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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
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