MOTHER TO CHILD TRANSMISSION OF HIV
AND ITS PREVENTION WITH AZT AND NEVIRAPINE
A Critical Analysis of the Evidence
ISBN 1 876763 72 8
By Eleni Papadopulos-Eleopulos, Valendar F. Turner, John M Papadimitriou, Helman Alfonso, Barry A. P. Page, David Causer, Sam Mhlongo, Christian Fiala, Todd Miller, Anthony Brink, Neville Hodgkinson
October 2001
PROLOGUE
"We absolutely must leave room for doubt or there is no progress and there is no learning. There is no learning without having to pose a question".
-- Richard P Feynman, Physicist and Nobel Laureate. Galileo Symposium Address 1964.
The impetus for this review arose as a result of the Presidential AIDS Panel meetings held in South Africa during May and July 2000 under the auspices of the South African Government and President Thabo Mbeki. Our purpose in this publication was not to discuss the HIV theory of AIDS or even the existence of HIV (Those interested in the fundamental question of proving the existence of HIV will find it discussed in Appendix XI). The question this monograph addresses, assuming that HIV does exist, is whether a unique retrovirus is transmitted from pregnant women to their children and whether compounds such as zidovudine (AZT) and nevirapine are able to prevent such transmission.
In Parts I-II we examine on the indirect methods said to prove HIV infection and transmission, as well as epidemiological data on mother-to-child transmission. Part III analyses data associated with breastfeeding practices and the possibility of infection. Part IV includes pharmacological data relevant to zidovudine and nevirapine as well as their effects on the several parameters claimed to be indicative of HIV infection and transmission. Included in Part IV is a detailed review of the Pediatric AIDS Clinical Trials Group (ACTG) 076 study which forms the basis of recommending the administration of AZT to all pregnant, HIV positive women and their newborn babies. In Part V we present data on non-retroviral factors which affect the putative mother-to-child transmission of HIV and its prevention, especially the role of nutrition including micronutrients. Part VI consists of a general discussion of the topic.
In reviewing evidence of such a voluminous nature authors face the perennial problem of space and balance. To present too much data is to overwhelm the reader. To present too little is to risk scientific scholarship. Notwithstanding, given the critical nature of this subject to continents of people, and that mother to child transmission is accepted as fact by virtually the whole scientific establishment, we decided to present and discuss at length all the data we could muster. However, with the reader in mind, many of the epidemiological studies are prefaced with a precis. We make apology for studies we may have inadvertently omitted.
Scientists who question prevailing theories are under an obligation to present alternatives or, as a minimum, explain particular observations by other means. Consequently, we have included data on the role of cellular oxidation in the genesis of “HIV” phenomenology as well as diseases constituting the clinical syndrome.
It is hoped that this critical analysis of the evidence will prompt a reappraisal of the data interpreted as proof of mother to child transmission of HIV and thereby direct resources towards appropriate efforts to ameliorate factors linked to such biological phenomena.
| CONTENTS |
| |
PROLOGUE |
1 |
| PART I |
TESTS USED TO DETERMINE HIV INFECTION |
3 |
| 1.1 |
Introduction |
3 |
| 1.2 |
Antibody Tests |
3 |
| 1.2.1 |
Non-specificity |
6 |
| 1.3 |
“HIV Isolation” |
8 |
| 1.4 |
Polymerase Chain Reaction (PCR) and “Viral Load” Tests |
8 |
| 1.5 |
Testing and the AIDS risk groups |
10 |
| 1.6 |
Discussion |
11 |
| 1.6.1 |
PCR |
11 |
| 1.6.2 |
Antibody tests |
12 |
| 1.6.2.1 |
If not HIV what leads to a positive test? |
12 |
| 1.6.2.2 |
Why are these tests not more often reported positive in individuals who do not belong to the AIDS risk groups? |
13 |
| 1.6.2.3 |
Why there is a relationship between a positive test and the appearance of AIDS? |
14 |
| 1.6.2.4 |
If the tests are specific, that is, if the tests prove infection, how did the women acquire HIV? |
15 |
| 1.7 |
Heterosexual transmission of HIV |
15 |
| 1.8 |
Conclusion |
24 |
PART II |
EPIDEMIOLOGICAL EVIDENCE FOR MOTHER TO CHILD TRANSMISSION OF HIV |
25 |
| 2.1 |
Introduction |
25 |
| 2.2 |
Studies from the USA |
25 |
| 2.3 |
Studies from Europe, Australia and Canada |
32 |
| 2.4 |
Studies from Africa and Asia |
38 |
| 2.5 |
Discussion |
42 |
| 2.5.1 |
Epidemiology |
43 |
| 2.5.2 |
Methods used to prove MCT |
43 |
| 2.5.2.1 |
Antibody tests |
43 |
| 2.5.2.2 |
Culture |
45 |
| 2.5.2.3 |
PCR |
46 |
| 2.5.2.4 |
Clinical symptoms and signs |
47 |
| 2.5.2.4.1 |
Pneumocystis carinii pneumonia in children |
48 |
| 2.5.2.4.2 |
Kaposi’s sarcoma in children |
51 |
| 2.5.2.4.3 |
“AIDS” in children before the AIDS era |
51 |
| 2.5.2.5 |
Experimental design |
58 |
| 2.6 |
Conclusion |
59 |
PART III |
BREAST FEEDING AND TRANSMISSION OF HIV |
61 |
| 3.1 |
Introduction |
61 |
| 3.2 |
HIV in Breast Milk |
61 |
| 3.3 |
HIV Transmission Via Breast Feeding |
63 |
| 3.3.1 |
The first Durban study |
66 |
| 3.3.2 |
The second Durban study |
66 |
| 3.3.3 |
Other studies |
68 |
| 3.4 |
Discussion |
69 |
| 3.5 |
Conclusion |
70 |
PART IV |
EVIDENCE CLAIMED TO PROVE AZT AND NEVIRAPINE REDUCE MCT OF HIV |
71 |
| 4.1 |
Introduction |
71 |
| 4.2 |
The ACTG 076 study |
71 |
| 4.2.1 |
Importance of the ACTG 076 study |
71 |
| 4.2.2 |
Patients and Methods used in the ACTG 076 study |
71 |
| 4.2.3 |
Experimental design of the ACTG 076 study |
73 |
| 4.2.4 |
HIV status of the infants in the ACTG 076 study |
73 |
| 4.3 |
Other Studies on the Effect of AZT on MCT |
75 |
| 4.3.1 |
Studies from Part II |
75 |
| 4.3.2 |
Further studies |
76 |
| 4.4 |
Discussion |
80 |
| 4.4.1 |
AZT |
80 |
| 4.4.2 |
AZT and Viral Load |
80 |
| 4.5 |
Nevirapine |
82 |
| 4.6 |
Conclusion |
83 |
PART V |
ALTERNATIVE PREVENTION OF THE PUTATIVE MOTHER TO CHILD TRANSMISSION OF HIV |
85 |
| 5.1 |
Introduction |
85 |
| 5.2 |
The safety of AZT |
85 |
| 5.3 |
Parameters associated with “MCT” and their modulation by means other than antiretroviral drugs |
89 |
| 5.3.1 |
Viral load data |
89 |
| 5.3.2 |
Malarial infection of the placenta |
92 |
| 5.3.3 |
Malnutrition |
93 |
| 5.3.4 |
Vitamin A |
100 |
| 5.3.5 |
Anti-oxidants |
104 |
| 5.3.6 |
Breast feeding |
108 |
| 5.3.7 |
Other Factors Reported to Affect MCT |
111 |
| 5.3.7.1 |
Drugs |
111 |
| 5.3.7.2 |
Antenatal obstetric factors |
111 |
| 5.4 |
Discussion |
111 |
| 5.5 |
Conclusion |
112 |
PART VI |
GENERAL DISCUSSION |
113 |
| 6.1 |
HIV Tests |
113 |
| 6.2 |
Epidemiological Evidence |
114 |
| 6.2.1 |
Racial distribution |
114 |
| 6.2.2 |
Low number of Paediatric AIDS cases |
114 |
| 6.2.3 |
Causes of death in HIV infected children |
115 |
| 6.3 |
Conclusion |
118 |
| |
References |
119 |
|
APPENDICES |
|
| I |
The WHO Bangui and Ghent Definitions of AIDS |
137 |
| II |
CDC 1987 Classification System for HIV Infection in Children under 13 years of age |
141 |
| III |
CDC 1994 Revised Classification System for HIV Infection in Children under 13 years of age |
143 |
| IV |
CDC 2000 Revised AIDS Surveillance Definition |
151 |
| V |
Reported Literature Measuring AZT triphosphorylation in Humans |
155 |
| VI |
AZT versus “Viral Load” |
157 |
| VII |
AIDS Reporting form for South Africa |
159 |
| VIII |
AIDS Reporting form for Uganda |
161 |
| IX |
Calculation of the probability of HIV transmission between sexual partners |
163 |
| X |
Email Correspondence with the CDC |
165 |
| XI |
A Critical Examination of the Evidence for the Existence of HIV |
175 |
|
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