Chapter Five
Built in 1825, the old Greenville County Courthouse is a red brick building featuring a typical southern portico with large white pillars located on East North Street in the center of this fast-growing city. Situated on Interstate 85 about halfway between Atlanta, Georgia and Charlotte, North Carolina, Greenville lies at the base of the Blue Ridge Mountains and serves as a premiere location for high performance automotive companies, as well as the home to more international manufacturing investment per capita than any other region in the U.S.
In 1994, Greenville County built a new annex attached to the courthouse, and this is where the trial is being held. Courtroom 8 is the largest of all the courtrooms and as modern and well-equipped as you could hope for, with the latest in audio and video equipment. It can seat over one-hundred spectators in wooden “pews,” has its own locked Evidence Room, and includes an adjoining area for jury deliberation.
As Sarah sits in the gallery facing the judge, the jury box is on the right wall with two rows of wooden swivel chairs mounted to the floor. Sarah wonders how comfortable those chairs would be after a few hours of trial.
The Solicitor’s table is on the right, closest to the jury, occupied at this moment with Mr. Armand and someone who Sarah guesses must be his assistant. On the left side, seated at the defendant’s table, is Bernard Campbell III, with Tyree Johnson, the defendant, next to him.
Sarah had arrived a half-hour early to try to get comfortable in her new surroundings. After almost three months of covering the AIDS trial in Phoenix, she knew the Federal Courthouse there like the back of her hand. This was different – not only the architecture and surroundings, but the culture as well. She never spent much time in the south, despite being raised in Connecticut. A couple of spring breaks in Florida as a teenager were about the extent of her exposure to this distinctly different way of life.
Not to mention the food. They’d deep fry a salad if they could, she thinks.
“All rise.” The bailiff’s voice has that typical, deep resonance that fills the courtroom. Well, at least that’s the same.
Judge Stevenson, walking quickly up the steps to his oversized chair on the podium, is a distinguished-looking man, glasses, a full head of shocking white hair, and a build that looks like he might have played football in his younger days.
“Be seated.” His voice is also firm and strong, with a pronounced southern accent.
“Mr. Campbell, is the defense ready with your first witness?”
“We are, Your Honor. We’d like to call Dr. Robert Richardson.”
Bernard Campbell III, “’Nard,” seems like he was cut from the same mold as the judge, except his hair is still dark. Same build, same accent. They must make them all that way in these parts, Sarah muses to herself with a poor southern accent, and then laughs quietly about the typical local slang she slipped into so easily.
As Dr. Richardson is sworn in, Sarah looks over the jury and the others around her who had come to watch. The first thing that struck her was how long it had been since she had seen so many black people in one place. Living in Arizona for the last fifteen years, she just wasn’t used to it. She wonders how much she’s missed, and the kids have missed, not having a more diverse environment around them.
She is also stunned by the small number of reporters who seem to be present. The gallery is only half-full to begin with, and most of them appear to be part of the defendant’s family or the family of Beth Ann Brooks. Either this trial has not been very well publicized, she thinks, or people here don’t care about it. She really can’t blame them. According to the CDC’s own estimates, HIV affects less than .4 percent (4 out of 1000) of the U.S. population; so unless someone is touched personally by HIV or AIDS, as Sarah has been since she was seventeen, there’s not much reason to care.
That’s fine with me. Maybe I can give Sam another scoop!
With the swearing in formalities over, Campbell asks his first question of Dr. Richardson.
“You’re a doctor, but not an M.D.?”
“Correct. I have a Ph.D. in bio-organic chemistry from the University of Colorado.”
“When did you graduate?”
“1982.”
“Just when AIDS was starting to be the center of attention for the medical and scientific world.”
“Yes.”
“And what did you do after you got your degree?”
“I went to work for a company called Applied Molecular Genetics.”
“That company is now known by another name, correct?”
“Yes. Amgen. It’s the largest biotech company in the world.”
“What were you doing at Amgen?”
“I was hired to develop bigger, better, cheaper, safer, and faster diagnostic products for infectious diseases.”
“And what happened in 1984?”
“That was the year Amgen went into a joint venture with Abbott Laboratories to develop HIV tests based on the patent Dr. Gallo had filed just hours before he announced that HIV caused AIDS.”
“I’m not sure I understand….”
“Abbott had secured a license from the government to make the first HIV test, based on Gallo’s patent, and they sub-contracted with Amgen to help them create it. Is that any clearer?”
“Yes, thank you. And your job at Amgen was to work on developing this new HIV test?”
Richardson shifted his position in the chair. He was there to cooperate fully with Campbell, and he didn’t like not being able to respond completely and honestly. “I’m afraid I can’t answer that question, Mr. Campbell.”
“Why not?”
“I, along with all the other people working at Amgen, signed confidentiality agreements with Abbott, preventing us from disclosing certain details about our work, so I would be liable for breach of contract. I can tell you that the Abbott and Amgen scientists shared all the developments – good and bad – surrounding the creation of the HIV ELISA test, so I was definitely privy to this information.”
“I assume you can admit that you hold several patents for viral testing?”
“Of course. That’s a matter of public record.”
“Well, I can’t think of anyone more qualified to tell us about these HIV tests than the man who was there when they were created, can you?”
Armand is out of his chair in an instant. “Objection. Dr. Richardson has already been accepted as an expert witness, and Mr. Campbell is just grandstanding for the jury.”
“Sustained.” The judge looks directly at Campbell. “We’re all duly impressed with Dr. Richardson, Mr. Campbell. Now move on.”
Campbell had been walking around, moving close to the jury box, then to the witness stand, and finally standing directly in front of the Solicitor’s table. He now moves back to the lawyer’s lectern and reviews his notes.
“Dr. Richardson, what is this test called that Abbott created when you were working with them?”
“It’s an Enzyme-Linked Immunosorbent Assay, usually referred to as an EIA, but more commonly called an ELISA.”
“Is there more than one ELISA test?”
“Yes, quite a few. An ELISA test can be used to detect antibodies to different kinds of viruses and bacteria, for example. It’s even used in finding potential food allergens and…”
Campbell wants to be very careful not to get too technical too soon and risk losing the jury, especially with this witness. He interrupts quickly.
“Dr. Richardson, we are obviously most interested today in one particular kind of ELISA test. So let me ask you: Is there an ELISA test for HIV?”
Richardson hesitates a moment before answering. “There is an HIV ELISA test, yes.”
“And is the HIV ELISA test the best test to use if you want to detect the presence of the Human Immunodeficiency Virus?”
“No, it’s not. In fact, an ELISA would be the third choice – and the least accurate test – if you wanted to detect HIV in someone.”
“What would be the first choice?”
It didn’t take long for Richardson to relax and warm to his role. Besides, he had explained this hundreds of times before in lectures and seminars over the years.
“If you were looking for HIV in a patient, the first choice – and most accurate – would be to isolate the virus itself from a patient’s blood or tissues. That’s called Direct Proof.”
“So why aren’t we using Direct Proof instead of an ELISA test to find out who is HIV-Positive?”
“Because you can’t find HIV very easily, even in patients with full-blown AIDS.”
Campbell searches his mind for the right example. “Dr. Richardson, if I had the flu right now, and you looked at my blood, what would you see?”
“I’d see millions and millions of flu viruses, and that would be Direct Proof that you had the flu.”
“But you’re saying that’s not true for HIV?”
“No. HIV can only be found in 1 out of 500, or 1 out of 10,000 cells, depending on whose study you want to believe. In other words, there isn’t enough of it to find, and it’s too difficult and too expensive to culture. So when the decision was made in 1984 that we needed to test large numbers of people for HIV, Direct Proof was simply not an option.”
A quick glance at the jury lets Campbell know they’re with him. So far, so good. He decides that’s enough about Direct Proof for the moment. He’ll come back to it.
“And what would be the second choice to detect HIV?”
“It’s called Direct Evidence. This is done by finding fragments that are known to belong to the virus.”
“Can you give us an example of what that would mean?”
Richardson was used to making this very simple for anyone to understand. “Let’s say that you were trying to find your car in a crowded parking lot, but you were blindfolded. You could go around feeling all the cars for certain things you knew your own car possessed, like unique hubcaps, a convertible top, a hood ornament, a special steering wheel cover, and such. When you found enough pieces that you knew belonged to your car and probably wouldn’t be found together on anyone else’s car, you’d be nearly certain you had the right car. Direct Evidence is not as accurate as Direct Proof, but it’s the next best thing.”
Campbell is not so sure the jury fully understood. “Dr. Richardson, is there another way you could explain the distinction between Direct Proof and Direct Evidence?”
Richardson pauses for a moment. “To use a different analogy, with Direct Proof you’re looking for a house. With Direct Evidence, you’re looking for the walls and shingles and windows that the house is made of.”
When Campbell sees the faces of the jurors relax, he continues. “So why don’t we use Direct Evidence to detect if someone is HIV-Positive?”
“At that time, in 1984, Direct Evidence was being attempted mainly by trying to measure what is called a p24 antigen level – the forerunner of the so-called viral load test. However, the results of this test were also very disappointing in terms of actually finding HIV, and the test was expensive and difficult to run or duplicate. I should also say that Direct Evidence does not prove the presence of the virus itself, since it is only finding fragments thought to belong to the virus, in the same way that finding a single wall does not prove that there is a house present.”
Good point, Campbell agrees silently. “So you were left with the ELISA test as the most practical method?”
“Yes, and an ELISA test is called Indirect Evidence. That’s when you look for things other than the virus that should only occur if the virus were present at some point. In other words, if you’re walking through the woods and you see bear tracks on the ground, that’s Indirect Evidence that a bear had been there sometime in the past.”
“And what is the Indirect Evidence you look for in an ELISA test?”
“The antibodies to the virus, and not the virus itself or pieces of the virus. The theory is that if antibodies are present, the virus had to be present some time as well. These antibodies are the bear tracks in the woods. You haven’t found the bear, or even the hair or a claw or any other piece of the bear itself. But you’ve got bear tracks that the bear supposedly produced, and in this case, you’ve got antibodies to a virus that your body would only have produced if the virus had been present at some point.”
Campbell goes to his table and picks up a stack of papers that he holds up toward the judge. “Your Honor, I would like to introduce into evidence the packages from all the different HIV ELISA tests that clearly say that the test is an HIV Antibody test.”
Armand rises from his chair. “Your Honor, I can save the court some time. We will agree that all HIV ELISA tests are called HIV Antibody Tests, and that the HIV ELISA test is designed to find antibodies to HIV….”
“…and is not designed to find the actual virus or pieces of the virus.” Campbell wants that part on the record as well.
“Agreed,” Armand nods.
“Thank you, Mr. Armand.” The judge seems pleased with Armand’s cooperation.
Campbell returns to the lectern to check his yellow pad and decides that it’s time to get into the specifics. “Dr. Richardson, can you tell us briefly and simply how an HIV ELISA test works?”
Richardson knew this question was coming and had spent a few days trying to decide on the best answer that was accurate and yet not over anyone’s head. He is just as anxious as Campbell to make sure the jury understands this process thoroughly.
“In the kind of ELISA test used for HIV, you essentially take a mixture that is thought to contain proteins of the Human Immunodeficiency Virus and test it against a person’s blood. If the test reacts, it is supposed to prove that the person’s immune system has already developed antibodies to the virus.”
Campbell stops him there, not wanting to go past words and concepts the jury could easily misunderstand. “You mentioned a mixture containing ‘proteins.’ Please explain more about these proteins.”
“Well, we know that there are approximately 100,000 different kinds of proteins in the normal human body, and each protein is unique in its size and shape. So if you are trying to work with a specific virus, for example, you can identify certain proteins that belong to that virus.”
“Okay. So you take these proteins that are supposed to belong to HIV….” Campbell is counting on Richardson to finish his sentence. Richardson doesn’t disappoint him.
“…and create a mixture with them that you then test against a person’s blood.”
Campbell looks at the jury. They’re with me. “So these proteins are all mixed together?”
“In an ELISA test, yes.”
“And what happens if the proteins in the test kit react with the person’s blood?”
“You make the test in such a way that the mixture changes color. Then there is a sliding scale to measure the intensity of the color change.”
“You mean that any color change would not translate into a Positive test result?”
“No…or I mean, Yes, you are correct. This is one of the problems with any ELISA test. You have to find the cut-off point on the sliding color scale where the result changes from Negative to Positive.”
“And how do you do that?”
“Basically, by moving the proposed cut-off point until you get the results you want on a sample group of patients.”
Campbell suddenly regrets going into this much detail. He’s afraid he’s starting to lose the jury, but it’s too late to turn back now. “I’m not sure I understand, Dr. Richardson.”
Richardson thinks for a moment before continuing. “You already know the patients who should test Positive and those who should test Negative. In this case, in 1984, there were people who were diagnosed with AIDS, and they better test positive on the HIV ELISA if the test was going to be any good. On the other hand, people who did not have AIDS – and were not in a high-risk group to get AIDS – should test Negative. So you keep moving up and down on this color scale until you find that point where most of your AIDS patients are Positiv
e, but very few of your non-AIDS patients are.”
“So this is a fairly arbitrary decision, this point that makes the difference between Positive and Negative.”
Richardson hesitates on the word “arbitrary.”
“I can’t use that particular word, Mr. Campbell. But what I can say is that the marker between Positive and Negative on an HIV ELISA test was determined by making sure as many AIDS patients as possible tested Positive, and conversely as many non-AIDS patients as possible tested Negative.”
“You mean, not all of the non-AIDS patients would test Negative?”
“No, not all. The HIV ELISA test was being developed to protect the blood supply from contamination, and it was better to err on the side of caution than allow HIV to be passed on in blood transfusions. So the final point on the sliding color scale signifying the change from Positive to Negative was intentionally set to be very sensitive, so as not to miss any anyone who should test Positive. That high sensitivity might create Positive test results for some people who didn’t have HIV, but it wouldn’t miss anyone who did, theoretically.”
Well, I think we got out of that okay. Campbell leaves the lectern and walks over toward the jury.
“Let me see if I have this straight. In general, you create an ELISA test – any ELISA test – by taking certain proteins that are supposed to be associated with a virus and putting them into a mixture that you then combine with a person’s blood, and if the mixture changes to the right color, you have a positive test result. Did I get all that right?”
“Essentially, yes.”
“And having a positive result means?”
“It means that the person has the antibodies to that virus in their blood.”
Campbell turns and looks directly at each member of the jury as he asks the next question.
“And in the specific case of an HIV ELISA test, you take proteins that are supposed to be associated with HIV, put them in a mixture in the test kit, combine that with a patient’s blood, and if the mixture turns a certain color, the person is said to be HIV-Positive?”
Richardson raises both hands immediately. “No, sir.” Then he hesitates, “Well, Yes, but No.”
Campbell leans back against the jury rail and looks at Richardson. “Yes, but No? What did I get wrong this time?”
Richardson leans forward in his chair as if to emphasize his concern. “You are correct about taking proteins that are supposed to be associated with HIV and testing them against a person’s blood. And essentially you are right when you say that if they react, we call that person HIV-Positive. But technically, that’s not a true statement. They are not HIV-Positive, although the mass media and many of the so-called AIDS experts say that.”
“Well, what would be technically correct to say?”
“First, we have to remember that the ELISA is not a test for AIDS, as many people think, and as some very misinformed journalists and reporters call it. It’s not even a test for HIV, even though it’s called that a lot. It’s a test that is supposed to detect the antibodies to HIV. So if the HIV ELISA test has a positive reaction with a person’s blood, the only thing we can say is that they are HIV-Antibody-Positive. There’s a very big difference in being HIV-Positive and HIV-Antibody-Positive. Unfortunately, most people have been saying the wrong thing for many years now.”
“Exactly what’s the difference again between saying ‘HIV-Positive’ and ‘HIV-Antibody-Positive’?”
“To say someone is ‘HIV-Positive’ means that they have been found to have the Human Immunodeficiency Virus in their blood or other tissues, by way of Direct Proof or Direct Evidence. To say someone is ‘HIV-Antibody-Positive’ means that they have the antibodies to HIV, which is all that the HIV ELISA tests can find by Indirect Evidence. In fact, the FDA has never approved a test for the diagnosis of actual HIV infection.”
Campbell had been walking back to the lectern during Richardson’s last comment, and he stops dead in his tracks, wheels, and looks at Richardson as if he didn’t believe what he just heard.
“What did you just say, Dr. Richardson?”
“I said that the FDA has never approved a test to diagnose HIV infection.”
Campbell goes to his table, shuffles through some papers, pulls out the sheet that he wants, and hands it to the witness.
“Dr. Richardson, what did I just hand you?”
“It’s from the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration… it’s from the FDA.”
“And will you please read the first two sentences from that paper.”
“AIDS is a serious disease that can be fatal. The United States Food and Drug Administration (FDA) regulates the tests that detect infection with Human Immunodeficiency Virus-1 (HIV-1), a virus that causes AIDS.”
Campbell goes back to his table and finds another sheet of paper, which he also hands to Richardson.
“And what is this?”
“It’s apparently from the National HIV Testing Resources, a service of the Centers for Disease Control and Prevention – from the CDC, in other words.”
“And would you please read the sentence that is highlighted?”
“HIV testing consists of an initial screening with two types of tests commonly used to detect HIV infection.”
“So, Dr. Richardson, don’t both these statements from the FDA and the CDC contradict what you just said, that the FDA has never approved a test for the diagnosis of HIV infection?”
“No, they don’t, and here’s why. The words ‘detect’ and ‘diagnose’ have very different meanings. I said the FDA has never approved a test to diagnose HIV infection, and that is true, and no one has ever claimed anything different. To diagnose HIV infection, you would have to test for, and find, the Human Immunodeficiency Virus itself in a person’s blood – Direct Proof, in other words. But that is not what the HIV tests do. No one looks for HIV itself, and therefore there is no test to diagnose HIV infection.”
“If we’re not testing for HIV, what are we testing for?”
“As I said, we’re testing to see if someone has the antibodies to HIV.”
“But the FDA and the CDC say these tests detect HIV infection…”
“…only because the CDC made an arbitrary decision in 1987 to equate a positive HIV antibody test result with HIV infection.”
Again, Campbell looks shocked. “What?”
Richardson is on a roll, finally reaching the core of his expertise. “Okay, here’s what happened. On March 14, 1986, after the HIV ELISA test had been in use for a little while, the CDC started to suggest that someone having a positive test result should be ‘presumed’ – that was the word they used, ‘presumed’ – to be infected with HIV. On May 23, 1986, they changed the word ‘presumed’ and said instead that people with a positive HIV test should be ‘considered’ to be infected – again, their word. On July 18, 1986, researchers from the CDC published a paper in the Journal of the American Medical Association that said having the antibodies to HIV meant being ‘infected’ with HIV. What they did, in fact, was to simply and arbitrarily define a positive antibody test result as being positive for actual infection as well. And finally, on August 14, 1987, without any reference to any scientific study at all, the CDC announced that, from then on, the presence of HIV antibodies would indicate a current infection with HIV.”
“They offered no proof for this assumption?”
“Worse than that, I’m afraid. All the proof suggested otherwise, even from their own papers. For example, in August of 1985, the CDC published a report of a study done on 51,000 blood donors, in which 106 of them had positive HIV ELISA test results. They then did a culture on those 106 people to find evidence of the actual Human Immunodeficiency Virus, and 44% of them had no HIV. They also reported on another study of seventy men in San Francisco who had positive HIV ELISA tests, and only 60% of them had a positive culture for HIV itself. In other words, at least 40% of the time, a positive HIV test result was not an indication of HIV i
nfection.”
“How did they go from that to the claim that all HIV-Positive test results meant infection with HIV itself?”
Richardson reaches into his pocket and takes out a piece of paper. “I thought I might get asked that question. Is it okay for me to read what the CDC itself said?” He looks at the judge for approval and gets it.
“This is from the Morbidity and Mortality Weekly Report, dated March 14, 1986, issued by the Centers for Disease Control and Prevention, and I quote: ‘Since a large proportion of seropositive asymptomatic persons have been shown to be viremic,’ – ‘viremic’ means having the virus in their blood; but remember that they only found anywhere from 56-60% with actual HIV, and I’m not sure that constitutes a ‘large percentage’ – ‘since a large proportion of seropositive asymptomatic persons have been shown to be viremic, all seropositive individuals, whether symptomatic or not, must be presumed capable of transmitting this infection.’”
“I don’t understand. Are you saying that the CDC simply made a pronouncement that since approximately 60% of people who tested positive on an HIV ELISA were found to have the virus itself, all people who tested positive were to be said to have the virus – even though 40% of them didn’t have the virus when they were tested? Is that what you’re saying?”
“That’s not what I’m saying, Mr. Campbell. That’s what the CDC said.”
“But how could they say that? Why would they say that when it clearly wasn’t true?”
“You’ll have to ask the CDC those questions.”
Campbell took this opportunity to let this part of Richardson’s testimony sink in with the jury. He went back to his table, moved some papers around, then went to the lectern, flipped through his yellow pad, and just when the judge was about to caution him for wasting time, he began again.
“Dr. Richardson, is there anybody else in the world who would agree with you that the FDA has never approved a test to diagnose HIV infection?”
“Absolutely. Every company that manufactures an HIV ELISA test agrees with me!”
“Why do you say that?”
“Just look at the printed insert that comes with every test and you’ll see.”
Campbell picks up a small folded piece of paper from his desk and hands it to the witness.
“Dr. Richardson, what is this?”
“It’s one of the printed inserts I was just talking about.”
“Where would I have gotten this?”
“I assume you got it out of an HIV ELISA test kit.”
“And what company does it say made this test and printed this insert?”
“Abbott Laboratories.”
“Isn’t Abbott the company you were working with to develop the HIV test?”
“Yes.”
“And what is the significance of this insert – or any insert that comes with medical tests and medications, for that matter.”
“An insert is the way these companies specify what the test can and cannot do, and in this case, what the test has been approved for.”
“Dr. Richardson, please read the part of that insert highlighted in yellow.”
“At present there is no recognized standard for establishing the presence or absence of antibodies to HIV-1 and HIV-2 in human blood.”
“And exactly what does that mean?”
“It means that Abbott Laboratories recognizes that there is no proven, agreed-upon way to diagnose HIV antibodies, let alone HIV infection, in anyone, and that they are not claiming their test does that. It’s to protect them from lawsuits, among other things.”
“What kind of lawsuits?”
“Well, first of all, if Abbott were to claim that this HIV ELISA test was diagnosing HIV infection in anyone, they’d be violating their FDA approval to make and market the test, which only allows them to make a test to detect HIV antibodies. Secondly, since there is no established way to diagnose HIV infection, they’d be lying if they claimed their test could do that and opening themselves to charges of fraud. And thirdly, Abbott is protecting their ass – excuse me,” and he looks at the judge in apology, “protecting themselves if someone – like a doctor somewhere – tells a patient they are infected with HIV as a result of taking this test. That would not be true, and Abbott is establishing their own innocence and putting the burden squarely on the doctors’ shoulders.”
“But isn’t that exactly how this test is being used – to determine whether someone is infected with HIV or not?”
“Of course it is. But Abbott Laboratories says right in this printed insert that it can not and should not be used for that purpose. So they’re legally off the hook if anyone does, in fact use it that way.”
Campbell goes back and picks up a stack of papers from his desk and holds them in the air.
“Dr. Richardson, do other companies besides Abbott have similar printed inserts?”
“They all do. Or I should say, they all better have, yes. I cannot imagine the legal department of any reputable biotech lab allowing them to sell a product that doesn’t have almost exactly that same disclaimer in every test kit. They’d get themselves in very deep legal trouble.”
“And to your knowledge, Dr. Richardson, do these printed inserts with these disclaimers still say exactly the same thing today that they said when the test was first developed in 1985?”
“Yes, they do. Nothing’s changed, unfortunately.”
Campbell turns to the judge, and then to Armand. “Your Honor, Mr. Solicitor, I would be happy to introduce a number of other test kit inserts from other companies into evidence as proof of what the witness is saying, unless Mr. Armand would again like to save the court a lot of time and stipulate that all FDA-approved HIV ELISA test kits come with the disclaimer that they are not designed and should not be used to diagnose HIV infection, and that there is no established standard for even establishing the presence or absence of antibodies to HIV.”
The judge looks at Armand, who turns to confer with a consultant seated in the row of chairs behind him. Finally he turns back and stands up.
“So stipulated, Your Honor.”
The judge is curious why Armand did not seem to be the least bit agitated by Richardson’s testimony and would give in so easily to such important points. But he wasn’t going to show it. “Then we agree,” the judge instructs the jury, “that all HIV ELISA test kits come with a similar disclaimer. You can put the papers down and go on to another topic, Mr. Campbell.”
“Thank you, Your Honor.”
Campbell puts the stack of papers back on his desk and breathes a sigh of relief. No use overwhelming the jury any more than necessary. They surely got the point.
The trial hasn’t been going much more than an hour and Sarah is already very impressed with Campbell, and astonished at the information she has learned herself so far. Why hasn’t this been made public before now, she wonders.
“So, Dr. Richardson, let’s go back and talk about the test that Abbott Laboratories and Amgen started working together on in 1984. What exactly did the project entail?”
“Dr. Robert Gallo had filed a patent on April 23, 1984, in which he said that he had produced a culture that supposedly contained the Human Immunodeficiency Virus. The job was to take that culture and design a test that would detect the antibodies in a person’s blood to the proteins in the culture.”
“And how would you know if your test worked?”
“As I explained before, the test was designed to change colors if antibodies to HIV were present.”
“Dr. Richardson, in any antibody test, such as the HIV antibody test, what is the most basic premise on which you depend?”
“Obviously, the whole test is based on the proteins used in the test kit being specific and unique to the thing being tested – in this case, specific and unique to HIV.”
“Please explain that.”
“It’s simple logic, Mr. Campbell. If the test results are positive, it means that the person has antibodies that reacted with the test proteins. But yo
u have to know exactly what those test proteins come from in order to know what the antibodies reacted with.”
“Let me see if I understand. As long as the proteins in the HIV test kit can only come from HIV itself, a positive test result indicates that the antibodies to HIV are present in the person’s blood. Is that correct?”
Richardson hesitates before answering. “I will say, Yes, that’s correct – at least according to the theory; but you should ask an antibody expert about the possibility of exceptional cross-reactions.”
Campbell certainly doesn’t want to get into cross-reactions yet, so he ignores the last part of Richardson’s answer. “So the results of any HIV ELISA test are dependent on the most basic assumption that the proteins used in the test kit are specific and unique to HIV. Is that correct?”
“Yes.”
“And that’s what Dr. Gallo claimed when he filed his patent, isn’t it?”
“Yes, it is.”
“But is it true, Dr. Richardson? Have the proteins that are used to create the HIV ELISA test actually been proven to be specific and unique to the Human Immunodeficiency Virus – HIV?”
“It took me a couple years to discover this, Mr. Campbell, but no, they haven’t. Quite the contrary. Most of those proteins – and particularly the most important ones – have now been proven to belong to things other than HIV.”
“Wait a minute. If the proteins used in the HIV ELISA test are not specific and unique to HIV, how can any HIV test be accurate?”
“It can’t be, Mr. Campbell. That’s the problem.”
“Dr. Richardson, this is very hard to believe. Why would Dr. Gallo say that these proteins belonged exclusively to HIV when, in fact, they don’t?”
“I can’t answer that question, Mr. Campbell. I know that Dr. Gallo has made a lot of money from his patent – well over a million dollars, I’m told. But you’ll have to ask him that question.”
“I intend to, Dr. Richardson.”
Sarah is stunned. She remembers Campbell saying in his opening statement that he had subpoenaed Gallo, but will Gallo actually testify? Will Campbell get him to appear and finally answer questions a lot of people have been wanting to ask for a very long time? Campbell has got some guts, she realizes.
Campbell walks over to a large flipchart set up on an easel in front of the jury and tears off the blank front page, exposing a list of letters and numbers. On the flipchart the jury could see:
gp160
gp120
gp41
p66/68
p51/53
p31/32
p55
p40
p24
p17/18
“Dr. Richardson, what is this?” Campbell asks as he points to the flipchart.
Richardson stares at the page for a minute to make sure. “It appears to be a list of the proteins used in HIV tests.”
“So let’s talk for a minute about these proteins. First of all, why do these proteins have these particular names?”
“The ‘p’ stand for ‘protein’ and the number after it is its molecular weight. Some of them are sometimes called ‘gp’ instead of just ‘p,’ meaning glycoprotein.”
Campbell leaves the flipchart and returns to the lectern. “Dr. Richardson, you said that at least some of these proteins have been proven not to be specific and unique for HIV, is that correct?”
“Yes, that’s correct.”
“Would you please tell us about those proteins?”
“Well, let’s start from the top of your list. Let’s take gp160. gp160 shouldn’t be found in HIV at all, even according to Dr. Gallo himself. It can be found in other cells, but not in HIV itself.”
“gp160 shouldn’t be found in the Human Immunodeficiency Virus? Then why is it on this list?”
“Well, you need to ask Dr. Gallo about that.”
“But why would you test for the antibodies to gp160 if it’s not found in HIV?”
“As I said, Mr. Campbell, that’s the problem.”
“And what about gp120?”
“As early as 1987, a study was published in the Journal of Virological Methods that showed that gp120 is a component only found on the surface of immature HIV particles, and not in the mature virus that is supposed to be causing AIDS. Basically, when HIV matures and goes into circulation where it is supposed to be able to infect other cells, gp120 is no longer present; and it is precisely the mature form of HIV that is used to create the HIV test. So how and why gp120 might be present is a mystery to me.”
“So I have to ask again: Why are we testing for a protein that’s not part of the dangerous virus that we want to detect?”
“And again, I would say that you’ll have to ask Dr. Gallo or others responsible for making this list of proteins.”
“Okay. Let’s keep going. gp41?”
“gp41 has been found to be associated with actin, a very common protein which is found in all cells, as well as bacteria and several other viruses.”
“In other words, definitely not specific or unique to HIV?”
“Definitely not.”
“Rather than go down this entire list, is there one of these proteins that is considered more important than the rest, in terms of detecting HIV, and can you tell us about that one?”
“Well, the most commonly detected protein on one of the HIV tests is p17/18; but, like gp41, p17/18 has been found to be associated with another common cellular protein called ‘myosin.’ So it’s not specific for HIV either. I would say, however, that p24 is the one that has become synonymous with HIV infection.”
“So is p24 specific and unique to HIV?”
“No. p24 has also been found in non-HIV-infected patients with generalized warts, patients with cutaneous T-cell lymphoma and prodrome, and patients with multiple sclerosis. So it’s definitely not unique to HIV.”
“But p24 must at least be found in all AIDS patients, I would think.”
“You would think so, but p24 is not found in all AIDS patients or even in all HIV-Positives. In one study, p24 was only detected in 24% of HIV-Positive patients. If the p24 protein was specific to HIV, it should show up on an HIV test 100% of the time.”
“That makes sense. So what you’re saying is that at least some of the proteins used in the HIV ELISA test – if not all of them – have never been proven to be specific and unique to HIV, and in fact have been shown in scientific studies to be associated with other proteins, other viruses, or other diseases.”
“Correct.”
“Then how could a test that used those proteins be accurate in detecting antibodies to HIV?”
“It can’t, Mr. Campbell. I keep telling you, that’s the problem.”
Campbell moves to his table again, buying time. He doesn’t want to give the jury anything more to digest at this point, and wonders how he can postpone his next set of questions. A quick glance at his watch gives him the answer.
“Your Honor, that’s an awful lot of information to process. May I suggest a lunch recess and let me continue with this witness this afternoon?”
“Mr. Armand, any objection?” asks the judge.
“No, Your Honor.”
“Very well, this court is in recess until two p.m.” The judge bangs his gavel once with great authority.
Not only was it a lot for the jury, it was a lot for Sarah as well, she realizes. She had taken copious notes throughout the morning and is feeling slightly overwhelmed, but excited. This is exactly what she had hoped it would be – another AIDS trial, except focused on the HIV tests themselves. She can’t wait for the afternoon session.
Now, if she could just find something to eat for lunch; or maybe all she needed was a Starbucks. Surely they had a Starbucks nearby with a bran muffin that wasn’t deep-fried….
Are You Positive? Page 5