Re: Re: Re: Re: Re: The predictions based upon the 'HIV/AIDS' hypothesis have been fulfilled 31 January 2005
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Anita L Allen,
David Allen & Associates, PO Box 65311, Benmore 2010, South Africa

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Re: Re: Re: Re: Re: Re: The predictions based upon the 'HIV/AIDS' hypothesis have been fulfilled

Some of your respondents seem to be confused about which HIV tests are approved or not approved. If one accepts the Food and Drug Administration as a credible licensing authority then all the HIV1/2 screening assays carry FDA approval to screen for biomarkers listed in genebanks as "HIV antibodies". They do not carry FDA approval to diagnose "HIV infection".

Patent holders of these tests pay something in the region of $1 million for FDA approval precisely because it protects them from litigation due to any use outside approved applications. Most manufacturers of FDA approved HIV antibody screening assays carry disclaimers on their test kit instructions warning against their use to diagnose HIV infection. For example, the Abbott Laboratories, HIVAB™ HIV- 1/2 Enzyme Immunoassay states "At present, there is no recognised standard for establishing the presence or absence of antibodies to HIV-1 or HIV-2 in human blood".

The same test kit instruction has an amazingly vague way of describing the link between HIV and AIDS. It states: "Epidemiologic data SUGGEST that the Acquired Immune Deficiency Syndrome (AIDS) is caused by at least two types of human immunodeficiency virus collectively designated HIV". (My emphasis). The references they give for this statement are the Popovic et al and Gallo et al papers Science 1984 and Barre-Sinoussi et al paper Science 1983. How can epidemiologic studies be considered as scientific evidence?

No PCR-based HIV tests carry FDA approval to diagnose HIV infection. As far as I know they are approved only for research purposes not diagnostics. For example the Roche Amplicor Monitor ® version 1.5 states: "The AMPLICOR HIV-1 Monitor Test, version 11.5, is not intended to be used as a screening test for blood or blood products for HIV or as a diagnostic test to confirm the presence of HIV infection".

Yet these so-called viral load tests are used to determine a patient's CD4 cell count. If it falls below 200 then a diagnosis of "AIDS" is made and antiretrovirals are commenced which are HIV specific, in which case HIV infection is inferred without having to do any HIV testing.

The question we should be answering is who bears legal responsibility for the non-approved application of these tests?

Competing interests: None declared