Summit Documents

Background Briefing by a Senior U.S. Administration Official on Health Issues
International Media Centre, Savannah, June 9, 2004, 11h00

SENIOR ADMINISTRATION OFFICIAL: Thank you very much. I’m going to take this opportunity now to give you a briefing on some of the G8 Summit health issues, but also to provide a little background that led up into these initiatives that are now being discussed and implemented vis-à-vis decision-making here at the G8 Summit. It’s fundamentally around the issue of HIV/AIDS, but I will, towards the end of my formal presentation, before I take questions, also talk a little bit about the initiatives on the eradication of polio.

Starting off with HIV/AIDS, there are a number of elements that are involved regarding the treatment, care and ultimately prevention and development of an HIV vaccine. The burden of HIV/AIDS is now well known to most people who are informed a bit about the terrible health crisis that’s faced globally.

There are about 40 million people living with HIV, about two-thirds of which are in the developing world of sub-Saharan Africa; about 95 percent are in individual countries that have low or middle income.

If you look at the numbers as shown on this particular PowerPoint, as are mentioned the range is in between 36 million and 46 million, with five million new infections in 2003, and three million deaths due to HIV/AIDS. Those are really astounding numbers that have surpassed in their magnitude what had been projected years ago in which some people said that the projections were over-inflated. We’re seeing now, in fact, that they’re not.

As I mentioned just a moment ago, 95 percent of these individuals are in low and middle income countries, and about 2,000 new infections per day are in children under the age of 15 years, with a total of 14,000 new HIV infections globally daily in 2003. And, again, if you look at the demography of that, about 12,000 of these 14,000 are in young people age 15 to 49, and 50 percent of them are women. So this is a problem of extraordinary magnitude.

One of the great scientific and public health triumphs in the developed world has been the development of what we call Highly Active Antiretroviral Therapy to treat directly HIV infection, which has really transformed the life expectancy and the ability to lead normal lives of people with HIV infection in the developed world. It is very clear that this has markedly transformed death rates and morbidity.

This is a list – and you don’t need to worry about the list – I just show it to show you the magnitude of the accomplishment of the 22 now antiretroviral drugs, or anti-HIV drugs that have been approved by the FDA and that have been available, again mostly in the developed world and only recently now is there availability through a number of programs that I’ll very briefly outline for you in the developing countries.

This is an important slide, because it shows you the disparity in availability of coverage of adults with antiretroviral therapy. As you can see, in the Americas, for example, 84 percent of the as-estimated needed – 250,000 people who need antiretrovirals are getting it, 210,000. In Europe it’s less so.

But look at Africa, which is what we will focus on for the next couple of minutes. Only about two percent of those individuals have gotten antiretroviral drugs in 2003, and that’s something that obviously is a main focus of how we’re going to change that through a number of programs.

If you look in the United States as a prototype of the success, you see on this slide that the newly-diagnosed cases in the red triangles and the deaths in the blue diamonds have dramatically gone down in the mid-’90s when triple-combination antiretroviral drugs were available, the circles, the blue circles that continue to go up in 2002 are due to the fact – and that’s people living with AIDS – is that there are new infections in the United States, about 40,000 per year. So as the deaths go down and the newly diagnosed cases go down, the people living with HIV go up.

This is a very important advance that has been available in developed nations such as the United States, Canada and Australia, Western Europe, et cetera. If you look, then, at what the response to that and this is a picture that we took in Durban, South Africa in July of 2000, in which the same sort of community activism that asked why not have drugs available for people in developing nations such as in South Africa, Uganda, Kenya and other countries that are suffering terribly, brought the first focus on the fact that the stumbling blocks were what we called lack of infrastructure and the very high cost of the drugs.

But what happened over a few years is that the cost of the drugs remarkably came down and we began to examine whether existing infrastructure would be amenable to the actual distribution and availability of drugs to people in developing countries; things that were in some respects, thought to be a foregone conclusion that it could not happen.

Well, in fact, President Bush, in the spring of 2002, sent Secretary Tommy Thompson of the Department of Health and Human Services with myself and a number of other individuals on a mission to southern Africa to a few countries to take a look at some of these questions of feasibility of what we as the United States could do, and globally what the world could do, and we came back and reported to the President that there were a number of opportunities that he was very interested in.

He immediately initiated, back in June of ’02, the President’s program on mother-to-child transmission, a $500-million program. But at the same time as he initiated that, he asked me and other members in the Department of Health and Human Service and his White House staff of what can we do even more than a mother-to-child transmission. And what about other areas in which we can take a very aggressive proactive approach with HIV/AIDS.

And that led to what was announced in the State of the Union Address in January of ’03 when President Bush announced the Emergency Plan for AIDS Relief, which I believe some of you, if not many of you, are familiar with, which is a $15-billion program over five years that is aimed at, engaged at preventing 7 million new infections, treating 2 million HIV infected people, and caring for 10 million HIV infected people, orphans and other vulnerable children.

This is a program which is the largest single-directed public health endeavor literally in the history of the United States with that much money – $15 billion over five years. The program, if you examine some of the details of it briefly, is $9 billion to new programs in 14 countries, 12 in sub-Saharan Africa and two in the Caribbean, with a 15 th country soon to be added shortly, and this now is under the auspices of Ambassador Tobias of what we call the PEPFA program, the President’s Emergency Plan for AIDS Relief, $5 billion to approximately 100 nations, and our bilateral programs that are already going on, and $1 billion over five years for the global fund. So there’s going to be $10 billion of new money there.

And rather than do it in the way in which we would impose Western standards, what we did was we embraced African individuals, people who are in positions, health authorities, to look in Africa as to whether or not this element of infrastructure is something that we could use low-tech, already-existing and supplement it a bit, build it up a bit, and try and do it the African way in which we can help them with a supply of drugs, namely having central medical centers as they had in Uganda. And when the President announced this in his State of the Union Address, some of you may remember Dr. Peter Mugyenyi was there in Washington as part of the back and forth that we had when we were putting the plan together and when the President was making his decision to endorse it, and then to have primary and secondary satellite organizations.

We went back to Africa to take a look at that, and this is a picture that I took with one of the young women, a 21-year-old woman who was part of the network that had gone on in Uganda in which we’re standing in front of her motorcycle, and this is her in her motorcycle taking us and we’re now about four and a half hours outside of Kampala, literally in the bush. We stopped, got out of the jeeps and then went in Land Rovers and she with her motorcycle, and this is the example of one of the individuals in the villages who has been and now will be, continue to be receiving drugs on the President’s emergency program. So it is something that is on the ground and working.

The actual roll-out of the President’s emergency plan vis-à-vis the appropriations that now in Fiscal ’04 was in February of this year – and this is a slide of Secretary Thompson together with Secretary Powell and Randy Tobias of the Coordinators’ Office, as well as the internuncios of USAID.

Already, the disbursement of funds has now begun, and in fact, as of the last tally, which was just a short time ago when we checked with Tobias’s office, there have been about $340-plus million that have been disbursed by the Office of the U.S. Global AIDS coordinator. So the program is already launched and the money is being disbursed.

We’re doing it through, as part of what we call “track one” our Catholic Relief Services, the Elizabeth Glaser Pediatric AIDS Foundation, Harvard School of Public Health and the Mailman School of Public Health who have in-country facilities there for the disbursal of that, and then we’re going to, in the second phase of it, make sure we get to the even secondary and tertiary.

What will this disbursement of funds do? The first round of funds, we plan to have an additional 50,000 people in sub-Saharan Africa and the Caribbean who are going to be receiving antiviral therapy, and within days of that disbursement that I mentioned, resources were put to use, for example, in eastern Uganda to deliver antiviral drugs to families in their homes by motor scooter. And that’s why I showed you that picture of that young woman who was actually going into the bush delivering. And then that was in Uganda.

And within a couple of weeks of that disbursement, the first people in a slum in Kampala receive antiviral therapy through a faith-based center, and within a few weeks adults and children in rural Kenya and then now of the 21 antiretroviral programs funded, 19 of them have finalized their plans and drugs are being ordered for multiple sites.

So this is a program that’s working.

Also, of importance – and I’m telling you this as a background, because this leads up to another phase of what’s going here at the G8 – there’s the Global Fund for AIDS, Tuberculosis and Malaria that we’re familiar with, which is a partnership between governments and civil society, the private sector, affected communities to increase dramatically the resources to fight these three very important diseases.

Dr. Richard Feachem is the Executive Director and Tommy Thompson, Secretary of HHS, is the Board Chairman.

This slide here shows that of the $5.3 billion that has been committed to the global fund – and that’s the amount of commitments that I’m going to show you – commitments, contributions and disbursements, and that’s where sometimes the numbers get confusing – the commitment is over $5 billion. The United States has committed $1.96 billion, or about 37 percent of that total. The contributions is $2.549 billion – and again, of which the United States – you see there are other countries that are very actively involved there. So this is a global effort, to be sure, with a number of countries in Europe, Japan, Italy, et cetera, Canada and others who have been involved in this $2.549 billion contribution, and the disbursements now by region, as shown on this particular slide, is about $348 million thus far. So we have a number of programs doing things that were thought to be impossible.

Now, again, as the same way that President Bush told us after the mother-to-child transmission that we need to go further and get adults treated – and that’s why you had the $15-billion President’s Emergency Plan – at the same time as we were doing that, he asked, can we do something about prevention and vaccine development. And that’s really quite problematic, because vaccine is a very difficult, from both the scientific standpoint and the idea about coordinating with people who are involved.

So clearly, it’s a critical element of the effective control of HIV globally, and it is clearly, at least in my experience at The National Institutes of Health developing a number of vaccines, it’s certainly the most important and difficult scientific challenge for reasons of the very special nature of the HIV virus.

The United States has invested in the science and in the logistics of clinical trial networks. In ’04, about NIH, about $467 million – if you add the Department of Defense, it’s $488 million in ’04 for HIV vaccine development. And we project that in ’05, it will be $533 million. That’s a substantial, vast majority of all the money that’s spent globally for HIV vaccine development.

These – and you don’t need to know these – these are just shown to you as a spectrum of the number of vaccine strategies that are being pursued. You have with vaccine a pipeline of products that go in, and you have the clinical trials that need to be done. There have been a number of clinical trials of products that have gone from pre-clinical in animals into humans for safety, and then looking towards going to what we call phase II and then ultimately phase III efficacy trials.

The problem has been is that there is not a lot of activity over the past couple of years of things that have actually gone into the efficacy trials, because although the candidates may seem promising in their early phase, we actually need to have a global coordinated effort to take a look at that, so that if the people in different countries do different things, the information is easily transferable.

And with that in mind, we have, for example, a number of networks that the United States government supports, either through the DOD, the CDC or The National Institutes of Health. So we have the availability of that, but we wanted to see if we can do something that will be in a much more coordinated fashion.

One of the ways that one can do this, for example, is on the NIH campus in Bethesda we have a vaccine research center, which does everything from the basic research up through and including the clinical trials, a critical mass of intellectual capital as well as facilities. And this is a model that’s working really very well.

Well, a year ago this June, in ’03, a group of scientists got together and we published a paper in science called “The Need For A Global HIV Vaccine Enterprise,” and what we meant by that enterprise – and this was scientific-driven, this was a group of scientists that got together – was the possibility of doing things in a coordinated way and essentially have a virtual consortium to accelerate HIV vaccine development by things like coordinating, sharing information and collaborating globally.

We met – and these are an international group of scientists, these are not just scientists from the United States, despite the fact that most of the resources would come from the United States – this was input from a large group of scientists, we met at Airlie House in Virginia, right outside of Washington, and we thought about the possibility of accelerating the development of an HIV vaccine by forming this alliance of multiple independent entities that are really joined by what we call “moral commitment to participate in the execution of a global strategic plan.”

We put together a group of individuals who formed working groups to look at things like vaccine development, product development, manufacturing, having laboratory standardization so we all agree upon the kinds of things we’re going to measure. “We” being the global scientific community. What about regulatory aspects or what have you.

There were about 150 scientists that were working on that from 12 separate countries. Again, this is something that attracted the attention of the administration and of President Bush who asked the staff to put together a proposal for the G8 for a vaccine enterprise. And let me explain what it is, because the strategic plan that is going to be called for by the G8 here in Sea Island will be calling for the enterprise which is the development of a strategic plan that’s a global strategic plan that would do several things: encourage the development of coordinated global HIV vaccine development centers that are very similar to the center that we have on the NIH campus, but to have it globally throughout the world.

It could be a virtual center of bringing people together who are intellectually bound, not necessarily in the same building, or actually a center that is a center similar to what we have at the NIH, to stimulate the capability of dedicating vaccine-manufacturing capacity, because the vaccine industry is very fragile. We’re not sure whether or not they’re going to be able to handle, if we have some red-hot candidates who need to have scale-up manufacturing to do phase I, II and III clinical trials.

We want to be able to have standardized laboratories so that if someone does something in England or Japan or in Africa that it’s usable because we’re looking at the same thing. How about expanding the international clinical trial system. I showed you that map of what we have in the United States with the U.S. government and globally in Africa, Asia and other countries, what about bringing together in a network the very good clinical trials networks that other countries have.

How about harmonizing regulatory authority so that if someone does a trial in the United States, it can be usable, the data in the regulatory capacity in Europe and vice-versa, and in Africa versus Canada and what about getting greater encouragement or engagement by scientists from developing nations. And that’s the strategic plan that was put forth by the President that is being embraced here in Sea Island by the G8. And I think it’ll be a very important way of bringing together in that commitment to that strategic plan and accelerate our ability to develop a vaccine.

And on this slide, we show, again, the fundamental things that we spoke about, that the President spoke to us about a few years ago when we were talking about what kind of initiative we could have with HIV it involves everything. The treatment that we spoke about in the PEPFA and the global fund, prevention would not only the kinds of prevention programs that are going on, but also vaccine development and ultimately care.

I just want to spend the last couple of minutes of the formal discussion just on some background on the global efforts to eradicate polio. Many of you are aware that this has been, globally, a very serious, important problem before the development of a safe and effective polio vaccine in 1955, when the Salk vaccine, the inactivated polio was used and in 1963 the live attenuated Sabin vaccine was used. The last wild poliovirus in the United States was in ’79.

In 1988, the World Health Assembly launched what we referred to as the PEI, or the Global Polio Eradication Initiative, and in 1994, the Western Hemisphere was certified to be polio-free. But the goal of the Eradication Initiative has been now, by 2005, to have the total global eradication of polio the same way that we totally – “we” the scientific global community and public health community – eradicated smallpox decades ago.

The United States efforts since 1988 to 2005 towards this global initiative in which many countries have been involved as shown on this slide where there was a pledge of contribution of almost $1 billion, $981 million, including $180 million for ’04 and ’05, also was a participation in an aggressive way with other countries in the goal to eradicate polio by ’05, by bilateral assistance and pledging and dealing with other countries.

This is a pie chart showing the global efforts, and there are many, many groups, both private and governmental, that are involved in addition to the United States. There’s Rotary International, there’s the World Bank. There’s – you can see in the light blue the U.K. and a number of countries – Germany, Canada, France, et cetera, et cetera – so it truly is a global program.

There has been a funding gap, which I’ll get to in a second, in that in ’04 and ’05 it was felt that there was a shortfall because there was an unexpected and unfortunate exacerbation of the polio spread when we were on a track looking like we were heading towards the eradication, the ’04 gap has been filled, and we hope with the G8 now to have the commitments to fill the ’05 gap and essentially have enough money to continue the vaccinations.

The Eradication Initiative, there are many achievements and there are challenges. The achievements are that there were 125 countries that had endemic polio in 1988. It’s now down to six, as I showed in the previous PowerPoint. The 2004 funding gap has been closed through efforts of a number of countries, including the United States.

The challenges are the six endemic countries that remain. I showed you on that other slide Niger, Nigeria; Egypt, India and Afghanistan as well as the nine countries to which it spread in sub-Saharan Africa apparently from Nigeria. So there was a setback, but there is a true concerted effort now to try and overcome this latest challenge and to fill that funding gap so that the immunizations can continue.

This is that map of the 1988 vs. 2004. An extraordinary amount of progress has been made, but this is something that’s truly a deliverable – that if we can get everyone involved here in the G8, and I believe they will be, to make the commitment to not only close the gap, but to keep that gap closed.

And the Eradication Initiative hopefully will turn these challenges into achievements, as I mentioned, by continual support of the six polio-endemic countries, and urging those governments to continue their commitment towards mass immunization, and on the part of the G8 and other developed nations of the world to have these donors and organizations to continue to support and encourage these countries in polio eradication efforts, which we believe can be successful.

So I’ll stop there and I’ll be happy to take some questions.

Q Doctor, as you know, there’s been some controversy over the WHO’s prequalification project process, and whether those drugs meet FDA standards. Has there been any discussion of whether the U.S. is willing to accept the WHO standards?

SENIOR ADMINISTRATION OFFICIAL: Yes. Again, we have to remember – that’s a very good question – they’re referring to a fixed-dose combination of three drugs that are used in a single pill that the WHO has prequalified. The WHO is not a regulatory agency. We have a great deal of respect for what they have done, but recently, literally weeks ago, the FDA has come out with guidelines that I believe is going to get us around that issue, and that is to markedly expedite the evaluation of drugs that are either drugs that the brand companies will put into a fixed-dose combination or in what we call a “co-packaging” of three separate versus one pill. And given the fact that there’s an enormous amount of data on those individual drugs, that they can get a rapid, within six-week, full approval to be used in the United States or in developing countries.

There’s a tentative approval component of that, which means, for example, the companies that are making the fixed-dose combination, they can get, if they pass certain fundamental issues that we think are very important – like are these chemically equivalent, do they have pharmacokinetics, or is the ability of the drug to get into the body and circulate well – based on that and other clinical data, they can get tentative approval – which means if they go through the steps which the FDA has promised they will expedite – and depending upon what the product is, that could be months or what have you – to expedite that so that if it gets tentative approval it can be used in countries, and even purchased by the PEPFA program, provided it doesn’t violate the individual country’s patent rules. But, example, if a country has compulsory licensure and is in an emergency situation, they will be able to use that. So I think it’s been a major breakthrough on the part of the FDA with their recent guidance to really be able to expedite that. And I think that those are the kind of things that we’re really actually pleased with that we’ve been able to move quickly on that.

Q Just a quick follow-up. Do you know how that will affect cost?

SENIOR ADMINISTRATION OFFICIAL: Excuse me?

Q Do you know how that would affect the cost of the drugs?

SENIOR ADMINISTRATION OFFICIAL: Well, again, the cost of the drugs – the drugs in question – right now the drugs have remarkably gone down. The brand companies themselves are selling it remarkably lower. We can do it with the drugs that are already available for several hundreds of dollars – $500 or what have you. You’ve heard or read about the fixed-dose combination, which they say can go down to even less than $200 – that’s not totally accurate because if you talk about the delivery costs of getting it to the people, it probably is a bit higher than that. But, hopefully, depending upon the lowering of prices by the brand name and the ability of those who are making copies – not generics – copies, which is what the fixed-dose combination is, that if they can get it down to several hundred dollars, I think it’s going to be quite good.

But remember, one point that I do want to make that sometimes gets misconstrued is that the disbursal of funds and the delivery of drugs through the President’s program is going on now anyway. So it isn’t as if people are not getting drugs because of this apparent dichotomy of acceptance of prequalification or not; that’s being worked out through the FDA guidance. But the people are still getting the drugs through the PEPFA program and through the global fund. So I know that sometimes you read that, gee, people are not getting drugs because of that, that’s really not the case.

Q Can you comment any on the bioterrorism measures that were expected to be discussed at the Summit?

SENIOR ADMINISTRATION OFFICIAL: The only thing I can comment is on biodefense issues – of which, at the NIH, the part of the Department of Health and Human Services we’re responsible for – certainly, President Bush has put an enormous commitment into the development of countermeasures in biodefense.

If you look at the amount of commitment just to the National Institutes of Health alone from, for example, fiscal Ô02 to Ô03, it was a $1.5-billion increase for the development of countermeasures such as new vaccines for smallpox, vaccines for Ebola, anthrax, botulism antitoxins, some drugs or what have you. So, the health issue vis-à-vis what we’re trying to do to develop appropriate countermeasures is one of the major health research initiatives that has occurred in years. And in fact, it is probably the largest single infusion of dollars into biomedical research for any individual specific issue that we have, literally, in the history of the NIH. So, it’s a substantial commitment on the part of the administration.

Q Two questions for you. I think you said the U.S. government spending for HIV vaccine research is about $488 million this year?

SENIOR ADMINISTRATION OFFICIAL: Yes, including the DOD, right.

Q Maybe I missed this, but what is the global total for research spending and will there be more money needed to accomplish the goals you laid out in the G8 strategic plan for the vaccine coordination.

My second question is also to do with money. I believe the European Union committed $70 million for polio earlier this week

SENIOR ADMINISTRATION OFFICIAL: Right.

Q – and I thought there was some sort of a gap of $100 million.

SENIOR ADMINISTRATION OFFICIAL: Right.

Q Right.

Q – You mentioned $23 million – maybe you can clear up those figures.

SENIOR ADMINISTRATION OFFICIAL: No, no, that’s a very good point. I’ll get to that in a second. Let me answer your first one.

We have tried – and organizations like IAVI – the International Aids Vaccine Initiative – have tried to get their arms around just what the global commitment is. We have a pretty good idea of what other countries are giving, of what other NGOs are giving. We don’t have a completely accurate idea about what individual pharmaceutical companies are putting in, because it’s very difficult to get precise data from them. But we have a pretty good idea, looking at what the relative commitment that they have for vaccines in general.

The ballpark estimate is that the total, including the U.S. Government, is somewhere between $650 million and $700 million at a high. So if you look at ’04 in which we put $488 million and ’05 in which will be $533 million, we have clearly – the United States – the vast majority of the resources that are going into the vaccine research endeavor. We hope that the alliance, which is really a virtual consortium of individuals, will stimulate not only resources from NGOs and other countries to join us in this effort, but we will also be able and we’ll hear that – this is off the record – that there will be, in addition to what we’re doing – some money that will be put in to have yet again another center that would not be at the NIH, but that would be funded through the standard mechanisms of the peer reviewed process to try and get the ball rolling in that regard.

But if you look at the amount of resources, we would like to see the other countries not only join us in this endorsement of a strategic plan so we could synergize together, but also countries that are trying to align their own resources and say, what can we do in HIV that’s not a silo that’s gone up but that’s part of the big plan. That’s really the fundamental philosophy of the G8 Initiative, is to get an agreed-upon strategic plan.

The point that you make about the gap – you are absolutely correct. The amount of money clearly closed part of the gap. It varies because of – it’s still a moving dynamic target. The gap is anywhere between $20 million, $30 million, and even as high as $100 million or more – it’s very difficult to pin down what that is, and that’s the reason why, in the proposal of polio that the G8 has endorsed that was put before the group by President Bush was that, let’s do what it takes to close the gap, whatever the gap is. If it’s $30 million, let’s close it, if it’s $100 million, let’s close it.

Q Just a quick follow-up. Is that $23 million you mentioned after the EU commitment?

SENIOR ADMINISTRATION OFFICIAL: No, that’s before – no, that was after the EU commitment. The EU commitment took care of ’04.

Q Okay, so the $23 million is remaining after the EU commitment?

SENIOR ADMINISTRATION OFFICIAL: Yes, the $23 million is the ’05.

Q Okay.

SENIOR ADMINISTRATION OFFICIAL: And it might be more than that, you’re quite correct – depending upon what this moving target is. Because remember, we have 6 countries in which it’s endemic, and we have 9 countries to which it has spread from one of those countries.

Q Okay. And you just mentioned, off the record, a second, perhaps, vaccine center. Did you mean in the U.S. or somewhere else?

SENIOR ADMINISTRATION OFFICIAL: It will be going through the peer review system, and most likely it will be – certainly not on the NIH campus, it will be something that likely would be funded. And you’ll hear more about that tomorrow.

Q I just wanted some clarification on the Global Strategic Plan. Does this mean that the G8 are going to put out a declaration of a specific timeframe on how to coordinate these global efforts to find a vaccine?

SENIOR ADMINISTRATION OFFICIAL: Yes. What will happen is that the G8 has embraced this concept of an enterprise. And I mentioned there’s some background for the – this is scientist-driven, as I mentioned – that was that meeting we had – the paper we wrote and the meeting we had last year.

What we’re calling for and what the G8 will be calling for will be an endorsement and an embracing of this strategic plan so that sometime within a period of months that the group will meet that has already been involved in this enterprise and report on a strategic plan that has been developed that is science-driven, and then, hopefully, each year as the presidency goes, like, for example, this year at the United States to

the U.K. that once a year we will report to the G8 country that has the presidency about A, the strategic plan and B, how we are, in fact, endorsing and implementing this synergy and collaboration that will ultimately get us to that goal.

Q Yes, this question is concerning the prevention of the spread of AIDS. I just wanted to know what does education play what role does that play in the prevention and how much is being spent for education in relation to the vaccine research spending?

SENIOR ADMINISTRATION OFFICIAL: A considerable about. In fact, if you look at prevention and look at the President’s program, for example – and there are other prevention issues that are going on in the United States and globally. If you look at the United States, there’s a significant amount of money in prevention. In fact, vaccine is just a part of the major prevention effort.

About – less than 20 percent of the total NIH budget is in vaccine – in my institute it’s about 23 percent. We have a modest amount – at least equivalent to that in prevention. The CDC, the Centers for Disease Control and Prevention, has a substantial amount. I don’t have the figure right on my fingertip what it is in prevention, but if you look at the PEPFA program, the President’s program, that’s in the international global for the 14 countries – again, I don’t want to restrict that to relative proportion, but originally, in the design of this, there was at least 20 percent of that that was going to various forms of prevention, ranging from education, behavioral modification, abstinence programs, condom distribution – the whole gamut of prevention efforts – is an important part of the President’s program.

Q Apart from Nigeria, what would the other countries be where polio is still endemic? I missed that.

SENIOR ADMINISTRATION OFFICIAL: Actually, I’ll get it for you so you can have it here. It’s Niger, Nigeria; India, Egypt, Afghanistan and Pakistan. I have them – let me see if I can get them for you.

Q No, that’s fine.

SENIOR ADMINISTRATION OFFICIAL: Well, I’ll leave it up on the screen for you so you don’t have to rush in your writing.

Q Thank you.

SENIOR ADMINISTRATION OFFICIAL: It’s right there. And those are the countries with the outbreaks through importation – it’s right on the lower left side of the slide.

Q I was wondering if you could clarify something for me. You talked about the global fund and the U.S. contribution and suggested the U.S. contribution was far larger than any other. NGO has been telling me that under President Bush’s plan the U.S. pledge for ’05 is actually a 64 percent reduction on what was spent before. I was wondering if you could clarify that.

SENIOR ADMINISTRATION OFFICIAL: Yes. I really would be happy to clarify that because I think that’s a – somewhat of a misunderstanding about what the global fund, vis-à-vis, the President’s program.

Prior to the President’s Emergency Plan for AIDS Relief, there was a considerable amount of money – and I could show you– I’ll put this slide back up – on what the commitment to the global fund is. When the President made the commitment to spend $15 billion on a bilateral based program – which is substantial; I mean, that is just the boldest, largest initiative that one has in HIV research globally, ever, by far – part of that program, as I mentioned, was a program that would be the $15-billion program, including $1 billion over 5 years to go into the global fund.

So, you know, people say, we’re cutting the global fund – we’re putting $200 million a year for 5 years – it looks like it is “a cut” but it really isn’t. It’s adding on to the totality. So if you look at what the United States contribution to the global AIDS effort, it’s the global fund, but an enormous amount on the President’s Emergency Plan for AIDS Relief, which includes a contribution to the global fund. So rather than looking at us cutting anything, you’re adding $15 billion on to it. Which, again, somehow gets misconstrued when people talk about the balance between global fund versus the President’s program

Q You know when you’re talking about the search for a vaccine you’re emphasizing the need for international global cooperation and coordination. However, in terms of actually caring and treating for AIDS, the emphasis now seems to be on the bilateral approach as opposed to the global fund. Is that the right message I’m getting?

SENIOR ADMINISTRATION OFFICIAL: I’m sorry, I’m not sure I understand what you were saying.

Q The $15 billion announced by the President is on bilateral programs U.S. sponsored

SENIOR ADMINISTRATION OFFICIAL: Right.

Q – with the government as opposed to going for an international approach – a coordinated approach.

SENIOR ADMINISTRATION OFFICIAL: Right.

Q – whereas some critics would argue that African countries would need to know that there is a one-stop shop for them to go to, to get funding for these antiretroviral programs –

SENIOR ADMINISTRATION OFFICIAL: Yes

Q – as opposed to having to look for individual donors to contribute bits and pieces. So I’m just saying, wouldn’t your view be that in terms of actually fighting and caring for AIDS, that the global approach and the global fund would be the better way to go?

SENIOR ADMINISTRATION OFFICIAL: I don’t think it’s appropriate to make a judgment as what is the better way to go. I think – I like to look at it as programs that ultimately, as things start to accelerate in the disbursal of the funds, in the distribution of the drugs, become almost seamless between the two, as opposed to one that’s opposed to the other. I don’t look at it that way. I look at is as multiple ways to get to the goal that we all want to get to.

There’s way that you put money into a pot and it gets distributed and there’s a way that where a bilateral arrangement can be very efficient. I might point out to you – I believe the global fund has done an excellent job, the President is committed to the global fund, Tommy Thompson is the chair of the global fund – they’ve disbursed about $348 million. The PEPFA program has disbursed already $342 million – so they’re both doing a very good job and I think it’s going to get better and better. So rather than look at as if there’s a – going in the direction of downplaying a particular approach, I look at more of the approaches coming together. And I think that’s going to work.

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Source: Official G8 Sea Island site

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