In today’s episode of More than Meets the IRB, we hear from awardee of the Presidential Medal of Honor Dr. Anthony Fauci on some of the ethical challenges he faced in addressing the HIV/AIDS pandemic. It’s an engaging and wide-ranging narrative: from Fauci’s publicly denouncing the FDA’s process of delivering certain drugs to individuals to his receiving presidential acknowledgement for a creative idea of how to bring drug access to these patients.
Dr. Anthony Fauci has been the director of the National Institute of Allergy and Infectious disease for over 30 years . He has played a critical role in research of HIV/AIDS and other immunodeficiencies.
Early Drug Development
When the government didn’t make available certain drugs quickly to the community of HIV/AIDS patients, they would acquire them through illicit groups known as Buyers Clubs (as featured in the 2013 film The Dallas Buyers Club).
We learn about the iconic randomized control trial of AZT as well as the treatment of patients with AIDS and similar diseases. A double-blind placebo controlled trial, published in the New England Journal of Medicine in 1987, successfully demonstrated the effectiveness of AZT. The delivery of the drug to those that needed it wasn’t easy (or approved) so the researchers came up with a creative solution on how to provide AZT to those who so urgently needed it.
What is Parallel Track?
Parallel Track denotes access to unproven drugs after a proven drug exists. It makes available (with appropriate informed consent) experimental drugs to those who do not meet the requirements for a drug trial for various reasons, such as geographic or demographic incompatibility.
Parallel Track represented a way to get HIV/AIDS drugs to the gay community outside the confines of a randomized controlled experiment, but doing so violated the rigid and durable guidelines of the regulatory bodies; Dr. Fauci recalls that “the federal government and the FDA thought this was anathema.” The passion of the activists and Dr. Fauci’s experience meeting with patients convinced him that this extraordinary measure was both appropriate and necessary for dealing with the AIDS crisis.
“Either you go blind or you die” –HIV/AIDS Patient
During the AIDS crisis, the rigor and ingrained nature of drug development regulations came up against the urgency and vigor of the activist community. In Dr. Fauci, this conflict caused a “sea change in my attitude toward the flexibility versus the rigidity of the scientific and regulatory community: that is, my relating to and putting myself in the place of a patient or a potential patient…. That was brought home to me by the AIDS activists.”