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From Alive & Well Emailer, November 13, 2003
Hidden Facts of HIV Tests: What’s in the Fine Print
By Christine Maggiore
“We've now gone from ‘HIV is thought to cause
AIDS,’ to something even more uncertain with the newly approved
HIV test: ‘Published data indicate A STRONG CORRELATION between
the acquired immunodeficiency syndrome (AIDS) and a retrovirus REFERRED
TO as HIV."
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Our August A & W emailer presented some remarkable information
about HIV tests including the fact that no HIV test has ever been
approved by the US Food and Drug Administration for the actual diagnosing
of HIV infection.
Few doctors, clinics, journalists, or AIDS organizations realize
that all current HIV tests are approved only as screening tests,
prognostic tests (for predicting a possible future outcome) or as
"an aid in diagnosis" and are not intended to be used
for determining if a person actually has HIV.
The FDA's lack of such approval speaks to the fact that no HIV test
can directly detect or quantify HIV or determine the presence of
specific HIV antibodies in human blood.
Recent changes in the fine print of the test kits acknowledge this
little known data and seem to indicate a change of thought with
regard to the role of HIV in AIDS. From 1984 until last year, test
literature contained the very certain statement that "AIDS
is CAUSED by HIV." Then in November of 2002, a new test kit
started what now seems to be a trend toward rethinking the causal
link between HIV and AIDS. It states, "AIDS, AIDS related complex
and pre-AIDS are THOUGHT TO BE CAUSED by HIV." (OraQuick Rapid
HIV-1 Antibody Test, OraSure Technologies, Inc)
Now it appears we've gone from "HIV is thought to cause AIDS,"
to something even more uncertain: "Published data indicate
A STRONG CORRELATION between the acquired immunodeficiency syndrome
(AIDS) and a retrovirus REFERRED TO as Human Immunodeficiency Virus
(HIV)."
This last quote is found in the package insert for a new ELISA test
(Vironostika HIV-1 Plus O Microelisa System) the FDA approved in
June 2003. The entire package insert can be downloaded from
http://www.fda.gov/cber/pma/P020066.htm
According to Alive & Well advisor Dr Rodney Richards, a chemist
and co-creator of the very first HIV test, as of June 2003, the
number of FDA approved tests that contain the term HIV or LAV (the
old school term for the so-called virus) have risen to 36. Of these,
13 have been approved in just the last three years.
Richards points out that "despite the increased number of HIV
tests, there is still no manufacturer that claims their test can
be used to diagnose infection with HIV. All of the RNA based tests
for viral load and genotyping clearly state they are 'NOT intended
for use in diagnosing HIV infection.' Instead of an indication for
use in detecting or quantifying the actual virus, these tests are
approved only for prognosis or monitoring therapy for people who
doctors assume are infected.”
Richards is working on a document to clarify what HIV test manufacturers
mean by the terms "prognosis," "monitoring of therapy,"
and "aid in the diagnosis of HIV." His report will focus
on what the tests cannot do (diagnose HIV infection) and what exactly
they can.
At first glance, the rapid tests may appear relatively benign since
the manufacturers clearly emphasize that "preliminary positives"
must be confirmed with follow up testing. This emphasis is due to
the fact that the accuracy of the rapid tests’ is widely known
to be more questionable than the already dubious HIV ELISA or Western
Blot. But the notion that medical personnel will await confirmation
of results before insisting patients take action is entirely misguided
since the true market for rapid tests is pregnant women in labor.
Incredibly, the recommendation to misuse rapid tests for women in
labor comes directly from the Deputy Commissioner of the FDA himself,
Dr. Lester M Crawford. The good doctor says "OraQuick will
be a great help in identifying pregnant HIV-infected women going
into labor who were not tested during pregnancy so that precautionary
steps can be taken to block their newborns from being infected with
HIV." (FDA News, November 7, 2002)
These precautionary steps include IV infusion of the toxic chemotherapy
AZT during labor, C-section delivery, six weeks of mandatory AZT
treatment for the baby regardless of their own HIV status, and orders
to the mother not to breastfeed. Even though chemotherapy, surgery
and denial of normal feeding are based on preliminary results from
a test never approved for detecting HIV infection, a mother who
declines such intervention risks losing custody of her child.
Perhaps more remarkable than official calls for misuse of rapid
tests is a disclosure by the manufacturer of the OraQuick that 7%
of women with a history of prior pregnancy will score falsely positive
on their test. Further, the manufacturer of the newly approved Reveal
test didn't even evaluate their product in multiparous women.
Worse still, as Dr Richards points out, the rapid tests may soon
be routinely administered to women tested negative before labor.
"Based on the erroneous belief these tests can actually diagnose
HIV infection, doctors may want to retest women in labor who’ve
previously come up negative just to be sure they haven'tseroconverted
in the mean time."
Another lucrative market for the rapid tests is among healthcare
workers who experience accidental needle sticks or other unintentional
contact with patient fluids. As Richard points out, this opens a
Pandora’s box of potential life-altering situations.
"Imagine a nurse sticks herself with a used needle. Ora-Sure
gives her the impression she can find out quickly if that needle
is contaminated with HIV. Should the needle score positive, she
would then be urged to start prophylactic chemotherapy right away.
Of course, if the needle scores positive, hospitals would most likely
feel an ethical responsibility to inform the patient and to urge
them to also start 'saving their lives' with AIDS meds. Since there
are 600,000 to 1,000,000 accidental needles sticks in the US annually,
this is a huge market for both the test and treatment manufacturers."
The great influence of drug and test manufacturers on public health
policy, media presentations and among AIDS activist groups may mean
that the hidden dangers of rapid tests will remain unknown.
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