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NEW YORK NATIVE/March 7, 1994

Thalidomide For Black Mothers
by Neenyah Ostrom

     The AZT pushers are at it again. On February 21, the
government issued a press release that resulted in a page-one
story in the New York Times by Lawrence K. Altman, "In Major
Finding, Drug Curbs HIV Infection In Newborns." The press
release and article referred to preliminary data- still
unpublished and unreleased-from yet another truncated AZT
study, AIDS Clinical Trials Group (ACTG) 076. This study gave
AZT to HIV-positive pregnant women (80 percent of whom are
black and/or Hispanic) to see if it stopped them from having
HIV-positive babies.
     According to the government dispatch, it does.
     Additionally, this newest piece of press-release science
is being used as another argument for instituting some form
of mandatory HIV testing.
     Although neither the New York Times nor any other
mainstream media reports mentioned it, previous U.S.
government-sponsored, prematurely-ended studies of AZT have
provided quite distorted pictures of what the drug does; some
of the statements and recommendations growing out of these
faulty U.S. studies, in fact, have subsequently been
contradicted by more rigorous foreign studies.
     The assertion by the National Institute of Allergy and
Infectious Diseases researchers that AZT slowed the progression
to "AIDS" when given to asymptomatic individuals, for instance,
was completely contradicted by the Franco-British Concorde
Study.
     Despite the Concorde Study results-which were effectively
"disappeared" by Altman's report in the Times and other major
media reports-and despite the fact that AZT is not only
extraordinarily toxic to adult humans but has never been found
to prevent HIV transmission(such as in cases of needlestick
injury), the National Institute for Allergy and Infectious
Diseases (NIAID) now says that AZT works in perhaps the
ultimately asymptomatic population:the unborn.
     And despite the overwhelming toxicity shown in adults
treated with AZT, the government press release about ACTG
076 insists that "both mothers and  infants tolerated the
AZT treatment well, with no significant short-term side effects
other than reversible mild anemia(low red blood cell counts)
in some infants."
     Perhaps little immediate toxicity was detected because
the women were given AZT therapy for a relatively short period,
one to 29 weeksor perhaps there were more serious problems
inherent in the study that caused this and other seemingly
anomalous findings. As usual in U.S. government AZT studies,
there has been no long-term followup of either the women or
their infants.
     Nevertheless, by interrupting an incomplete study
conducted on overwhelmingly black and Hispanic women and their
babies, U.S. government scientists, led by NIAID Director
Anthony Fauci have once again pronounced AZT to be a miracle
drug.

ACTG 076: The Early Returns
     According to the NIAID press release issued February
21, "Zidovudine(AZT) therapy has reduced by two-thirds the
risk of
transmission of virus from HIV-infected pregnant women to
their babies, according to preliminary results of a trial
sponsored by the National Institute of Allergy and Infectious
Diseases (NIAID), in collaboration with the National Institute
of Child Health and Human Development(NICHD) and Institute
National de la Sante et de la Recherche Medicale (IN-SERM)
and Agence Nationale de Recherches sur le SIDA (ANRS) of
France."(2)
     The prematurely-ended study showed, according to NIAID,
"a transmission rate of 8.3 percent when both mothers and
their babies received AZT, in comparison with a transmission
rate of 25.5 percent among those receiving a placebo."(3)
     Health and Human Services Secretary Donna E. Shalala
called the results "very promising."(4)
     NIAID Director Anthony S. Fauci said, "Long-term follow-up
of all of the children born to mothers in this study is
essential to learn more about the risks and benefits of the
treatment beyond these encouraging early results."(5)

     The researchers involved in directing the study, Edward
M. Connor(University of Medicine and Dentistry of New Jersey,
in Newark) and Rhoda Sperling (Mt. Sinai School of Medicine),
"will monitor the growth and development and look for any
unusual illnesses among the infants," according to NIAID's
press release.
     "Because long-term effects of therapy on the infants
are currently unknown, no recommendations about treatment
to prevent transmission of HIV during pregnancy and delivery
are being made pending development of consensus on the balance
between known benefit and unknown risk," the press release
concedes.(6)
     Altman's report in the New York Times emphasizes another
facet of this study: that these results are going to be used
to widen HIV antibody testing. He quotes Harold Jaffe, "the
top scientist on HIV at the Centers for Disease Control and
Prevention in Atlanta," as saying, "...[ACTG 076] will provide
a real impetus for identifying more HIV-infected women during
pregnancies so that they could consider the benefit of AZT
treatment to themselves and their children.(7)
     Altman amplifies this point later in the article:

   The new findings raise major practical and ethical
questions. Until now, testing for HIV infection in the
United States has been recommended for those who consider
themselves at risk. But testing is not mandatory, and there
is no general recommendation to test all pregnant women.
The American Academy of Pediatrics recommends testing of
pregnant women in areas where the prevalence of HIV is
high. But compliance among health officials varies.

   The new study offers impetus for more aggressive testing
programs for pregnant women because of the benefits of
the AZT treatment. But any calls for mandatory tests would
raise the issue of a woman's right to privacy. In addition,
developing countries would face the issue of paying for
the drug..."



     Another document, "ACTG 076 Questions and Answers" (issued
simultaneously by NIAID), inadvertently raises more questions
about the study than it answers.
     For instance, one of the questions is, "Were significant
side effects seen in the mothers that could be associated
with zidovudine use?"
     The answer provided by NIAID is:
     "The drug was tolerated well by women enrolled in the
trial. No significant differences in side effects between
zidovudine and placebo groups were reported. The most common
side effects reported were blood related toxicities with equal
numbers reported in both groups. Six women discontinued
treatment due to toxicities. Three of these were receiving
zidovudine and the other three were receiving placebo."
     What kind of placebo causes "blood toxicities?" And if
it does cause blood toxicities, doesn't that disqualify the
substance as a placebo, which is (or should be) by definition
an inactive substance, having neither positive nor negative
effects?
     According to Mary Culmane of NIH's Division of AIDS,
the placebo given to the pregnant women consisted of "inert
capsules." During delivery, when AZT or placebo was
administered intravenously, the placebo group received saline
(i.e., water with the physiological amount of salts in it).
The liquid placebo given to the infants, according to Culmane,
was flavored to taste like liquid AZT, but was also an inert
substance. Culmane could no explain why the same number of
"blood toxicities" would occur in the placebo group as were
seen in the AZT group.(9)
     "Blood toxicities" are caused by AZT, of course. The
types of blood toxicities observed in AZT poisoning were listed
by John Lauritsen in his collection of Native articles
published in book form, Poison by Prescription: The AZT Story.
According to Lauritsen's examination of the Phase II AZT
clinical trial data, "blood toxicities" were much more
prevalent in the group receiving AZT than in the placebo
group.(10)
     "Moderate anemia," for instance, was seen in 25 percent
of those receiving AZT, as compared to four percent of those
receiving placebo. Severe anemia was seen in 13 percent of
the AZT group, and in only two percent of the placebo
group.(11)
     Thirty-one percent of the AZT group required at least
one transfusion, as compared with ten percent of the placebo
group, according to Lauritsen. And "grade 3" bone marrow
suppression was found in 45 percent of those taking AZT as
compared with only 12 percent of those taking placebo.(12)
     Neutropenia, or low white blood cells, was observed in
16 percent of the AZT group, compared with only two percent
of the placebo group, according to Lauritsen.(13)
     But according to NIAID's "Questions and Answers," infants
in both the AZT and placebo arms of the study developed anemia
(i.e. low hemoglobin) and low white blood cells (neutropenia),
as well as "a high bilirubin level."(14)
     "While significant anemia was rare, the values of
hemoglobin for the zidovudine group were lower than those
for the placebo," the document admits.(15)
     Generally, however, the NIAID documents about ACTG 076
state that no greater toxicities were seen in the AZT group
of mothers and infants than were seen in the placebo
group-which should have experienced no toxicities. And
considering the severe side effects seen in adult patients
who take AZT-including damage to kidneys, liver, and nerves;
Muscle atrophy, fatigue, headache, nausea, dizziness, and
possibly cancer-it is difficult to believe that a very slightly
increased anemia is the most significant adverse result
observed among these infants given AZT before birth.(16)
     Unless, as Lauritsen documented for the Phase II AZT
trials, which he has termed "fraudulent," not only the AZT
group but also the "placebo" group were in actuality taking
AZT.
     As Lauritsen recounts in Poison by Prescription:
     "In practice, the study became unblinded almost
immediately. Some patients discovered a difference in taste
between the AZT and the placebo capsules. Other patients took
their capsules to chemists, who analyzed them. Doctors found
out which patients were receiving AZT from very obvious
differences in blood profiles. Thus, the very design of the
study was violated. For this reason alone the Phase II trials
were invalid."(17)
     Unless there is such a flaw in study design or
implementation in ACTG 076, why would the "blood toxicities"
seen in the participants taking AZT also be seen in the placebo
group?
     Paralleling the toxicity data in ACTG 076, there were
equal numbers of deaths in the treatment (AZT) and control
(placebo) groups of infants. The NIAID "Questions and Answers"
states, "No women on the study have died. Most women on ACTG
076 are at a relatively early stage of HIV disease. Seven
infants in the treatment group and seven infants in the control
group died. Infant deaths were attributed to serious congenital
anomalies present at birth or were due to rapid progression
of HIV disease."(18)
     History does appear to be repeating itself, if not in
the selfdestruction of this particular study (which may be
yet to come), at least in the government's handling of it:
ending the trial before adequate follow-up can be done and
trumpeting triumph for an incomplete study. Lauritsen describes
how these mistakes were made half-way through the Phase II
AZT trials:
     "Midway through-as the researchers were losing control
and the study was bombing-the trials were abruptly terminated.
With much media fanfare it was claimed that AZT had
miraculously preserved the lives of those taking it, and that
it would therefore be 'unethical' to withhold AZT from PWA's,
even for the few more weeks that would be required to carry
the study through to completion. Allegedly only one patient
on AZT had died, as opposed to nineteen patients on placebo,
during an average treatment time of seventeen weeks..."(19)

"The Hope That Doing Something Is Better Than Doing Nothing"
     Where are the actual data from this study? Based on
information received that babies born to the women in ACTG
076 had birth defects such as extra fingers and toes, I
requested that data from the study be released under the
Freedom of Information Act. When the request was denied, I
filed an appeal. The appeal was denied by Assistant Secretary
for Health and Human Services Philip Lee on January 6, 1994,
because ACTG 076 was an ongoing study.
     Now, however, the study has been ended-prematurely, like
all U.S. government AZT studies-and clinical alerts issued
to physicians, without-also as usual-any publication of the
actual data from the clinical trial.
     And perhaps most disturbingly, a great deal of research
has been totally disregarded in the government's push to get
HIV-positive pregnant women to take AZT.
     For instance, the major criterion used to select the
women for the study-a positive result on the HIV antibody
test-may be meaningless. According to a recent report from
Australian researchers, the HIV antibody test is completely
unreliable and there is, in fact, some question about not
only what it means but what it actually measures.(20)
     Additionally, there is no real rationale for using AZT
to prevent HIV transmission, even for those who believe that
the retrovirus causes "AIDS." No study of transmission of
HIV from patients' blood to health care workers via needle
stick injuries, for instance, has ever shown AZT to be
effective in blocking such transmission.
     One such study was performed by researchers from Queen
Elizabeth Hospital in Woodville South, Australia. They wrote
to The Lancet noting that, despite the fact that the risk
of contracting HIV after needlestick injury is only 0.47
percent, "it is recommended practice in many hospitals to
prescribe zidovudine after such injuries in an attempt to
reduce the risk of infection."(21)
     "This practice is based on limited animal data and on
the hope that doing something may be better than doing
nothing," the Australian researchers continue. "We describe
a case where the timely administration of zidovudine was not
successful."(22)
     After describing a case in which AZT did not prevent
a health care worker from becoming HIV-positive after taking
blood from an "AIDS" patient and getting stuck with the dirty
needle, the Australian researchers conclude, "Zidovudine cannot
be relied upon as an effective agent for prophylaxis after
a needlestick injury."(23)
     And most damningly for ACTG 076, the findings of the
Concorde Trial are ignored. The final results from the Concorde
Trial are about to be published; the preliminary report,
published in April 1993 in The Lancet, suggests that AZT is
of essentially no value.
     "Concorde was designed in 1988 to determine whether
symptom-free, HIV-infected individuals would benefit from
starting zidovudine at randomization rather than deferring
treatment until the onset of symptomatic disease," the
preliminary report explains. "The endpoints were progression
to CDC group IV disease (AIDS or 'minor' AIDS-related complex
[ARC] based on one or more minor opportunistic infections
or one constitutional symptom), death, and sever drug
toxicity."(24)
     The Concorde Trial was conducted from October 1988 to
October 1991. During that time, 1749 individuals from UK,
Ireland, and France were divided into two groups: asymptomatic,
HIV-positive people taking AZT immediately (dubbed the "Imm"
group, 877 people who took 250 milligrams zidovudine four
times a day); and 872 people in the deferred group("Def"),
who took "matching placebo" until they developed symptoms,
when they then took AZT.(25)
     The European researchers reported a "significant
difference" in CD4 cell counts; the asymptomatic individuals
taking AZT (the "Imm" group) lost fewer CD4 cells than did
those in Def group, who took placebo until they developed
symptoms.(26)
     However, theses researchers also found that number of
CD4 cells did not correlate with health status:
     "By contrast with the differences in CD4 count, there
was no significant difference in clinical outcome between
the two therapeutic strategies," they report. "The three-year
survival rates were 92 percent (90-94 percent) in the Imm
group and 93 percent (92-95 percent) in the Def
group....Similarly, there was no significant difference in
rates of progression of HIV disease; Three-year progression
rates to AIDS or death were 18 percent in both groups and
to 'minor' ARC, AIDS, or death these rates were 29 percent
(Imm) and 32 percent(Def).(27)
     The big news from the Concorde Trial is, however, that
AZT does not delay illness when given to asymptomatic,
HIV-positive people, as the European researchers make quite
clear:

  To date, the results of four placebo-controlled studies of
zidovudine in early HIV infection have been published from
the USA...Three of the four studies were terminated early with
average follow-up of about one year or less. The fourth had
an average followup of just over two years and did not show
a survival difference. The main finding from these four trials
was a delay in the clinical progression to AIDS or severe ARC.
The findings from Concorde at a comparable short follow-up
time were not inconsistent with this. However, such a delay
was not seen over the longer follow-up period.(28)

     So, not only did the Concorde study disprove the premature
conclusion that giving AZT to asymptomatic, HIV-positive
individuals delayed their disease and death, it also broke
an important chain of inference: the long-held assumption
that CD4 cell counts are predictive of disease progression.
The Concorde findings, these researchers report, cast "doubt
on the value of using changes over time in CD4 count as a
predictive measure for effects of antiviral therapy on disease
progression, as defined by the protocol, and survival."(29)
     In response to the Concorde Trial results, NIAID issued
new guidelines about administering AZT. It was still
recommended as the "first-line therapy" for people with CD4
cell counts between 200 and 500 who develop "AIDS"
symptoms.(30)
     In a deft move to protect the government panel that
devised the new guidelines, the NIAID press release announcing
them notes: "In writing the recommendations, the panel
emphasized the choice to accept or decline antiretroviral
therapy ultimately rests with the patient. Moreover, the panel
noted that early intervention does not necessarily mean just
giving these drugs to stable HIV-infected patients who have
not developed symptoms. Instead, early intervention involves
primary medical care, including management of the patient's
overall health status, and providing emotional and
psychological support."(31)
     It seems ironic, at the very least, that the same health
officials who might argue that a mother could be forcibly
detained to prevent drug use or smoking from injuring her
fetus, and who already argue that it is a matter of personal
choice for adults whether to take a drug as toxic and useless
as AZT, enthusiastically support giving it to an unborn child.
     So an ugly inference is drawn, by some, about the fact
that many of the non-gay men in this country-adults as well
as babiesbeing given AZT are black and Hispanic. In ACTG 076,
for instance, 80 percent of the women (and, of course, their
babies) are black, Hispanic, or Asian.
     Even before ACTG 076, some blacks considered AZT to be
racial genocide.

"The AIDS Plot Against Blacks"
     While this newspaper has argued that, by definition,
the "AIDS"/CFS dichotomy is a racist one, ours has not been
the only voice raising such questions. In May 1992, so many
voices were raising questions about HIV and AZT that the New
York Times editorial page writers felt compelled to refute
an alleged "AIDS 'Plot Against Blacks."(32)
     The language used by the Times is considerably less than
measured, as the first sentence illustrates: "Bizarre as it
may seem to most people, many black Americans believe that
AIDS and the health measures used against it are part of a
conspiracy to wipe out the black race."(33)
     Not only did a 1990 survey of black church members reveal
that "an astonishing 35 percent believed AIDS was a form of
genocide," the Times reports disapprovingly, but "Worse yet,
the treatments and preventives against AIDS have become
suspect."
     The Times editorial explains, "Some blacks believe that
AZT, the harsh drug used to combat the disease, is a plot
to poison them..."
     "At its most destructive, the paranoia causes many blacks
to avoid medical treatment," the editorial continues. "Unless
black and Hispanic leaders play a more vigorous role in
countering the fears and mistrust, it will become ever harder
to slow the epidemic..."(34)
     In this study (ACTG 076) giving the toxic drug AZT to
pregnant women, however, the participants are 80 percent black,
Hispanic, or Asian. And the putatively positive results from
yet another truncated AZT study are being used as rationale
to institute mandatory HIV testing of pregnant (black and
Hispanic) women.
     The data haven't been published. Nobody knows if theses
infants' nervous systems, for instance, have been irreparably
damaged by receiving AZT in utero.
     The most that U.S. health officials will say on that
score is, essentially, "Time will tell."

     Of all the badly-done AZT studies sponsored by NIAID,
the one health officials may regret the most could turn out
to be ACTG 076.


References

1. NIAID News;"AZT Reduces Rate of Maternal Transmission of
HIV"; Office of Communications, February 21, 1994.
2. Ibid.
3. NIAID News, op cit.
4. NIAID News, op cit.
5. NIAID News, op cit.
6. NIAID News, op cit.
7. Altman, Lawrence K.; "In Major Finding, Drug Curbs HIV
Infection in Newborns"; New York Times, February 21, 1994.
8. Ibid.
9. Personal communication, Mary Culmane, NIAID Division of
AIDS, February 24, 1994.
10. Lauritsen, John; Poison by Prescription: The AZT Story,
Asklepios Press, New York City, 1990.
11. Ibid.
12. Lauritsen, op cit.
13. Lauritsen, op cit.
14. "ACTG 076: Questions and Answers";National Institute of
Allergy and Infectious Diseases Office of Communication,
February 21, 1994.
15. Ibid.
16. "Questions and Answers," op cit.
17. Lauritsen, op cit.
18. "Questions and Answers," op cit.
19. Lauritsen, op cit.
20. Eleopulos, Eleni Papadopulos et al.;"Is a Positive Western
Blot Proof of HIV Infection?";Bio/Technology 11:696, June
1993.
21. Looke, D.F.M. and D.I. Grove; "Failed Prophylactic
Zidovudine After Needlestick Injury"; The Lancet, May 26,
1990.
22. Ibid.
23. Looke and Grove, op cit.
24. Aboulker, Jean-Pierre and Ann Marie Swart; "Preliminary
Analysis of the Concorde Trial";The Lancet 341:889, April
3, 1993.
25. Ibid.
26. Aboulker and Swart, op cit.
27. Aboulker and Swart, op cit.
28. Aboulker and Swart, op cit.
29. Aboulker and Swart, op cit.
30. News From NIAID:"HIV Therapy Guidelines Issued"; June
25, 1993.
31. Ibid.
32. "The AIDS 'Plot' Against Blacks";New York Times editorial,
May 12, 1992.
33. Ibid.
34. "The AIDS 'Plot' Against Blacks," op cit.

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