Aug 24, 2007
V 35 Issue 34

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Dr. Anthony Fauci, NAID director, White House advisor talks to SGN
Dr. Anthony Fauci, NAID director, White House advisor talks to SGN
NAID director, White House advisor sits down with SGN - Rare interview with three leading minds on HIV/AIDS by Robert Raketty - SGN Staff Writer

Global researchers, clinicians, and specialists convened on Seattle this week to examine an entire spectrum of issues in HIV vaccine development and deployment. More than 900 people from 47 countries attended the AIDS Vaccine 2007 Conference, which concluded on Thursday.

The Seattle Gay News sat down Monday, August 20, with three of the attendees; all doctors who share a passion to end the scourge of the Human Immunodeficiency Virus (HIV), the virus the causes AIDS, upon the world. They have each spent decades researching or reporting on the virus and agreed to share their knowledge and insight in a rare group interview high atop the Sheraton Seattle Hotel and Towers.

Dr. Anthony Fauci oversees a $4.4 billion 2007 fiscal year budget as the director of the National Institute of Allergy and Infection Disease at the National Institute for Health. He has been credited for expanding the agencies HIV research capacity. He continues to run a productive research program at NIAID, where he also serves as chief of Laboratory of Immunoregulation.

Dr. Lawrence Corey is the principle investigator of the HIV Vaccine Trials Network; head of the University of Washington's Virology Division; head of the Fred Hutchinson Cancer Research Center's Program in Infectious Diseases; professor of medicine and laboratory medicine at the UW; and infectious disease attending physician at Fred Hutchinson. He also was the chair of the AIDS Vaccine 2007 Conference in Seattle.

Dr. Lawrence Altman, a staff writer at the New York Times since 1969, is one of a select few full-fledged medical doctors working as a full-time daily newspaper reporter. He also writes for Science Times and is a published author. In addition, he is clinical professor at New York University Medical School; Master of the American College of Epidemiology and the New York Academy of Medicine; and a member of the Institute of Medicine of the National Academy of Sciences.

The doctors offered their frank assessments about the history, impact and potential threat of HIV/AIDS.

Seattle Gay News: Dr. Fauci. In the early days of this epidemic, do you feel enough was being done to address the problem?

Fauci: Well, it really depends on what you mean by the early days. In the very early beginning, in the summer of 1981, when the first cases of pneumocystis pneumonia were reported in five Gay men in Los Angeles, this was something that was clearly not fully appreciated among leaders of the country and, certainly, not among the general population. In some respects, understandably so, as to what the potential impact of this disease would be. I wouldn't say it was an epidemic; there were only a handful of cases. Then, over a period of months, including four weeks later when the [Morbidity and Mortality Weekly Report (MMWR)] on July 4 reported that 20-plus patients with capa sarcoma pneumocystis, that it became clear that this was beginning to be a serious problem.

Then, in a series of reports over the next several months, I think it was during that period when insightful people would say we have really got a problem here and Dr. Altman, who is here, is the earliest one reporting, among the classical standard media, about how this was progressing in our minds to being something that really needed to be addressed. In those early days, I think, there wasn't enough openness and discussion about what potential risks were. The research agenda; it was tough to get that jump started in months because the cycle of funding is usually and year and half ahead. So, it took about a year and a half to get money to jump start the situation-to get people interested in the science of it-- before HIV was actually discovered. Probably, if you want to talk about the criticism during those early years, was the lack of leadership on the part of the political apparatus in our country of, even, admitting that this was the beginning of a problem because I think things could have moved a little faster. Once they did start moving, the really began to move.

If you looked at the NIH budget, it literally took off to the point now where it is 2.9 billion dollars, which is 11 percent of the NIH budget. So, nobody can argue now that not enough research money is being put in. Although you could say there is not enough because, as a researcher, the only time you have enough is when you solve the problem and we haven't solved the problem. But, it is a substantial amount. People could argue that it might actually be disproportionate. Briefly, to get to your question, I think, in the beginning, it could have been a lit bit more quick than it was.

SGN: Dr. Altman. You have been reporting on this for many years. I wondered if you felt if the tactics of groups, such as ACT UP were productive, in your opinion?

Altman: I guess you would say that any time activism leads to focusing attention on something, yes, that's helpful. But, I'm not sure all of the tactics that were used were that helpful and some of them may have even been counter-productive. I think as Dr. Fauci has outlined, in the early days no one knew what we were dealing with. In New York State, state health officials were not convinced that it was a virus, going back to the days before the virus was discovered. They made the case that it could have been a drug and or a toxin. The New York State health commissioner, his background had been in the love cannal, naturally he was thinking in terms of the things you had done. So, until what was presumed to be a viral infection was shown to be a viral infection, there was a lot for which you could conjecture, but you couldn't be specific about. That part was hard to cover. Trying to convince people of the epidemiology findings that it wasn't contagious personal-to-person, except through sexual contact, blood, blood products, or mother to child transmission; people still refused to go to Greenwich Village or places perceived to have a number of employees who were Gay. They perceived themselves to be at risk just from eating at the there, which wasn't the case. I think what Dr. Fauci was saying is also true. There was a lack of precise definition of what health officials were saying from the epidemiology stand point and body fluids. They weren't very helpful without being more specific and that led to some confusion.

SGN: Dr. Altman. Because it was seen as a "Gay disease" early on, do you believe this played a role or, initially, hampered the response of the government and medical community? Altman: I am sure it was a factor, but whether it was the factor, I don't know. Many people, in the beginning, didn't believe it was a viral infection, regardless which part of the population or sub-set of the population was affected. There were people who said it was very small numbers and, therefore, didn't mean anything. They got proved wrong. Forgetting whomever, it is a disease that is clearly spread in the heterosexual population of the world. Nobody, in the beginning, could have foreseen that we would be in the position that we are today. If they are [saying that they did], I have never seen anything that they said at the time to document what claim to be saying now.

SGN: Dr. Fauci. Would you like to comment on that?

Fauci: I agree completely with what Larry said, but there was another area of it that was very difficult. The explosion of the infection in the Gay community in the early years, year and subsequent years, was devistatig to the community but there was a tremendous ambivalence in the Gay community about admitting that there was a problem. They had just recently, within the last several years, gained their ability to freely express their sexuality following the Stonewall Bar riots in New York City were they said, 'Enough of this prejudice and disenfranchisement from society. We want to do our thing.' So, it was difficult to get people to realize that the very essence of their sexuality and the practices they fought so hard to be able to freely engage in was the very risk that was causing all this. It was very difficult then. So, yes, the government, because this was in reality a disenfranchised group, did not do as much as they would have done it had been a bunch of 25 year-old girls in a private high school or college. That's a different story. But, there was also people like Larry Kramer, who was one of the ones that berated the Gay community very vehemently during those early years for not getting out there stepping to the plate to help themselves and, then, they finally did. They galvanized and were one of the great forces of the realization of the difficulty of the epidemic and the things to do about it. They played an important leadership role. But, in the beginning, it was very ambiguous. There were some segments of the government who didn't want to admit it was happening, then, there was some elements of the Gay community who didn't want to admit it was happening. It was very interesting period in '81 and '82.

Corey: Unfortunately, it is repeated by every government still today. Stigmatization is never a good thing, whether it be the social aspects of it or the medical aspects of it. Stigmatization of HIV continues worldwide and what you saw happen in the United State in the 1980's continues to occur in every country throughout the world. There is a stigmatization that goes with HIV infection. It has been very difficult to counter act; it leads to problems in implementing and diagnosing treatment and therapy; it leads to problems in identifying who is infected. Ninety-nine percent of people who are infected are A-symptomatic. It leads to the problem of control. So, one can see the same issues being played out world-wide, unfortunately.

SGN: Dr. Fauci. You worked for the government during ACT UP early years of activism, do you think that swayed anyone in the government level?

Fauci: Oh, absolutely. I think Larry put it well. A lot of what they did was very productive, both in their confrontational nature to get attention. Sometimes, they over did it. They got more attention than they needed to get to get their point across. But, the confrontive aspects of it, I think, served the purpose of getting attention. They got my attention early on and I started dealing with them very early on. I think that it is bit interesting, historically, that scientists are a bit prudish; the sacrosanct nature of science. No one can tell scientists how do science. They, for the first time, really in a forceful way-people have done that intimately for years, but never is such an organized way-brought up the point that they needed to be part of the decision making, both clinical trials and the regulation of approval of drugs since they were the stakeholders.

It was different from other diseases in which you have two or there, five or ten drugs. We had nothing in the early years. So, the idea about how you configured a clinical trial to maintain scientific integrity of the trial while still doing the ethically correct thing of making the drug available to people who had no other options-that was one of the things-the famous parallel track. The other was re-looking at the time it takes to approve drugs for life-threatening diseases when there is no other options available. So, I would say the Gay activist community played a major role-in a positive way-in getting scientists and regulators to re-think and re-look at the very rigid approaches that they did. In fact, we did do clinical trials that gave us the answer at the same time we made the drug available to people who had no options.

So, the idea that if you violate the sacrosanct nature of the clinical trial, that you will never get your answer is not correct. I was very impressed early on because it was the theater, as Larry said, that turned people on: dressing kind of funny and putting on theatrical gimmicks, such as smoke bombs or lying out in the street. For scientists, that was extremely shocking. That is not neat and proper. Instead of listening to what they were saying, they were completely put aback by the theater of what they were doing. I had the opportunity to kind of read and listen to what they were saying. If you kind of screened out the theater, a lot of what they were saying was making a lot of sense. Once people got passed the theater, then there was a good dialogue back-and-forth between the establishment and the Gay community.

SGN: Dr. Fauci. You serve as an advisor to both the White House and the Department of Health and Human Services on global AIDS issues. I wondered if you felt that enough was being done to combat the issue world-wide?

Fauci: I think, over the last few years, there has been a quantum leap over what has been done. With the President [Bush]'s Emergency Plan for AIDS Relief (PEPFAR), an original $15 billion five year program now up to $30 billion, now extended another five years; the Global Fund to Fight AIDS, Tuberculosis, and Malaria; private foundations, such ad the Gates Foundation, the Clinton Foundation... I know a lot is being done. Is it enough, quite frankly, no, it isn't enough. That in part because, I know, there are some partners, particularly in developed nations that have not really put in their share, number one. Number two; there's been, in some nations, a serious lack of leadership at the level of the host country of what needs to be done.

I think the problems that we have seen in South Africa are a very good example of that lack of leadership. In taking a long time and, even now, not yet approaching HIV with the seriousness it needs to be taken. There was an initial denial; the same kind of denial we have been talking about but with a different twist. In China, a long time went by before they admitted the problem of the blood contamination as well as the problem sexual, hetero and homosexual, transmissibility and injection drug use. So, there's a lot of things that are being done, but there is still a lot more that needs to be done.

SGN: Dr. Fauci. Are there other areas of the world, in addition to African and China that you mentioned, which concern you?

Fauci: The whole world concerns me. The developing world concerns me because if you look at the curves, they are still out of control. There are 4.3 million new infections each year, 2.9 million deaths. A statistic that is quite troubling is that for every one person you put on therapy, six people get newly infected. Every day that goes by we are getting worse and worse with the numbers game. So, treatment, although is necessary, is not the final solution. The final solution is prevention. So, I worry not only about the developing world, in which you have this acceleration of infection. I worry about the developed world. In the United States, we have a very embarrassing number.

We have 40,000 new infections each year. It's been 40,000 for the last 15 years. That is absolutely unacceptable. It went way up in the 80's to 150,000 new infections yet it went down to 40,000 and has stayed at 40,000. So, we are not cracking that 40,000 number. Even in a country like the United States, we are not seeing it go down linearly. So, I see a problem in the developing world and the developed world.

SGN: Dr. Fauci. How does political will in Washington, D.C., affect your efforts?

Fauci: You have to have political will for leadership. We have been very fortunate because we have a Congress with bipartisan support of HIV/AIDS generally over the years. You have presidents who in different manners and forms have done very well as far as HIV, including the current president who started the PEPFAR program. Clinton, he did a lot. He has been criticized for some of the things he didn't do. The first Bush, H. W. Bush, got away and broke away from the almost silence of the Reagon Administraition. So, I think, throughout the political scene, both houses of Congress have been supportive and the Administrations have been supportive.

Right now, unfortunately, we have a flattening of the budget both for the NIH and CDC over the last four or five years. It is unprecedented to have so many years in a row with a flat budget. So, if you look at the AIDS budget, its flat. That is not good when you have the opportunities that we are going to be talking about at this meeting: the vaccines, interventions and new drugs. To have a flat budget is very constricting.

SGN: Dr. Corey. I wanted to ask you about what you're doing and what role Seattle plays in the HIV vaccine research effort?

Corey: Well, Seattle is a pretty central place with respect to the HIV vaccine field. First of all, the HIV Vaccine Trials Network is centered in Seattle. Of course, it is a global network that is supported by the National Institute of Health, specifically, Allergy and Infectious Disease. That is a network that is in 10 countries, four continents, and involves 29 clinical trial sites. It really is sort of a conduit to developing and the platform to rapidly evaluate, in the clinical trials, candidate HIV vaccines. It has sort of created a scientific community in Seattle that is interested in vaccines development. There is no question that the Gates Foundation-when Gate gets up there and made the analogy that it is the most cost effective technology in all of medicine-are a big proponent of HIV vaccine development, which is a relatively new program. They have really put money into global vaccine development, whether that be Malaria, TB, leishmaniasis or various other diseases. So, that has created, in our biomedical community, a very directed approach to vaccines, which is frankly a tough area.

I take Lipitor that lowers my cholesterol by 40 percent, costs $1,100 a year and I have to get an SEOT test once a year. If I developed a vaccine that cost $1,100, had 40 percent efficacy and everyone would have to have a blood test; they would laugh me out of the [room]... Yet, it is making $13 billion a year. Every vaccine sold to mand-kind, up til this year, the papilloma virus will take it above that, the total consumer of all vaccines is about $12 billion a year. So, there is one drug versus the entire vaccine portfolio. So, it is a harder area to get people to work in. There is longer times and the scientific bars are higher. But, we have been able to sort of create a community in Seattle that says, 'Hey, vaccine development is something we should be working in and base our scientific community.' So, we are pretty active in a lot of areas, but that has sort of been an area of emphasis.

SGN: Dr. Corey and Dr. Fauci. What excites you about HIV vaccine research and its potential as a long term solution?

Fauci: I think the keyword to that question is potential. If we get a vaccine that is a good vaccine, it will be a major, major advance in prevention... We have to be careful. It would unlikely be the sole way that you prevent infection. Unlike other vaccines where once you take the vaccine you don't have to worry about any of the other risks, with HIV--even if we get a very good vaccine--we will have to continue to practice risk reduction and risk avoidance. But the role of vaccine in prevention is absolutely critical. If we get a good vaccines that prevents infection in a substantial portion of people, then, I think we will take a quantum leap in our preventive efforts globally and domestically. That is the reason why we are very excited and energized about a vaccine, even though it has some of the toughest scientific problems we have had to face in any discipline.

Corey: I don't think we have ever been able to handle a sexually transmitted disease and get it to the point where we take it from 40,000 [infected people] to 400 without a vaccine. That is not saying that we should be doing every preventive approach that we can, but-from a biomedical point of view, when you look at the biology of this with A-symptomatic acquisition, A- symptomatic transmission, sexual transmission-to really control this; to really take it to the levels that we are with Polio, Measles or Rubella, we have to are going to have to develop a vaccine now. Again, when you make that statement, you want be a little bit careful of how people perceive that. I am not minimizing all the other things that are being done, from microbicides to antiretrovirals and all the other vaccine approaches. But, when you really want to look at it from a global point of view, to say we have to take 4 million infections a year down to 4,000 infections a year; I actually can't imagine that any other technology can do that.

SGN: It seems like HIV vaccine research has become an academic endeavor where the government or foundations are funding these small groups of scientists. What can the average person do to help you all come to a solution?

Corey: We have had incredible support from the Seattle community in enrolling people in our clinical trials. It is important for people to know that clinical trials are the part of this enterprise that makes this thing work. Eventually, it has to have community understanding to do this. There aren't any stealth HIV trials of anything and that is both within the United States and world-wide. So, involving community and understanding the need for it, essentially. If you look at the people who enroll in clinical trials, they are in a very high degree some way affected, ether personally or their loved ones. In some fashion or some part of their community is affected by this epidemic.

So, we do need our community, as well as the global community, to understand what is trying to be done. We need both community understanding and community involvement in medical research. In fact, that's the activism in the '80's has lead to; some understanding on the researchers part, the necessity to get the community involved. Hopefully, there is understanding on the community's part that we actually need their help, otherwise we can't accomplish this mission.

SGN: Thank you all very much for your time.

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