Part two of our TAG Durban roundtable makes up the greater share of this month's issue of TAGline. Yvette, unfortunately, was not able to participate in this part of the discussion, but the rest of the gang is here -- with their no-holds-barred analysis and interpretation of the political proceedings at the 13th International Conference on AIDS, in Durban, South Africa this past summer. The first half of this interview appeared in the September TAGline and is available through the TAG office and on our web site.

Harrington: Did you want to talk about screaming at UNAIDS? I think that was a good activist moment.

Gonsalves: It was a good activist moment, but I'm not… Yeh, I guess we can talk about it. UNAIDS had a press conference.

Harrington: With WHO (the World Health Organization)..

Gonsalves: With Merck and the drug companies—all the drug companies were there to talk about…

Harrington: And five health ministers from developing countries—who weren't even up on the stage...

Gonsalves: Who were not even up on the stage. Awa-Marie Coll-Seck [from UNAIDS], who is an African woman, and Daniel Tarantola, you know, a French man…

Harrington: From WHO (World Health Organization).

Gonsalves: But they were not having a press conference; it was ostensibly to announce Merck's…

Harrington: No, it was ostensibly to announce that they're still talking about the Big Five price reductions but had no specifics to make about any of the Big Five or any of the prices that were going to be there—even though all the Big Five were there in the room. (The "Big Five" include Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Glaxo and Roche. Unidentified price reductions were publicly promised on May 11th of this year.)

Gonsalves: But also Merck was there to announce the fifty million dollar donation to Botswana.

TAGline: Yeh, with the Gates Foundation.

Harrington: Fifty million from Gates and fifty million in drug dollars denominated in some sort of xxxx from Merck.

Gonsalves: In any case, the day before we heard Peter Mugyenyi from Uganda say that…

Harrington: At the TAC workshop...

Gonsalves: …that the UNAIDS pilot drug access program was an utter failure and that...

Harrington: Because the prices ended up being higher than the ones that we already have…

TAGline: Yeh, wasn't that in the MSF [Médecins sans Frontières/Doctors without Borders] report? I read that somewhere.

Harrington: No.

Gonsalves: The prices actually turned out to be higher and he said UNAIDS better put its money where its mouth is or just shut up.

Harrington: No, what he said was, "If you're going to lower the price…

The two in unison: lower the price. If you're not going to lower the price, just shut up."

Harrington: …instead of keep making these announcements, one after the other, about these price reductions that are in the pipeline that aren't happening anywhere and that haven't even begun to happen because each price is going to be negotiated by each company in each country on a one-to-one basis, which means it will take forever.

Gonsalves: In any case, at the UNAIDS press conference I got up and I said, "Peter Mugyenyi from Uganda said yesterday at the TAC/MSF meeting that the UNAIDS pilot access program was an utter failure and that in some cases the prices are actually even higher. If you're not going to lower the prices, just shut up. And Daniel Tarantola said, "I will not shut up because silence equals death." And then the room erupted into bedlam.

Harrington: ACT UP/Paris started screaming.

Gonsalves: Well, ACT UP/Paris said some crazy things but also said some…

Harrington: No, they were great.

Gonsalves: …important things about generic importing…

Harrington: …why the generic [manufacturers] weren't in the room.

Gonsalves: Laurie Garrett took over the room saying, "Is this a press conference or a briefing or what is this?"

Harrington: And then they finally announced the Merck thing. Again, Merck had only told Botswana about it the week before. And so the health minister from Botswana was there and that helpful David Scondras from Boston got up and said, "Well, they have infrastructure everywhere. Which is more important? Infrastructure or drug?" And she was like, "Well, it's like asking whether you should give your baby food or water. They need both."

Gonsalves: But also this guy, Richard Laing, from Boston University gave one of the talks on compulsory licensing and parallel importing. He was paired with Jeff Sturchio the PR rep from Merck for Africa and Asia. And Richard Laing was just amazing...

Harrington: He's hilarious.

Gonsalves: He just deconstructed the market for drugs worldwide, the salaries of drug company executives, the stock options, the prices of drugs in different countries and it's just…

Harrington: He showed that you could make price cuts—that the price cuts with compulsory licensing and parallel imports are very steep—much steeper cuts than anyone had been talking about without affecting the level of pharmaceutical profits—at all, basically.

TAGline: He's from the University of Boston, did you say?

Unison: Boston University.

Harrington: His speech is up on the web now. (http://dcc2.bumc.bu.edu/richardl/ih820/GenevaPresentation/Geneva_Compulsory%20_Licensing.htm)

TAGline: And actually I guess if… on a more concrete level, I would like to know... I guess you could divide it into three parts, but we'll just focus on two. From the pharmaceutical side and from, let's say, the North American or "Western" activist side, what would be the three most immediate, concrete, effective things we could do?

Harrington: For pharmaceuticals or for activists?

Gonsalves: I think Peter Young, who used to be the Glaxo Wellcome HIV guy, said it best. He had a presentation where he said it in this arcane business school language but he said it privately at this cocktail party the night before. He said, "Tomorrow my speech is going to say that drug companies can basically give away drugs in the developing world and make back their investment in markets in the developed world." So they can give away in the South and make a healthy profit in the North. So that…

TAGline: This is the guy from where?

Gonsalves: Peter Young.

Harrington: He's from AlphaVax.

Gonsalves: He's the president of AlphaVax but, more importantly, he used to be the HIV guy at Burroughs Wellcome—Glaxo Wellcome, whatever.

TAGline: In the UK or here?

Harrington: Here. He worked with UNAIDS on some vertical transmission stuff. He helped, I think, open up… Glaxo is the only one that's made a specific dollar commitment as far as price reduction, which is the 85%—which isn't enough, but it's still better than anyone has done.

Gonsalves: Do you have the Wall Street Journal on-line, Mike?

TAGline: Yeh.

Gonsalves: He wrote an Op-Ed on this a while back, and it's really important. Because all these "left wing Commie pinkos" can talk about this stuff, but when a drug company executive says, you know, "you can give it away in the South and make your profits in the North," I think that's the most radical thing… It wasn't new—because he's said it in the Wall Street Journal and in other forums—but that's the most radical thing from a drug company person I've ever heard.

Marco: I think also, Mike, to answer your question. You know, there's everything from fungal infections to possibly getting Pfizer to give away fluconazole for cryptococcal meningitis and for esophageal candidiasis. Esophageal candidiasis is huge in South Africa, and people are not being treated for it at all. And then PCP prophylaxis.

TAGline: Yeh, I would think… The emphasis has been so much on triple combination antiretroviral therapy, but why aren't more people talking about making basic OI stuff available?

Harrington: Well, going back to the global drug company question that you asked... The drug companies were kind of whiney that people weren't jumping all over them, lapping like happy dogs that they were making these announcements. And they have to get over that and recognize that when the drug companies make a response to one of the demands that is placed on them, it is inevitable that that response is going to be deemed to have been not enough. And so the drug companies are going to have to figure out what they're going to do beyond what they're willing to do already—beyond what they've promised. And when somebody comes to activists with an issue like, okay Pfizer said, "We're giving it to you for cryptoccal meningitis" or "we're willing to do that," but we want certain conditions attached, like we want to know that the drug got into someone's body, if they're still taking it and if they're still alive.

Now whether or not that is really feasible, we don't exactly know. But they're going to have to be ready for the people in South Africa to come back and say, "Well, no, it's really not just good enough to have it for cryptoccal meningitis. We either want it for esophageal candidiasis as well," or "We also want it not just for South Africa but for other countries." The idea that they're going to get out of this by just shipping some drugs to a port and have it be sort of, "that's it" for them is naïve. And they're going to have to think about implementation.

At the same time, the country level people are also going to have to be thinking through some tough issues about implementation. Because, for example, what is the diagnosis procedure for cryptoccal meningitis in a resource-poor setting? And is fluconazole enough—or are some people going to need Amphotericin-B? And what kind of follow-up will be provided—or should be provided? And what is the capability of the system to provide follow-up? And what is the tradeoff between—these issues have come up here [in the U.S.] around expanded access programs—what is the tradeoff between getting better follow-up and encumbering your program with all this follow-up that actually interferes with the ability of your program to reach more people? So I think some of those issues are going to have to be explored now with the Pfizer offer.

The antiretroviral issues are even more complex because I don't think there's any consensus about the standard-of-care, and one of the things that people always talk about is that, "If you have X-thousand people infected with HIV and your country needs HAART for them..." Then they always do the multiplier by the current price of HAART, acting like the entire HIV-infected population in the country is going to need HAART. But that completely ignores the fact that probably—we don't really know but it's likely that—most of the people with T-cells above a certain level probably won't need HAART right away! What they need is monitoring. So who's going to provide the monitoring? I mean, even if Glaxo provides pills, they're not going to provide monitoring.

Gonsalves: And it's interesting because Art Ammann from the Global Alliance for HIV Prevention… He and Cathy Wilfert (Pediatric AIDS Foundation) were talking about if, outside of South Africa, if intervening with mother-to-child transmission stuff... whether you just intervene without even HIV testing. I mean, there's this whole new universe of, What do you do??

TAGline: Right.

Gonsalves: Can you go into a place, for example that has a 40+ percent incidence of HIV infection and then say, "Even if we don't have the resources to HIV test, if we could give all pregnant mothers a single dose of nevirapine, are we going to make a public health impact?" There are all these questions about public health.

You know, Laurie Garrett's new book has just come out. Has everybody seen it? It's called "Betrayal of Trust: The Collapse of Global Public Health." I'm just reading it now, and she's talking about a lot of these issues.

Harrington: Edwin Cameron talked about this, what he called this "collusive paralysis" between the drug industry and the African governments where each one is saying that the other one's on first. The African governments say the drug companies first have to reduce the prices and the drug companies say the African countries first must provide the infrastructure. So a lot of the arguments that came up are about doing stuff now with what we have, imperfect tools that there are, or waiting for more information.

So one thing that came up and was really big at the conference was doing nevirapine or short-course AZT now. But then what kind of recommendations should we make about breastfeeding? And should we wait for the answers on breastfeeding or should we provide it now, knowing that it's going to be imperfect? And what the South African government was doing was using everything that would come up about any caveats about MTCT (mother-to-child transmission)—whether it was breastfeeding or resistance or side effects of nevirapine, side effects of AZT/3TC—to say, "We can't do anything now because we want all the answers first."

And I think there's an analogy to what activists did before in the North with imperfect treatments in the imperfect era where they said, "ddI now!" And we were willing to take the risk—because the risk of not doing anything was greater. And studies will be done to iron out some of the questions about breastfeeding or resistance and so on. But the governments have to get over the issue of waiting for all the answers to be in before going ahead with programs. And also the donor community in the North has to be figuring out ways of providing resources to help support building the infrastructure—because that can't be done only by the South. And, I don't know if you saw that the Export Import Bank was going to lend 100 million dollars to African countries so they could buy AIDS drugs.

TAGline: Right

Harrington: Well, this is in the same year where there's a huge movement afoot to have global debt relief for poor countries. So what's the point of having a huge new loan for buying drugs especially if we haven't re-negotiated the prices down to a level that makes any sense?

TAGline: Right, it's just a transfer of money from...

Harrington: And putting more debt onto these countries that are probably spending more of their budget on debt service than they are on providing health care.

Gonsalves: Mike, Cameron also talked about sad truths and about…

Harrington: Or, "we in South Africa don't accept sad truths, sad realities."

Gonsalves: Sad realities. It's also… I think one of the transforming things about going to South Africa was to really be on the ground somewhere where... If could have been…. I don't want to get stupid here, but it's a sublime experience in the sense that it's just so overwhelming that it just sweeps over you, the enormity of the problem.

Harrington: But you went out to a township and there was a hospital there, right?

Gonsalves: Yeh. But being in those townships you think, "Oh, they're really going to..." I mean, there's no clean water! There's running sewage in those townships. There are places where there is the infrastructure in South Africa, but there's clearly places where it is not.

And that's why, looking at Laurie's new book, it's not like we're all going to get together and have a new world treatment movement and solve the epidemic in the developing world. We're really in a precarious condition around global public health. And all we're really going to be able to do is to sort of nip at the borders until there's a global revolution that puts an emphasis on healt

Harrington: But also, look at Brazil. I mean, what they've been able to do with political will in Brazil is that a fifth of the country's HIV population is on HAART or antiretroviral therapy! They have a national treatment plan, a treatment guarantee and they've got manufacturing capacity in place which is making generic quality nucleosides plus nevirapine and Crixivan, and...

Gonsalves: Although…

Harrington: Wait! Whenever they've been able to make a generic, they've been able to get the manufacturer's price down... about a log, I guess—somewhere between 80-90%.

Gonsalves: But even the…

Harrington: Wait, wait, wait. And so…. They just have started doing this in the last two years, so it's a really new program. And it's allowed under the TRIPS, and they're willing to provide technical assistance to other developing countries to help them do this themselves or they're willing to enter into sales negotiations with countries especially if they're willing to pool purchasing on a regional level to sell generics to, say, East Africa, or possibly to the Caribbean.

Gonsalves: That being said…

Harrington: That is super radical.

Gonsalves: Well also, the Brazilian…

Harrington: And they also showed that there was an off-setting cost savings by keeping people out of the hospital.

Gonsalves: But also the Brazilian activists were saying that they worry about the potency of some of those drugs and the quality control.

Harrington: The QA issues are big with generics.

Gonsalves: The quality assurance issues are big. None of this is really simple, and there's a temptation for... It's classic, you know… [Joseph] Conrad writes about this. You go to Africa and you have this transformation and it's like all of sudden everyone turns into Lord Jim. And there's going to be some utopian movement to save the South: the North can come save the South. There is a sense that this is a huge, huge…

Harrington: But there's a sense that things can be done and are being done—as opposed to the idea that the whole developing world is just a complete basket case and nobody's going to be able to do anything…

Gonsalves: No!

Harrington: Incremental but radical changes are going to take place at a lot of different levels. And I think, going back to what you asked about the activists and what we can do, Mike…

TAGline: Uh-huh.

Harrington: I'm really concerned about the disjunct between the media and the reality in Africa about this issue. And I don't know how to keep attention… I think they're going to play a key role, and I don't think mainstream media are really getting across the message about what happened there and the doability of some of the interventions that are being talked about.

Gonsalves: Well it's interesting, though, because Mark Schoofs is now going to be the Wall Street Journal Africa correspondent.

TAGline: Right.

Gonsalves: If you have somebody who cares about health care going to Africa… Again, there are these interventions on a personal level. I mean it was a career decision for him. Even some people in New York were able to change U.S. policy toward Africa.

TAGline: Yeh, when I read what's his name McNeil in the [New York] Times...

Harrington: He's been doing some pretty good coverage…

TAGline: People have often thought, "Oh, Julie Davids. Oh, Eric Sawyer." Then you realize that what they did really turned everything around!

Harrington: And we met with some people from MSF, and they've done their access report that showed the enormous impact generics have on pricing structures by big pharma in certain developing countries.

TAGline: Yeh, I downloaded that report from their site. (See: http://195.114.67.76/msf/accessmed/accessmed.nsf/html/4DTSR2?OpenDocument; scroll down and click on HIV/AIDS medicines pricing report. Setting objectives : is there a political will? by Carmen Pérez-Casas)

Harrington: It's really good. But MSF needs support here [in the U.S.] mobilizing intelligent activism around the drug companies and around... Another thing is we are going to have to start monitoring what NIH and CDC are doing with their research portfolios in developing countries because all the research is epi[demiology], prevention, a little tiny bit of MTCT or vaccines. And I think, going back to what Gregg said, stuff that works really well here, the standard-of-care, may or may not work in different parts of the world. We don't know what OIs people are getting sick of and dying from in different parts of the world. I mean, we know some, but we don't them all. And there are some that are very different. So we need to link the epi that is going on with treatment strategies that make sense.

Gonsalves: And we also have to tell people like Peter Lurie (from Public Citizen Watch) and Marcia Angells (former editor of the New England Journal of Medicine]—thank god she's out of there, but—certain people have to let the developing world set their research agendas and decide what is ethical for them and not be paternalistic about how to design studies to answer crucial questions for effectiveness research there. You know, the other thing about the momentum…

Harrington: Are we going to talk about UNAIDS? 'Cause I have something to say.

Gonsalves: The momentum that ACT UP/Philly and HealthGap and… all the momentum around… a lot of it hinges on what the United States' role in this. And I think we're at a turning point with the election coming up and it's going to be interesting to see how it all plays out. If there's a Republican in the White House and a Republican Congress, how much more progress is going to be made around compulsory licensing, parallel importing or the generics issue? And what kind of response would a Bush administration give?

Harrington: Can I talk about UNAIDS?

Gonsalves: Whatever, yeh.

Harrington: Another thing I think that we need to do is to look in a constructive but critical way at what UNAIDS has been doing and is doing around treatment. I think my emotional reactions to what their pilot access program has accomplished were all over the map, depending on which day of the conference it was and who[m] I talked to. But basically, I think about 800 people got HAART in one of the African countries and 600 got it in the other, through the program.

TAGline: This is, what, Ivory Coast and Uganda?

Harrington: Yeh. It was like 800 and 600. I can't remember which and which. And the prices, at least in Uganda, ended up being as high or higher than they already were! So they didn't help to reduce prices. They did show that it can be done, to an extent, but people are paying for this out of their own pockets. So you don't really know what kind of an impact that's going to have on their family and stuff. Of course, it's great if some people have the resources to do that, but…

Gonsalves: We heard from people at different places, not at the conference but beforehand, that people are paying for meds out of their own pockets and squandering their patrimony and after two years they don't have any more money for drugs, but they also have no inheritance to give their children. So there's all these issues…

Harrington: But that's an autonomy issue; I mean, anybody has the right to do that with his/her money. It's not a reason not to do it.

Gonsalves: No. But if the drug costed less… There's a way to make it less…

Harrington: The point I want to make is that… And then they moved ahead and got this announcement from the Big Five and they got some preliminary talks underway with generic drug companies. So they have made a couple of stabs at looking at treatment, but the resource level within the agency (UNAIDS) that they've put on to this is totally miniscule compared to all the other things they do. They are woefully under-resourced, and I think if we pushed for them to get more resources we're also going to need to push them to use the resources they have in a more intelligent way—and to do a better and more thoughtful job. And every time you say, "Well, we need a better sense of the epi in different countries" or…

They put out a totally inadequate standard-of-care [guidelines] in conjunction with IAS (International AIDS Society) that looks like Stefano Vella wrote it on a plane in between meetings. I think it's going to be time to take what we've done by looking at U.S. agencies and start looking at the multilateral funding agencies like WHO, the World Bank and UNAIDS. And looking at them pretty critically and figuring out how they can use their resources better.

TAGline: Would that be like your and Derek's report (America's Response to the Global HIV Pandemic)?

Gonsalves: Yeh, I also think there are dilemmas we have to face too about... Michael was talking about the ADAP (AIDS Drug Assistance Program) program in North Carolina and stuff like that. And in Mark's speech in Geneva, he said the south is not just Africa it's the South Bronx...

TAGline: And Mississippi…

Gonsalves: The epidemic is mushrooming in our country in communities of color and, I don't know, I came back with a sense that… it's an issue for us [here, too]. And if we talk about drug access in South Africa, we have to talk about it in North Carolina or Florida—where there are waiting lists for ADAP programs.

TAGline: When you have such limited resources in personnel and time, how much do you put into the battles here and how much do you put into there?

Harrington: Well, luckily, a lot of the issues already affect both, so it might simply mean changing the way we do our work around antivirals or OIs or interacting with drug companies, but it won't mean that this international piece over here is necessarily divorced from the domestic work.

TAGline: And even though we've been saying, "Africa, Africa, Africa," the same work would spill over into Asia and Latin America and the Caribbean?

Harrington: Well, Yvette's going to the Caribbean meeting in early September.

Marco: And, Michael, I think it's important to really note that, granted, a lot of the problematic issues in South Africa might be access to treatments or at least an infrastructure to give the treatments, but I think it still fuels us to work with industry here on getting better regimens, more effective regimens, easier-to-take regimens that are less toxic. Granted, they'll be used here first, but HAART right now is going to be difficult for the wealthiest American to take, who has the ideal schedule. So it's going to be imperative that good, effective, easy-to-use antivirals make a difference, one day, in developing counties.

Gonsalves: And I think people should do what they do best. I think Michael's right: from here in the U.S. one thing we can do something about is development of cheaper, simpler, easier-to-take drugs. We can push the NIH or CDC to do effectiveness research and epi stuff that fulfill the research needs of the developing world—not only the epidemic as it stands here. We should also keep pushing on the vaccine stuff. We're not going to be the leaders of a revolution in public health care access for the planet, but we can seek big changes—the same as we've done in the domestic AIDS research effort.

Marco: But if we can help get some Bactrim over there, cheaply, to start to saving some lives—and fluconazole—you know, you gotta start somewhere. ¤

At four in the afternoon (Monday 10 July) South African High Court Judge Edwin Cameron gave a press conference. "The availability of HIV/AIDS treatments has changed the moral landscape of the epidemic... They are being affordably produced. My call is a call to action. Immediately, the drug companies must reduce drug prices dramatically. African governments must seize the opportunity for direct action."

Someone asked Cameron, "Will drug companies have to pay reparations [in the future, if they fail to make drugs accessible in hard-hit countries now]?"

"We need a radically restructured global legal and trade system," he replied. "A moral emergency confronts the shareholders and the drug company executives."

I asked, "What steps are necessary to change the global legal and trade regime?"

"We already have the TRIPS agreement," replied Cameron," which provides for compulsory licensing, parallel importing, and the use of generics. The question is, will Western governments throttle it under drug company pressure?"

The TRIPS (Trade-Related Aspects of Intellectual Propery Rights) agreement applies to the 135 member nations of the World Trade Organization (WTO) and basically grants worldwide 20-year patent protection to companies. Not all countries, however, observe the TRIPS agreement.

Compulsory licensing is a mechanism by which a patented object can be used without permission of the rightful owner under special conditions. Canada had compulsory licensing for drugs from 1923-1993, during which time Canadian generic drugs cost approximately 53.6% less than brand name equivalents.

Parallel importation is the importation of a product without the authorization of the patent holder from another country where the drug is marketed at a lower price. It's common in the European Union (EU). While technically legal in terms of the TRIPS agreement, national laws and regulations may prevent or limit its use.

Subsequently David Barr, Lynda Dee and I attended an entertaining debate on compulsory licensing between Richard Laing, (Boston University) and Jeff Stuchio (Merck). Dr. Laing was hilarious. He showed the salaries of the top 20 pharmaceutical executives and suggested they could each pay the entire health care costs of a poor developing country. Laing laid out the following proposed criteria for drugs to be considered for parallel importation and/or compulsory licensing:

Suggested Criteria for Compulsory Licensing

• Serious disease in terms of mortality or morbidity
• Effective drug available to treat the condition
• Drug could be utilized in the country; infrastructure exists
• Drug could be used without sophisticated or expensive laboratory tests
• Suggested Criteria for Parallel Imports
• Price differentials between countries
• No obstacle in national laws
• Drug regulatory authority allows parallel import
• Drug can be used effectively

But the onus does not rest exclusively on the West and the global pharma-industrial complex, Laing was careful to point out. Host countries will also need to adjust their pricing and spending priorities. Diseases which can be effectively cured or prevented should be given top priority (e.g., TB and PCP pneumonia). We left as the hapless, yet forensically trained Jeff Sturchio, began his rebuttal. "As Dr. Laing said, compulsory licensing and parallel importation are "blunt swords." Perhaps we can find less blunt tools to alleviate the need..." That was enough. As for David, Lynda and me, we needed a rest, and returned back to our hotel. ¤

Data presented by researchers from the National Institutes of Health showed that a short course of nevirapine—one dose to the mother during delivery and one to the newborn—(HIVNET 012) reduced the risk of mother-to-child transmission by 40-50 per cent.

The first human trial of a vaccine designed for an African strain of HIV will begin this fall. The clinical trial will involve 36 healthy HIV-negative volunteers, 18 in the U.K. and 18 in Kenya.The vaccine candidate, developed by Oxford University researcher Andrew McMichael in collaboration with professor J. Bwayo of the University of Nairobi, is intended to mimic the reaction of a group of sex workers in Kenya who have not become HIV-positive despite repeated exposure to the virus. McMichael said that even if the vaccine proves effective, it will probably not be permanent, but will have to be administered periodically.

According to data from two America studies of people on HAART, temporary increases in viral load to just above undetectable levels (commonly referred to as viral "blips"), are not uncommon and do not raise the risk of loss of virological control. Apparently, archived virus spits out from infected cells periodically despite HAART, but it does does not go through enough replication cycles (because of HAART) to develop resistance.

CDC researcher Scott Holmberg, analyzing data from more than 1,600 HIV-infected individuals across the U.S., found that HAART use skyrocketed from 4%at the end of 1995 to 87% in late 1999. During that same period, deaths due directly to AIDS fell by more than 90%.

Holmberg also reported findings showing that HAART provides durable virologic suppression for more than 12 months in only about one-third of individuals. Others, Holmberg said, must regularly change their drug regimens in order to maintain low blood levels of HIV. Drug options, he conceded, "are increasingly being exhausted by the people who need them."

Tony Fauci, head of the National Institute for Allergies and Infectious Diseases (NIAID), told a packed audience that with our current antiretroviral classes of drugs, "eradication is not possible." "The virus has an uncanny ability to re-establish a reservoir," he said. "Even our most rigorous attempts to reduce or eliminate the reservoir have been unsuccessful." Fauci's conclusion was later publicly acknowledged by David Ho of the Aaron Diamond Center.

In the face of mounting data debunking the purported immunological benefit of structured treatment interruptions (STIs), Fauci went out on a limb and effectively lent his imprimatur to the practice, although not as a means to boost host control of the virus. In early (some would say premature) data from NIAID clinical tests, Fauci explained that interrupting therapy-either 1 week on, 1 week off or 2 months on, 1 month off-appears to control the virus as well as constant treatment while reducing the cost and the quality-of-life concessions.

A Canadian cohort study followed 1,353 individuals who had initiated HAART therapy from August 1996 through September 1999 and reported that neither baseline viral load nor the presence of an AIDS-defining diagnosis was found to be predictive of survival. Only the baseline CD4 cell count was predictive—and the effectiveness of HAART on survival was compromised only when treatment was begun at CD4 cell counts below 200 cells/mm³. Yet another indication that current treatment guidelines may be needlessly aggressive. ¤