Public Hearings At FDA Juxtapose Old Cries of Access With Those of Integrity, Accountability Paean to the 'Greater Good' The FDA recently held hearings about the perceived shortcomings of its Accelerated Approval program. Among many soul-searching and provocative addresses delivered…
Improved Clinical Outcomes Wrought By Immunosuppressive Medicine and Second-Rate Immune Responses - Where Will It All End? When Good 'Trapping' Is Bad Craig Sterritt has been tracking down the latest AIDS pathogenesis research - in addition to his project researching…
Research Paper Details Advances, Obstacles In The Treatment of Kaposi's Sarcoma Unwarranted Nihilism TAG's Michael Marco and APLA's Marty Majchrowicz debuted their joint collaboration, "The KS Project Report: Current Issues in Research and Treatment of Kaposi's Sarcoma" at the X…
Shot Down Early On, Merck Scientists Test Higher Doses And Combinations, Hoping for Success Production Problems Loom The Merck protease inhibitor, L-524, has recently begun to generate a lot of talk. The data from the first controlled study in 70…
Yokohama Roundtable Examines Treatment Quandary Facing Patients, Clinicians Alike Burning Last Lightbulb At Noon Mark Harrington was invited to speak at the Thursday afternoon roundtable discussion in Yokohama, "When To Start Antiretroviral Treatment." The session was moderated by Australia's BW…
Series of Research Papers Take To Task Would-Be Discoverers Of Cytokine Switch Scrutinizing the Knock-out Mice It was the big story out of Amsterdam, summer of 1992. Later that fall at the Vth International Vaccine Cooperative meeting in Chantilly, VA,…
Garbage In, Garbage Out; Could It Be We're Asking Good Questions Of Bad Systems? A Case of Turncoat Tropism -- Or, Living and Dying With "NSI" Why after more than a decade of AIDS research do we still know so…
Another meeting with the (FDA) Commissioner, Rockville, MD, 11 July 1994. Bruce Schackman insisted that we all prepare overheads for our presentations, so we did. We took the train to Washington, D.C., and the Metro to Rockville. There we met…
With Its First Protease Trial Completed, Roche Races to FDA With Lukewarm Results, While Activists Cry 'Foul' "Tarted-Up Anecdotes" Results from ACTG 229, a randomized, 24-week, 302-patient study comparing AZT+ddC+saquinavir (Ro 31-8959, Roche's first protease inhibitor) vs. AZT+saquinavir vs. AZT+ddC,…
Tome of Recommendations Would Abolish ACDDC, Mandate Costing-Out and Establish Advisory Review Group Finding the Political Will ... "The up-coming ACTG re-competition provides an opportunity to re-envision AIDS clinical research for the next 5 years. It looks likely, however, that…