IAS 2007 4th International AIDS Society Conference
on HIV Pathogenesis, Treatment and Prevention
Sydney, Australia
July 22-25, 2007
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Transcript: Fauci Defends Bush's AIDS Legacy

July 22, 2007

In a far ranging interview at the International AIDS Society Conference in Sydney, Australia, Peter Staley talks with Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, about his research on HIV "eradication," President Bush's AIDS legacy, why he likes gay men and Republicans, and that letter he wrote supporting Scooter Libby. Below is the transcript. To see the video click here.

I’m Peter Staley with AIDSmeds.com, and we’re here with Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, the institute that funds and does the bulk of the AIDS research for the U.S. government.

Thanks for joining us, Tony.

It’s good to be here, Peter.

Peter Staley: You’re giving one of the keynote speeches at tonight’s opening ceremonies, and you’ve titled it “HIV/AIDS in 2007: Much Accomplished, Much to Do.”  Can you give us a preview, or an abridged version of the main points you’ll be making tonight?

Tony Fauci: Sure, I picked that title, Peter, because I was reflecting back, in fact, eleven years ago, in 1996, when, following the meeting in Vancouver when we had just begun to see the results of the triple combination of therapy and we were seeing so much dramatic response in people that there was a lot of optimism and almost euphoria about what was going on. And the Journal of the American Medical Association asked me to write a commentary to balance that, and say what have we accomplished in reality but what are some of the challenges? And I did that in that commentary and now 11 years later with many, many more advances that we have, when the organizers asked me to talk about the subject of my choice, I harkened back to the title of “Much Accomplished, Much To Do.” So what I’m going to be doing tonight at the Opening Ceremony is I am going to be talking about, within the context of what we’ve done, what impact it has and what we really still need to do in the three major areas of pathogenesis treatment and prevention. So if you take pathogenesis for example and you look historically—that has served as the basis for much of the decisions and the advances that we’ve made in treatment and prevention—is understanding how the virus works. Probably the classic example of that which I’m going to show is understanding in detail the vulnerable points and the replication cycle of the virus which has allowed us to target, for example, reverse transcriptase, protease, and now, most recently, integrase, also diffusion and binding inhibitors. So that’s a great deal that has been accomplished.

What needs to be accomplished in pathogenesis? Well, we’re starting now over the last two years to realize the importance of early events—from the time an individual gets infected and the virus seeds—we know now that the gut-associated lymphoid tissue is critical to those early events. So you can get damage to the immune system, particularly your memory pool of cells, very, very early on which re-resurrects the question of should we be treating people earlier to prevent that. And what could a vaccine, even if it doesn’t prevent infection, what could it do by blunting those early catastrophic destructive events that occur in the gut-associated lymphoid tissue. So a lot has been done in pathogenesis but pathogenesis is informing us of a lot more that needs to be done.

The second issue that I’m going to talk about is treatment, probably the most important component of AIDS research with regards to results that are tangible. We’ve made spectacular strides with the development of so many drugs that have had such important impact. So what are the challenges? What must we do? We need a continued pipeline of drugs. And in this meeting you’re going to hear discussion of the integrase inhibitors, of the maturation inhibitors, of the fusion inhibitors. Those are very important things that we need to do.

What about access of therapy? We’ve been very successful over the last 3 or 4 years in getting drug to the developing world. Say two or three years ago there were about 100,000 people at most who were on therapy, now more than 2.2 million people, mostly through the PEPFAR program and the Global Fund as well as the Gates and the Clinton Foundations. But what are the challenges that need to be done? If you look at the numbers, even though they’re exciting in what we’ve done, they’re somewhat sobering. Only 28% of the people who really do need therapy, particularly in the developing world, are actually receiving it. And if you do the math that for every one person you put on therapy, six new people get infected, the math is telling us that treatment alone is not the answer.

Which brings us to the final part of my discussion, which is prevention. We’ve made great strides in prevention of sexually transmitted, blood transmitted and mother to child transmission. Even though that’s the case, if you go and examine carefully the accessibility of those proven preventive measures to people throughout the world it’s really shocking. Less than 10 and 20 percent in almost all of them—from access to condoms to access to behavioral changes to access to treatment of mother to child transmission—we need to do much better than that. So the challenge is really pretty daunting on that.

And then finally the issue of a vaccine, which is the last great scientific challenge, and there is much to do in that. We are starting to see we may need to accept, at least initially, somewhat of a modified paradigm of vaccine—mainly a vaccine that doesn’t necessarily prevent infection but that blocks the progression of disease, keeps the viral burst and set point low enough to have the secondary effect of preventing transmission to other individuals.

So going through that list of the three major components, there indeed is much to celebrate but there is an incredible amount to do. And I close by saying something that I feel sincerely. That whenever you come to a meeting and people talk about all the great accomplishments, particularly over the last 26 years from the day we first knew we were dealing with a new disease, as a global society we’re really going to be judged as much by what we do in the coming years than what we accomplished so greatly in the previous years. That essentially is my talk.



We’re going to get back to PEPFAR and discussion of vaccine. First, NIAID had some pretty amazing news this year. One of your researchers, Dr. Tae-Wook Chun, is a lead author of a study that you co-authored looking at the life span of so-called viral reservoirs in the body, and, correct if I’m wrong here, you made the bold claim that if someone started taking HAART soon after they were infected, they could potentially eliminate their viral reservoir within 7.7 years. Can you explain this in laymen’s terms?

Yeah, I think in laymen terms it was probably not said precisely enough that made it a little bit somewhat misinterpreted. What I was saying is that we studied for years assiduously people who had been on therapy who started their therapy years after they were infected. Two things happened to those people: They have a pretty substantial reservoir. So that even when they come in with antiretroviral therapy and suppress the viral load to below detectable levels, the reservoir is substantial. Its decay is a curve that doesn’t look like it’s going to disseminate and dissipate itself for a very long period of time. In addition, the immune system of those patients is damaged so much from the years of having active viremia and virus circulating that even if you did get down to a low reservoir, the immune system probably would not be able to be able to prevent the rebound after you stopped therapy. And we know that ourselves because we did the study where we looked at people who looked like they were having phenomenal control of their virus with a small reservoir, they stopped therapy and the virus came back.

What’s different about the study that we did this past year in the Journal of Infectious Diseases? We followed for over eight years people who had started literally within a few months of the time they were infected. And we waited eight years to go out and take a look at their viral reservoir. And we found two things that were striking. First of all, the viral reservoir was vanishing small—much smaller than we had seen in the people whose therapy was started when they were essentially viremic for years. The other thing is that the curve of the decline was much steeper suggesting that there is a possibility that you may get that viral reservoir so low—and I hesitate to use the word eradicate, Peter, because that’s a word that gets you into trouble.

It’s loaded…it’s cure.

It’s loaded. It really is a loaded word and you don’t want to talk about that right now because that’s not something that we have scientific evidence that we can do. But what we do have more accumulating scientific evidence is that if we can get that viral reservoir so low within a template of individuals who still have preserved HIV-specific immune function, it is conceivable, and that’s really the message, not eradication, but the message is that it’s conceivable that with those individuals when you ultimately stop therapy that the actual residual immune response that you have will contain the virus so that you don’t have to go back and give those people therapy—they won’t rebound. Making them, essentially, similar to the elite long-term non-progressives—people who you can demonstrate they have the virus but for one reason or another they don’t require treatment. That’s the goal.

But there was an accompanying editorial in the journal from Margolis and Nancy Archin of the University of North Carolina and they voiced skepticism about this. They maintained that once therapy is stopped the persistence of only a few HIV-infected cells could lead to replication and reinfection. How do you respond to the editorial?

I respond that we were the ones that proved that that’s the case. I mean, we were the ones that did the study years ago—that got the viral burden low and the reservoir low. And we stopped therapy and it bounced right back. So we’re not talking about eradication. I agree—eradication is something that very likely will not occur. The point we were making is that this study is a little bit different than the study that we did, in fact, a lot different. The one that we did years ago in which people were studied who were on therapy only after having had viremia for years. There’s a difference when you get people very early. Does that mean we’re going to eradicate it? Unlikely. But does that mean we have a better chance of the body’s residual immune response controlling that virus—I think there is a reasonable chance that that’s the case.

Let’s talk about PEPFAR. You and I had a long discussion about it in Toronto.

We’ve had a lot of discussions about it, right?

We just heard from President Bush about PEPFAR 2, which is basically a doubling of the amount of money spent during the first five years. And, for our audience, PEPFAR is the President's Emergency Plan for AIDS Relief. It’s his international AIDS program for treatment and prevention. This was billed as a doubling of his previous commitment—the $15 billion proposed for its first 5 years, from 2004 to 2008.   By any measure, it’s obvious that President Bush has done more on international AIDS than his predecessors. However, some AIDS activists claimed that the announcement was more hype than hope. For instance, PEPFAR’s first five years of spending had a very steep spending curve. It started at about 2 billion in its first year and will end at about 5 ½ billion in 2008. Since we’re almost at $6 billion a year, activists claim that PEPFAR 2 is basically an announcement of flat funding from here on out. Does the President assume there’ll be no need to increase PEPFAR funding each year over the next five years?

Well actually, I think it’s important to point out, Peter, that there are two levels of what we would call victory for PEPFAR here. The first is the anxiety of whether or not it was going to be renewed. Which many of us, myself right at the top of the list, were absolutely adamant that we had to renew PEPFAR. So the very fact that it was renewed for an authorization for an additional five years is a big plus. The point you make is a reasonable point, but really what it reflects is that the originally PEPFAR 1 went beyond what it was originally planned to do because you remember you and I had the conversations in the first year or two of PEPFAR that it was supposed to be $15 billion over five years equal to $3 billion a year. So in the first year or two when it was not quite three people were saying, “Oh, you’re going to underfund it—you’re not going to meet it.” And then when you get to the fifth year, you had almost twice as much in the fifth year as what the average would have been. So the $15 billion program actually turned out to be something like an 18 or 20 billion dollar program.

Eighteen.

Eighteen and change actually.

But wasn’t Congress the driving force for that overshooting of the 15 billion?

Actually, it was in the President’s budget with some modest changes by Congress. So when the President comes and says we’re going to make it thirty, you’re absolutely correct. It isn’t that the second part is going to totally double what the first part is because the first part turned out to be more than what was originally intended. So when I look at, in my way, who is always a cautious optimist, is that A) we wanted to nail it down that it got renewed and it’s renewed. Good news. B) Do I want it to be and think it likely will be more than 30 billion? I think when we get out five years past the 2008 that the cry and the need for more treatment and prevention will move whatever administration and/or Congress is in power in the United States to give more money. So I look at thirty billion as the floor, not the ceiling, of PEPFAR 2.

But Bush won’t even be in office for most of this. Why didn’t he announce a program that would call for annual increases because obviously we’re going to have increased need over time?

You know, I can’t answer what went in the mind of the president except to tell you that it is our hope, and I think it’s a reasonable hope, that we got over the first barrier—it was renewed. A successful program was renewed. It was renewed at more than what the original one was and even more than what the original turned out to be. It shouldn’t be interpreted that over the next five years we’re going to double the amount that we did in the last year of PEPFAR 1. It will double the amount that was originally—it doesn’t come out in real dollars to be double what was in the last year. So I hope as we get to the second, third, fourth and fifth year of PEPFAR 2 we’re going to follow the same trajectory as we did in PEPFAR 1. That at the end of that five-year period there’ll be more than 30 billion dollars. I hope it is the case and I think it will be.

What about the goals though? The stated goal of PEPFAR 1 was to treat 2 million people by the end of the five years—it missed that goal substantially. 1.1…

Uh, yeah. We’re not quite at the end of five years and it’s now 1.1 and the curve is like this so I wouldn’t make a final judgment that the PEPFAR program is going to substantially miss the two million mark.

But the new goal for 2013—six years from now—is 2 ½ million, another half million over the original goal. That’s very discouraging, especially—you just mentioned in your press conference—four million people infected every year. We’re losing ground—the goal itself is basically admitting defeat, that we’re losing ground.

See, I don’t look at it that by putting a goal—saying that that goal means we’re admitting defeat. I look at we’re going to do as much as we possibly can with whatever administration, whatever Congress is there. If you put a goal for 2.5 that doesn’t mean that you shouldn’t also shoot for 4. And I mean the point that I made in the press conference and that I’m going to make tonight is that if you look at what we’ve done, it’s a great accomplishment compared to a couple of years ago. But remember only 28% of the people who need therapy are receiving therapy. My goal is universal. That’s my personal goal and I will continue to push whatever administration and whatever Congress is in there to ultimately get to that.

How’s it going to work though? Bill Gates himself has talked about this a lot—that we’ll never be able to catch up with providing treatment to those that need it, unless we drastically slow the number of new infections each year. It just seems like everyone’s stated goals—the President’s, the G8, the World Health Organization, you name it—are nowhere near what will ultimately be needed to prevent the deaths of tens of millions of people in the next decade. What do we do? Don’t we need something like a Manhattan Project to find a vaccine?

Well we need two things. We need to accelerate greatly, and that’s the third part of my discussion tonight, the issue of prevention. If you do the math, the math tells you you’ll never be able to sustain a controlling of the HIV pandemic by treatment alone. We have got to make a full court press on prevention. And prevention includes a multifaceted approach. We’ve got to implement circumcision. We’ve got to do all of the things on the list. Needle exchange, preexposure prophylaxis—see if that works, do a clinical trial on that—and ultimately a vaccine.

But how can you preach prevention when we’ve never successfully done it even in the United States? Forty thousand infections every year—year in and year out— as long as you and I have been doing this, Tony. And now, we’re trying to tell the rest of the world to get their act together? There’s always going to be a vacuum of leadership. Traditional prevention methods are not going to solve this tide that’s coming our way. A vaccine is probably our only hope.

You’re correct. I think it’s not our only hope. A vaccine will greatly enhance what I would consider the multifaceted approach to prevention because it is unlikely, at least initially and maybe ever that we’re going to get a vaccine that will be a freestanding preventive measure. A vaccine will almost invariably have to be utilized in association with other proven prevention measures. One step that I think was the step in the right direction in the United States to what I call break “the barrier of the forty thousand” and “the barrier of the forty thousand,” for those not familiar with it, is the fact that we have forty thousand new infections in the United States each year for the last fifteen years. That is unacceptable. We’ve got to break down that barrier and the way we’ve got to do it is two ways. 1) The CDC, I think, made the right choice. They said they’re going to make testing an important part of routine care so that you can only opt out—it’s not going to be where you have to go through a very bureaucratic paperwork type of thing to get somebody tested. The reason that’s important is that there are a million people in this country who are infected in the United States. Twenty five percent of them, at least, do not know that they’re infected and of the new infections, the majority of them are transmitted by people who do not know that they are infected. So if we can get to those people who don’t know that they’re infected by a combination of two things: the objection to making it a part of routine medical care is that it’s great for people who have access to routine medical care. The people who are probably the ones who you’re really concerned about don’t have good access. So you’ve got to do two things—you’ve got to make it routine medical care and you’ve got to start targeting the groups that are high-risk groups. I hope, and again we’ve been doing this, both of us, for a very long time and we know that it’s not going to be easy, but I hope with those two issues of prevention we’re going to get down below—way below—that forty thousand.

Finally, Tony, I want to pick-up on a conversation you and I have been having off and on since my days in ACT UP 20 years ago. It’s more a personal line of questioning about your role as a national leader in AIDS research. I remain baffled by the dichotomy of the role you’ve played these many years. On the one hand, you’ve been able to foster and maintain very close relationships with many AIDS activists, many of whom are gay men. Larry Kramer is a prime example.

But on the other hand, your closest political relationships, whether it’s with the various presidents you’ve served under, or with Congress, have been Republicans. The first President Bush famously singled you out as an example of an American hero during a presidential debate. And now the current President Bush tapped you early on for advice and leadership in the war on terror by giving you and NIAID a key role in preparing our nation for a possible bioterrorism attack—the same president that used gay Americans as a political football during the last election and proposed enshrining in the Constitution an amendment that would discriminate against gay Americans.

How do you square all this in your head—your close relationships with gay men fighting AIDS and your close political relationships with presidents like Reagan and George W. Bush?

Well, first of all. If you look at the years since we both got into this from 1981 through the current time right now, the majority of the presidents have been Republican presidents. We had eight years of Bill Clinton and I had as close a relationship with Bill and Hillary Clinton when he was president as I had with other presidents. They called upon me for advice, sometimes they took the advice and sometimes they didn’t take the advice. So what I do, what I try to do, and I think the reason why I’ve been somewhat effective in this, is that I tell them exactly how I feel and what I think needs to be done. For example, the whole issue of getting condoms into the PEPFAR program. There was a very conservative group of people—not necessarily the President himself—who were pushing to just not go near that with regards to prevention and I actually told the president, and I think the relationship that we had over the years, that even though there were things ideologically that I don’t agree with, I said you cannot have a prevention program without having condoms. Period. And to his credit—he heard me, he listened to me and he did it. And it wasn’t just me—there were a number of people that were pushing that but since I had access, I made it very, very clear so the way I look at it is that A) I never compromise my own personal ideals. I never compromise my principles. I go in, I tell it like it is and sometimes they listen and sometimes they don’t. For the most part, the results, I think, have been good because many of the things that have been enacted by administrations and my congress have been things that I fully agree with. Some of the things I obviously don’t agree with and I tell them. And it isn’t just Republicans, because remember, during the Clinton administration I was part of a team that looked very, very carefully at needle exchange programs and I came up with the absolute firm recommendation that needle exchange A) would not increase the illicit use of drugs and B) would prevent HIV infection and yet the administration did not accept federal funding of needle exchange.

But it had a full conversation about it though. We haven’t heard a peep out of President Bush about needle exchange. Are you talking to him about that?

Oh, I say it every meeting I go to—I push needle exchange every slide I have.

We still have a ban on doing prevention targeted to gay men that’s been in effect as long as you and I have been around.

Exactly. And I disagree with that. I tell him that, but I don’t get my way all the time, Peter.

Forty thousand new infections every year and we don’t make any progress domestically.

And I disagree with that approach. And I’m vocal about it.

You know I’m a very political animal, so I have to ask this question. I was surprised to hear that you were one of 174 individuals who wrote a letter of support for Scooter Libby...

Right.

...before his sentencing for perjury. And this is going to circle back to HIV, trust me. Did Libby or the Vice President’s office ask you to submit a letter?

Scooter Libby asked me to do it and let me tell you the circumstances that he did. During the buildup of the bio-defense program there was a lot of debate as to whether the 1.5 billion dollars should go to the scientists that are funded by the NIH or they should go to the Department of Defense or the Department of Homeland Security. Scooter Libby was one of the individuals who was very helpful—he came to me and said what do you think the best science would be done by and I said the best science would be not necessarily to just target making a countermeasure against this bug or that bug or that one but to enhance the whole science of how we handle emerging diseases. He was extremely helpful in getting us the money to spend well scientifically and he was extremely helpful, for example in helping to draw up legislation that would expedite the NIH’s ability to move quickly by hiring people under certain authorities, so he really was very helpful, not necessarily agreeing or disagreeing with any of his ideology. As an individual in the administration, he was helpful to the NIH. When he was convicted and found guilty, it is very common for the defense to call upon people to make statements in letters as to what they know about the person and good things they may have done as the defense pleas for mercy. So he asked me. He said, “Could you do this for me? Could you write a letter and just explain how I helped you and the NIH in something that was beneficial for the country. I don’t want you to comment at all on your opinion of whether I’m guilty or not. I don’t want you to, in any manner or form, confront the decision of the judge. I don’t want you to question the jury. All I want you to do is to just write a letter explaining what it is I do,” and if you go on the Internet and you look at the letter, that’s exactly what I did. And it was Scooter himself—it wasn’t the vice president, it wasn’t the vice president’s office. He personally called me up and asked if I could do it. I asked for permission from the ethics offices if I could do it and they said, “Fine, you can do it.”

In that letter, one of the quotes was that you thank "the office of the vice president which took a keen interest and was extremely helpful in bridging the gaps between basic and applied research, production of countermeasures and acquisition of the actual products" in relation to the stockpiles that were needed for Project BioShield.

What did you mean by “the acquisition of actual products”?

The acquisition I am referring specifically, Peter, to the fact that Scooter Libby and the Vice President helped get the legislation called Project BioShield. There was a great stress on the resources of the NIH because we were doing the research to develop the products. The companies were refusing to partner with us because they did not have any guarantee that the products will be purchased or acquired once it was developed. What Project BioShield did was put aside several billions of dollars to guarantee for the pharmaceutical companies that if they partnered with us to help develop the product there would be money there to buy it even if it was never used because the companies were very concerned—they put all of this developmental research into getting a new vaccine for small pox or a new vaccine for Ebola or what have you and then nobody would want to buy it. What Project BioShield did was say, instead of putting the burden only on the scientists to help develop it, let’s get the companies to feel more confident that there will be acquisition of the product. That’s what I meant. I was referring specifically to Project BioShield.

This is how it brings back to HIV. So they were not involved with helping you to get VaxGen, a firm with a troubled history in HIV vaccine development, a contract for producing Anthrax vaccine?

No, not at all. No we had nothing to do with that. Project BioShield is a certain amount of set aside money that is not administered by me or by the NIH. It’s administered by the Department of Health and Human Services where contracts are let to purchase for the stockpile. You write a contract, if you don’t put the product in the stockpile, you don’t get any money for the contract. So VaxGen, although the contract was written for 877 million dollars, they didn’t get the money because they didn’t come through. It was a failed attempt on their part, but it wasn’t 877 million dollars thrown away.

You weren’t involved at all with the awarding of the original contract with VaxGen?

No, not at all.

I thought NIH was…

No, no, we supported research. We were totally uninvolved in the acquisition component of it. We did research to help to do the concept proving that this type of a vaccine would work. But we were not involved in any of the acquisition. We don’t do acquisition. We do research.

Do you still feel burned, like many activists do about how VaxGen handled the NIH grant...?

Unfortunately, the money that we invested in the science went to naught with them because they just didn’t come through in a way that would make the research get ultimately translated into a product. But that’s the chance you take when you do research. But we didn’t acquire anything with them—we didn’t give them any money for acquisition.

Who handles acquisition?

The Department of Health and Human Services Office of Public Health Emergency Management.

So you had nothing to do with it—Libby had nothing to do it with it—even though you talked about product in the letter.

No, the thing that Libby had to do with, Peter, was that he helped to get the legislation through that would ultimately get set aside money that would be administered by the Department.

Well, thanks for letting me ask some questions out of left field as I always do. I hope it won’t be my last interview.

No, I don’t think so, not at all.

And thanks and good luck at the conference.

Thank you.

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