Chapter Seven
“Dr. Richardson, yesterday morning you talked about the fact that at least some of the proteins on this list, which Dr. Gallo claimed came from HIV, were in fact not proven to be specific or unique for HIV at all.”
Campbell started where he left off the previous morning. The large easel is still in front of the jury with the list of the proteins used in the HIV ELISA test, and Richardson seems anxious to get on with his testimony.
“Isn’t there some way,” Campbell asks, “that we could prove whether an HIV test is accurate or not?”
“Accurate for what?” Richardson wants to know.
“Accurate for diagnosing infection with HIV, which is how the test is being used today,” Campbell clarifies.
“Definitely,” Richardson declares. “It’s actually a very simple process that’s been used to establish the accuracy of virtually every other test used to diagnose infection with any germ. It’s called validation.”
“Please explain to the court what ‘validation’ is.”
“It’s a fairly simple procedure. You run your ELISA antibody test on a large group of subjects, and let’s say you get 1000 people out of that group who test Positive. You take those 1000 people and you culture their blood or their tissues see if you can find the actual virus itself.”
“And if you find some virus?”
“Then you know your ELISA test for the antibodies to the virus matches up with the actual presence of the virus. Remember our analogy from yesterday about the bear tracks? Well, validation is like actually finding a bear in the woods that could have made the tracks. You would then have Direct Proof and ‘validation’ that the bear tracks were indeed a result of the bear having been there. If you can’t find the bear, then there is a distinct possibility that those tracks were made by something else and just looked like bear tracks. In exactly the same way, you have to find the actual virus to know for a fact that the antibodies are associated with it.”
“And if you don’t find the virus?”
“If you don’t find the virus, you can’t claim that a positive test result is synonymous with infection.”
“I see,” Campbell says as he looks at the jury, hoping they ‘saw’ as well.
“So half of the validation procedure is done when you’ve actually found the virus by culture in those people who tested Positive on the ELISA. The other half of the validation test is to take 1000 of those who tested negative on the ELISA and culture their blood or tissues well. And you better not find evidence of past or current viral infection in them, or your ELISA test is equally doomed.”
“So out of 1000 people who tested Positive, you have to find all 1000 with the virus, and out of….”
Richardson interrupts quickly. “No, I didn’t mean to imply that. I don’t know of any validation study that ever found an ELISA test accurate 100% of the time. In fact, this kind of validation study is what is used to determine what are called the ‘specificity’ and ‘sensitivity’ of an ELISA test. You don’t have to find all 1000 with the virus; but you better find a very high percentage, like 98% or more, or your ELISA test is suspect. So if you find the virus in 980 out of 1000 people who tested Positive, for example, then your test is considered to have a ‘specificity’ of 98%. In other words, you have 2% who were false positives. On the other hand, if you do find the virus in 20 of the 1000 who tested Negative, then your test is considered 98% ‘sensitive’ – with 2% false negatives. Validation results like that, in the 98-plus percentile for both specificity and sensitivity, would determine the accurate of your test.”
“And to take that and apply it specifically to the HIV ELISA test?”
“To validate the HIV ELISA as a diagnostic test, you would have to run it on quite a large group of people, since HIV is supposed to infect only about 4 out of 1000 people, and you should have at least 1000 people who test Positive to run any kind of validation study. So we would have to test at least 250,000 people to find 1000 who tested HIV-Antibody-Positive.”
“And then…”
“…and then you do a blood culture on those 1000 to isolate the virus and see how many people who tested Positive actually had HIV. If you could find the actual virus in 990 out of 1000, your test would be said to be 99% specific.”
“And you would also take 1000 people…”
“…who had tested negative on the HIV ELISA test. If you found ten of them, for example, who did have the actual virus – in other words, had a false negative result – your test would be 99% sensitive.”
Campbell pauses for effect, to set the stage for his next, very important question. “Dr. Richardson, was this validation procedure done with the HIV ELISA test?”
“No. Never.”
“Why not?”
“First of all, whenever it was tried, it failed – one of the reasons being that, as I said earlier, HIV is very difficult to find and culture in a patient, even in patients with full-blown AIDS. And secondly, most of the attempts at validation came back with very poor results, finding HIV in only a small percentage of those who had tested Positive on the ELISA. So they quit trying.”
“But I thought you said that this validation procedure was the accepted standard for all diagnostic tests?”
“It was. But ever since HIV came into the picture in the mid ‘80’s, a lot of standard medical science has been thrown out the window. First, to be able to say that HIV causes AIDS, Dr. Gallo had to ignore a set of rules that had been used for over a hundred years to determine the cause of an infectious disease, called Koch’s Postulates. He also ignored standard operating procedure for any new discovery, which was to send your research to your peers for them to test and corroborate prior to announcing your findings to the public as established fact. Instead Dr. Gallo just held a press conference and gave HIV to the world before anyone could see or test his work. Next he dismissed the standard protocol for proclaiming the discovery of a new retrovirus, saying an electron microscopic photograph of in vivo HIV was no longer necessary for isolation. And lastly he did away with needing a gold standard by which to judge the accuracy and efficacy of an antibody test by eliminating the need for validation studies.”
“I’m sorry… you used a term in there… ‘gold standard’? What’s a ‘gold standard’?”
“A gold standard is a test or procedure regarded as definitive proof of something. Actually, the American Medical Association now calls it a criterion standard.”
“And in the case of the HIV ELISA test, what would the gold standard, or criterion standard be?”
“As I just said, it would be a study that shows that when the HIV ELISA test has a positive result, the actual virus can be found in the vast majority of patients, and vice versa.”
“But you said that had never been done.”
“No, it hasn’t.”
“So what is the gold standard being used today for the HIV ELISA test?”
“There is none.”
Sarah is not the only one taken by surprise. She can hear a gasp make its way around the courtroom.
“None?” Campbell asks, almost in disbelief.
“No. There is nothing to prove how accurate or inaccurate the HIV ELISA tests are as a diagnostic test, just like there is nothing to prove that the proteins used in the test are specific or unique to HIV. Or maybe I should say that the other way around: since there is no proof that the proteins used in the HIV ELISA test are specific or unique to HIV, and no validation study to cross-check test results with actual virus isolation, there’s no way to determine the accuracy of an HIV ELISA test as a diagnostic tool.”
Campbell walks to the jury box, stops, turns to the witness, points to the defendant, and asks, “Dr. Richardson, in your expert opinion, if the HIV ELISA test has never been validated, is there any way to say that the defendant, who has supposedly tested Positive, actually has HIV?
“No, there isn’t, Mr. Campbell.”
“Or that he even has the antibodies to HIV?”
“No, there isn’t, Mr. Campbell.”
Campbell then turns to face the jury. “Dr. Richardson, in your expert opinion, if the HIV ELISA test has never been validated, is there any way to say that anyone who has supposedly tested Positive actually has HIV – or the antibodies to HIV?”
“No. There are no peer-reviewed scientific studies to prove that the proteins used in the HIV ELISA test are specific and unique for HIV, and no validation studies to be used as a gold standard for the test.”
Sarah is stunned, and quickly realizes that the jury is as well. What surprises her even more is that Armand is not objecting, or even showing any signs of concern. What a poker face, she thinks. Either he expected this testimony, or he’s got an Ace of Spades up his sleeve.
Campbell has slowly made his way back to the lectern. Sarah assumed he would end his questions there, with the big bang; but he’s obviously not finished with this witness.
“I know you may think this question is redundant, Dr. Richardson, but… why? Why isn’t there a gold standard for the HIV test?”
“The best answer I can give you is because HIV itself has never been properly isolated using the accepted protocols in place since 1973 for retroviral research. There is even a group of scientists who claim that it has never been proven that HIV exists; and although I know that sounds like a pretty far-out theory, I have to admit that they make some very good points.”
“But everyone agrees that HIV exists and causes AIDS and can be detected by an ELISA test.”
“Not everyone. Mr. Campbell. I don’t. Many well-respected scientists and doctors don’t. There’s a list of 2500 of them, along with health care workers, researchers, journalists, chiropractors, and other professionals at a website called RethinkingAIDS.com, including two Nobel Prize winners and members of the U.S. National Academy of Sciences.”
“So how did someone – whoever it was – convince us that the HIV tests could accurately detect antibodies to HIV, much less diagnose actual infection with the virus itself?”
“Let me see if I can draw a legal analogy.” Richardson pauses to collect his thoughts. “It would be like this jury coming to a conclusion that this defendant was guilty of murder based purely on circumstantial evidence, with no hard proof. Of course, no jury would make that kind of life-changing and far-reaching decision based solely on circumstantial evidence. At least, I hope they wouldn’t. But that’s exactly what Dr. Gallo and Dr. Luc Montagnier and other so-called AIDS experts are saying, that there’s a lot of circumstantial evidence that HIV exists and causes AIDS, so there’s no need for the hard proof, like actual virus isolation or a gold standard for the tests. But it’s the first time in history that I’m aware of where science has not required Direct Proof for diagnosing infection by indirect means. Instead we have accepted Indirect Evidence as gospel – gospel that is apparently not to be challenged by anyone wanting to ask legitimate questions. That’s what a religious cult does, and not what I would expect from scientists.”
Campbell pauses to look down the two rows of jurors, giving them time to think about that. Sarah also thinks about it, a lot. She writes herself a note in all capital letters: SCIENCE BECOMES A RELIGION – great title for an article!
Finally, Campbell continues. “Dr. Richardson, you’ve given us a lot of information in these two days. So let me ask just one more thing: When you put someone’s blood on the HIV ELISA test kit mixture, why do their antibodies react with the proteins, assuming they have the antibodies you’re trying to find?”
“When you take some blood from a person, you’re also getting their antibodies in that blood. But those antibodies don’t know they’re not still in your body, so they react as if they were; and when you mix them with a protein from a virus they were designed to recognize, they bind with that protein and make the test kit compound change color.”
Campbell is so pleased with Richardson’s clear explanation that he lets out an audible sigh of relief, and then covers it with the pretense of finally understanding himself.
“Oh, so in the HIV ELISA test, the antibodies in the person’s blood still think they’re in that person’s body, and when they are combined with the test kit proteins – assuming that those proteins actually belong to HIV – they would bind with those proteins; and it’s their binding that we call HIV-Antibody-Positive.”
“The only problem with what you just said is the assumption that the test kit proteins actually belong, as you said, to HIV. As I testified earlier, that has never been proven.”
“I think we need to learn a little more about how antibodies work to fully understand this, Dr. Richardson.”
“It might help. But, of course, I’m not qualified to do that for you. All I can say is that the key to understanding why the HIV ELISA test is very unreliable – not just in detecting HIV infection, but even in detecting HIV antibodies – is that the proteins used in the test have never been proven to be specific or unique for HIV through actual isolation of the virus, and the test itself has never been validated by finding the virus in people who test Positive.”
“Your Honor,” Armand starts his objection on the way out of his chair, “Asked and answered… a lot of times, as a matter of fact.”
The judge is just as quick to respond. “Sustained. Anything more for this witness, Mr. Campbell?”
“No, Your Honor.”
As Campbell sits down at his desk, Armand, already on his feet, goes to the lectern. He looks at his notes, looks at the jury, and finally looks at the witness.
“Dr. Richardson, isn’t it true that the HIV ELISA test was developed mainly to screen the blood supply, to keep people from being infected with HIV through blood transfusions?”
“Very true, Mr. Armand. One of the first things we were told in 1984 was that HIV – if it actually exists – is transmitted through blood; and there was great concern that our blood supply could be contaminated with it. So the ELISA was not developed to diagnose HIV infection in groups at high-risk for AIDS, but to protect the general population who may need to receive blood in emergency medical procedures or surgery, and for hemophiliacs who had to take blood injections on a regular basis. And that’s what the FDA approved the ELISA test for in 1985.”
“So you admit that the HIV ELISA test is designed to be very sensitive when it comes to detecting HIV antibodies.”
“I totally agree. The Red Cross, for example, wanted to have 100% certainty that the blood they were providing did not have any chance of containing HIV, so every effort was made to screen all blood donors who could possibly be infected.”
“You wouldn’t argue, then, that the ELISA test intentionally swung the pendulum to the other side – went out of its way, actually, to find any antibodies for which there was even a remote possibility they could be associated with HIV.”
“No, I wouldn’t argue with that at all.”
“So even if you might be correct in saying that the proteins used in the ELISA test might be associated with things other than HIV, if there is a chance they are also associated with HIV, shouldn’t we use them to make sure the blood supply is clean?”
“I’ll say this much, Mr. Armand… if the ELISA were used solely for the purpose for which it received FDA approval – to make sure our blood supply was not contaminated – I would not have nearly the problem with it that I do – providing that it was validated by finding actual HIV virus in those who tested positive, thereby proving it was a valid test. Otherwise, we could be throwing away or refusing to accept thousands of pints of blood from potential donors who happen to test Positive, causing a severe shortage in our blood supply, which is actually what happened in the early days.”
“But you do admit that in 1985, with AIDS rapidly becoming a deadly epidemic, it was important to have a test that would ensure that HIV was not transmitted to people through blood transfusions.”
“Look, Mr. Armand, if the government had said to us, ‘We want to do everything we can to prevent HIV from spreading through the blood
supply, and we’ve developed a test that goes overboard in trying to screen out HIV, and we’re going to use that test to protect everyone, and we are erring on the side of caution, so if you turn out to be Positive on this test, it doesn’t mean you have HIV,’ then I might have understood. But still I would have wanted to see the test validated to prove that it, in fact, could find the antibodies to HIV in blood so we at least knew that we were finding evidence of HIV, even if we were finding antibodies to other things at the same time.”
“But isn’t that exactly why the Western Blot test was developed?”
Campbell jumps up immediately. He doesn’t want to go there yet.
“Objection. Your Honor, there is no basis in my direct examination of this witness that would allow Mr. Armand to ask questions about the Western Blot.”
Armand turns to the judge. “Your Honor, the Western Blot is simply another HIV test, and that’s what we are discussing, is it not? I also want to ask Dr. Richardson about the viral load tests…”
By this time, Campbell has made his way directly in front of the judge’s podium to make sure he is heard loudly and clearly. “Your Honor, I would make the same objection to questions about the viral load tests as well.”
Armand is not giving up so easily. “I specifically recall hearing Dr. Richardson mention the viral load tests early in his testimony….”
“Yes,” Campbell cuts him off. “But only in the generic sense, and not specifically the HIV viral load tests, which I assume is what Mr. Armand’s questions will address.”
“Well, I…”
Campbell is determined not to let Armand win this one. “Your Honor, I will definitely be bringing witnesses forward to talk about the HIV Western Blot and HIV viral load tests. But not now. Not yet. There will be an appropriate time in the presentation of my case for Mr. Armand to ask about them. But I get to choose that time, and since there was no mention of the Western Blot or the HIV viral load test in my direct of Dr. Richardson, Mr. Armand should not be allowed to ask questions about it now.”
It doesn’t take Judge Stevenson very long to make up his mind. “The objection is sustained. You’ll have to wait, Mr. Armand.”
Disappointed, Armand goes back to the lectern and looks over his notes again. Finally, he raises his head and announces, “I have no more questions of this witness, Your Honor.”
Armand makes his way back to his seat, and Campbell gets up for his re-direct.
“Dr. Richardson, you said that you would have no problem if the government had told us… let me read your exact quote: ‘We want to do everything we can to prevent HIV from spreading through the blood supply, and we’ve developed a test that goes overboard in trying to screen out HIV, and we’re going to use that test to protect everyone, and we are erring on the side of caution, so if you turn out to be Positive on this test, it doesn’t mean you have HIV.’ But that’s not what happened, is it?”
“No, not by a long shot, Mr. Campbell.”
“What did happen, in reality?”
“First of all, starting in 1985 when the tests first gained widespread use, tens of thousands of people a year who wanted to donate blood were being told they were HIV-Positive as a result of an ELISA test. These were healthy people –people with no symptoms or signs of any disease at all – and this presented a very serious problem on both sides. For the person who received a positive test result, it was a serious problem because they were told by the blood collection agencies, ‘You may or may not be Positive, we don’t know, so please go to your doctor and he will clarify the issue.’ However, at that time, doctors had no tools to confirm whether or not these people were infected with HIV – and they still don’t, by the way.”
“So what happened next?”
“Well, this led to a nightmare, but the blood banks didn’t care. They were doing their job of protecting the blood supply, and they said, ‘We’re just going to throw away all the blood samples that test positive.’ But the CDC said, ‘No, we must tell all the blood donors who test Positive, because they potentially might be infected with HIV and they will go around infecting other people.’ So we had tens of thousands of people that went to donate blood being told they had tested HIV-Positive and suddenly living a life of anxiety about whether they were actually infected with HIV or not. It resulted in social turmoil. It created problems in the family, because how do you go home and tell your spouse or partner that you might be HIV-infected? As you can imagine, it was a mess. The general public was really unaware of all of this, and I think they still are today. But at that time there was no way to resolve whether or not a blood donor was truly infected.”
“And how was this problem resolved?”
“As I said earlier, by an arbitrary and highly questionable decision by the CDC in 1987 that said testing Positive automatically meant that a person was infected with HIV, without giving any scientific evidence or studies to back up that claim.”
“So all of a sudden, the HIV ELISA test was being used for something it was never approved for: the diagnosis of HIV infection.”
“Yes, and it’s still being used for that today.”
Campbell turns to the judge. “Your Honor, that’s all the questions I have for Dr. Richardson pertaining to the HIV ELISA test. I would like to ask more questions of this witness when it comes time,” Campbell shoots a glance at Armand, “to discuss other HIV tests, so I would like to reserve the right to recall Dr. Richardson at some point in the future.”
The judge looks at Armand. “Any objection, Mr. Armand.”
Armand could hardly object now, after expressing his interest in Dr. Richardson’s testimony about the Western Blot and viral load tests. “No, Your Honor.”
“Very well. The witness is excused for the time being.”
As Dr. Richardson leaves the witness stand, and before Campbell could call his next witness, the judge interrupts.
“Ladies and gentlemen, I want to apologize for not returning to court yesterday afternoon. My oldest son and his family were in a car accident, and I wanted to be at the hospital with them. It looks like they will all be alright, nothing critical, but I would appreciate the opportunity to go back to the hospital and be with them this afternoon as well. I also think we’ve heard a lot of testimony that we could use the time to consider. So I am recessing this trial until ten a.m. Monday morning.”
Are You Positive? Page 9