Are You Positive?

by Stephen Davis

  Campbell looks closely at the board and announces, “That’s seven Indeterminates and three Positives.”

  “Correct, Mr. Campbell,” Tanner agrees. “And does that make any sense to you? Again, it’s like taking an EKG on the same person and having three doctors say they had a heart attack but seven others disagreeing.”

  Campbell puts down the red marker and walks slowly by the jury box, looking at each juror on the way back to the lectern. When he thinks the jury has had enough time to consider the implications of this chart, he asks, “Dr. Tanner, what happens if the result is Indeterminate?”

  “They want you to come back in three months, and then again in another three months; and if these two follow-up Western Blots are also Indeterminate, you can be said to be Negative.”

  “So in this particular example, we have three Positives and seven that may well turn out to be Negative. That seems very strange.”

  “Think about it. Just in the United States, where you have five different criteria, the same blood sample would test Positive in two instances, and Indeterminate in the other three. So if someone got a Positive result, they could simply find a laboratory that used a different criteria, test Indeterminate there three times, and they’re cured! Many people have gone from being HIV-Positive to HIV-Negative simply by changing labs or moving to a different country. Can you name me any other disease that acts that way?”

  “Very strange indeed.” Campbell is hoping the jury feels the same way. He is about to ask another question when Tanner interjects.

  “But it gets even stranger.”

  “How so, Dr. Tanner?”

  “Unlike the ELISA, where the color change was measured on a sliding scale, the ‘color change’ on a Western Blot protein band varies a lot and really is measured in its intensity, from a very light grey to a dark black. It is left up to the laboratory technician or the doctor himself to make a determination whether that band actually lit up or not; and very often that determination will be made based on the sexual history the patient gives. If there’s a question about a protein band that reacted, and that patient is in a so-called high-risk group for AIDS, the band will be deemed to be Positive. But if they’re in a low-risk group, the band is often called Negative, or just ignored. As far as I know, that’s called ‘profiling’! It really boils down to whether the doctor or the lab expect that person to be HIV-Positive or not!”

  “Why would anyone want a patient to test HIV-Positive?” Campbell knows the answer, but he expects that the jury is somewhat shocked at Tanner’s suggestion.

  “Mr. Campbell, AIDS is now a huge industry worldwide. It’s become a cash cow for a lot of people. Many livelihoods depend on keeping the number of AIDS patients going up, and this is one way to do it.”

  “Objection. Speculative and inflammatory.” Armand wasn’t letting that one slip by.

  “Sustained.” The judge looks at his watch. “Mr. Campbell, we’re already into the lunch hour.”

  “Your Honor, I don’t have much more, and I would prefer not to keep Dr. Tanner up any later at night than necessary.”

  The judge sighs, obviously hungry and anxious for a break. He’s also trying to protect the jury from overwhelm from all the data. “Alright. If you can finish up in the few minutes, you can proceed.”

  “Thank you, Your Honor.” Campbell holds up his yellow pad in front of him, preparing to read. “Dr. Tanner, you said in the beginning of your testimony, and I’m quoting, ‘The Western Blot was originally designed and intended to find all the false positive reactions created by the ELISA, not to confirm the positive ones.’ And you said this was very important to understand. Why?”

  “Because it’s being used for exactly the opposite purpose – to confirm positive ELISA tests. It wasn’t designed to do that, and shouldn’t be used for that purpose.”

  Campbell goes to his table and picks up the Cambridge test kit insert again. “Dr. Tanner, reading again from the printed insert that come with the HIV Western Blot test kit made by Cambridge, it says, ‘Positive blot results using any specimen type (serum, plasma, or urine) should be followed with additional testing…. The clinical implications of antibodies to HIV-1 in an asymptomatic person are not known.’ What do they mean by that?”

  “Once again, Cambridge is saying that their Western Blot test kit should not be used to confirm HIV-antibodies to HIV without being followed up with further tests. In other words, this so-called ‘confirmation test’ should itself be confirmed by other tests. And they’re also saying that even if their test says that someone is HIV-Positive, there is no clinical evidence that it means anything for someone who isn’t sick. In other words, no one has a clue what having the antibodies to HIV means in a healthy person.”

  Campbell looks at the jury in disbelief. “But isn’t their test being used to confirm HIV infection?”

  “Of course it is.”

  Still acting as if he is surprised by all of this, Campbell continues, “And when HIV infection is confirmed, doesn’t that mean the person is going to get AIDS, according to all the so-called experts?”

  “Of course it does. But Cambridge says that neither of those statements is true, regardless of what anyone else says, and they want to be off the hook legally.”

  Campbell walks toward his table. “Dr. Tanner, do any other HIV Western Blot test kit manufacturers agree?”

  “Most of them, as far as I know. All the ones who are licensed by the FDA, I believe. For example, do you have the test kit insert from a company called Epitope?”

  Campbell searches through his stack and finds it. “Yes, right here.” He turns to the page he had already highlighted. “It says, ‘Do not use this kit as the sole basis for HIV infection.’”

  Tanner nods on the screen. “Exactly. With that, Epitope has covered themselves on two counts. First, they say not to use the Western Blot alone, without an ELISA, because they know that their test will have too many false positives by itself. And secondly, that sentence is so ambiguous that it could be interpreted to mean that, even if their test turns out positive after a positive ELISA, to get it confirmed with other tests as well.”

  Campbell drops the printed insert on the table and picks up another folder. He opens it and finds a particular sheet of paper with some markings on it. “Dr. Tanner, I have the defendant’s Western Blot test results here as part of his medical file. I wonder if you could give us your expert opinion on them.”

  “Be glad to. What protein bands reacted on his test?”

  “There were four of them. gp120, p32, p40, and p18.”

  Tanner is obviously writing them down, and then looks up at the camera again.

  “Okay. Since this was done in the U.S., we’ll just use the five different criteria available in your country. First, he’s clearly not Western Blot Negative, because he has at least one protein that lights up. But he’s Indeterminate on both of the CDC’s criteria, in one case because he has only one env protein reacting, and in the other case because he does not have p24 reacting. The FDA would also say he’s Indeterminate, again because he does not have p24. The Red Cross on the other hand would be Positive, and so would the US Consortium.”

  “So three out of five would not say he was Positive?”

  “That’s correct. Obviously, his test had to have been interpreted using the Red Cross or the Consortium criteria, if he was deemed to be HIV-Positive.”

  “But if we sent his blood to a laboratory that used either of the CDC’s criteria, or the FDA criteria, he wouldn’t be Positive?”

  “No. He’d be Indeterminate.”

  “So, again, in your expert opinion, the defendant cannot be said for sure to be HIV-Positive.”

  “There is no way anyone could make that statement with any scientific proof behind it.”

  “And what about the victim’s Western Blot results. In your expert opinion, could Beth Ann Brooks be said for sure to be HIV-Positive?”

  “I haven’t seen her actual Western Blot results, Mr. Campbe
ll; but I think I’ve given you enough testimony about the problems with the Western Blot test itself to say that her results would be highly questionable as well.”

  “Thank you….”

  Tanner interrupts him immediately. “Except…”

  What the hell? All of a sudden, Campbell’s worried. Oh well…. “Except what, Dr. Tanner?”

  “Except that there’s one huge problem with the Western Blot tests that we haven’t discussed that could change everything.”

  “What is that?”

  “The fact that there is no consistency from laboratory to laboratory, and you can get very different results of which proteins are reacting depending on which lab processes the test.”

  Campbell breathes a deep sign of relief. “Dr. Tanner, I’d like to save that testimony for my next witness, if you don’t mind. But tell us, what difference could that make?”

  “A huge difference. Your defendant might have very different proteins that light up, and he could actually be Indeterminate using all five criteria! You never know, he might even be Negative, depending on the lab. It’s happened before.”

  That couldn’t have gone better if I had planned it. “Thank you, Dr. Tanner. Your Witness, Mr. Armand.”

  This time it’s the judge’s turn to interrupt. “It’s time for lunch, counselors. We’ll have to continue with this witness later.”

  Campbell had just sat down when he gets back up out of his chair. “Your Honor, it’s after midnight for Dr. Tanner. May I ask the court, and Mr. Armand, to consider his situation, and to recognize that it will be the middle of the night for Dr. Tanner, and he may be too tired to continue his testimony if we break for lunch?”

  The judge wasn’t so sure. “We all need to eat, Mr. Campbell.”

  “True, Your Honor, so here’s what I suggest, if Dr. Tanner agrees. I have another witness whom I will call after lunch that will also be talking specifically about the Western Blot tests, but most specifically about how different laboratories process those tests, as Dr. Tanner just mentioned. May I suggest that Mr. Armand reserve his right to cross-examine Dr. Tanner until tomorrow morning when he is more rested, and that I present my next witness, whom Mr. Armand can cross-examine this afternoon? That way, Mr. Armand will have all of the testimony concerning the Western Blot tests that he may use for his cross of Dr. Tanner.”

  “Any objection, Mr. Armand?”

  Armand rises. “No, Your Honor. I actually concur with Mr. Campbell, because my cross-examination of Dr. Tanner may take a while and I do respect his need for sleep.”

  “And Dr. Tanner, do you agree to be available at ten a.m. our time again tomorrow morning?”

  “I do, Your Honor, and I appreciate the consideration you are showing me.”

  “Very well. This court is in recess until two p.m. this afternoon.” But just before the judge drops the gavel, his voice booms out again. “Oh, people, I forgot. I have a prior commitment in another court this Thursday and Friday. And then the following Monday is, of course, a holiday. So when we recess on Wednesday afternoon, it will be until ten a.m. the following Tuesday. Just so you know….” And the gavel bangs loudly.