The Boston AIDS Conference That Never Was — And Other Grim Tales
A Sick Lymph Node Makes Its Début
TAGline catches up with its peripatetic international scribe as he negotiates a perilous course around canals and through abandoned railway yards en route from the North Sea to a recently liberated East Berlin. (And, knowing David, straight on to Prague?) The penultimate installment of David Barr’s “irreverent, more factual than you might imagine, and sort of self-serving recollection with digressions” history of the international AIDS conference continues unapologetically below.
Two days before I left for the Amsterdam conference, a march and rally was held in Times Square with over 25,000 people demanding a better government response to AIDS. I developed and coordinated that project, United for AIDS Action, a coalition of over 400 AIDS organizations, unions, advocacy groups, and religious organizations. It was held in conjunction with the Democratic National Convention.
United for AIDS Action was a tremendous amount of work and it was very successful, so getting to Amsterdam was in itself a great relief. Amsterdam is a wonderful place and the Dutch AIDS policies are particularly sane. I think that for many of the activists, it felt as if we were on our turf. Certainly, being there was in and of itself a victory because we were supposed to be in dreary Boston but had successfully moved the conference to Amsterdam in protest of the U.S. HIV immigration policies. The weather was great, and I bicycled every day to the conference center.
Mark Harrington’s plenary talk was the high point. Mark was able to present a scientific agenda for AIDS research by using the results of the biopsy of one of his lymph nodes as a basis for discussion. He showed the slides of the lymph node, “crammed with virus” and articulated research questions that were raised from the findings of the biopsy. It was a brilliant coming together of abstract science, policy, and the personal. I think that particularly for many of the researchers in the audience, this combination was very powerful.
For the activists, it was equally powerful because one of our own was talking about science in a very sophisticated way. The speech was very well received — with a standing ovation. Of course, the underlying story is a bit more convoluted, since Mark had never really had an HIV antibody test before. He had assumed that he was infected for some time, but had not actually tested. He would get his T cells checked every once in awhile, but that confirmatory piece of information was never dealt with.
By 1992, many of us were strongly encouraging Mark to get tested. So, rather than go to the testing site, like everyone else, Mark, in typical fashion, goes to St. Luke’s Roosevelt Hospital and has Donald Kotler remove a lymph node and send it to Tony Fauci’s laboratory. Mark’s speech in Amsterdam was not only an analysis of his lymph node biopsy; it was also a disclosure of his HIV status, though most people didn’t know that part of the story. Drama queen. …
Elizabeth Taylor made her annual big splash at the conference.
(I forgot to mention her speech at the amfAR reception in the Florence villa, where she made special mention of the activists on the street. I got to chat with her, a gay man’s wet dream. She decided to go jewelry shopping on the Ponte Vecchio and caused such a commotion that the police had to be called. In San Francisco, the reception was at Wolfgang Puck’s Postrio. Ms. Taylor made her first appearance after a very well publicized and very serous bout of pneumonia. She didn’t look too well. Her hair was in frenzy, though I don’t think that was the pneumonia. As always, she spoke well and forcefully about AIDS and the lack of a sufficient government response.)
In Amsterdam, the amfAR reception was at the Bourse, and Ms. Taylor wore an incredibly unfortunate white puffy dress with black polka dots on it. The press went berserk at her press conference. GMHC’s Richard Elovich managed to approach her and started talking about needle exchange with her. She got very interested and starting talking to the press about it. She and amfAR have been champions for needle exchange ever since. The U.S. government still does not put a dime into what is probably the most effective form of HIV prevention other than antiviral therapy to prevent mother-to-child transmission (MTCT) of HIV.
Amsterdam was not a milestone conference, but it was invigorating. Berlin was a milestone, but a very depressing one, sort of a bitter pill not to swallow. Berlin heralded the collapse of the antiviral treatment strategy that industry, academia and community were all pushing so hard.
In Berlin, two central ideas at the heart of the treatment strategy were disproved. The first was that early use of AZT was beneficial. This was not a surprise, as the results from the Concorde study only proved what most people with AIDS on AZT found out the hard way: the drug stops working when used alone. The recommendation to use AZT monotherapy based on a T-cell rise was flat out wrong and people who started AZT early only became resistant to it before it could really help the alleviate symptoms of AIDS-related illness and prolong survival. The drug got wasted.
But we pretty much knew this going into Berlin. The research and drug development establishment had moved on, pushing the notion of dual nucleoside therapy either to replace failing AZT monotherapy or as a starting regimen. Two drugs would be better than one — and overcome the possibility of resistance. The results of ACTG 155 (a study which compared AZT or ddC monotherapy to dual therapy with both drugs) were released in Berlin, and the study showed that the two drugs did no better than one in helping people failing on AZT monotherapy. The bug was still mightier than the drug.
This was depressing enough. What made it even more depressing — and infuriating — was that NIAID and the researchers involved in the study skewed their reports on the study results. Instead of presenting the results of the planned analysis, which showed the AZT+ddC combo as ineffective, an unplanned and statistically underpowered substudy analysis was performed which showed, in one of the arbitrary T-cell groupings, that patients on two drugs did “better” than the other patients.
This was hogwash. But when I got to Berlin, already knowing the outcome of the study, and picked up a copy of the NIAID press release, only the substudy analysis was described. And a wonderful spin about positive study results was promoted. My comrades and I went ballistic. We were upset enough about the bad results, but to also have to deal with lies about it was really infuriating. We talked to the communications people at NIAID, who didn’t have much to say. So we went straight to Tony Fauci, who listened to our concerns, agreed with our position, and ordered the press release rewritten to reflect the real results of the study.
Then we went to the presentation of the study results given by Margaret Fischl. Before the study was ever finished, Dr. Fischl was known to say, “I can tell which patients are on combo therapy. I know its working.” Dr. Fischl presented the best possible case for randomized blinded trials ever in the history of clinical research. She began her presentation by saying that she was going to present the first data showing the effectiveness of combo therapy. She started presenting the post hoc substudy analysis, and we all lost it.
Mark Harrington, Gregg Gonsalves, Derek Link and I were all there, and we got up and just started to scream that this was a pack of lies. Dr. Fischl got all flustered. I got up from my seat and went to the microphone and started yelling that she was not telling the truth. She responded and had to admit that the planned results of the study were the exact opposite of what she was presenting. We continued to yell. The audience knew we were right and started applauding our comments. Finally, we all walked out of the auditorium.
We left the conference site and starting walking down the street. We were all worked up. On the one hand, we were exhilarated from our yelling and getting a good response from the audience, feeling that we had prevented the false presentation from being successful. And we were angry. But we were also depressed, as we knew that this news signaled a very dark time for us, our friends, and for people with AIDS. The treatment strategy that was being so heavily promoted by industry, upon which the clinical research infrastructure had been built, the strategy for which we as treatment activists pushed so hard to get early access, the strategy that provided hope to people with HIV around the world, had just collapsed.
We kept walking down the street, chattering away about how outrageous the presentation was and how angry we were, and how pleased we were with our performance. We were really worked up and needed to calm down. We walked into this park, and there was this big grassy open area full of naked German sunbathers. It was just down the block from the conference center and there were all these naked people lying in the grass. We were a bit taken aback, sat down, and began to relax, the unusual scene capturing our attention and taking us away from the scene we had just been through.
The ACTG 155 presentation was a life-changing incident for me. Not only was the news upsetting personally, but also professionally. I felt I learned an important lesson, which is that as a treatment activist, to the greatest extent possible, let study results determine the policy positions I support and for which I advocate. My hopes and dreams and fears should not guide that which I advocate for.
I was as responsible as anyone in pushing for early access and use of both mono- and dual-therapy treatment. But that recommendation was premature, never based on reliable data, and ended up not only being wrong, but making the situation worse for tens, perhaps hundreds of thousands of people. How many people followed the recommendations for early use of antivirals and became resistant to the drugs before ever becoming sick? How many people suffered from debilitating side effects without getting any benefits from the drugs?
The FDA allowed overly broad indications to be approved and never followed through in demanding that post-marketing studies be carried out. The NIH led the way in developing recommendations for early use of drugs without planning appropriate clinical studies to determine if those recommendations were right. Industry promoted early use to both physicians and patients. And treatment activists, including myself, pushed hard to make this all happen. Our community organizations taught their clients to start treatment early. We all fell short of our responsibility to get the research done, instead we let our sense of desperation and desire for success get the better of us.
Worst of all, most of those involved did not learn from the mistake but, instead, repeated it over and over again: first and most cynically with 3TC; then again, with saquinavir and the rest of the protease inhibitors.
The treatment guidelines that came out after protease approval once again pushed for early treatment. The researchers responsible for designing and conducting the clinical studies to learn when to start treatment were the most aggressive advocates for guidelines recommending early treatment. Those guidelines made the studies impossible to carry out. Now we know the recommendations were wrong.
I became a pain in the ass at FDA hearings, ACTG meetings, and, most vociferously, as a member of the panel that developed the HAART treatment guidelines. I bitched and moaned about the lack of data, the need for when to start studies, the potential problems with the new and untested therapies. Most of the researchers did not want to hear it. They belittled my concerns about adherence, about the possibility of unknown side effects, and the need for “when to start” studies. It was the people with HIV on the panel, mostly Mark and I, who were always calling for more conservative guidelines, facing pressure not only from the virologists, but also from other community advocates, who were concerned that our caution and call for guidelines that only recommended that people with AIDS (not HIV) start therapy, would interfere with their advocacy for more ADAP and Medicaid funds.
My colleagues and I were certainly in favor of more ADAP funds, but we had lived through the mistakes of the past and did not want to see them repeated. We did not want these promising, life-saving drugs to be wasted. I was labeled anti-treatment, even though I was on treatment. My position was never anti-drug, but for a more cautious use of the drugs. It is a position that is now, finally, reflected in the guidelines. But how many people are unnecessarily drug resistant today who never should have popped a pill? How many suffer from facial wasting or high cholesterol? How many will have no treatment options left for them after their T cells drop below 200? After we finally succeeded in getting the guidelines changed, I quit the panel in disgust.
I came home from Berlin demoralized and depressed. I knew that there was little hope to offer the clients pouring into GMHC. I left the GMHC policy department and turned my attention to developing treatment education programs for clients. I felt that for some time to come our best defense would be OI prophylaxis and treatment. And teaching people about these options, particularly Bactrim, just might be the most important thing I could do. So I started developing workshops, counseling programs, and treatment fact sheets, while continuing to advocate for better and more responsible clinical research and drug development. And just as I saw so many friends, colleagues, and clients get sick and die, I also saw my own T cells drop below 200, my energy wane, and my health begin to deteriorate. In 1995 I began to consider going on disability. I never imagined that, only three years after Berlin, there would be another revolution in AIDS care. We were very lucky — or, at least, some of us were.
One night in Berlin, Mark Harrington, Gregg Gonsalves, Derek Link, Simon Watney and I went to dinner at the revolving top of the telecommunications tower. Everyone was in a good mood. There was a photo taken of all of us that sat on Gregg’s computer in our apartment for years.