Thalidomide For Black Mothers

By Neenyah Ostrom
New York Native 7 March 1994

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 The press release and article referred to preliminary data- still unpublished and unreleased-from yet another truncated AZT study, AIDS Clinical Trials Group (ACTG) 076.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 ransmission(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 or 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 edicine), "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 imultaneously 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), is 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 AZTgroup 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 symptomatic 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.