Extended Interview: U.S. Global AIDS Coordinator Mark Dybul
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SUSAN DENTZER: Ambassador Dybul, thanks very much for talking with us. When the Global AIDS Initiative was announced by the president, there was a lot of skepticism in many circles. People said the pandemic is out of control, the expense of putting so many people on treatment will be very costly, Africans don’t have watches, they cannot adhere to treatment regimens. There was really a sense in many corridors that the effort was futile. How far have we come?
MARK DYBUL: We’ve come a long, long way, and I actually think you’ve put your finger on something very important because it’s not just about AIDS. The history of development is fundamentally a disbelief that countries, continents can actually change and develop, and PEPFAR is part of a much broader vision that President Bush has for development. And that’s the first time a country has pretty much stood up and said, “We can actually do this. We can tackle this epidemic. And the reason we can do it is not because of Americans, it’s because of the talent, commitment, and abilities of people in country.”
So I think that’s a very important point, and because of that, because what PEPFAR is doing is partnering with others. It’s non-Americans going and doing. It starts that way, but the goal is to turn it over to people in the country as rapidly as possible.
The reason PEPFAR has succeeded is because of the power of partnerships. And so we have actually exceeded or met where we thought we would be in terms of prevention, care, and treatment. Prevention is a little tough to monitor, but in terms of care and treatment.
We will meet the goals the President set for prevention, care, and treatment probably ahead of schedule. And again, the reason for that is the power of partnership.
So when President Bush started this, when he announced this, 50,000 people — 50,000 people in all of sub-Saharan Africa were receiving antiretroviral therapy. Through last September we supported treatment for 1.1 million people. That’s people in country moving within communities, nations, and in fact the continent to expand treatment.
Care — we’re spreading care for 4.5 million people, including 2 million orphans and vulnerable children. This is in three years.
So I think what it shows is that power partnership, the power of the American people standing with the people of Africa to support their efforts to expand their programs and tackle their problems. And that is actually teaching us that development is not this hopeless thing. And that, I think, is the greatest thing about PEPFAR, its hope. It’s creating hope where there was no hope, it’s telling people, and letting people see that they can tackle a fundamental problem, that they can succeed, and it’s spilling over into so many other areas.
So I think you’ve put your finger on what I believe is the most important thing of PEPFAR — changing despair, changing a disbelief in the ability of a continent to change, to hope, and to support their efforts to turn their epidemic around.
SUSAN DENTZER: You mentioned the progress toward the performance targets of so-called 2-7-10, and at least on treatment we're more than halfway through the goal, but as you said, the prevention goal remains somewhat elusive. Why?
MARK DYBUL: The goal -- we don't know where we are as much because of how you monitor it, and this is one of the challenging things, and what you basically do is predict where we thought we would be in terms of new infections, and then measure where we are and basically subtract the two. It's a very difficult thing to do, and one of the most difficult things is if you succeed in treatment and care, what we measure is the percent of positive people in the population.
Well, if you're successfully treating people, they're actually staying alive. So your prevalence could actually inch up. So it's a very difficult thing to evaluate. There are things called demographic health surveys that will be conducted every two or three times during the course of the initiative.
So far the data are pretty good. We've seen 30 percent reductions in Kenya, we've seen 23 percent reductions in Zimbabwe -- not one of our focus countries, but a place where we're very active. We're seeing stabilization or decline in Botswana for the first time. We're seeing stabilization or decline in Namibia. We're seeing stabilization -- we're seeing a decline in Nigeria and Ethiopia, we believe.
So it looks pretty good, but it'll take some time to be able to measure that, but it's more of a measurement issue than a success issue. The one thing we have seen is a significant success in the prevention of mother to child transmission. We need to do a lot more, but so far the American people have supported efforts that have saved about 100,000 babies from becoming infected.
So we're seeing real strides. We're seeing significant changes in behavior among particularly young men and young women, which is correlated with these changes and prevalent. But it's going to take some time to measure, so it's not a matter of prevention not working, we believe it's a matter of measuring it and then having the most effective interventions.
SUSAN DENTZER: You mentioned a moment ago, reductions. Are these reductions in the rates of new infections?
MARK DYBUL: It's a good question. It's actually not. That's incidence, the rate of new infections, and right now the way we measure incidence is an extrapolation from prevalence. Prevalence is the percent of HIV positive people in a country or in a community. New infections is incidents. We're developing incidents markers, but right now we do a mathematical calculation.
So in Kenya, we saw a 30 percent reduction in the prevalence rate, a 30 percent reduction in the number of HIV positive people in the community. When it was evaluated death was not the main reason for that, people would ask that question. The same in Zimbabwe -- a 23 percent reduction. It wasn't because of death. Death only accounted for 6 percent of that reduction.
What seemed to account for the reduction is changes in behavior. Fifty young men -- 50 percent reductions in casual partnerships. Delay of sexual debut, it's called, when young people become sexually active, going from 15 to 16 or 16 to 17, and some increase in condom use as well.
So it was a broad change in behavior that led to these reductions, we believe, in prevalence. But we're not quite there with incidents, and that's a key thing for us to understand what's going on. When we looked at those prevalence reductions and did a calculation of new infections, it did appear that there was a reduction in incidence, for example, in Kenya. But we need to do -- the science isn't quite there. We hope it will be there in about a year.
SUSAN DENTZER: And these are independent of the adjustments in prevalence data that were made after concluding that statistics gathered through prenatal centers were overstating prevalence rates.
MARK DYBUL: That's exactly right. And so when we do these calculations and look at demographic health surveys, and we actually support these, this is part of what we do, there are multiple things you look at. One is prevalence in antenatal care and antenatal sites, and actually we're seeing drops there as well. So that tells us it's not just a recalculation.
We're also seeing drops among young men and young women. So you do -- it's becoming very complicated. There is actually an international group that we participate in to look at all of the data and try to evaluate all these different components. But you're quite right, these are independent of just readjustments because of how we've gotten better at doing our surveys. And again, the key point is when you look at pregnant women, the rates are dropping significantly among them, so it's not - it's not just a readjustment for the general population.
SUSAN DENTZER: The PEPFAR officials we spoke with in Rwanda told us they believe that they will be the first country to meet the treatment targets, and of course they were, because there is a lower prevalence in Rwanda, by extension lower prevalence or lower treatment targets, but nonetheless, I think they will be there by the end of the year; and that is to say, the five year target is already by the end of this year. And it seemed to underscore a truism that I think has emerged from the PEPFAR experience, which is that the programs work best in the countries where there's the tightest partnership between the national government and the implementing partners of the US government.
MARK DYBUL: I think that's absolutely right, and that's why I began by saying this is all about partnerships and power of partnerships. If you don't have people to support and work with on the ground, this isn't going to work. And political leadership -- but not just at the national level. It gets down to tribal areas, it gets down to community leaders, it gets down to faith leaders. Everyone has got to be involved -- the private sector, and that's happening in Rwanda.
There are actually a few other countries as well -- Uganda, Namibia, Kenya -- we believe likely a few others will actually meet or exceed their targets early, and in fact Uganda and Botswana are already there. And a lot of times it's because the countries themselves are leading the charge, and we're supporting their efforts.
They're exactly right -- without a solid national strategy, without an integrated program, it's not going to work. And Rwanda is a tremendous example of that. Leadership from President and Mrs. Kagami, through the ministries, to all of the implementing partners, they include many implementing partners in the national strategy. There isn't this competition between private/public sector. It's everyone coming together to tackle an epidemic, and that's how you win this fight.
And I think that gets back to what I said -- it's also about hope. They thought they could tackle their epidemic, and that matters a great deal.
SUSAN DENTZER: Where do you think the Global AIDS initiative has run into difficulties precisely because the national government has not been as organized to deal with the challenge?
MARK DYBUL: Well, fortunately, even sometimes when the national government is not quite there, the local governments are, including the provincial or state governments, depending on the country. I think the biggest problem has actually been where a pre-existing infrastructure didn't exist, or a coordinated activity didn't exist around HIV/AIDS, and that includes within the U.S. government. We've had to bring the U.S. government together in a coordinated strategy as well, and we needed to coordinate with the rest of the world.
So there -- there are some countries where that process has not moved along quite yet. It's not a matter of the countries failing, or not -- not getting to where they needed to be. It's just everyone's in a different stage along the continuum, and so each country is a little bit different in terms of their continuum. But they're all on the right track right now.
If you look at the numbers in each country, they're all on this same pattern. It's just a matter of where we begin in terms of that upswing. Some countries were a little bit further along.
A lot of effort has gone into bringing people together. You know, we tried jointly to work with the global fund, other foundations -- the Gates Foundation, the Clinton Foundation -- others to support one national strategy, and wherever that happens it's highly successful. They'll all get there. They're getting there. It's just a matter of where they are in that pathway.
SUSAN DENTZER: And you're speaking here of the 15 PEPFAR "focus" countries.
MARK DYBUL: The 15 -- but it's not just the focus countries. I mean, I think an important piece is that the emergency plan is broader than the 15 countries. It actually covers around 120 countries around the world. The American people are providing as many resources as the rest of the world put together, and we also support the global fund, which is in many countries. The global fund -- we're the largest contributor. Thirty percent of every grant that goes to every country in the world comes from the American people. It's a part of the emergency plan. So it's a much broader strategy.
Those 15 countries are countries where we already had a good presence on the ground, where we had capacity and could do national scale-up. To get over that, the first question is could it be done to actually show -- yes, it can be done. We knew it could be done. So it's much broader than most people give it credit for.
Zimbabwe is not one of the 15. We have a huge program in Zimbabwe, for example. India is not one of the 15. We have a huge program in India. So we have large programs in many other countries.
Reauthorizing the program
SUSAN DENTZER: Let's talk about the reauthorization of the program. The president has proposed $30 billion over five years, and the activist community says that's great. Yet they take issue with the notion that this $30 billion would represent a doubling over, for example, the current expenditures, since at least in the House Appropriations Bill for Fiscal Year '08, more than $6 billion would be appropriated this year as is.
So they -- they quarrel with this notion of "doubling," and in fact say that probably something closer to $50 billion would be an optimal target for the five year reauthorization. How do you respond to that?
MARK DYBUL: Well, it certainly is a doubling. I mean, simple math is simple math. What the President said is he's going to double the original commitment. The original commitment was 15, he's calling for 30, that's just math. It's a doubling. It's a commitment of doubling.
And so together over a 10-year period, the American people are going to commit over -- or approximately $50 million -- $50 billion dollars to this disease.
I think it's worth noting that the first of it, 15 billion, was already the largest international initiative in history dedicated to a single disease, and he's proposed to double what was already the largest international health initiative in history to a single disease.
I think people can always ask, you know, how much is enough. But it gets back to partnerships. This can't just be the American people, especially for sustainable responses in countries. As I mentioned, already we are committing as much as the rest of the world combined. That 30 billion -- the G-8 subsequently committed 60, 30 of which would be ours -- so going forward, we would continue to provide as much as the rest of the world combined.
So I think what it points to is less what the American people should be doing more, and what the rest of the world should be doing more. The rest of the world needs to have the same commitment the President and our bipartisan Congress and the American people have had, which is we can tackle this epidemic if we commit the resources, and we need the rest of the world to respond.
We also need countries to kick in a little bit more. There are some countries, particularly middle income countries, that could provide substantially more resources than they already are. And so I think it's strategically going forward. What's the right mix? What's the right mix of partnerships, what's the right mix of resources.
So I understand the conversation, but I think what the President did is so forward leaning, and so extraordinary in the history not only of AIDS, but of public health, that I'm very comfortable with that $30 billion dollar amount, and we'll see where things go. We live in a democracy, and we'll work with Congress.
SUSAN DENTZER: There's a lot of discussion about what should be in the package going forward in terms of performance targets, whether those should be set as they were previously, should they be set up more in conjunction with countries, on a country by country basis as opposed to an aggregate basis. What do you think?
MARK DYBUL: Well, the totals actually happened on a country by country basis. They were -- those total amounts were aggregates of individual country totals, and I think this is something we need to work on. I think we do need to have goals.
There is probably pretty general agreement that those goals radically changed everything. We had never done that in development. It wasn't just the money. We're saying the money is actually going to achieve something, and we're going to monitor it.
There's also a lot of discussion about what the goals should be. We actually have 40 targets -- 42 targets, not just three. But the three big ones are how many people are in treatment, how many infections are (inaudible), and how many people are in care. That's what ultimately we need to know.
We're also looking at how much we reduce sickness and death, how much we increase kids in school and other secondary markers, but the bottom of it, you know, the ultimate goal there needs to stay the same.
But, you know, one of the things that the President called for is partnership compacts, that we work actually with countries to develop what our, what collectively our goals should be, what our resource commitment should be, what our policy should be. We need policies that optimally use the resources, such as in Botswana. The reason they're so successful in preventing mother to child transmission is they changed three key policies. If all countries changed those key policies, they could have reductions in transmission similar to the United States.
So we want to work with countries to get those policy changes too, but I think you're absolutely right, there needs to be an ever-expanding building on what we've already done in terms of partnership, going forward for what would be called sustainable development.
SUSAN DENTZER: A big discussion is being had and will continue to be had on earmarks and set-asides, and in particular the prevention component of that. The Institute of Medicine report on PEPFAR said that many people feel that particularly the abstinence requirement and the set-asides have been an issue. We also heard from people in the field that as abstinence monies get shoveled out the door, and implementing partners have to use those abstinence monies, they feel sometimes they're put in a position where they're in violation of the guidelines, depending on what they are able to use those abstinence monies for. This echoes the problem that the report commented on. Going forward, how should this be dealt with?
MARK DYBUL: Well, I think it's important to note the IOM criticized all directives. Remember, the IOM is a scientific group, and from a high level kind of detached scientific perspective, they're quite right. What do you need directives for? Just go to work in the countries and figure things out.
That is probably true, but from a policy standpoint, from the standpoint of trying to have the most effective program to optimize the use of resources, we have to look a little bit differently. The administration actually supports only two directives going forward, not the whole list of directives that existed the last time. But those directives were important.
The reason directives are important is because they direct. They redirect in many ways from where we were. So, for example, three years ago the US government was spending almost nothing on treatment. We needed a directive at that point to insure that we committed the resources for treatment. Now we've done that, we don't need it any longer.
Orphans and vulnerable children we had not committed much to before. When the emergency plan started, only $30 million across the entire US government went for orphans. Now it's around $270 million dollars for orphans. But it's still difficult to get commitment to orphans when we do our operations plans, and I think it's because there's not enough expertise, or the countries aren't as focused on it.
So we think we still need that 10 percent directive because when we make money available for orphan care, we don't see it utilized. So we need to continue to push on that.
How much longer I don't know. At some point it will become like treatment, and we don't need it. Same on prevention.
I think it's important to note that what our guidance is and what the law supports is comprehensive prevention. And again, it gets to direction and redirection. Before the emergency plan started, we were heavily one-prevention, one size fits all for prevention, which was a mistake. We took data from concentrated epidemics where small parts of the population are infected in Asia, Latin America, where we had effective programs - for example, in people in prostitution or intravenous drug users, and we took those data from concentrated epidemics and applied it to a generalized epidemic. And the data are overwhelming that that failed - nor surprisingly failed.
So what we needed to do was redirect our comprehensive program, which includes abstinence or delaying when you become sexually active, or secondary abstinence. There are data from Kenya and people who had been sexually active who are no longer sexually active. You need to be faithful to a single partner. We know that's very important in the epidemic. The data are overwhelming. That one piece, reduce your partners, has had a significant impact on generalized epidemics, and correct and consistent condom use.
We're also pushing forward on, for example, male circumcision which we believe will reduce prevalence, or HIV incidents further. We're hoping that pre-exposure prophylaxis or microbicide becomes available.
So we have this very comprehensive approach. We also then have prevention of mother to child transmission, safe blood, safe medical injections. So we have a very comprehensive approach.
What the directive does is insure we have that comprehensive approach so that we don't go back to applying principles from concentrated epidemics to generalized epidemics.
So we support some directive here to insure we have evidence based comprehensive prevention. Sen. Richard Lugar has introduced a bill. We actually support the language that is in that bill because it changes the previous directive in a way that we'll build on, and learn from what we've seen over the last couple of years in terms of effective prevention.
What the language says is how you apply that - these behavior change approaches apply to sexual transmission of HIV, which is 90 percent of the transmission in sub-Saharan Africa. It ought not to apply to prevention of mother to child transmission, or safe blood, or safe medical injection, or when we have them, microbicides or pre-exposure prophylaxis. But it's a behavior change, and that's - that makes a lot of sense, and therefore we - but we need that comprehensive approach.
It also talks about the difference between concentrated and generalized epidemic, following the epidemiology so you have the most effective approach in those countries.
We have very different approaches in a generalized epidemic in, for example, Kenya and Cambodia, because they're different epidemics, so you need a different approach. And that's what we've been doing. It simply is more codified in the law.
SUSAN DENTZER: Is that in effect saying that although the original law set forth this particular clear set-aside within the prevention bucket of abstinence, things have evolved, and now underneath the abstinence umbrella there's a much broader set of understandings of behavior change, including, as you said, partner reduction? It may not be abstinence purely speaking. It may be partner reduction, but that there is a much broader understanding of what these prevention initiatives ought to entail.
MARK DYBUL: Well, I think we've just learned how to implement them, but the original law allowed for all of that. It had abstinence and fidelity and correct and consistent condom use. It just had a directive related to insure that we had what's called abstinence, but it's really often delaying of sexual debut, or people who were sexually active not becoming sexually active, and this works very well. There have been studies to show that that's made a huge difference in epidemics.
So I think that the fundamental insight has changed. It's just in terms of how you apply it in a directive. And again, I think there will be a time when these directives aren't necessary. It's just not now. We're just not far enough along, and we can tell that from a policy perspective, which I think differentiates where we're going from the IOM.
The IOM is not looking at policy and implementation on the ground. They're looking at a purer standpoint, and again from a pure standpoint, why have a directive, you know. Just let the countries figure it out.
From a policy standpoint, that's not where we are yet. We're there on treatment, so we don't think we need that directive. We're there on care, except for orphans, so we don't need that directive, but we believe where we are right now means we still need directives for orphans, to protect the orphans and also to insure we have the most effective prevention strategy.
SUSAN DENTZER: Staying on prevention, many people have made the point that with 4 to 5 million new infections a year, it will be very difficult for the world to put everybody eventually on treatment, and that the - unless we want to consign ourselves to a future of constantly chasing our tail on this, there must be a dramatic cut in the rate of new infections. You mentioned some of the initiatives that one puts a lot of hope on - male circumcision, for example, the future development of a microbicide. What else can be done, as we think through the future of this program, to radically cut the rate of infection?
MARK DYBUL: Well, I think you've put your finger on what everyone is struggling with, and whether you're following your tail or turning off the tap, it's quite appropriate. We can't treat our way out of this epidemic.
That's one of the extraordinary things about the initiative. When the introduction of this initiative is remembered historically, it will not only be because it was the largest in history, it will be because it combined prevention, care, and treatment for the first time. No one had ever stood up and said, you can't just do treatment. You've got to include prevention with it. And you have to have care, too, as a comprehensive package. It's an extraordinary insight. The rest of the world isn't quite there yet.
So prevention has always been a bedrock of this epidemic and of this response of the American people. And if you look to "PEPFARTHER", as you called it, you'll see that the goals in prevention are actually growing higher than the goals in treatment and care, with that recognition that we need to do a better job of prevention.
What we're limited by is the science. As difficult as treatment is, it's actually easier than prevention because it's a medical intervention. Prevention is changing people's behavior right now, until we have a vaccine, or a microbicide, or pre-exposure prophylaxis, or some other technological interventions, we're relying on behavior change. And as we know from smoking campaigns and, you know, people - getting people to reduce fat content, and these types of health behavior change, it takes a long time.
I think actually we've made tremendous progress, given the short period of time that people have done these interventions. But what it means is really focusing on it, and what we're referring to it now as combination prevention. You can't just do one approach. You've got to do all approaches in a geographic area. And we're working with our international partners. We've got some exciting new initiatives, I think some of the most exciting things that will happen in HIV-AIDS, working on this concept of combination prevention.
So we think we need to concentrate on it more, use all the data available, which is what we've been doing. We're gathering more data, and fight the epidemic in terms of prevention. But I think people are getting a little bit too discouraged. I think we can do this. We've seen we can do it, whether it's Uganda, Kenya, Botswana, Namibia, South - parts of South Africa, Ethiopia, Nigeria. There's good reason to hope. We just have to concentrate on it and keep it up.
SUSAN DENTZER: What's an example of a place where you have a combination prevention strategy emerging?
MARK DYBUL: Well, we're actually working both in - I've just traveled to Africa, and we've been talking with folks in a number of our countries. Because of our partnerships, we're actually working - we're also near the private sector. For years we've been relying - what we're talking about is changing a young child's behavior.
So traditionally, we've been intervening on 20 to 25 year olds. Well, you've got to get to them a lot younger. So we're building life skills programs in and out of schools to teach kids at a very young age to respect themselves and respect others, which includes their sexual behavior. We're working with faith-based organizations to do the same.
You've got to have all segments of society coming together. We've got that going on in a lot of places.
But we also need to step into the 21st century. There are organizations in the private sector that live and die on whether or not they change a young kid's behavior, whether it's going to a movie, or drinking a certain soda, or buying a certain toy. We need to take that type of messaging, that type of 21st century approach. We need to use computers more, we need to use cell phones more.
We have some great initiatives to really take us to the next step. The difficult thing is maintaining that behavior. We've seen that in the United States, we've seen it in Europe. You can't have the same message for 20 years and still have the same impact, so we've got to have an evolving message, and then we've got to bring these other medical technologies in as they become available.
So I think there are a number of countries that are moving forward on this, and we're going to support them to do it, and we've got some really exciting programs that they'll be - we'll be rolling out in the next six months to a year that I think will fundamentally change our perception of how to effectively prevent HIV.
SUSAN DENTZER: Again, staying on another question about reauthorization, many people want to have a re-examination of the approach today in terms of working so heavily through implementing partners that are primarily US based or expatriate, and want to ask the question about whether, in effect, too much of the money goes to overhead for these organizations, whether more money should be channeled directly to governments, or directly to local NGOs, skipping the interim layer of the US-based INGOs or implementing partners. What do you think?
MARK DYBUL: What you've raised are actually, in my mind, not authorization issues, they're implementation issues. We're working on this now. We don't need to wait for the next five years. We are working on better prevention now, we're working on protecting orphans now, we're working on developing local capacity now.
I think it's important to note that 80 percent of our partners are local organizations. Eighty percent of them. And how you mix government and non-government is - depends on the country. In Kenya, 50 percent of the health care is in the faith-based sector, whereas in Nigeria 90 percent is in the public sector. So you work with what's there, and you build that capacity.
But I think you're right - we have actually instituted policies in every contract, in every grant that we sign now. There's actually a section that requires international organizations to build local capacity and turn over what they're doing to a local organization.
We're building what are called umbrella grants. We're limiting the amount of money that can go to any one organization, except an umbrella grant, to allow many small organizations in country to be engaged in the response.
But you're absolutely right, it gets back to transformational impact of all this. It's got to be local ownership, it's got to be local led. But for a time you often need technical support, and that - the conversation about overheads is one that I take very seriously. I think we probably do pay too much in overheads. We want to renegotiate and halve a number of those. But in that overhead category is often technical support, providing know-how that doesn't exist in country, and it takes some time to do that.
But some countries move rapidly along that course -- it gets back to their trajectory, and some don't. We have to make sure that when countries reach the point where whether it's the government or other organization, can take it on their own, that they take it on their own, and that's something we're working on.
But I don't think that's an authorization issue, I think that's an implementation constantly challenging ourselves to do that.
I do think it's important to note that the Institute of Medicine said that we are, in fact, building health capacity in country, whether it's government or non-government, because 80 percent of our partners are local. The challenge is to make sure we keep doing that.
SUSAN DENTZER: There is a lot of confusion about what has been accomplished under this program, particularly in the realm of condom supply. What actually has happened?
MARK DYBUL: You know, I think this has to do more with debates back here in Washington, and Europe and in the countries, because in the countries they know we're supporting comprehensive prevention. So we've expanded multiple areas, comprehensive areas of prevention.
In terms of condoms, Peter Piatt, the director of U.N. AIDS, recently said that we supply more condoms than the rest of the world combined. It's about 1.7 billion condoms since this program started. So we have a very comprehensive approach. Most countries - I was just in a country where three years ago we supplied one million condoms. Now we supply 15 million. One where we used to supply 7 million, now we supply 45 million. So it's a big myth out there that we don't support condoms. What's true is we support condoms in a comprehensive approach, and at the right age that's appropriate in this country - that's appropriate for African standards. The Africans developed this approach. But I think it's something most American parents would agree with.
Up until fifth grade, you teach kids that they shouldn't have sex, but if they're going to have sex, and when they do, they should be committed to a single partner.
After fifth, sixth grade, after you're 14 years old, you have a comprehensive message, in schools. Out of schools, because kids are at higher risk, you have a broad message at any point. So there's a lot of mythology out there about what we do and don't do, and when you talk to Africans, I think most of them will tell you what we're doing is what they want to do, and I think what most American parents would want to do. But we supply a lot of condoms, but we do it in a context of what's the best scientific approach for comprehensive prevention.
SUSAN DENTZER: So again to the question of the future, as we move out of what people think of as the emergency phase, and we move more into an era where we recognize it as a chronic disease, the sustainability of the programs becomes critical going forward -- not just in terms of who is going to pay the bill for treatment, and are other countries going to come in and step into that support, but the whole question of whether there's the capacity in the systems to provide that level of treatment for a long period of time for many, many millions of people.
What do you think the critical issues are for the U.S. taxpayer going forward, as we think through the most important contributions the U.S. can make?
Moving beyond emergency response
MARK DYBUL: I think the way you put it is exactly right. What's the right thing for the American taxpayer. What should our commitment be, and how do we build that local capacity, and that's why we've spent so much time building capacity.
So as you point out, we are still in an emergency response. We're going to be in an emergency response for a while. But some countries are getting towards where the international community think they need to be. But something you point out is important in terms of capacity building. For a long time in development, when you added up budgets, there were 400 percent of resources counted in some way or another. We're adamant that budgets add up to 100 percent. So when we say we're supporting anti retroviral therapy, people think all we're doing is buying drugs, which is why I've pointed out that 77 percent of that anti retroviral budget line is actually going to capacity building.
We spend an enormous amount of money supporting capacity for orphan care, for sustainable programs in all sectors - private, public, faith, community based organizations. That's what we're all about. That's the key for going forward. That's the key for how we're going to succeed and transform, and that's what it's about. It's transforming individuals, communities, countries - in fact, the whole continent - to take control of their epidemic.
And that, again, is the key thing we've done.
You can't do that unless you believe you can tackle your own problem, and what we've done, and I see this over and over and over again, is change from utter despair, we can't do anything about this, to we can tackle this problem. And not only can we tackle this problem, but hey, we can tackle some other problems.
I've seen people who used to think they couldn't tackle anything, beginning with AIDS, and now they're going after Malaria, and TB, and garbage collection, and controlling illegal bars. It's - a young Rwandan told me that what we're doing is building democracy, because we're building this local capacity in the sense of we can accomplish something. And that's what this is all about. That's what this is all about.
There are many different paths to doing that. We're working on lots of them. There's lots of implementation issues around building that local capacity. But that's how we're going to tackle this problem. That's President Bush's bigger vision for development.
PEPFAR is a piece of a much bigger approach that's doubled development overall, quadrupled it for Africa, includes free trade, debt relief, so that we can build local communities to take over their problems. Without free trade we're not going to have the resources in country to build health capacity.
So all of this is connected. All of this is connected, and we're a piece of that. Our piece is to build that capacity, to train doctors, nurses, health care workers to build facilities that will work, to have ongoing training in those facilities, to build laboratories, and to build that hope in the communities that they can tackle their problems.
That's what we need to work on. That's not an authorization issue. We're doing it now, and we need to keep doing it more, and think about the most intelligent ways to do it.
The best thing about the IOM report, to me, is they called PEPFAR a learning organization, and we are trying all the time to look from the lessons on everything, to learn from them so we can do a better job. And that's what it's all about, whether it's sustainability, and training, and capacity building, whether it's prevention, whether it's treatment. That's what we've got to keep doing, and if we're not constantly learning and changing, then we're not going to tackle this epidemic in any way.
SUSAN DENTZER: Finally, the IOM looked at the issue of generics under the provision of antiretroviral drugs, and noted that 27 percent of drugs supplied as of this year were generics, and made the recommendation that the US revert to the WHO prequalification standards as opposed to FDA approval going forward. What do you think should be done on that score? Is there room to move to the WHO prequalification standards?
MARK DYBUL: Well, you know, I've talked with the committee members. The one thing about that report is it was completed about a year ago. There's been a lot of progress since that year, and the Department of Health and Human Services and the FDA just announced the 51st generic product approved - tentatively approved for the emergency plan, generic product.
We're actually adding drugs to the WHO qualification list because since that IOM report, we have an agreement with WHO that anything that we approve, they will automatically put on their list, which means now for the first time, a three in one pediatric combination drug that is now on the WHO list for pediatrics. It wasn't there before. It's now going to be there because of the FDA approval process. So actually it's synergistic at this point, and move forward - that 27 percent is very old. We just met with our supply chain management system, and in the vicinity of 90 percent of all our products purchased through the Supply Chain Management system are now generic products.
SUSAN DENTZER: Ninety percent?
MARK DYBUL: Ninety percent. So through the Supply Chain Management System. Now, we have a lot of other partners and it will take us some time to figure out where those are, but it's gone way up in every category.
SUSAN DENTZER: What does that mean overall then? If it was 27 percent overall, what is it now?
MARK DYBUL: We won't know until next quarter. But we've gone from somewhere in the neighborhood of 40 percent, or I can't remember the exact number, to 90 percent within the supply chain management system, which is our largest system that we're just getting online.
The emergency plan now gets the lowest cost for that three in one adult pill of anyone in the world, $90 dollars a year, up through a generic product.
So we're moving rapidly where we can to generic products at cost. And I think we need to be smart, too. You've asked a lot of very good questions about what's happening in the future. This is a generational disease. We do not have a vaccine, we do not have a cure. We are unlikely to have either of those anytime soon, and by anytime soon I mean decades, not years. We don't have an effective microbicide. We're a ways away from that.
That means treatment for HIV positive people are going to be necessary in a generational way. Today we are not using the same drugs I used as a medical doctor five, six, seven years ago. Part of that is the drugs have improved with lower toxicity. Part of it is you develop drug resistance. Fifty percent of the people in California in this country have evidence for drug resistance, who are receiving anti retroviral therapy. Ten percent of the people in this country and in Europe who have never received anti-retroviral therapy but are infected have evidence for drug resistance because they had drug resistance transmitted - virus transmitted to them.
We need newer and newer products all the time. So we need a much more intelligent thinking about for the future, for this generational fight against HIV/AIDS, for this chronic disease management approach.
What's the right mix between intellectual property rights so that you can develop those new products, and getting the lowest cost product right now. To be honest, the US government has led the way in trying to figure out that balance. Everyone else seems to be on one end or the other. But we need everyone else to get to say what's the right balance there? Or in 10 to 15 years we could be back to where we were ten - five years ago, where our drugs aren't as effective.
So we have a lot of work to do here, but I don't think the answer - and I think many of the members of the IOM may have changed their mind because so much has changed in the last year in terms of how we approach generics, the amount we're purchasing, and the fact that now all those drugs go on the WHO list, so we've actually expanded the WHO list.
The last point I'll make is that system is good for Americans. Because of this rapid approval process, we now have, I think, three generic anti-retroviral drugs available to the American people, because they went through this process rapidly.
So I don't think we need to change that. People can look over time, but I think right now we have the right balance and the right mix for safe products at the lowest cost.
SUSAN DENTZER: Is there anything I haven't asked you about that you would like to say?
MARK DYBUL: I think the most important thing I would want to convey is that the American people have done something extraordinary in history. Not just in the history of HIV/AIDS, but in the history of global health, and in the history of global development.
The American people are standing with the people of Africa, and it's something they know and understand. I've been in villages in far remote Africa where we're providing - supporting anti-retroviral therapy, and have the tribal leader say, "Please thank the American people for what they're doing for us."
I asked a local leader what PEPFAR meant to him, because acronyms are not so common in rural Africa, and he said it means the American people care about us. That's one of the most important messages, that we are out there creating hope where there was none, it's transforming individuals, communities, nations, the heroes out there. You've got to meet some of them. People are giving all - their all for their communities, are doing it with the support from the American people. It's one of the most extraordinary things.
I go to site at six month intervals and see a radical transformation. A local leader, head of the District anti-retroviral program in rural Kenya probably put it the best. They said that what PEPFAR does - what PEPFAR's done is rebuilt our tractor. We had a broken tractor in public health in the field. We couldn't harvest anything.
What PEPFAR has done is supported us to fix that tractor so we can solve our problems. That's what we're doing, that's what we're all about, and the American people should know that. They are transforming the lives of individuals. They're not only saving their lives, they're creating hope where there was none, and that is transforming - that is transforming countries, continents, and through individuals. So I think the American people should know what they've done.
SUSAN DENTZER: Ambassador Dybul, thank you very much.
MARK DYBUL: Thank you.