P4P: "I wanted to ask you about the initiative for the Vaccine Trial Group that was announced at the end of the summit in Georgia earlier in June."

Dr. Fauci: "Right. It's called the HIV Vaccine Enterprise."

P4P: "I know it's calling for a bunch of different things, you know; development centers ..."

Dr. Fauci: "Formatization of clinical trials, formatization of immunological tests and monitoring ..."

P4P: "Yes. And have any of these ... Let me ask you this; they said there was support from some different allies. Who are the allies?"

Dr. Fauci: "Let me explain what the HIV Vaccine Enterprise is. It's a virtual consortia. It isn't an official organization. As you may know, a lot of money has been put into HIV vaccine. The United States is putting in about five-sixths of all the money in the world. We've calculated, though it's difficult to get an absolute number form the drug companies, but it's estimated that about $700 million a year is spent worldwide by the total of everybody in aggregate, for AIDS vaccine research. Of that, $588 million, in '05 and '06, is going to be by the United States, either the NIH and/or the Department of Defense, mostly the NIH. So the amount of resources put in is significant. What has become apparent to us scientists, and we got together over a year ago and put together a White Paper in the form of a paper that we published in the medical journal Science, called "The Need for a Global HIV Vaccine Enterprise," and what we meant by that, and it was myself and a group of other scientists, international as well as national scientists, is that we need to approach this very problematic HIV vaccine issue, that we've been unsuccessful up to now in getting vaccine, in a global coordinated way. Because research sometimes gets done in a stovepipe fashion. Somebody does something in Germany, versus the United States, versus Japan. We have to synergize with each other. The way we do that is to form almost a moral agreement to put together a strategic plan that's brought together by scientists, not by politicians, not by bureaucrats. We did the first cut at that strategic plan in the paper in Science. We refer to this consortia as an enterprise. The enterprise is not owned by any one group, any one country. It's an agreement to form a solid strategic plan so that when money does come in it will be aligned in a way that is transparent, coordinating, and collaborating, so that we don't have people going in different directions, that clinical trials are interchangeable among them, that laboratory tests that are monitoring clinical trials are useable in any clinical trial, that we address the gaps in scientific issues that we need to elucidate. For example, correlates of immunity. How do you do that? One of the ways is to get these Centers of Excellence on vaccine development, such as the Center that we have at the National Institutes of Health, which is the prototypic model. When we published this, we had a meeting, we had working groups, we're well on our way to a strategic plan. What happened at the G-8 Summit, in Sea Island, Georgia, just several weeks ago is that we convinced the Administration, and President Bush who was very enthusiastic about it, to present this proposal for an HIV Vaccine Enterprise to be endorsed by and supported by not only the G-8 countries, because the G-8 were at the Summit, but also any other country that wants to join in, to A.) get them to put more resources in, like we're putting a lot of resources in; B.) to adhere to a moral commitment to go by the strategic plan, so that what's done in UK is something that's compatible with what's being done in Japan, versus Italy, versus Germany. The countries of the G-8 indeed endorsed this HIV Vaccine ... global Vaccine Enterprise, and right now, this year, before the end of this year, we're going to have a meeting of G-8 representatives to in fact officially endorse the strategic plan and to allow these countries and others to put their resources into a coordinated, collaborated transparent approach, which we're calling the Enterprise. It's really a virtual organization, as opposed to a formal organization where you put in a pot of money."

P4P: "Okay. So there's not going to be any single fiduciary agent for this pot of money?"

Dr. Fauci: "No, absolutely not. There will not be a single fiduciary agent. Each entity, be it the NIH, the Gates Foundation, IAVI, the British government, Japan, scientific drug companies, each entity will own their own resources. But the commitment will be, that if you are putting resources in, that you will do it within the framework of this scientifically agreed-upon strategic plan."

P4P: "Okay. We've all seen in the past. ... we hear that so much money is going to be allocated for a specific purpose and then due to stuff that goes on on The Hill, in Congress, funding sometimes gets reduced, sometimes it gets pumped up. Is there really a firm commitment from the Administration for this $588 million?"

Dr. Fauci: "Well that's already being spent. So this isn't future promises. We already are spending, the federal government is already spending $588 million on vaccine development. So we're looking to other countries to start spending some more money. This is not something that's a promise. This is something we've been doing for years. We've been spending a lot of money on vaccines over the last several years, and I guess people get confused when they hear about committed future money. This is money that is in the budget for '04 and '05. It's four hundred and something in '04 and it goes up to over five hundred million in '05."

P4P: "So essentially what you're looking to do, and some of the work that you're already doing, you're looking to coordinate and collaborate ..."

Dr. Fauci: "Coordinate, collaborate, and make it transparent."

P4P: "Right. One other key question from me. In encouraging scientists and physicians from developing nations to participate without pulling them out of their native countries ... You know, a physician in Uganda might make six hundred bucks a month, and in this kind of a project you might make ..."

Dr. Fauci: "That's very true and that's something we're very sensitive about. We don't want to create a brain drain away from the countries, and a considerable amount of effort that goes beyond vaccine, that goes into drug distribution, training for people; of how to do clinical trials, and not only clinical trials but how to distribute and utilize drugs in a way that's safe and effective; all of that requires training of in-country people, and we, as well as our other developed nation colleagues, are very well aware that we don't want to establish a drain of brains, a brain drain, as it were. We want to train people and keep them in-country."

P4P: "How is ... is there any stipulation in the plan that would augment their salaries to encourage them to stay in their countries rather than leave."

Dr. Fauci: "The strategic plan is to embrace third world country scientists and help collaborators in this plan, particularly scientists in helping to develop not only vaccine itself but the vaccine trial. That is part of the strategic plan, so if company A or country B or organization C decide they want to join up with this enterprise approach, that would be one vehicle that they could use to put their money in."

P4P: "Okay. But, in other words, they might be ... a doctor in Uganda might not get as much, or a scientist in Uganda might not get as much as he could get in salary in the UK or ... Would any of this money that's allocated now for vaccine research from NIH or DOD be used to ... could any of that be used to supplement earnings of these scientists?"

Dr. Fauci: "... that's true, but the program has to be built, the program isn't there yet but that's absolutely a feasibility."

P4P: "Okay. One more thing in terms of manufacturing capacity. Brazil, Thailand, India are all developing some manufacturing capacity. In some of these developing nations that really don't have any manufacturing capacity, is ... are you anticipating countries that are in that position? And being able to help them in developing some of that capacity?"

Dr. Fauci: "Not necessarily. We don't necessarily need ... we need manufacturing capacity to make enough vaccine to do a clinical trial, because the problem is that pharmaceutical companies don't want to, understandably so, because it's a high risk, get involved in investing and making enough vaccine to do a large clinical trial, because the chances of success are so low. If the Enterprise, as a group, makes the capability available to make enough vaccine to use in a clinical trial, then pharmaceutical companies would be much more amenable to getting into the high risk arena of vaccine development. If they have to invest hundreds of millions of dollars to manufacture enough to make a clinical trial, and the risk is high, they may not want to get involved in it. So we're trying to create an environment that lessens somewhat the risk of the pharmaceutical companies and makes the field more permissive for them to get into it, because we need pharmaceutical companies to help out to make a vaccine. You're not going to do it by scientists alone."

P4P: "Switching gears. Mark Dybul's study, 7 days on/7days off with qd dosing of 3TC, DDI, efavirenz (Journal of Infectious Diseases 2004; 189:1974-1982) seemed to have pretty impressive results, and I know we had spoken about this earlier in Durbin, but it was a different drug combination then. At this point, are there other trial sites that are going to be trying to take a look at ..."

Dr. Fauci: "Yeah, Uganda. There's the trial in Uganda that's going on right now with the same thing."

P4P: "Okay. In the states. Are there going to be NIH trials, ACTG ...?"

Dr. Fauci: "The ACTG submits proposals for trials. They may very well submit a proposal for this. ... I think these trials get initiated by the investigators who are interested in the studies. We did a proof of concept, Doctor Dybul's study was a very good proof of concept."

P4P: "There's a million other things I'd like to ask, but I know you're trying to work on a 15 minute schedule here. So, if I can get one photo here, I'll call it a wrap."

Dr. Fauci: "Sure ..."

Back to the Summer 2004 issue of Positives for Positives.