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Member
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Join Date: Oct 2006
Posts: 492
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Member
Join Date: Oct 2006
Posts: 492
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From Impure Science by Steven Epstein, which I found at:
http://www.escholarship.org/editions...;brand=ucpress
..."As treatments activists followed, or contributed to, the debates surrounding AZT, they also devoted increasing attention to new drugs, such as ddI and ddC, that appeared likely to be the next additions to the therapeutic armamentarium of HIV antivirals. Since these drugs were chemically related to AZT, few thought that any of them would be an ideal therapy; but nothing else was anywhere near approval, and ddI and ddC at least showed promise. Perhaps they could provide alternatives for those who couldn't tolerate AZT's toxicity or for those who, over time, had stopped benefiting from AZT. Or perhaps some combination of these nucleoside analogues would prove more effective than AZT alone. Throughout 1989 and 1990, as AIDS treatment activists pursued the approval of these drugs as well as others that treated opportunistic infections, they became ever more enmeshed in the minutiae of clinical trial design—a set of topics that, increasingly, they would debate face-to-face with researchers and officials from the NIH and the FDA. This direct engagement with the terms of clinical research would both establish the scientific credibility of the activists (or certain of their representatives) and ultimately alter the pathways by which specific treatments came to seem credible in different quarters.
As with the parallel track initiative, a turning point came with the Montreal conference in the summer of 1989. ACT UP/New York had distributed an AIDS Treatment Research Agenda blasting the ACTG program and detailing the activists' demands: more compounds in clinical trials, an end to placebo-controlled trials that required "body counts" to prove efficacy, greater access to clinical trials by all social groups affected by the epidemic, and more flexible protocols with broader entry requirements. Susan Ellenberg, the chief biostatistician assigned to the ACTG trials at NIAID, recalled seeking out the ACT UP/New York document in Montreal in response to her own curiosity: "I walked down to the courtyard and there was this group of guys, and they were wearing muscle shirts, with earrings and funny hair. I was almost afraid. I was really hesitant even to approach them. …" But after picking up the document, Ellenberg quickly found herself "scribbling madly in the margins." Though most of her marginal notes reflected dismay at activists' failure to understand, "there were many places where I found it was very sensible—where I found myself saying, 'You mean, we're not doing this?' or 'We're not doing it this way?'"[51]
Ellenberg brought the ACT UP report back to Bethesda and shared it with her colleagues in a working group of statisticians who had been meeting to discuss challenges posed by the AIDS epidemic. "I've never been to such a meeting in my life," said Ellenberg. According to David Byar, the chief of the biometry branch of the Division of Cancer Prevention and Control at NCI: "I think anybody looking at that meeting through a window who could not hear what we were saying would not have believed that it was a group of statisticians discussing how trials ought to be done. There was enormous excitement and wide divergence of opinion."[52] Soon afterward, with Fauci's consent, Ellenberg expanded her Statistical Working Group by inviting representatives from ACT UP and other community-based organizations to participate"....
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