Mark R. Dybul On HIV/AIDS Generic Antiretrovirals

Special Briefing
Office of the Spokesman
Washington, DC
November 1, 2007

Ambassador Mark R. Dybul, Coordinator for the President’s Emergency Plan for AIDS Relief (PEPFAR) On the Impact of Generic Antiretrovirals on HIV/AIDS Treatment Programs

AMBASSADOR DYBUL: Good afternoon. We actually have a series of slides that are available for those who are interested in them, but rather than run through a slide series, I thought I'd just give a quick briefing and then take any questions you might have.

We're here to actually talk about a specific part of the President's Emergency Plan for AIDS Relief. I think everyone's aware of this initiative as the largest international health initiative in history dedicated to a single disease, dedicating over $15 billion to achieve prevention, care, and treatment goals. One of the essential pieces of expanding in a national way, for national coverage of prevention, treatment and care, is a supply chain.

So early in the initiative, this was identified as a challenge to work and support host countries to develop supply chain systems so that their programs could be the most effective possible. And I think the most important part about PEPFAR is that we are fundamentally supporting the systems of the countries in which we work. This isn't the work of Americans or others; it's the work of the Africans, the Asians, and people in the Caribbean themselves.

So in terms of the supply chain system, we actually competed for and were pleased with an award to a supply chain management system, our SCMS, partners from this country, from Africa, from around the world who are coming together to help support the building of supply chains. And their principal work is to strengthen existing systems; build local capacity; leverage best industry practices; importantly, negotiate bulk procurements, which we'll talk a little bit about; promote transparency; develop transparent and accountable systems; collaborate with in-country and international partners; and ultimately, the whole purpose of all this is to create a sustainable supply chain.

One of the important points I want to make is that the supply chain is not just for antiretroviral drugs. We're actually building a supply chain for many things that are needed for HIV/AIDS, including testing kits, laboratory equipment, drugs for opportunistic infections, drugs for sexually transmitted diseases, drugs for palliative and home care, tuberculosis, medical supplies, reagents, computers, everything that's needed in a supply chain.

As I'll talk about in a little bit, we also have to build warehouses and many other things, but this is not just about HIV/AIDS. And in fact, by building these supply systems for HIV/AIDS commodities, well over a hundred, we're building a supply chain system that's being used for everything else for the health system. So we're really building a supply health -- a health supply system.

I want to begin in -- on the specifics, because I think it's a topic that is of greatest concern, talking about our strategy for reducing the price of antiretroviral therapy. We've said from the beginning that we'll procure the lowest-cost drugs that are proven to be safe and effective regardless of where in the world they're produced. Part of our supply chain management system is to procure the lowest-cost medicines. One of the principal ways we do this is by pooling procurement, consolidating multiple orders to buy in large volumes; that's the principal means, but also procuring generics wherever possible, wherever they're demonstrated to be safe and effective and are part of a national strategy. We only purchase products that are part of a national program.

A couple of examples, which we're happy to provide you: through the bulk negotiating of power that we have, Efavirenz, one of the most commonly used products in first and second-line therapy through SCMS, comes at $12 per pack price, versus more than $15 per pack price through the WHO global price reporting mechanism. 3TC/Lamivudine, we get for $3 versus $7, more than $7 through the World Health Organization system. A combination 3TC and d4T or 3TC and Stavudine, also a very common product in first-line therapy, we get for $2 rather than $2.25; Nevirapine, $3.40 versus almost $6.

So you can see how this bulk purchasing is actually saving resources. And in fact, if you look at cost savings in a couple of places, for example, Rwanda, when -- these things sound like pennies and dollars, but when you add them up to hundreds of thousands of people, they actually cause great savings. So one order alone in Rwanda, we had a cost savings of 23 percent, which allowed us to -- which would actually provide resources to treat an additional 3,000 people. In Cote d'Ivoire, we had cost savings of over a million dollars compared to earlier purchases by using generic products.

These are just a couple of examples of what we saw in the last quarter, the last quarter we reported through the supply chain management system, where 90 percent of the antiretrovirals purchased through that system were generic products, for a savings of around $108 million. So this method that's being used to purchase greater quantities of generics and other antiretroviral drugs through these pooled mechanisms is saving money. And that savings is then translated into enhanced services.

I think it's important to know we're not just doing antiretroviral therapy. As I mentioned, there are many other products that are being purchased through this system. I just want to mention one other: test kits. Testing is one of the most essential pieces for HIV/AIDS. It's an entry point for prevention, treatment, and care. If people don't know their HIV status, it's very difficult to have effective prevention programs and you certainly can't begin care and treatment without it.

And these three components -- and actually, when you think about it, the -- when the history of global health is written, the emergency plan will be remembered, I think, for two things: the size of the initiative and its emphasis on results with those resources, but secondly, the integration of prevention, treatment, and care. So test kits are actually accounting for an increasing level of our procurement, increasing from around $390,000 in quarter 1 of 2004 to almost $4 million in this last quarter of the -- of this past year. So you can see the incredible increase that's needed.

Also, as I mentioned, we're building health systems and part of a health system is actually laboratory supplies, and again, we've seen an increase from around $76,000 overall lab supply over the same period of time to about $3.2 million. So you see these health systems strengthening, processes being built.

Now as I mentioned, we're building a supply chain; we're not just procuring drugs. And through a very innovative approach, we're actually developing hubs around the subcontinent of Africa. Three hubs have been created so far. Regional distribution centers, RDCs they're called; these regional distribution centers have been created to stock and supply products so that they can be rapidly deployed and be deployed in a cost-effective and rapid way. This is good because it helps reduce our price because the products are there and able to be shipped quickly. But it's also important because it can help to avert stockouts.

Unfortunately, we don't yet have the type of supply system that we have in this country or in Europe. And so we need to have some default mechanisms when supply systems fall short. Just a couple of examples: in Cote d'Ivoire, through these mechanisms, we are able to avert a stockout for $6.3 million in antiretroviral drugs. And actually, by purchasing through this mechanism, we saved $1 million from the original purchase price. So not only did we avoid a stockout; we saved resources.

In Mozambique, there is a stock -- there is a potential stockout of antiretroviral drugs. And through the Regional Distribution Center in Kenya, we were able to supply and fill that need. In Zimbabwe, there was a threat of a shortage of test kits, which is a very important, again, piece of what we would be doing in the overall program and we were able to fill that stock through the South Africa RDC or Regional Distribution Center. In Zambia, we almost had a stockout of antiretrovirals and again, through the Ghana RDC, we were able to fill that.

So the supply chain management system is building local capacity for supply chain systems not only for HIV, but for the health system. Could show you pictures -- I don't have them here -- of the warehouses that are being built, the refrigeration systems, the computer systems, the logistics systems, the communications systems to build a full supply chain that builds a health system. We're reducing prices by purchasing generics and by bulk procurement. And I think importantly, and this is the last point I want to make -- and by doing all of that, actually avoiding stockouts.

But the last point I want to make is this is part of a global collaboration. There are many players in the field right now, including the Global Fund. The American people supply 30 percent of all of the resources to the Global Fund currently. Every grant that goes out the door, whether it's TB, HIV or malaria, comes from the American people. And so we work closely with the Global Fund, the World Bank on a coordinated procurement mechanism.

We are also working with them on forecasting. In order to have an effective supply chain, you need to forecast appropriately. We're working with nongovernmental partners, such as the Ecumenical Pharmaceutical Network, which is very active in Africa. We have public-private partnerships to address the needs of children working with both generic and innovative pharmaceutical companies. And we're working closely with the World Health Organization medicine and diagnostic service, global price reporting mechanism, so that we can all work together on this initiative.

So we are part of a bigger whole, but the American people are doing its part to ensure that we have an effective supply chain which not only promotes the bilateral program of the Emergency Plan, but contributes to the larger whole, strengthens the health system in-country, which is our ultimate goal, to save lives. And again, we have slides available. For people that are interested, we're happy to share them. They'll also be posted on our website, if people would like to look there. I'd be happy to answer any questions.

MR. GALLEGOS: Lambros, do you have any questions?

QUESTION: Ambassador Dybul --

MR. GALLEGOS: Could you identify yourself and who you're with?

QUESTION: Oh, yes. Lambros Papantoniou, Greek correspondent of the Greek daily newspaper, Eleftheros Typos, Athens. Ambassador Dybul, have you see the HIV virus in the laboratory?

AMBASSADOR DYBUL: I've seen -- under a microscope, yes, I've seen photo -- electron micrographs of the virus. Yes.

QUESTION: And where and when?

AMBASSADOR DYBUL: Oh, they're all over the place. They're published in virtually every journal. I have a picture of one in my office.

QUESTION: Do you have to report any progress and cure of this deadly disease?

AMBASSADOR DYBUL: Unfortunately, not. Cure is a word we don't use in HIV/AIDS. We use treatment, lifelong treatment. Like many diseases, chronic diseases we're not able to cure, whether it's diabetes, hypertension, this is a chronic infectious disease which we can treat, we hope lifelong. We don't for sure yet, but we hope lifelong so that people live normal life spans. And in the clinics I actually still attend up at our National Institutes of Health, we're actually dealing with regular diseases now as people are living very long times -- 10, 15 years with antiretroviral therapy. But we don't have a cure. When we have a cure for HIV it is quite likely that we'll cure cancer because HIV is a retrovirus that puts itself into our human cells. Many infectious diseases live outside of cells and so we can get -- access to them relatively easily. To get rid of HIV you actually have to kill human cells much like cancer. So when we cure HIV and when we -- we will at some point have such a scientific advance, we'll be able to cure a lot of other things as well.

QUESTION: Ambassador Dybul, how do you allow U.S. doctors to prescribe this AIDS (inaudible) medication since they never saw the AIDS virus, as you say that is a part of (inaudible), but only pictures on the internet?

AMBASSADOR DYBUL: The reason we can do it is the evidence is overwhelming that HIV exists. We have pictures. We have budding virus. We have the virus itself. We know what its inner workings look like through crystallography. There's a lot of things you can't see under a microscope that we -- a standard microscope -- you have to use high-powered technology. You need technological advances to see it, but we can see it. The data are overwhelming that it's transmissible, and the data are overwhelming that drugs that interfere with its replication lead to healthy patients. So from every standard of clinical medicine, it would be immoral to not use it.

QUESTION: And the last one. How is your cooperation with South Africa since President Mbeki is rejecting the drugs therapy there?

AMBASSADOR DYBUL: Well, that's actually a myth. This year, South Africa -- the South African Government will dedicate in the neighborhood of $800 million to fight HIV/AIDS. They are supporting -- the South Africa public health sectors has the largest antiretroviral program in the developing world, over 250,000 last time I saw people receiving antiretroviral therapy at the direction of the Government of South Africa. We support the efforts of the South Africans, not only the government but in the nongovernmental sector. And they have rapidly expanding -- expanded services in the last several years.

QUESTION: Otherwise, do you communicate direct with President Mbeki?

AMBASSADOR DYBUL: Well, you know, I'm at the level of an Assistant Secretary of State so I don't talk to President Mbeki. But I do meet with the Minister of Health. I meet with presidents in other countries. South Africa is a big government and he has a lot of responsibilities. But we do meet regularly with many of the secretaries or ministers in South Africa and many of the deputy ministers at the regional, provincial and all other levels. And we see great commitment on the part of many of these people to combating HIV/AIDS.

MR. GALLEGOS: Thank you. One more question.

QUESTION: (Inaudible.) Thank you. I have -- may I ask two more questions? It's very important.

MR. GALLEGOS: Sure.

QUESTION: Yeah, Ambassador, do you know how many infected persons in the United States have taken the medications, stop them later, and they are living today?

AMBASSADOR DYBUL: I don't know.

QUESTION: What is your data?

AMBASSADOR DYBUL: I don't know. We do actually have data on people who have stopped drugs and there are actually two randomized control trials that looked at -- and this another reason it's clear that HIV is causing these -- causing all these deaths and sickness. I actually did some of this work myself at NIH, where we thought for a while if we stopped antiretroviral therapy, we could actually stimulate the immune system. So randomized control trial was done to do just this. And what they found is that there was -- there were so many more deaths in the stop arm that they had to stop the study and put everyone back on therapy. So that was one randomized control trial.

There are several others that I conducted myself that showed morbidity and death as a result of stopping drugs.

QUESTION: And the last one, Ambassador Dybul, how -- do you know how many infected persons in the U.S. never have taken the medications and they are living today from the 1980s up to the present?

AMBASSADOR DYBUL: Yeah, there are very few. Now, almost all diseases are a bell curve, infectious diseases, where on the ends people die or never get disease and then everyone's in the middle. This disease is actually unique in that less than 1 percent of people have been documented to be infected do not get sick or die over a 10 to 20 year period, which is the course of this disease. It's a chronic infectious disease. So this is actually more deadly than -- and atypical than almost any other disease and the reason is it actually attacks the immune system. It attacks and destroys the system that's designed to keep it from killing you. And so this disease actually kills at a slower rate, but kills at the rate of an Ebola virus or another type -- or a very aggressive type of disease because so few people can protect themselves against it because it destroys the very system that's supposed to keep you alive.

QUESTION: Thank you, Ambassador.

2007/956

ENDS

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