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…
Annus Mirabilis: A Look Back at an Extraordinary Year for Basic and Clinical Research on AIDS — and the Questions Raised
TAGline • 1996A Look Back at an Extraordinary Year for Basic and Clinical Research on AIDS — and the Questions Raised Additional Surprises Expected The year 1996 witnessed seismic developments in AIDS research. On many fronts — the basic and the clinical, the biomedical and the behavioral — the very ground has shifted under our feet. It…
Review and Reform: OAR Advisory Panel Would Meld 12 Trials Networks into One and Requests Improved Institute Collaboration
TAGline • 1996OAR Advisory Panel Would Meld 12 Trials Networks into One and Requests Improved Institute Collaboration 15 Studies of Oral Interferon The six Area Review Panels (ARPs) of the NIH AIDS Research Program Evaluation Working Group of the OAR Advisory Council (known informally, after the group’s chairman Dr. Arnold J. Levine, as the “Levine committee”) included…
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,…
Science South of the Border: Feel Good Merck Meeting Leaves Everybody Agreeing, But Brazil Study Bodes Ill for the Future
TAGline • 1995Feel Good Merck Meeting Leaves Everybody Agreeing, But Brazil Study Bodes Ill for the Future On June 23 1995, members of TAG met with statisticians from Merck and outside statistical experts to discuss the methodological assumptions of its Phase III program for its protease inhibitor Crixivan. TAG’s Michael Ravitch, who was instrumental in setting up…
Tyranny of the Minority: What the New Republican Congress Will Mean for AIDS Prevention, Treatment and Research
TAGline • 1995What the New Republican Congress Will Mean for AIDS Prevention, Treatment and Research The Horror of ‘Block Grants’ On November 8, 1994 less than 25% of the American electorate voted for a new Congress dedicated to radically reducing the size of the federal government, attenuating its regulatory authority, and severely restricting its leadership role in…
Letter to David Kessler, US FDA
Letters • 1994Dear 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”).
AIDS Research at the NIH: A Critical Review Part I: Summary
Publication • 1992By 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 of the US Food + Drug Administration (FDA), to expanded access for drugs still under…
Long-Acting Technologies Resource Compendium
Our resource compendium is a non-exhaustive list of materials covering long-acting technologies to inform the hepatitis C, latent tuberculosis infection, and malaria scope of work under the LONGEVITY Project. Long-Acting Technologies Trials Tracker Illustrated Glossary for Long-Acting Technologies Select Scientific and Technical Publications General (2018) Unitaid and Medicines Patent Pool Intellectual Property Report on Long-Acting…A Lower Price for Rifapentine Is Just a Start – Communities Need More Than Discounts to Access TB Preventive Therapy
Statement / PressCivil society and community-based organizations issued this statement welcoming the availability of lower-priced rifapentine, which is an essential medicine for preventing TB.