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To The Editors:

Re: "Who Makes National Health Policy:
The Government Or Burroughs Wellcome?"

Summer '95

The article by Ms. Meredith and Ms. Wolfe is to be commended for advocating that women should be able to make decisions about their health care and that of their children based on all of the available evidence. Why then, are the data from 076 and 152 misrepresented in this article? Women need to understand that 076 was conducted with careful review and attention to trial design and withstood all criticisms. Yes, it was terminated prematurely, because the data safety and monitoring board (not Burroughs Wellcome, not the investigators and not the government) studied the results and felt it was not ethical to continue this trial because evidence was unequivocal that AZT decreased transmission from mothers to infants. This was the question the trial addressed. Virus burden measurements are in progress to determine if there is a relationship to transmission. The women were randomized so well, that all variables from age to CD4 count were identical in women receiving AZT as compared to those receiving placebo. This study design is intentional so that if there is an unknown variable e.g., low levels of Vitamin A in some women, they will be distributed equally in the two trial groups because of the randomization process.

In fact, low Vitamin A levels were observed in African women with the lowest CD4 counts. Women with CD4 counts <200 were not eligible for this study. It is not correct to assume that Vitamin A levels in pregnant women in a developing nation will be the same in women where nutrition and health care are different. It remains to be seen if Vitamin A deficiency exists in U.S. women and if administration of Vitamin A alters prenatal transmission under any circumstances. Thus, we would be pleased to learn there is an additional means of intervention when it's proven. We can not fail to acknowledge that 076 provides compelling data that AZT diminished transmission. It did so without maternal untoward effects and with the only measurable difference in AZT treated infants being a transiently lowered hemoglobin.

Rupture of membranes greater than 4 hours is associated with increased transmission according to data from the women infant transmission (WITS) study and from the European collaborative studies. When C-section prevents the duration of membrane rupture from extending past 4 hours, transmission is decreased. The real variable is not the mode of delivery.

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ACTG trial 152 showed, unequivocally that another regimen (either AZT and DDI or DDI alone ) was better than AZT alone, it did not show AZT to be ineffective despite the title in the New York Times. Women must appreciate that AZT does improve the clinical status of patients including children who are infected. This has been shown in multiple studies. We need to be glad another therapy is better and not falsely believe AZT does nothing. These results are not at all contradictory of 076.

As someone caring for large numbers of infected children and their mothers it is important to call attention to the real problem which is the delivery of health care. Women need to have access, be informed, offered counseling and testing especially during pregnancy because an effective intervention for decreasing perinatal infection exists. Your article does women a disservice because it does not convey accurate information allowing an informed decision concerning AZT. Imparting inaccurate information does not serve women well.

Sincerely,
Catherine M. Wilfert, MD.
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This article was provided by Women Alive. It is a part of the publication Women Alive Newsletter.
 

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