Ambassador Randall Tobias, Global AIDS Coordinator, Dr. Mark Dybul, Deputy Global AIDS Coordinator and Chief Medical Officer, On the Release of the Second Annual Report to Congress on the President's Emergency Plan for AIDS Relief

AMBASSADOR TOBIAS: Madame Secretary, thank you for your comments and even more so for your steadfast support for the President's Emergency Plan from even before it was launched.

Let me echo the Secretary in honoring the people who bring hope to places where this pandemic has sown so much hopelessness. This document is not just another government report. It is the latest chapter in a story and the heroes of this story are ordinary people who are working together and accomplishing something truly extraordinary. The dedicated men and women of the U.S. Government working in our host nations and here at home are the leaders on one side of a partnering venture.

But they understand that the fight against this pandemic, if it is to be effective and sustainable, must truly be led by the people and the governments of our host nations. That partnership involves not just meeting the needs of the people we seek to help, but working with them to grow their capacity for the future. And that is the kind of partnering leadership that our U.S. Government teams have brought to this work and our nation can, indeed, be very proud of what they are doing.

Of course, there are no partnerships without willing partners and one of the most exciting developments today is the growing number of people from Africa, Asia, and the Caribbean who are stepping up to the challenge of HIV/AIDS. These leaders serve in governments or in non-governmental organizations or are simply grass roots leaders recognized by their communities. Many are living with the virus themselves and thus, bring a unique and essential perspective. Many are women overcoming significant obstacles to help build a better life for other women and for children and for men.

These leaders in our host nations are making vital contributions and we are very proud to work alongside them. One of those leaders is the young man pictured on the front cover of this report. Nkonzo lives in Soweto Township in South Africa and through his participation in a PEPFAR-supported program known as Men As Partners, he came to understand and see his responsibility as a man to help prevent the spread of HIV/AIDS in his sphere of influence.

He has become a volunteer peer educator with the organization and has also started a youth group at his church, talking to men of his generation about embracing behaviors that will keep them and their loved ones safe. He is supporting an HIV/AIDS positive family member and he is serving as a role model to his little brother, whom you see in this photo, helping to create a better future for those who come after him.

Nkonzo is just one leader among millions in the story of the worldwide fight against HIV/AIDS. Through the President's Emergency Plan, the American people are partners with him and with families and communities and nations that are reclaiming their future.

Now, I would like to introduce Dr. Mark Dybul, who is the Deputy U.S. Global AIDS Coordinator, who will be happy to answer your questions.

DR. DYBUL: Good afternoon. Why don't we just go ahead with questions, because the Secretary and Ambassador Tobias have covered the topics already.

Yes, sir.

QUESTION: Can I ask you about distribution? What percentage, roughly, of U.S. assistance goes to church groups and if it's heavy, which I think it is, is that an attempt to have the recipients counseled by the churches so far as their personal life is concerned?

DR. DYBUL: The -- as those of you who have spent some time in Africa know, the disease is not confined to cities. It grows out into the communities as a -- and is in the far reaches of countries at very remote, rural areas. The fact of the matter is that we cannot succeed in the fight against HIV/AIDS without enrolling the incredibly energetic and incredibly -- people with very strong credibility in their communities and those are faith-based and community-based organizations.

You go out to communities in Africa, Haiti, or other places; the only groups out there, the only groups in the villages are faith-based and community-based organizations. Because of that, we are supporting anyone who can help in this fight. We need all the resources and all the energy that's possible.

Because of that, about 20 percent of our partners are faith-based organizations, 20 percent. About 80 percent of our partners are local, are indigenous organizations. And as both Ambassador Tobias and the Secretary noted, these types of partnerships are critical if we're going to expand prevention, care and treatment services. So, our focus on faith-based organizations and community-based organizations is because we cannot succeed in the fight against HIV/AIDS and they are providing the types of services that we need to have provided. It's not an ideologic or other purpose; it is simply, simply to expand services in the most effective way, in ways that will reach the communities that need to be reached.

QUESTION: Indeed, I see your spending for condoms has gone up, but spending for talking people out of sex, if that's what it's called, is also going up. Don't you increase the possibility that people will not be given condoms, if you go through churches -- faith-based, if not all churches?

DR. DYBUL: Right. Well, there are a couple things on that. First of all, funding for everything has gone up. The Emergency Plan is an historic, historic dedication of resources and commitment by the American people. It's the largest international health initiative in history dedicated to a single disease. We've gone from when this Administration really began this effort from a billion dollars to $4 billion in the President's request for next year, so resources for everything has gone up, as they must.

ABC, as the Secretary mentioned, is our policy on sexual transmission, prevention of sexual transmission, is a three-component approach. It's not one component; it's three components. This an evidenced-based approach that was developed in Africa by Africans as the most effective prevention strategy and it's implemented by public health officers like myself who have been doing public health for 15, 20 years. These are the people who are implementing this approach.

There are data now which you may have seen last week from Zimbabwe showing that the national prevalence decreased because of ABC, all three components. In fact, the most impressive results were on the AB side. We have data from Kenya, another country that has reduced their prevalence showing the exact same thing. We have data from Uganda showing the exact same thing. There are only three countries with generalized epidemics in Africa that have seen a decrease in prevalence. In all three cases, the reason was exactly the same: A, B, and C. There are no data from generalized epidemics that I'm aware of showing that condoms alone are going to effectively tackle this epidemic. So you need all three components in a generalized epidemic and every spot of data says that, so this is an evidence-based approach developed by public health officials in Uganda, supported by public health officials in the United States.

So condom dollars have gone up, the supply of condoms from the United States has gone up dramatically since 2001. And in fact, just going from 2004 to 2005, we had a greater increase in dollars for condoms than abstinence and fidelity. But we have a balanced approach. Those condoms are now provided in the context of what we know works, which is A, B, and C. So dollars have gone up for everything, but you can't leave the A&B out because A&B is an essential piece of an effective approach and we know that now from the only three countries that have a decrease in prevalence.

Yes.

QUESTION: How do you ascertain the balance which ensures inclusion of C, if you're using faith-based groups that don't agree with C?

DR. DYBUL: Well, let me be clear about a couple things. One is faith-based groups don't just do prevention activities. They're very engaged in treatment and care as well. So that 20 percent of our partners aren't all doing prevention. They're doing prevention, care and treatment, as many of our other partners do.

The law, the law for the United States, is very clear. Organizations that do not support condoms do not need to provide that education, but for a ten-year-old kid you don't want to provide the full message and for a ten-year-old kid what you're teaching them is abstinence only, and so there are groups that are dedicated to that.

The law is also very clear that no group can provide medical misinformation. And so it's a balanced approach that provides A, B and C in the full context of a public health approach, and you need all three components so different groups can provide different pieces or one group can provide all three pieces. But you have different target populations, you don't provide the same message to all groups, and so it's perfectly natural to have some that provide some messages and some that provide others.

Yes, sir.

QUESTION: How serious is this problem in Asia, especially in India? Now the Secretary and President is going to visit there. Is this issue going to come up in this meeting?

DR. DYBUL: Well, AIDS is a very significant issue in India and other parts of Asia. India has a climbing epidemic and may have the largest number of HIV-infected people in the world, possibly more than South Africa now. And it's largely because of the size of the population. Even though the prevalence is still rather low, because it's a large population there are a fair number of HIV-infected people.

The United States is very engaged in battling the epidemic in India and support quite a bit in terms of resources, but it's a technical partnership. India has the wherewithal, resources and ability to tackle this epidemic and we're supporting their response to it. So we're very focused on India and any country where there's an AIDS epidemic and focused on providing support and partnership in any way we can.

QUESTION: So far, what types of efforts are going on in India as far as U.S. and India partnership on this problem?

DR. DYBUL: There are a number of prevention, care and treatment programs. We tend to focus in a couple of areas of India, particularly Tamil Nadu, which we've been very active in in prevention, care and treatment, but also other parts around Mumbai, Pune, Delhi. As I'm sure you know, there's been an agreement to focus on public-private partnerships in India because of the strong business community in India, so we're working in many ways in partnership. We also have strong scientific collaborations, you know, looking to the future it's important that we have new vaccines, or a vaccine, not a new vaccine, but vaccines, microbicides, better treatment options. And of course India has a strong research and development program as well so we're partnering with them on this as well.

Yes, sir.

QUESTION: You've spoken about -- you would imagine what you would determine as a best case scenario. These are communities with churches and community organizations, many run by NGOs. What about areas in conflict? We've seen, for instance, Darfur in western Sudan. We've seen the Democratic Republic of the Congo and other locations, for instance, in Africa where unrest goes on and rebels as well as all groups are using this as more a political weapon, in other words, the rapes and torture, and, well, obviously the virus will spread.

DR. DYBUL: Yes, right. Conflict areas are very difficult areas to work and we work in a number of them. But it really gets to something the Secretary and Ambassador Tobias highlighted, which is our focus is partnerships and building local capacity. If you're working with local organizations, even when the expats get ordered out of the country programs still go on. And so in Haiti, in Cote D'Ivoire and places we're working where there's conflict, these programs are continuing. In fact, Cote D'Ivoire has seen remarkable success in terms of expanding treatment because it's people from Cote D'Ivoire, people from Haiti, who are doing the work or supporting them. So you can still maintain efforts in conflict areas. It's difficult, but it's absolute possible and it's happening.

Yes, sir.

QUESTION: Doctor, you mentioned the area of condoms. Why then you have eliminated drastically the U.S. funds on the prevention program since there are lot of complaints from a bunch of organizations to this effect?

DR. DYBUL: Oh, I'm afraid your facts are completely wrong. We have not dramatically decreased any funding for prevention. In fact, the funding has gone up considerably for all three components: A, B and C. In fact, from 2004 to 2005, we went from funding for condoms and related activities around $45 million to $65 million. The number of condoms that have been supplied has gone from 348 million to 429 million from 2001 to 2005. In the 15 focus countries it's gone from 150 million to 198 million. Already in this calendar year only two months old, we have received orders for 367 million condoms that we will supply. So your facts are wrong. We have dramatically increased resources for A, B, and C. We've dramatically increased resources for prevention overall.

QUESTION: A follow-up. Why you do not formulate an international committee with the participation of the so-called founder of the HIV virus, Dr. Robert Gallo of Johns Hopkins University, who has been emphasizing internationally, even today, by thousands of biologists, doctors, professional scientists that he'll never prove that such a virus exists and that HIV is not causing AIDS but is something else in order to find out what is going on exactly with this catastrophic matter?

DR. DYBUL: If you're suggesting that HIV does not cause AIDS --

QUESTION: Not me. A bunch of -- thousands of biologists, scientists, doctors, et cetera. Go to the internet. You will see that.

DR. DYBUL: Anyone can put anything on the internet as we well know. But as a scientist I can tell you, the data are rock solid from a scientific perspective that HIV causes AIDS. And I think we don't need to discuss that matter any further because it's as solid as you'll get in the scientific world.

Yes.

QUESTION: What percentage of the funding is actually being spent on the medicine, shall we say? There's been some criticism that a lot of this money essentially comes back to the U.S. and people here in the U.S. in terms of salaries to consultants and technical assistance. What percentage is being spent on medicines or whatever?

DR. DYBUL: In 2005, so with this -- for this annual report, approximately $161 million went to purchase antiretroviral therapy drugs, which is around 15 percent of the overall pool. Remember, we're talking about prevention, care and treatment so the percent of resources going for treatment is about 45 percent overall and 15 percent of that went for the purchase of antiretroviral drugs. I think it's critical we all understand something we emphasize in the annual report and something which is misunderstand, and I can tell you as a physician this is absolutely true, antiretroviral therapy does not equal antiretroviral drugs. And there was a very important study in the New England Journal of Medicine from a group of researchers in Haiti about two months ago -- I think it was -- that showed that the average cost per person of antiretroviral therapy was approximately $1,600, if I remember correctly. The cost of the drugs was about $300. So the extra costs there are to pay for the salaries of and train doctors, nurses, community health aides, laboratory technicians and everyone else you need to provide therapy.

It's for infrastructure. You need medical equipment. I'm sure as many of you are aware in many of the areas we're working there is not physical infrastructure there at the moment and that has to be built and there's considerable costs in there: there's monitoring and evaluation costs, there's waste disposal costs, there's logistic systems costs. All the things that we take for granted here, when we look at the cost of drugs as being antiretroviral therapy is not the cost in the programs we're working on. So the percent that's going towards drugs is 15 percent which is about what this New England Journal of Medicine article said is approximately the cost of therapy, which is 20 to 30 percent. So we're pretty much on target.

We also partner with other organizations, for example, the Global Fund. In many areas the Global Fund provides -- or the country itself, in the case of Botswana, provides first-line therapy themselves. We support other types of therapy and support some of these infrastructure and other costs that are essential for antiretroviral therapy.

It again comes back to the issue raised and emphasized by Secretary Rice and by Ambassador Tobias, it's building the local capacity through partnerships or with locally-owned programs and that is a costly enterprise.

QUESTION: I have a follow-up question to that. So to the larger question, however, which is a concern in many countries, is this money sort of doing a circular route. That either through money spent on commodities that are manufactured here or products that are manufactured here -- money that might be better spent or more economically spent in other places. But only about, you know, 20 percent, shall we say, 50 percent at the most actually goes directly to do anything in that country itself.

DR. DYBUL: And that's why we're so focused on making sure the money does go where it needs to be -- focusing on building local groups that can, in fact, get the reach that they need to, which is why 80 percent of our partners are local partners, why our resources are going to expand prevention, care and treatment services.

Something you always need to be mindful of and we watch very carefully, that's why we are pushing every way we can to get the money to where it needs to get, to the local communities where it can be utilized. And that's why we're so strong on supporting partnerships and so strong on supporting the work to be done in the countries; that 80 percent needs to go up. But initially you need to have partnerships internationally at least to bring the technical abilities and to bring some of the expertise to bear to build that local capacity. So there is a cost at the beginning.

In terms of products, we've made very clear that we'll purchase drugs no matter where they're produced as long as they're safe and effective. We're going for the low-cost drugs, produced anywhere, as long as they're safe and effective. And that's why we've had a special FDA process to approve two generic drugs produced from all over the world, including India, Africa and other places. So we're moving to make sure the dollars are used -- what for what the American people expects them to be used for.

QUESTION: Sir, clarification. Were you saying that 80 percent -- I just want to be clear, I'm sorry. Were you saying that the 80 percent does come back to the U.S.?

DR. DYBUL: No, no, no. Eighty percent of our partners are local groups, not local in the United States; local in countries.

QUESTION: Okay, the partners are -- but in terms of the funds that are actually spent doing the job, does most of that money come back to U.S. grantees, back to the U.S.?

DR. DYBUL: Well, first of all, back to U.S. grantees doesn't mean back to the U.S. U.S. grantees are provided resources to do work in other countries. So the money is not coming back to the U.S. It may go through a U.S. organization to fund local organizations or to do work in countries. What our money has gone to do is to build local infrastructure to get drugs and services to the local communities, not to have money in the United States.

QUESTION: One more on the drugs and the manufacturing of generic drugs. You've had quite a bit of resistance in this country from pharmaceutical companies in terms of patents, in terms of producing cheaper drugs. I mean, have you pretty much given up on pharmaceutical companies in this country and you need to go abroad to find manufacturers?

DR. DYBUL: No, we haven't given up on anyone. We need all companies who are willing to engage in this battle, to engage in this battle. And in fact, about two weeks ago or three weeks ago, there was a new partnership between two companies to make the first one pill, once a day product by two companies in the United States, which is an incredibly important advance. What we're saying is we need everyone engaged. We're moving -- I mean, if you just think about it, we're moving from less than 50,000 people being treated in all Sub-Saharan Africa in 2002 to now hundreds of thousands. That is a capacity production issue. You need capacity and production from all over as many resources as possible, which is why we have this process so that we can use generic products that still are under -- still cannot be sold in the United States because of patent protection but that we can use in other countries.

We have a process so that we can use innovator and generic drugs, so it's a mix of both depending on what's appropriate for the country and where supply is easiest, as long as they're safe and inexpensive. So we're not giving up on anyone; everyone is contributing.

We have 15 such generic products. Remarkably, you know, one thing that’s gone little noticed is part of this process was to get to a tentative approval so that companies proved the safety and efficacy of a drug but can't be sold in the United States but we can purchase it for use internationally.

QUESTION: (Inaudible) I mean, could you at least concede that the pharmaceutical companies in this country have not been particularly cooperative in this endeavor?

DR. DYBUL: No, I wouldn't concede that. I mean, long before the Emergency Plan and other international efforts, drug companies were providing drugs at very low cost to provide treatment in the developing world, so I wouldn't concede that at all.

MODERATOR: (Inaudible) We only have time for a couple more. Why don’t we go over here.

QUESTION: There's obviously a big emphasis on mothers -- preventing mother-to-child transmission. Are all the women who get antiretrovirals to prevent transmission at birth, then offered them for, you know, indefinite lifetime treatment or there are still some programs where they say, sorry, we're going to stop giving them to you.

DR. DYBUL: Unfortunately, mother-to-child transmission is typically and what we're reporting on is basically single therapy for the mother and child to prevent the transmission. That's generally because the capacity in many sites is such that you can do that. You can do that relatively easily but the capacity isn't there yet for full treatment. What we are doing is pushing as rapidly as possibly to expand from prevention of mother-to-child transmission that just prevents transmission from the mother to the child to full treatment for the mother, to keep the mother alive and to keep the families together. But it takes some time to build the capacity to that.

And as you may recall before the President's Emergency Plan for AIDS Relief, you had his International Prevention of Mother and Child HIV Initiative and we're actually building on that, trying to expand as rapidly as possible from those stop-gap interventions to save the child, to save the whole family. And we're moving as quickly as we can but it's going to take some time to build that capacity.

QUESTION: Do you have any estimates on the number of women who only get the drugs during pregnancy or during delivery?

DR. DYBUL: Yes. The numbers we're providing you are generally women who have received that short-course therapy, so the 3.1 million that entered the services, the number who received the drugs and then the 47,000 infections averted is generally that single dose therapy as we're marching rapidly. But that is a very important reason and the Secretary emphasized the fact that 60 percent of the services that we're supporting are for women. So we're trying to do a better job of figuring out how many of the women are pregnant women so we can see how rapidly we're moving towards that. But that's where the programs are going. And you know, initially we actually asked for reporting based on -- people are doing what's called PMTCT-Plus or full therapy. But what's happening is the pregnant women are going to the national programs, rather than separate programs. So we're trying to work that out. But the goal is to get where we are in the United States -- full therapy, not just prevention with a single therapy.

MODERATOR: Yeah. One last one, Charlie.

QUESTION: One technical question. On a scientific basis, how good is the data that you're getting from these countries? How much do you -- are you relying on it? I mean, it may be the only data you can get, but from a scientific basis how good is it?

DR. DYBUL: Well, now one of the things we're working on building the capacity for is monitoring evaluation and the ability to collect information. And we're very focused on this because it is an issue. It's one of the systems that needs to be included and so you'll see in the report two types of support we provide, what's called downstream support or support to an individual site and upstream support which is more national support for, you know, logistic systems, supply chain management systems, training systems. And for those data we rely on the data that are collected from the governments, local government. For the downstream support, we actually collect data from our partners from individual sites and we've actually sent auditors out to look at those data, to see how reliable they are. And so far, they're holding up as extremely reliable. But it is a question we always work on.

We also work with our international partners, UNAIDS, the Global Fund, the World Health Organization to do a better job at ensuring that the data are accurate. And in fact, we spend a lot of time working with them and you'll see in our annual report that we make sure that there isn't double counting going on.

QUESTION: I want to see if I understand right. For the upstream part of that where you rely on local governments, do you actually send auditors for that or just auditors --

DR. DYBUL: We have, in fact, begun to send auditors out to look at all the data.

QUESTION: Begun to?

DR. DYBUL: Yeah.

QUESTION: So the data we're seeing has been audited?

DR. DYBUL: Some of it has and in some places we won't use it. For example, in Cote d'Ivoire, because of the conflict, it's not possible to -- for the government to collect data, so we only report downstream results because the upstream results aren't reliable.

MODERATOR: Thanks everyone. I appreciate it.

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