Shakedown: Federal Budget Shutdown and Flood of New Approvals Combine to Threaten Access to FDA-Approved AIDS Drugs
TAGline • 1996Federal Budget Shutdown and Flood of New Approvals Combine to Threaten Access to FDA-Approved AIDS Drugs Bankrupt ADAPs In the fall of 1995, the U.S. Food and Drug Administration (FDA) approved several expensive new AIDS drugs, including oral ganciclovir for cytomegalovirus (CMV) prophylaxis, 3TC (Epivir) in combination with AZT for HIV infection and the protease…
Viral Load in Vancouver: A Report from the 11th International Conference on AIDS
Publication • 1996A Report from the 11th International Conference on AIDS Vancouver, British Columbia, 8-11 July 1996 By Mark Harrington From the Introduction The year 1996 has brought a sea change in AIDS research and treatment. Three major factors have contributed to this sea change: a new understanding of viral pathogenesis, new and powerful antiretroviral treatment regimens,…
Access Versus Answers
Publication • 1996From 1996 by Mark Harrington After Berlin, no one could credibly believe that AIDS drug development was on track. Indeed, it looked likely that the various initiatives AIDS activists had worked with FDA, NIH and industry to develop were actually impeding the gathering of useful information about safety and efficacy. The first generation of anti-HIV…
Position Paper on Accelerated Approval for INVIRASE Brand Saquinavir
Publication • 1995by Mark Harrington 7 November 1995 In September, 1994, the Treatment Action Group spelled out the following conditions as necessary for our support of an accelerated NDA for an HIV protease inhibitor: Adequate and well-controlled clinical endpoints studies are well underway and likely to show whether the drug can prolong disease-free time or survival; Adequate…
Giving Away the Farm: How Corporate Cynicism, Savvy Schmoozing and Relentless PR Paved The Way to Unqualified Approval for Two New Antiretrovirals
TAGline • 1995How Corporate Cynicism, Savvy Schmoozing and Relentless PR Paved The Way to Unqualified Approval for Two New Antiretrovirals Grave disservice to the public health The FDA’s Antiviral Drug Products Advisory Committee met on November 6-8 in a marathon session to consider accelerated approval for Glaxo Wellcome’s Epivir brand lamivudine (3TC) and Hoffmann-La Roche’s Invirase brand…
Random Gleanings: FDA Antiviral Drugs Advisory Committee; Ambushed in the FDCs; Expanding T cells: Koenig weighs in on Good CTLs/Bad CTLs debate
TAGline • 1995FDA Antiviral Drugs Advisory Committee met earlier this month (November 6-8, 1995) to review approval applications for Roche’s protease inhibitor saquinavir (trade name Invirase ), Glaxo-Wellcome’s 3TC (lamivudine, trade name Epivir ) and Bristol’s d4T (stavudine, trade name Zerit ). The committee recommended approval for Roche’s saquinavir for use in combination with other nucleoside analogs…
Kiss My Access: Community Envoy to Food and Drug Panel Urges Caution in Approving New Anti-HIV Therapueutics and in Providing Early Access
TAGline • 1995Community Envoy to Food and Drug Panel Urges Caution in Approving New Anti-HIV Therapueutics and in Providing Early Access “Badgering, hijacking activists” The FDA recently convened hearings regarding its Accelerated Approval program and the future use of changes in plasma HIV-RNA as surrogate endpoints in AIDS clinical trials (September 6-7, 1995). TAG’s Peter Staley, representing…
Hope for Sale: Like the Wings of Icarus, Treatment Hype Sweeps Its prey Upward to the Heavens, Then Plucks Them Down Into icey Waters
TAGline • 1995Like the Wings of Icarus, Treatment Hype Sweeps Its prey Upward to the Heavens, Then Plucks Them Down Into icey Waters Dividends from Desperation While all the Western world beats its chest, proudly promoting the renewed, if disputatious, promise of (3TC) nucleoside combinations furiously FAXed around the world late last month; with nightly news teams…
FDA Regulation of Anti-HIV Drugs: A Historical Perspective
Publication • 1995August 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 available information regarding the clinical utility of those drugs at the time of their approval.…
Pathogenesis + Activism, Speech by Mark Harrington
Publication • 1992Speech 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 last met in Florence – to Charles Barber, Daniel Sotomayor, David Byar, David Lopez, Donald…