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From Alive & Well Emailer, November 21, 2002
New Tests, Same Old Problems
By Christine Maggiore
“Contrary to the statement that the new test can tell
people ‘whether they are infected,’ the FDA has not
approved the quick test (or any other HIV test) for actually diagnosing
HIV infection…”
===
FDA Approves While-You-Wait Rapid HIV Test:
Old Problems, Questionable Results Now Come Quicker
Earlier this month, the US Food And Drug Administration granted
approval for the widespread use of a new HIV test that gives results
in as little as 20 minutes. According to a November 8 New York Times
story, "experts hope the rapid tests will prompt thousands
more Americans to get tested."
Citing its "99.6 percent accuracy rate," the unnamed experts
characterize the test as "highly reliable [in telling people]
whether they are infected."
Apparently, these experts are not aware that the claim of 99.6%
accuracy is not based on any real data. Test accuracy can only be
determined through confirming the presence of actual HIV in people
with positive results, a necessary scientific step that has never
been taken in developing the newly approved rapid test or any other
HIV test in current use.
Contrary to the statement that the new test can tell people "whether
they are infected," the FDA has not approved the quick test
(or any other HIV test) for actually diagnosing HIV infection. HIV
tests have FDA approval only for prognostic use (for predicting
or foretelling a future outcome), as “an aid to a clinical
diagnosis (to assist in developing a diagnosis);” or as “highly
sensitive” screening tests known to err on the side of caution
by giving false positive results for a variety of non-HIV antibody
reactions. Only a test approved specifically for the purpose of
diagnosing HIV infection can be used to say someone has HIV or is
HIV infected. No HIV test has ever been approved for this express
purpose.
Citing more unnamed experts, the NY Times reports, "the [new]
test is important for several reasons. It may help reduce mother-to-infant
transmission of HIV by enabling doctors to test pregnant women while
they are in labor." But there’s no mention of the fact
that pregnancy is one of 60 conditions that can cause false positive
results on HIV tests. Or that expectant mothers who test positive—even
those in perfect health and with no known risk factors or possibility
of exposure—are routinely coerced into taking toxic AIDS drugs
during labor, ordered to have a C section delivery, and barred from
breastfeeding their babies.
The new test is praised for its ability to "offer health care
workers exposed to HIV-tainted blood a quick way to determine if
they need antiviral drugs that could prevent them from getting infected"
then notes "there is, however, one hitch: people infected with
HIV do not develop antibodies to the virus until three months after
exposure." In other words, the quick test should be administered
90 not-so-quick days following a suspected exposure!
The idea that AIDS drugs prevent post-exposure HIV infection in
healthcare workers is not based on any properly controlled study.
No research has ever compared test results among recently exposed
healthcare workers that take AIDS drugs and those that decline treatment.
Last January 4, the US Centers for Disease Control announced that
"most occupational exposures to HIV do not result in transmission…in
this setting, the risk of HIV transmission is very low." In
fact, during the past 20 years, the CDC has reported a total of
25 cases of AIDS in healthcare professionals that blame work related
exposure to HIV for their diagnosis.
And how do healthcare workers that "need antiviral drugs"
use them to prevent infection if they determine this need by testing
positive? According to the article, positive results mean they’re
already infected, right?
Maybe not, as it seems there are more hitches involving the previous
accuracy claim: "The FDA recommends that people who test negative
repeat the test if they believe they have been exposed to the virus.
The agency also recommends that in the case of a positive test,
a more traditional test be conducted to confirm the results."
So, negative results don’t count as negative for people that
believe they were exposed, while positive results don’t count
as positive for anyone.
The Times winds up this piece with a curious remark by Health and
Human Services director Tommy Thompson who says "an estimated
900,000 Americans are infected with the human immunodeficiency virus,
but as many as a quarter of them do not know it." Apart from
the fact this 900,000 figure has been touted since 1995 as evidence
of a growing epidemic, how does Tommy Thompson know that 25% of
these 900,000 Americans are positive but don’t know it, when
the people who are presumably positive don’t even know it
themselves?
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