Our Collective Response
Thank you for your interest in the mission of Women Alive. We appreciate that you took the time to write to us. We actively seek constructive input from the AIDS medical community. We assure you that we seek to be accurate, informative, honest, and helpful.
A primary concern that was not explained in the 1994 Fall issue of "Women Alive" for which we take full responsibility is: The article that you allude to ("Women Challenge Results of Trial 076") is basically a summarized transcript from a meeting of women with HIV and their advocates with Commissioner, David Kessler of the FDA. We apologize to our many subscribers for our failure to report this as a prelude to the article.
We assure you that we share your concern about reporting the cases of adverse effects of AZT on children in developing stages to proper authorities. Please realize that these reports of "plummeting T cells" and "tumors" in these HIV negative toddlers, whose mothers took AZT during pregnancy, are real life situations. The mothers themselves have come to us with this information. We cannot disclose the names of the mothers or their children for obvious reasons. Again, we have grave concerns of the adverse effects of AZT on these kids and others. As far as we know, there is no long term funding for documentation or dissemination of this information to the medical community at large. As stated previously, "...we have no faith in the Burroughs Wellcome registry or in the AIDS Clinical Trials Group to document or get this information out..."
On the issue of collecting actual real data; you have misquoted us. The article states that scientists collected data on 75 of the babies, not 75%. There was a mathematical error in the same paragraph, which should read: "They projected the data on the rest of the 325 kids." This information is well substantiated in the executive summary report of the 076 trial results: "Two hundred thirty-three infants had information about HIV infection status as of 24 weeks of life and 75 of these had confirmation at 18 months." Clearly, scientists had only confirmed the HIV status of 75 babies born on this study, which is closer to 20% of the study babies
The issue of when the mechanism of protection of HIV transmission occurred, is important. The comment on this should've been in quotes. The topic was brought to the FDA by a woman who is on the Community Constituency Group of the ACTG's. She's on the pediatric committee and has a clear understanding of the issues. The point is; study 076 failed to determine when the protection occurred. There are many remaining questions. If AZT worked, did it work in the months before delivery, during the birth process, or by giving AZT to the newborns?
On to the issue of "massive doses". The term is relative in relationship to the stage of HIV disease of the moms on study. The executive summary states: "...the median CD4+ lymphocyte count was 550 cells/mm3 (range 200 to 1818)". This average clearly indicates that the majority of women in study had over 500 T cells, when AZT would not normally be prescribed. Dosages of 100 mg 5 times a day is a huge amount of AZT for someone who would otherwise be taking 0mg per day. Also, during labor, the moms were given 2mg/kg initially & 1mg/kg every hour until delivery. If a woman weighed 70 kilos, she was given 140 mgs of AZT to start and 70 mgs every hour during labor. If she was in labor for 16 hours then she would have received 1260 mgs of AZT during that period. (12 hours at 980mgs, etc.) In relative terms this is a "massive" dose.
Our quest is for the truth about mother-to-infant transmission. Some feel that it is irresponsible of the research community to publicize study results via press release, and that it's bogus to report that AZT "prevents" mother-to-infant transmission. If there is any validity to this study, it would be more accurate of researchers to state that, at best, AZT reduces the risk of mother to infant transmission. Nothing in this study comes close to proving that AZT "prevents" transmission.
This leads us to the rippling effect of the results of this one (some would say; poorly designed) study. Policy makers have begun to propose legislation that could lead to mandatory HIV testing. Are policy makers going to mandate that all HIV positive pregnant women take AZT? The ramifications of the research community's bogus claims are far worse than those of anything we could possibly print in our newsletter.
Again, we thank you for your valuable input. We are happy to clarify any misconceptions of questions and issues raised about trial 076.
Editorial Committee, Women Alive
P.S. The thrust of the issue is that policy is being set. Standards of care are following in the footsteps of the 80's AZT hopefuls. We caution policy makers and medical professionals not to be too hasty and act on a single study that may have flaws.
This article was provided by Women Alive. It is a part of the publication Women Alive Newsletter.