The Hidden Face of HIV – Part 1
Mon, 3 Jan 2005 07:10:53 -0600
Positive
“Knowing is Beautiful”
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.
==========
The Hidden Face of HIV: Part 2
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.
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The Hidden Face of HIV: Part 2
Sex Crimes
Thu, 17 Mar 2005 08:24:20 -0600
The Hidden Face of HIV: Part 2
The last few months have been exciting for the medical industry. First there was the Nevirapine scandal at the NIH, then the FDA falls apart over prescription drugs, and now, with a bang, AIDS 2.0 has arrived in NYC.On February 12, The New York Times announced that “a rare strain of H.I.V. that is highly resistant to virtually all anti-retroviral drugs and appears to lead to the rapid onset of AIDS was detected…”
The carrier was a New York City man in his mid-40’s who “engaged in unprotected anal sex with multiple partners…hundreds of men… in recent weeks while using crystal methamphetamine.”
What made this man’s HIV different? Simple – he took lots of pharmaceuticals and got sick anyway. Clearly the AIDS drugs, which were supposed to cure his infection, weren’t able to, thus allowing the virus to make him very ill.
A New York City health official told the Times that it was the “first time” this had ever happened.
That said, a similar case does appear in the medical record. A 2001 case study in the British Medical Journal tells the story of a “26 year old man who was HIV positive [who] started taking stavudine, didanosine and nevirapine [AIDS drugs]…. He was receiving no other treatment…The patient began to experience malaise and pain in the upper abdomen…The symptoms worsened, and three weeks later he was admitted to hospital with severe pain, vomiting, fever, [and] tenderness of the upper abdomen.”
The doctors, perhaps not familiar with the benefits of treatment, or unaware that they had a supervirus on their hands, made an unusual choice.
“All drugs were stopped.”
The report notes: “The patient made an uneventful recovery with conservative treatment. He is no longer taking antiretroviral drugs” (British Medical Journal, January 2001; 322)
This suggests that AIDS drugs themselves might cause illness – it also implies that you can recover without the life-saving drug cocktail, which is of course, nonsense.
As any good doctor will tell you:
“I have a large population of people who have chosen not to take any anti-retrovirals. They’ve watched all of their friends go on the anti-viral bandwagon and die.” – Dr. Donald Abrams, MD, Director of AIDS Program, San Francisco General Hospital (“Lecture to Medical Students,” Synapse, 1996)
Yes, but treatment does improve quality of life:
“One of the major barriers to effectively treating HIV is that most people do not feel sick at the time that they are offered anti-HIV medications. In fact, it is only after starting the medications that they begin to feel sick…” (The Toronto Star, September 24, 1999).
Yes, there are side-effects, but the drugs are the only thing that will keep an AIDS patient alive – this is common knowledge.
“There’s no hope for a cure for AIDS with current drugs,” the head of the National Institute of Allergy and Infectious Diseases (NIAID) said at the 13th International AIDS Conference. ‘’Eradication is not possible,’’ Anthony Fauci said.” (Biotechnology Newswatch, July 17, 2000).
Yes, but…
“There is growing concern about the long-term toxicity and adverse effects of therapy, including liver damage and mitochondrial toxicity….Current research is not directed toward simple long-term survival…The fastest-growing treatment category in my clinic is no treatment or delayed treatment.”
(Annals of Internal Medicine, February 15, 2000; 132)
Fine. Maybe the drugs could have made him sick by themselves. It’s possible. But headline for headline, “Drugs Make Drug-Addict Sick” is not nearly as exciting as “New AIDS Supervirus Found in Meth-Sex Addict.” I mean, really. It’s not even news.
Robert Gallo, inventor of the Sex-AIDS theory was asked for comment. “My guess is that this is much ado about nothing,” he told the Times. What a buzz kill.
But thanks to the press coverage, we at last know that if you have marathon sex with hundreds of anonymous partners while high on crystal meth….you might become ill. And if you’re HIV-positive, the CDC will make sure you make the evening news, in every country in the western world.
In Washington State, another methamphetamine user, Anthony Whitfield will spend the rest of his life serving a prison sentence for the crime of being extremely sexually active. Whitfield tested positive in prison 12 years ago. Nobody asked why or how he remains alive and well – no AIDS drugs, a meth habit, living from day to day, hook-up to hook-up – but Whitfield’s health was not of interest to the judge.
What was of interest was Whitfield’s sexual orientation. Unlike the New York super-virus grower, Whitfield practiced heterosexual sex – and supposedly gave his bad HIV test result to five other people.
As we know, sex is the primary vector for HIV transmission, as the Whitfield case ably demonstrates.
From the Seattle Weekly (12/1/04):
“Five of the women tested positive for HIV, but there was little rhyme or reason to the distribution of the misfortune. “Some who had hundreds of incidents of unprotected sex, including anal sex, they’re negative,” says Thurston County deputy prosecutor Jodilyn Erikson-Muldrew. “Another woman who had protected sex all but twice, she’s positive.”
As we know, this is precisely how STDs work. While it’s hard to transmit an STD through hundreds of incidents of unprotected vaginal and anal sex, just two little exposures will always do the trick.
But HIV is, by definition, a sexually transmitted virus. We know this by rote. That said, AIDS researchers have had occasional difficulty proving it. While drug use correlates highly with HIV positivity; sex, outside of drug use, is not such a willing a participant in the HIV cycle.
Take this 1988 review from the Journal of the American Medical Association: “[N]one of the husbands of four seropositive [HIV positive] women were infected despite regular sexual contact for as long as three years. In another study involving 12 couples, no transmission from the infected woman to the male partner occurred after more than 100 sexual contacts. Thus, vaginal intercourse may carry a low risk to the insertive partner, as does anal intercourse. ” (JAMA, 1988; 259(20))
But that’s male to female contact – generally considered the least risky. What about female to male?
From the January 17, 2002 Journal of Infectious Disease: “The study…of 17 women who remained uninfected, despite a history of heavy exposure to HIV through repeated, unprotected sexual contact with an infected partner, and 12 of their regular, male HIV-positive partners.”
Well, what about male to male?
An April 1996 study in Nature Medicine focused on 24 hetero- and homosexual men who’ve remained HIV negative despite “histories of multiple high-risk sexual exposures to HIV-1,” including “sex with multiple HIV-1-infected partners,” or “long-term relationships involving unprotected sexual intercourse over many years [with] predominantly a single HIV-infected partner.” “All subjects were HIV-1 negative,” even though “several [of their] partners succumbed to AIDS.” (Nature Medicine. 1996 2(4))
What about longer studies?
“At Kenyatta National Hospital [Kenya] …out of 31 couples tested, 23 were discordant [one positive, one negative]. Some of them have stayed in a sexual relationship with the infected partner for more than six years without the infected one passing the virus to the other. And when these discordant couples brought their children for testing, all of them were free of the virus…” (Horizon Magazine, December 18, 2003)
What about larger studies?
“[W]e studied 50 sexually active couples with discordant antibody results [one positive, one negative]...seronegative partners continued to have negative results in all tests for a mean follow-up period of 17 months despite ongoing sexual relations with their seropositive partners….approximately one-half of each group reported some instances of unprotected intercourse…intercourse with outside partners was uncommon in both groups, as was current illicit drug use. (Clin Infectious Disease. July, 1995;211)
What about longer and larger studies?
From a study called “Heterosexual Transmission of HIV in Northern California: Results from a Ten-Year Study”: “We followed up 175 HIV-discordant couples over time, for a total of approximately 282 couple-years of follow up.…No transmission [of HIV] occurred among the 25% of couples who did not use their condoms consistently, nor among the 47 couples who intermittently practiced unsafe sex during the entire duration of follow-up…We observed no seroconversions after entry into the study [nobody became HIV positive]”(American Journal of Epidemiology. August, 1997.)
Ten years and no transmission? Huh. Every time I watch Law and Order: Special Victims Unit, HIV tracks like a muddy footprint from the “perp” to the victim.
But studies don’t prove anything. And belief always trumps logic. So in spite of evidence to the contrary, it remains possible that HIV is sexually transmitted. Not probable, but possible.
Of course, when we talk about transmission of HIV, we’re not talking about the virus itself – we’re only talking about what we pick up with HIV tests.
As the CDC Says, “HIV tests look for the presence of HIV antibodies; they do not test for the virus itself.”
But, they add: “The HIV-antibody test is the only way to tell if you are infected. You cannot tell by looking at someone if he or she carries HIV.” (CDC: National HIV Testing Resources; “HIV Test FAQ” 2005)
“The only way to tell” – and fortunately, the tests work extremely well, virtually error-free:
From the University of Michigan Health Service:
“Although the HIV tests are very precise, sometimes the test result can be positive even though you do not have HIV infection (this is called a false-positive test).” (“HIV Antibody Tests” McKesson Health Solutions LLC. 2004)
Okay, fine. There’s an occasional false-positive.
“1991 saw some 30,000 false positives out of 29.4 million tests, with only 66 confirmations…” (“HIV screening in Russia.” Lancet. 1992).
Well, sure, that can happen. But that was in Russia.
“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).
Well, that’s just a warning on the test for legal reasons, or something. Of course there are standards. The confirmatory test – the Western Blot – That’s the standard.
“[W]hat constitutes a positive Western blot test has not been standardized (various agencies use different reagents, testing methods, and test-interpretation criteria).” (“AIDS Counseling for Low-Risk Clients”; Max Plank Institute/Aids Care, 10, 1998 )
Well then, what is the standard?
“[F]or HIV infection, there is no independent, unequivocal way of identifying a group of individuals who are all assuredly infected or uninfected. ” (JAMA. 1987. 258)”
“There is no reference or ‘gold standard’ test that determines unequivocally the true infection status of the patient…”(JAMA. May,1 1996. 275(17)
“Thus, it may be impossible to relate an antibody response specifically to HIV-1 infection.” (Medicine International, 1988;56)
Alright, I get it.
“Serologic [blood] tests for HIV antibodies appear to be characterized by extra-ordinarily high false – positive results…Furthermore, any increase in false positive rate could turn a screening program into a social catastrophe. A false positive result may label an infant, born to HIV positive mother, as HIV positive where as the same infant may actually be HIV negative.” (“High Frequency of False Positive Results in HIV Screening in Blood Banks” Ayub Medical College, Pakistan. 1999)
Alright, fine. So the tests are crap. Then how do we know that Anthony Whitfield, or any of his partners, is really positive?
The answer is simple. Some tests are more positive than others.
No one asked about false positives with Whitfield because of his lifestyle and skin color. He was in what the CDC calls a high risk group.
That’s how testing works – if you belong to a certain group of people, you’re considered more likely to be positive. If you’re outside of that group, you’re considered more likely to be negative. And your test result is graded against that assumption.
Here’s how the CDC puts it:
“The likelihood that a positive screening test truly indicates the presence of HIV infection decreases as HIV prevalence in the tested population becomes lower. Therefore, false-positive HIV test results are more likely in settings where the tested population prevalence is lower than in settings where the tested population prevalence is higher.” (CDC: “Revised Guidelines for HIV Counseling, Testing, and Referral” November 9, 2001)
In other words – your actual test is less meaningful than the assumed prevalence of HIV positivity in the group the CDC believes you belong to.
Whitfield is a black man and a drug user, and he has unprotected sex. So he is at high risk
As we know:
The CDC looks for trends in targeted populations – an increase in STDs, drug use, teen pregnancy – if any of these factors are up, then it’s assumed that HIV prevalence will also be on the rise.
As Dr. Dan Cohen, medical director of Boston’s Fenway HIV test center told me in a 2003 interview:
“The majority of people who are going to be infected [in the Boston area] are in their teens and twenties.
“How do you know that?” I asked.
Dr. Cohen answered, “Because we’re seeing increasing number of other STDs in this young population, and it’s only a matter of time before HIV appears. That‘s especially true among people of color.”
I pointed out that in 2002, all of Massachusetts recorded 327 AIDS deaths – that included auto-accidents, overdoses and suicides (the state counts all HIV positive deaths as AIDS deaths).
Cohen answered, “Just because we’re not seeing high numbers, doesn’t mean that we shouldn’t pay attention – it’s lurking beneath the surface.”
“That’s why it’s an emergency,” he said.
And guess what, he was right. Now more Black and Hispanic people are being tested, and because they’re believed to be at higher risk, their test results are considered to be more accurate. That’s statistics at work.
The newest HIV tests are called Rapid Tests. These tests are used for on-the-spot screenings. They take as little as 20 minutes to give you your result. Their accuracy, however, depends mightily on your risk group.
From the industry journal “AIDS Alert”:
“[P]atients who test positive, but who live in a low-prevalence [low-risk] part of the country and engage in no activities that put them at risk for HIV infection, might be told a positive reaction means they “probably” or “very likely” don’t have HIV.
On the other hand, “In higher-risk settings, patients might be told that a positive test means they “probably are” infected.” (“Coming to Your Clinic: Candidates for Rapid Tests.” Aids Alert; March 1998)
And from the CDCs new guidelines for Rapid Tests:
When a preliminary, positive rapid test is explained to clients, phrases like “a good chance of being infected” or “very likely infected” can be used to indicate the likelihood of HIV infection and qualified based on the HIV prevalence in the setting and the client’s individual risk.” (CDC: “Revised Guidelines for HIV Counseling, Testing, and Referral” November 9, 2001)
The CDC is currently moving into testing all pregnant women with rapid tests, but this will probably only affect those people in public hospitals. You know, the poor.
“[A]ll pregnant women should be recommended HIV testing regardless of setting prevalence or behavioral or clinical risk…HIV prevention counseling and referral should target pregnant women based on risk screening.” (ibid)
[R]apid HIV testing should routinely be made available for the mother or her newborn” (CDC: National HIV Testing Resources; “HIV Test FAQ” 2005)
This is clearly a fantastic idea –as evidenced by this September, 2000 study “False Positive and Indeterminate HIV Test Results in Pregnant Women”:
“As the number of women being screened has increased, the proportion of false-positive and ambiguous (indeterminate) test results has increased….”(Archives of Family Medicine, Sep/Oct 2000)
Well, right… there is the problem of false positives in these women, caused by natural antibodies produced during pregnancy:
“[I]n 1991 alone some 8000 false-positive results were reported in pregnant women, with only 6 confirmations.” (Lancet, 1992;339).
But in a high-risk group, we can be assured that those positives aren’t “false.” They’re accurate – by definition.
In any case, the solution to the problem is obvious. As the Canadian government generously advices:
“One might expect that women found to be seropositive would opt for an elective abortion.” (Screening for HIV antibody. Health Canada, 1994)
The good news is that, for women who keep their babies, whatever the outcome of their rapid test, doctors will enforce a dose of AIDS drugs, like AZT and/or Nevirapine, the official world-wide therapies for mothers who test positive. In fact, the CDC and test manufacturers advise that the test be given at delivery, so drugs can be given during labor:
“For pregnant women who do not know their HIV status at the time of delivery, rapid HIV testing permits [drug] therapy to be initiated for these mothers during labor, and to their infants post partum.” (OraQuick Rapid HIV Test, 2003)
To be fair, there are some concerns about accuracy of tests in newborns:
“Newborns of HIV infected mothers may carry maternal antibodies for up to eighteen months, which may not necessarily indicate the true infection status of the new born.” (MedMira Reveal HIV test. 2003)
But for those at risk – better safe, with a good course of AIDS Drugs, than sorry.
Ironically, the low-risk populations don’t need to be tested very much. In fact, testing them is considered to be in bad form:
“Plans to test low-risk populations for HIV antibody generally ignore the possibility of false positive results…How many engagements should end to prevent one infection? How many jobs should be lost? How many insurance policies should be cancelled or denied? How many fetuses should be aborted and how many couples should remain childless to avert the birth of one child with AIDS? (“High Frequency of False Positives…” Ayub Medical College, Pakistan, 1999)
From the journal AIDS Care: “Counseling people at low risk requires paying particular attention to false positives, that is, to the possibility that the client has a positive HIV test even though he or she is not infected with the virus.…If clients are not informed about this fact, they tend to believe that a positive test means that they are infected with absolute certainty….Emotional pain and lives can be saved if counselors inform the clients about the possibility of false positives…” (“AIDS Counseling for Low-Risk Clients”; Max Plank Institute/Aids Care, 10, 1998 )
In fact, screening low-risk people is considered in such bad form, we simply don’t do it:
“The actual risk of transmission between women is unknown….lesbians have been excluded from epidemiological risk groups.” (“A lesbian at very low risk for HIV infection” HIV InSite/UCSF Center for HIV Information. 2004)
“[A]cceptable prevalence rates to justify screening [the general population] have not been defined. (Screening for HIV antibody. Health Canada, 1994)
“[T]here was no information about [HIV] prevalence in men and women with no risky behaviour.” (“AIDS Counseling for Low-Risk Clients”; Max Plank Institute/Aids Care, 10, 1998)
After all, they’re low risk. And sex isn’t a risky behavior for low-risk folks. Lucky bastards.
The statistical rule being abused here is Bayes rule or law. It states the higher the prevalence, the more accurate the tests. And prevalence is estimated from applying the test to groups that the CDC believes will eventually be at risk (as Dr. Cohen stated – where the new infections “are going to be,” based on targeted screenings of certain communities for drug use, pregnancy, and STDs). We test them more, assume their results are accurate…And voila – prevalence.
The end result of this equation is the “predictive value.” That’s the estimated likelihood that your tests are accurate – not positive or negative – but accurate: If you’re in a high risk group, your test is believed to have a high predictive value – so your reactive tests are considered to be positive.
For people in the low-risk group, the tests are believed to have a low predicative value – so a reactive test is considered a “false-positive.”
Here’s how it breaks down in numbers:
“Most patients (68 to 89%) from low risk groups who show reactivity on screening tests will have false-positive results…The predictive value of a positive ELISA varies from 2% to 99%…” (Mayo Clinic Proceedings , 1988; 63)
“[I]n low prevalence populations the predictive value [of an HIV test] was 11.1%, while in populations with known HIV-1 infection, the predictive value was 97.1%. ” (Abbott Laboratories. HIV Antibody Test. April, 1996).
In a high risk group, “The Positive Predictive Value of a home screening test would be 67%; 33 of 100 would be false positives. With a lower prevalence the PPV drops to 17%, and 83 out of 100 positive tests would be false. (“Advances in HIV Testing Technology”- AIDS Education and Prevention – 1997)
The test manufacturers list the following as their high risk group:
“Prison inmates, STD clinic patients, inner city hospital emergency room patients… homosexual men [and] intravenous drug users.” (Vironostika HIV Antibody Test. 2003). And these are the groups that they target for testing. For these people, HIV tests are nearly 100% accurate. For everybody else, just 2%.
But all of these numbers are a little confusing. Here’s how it looks in practice – from the March, 1998 “AIDS Alert” article on rapid tests:
“Whether the tests will perform as well in the United States as they have abroad is still unknown, experts add. For one thing, using a single rapid test in a low-prevalence population will give a lower positive predictive value….That error rate won’t matter much in areas with a high prevalence of HIV because in all probability the people testing false-positive will have the disease. But if the same test was performed on 1,000 white, affluent suburban housewives – a low-prevalence population – in all likelihood all positive results will be false, and positive predictive values plummet to zero.” (Coming to your clinic: Candidates for Rapid Tests. Aids Alert, March 1998)
So, if you take a test, and are “white, affluent and suburban,” you’ll have a false positive. If you aren’t, even your false positive is a true positive. Gosh, science is wonderful.
One thing’s for sure – if you are in a high risk group, you can never really be negative:
“If you have a negative test result but you are in a high-risk group, you may need to have another test 3 to 6 months later. (“HIV Antibody Tests” McKesson Health Solutions LLC.)
“Testing should be repeated after 6 months in seronegative people whose behaviour put them at risk.” (Screening for HIV Antibody, Health Canada, 1994)
In the UK, they don’t even wait that long. (From the 2003 UK National Guidelines for HIV testing) If you test negative but are considered to be at risk, then “clearly, waiting for six months to test is untenable, ….We would suggest testing using a sensitive [highly reactive] fourth (or third) generation screening test immediately after the exposure [the risky sexual encounter] and then: at one to two months, at three to four months, and six months.”
They’re thoughtful to add: “Some time and care will be needed to explain the reasons underlying the need for follow-up testing…despite negative results.” (“Towards error-free HIV diagnosis: guidelines on laboratory practice” Communicable Disease and Public Health 2003; 6,4)
But when a low-risk person has a reactive test, the process is quite different.
If a test is reactive “where the strong expectation is of a negative result,” – a low-risk population – the patient is not informed that he or she is HIV positive, or even “very likely infected.” Instead, the process stops – “Reactivity on these specimens needs very careful scrutiny, unhurried by inappropriate ‘turn-around’ targets.”
No rush to a verdict for the low-risk patient. What happens next? The positive result is expunged from the record – through official channels – and the “expected result” is sought: “Further testing is essential, employing several different tests carefully selected to minimize the possibility of each additional test being prone to the same false-positive effect as gave rise to the false reaction in the initial screening test.” (ibid)
How do they minimize false positives? They use less sensitive tests, or interpret them differently. The clinician’s opinion of what the test should be is considerably more important than test result itself: “Checking that the final result is not at odds with patients’ clinical and behavioural characteristics is a key element.” (ibid)
But how did they know that the first test was a “false reaction?”
Well, it’s like a kind of magic. Scientists have a special kind of wisdom, I suppose. Clearly, what the CDC says, at least on one topic, is incorrect. You can tell who’s going to be HIV positive – just by looking at them.
Liam Scheff is an investigative journalist whose work on uncovering medical malfeasance has been featured in the BBC documentary “Guinea Pig Kids” and in the alternative press. Scheff is currently writing a book about children and healthcare workers who have been uninformed participants in clinical drug trials or who have enforced or been subjected to damaging drug treatments as part of standard medical therapy. You can write him at liamscheff@yahoo.com.
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The carrier was a New York City man in his mid-40’s who “engaged in unprotected anal sex with multiple partners…hundreds of men… in recent weeks while using crystal methamphetamine.”
What made this man’s HIV different? Simple – he took lots of pharmaceuticals and got sick anyway. Clearly the AIDS drugs, which were supposed to cure his infection, weren’t able to, thus allowing the virus to make him very ill.
A New York City health official told the Times that it was the “first time” this had ever happened.
That said, a similar case does appear in the medical record. A 2001 case study in the British Medical Journal tells the story of a “26 year old man who was HIV positive [who] started taking stavudine, didanosine and nevirapine [AIDS drugs]…. He was receiving no other treatment…The patient began to experience malaise and pain in the upper abdomen…The symptoms worsened, and three weeks later he was admitted to hospital with severe pain, vomiting, fever, [and] tenderness of the upper abdomen.”
The doctors, perhaps not familiar with the benefits of treatment, or unaware that they had a supervirus on their hands, made an unusual choice.
“All drugs were stopped.”
The report notes: “The patient made an uneventful recovery with conservative treatment. He is no longer taking antiretroviral drugs” (British Medical Journal, January 2001; 322)
This suggests that AIDS drugs themselves might cause illness – it also implies that you can recover without the life-saving drug cocktail, which is of course, nonsense.
As any good doctor will tell you:
“I have a large population of people who have chosen not to take any anti-retrovirals. They’ve watched all of their friends go on the anti-viral bandwagon and die.” – Dr. Donald Abrams, MD, Director of AIDS Program, San Francisco General Hospital (“Lecture to Medical Students,” Synapse, 1996)
Yes, but treatment does improve quality of life:
“One of the major barriers to effectively treating HIV is that most people do not feel sick at the time that they are offered anti-HIV medications. In fact, it is only after starting the medications that they begin to feel sick…” (The Toronto Star, September 24, 1999).
Yes, there are side-effects, but the drugs are the only thing that will keep an AIDS patient alive – this is common knowledge.
“There’s no hope for a cure for AIDS with current drugs,” the head of the National Institute of Allergy and Infectious Diseases (NIAID) said at the 13th International AIDS Conference. ‘’Eradication is not possible,’’ Anthony Fauci said.” (Biotechnology Newswatch, July 17, 2000).
Yes, but…
“There is growing concern about the long-term toxicity and adverse effects of therapy, including liver damage and mitochondrial toxicity….Current research is not directed toward simple long-term survival…The fastest-growing treatment category in my clinic is no treatment or delayed treatment.”
(Annals of Internal Medicine, February 15, 2000; 132)
Fine. Maybe the drugs could have made him sick by themselves. It’s possible. But headline for headline, “Drugs Make Drug-Addict Sick” is not nearly as exciting as “New AIDS Supervirus Found in Meth-Sex Addict.” I mean, really. It’s not even news.
Robert Gallo, inventor of the Sex-AIDS theory was asked for comment. “My guess is that this is much ado about nothing,” he told the Times. What a buzz kill.
But thanks to the press coverage, we at last know that if you have marathon sex with hundreds of anonymous partners while high on crystal meth….you might become ill. And if you’re HIV-positive, the CDC will make sure you make the evening news, in every country in the western world.
In Washington State, another methamphetamine user, Anthony Whitfield will spend the rest of his life serving a prison sentence for the crime of being extremely sexually active. Whitfield tested positive in prison 12 years ago. Nobody asked why or how he remains alive and well – no AIDS drugs, a meth habit, living from day to day, hook-up to hook-up – but Whitfield’s health was not of interest to the judge.
What was of interest was Whitfield’s sexual orientation. Unlike the New York super-virus grower, Whitfield practiced heterosexual sex – and supposedly gave his bad HIV test result to five other people.
As we know, sex is the primary vector for HIV transmission, as the Whitfield case ably demonstrates.
From the Seattle Weekly (12/1/04):
“Five of the women tested positive for HIV, but there was little rhyme or reason to the distribution of the misfortune. “Some who had hundreds of incidents of unprotected sex, including anal sex, they’re negative,” says Thurston County deputy prosecutor Jodilyn Erikson-Muldrew. “Another woman who had protected sex all but twice, she’s positive.”
As we know, this is precisely how STDs work. While it’s hard to transmit an STD through hundreds of incidents of unprotected vaginal and anal sex, just two little exposures will always do the trick.
But HIV is, by definition, a sexually transmitted virus. We know this by rote. That said, AIDS researchers have had occasional difficulty proving it. While drug use correlates highly with HIV positivity; sex, outside of drug use, is not such a willing a participant in the HIV cycle.
Take this 1988 review from the Journal of the American Medical Association: “[N]one of the husbands of four seropositive [HIV positive] women were infected despite regular sexual contact for as long as three years. In another study involving 12 couples, no transmission from the infected woman to the male partner occurred after more than 100 sexual contacts. Thus, vaginal intercourse may carry a low risk to the insertive partner, as does anal intercourse. ” (JAMA, 1988; 259(20))
But that’s male to female contact – generally considered the least risky. What about female to male?
From the January 17, 2002 Journal of Infectious Disease: “The study…of 17 women who remained uninfected, despite a history of heavy exposure to HIV through repeated, unprotected sexual contact with an infected partner, and 12 of their regular, male HIV-positive partners.”
Well, what about male to male?
An April 1996 study in Nature Medicine focused on 24 hetero- and homosexual men who’ve remained HIV negative despite “histories of multiple high-risk sexual exposures to HIV-1,” including “sex with multiple HIV-1-infected partners,” or “long-term relationships involving unprotected sexual intercourse over many years [with] predominantly a single HIV-infected partner.” “All subjects were HIV-1 negative,” even though “several [of their] partners succumbed to AIDS.” (Nature Medicine. 1996 2(4))
What about longer studies?
“At Kenyatta National Hospital [Kenya] …out of 31 couples tested, 23 were discordant [one positive, one negative]. Some of them have stayed in a sexual relationship with the infected partner for more than six years without the infected one passing the virus to the other. And when these discordant couples brought their children for testing, all of them were free of the virus…” (Horizon Magazine, December 18, 2003)
What about larger studies?
“[W]e studied 50 sexually active couples with discordant antibody results [one positive, one negative]...seronegative partners continued to have negative results in all tests for a mean follow-up period of 17 months despite ongoing sexual relations with their seropositive partners….approximately one-half of each group reported some instances of unprotected intercourse…intercourse with outside partners was uncommon in both groups, as was current illicit drug use. (Clin Infectious Disease. July, 1995;211)
What about longer and larger studies?
From a study called “Heterosexual Transmission of HIV in Northern California: Results from a Ten-Year Study”: “We followed up 175 HIV-discordant couples over time, for a total of approximately 282 couple-years of follow up.…No transmission [of HIV] occurred among the 25% of couples who did not use their condoms consistently, nor among the 47 couples who intermittently practiced unsafe sex during the entire duration of follow-up…We observed no seroconversions after entry into the study [nobody became HIV positive]”(American Journal of Epidemiology. August, 1997.)
Ten years and no transmission? Huh. Every time I watch Law and Order: Special Victims Unit, HIV tracks like a muddy footprint from the “perp” to the victim.
But studies don’t prove anything. And belief always trumps logic. So in spite of evidence to the contrary, it remains possible that HIV is sexually transmitted. Not probable, but possible.
Of course, when we talk about transmission of HIV, we’re not talking about the virus itself – we’re only talking about what we pick up with HIV tests.
As the CDC Says, “HIV tests look for the presence of HIV antibodies; they do not test for the virus itself.”
But, they add: “The HIV-antibody test is the only way to tell if you are infected. You cannot tell by looking at someone if he or she carries HIV.” (CDC: National HIV Testing Resources; “HIV Test FAQ” 2005)
“The only way to tell” – and fortunately, the tests work extremely well, virtually error-free:
From the University of Michigan Health Service:
“Although the HIV tests are very precise, sometimes the test result can be positive even though you do not have HIV infection (this is called a false-positive test).” (“HIV Antibody Tests” McKesson Health Solutions LLC. 2004)
Okay, fine. There’s an occasional false-positive.
“1991 saw some 30,000 false positives out of 29.4 million tests, with only 66 confirmations…” (“HIV screening in Russia.” Lancet. 1992).
Well, sure, that can happen. But that was in Russia.
“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).
Well, that’s just a warning on the test for legal reasons, or something. Of course there are standards. The confirmatory test – the Western Blot – That’s the standard.
“[W]hat constitutes a positive Western blot test has not been standardized (various agencies use different reagents, testing methods, and test-interpretation criteria).” (“AIDS Counseling for Low-Risk Clients”; Max Plank Institute/Aids Care, 10, 1998 )
Well then, what is the standard?
“[F]or HIV infection, there is no independent, unequivocal way of identifying a group of individuals who are all assuredly infected or uninfected. ” (JAMA. 1987. 258)”
“There is no reference or ‘gold standard’ test that determines unequivocally the true infection status of the patient…”(JAMA. May,1 1996. 275(17)
“Thus, it may be impossible to relate an antibody response specifically to HIV-1 infection.” (Medicine International, 1988;56)
Alright, I get it.
“Serologic [blood] tests for HIV antibodies appear to be characterized by extra-ordinarily high false – positive results…Furthermore, any increase in false positive rate could turn a screening program into a social catastrophe. A false positive result may label an infant, born to HIV positive mother, as HIV positive where as the same infant may actually be HIV negative.” (“High Frequency of False Positive Results in HIV Screening in Blood Banks” Ayub Medical College, Pakistan. 1999)
Alright, fine. So the tests are crap. Then how do we know that Anthony Whitfield, or any of his partners, is really positive?
The answer is simple. Some tests are more positive than others.
No one asked about false positives with Whitfield because of his lifestyle and skin color. He was in what the CDC calls a high risk group.
That’s how testing works – if you belong to a certain group of people, you’re considered more likely to be positive. If you’re outside of that group, you’re considered more likely to be negative. And your test result is graded against that assumption.
Here’s how the CDC puts it:
“The likelihood that a positive screening test truly indicates the presence of HIV infection decreases as HIV prevalence in the tested population becomes lower. Therefore, false-positive HIV test results are more likely in settings where the tested population prevalence is lower than in settings where the tested population prevalence is higher.” (CDC: “Revised Guidelines for HIV Counseling, Testing, and Referral” November 9, 2001)
In other words – your actual test is less meaningful than the assumed prevalence of HIV positivity in the group the CDC believes you belong to.
Whitfield is a black man and a drug user, and he has unprotected sex. So he is at high risk
As we know:
Sex is unquestionably the primary vector for spreading HIV…
Drug use itself causes a massive antibody production, which is read by the HIV antibody test as HIV positive – so we know that’s accurate.
And finally, the CDC says that HIV positivity is up in the Black community. How do they know this? Because they’re doing more testing in the Black (and Hispanic) communities. And if the CDC is testing them more, then they must be at higher risk.But why are they at higher risk?
The CDC looks for trends in targeted populations – an increase in STDs, drug use, teen pregnancy – if any of these factors are up, then it’s assumed that HIV prevalence will also be on the rise.
As Dr. Dan Cohen, medical director of Boston’s Fenway HIV test center told me in a 2003 interview:
“The majority of people who are going to be infected [in the Boston area] are in their teens and twenties.
“How do you know that?” I asked.
Dr. Cohen answered, “Because we’re seeing increasing number of other STDs in this young population, and it’s only a matter of time before HIV appears. That‘s especially true among people of color.”
I pointed out that in 2002, all of Massachusetts recorded 327 AIDS deaths – that included auto-accidents, overdoses and suicides (the state counts all HIV positive deaths as AIDS deaths).
Cohen answered, “Just because we’re not seeing high numbers, doesn’t mean that we shouldn’t pay attention – it’s lurking beneath the surface.”
“That’s why it’s an emergency,” he said.
And guess what, he was right. Now more Black and Hispanic people are being tested, and because they’re believed to be at higher risk, their test results are considered to be more accurate. That’s statistics at work.
The newest HIV tests are called Rapid Tests. These tests are used for on-the-spot screenings. They take as little as 20 minutes to give you your result. Their accuracy, however, depends mightily on your risk group.
From the industry journal “AIDS Alert”:
“[P]atients who test positive, but who live in a low-prevalence [low-risk] part of the country and engage in no activities that put them at risk for HIV infection, might be told a positive reaction means they “probably” or “very likely” don’t have HIV.
On the other hand, “In higher-risk settings, patients might be told that a positive test means they “probably are” infected.” (“Coming to Your Clinic: Candidates for Rapid Tests.” Aids Alert; March 1998)
And from the CDCs new guidelines for Rapid Tests:
When a preliminary, positive rapid test is explained to clients, phrases like “a good chance of being infected” or “very likely infected” can be used to indicate the likelihood of HIV infection and qualified based on the HIV prevalence in the setting and the client’s individual risk.” (CDC: “Revised Guidelines for HIV Counseling, Testing, and Referral” November 9, 2001)
The CDC is currently moving into testing all pregnant women with rapid tests, but this will probably only affect those people in public hospitals. You know, the poor.
“[A]ll pregnant women should be recommended HIV testing regardless of setting prevalence or behavioral or clinical risk…HIV prevention counseling and referral should target pregnant women based on risk screening.” (ibid)
[R]apid HIV testing should routinely be made available for the mother or her newborn” (CDC: National HIV Testing Resources; “HIV Test FAQ” 2005)
This is clearly a fantastic idea –as evidenced by this September, 2000 study “False Positive and Indeterminate HIV Test Results in Pregnant Women”:
“As the number of women being screened has increased, the proportion of false-positive and ambiguous (indeterminate) test results has increased….”(Archives of Family Medicine, Sep/Oct 2000)
Well, right… there is the problem of false positives in these women, caused by natural antibodies produced during pregnancy:
“[I]n 1991 alone some 8000 false-positive results were reported in pregnant women, with only 6 confirmations.” (Lancet, 1992;339).
But in a high-risk group, we can be assured that those positives aren’t “false.” They’re accurate – by definition.
In any case, the solution to the problem is obvious. As the Canadian government generously advices:
“One might expect that women found to be seropositive would opt for an elective abortion.” (Screening for HIV antibody. Health Canada, 1994)
The good news is that, for women who keep their babies, whatever the outcome of their rapid test, doctors will enforce a dose of AIDS drugs, like AZT and/or Nevirapine, the official world-wide therapies for mothers who test positive. In fact, the CDC and test manufacturers advise that the test be given at delivery, so drugs can be given during labor:
“For pregnant women who do not know their HIV status at the time of delivery, rapid HIV testing permits [drug] therapy to be initiated for these mothers during labor, and to their infants post partum.” (OraQuick Rapid HIV Test, 2003)
To be fair, there are some concerns about accuracy of tests in newborns:
“Newborns of HIV infected mothers may carry maternal antibodies for up to eighteen months, which may not necessarily indicate the true infection status of the new born.” (MedMira Reveal HIV test. 2003)
But for those at risk – better safe, with a good course of AIDS Drugs, than sorry.
Ironically, the low-risk populations don’t need to be tested very much. In fact, testing them is considered to be in bad form:
“Plans to test low-risk populations for HIV antibody generally ignore the possibility of false positive results…How many engagements should end to prevent one infection? How many jobs should be lost? How many insurance policies should be cancelled or denied? How many fetuses should be aborted and how many couples should remain childless to avert the birth of one child with AIDS? (“High Frequency of False Positives…” Ayub Medical College, Pakistan, 1999)
From the journal AIDS Care: “Counseling people at low risk requires paying particular attention to false positives, that is, to the possibility that the client has a positive HIV test even though he or she is not infected with the virus.…If clients are not informed about this fact, they tend to believe that a positive test means that they are infected with absolute certainty….Emotional pain and lives can be saved if counselors inform the clients about the possibility of false positives…” (“AIDS Counseling for Low-Risk Clients”; Max Plank Institute/Aids Care, 10, 1998 )
In fact, screening low-risk people is considered in such bad form, we simply don’t do it:
“The actual risk of transmission between women is unknown….lesbians have been excluded from epidemiological risk groups.” (“A lesbian at very low risk for HIV infection” HIV InSite/UCSF Center for HIV Information. 2004)
“[A]cceptable prevalence rates to justify screening [the general population] have not been defined. (Screening for HIV antibody. Health Canada, 1994)
“[T]here was no information about [HIV] prevalence in men and women with no risky behaviour.” (“AIDS Counseling for Low-Risk Clients”; Max Plank Institute/Aids Care, 10, 1998)
After all, they’re low risk. And sex isn’t a risky behavior for low-risk folks. Lucky bastards.
The statistical rule being abused here is Bayes rule or law. It states the higher the prevalence, the more accurate the tests. And prevalence is estimated from applying the test to groups that the CDC believes will eventually be at risk (as Dr. Cohen stated – where the new infections “are going to be,” based on targeted screenings of certain communities for drug use, pregnancy, and STDs). We test them more, assume their results are accurate…And voila – prevalence.
The end result of this equation is the “predictive value.” That’s the estimated likelihood that your tests are accurate – not positive or negative – but accurate: If you’re in a high risk group, your test is believed to have a high predictive value – so your reactive tests are considered to be positive.
For people in the low-risk group, the tests are believed to have a low predicative value – so a reactive test is considered a “false-positive.”
Here’s how it breaks down in numbers:
“Most patients (68 to 89%) from low risk groups who show reactivity on screening tests will have false-positive results…The predictive value of a positive ELISA varies from 2% to 99%…” (Mayo Clinic Proceedings , 1988; 63)
“[I]n low prevalence populations the predictive value [of an HIV test] was 11.1%, while in populations with known HIV-1 infection, the predictive value was 97.1%. ” (Abbott Laboratories. HIV Antibody Test. April, 1996).
In a high risk group, “The Positive Predictive Value of a home screening test would be 67%; 33 of 100 would be false positives. With a lower prevalence the PPV drops to 17%, and 83 out of 100 positive tests would be false. (“Advances in HIV Testing Technology”- AIDS Education and Prevention – 1997)
The test manufacturers list the following as their high risk group:
“Prison inmates, STD clinic patients, inner city hospital emergency room patients… homosexual men [and] intravenous drug users.” (Vironostika HIV Antibody Test. 2003). And these are the groups that they target for testing. For these people, HIV tests are nearly 100% accurate. For everybody else, just 2%.
But all of these numbers are a little confusing. Here’s how it looks in practice – from the March, 1998 “AIDS Alert” article on rapid tests:
“Whether the tests will perform as well in the United States as they have abroad is still unknown, experts add. For one thing, using a single rapid test in a low-prevalence population will give a lower positive predictive value….That error rate won’t matter much in areas with a high prevalence of HIV because in all probability the people testing false-positive will have the disease. But if the same test was performed on 1,000 white, affluent suburban housewives – a low-prevalence population – in all likelihood all positive results will be false, and positive predictive values plummet to zero.” (Coming to your clinic: Candidates for Rapid Tests. Aids Alert, March 1998)
So, if you take a test, and are “white, affluent and suburban,” you’ll have a false positive. If you aren’t, even your false positive is a true positive. Gosh, science is wonderful.
One thing’s for sure – if you are in a high risk group, you can never really be negative:
“If you have a negative test result but you are in a high-risk group, you may need to have another test 3 to 6 months later. (“HIV Antibody Tests” McKesson Health Solutions LLC.)
“Testing should be repeated after 6 months in seronegative people whose behaviour put them at risk.” (Screening for HIV Antibody, Health Canada, 1994)
In the UK, they don’t even wait that long. (From the 2003 UK National Guidelines for HIV testing) If you test negative but are considered to be at risk, then “clearly, waiting for six months to test is untenable, ….We would suggest testing using a sensitive [highly reactive] fourth (or third) generation screening test immediately after the exposure [the risky sexual encounter] and then: at one to two months, at three to four months, and six months.”
They’re thoughtful to add: “Some time and care will be needed to explain the reasons underlying the need for follow-up testing…despite negative results.” (“Towards error-free HIV diagnosis: guidelines on laboratory practice” Communicable Disease and Public Health 2003; 6,4)
But when a low-risk person has a reactive test, the process is quite different.
If a test is reactive “where the strong expectation is of a negative result,” – a low-risk population – the patient is not informed that he or she is HIV positive, or even “very likely infected.” Instead, the process stops – “Reactivity on these specimens needs very careful scrutiny, unhurried by inappropriate ‘turn-around’ targets.”
No rush to a verdict for the low-risk patient. What happens next? The positive result is expunged from the record – through official channels – and the “expected result” is sought: “Further testing is essential, employing several different tests carefully selected to minimize the possibility of each additional test being prone to the same false-positive effect as gave rise to the false reaction in the initial screening test.” (ibid)
How do they minimize false positives? They use less sensitive tests, or interpret them differently. The clinician’s opinion of what the test should be is considerably more important than test result itself: “Checking that the final result is not at odds with patients’ clinical and behavioural characteristics is a key element.” (ibid)
But how did they know that the first test was a “false reaction?”
Well, it’s like a kind of magic. Scientists have a special kind of wisdom, I suppose. Clearly, what the CDC says, at least on one topic, is incorrect. You can tell who’s going to be HIV positive – just by looking at them.
Liam Scheff is an investigative journalist whose work on uncovering medical malfeasance has been featured in the BBC documentary “Guinea Pig Kids” and in the alternative press. Scheff is currently writing a book about children and healthcare workers who have been uninformed participants in clinical drug trials or who have enforced or been subjected to damaging drug treatments as part of standard medical therapy. You can write him at liamscheff@yahoo.com.
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Exclusive: The Truth about Nevirapine
Mon, 20 Dec 2004 19:05:58 -0600
Nevirapine blues
Stepping over bodies on the way to market
Last week, Dr. Edmund Tramont, Head of the National Institutes of Health (NIH) AIDS division, was outed by fellow NIH AIDS researcher Dr. Jonathan Fishbein, for burying evidence of drug toxicity in an African drug trial. Documents obtained by the Associated Press show that Tramont censored reporting of thousands of toxic reactions and at least 14 deaths in the ongoing Nevirapine study in Uganda. Nevirapine is the key component of George W. Bush’s $500 million donation to get AIDS drugs to Africans.South African President Thabo Mbeki accused the U.S. of using Africans as “guinea pigs.” The Rev. Jesse Jackson echoed the statement, calling the cover-up “an outrage.”
The media has seized on this like it’s news, but the truth about Nevirapine was known in 2000, when the FDA put a black-box label on the drug, warning of the drug’s ability to cause fatal liver damage and bloody rupturing of skin and flesh.
The drug’s manufacturer, Boehringer Ingelheim, had originally slotted the drug for pregnant HIV-positive women in the U.S. But Nevirapine’s toxicities were so great, they pulled it out of the FDA approval process. Then they did what all AIDS drug manufacturers do with their garbage – dump it into the gay, Black or foreign market and tell the soft-headed liberal media that it’s an “antiretroviral” that will stop AIDS.
The Ugandan study that Tramont helped bury was overseen by Dr. Laura Guay, a U.S. doctor from Johns Hopkins University School of Medicine. Under Dr. Guay, the drug found its approval overseas. How does a drug that kills Americans save Africans?
South African lawyer and journalist Anthony Brink scrutinized the study and approval process in his 2002 online publication, “The Trouble with Nevirapine.” Brink’s work on the drug AZT was widely read by South African leadership, and prompted President Thabo Mbeki’s early criticism of the drugs being used in AIDS care. Dr. Fishbein tracked down Brink, whose Nevirapine study he described as “an expertly written piece about this very dangerous drug.”
There’s not a word in last week’s NIH mea culpa that Brink didn’t outline in greater detail a year and a half ago.
The Ugandan study (HIVNET 012 – The Lancet, Sept. 4, 1999) started like most AIDS drug trials do. Guay discarded the study controls. There was no placebo group to compare the Nevirapine group to. The exclusion of a placebo group is a near-standard protocol in AIDS research trials, where doctors claim that it would be unethical not to offer patients at least one drug. In Guay’s study, Everybody was on one of two cell-killing drugs – Nevirapine or AZT.
The study put pregnant women on one of the two pills at labor. Why at labor? The idea is to prevent transmission of HIV from mother to child. The mother’s HIV status is determined, of course, by what we call an HIV antibody test.
Here’s a clever bit of information left out of the NIH report and the mainstream press coverage – HIV test inserts warn that pregnancy produces antibodies which cause the tests to come up positive. Pregnancy, on its own, can create positive HIV test results. You’ll find this over and over again in the test packets and the medical literature (ex. Arch Fam Med. Sep/Oct 2000; Vironostika HIV-1 EIA Test 2003). But it was ignored in Uganda (as it is in the U.S., every day).
The other line of missing logic in the Ugandan study is that, according to the test manufacturers, no child can be tested for at least 18 months with any certainty, because of normal “acquisition of maternal antibodies” that can trip up the hyper-reactive HIV tests. (Oraquick HIV-1 Antibody test; MedMira Rapid HIV-1 Test 2003)
In order to get around the standard tests’ shortcomings, the babies were instead tested with a genetic kit called PCR. But here’s a minor catch. PCR isn’t validated or approved to diagnose viral infection.
PCR is irreproducible. In the lab, it gives wildly varying results for the same sample material. (MMWR. 2001 Nov 16, 2001) There’s no standard to measure it against (JAMA. May 1, 1996). PCR tests amplify scraps of unidentifiable genetic material in cells. Researchers like to pretend that this material represents some aspect of a virus – but the manufacturer warns specifically against using the test for this purpose:
“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.” (Roche PCR HIV-1 Monitor Test)
But that’s exactly how doctors and researchers are using it, to get infants into a drug study.
The liberal media has been largely silent on the issue.
[Democracy Now! ran an interview with the director of “Guinea Pig Kids, the BBC documentary based on Scheff’s reporting on Wed. Dec. 22 – ed.]
But even if the tests were accurate, and the drugs weren’t biological weapons, there’s a terrible flaw in these studies. To paraphrase Brink – what’s the purpose of a last-minute drugging to prevent the passage of a retrovirus, when the child and mother have been sharing the same blood, tissue, cells and body for nine months?
Adding insult to injury, the Guay study also became immediately unblinded. Everybody knew who was on Nevirapine, who was on AZT, and who tested positive. From the study: “After randomisation, on-site study staff and investigators became aware of the treatment and infection status of the mother-baby pairs. Mothers also knew to what study group they had been assigned after randomisation and of the infection status of their babies during the study… mothers were not masked to treatment status or outcome after randomization.” In the absence of rigorously-maintained study controls, participants in drug trials tend to give into panic, pill-sharing, over-consuming, and the mixing in of non-study drugs to try to get the HIV-antibody response to go away.
The results of Guay’s study came in with an official recommendation for Nevirapine, but only after recording an 80% rate of “laboratory abnormalities” for mothers and a 20% rate of “serious adverse events” in newborns in both the Nevirapine and AZT groups. These infants had blood and tissue infection, pneumonia, blood cell death, severe rash and insufficient oxygen reaching their tissues.
Thirty-eight babies died. Sixteen on Nevirapine, twenty-two on AZT. But Dr. Fishbein’s outing of internal Boehringer-Ingelheim documents have added at least 16 more deaths, mostly in the Nevirapine group.
The drug was approved because the rate of PCR-inferred viral infection in the Nevirapine infants was 13.1%. Lower than that of the AZT group’s PCR rating. What’s PCR? A non-diagnostic test with no standard that gives different results for every sample.
According to the medical/pharmaceutical establishment, it was enough to get a profitable, deadly drug into the international marketplace.
In “The Trouble with Nevirapine,” Brink points to another transmission study, done in July, 1998 (Journal of AIDS and Human Retrovirology). The study looked at 561 expectant African mothers and newborns to see what the rate of presumed HIV infection was with no drugs, no pills and no placebos. The result – 12%. Less than the 13.1%, with none of the drug toxicities. This result was roundly ignored in the quest to bring Nevirapine to market.
In Africa, the reactions to last week’s revelations was anger. South African President, Thabo Mbeki, who has been roundly vilified in the U.S. press for his criticisms of the drugs and tests, commented in the December 17 ANC Today:
Hafford was 33. Before entering the study, she was healthy and pregnant, but was convinced to go on the drug because of her HIV test result. In early August doctors knew that Hafford’s liver was failing. But they kept her on the drugs.
She died two weeks later due to “drug-induced hepatitis” – fatal liver poisoning. An emergency cesarean-section was performed to get her baby out of her dying body. Neither she nor her family had been given the drug’s boxed warning label prior to her entrance into the study. If she had, she might be here today.
The Nevirapine (Viramune) label:
“Ouch! Not much wwe (we) can do about dumd (dumb) docs,” he wrote, in an inner-office email, leaked to the Associated Press.
Hafford’s family is currently consulting with lawyers to see exactly how much can, in fact, be done about “dumb docs.”
So far, the major media has covered these stories as though they were exceptions to the rule. Not a single media outlet has questioned the efficacy of HIV tests, even though the test manufacturers clearly do. The guardians of the Left – Mother Jones, Democracy Now!, et al – have, for over ten years, dismissed researchers and journalists who’ve sounded the warning bell about the tests and drugs, as the lunatic fringe. So how do they account for Nevirapine, and the drug it beat out, AZT?
The NIH blow-out has not impacted Washington. On Tuesday, December 14, White House press Secretary Scott McClellan stated that Nevirapine would continue to be used in pregnant women in the US and Africa: “[T]he U.S. Public Health Service guidelines continue to recommend short-term therapy with Nevirapine as an option for women who enter care late in pregnancy.” He described Nevirapine as “a drug that can help save lives.”
McClellan added, “The NIH is taking an appropriate step to ask for further analysis of the drug. That’s what their role is in this.”
On Friday, the NIH fired Dr. Jonathan Fishbein, the AIDS researcher and whistle-blower who exposed Dr.Tramont.
As for “their role” in “further analysis” of the drug, the NIH is “currently recruiting” patients in Africa, India, Brazil, the US and Puerto Rico for trials with titles like “Daily Nevirapine to Prevent Mother to Infant Transmission of HIV,” and “Nevirapine Use to Prevent Mother-to-Child Transmission of HIV.”
It seems that the Bush administration will be able to pay Boehringer to give Nevirapine to pregnant women, after all.
Additional info:
Dr. Fishbein’s webpage: www.honestdoctor.org
Anthony Brink’s Treatment Action Group page: http://www.tig.org.za/
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.
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The media has seized on this like it’s news, but the truth about Nevirapine was known in 2000, when the FDA put a black-box label on the drug, warning of the drug’s ability to cause fatal liver damage and bloody rupturing of skin and flesh.
The drug’s manufacturer, Boehringer Ingelheim, had originally slotted the drug for pregnant HIV-positive women in the U.S. But Nevirapine’s toxicities were so great, they pulled it out of the FDA approval process. Then they did what all AIDS drug manufacturers do with their garbage – dump it into the gay, Black or foreign market and tell the soft-headed liberal media that it’s an “antiretroviral” that will stop AIDS.
The Ugandan study that Tramont helped bury was overseen by Dr. Laura Guay, a U.S. doctor from Johns Hopkins University School of Medicine. Under Dr. Guay, the drug found its approval overseas. How does a drug that kills Americans save Africans?
South African lawyer and journalist Anthony Brink scrutinized the study and approval process in his 2002 online publication, “The Trouble with Nevirapine.” Brink’s work on the drug AZT was widely read by South African leadership, and prompted President Thabo Mbeki’s early criticism of the drugs being used in AIDS care. Dr. Fishbein tracked down Brink, whose Nevirapine study he described as “an expertly written piece about this very dangerous drug.”
There’s not a word in last week’s NIH mea culpa that Brink didn’t outline in greater detail a year and a half ago.
The Ugandan study (HIVNET 012 – The Lancet, Sept. 4, 1999) started like most AIDS drug trials do. Guay discarded the study controls. There was no placebo group to compare the Nevirapine group to. The exclusion of a placebo group is a near-standard protocol in AIDS research trials, where doctors claim that it would be unethical not to offer patients at least one drug. In Guay’s study, Everybody was on one of two cell-killing drugs – Nevirapine or AZT.
The study put pregnant women on one of the two pills at labor. Why at labor? The idea is to prevent transmission of HIV from mother to child. The mother’s HIV status is determined, of course, by what we call an HIV antibody test.
Here’s a clever bit of information left out of the NIH report and the mainstream press coverage – HIV test inserts warn that pregnancy produces antibodies which cause the tests to come up positive. Pregnancy, on its own, can create positive HIV test results. You’ll find this over and over again in the test packets and the medical literature (ex. Arch Fam Med. Sep/Oct 2000; Vironostika HIV-1 EIA Test 2003). But it was ignored in Uganda (as it is in the U.S., every day).
The other line of missing logic in the Ugandan study is that, according to the test manufacturers, no child can be tested for at least 18 months with any certainty, because of normal “acquisition of maternal antibodies” that can trip up the hyper-reactive HIV tests. (Oraquick HIV-1 Antibody test; MedMira Rapid HIV-1 Test 2003)
In order to get around the standard tests’ shortcomings, the babies were instead tested with a genetic kit called PCR. But here’s a minor catch. PCR isn’t validated or approved to diagnose viral infection.
PCR is irreproducible. In the lab, it gives wildly varying results for the same sample material. (MMWR. 2001 Nov 16, 2001) There’s no standard to measure it against (JAMA. May 1, 1996). PCR tests amplify scraps of unidentifiable genetic material in cells. Researchers like to pretend that this material represents some aspect of a virus – but the manufacturer warns specifically against using the test for this purpose:
“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.” (Roche PCR HIV-1 Monitor Test)
But that’s exactly how doctors and researchers are using it, to get infants into a drug study.
The liberal media has been largely silent on the issue.
[Democracy Now! ran an interview with the director of “Guinea Pig Kids, the BBC documentary based on Scheff’s reporting on Wed. Dec. 22 – ed.]
But even if the tests were accurate, and the drugs weren’t biological weapons, there’s a terrible flaw in these studies. To paraphrase Brink – what’s the purpose of a last-minute drugging to prevent the passage of a retrovirus, when the child and mother have been sharing the same blood, tissue, cells and body for nine months?
Adding insult to injury, the Guay study also became immediately unblinded. Everybody knew who was on Nevirapine, who was on AZT, and who tested positive. From the study: “After randomisation, on-site study staff and investigators became aware of the treatment and infection status of the mother-baby pairs. Mothers also knew to what study group they had been assigned after randomisation and of the infection status of their babies during the study… mothers were not masked to treatment status or outcome after randomization.” In the absence of rigorously-maintained study controls, participants in drug trials tend to give into panic, pill-sharing, over-consuming, and the mixing in of non-study drugs to try to get the HIV-antibody response to go away.
The results of Guay’s study came in with an official recommendation for Nevirapine, but only after recording an 80% rate of “laboratory abnormalities” for mothers and a 20% rate of “serious adverse events” in newborns in both the Nevirapine and AZT groups. These infants had blood and tissue infection, pneumonia, blood cell death, severe rash and insufficient oxygen reaching their tissues.
Thirty-eight babies died. Sixteen on Nevirapine, twenty-two on AZT. But Dr. Fishbein’s outing of internal Boehringer-Ingelheim documents have added at least 16 more deaths, mostly in the Nevirapine group.
The drug was approved because the rate of PCR-inferred viral infection in the Nevirapine infants was 13.1%. Lower than that of the AZT group’s PCR rating. What’s PCR? A non-diagnostic test with no standard that gives different results for every sample.
According to the medical/pharmaceutical establishment, it was enough to get a profitable, deadly drug into the international marketplace.
In “The Trouble with Nevirapine,” Brink points to another transmission study, done in July, 1998 (Journal of AIDS and Human Retrovirology). The study looked at 561 expectant African mothers and newborns to see what the rate of presumed HIV infection was with no drugs, no pills and no placebos. The result – 12%. Less than the 13.1%, with none of the drug toxicities. This result was roundly ignored in the quest to bring Nevirapine to market.
In Africa, the reactions to last week’s revelations was anger. South African President, Thabo Mbeki, who has been roundly vilified in the U.S. press for his criticisms of the drugs and tests, commented in the December 17 ANC Today:
“Clearly, what was important for Dr Tramont was not the health of the African people, but the success of President Bush’s visit to our continent, during which he would market Nevirapine to convince all of us that he is concerned about our health, not knowing that the U.S. state medical research authorities had kept him ignorant about the serious concerns relating to the use of Nevirapine.
In other words, Dr Tramont was happy that the peoples of Africa should be used as guinea pigs, given a drug he knew very well should not be prescribed.”This summer in the U.S. the same drug was being used in an NIH sponsored trial of U.S. patients. Another expectant mother, Joyce Ann Hafford, had been dosed with Nevirapine (commercially sold here as “Viramune”) because she too had a reaction on an HIV test.
Hafford was 33. Before entering the study, she was healthy and pregnant, but was convinced to go on the drug because of her HIV test result. In early August doctors knew that Hafford’s liver was failing. But they kept her on the drugs.
She died two weeks later due to “drug-induced hepatitis” – fatal liver poisoning. An emergency cesarean-section was performed to get her baby out of her dying body. Neither she nor her family had been given the drug’s boxed warning label prior to her entrance into the study. If she had, she might be here today.
The Nevirapine (Viramune) label:
“Warning: Severe, life-threatening, and in some cases fatal hepatotoxicity [liver poisoning], including fulminant and cholestatic hepatitis, hepatitic necrosis [liver death] and hepatatic [liver] failure, has been reported in patients treated with VIRAMUNE [Nevirapine]…Patients with signs or symptoms of hepatitis must discontinue VIRAMUNE and seek medical evaluation immediately.
Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with VIRAMUNE. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis [skin death], and hypersensitivity reactions characterized by rash, constitutional findings and organ dysfunction.
It is essential that patients be monitored intensively during the first 18 weeks of therapy with VIRAMUNE to detect potentially life-threatening hepatotoxicity or skin reactions….In some cases, hepatatic injury has progressed despite discontinuation of treatment. VIRAMUNE should not be restarted following severe hepatatic, skin, or hypersensitivity reactions.”Dr. Edmund Tramont, of the NIH, had these thoughtful words to offer on the subject:
“Ouch! Not much wwe (we) can do about dumd (dumb) docs,” he wrote, in an inner-office email, leaked to the Associated Press.
Hafford’s family is currently consulting with lawyers to see exactly how much can, in fact, be done about “dumb docs.”
So far, the major media has covered these stories as though they were exceptions to the rule. Not a single media outlet has questioned the efficacy of HIV tests, even though the test manufacturers clearly do. The guardians of the Left – Mother Jones, Democracy Now!, et al – have, for over ten years, dismissed researchers and journalists who’ve sounded the warning bell about the tests and drugs, as the lunatic fringe. So how do they account for Nevirapine, and the drug it beat out, AZT?
The NIH blow-out has not impacted Washington. On Tuesday, December 14, White House press Secretary Scott McClellan stated that Nevirapine would continue to be used in pregnant women in the US and Africa: “[T]he U.S. Public Health Service guidelines continue to recommend short-term therapy with Nevirapine as an option for women who enter care late in pregnancy.” He described Nevirapine as “a drug that can help save lives.”
McClellan added, “The NIH is taking an appropriate step to ask for further analysis of the drug. That’s what their role is in this.”
On Friday, the NIH fired Dr. Jonathan Fishbein, the AIDS researcher and whistle-blower who exposed Dr.Tramont.
As for “their role” in “further analysis” of the drug, the NIH is “currently recruiting” patients in Africa, India, Brazil, the US and Puerto Rico for trials with titles like “Daily Nevirapine to Prevent Mother to Infant Transmission of HIV,” and “Nevirapine Use to Prevent Mother-to-Child Transmission of HIV.”
It seems that the Bush administration will be able to pay Boehringer to give Nevirapine to pregnant women, after all.
Additional info:
Dr. Fishbein’s webpage: www.honestdoctor.org
Anthony Brink’s Treatment Action Group page: http://www.tig.org.za/
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.
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