By now most of us have heard the big hoopla about AZT reducing the risk of HIV transmission from mother to fetus but, should we believe it?
AIDS Clinical Trial Groups (ACTG) 076 is another study which is questionable on both scientific and ethical grounds. Trial 076 is a matter of grave concern to women with HIV and AIDS.
The study was to investigate whether giving AZT to pregnant HIV+ women during pregnancy & labor and to newborns for 6 weeks after birth would prevent transmission of HIV from a woman to her child. Advertisement
About a month ago NIAID (National Institute of Allergies & Infectious Diseases) issued a press release stating that they were stopping the enrollment because they had found the regimen to be effective. They claimed that there was a significantly lower transmission rate in the AZT group when compared to a placebo group. Recently, they called a meeting of the principal investigators to discuss issuing treatment guidelines based on this study...guidelines which could advise physicians to give AZT to pregnant women as a standard of care. I believe that women with HIV (pregnant or not) have the right to take AZT for their own health if they so choose, I do not believe that the National Institute of Health (NIH) has the information necessary to make it a standard of care
. THIS DECISION WOULD BE SCIENTIFICALLY UNJUSTIFIED AND UNETHICAL.
Bad Study Design!
Eligible participants were HIV infected pregnant women who had received no antiviral (AZT, etc.) treatment during the current pregnancy, and had a CD4 (t-cell) count over 200. Treatment began between 14 & 34 weeks of pregnancy, at least one month before delivery. The AZT regimen consisted of 500 mg/day until the start of labor, then IV AZT during labor, then a syrup form given to the newborn for six weeks.
Women were randomized to receive AZT or placebo. The researchers called it a double blind study. But, AZT produces side effects and shows up in blood work which is done as part of the research; placebos don't. Describing this as a "double-blind, placebo controlled trial" (implying that neither the women nor the researchers would know who received drug and who received placebo) is an attempt to legitimize the research as being "scientific."
Participants were mainly women of color (African-American and Latino), the overwhelming number were below twenty years of age. In examining the Executive Summary, we found that women with T-cell counts as high as 1800 were included in this research. Many are in very early stages of illness when AZT would not be prescribed for their own health.
The young age of the participants is a matter of serious concern. A study presented at the December AIDS Clinical Trial Groups (ACTG) found that most of the women who refused to participate were older and did not want to take toxic drugs during pregnancy because they were concerned about its effects on the fetus.
It is a cruel hoax to claim that this treatment will save children's lives.
A careful reading of the executive summary reveals that while researchers claim that 364 women & their children were involved, in fact only 75 children completed the full 18 months of study. It's impossible to determine from the summary, exactly how many children who completed the study were in each group (AZT or placebo).
There are many issues which concern us.
Most important is that the National Institute of Health (NIH) may issue standard of care recommendations based on flimsy evidence that could put the lives of women & children in danger.
This is especially upsetting because there are large numbers of cases of AZT resistance. If women in this trial ever want to take AZT for themselves, they may find they have developed resistance to taking it during this trial. We have also found out that women who have EVER taken AZT are being excluded from vaccine trials. In the consent forms, which women must sign to participate in the study, none of this information is being presented to the women. How "informed" can the consent be?
Finally, the Executive Summary has a section using a fancy statistical technique (regression analysis) to determine which of a whole set of factors (the drug itself, length of gestation, and so on) might have affected their findings. However, in this analysis one of the factors that was not included was "maternal viral load" a factor which has been shown to be highly correlated to transmission. So when they claim that this analysis showed that it was the drug only which worked, how can we believe them?
Regardless of whether you agree or disagree with the trial itself, we hope you will agree that no Standard of Care should be based on such flimsy evidence. The data from this study have not yet been published. All we have is NIAIDS's press release and an executive summary of findings. And, on this basis, doctors all over the country will start pressuring HIV positive pregnant women to take a drug which may be toxic to them and their children. They may even be unwilling to care for a woman who refuses to take AZT. There is also danger that the preliminary results from this one study will be taken as evidence for mandatory HIV antibody testing of all pregnant women.
We must be vigilant to fight any such proposals, as well as to insist on the rapid disclosure of the complete data from this trial for careful examination by participants, other HIV+ women and their advocates.
You may not know but, without any treatment, the known transmission rate of HIV from a woman to her child is, at it's highest, 30%. With good prenatal care, it is as low as 15%. This means that between 70% and 85% of the fetuses and born children in this study are being given a toxic drug whose long terms effects are not known. Some research, in fact, suggests that it can cause various cancers, including lymphomas. It is a cruel hoax to claim that this treatment will save children's lives. If it worked at all (and there are grave doubts about this based on what has been printed), it might prevent a small number of children from being born HIV+ but could be responsible for many more children dying from cancer and other illness.
The community needs to respond immediately to prevent a standard of care from being issued which could put both women and their children in danger. Demand an investigation of this research trial, it's procedures and it's findings. Demand a public hearing. Write your senators and congresspersons. For a sample letter call (213) 667-3262 in LA, in NY (212) 564-2437.
We don't want to fall into the same AZT trap set by pharmaceutical companies and researchers in the mid 1980's.
Please Act Now! Send A Letter Today!
Article submitted by Maxine Wolfe, Ph.D., Professor, City University of New York.