Dr. Wilfert's letter calls into question many of the points raised in our article. We respond to several of the most blatant errors in her analysis.
The clinical protocol for ACTG 076 was indeed conducted with careful review of the trial design; the protocol lingered in committee for several years before approval. HIV infected women and men, activists, advocates and researchers alike voiced many of the concerns raised in our original article over the approach taken by this trial. No one was willing to pay attention to any of these criticisms. In fact, it was in spite of these criticisms that ACTG 076 began. Dr. Wilfert's insistence that the "trial design withstood all criticisms" is simply untrue.
Anyone who has followed the history of interrupted trials (including ACTG 019/021 - the early trials of AZT
in asymptotic adults) will attest to the fact that things are not always as they seem. Thus, without the maternal viral load
data, and despite the "impeccable" randomization of the women in 076 (rarely in clinical research trials are participants so equally matched), we do not know if AZT was the reason for the reduction in perinatal transmission rates in 076.
This cause and effect, the original hypothesis, must be proven; and almost a year and a half later, this data is still not available. The clinical and political ramifications on the lives of women and their children demand that this data be analyzed and publicized before treatment and policy decisions go further.
We encourage Dr. Wilfert to reconsider her conclusions that AZT diminished transmission "without maternal untoward effects and with the only measurable difference in AZT treated infants being a transiently lowered hemoglobin". We do not know (and may never know given the low priority now assigned to the long term follow up of 076 trial participants by the ACTG) whether these women will develop AZT resistance or worse, and whether these infants, both HIV positive and negative, will experience AZT adverse effects in the future.
The interim analysis of the ACTG 152 data show that AZT is an inferior pediatric regimen, the least efficacious, and the regimen with the most adverse events.
We challenge Dr. Wilfert to let the large numbers of infected women in her practice to decide for themselves!
How can Dr. Wilfert applaud a decision by the Data Safety and Monitoring Board where 076 is concerned, and ignore that same Board's decisions regarding the 152 results?
How is it that women in Malawi with adequate Vitamin A levels, and not taking AZT, have a transmission rate comparable to the women in 076 who were given AZT, while women in Malawi with low levels of Vitamin A have a rate of transmission similar to those in the placebo arm of 076? Following Dr. Wilfert's logic, we must conclude that healthcare in Malawi for HIV infected pregnant women is better than the healthcare given to U.S. clinical research trial participants.
Women Can Decide
We agree that women need access to all the information about 076. That includes the information in our article. To conclude that AZT is the answer is the real disservice. We challenge Dr. Wilfert to let the large numbers of infected women in her practice to decide for themselves!
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