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Item #34: Why was BW 002 Aborted?

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Farber

The 1986 Phase II trial that preceded the FDA’s unprecedented rapid approval of AZT was presented as a double-blind, placebo-controlled study, though it was anything but that. As became clear afterward through the efforts of a few journalists, as well as the testimony of participants, the trial was “unblinded” almost immediately because of the severe toxicity of the drug. Members of the control group began to acquire AZT independently or from other study participants, and eventually the study was aborted and everyone was put on the drug.

Gallo

Farber states that the BW 002 trial was aborted. Her tone implies this was sinister. She fails to explain the legitimate reasons for terminating the trial.

The trial was terminated because an interim analysis revealed that AZT was much better than placebo. Continuing to keep patients on placebo would have therefore been unethical. This is standard practice in clinical trials. Anything else would endanger the lives of patients.

RA

See http://www.rethinkaids.info/GalloRebuttal/Farber-Gallo-32.html.

© Copyright January 7, 2008 by Rethinking AIDS.