Turn the Beat Around
Disco Queen Née Policy Gadfly Recalls Decade of Seismic Shifts in Clinical Landscape
Revolution of PragmatismAs doting friend, renegade attorney and seasoned circuit goer, Lynda Dee sometimes seems to have made a life out of rescuing buddies from their fixes. The boisterous, unflappable doyenne of John Waters-ville has, as she may well tell you herself, seen and done it all. The emergence of the AIDS epidemic, however, would test her talents as never before. And for the first time in her life she would find her fabled wits and wiles fall short of the mark. After her newly-wed husband succumbed to the disease in the late '80s, her colleague, close friend and sidekick Garey Lambert would follow nearly ten years later. "If only that bastard had hung on another couple of weeks," she sighs, alluding to his passing within mere days of Abbott's earth-shattering 2/96 Norvir survival data. People unaccustomed to her Italian-Irish tough-love mothering might understandably be taken aback, but for those who know and love and have worked with her over these past twelve years, the voice of her heart is as mellifluous as it is all consuming. She tells her story below.
My TAG experience is quite different from all the rest. First of all, I am a straight woman from Baltimore who has not lived in New York City since the early '80s -- pre-AIDS -- when life was one big party. My biggest worry in those days of sex, drugs and rock 'n' roll, or "sleaze" as we called it, was what to wear to 12 West or later to The Saint. I was the original party girl in a party dress, and fun was the name of the game.
During my years as a bar hag, I met scores of fabulous gay men from the Baltimore, Washington, Philadelphia, and New York as well as many other gay meccas around the country. (Yes, there was a circuit then too. And I knew we were having too much fun.)
In the early '80s, our lives started to change dramatically. People began to sicken and die -- sometimes in a matter of days. Many ignored the then underground dilemma and kept right on partying. I did too for a while. But all that was about to change.
In 1984, I got pregnant, got married and got back to Baltimore -- in that order. As luck would have it, my son died from sudden infant death syndrome (SIDS) in 1985. The following year, 1986, my husband was diagnosed with AIDS. He was admitted to the AIDS ward at Johns Hopkins a total of nine times before he died on July 16, 1987.
During his many hospitalizations, I watched him (and so many of my local friends) suffer and die from the ravages of unchecked HIV infection. They died of pneumonia, meningitis, CMV, MAI, diarrhea and by simply wasting, or from strange cancers like KS, and rare brain tumors -- but only after undergoing the tortures of endless intrusive medical procedures and oftentimes the curse of dementia. Many of them were destitute with no financial or emotional support. I felt so helpless: surely there must be something a pushy broad like me could do to help them and to keep them from dying (if for no other reason than to keep my own sanity.)
Pat Moran, Garey Lambert and I decided to start AIDS Action Baltimore to help our friends with financial assistance. Garey and I always believed that the answer would come from research. At that point, there wasn't even AZT. Through friends in New York, we began hearing about weird things like AL-721 and DNCB. We were also introduced to underground sources of literature and other alternative therapies. But none of it worked. People continued to drop like flies.
Soon after, ACT UP began to take angry shape. Mark Harrington, then a member of ACT UP's Treatment + Data Committee ("T and D"), and later a core member of the Treatment Action Group, wrote "A Critique of the ACTG." The work included an introduction by Jim Eigo and was edited by Ken Fornataro. I remember reading it in amazement. Who were these people? They had obviously spent hours studying the AIDS Clinical Trials Group, the preeminent national collaborative NIH/HIV research network. They knew a lot more about AIDS research than I did, and I wanted their knowledge.
My first real project with ACT UP/New York and T+D occurred in 1991 around the Roche tat inhibitor. Johns Hopkins is an important Phase I research site. Roche was about to begin Phase I accrual at Hopkins. It's hard to imagine in this day and age, but the protocol called for inclusion of women of child bearing age only if they would submit to surgical sterilization. Working together to eliminate this Nazi-like requirement forged a bond between us that exists to this very day.
I worked diligently with T+D's Derek Link to have the offensive prerequisite removed from the study protocol and to avert an ACT UP action at Hopkins. It is important to note that the tat inhibitor was a huge flop. Just imagine having been sterilized only to find that the drug was completely ineffective.
After this, my ties with T+D were cemented. Later, I would become what I jokingly refer to as "the Roche girl," working in very close contact with Karl Owens who was the T+D Roche point person at the time. It was during this period that we learned (the hard way) that a stagnant drug company community advisory board (CAB) is not necessarily better than no CAB at all -- for reasons that seem obvious today. Back in 1991, though, we were all still learning.
Our next experiment was the Community Constituency Group of the ACTG. ACT UP led the charge in 1990 at the Bethesda (Maryland) campus of the NIH with its "Storm the NIH" action, attended by hundreds of protesters from across the country. I'll never forget TAG cofounder Peter Staley on the roof of one of the NIH buildings. We were like an army that day, and we got results. After the NIH action, NIAID Director Tony Fauci decided to let the community into the NIH research process in an official capacity. We took the bull by the horns, and the affected community is still an integral part of NIH policy making. We set the precedent that has since been followed by cancer, Alzheimer's and many other types of health care activists.
Overall, I firmly believe that our involvement with the NIH has been a resounding success. It has not been without lumps and bumps, and we have not won every battle. But we are officially in for keeps. That will never change, thanks to pioneering treatment activist groups like TAG.
T+D-ers like Mark Harrington were founding members of what became the CCG of the ACTG. Mark and I became great personal friends. He helped mentor me in opportunistic infections. He was the first CCG-er on the old ACTG Opportunistic Infections Committee. He also groomed me to take his place. Remember, in the old days opportunistic infections (PCP, CMV, MAI, toxoplasmosis, cryptosporidiosis, KS, PML and the lot) were what really killed people. At the time, the OI Committee was doing all the ACTG's heavy lifting without meaningful support from the old "Gang of Five," the antiviral moguls who ran the show: Drs. Larry Corey, Margaret Fischl, Marty Hirsch, Tom Merigan and Doug Richman.
We had many important victories in our collaborations with the OI Committee that greatly advanced OI infection research, not the least of which was the "Countdown 18 Months" project. "Countdown 18 Months" was the brainchild of T+D's Garance Franke-Ruta. She believed that unlike HIV, the many OIs responsible for the tortures of Job that were actually killing people with HIV were in fact treatable. Treatable, and she believed, with a panoply of drugs both new and old which could be further studied and/or made available within an 18 month time period.
Johns Hopkins principal investigator John Bartlett, a prominent Infectious Disease researcher, was the first big name physician to publicly support T+D's visionary proposal. And the rest is history: Many of the major OIs responsible for actually causing the deaths of legions were conquered within 18 months.
We exerted pressure inside and outside the ACTG to ensure that more resources would flow to the OI Committee. Believe you me, this aspect alone was no easy task. The powers that be had most of the resources tied up with more "sexy" HIV protocols, none of which really changed the standard-of-care until the advent of triple combination therapy and the protease inhibitors.
It was also necessary for us to be involved in changing protocol entry criteria so that people with, for instance CMV, a sight-threatening eye condition, could be included in antiviral protocols without foregoing CMV treatment. Can you imagine choosing between your sight and an AZT protocol for the sake of some ivory tower research question? We had a very difficult task in those early days. We were often treated like Martians -- interloping Martians at that. But we trudged on, continuing the fight.
After OI treatment, we championed OI prevention. At this point, one former ACTG chieftain even complained about losing the endpoints of a trial because preventing Pneumocystis pneumonia, the largest killer of people with AIDS in the United States, would prolong the length of antiviral trials! Believe me, these were not the good old days. These considerations are taken for granted today, but they did not come easy. They required long, hard work and strategic planning. We learned and we became very successful with the formula of being prepared and learning great amounts of scientific information -- which in and of itself was no easy task for a bunch of liberal arts majors. Then, we worked tirelessly to implement our policy goals.
I was soon elected by the CCG to the ACTG Executive Committee, a position formerly held by T+D's David Barr. At this point, Mark Harrington was elevated to what was then called the "Primary Infection Committee" (and is now known as the HIV "RAC," for Research Agenda Committee). Together, we collaborated on many projects. I am extremely proud of our many accomplishments. Things that are included in protocols today, such as statistically significant numbers of female participants and quality-of-life assessments, were unheard of when we began our NIH journey.
I guess I can be best described as part of the second wave of community activists in the ACTG. With much guidance from T+D, I was one of the implementers, a relentless mouthpiece and detail person who tried to help make the ACTG a more streamlined operation, instead of an inefficient Leviathan and a sandbox for exploring erudite -- but clinically irrelevant -- scientific questions.
ACTG scientists are "collegial" types who don't like to tread on each others toes. In reality, this has a great deal to do with who will be sitting on their next grant review panel, judging their next project or determining their future funding. In any event, it took a lot of strategizing and arm twisting to convince the ACTG that it was essential to dump non-performing sites and protocols that were not enrolling -- or which were no longer relevant because it had taken so long to get them up and running. Many of these issues still plague the ACTG to this day, especially the protocol development time factor. But in those early days we planted the seeds of change and they continue to be cultivated today.
It was during this period that T+D officially broke away from ACT UP. By this time, ACT UP/New York had become paralyzed by anarchy, "... and the revolution devours itself." But TAG's pragmatic revolution was just beginning. In 1992, Mark Harrington and Gregg Gonsalves, both core TAG-ers, wrote the two part masterpiece, The NIH: A Critical Review, which carefully outlined and critiqued all AIDS research being conducted at the NIH. (As you might imagine, there was little or no collaboration among Institutes.) Once again, TAG identified another glaring omission in the NIH's AIDS research agenda.
Mark and I mentored Michael Marco who was one of the pioneers in AIDS-related cancer research. He was one of the first activists to forge a collaboration between NIH Institutes, namely, NIAID and the National Cancer Institute. Michael also did groundbreaking work with hepatitis C advocacy, again involving researchers from many disparate disciplines. His work with AIDS-related liver disease is continued today by new TAG-er Tracy Swan.
I became one of TAG's original Board members, working with the same great minds that initially propelled our new vision for AIDS research. I proudly remain a member of the TAG Board. And we are still moving the AIDS research agenda forward with government, with industry and now throughout the HIV ravaged Third World.
We continue to collaborate on important national and international strategies. TAG is a great ally of South Africa's Treatment Action Committee (TAC), which has been responsible for so many life-saving changes in the world's most HIV-devastated country. Through the TAG/TAC connection, AIDS Action Baltimore was able to make a $10,000 contribution to this group of South African activists. With this mere pittance, the Treatment Action Campaign was able to import generic fluconazole into South Africa from Thailand. (Fluconazole is the generic form of Diflucan, the treatment for fungal infections that cause the most disease and death in South Africa. Diflucan is manufactured by Pfizer, the world's largest drug company.)
With this purchase of fluconazole from a Thai generic drug manufacturer (and a public relations campaign to accompany it) -- all funded with this tiny $10,000 contribution, TAC obtained South Africa's first exception to President Mbeki's criminal refusal to acknowledge his country's AIDS epidemic. This was an enormous victory for a country where upwards of 20 percent of its citizens are HIV-infected.
More recently, TAC sued the South African government over the right of HIV-positive pregnant women to receive antiviral therapy during their pregnancy -- and won. Because of this victory, HIV-infected mothers will finally have the right to receive antivirals that will prevent mother-to-child transmission of HIV. Together, we are winning major battles in incremental steps.
And so the story goes ... and continues. The saga is far from over. Just when we thought things would be brighter, resistance to antiviral "cocktails" is gaining on us. Mercifully, new drugs are in the pipeline. But, enter first, "compassionate conservative" rhetoric notwithstanding, an unsympathetic Republican administration. At this very moment, à la the Imperial Presidency of impeached right-wing hero Tricky Dick Nixon, the Bush Administration is conducting audits of federally funded AIDS service organizations that dared to heckle HHS Secretary Tommy Thompson at the 14th International AIDS Conference in Barcelona this summer.
And so the fight continues, with TAG in the forefront. One of my current TAG projects involves membership in a new national grass roots group that is fighting to obtain more money for the essentially flat funded AIDS Drug Assistance Programs (ADAPs) across the nation. TAG is also a member of the Fair Pricing Coalition which is battling to keep drug prices level so that ADAP increases are not automatically devoured by the price increases constantly initiated by greedy drug companies.
Once again, TAG has proven its visionary mission by championing the AIDS Treatment Activist Coalition (ATAC) with many other national partners like the Gay Men's Health Crisis, the National Minority AIDS Council and other local community based organizations like AIDS Action Baltimore. So far, we have conducted two successful "teach-ins" in an effort to mentor the treatment activists of the future. We're still here. Still battling, day in and day out. For this, TAG's 10-year commemorative year, I have taken the time to memorialize some of our historical successes, to prove how national organizations working with local groups can produce significant change that benefits so many real people with HIV in their everyday lives; and, to congratulate our team on the anniversary of its first decade on a job well done.
This article was provided by Treatment Action Group. It is a part of the publication TAGline.