- Open Access
Preface: Evolving Ethical Issues Over the Course of the AIDS Pandemic
Public Health Reviewsvolume 34, Article number: 2 (2012)
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.
Office of NIH History, National Institutes of Health. In their own words… NIH researchers recall the early years of AIDS. NIH. Available from URL: http://history.nih.gov/NIHInOwnWords/index.html (Accessed 22 June, 2012).
National Institute of Allergy and Infectious Diseases. Directors page. NIAID. Available from URL: http://www.niaid.nih.gov/about/directors/Pages/default.aspx (Accessed 22 June, 2012).
Dr. Anthony S. Fauci is Director of the National Institute of Allergy and Infectious Diseases (NIAID). Dr. Fauci was appointed Director of NIAID in 1984. He oversees an extensive research portfolio of basic and applied research to prevent, diagnose, and treat infectious diseases such as HIV/AIDS and other sexually transmitted diseases, influenza, tuberculosis, malaria, and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma, and allergies. Dr. Fauci is a member of the National Academy of Sciences, the American Academy of Arts and Sciences, the Institute of Medicine (Council Member), the American Philosophical Society, and the Royal Danish Academy of Science and Letters, as well as a number of other professional societies. He has received a number of prestigious awards including the Presidential Medal of Freedom, the National Medal of Science, and the Lasker Award for Public Service. He serves on the editorial boards of many scientific journals; as an editor of Harrison’s Principles of Internal Medicine; and as author, coauthor, or editor of more than 1,200 scientific publications, including several textbooks.