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Clinical Trials

23Confronted with the difficulties in rationalizing anti-HIV prophylaxis and therapy with AZT, AZT advocates cite a controlled study that was conducted by Burroughs Wellcome, the manufacturer of AZT.  This investigation was do to justify the licensing of the drug for Aids therapy in the U.S. (Fischl et al., 1987); Richman et al., 1987).  The study included 289 patients with 'unexplained' weight loss, fever, oral candidiasis, night sweats, herpes zoster, and diarrhea.  All but 13 of these patients were males.  The study was planned to run for 6 months, but it was interrupted after 4 months.  At this time, they reported that:

        (1)after 4 months on AZT, only 1 out of 145 in the AZT group had died compared to 19 out of 137 in the placebo group.  Therefore the study claimed that AZT decreased mortality in AIDS patients.

        (2)T-cell counts first increased from 4 to 8 weeks and then declined to pretreatment levels within 4 months.

        (3)the lymphocyte count decreased over 50% in 34% of the AZT recipients, but in only 6% of the control group.

        (4)66 in the AZT group suffered from severe nausea compared to 25 in the control group

        (5)muscle atrophy was observed in 11 AZT recipients, but in only 3 from the control group

Even the primary apparently irrefutable claim of decreased mortality from AZT is not realistic if one considers that 30 out of the 145 in the AZT-group depended on multiple transfusions to survive anemia, compared to only 5 out of the 137 in the placebo group.  Thus, if transfusions were not given, the number of subjects in the AZT-group who would have died was 30 compared to those of the control group 24 (5 from lack of transfusions and the original 19).  The "decreased mortality' claim is further compromised by numerous accompanying medications other than transfusions for AZT-specific diseases and failure to match the AZT and placebo groups for the same treatments.  No information was given in regard to the cumulative effects of prior and parallel recreational drug abuse.

24In addition, some of the AZT-specific AIDS diseases observed in the placebo recipients appeared to be due to patient-initiated drug-sharing between AZT and placebo recipients (Lauritsen, 1990; Duesberg, 1992d; Freestone, 1992) and falsification of the case report forms (Lauritsen, 1992).

25The brief transient gains of T-cells observed upon AZT treatment by this study may reflect compensatory hemopoiesis, random killing of pathogenic parasites (Elwell, et al., 1987) and the influence of concomitant medication including multiple transfusions (Richman, et al., 1987).  The study concluded, based on the 'hematological toxicity' described above, "... the initial beneficial immunological effects of AZT may not be sustained" (Richman, et al., 1987).

26Moreover, the low mortality of 0.7% (1/145) claimed by the clinical licensing study for the first 4 months on AZT could not be extended in a follow-up study which found the 'survival benefits' of AZT rapidly declining after the original 4-month period.  By 18 months, 32% of the original AZT group had died and 35% of  the former control group, which by then had also received AZT for 12 months, had died (Fischl, et al., 1987).  Nor could the low mortality claimed by the licensing study be confirmed by later studies, which observed mortalities of  12 to 72% within 9 to 18 months.  In addition, a CDC study has recently reported a mortality of 82% in a cohort of 55 AIDS patients that had been on AZT for up to 4 years (Centers for Disease Control, 1991) - hardly recommending AZT as an AIDS therapy.

27A French Study investigated the effects of AZT on 365 AIDS patients.  The patients included 72% male homosexuals and 11% intravenous drug users with a median age of 36 years and with opportunistic infections and Kaposi's sarcoma.  The study observed new AIDS diseases including leukopenia in over 40% of the patients and death in 20% with 9 months on AZT (Dournon, et al., 1988).  The AIDS diseases of 30% worsened during AZT treatment.  the study reported no therapeutic benefits 6 months after initiating AZT therapy.  The authors concluded:  "the rationale for adhering to high-dose regimens of AZT, which in many instances leads to toxicity and interruption of treatment, seems questionable".

28After 67 weeks on AZT, 72% of the 91 male AIDS patients, averaging 39 years, died.  AZT-specific bone marrow damage requiring, on average, 5 blood transfusions was observed in 57%.  About 34% of the bone marrow damage resulted in anemia and 20% in leukopenia.  The authors concluded: "the majority of patients... cannot be maintained on these (AZT) regimens, most commonly due to the development of hematological toxicity" (Van Leeuwen et al., 1990).

29An Australian Study involving 308 homosexual and bisexual men with kaposi's sarcoma, lymphoma, and opportunistic infections and a median age of 36 years, reported 30% mortality with 1-1.5 years on AZT.  In addition one or more new AIDS diseases including pneumonia, candidiasis, fever, night sweats, and diarrhea were observed in 172 (56%) within one year (Swanson, et al., 1990).  Moreover, 50% needed at least one blood transfusion and 29% needed multiple blood transfusions to survive AZT treatment.  Yet the authors concluded that the "risk:benefit ratio (is) advantageous to AIDS patients" (Swanson, et al., 1990).

30The annual lymphoma incidence of AZT-treated AIDS patients ranges from an annual figure of 9% to a 3-year incidence figure of 31% (Pluda, et al., 1990; Yarchoan, et al., 1991; Peters et al., 1991; Centers for Disease Control, 1991).  The lymphoma incidence of untreated AIDS patients is 3% (Centers for Disease Control, 1992b).  It appears that AZT, at levels of 500-1500 mg/person/day, is responsible for the lymphomas.

31Four out of five AZT-treated AIDS patients recovered from myopathy (muscular disorders) two weeks after discontinuing AZT; two redeveloped myopathy on renewed AZT treatment (Till and MacDonnell, 1990), indicating that AZT is at least necessary for myopathy in HIV-positives.

Part 3: AZT Drug Trials

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