VIRUSMYTH HOMEPAGE
DEBATING AZT
Why the ‘AIDS Test’ is Useless, and Pathologists Agree
By Anthony Brink
15 March 2000
To the pathologist:
The Professional Provident Society
requires me to take an HIV test for the purpose of increasing my life
insurance. An ‘Informed Consent’ document supplied by the Life Offices
Association invites me to ask you to explain its contents if I have any
problems understanding it. I do have problems understanding it and I have
several questions.
According to the face of the
document, the test to be administered is an ELISA 3, which I understand to be a
third-generation enzyme immunoassay for HIV antibodies. I wish to be informed
of the name of the test kit employed and its manufacturer, and I require a copy
of the operating/information booklet in order to inform myself fully about the
test which I am obliged by my insurer to take.
Under the heading “Is the test always accurate? Can there be
mistakes?” I am told that “the tests used are very accurate.” Even more
categorical is the explanation under the heading “What does it mean if the
test is positive?”: “this means that you have been infected with the AIDS virus.”
Does the mere presence of
HIV antibodies in the absence of any clinical symptoms of illness signify an
active infection with HIV? Are significant levels of such antibodies not
consistent with a successful immune response? Are any other diseases diagnosed
purely on the basis of antibody detection in the absence of clinical
presentation?
I have looked up the specificity of four different third-generation ELISA HIV
antibody test kits, and all claim specificity of about 99.8%.
Two senior medical
technologists with the Natal Blood Transfusion Service tell me that the HIV
seroprevalence among white people is this province is negligible and less than
one in a thousand. I was told that the seroprevalence among Indian and Coloured
people was likewise very small.
With a sensitivity of 100%,
as all the test kits claim, the true positive in a thousand test subjects will
be detected (allowing for present purposes one in a thousand ‘true positives’).
With a specificity of 99.8%, two in a thousand non-infected test subjects will
also register positive.
It follows that for every
thousand people like me tested, there will be three reactive results, one true
positive and two false positives. In other words, for people from my low- risk
category in Natal-KwaZulu, HIV-positive test results will be wrong twice as
often as they will be right. Am I right? If not, in what respect is my
arithmetic unsound?
When I look at the
specificity data for the antibody tests of the kind under discussion, I find no
indication that any have been validated for specificity by comparing reactive
results with confirmed viral infection in test subjects. In a pregnancy test
for instance, the incidence of reactive urine tests would have been compared
with actual confirmed pregnancies to determine sensitivity, and non-pregnant
cases to establish specificity, that is the false-positivity rate. But looking
at the scientific literature cited by the test kit manufacturers and other
research papers, I find that this elementary control has never been performed
for any HIV antibody test kit. Is there any reason why the specificity of HIV
antibodies can’t be determined by comparing the incidence of reactive antibody
test results with actual cases of confirmed HIV infection, ascertained by viral
isolation in the suspected case?
I assume that we are agreed
that viral infections can be directly confirmed by harvesting and dismantling
putatively infected cells, by purifying and isolating the suspected virus by
zonal ultracentrifugation into isopynic density gradients, electron
photomicrography to confirm expected particle morphology, analysis of the
proteins and nucleic acids of the purified particles to establish their
exogenous origin, and confirmation of their infectivity by inoculation of
virgin cell lines and then repetition of this procedure.
Can you refer me to any
literature reporting that this has ever been done for HIV? Or am I correct in
understanding from Abbott Laboratories’s statement, “there is no recognized
standard for establishing the presence or absence of antibodies to HIV-1 and
HIV-2 in human blood”, that HIV has never actually been isolated, and that no
gold standard for the specificity of HIV antibody tests exists?
How does the claim in the
informed consent form that “a positive
test result means infection with the AIDS virus” square with Abbott’s warning,
“All enzyme immunoassays…may yield non-specific reactions due to other causes”
and therefore such results are required by Abbott to be “investigated further
in supplemental tests”?
One of the test kit manuals
that I have read states that the proteins employed as antigens by the test kit
for the detection of HIV-1 antibodies are p24 and gp160. I assume that other
HIV ELISA tests employ these same antigens, and/or p41 and its polymers, p80
and p120.
Have you any idea why p24 is
described as an HIV-1 protein when Professor Luc Montagnier himself points out
that p24 is not unique to HIV, and that it is also a constituent of HTLV-1 and
HTLV-2 viruses as well as of endogenous retroviral sequences that form up to 2%
of the human genome?
Since the glycoprotein with
the molecular weight of 160 daltons is a polymer of p41, and Gallo has pointed
out that Professor Luc Montagnier’s favoured ‘HIV-protein’ p41 is a ubiquitous
cellular protein (which he now admits), can you explain why gp160 is described
as an HIV protein? If the ‘co-discoverers of HIV’ are right, HIV antibody test
kit reactivity to p24, p41, p80, p120 and p160 would represent no more than the
detection of antibodies to cellular and other viral proteins from any number of
sources, whether endogenous or exogenous.
What prevents HIV antibody
test kits from lighting up to one or more of these non-HIV proteins?
I have difficulty
understanding why ELISA HIV antibody test kit results need interpretation, and
why reactivity or non-reactivity is determined not by reference to absolute
on/off values but to a cut-off value on a continuum. In plain terms, if I am
slightly reactive I am not infected, but if I am moderately strongly reactive I
am. How can this be? If the proteins employed in the test as antigens are
uniquely constituent of HIV-1, and HIV-1 antibodies are specific and monoclonal
- the fundamental assumptions underlying HIV antibody testing - how can the
test be reactive at all if I am not infected? How was this cut-off value fixed?
Under the heading “What is HIV?” I am told, “HIV is the
virus that causes AIDS…” I have copies of and have studied Luc Montagnier’s
1983, and Gallo’s 1984 Science papers
on LAV and HTLV-3 (now called HIV), and referred to as authority for this
proposition by the test kit manufacturers, and I think you’ll concede that none
come even close to establishing (a) that any virus was isolated under the well
settled protocol for the purification and isolation of viruses, discussed at a
symposium on this procedure at the Pasteur Institute in 1973, and (b) HIV-AIDS
aetiology, except by weak reliance perhaps on the post hoc, ergo propter
hoc fallacy that has so often has fooled
medical researchers. Could you please refer me to any other literature that
establishes HIV isolation by the Pasteur method, and the HIV-AIDS causality
claimed in the ‘Informed Consent’ document. I believe his quest for such
literature has occasioned some difficulty to Nobel laureate Kary Mullis Phd,
inventor of the PCR technology adapted to your ‘HIV viral load’ tests. He
complains that not even Luc Montagnier could refer him to any such literature,
and that medical experts just ‘know’ HIV causes AIDS, just like they ‘knew’ bad
air caused malaria. Because they ‘see’ it.
Under the heading “Is there a cure for HIV and AIDS?” I am
informed that “there is no known cure” but that with careful management “you
can greatly enhance the quality of your life before AIDS sets in.” Am I to
understand from this that a person who is HIV-positive will invariably die a
premature death from an AIDS indicator disease, and that his life will
deteriorate even before such disease develops? If so, what research reports
establish this?
What research reports
establish that any of the licensed AIDS drugs improve quality of life? Isn’t it
trite that they are all so poisonous and their ill-effects so severe that a
very high proportion of patients are unable to comply with their treatment
regimens and suffer dangerous toxicity injuries?
The ‘Informed Consent’
document restates a basic legal principle that persons urged to undergo any
medical procedure are entitled to the fullest information about it, and that
medical practitioners are required to supply it. Please consider this request
for clarification and deal with my queries in the light of this. I reiterate my
request for a copy of the information or operating manual supplied by the test
kit manufacturer as I wish to study it closely myself.
Yours faithfully
ANTHONY
BRINK
Postea:
Pietermaritzburg
pathologist, Dr Michael King, agreed unreservedly with my points made in
paragraphs 1 and 3, and told me that pathologists have been conducting “a
running battle with the Life Offices Association for years” regarding the
sufficiency of the test as a basis for an HIV-positive diagnosis. At least five
people preceded me for my ELISA test as I waited my turn including young black
middle class folk who presumably lead not dissimilar lives and enjoy a similar
healthy standard of living as their professional and business counterparts
among the other ‘low risk’ races. None were alerted to the misinformation
contained in the “Informed Consent” form that all were required to sign.
Orthodox ‘AIDS expert’ Professor Gerald Stine of the University of North
Florida made the same criticisms contained in paragraphs 1 and 3 above in
AIDS UPDATE 1999 An Annual Overview of the Acquired Immune
Deficiency Syndrome in his article The Performance Rate for
the Combined Elisa and Western Blot HIV Test – Is 99% accuracy good enough?
The Answer Is No. As the title tells, and
we’ll discuss below, a follow up Western blot test doesn’t plug the holes.
Imagine my surprise then to
see King asserting in the Natal Witness
newspaper on 28 June 2000, Diagnosis of
HIV highly specific: “A number of conditions have been described that can
give positive HIV Elisa results... Fortunately, these false positives are
uncommon and are excluded by the highly specific confirmatory tests… Occasional
samples give indeterminate results on Western Blotting and further patient
follow-up or testing with highly sensitive and specific nucleic amplification
techniques (PCR) may be required. Despite the admission by mainstream medicine
that occasional difficulties with diagnoses can occur, the serological
diagnosis of HIV infection using the combination of enzyme immunoassays and
Western Blotting is highly sensitive and specific (99%). Ref: Mandell: Principles
and Practice of Infectious Diseases, 5th ed, 2000, Churchill Livingstone.”
Roma locuta, ergo finita est!
Before
we look at these “highly specific confirmatory tests”, you might be interested
to learn that Lynn Morris of the National Institute for Virology told us at the
second meeting of President Mbeki’s AIDS Advisory Panel in July 2000 that two
reactive ELISA’s suffice for an HIV-positive diagnosis. You might wonder, “How
can one unvalidated test possibly confirm another? To which another expert
might offer the riposte, “We follow up with a different kind of test, the
Western blot; it’s more specific.” Actually, the manufacturers of HIV Western
blot tests do not make claims for better specificity than contemporary HIV
ELISA kits. And in England and Wales, positive HIV ELISA test results are not
confirmed or disconfirmed with an HIV Western blot test precisely because such
tests are regarded by the ‘AIDS experts’ there as being too non-specific. The
manual for one such HIV Western blot test (Epitope/Organon - Teknika
Corporation) warns, “Do not use this kit as the sole basis of diagnosis of
HIV-1 infection.” That’s how much confidence the manufacturer has in the
specificity of its test. But don’t King’s “highly sensitive”, “highly specific”
and “occasional” just roll off the tongue so nicely? No good upsetting the
customers. Can’t have them thinking for themselves. Trust us. We know. Anyway
Western blot is no different in principle from ELISA; it’s just that with
Western blot antibody testing, you get to see which supposed ‘HIV proteins’ on
the test strip react with the antibodies in your blood, whereas with ELISA the
proteins are served mixed. Both kinds of tests presuppose that the test
proteins have been shown to be uniquely constituent of a virus called HIV. But that’s
not true. Quite the opposite in fact. It gets worse. Western blot test results
for ‘HIV antibodies’ are interpreted differently in different places, kit to
kit, lab to lab, country to country. By these different diagnostic criteria,
you will be ‘infected with the AIDS virus’ and doomed to die in this country
but not that. According to one pathologist but not another. What an incredible
mess.
Some really clever guys like
Dr William Makgoba, president of the Medical Research Council, puff the
sophisticated technology of modern ELISA HIV antibody tests by treating you to
a little lesson on the purity of the proteins used in them as antigens to fish
for the presence of ‘HIV antibodies’. “They don’t use purified proteins
anymore”, he lectured us at the AIDS Panel’s second meeting. “They use
recombinant proteins now.” That big drop-dead word is sure to impress, until
your thoughts stray and you wonder, “What is the point of producing
magnificently pure proteins, all with precisely the same molecular weight by
means of bio-engineering techniques before ascertaining whether such proteins
are unique to HIV?”
King’s statement that one
can confirm or disconfirm HIV infection with “highly sensitive and specific
nucleic amplification techniques (PCR)” will be a shocker to anybody who has
read the contrary admonitions by the manufacturers of such tests. Makgoba spoke
the same way in an interview in Focus
in June 2000: “I have every confidence that the antibody test is so specific
now that we don’t get many false positives. And if you take that with the
identification of the virus by DNA techniques, there will be an abundance of
correlative results.”
The only HIV PCR test
licensed by the FDA for clinical (as opposed to experimental) use by
pathologists is Roche Diagnostics Corporation’s AMPLICOR HIV-1 MONITOR Test,
version 1.5. The manual says: “The AMPLICOR HIV-1 MONITOR Test, version 1.5 is
not intended to be used as a screening test for HIV-1 or as a diagnostic test
to confirm the presence of HIV-1 infection.” That’s because the manufacturer
recognises that it is not specific enough. No, no, the ‘AIDS expert’ points
out. That’s the wrong kind of PCR test. We don’t use quantitative monitoring
tests for diagnosing HIV infection; we use a qualitative test. Like Roche Diagnostics
Corporation’s other PCR test, their AMPLICOR HIV-1 Test. Well, it would help if
the ‘AIDS experts’ read the manual: “For research use only. Not for use in
diagnostic procedures.” As for “an abundance of correlative results” between
HIV PCR and HIV antibody tests, in the only comparative study of its type yet
performed - reported in AIDS in 1992
by the Multicenter Quality Control of PCR
Detection of HIV DNA - the concordance of reactive results when the same
blood was tested with both kinds of tests ranged unpredictably, hit and miss,
between 40% and 100%. Odd isn’t it?
Dr King relies on a textbook
for his statement that “the serological diagnosis of HIV infection using the
combination of enzyme immunoassays and Western Blotting is highly sensitive and
specific (99%).” All I can think is that by the time he wrote that, he had
forgotten our little chat - specifically our discussion of the Grand Canyon of
a difference between specificity and reliability in a low sero-prevalence
cohort.
Let’s
have a closer look at the significance or otherwise of King’s “99%” specificity
figure. I learned that the specificity of the test used on me - an Abbott HIV
gO EIA - was claimed to be 99.8%. Just how little such a specificity figure
really means is well set out by Christine Maggiore in Los Angeles in a letter
she wrote at the end of May 2000 to the webmaster of an AIDS information
website: “The fact is that the specificity and the accuracy of HIV tests were
determined by assuming that 100% of people with AIDS-defining illnesses who
tested positive had actual current infection with HIV. The specificity was
established by assuming that 100% of symptomless blood donors who tested
HIV-negative did not have a current infection with HIV.”
Abbott Laboratories’s HIVABtm HIV-1 EIA test manual tells how the ‘specificity’ of the
test was established: “Sensitivity and Specificity: At present there is no
recognized standard for establishing the presence and absence of HIV-1 antibody
in human blood. Therefore sensitivity was computed based on the clinical
diagnosis of AIDS and specificity based on random donors. The ABBOT studies
show that:
Sensitivity based on an assumed 100% prevalence of HIV-1
antibody in AIDS patients is estimated to be 100% (144 patients tested).
Specificity based on an assumed zero prevalence of HIV-1
antibody in random donors is estimated to be 99.9% (4777 random donors
tested).”
The stunning implications of this are highlighted when we recall our pregnancy test
illustration. The test gets tried out on 1000 women chosen because they are
plump around the middle. They are presumed pregnant because they are tubby.
Nobody thinks to establish by means of a scan whether they are actually
pregnant. Then the test is tried out on 1000 slender women. They are presumed
not to be pregnant because they have flat tummies. Nobody ascertains whether
any are in their first terms of pregnancy. The test reacts for all the
big-bellied women, and on this basis is declared 100% sensitive for pregnancy.
It reacts for only two of the slim women and so gets declared 99.8% specific.
Were such junk to be marketed for pregnancy testing, think how women’s groups
would freak out. Can you just imagine?
Suppose that after well over
a decade of use of this test it just coincidentally entered the heads of two
independent teams of researchers on separate continents each to do a scan on
one of these plump women who light up the test, and to publish their
photographs in their leading trade rag. Imagine if the photograph showed
nothing that looked like a foetus, in size and shape, bearing in mind how
foetuses look through these scanning devices. The analogy is not as wild as one
might think. Australian medical physicist Eleni Papadopulos-Eleopulos and her
colleagues at the Royal Perth Hospital tells what happened when two separate
teams of researchers went looking for HIV in the preparations of what they
thought would be masses of concentrated, purified retroviral particles (Virology, March 1997)(*). And the
astonishing concession made in the same year by the ‘discoverer of HIV’, Dr Luc
Montagnier of the Pasteur Institute, concerning why he never published any
electron photomicrograph of purified virus when making his claim to having
isolated HIV (then called LAV) in 1983(#). Papadopulos-Eleopulos’s collated
papers – all published in fine journals – are archived on the www.virusmyth.com/aids/perthgroup/
website.
When we leave our pregnancy
test analogy and return to ‘HIV antibody tests’, the tale curdles even more.
What if ‘AIDS defining illnesses’ in the absence of ‘HIV infection’ frequently
cause the ‘HIV antibody test’ to react as well? Like the state of being plump
setting off a pregnancy test. Such as the state of being thin lighting up an
HIV antibody test. It does, actually – simple malnutrition is a reported cause
of ‘false-positives’. As is tuberculosis. About seventy other conditions too,
amply documented in the medical literature from ‘flu through to malaria. That’s
the problem: ‘HIV antibody tests’ have never been validated against confirmed
infection, and what’s more, just about anything can set them off. It’s
something the ‘AIDS experts’ never get into. The manual for the test kit used
on me rightly concedes, “False positive test results can be expected with a
test of this nature” - contradicting the ‘Informed Consent’ form on the meaning
of a reactive result: “What does it mean
if the test is positive?”: “this means that you have been infected with the
AIDS virus.”
Dr Desmond Martin wrote an
article on the subject of ‘HIV diagnosis’ for the January 2000 issue of the South African Medical Journal. Reading
it, you’d think you were in good hands going for an ‘HIV test’. That these guys
know what they are doing. That their expert pronouncements on the state of your
health can be confidently relied on. That they are cleverer than mediaeval
doctors who wrote up an elaborate body of arcane learning on the exquisite
variety of diagnostic meanings that could be pegged, for a fee, upon the
qualities of your urine - its taste, colour, scent, density, viscosity and so
on.
King was unable to answer or ducked the rest of my questions (in fact I had
researched and knew the answers already) and referred me to the National
Institute for Virology, university virology departments, and to an outfit
called TOGA Laboratories, where Dr Desmond Martin currently makes his living. As
far as the first two went, I’m afraid it was a case of ‘been there, done that’.
Without any luck. None at all. The quality of my exchanges with ‘the experts’
at these places would bring tears to your eyes. University of Durban Virology
Professor Alan Smith’s article on ‘HIV testing’ published alongside Dr King’s
in the Natal Witness on 28 June 2000
is a good example of the brown-outs you encounter when ‘AIDS experts’ get asked
simple questions at the root of this business. I didn’t bother Dr Martin or Dr
Sim at TOGA Laboratories. Can you blame me? Nor did I go to the Life Offices
Association again. I had approached their Medical Underwriters Committee
before. They didn’t know what I was talking about. It all went right over their
heads. Meant nothing to the Natal Blood Transfusion Service’s chief medical
technologist, Dr Ravi Reddy, either, so I thought it would be pointless asking
him: Why should race rather than class and environmental factors predispose one
to contracting an infectious disease? (Are blacks really hornier than whites?)
How can you determine the seroprevalence (infection rate) in a given community
with an indirect (antibody) test before you have established the specificity of
the test - by comparing how closely its performance (reactive, non-reactive)
matches the incidence of infection (pathogen directly isolated in the patient)?
Because until you do this, you’re just chasing your tail.
Think of an antibody test as detecting the fire fighting
service out on a call. Usually to put out fires. But also to rescue kittens
from trees. Or coax suicide jumpers away from high ledges. Or free drivers
pinned inside their crashed cars. Apart from all this, there is an additional
problem with relying on antibody tests as the sole basis for a diagnosis of
infection: antibodies are often more partial to antigens other than those that
stimulated their production. The assumption is that antibodies are specific,
like faithful spouses. But as we all know, some husbands prefer their
girlfriends to their wives. In short, antibodies are generally poly- not
monoclonal. They are faithless partners. So you can’t just assume that
a reactive antibody test indicates
infection with a particular bug. You have to establish the specificity of the
test first. Properly. Not in the asinine manner in which the HIV antibody test
kit manufacturers have done. Imagine just assuming that a person lying in a
hospital bed is ‘infected with HIV’ and has AIDS, just because he has one of
the age-old diseases arbitrarily pulled under the CDC’s ever expanding
bureaucratic umbrella as an AIDS indicator disease, and because he is an
inner-city queer, black, or junkie – so in a ‘risk group’. Maybe just socially
unpopular, marginalised and poor. Just the kind of person to feed AZT.
Why the blood of the
impoverished black Africans (as opposed to the black middle classes and elites)
makes HIV antibody tests light up like Christmas trees is a matter elucidated
for the scientifically intrepid in papers that can be read on the internet: AIDS
in Africa: distinguishing fact and fiction (World Journal of Microbiology &
Biotechnology (1995) Vol. 11), Is a positive Western blot proof of HIV infection?
(Bio/Technology June 1993, Vol. 11), HIV antibodies: further questions
and a plea for clarification (Current Medical Research and Opinion Vol. 13:
1997), and HIV Antibody Tests and Viral Load - More Unanswered Questions and a
Further Plea for Clarification (Current
Medical Research and Opinion Vol. 14: 1998) all by Papadopulos-Eleopulos
et al and archived at the website
mentioned above. Frankly, after these papers, anybody who tells you that a
positive result to an ‘HIV antibody’ test means that you are infected with a
deadly virus is, to quote John Lauritsen, “either ignorant, lazy or stupid.”
The ‘three or four million
South Africans infected’ figure, which drives the hysteria in this country and
elicits funds galore for AIDS careerists, is based on the extrapolation of
anonymous HIV antibody test results of mostly poor black pregnant women at
antenatal clinics. Unfortunately ‘AIDS experts’ haven’t thought to figure into
their thrilling sums the fact that past pregnancy itself is a documented cause
of ‘false positives’, reported in five separate research papers. And warned
against by Abbott. Or, messing up the sums even more, that HIV infectivity is
eight times lower for men than women according to top ‘AIDS experts’ (Padian
et al 1997) - a curious notion for an
allegedly sexually transmitted disease, but then HIV-AIDS is a curious affair.
Whose mounting anomalies need interminable excuses, like that other rotting
paradigm in its death throes, Ptolemy’s geocentric model of planetary motion,
adjusted ad hoc to answer every
Copernican challenge, until it all became just too ridiculous, and the whole
thing finally collapsed, vehemently defended by the experts to the end.
If you are beginning to
suspect that ‘HIV antibody’ testing is nothing more than a vicious form of high
tech mumbo jumbo, bone throwing, divination, and death spell casting, with
modern witchdoctors keeping suckers like us terrified and in their power - and
their pockets full - I should emphasise that this little essay only scratches
the surface. In her papers to which I have referred above, Eleni
Papadopulos-Eleopulos and her colleagues take ‘HIV antibody testing’
comprehensively to task. And blow it to smithereens.
This much is certain: HIV
antibody test results are no more significant an indication of health or
disease than a phrenologist’s skull-chart. They’re worth a bowl of cold spit.
But while they shatter countless lives they sure rake in the cash. And the Life
Offices Association’s ‘Informed Consent’ form for HIV tests creates litigation
possibilities for psychic trauma claims enough to keep lawyers in business for
years.
(*) www.deltav.apana.org.au/~vturner/aids
(#) http://www.virusmyth.com/aids/data/dtinterviewlm.htm
CONTENTS
DEBATING AZT
VIRUSMYTH HOMEPAGE