Scientific Data Against the Use of Nevirapine
in Pregnant Women, Infants, Children, and Anybody Else
This primary intention of this paper is to provide technical assistance to the lawyers of the Ministry of Health of the Republic of South Africa in a court trial initiated by a lawsuit brought by the non-governmental organization Treatment Action Campaign against the Government of South Africa "for not providing Nevirapine to every HIV positive pregnant woman and babies born to HIV positive mothers.
The following data support the sensible intention of the Department of Health of South Africa to perform clinical trials at two research sites in all nine Provinces for a period of two years before deciding what is the best course for the prevention of what is known as mother to child transmission of HIV (MTCT) in South Africa (Ministry of Health 2001).
The information provided herein should be carefully analyzed, particularly now that the Government of Uganda has decided to make Nevirapine compulsory to all unmarried pregnant woman in that country, irrespective of their HIV status ( Mohamend 2001).
1. Avoidance of toxic substances during pregnancy and infanthood.
There are numerous scientific findings supporting the internationally accepted practice of avoiding as much as possible any potential toxic exposure of pregnant women, infants, and children (Needlemann & Bellinger 1994; Holmes 1994; Kavlock & Daston 1997a, b; Schardein 2000; Koren 2001).
1.1 Nevirapine is a non-nucleoside reverse transcriptase inhibitor that belongs to the dipyridodiazepinone chemical class of compounds (PDR 2001).
Nevirapine binds directly to reverse transcriptase and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing disruption of the enzymes catalytic site (PDR 2001).
Reverse transcriptase is an enzyme earlier thought to be unique to retroviruses. However, currently it is known than many different human cells have and use reverse transcriptase for very important chemical reactions ( Temin et al 1972; Temin 1985). Once in the body systems, Nevirapine can inhibit reverse transcription in normal human cells. This is why Nevirapine is a very toxic substance especially for the growing cells of fetuses and infants.
Animal studies have shown that nevirapine is widely distributed to nearly all tissues and readily crosses the blood-brain barrier (PDR 2001). Also, Nevirapine is widely distributed in humans, readily crosses the placenta and is found in breast milk (PDR 2001).
1.2. Long-term effects of Nevirapine are unknown.
Clinical trials with Nevirapine to prevent MTCT have been conducted only recently ( Guay et al 1999; Marseille et al 1999). It is too early to evaluate the potential long-term side effects of this chemical on the tissues and organs of the mothers and children who received it.
The PDR states The long term effects of Viramune are unknown at this time (PDR 2001).
There are no adequate and well-controlled studies in pregnant women. Viramune should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (PDR 2001).
However, it is known that Nevirapine produces significant decrease in fetal body weight (PDR 2001), which researchers have found can be the origin of several adult cardiovascular and metabolic diseases ( McDade et al 2001a ,b ). Interest in the fetal and infant origins of many adult chronic, degenerative diseases is currently high, and evidence is mounting for an association between intrauterine growth retardation (IUGR) and adult hypertension, abnormal blood lipid profiles, coronary artery disease, and diabetes (Barker 1992, 1994, 1998a,b; Leon 1998; McDade et al 2001a,b).
It is disturbing to note that the use of Nevirapine in infants is being recommended when the evaluation of the pharmacokinetics of nevirapine in neonates is ongoing and the safety profile of Viramune in neonates has not been established (PDR 2001). Additionally, three clinical trials with Nevirapine in pediatric patients reported an overall incidence of related adverse events in 46% of the children (PDR 2001). Insisting on prescribing Nevirapine to babies is akin to putting the cart before the horse, similar to soldiers commencing firing while awaiting confirmation of their superiors orders.
On the other hand, it is not even accepted that Nevirapine can prevent the transmission of HIV. This is why the PDR warns: Patients should be informed that Viramune therapy has not been shown to reduce the risk of transmission of HIV-1 to others through sexual contact or blood contamination (PDR 2001).
1.3. Nevirapine is a very toxic compound.
Roxane , the pharmaceutical company that produces and commercializes Nevirapine with the commercial name of Viramune , recognized its toxicity in the Physicians Desk Reference (PDR 2001), considered the best available source of information on the safety of medications for humans.
They write in capital letters:
WARNING: SEVERE LIFE-THREATENING SKIN REACTIONS, INCLUDING FATAL CASES, HAVE OCCURRED IN PATIENTS TREATED WITH VIRAMUNE. THESE HAVE INCLUDED CASES OF STEVEN-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, AND HYPERSENSITIVITY REACTIONS CHARACTERIZED BY RASH, CONSTITUTIONAL FINDINGS, AND ORGAN DYSFUNCTION. PATIENTS DEVELOPING SIGNS OR SYMPTOMS OF SEVERE SKIN REACTIONS OR HYPERSENSITIVITY REACTIONS MUST DISCONTINUE VIRAMUNE AS SOON AS POSSIBLE. SEVERE AND LIFE-THREATENING HEPATOTOXICITY, INCLUDING FATAL HEPATIC NECROSIS, HAS OCCURRED IN PATIENTS TREATED WITH VIRAMUNE. RESISTANT VIRUS EMERGES RAPIDLY AND UNIFORMLY WHEN VIRAMUNE IS ADMINISTERED AS MONOTHERAPY, THEREFORE, VIRAMUNE SHOULD ALWAYS BE ADMINISTERED IN COMBINATION WITH ANTIRETROVIRAL AGENTS (PDR 2001).
I strongly recommend that any government or institution regulating the use of Nevirapine in pregnant women and children at very least first carefully study the information from the PDR regarding this medication.
1.4. Nevirapine can be toxic for the immune system.
The potential long-term immunotoxic effects of Nevirapine have not been evaluated. However, it is very probable that Nevirapine can be toxic for the growing and dividing cells of the immune system. It could therefore be a risk factor for acquired immune deficiency rather than protecting against AIDS.
Nevirapine is known to be active in peripheral blood mononuclear cells, monocyte derived macrophages, and lymphoblastoid cell lines (PDR 2001), which are all cells of the immune system.
Nevirapine causes anemia, trombocytopenia and granulocytopenia , especially in pediatric patients (PDR 2001). It should be remembered that granulocytes also play an important role in the immune system.
Similarly, Nevirapine is known to increment oxidative metabolism in humans (PDR 2001). Interestingly, a growing body of scientific research supports the belief that oxidative stress has a crucial role in the pathogenesis of AIDS (Papadopulos-Eleopulos 1988, 1998/1999; Fuchs et al 1991; Papadopulos-Eleopulos et al 1992; Salvain & Mark 1992; Baruchel & Wainberg 1992; Favier 1994; Giraldo 1997). This is why antioxidants are effectively and widely used in the treatment and prevention of AIDS (Javier et al 1990; Turner 1990; Greenspan 1993; Zhang et al 1997; Giraldo 2000a ,b ). The increment of oxidative metabolism by Nevirapine is therefore one of the ways Nevirapine can contribute to immunosuppression and AIDS.
Viramune tablets, in addition to Nevirapine , contain cellulose, lactose monohydrate, povidone , sodium starch glycolate , colloidal silicon dioxide, and magnesium stearate . The oral suspension contains carbomer 934P, methylparaben , propylparaben , sorbitol , sucrose, polysorbate 80, sodium hydroxide, and water. (PDR 2001). Several of these compounds are known to be toxic for the cells and chemical reactions of the immune system. For example, silicon, methylparaben and propylparaben are well known to be immunotoxic ( Descotes 1988a). This is yet another way in which Nevirapine could cause immunosuppression and AIDS.
Nevirapine produces significant decrease in fetal body weight (PDR 2001), and it is scientifically recognized that prenatal undernutrition has been linked to deficits in several aspects of cell-mediated immunity, to involution of lymphoid tissues such as the thymus, and to suppression of antibody responses to vaccination and that These deficits persist for weeks or, in some cases, even years (Chandra 1975a,b, 1981; Moscatelli et al 1976; Ferguson 1978; Lewis & Wilson 1995; Hasselbach et al 1999; McDade et al 2000. 2001a,b). On the other hand, murine models have documented impairments in immunity after maternal undernutrition that last through adulthood and into the next generation, despite ad libitum feeding of both F1 and F2 generations (Chandra 1975c; Beach et al 1982). Therefore, it is probable that in this manner Nevirapine could also cause long-term damage to the immune system and contribute to the development of AIDS.
In this time of AIDS it must be emphasized that there is a growing number of chemicals that are immunotoxic , cause immunosuppression , and that therefore play significant roles in the pathogenesis of AIDS ( Descotes 1988a ,b ; Dean & Luster 1994; Holladay & Luster 1994).
1.5. Nevirapine is known to be toxic for many organs and systems.
In vivo studies in humans and in vitro studies with human liver microsomes have shown that nevirapine is extensively biotransformed via cytocrome P450 (oxidative) metabolism to several hydroxylated metabolites (PDR 2001).
It is well known that Nevirapine is extensively metabolized by the liver and nevirapine metabolites are extensively eliminated by the kidneys. However, the pharmacokinetics of nevirapine has not been evaluated with either hepatic or renal dysfunction (PDR 2001).
Severe or life-threatening hepatotoxicity , including fatal fulminant hepatitis ( trasaminases elevations, with or without hyperbilirubinemia , prolonged partial thromboplastin time, or eosinophilia ), has occurred in patients treated with Viramune (PDR 2001). This is why Clinical chemistry tests, which include liver function tests, should be performed prior to initiating Viramune (PDR 2001).
The CDC of the United States has issued a warning: The drug, nevirapine , can produce liver damage severe enough to require liver transplants, and has caused death in such use, the Centers for Disease Control and Prevention said in its weekly report (Altman 2001c).
It has been shown that Nevirapine can impair fertility in rats treated with it, and it produces a significant decrease in fetal body weight (PDR 2001).
Also, there are a growing number of substances with neurotoxic effects on fetuses and children ( Rodier et al 1994). Many have toxic effects in the developing bone marrow, heart, lungs, kidneys, liver, endocrine glands, etc. (Lau & Kavlock 1994; Koren 2001), Nevirapine could be one of them.
2. Nevirapine cannot prevent or cure AIDS.
The relationship between in vitro susceptibility of HIV-1 to nevirapine and the inhibition of HIV-1 replication in humans has not been established (PDR 2001).
At present, there are no results from controlled clinical trials evaluating the effect of Viramune in combination with other antiretroviral agents on the clinical progression of HIV-1 infection, such as the incidence of opportunistic infections or survival (PDR 2001). On the other hand, Resistant virus emerges rapidly and uniformly when Viramune is administered as monotherapy . Therefore, Viramune should always be administered in combination with at least one additional antiretroviral agent (PDR 2001).
Patients receiving Viramune or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore, should remain under close clinical observation by physicians (PDR 2001).
Viramune is not a cure for HIV-1 infection; patients may continue to experience illnesses associated with advanced HIV-1 infection, including opportunistic infections (PDR 2001).
3. Drastic changes in regulations to prescribe antiretroviral medications.
Since the middle of the 1980s, researchers have developed 15 drugs to combat HIV. Nevertheless, HIV is so wily that the drugs are still failing thousands of infected people, including many who have taken each of the 15 at one time or another. New, safer drugs are urgently needed (Altman 2001b).
During the summer 1996 at the 11th
International AIDS Conference in
Only a few years later, at the 13th International AIDS Conference in Durban in 2000, due to the high number and severity of side effects manifested by individuals on these cocktail therapies, many of the side effects being life-threatening, there was a shift in gears: it was ordered that intermittent therapy or therapy with holidays be instituted (Easterbrook et al 2000; Havlir et al 2000).
However, the toxicity of antiretrovirals
continued, with incrementing numbers and severity. On
Concern has grown over nerve damage, weakened bones, unusual accumulation of fat in the neck and abdomen, diabetes and a number of other serious sides effects of therapy. Many people have developed dangerous high levels of cholesterol and other lipids in the blood (Altman 2001a).
Among the most troubling side effects seen in people taking the HAART cocktails are death of hip bone tissue, increase in blood cholesterol levels, neuropathy or loss of nerve sensations, kidney failure, radical alterations of liver metabolism, diabetes, skin rashes, pancreas failure, severe anemia, liver dysfunctions so acute as to require transplants and near-instantaneous death due to buildup of lactic acid (Garrett 2001).
The fundamental issue in the field right now is the
toxicity of our drugs, explained Dr. Diane Havlir of
Altering a long-held policy, federal health officials are now recommending that treatment for the AIDS virus be delayed as long as possible for people without symptoms because of increased concerns over toxic effects of the therapies (Altman 2001a).
Pharmaceutical companies like Glaxo -Smith-Kline are very disappointed with the new directions ( Lews 2001).
Beginning in early January officials started announcing
the changed course: The shift, NIH scientists will explain at the annual
Conference on Human Retroviruses in
In December 2000, in a speech to the Royal Society of
The new guidelines can be viewed at www.hivatis.org (Altman 2001a).
Regarding the new shift in gears at the
Researchers meeting in
Since pharmaceutical companies continued advertising the great benefits of antiretrovirals , on April 27, 2001, the Food and Drug Administration (FDA) of the Federal Government of the United States ordered pharmaceutical companies to stop printing lies about the benefits of their antiretroviral products.
4. Alternative non-toxic measures to prevent MTCT.
The Department of Health of the
Scientific studies support the contention that the use of vitamins by themselves
could be enough to avoid what is known as mother to child transmission of
HIV (Stiehm 1995; Landers 1995; Fawzi & Hunter 1998). If this is the
case, as many clinical trials and scientific papers contend, it would constitute
a very inexpensive and nontoxic practice for
Regarding vitamins in HIV disease progression and vertical transmission, researchers
A growing body of data suggests that low serum levels of vitamin A among HIV-infected pregnant women is associated with higher risk of vertical transmission of HIV (Fawzi & Hunter 1998).
Mean vitamin A concentration in 74 mothers who transmitted HIV to their infants was lower than that in 264 mothers who did not transmit HIV to their infants ( Semba et al 1994a).
Women who had increasing serum retinol levels over time, however were at a lower risk, whereas women who had declining serum retinol were at a higher risk of transmitting the virus ( Landesman 1996; Fawzi & Hunter 1998).
Vitamin A supplementation to a population of HIV-infected pregnant women, many of whom had low vitamin A levels, was associated with a decreased number of preterm births and with reduced mother-to-child transmission of HIV in preterm babies, but was not associated with a reduction in HIV transmission overall. Vitamin A decreased HIV transmission in the preterm babies by 47% ( Coutsoudis et al 1999).
Detection of vaginal HIV-1 DNA was associated with abnormal vaginal discharge, lower absolute CD4 cell count, and severe vitamin A deficiency (John et al 1997).
Women with CD4 cell depletion, especially those with vitamin A deficiency, may be at increased risk of transmitting HIV-1 to their infants through breast milk ( Nduati et al 1995).
Increased risk of maternal-infant
transmission was associated with severe vitamin A deficiency among
non-breastfeeding women in the
Something to keep in mind is that vitamin A could be teratogenic and WHO recommends that pregnant women should not take more than 10,000 IU of Vitamin A per day (Shah et al 1987; Fawzi & Hunter 1998).
5. Optimal nutritional status to treat and prevent AIDS.
The Government of
Since the beginning of the AIDS epidemic well recognized researchers in the field of nutrition and immunology, such as Dr. Ranjit Kumar Chandra, noticed that: There is an uncanny similarity between the immunological findings in nutritional deficiencies and those seen in acquired immunodeficiency syndrome, AIDS (Jain & Chandra 1984).
There is a similarity between the immune deficiency, multiple infections, and severe weigh loss seen in AIDS patients, and the association of protein calorie malnutrition (PCM) with reduced resistance to infection observed in malnourished children, particularly in the Third World. It is also possible that nutritional deficiency may play a significant role in the clinical course of the immunodeficient state. These similarities between AIDS and PCM suggest that nutrition may contribute to the immunodeficient state. The immunodeficiency in children with PCM can be reversed by nutritional rehabilitation, which suggest that restoration of nutritional state may be a useful adjunct to therapy for AIDS patients (Gray 1983).
The immunological alterations found in protein energy malnutrition (PEM) are practically identical to those of AIDS: impaired delayed cutaneous hypersensitivity, lymphocyte proliferation response to mitogens , complement activity and secondary response to antigens. There is also a reduced number of rosetting T lymphocytes, increased deoxynucleotidyl transferase activity, decreased serum thymic factor, fewer helper T cells, impaired production of interferon gamma and interleukins 1 and 2, reduced antibody affinity, impaired secretory immunoglobulin A ( IgA ) antibody response and phagocyte dysfunction. The proportion of helper/inducer T lymphocytes recognized by the presence of CD4 positive antigen on the cell surface is markedly decreased. The ratio Cd4/CD8 is significantly decreased. Lymphoid atrophy is a prominent feature of nutritional deprivation. Serum antibody responses are generally intact in PEM. Most complement components are decreased, especially C3, C5, factor B and total haemolytic activity (Chandra1993).
On the other hand, Nutritional problems have been a part of the clinical aspects of AIDS from its earliest recognition as a new disease ( Keusch & Thea 1993). In fact, in many AIDS patients, death seams to be determined more by the individuals nutritional status than by any particular opportunistic infection. This is, when wasting of lean body mass approaches 55% of normal for age, sex, and height, death is imminent regardless of the forces resulting is such profound malnutrition ( Keusch & Thea 1993).
As explained above, it is scientifically known that prenatal undernutrition have been linked to deficits in several aspects of cell-mediated immunity, to involution of lymphoid tissues such as the thymus, and to suppression of antibody responses to vaccination. These deficits persist for weeks or, in some cases, even years (Chandra 1975a ,b , 1981; Moscatelli et al 1976; Ferguson 1978; Lewis & Wilson 1995; Hasselbach et al 1999; McDade et al 2000, 2001a,b).
Similarly, there is a growing scientific data showing that many chronic diseases of adulthood have their origin at in utero programming (Barker 1998a ,b ). This includes illnesses such as coronary heart disease and stroke, hypertension, type II diabetes and other endocrine alterations ( Naeye et al 1971; Barker 1992, 1994, 1998a ,b ), as well as several immunological disturbances ( Chjandra 1975a,b; Ferguson 1978; Beach et al 1982; McDade 2000, 2001a,b). Therefore, it appears that whatever happens during embryonic and fetal times will be remembered by cells, tissues, organs, and systems throughout a lifetime.
Research in Gambia associated season of birth with infectious disease mortality after the age of 15 years, suggesting an association between prenatal undernutrition , immune function, and adult vulnerability to infectious disease (More et al 1997, 1999). Prenatal undernutrition has been found to impair antibody responses to vaccination with Salmonella thyfi that last at least up to adolescent times ( McDade et al 2001a). The findings of these researchers suggest a role for fetal and early infant experience in programming the immune system which may accompany the individual during its entire life ( McDade et al 2001a ,b ).
In addition, murine models have documented impairments in immunity after maternal undernutrition that last through adulthood and into the next generation, despite ad libitum feeding of both F1 and F2 generations (Chandra 1975c). Also in mice, deprivation of zinc during pregnancy causes immunodeficiency that can last at least for three generations (Beach et al 1982).
It is therefore
very probable that in
In this light,
the crucial role of maternal undernutrition in the
pathogenesis of pediatric AIDS has seriously been considered to be the case in
developing countries ( Giraldo 1997). This reasoning also
concludes that malnutrition constitutes the main risk factor for AIDS in adults
in developing countries ( Giraldo 1997).
Scientifically speaking, there is no rational for indicting sexual promiscuity
as the cause of AIDS in
It is not surprising, therefore, that dietary therapy for AIDS has been proposed, debated, and more importantly surreptitiously or overtly used from the early days of the epidemic ( Keusch & Thea 1993).
Twenty years later, researchers insist: Because nutrient deficiencies may play an important role in the pathogenesis of HIV disease, medical nutrition therapy and counseling are critical aspects of treatment (Mahan & Escott -Stump 2000). Nutritional therapy is then a must in AIDS ( Gerrior & Wanke 2001).
5.1. Good nutrition as a mean to prevent AIDS.
An optimal nutritional status as well as adequate vitamin levels is known to be by themselves enough to prevent AIDS in people who react positively on the tests for HIV. Let us examine some scientific facts:
All persons with HIV infection should be screened for nutritional problems and concerns at the time of their first contact with a health care professional, and routine monitoring should be performed on an ongoing basis (Mahan & Escott -Stump 2000).
The risk of death among HIV-infected subjects with adequate serum vitamin A levels was 78% less, when compared with Vitamin A-deficient subjects (Semba et al 1994a,b; Fawzi & Hunter 1998).
In a study carried out among HIV-positive homosexual men, development of Vitamin A deficiency over an 18-month period was associated with a decline in CD4 cell count, widely used as a marker of HIV immune impairment. Normalization of vitamin A was associated with higher CD4 cell counts (Baum et al 1995; Fawzi & Hunter 1998).
Lower serum levels of vitamin A were associated with a faster rate of progression among men who participated in the Multicenter AIDS Cohort Study (MACS) (Tang et al 1997; Fawzi & Hunter 1998).
Among well nourished HIV- seropositive men who participated in the San Francisco Mens Health Study, high energy-adjusted vitamin A intake at baseline was associated with higher CD4 cell count at baseline, as well as with lower risk of developing AIDS during the 6 years period follow up (Abrams et al 1993; Fawzi & Hunter 1998).
In a placebo-controlled trial in South Africa among children born to HIV-positive women, Vitamin A supplements resulted in approximately 50% reduction in diarrheal morbidity among HIV-infected children ( Coutsoudis et al 1995; Fawzi & Hunter 1998).
5.2. Nutritional therapy as mean to treat AIDS.
Recent studies have begun to identify the vitamin and mineral needs of HIV-positive persons and those with AIDS. These studies suggest the need for increased intake of the following micronutrients: beta-carotene, vitamin E, ascorbic acid, vitamin B12, vitamin B6, and folic acid ( Prabhala et al 1990; Raiten 1990; Coodley et al 1993; Mahan & Escott -Stump 2000).
Regarding AIDS in children, scientists state: In addition to supporting optimal function of the immune system, nutrition is especially critical in children, as it provides the best opportunity for normal growth and development ( Heler 1997; Mahan & Escott -Stump 2000).
Since the early 1980s, since the beginning of the AIDS epidemic, researchers have provided scientific facts which support the belief that AIDS can be treated and overcome by guaranteeing an optimal nutritional status to the immune and other systems of the person suffering the syndrome. However, it seams that the propaganda spread by pharmaceutical companies to commercialize their toxic antiretroviral medications has prevented these ideas from being widely accepted. The following are just some of the scientific papers and books that review the issue of nutritional therapy for the treatment of AIDS: Collins 1988; Life Sciences 1990; Raiten 1990; Keusch & Farthing 1990; Keusch & Thea 1993; American Dietetic Association 1994, 1998; Bristol-Myers 1994; Romeyn 1995; Bahl & Hickson 1995; Steinbrook 1997; Young 1997; Beise 2000; Mahan & Escott -Stump 2000; Watson 2001; Gerrior & Wanke 2001.It is important to recommend to the members of the Treatment Action Campaign of South Africa, the Government of Uganda, as well as to any other organization, institution or government, that they carefully study this information instead of promoting toxic antiretroviral medications that without doubt contribute to the collapse of the immune system and may in fact cause AIDS. This is the only way to avoid what happened during the Second World War when Jewish people, with the best of intentions, helped to place their brothers and sisters onto trains going to concentration camps, because they erroneously thought that they were sending them to a better land.
6. International scientific debate about the causes and solutions of AIDS.
6.1. Hypothesis: AIDS is a toxic and nutritional syndrome.
Since 1987 there has been an international debate in the scientific arena about the causes and solutions for AIDS ( Duesberg 1987). There are a growing number of researchers and scientists, from more than 50 countries, who are now participating in these discussions.
A significant number of scientific arguments in favor of AIDS as a toxic and nutritional syndrome, rather than an infectious, viral, and contagious one, can be reviewed at:
Some scientists even question the very
existence of HIV as a real virus. In this regard, the arguments of the Perth
The Government of
At present, a series of experiments, described in the interim report, are being set up to try to determine once and for all the real causes, as well as the best solutions to prevent, treat, and eradicate, AIDS.
6. 2. Alternative explanations for reacting positively on the tests for HIV.
The basis for what is known as MTCT of HIV is the fact that often both mothers and babies, especially in developing countries, react positively on what are known as the tests for HIV. However, all tests used for the diagnosis of HIV infection are highly inaccurate.
The tests that are used most frequently to diagnosis HIV status are the ELISA or screening test, the Western blot or confirmatory test, and the Viral Load or PCR. The problems with these tests is that when they react as positive, they do not guarantee that the person is really infected with HIV ( Papadopulos-Eleopulos et al 1993; Hodkinson 1996; Turner 1996).
There are abundant scientific publications warning that there are more than 70 different conditions that cause these tests to react as positive without the person being infected with a virus named HIV.
Some of the conditions listed in the scientific literature which can cause these tests to react positively in the absence of HIV infection are: past or present infection with a variety of bacteria, parasites, viruses, and fungi, including tuberculosis, malaria, leishmaniasis , influenza, the common cold, leprosy, and a history of sexually transmitted diseases; the presence of polyspecific antibodies, hypergammaglobulinemias , the presence of autoantibodies against a variety of cells and tissues, vaccination and the administration of gammaglobulins or immunoglobulins ; the presence of auto-immune diseases like erythematous systemic lupus, sclerodermia , dermatomyositis and rheumatoid arthritis; the existence of pregnancy and multiparity ; a history of rectal insemination; addiction to recreational drugs; several kidney diseases, renal failure and hemodialysis ; a history of organ transplantation; presence of a variety of tumors and cancer quemotherapy ; many liver diseases, including alcoholic liver disease; hemophilia, blood transfusions and the administration of coagulation factor; even the simple condition of aging, to mention only a few (Johnson 1995, 1996).
It is interesting to note that most of the conditions that cause the tests to react positively in the absence of HIV infection are present in the vast majority of the inhabitants of the developing world. This means that, in all probability, people, including mothers and children, who have positive reactions to the tests for HIV in Africa do so due to conditions other than being infected with HIV.
The pharmaceutical companies that make and commercialize the kits for these tests acknowledge the inaccuracy of them, and this is why the inserts that come with the kits typically state the following: ELISA testing alone cannot be used to diagnose AIDS, even if the recommended investigation of reactive specimens suggest a high probability that the antibody to HIV1 is present (Abbott 1996). The insert for one of the kits for administering the Western blot warns: Do not use this kit as the sole basis of diagnosis of HIV-1 infection ( Epitope/Organon Teknika ). The insert that comes with a popular kit to run viral load warns: The Amplicor HIV-1 Monitor test is not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection (Roche 1999).
The fact that HIV has never been isolated as an independent viral particle is even accepted by the fabricants of the ELISA test when they state: At present, there is no recognized standard for establishing the presence or absence of antibodies to HIV-1 and HIV-2 in human blood (Abbott 1996).
Several scientific arguments support the belief that reacting positively on the erroneously named tests for HIV may be an indication of intoxication or oxidation rather than infection with what is known as HIV. This could explain why vitamins that are strong antioxidants are found in low levels in individuals that react positively on the test for HIV ( Papadopulos-Eleopulos 1988; Papadopulos-Eleopulos et al 1992, 1998/1999). This could also explain why antioxidants prevent the development of AIDS in HIV positive individuals ( Papadopulos-Eleopulos 1988; Papadopulos-Eleopulos et al 1992, 1998/1999; Turner 1990).
Similarly, scientific data strongly suggest that low vitamin levels, especially those known to be antioxidants, can be responsible for testing positively on the tests for HIV and for the progression to AIDS.
Several studies show that vitamin A deficiency is more prevalent among HIV-infected persons compared with HIV-negative individuals (Beach et al 1992; Coodley et al 1993; Ullrich et al 1994; Karter et al 1995).
A growing number of studies show that the HIV-infected are at higher risk of deficiency in vitamins B1, B2, B6, B12, C, D, and E (Baum et al 1991; Ehrenpreis et al 1994; Haug et al 1994; Periquet et al 1995; Fawzi & Hunter 1998).
Therefore, reacting positively on the tests for HIV, rather than indicating that the person is infected with HIV, may indicate that the individual is intoxicated or oxidized due to multiple, chronic, and repeated exposures to immunological stressor agents of chemical, physical, biological, mental, and nutritional origin ( Giraldo 1998, 1999; Giraldo et al 1999). Additionally, if a person who reacts positively on these tests continues to be exposed, voluntarily or involuntarily, to immunotoxic agents such as Nevirapine or to any other immunological stressor or oxidizing agent, very probably that person will develop AIDS ( Giraldo 1997).
The scientific facts described herein indicate, therefore, that it is not rational to prescribe Nevirapine to HIV-positive pregnant women and infants and that there exist effective nontoxic measures to avoid the development of AIDS in these individuals.
7. Informed consent.
The government of
People have the right to know all sides of a story even if they are contradictory or antagonistic, especially when they have to make decisions regarding their own health care. Not informing individuals of all the facts is a serious violation of the persons right to practice informed consent concerning medical decisions (Kent et al 1996; Silverman 1998; Berget et al 2001).
Self-determination and autonomy have been recognized, in
fact, as a fundamental moral value in the
The requirements for informed consent are as follows: 1) The practitioner must disclose all information, including risks and benefits that a reasonable person would need to know in order to make a decision. 2) The one consenting must be competent and must understand the information provided. 3) The consent must be given voluntarily and without coercion (OMara 1998).
I am sure that the lawyers of the Department of Health are
familiar with the regulations concerning informed consent in
In this vein, it is strongly recommended that when administering Viramune as part of an antiretroviral regimen, the complete product information for each therapeutic component should be consulted before initiation of treatment (PDR 2001).
Patients should be instructed that the major toxicity of Viramune is rash and should be advised to promptly notify their physician if any rash, since fatal skin reactions have been reported (PDR 2001).
Patients should be instructed that abnormal liver function tests and cases of clinical hepatitis, including fatal fulminant hepatitis, have been reported with Viramune (PDR 2001).
I dedicate this article to the memory of Huw Christie (1960 - 2001). His enthusiasm, dedication, and professionalism as Managing Editor of Continuum magazine permitted the debate about the causes and solutions of AIDS to spread over all the globe. Many lives were saved thanks to Huws work as an AIDS dissident activist. He was and will always be a light to lead us all.
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