Federal 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…
When Two Prophylaxis Studies Declare Opposite Findings, Clinicians And Their Patients Are Lost in the Quandary A Question of Patient Management The most important CMV data to come out of the recent ICAAC conference was the late-breaking presentation of CPCRA…
How 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…
Tracking Down the Elusive CD8 Cell Factor In two separate reports, one in Science and one in Nature, researchers at the Paul Erlich Institute in Langen, Germany and at Dr. Robert Gallo's new lab at the University of Maryland announced…
35th Interscience Conference Unveils Results from Several Important Clinical Studies Protease and Paradox Early last month, TAG members Spencer Cox, Mark Harrington, Tim Horn and Michael Marco headed home after attending the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy…
AIDS Treatment Activists from Across the Land Gather to Share Expertise and Ideas "A conversation long overdue" TAG was the proud co-sponsor of the first national gathering of AIDS treatment activists, the National AIDS Treatment Advocates' Forum (NATAF), in Los…
FDA 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 )…
Community 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…
Despite Pressure to Crown Combo King, 175 Investigators Soft-Pedal Combination Nucleoside Study's Startling Findings The Didanosine Surprise Even skeptics can find something to enjoy in the surprising results of AIDS Clinical Trials Group (ACTG) protocol #175. Last month's TAGline ("Combo…
In September, the Senate Appropriations Committee voted to maintain a consolidated appropriation for NIH AIDS research, sparing the Office of AIDS Research from becoming a paper tiger at the start of the next fiscal year. The Senate Committee's actions, however,…