Anita L Allen,
David Allen & Associates, PO Box 65311, Benmore 2010, South Africa
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It was not my intention in my response on which HIV tests carry approval to diagnose "HIV infection" to enter into a polemic with Nicholas Bennett. I am only interested in determining who takes legal responsibility for using these tests to determine "HIV infection". If Bennett could work with me to address that, it would serve a useful purpose.
I re-state: if one accepts FDA approved tests, which is the standard used by the World Health Organisation, and followed by the South African Government, then no so-called HIV tests are approved to diagnose "HIV infection". This is a fact.
It is also a fact that in South Africa if one's CD4 count falls below 200 then "AIDS" is diagnosed. Antiretroviral treatment is commenced, and since these drugs are HIV specific, then HIV is inferred without any testing being done. This follows WHO recommendations for the diagnosing of AIDS. It is a fact that none of the tests used to determine CD4 counts, or viral loads, are approved by the FDA to diagnose "HIV infection". They are only approved for research purposes.
It doesn't matter which test instructions one uses, there are always qualifications and disclaimers regarding their use to diagnose "HIV infection". It is interesting to note that Bennett did not give references in his various quotes from manufacturer instructions.
The one I previously quoted, which I chose because it is widely in use in South Africa, is Abbott Laboratories Human Immunodeficiency Virus Types 1 and 2: (E.coli, B Megaterium, Recombinant Antigen) HIVAB™ HIV-1/2 (rDNA) EIA 68-0158/R12, dated December 1996.
The instructions start with:
Name and Intended Use:
HIVAB™ HIV-1/2 (rDNA) EIA is an in vitro enzyme Immunoassay for the qualitative detection of antibodies to human immunodeficiency viruses type 1 and/or type 2 (HIV-1/HIV-2) in human serum or plasma.
Summary And Explanation of Test:
Epidemiologic data suggest that the Acquired Immune Deficiency Syndrome (AIDS) is caused by at least two types of human immunodeficiency virus collectively designated HIV. Human Immunodeficiency virus type 1 (HIV-1), the first discovered AIDS virus, has been isolated from patients with AIDS and AIDS-related complex (ARC), and from healthy persons at high risk for AIDS. (1,2,3) HIV-1 is transmitted by sexual contact, by exposure to blood or certain blood products, or from an infected mother to her fetus or child (4) The prevalence of HIV-1 antibodies in AIDS and ARC patients and persons at risk is high (5) and the virus can be isolated from nearly 90% of all seropositive individuals (6)
1. Barre-Sinoussi, F, et al Isolation of T-Lymphotropic retrovirus from a patient at risk for Acquired Immune Deficiency Syndrome (AIDS) Science, 220;868-871, 1983
2. Popovic M et al Detection, isolation and continuous production of cytopathic retrovirus (HTLV-111) from patients with AIDs and pre-AIDS. Science 224. 497-500 1984
3. Gallo RC et al Frequent detection and isolation of cytopathic retroviruses (HTLV-111) in the serum of patients with AIDS and at risk for AIDS Science 224;500-503 1984
4. Piot, P et al AIDS: An international Perspective Science 239:573- 579 1988
5. Samgadharan MG et al Antibodies reactive with human T-Lymphotropic retroviruses (HTLV-111) in the serum of patients with AIDS Science 224:506 -506 1984
6. Gallo D et al Comparative studies on use of fresh and frozen peripheral blood lymphocyte specimens for isolation of human immunodeficiency virus and effects of cell lysis on isolation efficiency J. Clin. Microbiology25:1291-1294, 1987.
The first three references here have been extensively analysed in these rapid responses. Had any of them established the isolation of HIV, and therefore its distinct genome, both structural genes and regulatory, then tests would not be based on screening for antibodies and there would be no need to qualify and disclaim the use of tests which were patented based on these studies. I repeat: all biomarkers listed in genebanks as "HIV" are just that: biomarkers used as surrogates for the real thing. It is a fact that none of the tests are FDA approved to diagnose "HIV infection".
Regarding reference 4 above: It is interesting to note that this is used to "prove" sexual and parental transmission. I hope Bennett will agree without further equivocation that this is hardly "evidence", let alone convincing. Yet one assumes this is the "best evidence" the manufacturer could name.
Regarding reference 5: An antibody reaction is not proof of isolation. It is also worth noting that FDA approvals are granted separately for HTLV-111 and HIV-1/2 tests. Why is this necessary when manufacturer instructions conflagrate the two groups?
Regarding reference 6: A 90% prevalence, begs the question why only 90%? If the virus can only be "isolated" from 90% of seropositives this is all the evidence that is needed to prove the point that antibody reactions cannot be construed as "HIV infection".
On a personal note, I am convinced that the stage has long since been reached where parties on all sides of the AIDS debate should have combined to settle the outstanding issues on HIV/AIDS. It is not a case of one side being right and the other wrong - there are just too many conflicting opinions from promoters of HIV causes AIDS and those questioning, and there are just too many outstanding questions which neither "side" appears able to settle.
One of these questions is: which test carries FDA approval to diagnose 'HIV infection"? Please could Bennett and other respondents just address this question
Competing interests: None declared