Chapter Twenty-Seven
Sarah shows her press badge to the security guard, as she did every time she entered the courtroom. Her new assistant, Gene, does the same and then follows her to the seats reserved for the Arizona Tribune. The place is packed, as usual; and as soon as Judge Watts takes her seat, Messick is up and ready to go.
“Your Honor, I want to shift gears at this time and move into a new section of our case, which mostly involves the other two defendants, the Food and Drug Administration and the drug company, Burroughs Wellcome. And I'd like to start by calling Dr. Jules Hoffmann.”
Sarah hasn’t fully recovered from her emotional crisis the previous night, but she’s determined to see this assignment through to the end. Besides, she’s got an assistant now, and she’ll be damned if she’s going to look unprofessional in front of this kid. She takes out her yellow pad and focuses on the matter at hand: Messick and Hoffmann.
“Dr. Hoffmann, where were you employed in the early 1960’s?”
“At that time it was called the Michigan Cancer Foundation. It's now called the Karmanos Cancer Institute.”
“And what was going on there in 1960 and '61?”
“A lot of things, but I assume what you’re most interested in is that we had some grant money from the National Cancer Institute to try to develop drugs that would improve chemotherapy for cancer patients.”
“And were you successful at that?”
“It depends on how you define ‘successful.’ We came up with some new drug compounds, yes.”
“Was one of those compounds called AZT?”
“Yes. That was one of its names. It was also called Compound S at one point, or zidovudine, or azidothymidine, and later it sold as Retrovir.”
“Is it okay if you and I just call it AZT while we’re talking this morning?”
“Fine with me. That’s what most people call it.”
Messick actually feels more comfortable with this part of the trial than he did the first part. He had focused most of his research on AZT and knew exactly what he wanted the jury to hear from his witnesses. He leaves the lectern and wanders over to lean on the railing that separated the jury from the main courtroom floor.
“So, Dr. Hoffmann, it would be safe to say that you were familiar with this drug, AZT, and how it works.”
“Mr. Messick, I created the drug. In all modesty I can say that there isn’t anyone in the world who knows AZT as well as I do.”
I wish all my witnesses were as good as this one. “Dr. Hoffmann, did AZT work as a cancer therapy?”
“Well, this compound did indeed kill cancer cells in very large numbers, yes.”
“But was there a problem?”
“Yes, because it also killed other healthy cells in equally large numbers.”
“In other words, it was highly toxic.”
“It was much too toxic to give to a human being, yes. It would kill the patient at the same time it was killing the cancer.”
“In fact, Dr. Hoffmann, isn’t AZT so toxic that every bottle had to carry a warning label that features the poison symbol of a skull and crossbones, and says, among other things, ‘Toxic if swallowed, wear suitable protective clothing’?”
Dr. Hoffmann’s affirmative answer is lost as a muffled chuckle ripples through the spectators, most of whom were probably imagining someone wearing protective clothing while swallowing their AZT pill. It would have been funny, if it weren’t so tragic.
Okay, jury, here’s the first thing you need to pay attention to.
“Why was AZT so toxic? What does AZT do in a human body?”
“Before I answer that, Mr. Messick, let me explain again what I was looking for. I was trying to develop drugs that would kill cancer cells. We have traditionally believed that cancer cells were cells that are multiplying too rapidly – there are too many of them, and they form a tumor. Ironically, the easiest way to stop cells from multiplying too fast is to stop them from dividing. So AZT was designed to destroy dividing cells that were producing cancer tumors. AZT was, however, indiscriminately cytotoxic, which meant that it would destroy any dividing cells – even healthy ones – by interfering with the reproduction of DNA.”
In case you missed it, jury…
“Let’s make sure I understand. The drug you developed called AZT killed virtually all the human cells it came into contact with that were trying to reproduce themselves, good cells as well as bad cells, correct?”
“That is correct.”
“Did you ever try to do anything with this drug, like get FDA approval for its use?”
“There was no way it would pass Phase 1 of an FDA approval.”
“And Phase 1 is what, Dr. Hoffmann?”
“Phase 1 is basically proving that the drug is safe for a human to take – that it does more good than harm to a patient.”
“And AZT didn’t qualify because it did more harm than good?”
“Yes.”
“So you dropped it.”
“Yes. We put it on a back shelf someplace.”
Messick left the jury rail and returned to the lectern to check his notes.
“In what year was this?”
“Let’s see...1964, I believe.”
“And what happened to AZT for the next twenty years? Did you know?”
“No, I didn't know. I totally forgot about it. I assume it stayed on that shelf where it belonged.”
“And when was the next time you heard about AZT?”
“When Burroughs Wellcome submitted it to the FDA for approval as a treatment for AIDS. I heard about it then.”
“Did this surprise you?”
“Well, yes, of course.”
“Why?”
Hoffmann wasn’t holding back or trying to avoid giving straight answers. He had already decided for himself he would provide all the information he could about AZT, since he didn’t want it on his own conscience.
“Why was I surprised? For several reasons. Obviously, we had already found the compound too toxic for human use. Secondly, it was a drug to treat cancer by killing large numbers of cells in a human body, and my understanding at the time was that AIDS was a disease in which there were already too many cells being killed. So why would you give someone with AIDS a drug that killed more cells than almost any other drug ever invented? And thirdly, Burroughs Wellcome didn't come up with this drug in the first place. I did.”
“But I don't understand. How could Burroughs Wellcome submit AZT to the FDA if you developed the drug?”
“I developed the drug on a government grant, so I never owned the rights to the compound myself. The government did. It’s called ‘works for hire.’ And by 1985, the compound was in the public domain. What I think happened...”
Crawley is out of his seat immediately. “Objection. Pure speculation is about to come out of this witness’s mouth, I can tell….”
Judge Watts holds up her hand to stop Crawley before he finishes. “Mr. Messick?”
“Your Honor, yes, that's true to a certain extent. Dr. Hoffmann might not have proof of all the things he's about to say, but I do. If he says what I think he's going to say, I have here...,” holding up a stack of papers from his table, “...all the documentation that will be needed to back up his ‘speculation,’ as Mr. Crawley calls it.”
“Your Honor….” Judge Watts once again silences Crawley and then pauses to consider the objection. Finally, she looks at the plaintiffs’ attorney. “I'll allow you to continue on that basis, Mr. Messick, on one condition. After Dr. Hoffmann has finished his speculation, if Mr. Crawley wants to object again and you can't provide the proof needed, I'll throw out that part of his testimony. Understood?”
“Yes. Thank you, Your Honor. Dr. Hoffmann, please continue with what you think happened.”
“It was 1985. Dr. Gallo had announced that he had found the cause of AIDS. Every drug company in the world wanted to find a treatment – a cure, if possible – and claim not only the fame and glory, but also the incredi
ble financial rewards that would follow. Burroughs Wellcome was one of the biggest and best drug companies in the world. And somewhere inside that company was a brilliant mind who said, ‘While our research department tries to come up with a new drug, why don't we see if there's a drug that's already been developed somewhere that would work against this HIV.’ They found my AZT sitting on the shelf, claimed it for themselves, and sent it around to various labs for testing. And low and behold, they were told that AZT destroyed infected HIV cells. So they submitted it to the FDA as a treatment for AIDS.”
“Did anyone challenge Burroughs Wellcome for the ownership of this drug?”
“Oh, yes. There were several lawsuits, and it got really messy at times. But they eventually won the all-important ‘key use’ patent in 1988.”
“Again, I don't understand. If you knew that AZT was too toxic to put in a human body, why would you fight for the patent to use it against AIDS?”
“Look, the only thing on people's minds at that time was finding anything that would get rid of the HIV. AZT did that. Who wouldn't want to have a piece of the action?”
“But AZT killed so many healthy cells at the same time, especially the all-important T cells of the immune system….”
“All I can tell you, Mr. Messick, is that the research environment created by this deadly epidemic made it easy for all of us to overlook the side effects and concentrate on the positive results of killing infected HIV cells.”
“But what if HIV had nothing to do with AIDS?”
“Dr. Gallo said it did, and we never considered any other possibility.”
Messick looks toward the defendants’ table and repeats, “Dr. Gallo said it did, so it must be true.” He then returns to the plaintiffs’ table where there are stacks of papers placed neatly in different piles. He picks a report off one of the stacks and reads it for a moment. “But, Dr. Hoffmann, you’re not the only one who knew that AZT was far too toxic for human consumption, were you?”
“Probably not.”
“In fact, Dr. Hoffman, there were a number of studies that clearly demonstrated the effects of AZT in patients, weren’t there?”
“I believe so, but I’m not necessarily familiar with all of them.”
“Well, Dr. Hoffmann,” Messick glances back at the papers in his hand, “are you familiar with a French study in 1988 on hundreds of AIDS patients taking AZT, which found that one-third of those patients experienced a worsening of their AIDS condition, others developed new AIDS opportunistic diseases, and one out of five patients taking AZT died within nine months?”
“I don’t know whether I have seen that particular study or not, Mr. Messick.”
Messick puts down those papers and picks up others off a different stack. “Well, how about an English study, also in 1988, of thirteen AIDS patients, all of whom developed severe anemia on AZT?”
“Don’t know about that one, either.”
Again, Messick puts that study back and chooses another. “1990, in Australia, more than half the patients taking AZT developed a new AIDS opportunistic disease during the first year, half of them needed blood transfusions to survive, and one-third died within eighteen months.”
By this time, Hoffmann has realized that Messick doesn’t really want an answer, so he doesn’t offer one. And Messick doesn’t wait for one either, as he continues picking up report after report from his table.
“A Dutch study in 1990 found that three-quarters of the patients on AZT died within fourteen months….”
Messick pauses for a second and looks at Hoffmann. “Of course, Dr. Hoffmann, these were all foreign studies, and maybe the studies done here in the U.S. got totally different results. What do you think?”
“I don’t know, Mr. Messick,” but I assume you’re going to answer your own question very soon, so why don’t I just shut up and let you have the stage.
Messick silently reads yet another report, and then another, and another. “Oops, I guess I was wrong. Let’s see, in 1994, right here in the United States, one study found twice as much dementia in AZT-treated patients. Another study says that HIV-positive hemophiliacs taking AZT had a 2.4 times higher mortality rate and a 4.5 times higher AIDS risk than HIV-positive hemophiliacs who weren’t taking AZT. In 1995 a study found that HIV-positive male homosexuals on AZT had anywhere from two to four times the risk to develop Pneumocystis carinii pneumonia – PCP….” Messick puts all those papers down and sees one on the far corner of the table. “And it says here, Dr. Hoffmann, that usually only three percent of AIDS patients get lymphoma, a deadly cancer. But fifty percent, I repeat fifty percent, of those patients taking AZT in the original FDA Phase 1 approval trials developed lymphoma within three years, if they lived that long.” Messick points to one particular stack on the table. “All in all, Dr. Hoffmann, these studies show that at least twenty-five percent more patients die if they are taking AZT, and they die thirty-three percent faster than non-AZT patients. Were you familiar with any of these studies?”
“A few,” was all that Hoffmann wanted or needed to say.
Messick looks at the jury and decides that’s enough. Then he sees a note on his yellow pad and changes his mind. “Dr. Hoffmann, even Paul Volberding, who was one of the earliest and biggest proponents of AZT, wrote a report in 1994 saying that the T cells of a placebo group – those taking a sugar pill, essentially – had increased gradually over a two-year study, while the T cells of those taking AZT had decreased. And Volberding finally admitted in 1995, and I quote, ‘AZT does not significantly prolong either AIDS-free or overall survival.’”
Messick looks at Hoffmann to give him the chance to comment if he wants. Apparently, he doesn’t want. Messick puts down all the papers and returns to the lectern, glances once again at his notes, and prepares for the kill.
“Dr. Hoffmann, you said that you knew AZT was too toxic to put into a human body, that even if it could kill the HIV or other ‘bad’ cells, it would kill many more good cells in the body at the same time, including the very important T cells of the immune system. In other words, AZT would destroy a human’s immune system.”
“Yes, I said that.”
“Dr. Hoffmann, if you had given AZT to a healthy person back in the 1960’s, when you first developed the drug, what would have happened to them?”
“I’m not sure what you’re asking, Mr. Messick. I thought I had answered that question.”
Messick stares at the witness, wondering if he’s being coy. “I’m asking what would happen if you gave someone who was not sick AZT? How would their body respond over time?”
“Oh. Well, as the AZT began to destroy healthy cells, they would get sick. They wouldn’t feel very good.”
“Like what? What kind of symptoms would they have?”
Hoffmann thinks for a minute. “For one thing, I would say they would start to have headaches and get sick to their stomach, vomit, probably some diarrhea.”
“Anything else?”
“Possibly pain in their neck and back from muscle degeneration, maybe also in their legs.”
“Anything else?”
“If they kept taking it? Well, then they’d start to lose their hair, also lose weight and get very weak and anemic.”
“Those sound just like the symptoms of AIDS, Dr. Hoffmann. And if they kept on taking the AZT, what would happen next?”
“Well, Mr. Messick, like these studies reported that you just read, if they took AZT long enough for it to destroy the T cells of the immune system, they would then develop any number of opportunistic diseases.”
“How long would that be, Dr. Hoffmann?”
“How long would they have to take the AZT? Oh, I’d say maybe just a couple of years. AZT is very toxic, Mr. Messick.”
Messick looks at the jury. Here it is, ladies and gentlemen, the keynote of the case.
“So let me understand, Dr. Hoffmann. If someone – anyone, even a very healthy person – were to take AZT, as far as you’re concerned, over an extended period, the
AZT itself, as cytotoxic as it is, would eventually cause immune deficiency and they would get very sick, is that correct?”
“Yes, that’s correct.”
“And from this immune deficiency, the patient would get various opportunistic diseases.”
“Correct.”
“And modern medicine would call that immune deficiency syndrome, wouldn’t it?”
“Yes, that’s correct as well.”
“And, Dr. Hoffmann, since this immune deficiency syndrome was the result of taking a drug, it would properly be called acquired immune deficiency syndrome, otherwise known as ‘AIDS,’ is that correct?”
Hoffmann nodded first, and then realized he had to verbalize his answer. “Yes, that’s correct, Mr. Messick.”
“So, is there any conclusion we could possibly reach, Dr. Hoffmann, other than the fact that AZT causes AIDS?”
Hoffmann doesn’t answer. He doesn’t want to. He’d rather not testify to the fact that, even though he technically did nothing wrong, he was the one who developed the drug that eventually caused AIDS in hundreds of thousands of American men and women.
When Hoffmann doesn’t answer, Messick turns from facing the jury and looks again at his witness, then back at the jury, then back at the witness. He decides that the jury got the point and that Dr. Hoffmann doesn’t need any more guilt heaped on his shoulders.
“Thank you, Dr. Hoffmann. Your witness, Mr. Crawley.”