I would be interested in hearing list members' views on the cervical cancer vaccine controversy. Is this a pharmaceutical industry plot to make piles of profits, a vital protection for young women, or both? How do progressive science-oriented folks deal with controversies like this?

Just asking.

Michael

On 2/17/07, Mitchel Cohen <[log in to unmask]> wrote:
The Hidden Face of HIV -- Part 1
http://www.gnn.tv/print/1035/The_Hidden_Face_of_HIV_Part_1

"Knowing is Beautiful"

By Liam Scheff
Published: Monday January 3rd, 2005

As a journalist who writes about AIDS, I am endlessly amazed by the
difference between the public and the private face of HIV; between
what the public is told and what's explained in the medical
literature. The public face of HIV is well-known: HIV is a sexually
transmitted virus that particularly preys on gay men, African
Americans, drug users, and just about all of Africa, although we're
all at risk. We're encouraged to be tested, because, as the MTV ads
say, "knowing is beautiful." We also know that AIDS drugs are all
that's stopping the entire African continent from falling into the sea.

The medical literature spells it out differently -- quite
differently. The journals that review HIV tests, drugs and patients,
as well as the instructional material from medical schools, the
Centers for Disease Control (CDC) and HIV test manufacturers will
agree with the public perception in the large print. But when you get
past the titles, they'll tell you, unabashedly, that HIV tests are
not standardized; that they're arbitrarily interpreted; that HIV is
not required for AIDS; and finally, that the term HIV does not
describe a single entity, but instead describes a collection of
non-specific, cross-reactive cellular material.

That's quite a difference.

The popular view of AIDS is held up by concerned people desperate to
help the millions of Africans stricken with AIDS, the same disease
that first afflicted young gay American men in the 1980s. The medical
literature differs on this point. It says that that AIDS in Africa
has always been diagnosed differently than AIDS in the U.S.

In 1985, the World Health Organization called a meeting in Bangui,
the capital of the Central African Republic, to define African AIDS.
The meeting was presided over by CDC official Joseph McCormick. He
wrote about in his book "Level 4 Virus hunters of the CDC," saying,
"If I could get everyone at the WHO meeting in Bangui to agree on a
single, simple definition of what an AIDS case was in Africa, then,
imperfect as the definition might be, we could actually start
counting the cases. . . " The results -- African AIDS would be
defined by physical symptoms: fever, diarrhea, weight loss and
coughing or itching. ("AIDS in Africa: an epidemiological paradigm."
Science, 1986)

In Sub-Saharan African about 60 percent of the population lives and
dies without safe drinking water, adequate food or basic sanitation.
A September, 2003 report in the Ugandan Daily "New Vision" outlined
the situation in Kampala, a city of approximately 1.3 million
inhabitants, which, like most tropical countries, experiences
seasonal flooding. The report describes "heaps of unclaimed garbage"
among the crowded houses in the flood zones and "countless pools of
water [that] provide a breeding ground for mosquitoes and create a
dirty environment that favors cholera."

"[L]atrines are built above water streams. During rains the area
residents usually open a hole to release feces from the latrines. The
rain then washes away the feces to streams, from where the [area
residents] fetch water. However, not many people have access to
toilet facilities. Some defecate in polythene bags, which they throw
into the stream." They call these, "flying toilets.''

The state-run Ugandan National Water and Sewerage Corporation states
that currently 55% of Kampala is provided with treated water, and
only 8% with sewage reclamation.

Most rural villages are without any sanitary water source. People
wash clothes, bathe and dump untreated waste up and downstream from
where water is drawn. Watering holes are shared with animal
populations, which drink, bathe, urinate and defecate at the water
source. Unmanaged human waste pollutes water with infectious and
often deadly bacteria. Stagnant water breeds mosquitoes, which bring
malaria. Infectious diarrhea, dysentery, cholera, TB, malaria and
famine are the top killers in Africa. But in 1985, they became AIDS.

The public service announcements that run on VH1 and MTV, informing
us of the millions of infected, always fail to mention this. I don't
know what we're supposed to do with the information that 40 million
people are dying and nothing can be done. I wonder why we wouldn't be
interested in building wells and providing clean water and sewage
systems for Africans. Given our great concern, it would seem foolish
not to immediately begin the "clean water for Africa" campaign. But
I've never heard such a thing mentioned.

The UN recommendations for Africa actually demand the opposite
--"billions of dollars" taken out of "social funds, education and
health projects, infrastructure [and] rural development" and
"redirected" into sex education (UNAIDS, 1999). No clean water, but
plenty of condoms.

I have, however, felt the push to get AIDS drugs to Africans. Drugs
like AZT and Nevirapine, which are supposed to stop the spread of
HIV, especially in pregnant women. AZT and Nevirapine also terminate
life. The medical literature and warning labels list the side
effects: blood cell destruction, birth defects, bone-marrow death,
spontaneous abortion, organ failure, and fatal skin rot. The package
inserts also state that the drugs don't "stop HIV or prevent AIDS illnesses."

The companies that make these drugs take advantage of the public
perception that HIV is measured in individual African AIDS patients,
and that African AIDS -- water-borne illness and poverty -- can be
cured by AZT and Nevirapine. That's good capitalism, but it's bad medicine.

Currently MTV, Black Entertainment Television and VH1 are running
advertisements of handsome young couples, black and white, touching,
caressing, sensually, warming up to love-making. The camera moves
over their bodies, hands, necks, mouth, back, legs and arms -- and we
see a small butterfly bandage over their inner elbow, where they've
given blood for an HIV test. The announcer says, "Knowing is
beautiful." Get tested.

A September, 2004 San Francisco Chronicle article considered the
"beauty" of testing. It told the story of 59 year-old veteran Jim
Malone, who'd been told in 1996 that he was HIV positive. His health
was diagnosed as "very poor." He was classified as, "permanently
disabled and unable to work or participate in any stressful situation
whatsoever." Malone said, "When I wasn't able to eat, when I was
sick, my in-home health care nurse would say, 'Well, Jim, it goes
with your condition.' That's the way I thought," he said.

In 2004, his doctor sent him a note to tell him he was actually
negative. He had tested positive at one hospital, and negative at
another. Nobody asked why the second test was more accurate than the
first (that was the protocol at the Veteran's Hospital). Having been
falsely diagnosed and spending nearly a decade waiting, expecting to
die, Malone said, "I would tell people to get not just one HIV test,
but multiple tests. I would say test, test and retest."

In the article, AIDS experts assured the public that the story was
"extraordinarily rare." But the medical literature differs significantly.

In 1985, at the beginning of HIV testing, it was known that "68% to
89% of all repeatedly reactive ELISA (HIV antibody) tests [were]
likely to represent false positive results." (NEJM -- New England
Journal of Medicine. 312; 1985).

In 1992, the Lancet reported that for 66 true positives, there were
30,000 false positives. And in pregnant women, "there were 8,000
false positives for 6 confirmations." (Lancet 339; 1992)

In September 2000, the Archives of Family Medicine stated that the
more women we test, the greater "the proportion of false-positive and
ambiguous (indeterminate) test results." (Archives of Family
Medicine. Sept/Oct. 2000).

The tests described above are standard HIV tests, the kind promoted
in the ads. Their technical name is ELISA or EIA (Enzyme-linked
Immunosorbant Assay). They are antibody tests. The tests contain
proteins that react with antibodies in your blood.

In the U.S., you're tested with an ELISA first. If your blood reacts,
you'll be tested again, with another ELISA. Why is the second more
accurate than the first? That's just the protocol. If you have a
reaction on the second ELISA, you'll be confirmed with a third
antibody test, called the Western Blot. But that's here in America.
In some countries, one ELISA is all you get.

It is precisely because HIV tests are antibody tests, that they
produce so many false-positive results. All antibodies tend to
cross-react. We produce antibodies all the time, in response to
stress, malnutrition, illness, drug use, vaccination, foods we eat, a
cut, a cold, even pregnancy. These antibodies are known to make HIV
tests come up as positive.

The medical literature lists dozens of reasons for positive HIV test
results: "transfusions, transplantation, or pregnancy, autoimmune
disorders, malignancies, alcoholic liver disease, or for reasons that
are unclear. . . "(Archives of Family Medicine, Sept/Oct. 2000).

"[H]uman or technical errors, other viruses and vaccines" (Infectious
Disease Clinician of North America 7; 1993)

"[L]iver diseases, parenteral substance abuse, hemodialysis, or
vaccinations for hepatitis B, rabies, or influenza. . . " (Archives
of Internal Medicine August, 2000).

"[U]npasteurized cows' milk. . . Bovine exposure, or cross-reactivity
with other human retroviruses" (Transfusion,1988)

Even geography can do it:

"Inhabitants of certain regions may have cross-reactive antibodies to
local prevalent non-HIV retroviruses" (Medicine International 56; 1988).

The same is true for the confirmatory test -- the Western Blot.

Causes of indeterminate Western Blots include: "lymphoma, multiple
sclerosis, injection drug use, liver disease, or autoimmune
disorders. Also, there appear to be healthy individuals with
antibodies that cross-react. . . ." (Archives of Internal Medicine,
August 2000).

"The Western Blot is not used as a screening tool because. . . it
yields an unacceptably high percentage of indeterminate results."
(Archives of Family Medicine, Sept/Oct 2000)

Pregnancy is consistently listed as a cause of positive test results,
even by the test manufacturers. "[False positives can be caused by]
prior pregnancy, blood transfusions. . . and other potential
nonspecific reactions." (Vironostika HIV Test, 2003).

This is significant in Africa, because HIV estimates for African
nations are drawn almost exclusively from testing done on groups of
pregnant women.

In Zimbabwe this year, the rate of HIV infection among young women
decreased remarkably, from 32.5 to 6 percent. A drop of 81% --
overnight. UNICEF's Swaziland representative, Dr. Alan Brody, told
the press "The problems is that all the sero-surveillance data came
from pregnant women, and estimates for other demographics was based
on that." (PLUS News, August, 2004)

When these pregnant young women are tested, they're often tested for
other illnesses, like syphilis, at the same time. There's no concern
for cross-reactivity or false-positives in this group, and no repeat
testing. One ELISA on one girl, and 32.5% of the population is
suddenly HIV positive.

The June 20, 2004 Boston Globe reported that "the current estimate of
40 million people living with the AIDS virus worldwide is inflated by
25 percent to 50 percent."

They pointed out that HIV estimates for entire countries have, for
over a decade, been taken from "blood samples from pregnant women at
prenatal clinics."

But it's not just HIV estimates that are created from testing
pregnant women, it's "AIDS deaths, AIDS orphans, numbers of people
needing antiretroviral treatment, and the average life expectancy,"
all from that one test.

I've certainly never seen this in VH1 ad.

At present there are about six dozen reasons given in the literature
why the tests come up positive. In fact, the medical literature
states that there is simply no way of knowing if any HIV test is
truly positive or negative:

"[F]alse-positive reactions have been observed with every single
HIV-1 protein, recombinant or authentic." (Clinical Chemistry. 37;
1991). "Thus, it may be impossible to relate an antibody response
specifically to HIV-1 infection." (Medicine International, 1988)

And even if you believe the reaction is not a false positive, "the
test does not indicate whether the person currently harbors the
virus." (Science, November, 1999).

The test manufacturers state that after the antibody reaction occurs,
the tests have to be "interpreted." There is no strict or clear
definition of HIV positive or negative. There's just the antibody
reaction. The reaction is colored by an enzyme, and read by a machine
called a spectrophotometer.

The machine grades the reactions according to their strength (but not
specificity), above and below a cut-off. If you test above the
cut-off, you're positive; if you test below it, you're negative.

So what determines the all-important cut-off? From The CDC's
instructional material: "Establishing the cutoff value to define a
positive test result from a negative one is somewhat arbitrary."
(CDC-EIS, "Screening For HIV," 2003 )

The University of Vermont Medical School agrees: "Where a cutoff is
drawn to determine a diagnostic test result may be somewhat
arbitrary. . . .Where would the director of the Blood Bank who is
screening donated blood for HIV antibody want to put the
cut-off?...Where would an investigator enrolling high-risk patients
in a clinical trial for an experimental, potentially toxic
antiretroviral draw the cutoff?" (University of Vermont School of
Medicine teaching module: Diagnostic Testing for HIV Infection)

A 1995 study comparing four major brands of HIV tests found that they
all had different cut-off points, and as a result, gave different
test results for the same sample: "[C]ut-off ratios do not correlate
for any of the investigated ELISA pairs," and one test's cut-off
point had "no predictive value" for any other. (INCQS-DSH, Brazil 1995).

I've never heard of a person being asked where they would "want to
put the cut-off" for determining their HIV test result, or if they
felt that testing positive was a "somewhat arbitrary" experience.

In the UK, if you get through two ELISA tests, you're positive. In
America, you get a third and final test to confirm the first two. The
test is called the Western Blot. It uses the same proteins, laid out
differently. Same proteins, same nonspecific reactions. But this time
it's read as lines on a page, not a color change. Which lines are HIV
positive? That depends on where you are, what lab you're in and what
kit they're using.

The Mayo Clinic reported that "the Western blot method lacks
standardization, is cumbersome, and is subjective in interpretation
of banding patterns." (Mayo Clinic Procedural, 1988)

A 1988 study in the Journal of the American Medical Association
reported that 19 different labs, testing one blood sample, got 19
different Western Blot results. (JAMA, 260, 1988)

A 1993 review in Bio/Technology reported that the FDA, the
CDC/Department of Defense and the Red Cross all interpret WB's
differently, and further noted, "All the other major USA laboratories
for HIV testing have their own criteria." (Bio/Technology, June 1993)

In the early 1990s, perhaps in response to growing discontent in the
medical community with the lack of precision of the tests, Roche
Laboratories introduced a new genetic test, called Viral Load, based
on a technology called PCR. How good is the new genetic marvel?

An early review of the technology in the 1991 Journal of AIDS
reported that "a true positive PCR test cannot be distinguished from
a false positive." (J.AIDS, 1991)

A 1992 study "identified a disturbingly high rate of nonspecific
positivity," saying 18% antibody-negative (under the cut-off)
patients tested Viral Load positive. (J. AIDS, 1992)

A 2001 study showed that the tests gave wildly different results from
a single blood sample, as well as different results with different
test brands. (CDC MMWR, November 16, 2001)

A 2002 African study showed that Viral Load was high in patients who
had intestinal worms, but went down when they were treated for the
problem. The title of the article really said it all. "Treatment of
Intestinal Worms Is Associated With Decreased HIV Plasma Viral Load."
(J.AIDS, September, 2002)

Roche laboratories, the company that manufactures the PCR tests, puts
this warning on the label:

"The AMPLICOR HIV-1 MONITOR Test. . . .is not intended to be used as
a screening test for HIV or as a diagnostic test to confirm the
presence of HIV infection."

But that's exactly how it is used -- to convince pregnant mothers to
take AZT and Nevirapine and to urge patients to start the drugs.

The medical literature adds something truly astounding to all of
this. It says that reason HIV tests are so non-specific and need to
be interpreted is because there is "no virologic gold standard" for HIV tests.

The meaning of this statement, from both the medical and social
perspective, is profound. The "virologic gold standard" is the
isolated virus that the doctors claim to be identifying, indirectly,
with the test.

Antibody tests always have some cross-reaction, because antibodies
aren't specific. The way to validate a test is to go find the virus
in the patient's blood.

You take the blood, spin it in a centrifuge, and you end up with
millions of little virus particles, which you can easily photograph
under a microscope. You can disassemble the virus, measure the weight
of its proteins, and map its genetic structure. That's the virologic
gold standard. And for some reason, HIV tests have none.

In 1986, JAMA reported that: "no established standard exists for
identifying HTLV-III [HIV] infection in asymptomatic people." (JAMA.
July 18, 1986)

In 1987, the New England Journal of Medicine stated that "The meaning
of positive tests will depend on the joint [ELISA/WB] false positive
rate. Because we lack a gold standard, we do not know what that rate
is now. We cannot know what it will be in a large-scale screening
program." ( Screening for HIV: can we afford the false positive
rate?. NEJM. 1987)

Skip ahead to 1996; JAMA again reported: "the diagnosis of HIV
infection in infants is particularly difficult because there is no
reference or 'gold standard' test that determines unequivocally the
true infection status of the patient. (JAMA. May, 1996)

In 1997, Abbott laboratories, the world leader in HIV test production
stated: "At present there is no recognized standard for establishing
the presence or absence of HIV antibody in human blood." (Abbot
Laboratories HIV Elisa Test 1997)

In 2000 the Journal AIDS reported that " 2.9% to 12.3%" of women in a
study tested positive, "depending on the test used," but "since there
is no established gold standard test, it is unclear which of these
two proportions is the best estimate of the real prevalence rate. . .
" (AIDS, 14; 2000).

If we had a virologic gold standard, HIV testing would be easy and
accurate. You could spin the patient's blood in a centrifuge and find
the particle. They don't do this, and they're saying privately, in
the medical journals, that they can't.

That's why tests are determined through algorithms -- above or below
sliding cut-offs; estimated from pregnant girls, then projected and
redacted overnight.

By repeating, again and again in the medical literature that there's
no virologic gold standard, the world's top AIDS researchers are
saying that what we're calling HIV isn't a single entity, but a
collection of cross-reactive proteins and unidentified genetic material.

And we're suddenly a very long way from the public face of HIV.

But the fact is, you don't need to test HIV positive to be an AIDS
patient. You don't even have to be sick.

In 1993, the CDC added "Idiopathic CD4 Lymphocytopenia" to the AIDS
category. What does it mean? Non-HIV AIDS.

In 1993, the CDC also made "no-illness AIDS" a category. If you
tested positive, but weren't sick, you could be given an AIDS
diagnosis. By 1997, the healthy AIDS group accounted for 2/3rds of
all U.S. AIDS patients. (That's also the last year they reported
those numbers, CDC Year End Addition, 1997).

In Africa, HIV status is irrelevant. Even if you test negative, you
can be called an AIDS patient:

From a study in Ghana: "Our attention is now focused on the
considerably large number (59%) of the seronegative (HIV-negative)
group who were clinically diagnosed as having AIDS. All the patients
had three major signs: weight loss, prolonged diarrhea, and chronic
fever." (Lancet. October,1992)

And from across Africa: "2215 out of 4383 ( 50.0%) African AIDS
patients from Abidjan, Ivory Coast, Lusaka, Zambia, and Kinshasa,
Zaire, were HIV-antibody negative." (British Medical Journal, 1991)

Non-HIV AIDS, HIV-negative AIDS, No Virologic Gold standard -- terms
never seen in an HIV ad.

But even if you do test "repeatedly" positive, the manufacturers say
that "the risk of an asymptomatic [not sick] person developing AIDS
or an AIDS-related condition is not known." (Abbott Laboratories HIV
Test, 1997)

If commerce laws were applied equally, the "knowing is beautiful" ads
for HIV testing would have to bear a disclaimer, just like cigarettes:

"Warning: This test will not tell you if you're infected with a
virus. It may confirm that you are pregnant or have used drugs or
alcohol, or that you've been vaccinated; that you have a cold, liver
disease, arthritis, or are stressed, poor, hungry or tired. Or that
you're African. It will not tell you if you're going to live or die;
in fact, we really don't know what testing positive, or negative,
means at all."

----------------------------------------------
GNN contributor Liam Scheff is an investigative journalist and health
advocate who's been published in the New York Press, LA Citybeat and
Boston's Weekly Dig. His reporting on cell-killing drugs like
Nevirapine was recently featured in a BBC documentary.



--
www.michaelbalter.com

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Michael Balter
Contributing Correspondent, Science
[log in to unmask]
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