Why the "HIV Tests" Canít Tell You Whether You Have HIV

By Mark Gabrish Conlan

Zengerís Newsmagazine Oct. 2001

Rodney Richards, Ph.D., didnít start out as an AIDS rebel when he began his career as an organic chemist in 1982. The company he started to work for that year -- then known as Applied Molecular Genetics and now called Amgen, the worldís largest biotech company -- originally had him work on synthesizing DNA. In 1984 Amgen started working on a joint venture with Abbott Laboratories, the first licensee of the ELISA [Enzyme-Linked Immunosorbent Assay] test for HIV antibodies from inventor Dr. Robert Gallo, in which Amgen would help Abbott develop new technologies for diagnostic tests. (Contrary to popular belief, as Dr. Richards explains below, ELISA and the other "HIV tests" are neither licensed nor marketed as diagnostic tests.) "Thatís how I got started with the HIV/AIDS business," Dr. Richards recalled.

Dr. Richardsí view of AIDS went through a dramatic change in 1991. Amgenís partnership with Abbott had ended, and he had been assigned to develop a competing technology to the so-called "viral load" test for HIV. As he explained, it was a company tradition at Amgen that before a new product was developed they would invite consultants on both sides -- those who felt the company shouldnít do the product as well as those who felt it should. As one of the "devilís advocates," so to speak, Dr. Richards invited UC Berkeley professor Peter Duesberg, Ph.D., to make a presentation on his view that HIV couldnít cause AIDS and therefore a test purporting to measure HIV levels would be useless in fighting AIDS. He also invited Kary Mullis, Ph.D., who had won the Nobel Prize for inventing the PCR technology on which the "viral load" was developed, and who told his Amgen audience about his fruitless struggle to find a scientific reference actually establishing HIV as the cause of AIDS.

Though Dr. Richards was stunned that the other Ph.D.ís at the company actually boycotted Duesbergís presentation, and the people who did come "went back to their bosses and were re-indoctrinated into the mainstream principles," he himself was inspired to study the issue further. The more he read, the more he decided that Duesberg and Mullis were right about HIV and AIDS, and all the mainstream sources were wrong. Because of his background, he has concentrated on debunking all the major HIV tests -- ELISA and Western Blot antibody tests, p24 antigen, PCR "viral load" and branch DNA [bDNA] -- and explaining how they canít actually establish whether or not a person has an active HIV infection, much less how many viruses are supposedly "infecting" them.

Dr. Richards will be carrying his message to three locations in Southern California in mid-October. Heís scheduled for two appearances in the Los Angeles area: an AIDS Reality Check meeting on Tuesday, October 9, 7:30 to 9:30 p.m., at the Community Room, 8000 Sunset Mall, 8000 Sunset Blvíd. at Crescent Heights in L.A.; and an Alive & Well AIDS Alternatives meeting Wednesday, October 17, 7:30 p.m., at West Hollywood Parkís Wirle Building, 626 N. Robertson Blvíd. between Melrose and Santa Monica. Dr. Richards will also speak to H.E.A.L. [Health, Education, AIDS Liaison]-San Diego Tuesday, October 16, 7 to 9 p.m., at the Fault Line Theatre, 3152 Fifth Avenue (between Redwood and Spruce) in Hillcrest.

Zengerís: In the proverbial nutshell, whatís wrong with the "HIV tests"?

Rodney Richards, Ph.D.: The main problem with so-called "HIV tests" is that people use them to diagnose HIV. In fact there is no test for HIV. Itís just an illusion. I didnít realize this when I first started developing HIV tests. I thought that we were actually going to detect HIV.

However, early on when we were working in collaboration with Abbott Laboratories, it was clear that there was no gold standard for HIV: no direct isolation of the virus. I was a little confused how Abbott Laboratories could make the test when they had no gold standard, but I also was young and uneducated to the field, so I just wrote it off as something that I did not understand. As I went along, I realized that the tests that are today called "HIV tests" do not detect HIV.

The problem with these tests is that people use them to diagnose infection with a virus called HIV, and theyíre not approved for that purpose. The manufacturers clearly state that the products that they develop are not intended to be used for diagnosing HIV. The two major problems with this are that physicians use these tests to tell people theyíre infected with a deadly virus, and, decisions to initiate therapy are based on these tests as well.

Zengerís: As I understand it, there are a number of these tests. There are the tests that measure, or purport to measure, HIV antibodies: the ELISA and the Western Blot. Then there are the so-called "viral load" tests, which are based, as I understand it, either on the PCR technology which Kary Mullis invented, or an older technology called branch DNA. Could you go down the list and explain to me whatís wrong with each of the tests, what are their limitations, do they have any validity at all, and if so, what?

Dr. Richards: Broadly speaking, there are two categories of tests for HIV. Again, I want to emphasize that there really is no test for "HIV," but tests that seek to find evidence for the presence of HIV. These can be broadly divided into two categories. One is looking for evidence of current or past presence of the virus by looking for antibodies. And the two tests that we know in this category are the ELISA and the Western Blot.

The other category of tests are those that look for fragments of the virus. These would include the viral load test, which looks for a small fragment of genetic material believed to be unique to HIV; and the p24 assay, which again is looking for evidence of a fragment of the virus -- in this case, a protein rather than genetic material. The branch DNA [bDNA] test, is another version of the viral load test. Again, it seeks to quantify or detect genetic material believed to be unique to the virus called HIV.

As I said before, the antibody tests are being used to diagnose infection, whereas even the manufacturers do not claim that their products can detect the presence or absence of HIV in a sample. The same is true of the other tests that look for fragments; neither the p24 assay nor the viral load or bDNA tests have been approved by the FDA for diagnosing HIV infection. Theyíre not even intended to diagnose HIV infection.

Zengerís: So why do the tests not work to diagnose HIV infection? What about them limits them so they cannot accomplish that?

Dr. Richards: The reason weíll never know the answer to that question is that, once again, there is no gold standard -- meaning a direct viral isolation -- to compare these tests to. For example, one could use the ELISA to diagnose HIV infection if there was a follow-up test to show that every time the ELISA shows that a sample is positive for antibodies, that indeed there is also virus in the sample. But in the case of HIV -- and also, these days, HCV, hepatitis C virus -- there is no gold standard, namely a way to isolate and prove that the virus is actually present in a sample.

Zengerís: Is that really so important? Because Luc Montagnier, who is generally credited with discovering HIV, and a number of other virologists have said, "Well, we donít have to do that anymore. We donít have to isolate an entire virus to prove that there is a virus. We have better, more sophisticated methods, and therefore pure viral isolation -- aside from it being incredibly difficult -- is something that we donít have to bother to do anymore."

Dr. Richards: I would be in disagreement with that. I think that, had it been done once or twice, with several hundred or several thousand samples that show that there indeed is a correlation, then I would say fine. Letís go on with life. Youíve proven to me, or youíve convinced me, that these test correlates with the actual presence of the virus. This is how most diagnostic products are developed. Once or twice, or maybe three times, we have to prove that the test result, regardless of what itís based on, correlates with the actual germ or pathogen in the sample.

This has never been done with any of the HIV tests; nor has it been done with hepatitis C either. What Luc Montagnier and the others are arguing is that since we have such a diverse collection of indirect evidence, we really should go ahead and believe that HIV is present. In other words, when the antibody test lights up, sometimes weíll see the PCR light up. And when they both light up, sometimes weíll see the culture light up. As I said before, thatís fine after youíve validated a test one single time. The problems go beyond this particular argument, but one of the fundamental disagreements between the dissidents and the mainstream is that they argue that we donít have to do this anymore. I would agree, provided you did it once.

Zengerís: Once again, can you take me through all the tests in sequence and tell me what else is wrong with them, besides the lack of validation of any of them with a gold standard of actual isolation? The ELISA first.

Dr. Richards: One of the problems with ELISA is, first of all, it was designed not to diagnose infection in the high-risk groups, but rather to protect the general population through the blood supply. This test was approved in 1985 by the FDA for screening blood. One of the first problems that came out of this was that thousands, literally perhaps tens of thousands of people per year, were testing positive on the ELISA. These were healthy blood donors.

This presented a very serious problem, depending on your point of view. For the person who received the positive test, it was a serious problem because they were told by collection agencies, "You may or may not be positive, we donít know, so please go to your doctor and your doctor will clarify the issue." However, at the time doctors had no tools -- which they still donít -- to confirm whether or not people are infected.

This led to a nightmare. Blood banks didnít care. They said weíre just going to throw away all the samples that test positive. This was maybe 1 in 400 to 1 in 100 samples that came into blood banks tested positive. So from the point of view of the blood banks, they just said throw them all away. However, the CDC [Centers for Disease Control] said no, we must tell all the donors, because they potentially might be infected and they will go around infecting other people. Doctors were presented with a dilemma as well, because they had no tools to resolve the dilemma that their patients were in.

So here we had tens of thousands of people that went to donate blood, suddenly living a life of anxiety. They had no idea whether they were infected or not. It resulted in social turmoil. It creates problems in the family, because how do you go home and tell your spouse that you might be HIV-infected? As you can imagine, it was a mess. The general public was really unaware of all this, and I think they are still today. But at that time there was no way to resolve whether or not a donor was truly infected.

Thatís what gave birth to the Western Blot. Doctors were faced with these thousands of patients that had no idea if they were going to die or not, and they had no tools to resolve it other than the CDCís recommendation that they could use the Western Blot -- even though the Western Blot was not yet approved by the FDA for diagnosing antibodies or virus.

It turned out that at least 50 percent of these people who were ELISA-positive also had antibodies to one or more of the nine bands on Western Blot. I donít know if you want me to explain what bands are, but itís a series of proteins on a strip of paper, and if antibodies stick to those proteins, it does something called "light up," which means it becomes visual.

This didnít really help resolve the problem of who was infected and who was not infected in the general public, because, as I said, approximately 50 percent of these healthy blood donors, without any risk factors, were not only testing positive on ELISA but Western Blot as well. Yet the same test results in the established AIDS "risk groups" -- the male homosexual community and the IV drug-using community -- were being used to say youíre confirmed "positive"!

So this presented a very big dilemma. Why were test results in the Gay community and IV drug-using community being declared positive, when the exact same test results in healthy blood donors were being called -- well, there wasnít really a term for it. It was just, "We donít know." The same tests results in healthy blood donors were meaningless; and yet in the risk groups they were said to be "confirming infection."

Zengerís: Iíve heard that argument before, and one of the arguments Iíve heard the mainstream make against it is that, at least in California and some other states as well, HIV testing is available anonymously. When the sample goes to the lab, itís supposed to be identified only by a number, and theyíre not supposed to have any idea where that number came from. So therefore they would have no way of knowing whether this came from a Gay man, or an IVDU, or a healthy blood donor, or anybody. They would have no way of doing this kind of social screening that youíre talking about.

Dr. Richards: Youíre saying that there would be no way to bias the results to a "positive" for a risk-group member, if I understand you correctly. And thatís true. What eventually happened to resolve this problem was that different institutions -- public-health institutions, government institutions, whatever -- developed something known as "evaluation criteria" for Western Blot. That means that instead of just looking for antibodies to HIV proteins on the Western Blot, they look for combinations of banding patterns. And they chose combinations that minimized the numbers of blood donors testing positive and maximized the numbers of people in risk groups testing positive.

For example, the CDC has their own criteria. The World Health Organization has a different set of criteria. Germany has a different set of criteria. Different countries, different institutions, all have different sets of criteria. Once you pick a set of criteria, you have to stick to it. I believe today that there is no bias in this direction. Itís been fairly much resolved. That does not mean, however, that these tests have anything to do with HIV.

I would like to point out that even on Abbott Laboratoriesí ELISA package insert, they do emphasize that the degree of risk of the person being tested may be useful in interpreting the test. So with a truly anonymous test at a public health clinic, I agree that thereís no bias. However, in a doctorís office, where a person is working with a patient, these tests can still be interpreted according to the risk factors.

Zengerís: In the September 1996 issue of Zengerís Newsmagazine we published a list compiled by Christine Johnson of Los Angeles of 64 possible causes of a false-positive, some just on the ELISA, some on the Western Blot -- her list did not specify which was which. Her argument was that the tests were non-specific and that a lot of other sorts of antibodies to other infections, including herpes, hepatitis, malaria and flu, could also trigger a positive test. Is that correct?

Dr. Richards: That is correct. In fact, every diagnostic test for any germ thatís based on antibodies has the same problem. Itís a well-recognized problem attributed to whatís known as "cross-reactivity." In other words, antibodies to germ A may coincidentally react to germ B. So this has been well known, although not well advertised in the area of HIV testing.

I think itís even more extraordinary in the field of HIV. Exactly why this is, I do not know. I think it is because in the case of HIV weíre relying only on antibodies, without any gold-standard validation, so we canít resolve the issue. But Christineís absolutely right. There are a plethora of different conditions or infections which can cause false-positive reactions on both ELISA or Western Blot.

In fact, most people donít know this, but 20 percent of the population of the United States have antibodies to one or more of the bands on Western Blot. When you start adding other potential bands by cross-reactions to other potential conditions or germs, you run the risk of getting that magic combination, which I call the "evaluation criteria," and as soon as you get that magic combination youíre unequivocally considered "infected."

Zengerís: Another thing I wanted to ask you about regarding the antibody tests: Dr. Roberto Giraldo of New York recently published an article in Rethinking AIDS where he said that the blood samples for the ELISA and Western Blot are extensively diluted, like to about 400 times; and if they werenít, every sample would test positive. Is that correct?

Dr. Richards: That is correct. I have not run that experiment, but thatís a correct interpretation of his results. He found out that if blood samples are not diluted, virtually 100 percent of them light up on ELISA. Weíve talked about the possibility of conducting the same experiment with Western Blot. We have not completed that yet, but I think it would be a very exciting experiment to run, and I would predict we would see the same thing: that probably 100 percent of Americans are positive on Western Blot if we do not dilute the serum.

Zengerís: Why would that be?

Dr. Richards: Thatís because, I believe, most of these are due to cross-reacting antibodies. As you dilute out the serum, youíre diluting out the concentration of cross-reacting antibodies. The more we dilute the serum, we see fewer and fewer cross-reactions. However, in people with elevated levels of antibodies, we would still see positive results.

So thereís a threshold where you can distinguish between people with a lot of antibodies, and those with a normal level of antibodies. And, though itís not well known, experts are well aware of the fact that in people with AIDS conditions, itís almost universal that thereís an elevated level of antibodies. This was known back in 1984.

In 1983, 1984, 1985 the experts in the field recognized that along with a loss of what we know today as CD-4 cells, there was a simultaneous increase in the circulating level of antibodies in people that were progressing in the syndrome. So persons with more antibodies are going to continue to test positive, even at a 400-fold dilution; while people with fewer antibodies are going to test negative.

Zengerís: So what youíre suggesting is that the correlation, to the extent that one exists, between testing "HIV-positive" and having AIDS is not because you get HIV, therefore you test positive, therefore you get AIDS; but is because you already have an immune-system disorder, you are cranking out elevated levels of antibodies, therefore you test positive, therefore they say you have HIV.

Dr. Richards: Yes, thatís the argument I am putting forth. Now, it may be that there is a virus called HIV and that people who are testing positive on these tests have antibodies to that virus. It may even be that this virus is lethal. Thereís no scientific evidence as such. However, I think in general, what these tests are measuring is a condition called hypergammaglobulinemia. I know thatís a big word, but that means too many antibodies to too many things. These tests are simply separating those with a broken immune system from those with a healthy immune system.

The reason we never hear about this other feature of AIDS -- namely, that thereís a broken antibody arm of the immune system -- is because people think thereís not a way really to test it. CD-4 cells are easy to measure. There are instruments that measure these. However, measuring a broken antibody arm of the immune system is perceived to be difficult, if not impossible. And I would argue that we do have a measure for that. Itís called the HIV ELISA and Western Blot.

Zengerís: So the tests do have a use after all, as long as you donít think they actually measure HIV infection.

Dr. Richards: Yes, I believe these tests could be of value if they were used as a prognostic tool; if we use these tests simply to acknowledge that there may be a problem. I believe in risk groups people who test positive, on average -- not everybody, but on average -- are predisposed to disease progression. The danger of using these for diagnosing "HIV" is that we start attacking the virus with dangerous, toxic chemicals. Not to mention a death sentence, which can cause a lot of psychological damage.

Zengerís: Moving on to the viral load tests -- and we can also talk about the p24, because these tests do purport to measure actual components of the virus -- could you just basically outline the problems with those?

Dr. Richards: Once again, these tests are not intended to diagnose HIV infection. The manufacturers make no such claims that they can diagnose infection. And yet theyíre still being used not only to diagnose infection, but also to initiate treatment. Neither the p24, nor the viral load, nor the bDNA test, has been approved by the Food and Drug Administration for initiating therapy.

Why is this happening? I donít know. Itís such an easy test to run, and it gives a person a feeling that there might actually be virus in the body; and not only that there is virus, but how much. I believe itís clear that the viral load, again, correlates with disease progression at whatís called baseline. In other words, when a person first gets sick, before theyíve received any therapy, there is a correlation with higher viral load levels and more rapid disease progression.

The problem is itís perceived that if we then lower that viral load count, the patients will do better. And the viral load test has been approved for this purpose. In other words, itís called "managing the treatment." The viral load test has been approved for "managing" the HIV infection, but not to initiate therapy. That has to be based on some other call.

Zengerís: As I understand, itís usually based on [CD-4] T-cell levels.

Dr. Richards: Thatís up to the doctor. Youíd be surprised. Today the viral load is the major decision-making factor in changing or initiating or altering therapy.

Zengerís: With most of the people with AIDS I know -- or people with HIV who are in "therapy" -- their doctors test for both T-cells and viral load, and make the decisions to start or stop or change drug regimens based on those two numbers.

Dr. Richards: Right. Itís a combination of factors. Certainly, somebody with low T-cell counts and high viral load will be treated much more aggressively, and earlier, than somebody with the opposite scenario.

Another problem with viral load tests is that both the CD-4 counts and the viral load levels are now being used to approve drugs. Over half of the drugs that are on the market for treating "HIV/AIDS" have been approved for marketing based only on these markers. Theyíre called "surrogate markers." The drugs have never been approved on the basis of what they actually do for the patient. Itís all been done on these surrogate markers that are believed to be correlated with disease progression. And yet there really is no sound scientific evidence that changes in these surrogate markers ultimately correlate with improved survival.

Zengerís: As I recall, that was a change that AIDS activists, and particularly AIDS patients, demanded in the late 1980ís and early 1990ís. They said, "We are dying. We donít have time to wait for actual proof that these drugs are effective. The FDA needs to get its ass in gear and get these things to the market faster, and approve them on the basis of surrogate markers rather than waiting the extra years it would take to determine actual clinical benefits based on running a research project and seeing who gets sick and dies."

Dr. Richards: Exactly. Youíre absolutely right. I think that this syndrome, AIDS, was predisposed for this type of approval process. Politically there was a great demand in the Gay community in particular for rapid approval. Also, progression from HIV to AIDS is so extremely slow that youíd have to enroll huge numbers of people into clinical trials to actually see a clinical benefit. You may need 2,000 or 3,000 or 4,000 people followed for one, two, three years to see a clinical benefit. Whereas these surrogate marker trials can be done on 200 or 300 people, or even fewer, in a period of 24 weeks.

So the standard today is a 24-week evaluation of viral load and CD-4 changes. Thatís all thatís required for what used to be called "provisional approval" of products by the FDA. The FDA provides these provisional approvals with the understanding that these drugs have ultimately to demonstrate clinical benefit or be pulled from the market. However, some of these have been on the market now for, I think, seven, eight years without demonstrating any clinical benefit, and the FDA has not yet pulled them from the market. Why? Because everybody loves them.

Zengerís: Right: the people with AIDS and HIV who think their lives are being saved by these drugs love them, and so do the shareholders of the drug companies that make them.

Dr. Richards: Exactly -- and not only that. The physicians, who are completely lost on how to manage this syndrome, can use the numbers, and they love them as well.

Zengerís: One other thing I wanted to ask you about is that people who inquire of the National Institutes of Health (NIH) for the evidence that HIV causes AIDS are referred to a very long document that was posted to their Web site in 1995, and I think has been revised a bit since, which says that the proof that HIV causes AIDS is based on PCR tests that show that HIV meets Kochís postulates as the cause. I wanted your comment on that.

Dr. Richards: Once again, I would say if PCR, or viral load, or ELISA, or Western Blot, had ever been validated against the presence of virus, then they could say that these tests can be used to fulfill at least a part of Kochís postulates: namely, that you have to find the germ in all cases of the disease. However, that is simply not true.

None of these tests -- and the manufacturers are the only ones that seem to know this -- but these tests are not claimed to correlate with the presence of virus. Yet in the research community, the mainstream research community, if any one of these tests comes up positive, itís used as evidence that the germ is there. Nobody has ever demonstrated that HIV is present when any combination, or any one, of these tests comes up positive.

Therefore, their position that a positive PCR proves the presence of virus is based on nothing other than pure faith. And if they want to have faith in that, thatís their choice. I would rather see some scientific evidence, and I think that Dr. Koch would have liked to see that as well.

At least one thing the mainstream admits is that viral load levels are disparate from actual culture tests by at least 10,000 to 1, up to 10 million to 1. On average I should say this is 60,000 to 1. Thatís sort of the number the mainstream accepts. In other words, if you have a viral load level of 60,000, that means you would have one culturable particle per milliliter of blood. Also, many, many people that are considered "positive" by PCR, ELISA, Western Blot, come up completely negative on culture.

Zengerís: Thatís a point thatís always confused me, because if the virus has never actually been isolated, what are these so-called "culture methods" culturing?

Dr. Richards: First of all, I would like to emphasize that the virologists will say that it has been isolated. The chemists, on the other hand, would say no, it hasnít. A chemist wants to see something purified in a bottle, and look at it under a microscope. The virologist just wants to see phenomena that are believed to be consistent with the presence of a virus, so you get to say something was "isolated."

So when someone says they have used "culture isolation" -- theyíve "isolated the virus by culture" -- that means theyíve seen indirect evidence for the presence of the virus such as reverse transcriptase activity; a fragment of the virus called p24. But nobody has used culture to actually put in a bottle or a jar or a test tube enough viral particles so they can be characterized.

Zengerís: One point Iíve heard from the mainstream, particularly in response to Dr. Mullis and his prestige as the inventor of the PCR, is that the current viral load tests are using branch DNA, which is supposedly a much more accurate, much more precise measure than PCR, and therefore all Dr. Mullisís objections to the validity of the viral load tests for diagnostic purposes, based on the limitations of the PCR, do not apply. Could you comment on that?

Dr. Richards: Well, once again, you can flip a coin, and as long as you can show that when it comes up heads thereís virus there, you can use that test to validate virus. None of these tests can be validated, ever. Period. Because we donít have a way to isolate and culture HIV to prove its existence.

The bDNA test does not do an amplification like the PCR. The PCR is prone to false positives because of small amounts of contamination in a testing laboratory, for example. Then itís amplified several million to a billion fold, and therefore a small amount of contaminant can come up positive, producing a false positive.

The bDNA looks directly for the genomic material -- or the genomic fragment, I should say. When I say "genome," that means the complete set of DNA -- or, in this case, RNA -- for the virus. Therefore itís less prone to problems in the testing lab. But it still does not prove the presence or absence of a virus in a sample. All that itís looking for is the presence or absence of a fragment of genetic material believed to be unique to HIV.

A shorter version of this article appears in the October 2001 issue of Zengerís Newsmagazine. Subscriptions to Zenger's are available by sending $25 (in the U.S.) or $40 (anywhere else) in U.S. funds to Zenger's, P. O. Box 50134, San Diego, CA 92165.