Chapter Twenty
Sarah could hardly believe what happened in court yesterday afternoon. First she’s amazed that it had taken over twenty years for someone to point out the fallacy in the premise that one HIV test could confirm another. Where had all the scientists been? Were they too afraid of challenging anything the CDC says any more, after what happened to Peter Duesberg? Were they all too financially invested in the HIV=AIDS paradigm that they didn’t want to look critically for fear of what they’d find? Was no one able to think logically these days to notice the glaring error in the CDC’s claims?
She is also amazed that it took an unknown southern lawyer nicknamed ‘Nard’ to bring it all out in the open. Fascinated with the man, she makes a note to do whatever is necessary to get an interview with him, one on one, and soon. She might not scoop this story for her paper, since more and more press had begun attending the latest court sessions; but she is determined to have an exclusive interview with the man who brought down the AIDS Industry, as they were now being called publicly.
The courtroom looks very different this morning, and feels different, too, Sarah notices. There’s still tension in the air from the previous day, and it’s quite obvious that the momentum in the trial has swung decidedly toward Campbell, especially after Armand’s outburst. Sarah can’t blame Armand; he was simply trying to defend the indefensible: a critical error made at the CDC that everyone had bought into. That probably could have sent anyone around the bend.
The other major difference, of course, was the absence of Armand at the Solicitor’s table, and the almost pathetic picture of Mr. Wilson, sitting there alone, looking totally perplexed and confused about what he was supposed to do. She almost felt sorry for him.
Campbell, on the other hand, appears like nothing happened. His face hasn’t changed, his demeanor is the same, and he is calling Dr. Robert Richardson back to the stand.
“Dr. Richardson, thank you for being willing to come back to testify again.”
“I wouldn’t have missed it for the world, Mr. Campbell.”
“Dr. Richardson, I want to talk today about the viral load tests that have been mentioned a couple times during this trial. And you, personally, hold – how many patents for viral load testing?”
“Seven.”
“So you are eminently qualified to talk about this subject.”
“I would hope so.”
“Dr. Richardson, are your patents in use today?”
“No, they aren’t. As I think I said in the beginning of my testimony a couple weeks ago, my job at Amgen was to develop bigger, better, cheaper, safer, and faster diagnostic products for infectious diseases; and while I did, in fact, develop a excellent test for viral load, it unfortunately was not any better or faster or cheaper than what was already available on the market. So the decision was made not to try to compete, and it was put on a back shelf, so to speak.”
“So you are intimately familiar with all the other viral load tests that are being used today.”
“Absolutely.”
That out of the way, Campbell is ready to get down to the nitty-gritty. He checks his yellow pad quickly to make sure he does this in the correct sequence, because the amount of information the witness is about to deliver can be overwhelming to anyone, especially if it’s not presented correctly.
“Dr. Richardson, let’s start by having you explain what a viral load test is.”
“Viral load has traditionally been used for two main purposes. One, to measure the quantity and quality of the virus in a patient’s blood; and two, to gauge the success of treatment by monitoring the rise and fall of the viral load results.”
“And how is that done?”
“There are actually several different methods being used today, each of them taking a slightly different approach. There’s the Polymerase Chain Reaction, or PCR; there’s the branched DNA test; and there’s the nucleic acid sequence based amplification, called the NASBA.”
“If they all use different methods, do they all get the same results?”
Richardson laughs out loud. “No, and that’s one of the problems. Even the AIDS Industry admits that different test methods often give different results on the same blood sample.”
“So there’s no consistency between the tests?”
“No. The results can vary a lot, as a matter of fact. So doctors are told to use the same test all the time on the same person to prevent confusion.”
Campbell turns to the jury and has this very puzzled look on his face. Then he shrugs his shoulders and turns back to the witness.
“Please tell us about these tests, Dr. Richardson.”
“Which one do you want me to talk about?”
“What’s the most common one?”
“Undoubtedly, the PCR.”
“Without getting too technical, can you explain how the PCR works?”
“It was invented by Dr. Kary Mullis in 1983, and he won the Nobel Prize for it in 1993. What Dr. Mullis did was come up with a very clever way to multiply and count the number of DNA matches in a patient’s blood.”
Campbell looks confused again. “I don’t understand. What does that mean, and how is it possible?”
“Using what are called ‘probes’ and ‘primers,’ the PCR finds little pieces of genetic material – snippets of DNA or RNA – that supposedly belong to a virus, for example, and then goes through a process of copying and multiplying them many, many times so they can be counted. Then you do some dilutions and compare the results with the patient’s blood, and finally you get what is in this case would be called ‘viral load.’ As a matter of fact, Forbes magazine once called the PCR ‘biotechnology’s version of the Xerox machine,’ and Dr. Mullis himself said his PCR made it possible to find a needle in a haystack by turning the needle into a haystack.”
Good analogy! If that’s all the jury understands about how the PCR works, we’re okay. Campbell feels safe in continuing. “This PCR is used for a lot of different things, is it not?”
“Absolutely. It’s become infamous, of course, for its use with HIV. But, in fact, when Dr. Mullis first invented the PCR, Dr. Gallo had not yet announced that HIV caused AIDS.”
“I assume, when Dr. Gallo finally made his famous pronouncement, Dr. Mullis was thrilled that his invention could be used to save people from the certain death of AIDS.”
Richardson laughs again. “Maybe initially, yes. But when Dr. Mullis was writing his proposal to use the PCR with HIV, he ran across a big problem right at the start. His paper began with the sentence, ‘HIV is the probable cause of AIDS;’ and like any good scientist writing a paper to be peer-reviewed, he wanted to reference that statement with the scientific studies that supported it.”
“What happened?”
“He couldn’t find those scientific studies in any of the scientific literature.”
Wilson finally musters up the courage to get out of his chair. “Your Honor, this sounds a lot like hearsay, so I would object.”
Campbell is quick to respond. “Your Honor, Dr. Richardson is simply recounting events that are a matter of public record. They have been written in a number of publications, and recorded on various video presentations. In fact, if it please the court, I am prepared to let Dr. Mullis speak for himself by playing one of those videos.”
“Mr. Wilson, do you object to watching a video and letting Dr. Mullis speak for himself?”
Wilson is way over his head. He probably should object, but he’s not confident that he could get a favorable decision from the judge and doesn’t want to take the risk. Besides, it was he who had brought up the issue of hearsay; how could he now object to hearing from the original source? “No, that would be fine, Your Honor.”
The judge looks back at Campbell. “How long is this video, Mr. Campbell?”
“Just a couple minutes.”
Then the judge tells the witness, “Dr. Richardson, you might as well stay where you are. Proceed, Mr. Campbell.”
Campbell fin
ds the remote and lowers the screen while a technician rolls the DVD player into place. Campbell presses Play and the video begins.
Dr. Kary Mullis is on the screen, dressed in a t-shirt and looking like he just came from the beach, being interviewed by someone who can only be seen from the back of the head. Mullis starts talking right away.
“I was working on a test for HIV with the PCR, and I needed to write a little report to the NIH [National Institutes of Health] and say, ‘here’s the progress we’ve made,’ and the first line of it was ‘HIV is the probable cause of AIDS.’ And I thought that was true – this was before I got involved. And I said, ‘what’s the reference for that quote?’ And I looked for it for about two or three years, and I never could find it. And by the end of two years I had asked everybody at every meeting I had gone to that talked about AIDS, I had looked in every computer data base. There is no reference.”
Campbell stops the video there, but leaves the screen down, glancing at his watch. “Your Honor, if Mr. Wilson is not satisfied, I actually have Dr. Mullis standing by on a video conference link, and I suggest we let him speak for himself live – very briefly.”
Wilson just sits there. He’s pretty sure this is highly unusual, interrupting one witness to ask questions of another one, but he’s already been shot down once by the judge, and he’s not willing to risk another embarrassment.
The judge also sees no reason to say No. He nods at Campbell to go ahead. The technician positions the video camera, makes a few mouse clicks on the computer, and Dr. Mullis appears live on the video screen.
“Dr. Mullis, thank you for taking the time this morning. I know it’s early in California.”
“Let’s make it quick, Mr. Campbell.” Sarah realizes that Mullis is not too happy to be doing this. Maybe Campbell had to subpoena him, she realizes, because he certainly doesn’t look like he’s here on his own free will. She assumes that if Mullis were being paid as an expert witness, his attitude would be different.
“Dr. Mullis, just for the record, you invented the PCR, correct?”
“Yes.”
“And you won the Nobel Prize in chemistry for it, correct?”
“Yes.”
“In your expert opinion, as the inventor of the PCR, can the PCR be used to measure the viral load of HIV?”
“No, it can’t.”
“Why not?”
“Because the results are meaningless.”
“Would you please tell the court why?”
“No, I won’t. Besides, Dr. Richardson can do a better job of that than I can anyway.”
Rather than pressing Mullis for more testimony, Campbell turns to Wilson and says, “Your Witness.”
Wilson is caught by surprise as much as the rest of the courtroom. Mullis’s testimony had taken less than two minutes; but still, it was a powerful two minutes, even if it appeared that Mullis wasn’t being too accommodating. For the inventor of the test used so often to detect the viral load of HIV to say that it couldn’t and shouldn’t be used for that purpose was monumental. Wilson has no idea how to counteract that, and can’t think of anything by the time he gets to his feet.
“No questions, Your Honor.”
The judge, whom Mullis can’t see, says, “The witness is excused. Thank you, Dr. Mullis.”
As Campbell raises the video screen and the technician removes all the equipment, the jury looks like they’ve had about all they can take of the twists and turns in this trial. I wonder how much more Campbell is going to put them through today, Sarah wonders. Lucky for him, when we finally do quit this afternoon, they’re going to get a break for five days. I could sure use it, too.
Campbell returns his attention to the witness in the box. “Dr. Richardson, let’s get back to the PCR. Why would this test win Dr. Mullis a Nobel Prize? What’s so great about it?”
“The PCR is able to detect the presence of things that are normally undetectable, or to make more of things that there is not enough of. For example, if there’s not enough DNA found at a crime scene to use to identify the criminal, the PCR can make lots more of it in just a couple hours, therefore allowing an identification to be made. And since HIV has been virtually undetectable in even the worst of AIDS cases, it seemed like the perfect tool for the AIDS Industry to use.”
“You also said there were other HIV viral load tests being used today.”
“Yes, there are. But they’re essentially all based on the same principle, and they still do the same thing – mathematically compute the viral load rather than counting actual HIV itself; and they all have the same problems.”
Campbell checks his notes very quickly. This wasn’t exactly how he had intended to proceed, but close enough. “Tell us about those problems.”
“Well, first, like the HIV ELISA test and the HIV Western Blot test, there is no proof that the probes and primers used in any of the viral load tests are specific and unique for HIV, since HIV has never been properly isolated, as I said the first time I was here. That means that we really have no idea what we’re counting in a viral load test.”
“Is that why Dr. Mullis said that the results would be meaningless?” Campbell knows he can get away with that kind of question now, since Wilson is so hesitant to object.
“That’s one of the reasons, yes.”
“What are the other reasons?”
“The viral load tests all get a huge number of false positives, just like the ELISA and Western Blot. It stands to reason that someone who had a false positive ELISA or Western Blot result would also have a false positive viral load result, since they’re all using the same proteins. But more than that, someone who has tested Negative for HIV antibodies on the ELISA or Western Blot can still have high viral load results.”
This is an important point, jury. I hope you’re listening carefully. “How can that happen?”
“It can only happen if the viral load test is counting something other than HIV, Mr. Campbell. And that’s why the CDC issued an order for laboratories not to run the viral load test on anyone who has not tested HIV-Positive on the ELISA and Western Blot.”
“Because these false high viral load results didn’t make the test look very good?”
“Exactly.”
Bingo. That had to have hit home. Campbell flips a page on his yellow pad and finds where he wants to go next. “When you talk about false positive viral load results, exactly what do you mean?”
“First we have to understand how the results are stated. Viral load is measured by the number of copies the test makes per milliliter of blood. If a viral load test cannot find any HIV, the results are said to be ‘undetectable.’ And that’s about all the experts can agree on.”
“What do you mean?”
“Well, some studies say that having even 50 copies per milliliter of blood is considered significant, while others say that anything under 10,000 copies per milliliter does not necessarily indicate HIV infection.”
“So from what you’ve just said, there is no ‘normal’ or ‘negative’ result, other than ‘undetectable,’ and virtually any other result is considered ‘Positive.’”
“Or false positive.”
Good. Now let’s make this clear. “What’s considered false positive?”
“This is the next biggest problem with the viral load. There have been people who have viral loads of 100,000 copies per milliliter than have been found not to have HIV by actual culture.”
Campbell asks his next question looking directly at the jury. “100,000 seems like an awful lot…”
Richardson completes his sentence, “…especially when just 10,000 is deemed to be dangerous enough to start someone on anti-retroviral medications.”
“How could someone have 100,000 copies and not have HIV?”
“Ahhh… good question. I already mentioned that the probes and primers used in the PCR are not specific or unique for HIV. So there is no proof that the DNA or RNA being copied and multiplied has anything to do with HIV either. In fact, studie
s have found that more than 99% of the copies made by the PCR represent non-infectious viruses. Non-infectious viruses are not considered to be able to cause disease, because they cannot infect cells. There’s also a very big question whether this 99% of the copies are even viruses at all, but may in fact represent the detection of RNA from other non-viral sources.”
Campbell is still looking at the jury, trying to assess their level of understanding in light of all the numbers being thrown around. He turns back to the witness for the next question. “Dr. Richardson, I still don’t understand how someone who doesn’t have HIV can have a viral load of 100,000.”
“Well, as Dr. Mullis says, the PCR is actually too efficient. It will make copies and multiply them for whatever DNA is in the sample, regardless of whether that DNA belongs to HIV, or is made up of non-infectious viruses, or is simply a contaminant. But there is no way to determine which part of the amplified material is HIV and which part is contaminant if you can’t detect HIV in the sample without using the PCR. In other words, only the PCR can verify the PCR results, and that’s not very good science.”
“You mean there’s no independent way to verify exactly what the PCR is actually measuring?”
“Correct.”
Campbell is counting on the jury to remember what ‘specificity’ means. “So you’re saying that the viral load test may not be very specific to HIV.”
“The CDC has said that the specificity and the sensitivity of the PCR has not been determined and is not known. That’s a direct quote.”
It’s time for Campbell to do one of his delaying tactics to give the jury a break. He walks to his table, shuffles some papers around pretending to be looking for something, then walks back to the lectern empty-handed. “Dr. Richardson, are there any studies that show how often the PCR can produce false positive results?”
“Definitely. A study published in the Journal of AIDS found what they called ‘a disturbingly high rate of non-specific positivity.’ That same study discovered that the PCR produced about the same viral load results for people who were HIV-Negative on the ELISA and Western Blot tests as those who were HIV-Positive, amazingly enough. A separate study also published in the Journal of AIDS concluded that ‘false positive results occur with sufficient frequency among uninfected individuals to remain a serious problem.’ So the World Health Organization set up its own PCR study group; but they also found high levels of false positives.”
“Do we know what percentage of the time these false positive viral load results can occur?”
“Estimate range anywhere from zero to as high as 60%. But it is generally agreed that there will be 3 to 10% false positive viral load results.”
Campbell turns to the jury and raises his hands in the air. “Ten percent doesn’t sound that outrageous.”
“Maybe not, until you stop to think about what it represents. If a thousand people were given a viral load test, for every 4 true positive viral load results, there would be anywhere from 30 to 100 false positive viral load results. 3-10% false positives may not sound like a lot by itself, but when you compare it to .4% true positives, we’re talking about at least 75 times more false positives than true positives.”
Campbell puts his hands back down, as if to retract his skepticism and acknowledge the seriousness of the situation. “Dr. Richardson, is there anything else wrong with these viral load tests?”
“Well, again, just like the ELISA and Western Blot tests, the viral load tests have never been validated – that is, no one has successfully taken a group of people with high HIV viral load test results and proved that a vast majority had actual HIV in their blood by viral isolation and culture. In other words, there is no Direct Proof that the viral load test is counting HIV. In fact, the one researcher who set out to prove the validity of the PCR by trying to culture HIV from the blood of those with high viral load results found that more than half did not have HIV – even though they had viral loads of as much as 300,000 copies.”
“So how would anyone prove that the numbers the PCR comes up with are accurate?”
“That’s a good point. If the PCR is being used to detect otherwise undetectable HIV, as you said a minute ago, there is no way to establish the precise viral load independently from the PCR to make sure that its results are correct.”
Campbell stares at his yellow pad a long time. He even makes some notes on it, seemingly working out something. “Here’s what I don’t understand, Dr. Richardson. If the viral load results are supposed to represent the amount of virus in someone’s blood, and if we are getting results like 100,000, 300,000…”
“…sometimes 800,000 or more, Mr. Campbell…”
“…even 800,000 on the PCR, with that much virus floating around, shouldn’t we be able to detect it without going through all the copying and multiplying that the PCR does?”
“You would think so, wouldn’t you?”
Campbell checks off the questions on his yellow pad and discovers that he’s asked them all; but he doesn’t feel like he’s finished with this witness yet. “Dr. Richardson, is there anything more we should know about the viral load tests?”
“I hate to be redundant, but just like the Western Blot, the results of HIV viral load tests can differ widely from laboratory to laboratory, meaning that there is no standardization or reproducibility.”
“But aren’t the viral load tests being used in some cases to confirm HIV infection after a Positive ELISA test?”
“Yes, they are; but they’re not supposed to be. I realize that the AIDS Industry is using the viral load results to say, ‘See, our ELISA and Western Blot tests are accurate, because we can find HIV on a viral load test. But the CDC does not list the viral load test as one of the ones they approve for confirming a Positive ELISA result. So whoever is doing that is not following the CDC’s protocol.”
“Dr. Richardson, I’ll ask you the same question I asked when we were talking about the ELISA tests. Does anyone else, other than Dr. Mullis, agree with you that the viral load tests should not be used to diagnose or confirm HIV infection?”
“And I’ll give you the same answer that I gave you then: All the manufacturers of the HIV viral load tests agree; and they put a written disclaimer to that effect in the printed insert that comes with every test kit.”
Campbell walks to his table, and this time he actually picks up a piece of paper. “Dr. Richardson, is this one of those printed inserts?”
Richardson takes the paper from Campbell and scans it briefly. “Yes it is. This one comes from Roche Diagnostic Systems for their Amplicor HIV-1 Monitor test, which is their viral load test.”
“And what does the insert say that is highlighted in yellow?”
Richardson looks for the highlighted area and then reads. “It says, ‘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.’”
“Can you say that for us in plain English?”
“It says that the viral load test should not be used to diagnose HIV, or to confirm that HIV exists in that person.”
“But, once again, isn’t that exactly how it’s being used today?”
“Yes, sir, that is how it’s being used. But Roche, and all the other manufacturers, are safe legally as long as they include this printed disclaimer in their test kits, and the responsibility falls squarely on the doctors who are misusing it.”
“Dr. Richardson, do you think these doctors have any idea they are not following the instructions of the viral load manufacturers, or following the CDC protocol when they use the viral load results as a confirmation of HIV infection?”
“Dr. Mullis once said,” and he looks directly at Mr. Wilson, “and I’ve seen it on video, so it’s not hearsay – that he doubted 50 doctors in the entire country knew what a Western Blot test was or how it worked. I would say that less than that know anything about a viral load test, or have even seen these printed inserts. But, Mr. Campbell, in a ma
tter such as this, where life and death hang in the balance, ignorance is not bliss; nor is it excusable.”
Campbell retrieves the printed insert from the witness. “If these tests are not supposed to be used to confirm HIV infection, what are they being used for?”
“Mostly for determining when to start or change anti-retroviral drug therapy.”
“And should they be used for that purpose?”
“Obviously not, if it’s not accurately measuring HIV viral load; and the AIDS Industry itself is coming to this realization. In a very recent scientific study, published September 27, 2006 in the Journal of the American Medical Association – one of the most prestigious and well-trusted scientific journals in existence – Dr. Benigno Rodriguez and a whole host of other AIDS researchers found that HIV viral load results failed in 90% of the cases to predict the loss of CD4 cells. In other words, having a high HIV viral load was not related to having a low CD4 cell count, which is supposedly the hallmark of AIDS. Therefore, the relationship between a high HIV viral load and getting AIDS is now being recognized as very questionable. In fact, this same study proved that these viral load tests were only able to predict the progression to AIDS in anywhere from 4% to 6% of the HIV-Positive patients studied.”
Looking at the jury, Campbell realizes that enough is enough; in fact, it is now getting to be too much. I need to wind this up quickly. “Did they draw any conclusions from this study, Dr. Richardson?”
“Yes, they did, and it’s most interesting. They said that there must be, and I’m quoting, ‘nonvirological mechanisms as the predominant cause of CD4 cell loss.’ Amazing, isn’t it, that after all these years, they would finally admit that HIV was not the major cause of a depressed immune system. Not only that, but that the real cause wasn’t even going to be a virus!”
One last point and that’s it. “Dr. Richardson, what should we learn from this study?”
Richardson also knows that his testimony is coming to an end and wants to make sure he gets his major points across one more time. “First and foremost, I would think that scientists would question the use of the HIV viral load test and come to the same conclusion that Dr. Mullis did: that the results are meaningless because the test is invalid. And more immediately, as was pointed out by Dr. Keith Henry in another paper in that same September, 2006 issue of JAMA, viral load test results alone should not be used to determine whether or when to start anti-retroviral drug therapy.”
“So we’ve just recently found out that high viral load results do not mean that someone who is HIV-Positive will get AIDS?”
“No, sir. I didn’t mean to imply that. In fact, we’ve known since 1996 that viral load results did not accurately predict progression to disease. When Roche sent their Amplicor viral load test to the FDA for approval, they included one of their own studies which showed that the lowest viral load results were actually more likely to predict progression to disease than the higher ones.”
There may be more that Richardson could say on this subject, but Campbell doesn’t care. He’s sure the point has been made and reasonable doubt raised about the viral load tests. But I haven’t actually asked that question directly, and I should.
“One last question, Dr. Richardson. In your expert opinion, would you consider any of the viral load test results done on the defendant to be accurate?”
“I don’t see how they could be, with all the things wrong with the tests themselves that I’ve mentioned.”
“And, in your expert opinion, would you consider any of the viral load test results done on the victim, Beth Ann Brooks, to be accurate?”
“I doubt it very seriously, Mr. Campbell.”
“And if Beth Ann Brooks’ viral load tests were used to prescribe anti-retroviral therapy for her?”
“Based on all the scientific studies that I’ve read, I would say that could be considered medical malpractice.”
“OBJECTION!” Wilson had put up with a lot, but he isn’t putting up with that.
Before the judge could rule, Campbell says, “I’ll withdraw the question. Thank you, Dr. Richardson.”
The judge looks at the Deputy Solicitor. “Mr. Wilson, do you wish to cross-examine this witness?”
Wilson is still standing. “You Honor, I’d like the witness’s last comment to be stricken from the record.”
“So ordered. Any questions for this witness, Mr. Wilson?”
There is nothing Wilson can think to ask at this point. “No, Your Honor.”
“Then, Mr. Campbell, you may call your next witness.”
Campbell looks at his watch. “Your Honor, it’s almost lunchtime. My next witness will begin a new section of this trial, examining the question of whether HIV can be transmitted through heterosexual intercourse, as is claimed by the State in this case. I wonder whether it would be appropriate to recess at this point.”
Without asking Wilson, the judge considers his options and then makes his decision. “Ladies and gentlemen, under the circumstances, I think we could all use a few days to digest the testimony we have heard this week, without starting something new. And I also think Mr. Wilson could benefit from some time to get his act together. I’ll remind you that court will not be in session tomorrow or Friday, or next Monday, which is a holiday. Therefore, I am going to recess this court at this time until ten a.m. next Tuesday morning.” He bangs his new gavel several times.
Chapter Twenty-One
DATE: Thursday afternoon
TO: [email protected]
RE: this week’s column
Dear Sam,
Court is recessed until Tuesday, and I’m off to Atlanta for the weekend, so I needed to get this to you before I left. Attached is the next HIV-Positive story for my column. Talk to you soon.
Sarah
Attachment:
Are You Positive? Page 32
