Rescuing Accelerated Approval: Moving Beyond the Status Quo
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…
The KS Project Report
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…
Letter to David Kessler, US FDA
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”).
The Crisis in Clinical AIDS Research
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…
Basic Research on HIV Infection: A Report From the Front
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…
Pathogenesis + Activism, Speech by Mark Harrington
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…
AIDS Research at the NIH: A Critical Review Part II: The NIH, A User’s Guide
By Gregg Gonsalves and Mark Harrington VIII International Conference on AIDS, Amsterdam, the Netherlands, July 20, 1992 From the Introduction The NIH, A User's Guide, is the final section of our report on the AIDS programs of the National Institutes…
AIDS Research at the NIH: A Critical Review Part I: Summary
By Gregg Gonsalves and Mark Harrington VIII International Conference on AIDS, Amsterdam, the Netherlands, July 20, 1992 From the Introduction Since 1987, the activist critique of AIDS research has worked its way back: from drug approval at the regulatory level…