Virus Hunters by Amy Cherrix

Author:Amy Cherrix
Language: eng
Format: epub
Publisher: HarperCollins
Published: 2024-07-05T00:00:00+00:00

Chapter 48

Parallel Trials

The ganciclovir controversy was a pivotal moment in the fight for people with AIDS. It demonstrated what the activists had been saying all along: the strict guidelines that governed experimental drug trials could not be written as one-size-fits-all policies because they risked excluding so many of the people the drugs were designed to help. Access to clinical trials was too limited. The activists wanted to make the experimental HIV/AIDS drugs available to people outside the clinical trials, arguing that race, class, gender, income, age, and health status should not be barriers to experimental treatments for any person who needed care. According to ACT UP member Mark Harrington, “People of color, women, poor people, rural people, IV-drug users, [the incarcerated], hemophiliacs, and children with HIV were routinely excluded.” In the summer of 1989, activists Peter Staley, Jim Eigo, and Mark Harrington met with Dr. Fauci at his office to propose a solution to the problem. It was called parallel trials. The program created large, separate “trials” that ran parallel to the conventional clinical trials. With a simple phone call to a toll-free number, a physician from anywhere in the country could enroll their patient. In exchange for access to the experimental drugs, parallel trial participants agreed to share basic data about the drugs’ effectiveness with the FDA. Fauci and the activists hammered out the details and, a few days later, Fauci announced his support of the program in the New York Times. The FDA followed Fauci’s lead, implementing the parallel trial program “on a case-by-case basis” at the agency. Thousands of people across the US gained access to experimental drugs as a result of ACT UP’s parallel trials program.

Download

Copyright Disclaimer:
This site does not store any files on its server. We only index and link to content provided by other sites. Please contact the content providers to delete copyright contents if any and email us, we'll remove relevant links or contents immediately.