Preface: Evolving Ethical Issues Over the Course of the AIDS Pandemic

Abstract

In the early years of the AIDS pandemic, one of the major ethical considerations facing frontline AIDS medical researchers was the issue of patient accessibility to clinical trials. This issue loomed large because at the time, there were no licensed antiretroviral drugs to treat people with the disease, there were only experimental drugs being tested in clinical trials.¹ Clearly, the standard approach to the design of clinical trials—that is, rigid eligibility criteria as well as the strict regulatory aspects that attend clinical trial investigations and drug approval—was not well-suited to a novel, largely fatal disease such as this with no effective treatments, and we had many intense discussions about how to make that approach more flexible and ethically sound.

One example, which I and others worked closely with the AIDS activists to develop, was called a parallel track for clinical trials. The parallel track concept, which the United States Food and Drug Administration ultimately came to support, meant that there would be the standard type of highly controlled admission criteria and data collection for the clinical trial of a particular drug. In parallel, however, the drug also could be made available to those who did not meet the trial’s strict admission criteria but were still in dire need of any potentially effective intervention, however unproven, for this deadly disease. So that to me was a prevailing ethical issue in the early years of the AIDS pandemic—the need to re-examine the justification or not of the rigidity and exclusivity of our clinical trial process. The ultimate resolution of the dilemma was to create this parallel track approach where you could be more flexible in letting people have access to experimental drugs.