Trials and Truth-Making
In the end, it remains somewhat unclear precisely what approaches to, or conceptions of, science activists would like to promote. Are AIDS activists really just trying to "clean up" science by eliminating "biases" that academic researchers are introducing? Or to supplant "clean science" with something that answers to different epistemological and ethical aspirations? It may be the tension between these conflicting and ambiguously defined goals, more than anything else, that characterizes the activist engagement with the AIDS research effort. The attempt to wrestle with such ambiguities is apparent in activists' views of the randomized clinical trial as a technology for producing knowledge. Generally speaking, activists have rejected a narrow, positivist conception of the clinical trial as a controlled laboratory experiment, pure and simple. But not many of them are prepared to replace the randomized clinical trial with an entirely different method of assessing drugs.
By contrast, in her analysis of controversial cancer trials, Evelleen Richards concludes with a call to curtail our reliance on the randomized clinical trial. Since the notion of a "definitive" clinical trial, she claims, is a myth that primarily serves the interest of professional legitimation, it would be better "to learn to live with the reality of uncertainty" and to introduce political, ethical, and subjective criteria into the evaluation of treatments. This "implies a more prominent role for non-experts, for patients and the public at large, in the processes of assessment and decision making. …" Quite similarly, AIDS activists have emphasized the artifactual and historical character of the clinical trials methodology, and they have placed a spotlight on the perception of the patient as a genuine participant in clinical research and not just the object of study. Yet—perhaps especially as they have become enculturated into the biomedical research process—most AIDS treatment activists share with doctors and researchers a profound investment in the belief that the truth about treatments is, in principle, knowable through some application of the scientific
method. Though many in the AIDS movement have at particular moments argued in favor of tolerating uncertainty as the necessary tradeoff for access to experimental drugs, in the end few activists, and perhaps few people with AIDS or HIV infection, are sanguine about the prospect of "[living] with the reality of uncertainty." This is not surprising, since activists and people with AIDS and HIV are confronted daily by a burning need to know whether given treatments "work" or not. The activist critique of the randomized clinical trial unseats that methodology from the pinnacle on which it is sometimes placed, but it also assumes (I think rightly) a greater role for such trials than analysts such as Richards would recommend.
Just how radical, then, is the critique of science offered by AIDS treatment activists? The question is hard to answer, especially as positions shift over time and vary significantly between individuals and groups. But what sparks the ambivalence between radical and reformist perspectives on science are just these painful ironies that vex efforts to influence clinical practice. On one hand, engagement with clinical research has always been driven by the dictates of expediency and dire need: activists have no time for the leisurely pursuit of truth; they'll settle for today's best guess. Yet on the other hand, treatment activists—particularly the New Yorkers with the Treatment Action Group, but to some extent nearly all of them—have increasingly become believers in science (however understood), and they desperately want clinical trials to generate usable knowledge that can guide medical practice. "My doctors and I make decisions in the dark with every pill I put in my mouth," complains David Barr, and this is not an easy way to live.
Insofar as activists want to rely on the knowledge generated by clinical trials, they must wrestle with the consequences of their own interventions. Do such actions enhance activists' capacity to push clinical research in the directions they choose? Or do activists and researchers alike become subject to the unintended effects of their words and deeds, trapped within evolving systems whose trajectories no one really controls? Here is a worst-case scenario of the spiraling effects of community-based interventions in the construction of belief in antiviral drugs—a caricature sketch, to be sure, but one that combines elements from a number of cases: Drug X performs well in preliminary studies, and a NIAID official is quoted as saying that X is a promising drug. The grassroots treatment publications write that X is the up-and-coming thing; soon everyone in the community wants access to
X, and activists are demanding large, rapid trials to study it. Everyone wants to be in the trial, because they believe that X will help them; but researchers want to conduct the trial in order to determine whether X has any efficacy. Those who cannot get into the trial demand expanded access, while others begin importing X from other countries or manufacturing it in clandestine laboratories. As X becomes more prevalent and emerges as the de facto standard of care, physicians begin to suggest to patients that they get hold of it however they can. Meanwhile, participants in the clinical trial of X who fear they are receiving a placebo or an inferior drug mix and match their pills with those of other participants. When the trial's investigators report potential treatment benefits, activists push for accelerated approval of X, leaving the final determination of X's efficacy to postmarketing studies. But who then wants to sign up for those studies, when everyone now believes that the drug works , since, after all, the FDA has licensed it and any doctor can prescribe it?
In seeking to control this troubling escalation, the recent moves on the part of TAG activists to extricate themselves from the "hype cycle" seem particularly important. "One disturbing but inevitable result of the urgency engendered by the AIDS crisis," wrote Mark Harrington in late 1993, "is that both researchers and community members tend to invest preliminary trials with more significance than they can possibly bear." To the extent that activists can develop a critique of this phenomenon and communicate the relative uncertainty of such trials to the broader public of HIV-infected persons, it may be possible to imagine a clinical trials process that more fully reflects the interests of those who are most in need of answers.
On the other hand, the turn toward positivism in the statements of some TAG members—the emphasis on "rigor," "objectivity," and "rule-following" as the guarantors of success —seems not only inadequate but inconsistent with the goal of not making more of trial results than we ought. As the earlier optimism about finding solutions to AIDS has given way to disappointment or resignation, it is understandable that some activists would find the lure of "good science" vastly preferable to the subordination of scientific judgment to the exigencies of the moment, however profound. The trick, though, is to encourage trials that are both ethical and well designed without reifying the method so as to suggest that such trials will provide degrees of certitude that they simply cannot provide. As Brian Wynne has suggested, the solution cannot be to further the myth that clinical
knowledge-production is a fully rule-bound enterprise. Rather, the only way forward is to open the "black box" of clinical research, expose the uncertainty and the value choices, and then convince people of the considerable importance of participating in such research even after they understand just how messy it truly is and how bounded is the usability of the knowledge produced by it.