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Reprinted from VirusMyth.Net, Edited and Updated for Alive &
Well May 2004
Questions on HIV-Antibody Tests
By Matt Irwin, MD
“A 20 to 40% rate of indeterminate on Western Blot,
a test that supposedly determines life or death, is outrageously
high. Yet few medical experts question whether it is appropriate
to use it for diagnosing HIV infection. This is only the tip of
the iceberg regarding the problems with HIV tests…”
===
As an introduction to the problems with HIV test, the following
quote on the Western Blot, the heavily relied upon "confirmatory"
test for HIV, raises questions about the test’s reliability
in making the life-altering diagnosis of HIV positive:
"Problems may be encountered when an HIV Western Blot is done
on someone at no identifiable risk of infection. For example, recent
studies of blood donors in whom no risk of HIV infection could be
ascertained, who were nonreactive on the ELISA, and for whom all
other tests for HIV were negative, revealed that 20% to 40% might
have an indeterminate Western Blot..." (Proffitt et al 1993,
page 209)
This excerpt from the medical literature demonstrates that indeterminate
results are hardly rare. It also shows the remarkable finding that
any person, if given a Western Blot HIV antibody test, will have
a 20% to 40% chance of having their serum react with proteins that
are supposedly specific to HIV. An indeterminate result by definition
means that the person's serum reacted to at least one of the "HIV-proteins"
used in the Western Blot. A 20 to 40% rate of indeterminate on a
test that supposedly determines life or death issues is outrageously
high, and yet Proffitt et al. do not mention having any doubts that
this is an appropriate test to use as the final determining factor
when diagnosing HIV infection. This is a common reaction from professionals
entrenched in the HIV-causes-AIDS belief system. The finding of
how incredibly common indeterminate results are on the Western Blot
is only the tip of the iceberg regarding the problems with these
tests.
There are two tests that are primarily used in the developed areas
of the world to diagnose HIV infection, the ELISA and Western Blot.
The ELISA is used as a screening test, and if the ELISA result is
positive, the Western Blot is performed as a confirmatory test.
When an ELISA result is negative, no Western Blot test is performed,
and the person is declared "HIV-negative". In order to
be considered HIV-positive one must test positive on both tests.
If someone tests positive on the ELISA but negative on the Western
Blot, they are considered HIV-negative. Following is a detailed
discussion of problems with the ELISA, Western Blot, and viral load
tests.
Problems with the ELISA Test
Everyone Tests Positive on the ELISA test
The most remarkable study of the ELISA test has unfortunately not
yet been published in a peer-reviewed medical journal. The study
was described by the physician who performed it, Roberto Giraldo,
M.D., in an article that he published in the magazine Continuum
(Giraldo 1998/1999).
Giraldo has worked in a laboratory of clinical immunology at Cornell
University Hospital in New York City since 1993. This lab regularly
performs the ELISA, Western Blot, and Viral load tests on the serum
of patients in the hospital. He became suspicious of the ELISA test
because when the test is run, the serum must be diluted 400 times
with a special diluting agent that is provided by the manufacturer
of the test, Abbott Laboratories. What is particularly unusual about
this practice is that no other antibody tests require such a high
dilution. Most antibody tests are run on straight serum, with no
dilution at all, as is the case for hepatitis A and B virus, rubella
virus, and many others. In Dr. Giraldo's own words:
“This extraordinarily high dilution of the person's serum
(400 times) took me by surprise. Most serologic tests that look
for the presence of antibodies use undiluted ("neat")
serum. For example, the tests that look for hepatitis A and B viruses,
rubella virus, syphilis, hystoplasma, and cryptococcus, to mention
a few of them, use straight, undiluted, serum.” (Giraldo 1998/1999,
page 8)
The closest comparison to this level of dilution required for HIV
tests is the rheumatoid factor (RF) antibody test which is run at
a dilution of 40:1. It is well known, however, that RF is an antibody
that all humans produce, and it is used as a non-specific marker
for autoimmune processes where the body is attacking itself. Thus
RF is referred to as an "autoantibody", and is only elevated
when the immune system is hyperstimulated as occurs in illnesses
like rheumatoid arthritis and lupus.
Another test that uses diluted serum is the Western Blot, which
uses a ratio of 50:1. This may explain why the Western Blot test
is almost always positive when the ELISA is positive, because serum
that reacts at a dilution of 400:1 on the ELISA test is even more
likely to react if only diluted 50:1 on the Western Blot. One wonders
what would happen if Western Blot tests were run on healthy blood
donors undiluted serum, since even when diluted 50 times the indeterminate
rate is between 20 and 40%. Unfortunately, no one has yet tried
to repeat Dr. Giraldo's experiment or do similar tests with the
Western Blot.
Given the unusual dilution required by the ELISA test, Dr. Giraldo
investigated what would happen if he took serum that had tested
negative for HIV when it was diluted 400 times, and reran the ELISA
test on the same serum without diluting it as with tests for other
viral antibodies. Here is Dr. Giraldo's description of his findings:
“I first took samples of blood that at 1:400 dilution tested
negative for antibodies to HIV. I then ran the exact same serum
samples through the test again, but this time without diluting them.
Tested straight like this, they all came up positive. Since that
time I have run about 100 specimens and have always gotten the same
result. I even ran my own blood which at 1:400 reacts negative.
But at 1:1 [undiluted] it reacted positive.” (page 8)
The results of this remarkable experiment seems significant enough
to immediately halt all ELISA testing until more detailed experiments
are done. This may be why Dr. Giraldo states that "No one will
be willing to publish my results because they are too threatening
to the HIV establishment" (Giraldo, personal communication).
As suggested by the comparison with RF antibodies mentioned previously,
one explanation for positive results on negative samples tested
as straight serum is that HIV antibodies are actually something
that all people produce and that they are not specific to any virus.
HIV antibodies might actually be "autoantibodies", rather
than antibodies to a viral invader. Another explanation is that
all people have been exposed to HIV, but some people produce more
antibodies than others. This is equally disconcerting if one considers
the psychological terrorism that accompanies the diagnosis "HIV-positive"
or the popular theory that only a small portion of HIV positives
do not develop AIDS as a result of exposure.
Papadopulos-Eleopulos et al. (1993a,b, 1995) have argued repeatedly
that since no one has completely isolated the virus, the specificity
of the tests used to diagnose HIV-infection is completely unknown.
Only by checking the accuracy of the tests against a gold standard
of purified HIV can specificity for the tests be established. All
available electron micrographic pictures of HIV show impure solutions
in which what is said to be HIV represents only a small minority
of the visible elements (Verney-Elliott 1999, de Harven 1998a,b),
and therefore there is no way to know whether the proteins that
are used in the ELISA and Western Blot tests are from HIV or from
the other cellular components present within the sample.
The opinions of Papadopulos-Eleopulos et al. are shared by Etienne
de Harven, Ph.D., who has been one of the world's leaders in electron
microscopy for over forty years. Dr. de Harven spent most of his
37 year research career studying retroviruses associated with leukemias
in animals. He spent 25 years at the Sloan Kettering Institute where
in 1958, he published the first electron micrographs of the Friend
leukemia virus, a retrovirus his colleague Charlotte Friend had
discovered in mouse leukemic cells. His electron micrographs from
1958 stand in stark contrast to micrographs claimed to show pictures
of HIV. This is because his micrographs of the Friend leukemia virus
show purified viral particles with only three small impurities viewed
in a field of hundreds of viruses (Verney-Elliott 1999, de Harven
1998a,b).
The only micrographs claimed to be of HIV are 99% impurities which
makes it impossible to know for sure what the micrographs show.
(Verney-Elliott 1999, de Harven 1998a,b). De Harven, like Duesberg,
became disillusioned with retrovirology as he saw more and more
researchers trying to side-step the frustration of having their
work disproved. According to Dr. de Harven, researchers did this
by lowering their scientific standards and by using less precise
measures in order to get their desired results. De Harven began
to see that the idea that retroviruses could cause disease was highly
unlikely, and he was upset that retrovirologistsstudying the issue,
instead of admitting that this was so, used more and more dubious
scientific methods in an attempt to keep their research alive.
When in 1984, Gallo claimed that a retrovirus was causing AIDS,
de Harven, who was an emeritus professor of Pathology at the University
of Toronto at the time, was highly skeptical. He was not only skeptical
that HIV could be the cause of AIDS, as Duesberg was, but also skeptical
as to whether Gallo had even found a real retrovirus. De Harven
had worked with many researchers in the past who claimed to have
isolated a new retrovirus only to find upon electron microscopy
that there was no virus present. This is why true isolation was
discontinued by most researchers, according to de Harven, and why
the term "isolation" is now used when the presence of
questionable surrogate markers are identified. He and Papadopulos-Eleopulos
et al. argue that what are thought to be "markers" of
HIV may simply be a collection of proteins produced by the body's
own cells when under stress. Here are some quotes from Dr. de Harven
regarding these problems and how they relate to the ELISA and Western
Blot tests:
“When Gallo and his followers attempted to demonstrate that
certain retroviruses can [cause disease in humans], to the best
of my bibliographical recollection, electron microscopy was never
used to demonstrate directly viremia [the presence of viruses in
the blood] in the studied patients. Why? Most probably electron
micrographic results were negative, and swiftly ignored! But over-enthusiastic
retrovirologists continued to rely on the identification of so-called
‘viral markers’ attempting to salvage their hypothesis.
ELISA, then Western Blot tests were hastily developed, at sizable
profits eagerly split between the Pasteur Institute and the U.S.
‘Seropositivity’ [based on these two tests] became synonymous
with the disease itself, plunging an entire generation into behavioral
panic and exposing hundreds of thousands of people to ‘preventative’
antiviral AZT therapy which actually hastened the appearance of
severe or lethal immunodeficiency syndrome.” (de Harven 1998b,
page 21)
De Harven concludes his article with the following plea:
“Obviously, the HIV/AIDS hypothesis has to be scientifically
reappraised. And, most urgently, the funding for AIDS research should
no longer be restricted to laboratories working on a hypothesis
which has never been proven.” (de Harven 1998b, page 21)
All tests are known to have false positives. In the case of antibody
tests this is much more likely to occur when antibodies are present
in large quantities, as often happens when the immune system has
been stimulated by multiple infections or by foreign agents injected
into the bloodstreams. Such immune stimulation is common among people
in the major risk groups for testing HIV positive in the United
States and Europe, including IV drug users, male homosexuals, and
hemophiliacs. The argument that ELISA and Western Blot tests simply
pick up false positives due to very high antibody levels is supported
by an article by Shallenberger on low CD4 counts. (Shallenberger
F, Medical Hypotheses: 50; 67-80 1998).
He argues that AIDS is not infectious at all, but rather that is
caused by an imbalance of the immune system with a hyperstimulated
antibody-mediated immunity. He documents that this is exactly what
happens to people in the risk groups for AIDS, and that hyperactive
antibody mediation causes suppression of cellular immunity. He does
not discuss the HIV antibody tests, but it appears that the finding
that HIV tests must be run on heavily diluted blood shows that the
test is a measure for excess antibodies in the blood, also called
"hypergammaglobulinemia”.
Several reports discussing false positives published by researchers
who support the use of these tests and who support the conventional
explanations for AIDS shed light on why such concerns have been
raised. MacKenzie et al (1992) for example, found seven people who
had repeated false positives on the ELISA test apparently due to
flu vaccination, and estimate that "0.6% to 1.7% of blood donors
who received influenza vaccine this season had multiple false positives."
This rate is much higher than the prevalence of HIV in the US population
(which is officially estimated at about 0.4%) meaning that people
who receive a flu vaccine are much more likely to get a false positive.
If there is no independent measure or “gold standard”
for determining a true positive, how did MacKenzie et al decide
that the ELISA results they reported were false positives? They
based their decision on Western Blot confirmatory tests which were
negative or in one case indeterminate, and the fact that about 3
months later the six people available for follow-up tested negative
on the ELISA (Western Blot was not repeated after a negative ELISA).
Thus we see that the accuracy of the ELISA test is gauged by the
results of Western Blot tests.
A letter to the Western Journal of Medicine (Challakere 1993) reported
finding 5 false positives in a sample of 127 people for a false
positive rate of 4%. Through careful history taking Challakere determined
that the flu vaccine as well as previous viral infections like herpes
simplex 2 were the probable causes of these false positives. A rate
of 4% means that 1 in 25 people had a false positive which would
lead to ten times as many false positives as true positives since
only about one in 250 people in the United States are thought to
be HIV positive according to the most recent estimates by the Centers
for Disease Control. Challakere also relied on negative Western
Blots to decide which tests were true positives and which were false,
showing again how critical the accuracy of the Western Blot is to
current practices regarding the diagnosis of HIV infection. A summary
article on the use of HIV antibody tests that appeared in Infectious
Disease Clinics of North America (Proffitt et al. 1993) discussed
some of the known causes of false positives on the ELISA HIV-1 antibody
test:
“Notable causes of false positive reactions have been antibodies
that sometimes occur in multiparous women and in multiply transfused
patients. Likewise, antibodies to proteins of other viruses have
been reported to cross react with HIV determinants. False positive
HIV ELISA's also have been observed recently in persons who received
vaccines for influenza and hepatitis B virus.” (page 205)
Since such heavy reliance is placed on the Western Blot test, one
rightfully needs to know how specific it is and how this specificity
was determined. As it turns out, false positives and indeterminates
for the Western Blot test are also quite common and the claimed
specificity of the test is highly questionable. The specificity
of the Western Blot is called into question by other reports, including
Proffitt et al.’s 1993 article.
Problems with the Western Blot Antibody Test
The Western Blot has ten "bands", all of which have a
protein or antigen that is supposedly only produced by HIV. The
ELISA test also uses these "HIV proteins", but as a mixture
so only one band needs to be used. The patient's serum is run separately
through all ten bands of the Western Blot to see how it will react
with each one individually. When the serum reacts with a protein
in a given band it is considered to mean that the patient's serum
contains antibodies to that particular protein. Not all ten bands
have to be positive in order for a person to be diagnosed HIV-positive
however, and the combinations of reactive bands needed for a positive
result vary greatly from country to country. This fact alone shows
how arbitrary the tests are, since a person diagnosed HIV-positive
in one country may be considered "indeterminate" in another.
The following quote from Proffitt et al. describes the inconsistent
guidelines for the reading of this test (Proffitt 1993):
“Indeed, not even the interpretation guidelines in the brochures
of each FDA-licensed manufacturer of HIV Western Blots are the same.
However, the majority of the laboratories have accepted the recommendations
of the ASTPHLD. Following those recommendations, a negative Western
Blot would have no bands, a positive would have at least two of
the key bands, and an indeterminate would have a single band or
a combination that does not fit the interpretation of positive.”
(page 208)
This comment hardly inspires confidence that interpretations of
results are based on sound scientific principles. It also explains
why different countries have widely varying criteria for when a
test is "positive" and when it is "indeterminate".
The most disturbing evidence they cite, however, is the rate of
indeterminates that appear for Western Blots in healthy blood donors
as discussed previously. An indeterminate occurs when an insufficient
number of bands come up positive or when the combination "does
not fit the interpretation of positive". One would expect,
since all of the bands contain proteins that are supposedly specific
to HIV that indeterminate results would be quite rare, but this
is hardly the case.
Problems may be encountered when an HIV Western Blot is done on
someone at no identifiable risk of infection. For example, recent
studies of blood donors in whom no risk for HIV infection could
be ascertained, who were nonreactive on the ELISA, and for whom
all other tests for HIV were negative, revealed that 20% to 40%
might have an indeterminate Western Blot. (page 209) This means
that any one of us, if given a Western Blot HIV antibody test, will
have a 20% to 40% chance of having our serum react with proteins
that are supposedly specific to HIV! As mentioned before, such a
high rate of indeterminates on a test that supposedly determines
life or death issues is outrageous in my opinion, and yet Proffitt
et al. do not question its accuracy in any way.
Given the high rate of indeterminate results on the Western Blot,
it is reasonable to wonder how the extremely high specificity claimed
for this test can possibly be true. It is claimed is that only 1
in 20,000 tests will give a false positive. An article from 1995
that also supports the use of these tests places these two seemingly
irreconcilable claims in the very same sentence:
“Thus, incidences of inaccurate results [on the Western Blot]
vary from a false positive rate of 1 in 20,000 to indeterminate
results in 20% to 40% of cases in which the ELISA test was serum
negative.” (Cordes 1995, page 185)
The only conclusions that Proffitt et al. draw from this extremely
high false indeterminate rate is that the Western Blot should not
be used as an initial screening test, and the only potential harm
mentioned is that "the anxiety an indeterminate result creates
in a test subject is understandably intense." (Proffitt 1993,
page209).
If an indeterminate result creates "intense" anxiety,
a result considered to be a true positive will create levels of
stress and anxiety that are many times more intense. I have called
the fear and social isolation caused by a positive HIV antibody
test result "psychological terrorism" because of how devastating
it can be, and yet the decision about what is "true",
"false" or "indeterminate" does not appear to
be based in any well controlled experiments and appears to ignore
many conflicting results.
The arbitrary nature of the Western Blot has been analyzed in detail
by Papadopulos-Eleopulos et al. (1993) who document that all of
the proteins used in the Western Blot, which are supposedly specific
to HIV, have been commonly found in people who are HIV-negative
on the other HIV tests. They also point out that HIV was never isolated
so there is no way to know if these proteins are from HIV or from
other cells and viruses. Before analyzing their work, however, here
is a quote from a team of researchers who reported a number of false
positive results on the Western Blot tests:
“Our results document a fourth source of false positive HIV-1
Western Blot results which is the reproducible but nonspecific reactivity
[to proteins from HIV]... Preliminary studies suggest that the basis
for this cross reactivity with HIV-1 gp 41 proteins may be infection
by paramyxoviruses, carbohydrate antibodies, or autoantibodies against
cellular proteins. (Sayre et al., 1996, page 48-49).
The authors also looked at rates of these types of false positives
among all tests performed on blood donors in the U.S. and concluded
that 1992 had the highest rates to date with 52 out of 683, or 8%
of Western Blot positives on donated blood actually being false
positives.
The quote above from Sayre et al. mentions false positives due to
reactions with the "gp 41 proteins" which include gp 41
and gp 120/160. However, there have been problems with the proteins
in all the other bands used in the Western Blot as well. It has
been shown in a number of studies that none of the ten proteins
are actually specific to HIV. "Gp" stands for "glycoprotein",
which is a protein with some sugar molecules attached to it, and
the number after the letters represents the molecular weight of
the protein, in kilodaltons. Glycoproteins of all shapes and sizes
are extremely common components of cells in both plants and animals.
(These proteins are sometimes referred to with only a “p”,
i.e. “p41” and “p120/160” instead of “gp”.)
The research calling into question whether any of the "HIV
proteins" is really specific to HIV is presented in detail
in an article published in Bio/Technology, by Papadopulos-Eleopulos
et al., entitled "Is a Positive Western Blot Proof of HIV Infection?"
(Papadopulos-Eleopulos et al.1993). The authors point out that even
the original papers by HIV co-discoverer Luc Montagnier found gp41
to occur in normal cells which were not infected by HIV, and that
Montagnier's group concluded that gp41 "may be due to contamination
of the virus by cellular actin which was present ... in all the
cell extracts" (Barre-Sinoussi et al. 1983). Actin is an extremely
common protein that is present in all cells, including bacteria
and viruses. The gp 120/160 protein was shown in 1989 to actually
be several gp 41 proteins hooked together ("oligomers"
of gp 41), so it is equally non-specific. This was reported by Pinter
et al in 1989 in the Journal of Virology in an article entitled,
"Oligomeric Structure of gp41, the Transmembrane Protein of
HIV-1".
Another protein, gp24, is of special significance because it is
often used alone as a test to claim the presence of HIV and gp24
testing is commonly done in newborn children where the ELISA and
Western Blots are thought to give false positives due to antibodies
passed on by an HIV positive mother. Additionally, when HIV is "cultured",
it is the finding of gp24 that is used to say HIV has been found.
In other words, the way they test for HIV is to test for gp24. Thus,
this glycoprotein has special importance, and one would expect that
it would be extremely rare to find it in people considered HIV negative.
As Papadopulos-Eleopulos et al. put it:
"Detection of p24 is currently believed to be synonymous with
HIV isolation and viremia. However, ... Gallo and his colleagues
have repeatedly stated that the p24's of HTLV-1 (a different retrovirus)
and HIV cross-react." (Papadopulos-Eleopulos et al.1993 page
697, Wong-Staal & Gallo 1985).
Papadopulos-Eleopulos et al. continue with further examples showing
how incredibly common it is to find gp 24 and antibodies to gp 24
in people who are considered HIV-negative:
“Genesca et al (1989) conducted Western Blot assays in 100
ELISA-negative samples of healthy blood donors. 20 were found to
have positive bands which ... were considered indeterminate Western
Blots, with p24 being the predominant band (70% of cases). Among
the recipients of Western Blot indeterminate blood, 36% were Western
Blot indeterminate 6 months after transfusion, but so were 42% of
individuals who received Western Blot-negative blood samples. Both
donors and recipients of blood remained healthy. They concluded
that Western Blot indeterminate patterns "are exceedingly common
in randomly selected donors and recipients and such patterns do
not correlate with the presence of HIV-1 or the transmission of
HIV-1... Most such reactions represent false positives."
Antibodies to gp24 have been detected in 1 out of 150 healthy, ELISA-negative
individuals, 13% of randomly selected otherwise healthy patients
with generalized warts, 24% of patients with cutaneous T-cell lymphoma,
and 41% of patients with multiple sclerosis (Ranki et al. 1988).
Conversely, the p24 antigen is not found in all HIV positive or
even AIDS patients. In one study of patients at various stages from
asymptomatic (HIV positive) to AIDS, p24 was detected in only 24%
(Delord et al. 1991).
Here we have researchers discussing the "exceedingly common"
occurrence of Western Blot indeterminate results and deciding that
they represent false positives because the ELISA is negative. As
noted previously, ELISA positives are considered to be false when
the Western Blot was negative. The incredible reliance of patients,
doctors, and scientists on tests with such obvious inconsistencies
is a cause for alarm, and yet it appears that the only people sounding
the alarm are not being heard, or at least not being listened to.
The rest of the article by Papadopulos-Eleopulos et al. goes on
to discuss similar findings with the rest of the Western Blot "HIV
proteins" and concludes with a relatively conservative call
for reappraisal:
“We conclude that the use of the HIV antibody tests as a diagnostic
and epidemiological tool for HIV infection needs to be reappraised.”
(page 696)
Of even greater concern than the existence of these problems is
the fact that no one in the conventional medical and scientific
establishment seems to be asking questions about them.
Problems with the Viral Load Test
Two papers published in 1995 in the journal Nature appeared to resolve
the dilemma of either not being able to find any actual HIV particles,
or finding only extremely small quantities of HIV, in people diagnosed
HIV-positive (Ho 1995, Wei 1995). These researchers used a new genetic
detection system called "quantitative PCR", which relies
on a complex mathematical formula to quantify the amount of virus
in people's blood. This abstract quantification system is what is
still used today to find what is called a person's "viral load",
and has become a major method used by clinicians to determine the
health status of people diagnosed HIV-positive. Contrary to what
most people believe, however, PCR does not directly detect any intact
viral particles, but only tiny fragments of what is thought to be
HIV's genetic material. Thus, "viral load" is not determined
by counting even one intact particle of HIV, but rather by using
a complex mathematical system of estimation. This quantification
system has serious problems that have been largely ignored in spite
of being clearly reported in the medical literature, and yet it
has become the primary marker of health both in research as well
as in treatment decisions with people diagnosed HIV positive.
How many HIV particles does "viral load" really
represent?
Viruses can only cause damage if they are infectious. They cause
ill health by infecting cells and then causing cell death. Researchers
attempting to see what portion of the huge numbers of HIV reported
by quantitative PCR represent active, infectious viruses, have found
that as few as 1 in 10 million of the “HIV” reported
are actually infectious. They determine this by "culturing"
the virus, which usually means looking for surrogate markers of
HIV like gp 24. As outlined previously, these proteins are actually
quite non-specific and are often found in people who are HIV-negative.
A virus that cannot infect another cell is essentially sterile since
it cannot harm any cells if it cannot infect them. Here are some
comments on the results from one major study published in Science
in which researchers found that the vast majority of "viral
particles" found by viral load/quantitative PCR were non-infectious:
“Circulating levels of plasma virus determined by [quantitative]
PCR correlated with, but exceeded by an average of 60,000-fold,
numbers of infectious HIV-1 that were determined by quantitative
culture of identical portions of plasma... Total virions have been
reported [in other studies] to exceed culturable infectious units
by factors of 1,000 to 10,000,000, ratios similar to those we observed
in plasma.” (Piatak et al., 1993, page 1752)
In other words, these researchers estimated that only about 1 in
60,000 "virions" found using "quantitative"
PCR were actually infectious, and that other studies have found
even more dismal results. Because they use the presence of gp24
which is a non-specific protein found in 41% of patients with multiple
sclerosis (Ranki et al. 1988) to determine if a cell has become
infected, even their estimate of 1 in 60,000 is probably exaggerated.
Even using a non-specific marker like gp24, these researchers were
not able to culture any virus at all in more than half (35 of 66)
patients. This means that people with no infectious virus at all
had "viral loads" as high as 815,000 "copies per
milliliter"! The study subjects had all tested positive on
the ELISA and Western Blot antibody tests, the two tests currently
used to diagnose people as being "HIV-infected". They
all had extremely high "viral loads", and yet the majority
of them had no "culturable infectious units" of HIV. Results
like these bring up some obvious questions about what proof exists
that testing positive on antibody tests means that a person had
an active infection. Unfortunately, in the world of HIV science,
no one seems to question these tests. Instead, articles commonly
quote amazing levels of specificity and sensitivity.
This difficulty in finding active HIV particles is not surprising
to those familiar with the literature on this topic, since similar
results have been found by many researchers who have tried to confirm
the presence of HIV in people's blood (Chiodi 1988, Gallo 1984,
Learmont 1992, Popovic 1984, Sarngadharan 1984, Schupbach 1984).
Based on results like these, the abstract system used by quantitative
PCR technology in which tiny bits of genetic material are amplified
by a complex set of mathematical equations into frighteningly large
numbers is highly questionable. Most people diagnosed HIV positive,
even with high viral loads, may have noinfectious virus in them
at all. As will be discussed in the next section, many people who
test negative on both the ELISA and Western Blot have substantial
viral loads when tested using "quantitative PCR". This
brings up the question of whether PCR is capable of mistaking tiny
bits of a person's own genetic material for genetic material of
HIV. Since the human genome has about 3 billion base pairs while
that of HIV has only about 10,000, and PCR only looks for about
3% of HIV's genetic material, about 300 base pairs, it appears likely
that some of the 3 billion base pairs in the human genome could
accidentally be attributed to HIV.
As mentioned before, "viral load" has become the only
measure of alleged health in clinical trials of new drugs. News
reports about people "doing well" on the new anti-retroviral
cocktails often speak about people whose "disease is controlled"
on the drugs, or whose "disease came roaring back" after
stopping the drugs. What they are referring to, however, is not
clinical health at all. Careful reading of such articles reveals
that the person in question often feels much better when they discontinue
the drugs because of the numerous toxic effects suffered while taking
them. The description of the disease "roaring back" is
based entirely on the fact that their "viral loads" have
risen, even though they may be feeling much better and have no clinical
symptoms of illness.
As often occurs in studies that fundamentally challenge HIV science
like Piatak et al, the authors appear unphased by their results
and focus completely in the discussion section of their paper on
other aspects of their study that fit better with conventional views
about what it means to be "HIV-positive" and to have a
high "viral load". They do not even mention in their discussion
that the majority of their subjects had no infectious viral particles.
While it is of questionable significance to have such high "viral
loads" if only a tiny minority, or none of the particles is
actually infectious, it can still be terrifying to be told that
one has several million copies of HIV in every milliliter of blood.
This type of news has a powerful symbolic meaning to clinicians
and patients, which may result in profound immunosuppression whether
HIV is causing damage or not.
High viral loads in people who are "HIV-Negative"
Adding further confusion to the issue, PCR technology has found
extremely high viral loads in people who are HIV negative by the
ELISA and Western Blot antibody tests. For instance, Schwartz et
al. (1997) found a person with a viral load of 100,000 who was negative
on the ELISA and Western Blot antibody tests. The authors concluded
that lab error had led to this reading, which would be a reasonable
explanation if not for the presence of other studies finding similar
results.
Gerberding et al. (1994) conducted a study of HIV contaminated needle
sticks and in the process uncovered data that calls into question
the value of viral load/PCR testing. They conducted PCR tests on
133 of the 327 healthy workers who had experienced needle sticks
in their clinic. All of these 133 subjects remained HIV negative
on the ELISA antibody test, but seven of them had "indeterminate"
PCR results and four others had one or more actual positive results
for a false positive rate of 3%. If the "indeterminate"
results are counted as well, the false positive rate is 8%. For
a very rare infection like HIV, with an estimated prevalence of
only 0.4%, these rates of false positive results in perfectly healthy
people are extremely high. The ratio of 3% to 0.4% reveals that
for every 30 people with "positive PCRs" only 4 will be
considered true positives. The decision regarding which are actual
positives is based on the ELISA and Western Blot antibody tests,
which are also highly questionable as discussed previously. Gerberding
et al. comment on their findings with PCR as follows:
“The failure to demonstrate seroconversion... among those
with positive PCR tests suggests that false positives occur even
under stringent test conditions. The low predictive value of a positive
or indeterminate PCR test... contraindicates the routine use of
gene amplification in this clinical setting.” (Gerberding
et al. 1994, page 1415)
Other cases of people with positive PCR tests but who were negative
on the ELISA test were reported by Rich et al. (1999). They report
on three such cases which occurred over a two month period. The
third case has a particularly interesting series of conflicting
results:
“[Case 3] had a positive result on ELISA and an indeterminate
result on a Western Blot (WB) test... During a four month period
after her initial indeterminate result, she had a positive result
on ELISA and another indeterminate result on WB test, on separate
occasions. Five months later, both ELISA and WB tests yielded negative
results, but the patient had a plasma viral load of 1300 copies/ml.”
(page 38).
Another study looking at this question was published in 1992 in
the Journal of AIDS (Busch et al. 1992). In this instance, researchers
performed PCR tests on 151 ELISA-negative people and found that
18.5% (28 people) had positive PCRs. Furthermore, they found that
only 25.5% of people diagnosed HIV-positive had "positive"
PCRs!
Finding viral loads and false positive PCRs in HIV-negative people
should be a major wake-up call to people diagnosed "HIV-positive,”
their doctors, scientists working in the field, and the public at
large because these tests are repeatedly used to make clinical decisions
about treatment. What makes results like these even more surprising
is that they were never reported in the media, nor were they discussed
in the research community, nor were they presented to physicians
at AIDS conferences, and finally, they were definitely never shared
with people diagnosed "HIV-positive".
Perhaps this is why Kary Mullis, the scientist who won the Nobel
Prize in chemistry in 1993 for inventing the PCR test says that
the "viral load" is meaningless (Duesberg 1996). Kary
Mullis is one of the signatories of a statement calling for a reappraisal
of the causes of AIDS.
The manufacturers of these tests know that their tests are of questionable
accuracy, although it is doubtful that they realize just how questionable
the accuracy really is. They reveal this knowledge through the following
disclaimers that they include with their test kits:
1) Abbott Laboratories puts the following statement in their ELISA
test kit: "ELISA testing alone cannot be used to diagnose AIDS."
(Abbott 1997) This warning is not surprising since current practice,
at least in the United States, suggests that the Western Blot test
is the way to assess infection.
2) Epitope, the maker for one of the Western Blot kits warns in
their package insert: "Do not use this kit as the sole basis
for HIV infection." (Epitope 1997). This is somewhat more alarming,
since the Western Blot is supposed to be a highly accurate test
used to confirm that the ELISA is not a false positive.
3) Roche, the maker of a popular "viral load" test kit,
state: "The amplicor HIV-1 monitor test is not intended to
be used as a screening test for HIV, nor as a diagnostic test to
confirm the presence of HIV infection." (Roche 1996). This
is also not surprising, since viral load is not normally used to
diagnose HIV infection.
In summary, all the test makers deny that their test is accurate
to diagnose HIV infection when used "alone". Yet combining
three inaccurate tests will create yet another inaccurate test,
especially given the evidence showing how severe the accuracy problems
are.
I continue to be amazed that these tests are relied upon daily to
make life or death decisions. I would propose that simple but thorough
experiments be carried out by an independent and unbiased body of
researchers. In the meantime, I could not in good conscience recommend
that anyone take these tests.
===
While attending medical school at George Washington University,
Matt Irwin, MD wrote several literature reviews on HIV and AIDS.
In addition to his degree in medicine, he holds a Master's degree
in social work from the Catholic University of America. Dr. Irwin
uses nutritional, psychological, social and spiritual interventions
as well as classical homeopathy in his practice of family medicine
near Washington, D.C.
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