Are You Positive?
Page 16
Chapter Twelve
Last night’s snow had not amounted to much, and although the roads were a little icy in places, the drive to the Greenville Courthouse from Lake Bowen was not bad at all. Sarah had left early to make sure she wasn’t late for court; and since it had been a short night of sleep, she also made sure she had time for a Starbucks stop.
Campbell had called Carolyn Jennings to the stand, his first non-expert witness. Although she had done extensive research in the 1990’s on the HIV tests as a free-lance journalist, because she did not have special letters after her name signifying some scientific degree, she was not considered an ‘expert’ by the court. Sarah wonders what Campbell is going to do with her. She doesn’t have to wait very long.
“Ms. Jennings,” he begins, handing her some pages stapled together, “do you recognize this?”
Jennings looks briefly at the paper. “Yes, I do. It’s an article I wrote that was published in Continuum Magazine in its September/October issue, 1996.”
“And will you please read the title of that article?”
“It’s called Whose Antibodies Are They Anyway? Factors Known to Cause False Positive HIV Antibody Test Results.”
“Please tell the court how you came to write this article.”
“Well, I had been doing a lot of research about the various scientific studies that were finding a number of things causing false positive HIV test results. I had developed a list of more than fifty of those studies, naming more than sixty factors causing false positives, and I decided to write this article at that point.”
“Ms. Jennings, before we go any further, we probably should define what ‘false positive’ means on the so-called HIV antibody test.”
“Be happy to. A ‘false positive’ is when someone has a positive test result, supposedly indicating that they have the antibodies to HIV in their blood; but it turns out later, on some kind of confirmation procedure, that they don’t have HIV antibodies after all, and that their positive test result was due to something else other than HIV antibodies.”
“In other words, one or more of these factors we will discuss, that have nothing to do with HIV, will react with one of the test kit proteins and cause a reaction?”
“One or more of the test kit proteins, yes.”
“Ms. Jennings, is this list of these factors you compiled causing a false positive reaction on just one or two of the test kit proteins?”
Jennings looks slightly confused. “I thought I just answered that, Mr. Campbell. These factors can react with one or more of the test kit proteins to create a false positive.”
Campbell quickly realizes his mistake. “I’m sorry, Ms. Jennings. I didn’t state that last question properly. What I want to know is this….” Campbell searches his mind for a better way to ask what he wants to know. “Is it just one or two of the test kit proteins that are causing these false positive reactions with this list of factors?”
“Oh, now I understand. No. False positive reactions have been found to occur with every single one of the test kit proteins, Mr. Campbell.” Jennings was glad that Campbell had her state that point so clearly.
“Ms. Jennings, you’re saying that every single one of the test kit proteins can cause a false positive reaction on the test? In other words, no protein in the test kit has been found not to cause a false positive?”
“Not a one.”
Campbell intentionally pushes the issue. “Do I understand that not one of the test kit proteins reacts only with HIV antibodies?”
Before Ms. Jennings can answer, Armand jumps to his feet. “Asked and answered, Your Honor.”
“I’ll withdraw the last question.” It didn’t matter. The jury had heard it, and they couldn’t possibly miss the importance of that last bit of information. “Now, Ms. Jennings, you took it upon yourself to create this list of things that had been proven by scientific studies could create one of these false positive test results – in other words, that if a person had one of these factors but did not have HIV antibodies in their blood, they could still test Positive on a so-called HIV antibody test.”
“That’s correct.”
Campbell walks over to the large easel that had been set up again, tears off the blank page on top, revealing a list of about a dozen medical terms that filled the page. “Is this that list, Ms. Jennings?”
She looks at the easel and quickly answers, “That’s a few of them, yes.”
Campbell flips that page up to reveal another one, also filled with medical terms. “And this?”
“Yes, that’s more of them.”
It takes Campbell six pages to show the entire list. He obviously had planned this as a way to impress the jury with the large number of factors that supposedly cause false positives. When he finishes, he addresses the judge, but is really speaking to the jury. “Your Honor, I realize that I have glossed over this list very rapidly, without explaining what all these medical terms mean. I fully intend to do that over the course of the next couple of days. I also intend to ask Ms. Jennings about the scientific studies she used to create this list, to verify that each one of the items were not something she made up, but were proven by experts in the field to cause a false positive reaction on the so-called HIV test.”
Campbell flips all the pages back over on the easel to the first page and continues. “But, Your Honor, first I would like to ask Ms. Jennings to simply read through this list to get all the items on the record, and then we will take them one by one and see the actual scientific studies that qualified them for this list.”
The judge looks at the Solicitor. “Any objection, Mr. Armand?”
“No, Your Honor,” Armand says without standing.
“Very well. Proceed, Mr. Campbell.”
“Thank you, Your Honor. Ms. Jennings, would you please read that list from the original article that I handed you when we started.”
Jennings picks the article back up from the railing of the witness box where she had laid it and begins reading. “Anti-carbohydrate antibodies (13, 19, 52).” She stops immediately. “Mr. Campbell, do you want me to read the numbers after the items that are the studies referenced at the bottom of the article?”
Campbell shakes his head. “No, please just read the items themselves. We will go back and talk about the referenced studies later.”
Jennings begins again. While she’s reading from her article, Campbell is pointing to the same thing on the large easel so the jury can see that the two lists are identical.
Anti-carbohydrate antibodies
Naturally-occurring antibodies
Passive immunization: receipt of gamma globulin or immune globulin (as prophylaxis against infection which contains antibodies)
Leprosy
Tuberculosis
Mycobacterium avium
Systemic lupus erythematosus
Renal (kidney) failure
Hemodialysis/renal failure
Alpha interferon therapy in hemodialysis patients
Flu
Flu vaccination
Herpes simplex I
Herpes simplex II
Upper respiratory tract infection (cold or flu)
Recent viral infection or exposure to viral vaccines
Pregnancy in multiparous women
Malaria
High levels of circulating immune complexes
Hypergammaglobulinemia (high levels of antibodies)
False positives on other tests, including RPR (rapid plasma reagent) test for syphilis
Rheumatoid arthritis
Hepatitis B vaccination
Tetanus vaccination
Organ transplantation
Renal transplantation
Anti-lymphocyte antibodies
Anti-collagen antibodies (found in gay men, hemophiliacs, Africans of both sexes and people with leprosy)
Serum-positive for rheumatoid factor, antinuclear antibody (both found in rheumatoid arthritis and other autoantibodies)
Auto
immune diseases: Systemic lupus erythematosus, scleroderma, connective tissue disease, dermatomyositis
Acute viral infections, DNA viral infections
Malignant neoplasms (cancers)
Alcoholic hepatitis/alcoholic liver disease
Primary sclerosing cholangitis
Hepatitis
"Sticky" blood (in Africans)
Antibodies with a high affinity for polystyrene (used in the test kits)
Blood transfusions, multiple blood transfusions
Multiple myeloma
HLA antibodies (to Class I and II leukocyte antigens)
Anti-smooth muscle antibody
Anti-parietal cell antibody
Anti-hepatitis A IgM (antibody)
Anti-Hbc IgM
Administration of human immunoglobulin preparations pooled before 1985
Hemophilia
Hematologic malignant disorders/lymphoma
Primary biliary cirrhosis
Stevens-Johnson syndrome
Q-fever with associated hepatitis
Heat-treated specimens
Lipemic serum (blood with high levels of fat or lipids)
Hemolyzed serum (blood where hemoglobin is separated from the red cells)
Hyperbilirubinemia
Globulins produced during polyclonal gammopathies (which are seen in AIDS risk groups)
Healthy individuals as a result of poorly-understood cross-reactions
Normal human ribonucleoproteins
Other retroviruses
Anti-mitochondrial antibodies
Anti-nuclear antibodies
Anti-microsomal antibodies
T-cell leukocyte antigen antibodies
Proteins on the filter paper
Epstein-Barr virus
Visceral leishmaniasis
Receptive anal sex
Campbell takes the Continuum article from her when she’s finished. “Ms. Jennings, these are all the things that can cause a false positive reaction on a so-called HIV antibody test, is that correct?”
Jennings shakes her head immediately. “No, it’s not. These are all the ‘things,’ as you put it, that had been scientifically proven could cause a false positive reaction at the time I wrote the article in 1996. There can be a lot of other factors that could also cause a false positive for which there were no scientific studies at the time, so I could not include them on my list. Plus, there have been additional studies done since 1996 that have found more of these factors, but since I have not published an article about them, I cannot testify about them at this trial. You may want to have other witnesses come update this list for you.”
“I’ll do that, Ms. Jennings Thank you.”
As Campbell looks at his legal pad to decide on his next question, Jennings interjects. “I also need to mention…”
“Yes, Ms. Jennings?” Campbell looks up at the witness, curious and concerned that he had missed something.
“I need to say that just because someone has one of these factors, it does not automatically mean that they will test positive on an HIV antibody test – that they will get a false positive. It means that others with these same factors have gotten false positives, and it’s possible – but not mandatory – that someone else could get a similar false positive reaction.”
Good point, Campbell realizes. “Perhaps if we actually take one of these factors on your list and examine it, all this will become more clear.”
“I think that’s a good idea. Where do you want to start, Mr. Campbell?”
“Normally, I would start at the beginning, Ms. Jennings, but I think it would be easier if we didn’t get quite so technical so fast and perhaps take a disease on the list that I think everyone will recognize, like tuberculosis.”
Jennings nods her agreement. “So let’s talk about tuberculosis.” While Campbell finds ‘Tuberculosis’ on the first page on the easel chart and puts a check mark beside it, Jennings reminds him, “But I need the actual studies now, Mr. Campbell.”
“Oh, yes. Sorry. Your Honor, we need to introduce the studies we will be talking about into evidence.”
“Very well.”
Campbell hesitates. “Well, Your Honor, there are a number of them.”
“So?”
Campbell nods to the back of the courtroom, and two men get up from their seats in the gallery and walk to the front of the courtroom toward the Evidence Room. Each man grabs a large white box that appears to be fairly heavy and deposits the box on Mr. Campbell’s table. He thanks them as they leave and opens the lid on one of the boxes, taking out some papers. He leafs through them until he finds the one he’s looking for.
“Your Honor, the study concerning tuberculosis,” and he hands the papers to the judge, who glances at them briefly, hands them to Mr. Armand, who also hands them back very quickly. They finally end up in the hands of Ms. Jennings in the witness box.
“Thank you. Alright, Mr. Campbell, I’m ready now,” Jennings says.
“Ms. Jennings, please tell the court what you’re holding.”
“This is a study done by a Dr. Oscar Kashala and a whole list of other researchers in 1994.”
“Is there a brief biography of Dr. Kashala attached to the study, Ms. Jennings?”
“Yes, there is.”
“Would you please read that biography to give the court a little background about Dr. Kashala and his credentials that back up this study?”
“Certainly. Dr. Kashala was born and raised in the Congo, in Africa, and graduated with his M.D. degree Magna Cum Laude from the University of Kinshasa after training at the University of Lausanne in internal medicine, and at the University of Geneva in pathology. He wrote and defended a thesis still considered to be the most meritorious in the Kinshasa Medical school history. He also received training from the World Health Organization’s Immunology Training & Research Center in Switzerland. In 1987 Dr. Kashala came to the United States to continue his studies at Harvard University and at the Massachusetts Institute of Technology (MIT), and in 1992 received his Doctor of Science (D.Sc.) from Harvard. He then joined Cambridge Biotech, a pharmaceutical company, and became the Director of Medical Affairs and Tropical Diseases, and the Director of the Molecular Pathogenesis Laboratory. Dr. Kashala continues to work in the pharmaceutical research industry, is recognized as a world leader in health issues affecting developing nations, and has served for several years as advisor to the World Health Organization. In addition, he was a candidate for President of the Democratic Republic of the Congo in the 2006 elections.”
Campbell looks directly at the jury as he says, “Basically, a highly qualified and objective researcher.”
“That’s an understatement, Mr. Campbell.”
“I hesitate to ask you to read the title of this study, because there are so many words than none of us will understand, but I need it on the record.”
“It’s called, Infection with human immunodeficiency virus type 1 (HIV-1) and human T-cell lymphotropic viruses among leprosy patients and contacts: correlation between HIV-1 cross-reactivity and antibodies to lipoarabionomanna.”
“And where was it published?”
Jennings looks back at the study she is still holding. “In the Journal of Infectious Diseases, Volume 169.”
“Okay, now we can get down to the important part. What does the study say?”
Jennings puts the study down on the railing of the witness box and settles back in her chair. This part she knows very well. “The bottom line is that Dr. Kashala found people who had tuberculosis will often test positive on an HIV antibody test, due to anti-lipoarabionomanna antibodies in their blood.”
“Even if they don’t have HIV?”
“Correct. In other words, the patient will have developed antibodies to tuberculosis, and those TB antibodies will cause a false positive HIV test result. It’s called a cross-reaction.”
Campbell wishes she hadn’t introduced another new term, but, oh well. “Ms. Jennings, could you define �
��cross reaction’ for us?”
“A cross reaction is when an antibody in the patient’s blood reacts with a protein in an antibody test kit, but it wasn’t a protein that the antibody was created against. It might be a similar protein, but not the same one.”
Campbell’s not sure that was very clear to anyone, much less the jury. “Our last witness, Dr. Fowler, talked about antibodies trying to save the body time and effort by seeing if they will work against a new foreign invader – seeing if they have a close enough key to unlock the threat.”
“Yes, that’s a good way to put it. And in Dr. Kashala’s study, he found that antibodies against tuberculosis in a patient’s blood reacted with one or more of the proteins of the HIV test kit, even though the patient did not have antibodies that were specific to HIV. So he got false positive HIV test results from people with tuberculosis antibodies.”
I hope that made sense, and he decides to move on. “Ms. Jennings, what’s the problem with getting a false positive HIV test result?”
Jennings looks at Campbell like he had just asked the stupidest question she’d ever heard. “There are quite a few problems, Mr. Campbell!” Then she settles down, realizing that this is how the information had to be presented in court. “The first problem is that the person doesn’t know it’s a false positive. They are told, and believe, that they tested positive for HIV antibodies, not some other antibodies that cause a cross-reaction.”
“And we’ve already heard testimony from another witness, Ms. Jennings, that they are then told they are actually infected with HIV, based on the CDC’s announcement in 1987 that a positive test result meant active infection.”
“Yes, unfortunately. So these people who had a cross-reaction and a false positive HIV test result walk around thinking they have HIV, that they are going to get AIDS and possibly die from it, and that they need to be taking very toxic and often lethal drugs to combat the HIV. It would be like being told you have terminal cancer when you don’t.”
When Campbell doesn’t ask another question right away, Jennings keeps going. “Imagine, Mr. Campbell – just imagine a doctor telling a patient they had terminal cancer from a blood test alone, without doing a biopsy and confirming that the tumor was in fact cancerous. But for some reason, doctors do that all the time with HIV – tell a patient they have a deadly virus based strictly on a blood test without even trying to find that virus in their body. It’s absolutely insane; and if a doctor actually did that with cancer, they’d lose their license and get sued for malpractice, I can promise you. But for some reason, we let them get away with it with HIV every day.”
Campbell likes the analogy and let’s a moment pass for the jury to consider that before asking his next question. “And you said there were other problems with getting a false positive HIV test result?”
“Well, in addition to the person’s own emotional and psychological trauma, there is of course a lot of stress placed on their family and loved ones. I mean, an HIV-Positive diagnosis literally tears everyone’s life apart who are close to this individual. They may lose a lot of their friends who don’t want to be associated with someone who has HIV, along with their job and their livelihood – not to mention their insurance coverage – all from a wrong diagnosis.”
Campbell walks around from behind the lectern and moves slowly toward the jury box. “And what about their health? If this is a wrong diagnosis and they are not actually HIV-Positive, can it still affect their health?”
“Yes, without a doubt. Not only can they get depressed mentally, but their immune systems can become depressed as well just from the stress and the worry that come with this kind of diagnosis. Along with a depressed immune system can come various physical symptoms and debilitating diseases. And in the cases we’re talking about – false positive test results – all of this happens needlessly, since they are not really HIV-Positive at all.”
Campbell had no idea Jennings was going to be such a good witness when he first talked to her. However, the next part had been carefully planned in advance. “Ms. Jennings, can you give the court one specific example that would take all this out of a theoretical discussion and bring it down to cold, hard facts?”
“Of course. I actually brought some video with me to make it as real as possible. Can we show that video, Mr. Campbell?”
Campbell looks at the judge for approval to continue, gets it, picks up the remote control and lowers the big screen in the front of the courtroom, and then wheels the computer/projector into place. “Ms. Jennings, why don’t you explain a little about what we’re going to see before we start the video.”
“This is from a documentary by Gary Null called, ‘AIDS: A Second Opinion,” and this particular segment features Joan Shenton, director of Meditel Productions, who makes science and medical TV documentaries for the BBC in England, among others. In fact, Meditel was the first independent company ever to win a Royal Television Society Journalism Award. This clip is only a couple minutes long, and the first person you will see and hear is Joan Shenton.”
Campbell presses a button to dim the lights and then hits Play. Joan Shenton is on the screen, saying: “I recently went to Haiti, because I’m writing a book about AIDS, about our nine-year experience. It’s called ‘Only Make-Believe.’ I went to Haiti to research a chapter called ‘Whatever Happened to AIDS in Haiti?’ I went to one of the hospices there; it was actually St. Teresa’s Hospice in the middle of Port-au-Prince, Haiti, where they told me there were lots of AIDS cases.”
The picture changes to show a Haitian woman talking to a group of young girls, while Shenton continues narrating.
“I was shown around by a very, very nice Mother Superior, and she was obviously doing her best but didn’t know, in a sense, how awful it was what was going on. She told me that 100% of the people in these wards had TB.”
Now the jury sees an older woman dressed like a patient walking down the hall and pictures of rooms on the ward with other women lying in bed, obviously very sick. Shenton’s voice continues.
“But because the charity had enough money to test them for HIV, they sent everyone’s blood for testing. 90% of the women in the ward I was in, she said, were HIV-Positive. Because they had AIDS and were going to die anyway, they were not receiving medication for TB.”
Shenton is back on the screen being interviewed.
“But as you know, if you have TB, you’re very likely to test positive because there is a cross-reaction, and they weren’t being treated because they were going to die anyway. And this is something I saw in Africa as well.”
The video ends and the lights come up. It is Jennings who speaks first. “So, in this case, Mr. Campbell, getting a false positive HIV-test result because of a cross-reaction with the tuberculosis antibodies meant certain death for these women.”
“But wouldn’t they have died from the TB anyway?”
“Some of them might have, yes. But TB medications are very effective these days, and if they had been allowed to continue taking their TB drugs, many of them could have lived. So I can say, without exaggeration, that these women died as a result of a false-positive HIV test.”
Campbell doesn’t look at the jury, but he knows they were moved. He goes through the process of raising the screen back up into the ceiling, rolling the projector out of the way, and looking through his notes – all to give time for the video’s maximum impact. Finally, he decides to continue.
“Ms. Jennings, let’s move on to another on your list of factors that can cause a false positive HIV test result. And once again, I want to take something we all recognize before we start tackling the more obscure medical words; so let’s talk about ‘flu vaccination.’”
Jennings points to Campbell’s table. “There are six studies that address that question, Mr. Campbell, if you’ll pull them out.”
As Campbell sorts through the papers in the boxes, he asks, “I assume that this means six different researchers have all agreed on this?”
“That’s correct.
Well, technically, there were a lot more researchers than six, because there were multiple scientists doing the research on most of these studies.”
Campbell finds the last one he was looking for and hands all six to the judge. Meanwhile, he continues to ask Jennings questions. “But this isn’t a case of just one man publishing a small study he did. This is six different studies published in six different scientific journals?”
“Frankly, Mr. Campbell, it wouldn’t matter whether it was one man, or woman, or not. The important point is that these are all studies that were published in respected, peer-reviewed scientific journals, and that is more of a credibility factor than how many researchers participated.”
The studies make their way from the judge to Armand back to Campbell and finally to Jennings.
“What kind of scientific journals are we talking about, Ms. Jennings?”
“Let’s see.” Jennings thumbs through the stack of papers. “One study was published in the Journal of the American Medical Association; another in the Journal of Infectious Diseases; here’s one in the Western Journal of Medicine…”
Campbell interrupts. “So, as you said, all of them are mainstream, prestigious journals. And you say that all six of these different studies came to the same conclusion?”
“That’s correct.”
“Which was?”
“That someone who had a recent flu shot could have a false positive reaction on an HIV antibody test.”
“How recently, Ms. Jennings?”
“Generally within a month prior to taking the test.”
Campbell makes a split-second decision and opts to follow up with one additional question – but only because Jennings is doing so well. “Do these studies suggest why this could happen? Why would a flu shot produce a false positive test result?”
“Apparently because the flu shot introduces a foreign agent into the patient, which then stimulates the immune system to go into action to fight it. In the process, the patient develops antibodies to the flu virus, and these antibodies react with the HIV test kit proteins. There is also some speculation that it is the stimulated immune system that has awakened, if you will, all of its antibody defenses to fight the flu virus that creates the possibility of the cross-reaction, and that when the immune system calms down again after a few weeks, the cross-reaction might disappear as well.”
I couldn’t have asked for a better witness. “Ms. Jennings, I’m going to let you go through each study one by one, but essentially you’re saying that someone who got a flu shot a couple weeks before taking a so-called HIV antibody test could have had a false positive test result – could be told they were HIV-Positive when in fact it was just the flu shot causing the test reaction?”
“That’s not what I’m saying, Mr. Campbell. That’s what these studies showed.”
Perfect. The stage is set; now let’s get down to the nitty-gritty.
“Okay. Ms. Jennings. Why don’t I let you read the title of each study into the court record and talk about the author of each one and then the specific results of each study, if you don’t mind….”