Minutus

In this three part emailer from Alive & Well:

Part one: Neville Hodgkinson reports for the UK news journal The Business on
the flaws of HIV tests and on two law suits filed against manufacturers.

Part two: Details on the law suit against HIV test makers brought by Alive &
Well list member Kim Bannon of Wichita, Kansas (Go Kim!)

Part three: California attorney seeks drug injured HIV positives for
potential legal action against AIDS drug manufacturers; news on a
discussion/action group for HIV positive diagnosed persons interested in
exploring legal recourse.

===

Reprinted from The Business, May 9/10, 2004

Why an HIV Test May Not Provide Proof Positive
The critical flaws in the methods we use to detect the killer virus

By Neville Hodgkinson

Legal challenges to the validity of the HIV test, whose introduction 20
years ago led to the belief that millions of people are infected with a
virus that will eventually cause them to die of Aids, are being mounted in
the United States and France. In both cases, plaintiffs are citing the work
of a group of scientists based in Perth, Western Australia, which has
published evidence that contrary to widespread medical belief, none of the
HIV test kits is capable of showing a person to be infected.

In Kansas, Calypte Biomedical Corporation (CBC) and Roche Diagnostics, two
test kit manufacturers, are being sued for damages under that state9s
Consumer Protection Act. In court papers filed on April 12, Kim Bannon says
that 12 years ago, during routine medical testing, she was diagnosed
3indisputably2 HIV-infected at Kansas University School of Medicine. She was
told that she would develop Aids within five to seven years and die soon
afterwards.

Subsequent testing from 1996 to 2003 repeatedly reconfirmed the diagnosis.
Today, she remains healthy and free of any symptoms of Aids.

Bannon says that two years ago, she discovered that the science, methodology
and assumptions relied on by CBC and Roche as the basis for their tests are
flawed. She is claiming civil penalties for misrepresentation and damages
for the resulting 3mental anguish, pain and suffering, shame and
humiliation2 as well as loss of earnings. She has sold her house to finance
the law suit; with the support of her counsel, Dennis Webb, a Wichita,
Kansas attorney, she is inviting others with an 3HIV2 diagnosis to join her,
possibly in a type of class action.

In Paris, Philippe Autrive, a lawyer specialising in health and human
rights, has taken up the case of Mark Griffiths, an Englishman living in
France who was diagnosed HIV-positive in May 1986 while undergoing treatment
for heroin addiction. He still tests HIV-positive but remains well. His
complaint, against the Institut Pasteur and others, is for 3administering
dangerous substances, endangering life, falsification and using falsified
material.2

Bannon and Griffiths both say their diagnosis led them to a journey of
discovery in which they became outraged by misunderstandings over the tests
for HIV and the failure of commercial and other interests to put them right.
Griffiths, who has researched the issue for 16 years, said he hopes his case
will lift the 3fear, stigmatisation and ignorance2 surrounding a positive
test result. Bannon says she spent 10 years 3doubting yet living with the
stigma of conventional AIDS dogma2 before stumbling on an article by the
Perth scientists.

3I realize that my life might be more peaceful if I just kept my HIV status
under wraps and went on with the knowledge that I9m not going to die from
AIDS,2 she says. 3But my soul would not be at peace knowing that so many
suffer from the orthodox viewpoint.2

In a series of papers published over more than a decade but ignored to date
by most mainstream AIDS experts, the Perth group has challenged the belief
that the HIV test has ever been shown to relate to a specific virus. They
say it is a non-specific test that detects raised levels of a variety of
protein antibodies commonly found in the blood of AIDS patients, but caused
by a variety of conditions.

They cite evidence that in Africa and elsewhere, the main causes both of
testing positive, and of the immune system deficiencies currently being
interpreted as AIDS. are poverty-linked diseases such as TB, malaria and
other common infections. In the West the causes include the effects of
drugs, infections such as hepatitis viruses picked up through needle-sharing
and exposure to other people9s body fluids through promiscuous anal sex or
repeated transfusions of blood products.

The group argues that genetic as well as biochemical signals interpreted as
meaning the presence of 3HIV2 are a consequence rather than cause of immune
system abnormality. Once this is understood, it says, the grounds for
believing that Africans and other impoverished people are in the grip of a
devastating new viral epidemic will fall away and help can be directed to
fighting the real causes of immune deficiency.

HIV test kits were developed and marketed by US National Cancer Institute
scientists at the same time as the HIV paradigm itself; the first kits were
licensed in March 1985. France and the UK quickly followed. The kits were
introduced as a means of protecting blood supplies, but their use in
screening surveys gave rise to the idea that hundreds of thousands of
Americans, and millions of Africans and others, were already infected.

The tests do not look directly for an AIDS virus but for HIV antibodies -
proteins thought to be produced by the immune system in response to the
presence of the virus. They do this by bringing a sample of blood serum
(the fluid that separates from blood after it clots) from the person being
tested into contact with proteins (antigens) that are believed to be virus
components. This should then trigger an antibody-antigen reaction in people
who are HIV-infected; but not in those who are uninfected.

It could be a valid approach for establishing HIV infection if the proteins
looked for by the test really do specify HIV9s presence; but this has never
been shown to be the case. None of the proteins used in the tests has been
shown to be specific for HIV and therefore to mean that a person is
HIV-infected. They have been presumed but never demonstrated to come from
HIV particles. Furthermore, all of the proteins used in the tests have been
shown by the Perth group to have other potential sources, including normal
cell constituents released when immune cells become over-stimulated and
disordered.

Central to the Perth scientists9 re-examination of the foundations of the
virus theory is their finding that, despite early claims to the contrary, it
never proved possible to obtain pure particles of the purported virus,
separate from everything else, with which to validate the tests.

Several steps are essential for identifying retroviruses, the type of virus
HIV was supposed to be. The most fundamental is to purify the virus through
the use of a filter (a high-speed centrifuge that separates materials of
different densities), thus isolating the virus material from other cell
constituents. Retroviral particles gather at a specific density. The
purified particles can then be visualized and photographed with an electron
microscope and their constituents analysed. A final step is to show that
they replicate in other cells.

With HIV, none of those crucial steps has proved possible. Neither France9s
Luc Montagnier nor America9s Robert Gallo, the two scientists who after a
long dispute shared the credit for discovering HIV, was able to publish a
photograph of purified virus. Nor has anyone else since. The photographs
that have been published in numerous newspaper and magazine articles,
labelled as showing HIV, are not from purified material. They are from
cultures containing a variety of particles emerging from supposedly
HIV-infected cells; but these particles are of unspecified character and
similar particles appear in cultures of non-infected cells as well. When
the next step is taken -- trying to filter particles to identify them and
characterise them -- experts have never been able to obtain pure HIV.

Yet purification is essential to know which proteins as well as which
stretches of genetic material (DNA and RNA) belong to a presumed virus. If
the culture materials on which a test is to be based are not pure, test kits
made from such materials will be liable to contain proteins of undetermined
origin.

According to the Perth group, and growing numbers of scientists who support
their position, that is exactly what happened with HIV. But because of
political pressures, and a general sense of panic about AIDS, regulators
allowed the tests to come into use in ways that they knew were
inappropriate. It was felt that the public health benefits outweighed the
disadvantages.

The quandary was expressed clearly by Dr Thomas Zuck, from the US Food and
Drug Administration9s office of biologics research and review, at a World
Health Organisation (WHO) meeting in Geneva in 1986. He said the first test
kits, using a technology known as ELISA, were licensed as a screen to
protect blood and plasma donations, not as a screen for AIDS or people at
risk of AIDS; their usage was intended to be limited by phrases to that
effect in the package inserts. But 3enforcing the intent of this language
would be analogous to enforcing the Volstead Act, which prohibited alcoholic
beverage sales in the United States in the 1920s - simply not practical.2

Dictated by public health needs, Zuck said, usage had expanded beyond the
indications for which the tests were designed; broad application was evident
among hospital patients, healthcare personnel and members of groups at high
risk of AIDS.

The 100 experts from 34 countries who attended the meeting heard that,
though the tests were sensitive enough to safeguard blood supplies,
something more was needed to distinguish which people had genuinely been
infected with HIV. Dr James Allen, assistant director for medical science in
the US Centers for Disease Control (CDC) AIDS program, said studies
suggested some people were reacting to components of the cell line used to
grow HIV for many of the test kits licensed in the US. Other reactions
occurred because of antibodies to normal cell proteins, naturally occurring
in the body. Allen warned that the problems could be magnified in areas of
the world that did not have the sophisticated facilities of the United
States.

Several delegates spoke of the need for a definitive, confirmatory test.
They were clear that a commonly used confirmatory method, called Western
Blot, was not up to the job. It reduced false positives: surveys in the US
showed that, of blood donors who tested positive with the most commonly used
ELISA kits, only about 4% were confirmed with western blot. But were any of
those 4% truly infected?

The ELISA kits use a mixture of proteins attributed to HIV. When these react
with antibodies in a patient9s serum, a colour change results. The first
kits of this kind were made from materials filtered from cell cultures
thought to be growing HIV and to be constituents of the virus. It soon
became accepted that these materials were not pure virus. They contained
normal cell proteins which confounded the test results, falsely producing
large numbers of positive results.

The Western Blot kits are more refined. They use individual test proteins,
separated along the length of a strip. These are incubated with the blood to
be tested. If the blood contains antibodies to the test antigens, the
reactions show up as a series of bands.

The problem is that without having pure virus particles to refer back to,
nobody is sure which, if any, of the protein antigens selected for use in
the tests really come from HIV and therefore signal HIV infection.

There has been a lot of argument over which proteins should be used and how
to interpret the reactions. Even Montagnier and Gallo differ on this. The
same uncertainty surrounds later versions of the ELISA test kits, using
manufactured proteins rather than the 3soup2 of materials filtered from cell
cultures. These kits overcome the earlier problem of not knowing which
antigens were in the kits, but that is not much use when you do not know
whether the antigens chosen really belong to HIV.

Dr MV O9Shaughnessy, head of viral surveillance at the Laboratory Centre for
Disease Control, Ottawa, Canada, told the WHO meeting that when the proteins
from an HIV preparation were separated and stained using ultra-sensitive
techniques, 3more than 30 individual proteins can be recognised.2

So, which were viral and which were normal cell components? Several large
Canadian studies had shown extensive and generalized cross-reactivity,
especially in haemophiliacs and in North American native populations.

Dr John Barbara, head of microbiology at the North London Blood Transfusion
Centre in Britain, pointed out that both tests relied on the same principle,
of antigen-antibody reactions. 3It is important to remember that the Western
Blot is itself an antiglobulin assay [a test for antibodies. It is liable,
therefore, to the same kind of false-positive reactions as the screening
test it might be confirming.2 In other words, if there was uncertainty over
whether the first test gave valid results, a second test based on the same
principle could hardly be used to confirm the other.

Zuck, asked if better tests were in the pipeline, commented: 3Don9t hold
your breath. One of the difficulties we have in looking at claims for
confirmatory tests or designing systems to validate what in fact is going to
be Oconfirmatory9 is determining how you define and validate it.2

It was a muddle. At that point, little more than a year into widespread use
of the tests, the delegates were frank with one another about the
difficulties, though their uncertainties did not enter the public arena
except in an expensive specialist textbook. As time went on, and the HIV
paradigm won worldwide acceptance, increasingly complex procedures for
trying to make a reliable diagnosis came into being. But the basic problem
-- not being able to validate any of these procedures against pure virus
preparations taken from patients -- still remains.

Next week in The Business: The deadly flaws in diagnosing HIV

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--
Christine Maggiore, Founder/Director
Alive & Well AIDS Alternatives
http://www.aliveandwell.org
11684 Ventura Boulevard Studio City, CA 91604 USA
Tel 818/780-1875 National Toll-free 877/411-AIDS Fax 818/780-7093
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