Dissident AIDS Database

NIAID paper : HIV causes AIDSDeveloped countriesSurvival with AZT/PIsAZT trials
AZT and cancer
 Lauritsen John
  Documents that the Food and Drug Administration (FDA) was forced to release under the Freedom of Information Act revealed that the Phase II ("double-blind, placebo-controlled") AZT trials were worthless. The researchers covered up the fact that the study had become unblinded (thus violating the basic test design). Protocol violations were overlooked. Worst of all, the researchers deliberately used data that they knew were false. These fraudulent trials were the basis of government approval of the drug. [John Lauritsen, "AZT on Trial: Did the FDA Rush to Judgment -- And Thereby Further Endanger the Lives of Thousands of People?", New York Native, Issue 235, 19 October 1987. Another highly critical review of the Phase II trials was written by Joseph A. Sonnabend, "Review of AZT Multicenter Trial Data Obtained Under the Freedom of Information Act by Project Inform and ActUp", privately published, New York City, 1987]. Another study often cited as proof of AZT's benefits concerns patients who received AZT after the Phase II trials were prematurely terminated. [Terri Creagh-Kirk et al., "Survival Experience Among Patients With AIDS Receiving Zidovudine [AZT]: Follow-up of Patients in a Compassionate Plea Program", Journal of the American Medical Association, 25 November 1988] I have written an extensive analysis of this study, which is a rotten mixture of incompetence and dishonesty. [John Lauritsen, "On The AZT Front: Part Two", New York Native, 16 January 1989] Through colossal incompetence the researchers lost track of 1120 patients, not knowing if they were even alive or dead. They then used statistical projection methods to guess what results they would have obtained if they had not lost the 1120 patients, presented their guesses as actual survival statistics, and made a number of grossly invalid comparisons in order to claim that AZT had extended lives… On 17 August 1989 The U.S. Department of Health and Human Services (HHS) issued a press release, which began: "A multicenter AIDS drug trial with more than 3,200 volunteers has shown that zidovudine (AZT) delays progression of disease in certain HIV-infected persons who have not yet developed symptoms." The alleged findings of the study (known as ACTG Protocol 019) were described in a vague paragraph, which did not give a single hard statistic ("The Board found that, in those participants with fewer than 500 T4 cells who received zidovudine [AZT], the rate of progression to AIDS or severe ARC was roughly half that for participants with fewer than 500 T4 cells who received placebo. Progression to symptoms was about the same in patients receiving either 500 mg per day of 1,500 mg per day of the drug. Toxicities were minimal in both treatment groups. More importantly, with the exception of nausea that occurred in about 3 percent of the volunteers, virtually no differences in side effects were observed in persons receiving the lower dose and persons receiving placebo.") Then on 24 August 1989 NIAID issued its own press release, "Results of Controlled Clinical Trials of Zidovudine in Early HIV Infection". This two-pager covered both Protocol 019 (healthy persons) and Protocol 016 (persons with "mild symptoms"), and gave even less information than the HHS statement had. It made the preposterous assertion that "zidovudine toxicity experienced by the persons studied in Protocol 019 was minimal." I spent several days calling NIAID and various other PHS branches in an attempt to obtain some hard information about Protocol 019. They sent me a three-page "Backgrounder" entitled, "ACTG 019 - Questions and Answers". This Q & A described the "results" of the study in one paragraph. ("Zidovudine [AZT] delayed the onset of advanced ARC or AIDS for individuals who entered the study with less than 500 T4 cell counts. As of August 10, 1989, 38 individuals randomized to placebo had developed endpoints (33 of which were AIDS). Only 17 individuals randomized to 100 mg zidovudine five times daily had developed endpoints (11 of which were AIDS), and 19 individuals receiving 300 mg five times daily developed endpoints (14 of which were AIDS). The substantial difference in outcome between treatment groups was observed for those entering the study with a T4 cell count less than 500. However, for individuals entering with T4 cell counts between 500 and 800, fewer endpoints occurred, and no definite statement regarding differences in event rates can be made at this time.") As the reader can see, the NIAID statement is gibberish, it gives no real data, and it is in contradiction with the earlier HHS press release.
  New York Native 30 Oct. 19891989