NOTWITHSTANDING ANY OTHER NOTICE ON THIS PAGE, the material on this page is NOT available under the GNU Free Documentation License; in accordance with Title 17 U.S.C. section 107, it is posted in the manner of bulletin boards in schools and workplaces, to encourage public education and citizen awareness, without profit or payment, for persons and entities engaging in non-profit research and educational activities and purposes only.
Kris Chmiel is a housewife and mother of two young children, living in Denver. When she was pregnant with her second child, a movement had just gotten under way to test all pregnant women in the state of Colorado for HIV, the virus widely believed to cause AIDS. (Critics remind us that what is tested for is not, in fact, HIV, but antibodies to HIV.) She was perfectly healthy and in her first month of pregnancy. She wasn't worried – she had been monogamous with her husband for the past nine years. When the test came back "positive," she literally did not believe it.
Her doctors strongly urged her to immediately start taking the AIDS drug AZT, in an effort to prevent transmission to her child. "They finally wore me down," she says, "even though it was totally against my intuition."
In her fifth month of pregnancy, Chmiel began taking 500 milligrams of AZT, a drug that has been routinely given to pregnant HIV-positive women following a 1994 study – ACTG 076 – which claimed efficacy in reducing the transmission from mother to child.  (AZT stands for azidothymidine and is marketed under the names Zidovudine or Retrovir.)
Chmiel's daughter is two years old today, and has twice tested negative for HIV infection. By the standards of the AIDS establishment, she is not only a success story, but the very epitome of medicinal victory – perhaps the only "victory" in the entire realm of AIDS research. She is precisely the kind of baby who would serve as a poster child for those forces that are pushing hard for mandatory testing, as well as mandatory treatment, and maybe even mandatory AZT use by all pregnant women – a "saved" baby.
But to Chmiel, there are strong undertones of regret, anger, and even despair when she thinks back on her choice to take AZT. Follow-up HIV tests after her child was born gave results different from the first one, throwing into question whether she ever did have HIV. One test was indeterminate, and another was negative. She soon started doing her own research, and found a paper citing all the underlying conditions – as many as 64 – that can cause a false positive HIV-antibody test. One of them is pregnancy.
She also became more and more aware of the potential toxic effects of AZT, which, although it is said to be "safe" for both mother and child, is a known carcinogen, mutagen, and teratogen – a drug long classified as "contraindicated" in pregnancy. For Chmiel, who stayed on AZT for a year after her child was born, the breaking point with AZT came when the drug's toxicity became so overwhelming that she crawled to the bathroom and kept vomiting for hours. "I just couldn't take it anymore," she says, adding that when she stopped taking the drug, her health returned.
There are five categories that the FDA uses for pregnancy drug classification, listed from the safest to most dangerous – A, B, C, D, and X. AZT is listed in Category C and is described as a drug in which "safety in human pregnancies has not been determined, animal studies are either positive for fetal risk or have not been conducted, and the drug should not be used unless the potential benefit outweighs the potential risk to the fetus."
In the case of AZT and HIV, the "risk" is a variable that is inextricable from a core question that hasn't been resolved, namely, "Does a positive HIV antibody test predict an inevitable progression to sickness and death?" Some experts say yes, others say no. Several studies, particularly in recent years, have noted how an increasing number of children born HIV-positive are growing into adolescence without any sign of sickness. A study that came out of the 1996 International AIDS Conference in Vancouver reported that 37 percent of all HIV-positive babies would never progress into full-blown AIDS.  In his landmark book Rethinking AIDS, Dr. Robert Root-Bernstein states, "Less than a third of HIV-seropositive infants go on to develop AIDS." 
It may be nearly impossible to ferret out what precisely we mean when we talk about children "progressing," because the waters are clouded from the start. Progressing from what to what? As Root-Bernstein points out, 80 percent of HIV-positive infants in the US are born to drug-addicted mothers – whose immune systems are severely compromised with or without HIV – and those babies all will inherit their mother's immune system. If the mother is sick, the baby will be sick.
Unfortunately, few research efforts have been aimed at truly resolving the fundamental question of how HIV, as distinct from all other factors, affects children, because mainstream HIV dogma holds that there is no question. If a mother has HIV, she and her child will be viewed through the lens of HIV, and not seen in the context of their whole immediate environment – although, as Root-Bernstein documents extensively, babies born to HIV-positive mothers often have identical health profiles to their mothers, whether these babies are positive or negative. 
The unified voice of AIDS research takes a far more simplistic view of the problem. "There are children, about one third, who we call long-term nonprogressors," says Dr. Ellen Cooper, principal researcher of Women and Infants Transmission Study (WITS), an ongoing federal research program. "We've not followed the disease long enough to know absolutely, but the thinking now is, there's nobody who doesn't progress, it's just a question of how quickly you progress, and how good we are at coming up with new therapies to help you maintain your health and predict when you're going to decline."
The thought is, there is nobody who doesn't progress...
Where did this "thought" originate? And how is it influencing HIV-positive women, every day, all around the country? In the fractious, vast, and complex universe of HIV and AIDS, these women are looking through a kaleidoscope of information, both in written form and learned firsthand, and making very difficult decisions about how to handle the news of a positive HIV-antibody test – for themselves, and for their children, both born and unborn.
"Do you think that AZT had any adverse effect on your child?" I ask Chmiel.
"Yes, I do," she says firmly. "She has a very enlarged cranium. That's typical of most of the AZT babies I have observed."
What she tells me next sounds like a terrible dream. "They're killing babies," she says emphatically. One young woman who came to Chmiel for counseling at the dissident AIDS activist group HEAL in Denver, had watched her child test positive for HIV shortly after being vaccinated (vaccinations can cause the HIV test to produce a false positive). The baby was put on AZT, despite the fact that the mother was HIV negative. Three months later, the baby was dead. Another mother who contacted Chmiel had a baby with hemophilia, who had received Factor 8 clotting plasma (yet another possible source of false positives). After testing positive, the baby was put on several medications and died after only five months. "That child's mother is still devastated," Chmiel says. "She believes it was the drugs that killed her son."
Even when children taking AZT survive, Chmiel firmly believes, the consequences of the drug use can be dire. "I went to this conference that they held on HIV and pregnancy at Children's Hospital here in Denver," she says, "and a lot of the mothers there had taken AZT during pregnancy, and they had their kids with them. I looked from one to the other, and every single one of those kids had enlarged craniums. Their heads looked exactly like my kid's head. They're all AZT babies."
Few, if any, studies in the history of AIDS research have caused such a momentous shift in policy, medical practice, and zeitgeist as the one called ACTG 076. To believers, it is perhaps the single greatest breakthrough in the history of AIDS research; to detractors, it is the most alarming and radical turn prenatal care has ever taken.
Call up virtually anybody who works within obstetrics, HIV/AIDS, and pediatrics and they will tell you the same thing: that the protocol now known simply as 076 – the study that first caused the FDA to approve the use of AZT in pregnant women – has been perhaps the most unequivocally encouraging news in all of HIV/AIDS research. Fourteen hundred babies per year in the United States alone, they say, are "saved" by AZT use, which by unknown mechanisms is said to reduce maternal transmission of HIV. They will also tell you that there have been no documented complications from AZT, and that even if there were, they would pale in comparison to the dreadful effects of HIV itself.
In ACTG 076, the transmission of HIV during labor was reduced from 25.5 percent in the placebo group to 8.3 percent in the group that was given AZT throughout the second and third trimesters and intravenously during labor. The babies in that group were then given AZT for six weeks after birth. Maternal transmission rates vary greatly – in industrialized countries, 25 percent is certainly the high end. In several European studies, the rate is as low as between about 7 percent and 14 percent – levels that are said to correlate with improved prenatal care.  In one quite surprising study from Malawi, it was found that transmission was closely correlated with levels of vitamin A in the mother. Those with the lowest levels transmitted HIV to their babies at a rate of 32.4 percent, while those with the highest levels had a transmission rate of only 7.2 percent – a figure lower than the lowest figures attributed to AZT.  And yet, the discourse around this subject is framed inextricably around the notion that toxic medications constitute the only legitimate and, for the mother, "responsible" route to reduced transmission.
Such pharmaceutical intervention during pregnancy is obviously a major shift in policy. Following recent disasters – remember thalidomide? – the FDA imposed far stricter regulations on what women could be exposed to while pregnant – essentially nothing. Thalidomide, of course, was prescribed as a sedative in both Great Britain and Europe in the 1950s. Years later, it was found to have caused at least 10,000 severe birth defects. Not too long afterward, DES, a synthetic hormone that was prescribed to women in the 1940s and 1950s to prevent miscarriages, was found to be causing vaginal cancer in the daughters of the women who had taken it during pregnancy.
These two catastrophes produced a powerful impact on both the public and the medical community, resulting in a total ban on exposing women to chemicals during pregnancy. In 1990, however, ACTG 076 broke that policy, opening the medical floodgates for the chemically promiscuous scenario that we have today, in which pregnant women are given not just AZT, but multiple combinations of other drugs – including the new protease inhibitors – aimed at reducing "viral load" of HIV. (This is despite the fact that, as of now, no safety studies have been done on the possible ill effects of these protease inhibitor drugs on either mother or child.)
This extreme break in policy can only be explained by the climate of AIDS and HIV, which dictates that no measure is too extreme, or too risky, if it results in the perceived diminishment of HIV transmission. Recently, UNICEF and the World Health Organization (WHO) launched a drive to get AZT distributed to all pregnant HIV-positive women in developing countries. But since they lack the facilities for proper HIV testing, the only possible scenario is that AZT be handed out indiscriminately. When the plan was first unveiled years ago, Laurie Garrett, a reporter for New York Newsday, speculated that, not knowing which women are truly infected and which are not, "They would have no other choice but to treat every woman in labor with the chemical."
This speaks volumes about the decline of critical thinking in the era of AIDS – it is now considered reactionary, even outright "irresponsible" to question the wisdom of exposing pregnant women to such a wide array of mutagenic, carcinogenic, teratogenic agents. (The new drugs, including the various protease inhibitors, are all of the above, and are listed in Category C of the FDA's pregnancy hierarchy.) One researcher I spoke to sounded incredulous when I told her that this article would look at both sides of the issue.
"Both sides? What do you mean?" she asked.
"Well," I said haltingly, "there are people who are very concerned about the ramifications of all these pregnant women on AZT and..."
"Not people who work with HIV and AIDS?" she interjected. "I don't think there's anybody who works with HIV and AIDS who is against this."
"Not too many," I conceded with a sigh. "But there are some who are extremely concerned about the long-term effects on both the mothers and the children."
"Well, we are looking at that, and we are concerned about that. But the main thing is to deal with the HIV."
I fell silent, realizing from years of reporting on this issue how futile it is to argue when the big club of HIV has been pulled out. Like the child's game of rock, paper, scissors, HIV is always the rock and the scissors.
"AZT is the only drug with proven efficacy," says WITS's Dr. Cooper. "But we also know that pregnant women with high viral load are at most risk of transmitting the virus to their babies. So a few studies are now looking at the ability of different drug combinations on reducing viral load during pregnancy. But," she concludes, "the truth is, nobody really knows what to do."
It is common today for AZT to be referred to as "safe" for pregnant women. But the FDA never considered it so before and banned pregnant HIV-positive women from taking it, prior to 076. AZT was classified as a mutagenic agent, which thalidomide also is, and the controversy in the early days of AIDS – the activist outcry – was that women were being excluded from all clinical AIDS drug trials. Indeed they were – the FDA was rightly concerned about the possible effects of these potent drugs on future babies.
ACTG 076, which was funded in part by AZT's maker, Glaxo-Wellcome, was designed to determine whether treating pregnant, HIV-positive women with AZT during pregnancy would reduce the rate of HIV transmission from mother to child. That was the first objective. The second, strangely enough, was to see whether AZT is safe – for mother or for child. An 076-trial memo stated that, "although safety [is] unknown it can be argued that any possibility of stopping transmission to the fetus outweighs perceived risks to the woman."
"You have to put all this into a framework," says Dr. Kathleen Nokes, an RN and Project Director of Nursing Persons With HIV/AIDS. "Many people are angry that these women are getting pregnant. So it's like, 'Well, if the mother is going to have this baby, we will have to intervene to protect it.' That is the mind-set. And the intervention is AZT."
This despite the fact that criticisms have been made of the design and the conclusions of 076. The study's authors themselves, when they reported their findings in the New England Journal of Medicine (NEJM) in 1994 admitted that the efficacy of AZT in reducing maternal transmission of HIV is "impossible to quantify [absolutely] because of the very small numbers of infected babies [studied]." They also noted that the rate of the HIV transmission in the placebo group was inexplicably high. 
And could the results be repeated? It is impossible to say, since the "overwhelming" results of 076 rendered it "unethical" to ever again use a placebo control group. In fact, when it later came to light that studies using placebo controls were underway in Thailand and Africa, there was an uproar in the medical community that was so loud several editors from the NEJM quit their jobs over the perceived immorality of the trials. A preliminary report from the trial in Thailand, however, showed no difference between the group treated with AZT and the placebo group in terms of transmission rates. 
Like so many of the studies involving AZT, ACTG 076 was terminated as soon as a benefit was seen on the AZT side. At the study's first interim analysis, 13 babies (8.3 percent) in the AZT group were reported to be HIV positive, versus 40 (25.5 percent) in the placebo group. (A total of 477 women were recruited for the study.) 
The popular media trumpeted the news that the discredited AIDS drug AZT had made an astonishing comeback in a patient group that had previously been exiled from clinical trials. This was now seen as the medical community almost honoring women by including them. The Clinton administration touted the study's surprising results as proof of an unprecedented breakthrough in AIDS. A kind of wild D-Day euphoria spread through the OB-GYN community, which now finally had something hopeful to tell pregnant HIV-positive mothers. This "science by press release" took hold before any independent review board had verified the data, and nine months before the study itself was published.
Eventually it came to light that the doctor who had leaked the ACTG 076 story to the New York Times was a paid consultant to the drug's maker, Glaxo-Wellcome (then Burroughs-Wellcome). Still, the influential US Pediatric AIDS Foundation and many other pediatric institutions immediately announced that all HIV-infected women should be offered AZT, and that this "lifesaving treatment cannot be ethically denied because of ineffective HIV screening."
In 1994, soon after the results of ACTG 076 were announced, Congress debated legislation for mandatory HIV testing, with possible enforced treatment for identified babies. It was rejected by a narrow margin. But President Clinton recently signed another bill that makes the testing of all infants born at public hospitals mandatory, together with counseling to all pregnant women. Groups that don't comply risk losing millions of dollars in federal funding.
"A lot of otherwise progressive, liberal people have bought into this issue as one of the babies' rights versus the mothers' rights," says Marc Elovitz, an ACLU lawyer. "But a mother's rights and a baby's rights are the same thing."
Meanwhile, AZT has been approved for use not only in pregnant HIV-positive women, but also in newborns, for whom there previously had been no "standard of care."
"They have progressed from basic research to 'standard of care' so fast," says Nokes. "And once it is standard care, that's that. If we prescribe AZT to your baby, and you don't give it to her, we take you to court for child abuse."
Many women have had precisely this nightmarish experience.
Jenny Guembes, an HIV-positive mother of a healthy seven-year-old boy, counsels HIV-positive women for the AIDS Healthcare Foundation in Los Angeles. "When these pregnant women come here, I tell them, 'Look, if you have a low viral load, there's a good chance you won't transmit.' I tell them that I never took anything and my son is fine. But they want so badly to do everything they can for their unborn child, that they will take anything. Anything."
I ask her whether she has heard of any cases where women were threatened with loss of custody over the issue of AIDS drug compliance, and she recounts the story of a client whose two-year- old daughter was crying so hard whenever it came time to give her the AZT that she stopped giving it to her.
"They found out she wasn't giving it to the child," Guembes says, "and they took her daughter away from her." It took her two years to get her child back, and she was warned that, to keep her, she would have to comply with the medical protocol.
"Now she doesn't miss a dose," Guembes says somberly.
The intimidation experienced by women who test positive for HIV is, in fact, intense. "It's not like with gay men," says Emily Gordon, a social worker, editor of the newsletter Just Kids, and a former health consultant to the New York Department of Health. "With parents, the doctor or social worker will look at the mother and say, 'You love this child? Do you want this child to die?' And she'll walk out with a prescription for whatever the doctor is pushing at that point."
"It's shocking, but nobody cares," agrees Terry McGovern of the HIV Law Project, a group that represents many HIV-positive mothers in their struggles with the system. "It's far from clear that any treatments do any good, and yet these women are viewed as baby killers when they hesitate to give toxic drugs or take them when they're pregnant."
McGovern likens the current battle to the reproductive rights movement. "From a lawyer's viewpoint," she says, "we are squarely within Roe v. Wade territory here, with the big question of whether the mother can overcome the doctor's decision not to take AZT."
For her part, Guembes decided not to take any medication while pregnant or after. (AZT was offered to her years before ACTG 076.) Today, she remains healthy, as does her boy, who is HIV-negative. "When people found out I wanted to have this baby," she recalls, "everybody said that I should have an abortion. Everybody."
That was the informal "standard of care" for all HIV-positive pregnant women in the past – they were counseled to have abortions. Initially, the belief was that 100 percent of babies would inherit their mother's HIV. Even today, women often are told that the risk of transmission with AZT is 50 percent. In fact, it usually takes six to 18 months for children who are born to HIV-positive mothers but who have not been infected with HIV to revert to negative. 
Today Guembes doesn't go around expecting to get sick. "I don't think HIV is the sole cause of AIDS," she says. But her colleagues at the AIDS organization where she works still pressure her relentlessly to start taking medications.
"I just smile at them," she says, "and say, 'Nah, not just yet.'"
What I've been hearing from many people who work with women and HIV is similar to Guembes's story: Growing numbers of these mothers are intuitively rejecting the medicines. They often pretend they're taking the drugs and giving them to their children, but in fact they're stockpiling the pills at home, or flushing them down the toilet.
"Mothers will never tell their doctors, but they'll tell me," says Emily Gordon, the New York social worker. "Parents are often very much against using AZT. They feel like they are poisoning their kids."
But AZT is only part of the problem – or the solution, depending on your particular beliefs – because now the pharmaceutical companies are developing new drugs faster, and the FDA is approving them faster. Despite the total lack of safety or toxicity data, pregnant women are taking them, and the FDA recently approved several of the new drugs for use in children. (A few years back, a federal pediatric trial had to be stopped when children in the AZT-only arm of the trial started dying much faster than children in the other arms of the trial, which involved other drugs.) 
"These are really tough regimens," admits Dr. Cooper, who nonetheless believes staunchly that they are effective in keeping kids alive. "Some of this stuff tastes really bad. Beyond bad. The worst-tasting medicine used to come as a liquid, Retrovir, and adults could not tolerate it. They just gagged and vomited. It's now liquid inside a capsule, but the capsule is really big.
"It's a full-time job giving some of these children their medicines," she continues. "They often may be on 15 different drugs, given multiple times a day, some with food, some without. But," she says, "I've never seen any kid who's done well without medications."
Gordon, by contrast, says she has seen perhaps the greatest treatment successes among HIV-positive children who have done nothing, meaning no toxic drugs, relying instead mainly on nutritional supplements, medicinal herbs, and generally improved diets. "I have several HIV-positive kids who have never taken AZT who are now teenagers," she says.
I ask Cooper whether she thinks that HIV-positive women's attitudes toward having children are changing. "Probably," she says. "There are some HIV-infected women who are more likely to have children now. But an 8 percent risk of transmission is still a risk. It is different than it was, but it's not zero. An 8 percent risk is a higher risk than most people would take with other congenital diseases. As long as the women understand that, we totally support them if they decide to have a child."
Christine Maggiore, who was pregnant, healthy, and HIV-positive, found no such support. Searching high and low for a midwife in the Los Angeles area who was willing to deliver her child at home, she was turned down by almost everyone. "All this loving, warm, fuzzy stuff, and then you're still a leper," Maggiore says sardonically. "Even the head of the Association for Childbirth at Home turned me down. And this very progressive clinic where they specialize in lesbian births, they wouldn't even call me back. The ones that did return my call asked me the same stupid questions in the same aghast tone: 'Why would you want to have a baby if you have AIDS?'"
Maggiore is quite well-equipped to answer that question, having devoted most of the past six years of her life to deconstructing what she calls the many "myths" concerning AIDS – chief among them that being HIV-positive means you are going to die of AIDS.
Maggiore, author of the booklet What If Everything You Thought You Knew About AIDS Was Wrong? has been HIV-positive for seven years and has remained symptom-free. (Her doubts concerning the HIV paradigm originally were triggered when several HIV tests revealed different results – positive, indeterminate, and negative.)
She had a "blissfully uneventful" pregnancy, and a normal childbirth, at home, with a midwife who was very reluctant, but eventually agreed. She describes her baby, Charlie, who was exclusively breastfed for the first eight months of life, as "super alert, strong, and happy. Everywhere we go, people stop us and say, 'You look amazing... what kind of vitamins are you taking? You don't look like you're living with any life-threatening illness.'" Maggiore laughs. "There was this one lawyer who was threatening to slap an injunction on me as an unfit mother," she remembers. "But my friends finally convinced him that I'm as fit as they come."
One of the problems with assessing the true toxicity data from 076 is that they are collected in a "Pregnancy Registry," which is largely under the control of the company that makes AZT: Glaxo-Wellcome. But some bits of data have been mined, and they are not exactly reassuring.
AZT was first tested on minority populations in the United States and cohorts of pregnant women in the Third World – the same populations on whom contraceptives are commonly tested. Prior to the launch of 076, data on 41 women who took AZT during gestation was collected and surveyed by the ACTG OB-GYN Working Group. Two children were born with extra digits on their hands and feet. Other serious birth defects included low-set ears, misshapen craniums, and heart defects.  Another study, published the same year as 076 in the Journal of Acquired Immune Deficiency Syndrome, studied AZT in pregnant women in India, focusing on birth defects. Out of 104 pregnant women treated with AZT, there were eight reported spontaneous abortions, eight therapeutic abortions, and eight babies (13 percent) born with serious birth defects, including cavities in the chest, abnormal indentations at the base of the spine, misplaced ears, heart problems, extra digits, and albinism.  Birth defects generally occur in the population at the rate of 2 to 3 percent of live births. The results of this investigation were described by the study's authors, with what appears now to be some considerable understatement, as "not proving [AZT's] safety" during pregnancy.
Similarly, a 1996 study from the American National Institute of Child Health and Human Development concluded, "In contrast with anecdotal clinical observations and other studies [showing] that Zidovudine favorably influences [fetal] weight-growth rates, our analysis suggests the opposite." 
A list of complications caused in animals (rats, mice, dogs, monkeys) subjected to AZT includes: anemia, bone marrow depletion, leukemia, T-cell depletion, atrophy of the thalmus gland, lymphotoxicity, nephrotoxicity, cell death, lung, liver, and vaginal cancer, retarded development, and, worst of all, fetal death.
As a result of such findings, a 1994 study published in the Journal of the American Medical Association stated categorically that AZT taken during pregnancy resulted in an increased rate of structural birth defects.
"Anecdotally, there certainly have been rumors that some of the HIV-negative children enrolled in 076 have heart problems," says Marion Banzhaf, who works with women and AIDS in New York City as a consultant.
But several doctors working in the field of HIV, AIDS, and obstetrics, interviewed for this article, insisted that no such abnormalities have been observed in US babies exposed to AZT in utero. A faxed copy of an abstract that summarized the results of ACTG 219, the federal study that is supposed to be following the babies given AZT during 076, is extremely cursory. "No adverse effects for [AZT] exposed infants followed for as long as four years [were found]. While that data are reassuring, continued prospective evaluations of perinatally exposed infants are critical to assess the long-term safety of successful...prevention strategies." 
"I agree that it's scary that we do not know what the long-term adverse effects of AZT may be," says Dr. Lynne Mofenson, who co- authored the CDC's recent Perinatal Transmission Treatment recommendations. "But it is clear from the data that the adverse effects so far have been minimal."
"I've never seen any enlarged craniums in the children whose mothers received AZT," says Dr. Cooper, when I questioned her about Kris Chmiel's observation.
"We don't yet know what the long-term effects of AZT may be," she goes on, "but so far we have seen virtually no adverse effects in the short term. The babies are perfectly normal. I have an unpublished paper in front of me that looks at the possibility of tumors developing in these kids. There was not one single tumor. Not one. And no abnormalities either."
"I mean," she adds, "they have cancers, lymphomas, and other problems like that, because cancers tend to be more prevalent in HIV children than in others, but there is no reason to link those cancers to the AZT." (Studies have shown that the risk for lymphomas is 70 percent higher in adults who have been on AZT.) 
"You have to realize," says Nokes, "that they are never going to say that any serious side effect is 'caused' by AZT, because typically, in these children, you can find countless other adverse external factors. Crack. Heroin. Smoking. Alcohol. Hepatitis B and C. So first you would have to reach the high level of complications that is caused by all that, and then exceed that by a wide margin, and then maybe we can start to talk about the adverse effects of AZT."
What also complicates the question is that AIDS, as currently defined by the CDC, is a collection of at least 40 disparate symptoms in the presence of an HIV antibody. Critics of the almost indiscriminate use of both AZT and other pharmaceuticals have long argued that the drugs used to combat HIV can create some of the very AIDS-related symptoms they are supposed to help ameliorate.  Glaxo-Wellcome states this fact, too, on page 1170 of the 1998 Physician's Desk Reference: "Serious adverse events have been reported with Retrovir... [These] pathological changes, similar to that produced by HIV disease, have been associated with prolonged use of Retrovir."
AZT is, in fact, both an immune suppressant and a potent carcinogen. It was originally developed during the National Institutes of Health's Virus-Cancer Program in the 1960s, when it was widely believed that cancer was caused by an infectious virus. Designed to kill growing cancer cells by blocking the formation of DNA chains, AZT not only failed to cure any cancer in tests on mice, but was so effective in destroying healthy growing cells that the mice died of extreme toxicity. Studies showed that it caused cancer in any dose and that it was too toxic for even short-term use. AZT was shelved for two decades and no patent was ever filed. 
At the National AIDS Malignancy Conference held in Bethesda, Maryland, last year, a research paper was presented that acknowledged the positive results of 076 in reducing maternal HIV transmission. "But," the paper continued, "in adult mice, lifetime AZT administration induces vaginal tumors at a 10 to 20 percent incidence." The paper's authors went on to specify that "... in female reproductive organs, the controls had no tumors, and there was a 17 percent incidence of ovarian and uterine tumors at the 25 mg dose. Compared to other known chemical carcinogens," the authors concluded, "AZT appears to be a moderately strong transplacental carcinogen [meaning it's able to cross the placenta]." 
Critics of the study, most notably Glaxo-Wellcome, insisted that the data was irrelevant, because the researchers had given much higher doses of AZT, proportionally, to their monkey and mice subjects than would be given to humans. The authors, however, insisted that the total drug doses given to the animals were quite similar to those that would be received by any woman who took AZT for about six months. "The data suggest," the researchers concluded, "that the [medical] surveillance of [all] AZT-exposed children should be carried out well into adulthood."
"What's to make us think that there is not going to be some kind of major price to pay somewhere later down the road for giving AZT to these babies?" asks Kathleen Nokes. "And I don't mean a minor price, I mean a major price. All I know is, this drug has been shown to cause vaginal cancer in rodents. It is affecting the blood of these infants, causing various abnormalities. The party line up to this point had been: 'Don't give pregnant women anything' – especially coming off of the big thalidomide study, which everyone in the United States still pats themselves on the back for."
"I don't think we're going to have the answer to the toxicity questions in just a year or two," she continues. "I think we're talking more like six years or, seven, eight, even ten years. A lot of supposed experts are saying, 'Oh come on now, you're overreacting. This isn't DES.' Well, I've been in nursing for 27 years, and I'm not so sure about that. I'm not sure that it's not DES."
Nokes does say that she has been reassured somewhat in the past year or so by the fact that AZT is now usually being given in smaller doses and for shorter periods of time than in the years immediately following ACTG 076.
"We don't yet know the long-term effects of AZT or other HIV drugs, that's true," counters WITS's Dr. Cooper, "and we are looking very closely at that. But if you compare the terrible risk of contracting HIV, which is always fatal, to the minimal risks of AZT, I would say there is no comparison."
This, then, is precisely where today's ideological battle line is drawn: To those who are convinced that HIV is "always fatal," AZT, even during pregnancy, is essential. But to a growing number of people who question that presumption, this now-standard treatment for nonsymptomatic and risk-free HIV-positive patients – and their children – has come to seem almost diabolical.
- ↑ E. M. Connor et al., "Reduction of Maternal-Infant Transmission of Human Immunodeficiency Virus Type I With Zidovudine Treatment," The New England Journal of Medicine 331, no. 18 (November 3, 1994): 1176-1177.
- ↑ V. Pliner, Poster We.C.3473, "Estimation of Long Term Survival to AIDS in Perinatally Infected Children."
- ↑ R. Root-Bernstein, Rethinking AIDS (New York: Free Press, 1993), 252-257.
- ↑ Ibid.
- ↑ "Retrovir Indicated to Prevent Transmission of HIV from Pregnant Women to Their Babies", News Release from Burroughs Wellcome Co. (now Glaxo Wellcome Co.), August 9, 1994.
- ↑ R. D. Semba, N. M. H. Graham, W. T Caiaffa, L. Clement, and D. Vlahov, "Increased Mortality Associated With Vitamin A Deficiency During Human Immunodeficiency Virus Type-1 Infection," Arch Intern Med 153 (1993): 2149-2154.
- ↑ The New England Journal of Medicine 331, no. 18 (November 3, 1994) 1176-1177.
- ↑ Science 278, no. 5343, 1553.
- ↑ The New England Journal of Medicine 331, no. 18 (November 3, 1994): 1176-1177.
- ↑ "HIV and Infant Feeding: A Guide for Health Care Managers and Supervisors," WHO FRH/Nut 98.2 UNAIDS/98.4, 1998.
- ↑ The New England Journal of Medicine 331, no. 18 (November 3, 1994): 1176-1177.
- ↑ Antiretroviral Pregnancy Registry for Zalcitabine (HVID, DDC) and Zidovudine (Retrovir, AZT): A Collaborative Project Managed by: Burroughs Wellcome Co., Hoffman-La Roche, Inc.
- ↑ R. Kumar, P. F. Hughes, and A. Khurranna, "Zidovudine Use in Pregnancy: A Report on 104 Cases and the Occurrence of Birth Defects," Journal of Acquired Immune Deficiency Syndrome 7 (1994): 1034-1039.
- ↑ Ibid.
- ↑ M. Culnane, and M. G. Fowler, "Evaluation for Late Effects of In Utero (IU) ZDV Exposure Among Uninfected Infants Born to HIV+ Women Enrolled in ACTG 076 and 219."
- ↑ P. Duesberg, Inventing the AIDS Virus (Washington, D.C.: Regnery Publishing, 1996), 229-359.
- ↑ Ibid.
- ↑ P. Duesberg and D. Rasnick, "The AIDS Dilemma: Drug Diseases Blamed on a Passenger Virus," MS # A461, University of California at Berkeley, Department of Molecular and Cell Biology, June 25, 1998.
- ↑ Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 14, no. 4 (April 1, 1997): A29.