...
Those who were not able to attend the first meeting in Pretoria, as well as other invited scientists, could, however, participate in the Internet discussion forum that ran between the first and the second panel meetings.
1.
...
3 Terms of reference for the Presidential AIDS Advisory Panel
The terms of reference set for the panel before the first meeting in May 2000 were:
...
Extensive references to original articles and sources were made, especially during the Internet deliberations (Appendix 1). It should, however, be recorded that at times panellists, without any supporting data or evidence, made broad and sweeping statements.
1.
...
4 The report
The transcripts from audio recordings of the two meetings and the electronic record of the Internet deliberations will undoubtedly provide the South African government with a rich source of information as it confronts the AIDS challenge. It is only these transcripts that will convey the full richness of the deliberations, debates and discussions that took place over a two-month period. However, the audio recordings will only convey the temperament of the two meetings. This report captures the deliberations of the panel. It was written from these transcripts and will undoubtedly lack the completeness that the transcripts themselves can boast of.
...
Finally, the report reflects the recommendations made by the panellist and identifies areas for future research and collaboration. Where consensus was not reached, the recommendations reflect the divergence of views. Considerable care has been taken to employ a language which does not take for granted one set of conclusions.
CHAPTER 2 - AETIOLOGY AND TRANSMISSION OF AIDS
2.
...
1 Introduction
Most of the participants agreed that HIV exists, but not all acknowledged that it causes AIDS. Prof Duesberg reminded the panel that he had studied retroviruses for 30 years; and had elucidated their genetic structure, as well as the complexity of their genome and its three genes. He had also analysed the composite proteins, including the glycoproteins, which are the basis for the HIV test. (Note: p24 used in most diagnostic tests is not a glycoprotein). Intrigued by claims that retrovirus can cause disease in humans, he had started research in this field. In his experience, retroviruses do not kill the cells they invade but are latent passengers in humans and animals. He pointed out that 16 years and
...
· Do the anti-HIV drugs do more harm than good?
2.
...
2 Does HIV cause AIDS?
Dr Williamson gave a presentation that affirmed that HIV causes AIDS. It is a retrovirus belonging to the lentivirus family of these RNA (ribonucleic acid) viruses. Its genome consists of the following genes: gag, pol, env, nef, tat, vpr, vpu, vif. Like other retroviruses, it utilises the enzyme reverse transcriptase to produce DNA (deoxyribonucleic acid) within the host cell from the template of viral RNA. This DNA is then inserted into the host cell’s genome. She reminded everyone that there are two types of HIV: HIV- 1 and HIV-2; but that HIV-2 is much less common and is clustered in various geographical areas of the world such as West Africa. She displayed a phylogenetic tree of the various subtypes of HIV-1 that have been well characterised and sequenced and also showed a slide of an electron micrograph of the virus by Hans Gelderblom (1997). She further alluded to the Simian Immune Deficiency Virus (SIV) that causes AIDS in some monkeys.
...
There was a body of opinion expressed in the panel that 'purification' of a virus, as well as electron micrographs of the 'pure' virus was essential to answering the question as to whether a particular virus exists or not. According to Drs de Harven and Turner, HIV has never been 'purified' and no electron micrograph of the 'pure' HIV ever published.
2.2.
...
1 Visualisation and Isolation of the Virus
2.2.1.
...
1 Visualisation of HIV
Dr Turner in a presentation to the panel referred to the first description of the human immune deficiency virus by the groups of Montagnier and Gallo (1983). He described how Prof Montagnier 'supposedly purified' the retrovirus by running culture material from AIDS patients through sucrose density gradients. One of the three proteins extracted from this purified material reacted with sera from AIDS patients, and was later 'claimed' to be HIV p24 – a protein that is unique to HIV.
...
Dr Morris pointed out that it was still difficult to visualise the virus in peripheral blood in spite of high viral loads. She asserted, however, that visualising the virus is not really necessary since there were other equally acceptable ways of 'seeing' the virus including PCR, p24 antigens and viral culture. She further argued that it would hardly be possible to culture an organism that was not found in peripheral blood in the first place. She also indicated that purifying HIV from blood is really not relevant in terms of validating ELISAs. Thus, while it may be difficult to visualise HIV in peripheral blood, it is extremely easy to see it in lymph nodes that are the major site of viral replication. In the light of the above, she argues that Dr Turner’s insistence on withdrawing the ELISA test was inconsistent, especially when he admits that these tests in fact do correlate with AIDS. Dr Giraldo also accepted the epidemiological correlation between AIDS and positive ELISA and Western Blot tests. He stressed, however, that his difficulty lay in the conclusion that positive ELISA and Western Blot tests resulted from patients being infected with HIV.
2.2.1.2. Isolation of HIV
By contrast, Prof Montagnier further stated that HIV could be readily isolated from peripheral blood lymphocytes (after in vitro activation) of patients at the full-blown stage of AIDS. This was indeed the case of the virus isolated by his group from patient LAI who had full blown AIDS with Karposi’s Sarcoma. The virus that was isolated from both the blood and the lymph node biopsy of this patient became the prototype for all HIV-1-antibody testing. Dr Williamson pointed out that isolating HIV from peripheral blood is still difficult because of interference by plasma proteins. Dr De Harven was not convinced by the 'difficulty' argument stating that it had been routine for him in his training to isolate other retroviruses from the blood of leukaemic mice.
...
Dr Turner insisted that in order to determine the specificity of an antibody test, a viral load test or a viral burden test for HIV infection, it is essential to use a gold standard, which in this case is isolation of HIV from infected individuals. This, he asserted, should not be difficult to establish in South Africa.
2.2.
...
2 PCR (Polymerase Chain Reaction) and ELISAs
As already stated above, some panellists, including Dr de Harven, concurred that there is not one single report in the entire medical literature in which a correlation has been established between high viral load measured by PCR of AIDS patients and the observation of HIV particles by electron microscopy. According to him, the best experts in the field concur that this essential correlation has never been made. Dr de Harven went on to stress that (1) any epidemiological studies based on ELISA or Western Blots would have to be fundamentally re-appraised; and (2) that following up AIDS patients with PCR measurement of viral load is, in his opinion, scientific nonsense.
...
Dr Duesberg remarked that two million young people are tested each year for HIV antibodies when they are screened for the US Army. One in a thousand tests positive but there has never been any report of any developing AIDS in the 12–15 years that these tests have been performed. These assertions were contested by Dr Gayle who argued that data existed which contradicted what Dr Duesburg was claiming. Dr Duesberg remarked upon a paper describing a subset of AIDS patients who were antibody positive but PCR negative.
2.2.
...
3 Clinical and Laboratory Evidence of Causation
Opinion was divided as to whether HIV causes AIDS.
...
Dr Bialy asserted that the case of Kimberly Bergallis, who was reported to have died after contracting HIV from her dentist, was actually a case of AZT (azidothymidine) poisoning. Dr Bialy asserted that the replicatory behaviour of HIV during the so-called ‘latent period’and its sporadic changes in titre during the natural history of the disease were typical of a passenger virus.
2.2.
...
4 Evidence from Animal Models
Dr Williamson then covered evidence from animal models. She explained that one can clone the entire genome of SIV, a virus that is a close relative of HIV, insert this into a plasmid and then inject this into macaques. The macaques then get a viraemia and they develop antibodies against SIV. Subsequently they experience a reduction of CD4 T-lymphocytes and the development of AIDS. This progression of disease mimics what happens in humans. According to Dr Williamson, this is clear evidence that SIV, a virus closely related to HIV, causes AIDS with no cofactors present.
...
Dr Rasnick proposed treating chimpanzees that had been inoculated a long time ago with blood from AIDS but never developed the disease, with the same anti-retrovirals now given to human patients. He was certain that these chimpanzees would develop AIDS because of the drugs.
2.2.
...
5 Epidemiological Evidence
Prof Abdool-Karim quoted epidemiological evidence that HIV causes AIDS. The South African Demographic and Health Survey (SADHS) shows a reversal in mortality trends in South Africa, and a study from King Edward VIII Hospital in Durban show that the two-year fatality for children infected with HIV is almost 60%. The infant mortality rate has been shown to be more than double in HIV- positive children versus HIV-negative children at Chris Hani Baragwanath Hospital in Soweto. Data collected at the King Edward VIII Hospital shows that case fatality rates over the last four years have increased from 4.5% to 22.6%.
...
Dr Stewart observed that in the USA and Europe AIDS was spreading only in very well-defined risk groups who were mainly homosexual men, their female partners who were consorts to bisexual men, and also in some groups of drug addicts. The plain fact was that it was spreading only in well-defined groups where behaviour and lifestyle was a predominant feature. Epidemiological information to date would not support any hypothesis that assumed that there was a single exclusive microbial cause of AIDS. “It is a fact that the passage of time has shown beyond all doubt that in the USA and Europe, AIDS is a disease that is not spreading in the general population by heterosexual transmission of HIV or anything else, although that may be a marker, but it is continuing to occur in the original risk groups.”
2.
...
3 Alternative hypothesis on the cause of AIDS
The panellists who do not subscribe to the notion of HIV causing AIDS presented various alternative theories and hypotheses on the cause of AIDS.
2.3.
...
1 The Chemical AIDS Hypothesis
Dr Duesberg believes that the ‘chemical AIDS hypothesis’, and not HIV, explains all aspects of AIDS in the USA, Europe and Africa. The steady rise in AIDS cases is more in keeping with toxic causes as an infection would be expected to produce a bell-shaped curve with decline due to spontaneous immunity and deaths. Furthermore, infections would be expected to affect people randomly, rather than the selectivity shown by AIDS. Also, viral infections are specific causing only one syndrome and not over 30 AIDS-defining conditions. Dr Morris countered by stating that the steady rise in AIDS cases is not incompatible with HIV as the cause of AIDS because of the long period between infection and the onset of disease. Concerning the selectivity of AIDS, she explained that the sexual transmission of HIV meant that the virus will only be transmitted to sexually active individuals, and will not affect people randomly. Prof Duesburg suggested that the panel perform a study in which 100–200 patients, identified as having AIDS according to the Bangui definition,4 have their actual antibody status assessed.
...
Dr Bialy felt that the chemaids hypothesis alone was not sufficient to explain AIDS in Africa but that factors such as the biological parasitic burden that Africans experience in terms of multiple infections, etc over long periods of time is most definitely a contributor to the chronic immunodeficiencies that Africans experience.
2.3.
...
2 The Immunotoxicological Hypothesis
The proponent of the immunotoxicological model (Dr Giraldo) listed five groups of stressors that can destroy the immune system - chemical stressors, physical stressors, biological stressors, mental stressors and nutritional stressors. The immunosuppression caused by these stressors can lead to AIDS even in people who are HIV-negative. The members of the panel who subscribe to HIV as the cause of AIDS accepted the suppression of the immune system by the stressors listed above. They did, nevertheless, point out that immunosuppression due to HIV is very different from toxin-related immunosuppression.
2.3.
...
3 The Oxidation Hypothesis
Dr Papadopoulos-Eleopoulos suggested that oxidising agents could lead to immunosuppression and cause AIDS.
2.
...
4 The involvement of cofactors (or risk factors) in AIDS
In a paper entitled 'AIDS pathogenesis: Alternative views', Prof Root-Bernstein advances several theories that may elucidate the relationship between HIV infection and what are termed cofactors. The interaction between these may explain the nature of the epidemic in different parts of the world.
...
which has not yet happened. Instead, these panel members asserted that the elements commonly called 'cofactors' are the primary factors that cause AIDS in the absence of any requisite HIV infection. A more neutral term to accommodate factors involved in AIDS without denoting the primacy of HIV as a cause of the disease was 'risk factors'. Therefore 'cofactor' is used in this chapter only in the context of proponents of HIV as the cause of AIDS.
2.4.
...
1 Involvement of cofactors in HIV-causes-AIDS Hypothesis
The paper by Prof Root-Bernstein articulated three theories on the primary cause of AIDS where cofactors may or may not be required:
2.4.1.
...
1 Theories that link cofactors to the cause of AIDS by HIV
(a) Theory A: The HIV-only theory
...
Many cofactors induce the production of cytokines, immune suppression and immune depression independent of HIV. Many of these cofactors induce immune system cells to express the receptors required by HIV for the infection of cells.
2.4.1.2 Cofactors that need to be considered strongly
I. Allergenic cofactors
...
It was reported to the panel that researchers from the USA and Malawi have shown that the deficiency of the anti-oxidant vitamin A is common among pregnant women in Africa, and that the deficiency is strongly associated with increased mother-to-child transmission of HIV.
2.4.
...
2 Risk factors that are the primary cause of AIDS according to alternative hypotheses/theories
According to the alternative hypotheses/theories on the cause of AIDS that were presented in section
...
Dr Giraldo made a presentation to outline the following risk factors that cause AIDS:
2.4.2.
...
1 Malnutrition
Malnutrition has been shown to result in:
...
women over a period of 24 months, beginning in 1998, it was reported that nutritional status assessed by loss of body weight “was a significant predictor of eventual HIV seroconversion”.
2.4.2.
...
2 Chemical stressors
Industrial chemicals and environmental pollutants are important causes of different abnormalities upon lymphocyte activation, proliferation and differentiation. Heavy metals, pesticides, diesel engine emission and food additives are also capable of this immune-suppression.
2.4.2.
...
3 Physical stressors
Exposure to lasers, electromagnetic fields, infrared light radio frequencies and free radicals have been shown to affect the immune system.
2.4.2.
...
4 Biological stressors
Human semen has been shown to induce chronic stimulation of the immune system with subsequent depression of the immune system. Blood and its components are known to be immuno-suppressive.
2.4.2.
...
5 Mental stressors
Different immunological abnormalities have been found in people under psychological stress. For example, anxiety and depression decrease lymphocyte counts. Bereavement decreases the response of lymphocyte proliferates to mitogen and lowers natural killer cell activity.
...
At a molecular level, AIDS is the result of alterations of immuno-competent cells and immune metabolic reactions due to an excess of free radicals, especially oxidising agents. Whilst the proponents of HIV as the cause of AIDS acknowledged that malnutrition and the stressors listed above will weaken immunity and increase vulnerability to HIV, these factors could not, on their own, result in the collapse of the immune system that is witnessed in AIDS patients. Nevertheless, Prof Montagnier requested that identification of the relative weights of these cofactors and/or risk factors on the immune system was vital to build up a rational policy on the prevention and treatment of AIDS.
2.
...
5 Transmission of HIV and AIDS
Several of the panellists accept that HIV is blood-borne, transmitted through both heterosexual and male homosexual sex and vertically transmitted in breast milk from infected mothers to babies. However, as reported above, there were panellists who disputed that AIDS is an infectious and transmittable disease.
...
The latter panellists noted that HIV does not survive freeze drying yet haemophiliacs get AIDS. This was contested by Dr Williamson who noted that there are a large number of reports that have shown that transmission of HIV results in AIDS and a number of examples where it has been proven, by characterising the virus in both the donor and the recipient, that transmission has occurred. Furthermore, she stated that haemophiliacs who developed AIDS all received HIV contaminated blood whereas haemophiliacs who did not receive contaminated blood did not develop AIDS.
2.5.
...
1 HIV Transmission as Estimated from ‘AIDS Deaths’
Some panellists disputed the estimated size of the ‘AIDS epidemic’in South Africa.
...
Prof Geshekter quoted from two articles written by Morgan et al. that were published in Lancet in January 1998 and July 1997. As of 1987, there were approximately 1 to 1.5 million Ugandans said to be HIV-positive. However, according to the WHO's weekly epidemiological record of November 1999 the cumulative number of cases of AIDS reported in Uganda is 54,712. The question therefore is “what has happened to the other 946 000 HIV-positive Ugandans who after 10 years, evidently according to the WHO have not progressed to AIDS?”
2.5.
...
2 Sexual Transmission
Dr Morris described a study published just a few months ago by Thomas Quinn showing that the level of virus in the plasma was directly related to the risk of transmitting to an uninfected person. Those individuals with undetectable levels of virus did not transmit to an uninfected partner. All the patients were antibody positive. The transmission data were true for both male to female transmission and female to male.
...
Dr Stewart revealed that, from his experience as an AIDS epidemiologist, predictions that were correct were those which were based on lifestyle and behavioural parameters. Thus drug addiction, men having sex with men and disadvantaged people, were good predictors of AIDS. But if seroprevalence was used as a guide to predict AIDS, one derived a gross over-estimate.
2.5.
...
3 Mother-to-Child Transmission
For more than a decade, publications have addressed the possibility that HIV can be transmitted through breast-feeding. Several studies in Africa have shown that those HIV-negative infants born to HIV-positive mothers later tested positive when their mothers continued to breast-feed them. This was considered enough proof of the infectivity of breast milk.
...
Dr Rasnick quoted a paper by Coovadia et al. of follow-up of 133 infants born HIV-negative to HIV- positive mothers. Twenty-one of the cohort were exclusively formula-fed in the subsequent months, 36 were exclusively breast-fed and 76 received mixed feeding. Transmission rates among exclusively formula-fed infants were 24%, among mixed fed 32%, and 39% among breast-fed infants. How was it, he asked that some of the exclusively formula-fed, initially HIV-negative babies could contract the disease?
2.5.
...
4 Blood-borne transmission and Occupational Exposure
In the report-back from the group of panellists who deliberated on prevention strategies, Dr Mossie reported that evidence for blood transmission had been derived from occupational exposure data, which the CDC had accumulated over time. From these data health workers who had been exposed through needle stick injuries involving their HIV-positive patients, had subsequently contracted HIV infection and sero-converted to HIV-positive status.
...
Dr Turner requested clarification on the blood-borne transmission of HIV infection in haemophiliacs as the latter received plasma, which had been freeze-dried and stored prior to transfusion. Scientifically, the virus does not survive extreme conditions such as freezing and in the light of this fact how did freeze dried plasma still infect those who received it a few months after it had been stored. No explanation for this was proffered during the deliberations.
2.5.
...
5 Epidemiology of Transmission
Prof Duesberg described the three classical hallmarks or the characteristics of an infectious epidemic that distinguish it from an epidemic caused by toxins or lack of nutrients.
...
For recommended research and studies please see Chapter 9.
CHAPTER 3 – SURVEILLANCE
The discussions on surveillance occupied a significant part of the deliberations of the panel with particular emphasis placed on the availability of surveillance data from South Africa and elsewhere and the ability of these data to demonstrate the presence and magnitude of an AIDS epidemic. Several panellists insisted that the unavailability of direct statistical data on how many South Africans have contracted AIDS or have died from AIDS as distinct from the question of how many South Africans were HIV-antibody positive bedevilled any proper discussion on AIDS and its impact on South Africa. These questions were critical given the arguments already advanced in Chapter 2 of this report on the cause of AIDS or whether an HIV antibody positive test could be declared indicative of infection by HIV in the absence of isolation of the virus from seropositive patients. Several panellists argued that the answers to these questions would fundamentally influence the debates as well as any recommendations that could be made on the issue of surveillance.
3.
...
1 What are the questions and issues?
Some key discussion points that were raised with respect to HIV and AIDS surveillance include:
...
· What elements are necessary to strengthen surveillance in South Africa so as to better plan for the impact of the epidemic
3.
...
2 Overview on the necessity for surveillance
There was widespread agreement that surveillance is a necessary tool for understanding the AIDS epidemic. However, there were two opposing schools of thought on the issue of HIV surveillance. One group subscribed to the argument that HIV surveillance is an exercise in futility as it has not been proved that an individual that is HIV-positive will develop AIDS. Thus a more useful marker is AIDS disease. The opposing school of thought argued for the importance of conducting both HIV and AIDS surveillance. They argued for observed correlation between HIV-positive status and AIDS disease.
...
There was a debate arising largely from the school of thought that questioned the causal link between HIV and AIDS and around the philosophy underlying the current public health surveillance practice. Other concerns that were debated included whether surveillance tools (such as the serological ELISA test) are sufficiently sensitive and specific to accurately detect true HIV-positive status; whether measuring sexual behaviour, for instance, is informative, since the causal link between HIV and AIDS is still in question, and whether mathematical models are reliable predictors of epidemics.
3.
...
3 South African epidemic – Fact or fiction
There were differences of opinion on whether there is an AIDS epidemic in South Africa. Those from the school of thought that argues that HIV does not cause AIDS also argued the futility of discussing an HIV epidemic, as they do not believe that HIV causes AIDS. There were some in this latter group who even argued that there was insufficient evidence to support the notion of an AIDS epidemic in Africa.
...
HIV indicator diseases such as other sexually transmitted infections (STIs) and TB are seen to be useful markers of the burden of HIV-associated disease. Studies show that STIs make individuals more infective and more susceptible to HIV infections. Data obtained from a community-based randomised trial in Mwanza, Tanzania substantiate this position, demonstrating that improved treatment of STIs lowered HIV incidence by 42%.
3.3.
...
1 AIDS mortality
On the issue of whether there is an AIDS epidemic in South Africa, Dr Rasnick argued that no evidence on AIDS had been presented to demonstrate an AIDS epidemic. He emphasised that the evidence required was “not HIV, not antibodies to HIV but people who have died from AIDS”.
...
Dr Fiala and other panellists responded to the South African mortality data presented by Dr Makgoba with the argument that they were unable to analyse and adequately comment on the statistics as they had not been presented with the information prior to the verbal presentation (in the second panel discussions) and had therefore not been afforded the opportunity to apply their minds to the data. Dr Bialy's views were that if South Africa had not already determined the epidemic before external influence, the observations made on the epidemic might not be real. He suggested that Dr Duesberg's hypothesis of a chemical causal agent for AIDS be closely examined.
3.
...
4 Epidemiological Theory of Causal Inference
The concept of causal inference is critical to epidemiological practice because theory on causal inference in the context of a particular disease sets ‘standards’on whether a specific infection could or does result in disease. Various theories and hypotheses on the cause of AIDS are presented in Chapter 2 (sections 2.2–2.4) of this report.
...
This view was challenged by Dr Papadopoulos-Eleopoulos, who turned the argument around to support an alternative theory (that AIDS may be caused by another agent e.g. Chemical agent) by concluding that, if a factor can cause disease without necessarily being sufficient, then we can have AIDS without HIV. Scientifically that is the only conclusion that can be drawn. Dr Fiala contributed to this debate a presentation of data published in the European Journal of Epidemiology, which demonstrated that of a total of 465 patients with clinical AIDS, 40% were found not to be HIV-positive. Views expressed by panellists in other discussion suggest that this may not necessarily be unusual and could be influenced by the progression of disease state or tests used.
3.
...
5 Socio-economic risk factors
There were two opposing views on the debate around risk factors that are critical for the transmission and spread of AIDS. One school of thought argued that poor economic status was a sufficient risk factor in the acquisition of AIDS. Another argued that low socio-economic status and poverty contributed to circumstances that would increase the risk of acquiring AIDS, but that these factors are not in themselves sufficient in the acquisition and spread of AIDS.
...
Dr Reddy cautioned against interpretation of the mortality data for causality of death without taking socio-economic and political parameters into consideration. She proposed that the data be studied by a trans-disciplinary team which included Social Scientists.
3.
...
6 Differences in the African epidemic, compared with Europe and the USA
Several panellists presented the issues surrounding why and how the South African epidemic differs from the epidemic in Europe and the USA. According to one group, the similarities are that initially AIDS occurred predominantly among homosexuals and haemophiliacs in the USA, Europe and South Africa, and that subsequent heterosexual spread and perinatal transmission were predominantly low among all socio-economic groups in all regions.
...
A study comparing 70 couples where one partner was a migrant and 50 couples where both were non- migrants showed that the level of HIV discordance (where one person is positive and the other negative) is 30% in migrant couples and 12% in non-migrant couples.
3.
...
7 The role of mathematical models in forecasting the epidemic
Data obtained through mathematical modelling were presented to support the argument that AIDS deaths are on the increase. This argument was supported by data from the national population register of the Department of Home Affairs (see section 3.3.1). While the CDC documentation and other official statistics including the South African Department of Health apply models to forecast events and the epidemic, information published by WHO, UNAIDS and other agencies were widely criticised by panellists such as Prof Duesberg and Drs Fiala and Giraldo. Prof Abdool-Karim expressed a concern about the use of mathematical models.
...
It was widely recognised that there are inherent limitations in the use and application of mathematical models. These limitations result from the wide number of assumptions, and sometimes simplifications, that are made. The point of departure seemed to be the extent to which different individuals and groups are prepared use data obtained from models in spite of their limitations. While panellists suggest that using models is unhelpful, and even misleading, others ascribe to the position (evident from their continued use of models) that models have their usefulness in situations where planning data are required and unavailable and that they should continue to be used with caution.
3.
...
8 Surveillance recommendations – what should be done about the South African epidemic?
3.8.
...
1 Deliberations of the panel
The deliberations of the panel were at all times bedevilled by the absence of accurate and reliable data and statistics on the magnitude of the AIDS problem or even HIV prevalence in South Africa. Repeated requests for such data and statistics, particularly by panellists who refuted the causal link between HIV and AIDS, failed to result in the provision of such data by either South African panellists or the officials of the Department of Health.
Recommendation
It is therefore strongly recommended that appropriate measures be taken to establish the necessary infrastructure and provide the necessary expertise and resources to collect the data and develop reliable and up-to-date statistics on the magnitude of AIDS and prevalence of HIV in South Africa. All efforts must be made to ensure AIDS reporting in South Africa is up to the highest standards in the world.
3.8.
...
2 Discussion on mortality data
The discussions around the mortality data presented by Dr Makgoba revealed the necessity for a study to unpack the numbers and gain deeper understanding as to whether the changing mortality profile resulted from AIDS only and/or from factors other than AIDS.
Recommendation
It is recommended that a trans-disciplinary team comprising members from all the relevant branches of science, including social sciences and humanities, other relevant professional spheres and representatives of relevant government departments be constituted to undertake an in-depth study of the mortality trends in South Africa and report on the results of the study to the South African government.
3.8.
...
3 Recommendations from panellists who do not subscribe to the causal linkage between HIV and AIDS
It was recommended that the South African government commit to the folowwing:
...
f) Continue to increase the nutritional status of the population.
3.8.
...
4 Recommendations from panellists who subscribe to HIV as the cause of AIDS
Dr Gayle and Prof Abdool-Karim, representing panellists who endorse the causal link between HIV and AIDS, reinforced the importance of the following initiatives for the South African government:
...
i) Health facility reporting.
3.8.4.
...
1 Recommendations on surveillance as it pertains to reduction of blood-borne infection
The South African government needed guidance on the following issues:
...
(f) Policies on intravenous drug use
3.8.4.
...
2 Recommendations on surveillance as it pertains to reduction of HIV from Mother to Child
The South African government needed to pay attention to the following issues:
...
· what other mechanisms can be devised to reduce transmission of HIV from Mother to Child
3.8.4.
...
3 Recommendations on surveillance as it pertains to sexual transmission of HIV
The following issues require attention:
...
(f) Research into finding an efficacious and effective microbicide and into the development of a vaccine for therapy and prevention needs to be continued vigorously
3.8.
...
5 General recommendation
There was general consensus on the need for the case definition of AIDS to be standardised for clinical practice in South Africa.
CHAPTER 4 - HIV TESTS AND THEIR ACCURACY
4.
...
1 HIV testing
The ELISA, Western Blot and PCR viral load are the most frequently used tests to confirm HIV infections. The ELISA and Western Blot tests detect HIV antibodies in the serum of patients, whereas the PCR Viral Load test is a genetic test that detects small HIV nucleic acid fragments in whole blood. The veracity and reliability of these tests are key to the validity, reliability, quality and accuracy of epidemiological data used by any country. The ELISA test is mainly used to screen for HIV infection in blood donors and for general surveillance, whereas the Western Blot and PCR are generally used as confirmatory tests and in the context of research. All these tests, individually or in combination, are considered by the proponents of the HIV/AIDS theory as important indicators of infection by HIV. The CD4 count is an additional laboratory test used in combination with ELISA to make a diagnosis of AIDS; and with the Viral Load Test to determine the clinical progression of the AIDS disease and the monitoring of the effectiveness of anti-retroviral treatment. The Western Blot test is more expensive and requires a well-developed laboratory infrastructure; it is therefore not affordable for many developing countries. Dr Fiala also informed the panel that the Western Blot test is not accepted in the United Kingdom as a confirmatory test for HIV infection due to its unreliability.
...
A particular concern raised by some members of the panel was that after 15 years of research, there is the lack of a 'gold standard' against which to measure the accuracy and reliability of the data generated from the commonly used methods to diagnose HIV infection.
4.1.
...
1 ELISA test
The ELISA test is the most commonly used test for screening blood from donors. Its specificity and high sensitivity make it widely acceptable since it is able to detect all the possible HIV infections. It has also been found to be useful in surveillance. It is generally accepted that a single test cannot be regarded as proof of HIV infection. However, in order to improve the reliability and validity of ELISA, the CDC testing guidelines state that “a test for HIV antibody is considered positive when a sequence of tests, starting with a repeatedly reactive enzyme immunoassay (EIA) and including an additional, more specific assay, such as a Western Blot, are consistently reactive”.7 Similarly, the WHO testing guidelines require confirmation of samples that are repeatedly reactive by ELISA using the same blood sample but a different ELISA kit. Both testing regimes call for repeated ELISA testing of a single blood sample rather than ELISA testing of more than one blood sample. However, the UNAIDS–WHO recommendations state: “An additional blood sample should be obtained and tested from all persons newly diagnosed as seropositive on the basis of their first sample. This will help eliminate any possible technical or clerical error”.8 Major concerns surrounding the ELISA test, however, include its specificity, reliability and reproducibility, as well as the lack of a comparative 'gold standard'.
...
The lack of standardisation of ELISA results, both within the country and across countries, was a source of major concern to some panellists. Results of ELISA tests may be interpreted differently within a single laboratory, between laboratories within one country, and between countries. This may mean that a person that tests positive at one laboratory in South Africa may test negative at a different laboratory in the same country. Moreover, the lack of standardisation across countries could result in an individual's testing positive in one country and negative in another.
4.1.
...
2 Western Blot
The Western Blot is an antibody test, which, according to Dr Makgoba, is one of the tests used to confirm the diagnosis of HIV infection in South Africa. Dr Sonnabend reported that he regularly uses the Western Blot as a confirmatory test for HIV infection in the USA. A positive Western Blot result is
...
Dr Papadopoulos-Eleopoulos presented a transparency showing the results of a Western Blot test with a number of samples from leprosy, TB and AIDS patients. It appeared that the Western Blot results from the different samples were indistinguishable from one another, showing the Western Blot test to be non-specific and unreliable. All the samples tested positive, even those from leprosy and TB patients. In further deliberations, Dr Mark Smith pointed out that Max Essex had already demonstrated the indeterminate results from Western Blot results in 1994. The above underlines the fact that the Western Blot test cannot be used as a determinate diagnostic tool.
4.1.
...
3 PCR test for viral load
The PCR viral load test is also used as a confirmatory test. It is based on the amplification of tiny HIV viral particles that are supposed to originate from HIV in the blood. This test is virus specific and specifically detects HIV RNA. It is used to determine the level of viral load in the blood. It is mainly used in the tracking of the clinical progression of advanced HIV infection to AIDS disease, the monitoring of the effect of anti-retroviral treatment and the monitoring of mother-to-child transmission. There is a high correlation between clinical disease progression and the viral load. A high viral load is associated with an increased risk of transmission and the clinical progression to AIDS. Also the level of virus in the blood is directly related to the degree of risk of transmission to uninfected individuals. People with undetectable levels of virus in their blood do not transmit to uninfected partners. Mothers with high viral loads had the highest chance of transmitting the virus to their infants.
...
Another point of concern that was raised was the fact that the PCR test was developed for the non-C- clade virus, whereas the clade-C virus is the most prevalent in South Africa.
4.1.
...
4 CD4 count
The CD4 count is a determination of the concentration of CD4 T-lymphocytes in the blood. The associated immune deficiency leading to infection by opportunistic infections is ascribed mainly to the depletion of CD4 T-cells. The CD4 count can therefore be regarded as an accurate determination of the robustness and functionality of the immune capability and status to effectively protect the body against general infections. HIV infects and destroys CD4 cells (though some dispute this), rendering the immune system incapable of protecting the body against general infections, hence the resultant immunodeficiency in HIV infection and AIDS. This immunological test is used to monitor the progression of HIV infection to clinical AIDS disease and to monitor the effectiveness of anti-retroviral therapy. The CD4 count can be inversely correlated with the viral load. The higher the viral load, the lower the CD4 count will be. Intermediate progressors (patients who take longer than 10 years to progress from HIV infection to AIDS) consistently maintain the concentration of CD4 within normal range. When the CD4 count drops, it predicts the onset of opportunistic infections. In rapid progressors (those who developed AIDS within 2-4 years after infection), the CD4 drops precipitously, coinciding with the onset of infections and clinical progression to AIDS.
...
The improvement of the concentration of CD4 during anti-retroviral therapy is used as a surrogate marker for the effectiveness of the treatment.
4.
...
2 Virus isolation or co-culturing
It is standard practice in virology to use virus isolation or co-culturing to confirm the presence of a virus in any sample (a requirement stated by Prof Montagnier's co-workers a decade ago). Two laboratories have been credited with the successful isolation of the virus from AIDS-infected patients. These are the Koch Institute (work published by Hans Gelderblom) and the US National Cancer Institute. In both of these cases, the authors admitted the possibility of contamination from other viruses in the blood. Once the virus has been cultured, it can be visualised by electron microscopy. While the difficulty of visualising HIV in blood culture is generally accepted, it is possible to see the virus in lymph nodes, which is the major site for replication. Dr Morris pointed out that the large amounts of plasma proteins complicate the visualisation, so that, even when the viral load is high, it is difficult to see any virus by electron microscopy. Transmission electron microscopy, as well as in situ hybridisation, demonstrating that HIV resides on the surface of follicular dendritic cells, are satisfactory means for the visualisation, she said.
...
Dr Turner supported a proposal that will enable comparison of the antibody titre with the isolation of the virus. However, HIV isolation is difficult and expensive to undertake.
4.
...
3 Moratorium on HIV testing
Dr Rasnick, supported by Prof Mhlongo, recommended that the South African government should consider terminating HIV testing by blood banks and for general surveillance since the results of all the
...
Prof Mhlongo spoke of the preoccupation with biomedicine in an attempt to be scientific even at the expense of the wider distressing situation of poverty, poor housing, lack of sanitation and a multitude of diseases associated with the deprivation and urban squalor that characterise the reality of the majority of black South Africans. He presented evidence to show that mortality in England and Wales due to tuberculosis declined precipitously from 1838 with hardly any people dying of TB in the United Kingdom by 1960 (McKeown). This occurred despite the fact that TB chemotherapy only started in 1945 and the BCG vaccine was only developed in 1956. This decline in mortality due to TB had nothing to do with medical interventions but was rather a consequence of improved sanitation, improved housing, improved nutrition and improved environmental conditions that occurred in the United Kingdom during the course of the period under review. Prof Mhlongo went on to present evidence that a similar picture was demonstrated in the USA from 1920 to 1991 (Seale and Stephen).
4.
...
4 Recommendations on HIV testing
4.4.
...
1 Proposed studies and experiments
The key issue that came under focus was the reliability of the ELISA testing in terms of delivering time infection data. As a diagnosis of HIV infection has such a profound effect on a person’s life and future, it was considered of utmost importance that the tests are unimpeachably reliable. Since all epidemiological predictions concerning HIV/AIDS in South Africa are based on the results of such tests, their absolute reliability was declared to be of utmost importance.
...
These tests will be performed on cohorts chosen to represent the full spectrum of the South African population.
4.4.
...
2 Recommendation on future HIV testing
The panellists who refuted the causal linkage between HIV and AIDS recommended the suspension of all HIV testing until its relevance is proved, especially in the African context, given the evidence of false results in a tropical setting and the fact that most assumptions and predictions on AIDS in Africa are based on HIV testing.
4.4.
...
3 General recommendations on testing
(a) The case definition of AIDS to be standardised for clinical practice in South Africa.
...
(c) Apply a series of HIV tests of increasing stringency in order to establish the validity, veracity, rigour, reliability and concordance of ELISA, PCR and viral isolation.
CHAPTER 5 –THE TREATMENT OF AIDS AND THE USE OF ANTI-RETROVIRAL DRUGS
5.
...
1 Introduction
Issues pertaining to the use of anti-retroviral drugs dominated the debate on the treatment of AIDS. On the one hand, panellists who disputed the causal linkage between HIV and AIDS, the use of an anti- retroviral drug to treat a disease that was not caused by a retrovirus was deemed morally indefensible. On the other hand there were panellists who subscribe to the causal linkage between HIV and AIDS and who argued that sufficient and incontrovertible evidence existed in the scientific literature and from clinical experience which affirmed the value of anti-retroviral drugs in the treatment of HIV/AIDS.
...
The toxicity of anti-retroviral drugs was not in dispute from any of the panellists. It nevertheless generated two different sets of attitudes based on whether these drugs should be used or not. One group felt strongly that anti-retroviral drugs were toxic to the point of producing disease conditions in otherwise healthy people. Consequently the drugs should under no circumstances be used in the treatment of AIDS. The other group felt there was incontrovertible evidence from well-conducted randomised clinical trials that anti-retroviral drugs were of substantial clinical value when used in correct dosages and under carefully monitored conditions. The latter group presented varying opinions on which drugs to use, and how and when to use them.
5.
...
2 Evidence in support of the use of anti-retroviral drugs
Proponents for the use of anti-retroviral drugs produced evidence that these drugs improve the quality of life of HIV-infected people. There was reference to clinical experience proving this effect.
...
In developing countries, where issues of costs are significant, the choice of drugs may be dictated by what is affordable. Strategies in this regard may include negotiating for price reductions, parallel importation, local manufacturing and the use of generics.
5.
...
3 Evidence against the use of anti-retroviral drugs
Panellists opposed to the use of anti-retroviral drugs asserted that the evidence in favour of their use comprised only anecdotal claims of benefits, and no real scientific data. They requested that any recommendation to provide anti-retroviral drugs to South Africans must be accompanied by scientific evidence.
...
Dr Giraldo concluded by stating that enough data exist to demonstrate that it is not rational to treat or prevent AIDS with toxic anti-retroviral drugs. It is contrary to common sense to treat a highly toxic syndrome with even more toxicity.
5.
...
4 Recommendations on treatment with anti-retroviral drug
5.4.
...
1 Recommendations on the use of anti-retroviral drugs from the group opposed to their use
The recommendations on the treatment of AIDS from panellists who refute that HIV has a causal link to AIDS were informed by their observation that the definition of AIDS in western countries was different from that used in Africa. These definitions have changed over time to the point where a person diagnosed with AIDS in Africa would not be considered an AIDS patient in the USA, Europe and Australia. There was also the critical question of whether Africans clinically diagnosed with AIDS were in fact HIV-positive. These considerations led to the following assertions:
...
Anti-retroviral drugs and any other immune suppressive drugs should under no circumstances be used to treat AIDS patients or any other patients that are immune-compromised. These drugs inevitably require significant amounts of compensatory medications and are claimed to produce, at best, only short-term benefits in seriously sick patients.
5.4.
...
2 Recommendations from the proponents of anti-retroviral drug use
Given the demonstrated benefits of anti-retroviral drugs in the treatment of HIV/AIDS, the usage of that accumulated knowledge to the benefit of South Africans living with HIV infection was critical. However, given the fact that there is relatively little relevance of the recommendations on the use of anti-retroviral drugs in the USA and Europe for a developing country like South Africa, there is a need for more locally derived evidence based on strategies that are based on locally relevant research. This research will enable the identification of manifestations of HIV infection and of cofactors as well as the definition of local standards for the diagnosis of the conditions and the description of the local epidemiology. There is also a need for South Africa to collaborate with other countries and international organisations that are addressing the issue of how anti-retroviral drugs use is or should be different in a South African type setting. The development of these strategies would need to address the following specific issues:
...
(h) Finally, there seems to be a need to have guidelines on the use of anti-retroviral drugs, which must be updated regularly as new developments emerge.
Recommendations:
A constantly evolving set of guidelines needs to be developed for the treatment, care and support of patients with HIV and AIDS. These guidelines need to address patients at all levels of care, including those in institutions and under community-based care, and include the following:
...
The Strategic Plan (2000–2005) developed by the South African government to combat HIV, AIDS and sexually transmitted diseases was considered a good start to addressing some of the recommendations made here.
CHAPTER 6: PREVENTIVE AND PROPHYLACTIC MEASURES AGAINST AIDS
The basic tenets for the prevention of any disease have to be based on a good understanding of the aetiology as well as the natural progression of that disease. Chapter 2 of this report reflected the split of the panel into two factions around the aetiology of AIDS. The diametrically opposing views on the causal link between HIV and AIDS made the deliberations on prevention strategies extremely challenging. This split on aetiology produced the unavoidable consequence that the deliberations on the prevention of AIDS necessarily had to take place in two parallel streams. Some proponents of HIV as the primary cause of AIDS declared their disinterest in discussing preventive strategies with panellists who did not believe that HIV causes AIDS. Similarly, panellists who do not support the causal link between HIV and AIDS argued that prevention strategies based on this assumption were doomed to fail. The report will therefore present two sets of recommendations in order to capture the arguments accurately.
...
There was consensus that whilst the search for scientific solutions was being pursued, everything should be done to slow the spread of the disease and to mitigate its impact.
6.
...
1 Prevention of AIDS from the point of view of panellists who do not support the causal link between HIV and AIDS
Sections 2.3 and 2.4 of this report captured the submissions on the causes of AIDS from the point of view of those panellists who do not subscribe to the notion that HIV causes AIDS.
6.1.
...
1 Recommendations
The recommendations listed below were proposed as necessary and sufficient to combat all the risk factors that are the real cause of AIDS:
...
· Improving literacy.
6.
...
2 Prevention of AIDS from the point of view of panellists who support the causal link of HIV to AIDS
Panellists who support the causal link of HIV to AIDS proposed that preventive strategies be linked more specifically to the different modes of transmission of HIV/AIDS. These panellists did, however, also support some of the more general medical and public health interventions listed in section 6.1.1 above as critical to ensuring a healthy society.
...
· Mother-to-child transmission during pregnancy, at the time of delivery and during breastfeeding.
6.2.
...
1 General recommendations
· Other strategies need to be put in place to address the social environment, promote safer sexual practices and provide a supportive environment for people who are infected.
...
· Establish and support programmes that minimise the spread of disease through the migrant labour system
6.2.
...
2 Recommendations on prevention of HIV/AIDS through sexual transmission
· A stronger emphasis should be placed on sex education.
...
Dr Fiala suggested that although he did not support the view of the sexual transmission of HIV, the above recommendations did make sense as long as the focus was on a broader approach to healthy sexual habits which encompass prevention of unwanted pregnancy, rather than a single focus on HIV.
6.2.
...
3 Recommendations on prevention of blood-borne transmission of HIV/AIDS
· Improving screening methods for infectious agents in blood.
...
· Strict adherence to universal precautions by healthcare providers at all times.
6.2.
...
4 Recommendations on prevention of mother-to-child transmission of HIV
Panellists who believe that infants can be infected during pregnancy and delivery and through breast- feeding provided several recommendations on preventing these forms of transmission from mother to infant.
6.2.4.
...
1 General
· Supportive and effective reproductive health services must be provided to all women.
6.2.4.
...
2 Education
· Healthcare providers must inform women about the risks of being infected with HIV. They must educate women that infection occurs through sexual exposure, and that abstinence, mutual monogamy and consistent condom use are the only preventive methods known. (This, according to Dr Fiala, was futile, as 2000 years of such messages from the Catholic Church do not seem to have had much success.)
...
possible, couple counselling must be encouraged in order to expand access to care to the family and to ensure psychological and emotional support for the woman.
6.2.4.
...
3 Breastfeeding
· Where feasible, HIV-positive mothers should not breastfeed their babies.
...
Dr Stein cautioned that the recommendations on breastfeeding had to be done in such a way that the long-established benefits of breastfeeding for other women are not undermined.
6.2.4.
...
4 The use of anti-retroviral drugs
Evidence of the efficacy of anti-retroviral drugs is obtained from randomised-controlled trials as well as systemic reviews.
...
Good evidence has been presented from the PETRA trial. This randomised trial assessed the combination of AZT and Lamivudine (3TC). This regimen resulted in a 48% risk reduction of HIV transmission.
6.2.4.
...
5 Caesarean section in preventing HIV-1 vertical transmission
The role of caesarean section has been tested in a recent randomised-controlled trial (RCT). This demonstrated an 87% reduction in vertical transmission in the group randomised to caesarean section. In a further analysis of this subgroup, which focused on women who had had prior exposure to AZT, the effect of caesarean section became less dramatic.
...
· In the absence of anti-retroviral drugs, 29 caesarean sections would have to be done to prevent one case of HIV-1 vertical transmission.
6.2.4.
...
6 Vaginal lavage during labour
The evidence from a RCT indicates that vaginal lavage is only of value if the labour is longer than four hours in duration. Reasonable guidelines would include not rupturing membranes in active labour unless there is an obstetric or foetal indication. Invasive monitoring techniques are not recommended. Routine performance of an episiotomy is also contraindicated.
6.
...
3 Prophylaxis against opportunistic infections
6.3.
...
1 Introduction
Dr Sonnabend pointed out that the control of AIDS infections should not be seen in isolation from other morbidity factors that exist in society, but should be considered in the context of broader social conditions. There is a need to improve overall public health measures in order to improve the health of the population in general. The control of endemic diseases such as TB, malaria, helminthic infections and diarrhoeal diseases and the general provision of clean water have a major impact on the reduction of morbidity and on the spread of the AIDS epidemic in the population. Although HIV infection is diagnosed by antibody tests, other very important baseline tests need to be conducted to provide an indication of the presence of other infections, namely, the Skin test for TB, as well as tests for syphilis,
...
The most common opportunistic infections are cryptococcal meningitis, TB, bacterial, yeast and parasitic infections, Pneumocystis carinii, as well as cervical cancer associated with the human papilloma virus.
6.3.
...
2 Opportunistic infections
A frequent question is how early prophylactic therapy against opportunistic infection should be initiated after HIV infection/diagnosis. Work done in the Ivory Coast suggests that early intervention for opportunistic infections with co-trimoxazole is beneficial and effective. Where facilities exist for conducting a CD4 cell count, an additional guideline is that anyone with a CD4 cell count of less than 500 should be given prophylactic treatment.
...
For prophylactic therapy against mycobacterium avium, the drugs of choice are Perithromicin and Rifobutin.
CHAPTER 7 – Socio--economic factors in the context of HIV/AIDS
Socio-economic factors that enhance the spread of AIDS were not discussed extensively in the two meetings of the Presidential Aids Advisory Panel. They formed part of discussions on other issues and were used as contributing factors or otherwise in defending the various theories. Prof Abdool-Karim made it very clear on several occasions that in South Africa, “it is not enough to educate, it is not enough to inform, it is also necessary to create the social environment to implement health promotion in its broadest context”. What is needed is the training of healthcare workers in implementing solutions to the needs.
...
The socio-economic factors that are related to the spread of HIV/AIDS include:
7.
...
1 Malnutrition and sanitation
The issues of malnutrition and sanitation were discussed at both meetings. These two factors exacerbate the spread of the disease and hamper recovery, not only among HIV-positive patients but also among those with sexually transmitted diseases.
...
The solutions offered throughout are to adopt a preventative strategy as a policy that will involve commitment from services and also counselling to women and, ideally, also those close to them.
7.
...
2 Orphans
The issue of children, with or without AIDS, that are orphaned when their parents die of AIDS was not discussed in any significant detail at either meeting. Prof Whiteside quoted Dr Makgoba as saying that South Africa faced an increase in mortality among the people it could least afford to lose, the young people in society, and that the country should not lose sight of the equally important issues that many of those who died were leaving behind orphans. Dr Rasnick requested data to support the claim that AIDS deaths have generated orphans.
7.
...
3 Ethics and human rights
7.3.
...
1 Ethics
Panellists who advocated that HIV/AIDS patients should be given drugs to assist them in recovery argued that it was unethical to deny drugs to HIV/AIDS patient, regardless of which laboratory they come from, as long as the drugs are known to be beneficial. The main concern of the panellists opposed to anti-retroviral therapy was the ethics of administering such drugs if they are not properly tested through a controlled study. Prof Duesberg maintained that there are no studies to show that AZT and other anti-retroviral drugs have been tested on animals and have shown that they benefit the animals, or at least have no side effects. Additionally, there is a solid body of published research that implies that these drugs are indeed harmful, and, according to some, it is therefore unethical to administer drugs whose clinical actions in relation to dosage and time of application are poorly known, or not known at all. Prof Montagnier held that such drugs are toxic and should not be administered without appropriate monitoring, while Dr Vella maintained that, due to new techniques, drugs are now less toxic than previously.
...
The panellists who disputed that AIDS is caused by HIV declared it unethical for any person who reacted positive to HIV test to be told that they suffer from a deadly disease and face certain death unless they received treatment.
7.3.
...
2 Human rights
Within the South African environment, the most important issues related to a non-discriminatory supportive social environment, according to Dr Bertozzi, include issues related to social conditions, the status of women and other marginalised groups in society, inequality, the alleviation of poverty and human rights.
...
The AIDS epidemic highlights the dynamics of gender-based inequalities, as shown by an already cited survey in KwaZulu-Natal, which demonstrated far higher levels of HIV infection among women than among men in the age groups 20 to 24 and 25 to 29.
7.
...
4 Sexual behaviour
The only data on sexual behaviour came from an international comparison by Durex to evaluate the commercial potential to sell condoms, which was presented by Dr Fiala. The data showed that Americans and Europeans are in the lead when it comes to the number of sexual partners and that South Africans as well as Thailanders are rather average. Americans and Europeans also have the highest frequency of sexual intercourse.
...
Age at first sexual encounter is an important risk factor in HIV infection. In many countries in sub- Saharan Africa, girls become sexually active at an earlier age than boys. They also tend to have sex with older men. Data have already been cited on the higher HIV-infection rates among girls than among boys aged between 15 and 19. A further risk factor for young women is that studies have shown that in some societies, initiation into sex often involves coercion, increasing the risk of trauma during intercourse and the potential for HIV transmission.
7.4.
...
1 Rape
Most panellists maintained that addressing gender issues and reducing the risk of rape were very important factors in reducing the spread of HIV. However, Dr Duerr made the point that there are very few data on the efficacy of post-exposure prophylaxis in rape victims. Prof Abdool-Karim recommended that, in the case of rape, the panel should advise the administration of a combination of two anti-retroviral drugs, which would mean a very short course of anti-retroviral therapy. He was, however, opposed to recommending a policy of administering the drugs to everybody that was raped.
7.4.
...
2 Stigmatisation
Stigmatisation of HIV sufferers is very common in South African society, as is the case in other African countries, Asia, Europe or the USA. Changing people’s attitudes is not easy.
...
Protection of the right to confidentiality and freedom from inhuman treatment has been proved to encourage and facilitate people seeking voluntary counselling and testing.
7.4.
...
3 Promiscuity
During the first Presidential AIDS Advisory Panel meeting, it was suggested that the initial spread of AIDS originated with promiscuous, homosexual drug users, from Los Angeles, through the United States, into Europe and various other countries. However, the concern was raised that certain other, possibly toxic factors, had not been taken into consideration with regard to the spread of the AIDS disease.
...
Since it seems that most of the people infected with HIV in South Africa are black, any sex theory about the transmission of HIV/AIDS would have to postulate that African people are highly promiscuous. Moreover, Dr Fiala had presented figures that showed that Europeans and Americans are much more highly promiscuous than people in South Africa, or in Africa as a whole (see section 2.5.2).
7.4.
...
4 Condom use
According to the macro international DHS surveys, which are used by a whole range of agencies, condom are used between 60% and 80% of the time in the case of first sexual acts in the USA and Europe, compared to only 14% in South Africa. This shows that people are not adapting their behaviour, despite the fact that there is a high level of knowledge in many South African communities about the nature of AIDS and the fact that it is sexually transmitted. However, Dr Fiala cited contradictory data from the Deutsche Latex Forschung that suggested that condom usage in Germany increased only from 2 to 2.3 condoms per year per capita between 1980 and 1995.
...
Prof Abdool-Karim suggested that it is necessary to create the social environment to implement health promotion in its broadest sense when one is looking at creating condom use as the normative behaviour – to bring about a change in mindset that it is ‘cool’to use a condom.
7.4.
...
5 Issues of economics
Reference was made to a World Bank study that claimed that post-exposure prophylaxis is only likely to be cost-effective where the probability of HIV infection in the course of rape is high. Dr Giraldo, however, claimed that pharmaceutical companies would welcome such an idea, as they would commercialise the production of anti-retroviral drugs, syringes, condoms, formula meals and so on. He criticised the World Bank for promoting international loans to get Africa to purchase AZT and other anti-retroviral drugs and condoms as well as do more HIV testing. This, he claimed is bound to increase poverty in Africa and increase the wealth in the west.
...
However, Dr Giraldo suggested that the only rational way to stop the spread of the AIDS epidemic in the African continent is by finding solutions to the economic disparities that are rampant.
7.
...
5 Vaccine development
The main criteria for a vaccine for use in South Africa are that it should be suitable for South African conditions and sub-types of virus, as well as affordable for South Africa, its neighbours and the rest of Africa. Dr Prozesky reminded the meeting that with almost every virus-caused disease, real progress in fighting the disease had only been made with the development of a vaccine, often leading to effective eradication.
7.
...
6 Summary and recommendations
As Dr Sonnabend put it: “It is not simply the cost of drugs. We need a whole lot more. We need the capacity to provide for people and to be able to monitor.” Starting treatment too early increases the cost of treatment without being appropriately effective.
...
Improving sanitation and public health measures.
CHAPTER 8: RECOMMENDATIONS
8.1 1 Introduction
The purpose of this chapter is merely to group together all the recommendations made in the different chapters of this report.
8.
...
2 Recommendations on surveillance – what should be done about the South African epidemic?
8.2.
...
1 Deliberations of the panel
The deliberations of the panel were at all times bedevilled by the absence of accurate and reliable data and statistics on the magnitude of the AIDS problem or even HIV prevalence in South Africa. Repeated requests for such data and statistics, particularly by panellists who refuted the causal link between HIV and AIDS, failed to result in the provision of such data by either South African panellists or the officials of the Department of Health.
Recommendation
It is therefore strongly recommended that appropriate measures be taken to establish the necessary infrastructure and provide the necessary expertise and resources to collect the data and develop reliable and up-to-date statistics on the magnitude of the AIDS problem and the prevalence of HIV in South Africa. All efforts must be made to ensure AIDS reporting in South Africa is up to the highest standards in the world.
8.2.
...
2 Discussions on mortality data
The discussions around the mortality data presented by Dr Makgoba revealed the necessity for a study to unpack the numbers and gain deeper understanding as to whether the changing mortality profile resulted from AIDS only and/or from factors other than AIDS.
Recommendation
It is recommended that a trans-disciplinary team comprising members from all the relevant branches of science, including social sciences and humanities, other relevant professional spheres and representatives of relevant government departments be constituted to undertake an in-depth study of the mortality trends in South Africa and report on the results of the study to the South African government.
8.2.
...
3 Recommendations from panellists who do not subscribe to the causal linkage between HIV and AIDS
It was recommended that the South African government commit to the following:
...
f) Continue to increase the nutritional status of the population.
8.2.
...
4 Recommendations from panellists who subscribe to HIV as the cause of AIDS
Dr Gayle and Prof Abdool-Karim, representing panellists who endorse the causal link between HIV and AIDS, reinforced the importance of the following initiatives for the South African government:
...
i) Health facility reporting.
8.2.4.
...
1 Recommendations on surveillance as it pertains to reduction of blood-borne infection
The South African government needed guidance on the following issues:
...
f) Policies on intravenous drug use.
8.2.4.
...
2 Recommendations on surveillance as it pertains to reduction of HIV from Mother to Child
The South African government needed to pay attention to the following issues:
...
· What other mechanisms can be devised to reduce transmission of HIV from mother to child.
8.2.4.
...
3 Recommendations on surveillance as it pertains to sexual transmission of HIV
The following issues require attention:
...
(l) Research into finding an efficacious and effective microbicide and into the development of a vaccine for therapy and prevention needs to be continued vigorously
8.2.
...
5 General recommendation
There was general consensus on the need for the case definition of AIDS to be standardised for clinical practice in South Africa.
8.
...
3 Recommendations on HIV Testing
8.3.
...
1 Proposed studies and experiments
The key issue that came under focus was the reliability of the ELISA testing in terms of delivering time infection data. As a diagnosis of HIV infection has such a profound effect on a person’s life and future, it was considered of utmost importance that the tests are unimpeachably reliable. Since all epidemiological predictions concerning HIV/AIDS in South Africa are based on the results of such tests, their absolute reliability was declared to be of utmost importance.
...
These tests will be performed on cohorts chosen to represent the full spectrum of the South African population.
8.3.
...
2 Recommendation on future HIV testing
The panellists who refuted the causal linkage between HIV and AIDS recommended the suspension of all HIV testing until its relevance is proved, especially in the African context, given the evidence of false results in a tropical setting and the fact that most assumptions and predictions on AIDS in Africa are based on HIV testing.
8.3.
...
3 General recommendations on testing
a) The case definition of AIDS to be standardised for clinical practice in South Africa.
...
c) Apply a series of HIV tests of increasing stringency in order to establish the validity, veracity, rigour, reliability and concordance of ELISA, PCR and viral isolation.
8.
...
4 Recommendations on treatment of AIDS with anti-retroviral drug
8.4.
...
1 Recommendations on the use of anti-retroviral drugs for the treatment of AIDS from the panellists opposed the causal link between HIV and AIDS
The recommendations on the treatment of AIDS from panellists who refute that HIV has a causal link to AIDS were informed by their observation that the definition of AIDS in western countries was different from that used in Africa. These definitions have changed over time to the point where a person diagnosed with AIDS in Africa would not be considered an AIDS patient in the USA, Europe and
...
The Strategic Plan (2000–2005) developed by the South African government to combat HIV, AIDS and Sexually Transmitted Diseases was considered a good start to addressing some of the recommendations made here.
8.
...
5 Recommendations on prevention of AIDS
8.5.
...
1 Recommendations on prevention of AIDS from the point of view of panellists who do not support the causal link between HIV and AIDS
The recommendations listed below were proposed as necessary and sufficient to combat all the risk factors that are the real cause of AIDS:
...
14. Improving literacy.
8.5.
...
2 Recommendations on prevention of AIDS from the point of view of panellists who support the causal link of HIV to AIDS
Panellists who support the causal link of HIV to AIDS proposed that preventive strategies be linked more specifically to the different modes of transmission of HIV/AIDS. These panellists did, however, also support some of the more general medical and public health interventions listed in section 6.1.1 above as critical to ensuring a healthy society.
...
· Mother-to-child transmission during pregnancy, at the time of delivery and during breastfeeding.
8.5.2.
...
1 General recommendations
Other strategies need to be put in place to address the social environment, promote safer sexual practices and provide a supportive environment for people who are infected.
...
Establish and support programmes that minimise the spread of disease through the migrant labour system.
8.5.2.
...
2 Recommendations on prevention of HIV/AIDS through sexual transmission
A stronger emphasis should be placed on sex education.
...
Dr Fiala suggested that although he did not support the view of the sexual transmission of HIV, the above recommendations did make sense as long as the focus was on a broader approach to healthy sexual habits which encompass prevention of unwanted pregnancy, rather than a single focus on HIV.
8.5.2.
...
3 Recommendations on prevention of blood-borne transmission of HIV/AIDS
Improving screening methods for infectious agents in blood.
...
Strict adherence to universal precautions by healthcare providers at all times.
8.5.2.
...
4 Recommendations on prevention of mother-to-child transmission of HIV
Panellists who believe that infants can be infected during pregnancy and delivery and through breast- feeding provided several recommendations on preventing these forms of transmission from mother to infant.
...
The evidence from an RCT indicates that vaginal lavage is only of value if the labour is longer than four hours in duration. Reasonable guidelines would include not rupturing membranes in active labour unless there is an obstetric or foetal indication. Invasive monitoring techniques are not recommended. Routine performance of an episiotomy is also contraindicated.
8.
...
6 Recommendations on socio-economic factors that impact on AIDS
As Dr Sonnabend put it: “It is not simply the cost of drugs. We need a whole lot more. We need the capacity to provide for people and to be able to monitor.” Dr Coll-Seck strongly recommended an efficient system for monitoring and evaluating the following recommendations to ensure that they would be helpful, not only to South Africa but also to the countries and continents in the developing world:
...
e) Improving sanitation and public health measures.
CHAPTER 9: PROPOSED RESEARCH PROJECTS AND STUDIES
9.
...
1 General recommendations on research
To undertake a series of immediately doable laboratory, epidemiological and mortality studies on the South African AIDS epidemic to gain better insight into the link between HIV infection and the development of AIDS.
...
The proposals that follow (proposals 1,2 and 3) have been put forward by the group that was set up by the Presidential AIDS Advisory panel during their meeting in South Africa in May 2000. The members of the group are Drs H Bialy, P Duesberg, H Gayle and MW Makgoba.
9.
...
2 Proposal 1: Quality assessment of HIV testing: Establishing a Baseline and validating HIV ELISA testing in South Africa.
9.2.
...
1 Rationale
The basic idea in the validation of HIV ELISA Testing in South Africa is to proceed in stages, graded in order of simplicity, and designed so that the results of each stage will determine what, if any, form the next stage will take. This study is based on the fact that:
...
· The validity and quality assessment of HIV testing is critical for accurate estimates, diagnosis, monitoring and surveillance (mostly for epidemiological data) of the HIV/AIDS epidemic
9.2.
...
2 Establishing a Baseline: Quality Assessment of HIV Testing of five independent sites in South Africa
A random and blinded Quality Assessment study of 2500 samples from different sites will be undertaken. The sites are:
...
Costs: The MRC and the CDC will cover the costs of shipping and testing, respectively which will add up to US$75 000.00.
9.
...
3 Proposal 2: Determination of the robustness of the current HIV ELISA tests that are being used in South Africa.
9.3.
...
1 Purpose of experiment
To determine the robustness of the current HIV ELISA tests that are being used in South Africa when the sera that is being tested has been treated to remove antibodies that are reactive to a series of known antigens that have been previously reported to interfere under certain conditions with HIV ELISA tests that depend on either recombinant proteins, or recombinant proteins and synthetic peptides such as V3.
9.3.
...
2 Methodology
Blood samples from 100 TB patients that have had no prior HIV serology will be obtained by Professor Mhlongo. An additional 100 blood samples from "HIV/AIDS" patients from the most densely affected region in the country will be obtained by Dr Makgoba.
...
Sera from each of the 200 samples will be added to the ELISA wells of these plates and incubated for two hours, after which the contents of the wells will be transferred to HIV ELISA plates and treated as is normally done. Everything will be done in duplicate.
9.
...
4 Proposal 3: Molecular beacons
South African HIV researchers need to be assisted to gain even greater awareness of the power and usefulness of the beacon technology as a general diagnostic tool, but particularly with reference to Multiple Drug Resistant Tuberculosis. It is not being proposed that the beacon assay be used as any form of gold standard.
...
The proposals that follow were suggested by members of the Presidential AIDS Advisory Panel either during the panel meetings in May and July 2000 or during the Internet debate between the two meetings.
9.
...
5 Proposal 4: Do most people with HIV infection show signs of AIDS within five (5) to ten (10) years?
Proposer: Prof Peter Duesberg
...
One Thousand and Five Hundred (1500) healthy HIV-positive and 1500 matched healthy HIV-negative men from the South African army and/or mining industry, or some other governmental institution would be required for this study. This experiment will exclude people who suffer poverty, malnutrition, poor sanitation. Since the time of infection of these men is not known, and since they are currently healthy, their times to AIDS would be randomly distributed from a maximum of 5-10 years to a minimum of one day to AIDS. On average they are half way into their HIV to AIDS latent period of 5- 10 years, or 750-1500 days (1/2 of 5-10 years) from getting AIDS. Therefore in the HIV positive group there should be 1 or 2 AIDS cases per day, and in the negative group there should be no AIDS cases. We would know much of the answer in a few months and certainly within a year if we had 1500 men in each group. It would take longer if the groups are smaller. The cost would be one conventional HIV test per person, and perhaps a second one if a AIDS disease co occur and a phone call per person or to their supervisor every 2 months to find out how they are.
9.
...
6 Proposal 5: Preadsorption and Virus Isolation Experiments - The need for a Gold Standard in the diagnosis of HIV infection.
The proposal on the preadsorption studies has strong similarities with proposal 2 above, but is included in this document as it appears as a package with the proposed experiments on virus isolation.
...
Proposers: Dr Eleni Papadopoulos-Eleopoulos and Dr Val Turner
9.6.
...
1 Importance of the Proposed HIV Experiments
At present, all the HIV experts admit that:
...
b) If some of the particles in the "purified HIV" material were indeed "HIV" then this material will have at least some proteins which were not present in the "mock virus" which originated from the non- infected cultures.
9.6.
...
2 Principles of the Proposed Experiments
9.6.2.
...
1 Pre-adsorption experiment
Serum is taken from patients who have a positive "HIV" ELISA and divided into two parts.
...
10. Extract the nucleic acids from the 1.16gm/ml band obtained from both test and control cultures and compare them. If no difference exists then there is no proof that the test cultures contain "HIV" regardless what the EMs show.
9.
...
7 Proposal 6: Questionable African AIDS /HIV Statistics - Epidemiology
Proposers: Prof. Gordon Stewart, Prof. Sam Mhlongo, Dr. Christian Fiala, Prof. Charles Geshekter and Dr. Roberto Giraldo
...
The proposers will need to spend some 2 - 3 days in Geneva re: UNAIDS data.
9.
...
8 Proposal 7: Proposed investigation of the diagnosis of HIV/AIDS
Proposers: Prof. Gordon Stewart, Dr. Roberto Giraldo, Dr. Harey Bialy and Prof. Sam Mhlongo
...
Principal Proposer: Prof Gordon T. Stewart
9.8.
...
1 Current procedure
The investigations should be arranged in consultation with Professor Schoub or Dr Gray, and performed in the laboratory or laboratories responsible for routine serological tests for HIV by the ELISA method or Western Blot or both.
...
Reliability of sero-diagnosis is therefore the critical element in the identification and management of all forms of HIV/AIDS, and for assessment and prevention of vertical as well as horizontal transmission. To improve quality control in diagnosis and surveillance, it is suggested that the following method and precautions be adopted This will measure the overlap between HIV/AIDS and other prevalent disorders, give ongoing estimates of sensitivity and specificity of serological results, and provide a data-base for checking projections. Since the object of the exercise, is to check and improve the reliability of diagnosis and prognosis by these tests, which often precede clinical diagnosis or development of disease, especially in pregnant women and infants, the test is regarded as the independent and the outcome as the dependent variable.
9.8.
...
2 Investigation of reliability of serological tests for HIV
Under present procedure, a person who is seropositive to HIV (i.e. whose blood contains antibodies to HIV) is diagnosed as having AIDS or a related condition (ARC, or AIDS-defining Disease (ADD)), or being at risk of it. But it is known that many conditions unrelated to HIV/AIDS can also give positive or indeterminate results for shorter or longer periods. These conditions include tuberculosis and malaria, recent vaccinations, certain tumours, pregnancy and other altered states of health which are commonplace in populations where AIDS is prevalent, especially in Africa. For accurate diagnosis and to enable appropriate advice to be given to patients, contacts and families, it is important to recognise this overlap. For doctors and health authorities, it is essential to know the full implications and extent.
...
Because direct identification of HIV itself is not required and is indeed impracticable at present for routine diagnosis, indirect serological tests are the measures used for decisions about all aspects of HIV/AIDS, and especially for assessing and controlling vertical, perinatal and puerperal transmission. Failure to detect false positive and false negative reactions leads to errors not only in diagnosis, treatment and other interventions, but also to erroneous projections and fear – or alternatively irresponsible disregard – of dangers to persons, families and entire communities. These dangers apply to underestimates no less than to overestimates of AIDS and also to risks of overlooking other diseases submerged in the over-riding classification of HIV/AIDS. The present proposal, which should be discussed and implemented co-operatively with existing clinical and laboratory services, is designed to minimise these dangers.
9.8.
...
3 Extensions
This investigation could be extended to Sentinel surveillance and all cases of AIDS (with controls) admitted to hospitals. Samples giving positive and indeterminate results should be, as often as is practicable, subjected to tests for antibodies to other agents, for example: CMV, HSV, VZ, EBV, and to tests for auto-immune and non-specific antibodies, in such conditions as pregnancy, disseminated lupus erythematosis and other auto-immune disorders to see if patterns of cross reactions can be identified. These data might then be used for more critical analysis of the hypothesis that HIV is the essential cause of AIDS.
9.8.
...
4 Interpretation of findings
a) Measure sensitivity as % of cases detected in one or two tests, and also consistency and reproducibility between the tests.
...
Although Sentinel Surveillance as organised by the WHO requires serodiagnosis by Elisa, using recombinant antigens prepared from co-cultures of HIV, it should be noted that the Bangui definition of AIDS agreed by the WHO and member States in 1987, is regarded as sufficient to warrant a diagnosis of AIDS or AIDS-related conditions without any serological test. National and international data do not normally indicate the proportion or location of diagnoses or projections made on this basis but it is obviously important to include in the programme described above some provision for identifying this proportion.
9.
...
9 Proposal 8: Study to find out the real meaning of HIV Tests
Principal Proposers: Dr Harvey Bialy and Dr Roberto Giraldo
...
Bases and references for these experiments can be seen in my postings "Tests for HIV are highly inaccurate" and "Everybody is HIV-positive".
9.
...
10 Proposal 9: To test the reliability of one of the main laboratory methods currently used to quantify HIV in the blood of seropositive individuals - using the Electron Microscope.
Proposer: Prof. Etienne de Harven:
9.10.
...
1 Aim of the experiments.
To test the reliability of one of the main laboratory method currently used to quantify so-called HIV in the blood of sero-positive individuals. More specifically, to use electron microscopy (EM) to verify that the blood plasma of patients identified as having a high "viral load" by PCR does indeed contain retroviral particles, and that, therefore, such samples could be used to isolate and purify HIV, free from cell debris and adventitious material from co-cultures.
9.10.
...
2 Materials and Methods
Using the Roche Diagnostics Corporation "Amplicor HIV-1" monitor test: Readily access to 5 patients with very high PCR counts. (Group A) Readily access to 5 patients with undetectable PCR counts. (Group B)
...
Control samples should be prepared by the double Millipore filtration method that is known to eliminate most cell debris and to concentrate retroviruses in an almost pure form. The final viral pellet will be compared to a "microfuge" pellet from the same patients, both pellets being then processed identically for RNA amplification.
9.10.
...
3 Technical assistance needed:
Technical assistants, trained in routine virology, knowledgeable in ultrafiltration and ultracentrifugation methods, and fully trained in routine Roche Amplicor PCR method.
...
Finally, it would be of considerable importance for me to be informed of the experimental proposals presented by Dr. Peter Duesberg and by the Perth group, in order to coordinate the entire project in a coherent fashion.
9.
...
11 Proposal 10: To determine which is more harmful - HIV or Anti HIV drugs?
Proposers: Dr. David Rasnick and Dr. Claus Köehnlein
...
a) which animals come down with AIDS-defining and other diseases?
b) which live longer?
CHAPTER 10: CONCLUSION
Chapter 1 of this report set the scene to explain the events that led to the constitution of the Presidential Advisory Panel on AIDS. The Terms of Reference for the panel included very specific questions that the panel had to deliberate on and generate possible answers to. The Presidential Advisory Panel on AIDS was quite deliberately constituted in such a manner as to bring together individuals who were expert and/or had experience in a broad diversity of areas that are relevant to the understanding of the AIDS issue. This diversity of expertise and experience also included diametrically contrasting views on several key questions pertaining to AIDS. The assumption, therefore, was that members of the panel would unpack the merits and de-merits of particular scientific, public policy and health policy viewpoints in a dispassionate manner and generate the best possible collective advice to the South African government. This lofty ideal usually underpins the constitution of advisory panels. A possible alternative of constituting panels according to common belief systems of the members would necessarily generate advice that is biased in favour of those particular belief systems.
...