Dissident AIDS Database

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Manufacturer's notice
 Glaxo Wellcome
  "A second study administered zidovudine at maximum tolerated doses of 12.5 mg/day or 25 mg/day (~1000 mg/kg nonpregnant body weight or ~450 mg/kg of term body weight) to pregnant mice from days 12 through 18 of gestation. There was an increase in the number of tumors in the lung, liver, and female reproductive tracts in the offspring of mice receiving the higher dose level of zidovudine."
  addendum to the AZT notice, March 4, 19981998
Review & Evaluation of Pharmacology & Toxicology Data for the drug Retrovir, 29 December 1986.
 Chernov Harvey I. (FDA toxicology analyst),
  "AZT "was found weakly mutagenic in vitro in the mouse lymphoma cell system. Dose-related chromosome damage was observed in an in vitro cytogenetic assay using human lymphocytes." Evidence from the "Cell Transformation Assay" indicated that AZT was likely to cause cancer. Burroughs Wellcome resolved this problem by simply dropping the offending sentence, with the end result being every bit as obscurantist. In the Retrovir entry in Physicians' Desk Reference, written by Burroughs Wellcome, carcinogenicity is dealt with in the following way:"Long-term carcinogenicity studies of zidovudine in animals have not been completed. However, in an in vitro mammalian cell transformation assay, zidovudine was positive at concentrations of 0.5 mcg/ml and higher." Chernov said what the findings meant: AZT is presumed to be a carcinogen! But most physicians would assume that AZT was not carcinogenic, for the simple reason that the Physicians' Desk Reference entry hadn't said it was.
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