The Business, 16/17 May 2004
[
HIV Diagnosis: A Ludicrous Case Of Circular
Reasoning
The Concluding Part Of
Our Investigation Into A Global Healthcare Scandal
Is The Way We Test For HIV More Harmful Than The
Disease Itself?
By Neville Hodgkinson
FROM the start
HIV tests had severe limitations. But these were disregarded, and their
widespread use rapidly led to the idea that hundreds of thousands of Americans
and millions of Africans are infected. Now a group of scientists based in
As long ago as
1986, Dr Thomas Zuck, a scientist with the
Other experts admit there were early problems with HIV tests, but say
these were soon overcome. Not true, according to evidence cited in the 1994
edition of Aids Testing, a 400-page textbook edited by
two US Centres for Disease Control experts. In a review of the various test
methods used, they emphasise the need not to tell people they are HIV-positive
or take medical decisions about them based on Elisa alone. "Testing by the
sensitive EIA [Elisa] is done to identify those persons who need additional,
more specific supplemental testing,” they say.
“Counselling and medical decisions are made based on the results of the
supplemental assay, not on those of the screening test alone."
Dr Jay Epstein, another FDA scientist, says in
another chapter that western blot, a method used to check first results,
remains by far the most widely used "confirmatory" procedure; but
with this "the greatest concern has been the high prevalence of
non-specific banding patterns, resulting in indeterminate test results”. Unfortunately, he says, this phenomenon is
intrinsic to the technology.
The FDA has relaxed its criteria for a positive
result on the western blot to get over the embarrassing fact that with the
first kit licensed for confirmatory testing, which required a positive result
on three different bands, fewer than half of AIDS patients tested HIV-positive. Other authors comment that production of the
western blot strips is not a precise process.
There had been extensive debate over how the tests should be
interpreted. "Differences in
protein concentrations, identities and positions are observed between manufacturers
and even between lots from the same manufacturer."
Depending on the choice of proteins used as
antigens, the tests give widely differing results in different patient
groups. Elisa tests using genetically
engineered or synthetic proteins bring the same problems.
If you cannot be told you are HIV-infected on the
basis of the Elisa and there are such big problems with the western blot (in
the
In the early AIDS years, scientists often equated
and described as “virus isolation” the detection in cultured cells of reverse
transcriptase, an enzyme that enables a retrovirus to become integrated with
the DNA of its host cell. It is now
known that this enzyme has a much wider role in cell function and does not
specify the presence of any retroviruses, let alone a specific one.
Similarly, detection of a protein of a particular
molecular weight, believed but never proved to belong
to HIV, also turned out to be of little diagnostic value. Both techniques “may be insensitive and/or
non-specific”, according to guidance issued by
Today, a technique called the polymerase chain
reaction (PCR), used to detect genetic sequences attributed to HIV by
amplifying them millions of times over, is employed extensively in monitoring
so-called “HIV disease”. Like the
antibody tests, the method probably has value in indicating certain types of
immune system activation or disturbance; but the segments of genetic material
detected have not been shown to belong to a specific virus, HIV or any
other.
Dramatically different results are obtained
depending on the genetic "primers" chosen to start the reaction off,
the probes used to analyse the results, the concentration of the various
reagents used and the temperature and time over which the reaction is run. Such factors explain why results quoted in
papers cited by US government scientists as having “confirmed the validity of
the antibody tests” are not reproducible in other laboratories.
A meta-analysis by researchers from several
institutions in the
So, contrary to the impression most have lived with
for years, the HIV test has never been proved to specify the presence of
HIV. “The general belief that almost all
individuals, healthy or otherwise, who are HIV-antibody-positive are infected
with a lethal retrovirus, has not been scientifically substantiated,” the
THERE is a strong association between testing
HIV-positive and the risk of developing AIDS.
Evidence to this effect was and is the main reason why scientists
believe HIV is the cause of AIDS. But
the link is a consequence of the way the test kits were constructed, calibrated
and clinically tested.
As described above, it never proved possible to
validate HIV tests by culturing, purifying and analysing particles of the
purported virus from patients who test positive, then demonstrating that these
particles are not present in patients who test negative. This was despite heroic efforts to make the
virus reveal itself in patients with AIDS or at risk of AIDS, in which their
immune cells were stimulated in laboratory cultures with a variety of agents,
sometimes over many weeks.
After the cells had been activated in this way, HIV
pioneers selected some of the 30 or so proteins found in the filtered material
that gathered at the density characteristic for retroviruses, and attributed
some of these to various parts of the virus.
But they never presented evidence that these so-called “HIV antigens”
were constituents of a retrovirus particle of any kind, let alone a unique new
retrovirus.
So, how did they define the proteins as being from
HIV?
Amazingly, on the basis of selecting proteins most
reactive with antibodies in blood samples from AIDS patients and those at risk
of AIDS. This means that HIV antigens
are being defined as such on the basis that they react with antibodies in AIDS
patients, and AIDS patients are then diagnosed as being infected with HIV on
the basis that they have antibodies reactive with those same antigens. The reasoning is entirely circular – which is
probably why Zuck was so emphatic that none of the “HIV tests” was suitable for
confirming HIV infection.
It gets worse.
When Elisa test kits were developed, the priority was to protect blood
supplies. For this, two limits were
established. As a measure of the
sensitivity of the kits in detecting unsafe blood, it was postulated that 100%
of blood samples from patients with AIDS would be reactive and therefore test
positive. So, if the actual proportion
of samples from AIDS patients that prove reactive in clinical trials is 98%, that defines the sensitivity of that kit.
Second, as a measure of how specific the kits are
in detecting unsafe blood – that is, in not causing healthy blood to test
positive – it was postulated that 0% of healthy blood donors would be
repeatedly reactive. Thus, if 2% of
samples from healthy blood donors were found reactive during clinical trials,
the specificity would be defined as 98%.
On the basis of such trials, the World Health
Organisation and other agencies say that current HIV antibody tests have
sensitivity and specificity in excess of 98% and are therefore extremely
reliable. In reality, these measures
tell us nothing about whether or not a person is infected with HIV.
The tests discriminate between healthy blood on the
one hand and the blood of patients with AIDS or AIDS-like conditions on the
other. That is why they are useful as a
screen for the safety of blood supplies.
Since AIDS patients suffer a range of active infections and other blood
abnormalities, some of which will be transmissible through blood, the tests
definitely help to safeguard blood quality.
Gay men leading “fast-track” sex lives, drug
addicts, blood product recipients and others whose immune systems are exposed
to multiple challenges and who are at risk of AIDS are much more likely to have
raised levels of the antibodies looked for by the tests than healthy Americans
– because the antigens in the tests were chosen on the basis that they were
reactive with antibodies in AIDS patients.
But this association does not prove the presence or otherwise of a lethal
new virus.
In the absence of a specific test for HIV, the
tests had to be calibrated so as to try to find a balance between detecting
suspect blood samples and not causing healthy blood to be discarded. The safety of supplies was given priority, so
the cut-off value for defining blood as reactive was set appropriately
low. This ensures that the tests detect
most samples of blood from people with AIDS.
But a low cut-off value also means that in
screening surveys covering large numbers of people, many healthy individuals
test positive. In early surveys covering
8m blood donors in the
When the tests are used for the purpose for which
they were originally designed – as a screen for blood safety – these flaws are
not too big a price to pay. Repeated
testing reduces the number of suspect samples and therefore the waste of
healthy blood. But the flaws are deadly
when it comes to screening for or diagnosing HIV/AIDS.
In wealthy countries that can afford repeated
testing using a variety of approaches, and where the risks in a patient’s life
are also taken into account in interpreting test results, the numbers of people
falsely given to understand that they are infected with a lethal virus will be
much lower than in poor countries where only a single positive result can be a
sentence of death.
In the
Even so, in the light of the evidence and reasoning
described above, to tell even one person that they are HIV-infected on the
grounds that they have antibodies that react with the proteins in these
unvalidated tests is an unwarranted assault.
Manufacturers may be aware of this and some include cautious statements
in their packet inserts, such as: “At present there is no recognized standard
for establishing the presence or absence of antibodies to HIV in human
blood.”
In countries where a single test is commonly all
that can be afforded, screening surveys have given rise to the idea that
millions are HIV-infected. The tests
have caused countless individuals to be falsely diagnosed and nations to be
deceived into believing that HIV/AIDS is set to decimate their population.
Dr Etienne de Harven, former professor of
pathology, University of Toronto, who worked on retroviruses for many years at
the Sloan Kettering Institute, New York, told a recent conference on AIDS at
the European Parliament in
He added that over the past 20 years, the medical
literature “has been inundated with innumerable papers attempting to dodge the
lack of electron microscope evidence for the presence of retroviral particles
in samples directly collected from AIDS patients.”
Ann James, a Houston, Texas lawyer, writes in AIDS
Testing: "No other disease, except perhaps leprosy from the beginning of
the millennium to the 1800s, has brought so much societal pressure on its
victims and caused such cataclysmic social consequences over such a long
period."
Remarkably, this cataclysm may have been caused not
so much by AIDS itself as by the concept of an epidemic of HIV disease, a
concept that arose because in the atmosphere of emergency surrounding the idea
that a deadly virus was spreading surreptitiously among sexually-active people,
public health experts considered it “simply not practical” to stop the HIV test
from being used for a purpose for which it was unsuited.
As Eleni Papadopulos-Eleopulos, who heads the