I did ask about this recently: surprisingly there's no real plans to
replace AZT in the "PEP" protocol for babies born to infected mothers.
Yet.

GTG, a peds ID meeting in 5 :o)

Bennett

AZT ROULETTE
The impossible choices facing HIV-positive women.

By Celia Farber

Mothering

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. (1) (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. (See "How Accurate Is the HIV Test" on page 60.)

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. (See "Does HIV Cause AIDS?"
page 56.) 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. (2)
In his landmark book Rethinking AIDS, Dr. Robert Root-Bernstein states,
"Less than a third of HIV-sero-positive infants go on to develop AIDS."
(3)

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. (4)

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. (5) 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. (6)
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. (7)

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. (8)

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.) (9)

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." (10)

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.)
(11)

"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. (12) 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. (13) 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." (14)

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." (15)

"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.) (16)

"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. (17) 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. (18)

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]." (19)

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. *

Celia Farber has written on the issues and controversies surrounding HIV,
AZT, and AIDS for more than a decade. She is a regular contributor to
Esquire, Spin, USA Today, and Gear, among other national publications. She
is the mother of one son and resides with her family in New York City.

Notes:

1. 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.

2. V. Pliner, Poster We.C.3473, "Estimation of Long Term Survival to AIDS
in Perinatally Infected Children."

3. R. Root-Bernstein, Rethinking AIDS (New York: Free Press, 1993),
252-257.

4. Ibid.

5. 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.

6. 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.

7. The New England Journal of Medicine 331, no. 18 (November 3, 1994)
1176-1177.

8. Science 278, no. 5343, 1553.

9. The New England Journal of Medicine 331, no. 18 (November 3, 1994):
1176-1177.

10. "HIV and Infant Feeding: A Guide for Health Care Managers and
Supervisors," WHO FRH/Nut 98.2 UNAIDS/98.4, 1998.

11. The New England Journal of Medicine 331, no. 18 (November 3, 1994):
1176-1177.

12. Antiretroviral Pregnancy Registry for Zalcitabine (HVID, DDC) and
Zidovudine (Retrovir, AZT): A Collaborative Project Managed by: Burroughs
Wellcome Co., Hoffman-La Roche, Inc.

13. 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.

14. Ibid.

15. M. CuInane, 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."

16. P. Duesberg, Inventing the AIDS Virus (Washington, D.C.: Regnery
Publishing, 1996), 229-359.

17. Ibid.

18. 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.

19. Journal of Acquired Immune Deficiency Syndromes and Human
Retrovirology 14, no. 4 (April 1, 1997): A29.