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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unpublished and unreleased-from yet another truncated AZT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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