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Publications 1994

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tagline 1994

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

Letter to David Kessler
June 16, 1994 - Dear Commissioner Kessler: We are 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 KS Project Report: Current Issues in Research & Treatment of Kaposi's Sarcoma
July 1994
by Michael Marco with Martin Majchrowicz

In October 1993, the National Institute of Allergy and Infectious Diseases (NIAID) published its HIV/AIDS Research Agenda . Only two pages were dedicated to AIDS oncology research. NIAID stated that, "While advances have been made in the treatment of KS, no optimal or adequate long-term management options have been defined. There is no curative therapy for KS at the present time." (NIAID 1993)

There is no mention of the fact that AIDS-related malignancies -- with KS being the most common -- now complicate the lives of at least 40% of patients living with AIDS (Peters 1991). Recent evidence suggests that the incidence of KS, particularly in late-stage AIDS patients, may be increasing as more people survive OIs such as PCP and MAI, or avoid them altogether through the use of prophylaxis. Much of this progress with OIs only happened when activists, abetted by Congress, insisted that NIH increase the resources devoted to OI research. This must happen now if progress is to be made with KS and other AIDS-related malignancies.