundamental and difficult realities. So actually the first question I wanted to put to you is to follow up on what you remarked on as two of the most important outcomes coming out of the high level meeting. And the first you said was this sense of shared responsibility. And I think everyone is very energized and encouraged by the fact that that meeting said, specific targets, 15 million more people on treatment, 50% reduction in sexual transmission, elimination of vertical transmission with the caveat moving towards in the official document. But at the same time a recognition and in fact even I think a report that was released about the same time as the high level meeting that for the first time in about a decade, funding for HIV is actually starting to decline. So we have very lofty and worthy aspirations. We have trend lines on the money that are going in a less than positive direction. How do you see us reconciling that? And how do you see us still having light at the end of the tunnel with that being the reality of where we are today? Well I think that the truth of it is that for our ability to curtail this epidemic, that the tools that we need to do that are becoming clear. Our ability to stop the movement of the virus in a specific population is getting very concrete and doable understanding that we can get in front of that movement by prevention interventions that are of high impact, male circumcision, PMTCT, being examples of that. And with the recent 0052 study that came through for looking at discordant couples and anybody who's HIV positive and HIV negative qualifies as a discordant couple, is at 96% is an extraordinary finding that we are in the intense process of trying to understand the programmatic implications for that. It is something that is really validating the continuum of prevention and treatment as really part of the same response to this epidemic that many of us felt decades ago. But because of the nature of funding and programmatic rollout, people began to move to prevention and treatment camps. This shows that you need both, that the opportunity should define which is emphasized more over the other. And now with the 96% effective diminution and transmission in an anti-retroviral treated person versus non-treated, that now becomes also part of the prevention toolbox. We, with the appropriate orchestration in any given country, in any given province, in any given district, in any given village can now begin to see what the components are that will be necessary to diminish or stop transmission or movement of that virus in the population so transmission is stopped. That's what I mean by the end of the light of the tunnel. So let me ask you actually to expand a little bit on the great news in prevention and the news around treatment being an effective prevention intervention. That also seems to present really fundamental implementation and ethical issues. And maybe, I know this is recent news, you said you're just starting to think about it. Maybe you could tell us a little bit more about how you're thinking about those choices and where this might fit over the longer term. Well, I think that we are thrilled that the science has answered this for us. It was an impression that people had and that we had kind of anecdotal data on for many years that this really in a prospective randomized controlled study really does definitively answer that question. And because of the ethics of it, really it'll probably be the last time we have a chance to study it in this way. The dilemma to me is in reconciling the inherent tension in a physician, provider, relationship to a patient, person. That provider, person, relationship has been predicated on the belief on part of the patient that that provider is going to every time, always and every time make a decision in their best interest. Asking that provider now to click into a public health thought process is the dilemma. And understanding that that's not inappropriate for a ministry of health to think in terms of public health. But now are we gonna be putting our provider cohort in front of people, patients, to now make that decision, not knowing if it really is between 300 and 500, we think 350 to 500, probably 500 and above, we're not sure that there is a real benefit in terms of immune reconstitution or trajectory, changing the natural history of evolution for HIV in that individual. And for that reason, the 0052 study is gonna continue to follow the cohort out. But that public health versus the individual responsibility to that person in front of you as the provider that you have is now gonna be challenged. As a program, I think we need to decide should this be available for high risk populations for those who clearly are in discordant relationships, for those who are likely to be exposed because of multiple partners or because of their work, sex workers versus MSMs, injection drug users who are gonna continue to share needles, don't have options for drug treatment or for needle exchange in place yet. Are those sites that we should target earlier should it be blanketed and what are the resource constraints and issues around that? Where we made it widely available, should it be prioritized? What does the country think about it in terms of the country leadership? What is those using the services and those impacted by HIV in the country think? Those are gonna be especially important in this kind of implementation move and we are exploring all of those areas. And clearly just at the start of that and there'll be a lot more interesting discussion to come in terms of your thinking as it evolves. But to stay on the theme of high risk populations and I think it was also something you remarked on in your presentation as an important outcome of the high level meeting was the strengthening of a human rights based approach. And we all know that's been very problematic in many countries. It would be interesting to hear your thinking on what more you think the US can do through its partnership frameworks, through broader US approaches to help in those countries where we don't yet have the access or the legal processes in place that ensure people who are at the greatest risk are gonna have access to the services they need. Seems particularly important in terms of the high level meeting goal around reducing transmission among injecting drug users by 50%. I think that it's our position in trying to understand the impact of these programs in high risk populations has been a real worry focus of PEPFAR really since the beginning. Being positioned in the State Department has given us another tool to engage in discourse around our concerns, around behavior, around patient populations in high risk groups not having the same access to services as other populations. The unacceptability of that, why in a public health sense it allows the virus to move through the population unchecked and why it is in the larger populations interest to identify high risk groups, more rapid movement of virus through these populations in their overall response to the epidemic and the contribution that makes to curtailing it. But the issue around first doing no harm is a definite theme. Prematurely exposing populations that do not have safe space can result in a disastrous outcome, vulnerability to attack, to being singled out, the least of which is being blocked from accessing services, the worst of which is physical harm that can come to them. We through a diplomatic dialogue with our Ambassador Diplomatic Force with the support of the Secretary and the President have been able to have very difficult conversations with countries that have moved to a legislative response, moved to criminalization, all of those issues. None of which is in the public sector but which is very much in the dialogue between the bilateral dialogue. And I'm very grateful for that and it's added a different component to it. The partnership framework is a much more visible tool, very public tool that we then try to concretize some of those more private conversations in that to hold it. But the best backstop to that fallen off the cliff is civil society having enough safe space so they can generate and empower themselves to be the voice of criticism, of oversight, to challenge power around an inappropriate behavior. That's our goal. I believe that is the critical ingredient to sustainability ultimately. And PEPFAR is very actively trying to look for ways to put that into program. Maybe a turn for a minute to the smart investment strategy. And certainly the figure you put up on the screen of total program costs, not just drug costs but total costs averaging at around $450 per person a year is impressive and a very significant accomplishment. And the smart investment theme is one that you all have been highlighting and very much focused on. How much more room do you think there is to actually drive those costs down? And at some point in the next year or two are you going to hit a wall where further savings just can't be realized? And then what's the thinking beyond that? How are we going to continue to stretch these declining global budgets so that everyone that needs treatment, everybody that needs prevention is still going to be able to get it? I think it is important and we are right on every level to have an agenda that tries to identify savings. I have been startled at how effective it has been in the first couple of years of really aggressively going after it. We will probably continue to reap savings for another year and a half, two at the most, that are significant to support continued expansion in treatment care and prevention services to have those resources fold back into program. I also want to say that folding back into program and I didn't show you the two slides at the end there, but is the DRC, we had a photograph of kind of the Lazarus effect on a child in DRC. And DRC is very high levels of morbidity and mortality still going on in many countries in sub-Saharan Africa that we're not part of the original 15 PEPFAR focused on but need to be. Our ability to do that in a flat budget is very constrained and our only real strategy is to save in one country, move resources to Global Fund and to partner country resources and then to fold those out into another country. We are thinking hard about how to do that in a couple of countries in sub-Saharan Africa. We think it's where things were in 2002 in those countries. Our real next big saving win is going to be in the integration with the Global Fund. If we start planning together and implementing together, we will realize significant savings. The third piece to that and the critical piece to our involvement and other bilateral involvement and the Global Fund involvement in country is the country ownership. There needs to be a convening focal point within the country leadership, government, civil society that convenes the discussion to set and establish the unmet need, prioritize the unmet need. Without that, we fly blind. So it really is this orchestrated many components contributing to a process that allows us continually to continue to correct, self-correct, identify new savings, become more efficient, maximize impact, and save more lives. That will not be realized until countries that are currently not seeing their responsibility in that international global response to this epidemic. It will not be realized until they engage. We need to get all the countries that are capable of engaging to engage to feel empowered, challenged to contribute, but feel compelled to contribute because of the ethics around it. That hasn't been part of the dialogue. It needs to now come into the international discourse. We're going to go to the audience in a second, but one question before you finish this part. Of course, couldn't let this part of our conversation end without a question about PEPFAR and the Global Health Initiative. So it would be great to hear a little bit from you about how those platforms are interfacing and think particularly around the commitments of the Global Health Initiative to expand maternal neonatal child health programs, how you're thinking about PEPFAR being a part of that picture. Well, we see the Global Health Initiative as the logical correct evolution of the USG programmatic footprint. It makes sense for us to build off of platforms that we have already spent resources to establish and add services to already existing platforms, maternal and child health, family planning, TB, HIV AIDS, malaria. Those platforms have different characteristics and are capable of supporting different combinations of service expansion. Defining explicitly what those service expansions should look like on a HIV AIDS platform versus a maternal and child health platform is where we are. Getting our country operating plans to loosen up and move toward that integrative effort and see that as valuable and important has been part of the process that we've been in over the last two years. I'm confident that we will have a much better product with an HIV AIDS platform now also having maternal and child health, immunizing the kids, being able to treat neglected tropical diseases, also focusing on hypertension, diabetes, and coronary artery disease in that they're the same person with those diseases who are already in front of us. So to me, it's about getting smarter, getting better, increasing impact, doing it in a way that is cost-effective and at the same time, centrally positioned women, girls, and government in country, civil society in country to be the management force around these programs. We as the United States cannot be the Ministry of Health for countries realizing and believing that and then internalizing that and how USG operates has been quite a lift. But that's what GHI is trying to do. I can imagine it's quite a lift, but you look like you're up to the task and still enthusiastic about it. Still enthusiastic. So let's take some questions. What we'll do is take them in groups of three and if you could please identify yourself and then just make your question as concise as possible, please. So the gentleman right here who had his hand up first. Hello. Hi, I'm Matt Kavanaugh from HealthCap. So I guess a question very specifically about kind of what in terms of plans OGAC is putting together. So I want to challenge for just a minute the kind of notion that there's a tension between the doctor when it comes to the public health and the treatment piece because the reality is HHS decided over a year before HPT052 that 500 was in fact their recommendation for individuals being treated. And in the Global South, no one's arguing about whether or not someone at 600 or 800 most of the time in most clinics should be put on. We're still seeing people come in way, way, way below, sometimes below 200, certainly below 350 and well below 500. And so the barrier there is not people walking in at 800 who are being turned away. Instead the barrier really is massively expanded testing, massively expanded treatment programs that really free up tons more slots and have many more people coming in to contact there. So given that reality and also given the kind of incredible new science as you said, not just on treatment as prevention but also on male circumcision, also on kind of emerging prevention technologies along with condoms, right? Things that we know work. You guys I think have done an incredible job at this point of identifying where the gaps are. And my worry is that after New York what the next step has to be, the creation of a plan to actually fill all those gaps. So there is not within the PEPFAR five year strategy or within any of the PEPFAR partnership frameworks or frankly within the Global Fund applications and strategies currently being implemented and certainly not at country level, at nearly any place, maybe outside of South Africa, Botswana, a handful of places. A strategy that actually hits universal access levels on those key, you know, set of interventions that the new UNAIDS investment framework shows hits that turning point and eventually brings everything down. So isn't it time for a strategy in countries and especially I guess I would say in all of the hyper-indemic and hyper-burden countries at this point to say step up funds, key investments to dramatically scale up those things that we know work so that we can end up getting that benefit to that light at the end of the tunnel because I worry, right, that we're not actually, we imagine that there is a light at the end of the tunnel. Right now we don't see it, right? And so we're pretty far away from the plan to actually get there. What are you guys doing to kind of make that happen? Thanks. Thanks, Matt. There is a lady right to the left here. I had a question, please. My question is sort of Matt's question, actually. Treatment as prevention is widely touted now as being able to reduce transmission and I'm just curious as to what HEPFAR's implementation goals are for redirecting funds from programs that show little evidence of working, two programs that actually do redirecting funding, like what are you doing to directly allocate funding for treatment as prevention in HEPFAR? And could you identify yourself, please? Oh, I'm sorry. I'm Amonago Fumata from the AIDS Healthcare Foundation. Great. And maybe one other gentleman over here, please. Thank you. Thank you very much. My name is John Osika from Apt Associates. First of all, I would like to thank you for allocating more money for PMTCT, another 75 million over the 300 million, which is really very good. But my question relates to whether that is enough. How was the high level forum informed by some evidence as to what is required to eliminate prevention of mother-to-child transmission by 2015 so that we can cost how much we need and then look at on one side how much is available so that we can calculate what more money needs to put in in order to sustain the program? Because having a target is okay, but is it enough and can we see what the gap is? Thank you. Should we take those three? Sure. I guess I would say that Matt is correct in saying that we are mostly seeing people who are coming into care in the PEPFAR program family at 140 CD4 count. That still is who's showing up. Our ability to identify individuals at higher T cell counts, you rarely see someone above 250 coming in. In that group, it tends to be pregnant women who are in the higher CD4 count. And it creates a dilemma that a medical delivery system and country needs to think through over is there a prioritized capability of getting that lower CD4 count on antiretrovirals before a higher CD4 count? Or should they ignore that and take anybody that presents themselves above 350 or lower or 500 or lower or some variation of all of that? That's a country level decision that ideally the partner country leadership, again, government and civil society need to decide. We want to participate actively in those discussions. We want the science to inform the decisions and be traceable to the decision that is finally put in place. That's important to us. We don't want to fund things that do not make sense scientifically. At the same time, we realize that they're competing difficult decisions, hard met, unmet, large unmet need, burdens that countries are struggling with on multiple levels. We think a rational approach to thinking through how best to use resources to respond to those most in need still should dominate. And we try to support those types of dialogue in country. I think that our ability to move from one prevention intervention to another prevention intervention or a treatment modality has been through our ability to put that dialogue in the country, to convene the dialogue with partner countries, ministries of health and civil society to have what are generally dialogues around limited resources for a larger unmet need. But we do not feel that PEPFAR as a program should be defining, prescribing how a country decides that ultimate kind of prioritization of unmet need should look, although as I say we want to be in it. I think that our approach to the PMTCT strengthening is country by country. We are doing a rigorous review with ministries of health, partner government, leadership in what their current plan is, what their epidemic shows in terms of where women are, where children are, if there's incidence data using the incidence data. And then going backward into how are our testing programs identifying individuals, how are they entering and retaining them in care over time, what are the holes in that continuum of care and services that we are now challenging our country USG teams in dialogue with country leadership to define explicitly for prevention, care and treatment. So the parallel, redundant, duplicative activities are identified, seen and eliminated. That requires some real planning capability. It needs real information to make those decisions. It's rare that countries have that level of granularity with it, but we are committed in this PMTCT strengthening exercise to make it really based on a specific plan about a specific setting. And that's where our commitment is. We will then funnel the resources we have available to close those gaps, but we expect in every instance that there be a rejuvenation of the country's interest and commitment in resources to this effort. And that is a central piece of the strengthening exercise dialogue. Additional questions. There's all the way in the back here. Thanks. I'm Rich Owens. I'm the director of the Supply Chain Management System project, and we also buy ARVs for the Global Fund through the Voluntary Pool Procurement Program. My question is that most, as you know, Ambassador Guzbi, many of our ARV suppliers are already operating at 90% of capacity. We have lead times for procurements in the volumes that we purchase of up to nine months now, and expanding that to meet any of the targets that are being talked about today, and we're talked about that meeting is going to require a tremendous expansion of manufacturer capacity, which will require a significant effort to come up with believable forecasts and believable commitments of money. And I just wonder whether in the meetings in New York or elsewhere those issues are being talked about already, because if not, we would love to come and talk to them with you about them. I think we have a question up in the front here. Hi. My name is Bantel Azaz. I am a student at Washington University in St. Louis. My question just on the accessibility of HIV-AIDS medications, especially second-line drugs, which are, while they are much more effective, are certainly much more expensive. And in the recent meeting in New York and Doha declaration, there has been much progress on the patent issue. And just what do you think, and how do you think the line will be drawn between a company's right to make profits off its patents, and the negative consequences they can have from trade retaliations to lack of treatment, and who do you think will be able to determine that line and the measures that can be laid? There was someone over here in the corner if they still have a question. Hi. Kelly Kiesling from the M Health Working Group. You mentioned one of the topics you covered was scale up of evidence-based innovations. And this could potentially include two recent randomized control trials by using text messages for ART adherence. I was wondering what is PEPFAR's strategy or approach for funding and scaling up mobile technology in developing countries for HIV-AIDS? Okay, I'll start with that one. I guess our approach has been one of high interest, have seen most all of the studies that have demonstrated an impact that is gratifying to see, although be it how long it lasts, not clear, but too good to ignore. We have two years ago initiated an attempt to take to scale, not just a pilot, an effort in Cambodia and then Rwanda that will attempt to use many of these strategies, not just one or two, but five or six, to increase adherence and loss to follow-up a variety of different applications. I think that if we can show that this indeed is something that results in higher adherence that's sustained and that people's ability to be retained in care is significantly improved, that it should become part of our expectation in how we roll out all of the programs and should kind of retrospectively reinsert itself as a strategy to increase identification and retention. But I still think that on a to scale level it needs to be demonstrated. So we are two years into that effort. In terms of second-line drugs, we are seeing two to three percent rates of development of resistance in the first-line cohorts in most of our countries. Very, very, very low rates of second-line need compared to developed world stats. San Francisco, Hopkins, Mass General, the Brigham, AIDS clinics, all of which have been followed for many years, had 30, 40 percent resistance rates, largely due to the evolution of monotherapy, dual therapy, before we started treating three drugs right off the bat. But we are still suffering from high rates of resistant organism in the general population. So people are infected primarily with a resistant organism. In sub-Saharan Africa, because we started with three drugs in most everyone, we are not seeing those rates of resistance. And indeed, in surveillance data coming mostly out of WHO's attempt to do it, and then in smaller studies, are not seeing the development of resistance except in places that had a similar history, like China. In the Henan province, they had a stuttered start where they were giving mono and dual therapy, and then because of D4T, patients were on and off of therapy a lot, and resulted in high rates of resistance. We are monitoring the dialogue around the pooled patent and TRIPS discussions that is mainly in our trade representatives and in Treasury very closely. The White House is also monitoring this very closely. We believe that it is a fine line to maintain an incentive versus a disincentive that the United States wants to be on the side of maintaining the incentive, but at the same time wants to be very clear that when a country decides that there is a need to go to generic before the patent is expired, that there be that avenue for a country to decide that it needs to take that step. I would just say that we are committed to ensuring that that be preserved. I'm old enough to know and have been in the development of many anti-retroviral drugs on their first phase one and phase two levels to know that this is a very costly endeavor that our system, like it or hate it, is one that engages private sector in making those investments. Governments don't make those investments. Maybe they should. That's a whole different discussion. For orphan drugs as well, for pediatric formulations as well, many diseases have treatments that are not pursued because they're not profitable. Those are real issues for every country on the planet, so I could argue that we really do need to go down this road for a lot of reasons, but I would say that our commitment to keeping that conduit open is there and we are looking for ways to make sure that that is clear to everyone, but thanks for that question. And what was the first one then? First one was on the supply chain management issues. Supply chain management is, I think, most significant contributions in PEPFAR. Our ability to continue to deliver services every day is predicated on our ability to put both in laboratory as well as in commodities, pharmaceuticals, to put that in front of the people who can deliver it to the people who need it. When it doesn't happen and we see this every day and are involved weekly in scrambles to respond to other programs' inability to keep that funding, keep that conduit of resources influxing coming in regularly so people can anticipate it and get it. Deborah and I were involved and Chip, actually, and a coach of WARS, the political upheaval that occurred there and the displacement of our supply and procurement lines, the role that it played in making sure that people did not have interrupted medications and therapy, that those who had problems had a place to go to. All was built off of the back of that procurement distribution line and we have seen it play out like that in many countries over and over again. So real important, I think it's on our radar screen but I'd be happy to hear if you feel differently. I think the Global Fund realizes this is a weakness. The board has been clear that this is unacceptable and I believe that the fix is in play. It'll probably take another nine months before it's realized. But things like that, countries should hold us and those who use these services accountable for those types of disruptions. They're unacceptable. Our voice is one thing but the person who needs these drugs and services in the face of the allocation makers and country is a much more urgent, emergent process that, as I say, is self-correcting. We need to ensure that that system is there. We'll take a couple of more questions but let me just follow up on the Global Fund issue for a second which is, you talked about the fund as being an indispensable partner but there is sometimes at least a perception in Washington that PEPFAR and the Global Fund are at least competing over the same pot of resources. So as you're attempting to get this closer alignment in specific countries between what the Global Fund does and its planning through the CCM and its implementation through its principal recipients and what PEPFAR's own internal processes are around developing a COP and everything that happens from there, what do you think the most important points of alignment are going to be and what are the challenges going to be in getting there? We really do believe that our best common future with the Global Fund and PEPFAR is together. We believe that that converges on a capacity expansion of country capability in the correct way, that some of the specific management requirements that PEPFAR has more in country capability than Global Fund needs to be for both. We have identified 10 countries that we are doing planning and implementation together. We are planning to do that together. That's what the process is. We have agreement from the Global Fund at the executive director and board level to move forward with this. I really don't want to overstate it, but we really do believe that the biggest savings that we are going to see will be in converging both of these efforts together. So we are not into parallel systems. We have one procurement distribution system. We converge our administrative and oversight and monitoring and evaluation components. We converge our research components that are basically impact evaluations. So we continue to have economies of scale to buy and drop unit costs to work together to share planning, training and a common implementation strategy. Again, convened by country leadership that allows for those synergies to be realized instead of talked about and missed opportunities. So we are very committed to moving forward with that. Time for another question or two. Probably maybe this would be our last round. A gentleman here please. My name is Bill Harrop. I am a director of PSI. I wanted to ask whether you think that this remarkable 96% effectiveness finding in discordant couples in this recent survey what effect do you think that is going to have on the resources that are placed in different types of prevention as opposed to testing and treatment? In other words, you speak about the need in each country to look at what the mix of activities properly most effectively should be. But on the other hand, resources are finite. Do you foresee that there is going to be a little less emphasis upon male circumcision, upon behavior change communication, upon condoms in favor of stressing the testing and treatment? I think there was a Janet here please. Janet Fleischman. Thank you, Ambassador Goosby. My name is Janet Fleischman with CSIS. And I wonder if you could speak for a minute about the issue of linkages between PEPFAR and the family planning reproductive health platforms. Both as part of GHI, but also how PEPFAR is addressing that and what some of the challenges may have been at the high level meeting in looking at those issues. One other question? Please. Hi, I'm Ben Power from Vestigrad Forensics. I'd just like to piggyback on that question and add an additional topic of the integration with WASH programs and clean drinking water that have co-benefits for families living with HIV patients in the same household. The implications of the treatment and prevention study, we are still understanding and looking at really running kind of models of how this would enter our portfolio. What does it mean to the prevention portfolios that we currently are holding? What increases or decreases the impact that we can demonstrate by moving movement toward high impact prevention interventions? We have been very clear in the two years that we've been in this position. We have changed our guidances. We have reprioritized our entire prevention portfolio to high impact first. Less impactful interventions can be engaged with if the country decision is such that they want to, but I want to know why you haven't done the high impact before you do the low impact or the unclear impact. We also want the ability to get our prevention efforts to physically in geomapping sense in front of the movement of that virus in the population. I want the continuum of care and services in the prevention arena to be explicitly delineated for each group that your epi defines in your population. So for sex workers, for MSMs, for injection drug users, as well as general population, what is the combination of prevention efforts you want interfaced with them in this village, in this district, in this province? And how does that inform or complete the saturation of that need? And the dialogue has shifted in the last two years around doing behavioral interventions and not doing some high impact interventions such as PMTCT, male circumcision. I want to know the explanation for that. And in most instances, it's not a good explanation. It's because we did it that way and there's no real justification to continue it. So it talks itself out of continuation. The 0052 study is a confounder with this because it has taken traditional treatment pots and now kind of put a fuzzy line as to where the treatment starts and stops versus prevention starting and stopping. The 96% is breathtaking. We don't have vaccines that are in that range. But at the same time, I think there are those inherent tensions in thinking through how to deploy and implement this, that we are exploring aggressively within PEPFAR and in our dialogue with countries. And I have pulled in really the best brains that I can find out there to help me understand what the ethics are of this. And we have not made any kind of formal recommendation as to shifting pots. But it is on the horizon as a potential as where we are going in giving guidance to the local and country discussion. I hope we can help with that because these are difficult decisions. The pot expanding is the answer to all of it and we're actively engaged in that side of the equation as well. And that's the whole shared responsibility component. In terms of the family planning, maternal and child health services, we have made a commitment to saturate our HIV AIDS platforms with linkages and common implementation of maternal child health family planning on HIV AIDS platforms. I believe we will saturate that in terms of the available resources to do that. In many places we've already reached that point. We are in an internal dialogue around how do we move this dialogue further. It will involve intense convening of discussion with our Hill leadership around this need. But we do see it as something that is in front of us as a program and there is an ethical responsibility we have to respond to the needs of that woman in front of us. And we have not taken that lightly. We have put referral linkages in place when individuals do not feel comfortable in moving in that direction understandably. We've tried to accommodate that. In most instances we've been successful with it. But I believe there is a basic resource need that is present in both our portfolio and resource availability and in USAIDs to cover the already observed defined need. So we need to move further with that in Hill discussion. And the third question was... Water and sanitation. Well, I certainly can't argue with the need for water and sanitation. We're involved in some extraordinary conversations in Haiti around this now. There are pots that are available for that that we have been trying to make sure that we have tapped into. We were really humbled at the drop in diarrheal disease as well as cholera in Haiti just with the infusion post earthquake of bottled water. It was dramatic. And deaths dropped off with it. So we see the importance of that. There are in the reconstructive efforts in Haiti a huge pot of money that is set there for just that wash that we had not tapped into. So we believe we've been given a reprieve a little bit in Haiti. But it has come up in other countries as well. And I don't think we are fully positioned on a policy level to know and think through how and what the most appropriate response is for PEPFAR dollars in that setting. I know that there's a clear overlap. I can make an argument for it. But it's up against a lot of other competing priorities where we're the only pot. So it's that kind of convoluted thinking. I think there are probably many other questions we could come up with for you. But I think out of respect for your time we're going to say thank you at this point for your commitment and for your candor in today's discussion. We hope that we'll be able to have you back again soon. Thank you.