News Conference: Tuesday July 9, 2002

JUSTIN MALEWEZI: Okay, good morning. We are going to present the second plenary of the conference. The title of this session -- the plenary session was Prevention Strategies in the 21st Century, and as I tell you the first day, the plenary sessions have been organized that today we’re focusing on prevention issues. And I’m very happy about this session because it has been bringing forth some of the messages that we have been discussing in previous days and because prevention means that everything which will help the prevention -- prevention of infection given the exposure to providers we have included here, from biological aspects to behavioral and to community aspects. So, we have a range of speakers who are targeting different fields, which I’m just going to announce here.

First, Dr. Helene Gayle, Director of the Global Program on HIV and Antiretrovirals from the Bill Gates and Melinda Foundation, and also a Director of the Global Prevention Group, have addressed on (MS?) covering most of the absence of prevention and thinking about the challenges for prevention in this century, and in particular in liaison with the antiretroviral treatment.

Secondly, Lawrence Corey, head of the Program of Infectious Diseases of the Clinic (MS?) in Seattle, has been covering issues about preventive vaccines and not only immunilogical and biological issues, but also policy-related issues regarding the agenda of research and possible preventive vaccines.

In this conference, we wanted also to highlight antiretrovirals use issues, since in South Europe that has been the main driving force of the epidemics and is very important now in Eastern European countries as well. So, we asked Kasia Malinowska to talk about antiretrovirals uses and she has made a presentation on that called “From Consent To Action: Addressing HIV and Drug Use.”

And finally, Suniti Solomon, who is -- let me read it for you -- the Chairperson of the Advisory Board of Trauma Care Consortium and also the Chairperson of the Indian Centers of Community Health, has been addressing issues related to woman and its role in the context of prevention.

And finally, we are very happy to announce that in this session we have come with the (MS?) and with the support of two politicians. First, Mr. Shutavan Synajah, who is currently the Health Minister from India. And also the General Director for Drugs and AIDS of the Department of Health of (MS?) here in Barcelona and (MS?).

So, we’ll follow this order. I have asked the speakers to make a very short summary of the key points of their speech and then we can open the floor for questions. So, Dr. Gayle?

DR. HELENE GAYLE: Thank you. It’s a pleasure to be here with you this morning. In my talk, what I tried to highlight were a few important points. One, that there is a lot that we can do today now to make a huge difference in reducing the number of new HIV infections. The current estimates are that 45 million new infections will occur over the next decade. However, if we were to scale up at a larger -- much larger scale, the existing prevention strategies that we know work, we could avert 29 million new infections, or decrease by almost two-thirds the number of new infections that will occur over the next decade. So, there’s much that we can do today, now, using the existing prevention of strategies like information, particularly information to young people, school-based information programs, access to condoms, treatment of other sexually transmitted diseases, voluntary counseling and testing, etc., all of the things that we currently know work. And we also know that these things are tremendously cost effective.

In addition, there are many things that are going on -- research that is occurring that will expand our prevention options. Research into better treatment for STDs, including STDs like herpes simplex virus, long-term viral infections that haven’t traditionally been treated as part of the prevention strategies, access to other female-controlled barriers like perhaps diaphragms or female condoms. More work doing on circumcision that has for a long time been a risk factor for transmission and now work is being done to look at the actual effectiveness of this as an intervention.

And finally, in terms of the realm of new ways in which we may be able to increase our prevention options, I discussed a range of uses of antiretroviral therapies, post-exposure prophylaxis, new studies that will be occurring looking at using drugs, antiretroviral drugs as a pre-exposure prophylaxis. And then looked at some of the other issues around a current use of antiretroviral therapies for treating people with HIV and what some of the challenges to prevention because of the treatment optimism or complacency that has set in and particularly in rich countries where there’s wide access to antiretroviral therapies, and we started to see increase in risk behaviors and even increase in HIV infection as a result of that. And discussed the importance of balancing and maintaining a strong focus on prevention all the while that we’re scaling up access to antiretroviral therapies.

And then, finally, just highlighting the points that we have lost a lot of time in terms of scaling up and providing the adequate resources for prevention, and there have been many predictions already that show that we have – we have lost time by not being vigorous in our commitment to prevention. But all the data suggests that the sooner we start in scaling up our efforts and making a commitment to prevention, the sooner we will have the impact of slowing down the rate of infection with these things that we currently have today as we develop these new interventions, including vaccines, microbicides and the other things I’ve mentioned.

JUSTIN MALEWEZI: Thank you. Dr. Lawrence Corey, please?

DR. LAWRENCE COREY: Well, I tried to review a rather complex topic today with respect to HIV vaccines and gave several messages that I would like to highlight. Number one, is that there has been progress being made in a sort of new generation of vaccines that induce cytotoxic T-cell responses that we think are important in killing HIV viral infected cells. Now, these vaccines work somewhat different than the vaccines that you’re traditionally used to thinking about and actually prevent you from getting infected. These vaccines work a little bit later and are -- really appear to be directed at controlling viremia and decreasing the viral load so that transmission could be reduced, as well as reduce the time for AIDS. This also means that these vaccines need to be developed within the context of continued prevention and treatment strategies. They are very much complementary to the kind of programs and issues that Helene has outlined in her first talk.

Also, one needs to recognize that what we’re asking in HIV vaccines is really also, I think, somewhat very different than what is done in other traditional vaccines, is that we are asking the -- we’re actually developing HIV vaccines on a global scale, requiring both local cooperation and coordination involving countries in the Southern Hemisphere in HIV vaccine research much earlier than traditionally has been done trying to put together consortiums of global scientists and global communities in developing and conducting clinical trials of HIV vaccine.

This raises a number of questions and issues and probably one of the areas that I’m happy to answer questions about and I hope I do get questions about, is the tackling of the issue of country-specific or what is called Clade-specific vaccines. There is increasing evidence to show that in natural infection as presented by researchers at this conference earlier, sub-Saharan Africans had as good T-cell responses to vaccine strains that circulated in the United States and Europe as North Americans and Europeans. The vaccines that we’re talking about actually do elicit what we call cross-Clade immune responses, and so I think we need to start looking at the issue of -- as we move these scientific issues at the sign that says that country-specific vaccines and Clade-specific vaccines may not be necessary, but the policy issues that go with this are discussed and debated and understood. And I’ll stop there.

JUSTIN MALEWEZI: Yeah, Kasia Malinowska, who I think I noted before was -- is the Director of the (MS?) Society.

KASIA MALINOWSKA: Thank you. Good morning, everyone. It really is a pleasure to be here with you. I’ll just give -- try to quickly summarize the points I was trying to make in a speech. Well, first of all, we have another region with a massive increase of HIV and I think that was clear in the presentation that was given tomorrow at the plenary, and that region is next door. It’s right here. It’s Eastern Europe with one million estimated injecting drug users infected with HIV and in Russia and in Ukraine we have 1% prevalence. And that is the only country in the European region that, in fact, has 1% prevalence. Western Europe responded quickly enough to avert that, to prevent that. And then an important point about Eastern Europe is that those who are mostly affected by the HIV are (MS?) and injecting drug users. So, again, massive epidemic of injecting drug use, massive epidemic of HIV that followed.

And another issue that I just wanted to highlight is that drug trafficking routes from Afghanistan through Central Asia and the former Soviet Union are also fueling the problem. So, the economic dislocation, the unhappiness that people are now struggling with, all of this comes together, merges together to fuel a very serious HIV epidemic.

What’s disappointing for someone who has done work in our region is that all of you and all of Western Europe and all of the West celebrated with us 12 years ago when we overcame Communism. And now, we feel very much left alone to address the social consequences, the health crises that are -- that are experienced by pretty much all of the countries of the region. So, I think this is something that we would really wish changed and there was a lot more support coming from the more developed countries.

Repressive drug policies are something that we are unfortunately embracing as people are being put to prison for even the smallest amount of drugs found on their bodies. The policing is very repressive, very, very damaging and that clearly - that clearly has implications for HIV because those people are afraid to admit that they’re drug using. They’re afraid to go to needle exchange sites. They’re afraid to act to services and HIV spreads among that population very, very rapidly.

We know what works. We know what works because we have amazing examples from (MS?), from other parts of the world. We know that methadone and replacement therapy in general works for those who are ready and want to use it. We know that needle exchange works. And there are, in fact, quite a number of small initiatives throughout the region, people who are setting up needle exchanges, people who are setting up methadone programs, but that in no way is enough to stop this very, very overwhelming tide of an HIV epidemic.

In terms of HIV treatment, I wanted to -- I wanted to mention a report that was -- that was publicized yesterday, put together by the Eastern European Harm Reduction Network. This is a very, very important report, because it clearly tells us that drug users have no access to primary care and drug users have no access to antiretroviral therapy. So, in a country like Russia where you have 900,000 infected injecting drug users and there is no care for them, I think we’re all heading for a major social disaster. And again, I would hope that there is a lot of support to those who are already implementing Harm Reduction policies and to those who are addressing HIV treatment and need for drug users. Thanks.

JUSTIN MALEWEZI: Thank you, Kasia. Dr. Solomon?

DR. SUNITI SOLOMON: I’m not used to all these lights and the press. I’m more a person working in the field with patients, so this is a new experience altogether to me. And I had to talk on empowerment of women in prevention of HIV, which I’m sure you all know how difficult it is. So, in my short talk, I started with a story of one of my patients, a young girl of 17 and how she got infected because of her marriage. And so, how do we empower women, more importantly in developing countries, is what I tried to do in the short time I had.

So, I started with the social cultural issues where even from birth, you know, girls and boys are treated differently, which I think should be stopped and they should be brought up together as equals right from the time children are born. I think that is one of the ways we can prevent HIV infection and empower girls right from the day they’re born and there is a lot of difference in the way children are brought up, not only in India, in most of our developing countries. So, that is what we find. Children or girls are infected ten years earlier than men and this is very obvious in African countries. So, how do we change the gender norms of the unequal balance of power between men and women? Can we educate women and you think that will solve the problem? Not really, because what is literacy and what are we talking about? We need to change, to give them the skills and the information, which is much more important than giving them a degree in a college. It doesn’t really empower women.

The other thing I spoke about is the violence women face. For example, some of the statistics I had from the progress of South Asian women -- every 34 minutes a woman is raped, every 42 minutes a woman is sexually harassed because the food is not tasting good, and every 93 minutes a woman is blamed for some problem she had in the household. You know, unless we stop that, we cannot empower women. And we need to get this information to the women in time, reach it in time before they get infected.

I also addressed on my success total responses, which is necessary and that is the success story of Thailand and Senegal. I spoke about transforming power relationships to equalize the power between men and women and how women should be represented in all the - whatever the political and leadership to enable -give an enabling environment. For example, in India, we are trying to bring in a Reservation Bill for women, so that they will be -- have representation at least at 33% in the elected bodies, and I’m sure this time it will go through.

And the next one is economic independence. If women start earning, will they just be empowered? No. You can earn, but the money, how we spend the money is decided by the male in most of these. And then I was talking about protection of women’s property and inheritance. I was talking an example from Zambia where when a husband dies, a woman can cry only with one eye and with the other eye she has to look at her property, her home, her children and ways it will be grabbed. That’s known as “property grabbing.”

And then I spoke about options to be given to young girls and boys, you know, not of only of abstinence. Many of the countries because of their culture talk about abstinence, but we should give them options because of the changing cultures in different countries. This is very important.

The next way we can prevent infection to women is to give them access to health care, you know, to have cost-effective services, have timings in the clinics which are more suitable for women, so that they can finish their work at home and then get to. And the stigma attached to STI and HIV is very high in most of the countries. Unless we remove that and incorporate or integrate STI/HIV treatment in the family welfare, we will not be able to. I also spoke on the burden of care in poverty and sect workers. You know, we have a shining example in India, the (MS?) program of Calcutta. And then the unavailable promises of technology (microbicides, female condoms) but how many women in developing countries can ask their men to use them, allow them to use a female condom when even if they know the man has been to multiple partners.

You know, these are some of the major problems I discussed, and finally, I ended with trying to compare our family to a bull cart in India, where if you want to balance, both the wheels have to be balanced. Similarly, a man and woman have -- should have equal power if you want the family to be really successful. And that’s what was my talk was about.

JUSTIN MALEWEZI: Thank you. Mr. Synajah, you want to add a few remarks?

SHUTAVAN SYNAJAH: My name is Shutavan Synajah and I’m the Union Health Minister of India. I’ve just become the Minister only last week, but I’m here representing the government of India. We are here for knowledge and to go back with commitment for the action on the war footing. India has the second-largest community of HIV/AIDS patients. The situation is very alarming. Almost 4 million people are suffering from HIV/AIDS. We understand the gravity of the situation and we are doing our best and we intend to do our best when we go back.

We have also -- we have technology that our pharmaceutical companies have done some dramatic -- have achieved some -- have achieved dramatically in terms of low-cost drugs compared to international/multinational prices. There’s 11 companies manufacture in India are producing low cost, preventive medicines, and to support them, we have also waived the custom duty, import duty and excise duty. We are also going for training of doctors on national use of antiretroviral drugs. Though the prices are lower comparatively, these drugs are not still affordable because India is a poor country. Since India is a poor country, we’ve also got other things, other varieties. So we -- our main focus is on prevention -- prevention of course we are not –- we are not going back on the treatment, but prevention is the main focus.

I also (MS?) our offer of hosting in India the XVI International AIDS Conference. Also, I have been inviting the Health Ministers of SAC and Southeast Asian Countries for a conference, so that we can go about it, or we can fight against the disease in the best possible way. And fighting against AIDS is also fighting for the rights of the AIDS’ patients, fighting for their equality, liberty, for their dignity. I also firmly believe women of India that quality of life tomorrow shall be different than the quality of life today. Thank you very much. This is Health Minister of India, Shutavan Synajah. Thank you.

JUSTIN MALEWEZI: Thank you. Dr. (MS?), a few remarks?

UNIDENTIFIED MAN: [Presentation made in Spanish.]

[CUT IN AUDIO]

[QUESTION/ANSWER SESSION]

UNIDENTIFIED MAN: -- For companies, (MS?). It is something that has worked from this rather than maybe investing in pharmax or retrovirals or drugs for AIDS. And I would address you, if it is not -- if that has (MS?), you know the progression of the attention of the vaccine that we have now at this moment?

DR. LAWRENCE COREY: As I said in my talk, when we look at vaccines as a technology, it has been the most cost-effective technology from a public health point of view, but if you actually look at the dollars per investment from a business point of view, they actually come out very poorly and this is actually universally seen in the pharmaceutical and biotechnology industry in which the amount of effort and research that goes on in HIV -- in any vaccine, but certainly in HIV vaccines was just miniscule.

My own particular laboratory, which works on a general herpes vaccine, has almost as large a group that is working on many -- as a large pharmaceutical company working on a HIV vaccine. That’s not commensurate with the importance of developing an HIV vaccine. Now, this has been recognized five to six years ago by both nongovernmental organizations, as well as governments, and public funding what the economists call “push mechanisms” to try and essentially induce pharmaceutical companies to engage in HIV vaccine research is what is occurring. And if you actually look at most of the pharmaceutical research that is being done in pharmaceutical or biotechnology companies certainly in the United States and Western Europe, it’s actually now being funded by grant mechanisms through public foundations, either through the government or a lend organization like IAVE.

So, vaccines still do very poorly. When you look at the economic realities of it, and the paradigm that has to be, is that the public sectors need to understand this and create the incentives in order to provide the resources, to provide the scientific personnel and to recognize that this is still a very difficult process. Frankly, the pipe -- the ability to manufacture vaccines even if they -- once they get to come out into clinical trials is still a very significant problem in the whole vaccine field. So, this is not something that has been solved.

UNIDENTIFIED MAN: (MS?). Can I ask about -- two questions about Eastern Europe? First of all, whether you have any projections for the track which the epidemic is likely to follow over the next 10, 20 years in the region if it is on track? And secondly, to what extent a growing epidemic in Eastern Europe presents a threat to Western Europe as well? Particularly, I’m thinking of through the biotech industry.

KASIA MALINOWSKA: Well, what we do know about the epidemiology of HIV in our region is that the HIV epidemic in Russia has been doubling every year for the last three years. And if you look at the numbers of estimated drug users and the number is now around 4 million people in the region, we are still a long way to go before -- before there is a saturation point. And obviously, we are now already seeing those who are becoming HIV infected through such rural contact with drug users. You know, it’s hard to predict where is it going to go. I don’t think we ever expected Africa to look as dramatic as it does now ten years ago. But all the -- unfortunately, all the socio and human factors are in place for a major, major disaster.

What implication does this have for the rest of Europe? Well, I think we’re seeing how HIV spreads from one country to the other very, very quickly and Poland is a country that actually has managed to keep an HIV epidemic in check. But now, their next-door neighbor, Ukraine, is so -- has such high levels of infections, I’m sure they’re going to start noticing that their -- that the border areas are also increasingly more infected -- tech industry but also drug industry. Drugs travel and there are quite a few studies that have shown how drug trafficking follows -- how HIV follows drug trafficking routes. So, you could look at Central Asia, then you look at Russia, and then you look at drugs coming into Western Europe. My assumption is that we’ll see that sort of follow also, so drug use affects us. And then, I think, the more -- the longer we wait it will be HIV among the hetero population.

UNIDENTIFIED WOMAN: My question is for Dr. Corey. (MS?) from America, “Washington Post.” Can you elaborate a little bit more on the mechanisms of action of the new drug generation of vaccines you’ve found?

DR. LAWRENCE COREY: Vaccines that are being -- that are really entering clinical trials now are mainly aimed at inducing what we call the T cell response to HIV. Now, this all came about from a series of observations that were started five to seven years ago when one recognized that it was the cytotoxic T cell response that occurred very early after acquisition of HIV, which we called primary infection. And it was these cytotoxic T cells that were associated with dropping viral lode from very high levels to small levels, and it was also shown at that time that long-term non-Progressors had very high cytotoxic T cell responses to HIV. That was seen by scientists in vaccine development, and then there became a concentration in seeing if we could, in effect, develop vaccines that would induce these T cell responses. And these kinds of vaccines generally are made either by, again, using combination vaccines, at the moment using DNA usually as a priming and following it by the use of some virus that carries the HIV gene into cells. So, we call these viral vector vaccines.

So, these combination DNA viral vector vaccines are what is being seen in the animal models and what comes out of early clinical trials that are making these T cell responses. And they are making them at the levels that we usually see vaccines that are effective, that work -- that are effective that work. And the other advantage of T cell vaccines is that the side effects of T cell is directed at more conserved parts of the HIV -- HIV virus and, therefore, these T cells that you induce by vaccination not only kill strains of Clade B, but also kills viral infected cells that are Clade A, or Clade C, or Clade E, or as this epidemic continues, re-combinant virus. I mean, the one thing we’ve learned as the epidemic continues, is that the virus is always making new strains, and so one of the issues in vaccine development is to try and come up with vaccines that will be more universal in their scope, because the virus, frankly, is always going to be able to move ahead. And that -- these vaccines offer that potential.

UNIDENTIFIED WOMAN: Dr. Corey, further towards what you were just talking about right there, I’m a little confused. Two years ago in Durban we were talking about the great excitement in launching these new tests on vaccines and primarily the African population. Now, you’re telling me that that’s not where the emphasis should be anymore, that one vaccine is easily applicable to the future?

DR. LAWRENCE COREY: I’m saying that there’s scientific evidence that suggests that these T cell vaccines will have some cross-Clade activity. My own organization, the HBTN, as a global organization is very much committed to the development of vaccines globally and recognizes that Clades, or these -- are real important, especially as they relate to antibodies and neutralizing antibodies. And it also may be that the Clade-specific T cell responses may actually also be slightly better. But the reality of the situation is, is that we actually don’t know and we have a series of vaccines that look potent, that have cross-Clade immune responses. And it seems logical to me, and the organizations that I represent, that we should take a look at these vaccines whether they protect not just in the United States and Western Europe, but also in Africa and Asia.

And similarly, the converse is true. We are testing Clade C vaccines when they get developed. They are being developed in the United States. Persons in the United States, subjects in the United States, are getting Clade C vaccines, getting Clade E vaccines. And so, we are trying to look at this in a global framework to try and do things as expeditiously as we can.

My remarks are not to say that I don’t think Clade C vaccines need to be developed, in fact, quite the contrary. I really do believe they do need to be developed, but I also think that it’s time to start looking at -- stop looking at this colloquialism of Clades as they relate to these types of T cell vaccines. They are still very pertinent when it comes to antibody-based vaccines. There’s no question about that, but we don’t have great antibody-based vaccines at the moment. We do have reason to believe that these vaccines will offer benefits and they are like -- and we are trying to get them into wide-scale clinical trials. And frankly, I’d like to see these clinical trials be global in nature and not just be restricted to the Northern Hemispheres.

SEGANOS: Seganos with “The San Francisco Chronicle.” I’d like to address a question perhaps to Dr. Gayle. You mentioned male circumcision. It’s one of the first times I’ve heard that discussed in this forum and by a leading official. Having just attended a vaccine session where there was talk of a 30% effective vaccine being perhaps a goal we could hope for in many years down the road, there’s tests going on in Africa to try to determine if it’s really true that you get a 50% protective effect from male circumcision. I’m wondering why there isn’t simply more discussion of this issue in a forum like this given the enormity of the protective effect that 35 scientific studies have shown so far? Is it because the science isn’t good enough, or is it because people are, frankly, embarrassed to discuss the issue, or is it because perhaps this intervention is off-message from the notion of behavior change?

DR. HELENE GAYLE: Well, as I said-- thank you for the question -- as I said in my talk earlier, in a lot of ways I think there are parallels between circumcision and where we were with treatment of STDs. We had a lot of studies that continued to show that there was an association between STDs and risk of HIV and it wasn’t until the mid-1990s, so probably 10, 15 years later after we had been talking about the association between STDs, that we finally did intervention studies that demonstrated that actually treatment of STDs could reduce the spread of HIV. So, I think that it’s analogous with circumcision.

I think there are clearly other issues around circumcision though. I outlined some of the questions that remain and those need to be looked at in some of these intervention trials, but circumcision is something that is very linked to people’s cultural and traditional practices. And so, I think it has an added air of complexity, because even before the first intervention trials were done, the ones that started in Kenya, there was a lot of work with the community and with the cultures to look at the acceptability and feasibility of something that really does -- is very enmeshed with traditional practices.

And so, you know, I think it’s something where intervention trials are clearly necessary. I’m glad that there is one ongoing and that I hope that there will be others. As you mentioned, what we’ve seen in association is a reduce in risk that is 40%, 50% and even greater, particularly among high-risk men. But I think we need to have more discussion, but we particularly need to have more research that looks at it in an intervention way, but takes into consideration all the traditional and cultural aspects that go along with circumcision.

ANGILENE: My name is Angilene. I’m from Malaysia. I’d like to direct this question to Dr. Lawrence Corey. We tracked the (MS?) partnership with (MS?) on clinical trials and development of vaccine. I wonder if you are aware of this, the (MS?), which is developed by Thai scientists, and (MS?) and the many success stories about individuals using the (MS?) has been documented. And they’re currently conducting some clinical trials and theirs all seem to be facing a glass ceiling in bringing this discovery to the international (MS?). Additionally, I need to commend (MS?). Thank you.

DR. LAWRENCE COREY: I am not aware of this specific product. I would, however, take the opportunity to commend Thai scientists and the Thai government for the role that they’ve played in HIV vaccine research. They’ve been really leaders in conducting the current TP-120 trial and yesterday they are the leaders, essentially, of doing the second large Phase III vaccine trial with a (MS?) vector followed by a GP-120. So, at least the Thai scientific community is really behind vaccine research and really have been leaders and models of global vaccine development.

HANS JAEGER [sp]: Hans Jaeger from Munich, Germany, the German Medical Journal, I have two questions for the Union Health Minister. One question would be, what kind of new steps in prevention and treatment does your government foresee for the next future, maybe along the lines of what Dr. Solomon just told us? And the second question, I think it’s a good idea to get the XVI Conference to India, but do you have a venue where you can even host 20,000 people or so?

SHUTAVAN SYNAJAH: Thank you very much. Before I answer this question, I know my name is a bit of a tongue twister, but I’m also sure when you can remember Richard Burton and Rock Hudson, you can also remember my name, Shutavan. Now, coming to your basic point, as I said earlier, we have had some success with the vaccine. For so long, vaccine we cannot provide for each and every person and so long the medicine, which has been manufactured by 11 companies on a very comparatively lower price, but still not affordable. We have to go through awareness program, prevention awareness through mass media, through friends and television. They have phenomenal reach. I’ve been an actor for more than about three decades in the film industry. I also like to use my own influence and sense in media and television. Besides, we’re also having a special focus by convening a special session of the Parliament and warning all the Parliamentarians and the policymakers for their involvement and commitment. These are the -- as I said, our focus mainly is on the prevention and in the meantime we are working on it.

Now, your question whether we can afford to have 20,000 people in Delhi. I can assure you today’s Delhi is not yesterday’s Delhi. Delhi can afford to have all the delegates quite comfortably and we are looking forward for that for the XVI International AIDS Conference in Delhi. Thank you.

UNIDENTIFIED MAN: My question is to Mr. Shutavan Synajah, and the next question to Mr. Lawrence. I am from Bangkok, India (MS?). Mr. Synajah, (MS?) the long-term is there to be to tackle this problem, HIV and AIDS. I want to know what are your immediate (MS?) to get and see the provide of drugs for the 14 million peasants you just referred to? (MS?).

And my next question to Mr. Lawrence, by which time do you think this anti-AIDS vaccine can be manufactured? What is time frame is it? Thanks.

SHUTAVAN SYNAJAH: (MS?), firstly, the figure is not 14 million. The figure is almost 4 million in India. 14 million could be all over the world, but in India there are 4 million, 3.79. As far as the antiretroviral drug we just mentioned about, we are -- we are certainly working on it. As I said, we have already waived custom duty, import duty, excise duty, and the drug has become quite cheap in terms of international pricing, almost ten times cheaper. But still, India being a poor country and a very big country whose prime concern is population, it is not at the moment viable, affordable for all of them.

So before that, we are going for all that we can do, including prevention awareness, including -- in the meantime, (MS?) already being administered to mothers and children. Doctors and health care are the providers of the (MS?) exposure treatment. Whatever we can do we are doing at the moment, but we are also looking for and before we look for the medicine being afforded to everybody, we also need funds for that. We also appeal to the donors, because from donors still the funds we have got is far short of expectations. So there are a lot of things, we are working on it, but in the meantime as I explained to you, these are our prime concern and the priorities.

JUSTIN MALEWEZI: Thank you. We have time for a couple of questions more. I would you like please to concentrate on the topics of the plenary. Tomorrow, you will have time to talk about access to treatment and these other issues.

UNIDENTIFIED MAN: Thank you. Thank you, Dr. Gayle, for the courage in raising the circumcision question, but given the urgency of the epidemic, there’s an International AIDS Vaccine Initiative and there’s an International Microbicide Alliance. I understand the squeamishness around the subject and I also understand the respect for traditional practices, but I was amazed to hear that there are 35 studies already and I just wonder where the world is on this. And specifically with the traditional practices, don’t we have experience with female genital mutilation and intervening on the practice? I guess the point is, shouldn’t we be going as a world a lot faster, if indeed, it looks 45% to 50% effective and not be paternalistic and assume what communities -- how communities would react? Just tell them this might help prevent AIDS.

DR. HELENE GAYLE: Yeah, I think those are very good points, and when I talked about the cultural practices and traditions, I was just explaining that I think that those have to -- that clearly part of why it has been -- it is difficult and has been difficult to address that in reference to the question of why has that not -- why has that been more difficult to tackle than some of the other issues.

There are now intervention studies underway. And just, again, I think it’s very analogous to STDs. You know, we had two very lovely intervention studies that had conflicting results, and so it’s not clear that just because you see an association with something, that that’s the same as saying that if you put that intervention in practice, you’re going to see the same -- the same results. And there’s a difference between an association and a causation, and so what you have to prove with an intervention trial, is that if you change something by doing -- you know, putting in place an intervention like circumcision, you actually get that same result that you observed as an association.

One of the big things that I think is a question in people’s minds, most all of the studies that have looked at circumcision are looking at men who got circumcised early in life, at birth. Most of the interventions would most likely be, and particularly the interventions now, are looking at men or adolescents. There may be a huge difference and there’s reasons to believe that that could be different.

So, there are a lot of questions about whether or not what’s been observed as an association actually has a cause and effect impact, and that’s what’s being done. But clearly, it is imperative to have that kind of research because you’re right, if we had something that tomorrow we could start doing that has the impact of reducing the risk by 50%, we ought to do it and we ought to work with communities to make that feasible. The results have already shown that even men in very traditional societies where circumcision is not practiced, when you give people the information, they say of course we would want this. So, agreed 100%.

JUSTIN MALEWEZI: Okay, one more question, please.

BASHEKA TORIAK: I am Basheka Toriak from India. I have two questions. One to Dr. Corey and one to Mr. Synajah. Dr. Corey, could you give us your views on vaccines -- manufacturing the vaccines that we’re going to use? And secondly, Mr. Synajah, do you use your popular clout as a film star to take a politically unpopular action, that is, campaigning for AIDS during the next election?

DR. LAWRENCE COREY: Okay, I’ll take the easier answer. The resources to make vaccines are really considerable, and unfortunately, we’ve also seen difficulties in manufacturing these viral vector based vaccines. We’ve actually, even in the United States had a number of significant delays because of the complexity and the technologies required to develop these new vaccines. So, as much as my heart would like country-specific vaccines to be made and to be available, the reality of -- if you work in this field, is that one needs to be concerned about the ability to make the kind of plethora of vaccines that people will “want” for HIV.

There is no paradigm in any vaccine to do this, and what we have to do here is as great enough a challenge without increasing the complexity. And I think you have to look at it, is the cup half full or the cup half empty, and that’s why in my talk I said that one needs -- each country needs to look at the risk and benefit and debate these issues from the national plan and decide do they want to try for good. Do they want to reject something that might be potentially good for something that they would perceive might be better? But can you deliver the fulfillment of what might be better, and I want -- and the issue I’m raising is the realistic expectations here and where realism should be with an epidemic that is unabated, that is growing at 15,000 new infections per day. It is the error of omission that is the major issue in HIV vaccines. There is just not enough effort and every day is a problem. So, it’s that continuing issue of sort of what I want. It is up to our leadership to decide what you can deliver and that was the point I am trying to make.

SHUTAVAN SYNAJAH: (MS?). As far as the campaign is concerned, this campaign of awareness had to be taken to the length and breadth of the entire country, to the villages, to the district level, to the poor, to the farmers, to the laborers, all throughout India. And far as campaigning during the election is concerned, I know it is a very gigantic task. It’s a great challenge, and if we fail, which we don’t intend to, there will not be -- the other political party will speak against us during the political campaign that these people have failed on the basic human issue also, that these people have failed in their campaign against AIDS. So, and during the campaign, we generally focus on the politics. So politics, we will focus on the politics and will achieve, and if we don’t achieve, the other people will focus on us and our failures. Thank you.

JUSTIN MALEWEZI: Okay, thank you very much and we’ve finished on time, so see you tomorrow.

Special coverage from the XIV International AIDS Conference provided by kaisernetwork.org, a free service of the Kaiser Family Foundation.