August 1995 By Spencer Cox Edited by Mark Harrington & Bruce Schackman From the Executive Summary Over the period in which FDA has reviewed and regulated anti-HIV therapies, there has been a substantial decline in the quality and quantity of…
Current Issues in Research and Treatment of AIDS-Associated Lymphoma by Michael Marco May 1995 From the Introduction Lymphomas are not new. They pre-date AIDS for many many years. We have known for some time that organ transplant patients and others…
February 1995 By David Barr, Spencer Cox, Gregg Gonsalves, Mark Harrington, Derek Link, Michael Ravitch & Theo Smart Edited by Mark Harrington for the National Task Force on AIDS Drug Development From the Introduction The development of protease inhibitors offers…
A Report to the FDA Antiviral Drugs Advisory Committee By Spencer Cox, Dennis Davidson, Gregg Gonsalves, Mark Harrington, Carlton Hogan, Rebecca Pringle Smith 12-13 September 1994 Silver Spring, Maryland Moving Beyond the Status Quo: A Statement of Principles on AIDS…
Current Issues in Research & Treatment of Kaposi's Sarcoma by Michael Marco with Martin Majchrowicz July 25, 1994 From the Introduction In October 1993, the National Institute of Allergy and Infectious Diseases (NIAID) published its HIV/AIDS Research Agenda . Only…
Dear Commissioner Kessler: We're writing with reference to FDA’s plans to regulate the development of a new class of anti- HIV therapies known as “protease inhibitors,” and with specific reference to possible regulatory decisions regarding Hoffmann-LaRoche, Inc.’s Ro 31-8959 (“saquinavir”).
By Mark Harrington December 1993 From the Introduction In November 1989, AIDS activists attended our first AIDS Clinical Trials Group (ACTG) meeting. We were not given a warm welcome. After many months of struggle, activists and people with HIV were…
June 1993 Prepared by Gregg Gonsalves From the Introduction For over five years now, AIDS activists have focused their energies on clinical research and the drug development process, hoping to speed promising therapies for HIV infection to the people who…
Speech by Mark Harrington Presented at VIII International Conference on AIDS, Amsterdam, July 22, 1992 I would like to dedicate my remarks today to my colleagues in the struggle against AIDS who did not survive the year since this group…