Dissident AIDS Database

NIAID paper : HIV causes AIDSDeveloped countriesSurvival with AZT/PIsHammer study
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  (Hammer SM, Squires KE, Hughes MD, Grimes JM, Demeter LM, Currier JS, Eron JJ Jr, Feinberg JE, Balfour HH Jr, Deyton LR, Chodakewitz JA, Fischl MA., A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team, N Engl J Med 1997 Sep 11;337(11):725-33) Protease inhibitors were introduced on the market in December 1995 with much fanfare, but only two randomized studies were ever done that claimed reduced infections or death from use of protease inhibitors and not just reduced viral load. One of these studies (Hammer et al. in 1997) was short-term, showed significant toxic side effects and did not really use a placebo (but instead a completely unproven combination of AZT with another DNA chain terminator like ddI or ddC which eliminates these studies from any meaningful scientific discourse). This study relied on statistical manipulations : ACTG-320 was a phase III clinical trial involving almost 1200 people, roughly half taking two AZT-style drugs, and the rest taking a cocktail consisting of those same two nucleoside analogs plus a protease inhibitor. The trial was stopped early for reasons that are unclear. When the records were unblinded, the data showed that only 8 patients had died in the cocktail group, versus 18 in the group not taking the protease inhibitor. Based on these figures, Mellors and the rest of the medical establishment are saying that cocktail therapy reduces mortality 50% compared to treatment without protease inhibitors. But the leader of the trial, Scott Hammer of Bostonís Beth Israel Deaconess Medical Center, admitted that ACTG-320 had not proceeded long enough for differences in the two treatment groups to have reached statistical significance (Boston Globe, Feb 25). Moreover, the Hammer study suffered from very incomplete reporting (gross underreporting of "AIDS-defining" events since it only reports on one or two of the thirty one "AIDS-defining illnesses", making it difficult to assess toxicity or results) and the researchers broke their own study design in order to increase their study's statistical significance (by combining two separate treatment groups, the statistical "P value" was artificially increased).
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